Clinical Care 2013

The

Clinical Care Journal The latest developments in Irish healthcare // March 2013

The Clinical Care Journal // The latest developments in Irish healthcare

NEW PATHWAYS OF CARE

INTEGRATING ASSESSMENT, IMPROVEMENT & QUALITY

OPHTHALMOLOGY

EPILEPSY

PAEDIATRICS

REDUCING CASES OF PREVENTABLE BLINDNESS

SIGNIFICANT REDUCTION IN WAITING LISTS

THE LIFE BLOOD OF THE NATION

PLUS: ACS // DERMATOLOGY //RHEUMATOLOGY// STROKE

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IE_DUTT_0012_12_Combodart_Advert_A4_Golf_May2012

02.05.2012

12:25

Side 1

A single step forward in BPH management

Combodart provides: Symptom relief as rapid as tamsulosin monotherapy1,2

Start with

Superior Symptom improvement Vs tamsulosin or dutasteride monotherapy1,2 In moderate BPH patients

After more than 50 years of combined oral contraceptives…

COMBODART ABRIDGED PRESCRIBING INFORMATION (API). (Please refer to the full Summary of Product Characteristics before prescribing) PRESENTATIONS: Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, (equivalent to 0.367 mg tamsulosin). INDICATION: Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. POSOLOGY & ADMINISTRATION: Adults (including elderly): The recommended dose is one capsule (0.5 mg/ 0.4 mg) taken orally approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. Contact with the contents of the dutasteride capsule contained within the hard-shell capsule may result in irritation of the oropharyngeal mucosa. Where appropriate, Combodart may be used to substitute concomitant dutasteride and tamsulosin hydrochloride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from dutasteride or tamsulosin hydrochloride monotherapy to Combodart may be considered. Renal impairment: The effect of renal impairment on dutasteridetamsulosin pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment. Hepatic impairment: The effect of hepatic impairment on dutasteride-tamsulosin pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of Combodart is contraindicated. CONTRAINDICATIONS: Combodart is contraindicated in: women, children and adolescents; patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, tamsulosin (including tamsulosin-induced angio-edema), soya, peanut or any of the other excipients; patients with a history of orthostatic hypotension: patients with severe hepatic impairment. SPECIAL WARNINGS & PRECAUTIONS: Combodart should be prescribed after careful benefit risk assessment and after consideration of alternative treatment options including monotherapies. In two 4-year clinical study, the incidence of cardiac failure (a composite term of reported events, primarily cardiac failure and congestive cardiac failure) was higher among subjects taking the combination of dutasteride and an alpha blocker, primarily tamsulosin, than it was among subjects not taking the combination. Digital rectal examination, as well as other evaluations for prostate cancer or other conditions which can cause the same symptoms as BPH, must be performed on patients prior to initiating therapy with Combodart and periodically thereafter. Combodart causes a decrease in mean serum PSA levels by approximately 50%, after 6 months of treatment. Patients should have a new baseline established after 6 months of treatment with Combodart and PSA should be monitored regularly thereafter. Any confirmed increase from the lowest PSA levels while on Combodart may signal the presence of prostate cancer (particularly high grade cancer) or non-compliance to therapy with Combodart and should be carefully evaluated, even if those values are still within the normal range for men not taking α 5 reductase inhibitor (see SPC section 5.1). The relationship between dutasteride and high grade prostate cancer is not clear. Men taking Combodart should be regularly evaluated for prostate cancer risk including PSA testing (see SPC section 5.1). Results of one clinical study (the REDUCE study) in men at increase risk of prostate cancer revealed a higher incidence of Gleason 8 – 10 prostate

cancers in dutasteride treated men compared to placebo. The relationship between dutasteride and high grade prostate cancer is not clear. Men taking Combodart should be regularly evaluated for prostate cancer risk including PSA testing (see SPC section 5.1). As with other alpha-blockers, a reduction in blood pressure can occur during treatment with tamsulosin, as a result of which, rarely, syncope can occur. Intraoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin and may lead to increased procedural complications during the operation. Breast cancer has been reported in men taking dutasteride. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Dutasteride is absorbed through the skin, therefore, women, children & adolescents must avoid contact with leaking capsules. Caution should be used in the administration of Combodart to patients with mild to moderate hepatic impairment. The treatment of severely renally impaired patients (creatinine clearance of less than 10 ml/min) should be approached with caution. This medicinal product contains the colouring agent Sunset Yellow (E110), which may cause allergic reactions.

INTERACTIONS: There have been no drug interaction studies for Combodart. The following reflect information available on the individual components. Dutasteride: is mainly eliminated via metabolism and studies indicate that this metabolism is catalysed by CYP3A4 and CYP3A5. Longterm combination of dutasteride with drugs that are potent inhibitors of the enzyme CYP3A4 (e.g. ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase serum concentrations of dutasteride. Tamsulosin: Concomitant administration of tamsulosin hydrochloride with drugs which can reduce blood pressure, including anaesthetic agents and other alpha-1 adrenergic blockers could lead to enhanced hypotensive effects. Dutasteride-tamsulosin should not be used in combination with other alpha-1 adrenergic blockers. Caution should be used when dutasteride-tamsulosin is used in combination with cimetidine and with concomitant administration of warfarin and tamsulosin hydrochloride. Diclofenac may increase the elimination rate of tamsulosin. FERTILITY, PREGNANCY & LACTATION: Combodart is contraindicated for use by women. There have been no studies to investigate the effect of Combodart on pregnancy, lactation and fertility - the following statements reflect the information available from studies with the individual components; Fertility: Dutasteride has been reported to affect semen characteristics in healthy men. The possibility of reduced male fertility cannot be excluded. Effects of tamsulosin hydrochloride on sperm counts or sperm function have not been evaluated. Pregnancy: As with other 5 alpha reductase inhibitors, dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male foetus, inhibit the development of the external genitalia of the foetus. It is not known whether a male foetus will be adversely affected if his mother is exposed to the semen of a patient being treated with dutasteride (the risk of which is greatest during the first 16 weeks of pregnancy). As with all 5 alpha reductase inhibitors, when the patient's partner is or may potentially be pregnant it is recommended that the patient avoids exposure of his partner to semen by use of a condom. Lactation: It is not known whether dutasteride or tamsulosin are excreted in human milk. ABILITY TO DRIVE & USE MACHINES: No studies on the effects of Combodart on the ability to drive and use machines have

For more information on this and other GSK brands visit www.Health.gsk.ie

Clinical Care Cover 2013_final.indd 2

been performed. However, patients should be informed about the possible occurrence of symptoms related to orthostatic hypotension such as dizziness when taking Combodart.

UNDESIRABLE EFFECTS: DUTASTERIDE AND TAMSULOSIN CO-ADMINISTRATION: The following adverse events have been reported with an incidence of ≥1% during the four years of treatment in the CombAT Study (Combination of Avodart and Tamsulosin-study, a comparison of dutasteride 0.5mg and tamsulosin 0.4mg once daily for four years as co-administration or as monotherapy): Cardiac failure, impotence, altered (decreased) libido, ejaculation disorders, breast disorders (includes breast enlargement and/or breast tenderness), dizziness. Adverse Events identified through post-marketing experience (therefore the true incidence is unknown) with dutasteride monotherapy include allergic reactions, including rash, pruritus, urticaria, localised oedema, and angioedema, skin and subcutaneous tissue disorders. Uncommon: Alopecia (primarily body hair loss), hypertrichosis. The following adverse events related to tamsulosin monotherapy have been reported from both clinical trials and post marketing data: Common (≥1/100 <1/10); dizziness. Uncommon (≥1/1000 <1/100); palpitations, constipation, diarrhoea, nausea, vomiting, asthenia, headache, abnormal ejaculation, rhinitis, rash, pruritis, urticaria, postural hypotension. MA Number PA1077/118/001. Marketing authorisation holder GlaxoSmithKline (Ireland) Limited, Stonemasons Way, Rathfarnham, Dublin 16, Ireland. Legal category POM; S1A. Date of preparation of API: April 2012. Copy Approval Code: IE/COM/0021/12. Further information available on request from GlaxoSmithKline, Stonemasons Way, Rathfarnham, Dublin 16 Ireland. Tel: 01-4955000.

The recommended dose of Combodart is one capsule (0.5 mg/ 0.4 mg) taken orally approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. * vs either tamsulosin or dutasteride monotherapy † No significant difference was seen between combination and dutasteride monotherapy (RRR 19.6%, p=0.18) References: 1. Combodart Summary of Product Characteristics, 2010.

2. Roehrborn CG et al. Eur Urol 2010; 57: 123-131.

IE/DUTT/0012/12

®

Zoely—the pill made from an innovative combination of hormones is here.1,2 Zoely® 2.5 milligram nomegestrol acetate and 1.5 milligram estradiol film coated tablets.

Abbreviated Prescribing Information (Refer to Summary of Product Characteristics before prescribing) PRESENTATION: One blister containing 1 strip of 28 tablets (24 white film-coated tablets, each tablet containing 2.5 milligram nomegestrol acetate and 1.5 milligram estradiol (as hemihydrate) and 4 yellow placebo film-coated tablets). Three blisters per pack. USES: Contraception. DOSAGE: One tablet daily at about the same time. There is no pill-free week between strips. CONTRAINDICATIONS: Known or suspected pregnancy, presence or history of venous thrombosis (deep venous thrombosis, pulmonary embolism), arterial thrombosis (e.g. myocardial infarction) or prodromal conditions, severe hepatic disease with current abnormal liver function tests, liver tumor, cerebrovascular accident, pancreatitis associated with severe hypertriglyceridaemia, known or suspected sex-steroid sensitive malignancies, undiagnosed vaginal bleeding, history of migraine with focal neurological symptoms, hypersensitivity to any ingredients. PRECAUTIONS AND WARNINGS: All data below are based upon epidemiological data obtained with COCs containing ethinylestradiol. Zoely contains 17β estradiol.

As no epidemiological data are yet available with estradiol containing COCs, the warnings are considered applicable to the use of Zoely. The use of any COC (including Zoely) carries an increased risk of venous thromboembolism (VTE) compared with no use. The excess risk of VTE is highest during the first year a woman ever uses a combined oral contraceptive. Epidemiological studies have also associated the use of COCs with an increased risk of thromboembolism.

Extremely rarely, thrombosis has been reported to occur in other blood vessels, e.g. hepatic, mesenteric, renal, cerebral or retinal veins and arteries, in COC users. There is no consensus as to whether the occurrence of these events is associated with the use of COCs. Discontinue in the event of a thrombosis. The risk of venous thromboembolic events in COC users increases with age, positive family history and obesity. Also prolonged immobilisation, major surgery, any surgery to the legs, or major trauma where discontinuation is advisable. There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset of venous thrombosis. The risk of arterial thromboembolic complications or of a cerebrovascular accident in COC users increases with increasing age, smoking, dyslipoproteinemia, obesity, hypertension, migraine, valvular heart disease, atrial fibrillation, a positive family history. Other medical conditions, which have been associated with adverse circulatory events, include diabetes mellitus, systemic lupus erythematosus, hemolytic uraemic syndrome, chronic inflammatory bowel disease and sickle cell disease. Consider stopping if there is an increase in frequency or severity of migraine.

An increased risk of cervical cancer in long-term users of COCs has been reported however, the risk in users of Zoely is not available. Epidemiological studies reported that there is a slightly increased risk of having breast cancer diagnosed.

Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs. If a sustained clinically significant hypertension develops suspend use. The following conditions have been reported to occur or deteriorate with both pregnancy and COC use, but the evidence of an association with COC use is inconclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea; herpes gestationis; otosclerosis-related hearing loss.

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

Worsening of depression, Crohn’s disease and ulcerative colitis have been associated with COC use. Chloasma may occasionally occur. Monitor patients with diabetes. Zoely contains less than 65mg lactose, and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. USE IN PREGNANCY AND LACTATION: Not recommended during pregnancy. Not recommended during breastfeeding. INTERACTIONS: Interactions may lead to breakthrough bleeding and contraceptive failure. This may be seen with enzyme inducers such as phenytoin and phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, nevirapine, efavirenz riseofulvin and products containing St John’s Wort. Reduced absorption of etonogestrel may be seen with medical charcoal. Hormonal contraceptives may interfere with metabolism of other drugs, and therefore increase or decrease their plasma or tissue concentrations. UNDESIRED EFFECTS: Refer to SmPC for full details. Very Common: acne and abnormal withdrawal bleeding. Common: headache, migraine, weight gain, nausea, decreased libido, depression, depressed mood, mood altered, metrorrhagia, menorrhagia, breast pain, pelvic pain. Breast discharge may also occur. OVERDOSE: No serious effects have been reported. Symptoms may include nausea, vomiting and in young girls, slight vaginal bleeding. Treatment should be symptomatic. LEGAL CATEGORY: Prescription Only Medicine. MARKETING AUTHORISATION NUMBER: EU/1/11/690/002 MARKETING AUTHORISATION HOLDER: Theramex S.r.l., Via Messina 38, 20154 Milano, Italy Please refer to the full SmPC text before prescribing this product. Adverse events should be reported. Reporting forms and information can be found at www. imb.ie Adverse events with this product should also be reported to MSD Drug Safety Department on +44 (0) 1707 363773. Date of review: January 2012. Copyright © 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved.

References: 1. Dhont M. History of oral contraception. Eur J Contracept Reprod Health Care. 2010;15(S2):S12-S18. 2. Mansour D et al. The Eur J Contracept Reprod Health Care. 2011;16;6:430-443.

Further information is available on www.medicines.ie or on request from MSD, Pelham House, South County Business Park, Leopardstown, Dublin 18.

Date of preparation: January 2012

Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland

01-14-WOMN-1022638-0000

66% Relative Risk Reduction in AUR or BPH related surgery Vs tamsulosin at 4 years1,2

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Contents

Contents 5: The Way Forward: Dr Aine Carroll, the HSEâ&#x20AC;&#x2122;s new National Director of Clinical Strategy & Programmes explains the next phase of the clinical care programmes.

11: Heart Failure Units: Prof. Ken McDonald, Consultant Cardiologist, is optimistic about the further development of heart failure units around the country.

15: COPD: Ten new sites are in place nationwide to address Chronic Obstructive Pulmonary Disease (COPD) says Professor Tim McDonnell, Consultant Respiratory Physician.

21: Cerebral Palsy: Prof. Michael Turner on the development of a national Cerebral Palsy register as part of a new set of protocols for addressing the condition.

25: Geriatrics:

Dr. Diarmuid Oâ&#x20AC;&#x2122;Shea, Clinical Lead of the HSE programme for older people, explains that meeting the needs of older patients will require a lot of reorganisation.

31: Epilepsy: The appointment of specialised nurses to triage epilepsy patients has resulted in significant waiting list reductions, says Dr. Colin Doherty, Clinical Lead of HSE epilepsy Programme.

35: Renal Programme: Dr. Liam Plant, Director of the HSE National Renal Office, says that home dialysis offers many positive lifestyle benefits, such as patients being able to manage their own care and fit their treatment times around their everyday lives.

40: Acute Coronary Syndrome: HSE Clinical Lead for Acute Coronary Syndrome, Prof. Kieran Daly, on the new standardised national protocol for the diagnosis and treatment of ST-Segment elevated myocardial infarction (STEMI).

45: Asthma: Dr Pat Manning, HSE Clinical Lead of the National Asthma Programme, on the overarching aim of the programme to reduce morbidity and mortality associated with the condition.

53: Anaesthesia: Dr Bairbre Golden, Director of the HSE National Anaesthesia programme says that collaboration is the key message of the programme.

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Contents

57:

diAbeteS: Dr Diarmuid Smith, Clinical Lead of the Diabetes Programme, explains the imminent roll-out of the first phase of the national retinopathy programme.

63: dermAtoloGy: Outgoing programme lead, Prof. Louise Barnes, reflects on the progress of the HSE Clinical Programme on Dermatology.

69: PAediAtricS: Clinical Lead of HSE Paediatrics Programme, Prof. Alf Nicholson explains the ethos behind the programme – safeguarding the future of Irish children.

73: rheumAtoloGy: Prof. Oliver Fitzgerald, who heads up the HSE National Rheumatology Programme, says there has been a significant increase in outpatient activity without a major increase in resources.

77:

oPhthAlmoloGy: Mr Paul Moriarty, HSE Clinical Lead for Ophthalmology, explains the aim of the programme, to move care away from hospitals and into the community.

81:

mentAl heAlth: Clinical Lead, the HSE Clinical Care Programme on Mental Health, Dr. Ian Daly says the Programme is moving to implementation as over 400 new posts in psychiatry arrive.

85: AudioloGy: Programme Manager Ms. Aisling Heffernan explains the roll-out of a universal newborn hearing screening programme.

91:

rAdioloGy: Maureen Browne looks at the rollout of the HSE National Clinical Programme on Radiology.

95: StroKe: Prof. Peter Kelly, Joint HSE Clinical Lead, says that the thrombolytic rate in Ireland is now one of the best internationally, with the nation’s 28 Stroke Units a major success.

101: PrimAry cAre: Maureen Browne explains that the HSE Primary Care programme will change the emphasis from acute episodic care to proactive, structured care.

Clinical Care Journal The

Managing Editor: maureen browne Staff Editor: ruairi Kavanagh Design & Layout: edel Quinn Advert Design: rebecca dobson, linda Kavanagh Illustrations & Photography: iStock Photo, thinstock Photo Production Manager: leonard Wilson Production Assistant: rebecca mcnamee,

Sales Director: Paul clemenson Printed by: W&G baird Distribution by: magazine mailing Ashville Media Group the old Stone building blackhall Green, dublin 7 tel: (01) 432 2200 Fax: (01) 672 7100 Web: www.ashville.com

All articles ©2012. no part of this may be reproduced, stored in a retrieval system or transmitted in any form or by any means without written permission from the publisher. opinions and comments expressed herein are not necessarily those of Ashville media Group. readers should make their own independent evaluation of the information contained within this publication and make such other investigations as they consider necessary (including obtaining independent financial advice) before acting in reliance on this information.

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Interview FEATURE

The Way Forward The next phase of the HSE Clinical Programmes will be about the implementation of pathways of care and an integrated approach to assessment, improvement and quality, according to Dr. Aine Carroll, the HSE’s new National Director of Clinical Strategy & Programmes. Maureen Browne reports.

T

NOND-1070130-0000

he next phase of the HSE Clinical Programmes will be about the implementation of pathways of care and an integrated approach to assessment, improvement and quality, according to Dr. Aine Carroll, the HSE’s new National Director of Clinical Strategy & Programmes. Originally from Northern Ireland, Dr. Carroll took her primary medical degree in Queen’s University in Belfast. She did a postgraduate MD in Newcastle University, Newcastle upon Tyne and completed higher specialist training in Rehabilitation Medicine in Newcastle upon Tyne before coming to work in Dublin in 2005. She is a Fellow of the Royal College of Physicians of Edinburgh and of the Royal College of Physicians in Ireland and was a consultant in rehabilitation medicine, Senior Clinical Lecturer at University College. Dublin and the

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National Clinical Lead of the HSE Programme on Rehabilitation Medicine before taking up her present post. She is a member of the HSE Management Team and has succeeded Dr. Barry White who has returned to clinical practice after three years as National Director of Clinical Programmes and Strategy with the HSE. “My first piece of work is to restructure the programmes to facilitate integrated working across the programmes and ensure we have effective governance.

The single disease focus of some of the programmes was the correct way to start, as we needed to design the pathway for people with specific conditions.

We have these pathways now and the next step is to develop an integrated approach to providing appropriate care for individuals with multiple conditions.

Every health care system in the world

I want to foster better collaborative working and develop an appropriate framework for the management of long term conditions, right across the spectrum of services from acute to community and back again, if that is required.”

is struggling to manage people with long term conditions. I want to foster better collaborative working and develop an appropriate framework for the management of long term conditions, right across the spectrum of services from acute to community and back again, if that is required.”

She said it was vital that the health service changed and that she welcomed the proposed changes. “We see the need for change every day with stories of inequitable access either with patients on trolleys or waiting lists or some incident where things go wrong. Like many healthcare systems, there are many reasons for transformation including capability and management deficits, inadequate governance and financial systems.

“This is all happening at a time of great financial challenge, when staff resources are very stretched, with an ageing population and increased demand. In addition, the public quite rightly, has significant expectation for the health system. Our challenge is how to plan for transformation in a system which is

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FEATURE Interview

already creaking and where we cannot even afford our current health spend.

“Part of the solution is a partnership of clinicians and managers. We are inherently distrustful of each other and of government for all sorts of reasons and we need to heal this divide.

“We also have to change public opinion.

Speaking as a doctor, I was fascinated by the opening ceremony at last year’s London Olympics where they spelled out the NHS to the whole world. Their pride in their national health system was palpable. For whatever reason, I can’t see us doing that for the HSE. “Yet we have an awful lot to be proud of in our health system. There are very few countries where you will be looked after if you get sick without somebody insisting you produce an insurance cert. I am extremely proud to be a healthcare worker in Ireland, but there are things we need to improve, to transform and from international best practice, we know how to do it. There are lots of examples in lots of different organisations about how large systems can be transformed. There is also a lot of very good work internationally about the best way to do this in a healthcare system. We need effective leadership from the frontline to the Director General or Chair of the Board and individuals need to honour their work and appreciate the work done by others.”

Dr. Carroll said that in the healthcare system, the key was for managers to engage with clinicians and for clinicians to engage with their patients and their families and this was being done in the Clinical Care Programmes. “These started as a partnership between the HSE and postgraduate training bodies.

It was the right way to go and we have built up a partnership that has brought clinicians on board and they have taken the lead in changing practice. There is a need for multidisciplinary team working, so each programme has a team that is multidisciplinary and involves patients and their families through the HSE

Patients Advocacy Forum. I applaud my colleagues who have effected so much change and without any additional remuneration.

“The Programmes are meeting the rules for transformation and the result has been enormous achievements to date. Ireland was the first country in the world to roll out the National Early Warning Score. Don Berwick (the US healthcare guru and former Obama adviser, who is now considering running as Governor of Massachusetts) quoted the work of the Stroke Programme in a keynote lecture just before Christmas, where he cited Ireland as an example to the rest of the world about how significant change could be affected at scale and in a short timeframe. The Epilepsy Programme has received an international nursing award and the COPD and Heart Failure Programmes, among others, have made amazing changes.”

Dr. Carroll sees a major challenge in developing education and training without resources. “Education and training always get hit when you have cut backs, but we have to maintain our health force and train people not just for the past but for the future, because healthcare is changing all the time. I think this is absolutely vital.

PICTURED: Dr Aine Carroll

}

Part of the solution is a partnership of clinicians and managers. We are inherently distrustful of each other and of government for all sorts of reasons and we need to heal this divide.”

“We must also aim for health and not care. As individuals in a society, we need to take responsibility for our care.

We can’t expect our GPs to do it for us. We need to be working towards a healthier society.

“I would love to see us start to train and develop our own real quality experts with a deep knowledge of quality improvement in healthcare. We have to start doing this and I believe it will mean that we will be able to improve things sustainably. A sustainable, quality driven change in health care will happen in the next few years and I am delighted to be involved in healthcare at a moment when so much is happening.”

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NEBIL

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Nebilet® 5 mg tablets (nebivolol) Abbreviated Prescribing Information Please consult the Summary of Product Characteristics (SPC) for full prescribing information. Presentation: Tablets containing nebivolol hydrochloride 5.45mg (equivalent to 5mg nebivolol). Use: Essential hypertension. Stable mild and moderate chronic heart failure in addition to standard therapies in patients aged 70 or over. Dosage: Hypertension: Adults: One 5mg tablet daily. Over 65 years or renal insufficiency: Starting dose 2.5mg. Do not use in patients with hepatic insufficiency.

Not recommended for children. Chronic heart failure: Adults: Starting dose 1.25 mg and titrated up to 10 mg daily, adjusted individually over 4-8 weeks. Do not use in patients with hepatic or severe renal insufficiency. Not recommended for children. Contra-indications: Hypersensitivity to nebivolol or any of the excipients, liver function disorder, acute heart failure, cardiogenic shock or episodes of heart failure decompensation requiring i.v. inotropic therapy.

As with other beta-blockers: sick sinus syndrome, second and third degree heart block, history of bronchospasm and bronchial asthma, untreated phaeochromocytoma, metabolic acidosis, bradycardia, hypotension, severe peripheral circulatory disturbances. Warnings and precautions: As with other beta-blockers: Anaesthesia, ischaemic heart disease, untreated congestive heart failure, peripheral circulatory disorders, first degree heart block, Prinzmetal’s angina, use with calcium channel antagonists, Class I antiarrhythmic drugs, centrally acting antihypertensive drugs, diabetes, hyperthyroidism, chronic obstructive pulmonary disorders, psoriasis, allergen sensitivity. Contains lactose. Not recommended in pregnancy or lactation.

Interactions: Not recommended: Class I antiarrhythmics, calcium channel antagonists of the verapamil/diltiazem type, centrally acting hypertensives. For other interactions where combinations should be used with caution or be taken into account, please consult the SPC. Side-effects: Hypertension: Mostly mild to moderate. Common (1-10%): headache, dizziness, paraesthesia, dyspnoea, constipation, nausea, diarrhoea, tiredness, oedema. Uncommon (0.11%): nightmares, depression, impaired vision, bradycardia, heart failure, slowed AV conduction/ AV block, hypotension, (increase of) intermittent claudication, bronchospasm, dyspepsia, flatulence, vomiting, pruritus, rash erythematous, impotence. Very rare (<0.01%): syncope, psoriasis aggravated. Not known: angioneurotic oedema, hypersensitivity. Chronic heart failure: Data from clinical trials that were commonly reported – bradycardia, dizziness. Other incidences considered relevant – aggravation of heart failure, postural hypotension, drug intolerance, first degree atrio-ventricular block, oedema of the lower limb. Pack size: Blister packs of 14 and 28 tablets. Legal category: POM. Marketing authorisation number: PA 865/5/1. Marketing authorisation holder: Menarini International Operations Luxembourg S.A., 1 Avenue de la Gare, L-1611 Luxembourg. Marketed by: A.Menarini Pharmaceuticals Ireland Ltd. Further information is available on request to A Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Co. Dublin or may be found in the SPC. Date of preparation: May 2011.

Nebilet® Plus 5 mg / 12.5 mg, 5 mg / 25 mg film-coated tablets (nebivolol hydrochloride/ hydrochlorothiazide) Abbreviated Prescribing Information Please consult the Summary of Product Characteristics (SPC) for full prescribing information. Presentation: Filmcoated tablets containing 5mg nebivolol (as nebivolol hydrochloride) and 12.5 mg or 25 mg hydrochlorothiazide. Use: Essential hypertension. Nebilet Plus is indicated in patients whose blood pressure is adequately controlled on nebivolol 5 mg and hydrochlorothiazide 12.5 mg or 25 mg given concurrently. Dosage: Adults: One tablet daily. Do not use in patients with severe renal insufficiency, hepatic insufficiency or impaired liver function. Caution in the elderly.

Not recommended for children or adolescents. Contra-indications: Hypersensitivity to the active substances, to any of the excipients or to other sulphonamide-derived substances, liver insufficiency or liver function impairment, anuria, severe renal insufficiency, acute heart failure, cardiogenic shock or episodes of heart failure decompensation requiring i.v. inotropic therapy, sick sinus syndrome including sino-atrial block, second and third degree atrioventricular block (without a pacemaker), bradycardia, hypotension, severe peripheral circulatory disturbances, history of bronchospasm and bronchial asthma, untreated phaeochromocytoma, metabolic acidosis, refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic

A. MENARINI

PHARMACEUTICALS IRELAND LTD

Healthcare for Life

ClinicalCare2013_1_104.indd 1 9 NEBILET_PLUS_OCT12.indd

hyperuricaemia. Pregnancy and Lactation: There are no adequate data from the use of Nebilet Plus in pregnant women. However, nebivolol has pharmacological effects that may cause harmful effects on pregnancy and/or the foetus/newborn. Limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester. Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease. Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used. Not recommended during breast feeding. Warnings and precautions: Nebivolol: Anaesthesia - allow 24 hours if therapy interrupted, caution with anaesthetics that cause myocardial depression. Untreated congestive heart failure, ischaemic heart disease, may induce bradycardia, peripheral circulatory disorders, first degree heart block, Prinzmetal’s angina. Use with calcium channel antagonists, Class I antiarrhythmic drugs, centrally acting antihypertensive drugs is not recommended. Diabetes, hyperthyroidism, chronic obstructive pulmonary disorders, psoriasis, increased allergen sensitivity and severity of anaphylactic reactions. Hydrochlorothiazide: renal impairment, may impair glucose tolerance, may increase cholesterol and triglyceride levels. May precipitate hyperuricaemia and/or gout. Fluid or electrolyte imbalance. Monitoring of serum potassium in patients at risk of hypokalaemia, hyponatraemia, and hypochloraemic alkalosis, hypercalcaemia, hypomagnesaemia is recommended. Exacerbation or activation of systemic lupus erythematosus.

May cause a positive result in an anti-doping test, sensitivity reactions and a decrease in protein bound iodine. Nebivolol/hydrochlorothiazide combination: Contains lactose. Interactions: Not recommended: Nebivolol: Class I antiarrhythmics, calcium channel antagonists of the verapamil/ diltiazem type, centrally acting hypertensives. Hydrochlorothiazide: lithium, medicinal products affecting potassium levels. For other interactions where combinations should be used with caution or be taken into account, please consult the SPC. Side-effects: Nebivolol: Common (110%): headache, dizziness, paraesthesia, dyspnoea, constipation, nausea, diarrhoea, tiredness, oedema. Uncommon (0.1-1%): nightmares, depression, impaired vision, bradycardia, heart failure, slowed AV conduction/AV block, hypotension, (increase of) intermittent claudication, bronchospasm, dyspepsia, flatulence, vomiting, pruritus, erythematous rash, impotence. Very rare (<0.01%): syncope, aggravated psoriasis. Not known: angioneurotic oedema, hypersensitivity.

Hydrochlorothiazide: Common (1-10%): hyperglycaemia, glycosuria, hyperuricaemia, electrolyte imbalance (including hyponatraemia, hypokalaemia, hypomagnesaemia, hypochloraemia, hypercalcaemia), blood cholesterol increased, increased blood triglycerides, confusional state, vertigo, nausea, vomiting, diarrhoea, constipation, abdominal pain, headache, asthenia, fatigue.

Uncommon (0.1-1%): anorexia, orthostatic hypotension, urticaria, photosensitivity reaction, rash.

Rare (0.1- 0.01%): sialadenitis, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anaemia, haemolytic anaemia, bone marrow failure, apathy, depression, restlessness, sleep disorder, paraesthesia, convulsions, xanthopsia, blurred vision, decreased lacrimation, cardiac arrhythmias, thrombosis, embolism, pneumonitis, pulmonary oedema, pancreatitis, cutaneous lupus erythematosus, necrotising vasculitis, anaphylactic reaction, toxic epidermal necrolysis, muscle spasms, paresis, renal impairment, renal failure acute, nephritis interstitial, dehydration, erectile dysfunction, pyrexia. Very rare (<0.01%): paralytic ileus. Other: gout, diabetes mellitus, metabolic alkalosis, hyperamylasaemia, nervousness, depressed level of consciousness, coma, dizziness, myopia (aggravated), palpitations, shock, respiratory distress, interstitial lung disease, dry mouth, stomach discomfort, flatulence, cholestatic jaundice, cholecystitis, pruritus, purpura, myalgia, thirst, electrocardiogram change. Pack size: Nebilet Plus 5 mg / 12.5 mg tablets: Blister packs of 14 and 28 tablets. Nebilet Plus 5 mg / 25 mg film-coated tablets Blister packs of 28 tablets. Legal category: POM. Marketing authorisation number: PA 865/15/12. Marketing authorisation holder: Menarini International Operations Luxembourg S.A., 1 Avenue de la Gare, L-1611 Luxembourg. Marketed by: A.Menarini Pharmaceuticals Ireland Ltd. Further information is available on request to A Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Co. Dublin or may be found in the SPC. Date of preparation: June 2011.

Date of item: October 2012 Item code: 12NebP003

13/03/2013 30/10/201217:25:16 09:58

with

®

r a no l a z i ne

For stable angina patients inadequately controlled on beta blockers or calcium antagonists1 Prescribing Information: Ranexa (ranolazine). Please consult the Summary of Product Characteristics (SPC) for full prescribing information. Presentation: Prolonged-release tablets containing 375 mg, 500 mg or 750 mg of ranolazine. 500 mg tablet may contain E110. 750 mg tablet contains E102 and lactose. Use: Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).

Dosage and administration: Oral administration. Patients should be instructed to present their Patient Alert Card (inside the box) and medication list to their health care professional at each visit. Adults: Initial dose is 375 mg twice daily. After 2-4 weeks, dose should be titrated to 500 mg twice daily and, according to patient’s response, further titrated to 750 mg twice daily. Concomitant treatment with moderate CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended. Renal impairment: Careful dose titration is recommended in mild to moderate renal impairment, and contraindicated in severe renal impairment. Hepatic impairment: Careful dose titration is recommended in mild hepatic impairment, and contraindicated in moderate to severe hepatic impairment. Elderly: Dose titration in the elderly should be exercised with caution. Low weight: Dose titration in patients with low weight should be exercised with caution. Congestive Heart Failure (CHF): Dose titration in moderate to severe CHF should be exercised with caution. Paediatric patients: No data in children below the age of 18 years. Ranexa tablets should be swallowed whole and not crushed, broken or chewed. They may be taken with or without food. Contra-indications: Hypersensitivity to the active substance or to any of the excipients.

Severe renal impairment. Moderate or severe hepatic impairment. Concomitant administration of potent CYP3A4 inhibitors. Concomitant administration of Class Ia or Class III antiarrhythmics other than amiodarone. Warnings and Precautions: Caution should be exercised when prescribing or up titrating ranolazine to patients in whom an increased exposure is expected. QT prolongation: Caution should be observed when treating patients with a history of congenital or a family history of long QT syndrome, in patients with known acquired QT interval prolongation, and in patients treated with drugs affecting the QTc interval. Interactions: Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy. Renal impairment: Check renal function at regular intervals during treatment. Interactions: CYP3A4 inhibitors: Increase plasma concentrations of ranolazine. Combining ranolazine with potent CYP3A4 inhibitors is contraindicated. CYP3A4 inducers: Avoid initiation with Ranexa during administration of CYP3A4 inducers. CYP2D6 inhibitors: May increase plasma concentrations of ranolazine. Effect of ranolazine on other medicinal products: Dosage adjustment of sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range may be required. Lower doses of CYP2D6 substrates may be required. Caution with

RANEXA_A4_AD_JAN13.indd 1 ClinicalCare2013_1_104.indd 10

CYP2B6 substrates. Monitor digoxin levels following initiation and termination of Ranexa. Limit dose of simvastatin to 20mg once daily in patients taking Ranexa. Monitor blood levels of tacrolimus when co-administering with Ranexa and adjust tacrolimus dose accordingly. Also recommended for other CYP3A4 substrates with a narrow therapeutic range. Theoretical risk that concomitant treatment with drugs known to prolong the QTc interval may increase the possible risk of ventricular arrhythmias. Pregnancy and lactation: Ranexa should not be used during pregnancy unless clearly necessary. Ranexa should not be used during breast-feeding. Effect on fertility unknown. Side-effects: Generally mild to moderate in severity and often develop within the first 2 weeks of treatment. Common (1-10%): dizziness, headache, constipation, vomiting, nausea, asthenia. Uncommon (0.1–1%): anorexia, decreased appetite, dehydration, anxiety, insomnia, confusional state, hallucination, lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness, blurred vision, visual disturbance, vertigo, tinnitus, hot flush, hypotension, dyspnoea, cough, epistaxis, abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort, pruritus, hyperhydrosis, pain in extremity, muscle cramp, joint swelling, dysuria, haematuria, chromaturia, fatigue, peripheral oedema, increased blood creatinine, increased blood urea, prolonged QT corrected interval, increased platelet or white blood cell count, decreased weight. In a long term study, acute renal failure was also reported with an incidence less than 1% in placebo and ranolazine patients. Rare (0.1-0.01%): disorientation, amnesia, depressed level of consciousness, loss of consciousness, parosmia, impaired hearing, peripheral coldness, orthostatic hypotension, throat tightness, pancreatitis, erosive duodenitis, oral hypoaesthesia, angioedema, allergic dermatitis, urticaria, cold sweat, rash, acute renal failure, erectile dysfunction, elevated levels of hepatic enzyme. Elderly, renal impairment and low weight: In general, adverse events occurred more frequently among elderly patients and patients with renal impairment. Adverse events in patients with low body weight were similar to those of patients with higher weight. Please consult the SPC for further information. Pack size: 60 tablets. Legal category: POM. Marketing authorisation numbers: EU/1/08/462/001-006. Marketing Authorisation holder: Menarini International Operations Luxembourg S.A. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Co. Dublin or may be found in the SPC. Last updated: April 2012.

References: 1. Ranexa® Summary of Product Characteristics, April 2012.

Date of item: January 2013 13Ranexa003

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PHARMACEUTICALS IRELAND LTD

Healthcare for Life

05/02/2013 10:27 13/03/2013 17:25:54

FEATURE

© stockbyte/thinkstock.com

Cardiology

Improving all stages of tacklin

heart failure syndrome.

The HSE National Heart Failure Programme has officially opened ten Heart Failure Units in hospitals throughout the country and Prof.

Ken McDonald, Consultant Cardiologist at St. Vincent’s University Hospital in Dublin and Clinical Lead of the Programme is optimistic that a further three or four will be opened shortly.

Maureen Browne reports.

T

he HSE National Heart Failure Programme has officially opened ten Heart Failure Units in hospitals throughout the country.

Prof. Ken McDonald, Consultant Cardiologist at St. Vincent’s University Hospital in Dublin and Clinical Lead of the Programme is optimistic that a further three or four will be opened shortly, with the ultimate aim to have a Unit in each admitting hospital.

Prof. McDonald said the reason for focusing initially on hospitals was to ensure that at the outset, they directed attention to those most in need of care, those requiring hospitalisation.

It had been shown by local as well as international experience that restructuring how these individuals were looked after once in hospital could have

significant impact on their intermediate and long term clinical course. In particular it had been shown that a structured coordinated multidisciplinary approach to care could shorten length of stay in hospital and also reduce the likelihood for immediate readmission within three months post discharge.

}

The model of care is being implemented by a multidisciplinary team, led by a physician in the hospital and in the community with close liaison with hospital and community health care managers.”

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FEATURE Cardiology

The initial aim of focusing on 12 units was to provide the structures for these units to focus in on patients who had been admitted to the hospital, to shorten length of stay, improve quality of care and reduce the need for readmission. The major metric to assess the effectiveness of this programme would be the three month readmission rate for patients.

The National Heart Failure Clinical Programme is concerned with improving all stages of the heart failure syndrome, from prevention right the way through to treatment of the most severe case. It aims to bring about a systematic approach to how care for chronic disease is delivered to improve outcomes for patients but also to reduce unnecessary hospitalisation for this cohort.

The model of care for heart failure established by the clinical programme follows international best practice allied to the experience from some centres in Ireland, most notably St. Vincent’s University Hospital. The programme focuses on the full spectrum of care provided in the hospitals and community with an aim to develop partnerships between the acute services and the community services to optimise care and maintain patient wellbeing safely in the community.

The model of care is being implemented by a multidisciplinary team, led by a physician in the hospital and in the community with close liaison with hospital and community health care managers. The programme is supported by international guidelines, decision making tools as well as guidance on governance and roles of responsibilities within the programme. Importantly, as is the case with all chronic diseases, information is also available for patients

}

and their families and carers in regard to self care on a day to day basis, a facet of care that is critical to maintain wellbeing in the community.

While focusing initially on hospitals, the programme realises that the optimal care for the heart failure patient population in general will require effective coordinated heart failure management in the community. The Heart Failure Programme has started a pilot project directed at improving access to early diagnostics and consultant opinion in those presenting with heart failure for the first time in the community This and other pilot projects will help inform how best to develop the community aspect of this programme.

The new early diagnostic project, which is based in Gorey, is a partnership between local GPs and St. Vincent’s, St. Michael’s and Wexford General Hospital.

It is also hoped to further develop heart failure prevention strategies in the coming year by developing care structures which will facilitate better risk stratification for heart failire.

This approach has been shown to be successful in a pilot project run from St Vincent’s involving general practitioners in the Dublin South/ Wicklow and North Wexford regions.

Prof. McDonald said that this could be a template for the country and for other disciplines and it was hoped to introduce a second pilot in the midland area this year.

Prof. McDonald said that lack of funding was a generic programme across all the HSE Clinical Programmes.

“While it is reassuring to hear that the Programmes remain central to health care development in the coming years, the lack of funds to push ahead with

This approach has been shown to be successful in a pilot project run from St Vincent’s involving general practitioners in the Dublin South/ Wicklow and North Wexford regions.”

plans is very frustrating for all working with the Programmes.”

He said heart failure was one of the major chronic diseases with which the Irish healthcare system had to contend. As distinct from many other cardiovascular problems, the prevalence of heart failure continued to climb, reflecting the aging population, the improved survival from major cardiovascular events such as myocardial infarction and the continued poor management of risk factors for heart failure, in particular hypertension. Also contributing to the increasing prevalence of the heart failure syndrome was the improvement in care for patients with established heart failure resulting in increased longevity with the resultant increase in numbers of patients with this syndrome.

The major clinical problems associated with the heart failure epidemic were the decline in quality of life and the need for frequent hospitalisations. It was estimated that as many as 20 per cent of the 100,000 patients in Ireland who had heart failure were at risk of at least one hospital admission per year as a result directly or indirectly of their heart failure syndrome. The average length of stay for a heart failure admission in Ireland was approximately 12 days and the result in morbidity and cost was well established. It was estimated in the UK, where the demographics and outcome of the problem were similar, that about two per cent of the total NHS budget was spent looking after patients with heart failure, predominantly as a result of the need for inpatient hospital care.

Therapy for patients with heart failure had improved and it was now generally accepted that with structured organised care for this condition, significant improvements could be made, which most importantly would improve the quality of life for the patient but also reduce hospital needs, free up beds for other conditions and also save money in terms of what heart failure costs the exchequer.

12 | CLINICAL CARE

ClinicalCare2013_1_104.indd 12

13/03/2013 17:25:58

Omes

Olmesartan Medoxomil

20 PLUS ®

mg

Olmesartan Medoxomil

Olmesartan Medoxomil/HCTZ

®

1,2

20/12.5mg & 20/25mg

Available Doses3

Omesar

10mg

Omesar

Omesar 10, 20, 40 mg film-coated tablets (olmesartan medoxomil). Prescribing information Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Film-coated tablets containing 10 mg, 20 mg, 40 mg olmesartan medoxomil. Contains lactose. Uses: Treatment of essential hypertension.

Dosage: Oral administration. Adults (18-65 years): Recommended starting dose 10 mg daily. If required the dose may be increased to 20 mg daily. Maximum daily dose is 40 mg. Elderly: No dose adjustment generally required. If up-titration to maximum dosage required, monitor blood pressure closely. Patients with renal and moderate hepatic impairment: Maximum daily dose is 20 mg. Children, adolescents and patients with severe hepatic impairment: Not recommended.

Contra-indications: Hypersensitivity to any component. Second or third trimesters of pregnancy. Patients with biliary obstruction. Warnings and Precautions: Correct intravascular volume depletion before administering olmesartan medoxomil. In patients with other conditions associated with stimulation of renin-angiotensin-aldosterone system, possible side effects include acute hypotension, azotaemia, oliguria or, rarely, acute renal failure. Increased risk of severe hypotension and renal insufficiency in patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Periodic monitoring of serum and potassium levels is recommended in patients with impaired renal function and kidney transplantation. Not recommended in patients with severe renal impairment or with severe hepatic impairment. Hyperkalaemia (which may be fatal), risk factors include diabetes, renal impairment, age (> 70 years), combination with medicines which increase potassium levels, potassium supplements, intercurrent events. Close monitoring of serum potassium in at risk patients is recommended. Not recommended for combination use with lithium.

Special caution is recommended in patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. Not recommended in patients with primary aldosteronism. The blood lowering effect of olmesartan medoxomil is some what less in black patients than non-black patients. Do not initiate during pregnancy and change to alternative therapy, if appropriate, if pregnancy is planned or occurs during therapy. Excessive blood pressure decrease in patients with ischaemic heart disease or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke. Contains lactose. Pregnancy and lactation: Do not use in the first trimester and discontinue as soon as possible if pregnancy occurs during therapy. Contraindicated in second and third trimester of pregnancy. Not recommended during lactation, change to alternative therapy, if appropriate. Interactions: Concomitant use with potassium supplements, potassium sparing diuretics and lithium is not recommended. The blood lowering effect of olmesartan medoxomil can

Omesar_IMD_A4_rhs.indd ClinicalCare2013_1_104.indd1 13

20mg

Omesar

40mg

be increased by concomitant use with other antihypertensive medications. Risk of acute renal failure with concomitant use of NSAID’s and angiotensin II antagonists. Monitoring of renal function and regular hydration of the patient is recommended. Use with NSAID’s can reduce the effect of olmesartan medoxomil. Coadministration of warfarin and digoxin had no significant effect on the pharmacokinetics of olmesartan, warfarin or digoxin. No clinically relevant interactions between olmesartan and drugs metabolised by cytochrome P450 enzymes 1A1/2, 2A6, 2C8/9, 2C19, 2D6 and 3A4 are expected. Side Effects: Clinical trials: Common side effects include dizziness, bronchitis, cough, pharyngitis, rhinitis, abdominal pain, diarrhoea, dyspepsia, gastroenteritis, nausea, arthritis, back pain, skeletal pain, haematuria, urinary tract infection, chest pain, fatigue, influenza-like symptoms, peripheral oedema, pain, increased creatinine phosphokinase, hypertriglyceridaemia, hyperuricaemia, and liver enzyme elevations. Less common side-effects include vertigo, hypotension, angina pectoris, rash, hyperkalaemia. Postmarketing experience: The following have been reported very rarely (< 1/10,000): Thrombocytopenia, hyperkalaemia, abdominal pain, allergic conditions such as angioneurotic oedema, dermatitis allergic, facial oedema, urticaria, acute renal failure, renal insufficiency, asthenia, abnormal renal function tests, abnormal hepatic function tests. Please consult the Summary of Product Characteristics for a full list of side effects observed from market experience. Overdosage: Most likely effect is hypotension. In the event of overdosage, monitor the patient carefully and give symptomatic and supportive treatment. Pack Sizes: Blister containing 14, 28, 56 and 96 film-coated tablets. Not all pack sizes may be marketed. Legal Category: POM. Product Authorisation Numbers: PA 865/11/1-3. Product Authorisation Holder: Menarini International Operations Luxembourg S.A, 1 Avenue de la Gare, L-1611 Luxembourg. Marketed by: A. Menarini Pharmaceuticals Ireland. For further information please contact: A.Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Co. Dublin or may be found in the SmPC. Date of Preparation: February 2010.

References: 1. Puchler K et al. J Hypertens 2001; Vol19 (Suppl 1): S41-48. 2. Oparil S et al. J Clin Hypertens 2001; 3(5): 283-91. 3.

Omesar SMPC October 2009.

Date of item: September 2011

11Om011

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PHARMACEUTICALS IRELAND LTD

Healthcare for Life

31/01/2012 15:16 13/03/2013 17:26:03

s r e n n i w g n i Produc

since 2002

With a long-term record of success in reducing symptoms, exacerbations and hospitalisations vs placebo, SPIRIVA® is a LAMA you can count on to help lead your COPD patients to everyday victories.1,2

Founded on a decade of proven success LAMA = long-acting muscarinic antagonist.

References: 1. SPIRIVA® 18 μg Inhalation powder, hard capsule - Summary of Product Characteristics. http://www.medicines.ie. Accessed August 2012. 2. Tashkin DP et al. for the UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008;359:1543–1554.

Prescribing Information (Ireland) SPIRIVA® (tiotropium) Inhalation powder, hard capsules containing 18 microgram tiotropium (as bromide monohydrate). Indication: Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). Dose and Administration: Adults only age 18 years or over: Inhalation of the contents of one capsule once daily from the HandiHaler® device. Contraindications: Hypersensitivity to tiotropium bromide, atropine or its derivatives, or to the excipient lactose monohydrate which contains milk protein. Warnings and Precautions: Not for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions may occur after administration of tiotropium bromide inhalation powder.

Caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. Inhaled medicines may cause inhalation-induced bronchospasm. In patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) tiotropium bromide should be used only if the expected benefit outweighs the potential risk. Patients should be cautioned to avoid getting the drug powder into their eyes.

They should be advised that this may result in precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, temporary blurring of vision, visual halos or coloured images

ClinicalCare2013_1_104.indd 14 5079 Spiriva A4 Ad_IRE.indd 1

in association with red eyes from conjunctival congestion and corneal oedema. Should any combination of these eye symptoms develop, patients should stop using tiotropium bromide and consult a specialist immediately. Tiotropium bromide should not be used more frequently than once a day. Spiriva capsules contain 5.5 mg lactose monohydrate. Interactions: Although no formal drug interaction studies have been performed tiotropium bromide inhalation powder has been used concomitantly with other drugs without clinical evidence of drug interactions. These include sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids, commonly used in the treatment of COPD. The co-administration of tiotropium bromide with other anticholinergic-containing drugs has not been studied and is therefore not recommended. Fertility, Pregnancy and Lactation: No clinical data on exposed pregnancies are available. The potential risk for humans is unknown. Spiriva should therefore only be used during pregnancy when clearly indicated. It is unknown whether tiotropium bromide is excreted in human breast milk. Use of Spiriva is not recommended during breast feeding. A decision on whether to continue or discontinue breast feeding or therapy with tiotropium bromide should be made taking into account the benefit of breast feeding to the child and the benefit of tiotropium bromide therapy to the woman. Clinical data on fertility are not available for

tiotropium. Effects on ability to drive and use machines: No studies have been performed. The occurrence of dizziness, blurred vision, or headache may influence the ability to drive and use machinery. Undesirable effects: Common (≥1/100, <1/10): Dry mouth. Uncommon (≥1/1,000, <1/100): Dizziness, headache, taste disorders, vision blurred, cough, pharyngitis, dysphonia, rash, oropharyngeal candidiasis, dysuria, urinary retention, gastrooesophageal reflux disease, atrial fibrillation, constipation. Serious undesirable effects consistent with anticholinergic effects include glaucoma, constipation and intestinal obstruction including ileus paralytic as well as urinary retention. An increase in anticholinergic effects may occur with increasing age. Prescribers should consult the Summary of Product Characteristics for further information on side effects.

Pack sizes: HandiHaler device and 30 capsules (3 blister strips); HandiHaler device plus 10 capsules (1 blister strip); 30 capsules (3 blister strips). Marketing authorisation number: PA 775/2/1.

Legal category: POM. Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, D-55216 Ingelheim am Rhein, Germany. For full prescribing information please see Summary of Product Characteristics. Prepared in August 2012.

Date of preparation: August 2012

IRE/SPI-121396

13/03/2013 17:26:04 20/08/2012 12:26

COPD

FEATURE

Outreach COPD programmes in ten new sites The HSE Chronic Obstructive Pulmonary Disease (COPD) Programme has now got outreach programmes in place in 10 new sites building on the three existing services. It is hoped that two more sites will be operational shortly according to Prof. Tim McDonnell, Consultant Respiratory Physician at St. Vincentâ&#x20AC;&#x2122;s University Hospital and St. Michaelâ&#x20AC;&#x2122;s Hospital, Dublin and Clinical Lead of the Programme.

Maureen Browne reports.

T

he HSE Chronic Obstructive Pulmonary Disease (COPD) Programme has now got outreach programmes in place in 10 new sites building on the three existing services. It is hoped that two more sites will be operational shortly according to Prof. Tim McDonnell. He said that because of the moratorium there had been difficulty in filling all the posts involved. However, five of the 10 sites have a team consisting of both a respiratory physiotherapist and a senior respiratory nurse in place and had programmes up and running.

Six other sites had either a respiratory physiotherapist or a senior respiratory nurse in place and were beginning to develop programmes and it was hoped

PICTURED: Prof. Tim McDonnell

CLINICAL CARE | 15

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It’s time to change your ideas about ORENCIA® ORENCIA® has similar efficacy in RF-positive and RF-negative patients over 12 months.1

ORENCIA® is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA), in combination with methotrexate, in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDS), including methotrexate (MTX) or a Tumour Necrosis Factor (TNF) – alpha inhibitor.

ORENCIA® (abatacept) PRESCRIBING INFORMATION See Summary of Product Characteristics before prescribing. PRESENTATION: 250mg powder for concentrate for solution for IV infusion containing 250mg abatacept per vial. Each ml contains 25mg of abatacept, after reconstitution. INDICATION: Rheumatoid arthritis: Treatment of moderate to severe active rheumatoid arthritis (RA), in combination with methotrexate, in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a Tumour Necrosis Factor (TNF) -alpha inhibitor. A reduction in the progression of joint damage and improvement of physical function has been demonstrated during combination treatment with abatacept and methotrexate. Polyarticular juvenile idiopathic arthritis (pJIA): treatment of moderate to severe active pJIA in paediatric patients six years of age and older who have had an insufficient response to other DMARDs including at least one TNF inhibitor. DOSAGE: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of RA. Adult and elderly patients weighing < 60kg: 500mg (2 vials). Patients weighing ≥ 60kg ≤ 100kg: 750mg (3 vials). Patients weighing > 100kg: 1000mg (4 vials). Treatment of pJIA: Paediatric patients, 6 to 17 years of age, weighing less than 75 kg: 10 mg/kg. paediatric patients weighing 75 kg or more: to be administered adult dosage, not exceeding a maximum dose of 1,000 mg. See SmPC for details of reconstitution and administration as a 30 minute IV infusion. After initial administration, Orencia should be given at 2 and 4 weeks, then every 4 weeks thereafter. Consider therapeutic alternatives if there is no response within 6 months. Use in children below 6 years of age is not recommended. CONTRAINDICATIONS: Hypersensitivity to the active substance or excipients. Severe and uncontrolled infections such as sepsis and opportunistic infections. WARNINGS AND PRECAUTIONS: Infections: Treatment should not be initiated in patients with active infections until infections are controlled. Caution should be exercised when considering the use in patients with a history of recurrent infections, in patients with underlying conditions which may predispose them to infection or in patients on concomitant immunosuppressive therapy. Any patient who develops a new infection should be closely monitored and Orencia should be discontinued if a patient develops a serious infection. Screening for tuberculosis and hepatitis B should be performed prior to therapy. Monitor for signs of infection when transitioning from a TNF-antagonist to Orencia. Treatment with immunosuppressive therapy may be associated with progressive multifocal leukoencephalopathy (PML). ORENCIA treatment should be discontinued if neurological symptoms suggestive of PML occur, and appropriate diagnostic measures initiated. Allergic Reactions: Caution in patients with a history of allergic reactions.Orencia should be discontinued if a patient develops serious allergic or anaphylactic reaction. Malignancies: The potential role of abatacept in the development of malignancies is unknown, see SmPC. Elderly: Caution should be used when treating elderly patients due to a higher incidence of infections and malignancies in this patient group. Autoimmune processes: Theoretical risk of deterioration in autoimmune disease. Immunisation: Live vaccines should not be given concurrently or within 3 months of discontinuation of Orencia. It is recommended that patients with pJIA be brought up to date with all immunisations in agreement with current immunisation guidelines, prior to initiating ORENCIA therapy. Blood Glucose Tests: False elevations on day of infusion can occur, see SmPC. DRUG INTERACTIONS: Concomitant therapy of Orencia with a TNF inhibitor is not recommended. No major safety issues were identified with the use of Orencia in combination with sulfasalazine, hydroxychloroquine or leflunomide. PREGNANCY AND LACTATION: Do not use in pregnancy unless clearly necessary. Women should use contraception and not breast-feed during treatment and up to 14 weeks after last dose. UNDESIRABLE EFFECTS: in adult placebo-controlled trials the following adverse drug reactions were reported Very Common (≥ 1/10): upper respiratory tract infection; Common (≥ 1/100 to < 1/10) Hypertension, flushing, increased blood pressure, headache, paraesthesia, conjunctivitis, abnormal LFTs, dizziness, cough, abdominal pain, diarrhoea, nausea, dyspepsia, mouth ulceration, aphthous stomatitis, vomiting, rash, alopecia, pruritus, leukopenia, pain in extremity, fatigue, asthenia, infections including LRTIs, UTIs, herpes simplex, rhinitis, pneumonia, influenza Uncommon (≥ 1/1,000 to < 1/100): tooth infection, onychomycosis, herpes zoster, sepsis, musculoskeletal infections, skin abcess, pyelonephritis, basal cell carcinoma, skin papilloma, thrombocytopenia, hypersensitivity, depression, anxiety, sleep disorder, migraine, dry eye, reduced visual acuity, vertigo, palpitations, tachycardia, bradycardia, hypotension, hot flush, vasculitis, decreased blood pressure, bronchospasm, wheezing, dyspnea, gastritis, increased tendency to bruise, dry skin, urticaria, psoriasis, arthralgia, amenorrhea, menorrhagia, influenza-like illness, weight increase. Rare: Bacteraemia, gastrointestinal infection, lymphoma, malignant lung neoplasm, throat tightness. In COPD patients, a greater percentage of abatacept than placebo-treated patients developed a serious adverse reactions. In paediatric patients with pJIA, adverse reactions were similar in type and frequency to those seen in adults except: Common (≥ 1/100 to < 1/10): upper respiratory tract infection (including sinusitis, nasopharyngitis and rhinitis), otitis (media and externa), haematuria, pyrexia. See SmPC for further details. LEGAL CATEGORY: POM. MARKETING AUTHORISATION NUMBER: EU/1/07/389/001, 1 vial pack MARKETING AUTHORISATION HOLDER: Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH FURTHER INFORMATION FROM: Bristol-Myers Squibb Pharmaceuticals, South County Business Park, Leopardstown, Dublin 18. Tel: 1-800-749-749 or medical.information@bms.com DATE OF PREPARATION: March 2012 1. Sibilia J et al. Abatacept plus MTX treatment confers similar clinical efficacy in rheumatoid factor negative and positive patients in the AIM trial. 24th French Society of Rheumatology (SFR) Conference 2011, 11-14 December, Paris, France. In Press. © 2012 Bristol-Myers Squibb Company Date of preparation: June 2012 427IE12PM011 IROC-K0004

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2:24 PM

COPD

FEATURE

that the moratorium would be relaxed this year so that all the posts could be filled.

The outreach programmes facilitate patients with exacerbation of COPD being treated in the community by teams from the hospital so that patients need not be admitted or may be discharged earlier. Similar initiatives have been used in Britain and based on their experience the Irish Programme is aiming for a two day reduction in the length of stay of these COPD patients.

© wavebreakmedia/thinkstock.com

The Programme is also rolling out bundles of care for patients with COPD exacerbations, to ensure safer management and hopefully reduce their length of stay in hospitals. The problem has been that if you generate a clinical pathway for patients presenting with exacerbations of COPD, some patients may have diabetes or heart failure and need to conform to two separate pathways. Using a checklist or bundle of care, key steps in the care of such patients are identified and highlighted. These steps are the components of the bundle, which should be done if a patient is admitted to hospital with a COPD exacerbation.

Prof. McDonnell said there had been increasing awareness of COPD as a public health problem over the past few years. Approximately one in four people over the age of 35 are likely to be diagnosed with COPD, which will require treatment during their lifetime.

Data from Canada has demonstrated that COPD is the most frequent cause of patients with chronic disease requiring admission to hospital and furthermore the most frequent cause of patients requiring readmission. This disorder is a large cause of morbidity and indeed mortality in Ireland, with approximately 1,500 deaths and 12,000 admissions a year from the disease.

Prof. McDonnell said that the overall goal of the Programme was to save 50 lives a year from COPD, through a number of measures to decrease

}

The problem has been that if you generate a clinical pathway for patients presenting with exacerbations of COPD, some patients may have diabetes or heart failure and need to conform to two separate pathways.” morbidity and mortality, including obtaining a correct and earlier diagnosis and allowing institution of correct treatment based on best practice guidelines at an earlier stage.

It is hoped to reduce COPD admissions to hospital by 1,500 a year through the COPD outreach programme which aims to decrease admissions and pulmonary

rehabilitation for COPD which aims to improve exercise tolerance, quality of life and reduce dyspnoea for patients.

Prof. McDonnell said that as part of the Programme’s model of care, the Beaumont Passport, which had been developed in Beaumont Hospital by Niamh McCormack and Prof Richard Costello has been nationalised and distributed to all outreach sites. This

CLINICAL CARE | 17

ClinicalCare2013_1_104.indd 17

13/03/2013 17:26:11

s r e n n i w g n i Produc

since 2002

With a long-term record of success in reducing symptoms, exacerbations and hospitalisations vs placebo, SPIRIVA® is a LAMA you can count on to help lead your COPD patients to everyday victories.1,2

Founded on a decade of proven success LAMA = long-acting muscarinic antagonist.

References: 1. SPIRIVA® 18 μg Inhalation powder, hard capsule - Summary of Product Characteristics. http://www.medicines.ie. Accessed August 2012. 2. Tashkin DP et al. for the UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008;359:1543–1554.

Prescribing Information (Ireland) SPIRIVA® (tiotropium) Inhalation powder, hard capsules containing 18 microgram tiotropium (as bromide monohydrate). Indication: Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). Dose and Administration: Adults only age 18 years or over: Inhalation of the contents of one capsule once daily from the HandiHaler® device. Contraindications: Hypersensitivity to tiotropium bromide, atropine or its derivatives, or to the excipient lactose monohydrate which contains milk protein. Warnings and Precautions: Not for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions may occur after administration of tiotropium bromide inhalation powder.

Caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. Inhaled medicines may cause inhalation-induced bronchospasm. In patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) tiotropium bromide should be used only if the expected benefit outweighs the potential risk. Patients should be cautioned to avoid getting the drug powder into their eyes.

They should be advised that this may result in precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, temporary blurring of vision, visual halos or coloured images

ClinicalCare2013_1_104.indd 18 5079 Spiriva A4 Ad_IRE.indd 1

in association with red eyes from conjunctival congestion and corneal oedema. Should any combination of these eye symptoms develop, patients should stop using tiotropium bromide and consult a specialist immediately. Tiotropium bromide should not be used more frequently than once a day. Spiriva capsules contain 5.5 mg lactose monohydrate. Interactions: Although no formal drug interaction studies have been performed tiotropium bromide inhalation powder has been used concomitantly with other drugs without clinical evidence of drug interactions. These include sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids, commonly used in the treatment of COPD. The co-administration of tiotropium bromide with other anticholinergic-containing drugs has not been studied and is therefore not recommended. Fertility, Pregnancy and Lactation: No clinical data on exposed pregnancies are available. The potential risk for humans is unknown. Spiriva should therefore only be used during pregnancy when clearly indicated. It is unknown whether tiotropium bromide is excreted in human breast milk. Use of Spiriva is not recommended during breast feeding. A decision on whether to continue or discontinue breast feeding or therapy with tiotropium bromide should be made taking into account the benefit of breast feeding to the child and the benefit of tiotropium bromide therapy to the woman. Clinical data on fertility are not available for

tiotropium. Effects on ability to drive and use machines: No studies have been performed. The occurrence of dizziness, blurred vision, or headache may influence the ability to drive and use machinery. Undesirable effects: Common (≥1/100, <1/10): Dry mouth. Uncommon (≥1/1,000, <1/100): Dizziness, headache, taste disorders, vision blurred, cough, pharyngitis, dysphonia, rash, oropharyngeal candidiasis, dysuria, urinary retention, gastrooesophageal reflux disease, atrial fibrillation, constipation. Serious undesirable effects consistent with anticholinergic effects include glaucoma, constipation and intestinal obstruction including ileus paralytic as well as urinary retention. An increase in anticholinergic effects may occur with increasing age. Prescribers should consult the Summary of Product Characteristics for further information on side effects.

Pack sizes: HandiHaler device and 30 capsules (3 blister strips); HandiHaler device plus 10 capsules (1 blister strip); 30 capsules (3 blister strips). Marketing authorisation number: PA 775/2/1.

Legal category: POM. Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, D-55216 Ingelheim am Rhein, Germany. For full prescribing information please see Summary of Product Characteristics. Prepared in August 2012.

Date of preparation: August 2012

IRE/SPI-121396

13/03/2013 17:26:12 20/08/2012 12:26

COPD

FEATURE

}

There is huge potential for improving patient care and making bed savings if we had facilities in places like the Mater Hospital or Waterford and Sligo, just to mention a few areas.”

©istockphoto/thinkstock.com

records medications and vaccinations and patient advice.

We need to educate patients so that they take greater responsibility for self management as compliance can be poor. He said that the next big project would be to improve access to pulmonary rehabilitation. “Pulmonary rehabilitation is a comprehensive programme for patients with respiratory disability built around a structured exercise programme in conjunction with a dedicated education and a self-management programme. It is very useful for patients with COPD and helps to improve exercise tolerance, reduce dyspnoea and improve quality of life. It will also reduce health care utilisation. Most of the programmes to date have been hospital based but it is becoming more available in community-based settings. About 84 per cent of acute hospitals and 40 per cent of local health areas have access to pulmonary rehabilitation. However, access means that there is a programme available to them, however capacity may be a problem with some having long waiting lists. Our next priority will be to build up capacity. The COPD programme has established a model of care for pulmonary rehabilitation together with training materials and DVDs which we can give to patients. Our website “www. livingwithCOPD.ie” is also a useful resource for both patients and doctors.”

The Programme has been updating national guidelines and hopes to be in a position to submit them shortly to the National Clinical Effectiveness. GP

Guidelines have been submitted to the Irish College of General Practitioners.

Said Prof. McDonnell “The big question is where we need to go next.

A major issue is primary care and particularly the lack of availability of spirometry in primary care. A proper diagnosis of COPD is impossible without spirometry. Without a proper diagnosis patients are being needlessly referred into already overcrowded hospital outpatient clinics and may be getting inappropriate medication.

Over the last number of years a number of studies have pointed the way to an increasing awareness of the need to treat COPD differently from asthma and that such treatment may slow the progression of the disease and will certainly reduce exacerbations.

Spirometry is a relatively simple procedure but does require some training and equipment. We have training courses up and running but it may need some type of outreach solution to provide spirometry.

This is something which we are still examining.

“We need to get money freed up for COPD outreach in places where we

are struggling to get it in place. There is huge potential for improving patient care and making bed savings if we had facilities in places like the Mater Hospital or Waterford and Sligo, just to mention a few areas.”

The COPD programme is headed up by a respiratory physician with an interest in COPD but more importantly is backed up by a number of regional leads and a clinical advisory group made up of respiratory physicians all with an interest in the management of COPD. The rest of the steering committee is made up of representatives of other relevant clinical interest groups including public health doctors, GPs in primary care, practice nurses, respiratory nurses, respiratory physiotherapists, respiratory scientists and pharmacists and there is a project manager provided to structure the programme. All the various clinical representatives’ feedback information and get advice from their representative bodies. This hopefully ensures that there is significant clinical accountability in the programme. Importantly, the people involved will have a realistic idea about what is required to drive through any changes in the clinical environment.

CLINICAL CARE | 19

12:26

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13/03/2013 17:26:14

Because oestrogen may not be right for many women,

Consider Cerazette ®, an oestrogen-free solution1

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Cerazette® 75 microgram film-coated tablets Desogestrel ABBREVIATED PRESCRIBING INFORMATION (Refer to Summary of Product Characteristics before prescribing) PRESENTATION: One sachet containing 1 strip of 28 tablets, each tablet containing 75mcg desogestrel. USES: Contraception.

DOSAGE: One tablet daily at about the same time. There is no pill-free week between strips. CONTRAINDICATIONS: Known or suspected pregnancy, active venous thromboembolic disorder, presence or history of severe hepatic disease with current abnormal liver function tests, known or suspected sex-steroid sensitive malignancies, undiagnosed vaginal bleeding, hypersensitivity to any ingredients. PRECAUTIONS AND WARNINGS: Women currently using combined oral contraceptives (COCs) have a slightly increased risk of having breast cancer diagnosed. The risk in users of progestogen only pills is possibly of similar magnitude to COCs. This risk is low compared to the risk of getting breast cancer ever in life. The increased risk in COC users may be due to an earlier diagnosis, biological effects of the pill, or a combination of both. Refer to a specialist if acute or ch ronic disturbances of liver function occur. Epidemiological studies have associated the use of COCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). It is unclear whether desogestrel used alone carries the same risk. Discontinue in the event of a thrombosis. Consider stopping prior to long term immobilisation due to surgery or illness. Caution patients with a history of thromboembolic disorders. Consider discontinuation if hypertension develops. Benefit/risk assessment should be made in women with liver cancer. Monitor patients with diabetes during the first months of use. Effects on bone density are unknown. Despite the fact that Cerazette consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain. Chloasma may occasionally occur. Cerazette contains less than 65mg lactose, and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. USE IN PREGNANCY AND LACTATION: Not recommended during pregnancy. Cerazette does not influence the production or quality of breast milk. Small amounts of the metabolite etonogestrel are excreted with the milk. Limited long term follow-up data

ClinicalCare2013_1_104.indd 20

www.talkoptions.ie (up to 2.5 yrs) on children who were breast-fed do not indicate any differences compared to those whose mother used a copper IUD. However development and growth of the nursing infant should be carefully observed. INTERACTIONS: Interactions may lead to breakthrough bleeding and contraceptive failure. This may be seen with enzyme inducers such as hydantoins, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St John’s Wort. Reduced absorption of etonogestrel may be seen with medical charcoal. Hormonal contraceptives may interfere with metabolism of other drugs, and therefore increase or decrease their plasma or tissue concentrations. ADVERSE REACTIONS: Refer to SmPC for full details. Common: irregular bleeding, amenorrhoea, headache, weight gain, breast pain, nausea, acne, mood changes, decreased libido. Breast discharge may also occur. Other less common and rarely reported side effects are listed on the SmPC. OVERDOSE: No serious effects have been reported. Symptoms may include nausea, vomiting and in young girls, slight vaginal bleeding. Treatment should be symptomatic.

Legal Category: Prescription Only Medicine. Product Licence Number: PA 61/27/1. Product Licence Holder: Organon (Ireland) Limited, P.O. Box 2857, Drynam Road, Swords, Co. Dublin, Ireland. Date of revision of Prescribing Information: July 2009. Date of preparation: June 2011. Cerazette/API/1RL/07-09/1.

References: 1. Cerazette Summary of Product Characteristics: www.medicines.ie 2. Data on file. Kenilworth, NJ: Schering Corporation.

Full prescribing information is available on www.medicines.ie or on request.

Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland

06-12-CER-2011-IRL-4611-J

women per year2

13/03/2013 17:26:16

Obstetrics FEATURE

National Cerebral Palsy Register to be developed A national Cerebral Palsy Register, national clinical guidelines, patient pathways for critically ill mothers and a charter for maternity hospitals are to be developed as part of the work of the HSE Clinical Care Programme on Obstetrics & Gynaecology, according to the Programme Clinical Lead, Prof. Michael Turner, Consultant Obstetrician Gynaecologist at the Coombe Women and Infants University Hospital, Dublin. Maureen Browne reports.

A

National Cerebral Palsy Register is to be developed by the HSE’s Clinical Obstetrics & Gynaecology Programme, working in conjunction with the Clinical Programmes in Paediatrics, Neonatology and Rehabilitation.

Prof. Michael Turner, Clinical Lead of the Obstetrics & Gynaecology Programme said he hoped the register - which is a priority for the Minister for Health and which will only require modest resources - would be started this year.

“Prior to the establishment of the Programme there were no Irish national guidelines in obstetrics and gynaecology.

There was use of UK guidelines from the RCOG which was not always for the Irish health care services. More than 20 guidelines have now been developed and to my knowledge,

}

There is anecdotal evidence that the number of cases of NTDs has increased nationally in recent years and the result of this audit will inform not only service provision but also public health policies on mandatory folic acid food supplementation.”

06-12-CER-2011-IRL-4611-J

“Its main purpose will be to help develop services for children with cerebral palsy and their families, but we are also hoping that it will be used for research purposes to allow us to get an accurate picture of the national incidence of cerebral palsy and of its causes.”

The Obstetrics & Gynaecology programme has also made good progress in other areas and, very importantly, some initiatives are being included in this year’s HSE National Service Plan.

Progress has been made with the development and dissemination of national clinical guidelines. Prof. Turner said there had been major variations in clinical practice in obstetrics and gynaecology nationally and there was also evidence that best practices were not always implemented - something which was not unique to Ireland.

CLINICAL CARE | 21

ClinicalCare2013_1_104.indd 21

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NXT

®

Getting pregnant may be in her plans one day.

Just not today.

A highly reliable, compliance-free, 3 year contraceptive option 1,2 No pills to remember or forget Discreet subdermal method 2

ClinicalCare2013_1_104.indd 22

drugs - consult their prescribing information for details. UNDESIRABLE EFFECTS: Very Common: Vaginal Infection, headache, acne, irregular bleeding, weight increase, breast tenderness and pain. Common: Alopecia, dizziness, depressed mood, affect lability, nervousness, nausea, flatulence, libido decreased, increased appetite, abdominal pain, ovarian cyst, painful menstruation, flu-like illness, pain, fatigue, weight decrease, insertion site pain or reaction and hot flushes. Other less common and rarely reported side effects are listed in the SPC. OVERDOSE: Remove previous implant before inserting a new one. There are no data on overdose with etonogestrel. Legal Category: Prescription Medicine Marketing Authorisation Number: PA 61/28/1. Marketing Authorisation Holder: Organon Ireland Limited, P.O. Box 2857, Drynam Road, Swords, Co. Dublin, Ireland. Please refer to the full SPC text before prescribing this product. Adverse events should be reported. Reporting forms and information can be found at www.imb.ie (Ireland). Adverse events with this product should also be reported to Merck Sharp & Dohme Ireland (Human Health) Limited Drug Safety Department on +353 1 2998700 Date of review: January 2012 References 1. Otero Flores JB et al. Int J Gynecol and Obstet 2005;90:228-33. 2. Implanon NXT Summary of Product Characteristics February 2011.

Further information is available on www.medicines.ie or on request from MSD, Pelham House, South County Business Park, Leopardstown, Dublin 18.

Date of preparation: January 2012

Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland

01-14-WOMN-1023212-0000

Implanon NXT ® (See SPC before Prescribing) Etonogestrel PRESENTATION: Preloaded applicator with a radiopaque non-biodegradable implant containing 68mg of etonogestrel. USES: Contraception. DOSAGE AND ADMINISTRATION: One implant should be inserted subdermally after pregnancy has been excluded. Each implant will last for up to 3 years. Implanon NXT should only be inserted or removed by HCPs familiar with the insertion and removal technique. Insertion, removal and replacement instructions must be strictly followed. CONTRAINDICATIONS: Active venous thromboembolic disorder, known or suspected sex-steroid sensitive malignancies, presence/history of severe hepatic disease with current abnormal liver function tests, undiagnosed vaginal bleeding, hypersensitivity to ingredients. PRECAUTIONS AND WARNINGS: Risk of having breast cancer diagnosed in users of progestogen-only preparations is possibly similar to the slightly increased risk associated with combined OCs. This may be due to earlier diagnosis, the biological effects of the OC, or a combination of both. Some epidemiology studies have associated combined OC use with an increased incidence of VTE, DVT and PE. It is unclear whether etonogestrel carries the same risk. Remove implant in the event of a thrombosis and prior to long-term immobilisation.

Caution patients with a history of thromboembolic disorders. Abnormal liver function. Hypertension. Diabetes. Chloasma. HCPs may need to consider earlier replacement of the implant in heavier women. Ectopic pregnancy should be ruled out if a women presents with abdominal pain and amenorrhoea. History during pregnancy or previous use of sex steroids: jaundice and/or pruritis related to cholestasis, gallstone formation, porphyria, SLE, HUS, Sydenham’s chorea, herpes gestationis, otosclerosis, (hereditary) angioedema.

Expulsion may occur if the implant is not inserted correctly or as a consequence of local inflammation. In rare cases the implant may migrate from the insertion site. PREGNANCY AND LACTATION: Not indicated during pregnancy. Exclude pregnancy prior to insertion.

Implanon NXT may be used during lactation, growth and development of the child should be carefully followed. INTERACTIONS: Possible interactions with phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, nevirapine, griseofulvin and St John’s Wort. Implanon NXT may also interfere with the metabolism of other

www.talkoptions.ie

13/03/2013 17:26:25

Obstetrics FEATURE

}

It has been agreed that in the short-term, gynaecological cancer cases will be managed in eight hospitals and that subsequently they will be centralised in four hospitals – Cork and Galway and the Mater and St. James’s in Dublin.” we are the first country in the world which has launched a smart app for our clinical guidelines. This means that anybody in the country can, go in and download them on their iPhone for free, which is important in terms of dissemination and implementation in the future.”

He said that two important national audits had just been completed. An audit on Neural Tube Defects (NTDs) was carried out in partnership with Dr. Bob McDonnell and Ms. Virginia Delaney in Eurocat in the HSE and a national meeting will be held later this year. There is anecdotal evidence that the number of cases of NTDs has increased nationally in recent years and the result of this audit will inform not only service provision but also public health policies on mandatory folic acid food supplementation.

01-14-WOMN-1023212-0000

A national audit on gestational diabetes mellitus has also been carried out in association with Prof. Fidelma Dunne in Galway and Dr Diarmuid Smith from The National Diabetes Clinical Care Programme. Prof. Turner said they would like to develop a National Formulary for obstetrics and gynaecology, but this would require resources. The main purpose of the formulary would be to reduce clinical risk but they would also hope that it would lead to savings in the drug budget. However, its main purpose would be clinical.

warning assessment for obstetrics and gynaecology. A considerable amount of work has been done on early warning scores in acute Medicine, under the direction of Dr. Eilis Croke and in the next few months we hope to extend it to obstetrics and gynaecology.

National clinical guidelines have been developed on Ultrasound diagnosis of Early Pregnancy Loss and the Management of Miscarriage, formal training for ultrasound in the first trimester has been established by the Institute of Obstetrician and Gynaecology, for trainees in obstetrics and gynaecology and for all other disciplines, by the UCD School of Medicine and Medical Science. New high specificaltion ultrasound machines have been installed in all early pregnancy assessment units and viewpoint software has been made available to all 19 units, for data storage and for the provision of clinical audit.

“We want to repeat the audit of early pregnancy assessment services. The first audit identified 18 cases of miscarriage misdiagnosis in five years but when we did a national follow up audit of all 19 Early Pregnancy Services for 2011, we were unable to identify any case. We are going to repeat that audit.”

“We are developing patient pathways for critically ill mothers in association with the Anaesthesia and Critical Care Programmes, which we hope to implement in all 19 maternity units.

The Programme has been collaborating closely with Dr. Susan O’Reilly and her colleagues in the National Cancer Control Programme. It has been agreed that in the short-term, gynaecological cancer cases will be managed in eight hospitals and that subsequently they will be centralised in four hospitals – Cork and Galway and the Mater and St. James’s in Dublin.

“We also hope to launch a national early

The Programme in collaboration

with the Advocacy Unit in the HSE is developing a patient charter for maternity services. The maternity charter will be based on the acute services charter and is due to be completed this year. Prof. Turner said that the overall aim of the Programme was to improve choices in women’s healthcare. The key objectives of the programme were based on the key metrics of all the Clinical Care programmes- quality, financial value, access and compliance.

“Most important is quality. We want to maintain the low national maternal and perinatal morality rates, to stop the rate of caesarean sections increasing in first time mothers, to reduce the number of miscarriage misdiagnoses, to reduce the number and cost of medical negligence cases in obstetric and to reduce the medication costs in obstetrics and gynaecology.

“We also want to improve the quality of information available to women and healthcare professionals, increase the number of patients attending for antenatal care for early pregnancy, improve choice by developing and delivering new models of maternity care, develop and implement national guidelines and improve the quality of analysis of key clinical performance indicators.”

PICTURED: Prof. Michael Turner

CLINICAL CARE | 23

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The unique delivery system of NuvaRing1,2,†

ClinicalCare2013_1_104.indd 24

PREGNANCY AND LACTATION: Not recommended. Common Undesirable effects: Vaginal infection, depression, decreased libido, headache, migraine, abdominal pain, nausea, acne, pelvic pain, breast tenderness, genital pruritis, female dysmenorrhoea, vaginal discharge, weight increased, discomfort, device expulsion. See SPC for full details of other uncommon side effects. OVERDOSE: No reports of serious effects from overdose. Legal Category: Prescription Medicine Product Authorisation Number: PA 61/29/1. Product Authorisation holder: Organon Ireland Limited, P.O. Box 2857, Drynam Road, Swords, Co. Dublin, Ireland. Please refer to the full SPC text before prescribing this product. Adverse events should be reported. Reporting forms and information can be found at www. yellowcard.gov.uk (UK) and www.imb.ie (Ireland). Adverse events with this product should also be reported to Schering-Plough Drug Safety Department on +44 (0)1707 363773. Date of review: January 2012 † The only vaginal contraceptive ring in Ireland References: 1. Nuvaring Summary of Product Characteristics August 2010 2. MIMS Ireland, Dec 2011 3. Novák A, de la Loge C, Abetz L, van der Meulen EA. The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability. Contraception.

2003;67(3):187-194.

Further information is available on www.medicines.ie or on request from MSD, Pelham House, South County Business Park, Leopardstown, Dublin 18.

Date of preparation: January 2012

Pelham House, South County Business Park, Leopardstown, Dublin 18.

01-14-WOMN-1022662-0000

Nuvaring 0.120 mg/0.015mg per 24 hours vaginal delivery system® (See SPC before Prescribing) Etonogestrel and ethinylestradiol PRESENTATION: Vaginal ring. USES: Contraception. Dosage and Administration: A ring should be inserted into the vagina and left in for 3 weeks. Strictly follow insertion instructions. CONTRAINDICATIONS: Presence/history of venous thrombosis, with/without the involvement of pulmonary embolism. Presence/history of arterial thrombosis or prodromi of a thrombosis. Known predisposition for venous/arterial thrombosis, with/without hereditary involvement or the presence of severe/multiple risk factors. History of migraine with focal neurological symptoms. Diabetes mellitus with vascular involvement. Pancreatitis or history thereof if associated with severe hypertriglyceridemia. Presence/history of severe hepatic disease if liver function values abnormal. Presence/history of liver tumors. Known/suspected sex-hormone dependent tumors. Undiagnosed vaginal bleeding. Hypersensitivity to any ingredients.

PRECAUTIONS AND WARNINGS: No epidemiology data available on vaginal administration but the warnings for combined OCs (COCs) are considered applicable. Risk of breast cancer possibly similar to that associated with COCs. This may be due to earlier diagnosis in COC users, the biological effects of the COC, or a combination of both. Use of hormonal contraceptives has been associated with increased risk of venous thromboembolism (VTE, DVT, PE) and arterial thrombosis. It is unclear whether NuvaRing carries the same risk. Remove ring in event of a thrombosis and before long-term immobilisation. Council patients on symptoms of thrombosis. Increased risk of cervical cancer in long term COC users has been reported, but this may be confounded by other factors. Abnormal liver function or liver tumors. Increased risk of pancreatitis in women with hypertriglyceridemia taking hormonal contraceptives. Hypertension. Diabetes. Crohn’s disease/ulcerative colitis. Chloasma. History during pregnancy/previous use of sex steroids: jaundice and/or pruritis related to cholestasis, gallstone formation, porphyria, SLE, HUS, Sydenham’s chorea, herpes gestationis, otosclerosis. Remove ring if there is increased frequency/severity of migraine. Increased risk of thromboembolism in the puerperium. May not be suitable for women with a prolapse or severe constipation. Consider incorrect positioning in case of cystitis. Occasional vaginitis. Very rarely it has been reported that the ring adhered to vaginal tissue, necessitating removal by a healthcare provider.If ring accidentally expelled follow SPC instructions. INTERACTIONS: Possible interactions with phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, penicillins, tetracyclines, ciclosporin, lamotrigine and St John’s Wort. Use of antimycotic ovules may increase the chance of ring disconnection.

13/03/2013 17:26:43

©istockphoto/thinkstock.com

Geriatrics FEATURE

A major change in the delivery of

specialised care for older people M

Meeting the societal and health care needs of our changing ageing demographic will take a lot of reorganisation, particularly of how care is delivered, according to Dr. Diarmuid O’Shea, Clinical Lead of the HSE National Clinical Programme for Older People and Consultant Physician in Geriatric Medicine at St. Vincent’s University Hospital, Dublin.

Maureen Browne reports.

eeting the societal and health care needs of our changing ageing demographic will take a lot of reorganisation, particularly of how care is delivered. This type of reorganisation is required to provide the kind of care people require to maximise their own health care outcomes when illness and frailty strike. Doing this while staying truly person and patient centred will not be easy - and education will play a big part, according to Dr. Diarmuid O’Shea, Clinical Lead of the HSE National Clinical Programme for Older People and Consultant Physician in Geriatric Medicine at St. Vincent’s University Hospital, Dublin.

The second part of this model would do likewise for ongoing care in the community – including general practice and primary care which is being lead out by the ICGP and HSE – Dr Tony Lee. Dr. O’Shea said this would be the start of a major change in the way specialised care for older people in Ireland will be delivered.

The number of people over the age of 65 in this country is projected to increase from 535,400 in 2011 to 885,600 in 2016 and to soar to 1.2 million in 2041. The numbers aged over 85 are set to increase from 58,400 in 2011 to 116,300 in 2026 and to 248,200 in 2041. The hospital care model, which will be the initial focus of the Clinical Programme for Older People, covers standards and principles by which

01-14-WOMN-1022662-0000

He said the National Clinical Programme for Older People has set out in Part 1 of its model of care what will guide the principles and ethos by which health care professionals in the acute hospital sector can provide improved and high quality care for older people, This was the initial focus of the Model of Care for Specialist

Geriatric Services. It had been developed in conjunction with representatives of the nursing, health and social care professionals, clinicians, HSE Services for Older People, patients and their advocacy groups.

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To you, it’s about getting the help you need.

To us, it’s personal.

• Companionship & Medication Reminders

• Light Housekeeping & Laundry

• Dementia & Alzheimer’s Care

• Meal Preparation

• Respite Care

• Personal Care

• Transportation & Errands

• Post Hospital Care

• Disability Care

18 Offices in Ireland

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| homeintsead.ie 13/03/2013 17:26:48

e

Geriatrics FEATURE

health care professionals in the acute hospital sector can provide high quality care for older people.

It will involve access to Specialist Geriatric Teams, (SGTs), dedicated Specialist Geriatric Wards, (SGWs) Multidisciplinary Teams (MDTs).

Rehabilitation, Ambulatory Day Care, Outreach to Long Term Care and timely access to home supports and long term care. The benefits would be to improve outcomes and give a person the best chance of getting back to their own home. Patients would be more likely to go home, less likely to have an extended hospital stay, less likely to decline functionally when in the hospital and less likely to go into a nursing home.

Dr. O’Shea said that planning effectively for population ageing and the predicted growth would have positive consequences for health and well being of the whole population. He said there might well be some differences in the emphasis placed on which components of the model were required in the health care regions around the country. “We want to build on the variety of excellence and innovation already being implemented by the motivated and hardworking health care professionals looking after older people.

“Future developments such as the implementation of a Single Assessment Tool across services for older will drive coordination and coherence between the community and hospital sectors and allow ease of data transfer between all services.”

The new Programme is all about integration and not working in isolation – integration between the Emergency Department, the Acute Medical Unit, CPOP, the community older persons, GPs, mental health services and surgical care. Dr. O’Shea said timely access to all patients in all specialties was dependent on access to home supports and longterm care, family supports and voluntary support “This should be a resource available in a timely manner, with ease and equitable access for all older adults

discharged from the acute hospital.

“We want the system that works in an organised, co-ordinated and coherent manner and focuses on not just admission to the acute hospital sector, but on the community and discharge implementation.”

He said the aims of the service which were the delivery of care to vulnerable older adults in the community, and throughout their acute hospital course required a specific focus both for geriatric medicine and training in geriatric medicine for doctors and all other health care professionals in responding to this combination of acuity and complexity.

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Patients would be more likely to go home, less likely to have an extended hospital stay, less likely to decline functionally when in the hospital and less likely to go into a nursing home.”

A particular challenge for the specialty of geriatric medicine was to maintain their other areas of expertise while contributing to the development of the acute medical services.

“Not all older patients can, will or need to be looked after by geriatricians, but all patients should expect that those who do provide their care have training and competence in geriatric medicine as a core element of their training.

“It is here also that education will have a key role to play – not just from undergraduate, through to post graduate and beyond in all health care disciplines but also in schools.

“Our Model of Care has been developed by and in consultation with representatives of the clinicians, nursing, health and social care professionals, other health care providers, HSE Services for Older people and patients and their advocacy forum in the HSE – many have been involved via the RCPI, the HSE the CAG and WAG – and I would like to sincerely thank each and everyone of them. “This is particularly timely as recent international evidence (Cochrane review) demonstrates striking efficiency of this acute geriatric medicine model, with substantial reductions in death,

CLINICAL CARE | 27

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FEATURE Geriatrics

H O C

}

“For each of us, the personal challenge in knowing that we are likely to live longer is to make the lifestyle choices so that these added years are healthy years. This challenge does not start at the age of 65, it starts when we are much younger.”

H s p

H u N Y C

T T

1. Improve outcomes for older people admitted – so that they were more likely to go home rather than go to a nursing home, more likely to get out of hospital quickly and with less functional decline, while at the same time advocating for better access to community services.

2. Improve quality and access for the older person admitted to hospital.

3. Improve outcome for the older person admitted to hospital.”

Ultimately it would give a person the best chance of remaining in their own home. Whilst being cognisant of the pressures being placed on everybody by current financial constraints.

Dr. O’Shea said we knew that older people were attending hospital in greater numbers and needed admission more frequently than younger people and we must “age attune” the health care service delivery to decrease the likelihood of poor outcomes for these

patients – which in fact included all of us. At present older patients who were admitted to hospital were more likely to have longer lengths of stay, suffer from poorer outcomes like death, functional decline, and subsequently more likely to need added home supports or be discharged to nursing homes.

“We have all have a duty to ensure that health care provision for older people is identified as one of the main priorities in our continuing recovery as a country and we must not miss the opportunity to have a plan and system in place for this as our society ages in the years to come. “Not all older people will need this type of specialist care, in particular those who are functionally independent, and do not have complex medical or care needs (and we know from Irish data for example that the majority (80 – 90 per cent) of people over the age of 70 live well and independent lives at home.) “Meeting the societal and health care needs of our changing ageing demographic will take a lot of reorganisation in particular how care is delivered.

“We all like progress but if we are

honest we find the change bit of that difficult. We face a major challenge in reorganising ourselves as health care professionals to deliver the highest quality and standards of care for our patients.

A O f i

“We also face a major challenge in redesigning the health care system we all work in – making it coordinated and coherent. This reorganisation is required to provide the kind of care people require to maximise their own health but also improve their health care outcomes when illness strikes.

C 4 e a i c e

“Doing all this while staying truly person and patient centred will not be easy – and education will play a big part in this.

For each of us, the personal challenge in knowing that we are likely to live longer is to make the lifestyle choices so that these added years are healthy years. This challenge does not start at the age of 65, it starts when we are much younger. Clearly these challenges are not purely personal. It is also a challenge for Irish society, Irish policy makers and Government.”

©cornstock/thinkstock.com

disability and institutionalisation compared to general medicine.” He said the implementation of the new programme would:

T O p

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O W t q f

13/03/2013 17:26:51

HOME INSTEAD SENIOR CARE OFFER INDEPENDENCE TO CHANGE THE FACE OF AGEING Home Instead Senior Care is part of an international organisation of nearly 1000 offices that provide a wide range of services to older people allowing them to remain independent and live in their home for longer than would otherwise be possible.

Home Instead have 18 offices in Ireland since opening the first office in Leopardstown, Dublin in June 2005. The organisation in Ireland was set up by Michael Kearney and Ed Murphy who have operated Snap Printing in Ireland for many years. Since then, Home Instead have won the National Small Business of the Year Award in 2007 and Franchise of the Year Award in 2008 and 2011, been finalist in the Entrepreneur of the Year Awards 2009, and most recently winner of Health Care Provider of the Year Award in the InBusiness Editors’ Choice Awards and National Champion in the European Business Awards 2012/13.

The Services Provided by Our Trained CAREGiver Team Includes: • Personal care (such as meal preparation, assistance with personal hygiene, grooming and medication reminders) • Home care (such as light housekeeping, laundry and local transportation) • Respite and Convalescent care • Post Hospital care • Dementia and Alzheimer’s care • Care for people with physical and sensory disabilities • Overnight and Live-in care • Assistance & advice on Old Age Pension Entitlements and Community Services About Our CAREGivers Our CAREGivers are employees not contractors, which means we pay for their wages, PRSI, training, holidays, public and employers liability insurance and are supervised by our Quality Control personnel.

CAREGivers complete extensive application forms, submit at least 4 references, are interviewed and Garda-checked before being employed with Home Instead. Once hired, they start comprehensive and continuous Fetac Level-5 accredited training. This training includes patient handling, personal care, dementia care and advanced care for seniors. Over 70 percent of our CAREGivers have previous experience of caring prior to working with Home Instead.

Our Charges We charge on a rate per hour basis. This rate per hour includes the CAREGiver’s wages, training, PRSI, holidays, insurance and quality control by our Care Manager. We have a discounted flat rate for Live-in care.

Tax Relief Our client or their family can avail of tax relief of either 41% or 20% on payments to Home Instead Senior Care of up to ?50,000 per annum.

ClinicalCare2013_1_104.indd 29

Our Services work as follows: • When we get enquiries, we visit the person to assess their needs and gather enough information so that we can match the client with the most compatible CAREGiver.

• We maintain a panel of qualified CAREGivers ranging from age 18 to 80, making it possible to ensure client-CAREGiver compatibility. Our specialised software helps us do searches for suitable CAREGivers and organise scheduling.

• In the event of our CAREGiver being sick or on holidays, we will provide suitable cover.

• We bring and introduce the CAREGiver to the client. The introduction includes leaving a Communications Journal in our client’s house for ongoing communications between all parties involved in the care.

• Our Care Manager visits our clients on a periodic basis to support and supervise the CAREGiver, assess the continuing needs of the client and monitor the quality of service.

Benefits of Using Home Instead Senior Care • We handle the administration of payroll, payroll taxes, PRSI, holidays and employers & public liability insurance.

• Our service includes a free in-home consultation and continues with ongoing status reports and dialogue with client’s family.

• It is private care, so you decide the hours, whether 3 hours a week, or 24/7 x 365 days a year. We will increase or reduce hours as the client’s needs change.

• Family harmony is maintained by having an outside professional rather than some family members having to take the full responsibility of care.

• We have a bank of CAREGivers and so can provide care on short notice.

• Our office is manned by trained professionals who are responsive to the many needs of clients, their families and our CAREGivers.

Benefits of Home Care Services • Older people now have a real option to continue living in their own home (where they are happier and live longer) rather than having to go to a nursing home or a hospital for care.

• Our over-stretched hospitals have Home Instead as an option when having to discharge patients more quickly from hospital, and can be confident these patients will receive professional, quality, convalescent care.

• Older people and their families can save money by staying at home rather than paying the high costs of nursing home care.

Tel: 1890 930013 Email: info@homeinstead.ie www.homeinstead.ie Each office is independently owned and operated.

13/03/2013 17:26:51

FEATURE Science in Progress

An element of change A first in class potassium channel opener for the adjunctive treatment of adults with partial epilepsy.1

For more information please visit www.trobalt.ie Trobalt is for adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy1 TROBALT ABRIDGED PRESCRIBING INFORMATION (API).

(Please referto the full Summary of Product Characteristics before prescribing) PRESENTATIONS: Trobalt 50mg, 100mg, 200mg, 300mg & 400mg film-coated tablets contain 50mg, 100mg, 200mg, 300mg or 400mg of retigabine, respectively. INDICATION: Adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy. POSOLOGY & ADMINISTRATION: Titrated, according to individual patient response. Max total daily starting dose is 100 mg three times daily. The total daily dose is increased by a max of 150 mg every week. An effective maintenance dose is between 600 mg/day and 1,200 mg/day. Max total maintenance dose is 1,200 mg/day. When withdrawing Trobalt, the dose must be gradually reduced. Renal Impairment: No dose adjustment required in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min). A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe renal impairment (creatinine clearance <50 ml/min). The total daily starting dose is 150 mg & should be increased by 50 mg every week, to a max total dose of 600 mg/day. The effect of haemodialysis on retigabine clearance has not been adequately evaluated. Hepatic Impairment: No dose reduction required in patients with mild hepatic impairment (Child Pugh score 5 to 6). A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe hepatic impairment (Child Pugh score ≥7). The total daily starting dose is 150 mg & should be increased by 50 mg every week, to a maximum total dose of 600 mg/day. Paediatric population: No data is available. Elderly (65 years of age & above): There is only limited data. The total daily starting dose is 150 mg/day and should be increased by a max of 150 mg every week, according to the individual patient response and tolerability. Doses greater than 900 mg/day are not recommended. Method of administration: Trobalt must be taken orally in three divided doses each day. It may be taken with or without food. The tablets should be swallowed whole, and not chewed, crushed or divided. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients. SPECIAL WARNINGS & PRECAUTIONS: Urinary Retention: Urinary retention, dysuria and urinary hesitation were reported in controlled clinical studies with retigabine. Trobalt must be used with caution in patients at risk of urinary retention. QT Interval: A study of cardiac conduction in healthy subjects has demonstrated that retigabine titrated to 1,200 mg/day produced a QT prolonging effect. Caution should be taken when Trobalt is prescribed with medicinal products known to increase QT interval and in patients with known prolonged QT interval, congestive cardiac failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia and in patients initiating treatment who are 65 years of age and above. In these patients it is recommended that an ECG is recorded before initiation of treatment with Trobalt and in those with a corrected QT interval >440ms at baseline, an ECG should be recorded on reaching the maintenance dose. Psychiatric disorders: Confusional state, psychotic disorders and hallucinations were reported in controlled clinical

retigabine tablets

studies with retigabine. Suicide Risk: A meta analysis of randomised placebo controlled trials of antiepileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Elderly (65 years of age & above): Elderly patients may be at increased risk of central nervous system events, urinary retention and atrial fibrillation. Use with caution in this population and a reduced initial and maintenance dose is recommended. Withdrawal Seizures: Trobalt must be withdrawn gradually to minimise the potential for rebound seizures. It is recommended that the Trobalt dose is reduced over a period of at least 3 weeks, unless safety concerns require an abrupt withdrawal. INTERACTIONS: Interaction studies have only been performed in adults. Other antiepileptic drugs: Phenytoin can reduce retigabine systemic exposure by 35% & carbamazepine can reduce retigabine systemic exposure by 33%. Administration of Trobalt at therapeutic doses may increase digoxin serum concentrations. Trobalt may increase the duration of anesthesia induced by some anaesthetics: Co administration of alcohol with retigabine (200 mg) resulted in an increase in visual blurring in healthy volunteers.

Retigabine has been shown to interfere with clinical laboratory assays of both serum and urine bilirubin, which can result in falsely elevated readings. PREGNANCY & LACTATION: Pregnancy & Antiepileptics in general: Specialist advice should be given to women who are of childbearing potential. The need for treatment with antiepileptic drugs should be reviewed when a woman is planning to become pregnant. In women being treated for epilepsy, sudden discontinuation of antiepileptic drug therapy should be avoided as this may lead to breakthrough seizures. The risk of congenital malformations is increased by a factor of 2 to 3 in the offspring of mothers treated with antiepileptic drugs. Preganancy & Trobalt: Trobalt is not recommended during pregnancy and in women of childbearing age, not using contraception as there is not adequate data from the use of retigabine in pregnant women. Breastfeeding: It is unknown whether retigabine is excreted in human breast milk. Fertility: The effect of retigabine on human fertility has not been established. ABILITY TO DRIVE & USE MACHINES: Adverse reactions such as dizziness, somnolence, diplopia and blurred vision were reported in controlled clinical studies, particularly during titration. UNDESIRABLE EFFECTS: Very common (≥1/10): Dizziness, Somnolence, Fatigue. Common (≥1/100 to <1/10): Weight increased, Increased appetite, Confusional state, Psychotic disorders, Hallucinations, Disorientation, Anxiety, Amnesia, Aphasia, Coordination abnormal, Vertigo, Paraesthesia, Tremor, Balance disorder, Memory impairment, Dysphasia, Dysarthria, Disturbance in attention, Gait disturbance, Myoclonus, Diplopia, Blurred Vision, Nausea, Constipation, Dyspepsia, Dry Mouth, Increased Liver function tests, Dysuria, Urinary hesitation, Haematuria, Chromaturia, Asthenia, Malaise & Peripheral oedema. See SPC section 4.8 for a full list of Undesirable Effects. MA NUMBER: EU/1/11/681/001-013. Marketing authorisation holder: Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom. Legal category: POM. Date of preparation of API: April 2011. Copy Approval Code: IE/RTG/0002/11 Further information available on request from GlaxoSmithKline, Stonemasons Way, Rathfarnham, Dublin 16 Tel: 01-4955000.

Adverse events should be reported. Reporting forms and information can be found www.medicines.ie/yellowcardreporting.aspx IE/RTG/0034/12 Date of preparation: November 2012

IE_RTG_0034_12_Trobalt_Advert_A4_4Dec2012.indd 1 ClinicalCare2013_1_104.indd 30

Adverse events should be reported to 1800-244 255 or Ireland.drugsurveillance@gsk.com

04.12.2012 13/03/2013 09:19:38 17:26:54

9:19:38

Epilepsy FEATURE

Significant reduction

in epilepsy waiting lists

The appointment of specialised nurses to triage epilepsy patients has resulted in very significant reductions in waiting lists over the last 12 months, while a new initiative is saving thousands of bed days a year, according to Dr. Colin Doherty, National Clinical Lead of the HSE Clinical Programme on Epilepsy and Consultant Neurologist, St. James’s Hospital, Dublin. Maureen Browne reports.

The appointment of specialised nurses to triage epilepsy patients has resulted in very significant reductions in waiting lists over the last 12 months, while a new initiative is saving thousands of bed days a year, according to Dr. Colin Doherty, National Clinical Lead of the HSE Clinical Programme on Epilepsy and Consultant Neurologist, St. James’s Hospital, Dublin.

He said that over the last months significant progress had been made on the four main components of the program - ambulatory care, the treatment of acute seizures at hospital level, caring for highly complex epilepsy patients and education and governance for the specialty.

Epilepsy is a chronic disease characterized by unpredictable, sometimes lifelong, often dangerous seizures which result in involuntary alterations in behaviour and consciousness. The condition affects about one in every 100 people and is second only to stroke as the commonest chronic neurological disorder in Europe.

Of the 40,000 sufferers in Ireland (10,000 0f whom are under 16 years), only about 70 per cent are well controlled on medication, leaving about 12,00015,000 people who have breakthrough seizures, and are in regular contact with secondary and tertiary hospital services.

The condition kills about 130 people per year. Many patients with epilepsy suffer from mental health problems, and the condition has significant implications

PiCtUReD: Dr Colin Doherty

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FEATURE Epilepsy

for social, vocational and occupational aspirations.

The National Epilepsy Care Programme has been charged with addressing the historic deficiencies in epilepsy care through a comprehensive change programme that delivers care from cradle to grave in epilepsy.

Dr. Doherty has a five-year vision for the transformation of epilepsy care in Ireland.

By then he envisages a whole cohort of new experts in nursing will be helping to manage the requirements of good quality care in this chronic disorder. Care will be centralized in six regional epilepsy centres when necessary and decentralized in a structured primary care programme where possible. A sophisticated and robust means of electronic information management will be developed within which the important evidence-based metrics underlying good clinical practice will be gathered. Front-line physicians delivering care at the emergency room interface will be provided with an integrated care pathway that will reduce admissions and length of stay, whilst improving patient safety by eliminating treatment variability. Finally, for the 15 per cent or so of very difficult to control epilepsy, the once well-funded national epilepsy surgical programme, will be enhanced and expanded over two sites to provide world-class access to complex but potentially curative surgery.

Looking at progress made over the last year he said that in the area of ambulatory care, the Programme’s objective was to have approximately 30 advanced nurse practitioners in place. Thirty nurses would give a ratio of one nurse per 140,000 patients. That would include adults and paediatrics, with the split being nine paediatric nurses and 21 adult nurses.

“About two thirds of these nurses are now in place but we have hit a big snag in relation to the employment pause. However, I am pleased to see a commitment to delivering the objectives of the Clinical Programmes in this year’s HSE Service Plan and I am optimistic

that the appointment of epilepsy nurses appointments will not necessarily be subject to the same strict controls this year.”

Dr. Doherty said that a problem was that the current advanced nurse practitioner cover around the country was patchy. The North East, The West and Dublin Mid Leinster areas had their full complement but there were shortages in Sligo and Cork. However, this provided an impetus to get sorted out, as otherwise there would be a disparity in the service. “We are working on a national programme, the nurses are in contact with each other and we are working to reduce variations across the system and it has been very positive.

Despite the lack of specialised nurses in Cork, I think the waiting list there is on target to be down to down to about a month. The Dublin Mid Leinster waiting list generally is also down to a month and Beaumont has brought its list down from 18 to 12 months, because of the nurses triaging cases.

“The second piece of work is the treatment of acute seizures at hospital level. The Programme has promised delivery savings and apart from the improvement in the quality of care, this has huge potential to deliver savings.

“Reducing bed days is a key feature of what we said we would do to pay for the investment in nurses. We are rolling out our integrated care pathway involving Emergency Departments very effectively in Dublin mid Leinster and we have shown that we can reduce the median length of stay from five to two days.

That means a saving of about 1,000 bed days a year in St. James’s alone and thousands of beds days in hospitals around the country. This programme is now being implemented in other larger hospitals outside the Dublin mid Leinster area. The model of care relies not so much on neurology or epilepsy staff but is about co-operation with the Emergency Departments and the acute medicine programmes.”

The third strand of the work is the provision of manpower and facilities to

}

We are rolling out our integrated care pathway involving Emergency Departments very effectively in Dublin mid Leinster and we have shown that we can reduce the median length of stay from five to two days.” help care for the 4000 – 5000 highly complex epilepsy patients in the country who should be evaluated for surgery. The overall death rate from epilepsy is one in 1, 000, but in this very difficult group it is one in 100 per year.

“This group of patients are at risk and need to be evaluated for possible surgery. We made the first investment in this area for over 30 years (since Dr. Hugh Staunton set up the service in Beaumont.) Since then there have been just two pre surgical evaluation beds available in Beaumont. We have increased this to six, spread between Beaumont and Cork, so effectively we have trebled the number of available beds. We are about to open a state of the art epilepsy monitoring units in Beaumont. and Cork. We need these units to be self sustaining national units and they need ten nurses across the two sites. However, with the employment embargo we haven’t been able to achieve this and as a result we have funded a state of thee art monitoring unit but do not have staff to run it.

“Again it is crucial that we go forward with this, but again I am optimistic that employment controls will be less rigid this year and we can employ the necessary nurses. The final piece of work is on education and governance. We have a Masters programme in nursing in the Royal College of Surgeons in Ireland which has been most successful. We have a set of key performance indicators and we will start to report on them nationally in the first quarter of this year.”

32 | CLINICAL CARE

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IE_RT

An element of change A first in class potassium channel opener for the adjunctive treatment of adults with partial epilepsy.1

For more information please visit www.trobalt.ie Trobalt is for adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy1 TROBALT ABRIDGED PRESCRIBING INFORMATION (API).

(Please referto the full Summary of Product Characteristics before prescribing) PRESENTATIONS: Trobalt 50mg, 100mg, 200mg, 300mg & 400mg film-coated tablets contain 50mg, 100mg, 200mg, 300mg or 400mg of retigabine, respectively. INDICATION: Adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy. POSOLOGY & ADMINISTRATION: Titrated, according to individual patient response. Max total daily starting dose is 100 mg three times daily. The total daily dose is increased by a max of 150 mg every week. An effective maintenance dose is between 600 mg/day and 1,200 mg/day. Max total maintenance dose is 1,200 mg/day. When withdrawing Trobalt, the dose must be gradually reduced. Renal Impairment: No dose adjustment required in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min). A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe renal impairment (creatinine clearance <50 ml/min). The total daily starting dose is 150 mg & should be increased by 50 mg every week, to a max total dose of 600 mg/day. The effect of haemodialysis on retigabine clearance has not been adequately evaluated. Hepatic Impairment: No dose reduction required in patients with mild hepatic impairment (Child Pugh score 5 to 6). A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe hepatic impairment (Child Pugh score ≥7). The total daily starting dose is 150 mg & should be increased by 50 mg every week, to a maximum total dose of 600 mg/day. Paediatric population: No data is available. Elderly (65 years of age & above): There is only limited data. The total daily starting dose is 150 mg/day and should be increased by a max of 150 mg every week, according to the individual patient response and tolerability. Doses greater than 900 mg/day are not recommended. Method of administration: Trobalt must be taken orally in three divided doses each day. It may be taken with or without food. The tablets should be swallowed whole, and not chewed, crushed or divided. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients. SPECIAL WARNINGS & PRECAUTIONS: Urinary Retention: Urinary retention, dysuria and urinary hesitation were reported in controlled clinical studies with retigabine. Trobalt must be used with caution in patients at risk of urinary retention. QT Interval: A study of cardiac conduction in healthy subjects has demonstrated that retigabine titrated to 1,200 mg/day produced a QT prolonging effect. Caution should be taken when Trobalt is prescribed with medicinal products known to increase QT interval and in patients with known prolonged QT interval, congestive cardiac failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia and in patients initiating treatment who are 65 years of age and above. In these patients it is recommended that an ECG is recorded before initiation of treatment with Trobalt and in those with a corrected QT interval >440ms at baseline, an ECG should be recorded on reaching the maintenance dose. Psychiatric disorders: Confusional state, psychotic disorders and hallucinations were reported in controlled clinical

retigabine tablets

studies with retigabine. Suicide Risk: A meta analysis of randomised placebo controlled trials of antiepileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Elderly (65 years of age & above): Elderly patients may be at increased risk of central nervous system events, urinary retention and atrial fibrillation. Use with caution in this population and a reduced initial and maintenance dose is recommended. Withdrawal Seizures: Trobalt must be withdrawn gradually to minimise the potential for rebound seizures. It is recommended that the Trobalt dose is reduced over a period of at least 3 weeks, unless safety concerns require an abrupt withdrawal. INTERACTIONS: Interaction studies have only been performed in adults. Other antiepileptic drugs: Phenytoin can reduce retigabine systemic exposure by 35% & carbamazepine can reduce retigabine systemic exposure by 33%. Administration of Trobalt at therapeutic doses may increase digoxin serum concentrations. Trobalt may increase the duration of anesthesia induced by some anaesthetics: Co administration of alcohol with retigabine (200 mg) resulted in an increase in visual blurring in healthy volunteers.

Retigabine has been shown to interfere with clinical laboratory assays of both serum and urine bilirubin, which can result in falsely elevated readings. PREGNANCY & LACTATION: Pregnancy & Antiepileptics in general: Specialist advice should be given to women who are of childbearing potential. The need for treatment with antiepileptic drugs should be reviewed when a woman is planning to become pregnant. In women being treated for epilepsy, sudden discontinuation of antiepileptic drug therapy should be avoided as this may lead to breakthrough seizures. The risk of congenital malformations is increased by a factor of 2 to 3 in the offspring of mothers treated with antiepileptic drugs. Preganancy & Trobalt: Trobalt is not recommended during pregnancy and in women of childbearing age, not using contraception as there is not adequate data from the use of retigabine in pregnant women. Breastfeeding: It is unknown whether retigabine is excreted in human breast milk. Fertility: The effect of retigabine on human fertility has not been established. ABILITY TO DRIVE & USE MACHINES: Adverse reactions such as dizziness, somnolence, diplopia and blurred vision were reported in controlled clinical studies, particularly during titration. UNDESIRABLE EFFECTS: Very common (≥1/10): Dizziness, Somnolence, Fatigue. Common (≥1/100 to <1/10): Weight increased, Increased appetite, Confusional state, Psychotic disorders, Hallucinations, Disorientation, Anxiety, Amnesia, Aphasia, Coordination abnormal, Vertigo, Paraesthesia, Tremor, Balance disorder, Memory impairment, Dysphasia, Dysarthria, Disturbance in attention, Gait disturbance, Myoclonus, Diplopia, Blurred Vision, Nausea, Constipation, Dyspepsia, Dry Mouth, Increased Liver function tests, Dysuria, Urinary hesitation, Haematuria, Chromaturia, Asthenia, Malaise & Peripheral oedema. See SPC section 4.8 for a full list of Undesirable Effects. MA NUMBER: EU/1/11/681/001-013. Marketing authorisation holder: Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom. Legal category: POM. Date of preparation of API: April 2011. Copy Approval Code: IE/RTG/0002/11 Further information available on request from GlaxoSmithKline, Stonemasons Way, Rathfarnham, Dublin 16 Tel: 01-4955000.

Adverse events should be reported. Reporting forms and information can be found www.medicines.ie/yellowcardreporting.aspx IE/RTG/0034/12 Date of preparation: November 2012

IE_RTG_0034_12_Trobalt_Advert_A4_4Dec2012.indd 1 ClinicalCare2013_1_104.indd 33

Adverse events should be reported to 1800-244 255 or Ireland.drugsurveillance@gsk.com

04.12.2012 13/03/2013 09:19:38 17:26:58

PD therapy with Baxterâ&#x20AC;&#x2122;s low-glucose PD prescription

RR-RD-449 Aproval date: November 2012

Start Strong and Stay Strong

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Renal Programme FEATURE

The HSE

Renal Programme

© istockphoto/thinkstock.com

The HSE Renal Programme has established a National Home Haemodialysis Programme, and five hospitals – Beaumont Hospital, Waterford Regional Hospital, Cork University Hospital, Galway University Hospital and A.M.N.C.H. - are now approved sites for training patients for Home Haemodialysis, according to Dr. Liam Plant, National Clinical Director of the HSE National Renal Office, and Consultant Renal Physician, Cork University Hospital. Maureen Browne reports.

“

H

ome-based dialysis therapies offer a significantly improved quality of life for selected patients and are less costly than Centre-based therapies” Dr. Plant said.

He said that, in 2012, the rate of kidney transplantation from Deceased Donors remained at a satisfactory level, and that the rate of Living Donor kidney transplantation has continued to increase. The National Renal Office is working closely with the National Organ Donation and Transplantation Office, which is leading on all aspects of organ transplantation in Ireland, to increase this rate in the future. In 2012 there were over 160 kidney transplants performed by the National Renal Transplant Unit at Beaumont Hospital, and an increased proportion (over 30) of these were from Living Donors.

“At the end of 2012, more than 2,000 patients had a functioning kidney transplant, more than 1,500 patients were receiving long-term Centrebased Haemodialysis and more than 200 patients were performing either Home Peritoneal Dialysis or Home

Haemodialysis. The number of people with End-Stage Kidney Disease (ESKD) continues to rise every year, but the number of people with a functioning kidney transplant is increasing at a rate greater than the number treated by dialysis. Between 2007 and 2011, the number of people with a functioning kidney transplant increased by 24% (384), whereas the number on dialysis of any kind increased by 15% (248).”

Dr. Plant said that the ESRI Activity in Acute Public Hospitals Annual Report 2010 indicated that 21.2% of all Day Case Procedures in that year were accounted for by 187,792 Haemodialysis procedures. These account for 75% of all Centre-based Haemodialysis treatments delivered, with an additional 25% of treatments delivered in Contracted Haemodialysis Units under the clinical governance of HSE Parent Renal Units.

Between 2010 and 2012 the annual cost of Haemodialysis delivered in HSE Units decreased by €11 million, despite an increase in activity of over 10,000 treatments. This was largely due to changes in work practice and centralised co-ordination of the procurement of

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FEATURE Renal Programme

}

Diabetes, which affects 1 in 20 people in Ireland, has been responsible for 15% of all new cases of ESKD in the last decade and the prevalence of ESKD due to diabetes has more than trebled in that interval.” equipment and consumables.

“Our strategic objective for ESKD care is to maximize the proportion of patients with a functioning kidney transplant and to increase access to Home Dialysis therapies for suitable patients. Home Haemodialysis has only recently been re-introduced as a choice” said Dr. Plant. “Home Dialysis offers many positive lifestyle benefits, such as patients being able to manage their own care and fit their treatment times around their everyday lives, which can be more difficult for those receiving Centrebased therapies. We hope to increase the numbers of patients availing of these choices in 2013 and beyond.

“There have also been a number of significant developments in the provision of Centre-based Haemodialysis.

Amongst these have been: A new, state-of-the art, Haemodialysis Unit commissioned and opened in Cavan General Hospital last year, an Acute Haemodialysis Unit commissioned in Galway University Hospital (reducing the previous dependence on Merlin Park University Hospital), plans to commission four Contracted Satellite Haemodialysis Units around Dublin in 2013. Two will be sited in South Dublin, one in North Dublin and one in the North East. We then plan to commission additional Contracted Satellite Haemodialysis facilities in the Midlands and in the South East, although the precise sites for these have not yet been identified.”

ESKD in Ireland is projected to increase by between 600 and 900 patients over the next five years, partly due to the increase in diabetes, along with other risk factors such as high blood pressure, obesity and the increasing ageing of the population Diabetes, which affects 1 in 20 people

in Ireland, has been responsible for 15% of all new cases of ESKD in the last decade and the prevalence of ESKD due to diabetes has more than trebled in that interval.

The Aims of the National Renal Office are: �T o continue development of patientcentred renal services. �T o provide services to populations at local level, consistent with safe and effective care and practice. �T o develop networks of appropriately designed and maintained hospitals/ dialysis facilities, with adequate inpatient, outpatient, laboratory and radiology facilities, supporting patient care in a fully integrated manner. �T o ensure access to the most modern diagnostic and therapeutic equipment. �T o establish and maintain effective governance models to ensure that Renal Services are delivered to nationally defined standards.

The Strategic Vision for ESKD Services over the next few years envisages that: �T he number of patients with ESKD will increase by 30-40 p.m.p. (135-180 patients) per annum. �T ransplantation is the best therapy for suitable patients and represents the best value for money. �H ome therapies offer an enhanced quality therapy and represent the next best value for money. �H ospital/Clinic-based haemodialysis can also be an excellent therapy but is associated with the highest social costs, consumable costs, overhead costs, transport costs and ancillary costs. �P lanning should aim to maximise the proportion of patients receiving the best value therapies. �H SE Area-based planning will optimise regional Capacity, Configuration and Governance of services. �S ystem-wide streamlining of

Procurement, Contracting and Funding will enhance this.

Dr Plant said that the objectives of the National Renal Office for 2013 would be “to witness over 200 Kidney Transplant procedures, to make Home Haemodialysis or Home Peritoneal Dialysis more widely available (availed of by 60 per million of the population compared to the current figure of just under 50 per million of the population), to continue to roll out an integrated network of Haemodialysis Units in the regions, with Satellite Units linked to Parent Renal Units.

“We are rolling out a uniform national Renal patient management system (The Kidney Disease Clinical Patient System – KDCPMS) which will standardise the clinical datasets used in patient management, facilitating audit, activity analysis and allowing a focus on how best to improve clinical outcomes, whether a patient is resident in Waterford, Donegal, Louth or Kerry. If people transfer from one part of the country to another or have holiday dialysis at another site, the same type of clinical information about them will be available. It also means that, if a patient is called for a transplant in the middle of the night, the Transplant Unit can easily access all recent relevant clinical information about them.

KDCPMS is in use in about half of our Renal Units and we plan to introduce it into the remainder in the next 12-18 months.

“Renal Service expansion and development will be based on clinical need, in line with priorities identified by the National Renal Office and will encompass the key considerations of capacity, configuration and governance.

“World Kidney Day is on the first Thursday of March this year.

This year’s theme is ‘Acute Kidney Injury’ and focusesw on educating patients, health care professionals, administrators, and members of the public on this important and serious complication, which afflicts many patients with many different illnesses.”

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PD therapy

with Baxter’s low-glucose PD patients prescription Peritoneal dialysis (PD) provides your Peritoneal dialysis (PD) provides your patients with a strong Start Strong and Stay Strong start and may contribute to long-term success with a strong start for long-term success PD has has shown shown effective effective clinical PD clinical outcomes outcomesthat thatmake makeititaacompelling compellingchoice choicefor forrenal renal replacement therapy Compared with with conventional replacement therapy (RRT).

(RRT). Compared conventional haemodialysis haemodialysis (CHD), (CHD), PD PD can can have a positive impact on a patient’s health: have a positive impact on a patient’s health: 1,2 1,2 • PD patients have shown improved survival in the first 2 to 3 years • 3-5 • PD • PD better betterpreserves preservesresidual residualrenal renal function function3-5 6-9 • PD a strong bridge to transplant • PD is may provide a strong bridge to transplant6-9 • PD • PD preserves preserves vascular vascular access access1010

Additionally, PD can have have aa positive positive effect effecton onquality qualityofoflife lifeand andimproves improvespatient patientsatisfaction satisfaction 11 11 with therapy therapy due due to to aa manageable manageable transition transitionto toflexible flexibletreatment treatmentschedules. schedules.

Although advances in PD therapy therapy have have improved improvedpatient patientoutcomes, outcomes, there are additional approaches that can be used to help a approaches that can be used to help apatient patient 12-14 12-14 stay on therapy longer while helping reduce their metabolic risks. therapy longer while helping reduce their metabolic risks.

References: 1. Yeates K, et al. Nephrol. Dial. Transplant.

(2012) 27 (9): 3568-3575. doi: 10.1093/ndt/gfr674., 2. Mehrotra R et al. Arch Intern Med. 2011;171(2):110118. 3. Bargman JM et al. J Am Soc Nephrol.

2001;12(10):2158-2162. 4. Rumpsfeld M, et al. Perit Dial Int. 2009;29(6):637-646. 5. Jansen MA, et al. Kidney Int. 2002;62(3):1046-1053. 6. Schwenger V et al, Nephrol Dial Transplant. 2011;26(11):3761-3766. 7. Molnar MZ, et al. Clin J Am Soc Nephrol. 2012;7(2):332-341. 8. Snyder JJ, et al. Kidney Int. 2002;62(4):1423-1430. 9. United States Renal Data System. http://www.usrds.org/2006/ pdf/04_modalities_06.pdf. Accessed June 12, 2012.

10. Covic A, Nephrol Dial Transplant. 2010;25(6):17571759. 11. Kutner NG et al. Nephrol Dial Transplant.

2005;20(10):2159-2167. 12. Davies SJ et al. J Am Soc Nephrol. 2003;14(9):2338-2344. 13. Davies SJ et al.

Kidney Int. 2005;67(4):1609-1615. 14. Furuya R, Nephrol Dial Transplant. 2006;21(2):494-498.

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PD. Start Strong and Stay Strong.

For further information contact: Baxter Healthcare, Unit 7, Deansgrange Business Park, Deansgrange, Co. Dublin.

Phone: 00353 1 2065500 Fax: 00353 1 2065555 Web:www.baxterhealthcare.ie

Ref: ROI/HODIAL/12-0010 December 2012

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FEATURE Acute Coronary Syndrome

Acute Coronary Syndrome

T

he new standardised national protocol for the diagnosis and treatment of ST-Segment Elevation Myocardial Infarction (STEMI) patients have now been implemented throughout the country, as part of the HSE’s Acute Coronary Syndrome Clinical Programme, according to the Programme’s Clinical Lead, Prof. Kieran Daly, Consultant Cardiologist at University College Hospital, Galway.

Ambulances nationally have been equipped with ECG machines and personnel trained in ECG recognition, which means ECGs can be carried out in an ambulance, home or workplace.

This allows ambulance crews to make the necessary diagnosis, have a one to one

conversation with the primary PCI staff and make a decision about where to take the patient.

Prof. Daly said STEMI patients who are within 90 minutes travel time from first medical contact ( ECG diagnosis ) are taken directly to a designated Primary Percutaneous Coronary Intervention Centre (PPCI) for acute intervention to open blocked coronary arteries. If they are outside this timeframe, they are taken first to the nearest Emergency Department, where they will be assessed for thrombolysis and then transferred asap to the PPCI centre for assessment.

A small group of GPs are also giving thrombolysis out of hospital.

“STEMIs are taken directly to the PPCI centre, provided the transport time is.

©istockphoto/thinkstock.com

The new standardised national protocol for the diagnosis and treatment of ST-Segment Elevation Myocardial Infarction (STEMI) patients have now been implemented throughout the country, as part of the HSE’s Acute Coronary Syndrome Clinical Programme, according to the Programme’s Clinical Lead, Prof. Kieran Daly, Consultant Cardiologist at University College Hospital, Galway. Maureen Browne reports.

40 | CLINICAL CARE

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RRD0

clopidogrel hydrogen sulphate 75mg / acetylsalicylic acid 75mg

for Acute Coronary Syndrome (ACS)1

+

DuoPlavin® - Dual protection for ACS Patients1

 

Convenience - two proven therapies in one tablet2,3,4,5,6 Compliance* - leading to better outcomes7,8

* based on Hypertension studies 1. DuoPlavin SPC. 2.The CURE Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 2001; 345:494 - 502 3. Mehta SR,Yusuf S, Peters RJG, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H-J, Zhao F, Chrolavicius S, Copland I. for the CURE trial investigators. Effects of pre-treatment with clopidogrel and aspirin followed by longterm therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001; 358:527 - 533 4. Sabatine MS, Cannon CP, Gibson CM, et al, for the CLARITY-TIMI 28 investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med. 2005;352:1179-1189 5. Sabatine MS, Cannon CP, Gibson CM et al. Effect of clopidogrel pretreatment before percutaneous coronary intervention in patients with ST-elevation myocardial infarction treated with fibrinolytics. The PCI-CLARITY study. JAMA. 2005;294:1224-1232. 6. COMMIT Collaborative Group. Addition of clopidogrel to aspirin in 45 852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet 2005;366:1607–21 7. Bangalore S et at. Fixed-dose combinations improve medication compliance: a meta-analysis. Am J Med. 2007 Aug;120(8):713-9 8.

Gupta AK et al Compliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a meta-analysis. Hypertension. 2010 Feb;55(2):399-407

IE.GNL.09.12.01

clopidogrel hydrogen sulphate 75mg / acetylsalicylic acid 75mg

SPC available on request from stand Marketing Authorisation Number: EU/1/10/619/002 sanofi Ireland Ltd, Citywest Business Campus, Dublin 24. Date of preparation: October 2012. IE.CLO.12.10.01

RRD01098 Sanofi_Duoplavin Banner A4.indd 1 ClinicalCare2013_1_104.indd 41

17/12/2012 12:53 13/03/2013 17:27:13

FEATURE Acute Coronary Syndrome

90 minutes or less. The reason for this is that all the evidence indicates that the best treatment for STEMI is angioplasty to open the blocked artery if transfer and door to balloon time is within 120 minutes. If the transport time is longer than 90 minutes, the patient should have thrombolysis in the nearest ED (or in the field in limited circumstances) and then be moved urgently to a PPCI centre.”

Everybody, whether ED staff or ambulance crew has access to a 24/7 phone number in the PPCI centre, to allow direct contact with the cardiology staff to discuss the case briefly and decide how the patient should be managed.

PPCI centres, which are open 24/7 have been established in the Mater Hospital in Dublin’s northside, in St. James’s and St. Vincent’s University Hospital in Dublin’s southside, in University Hospital Galway, Cork University Hospital and the Mid Western Regional Hospital in Limerick.

There is a 9/5 centre in Waterford.

24/7 PPCI centres have at least five interventionist cardiologists on call and have an on-call rota of nursing, technical

}

Patients brought into a PPCI Centre are dealt with by angioplasty and repatriated very quickly, ideally on the same day or at worst the next day to keep CCU beds free in PPCI centres.” and radiological staff and at least two cath labs.

Patients brought into a PPCI Centre are dealt with by angioplasty and repatriated very quickly, ideally on the same day or at worst the next day to keep CCU beds free in PPCI centres. If they have come from a regional hospital they go back there, if they are brought direct by ambulance from home they go back to the hospital nearest their home for mobilisation and cardiac rehabilitation. Prof. Daly said that less than 20 per cent of the population is now outside the 90 minute transfer time but for all patients the new standardised, streamlined protocols should ensure earlier diagnosis and more efficient and effective treatment. The ACS protocols have the potential to save in the region of 8,000 bed days a year nationally.

“The more rapid treatment and transfer under the protocols allows STEMIs to be out of hospital one day sooner than previously, so that is one bed day saved per patient. Where the non STEMIs are concerned, the aim is where appropriate to have angiograms within 24 hours of diagnosis, which then potentially saves one bed day per patient. This means we are talking about potential savings of 8,000 bed days a year.”

new protocols was carried out in a staged basis in different areas across the country and the experience to date has been very positive.

“The whole idea was to set up a national programme where everybody would be working according to standard protocols.

Our initial work was to develop protocols based on international best practice. We analysed in detail protocols from various parts of the world, matching them with different urban and rural communities in Ireland. From the outset, it was obvious that not everyone would get the exactly the same treatment. If you live in an extremely remote part of rural Ireland you will have a different treatment pathway than if you live close to a designated PCI. But accepting that, everyone presenting with an acute coronary syndrome, no matter where they live, will now be treated according to national protocols, from their diagnosis to the completion of their treatment.”

Helicopter transfer, which was just an aspiration a year ago has now become active with the Emergency Air Ambulance Base in Athlone and the involvement of the Coastguard Helicopter Service and quite a number of ambulance transfers have been carried out both for primary PCI and post thrombolysis patients.

Prof. Daly said the implementation of the “The focus of the Programme up to now has been on the STEMIs, full blown infarcts, but there are less than 2,000 of these per year. The other main acute coronary syndrome is the non STEMI and we will now be moving on to look at these, which are less acute but equally life threatening in the long term. The non STEMIs is a much bigger group – about 6,000 cases occur each year - and the challenge will be how we can arrange more efficient inter hospital transfer and management for these patients.

42 | CLINICAL CARE

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NEW oral anti-platelet treatment for a broad range of ACS patients

BRILIQUE saves more lives than clopidogrel as measured by CV deaths (PLATO study)1

BRILIQUETM 90MG FILM-COATED TABLETS (ticagrelor) Abridged Prescribing Information (For full details see Summary of Product Characteristics (SmPC)) Use: Adults aged 18 years and older, co-administered with acetylsalicylic acid (ASA) daily: for the prevention of atherothrombotic events in patients with acute coronary syndromes (unstable angina, non-ST-segment elevation myocardial infarction [NSTEMI] or ST-segment elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

Presentation: 90mg ticagrelor film-coated tablets. Dosage and administration: Treatment should be initiated with a single 180mg loading dose (two tablets of 90mg) and then continued at 90mg twice daily. Following an initial dose of ASA, patients should also take a daily maintenance dose of 75-150mg of ASA with Brilique, unless ASA is specifically contraindicated. Treatment is recommended for up to 12 months unless discontinuation is clinically indicated. Premature discontinuation of treatment or lapses in therapy should be avoided. Patients treated with clopidogrel can be directly switched to Brilique. For oral use. Contraindications: Hypersensitivity to the active substance or to any of the excipients.

Active pathological bleeding. History of intracranial haemorrhage. Moderate-to-severe hepatic impairment. Co-administration with strong CYP3A4 inhibitors (e.g. ketoconazole).

Precautions: Due to the increased risk of non-fatal or non-life threatening bleeding, use with caution in patients at an increased risk for bleeding (e.g. recent trauma or surgery, bleeding disorders or recent gastrointestinal bleeding) or those on concomitant medication that may increase bleeding risk (e.g. NSAIDs, anticoagulants) within 24 hours of taking Brilique. Brilique should be stopped 7 days prior to elective surgery if the antiplatelet effect is not desired. Use with caution in patients with an increased risk of bradycardic events (e.g. patients on digoxin), as asymptomatic ventricular pauses have been observed with Brilique, a history of asthma and/or COPD, a history of hyperuricaemia or gouty arthritis.

Creatinine levels may increase during treatment with Brilique. Renal function should be checked after one month and thereafter according to routine medical practice, paying special attention to patients ≥ 75 years, patients with moderate-to-severe renal impairment and those receiving concomitant treatment with an ARB. Co administration of Brilique is not recommended with a high maintenance dose of ASA (> 300mg) or with doses of simvastatin > 40mg. Co administration of ticagrelor with strong CYP3A4 inducers is discouraged, as this may lead to a decrease in exposure and efficacy of ticagrelor. Co-administration with CYP3A4 substrates with narrow therapeutic indices is not recommended. Concomitant use of ticagrelor with doses of simvastatin or lovastatin > 40mg not recommended. Caution with concomitant use of P-gp inhibitors or P-gp substrates with narrow therapeutic indices e.g. verapamil, quinidine and cyclosporin. Caution with concomitant administration of SSRIs. Brilique is not recommended during pregnancy and breastfeeding. Undesirable effects: Common: Dyspnoea, epistaxis, gastrointestinal haemorrhage, subcutaneous or dermal bleeding, bruising and procedural site haemorrhage. Other undesirable effects include intracranial bleeding, elevations of serum creatinine and uric acid levels. Consult SmPC for a full list of undesirable effects. Legal category: POM. Marketing Authorisation Number: EU/1/10/655/004. Market Authorisation Holder: AstraZeneca AB, S 151 85, Södertälje, Sweden. Further information on request from: Freephone 1800 800 899 or contact AstraZeneca UK Limited, Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU, United Kingdom. Abridged prescribing information prepared: 04/12. BRILIQUE is a trade mark of the AstraZeneca group of companies. Reference 1: Brilique Summary of Product Characteristics. URN: 12/0266. Date of preparation: May 2012

Cardiovascular ClinicalCare2013_1_104.indd 43

13/03/2013 17:27:21

Symbicort® Turbohaler® (budesonide/formoterol)

the ived Rece Design Good Japan rd Awa 10* 20

1

Easy to use

120

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High lung deposition se)² (25-40% of delivered do

Peak Inspiratory Flow3 from around 30 L/min

Symbicort® Turbohaler® – For Asthma and severe COPD

Turbohaler

Consult SmPC for full information

PRESCRIBING INFORMATION. Refer to full Summary of Product Characteristics (SmPC) before prescribing Symbicort® Turbohaler® 100/6; 200/6; 400/12; Inhalation Powder (budesonide/formoterol fumarate dihydrate) Presentations: Inhalation powder. Symbicort Turbohaler 100/6: Each metered dose contains 100mcg budesonide/inhalation and 6mcg formoterol fumarate dihydrate/inhalation. Symbicort Turbohaler 200/6: Each metered dose contains 200mcg budesonide/inhalation and 6mcg formoterol fumarate dihydrate/inhalation. Symbicort Turbohaler 400/12: Each metered dose contains 400mcg budesonide/inhalation and 12mcg formoterol fumarate dehydrate/inhalation. Uses: Asthma: Treatment of asthma where the use of a combination (inhaled corticosteroid and long acting β2 adrenoceptor agonist) is appropriate. Symbicort 100/6 is not appropriate for patients with severe asthma. COPD (Symbicort 200/6; 400/12): Symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. Dosage and Administration: Asthma (Symbicort maintenance therapy – regular maintenance treatment with a separate rescue medication): Adults (including elderly) 100/6 and 200/6: 1-2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily; 400/12: 1 inhalation twice daily. Some patients may require up to a maximum of 2 inhalations twice daily Adolescents (12-17 years) 100/6 and 200/6: 1-2 inhalations twice daily; 400/12: 1 inhalation twice daily. Children 6 years and older 100/6 only: 2 inhalations twice daily. Symbicort is not recommended for children under 6 years. Symbicort 400/12 is not recommended for children under 12 years. Not intended for the initial management of asthma. Dose should be individualised. If an individual patient requires dosages outside recommended regimen, appropriate doses of β2 adrenoceptor agonist and/or corticosteroid should be prescribed. When long-term symptoms are controlled, titrate to the lowest effective dose, which could include a once daily dosage. Asthma (Symbicort maintenance and reliever therapy – regular maintenance treatment and as needed in response to symptoms) for Symbicort 100/6 and 200/6 only (NOT recommended with 400/12 strength): especially consider for (i) patients with inadequate asthma control and in frequent need of reliever medication (ii) patients with asthma exacerbations in the past requiring medical intervention. Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of Symbicort as-needed inhalations. Adults (including elderly) 100/6 & 200/6: 1 inhalation twice daily or as 2 inhalations once daily. For some patients a dose of 2 inhalations twice daily may be appropriate (200/6 strength only). Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. A total daily dose of more than 8 inhalations is not normally needed; however, up to 12 inhalations a day could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice and should be reassessed; their maintenance therapy should be reconsidered. Patients should be advised to always have Symbicort for reliever use. Children and adolescents under 18 years of age: not recommended. COPD (200/6): Adults: 2 inhalations twice daily. (400/12): 1 inhalation twice daily. Contraindications, Warnings and Precautions etc.: Contraindications: Hypersensitivity (allergy) to budesonide, formoterol or lactose (which contains small amounts of milk proteins). Warnings and Precautions: If treatment is ineffective, or there is a worsening of the underlying condition, therapy should be reassessed. Sudden and progressive deterioration in control requires urgent medical assessment. Patients should have their appropriate rescue medication available at all times, i.e. either Symbicort or a separate reliever. If needed for prophylactic use (e.g. before exercise) a separate reliever should be used. Therapy should not be initiated during an exacerbation. Serious asthma-related adverse events and exacerbations may occur and patients should continue treatment but seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of Symbicort. Paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath after dosing. This responds to a rapid-acting inhaled bronchodilator and should be treated straightaway. As with any inhaled corticosteroid, systemic effects may occur, particularly at high doses prescribed for long periods. These may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract and glaucoma and more rarely a range of psychological or behavioral effects. Potential effects on bone should be considered especially in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis. Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may also result in clinically significant adrenal suppression. Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery. Treatment with supplementary systemic steroids or inhaled budesonide should not be stopped abruptly. During transfer from oral steroid therapy to Symbicort, a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms which will need treatment. In rare cases, symptoms such as tiredness, headache, nausea and vomiting can occur due to insufficient glucocorticosteroid effect and temporary increase in the dose of oral glucocorticosteroids is sometimes necessary. Observe caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, or severe cardiovascular disorders. As with other β2 adrenoceptor agonists, hypokalaemia may occur at high doses. Particular caution recommended in unstable or acute severe asthma as this effect may be potentiated by xanthine-derivatives, steroids, diuretics and hypoxia. Monitor serum potassium levels. Hypokalaemia may increase the disposition towards arrhythmias in patients taking digitalis glycosides. In diabetic patients, consider additional blood glucose monitoring. Symbicort contains lactose monohydrate, as with other lactose containing products the small amounts of milk proteins present may cause allergic reactions.

Interactions: Concomitant treatment with potent CYP3A4 inhibitors should be avoided. If this is not possible the time interval between administration should be as long as possible. Symbicort maintenance and reliever therapy is not recommended in patients using potent CYP3A4 inhibitors. Not to be given with beta adrenergic blockers (including eye drops) unless there are compelling reasons. Concomitant administration with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAOIs and TCAs can prolong the QTc-interval and increase the risk of ventricular arrhythmias. L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance.

Concomitant administration with MAOIs, including agents with similar properties such as furazolidone and procarbazine, may precipitate hypertension. Risk of arrhythmias in patients receiving anaesthesia with halogenated hydrocarbons. Concomitant use of other beta adrenergic drugs or anticholinergic drugs can have a potentially additive bronchodilating effect. Pregnancy and Lactation: Should only be used when the benefits outweigh the potential risks. Budesonide is excreted in breast milk, however at therapeutic doses no effects on the child are anticipated. Undesirable effects: Common: headache, palpitations, tremor, candida infections in the oropharynx, coughing, mild irritation in the throat, hoarseness. Uncommon: tachycardia, nausea, dizziness, bruises, aggression, psychomotor hyperactivity, anxiety, sleep disorders. Rare: hypokalaemia, cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles, bronchospasm and immediate and delayed hypersensitivity reactions including exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction. Very Rare: psychiatric disorders including depression, behavioural changes (predominantly in children), angina pectoris, prolongation of QTc-interval, hyperglycaemia, taste disturbance, Cushing’s syndrome, adrenal suppression, growth retardation, decrease in bone mineral density, cataract and glaucoma and variations in blood pressure. As with other inhalation therapy, paradoxical bronchospasm may occur in very rare cases. Package Quantities: Each Symbicort Turbohaler 100/6 or 200/6 contains 120 inhalations. Each Symbicort Turbohaler 400/12 contains 60 inhalations. Legal Category: Prescription Only Medicine (POM). Marketing Authorisation Number(s): PA 970/28/1-3. Marketing Authorisation Holder (MAH): AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK. Further product information available on request from: The MAH (address above), Freephone -1800 800 899. Abridged Prescribing Information prepared: 04/12. Symbicort and Turbohaler are Trade Marks of the AstraZeneca group of companies. URN: 12/0540 Date of Preparation: November 2012.

Reference: 1. Adelphi Respiratory Disease Specific Programme 2009. 2. Olof Selroos et al. Treat Respir Med 2006; 5 (5): 305-315. 3. Engel et al. Br J Clin Pharmacol 1992; 33(4): 439-44. *JIDPO (Japan Industrial Design Promotion Organisation) Good Design Award Japan 2010: http://www.g-mark.org/award/detail.html?id=36687&sheet=outline&lang=en

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Asthma FEATURE

A WELL MANAGED INTEGRATED SYSTEM

of care for asthma patients.

The overarching aim of the National Asthma Programme (NAP) is to reduce the morbidity and mortality associated with asthma in Ireland and to improve clinical outcomes and the quality of life of all patients with asthma, according to Dr. Pat Manning, Consultant Respiratory Physician and the Programme’s National Clinical Lead. Maureen Browne reports. year over the next three years through implementing our programme’s asthma guidelines and model of care, best practice and international research, according to Dr. Pat Manning, Consultant Respiratory Physician and the Programme’s National Clinical Lead.

Asthma is the most common chronic respiratory disease in the Republic of Ireland affecting people of all ages and

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all socio-economic groups. Ireland has the fourth highest prevalence of Asthma worldwide, and current estimates suggest that there are approximately 450,000 people with doctor- diagnosed asthma in Ireland (over 1 in 8 of the population).

The prevalence is even higher in children with about 21 per cent of children affected. Asthma is often underdiagnosed and uncontrolled, creating a substantial burden of ill-health to

In the first year of the programme implementation in 2011 there has been an eight per cent reduction in acute hospital bed days for acute asthma.”

© istockphoto/thinkstockphoto.com

The Overarching Aim of the National Asthma Programme (NAP) is to reduce the morbidity and mortality associated with asthma in Ireland and to improve clinical outcomes and the quality of life of all patients with asthma. A key component is improved management of people with asthma in primary care and thereby avoiding emergency attendance at GP out of hour services and at hospital ED and in-patient admission services. Already in the first year of the programme implementation in 2011 there has been an eight per cent reduction in acute hospital bed days for acute asthma. We believe that we can achieve a further fall by ten per cent or more per

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© wavebreakmedia/thinkstockphoto.com

FEATURE Asthma

individuals. Between 35 and 50 per cent of medical expenditure for asthma are a consequence of exacerbations, an asthma outcome most view as representing treatment failure. Hospitalisation, emergency department and unscheduled clinic visits, and use of rescue medication comprise the majority of exacerbationrelated treatment costs “The initial focus of the work of the NAP has been primarily on three main areas, firstly on the development and implementation of national asthma guidelines based on international best practice for acute and ongoing asthma management and national asthma education initiatives for patients and health care professionals around this; secondly on the organisation and better integration of national asthma services at primary and secondary care levels through development of a national model of care; and thirdly on a national project of auditing acute asthma deaths” said Dr. Manning.

“There was a good scientific rational for this approach which has been shown to be effective at international levels, with significantly improved outcomes leading to better asthma control in the community and significantly reducing acute asthma attendances at EDs (currently estimated at about 20,000 annually) and their associated in-patient admissions in hospital (currently about

5,000 annually) and also to prevent avoidable deaths from asthma - currently there is approx one death per week.”

National Asthma Guidelines The acute adult and paediatric asthma guidelines and associated care pathways, treatment protocols and care bundles have now been developed for use in all care settings (primary and secondary care levels) in conjunction with the HSE National Emergency Medicine Programme, the HSE Acute Medicine Programme, the HSE Paediatric Programme, and the Irish College of General Practice. (ICGP) quality in practice committee (QIP).

“The Acute Adult Emergency Guidelines are freely available through the HSE website. This user friendly resource will facilitate all healthcare staff in optimising the management of adult patients attending services with an acute asthmatic episode. Patients who attend our services with an acute asthma episode require high risk management and follow up strategies as outlined in the guideline.”

The guidelines for acute asthma in children are completed and should also be available soon on HSE website and an educational programme around this is being developed.

“In terms of implementing the acute

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Between 35 and 50 per cent of medical expenditure for asthma are a consequence of exacerbations, an asthma outcome most view as representing treatment failure. Hospitalisation, emergency department and unscheduled clinic visits, and use of rescue medication comprise the majority of exacerbation-related treatment costs.”

46 | CLINICAL CARE

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“I’m getting there, but each day is still a struggle” Maria, age 35.

Seroquel XR a next step for MDD * *Indicated for add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy.

Prior to initiating treatment, clinicians should consider the safety profile of Seroquel XR. Seroquel XR™ Abridged prescribing information (For full details see summary of product characteristics (SmPC)) Presentations: Prolonged-release tablets containing 50mg, 150mg, 200mg, 300mg and 400mg of quetiapine (as quetiapine fumarate). Uses: Schizophrenia including preventing relapse in stable schizophrenic patients who have been maintained on Seroquel XR. Treatment of bipolar disorder: treatment of moderate to severe manic episodes in bipolar disorder; treatment of major depressive episodes in bipolar disorder; prevention of recurrence in patients with bipolar disorder, whose manic or depressive episode has responded to quetiapine treatment. Add on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. Prior to initiating treatment, clinicians should consider safety profile of Seroquel XR. Dosage and Administration: Ensure that patients receive clear information on the appropriate dosage for their condition. Administer once daily, without food. To be swallowed whole, not split, chewed or crushed. Adults: Treatment of Schizophrenia and moderate to severe manic episodes in bipolar disorder: To be administered at least one hour before a meal. The daily dose at the start of therapy is 300 mg on Day 1 and 600 mg on Day 2. Recommended daily dose is 600 mg, if clinically justified the dose may be increased to 800 mg daily. Adjust dose within the effective dose range of 400 mg to 800 mg per day, depending on clinical response and tolerability. For maintenance therapy in schizophrenia no dosage adjustment necessary.

Treatment of depressive episodes in bipolar disorder: Administer at bedtime. Daily dose for the first four days is: 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Recommended daily dose is 300 mg. In clinical trials, no additional benefit was seen in the 600 mg group compared to 300 mg group. Individual patients may benefit from a 600 mg dose. Doses greater than 300 mg should be initiated by physicians experienced in treating bipolar disorder. In the event of tolerance concerns, clinical trials have indicated that dose reduction to a minimum of 200mg could be considered. For preventing recurrence in bipolar disorder: Patients who have responded to Seroquel XR for acute treatment of bipolar disorder should continue on Seroquel XR at the same dose administered at bedtime. Dose can be adjusted depending on clinical response and tolerability within the dose range of 300 mg to 800 mg/day. Use lowest effective dose for maintenance therapy. For add-on treatment of major depressive episodes in MDD: Administer at bedtime, daily dose at the start of therapy is 50mg on Day 1 and 2 and 150mg on Day 3 and 4. Use lowest effective dose for treatment, starting with 50mg/day. The need to increase the dose from 150 to 300mg /day should be based on individual patient evaluation. Elderly: Use with caution. Rate of dose titration may need to be slower and daily therapeutic dose lower than in younger patients. Patients should be started on 50mg/day and can be increased by 50mg/day to an effective dose. Efficacy & safety not evaluated in patients > 65 years with depressive episodes in framework of bipolar disorder. In elderly patients with major depressive episodes in MDD, dosing should begin at 50mg/day on Day 1-3 increasing to 100mg/day on Day 4 and 150mg/day on Day 8. Use lowest effective dose, starting from 50 mg/day. If dose increase to 300 mg/day is required this should not be prior to Day 22 of treatment. Children & Adolescents: Not recommended. Renal Impairment: No dose adjustment required. Hepatic Impairment: Use with caution. Patients should be started on 50mg/day and can be increased by 50mg/day to an effective dose, depending on clinical response and tolerability. Contra-indications: Hypersensitivity to quetiapine fumarate or excipients. Concomitant administration of cytochrome P450 3A4 inhibitors, e.g. HIV-protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin and nefazodone. Precautions and warnings: Children and adolescents (10-17yrs): not recommended if <18yrs old. Refer to SmPC for specific precautions and warnings relating to this patient group. Suicide/suicidal thoughts or clinical worsening: Refer to SmPC for information including recommendations on supervision and monitoring of all patients, particularly those at high risk. Extrapyramidal Symptoms (EPS): In clinical trials, quetiapine associated with increased incidence of EPS vs. placebo in patients treated for major depressive episodes in bipolar disorder and MDD. Quetiapine has been associated with akathisia and is most likely to occur in first few weeks of treatment – in these patients dose increase may be detrimental. Tardive dyskinesia (TD): If signs and symptoms of TD appear consider dose reduction or discontinuation. Symptoms of TD can worsen or even arise after discontinuation of treatment.

Somnolence and dizziness: quetiapine has been associated with somnolence and related symptoms, e.g. sedation. In clinical trials for bipolar depression and MDD onset was usually within the first 3 days of treatment and predominantly of mild to moderate intensity. If somnolence intensity is severe, patients may need more frequent contact for a minimum of 2 weeks after onset or until symptoms improve. Treatment discontinuation may need to be considered. Advise caution in patients regarding somnolence & dizziness (see below).

Cardiovascular: Use with caution in known cardiovascular disease (consider slower titration), cerebrovascular disease, or other conditions predisposing to hypotension. Possible initial orthostatic hypotension (and related dizziness) during the dose titration period (if it occurs consider lower dose or slower titration). Seizures: Caution where history of seizures. Neuroleptic malignant syndrome (NMS): NMS has been associated with antipsychotic treatment, including quetiapine. In the event of NMS discontinue treatment and give appropriate medical treatment. Severe neutropenia: has been uncommonly reported in clinical trials. Possible risk factors include preexisting low white cell count and history of drug-induced neutropenia. Discontinue quetiapine if neutrophil count < 1.0 x 109/L. Observe patients for sign/symptoms of infection and follow neutrophil counts until they exceed 1.5 x 109/L. Weight: weight gain should be monitored & managed as appropriate. Hyperglycaemia: Hyperglycaemia and /or development or exacerbation of diabetes (occasionally associated with ketoacidosis or coma) has been reported rarely, including some fatal cases. Observe for signs & symptoms of hyperglycaemia & regularly monitor patients with diabetes or risk factors for developing diabetes for worsening glucose control. Monitor weight gain regularly. Lipids: Increases in triglycerides, LDL and total cholesterol and decreases in HDL cholesterol observed in clinical trials – manage lipid changes as clinically appropriate. Metabolic risk: Possible worsening of the metabolic risk profile in individual patients, which should be managed as clinically appropriate. QT Prolongation: reported at therapeutic doses and in overdose. Exercise caution in patients with cardiovascular disease or family history of QT prolongation, and when quetiapine is prescribed with medicines known to increase QT interval or with concomitant neuroleptics, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia. Withdrawal: Acute withdrawal symptoms have been described after abrupt cessation of quetiapine. Gradual withdrawal (over at least 1 –2 weeks) is advisable. Elderly patients with dementiarelated psychosis: Not approved for treatment of dementia – related psychosis. Use with caution in patients with risk factors for stroke.

Dysphagia: has been reported with quetiapine. Use with caution in patients at risk for aspiration pneumonia. Pancreatitis: Pancreatitis has been reported. In many, but not all cases, patients had confounding risk factors. Venous Thromboembolism: cases have been reported, all possible VTE risk factors should be identified before & during treatment and preventive measures taken. Lactose: Contains lactose, patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interactions: Use with caution with other centrally acting drugs and alcohol. CYP3A4 inhibitors such as ketoconazole are contraindicated. Grapefruit juice (concomitant use not recommended). Hepatic enzyme inducers such as phenytoin & carbamazepine can significantly increase quetiapine clearance – refer to SmPC. Concomitant use with thioridazine caused an increased clearance of quetiapine with approx. 70%. Observe caution when used concomitantly with medicinal products known to cause electrolyte imbalance or to increase QT interval. Fertility, Pregnancy & lactation: Safety and efficacy not established – refer to SmPC. Effects on ability to drive: Advise patients not to drive or operate machinery until individual susceptibility known. Undesirable effects: Very Common: Dizziness, somnolence, headache, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin. Common: Leucopenia, decreased neutrophil count, eosinophils increased, hyperprolactinaemia, decreases in total T4, free T4, and total T3, increases in TSH, increased appetite, syncope, extrapyramidal symptoms, tachycardia, palpitations, vision blurred, orthostatic hypotension, rhinitis, dyspnoea, constipation, dyspepsia, vomiting, mild asthenia, peripheral oedema, irritability, pyrexia, elevations in serum transaminases (ALT, AST), elevations in gamma-GT levels, blood glucose increased to hyperglycaemic levels, abnormal dreams and nightmares, dysarthria, suicidal ideation and suicidal behaviour. For a full list of undesirable effects (that also includes data for children/ adolescents) refer to SmPC. Pharmaceutical precautions: No special requirements. Legal category: POM. S1A Marketing Authorisation Numbers: Seroquel XR 50mg, 150mg, 200mg, 300mg and 400mg PA 970/18/8-12 Marketing Authorisation Holder (MAH): AstraZeneca UK Ltd., Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU. Further product information available on request from: The MAH (address above), Freephone -1800 800 899. Abridged Prescribing Information prepared: 05/12. Seroquel XR is a trademark of the AstraZeneca group of companies.

Date of preparation: June 2012 URN: 12/0231

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Symbicort® Turbohaler® (budesonide/formoterol)

the ived Rece Design Good Japan rd Awa 10* 20

1

Easy to use

120

ot Patients do n their need to hold halation breath after in

High lung deposition se)² (25-40% of delivered do

Peak Inspiratory Flow3 from around 30 L/min

Symbicort® Turbohaler® – For Asthma and severe COPD

Turbohaler

Consult SmPC for full information

PRESCRIBING INFORMATION. Refer to full Summary of Product Characteristics (SmPC) before prescribing Symbicort® Turbohaler® 100/6; 200/6; 400/12; Inhalation Powder (budesonide/formoterol fumarate dihydrate) Presentations: Inhalation powder. Symbicort Turbohaler 100/6: Each metered dose contains 100mcg budesonide/inhalation and 6mcg formoterol fumarate dihydrate/inhalation. Symbicort Turbohaler 200/6: Each metered dose contains 200mcg budesonide/inhalation and 6mcg formoterol fumarate dihydrate/inhalation. Symbicort Turbohaler 400/12: Each metered dose contains 400mcg budesonide/inhalation and 12mcg formoterol fumarate dehydrate/inhalation. Uses: Asthma: Treatment of asthma where the use of a combination (inhaled corticosteroid and long acting β2 adrenoceptor agonist) is appropriate. Symbicort 100/6 is not appropriate for patients with severe asthma. COPD (Symbicort 200/6; 400/12): Symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. Dosage and Administration: Asthma (Symbicort maintenance therapy – regular maintenance treatment with a separate rescue medication): Adults (including elderly) 100/6 and 200/6: 1-2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily; 400/12: 1 inhalation twice daily. Some patients may require up to a maximum of 2 inhalations twice daily Adolescents (12-17 years) 100/6 and 200/6: 1-2 inhalations twice daily; 400/12: 1 inhalation twice daily. Children 6 years and older 100/6 only: 2 inhalations twice daily. Symbicort is not recommended for children under 6 years. Symbicort 400/12 is not recommended for children under 12 years. Not intended for the initial management of asthma. Dose should be individualised. If an individual patient requires dosages outside recommended regimen, appropriate doses of β2 adrenoceptor agonist and/or corticosteroid should be prescribed. When long-term symptoms are controlled, titrate to the lowest effective dose, which could include a once daily dosage. Asthma (Symbicort maintenance and reliever therapy – regular maintenance treatment and as needed in response to symptoms) for Symbicort 100/6 and 200/6 only (NOT recommended with 400/12 strength): especially consider for (i) patients with inadequate asthma control and in frequent need of reliever medication (ii) patients with asthma exacerbations in the past requiring medical intervention. Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of Symbicort as-needed inhalations. Adults (including elderly) 100/6 & 200/6: 1 inhalation twice daily or as 2 inhalations once daily. For some patients a dose of 2 inhalations twice daily may be appropriate (200/6 strength only). Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. A total daily dose of more than 8 inhalations is not normally needed; however, up to 12 inhalations a day could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice and should be reassessed; their maintenance therapy should be reconsidered. Patients should be advised to always have Symbicort for reliever use. Children and adolescents under 18 years of age: not recommended. COPD (200/6): Adults: 2 inhalations twice daily. (400/12): 1 inhalation twice daily. Contraindications, Warnings and Precautions etc.: Contraindications: Hypersensitivity (allergy) to budesonide, formoterol or lactose (which contains small amounts of milk proteins). Warnings and Precautions: If treatment is ineffective, or there is a worsening of the underlying condition, therapy should be reassessed. Sudden and progressive deterioration in control requires urgent medical assessment. Patients should have their appropriate rescue medication available at all times, i.e. either Symbicort or a separate reliever. If needed for prophylactic use (e.g. before exercise) a separate reliever should be used. Therapy should not be initiated during an exacerbation. Serious asthma-related adverse events and exacerbations may occur and patients should continue treatment but seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of Symbicort. Paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath after dosing. This responds to a rapid-acting inhaled bronchodilator and should be treated straightaway. As with any inhaled corticosteroid, systemic effects may occur, particularly at high doses prescribed for long periods. These may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract and glaucoma and more rarely a range of psychological or behavioral effects. Potential effects on bone should be considered especially in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis. Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may also result in clinically significant adrenal suppression. Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery. Treatment with supplementary systemic steroids or inhaled budesonide should not be stopped abruptly. During transfer from oral steroid therapy to Symbicort, a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms which will need treatment. In rare cases, symptoms such as tiredness, headache, nausea and vomiting can occur due to insufficient glucocorticosteroid effect and temporary increase in the dose of oral glucocorticosteroids is sometimes necessary. Observe caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, or severe cardiovascular disorders. As with other β2 adrenoceptor agonists, hypokalaemia may occur at high doses. Particular caution recommended in unstable or acute severe asthma as this effect may be potentiated by xanthine-derivatives, steroids, diuretics and hypoxia. Monitor serum potassium levels. Hypokalaemia may increase the disposition towards arrhythmias in patients taking digitalis glycosides. In diabetic patients, consider additional blood glucose monitoring. Symbicort contains lactose monohydrate, as with other lactose containing products the small amounts of milk proteins present may cause allergic reactions.

Interactions: Concomitant treatment with potent CYP3A4 inhibitors should be avoided. If this is not possible the time interval between administration should be as long as possible. Symbicort maintenance and reliever therapy is not recommended in patients using potent CYP3A4 inhibitors. Not to be given with beta adrenergic blockers (including eye drops) unless there are compelling reasons. Concomitant administration with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAOIs and TCAs can prolong the QTc-interval and increase the risk of ventricular arrhythmias. L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance.

Concomitant administration with MAOIs, including agents with similar properties such as furazolidone and procarbazine, may precipitate hypertension. Risk of arrhythmias in patients receiving anaesthesia with halogenated hydrocarbons. Concomitant use of other beta adrenergic drugs or anticholinergic drugs can have a potentially additive bronchodilating effect. Pregnancy and Lactation: Should only be used when the benefits outweigh the potential risks. Budesonide is excreted in breast milk, however at therapeutic doses no effects on the child are anticipated. Undesirable effects: Common: headache, palpitations, tremor, candida infections in the oropharynx, coughing, mild irritation in the throat, hoarseness. Uncommon: tachycardia, nausea, dizziness, bruises, aggression, psychomotor hyperactivity, anxiety, sleep disorders. Rare: hypokalaemia, cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles, bronchospasm and immediate and delayed hypersensitivity reactions including exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction. Very Rare: psychiatric disorders including depression, behavioural changes (predominantly in children), angina pectoris, prolongation of QTc-interval, hyperglycaemia, taste disturbance, Cushing’s syndrome, adrenal suppression, growth retardation, decrease in bone mineral density, cataract and glaucoma and variations in blood pressure. As with other inhalation therapy, paradoxical bronchospasm may occur in very rare cases. Package Quantities: Each Symbicort Turbohaler 100/6 or 200/6 contains 120 inhalations. Each Symbicort Turbohaler 400/12 contains 60 inhalations. Legal Category: Prescription Only Medicine (POM). Marketing Authorisation Number(s): PA 970/28/1-3. Marketing Authorisation Holder (MAH): AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK. Further product information available on request from: The MAH (address above), Freephone -1800 800 899. Abridged Prescribing Information prepared: 04/12. Symbicort and Turbohaler are Trade Marks of the AstraZeneca group of companies. URN: 12/0540 Date of Preparation: November 2012.

Reference: 1. Adelphi Respiratory Disease Specific Programme 2009. 2. Olof Selroos et al. Treat Respir Med 2006; 5 (5): 305-315. 3. Engel et al. Br J Clin Pharmacol 1992; 33(4): 439-44. *JIDPO (Japan Industrial Design Promotion Organisation) Good Design Award Japan 2010: http://www.g-mark.org/award/detail.html?id=36687&sheet=outline&lang=en

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Asthma FEATURE

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The NAP is developing a National Model of Care (MOC) for Asthma with an implementation plan which will detail how physicians, nurses, and other health care professionals will work with engaged patients to make the clinical decisions most appropriate to their circumstances; and to collaborate with specialist colleagues in providing a safe, seamless experience through their journey within the health system in Ireland.

adult guidelines we have developed an in-hospital practical asthma education programme for nurses to underpin and support the implementation of the acute adult guidelines”. Dr. Manning said the NAP had actively engaged with Directors of Nursing in relation to the identification of respiratory clinical nurse specialists (CNS) within local hospital sites to assist with the implementation of this work of NAP. Many of these respiratory CNSs were now delivering an ongoing standardised asthma practical programme to the target nurses groups within the hospital system (ED, MAU, AMU nurses) and to nurses in primary care (acute out-of-hours nurses and practice nurses) focussing of acute asthma guidelines, peak flow use, inhaler technique and asthma management plan.

“In addition, the NAP has developed general management asthma guidelines for use in all healthcare settings especially in primary care, in conjunction with the Irish College of General Practice.

(ICGP) quality in practice committee (QIP) and with input from the Primary Care Clinical Lead Dr Joe Clarke and National Manager Brian Murphy.

“An additional self-learning asthma E-Learning 6 modular theoretical programme based on the national evidenced based guidelines and developed

by NAP in conjunction with Asthma Society of Ireland (ASI) is freely available on http://www.hseland.ieand www. asthmasociety.ie: for any healthcare professional who wishes to update their knowledge. This will enable healthcare professionals to underpin their skill sets with theory. In addition, the practical component is also being delivered by the respiratory CNSs. “We anticipate that about 90 per cent of 600 practice nurses in primary care who are likely to be involved in the future planned structured asthma programme will have completed this National Education Asthma Programme by end of 2013. There is also a similar programme available for GPs on ICGP website.

“Up to date Information is available for patients and their families and

carers. These easily accessible patient asthma education supports have been implemented in conjunction with the NAP’s key stakeholder, the Asthma Society of Ireland, to assist guided self management for this chronic condition”.

These are also jointly available on the HSE and ASI websites.”

National Model of Care for Asthma The NAP is developing a National Model of Care (MOC) for Asthma with an implementation plan which will detail how physicians, nurses, and other health care professionals will work with engaged patients to make the clinical decisions most appropriate to their circumstances; and to collaborate with specialist colleagues in providing a safe, seamless experience through their journey within the health system in Ireland. This is a key deliverables of the National Asthma Programme for 2013. Dr. Manning went on to say that as 85 per cent of asthma is managed in primary care without coming near the hospital specialist services, the NAP is undertaking work to look at providing a yearly programme of assessment for asthma called Chronic Disease Watch (CDW)-Asthma or Asthma Check for short at primary care.

The development of Asthma Check is being done in conjunction with ICGP and is headed by Dr. Dermot Nolan a GP in Waterford and who is the ICGP national lead on NAP. “Since the majority of people with asthma are managed primarily in general practice, we are confident that a structured annual review asthma programme at primary care level can reduce acute exacerbations and thus their associated overall costs with fewer hospital bed days and less time off school/work. It will also ensure that patients with asthma maximize their quality of life.”

The MOC will focus: � On Asthma Check development which outlines the step-by-step process for implementation of guideline based asthma management

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FEATURE Asthma

describing care pathways, clinical guidelines and other decisionmaking tools.

in primary care to deliver optimal outcomes for patients. The aim being to facilitate the implementation of best practice asthma guidelines in primary care in order to improve asthma control. �T o improve access to hospital based specialist asthma service from secondary care services and primary care through Scheduled / Rapid access asthma services (adult/paeds), and access to specialist asthma therapies. � T o improve links through CNS/ Asthma nurse specialist within the community services � T o develop and implement a standard referral pathway to asthma services � T o develop structured assessment and review protocols throughout the system �T o establish uniform discharge protocols � T o facilitate access to accurate asthma diagnostics � To examine solutions to develop and subsequently implement an Asthma database/register linked into all care levels (GP, Community Pharmacist and Hospital).

Implementation of the Model of Care by clinicians and managers is and will be supported by a range of documents

Asthma Death Audit Project Dr. Manning thinks the number of deaths due to asthma – about one per week - is likely to be accurate but the most recent year of validated data on ‘cause of death’ is 2009. However, very little else is known about asthma deaths in Ireland and it is not known how many, if any, of these deaths could have been prevented, or how they reflect the quality of health services provided.

Studies on asthma deaths internationally, such as Confidential Enquiries in the UK, have shown that around 90 per cent of asthma deaths have preventable factors.

The National Asthma Programme in Ireland would like to examine asthma deaths in Ireland on a similar basis to what has been done in the UK and is planning to use the methodology of the UK study in the ROI with their agreement, adapting it where this is necessary.

The aim of the project is to identify and understand preventable factors related to the management and self-management of asthma, so that we can improve future care of people with asthma, and prevent future asthma deaths.

The objectives are to: � To identify all asthma deaths in the

Republic of Ireland during the study period � To explore the circumstances surrounding each death from asthma including trigger factors, awareness at school or work, environmental conditions, lifestyles and activities, medication and adherence to treatment plan, and organizational aspects of care � To analyze key themes, particularly preventable factors � To propose solutions for adoption by the National Asthma Programme in

relation to clinical practice, service provision, education of professionals and patient education.

Summary The work of the NAP will ensure that patients with asthma will benefit from being part of a well-managed integrated system of care, coordinated at primary care level and financed to support seamlessness and patientcenteredness. The team at primary care level will deliver high quality health care for patients with asthma with 24/7 access to care. The team will be led by an experienced GP with knowledge, and training in asthma care, with a trained practice nurse that will educate, support and enable patients to effectively manage their asthma. The community pharmacist will assist the GP in asthma management by communicating concerns about patient’s control, identification of potential medication errors and provide patient education on inhaler technique and peak flow monitoring. They will also advise patients on asthma drug therapies and potential drug interaction (medicine use review). All patients with asthma will be offered an annual review. GPs will refer patients to the specialist service in secondary care who will assist the GP to manage difficult to control asthma in the community and be responsible for monitoring acute asthma care in ED and AMU/MAU. If necessary people with asthma will be admitted for acute management and stabilisation in accordance with best practice guidelines.

The specialist service for difficult to control asthma, will be led by a consultant with expertise in the management of asthma, supported by a specialist respiratory trained nurse who will facilitate access, assessment, management and education for this cohort of patients referred by GPs, ED physicians or hospital based physicians when required in a timely fashion.

To achieve this will also require continued IT support to facilitate electronic mechanisms in managing asthmatic patients throughout the healthcare system.

P X A S X s a w a I m d u g m R i x b o A o R a e c w ( C p D d f d p c

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PRESCRIBING INFORMATION HepaticXEPLION impairment: Caution in severe hepatic impairment.

CONTRAINDICATIONS: e.g., anxiolytics, antipsychotics, P Potential for XEPLION to affect other medicines: Not expected to cause hypnotics, clinically opiates, alcohol; medicin agranulocytosis reported with antipsychotics, including - additional monitoring PRESCRIBING INFORMATION ® medicines metabolised by cytochrome or cessation of treatment be required.

Malignant Syndrome (NMS) orimportant XEPLION® 50 mg, 75 mg, 100 mg & 150 mg prolonged release injection 50suspension mg, 75 mg,for100 mg & 150 mg prolonged releasemay suspension forIf Neuroleptic Hypersensitivity to paliperidone, risperidone any of the pharmacokinetic excipients. SPECIALinteractions WARNINGSwith seizure threshold i.e., phenothiazines, butyrophenones, clozapine, tricycl Xeplion P-450 isozymes.

Caution in conjunction with: other centrally acting medicines occurs discontinue all antipsychotics.

Appropriate clinical monitoring in diabetics and those ACTIVE INGREDIENT(S): 50 mg, 75 mg, 100 mg orinjection.

150 mg paliperidone.

Please refer to inducing orthostatic hypotension ACTIVE INGREDIENT(S): 50 mg, 75 mg, 100 mg or 150 mg paliperidone. & PRECAUTIONS: Do not use in acutely agitated or severely psychotic patients. Use with mefloquine etc; medicines capable of e.g., ® anxiolytics, antipsychotics, hypnotics, opiates, alcohol; medicines known to lower seizure with risk factors for diabetes advisable.

Advise of potential for weight gain, monitor weight Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S): Please refer to Summary of Product Characteristics (SmPC) before prescribing. caution in elderly dementia patients with risk factors for stroke. Caution in cardiovascular may be observed when Xeplion is co-administered); levodopa and other XEPLION is indicated for maintenance treatment of schizophrenia in adult ® patients regularly. Priapism reported during postmarketing surveillance of oral paliperidone. Caution threshold i.e., phenothiazines, butyrophenones, clozapine, tricyclics, SSRI’s, tramadol, INDICATION(S): Xeplion is indicated for maintenance treatment of schizophrenia in disease (including family history of QT prolongation), cerebrovascular disease, hypotension, (paliperidone may antagonize their effect-use the lowest effective dose stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia in patients experiencing ®conditions which may contribute to core body temperature mefloquine etc; medicines capable of inducing orthostatic hypotension (an additive effect may be used prolactin-dependent seizures, disease and conjunction with if this combination patients XEPLION stabilised may with be paliperidone or risperidone. prescribed e.g., end-stage Parkinson’s dis may be observed wheninXEPLION is coadministered); levodopamust andbe other dopamine Identify Xeplion all possible riskalso factors for venous thromboembolismtumours, (VTE) before and Parkinson’s and previous responsiveness to oral paliperidone oradult risperidone, used elevation. ® in selected, previously schizophrenia patients without prior oral Antiemetic medicineseffect that prolong QT interval.

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DOSAGE(please & ADMINISTRATION: Interaction of XEPLION with lithium unlikely. inPotential for other affect be administered in deltoid Intramuscular injection. Initiation doses (days 1 and 8) mustInitiation discontinue all antipsychotics.

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150 mgeffects: on treatment CYP3A4 are significant in metabolism of paliperidone.

Concomitant administration of respiratory tract infection, urinary tract infection, influenza, hyperprolactinaemia, day 1 and 100 mg one week later (day 8 ± 2), both doses administered in deltoid muscle, day 1 and 100 mg one week later (day 8 ± 2), both doses administered in deltoid surveillance of oral paliperidone. Caution in patients experiencing conditions which may pharmacokinetics. Co-administration of oral paliperidone once daily w oral paliperidone andriskparoxetine potent CYP2D6 inhibitor) showed no clinically weight weight decreased, triglycerides increased, using 1½ inch, 22 gauge needle (38.1 mm x 0.72 mm) for patients kg, or 1-inch, 23 hyperglycaemia, muscle, using ≥the901½-inch, 22 gauge needle (38.1 mm x 0.72increased, mm) for patients contributeblood to core body temperature elevation.

Identify all possible factors for (a venous 200 mg twice daily decreases plasma concentration of paliperidone b gauge needle (25.4 mm x 0.64 mm) for those < 90 kg. Recommended monthly agitation, depression, anxiety, parkinsonism, akathisia, sedation/somnolence, dystonia, significant effect on paliperidone pharmacokinetics. Co-administration of oral

≥ 90 kg, or the 1-inch, 23 gauge needle (25.4 mm x 0.64 mm) for those < 90 kg. thromboembolism (VTE) before and during treatment and take preventive measures. renal P-gp by carbamazepine increases renal clearance). Re-evaluate

maintenance dose is 75 mg (range 50 mg-150 mg) in either deltoid or gluteal muscle. dizziness, dyskinesia, tremor, bradycardia, tachycardia, hypertension, cough, nasal paliperidone once daily with carbamazepine 200 mg twice daily decreases plasma Antiemetic effect (observed in paliperidone preclinical studies) may mask overdosage with dose at carbemazepine initiation.

No clinically significant interaction Recommended monthly maintenance dose is 75 mg (range 50 mg-150 mg) in either

Recommended needle size for maintenance administration of XEPLION into deltoid muscle congestion, abdominal pain, vomiting, nausea, constipation, diarrhoea, dyspepsia, concentration of paliperidone by 37% (induction of renal P-gp by carbamazepine ® deltoid22orgauge gluteal muscle. needle size for maintenance certain medicines, intestinal obstruction, Reye’sincreases syndrome, brain etc. Avoid inadvertent valproate and Xeplion . Risperidone is part metabolised to paliperidon renaltumour clearance).

Reevaluate/increase XEPLION dose at carbemazepine toothache, transaminases increased, rash, musculoskeletal pain, back pain, pyrexia, is as for initiation doses, and for gluteal muscle i.e. the 1½-inch, needle (38.1 The mm recommended ® administration Xeplion upinto deltoid musclefatigue is as forand initiation doses, and for the injection intoreported a blood vessel.

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Other side effects with paliperidone x 0.72 mm). To avoid a missed monthly dose patients may be givenofinjection to 7the days Risperidone part metabolised to paliperidone so consideration should given ifPRESENTATIONS, PACK S include: reaction, before or after monthly time point. Consider maintenance dosesis in range22for gluteal muscle theupper 1½-inch, gauge needleagranulocytosis, (38.1 mm x 0.72thrombocytopenia, mm). To avoid a hypersensitivity, reactions (ADRs) anaphylactic reported in clinical trials were insomnia,isheadache, weight increased, CATEGORY: Prescription Only be Medicine. diabetic dyskinesia, convulsion, neuroleptic overweight/obese patients. Adjust maintenance dose at monthly intervals as necessary. risperidone oral paliperidone is co-administered with NUMBERS: XEPLION. LEGAL missed monthly dose patients may be given theketoacidosis, injection up tohypoglycaemia, 7 days before ormania, after tardive injection site reactions, agitation, somnolence, akathisiaor(dose-related), extrapyramidal LICENCE PrefilledCATEGORY: syringe containing 50, 75, 100 or 15 malignant syndrome, abnormal,tremor, Alternate injections between left and right sides. Discontinue oralConsider paliperidone Prescription Only respiratory Medicine. tract PRESENTATIONS, PACK SIZES &EU/1/11/672/003, PRODUCT LICENCE disorder,coma, nausea,coordination constipation, dizziness, vomiting, upper infection, EU/1/11/672/002, EU/1/11/672/004, EU/1/11/672 the monthlyprevious time point. maintenance doses in upperloss rangeofforconsciousness, overweight/ diabetic or risperidone at time of initiation of XEPLION treatment. When switching patients from glaucoma, atrial fibrillation, atrioventricular block, pulmonary embolism, pneumonia, NUMBERS: Prefilled syringe containing 50, 75, 100 or 150 mg paliperidone. obese patients. Adjust maintenance dose at monthly intervals as necessary. Injections diarrhoea, and tachycardia. Injection site reactions: Mild to moderate pain was the most AUTHORISATION HOLDER: JANSSEN-CILAG INTERNATIONAL NV, RISPERDAL® CONSTATM, initiate XEPLION in place of next scheduled injection, continue venous thrombosis, pancreatitis, intestinal obstruction, jaundice, angioedema, joint EU/1/11/672/002, EU/1/11/672/003, EU/1/11/672/004, EU/1/11/672/0055. should be alternated between left and right sides.

Discontinue previous oral paliperidone B-2340 Beerse, Belgium.

FURTHER INFORMATION IS AVAILABLE FR commonly reported (tended to lessen in frequency and intensity over time).

Weight gain: and face oedema. Other side effects reported with risperdone at monthly intervals. Children: No safety or efficacy data available. Elderly: No safety or stiffness,rhabdomyolysis ® Presentation Pack SizeLtd, 50-100Product Number or risperidone at timeMild of initiation of Xeplion treatment.

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Consta place of therisperidone) next scheduled injectionsite andnecrosis then and phaseinjection to endpoint) phase of long-term recurrence prevention © Janssen-Cilag Ltd 2011 injection site during ulcer. 33-week Injectionopen-label site clearance ≥ 50 to < 80 ml/min): Initiate with 100mgRisperdal on treatment day 1, initiate and 75Xeplion mg one in(injectable 50 mg pre-filled syringe EU/1/11/672/002 continue at monthly intervals.

Children: No safety cacy data available.

Laboratory Serum prolactin: Median increases in serum prolactin were Prescribing information last revised: PIVER01 28.01.11. reactions: mildor to effi moderate painare most commonly study. reported (tended totests: lessen in frequency week later (day 8). Recommended monthly maintenance dose 50 mg. Moderate or severe 75 mg pre-filled syringe EU/1/11/672/003 andforintensity Weightimpairment: gain: 12 % of XEPLION-treated experienced (creatinine clearance < 50 ml/min): Not recommended.

Hepatic impairment: Elderly: No safety or efficacy data available patients over > 65 time). years. Renal observed in clinicalsubjects trial subjects (both genders) who received Xeplion®. Adverse reactions 1 dose pre-filled syringe EU/1/11/672/004 weight gainInitiate of ≥ 7%with (from phase to endpoint) III antiarrhythmics, some Caution in severe hepatic impairment.

Hypersensitivity Mild (creatinine clearance ≥ 50 to to < 80 ml/min): 100double-blind mg on treatment that may class suggest increase in prolactin levels 100 weremg reported overall in < 1% of subjects. * In comparison

CONTRAINDICATIONS: to placecbo. antimalarials.

Potential for XEPLION to arrhythmias, othermaintenance antipsychotics, paliperidone, risperidone or any of the excipients. SPECIAL WARNINGS & PRECAUTIONS: 150 mg pre-filled syringe death, cardiac EU/1/11/672/005 effects: QT prolongation, ventricular sudden unexplained day 1 and 75 mg one week later (day 8).antihistaminics, Recommendedsome monthly dosesomeClass

Do not use in acutely agitated or severely psychotic patients. Use with caution in elderly affect other medicines: Not expected to cause clinically important pharmacokinetic severe (creatinine clearance < 50 ml/min): Not recommended. arrest, and Torsade de pointes may occur with antipsychotics. Cases of venous thromboembolism,

in cardiovascular Moderate or Caution 50 mg. dementia patients with risk factors for stroke. disease (including interactions with medicines during 33-week open-label phase of long-term recurrence MARKETING AUTHORISATION HOLDER: Janssen-Cilag International References: 1. MarderNV, SR.Turnhoutseweg J Clin Psychiatry 2003; 64(suppl 16): 3-9. 2 including pulmonaryembolism andprolactin deep vein thrombosis, also been reported (frequency median increases in serum family history of QT prolongation), cerebrovascular disease, hypotension, prolactin- prevention study. Laboratory tests: Serum prolactin: 30, B-2340have Beerse, Belgium.

FURTHER INFORMATION FROM: JanssenSummaryISofAVAILABLE Product Characteristics.

3. Llorca PM. Psychiatric Res 20 unknown).

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Should notWay, be used Cilag Ltd,PREGNANCY: 50-100 Holmers Farm High Wycombe, Buckinghamshire HP12116: 4EG107-117.

UK. with XEPLION. Adverse dependent tumours, seizures, Parkinson’s disease and in conjunction with medicines that observed in clinical trial subjects (both genders) 4. Hough D et al. Schiz Res 2010; 5. Pandina GJ et al. J Cli duringinpregnancy unless Class clearlyeffects: necessary.

LACTATION: Should notPrescribing be used while © Janssen-Cilag Ltd 2011 information last revised: 06/2012 PIVER20120628 <1% of subjects. prolong QT interval. May induce orthostatic hypotension. If tardive dyskinesia occurs suggesting increase in prolactin levels reported overall 2010; 30: 235-244. 6. Bossie C et al. Poster NR6-5 presented at the A * In comparison to placebo. unexplained INTERACTIONS: death, cardiac arrest and consider discontinuation of all antipsychotics. Events of leucopenia, neutropenia, and QT prolongation, ventricular arrhythmias, suddenbreastfeeding.

Caution prescribing with medicines that prolong QT interval Association Annual Meeting, 22-26 May 2010, New Orleans, Louisian Torsade de pointes mayoccur with antipsychotics.

Cases e.g., classofIA venous and classthromboembolism, III antiarrhythmics, some antihistaminics, some other antipsychotics, References: including pulmonary embolism and deep vein thrombosis, also reported.

Drug withdrawal some antimalarials.

Potential for Xeplion® to affect other medicines: Not expected to syndrome in neonates observed with antipsychotics. Frequency unknown. Refer to SmPC 1. Xeplion® Summary of Product Characteristics. 2. Hough D et al. Schiz Res 2010; cause clinically important pharmacokinetic interactions with medicines metabolised by Date of Preparation: March 2011 for other side effects. PREGNANCY: Should not be used during pregnancy unless clearly 116: 107-117. 3. Pandina GJ et al. J Clin Psychopharmacol 2010; 30: 235-244. 4. Bossie cytochrome P-450 isozymes. Caution in conjunction with: other centrally acting medicines IRE/XEP/0011/2011 necessary. LACTATION: Should not be used while breastfeeding. INTERACTIONS: CA et al. BMC Psychiatry 2011, 11:79.

Caution with medicines that prolong QT interval e.g., class IA and class III Date of Preparation: July 2012 antiarrhythmics, some antihistaminics, some other antipsychotics, some antimalarials. IRE/XEP/2012/0063a ®

XEPLI

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11 03 18 13 07 13/03/2013 17:27:41

Continuous Wound Continuous Wound Infusion Infusion for for Postoperative Pain Postoperative Pain Relief Relief

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www.baxterhealthcare.ie ROI/PAIN/12-0001 | Date of Preparation: May 2012 Any adverse events relating to Baxter products should be reported to Baxter Healthcare directly by calling 01-2065500 and asking for the Quality Department.

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ClinicalCare2013_1_104.indd 52 www.baxterhealthcare.ie

ROI/PAIN/12-0001 | Date of Preparation: May 2012

13/03/2013 17:27:45

Anaesthesia FEATURE

Collaboration is the fundamental message of

National Anaesthesia Programme.

Collaboration is the fundamental message of the HSE National Clinical Programme in Anaesthesia (NCPA), according to Dr. Bairbre Golden, Director, NCPA and Consultant Anaesthetist at the UPMC Beacon Hospital, Dublin.

Maureen Browne reports.

Collaboration is the fundamental message of the HSE National Clinical Programme in Anaesthesia (NCPA), according to Dr. Bairbre Golden, Director, NCPA and Consultant Anaesthetist at the UPMC Beacon Hospital, Dublin.

“I would call it the linked-in programme.

We take a very collaborative approach, working with a great number of the programmes, including primary care.”

“We decided at the outset to focus on initiatives that would result in better patient safety, better patient care and better consultant support. This requires us to work closely with our nursing colleagues, fellow clinicians, hospital management and administration.”

pictured: Dr. Bairbre Golden

Dr Golden was appointed Director of the HSE National Clinical Programme in Anaesthesia in January of 2012. “I saw part of the role as an opportunity to liaise with all the different agencies involved in anaesthesia so that we could develop one agenda and speak with one voice.

“We started off in the office of the President of the College of Anaesthetists and our first meeting was with the President and CEO of the College, the Convenor of the Irish Standing Committee of the Association of Anaesthetists of Great Britain and Ireland, (ISC governance structure of

the programme replicates that of the National Clinical Programmes, with both an Advisory Group and a Working Group. The NCPA has a Programme Lead in every hospital in the country, both public and private, and this allows for very rapid bi-directional exchange of information.”

Dr. Golden is a very strong believer in communication and is at present conducting face to face meetings with all the anaesthetic departments in the country, to ensure that they are fully briefed on developments within the NCPA. The National Clinical Programme in Anaesthesia is all about quality and patient safety. It aims to increase same day admissions, decrease length of stay and increase the number of patients scheduled for surgery on a given day for a given theatre. “Our intention is that this will lead to improved patient care, greater efficiency and a reduction of operational and theatre costs, helping to ensure best value for the tax-payer’s money.”

The National Clinical Programme in Anaesthesia has two significant responsibilities. Firstly, is The Productive Operating Theatre Programme (TPOT) and secondly, the Pre Admission Programme. In addition, the programme also has a lead for Transport and Retrieval, Obstetric Anaesthesia, Communications and Audit.

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FEATURE Anaesthesia

“We are working with surgeons in TPOT initiative, which is under the direction of Prof. Frank Keane and myself. The NHS delivered this model and we obtained the licence to use their model. It is really a skill-set to help people address issues in the hospital which are causing delays within the theatre suite. Basically, they are commonsense initiatives but the NHS quantified them into a package.

We are going into hospitals and helping staff understand what is in the package and assisting them to apply that knowledge to address their issues within their own institution.

“You can have your theatre suite working efficiently, but if you are waiting an hour for the next patient to come from the ward, or if you don’t have sufficient recovery facilities for patients following surgery the process is still not going to work efficiently. It is often as much about what goes on outside as inside the theatre.

“Another extremely important initiative is the Pre-Admission Programme which is being led by Dr. Ann Elizabeth Burke, a Consultant Anaesthetist in Nenagh, part of the Mid Western Hospital Group. She is working on developing a model of care for pre- admission in association with the NCPA. Traditionally anaesthetists would have been involved in the pre-assessment of patients but the pre-admission programme will bring all the other key healthcare workers into a comprehensive model. If you have a very good pre-admission programme, you can achieve in excess of 90 per cent of admissions on the day of surgery and very few ‘no shows’ on theatre lists.

“A good pre-admission model will link in with hospital administration, with hospital management and the people who put the theatre list together. You can have an understanding of pre-op assessments which anaesthetists do, but you have to look at the bigger picture.

Anaesthesia is just a small part of a much more complicated integrated structure with hospital managers and admission staff making sure that notes are ready, patients are contacted, that there are “short notice” waiting lists, where people

}

We are going into hospitals and helping staff understand what is in the package and assisting them to apply that knowledge to address their issues within their own institution. are prepared to be called at a week or even a day’s notice and maybe stay in a B & B the previous night. People will make lots of proactive choices if it means they will get their operation faster.”

Nurses are a key resource for these initiatives. “We have a nurse lead in over 90 per cent of hospitals in the country and great progress continues to be made with the initiatives. The programme is developing a survey to quantify and confirm the competencies of anaesthetic nurses in Ireland. The survey will be issued shortly and when this work is completed it will give us a very good understanding of the kind of anaesthetic nursing service currently available.”

The Programme is very involved in transport and retrieval of critically ill adult patients and has heavily influenced the development of the next phase of the model of care for transport and retrieval around the country. Dr. Golden says a good transport service is fundamental to the delivery of the small hospitals framework and NCPA regard it as a high priority.

“The Programme has also been working with the Directors of the Galway Hyperbaric Medicine Unit, the Coastguard, the Navy and Emergency Medicine to develop a pathway for the management of patients who might have hyperbaric illness. This is now completed and we are now working on a plan to secure ring-fenced funding for this service”.

A significant issue for Anaesthesia is manpower planning. “It is a key component of our programme and specialty and has not been addressed in medicine overall over many years. If I was to do this through the Programme, it would be restricted just to anaesthetics

but it is a far more complex matter as it involves critical care, pain, paediatric anaesthesia, training much of which falls largely within in the remit of the College. We met with Dr. Eilis McGovern, the HSE National Director of Medical Education and through the College a group has been convened to include a multi-agency group of key stakeholders to examine manpower planning. This will be chaired by the CEO of the College of Anaesthetists of Ireland, and will have representatives, of anaesthesia, training, critical care, pain, different hospital types, academia and the HSE on this group”.

Dr. Golden has herself pursued an unusual career course, dividing her time between clinical practice and healthcare management consulting. She completed an MBA in the Smurfit Business School, the European Health Leadership Programme in INSEAD, France and the Managing Healthcare Delivery Programme at Harvard Business School. “It was a wonderful opportunity to meet and mix with clinical and business leaders and appreciate the depth and breadth of their work internationally.

“I am a passionate advocate of clinicians having knowledge of business and I believe that business training should be a part of undergraduate and postgraduate medical training. This is becoming more and more important now that the National Clinical Programmes have given clinicians a real leadership role and an opportunity influence how medicine generally and our specialty in particular is developed in Ireland.”

Before returning to Ireland, Dr Golden worked for six years as a Consultant Anaesthetist in St. Bartholomew’s Hospital, London and has also extensive experience in a wide variety of advisory work.

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â&#x20AC;Ś supporting healthcare professionals

ROI/COPR/12-0001

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JANUMET® targets the 3 key defects of Type 2 Diabetes to improve glycemic control1 (sitagliptin/metformin)

Increases insulin sensitivity • Metformin increases glucose uptake and utilization (greater effect in the liver than in muscle and fat)3,4

Increases insulin synthesis and release • Sitagliptin works in a glucose-dependent manner to increase active incretins, which stimulate the synthesis and release of insulin from β cells2

Decreases hepatic glucose overproduction • Metformin reduces glucose production in the liver (gluconeogenesis) and diminishes the breakdown of glycogen into glucose (glycogenolysis)4,5 • Sitagliptin suppresses glucagon secretion from pancreatic α cells (by enhancing active incretin levels), which results in reduced glycogen breakdown and glucose synthesis2 • By enhancing active incretin levels, sitagliptin increases insulin synthesis and release from pancreatic β cells, which helps reduce hepatic glucose overproduction2

ClinicalCare2013_1_104.indd 56

risk factors. If suspected, discontinue treatment and hospitalise patient immediately. If changes in clinical status of patients with previously controlled type 2 diabetes occurs, evaluate promptly for evidence of ketoacidosis or lactic acidosis in any patient with type 2 diabetes previously well controlled on Janumet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness). If acidosis of either form occurs, stop Janumet immediately and initiate corrective measures. Determine serum creatinine concentrations regularly, i.e. at least once a year in patients with normal renal function and at least two to four times a year in patients with serum creatinine levels at or above the upper limit of normal and in elderly patients. Decreased renal function in elderly patients is frequent and asymptomatic. Exercise special caution where renal function may become impaired, e.g. when initiating antihypertensive or diuretic therapy or when starting treatment with a non-steroidal anti-inflammatory drug (NSAID). Surgery: due to metformin hydrochloride content of Janumet, discontinue treatment 48 hours before elective surgery with general, spinal or epidural anaesthesia. Do not resume earlier than 48 hours afterwards and only after renal function is normal. DRUG INTERACTIONS For Janumet only - Alcohol: avoid alcohol and medicinal products containing alcohol due to risk of lactic acidosis. Cationic agents that are eliminated by renal tubular secretion (e.g., cimetidine): these may interact with metformin by competing for common renal tubular transport systems. Consider close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment when these agents are co-administered. Iodinated contrast agents in radiological studies: intravascular administration of these agents may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis. Discontinue Janumet prior to, or at the time of the test and do not reinstitute until 48 hours afterwards, and only after renal function is found to be normal. Combination requiring precautions for use: glucocorticoids (given by systemic and local routes) beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity. Inform the patient and perform more frequent blood glucose monitoring, especially at the beginning of treatment. If necessary, adjust dose of the anti-hyperglycaemic medicine during therapy with, or on discontinuation of the other medicine. ACE-inhibitors: as these may decrease the blood glucose levels, if necessary, adjust dose of the antihyperglycaemic during therapy with, or on discontinuation of the other medicine. For Januvia and Janumet - Low risk of clinically meaningful interactions with metformin and ciclosporin. Meaningful interactions would not be expected with other p-glycoprotein inhibitors. The primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8. Digoxin: sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild inhibitor of p-glycoprotein in vivo. No dosage adjustment of digoxin is recommended, but monitor patients at risk of digoxin toxicity if the two are used together. Fertility, pregnancy and breast-feeding: Do not use during pregnancy or breast-feeding. Animal data do not suggest an effect of treatment with sitagliptin on male and female fertility. Human data are lacking. SIDE EFFECTS Refer to SmPC for complete information on side effects There have been no therapeutic clinical trials conducted with Janumet tablets however Janumet is bioequivalent to co-administered sitagliptin and metformin. Sitagliptin: Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported.

Hypoglycaemia has been reported in combination with sulphonylurea and insulin. The following adverse reactions reported from both clinical trials and post-marketing experience using the following conversion: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000) and not known (cannot be estimated from the available data). Sitagliptin only: Common: hypoglycaemia, headache, upper respiratory tract infection, nasopharyngitis, osteoarthritis and pain in extremity. Uncommon: dizziness, constipation. Metformin only: Clinical Trial Data and Post-marketing data: Very common: gastro-intestinal symptoms; Common: metallic taste; Very rare: urticaria, erythema; pruritis; lactic acidosis; vitamin B12 deficiency; liver function disorders, hepatitis. Sitagliptin with metformin: Common: hypoglycaemia, nausea, flatulence and vomiting; Uncommon: somnolence; upper abdominal pain, diarrhoea, constipation and blood glucose decreased. Sitagliptin with a sulphonylurea: Common: hypoglycaemia. Sitagliptin with metformin and a sulphonylurea: Very common: hypoglycaemia; Common: constipation. Sitagliptin with a PPARγ agonist (pioglitazone): Common: hypoglycaemia, flatulence, peripheral oedema and blood glucose decreased.

Sitagliptin with a PPARγ agonist (pioglitazone) and metformin: Common: hypoglycaemia, peripheral oedema. Sitagliptin with insulin with/ without metformin: Common: headache, hypoglycaemia, influenza; Uncommon: dry mouth, constipation. Sitagliptin with metformin and insulin: Very common: hypoglycaemia; Uncommon: headache and dry mouth. Post-marketing experience additional side effects have been reported (frequency not known): hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis and exfoliative skin conditions including Stevens-Johnson syndrome (see precautions); acute pancreatitis, including fatal and non-fatal haemorrhagic and necrotising pancreatitis (see precautions); impaired renal function, including acute renal failure (sometimes requiring dialysis); vomiting; pain in extremity, arthralgia, myalgia, back pain, interstitial lung disease.

PACKAGE QUANTITIES Januvia 25 mg, 50 mg and 100 mg film-coated tablets 28 tablets Janumet 50mg/850mg and 50mg/1000mg filmcoated tablets 56 tablets Legal Category: POM. Marketing Authorisation Number Januvia 25 mg: EU/1/07/383/002 Janumet 50 mg/850 mg: EU/1/08/455/003 Januvia 50 mg: EU/1/07/383/008 Janumet 50 mg/1000 mg: EU/1/08/455/010 Januvia 100mg: EU/1/07/383/014 Marketing Authorisation Holder Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK Date of review of prescribing information: January 2013 Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin 18 or from www.medicines.ie. © Merck Sharp & Dohme Ireland (Human Health) Limited, 2013.

All rights reserved. Date of Preparation: February 2013.

References: 1. Ramlo-Halsted BA, Edelman SV. The natural history of type 2 diabetes: practical points to consider in developing prevention and treatment strategies. Clin Diabetes. 2000;18(2):80-88. 2. Janumet SPC available at www.medicines.ie. 3. Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996;334(9):574-579. 4. Kirpichnikov D, McFarlane SI, Sowers JR. Metformin: an update. Ann Intern Med. 2002;137(1):E-25-E-33. 5. Krentz AJ, Bailey CJ. Oral antidiabetic agents: current role in type 2 diabetes mellitus. Drugs.

2005;65(3):385-411.

DIAB-1067195-0002

JANUVIA® JANUMET® Sitagliptin Sitagliptin/metformin hydrochloride ABRIDGED PRESCRIBING INFORMATION Refer to Summary of Product Characteristics (SmPC) before prescribing PRESENTATION Januvia® 25 mg, 50 mg and 100 mg film-coated tablet each containing 25 mg, 50 mg or 100 mg of sitagliptin respectively. Janumet® 50 mg/850 mg and 50 mg/1000 mg tablets each containing 50 mg sitagliptin and 850 mg or 1000 mg metformin hydrochloride. USES For adult patients with type 2 diabetes mellitus Januvia is indicated to improve glycaemic control: as monotherapy • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance as dual oral therapy in combination with • metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control • a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contra-indications or intolerance • a PPARγ agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control as triple oral therapy in combination with • a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. • a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control. Janumet: as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. • in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. • as triple combination therapy with a PPARγ agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist. • as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control. DOSAGE AND ADMINISTRATION Januvia - One 100 mg tablet once daily, with or without food.

Janumet - The dose of antihyperglycaemic therapy with Janumet should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin. For patients not adequately controlled on metformin alone, the usual starting dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken. For patients switching from co-administration of sitagliptin and metformin, Janumet should be initiated at the dose of sitagliptin and metformin already being taken. For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea or with maximal tolerated dose of metformin and a PPARγ agonist or with maximal tolerated dose of metformin and insulin, the dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. All patients should continue their diet with an adequate distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet. Januvia and Janumet - In combination with a sulphonylurea or with insulin, consider a lower dose of sulphonylurea or insulin, to reduce risk of hypoglycaemia. Renal impairment: For Januvia only: When considering sitagliptin with another anti-diabetic product, its use in patients with renal impairment should be checked. Moderate impairment (CrCl ≥30 to <50 mL/min), the dose is 50 mg once daily. Severe impairment (CrCl <30 mL/min) or with end-stage renal disease (ESRD), the dose is 25 mg once daily. Mild impairment, no dose adjustment. Assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter. For Janumet only: Should not be used in patients with moderate or severe renal impairment (creatinine clearance < 60 ml/min). Hepatic impairment: For Januvia only - no dosage adjustment necessary for patients with mild to moderate hepatic impairment. Januvia has not been studied in patients with severe hepatic impairment. For Janumet only – do not use. Elderly < 75 years: For Januvia only - no dosage adjustment necessary. For Janumet only - use with caution as age increases. Monitoring of renal function is necessary to aid prevention of metformin-associated lactic acidosis. Elderly ≥ 75 years: Exercise care as there are limited safety data in this population. Children: not recommended below 18 years of age. CONTRA-INDICATIONS For Januvia Hypersensitivity to active substance or excipients. For Janumet - Hypersensitivity. Diabetic ketoacidosis and diabetic pre-coma.

Moderate and severe renal impairment (creatinine clearance < 60 ml/min). Acute conditions with the potential to alter renal function such as dehydration, severe infection, shock. Intravascular administration of iodinated contrast agents. Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction, shock. Hepatic impairment.

Acute alcohol intoxication, alcoholism. Lactation. PRECAUTIONS For Januvia and Janumet - General: do not use in patients with type 1 diabetes or for diabetic ketoacidosis. Pancreatitis: Post-marketing experience - spontaneously reported adverse reactions of acute pancreatitis. Inform patients of the symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of sitagliptin, but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported. If pancreatitis is suspected, Januvia or Janumet and other potentially suspect medicinal products should be discontinued. Hypoglycaemia when used with other anti-hyperglycaemic agents: Rates of hypoglycaemia reported with sitagliptin were generally similar to rates in patients taking placebo. When sitagliptin was added to a sulphonylurea or to insulin, the incidence of hypoglycaemia was increased over that of placebo; therefore consider a lower dose of sulphonylurea or insulin to reduce the risk of hypoglycaemia when administering Janumet or Januvia. Hypersensitivity reactions: Serious hypersensitivity reactions have been reported, including anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset occurred within the first 3 months after initiation of treatment with some reports occurring after the first dose. If suspected, discontinue Januvia or Janumet. For Januvia only– Renal Impairment: Lower dosages are recommended in patients with moderate and severe renal impairment, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis- see Dosage. For Janumet only - Lactic acidosis and renal function: a very rare, but serious, metabolic complication can occur due to metformin accumulation. Cases in patients on metformin have occurred primarily in diabetic patients with significant renal failure. Reduce incidence by assessing other associated

Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland

13/03/2013 17:28:14

Diabetes FEATURE

Rolling out a

National Retinopathy Programme T

he HSE Clinical Programme on Diabetes hopes to be in a position very shortly to roll out the first phase of a national retinopathy programme for the early identification of eye disease in people with diabetes, to ensure earlier treatment and to reduce the risk of sight loss.

Dr. Diarmuid Smith, Consultant Endocrinologist at Beaumont Hospital, Dublin and Clinical Lead of the Programme said that in other countries, this type of programme had been shown to reduce the risk of sight loss and blindness and to be cost effective.

The screening programme has been subcontracted out to the National Cancer Screening Programme; (NCCS) which he said had done “an incredible job in driving it forward.”

There are an estimated 190,000 people with diabetes in the country and the first phase of the screening will target 30 per cent of these, with the remaining 70 per cent screened in 2014. In 2015, the programme will screen the entire diabetic population.

The cost of screening 30 per cent of the population in 2013 is estimated at €3.1 million and it will cost approximately €1.8 million to treat screened patients.

The total projected cost of the project in 2013 is €5.1 million. The National Diabetes Programme has secured the funding for treatment in 2013 but a deficit of €1.1 million remains to fund screening in 2013.

“We need to find the deficit, but we are adamant that the screening will get

DIAB-1067195-0002

© istockphoto/thinkstockphoto.com

The HSE Clinical Programme on Diabetes hopes to be in a position very shortly to roll out the first phase of a national retinopathy programme for the early identification of eye disease in people with diabetes, to ensure earlier treatment and to reduce the risk of sight loss, according to Dr. Diarmuid Smith, Consultant Endocrinologist at Beaumont Hospital, Dublin and Clinical Lead of the Programme.

Maureen Browne reports.

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FEATURE Diabetes

underway this year,” said Dr. Smith.

He said the National Diabetes Programme had a number of different objectives, as diabetes was such an important disease which was becoming increasingly prevalent. The diabetic population was set to increase by 60 per cent over the next 10 to 12 years.

Diabetes is the commonest cause of sight loss in the working aged adult, commonest cause of lower limb amputation, renal failure dialysis and renal transplantation in Ireland.

At the moment there is no national diabetes register, so the precise number of people with diabetes in the country is not known, and it is hoped that the retinopathy screening programme will facilitate the establishment of a national diabetes register.

Dr. Smith said the other area the Programme was pursuing was the foot programme. “We have a model of care for foot disease and we got €1 million of new money to employ 16 new podiatrists to look after high risk people with diabetes with active foot disease.

International recommendations indicate that a country the size of Ireland should have 90 – 100 podiatrists dealing with diabetic foot disease.

“Before the Programme was established, there were only three podiatrists in the entire country as members of an active diabetes multidisciplinary specialist foot team. Our objective

was to employ 16 new podiatrists which would be a big improvement, but we have a long way to go before we get to international standards. Because of the moratorium, we have only been able to get seven in post and we are trying to ensure that the funding for the remaining nine is secure for 2013. The seven who are in post are making a big difference but the national model needs the 16 new podiatrists in post.

}

Diabetes is the commonest cause of sight loss in the working aged adult, commonest cause of lower limb amputation, renal failure dialysis and renal transplantation in Ireland.”

“We devised a national model of care, classifying people as low, medium or high risk and patients with high risk and active foot disease will seen by a specialist multidisciplinary foot team including a podiatrist in the hospital.

Regional pathways have also been established between the four regions to ensure that each person with diabetes and active foot disease receives the appropriate specialty input.”

The Clinical Programme on Diabetes has developed a FETAC approved Programme for practice nurses in GPs’ surgeries, so that they have the expertise for specialised foot examination.

Another major project for the National Diabetes Programme is integrated diabetes care for patients with Type 2 diabetes. It is estimated that there are approximately 160,000 patients with Type 2 diabetes in Ireland and the numbers are increasing. It is estimated that 100,000 of these have uncomplicated diabetes and the model provides that they be managed in the community by their GP. The other 60,000 which have complicated diabetes would have shared care between hospitals and the community. The benefits of this would be that consultants could see the more complicated type 2 patients and the patients with type 1 more frequently and those patientswith uncomplicated Type 2 diabetes will be seen 2 to 3 times per year by their GP in a structured fashion.

If these uncomplicated Type 2 patients develop problems then the GP can access a specialist opinion rapidly.

The number of consultant

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10141

Diabetes FEATURE

SIMPLE | EFFECTIVE | REASSURING

THE YOU KNOW NUMBER 1 INSULIN brand worldwide1 10 YEARS of established efficacy and safety profiles2–9

Once-daily Lantus: The one you know. For the treatment of both type 1 and type 2 diabetes mellitus, when patients require a basal insulin 9. Lantus contributes to early and sustained HbA1c control2–8, with a hypoglycaemia rate comparable to that of OAD intensification2. With 10 years of established efficacy and safety profiles, Lantus is the one you know2–9.

excreted in breast milk. Adverse reactions: Very common: hypoglycaemia. Prolonged glucose control or a tendency to hypo/hyperglycaemic episodes all relevant factors Prescribing Information or severe hypoglycaemia may be life-threatening. Common: lipohypertrophy, injection must be reviewed before dose adjustment is considered. Insulin administration may Lantus® (insulin glargine) site reactions, including redness, itching, pain, hives, swelling or inflammation. cause insulin antibodies to form. Rarely, this may necessitate dose adjustment.

Please refer to Summary of Product Characteristics prior to use of Lantus.

REFERENCES: 1. UK IMS – MAT, September 2012. 2.CSD Cegedim – MAT, September 2012. 3. Sanofi, Data on file. 4. Gerstein HC, et al. Diabet Med 2006;23:736-42. 5. Rosenstock J, et al.

Rarely: immediate-type allergic reactions; which may be associated with generalised Particular caution should be exercised, and intensified blood monitoring is advisable Lantus cartridges and Solostar prefilled pens each contain 300 Units of insulin Diabetes Care 2006;29:554-9. 6. Aschner P, et al. Lancet 2012;379:2262-9. 7. Yki-Järvinen H, et al. Diabetologia 2006;49:442-51. 8. Riddle MC, et al. Diabetes Care 2003;26:3080-6. 9. Schreiber skin reactions, angio-oedema, bronchospasm, hypotension and shock and may be for patients in whom hypoglycaemic episodes might be of clinical relevance and in glargine in 3ml, equivalent to 10.92mg. Lantus vials contain 1000 Units insulin SA,glargine et al.inDiabetes Technol Ther 2008;10(2):121-7. 10. DeVries JH, et al. where Diabetes 2012;61(Suppl 1):A552-3.

Sanofi , data on file.life threatening; visual impairment, retinopathy and oedema. Very rare: dysgeusia, those dose adjustments may be required.

Warning11. signs of hypoglycaemia 10ml, equivalent to 36.4mg. Indications: Treatment of diabetes mellitus myalgia. Insulin administration may cause insulin antibodies to form and may, in rare may be changed, less pronounced or absent in certain risk groups, potentially in adults, adolescents and children of 2 years or above. Dosage and administration: cases, necessitate adjustment of the insulin dose. Overdose may lead to severe and resulting in severe hypoglycaemia and loss of consciousness. Risk groups include Lantus is administered subcutaneously once daily, at the same time each day. Do sometimes long-term and life-threatening hypoglycaemia. Please consult Summary patients in whom glycaemic control is markedly improved, hypoglycaemia develops not administer intravenously. Insulin glargine dosage should be individually adjusted. of Product Characteristics for full details of the recognised side effects with Lantus. gradually, an autonomic neuropathy is present, or in elderly patients. The prolonged In type 2 diabetes mellitus, Lantus can also be used in combination with orally MA holder: Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia. Due active antidiabetic medicinal products. Close metabolic monitoring is recommended MA Numbers: Lantus cartridge: EU/1/00/134/006. Lantus vial EU/1/00/134/012. to more sustained basal insulin supply with Lantus, less nocturnal but more early during, and for a period after, transition from other insulins to Lantus. Dose and Lantus SoloStar: EU/1/00/134/033. Legal category: POM Further information is morning hypoglycaemia can be expected. Cases of cardiac failure have been reported timing of other antidiabetic medicines may need to be adjusted. Dose adjustments available from: Sanofi 18 Riverwalk, Citywest Business Campus, Dublin 24 or when pioglitazone was used in combination with insulin, especially in patients with may also be required if the patient’s weight or lifestyle changes, the timing of contact IEmedinfo@sanofi.com Tel.: (01) 4035600. Please refer to the Summary risk factors for development of cardiac heart failure. Patients on this combination insulin dose is changed or other circumstances arise that increase susceptibility to of Product Characteristics which can be found on IPHA @ http://www. should be observed for signs and symptoms of heart failure, weight gain and oedema. hypo- or hyperglycaemia. Lantus must not be mixed with other insulins or diluted. medicines.ie/ before prescribing. Information about adverse event reporting Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Insulin requirements may be diminished in the elderly or patients with renal or can be found at www.imb.ie Adverse events should be reported to the Sanofi Pregnancy and lactation: No clinical data on exposed pregnancies from controlled hepatic impairment. The efficacy and safety of Lantus in children have only been clinical trials are available. Moderate post-marketing data indicate no adverse effects Drug Safety Department at the above address Date of Revision: July 2012 demonstrated when given in the evening. Contraindications: Hypersensitivity of insulin glargine on pregnancy and no malformative nor feto/neonatal toxicity. Use of to insulin glargine or any excipients. Precautions and warnings: Lantus is not GBIE.GLA.12.11.03c. Date of preparation: February 2013 Lantus in pregnancy can be considered if necessary. It is unknown if insulin glargine is the insulin of choice for treatment of diabetic ketoacidosis. In case of insufficient

REFERENCES: 1. IMS – MAT, June 2012. 2. Gerstein HC, et al. Diabet Med 2006;23:736-42. 3. Rosenstock J, et al. Diabetes Care 2006;29:554-9. 4. Aschner P, et al. Lancet 2012;379:2262-9. 5. Yki-Järvinen H, et al. Diabetologia 2006;49:442-51. 6. Riddle MC, et al. Diabetes Care 2003;26:3080-6. 7. Schreiber SA, et al. Diabetes Technol Ther 2008;10(2):121-7. 8. DeVries JH, et al. Diabetes 2012;61(Suppl 1):A552-3. 9. Lantus SmPC.

Job code: xxxxxx Date of preparation: December 2012

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FEATURE Diabetes

}

There are about 2,700 children with type 1 diabetes in Ireland and the service is extremely under-resourced, with only about 58 per cent having access to specialist diabetes multidisciplinary care.” endocrinologists, diabetes nurse specialists and dieticians in the area of diabetes are considerably below international standards and primary care is also under-resourced to look after people with diabetes in the community.

There are only about 38 consultant endocrinologists in the country, one of the lowest number per head internationally, which means that there is a very long waiting list for specialist care, with patients having to wait up to two or three years in some instances.

“One of the problems is that in certain areas of the country, primary care does not have the resource to look after people with diabetes in the community and they are sent to hospitals which don’t have the numbers of specialist diabetes staff required to look after the huge number of patients, so waiting lists increase.

“Because of the long waiting lists in hospital, patients with type 2 disease are only being seen once a year, while internationally it is recommended that they are seen three to four times year.

There are pockets around the country particularly in the Midlands, the North East and the South, where GPs are providing excellent diabetes care and we want to invest more in primary and secondary diabetes care to facilitate an integrated model of care, where primary and secondary care work together to deliver the best care possible to our patients with diabetes across the country.”

Dr. Smith said it was estimated that 30,000 patients in the country had type 1 diabetes and the model of care provided that they would receive their diabetes related care and management in hospital. They were hoping to develop a national ICT solution to support the Programme’s clinical model. This

system would mean that changes made to treatment in primary care would be communicated directly to secondary care centres and vice versa.

“We want to ensure equal access to patients of high quality diabetes care both in primary and secondary care across the country. This type of integrated care requires investment in primary and secondary care. Discussions have to take place with GPs regarding work practices and payments but this is a matter for the Department of Health and the HSE to initiate with the GPs.

about 58 per cent having access to specialist diabetes multidisciplinary care. The model of care provided for the development of new paediatric centres around the country. Because the children under five particularly benefit from insulin pump therapy we have developed a national model of care for children with Type 1 diabetes < 5 years of age and tried to put a new resource into Tallaght Hospital, the Children’s University Hospital at Temple Street, Cork University Hospital and the Mid Western Regional Hospital in Limerick to help them deliver an insulin pump service. Money was identified from cost savings and 4.2 new WTE staff are to be recruited. This service has not yet started, partly because of the moratorium but it is hoped that the new personnel will be in place in the early part of 2013.

“Some of the hospital nurses will apply for the posts and might get them, but if we lose hospital resources they will have to be replaced. Otherwise it would just be a stripping of assets which would significantly affect the delivery of diabetes care and make the situation worse for patients rather than better.”

The Programme is also concerned with gestational diabetes, which can affect foetal outcome and perinatal morbidity and mortality. Dr. Smith said that about 12 per cent of the pregnant population have gestational diabetes.

Working with Professor Fidelma Dunne and consultant obstetric and gynaecology colleagues there was good evidence that with a targeted screening programme for gestational diabetes, it was possible to diagnose it earlier, initiate treatment earlier and improve foetal and maternal outcomes.

Unfortunately there was no money in the service for this at present, but they were proceeding with planning and continuing to advocate for a targeted screening approach to gestational diabetes. It would be an important change in clinical management as it would make a difference to women and their babies.

Turning to paediatric diabetes, Dr. Smith said Dr. Stephen O’Riordan, Consultant Endocrinologist in Cork University Hospital was the driver behind paediatric diabetes. There are about 2,700 children with type 1 diabetes in Ireland and the service is extremely under-resourced, with only

The National Diabetes Programme is also anxious to ensure that all people with diabetes are offered a place on a structured diabetes education programme and will be pushing for the appointment of a national co-ordinator of structured education programmes for all chronic illness.

“To support our model of clinical care, we have secured funding for 17 new integrated care diabetic nurse specialists, one per Integrated Service Area.

Interviews have been carried out. The theory is that they will spend four days per week in the community helping the GP and the practice nurse deliver the integrated model of care and one day within the local specialist diabetes centre and be a key link between primary and secondary care, a resource for practice nurses and facilitate the setting up of diabetes clinics within the GP practice.

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JANUMET® targets the 3 key defects of Type 2 Diabetes to improve glycemic control1 (sitagliptin/metformin)

Increases insulin sensitivity • Metformin increases glucose uptake and utilization (greater effect in the liver than in muscle and fat)3,4

Increases insulin synthesis and release • Sitagliptin works in a glucose-dependent manner to increase active incretins, which stimulate the synthesis and release of insulin from β cells2

Decreases hepatic glucose overproduction • Metformin reduces glucose production in the liver (gluconeogenesis) and diminishes the breakdown of glycogen into glucose (glycogenolysis)4,5 • Sitagliptin suppresses glucagon secretion from pancreatic α cells (by enhancing active incretin levels), which results in reduced glycogen breakdown and glucose synthesis2 • By enhancing active incretin levels, sitagliptin increases insulin synthesis and release from pancreatic β cells, which helps reduce hepatic glucose overproduction2

ClinicalCare2013_1_104.indd 61

risk factors. If suspected, discontinue treatment and hospitalise patient immediately. If changes in clinical status of patients with previously controlled type 2 diabetes occurs, evaluate promptly for evidence of ketoacidosis or lactic acidosis in any patient with type 2 diabetes previously well controlled on Janumet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness). If acidosis of either form occurs, stop Janumet immediately and initiate corrective measures. Determine serum creatinine concentrations regularly, i.e. at least once a year in patients with normal renal function and at least two to four times a year in patients with serum creatinine levels at or above the upper limit of normal and in elderly patients. Decreased renal function in elderly patients is frequent and asymptomatic. Exercise special caution where renal function may become impaired, e.g. when initiating antihypertensive or diuretic therapy or when starting treatment with a non-steroidal anti-inflammatory drug (NSAID). Surgery: due to metformin hydrochloride content of Janumet, discontinue treatment 48 hours before elective surgery with general, spinal or epidural anaesthesia. Do not resume earlier than 48 hours afterwards and only after renal function is normal. DRUG INTERACTIONS For Janumet only - Alcohol: avoid alcohol and medicinal products containing alcohol due to risk of lactic acidosis. Cationic agents that are eliminated by renal tubular secretion (e.g., cimetidine): these may interact with metformin by competing for common renal tubular transport systems. Consider close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment when these agents are co-administered. Iodinated contrast agents in radiological studies: intravascular administration of these agents may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis. Discontinue Janumet prior to, or at the time of the test and do not reinstitute until 48 hours afterwards, and only after renal function is found to be normal. Combination requiring precautions for use: glucocorticoids (given by systemic and local routes) beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity. Inform the patient and perform more frequent blood glucose monitoring, especially at the beginning of treatment. If necessary, adjust dose of the anti-hyperglycaemic medicine during therapy with, or on discontinuation of the other medicine. ACE-inhibitors: as these may decrease the blood glucose levels, if necessary, adjust dose of the antihyperglycaemic during therapy with, or on discontinuation of the other medicine. For Januvia and Janumet - Low risk of clinically meaningful interactions with metformin and ciclosporin. Meaningful interactions would not be expected with other p-glycoprotein inhibitors. The primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8. Digoxin: sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild inhibitor of p-glycoprotein in vivo. No dosage adjustment of digoxin is recommended, but monitor patients at risk of digoxin toxicity if the two are used together. Fertility, pregnancy and breast-feeding: Do not use during pregnancy or breast-feeding. Animal data do not suggest an effect of treatment with sitagliptin on male and female fertility. Human data are lacking. SIDE EFFECTS Refer to SmPC for complete information on side effects There have been no therapeutic clinical trials conducted with Janumet tablets however Janumet is bioequivalent to co-administered sitagliptin and metformin. Sitagliptin: Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported.

Hypoglycaemia has been reported in combination with sulphonylurea and insulin. The following adverse reactions reported from both clinical trials and post-marketing experience using the following conversion: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000) and not known (cannot be estimated from the available data). Sitagliptin only: Common: hypoglycaemia, headache, upper respiratory tract infection, nasopharyngitis, osteoarthritis and pain in extremity. Uncommon: dizziness, constipation. Metformin only: Clinical Trial Data and Post-marketing data: Very common: gastro-intestinal symptoms; Common: metallic taste; Very rare: urticaria, erythema; pruritis; lactic acidosis; vitamin B12 deficiency; liver function disorders, hepatitis. Sitagliptin with metformin: Common: hypoglycaemia, nausea, flatulence and vomiting; Uncommon: somnolence; upper abdominal pain, diarrhoea, constipation and blood glucose decreased. Sitagliptin with a sulphonylurea: Common: hypoglycaemia. Sitagliptin with metformin and a sulphonylurea: Very common: hypoglycaemia; Common: constipation. Sitagliptin with a PPARγ agonist (pioglitazone): Common: hypoglycaemia, flatulence, peripheral oedema and blood glucose decreased.

Sitagliptin with a PPARγ agonist (pioglitazone) and metformin: Common: hypoglycaemia, peripheral oedema. Sitagliptin with insulin with/ without metformin: Common: headache, hypoglycaemia, influenza; Uncommon: dry mouth, constipation. Sitagliptin with metformin and insulin: Very common: hypoglycaemia; Uncommon: headache and dry mouth. Post-marketing experience additional side effects have been reported (frequency not known): hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis and exfoliative skin conditions including Stevens-Johnson syndrome (see precautions); acute pancreatitis, including fatal and non-fatal haemorrhagic and necrotising pancreatitis (see precautions); impaired renal function, including acute renal failure (sometimes requiring dialysis); vomiting; pain in extremity, arthralgia, myalgia, back pain, interstitial lung disease.

PACKAGE QUANTITIES Januvia 25 mg, 50 mg and 100 mg film-coated tablets 28 tablets Janumet 50mg/850mg and 50mg/1000mg filmcoated tablets 56 tablets Legal Category: POM. Marketing Authorisation Number Januvia 25 mg: EU/1/07/383/002 Janumet 50 mg/850 mg: EU/1/08/455/003 Januvia 50 mg: EU/1/07/383/008 Janumet 50 mg/1000 mg: EU/1/08/455/010 Januvia 100mg: EU/1/07/383/014 Marketing Authorisation Holder Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK Date of review of prescribing information: January 2013 Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin 18 or from www.medicines.ie. © Merck Sharp & Dohme Ireland (Human Health) Limited, 2013.

All rights reserved. Date of Preparation: February 2013.

References: 1. Ramlo-Halsted BA, Edelman SV. The natural history of type 2 diabetes: practical points to consider in developing prevention and treatment strategies. Clin Diabetes. 2000;18(2):80-88. 2. Janumet SPC available at www.medicines.ie. 3. Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996;334(9):574-579. 4. Kirpichnikov D, McFarlane SI, Sowers JR. Metformin: an update. Ann Intern Med. 2002;137(1):E-25-E-33. 5. Krentz AJ, Bailey CJ. Oral antidiabetic agents: current role in type 2 diabetes mellitus. Drugs.

2005;65(3):385-411.

DIAB-1067195-0002

JANUVIA® JANUMET® Sitagliptin Sitagliptin/metformin hydrochloride ABRIDGED PRESCRIBING INFORMATION Refer to Summary of Product Characteristics (SmPC) before prescribing PRESENTATION Januvia® 25 mg, 50 mg and 100 mg film-coated tablet each containing 25 mg, 50 mg or 100 mg of sitagliptin respectively. Janumet® 50 mg/850 mg and 50 mg/1000 mg tablets each containing 50 mg sitagliptin and 850 mg or 1000 mg metformin hydrochloride. USES For adult patients with type 2 diabetes mellitus Januvia is indicated to improve glycaemic control: as monotherapy • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance as dual oral therapy in combination with • metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control • a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contra-indications or intolerance • a PPARγ agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control as triple oral therapy in combination with • a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. • a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control. Janumet: as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. • in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. • as triple combination therapy with a PPARγ agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist. • as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control. DOSAGE AND ADMINISTRATION Januvia - One 100 mg tablet once daily, with or without food.

Janumet - The dose of antihyperglycaemic therapy with Janumet should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin. For patients not adequately controlled on metformin alone, the usual starting dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken. For patients switching from co-administration of sitagliptin and metformin, Janumet should be initiated at the dose of sitagliptin and metformin already being taken. For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea or with maximal tolerated dose of metformin and a PPARγ agonist or with maximal tolerated dose of metformin and insulin, the dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. All patients should continue their diet with an adequate distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet. Januvia and Janumet - In combination with a sulphonylurea or with insulin, consider a lower dose of sulphonylurea or insulin, to reduce risk of hypoglycaemia. Renal impairment: For Januvia only: When considering sitagliptin with another anti-diabetic product, its use in patients with renal impairment should be checked. Moderate impairment (CrCl ≥30 to <50 mL/min), the dose is 50 mg once daily. Severe impairment (CrCl <30 mL/min) or with end-stage renal disease (ESRD), the dose is 25 mg once daily. Mild impairment, no dose adjustment. Assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter. For Janumet only: Should not be used in patients with moderate or severe renal impairment (creatinine clearance < 60 ml/min). Hepatic impairment: For Januvia only - no dosage adjustment necessary for patients with mild to moderate hepatic impairment. Januvia has not been studied in patients with severe hepatic impairment. For Janumet only – do not use. Elderly < 75 years: For Januvia only - no dosage adjustment necessary. For Janumet only - use with caution as age increases. Monitoring of renal function is necessary to aid prevention of metformin-associated lactic acidosis. Elderly ≥ 75 years: Exercise care as there are limited safety data in this population. Children: not recommended below 18 years of age. CONTRA-INDICATIONS For Januvia Hypersensitivity to active substance or excipients. For Janumet - Hypersensitivity. Diabetic ketoacidosis and diabetic pre-coma.

Moderate and severe renal impairment (creatinine clearance < 60 ml/min). Acute conditions with the potential to alter renal function such as dehydration, severe infection, shock. Intravascular administration of iodinated contrast agents. Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction, shock. Hepatic impairment.

Acute alcohol intoxication, alcoholism. Lactation. PRECAUTIONS For Januvia and Janumet - General: do not use in patients with type 1 diabetes or for diabetic ketoacidosis. Pancreatitis: Post-marketing experience - spontaneously reported adverse reactions of acute pancreatitis. Inform patients of the symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of sitagliptin, but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported. If pancreatitis is suspected, Januvia or Janumet and other potentially suspect medicinal products should be discontinued. Hypoglycaemia when used with other anti-hyperglycaemic agents: Rates of hypoglycaemia reported with sitagliptin were generally similar to rates in patients taking placebo. When sitagliptin was added to a sulphonylurea or to insulin, the incidence of hypoglycaemia was increased over that of placebo; therefore consider a lower dose of sulphonylurea or insulin to reduce the risk of hypoglycaemia when administering Janumet or Januvia. Hypersensitivity reactions: Serious hypersensitivity reactions have been reported, including anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset occurred within the first 3 months after initiation of treatment with some reports occurring after the first dose. If suspected, discontinue Januvia or Janumet. For Januvia only– Renal Impairment: Lower dosages are recommended in patients with moderate and severe renal impairment, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis- see Dosage. For Janumet only - Lactic acidosis and renal function: a very rare, but serious, metabolic complication can occur due to metformin accumulation. Cases in patients on metformin have occurred primarily in diabetic patients with significant renal failure. Reduce incidence by assessing other associated

Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland

13/03/2013 17:28:29

When metformin alone is no longer enough

add Victoza ... ®

...to help your patients with type 2 diabetes achieve: • Significant and sustained reductions in HbA1c : up to 1.5% (16 mmol / mol) at 52 weeks1 • Significant weight loss: up to 3.7 kg1 • Improved beta-cell function1

Abbreviated Prescribing Information Victoza® 6 mg/ml solution for injection in pre-filled pen (liraglutide). Please refer to the Summary of Product Characteristics for full information. Victoza® 2 x 3 ml pre-filled pens. Victoza® 3 x 3 ml pre-filled pens. 1 ml of solution contains 6 mg of liraglutide. Indication: Treatment of adults with type 2 diabetes mellitus in combination with metformin or a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of metformin or sulphonylurea monotherapy; or in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy. Dosage: Victoza® is administered once daily by subcutaneous injection and can be administered at any time independent of meals however, it is preferable that Victoza® is injected around the same time of the day.

Victoza® should not be administered intravenously or intramuscularly. Recommended starting dose is 0.6 mg daily. After at least one week, the dose should be increased to a maintenance dose of 1.2 mg. Based on clinical response, after at least one week the dose can be increased to 1.8 mg to further improve glycaemic control in some patients. Daily doses higher than 1.8 mg are not recommended. When used with existing metformin therapy or in combination with metformin and thiazolidinedione therapy, the current dose of metformin and thiazolidinedione can continue unchanged. When added to existing sulphonylurea therapy or in combination with metformin and sulphonylureas, a reduction in the dose of sulphonylurea may be necessary to reduce the risk of hypoglycaemia. Victoza® can be used in the elderly (>65 years old) without dose adjustment but therapeutic experience in patients ≥75 years of age is limited. No dose adjustment is required for patients with mild renal impairment (creatinine clearance 60-90 ml/min). Due to lack of therapeutic experience Victoza® is not to be recommended for use in patients with moderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinine clearance below 30 ml/min), patients with end stage renal disease, patients with hepatic impairment and children below 18 years of age. Contraindications: Hypersensitivity to the active substance or any of the excipients. Warnings and Precautions for use: Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Victoza® is not a substitute for insulin. Addition of liraglutide in patients already treated with insulin has not been evaluated and is therefore not recommended.

Limited experience in patients with congestive heart failure New York Heart Association (NYHA) class I-II and no experience in patients with NYHA class III-IV. Due to limited experience Victoza® is not recommended for patients with inflammatory bowel disease and diabetic gastroparesis. Victoza® is associated with transient gastrointestinal adverse reactions, including nausea, vomiting and diarrhoea. GLP-1 analogues have been associated with pancreatitis; patients should be informed of symptoms of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis suspected, Victoza® and other suspect medicinal products should be discontinued. Thyroid adverse events, including increased blood calcitonin, goitre and thyroid neoplasm reported in clinical trials particularly in patients with pre-existing thyroid disease. Risk of hypoglycaemia in combination with sulphonylureas; lowered by dose reduction of sulphonylurea. Signs and symptoms of dehydration, including renal impairment and acute renal failure reported with Victoza®. Patients should be advised of potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. No Reference 1. Pratley R et al. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract 2011;65(4):397-407

Victoza A4 Nov 12(F).indd 1 62 ClinicalCare2013_1_104.indd

studies on the effects on the ability to drive and use machines performed. Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Victoza® is used in combination with a sulphonylurea. Substances added to Victoza® may cause degradation; in the absence of compatibility studies Victoza® must not be mixed with other medicinal products. Fertility, pregnancy and lactation: Victoza® should not be used during pregnancy or during breast feeding. If a patient wishes to become pregnant, or pregnancy occurs, treatment with Victoza® should be discontinued; use of insulin is recommended instead. Apart from a slight decrease in number of live implants, animal studies did not indicate direct harmful effects with respect to fertility.Undesirable effects: The most frequently observed adverse reactions from long term phase 3 controlled studies and spontaneous (postmarketing) reports were: Very common (≥1/10): nausea, diarrhoea, hypoglycaemia when used in combination with sulphonylureas, headache when used in combination with metformin and vomiting when used in combination with metformin and rosiglitazone; Common (≥1/100 to <1/10): vomiting, constipation, abdominal pain, discomfort and distension, dyspepsia, gastritis, flatulence, gastroesophageal reflux disease, gastroenteritis viral, toothache, headache, dizziness, nasopharyngitis, bronchitis, hypoglycaemia, anorexia, appetite decreased, fatigue,pyrexia and rash. GI adverse reactions are more frequent at start of therapy but are usually transient. Patients >70 years or with mild renal impairment (CrCl 60-90 ml/min) may experience more GI effects. Consistent with medicinal products containing proteins/ peptides, patients may develop anti-liraglutide antibodies following treatment but this has not been associated with reduced efficacy of Victoza®. Few cases of: angioedema (0.05%), acute pancreatitis (<0.2%), injection site reactions (usually mild, approx. 2%). Rates of thyroid adverse events - 33.5, 30.0 and 21.7 events/1000 subject years of exposure for liraglutide, placebo and total comparators; Thyroid neoplasms, increased blood calcitonin and goitres are the most frequently reported thyroid adverse events/1000 subject years of exposure were 6.8, 10.9 and 5.4 of liraglutide treated patients in comparison with 6.4, 10.7 and 2.1 of placebo treated and 2.4, 6.0 and 1.8 of total comparator treated. Few cases of allergic reactions (including urticaria, rash and pruritus) and anaphylactic reactions with additional symptoms (such as such as hypotension, palpitations, dyspnoea, oedema) have been reported with marketed use of Victoza®. The Summary of Product Characteristics should be consulted for a full list of side effects. Overdose: In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. MA numbers: Victoza® 2 x 3ml pre-filled pens EU/1/09/529/002. Victoza® 3 x 3ml pre-filled pens EU/1/09/529/003. Legal Category: POM. For complete prescribing information please refer to The Summary of Product Characteristics which is available on www. medicines.ie or by email from info@novonordisk.ie or from Medical department, Novo Nordisk Limited, 2nd Floor, 2 Hume Street, Dublin 2, Ireland; www.novonordisk.ie. Date created: Nov 2012 Information about adverse event reporting is available at www.imb.ie.

Adverse events should be reported to the Novo Nordisk Medical department: Tel: 1850 665 665.

Victoza ®, Changing Diabetes ® and the Apis bull logo are registered trademarks of Novo Nordisk A/S. Date of preparation: November 2012. IR/LR/1112/0305 Further Information is available from: Novo Nordisk Limited 2nd Floor, 2 Hume Street, Dublin 2, Ireland Tel: 01 678 5989 Fax: 01 676 3259 Lo Call: 1850 665 665 www.novonordisk.ie

14/12/201217:28:35 11:10 13/03/2013

© istockphoto/thinkstockphoto.com

Dermatology FEATURE

Major increase in

numbers of new patients assessed

Following significant achievements by the HSE Clinical Programme on Dermatology - which was one of the first outpatient programmes to be set up within the HSE Clinical Programme structure almost three years ago - Prof.

Louise Barnes is stepping down as Clinical Lead, to take up the post of Clinical Director of the SaMS Directorate in St. James’s, Hospital, Dublin. Maureen Browne reports.

F

ollowing significant achievements by the HSE Clinical Programme on Dermatology - which was one of the first outpatient programmes to be set up within the HSE Clinical Programme structure almost three years ago - Prof. Louise Barnes is stepping down as Clinical Lead, to take up the post of Clinical Director of the SaMS Directorate in St. James’s, Hospital, Dublin.

“It’s been an interesting three years; it was a difficult role at times. The clinical programmes are the first time that clinicians have had an opportunity to engage directly with management at all levels. At this stage I think the clinical programmes need some re-structuring and this is happening at present under the leadership of Dr. Aine Carroll who has replaced Dr Barry White as HSE

}

National Director of Clinical Strategies & Programmes.” Dermatology is primarily an outpatient based speciality and the fact that there were over 23,000 patients all over Ireland waiting for a new patient appointment probably brought the speciality under a certain degree of scrutiny in 2010.”

Prof. Barnes said that since then, there has been an impressive increase in the number of new patients seen in Irish dermatology clinics. Approximately 45 per cent more new patients were assessed in 2012 compared to 2009. This increase which emerged from data compiled with the Department of Health Special Delivery Unit (SDU) was one of the most significant achievements of the Programme.

She said the increase in numbers of

Dermatologists like all other consultants want to deliver the best possible service to their patients, the establishment and dissemination of accurate data and establishing targets facilitates this.”

CLINICAL CARE | 63

11:10

ClinicalCare2013_1_104.indd 63

13/03/2013 17:28:41

* That’s days to focus on life... not psoriasis Clearance l l

l

Early onset of action with visible efficacy by week 2†1,2,3 Superior efficacy to etanercept 50mg twice weekly at 12 weeks4 Efficacy response maintained through 5 years in Week 40 PASI 75 responders5**

Convenience l

Four doses per year, after 2 induction doses6

Confidence l

In 3,104 patient years of follow-up in the Phoenix 1 trial, Stelara® was generally well tolerated, with rates of serious infection remaining low and stable through 5 years of treatment5

*4 = Doses maintenance therapy after 2 induction doses. **Week 40 responders comprised of patients who were randomised to Stelara® at baseline, were PASI 75 responders at both Weeks 28 and Week 40, and were re-randomised at Week 40 to continue 12-weekly maintenance treatment with Stelara®. †PASI 50

STELARA® solution for injection in pre-filled syringe PRESCRIBING INFORMATION ACTIVE INGREDIENT(S): Ustekinumab. Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S): Treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA. DOSAGE & ADMINISTRATION: Under the guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis.

Subcutaneous injection. Avoid areas with psoriasis. For self-injecting patients ensure appropriate training, follow-up and monitoring during treatment. Adults & Elderly: Patients ≤ 100kg, 45 mg at week 0 followed by a 45 mg dose at week 4, then every 12 weeks. Patients >100 kg, 90 mg at week 0 followed by a 90 mg dose at week 4, then every 12 weeks (45 mg was less effective in these patients). Consider discontinuation if no response after 28 weeks. Children <18 years: Not recommended. Renal & Hepatic impairment: Not studied. CONTRAINDICATIONS: Hypersensitivity to product; clinically important, active infection. SPECIAL WARNINGS & PRECAUTIONS: Infections: Potential to increase risk of infections and reactivate latent infections. Caution in patients with a chronic infection or history of recurrent infection, particularly TB. Patients should be evaluated for tuberculosis prior to initiation of STELARA. Consider anti-tuberculosis therapy prior to initiation of STELARA in patients with past history of latent or active tuberculosis. Patients should seek medical advice if signs or symptoms suggestive of an infection occur. If a serious infection develops, they should be closely monitored and STELARA should not be administered until infection resolves. Malignancies: Potential to increase the risk of malignancy. No studies in patients with a history of malignancy or in patients who develop malignancy while receiving STELARA. Concomitant immunosuppressive therapy: Caution, including when changing immunosuppressive biologic agents. Hypersensitivity reactions: Serious hypersensitivity reactions (anaphylaxis and angioedema) reported, in some cases several days after treatment. If these occur, discontinue STELARA immediately and institute appropriate therapy. Immunotherapy: Not known whether STELARA affects allergy immunotherapy. Latex sensitivity: Needle cover contains natural rubber (latex), may cause

ClinicalCare2013_1_104.indd 64

allergic reactions. SIDE EFFECTS: Serious side effects: Serious infec tract infection, nasopharyngitis. Common: hypersensitivity reactions infection, depression, dizziness, headache, pharyngolaryngeal pain myalgia, arthralgia, fatigue, injection site erythema, antibodies to ustek site reactions. Rare: serious hypersensitivity reactions (including anap other side effects. FERTILITY: The effect of ustekinumab has not bee of childbearing potential: Use effective contraception during treatmen Limited data in humans. INTERACTIONS: In vitro, STELARA had no ef should not be given concurrently with STELARA, and should be with STELARA can resume at least 2 weeks after such vaccinations. No vaccines in patients receiving STELARA. Concomitant immunosuppre combination with other immunosuppressants, including biologics, CATEGORY: Prescription Only Medicine. PRESENTATIONS, PACK SIZE 0.5ml pre-filled syringe. EU/1/08/494/003. STELARA 90mg: 1 x 1.0 AUTHORISATION HOLDER: JANSSEN-CILAG INTERNATIONAL NV, Tu INFORMATION IS AVAILABLE FROM: Janssen-Cilag Ltd, 50 – 100 Ho HP12 4EG UK. © Janssen-Cilag Ltd 2012 Prescribing information last revised: 20/03/2012 PIVER: 200312

13/03/2013 17:28:43

cts: Serious infections, malignancies. Very common: upper respiratory sitivity reactions (rash, urticaria), cellulitis, viral upper respiratory tract ngolaryngeal pain, nasal congestion, diarrhoea, pruritus, back pain, ntibodies to ustekinumab. Uncommon: herpes zoster infection, injection ns (including anaphylaxis, angioedema), facial palsy Refer to SmPC for mab has not been evaluated. PREGNANCY: Should be avoided. Women during treatment and for at least 15 weeks post-treatment. LACTATION: ELARA had no effect on CYP450 activities. Vaccinations: Live vaccines d should be witheld for at least 15 weeks after last dose of STELARA. vaccinations. No data on secondary transmission of infection by live nt immunosuppressive therapy: The safety and efficacy of STELARA in luding biologics, or phototherapy have not been evaluated. LEGAL IONS, PACK SIZES, PRODUCT LICENCE NUMBER: STELARA 45mg: 1 x RA 90mg: 1 x 1.0ml pre-filled syringe. EU/1/08/494/004 MARKETING ATIONAL NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER td, 50 – 100 Holmers Farm Way, High Wycombe, Buckinghamshire,

For further information on STELARA®, contact Janssen Medical Information at medinfo@janssen.ie or call 1800 709 122.

References: 1. Rich et al, Ustekinumab demonstrates rapid onset of efficacy in the treatment of moderate-to-severe psoriasis.

Poster 040 presented at Psoriasis 2010, July 2. Leonardi C et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet 2008: 371: 1665-1674 3. PAPP KA et al. Eicacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2) Lancet 2008: 371: 1675-1684 4. Griffiths C et al. Comparison of Ustekinumab and Etanercept for Moderate to Severe Psoriasis. N Eng J Med 2010; 362: 118-128 5. Kimball A et al. Spring EADV 2012. P582 6. Stelara® (ustekinumab) Summary of Product Characteristics PHIR/STE/1112/0106 Date of preparation: November 2012

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FEATURE Dermatology

new patients assessed should not be attributed entirely to the new consultant posts. She believed it had been achieved through co-operation between clinicians and management and through the dissemination of data.

“Dermatologists like all other consultants want to deliver the best possible service to their patients, the establishment and dissemination of accurate data and establishing targets facilitates this. There are still some long waiting lists out there, we need extra productivity but we also need better facilities to tackle them.”

Another success story of the Programme is that there has been a significant increase in the number of new consultants appointed.

There were in total 25.5 dermatologists in the Republic of Ireland three years ago, giving a ratio of one per 166,269 of the population. A total of 12 new posts were approved. When all 12 are appointed that will give a ratio of one dermatologist per 113,063 of the population. At this point, six of these new consultants have taken up their posts, two commence in April and hopefully all 12 will be in post by year end.

“As part of the programme we tried to visit most of the hospitals providing a dermatology service. We were impressed by the enthusiasm of the staff working together to deliver a patient focused service. However in many units there are inadequate outpatient rooms, poor surgical and day care facilities. The gold standard is a self-contained department with adequate outpatient rooms, day care and surgical and nurse treatment facilities.

This was achieved in the department of dermatology in St. Vincent’s University Hospital, Dublin, following the closure of Hume Street Hospital. It was encouraging to see the excellent new dermatology unit in the Mater Hospital (though the day care is separate) and the lovely Rainbow unit in Our Lady’s Hospital, Crumlin.

“In other hospitals there are shared and scattered outpatient rooms, cramped day

care facilities and sometimes lack of access to surgery facilities. I really hope that each hospital in need of improved facilities receives the structural support necessary to deliver the best service to all.”

Prof. Barnes said that the objective of the Clinical Programme is to have what she terms “acceptable” waiting lists. This means that if somebody had a suspected rapidly growing skin cancer, that patient would be seen within a very short time, while it might not be inappropriate for somebody, for example, with acne to have to wait up to 12 weeks.

“To achieve that even with our increased consultant numbers will require considerable referral management. We want to make sure the patient gets to the right person, at the right clinic and in a timely fashion. This entails active referral management and working towards a standard whereby a patient with a skin cancer sees a dermatologist and then in some instances may have his or her surgery the same day. The Programme is encouraging safe but lean standards and an integrated service where the patient will not be brought back unnecessarily. It is a slow painful process, but I hope these new consultants will be facilitated to work hard and we will see even better results than what we have had over the last three years.

“I think we need to look not just at the numbers but at the quality of care. We are trying to see that each department has a minimum data set which collects not only new patients and returns but the conditions from which they are suffering and how timely is their treatment. For example we would like to know how many psoriasis patients are being seen and how timely is their ultraviolent light treatment, how many skin cancers etc.

“There are some university hospitals which either don’t have a phototherapy service or there is a four to ten months waiting list for this treatment. We want to standardise the quality of care as much as possible. Patients should receive the same quality of care wherever they

}

Clinical Programmes have made clinicians and managers re-think about how things are done and I think that dermatology was lucky to get in there early.”

PICTURED: Prof. Louise Barnes

are located and this will require more funding, especially at nursing level. I think in the future we have to face reality.

The recession has given rise to agonising healthcare choices and clinicians have engaged and must continue to engage with management.

“OPD guidelines are now being given to all specialties, but clinicians need to be involved and not dictated to. There is much talk about the NHS. I think the NHS has done a lot of good things, but we don’t want to become tick boxes and we should learn from the things that have been done well and the things that are not working for them.”

Prof. Barnes said that the process of extracting data had been slow and inconsistent but it was improving. “You cannot set targets unless data is validated around the country. I am cautiously optimistic about the future of the clinical programmes. They have made clinicians and managers re-think about how things are done and I think that dermatology was lucky to get in there early. It is key to keep the patients central to everything we do.”

66 | CLINICAL CARE

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13/03/2013 17:28:46

Dovo

Body

Sca

lp

calcipotriol / betamethasone dipropionate

t® Gel e b o v o iasis D r o s P p d Scal n a y d Bo

Topical treatment of scalp psoriasis in adults.

Topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults.

Dovobet® 50 microgram/g + 0.5 mg/g gel Name and address of P.A. holder: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark. P.A. Number: PA 1025/1/2.

Available only on prescription. Full prescribing information is available from LEO Pharma, Cashel Rd., Dublin 12. Telephone: 01 4908924 or email: medical-info.ie@leo-pharma.com. Date of preparation: November 2012. Further information is available on request or within the relevant SmPC. LEO® © LEO Pharma November 2012. IE/Derm/2012/33. ALL TRADEMARKS MENTIONED BELONG TO THE LEO GROUP.

ClinicalCare2013_1_104.indd 67 Dovobet_A4_Nov12.indd 1

13/03/2013 17:28:59 26/11/2012 14:52

Protecting today.

Growing tomorrow.

Pfizer Vaccines â&#x20AC;&#x201C; helping to protect children right from the start.

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Paediatrics FEATURE

The life and blood of the nation There are 1.1 million children living in Ireland and they deserve the best care as they are the life-blood of the nation and vital for our future, says Prof. Alf Nicholson, Clinical Lead of the Paediatrics Programme and Consultant Paediatrician to the Children’s University. Maureen Browne reports.

T

here are 1.1 million children living in Ireland and they deserve the best care as they are the life-blood of the nation and vital for our future, according to Prof. Alf Nicholson, Clinical Lead of the Paediatrics Programme and Consultant Paediatrician to the Children’s University Hospital, Temple Street, Dublin. “Our birth rate (75,000 per annum) is the highest in the EU, our preschool population has increased by 34 per cent over the past ten years and up to 25 per cent of our children live in relative poverty.”

Murphy, National Clinical Lead in Neonatology and Consultant Neonatologist to the National Maternity Hospital in HollesStreet, Dublin, have been involved in a very extensive consultation process involving a formal visit to every paediatric department in the country.

Throughout the past year Prof.

Nicholson, as the National Clinical Lead in Paediatrics and Dr. John

� Involve and empower parents and

He said that based on their discussions, they believed the following pillars should help underpin the future care of children and young people in Ireland:

}

There is a need to ensure that children and young people access the necessary generalist or specialist paediatric care in a timely manner, in an appropriate environment and as close to home as possible.”

patient groups in decisions: “The doctor-patient relationship is

© digitalvision/thinkstockphoto.com

“

CLINICAL CARE | 69

ClinicalCare2013_1_104.indd 69

13/03/2013 17:29:06

FEATURE Paediatrics

national neonatal and paediatric retrieval services need urgent implementation.

The expansion of the neonatal retrieval service to a 24/7 service would, for head cooling alone, save death or handicap in 10 babies per annum. A paediatric retrieval service is essential also.

Additional consultant intensivists need to be appointed. The development of a national retrieval service is the number one priority in terms of child safety wand risk.”

changing. We need to listen to patients and their families to understand their needs and the new Paediatric Patient Charter will enhance a culture of partnership which promotes shared decision making in health care.”

for the management of acute and chronic childhood conditions, health surveillance, health promotion and disease prevention.

Algorithms and close working relationships with the ICGP are critical.

The central and key role of general paediatrics needs to be revitalised.”

� Governance and uniformity of clinical

care: “The service provided should aim to provide high quality, equitable and safe care to children, young people and their families that is benchmarked with comparable best international and national services. Each unit should have a formal governance structure and a clear understanding of their clinical role. We aim to end fragmentation of care and end post-code disadvantage. Uniformity of care delivered via clinical pathways, algorithms and clinical guidelines.

Algorithms have been developed for both newborn and paediatric patients.” � Improve access to scheduled care

for children: “There is a need to ensure that children and young people access the necessary generalist or specialist paediatric care in a timely manner, in an appropriate environment and as close to home as possible.”

community child health services: “There is a lack of a streamlined approach to community child health with significant gaps in the service. A formal national review and significant investment is required. Community child health services should be reconfigured into managed clinical networks with far greater integration with primary care teams.” � Focus on health promotion,

� Facilities for children in Emergency

Departments: “We state that there should be full audiovisual separation of children from adults / a separate waiting area / adequate observation spaces and the presence of a paediatric nurse per shift - many paediatric units do not currently meet these standards.”

prevention and screening: “Immunisation programmes, injury prevention programmes, screening and early detection of existing conditions with timely intervention can make a significant difference to the health and well being of children.” � Develop good practice as the norm:

• � Develop a national model of care

for newborns: “There are 19 neonatal units in the country, operating at different levels of complexity. There is a need to group the various units into appropriate networks to ensure that the newborns most in need are managed by appropriately trained neonatologists. In addition, the need to have appropriate neonatal trained nurses and allied health professionals in place requires urgent attention.”

•

•

•

� Develop a 24/7 newborn retrieval � Improve primary care of children:

“The vast majority of care children receive is in primary care. Our primary care services need to be able to provide

service and start a paediatric retrieval service: “In order for neonates and children to be managed in the most appropriate setting,

•

Patient Safety: early warning scores / daily consultant rounds / formal handover using SBAR / minimal dataset of unit activities Outpatients: texting reminders / central weekly review of GP requests / target 1:2 new/review ratio for general paediatrics / structured referral forms / focus on did not attend reduction Inpatients: implement discharge planning / measure harm using trigger tool Newborn care: procedural training for NCHD’s / discharge planning / neonatal networks / advice from allied health professionals Reduce waste: reduce process inefficiency / reduce hospitalacquired infections.

© istockphotokstockphoto.com

}

The development of a national retrieval service is the number one priority in terms of child safety and risk.”

� Set out a root and branch review of

70 | CLINICAL CARE

ClinicalCare2013_1_104.indd 70

13/03/2013 17:29:08

Haem

ENHAN

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G

AC

TIV E

LIVIN G

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01/09/2011 08:26 13/03/2013 17:29:10

ENBREL

is Different A unique mechanism of action •

Enbrel is the only fully human soluble tumour necrosis factor (TNF) receptor 1,2,3,4,5,6

•

It works differently than MAB’s 1

No neutralising antibodies •

1

Enbrel is not associated with the production of neutraIising antibodies in humans

Enbrel has a short half life (<3 days) •

1

The half-life of anti-TNF agents should be taken into account if a treatment break is required

Efficacy •

Registry data and Cochrane Review data support efficacy & safety of Enbrel 7,8

ABBREVIATED PRESCRIBING INFORMATION Enbrel® etanercept Before prescribing Enbrel® please refer to full Summary of Product Characteristics (SmPC). Presentation: Enbrel Pre-filled Syringe: Enbrel 25 mg and 50 mg solution for injection in pre-filled syringe. Each prefilled syringe contains either 25 mg or 50 mg etanercept. Enbrel Pre-filled Pen (MYCLIC®): Enbrel 50 mg solution for injection in pre-filled pen.

Each pre-filled pen contains 50 mg etanercept. Enbrel Powder: Enbrel 25 mg powder and solvent for solution for injection. Each vial contains 25 mg etanercept and each pre-filled syringe contains 1 ml water for injections. Enbrel Paediatric: Enbrel 10 mg powder and solvent for solution for injection for paediatric use. Each vial contains 10 mg etanercept and each pre-filled syringe contains 1 ml water for injections.

Uses: Adults: Moderate to severe active rheumatoid arthritis (RA), in combination with methotrexate, when response to DMARDS, including methotrexate (unless contraindicated), has been inadequate. Enbrel can be given as monotherapy in the case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Severe, active and progressive RA without prior methotrexate treatment. Enbrel alone or with methotrexate has been shown to reduce the rate of progression of joint damage measured by X-ray and to improve physical function. Patients with moderate to severe plaque psoriasis (PP) who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporine, methotrexate or PUVA. Active and progressive psoriatic arthritis (PsA) when response to DMARDS has been inadequate. Enbrel has been shown to improve physical function in PsA patients, and to reduce the progression rate of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of PsA. Severe active ankylosing spondylitis (AS) when response to conventional therapy has been inadequate. Children aged 2-17 years: Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis from the age of 2 years when inadequate response to, or intolerant of methotrexate. Psoriatic arthritis from the age of 12 years when inadequate response to, or intolerant of methotrexate. Enthesitis-related arthritis from the age of 12 years when inadequate response to, or intolerant of, conventional therapy. Children aged 6-17 years: Chronic severe psoriasis when inadequately controlled by, or intolerant to, other systemic therapies or phototherapies. Dosage: By subcutaneous injection. Adults: RA – 25 mg twice weekly or 50 mg once weekly PP - 25 mg twice weekly or 50 mg once weekly for up to 24 weeks, or 50 mg twice weekly for up to 12 weeks followed by 25 mg twice weekly or 50 mg once weekly for a further 12 weeks if needed. Continuous therapy may be appropriate for some adult patients. Discontinue if no response after 12 weeks. For retreatment: 25 mg twice weekly or 50 mg once weekly for up to 24 weeks.

AS and PsA – 25 mg twice weekly or 50 mg once weekly. Children aged 2-17 years: Juvenile idiopathic arthritis (JIA) – 0.4 mg/kg (maximum per dose 25 mg) twice weekly with an interval of 3 – 4 days or 0.8 mg/kg (maximum per dose 50 mg) once weekly. Discontinuation of treatment should be considered in patients who show no response after 4 months.

Children aged 6-17 years: Plaque psoriasis in children aged 6-17 years – 0.8 mg/kg (maximum per dose 50 mg) once weekly for up to 24 weeks.

Discontinue if no response after 12 weeks. For re-treatment: 0.8 mg/kg (maximum per dose 50 mg) once weekly for up to 24 weeks. Contraindications: Hypersensitivity to any of the ingredients, sepsis or risk of sepsis, active infections. Warnings and Precautions: Enbrel should be initiated and supervised by specialist physicians experienced in the

ClinicalCare2013_1_104.indd 72

diagnosis and treatment of RA, JIA, PsA, AS, PP or Paediatric PP. Patients treated with Enbrel should be given the Patient Alert Card. Use carefully in patients predisposed to, or with history of, infection due to underlying diseases other than RA (e.g. advanced or poorly controlled diabetes) or with history of blood dyscrasias, pre-existing or predisposition to demyelinating disease or congestive heart failure. Cases of active tuberculosis have been reported, therefore all patients should be evaluated for both active and inactive TB prior to being treated with Enbrel. If active TB is diagnosed, Enbrel should not be initiated. Caution should be used when administering Enbrel to patients identified as carriers of hepatitis B virus and there have been reports of worsening hepatitis C in patients receiving Enbrel. Use with caution in patients with a history of hepatitis C. Whether treatment with Enbrel might influence the development and course of active and/or chronic infections is unknown. Concurrent administration of Enbrel and anakinra has been associated with increased risk of serious infections and neutropenia, and is therefore not recommended. In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events, and is therefore not recommended. Use caution when considering combination therapy with sulfasalazine.

Reports of various malignancies have been received in the postmarketing period, therefore with current knowledge, a possible risk for the development of lymphomas, leukaemia or other haematopoietic or solid malignancies in patients treated with a TNF-antagonist cannot be excluded. Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNFantagonists (initiation of therapy ≤ 18 years of age) in the postmarketing setting. Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including Enbrel.

Post-marketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Enbrel has not been studied in combination with other systemic therapies or phototherapy for the treatment of psoriasis. Monitor closely if patient develops new infection during treatment. Discontinue treatment if serious infection or allergic reaction develops or if blood dyscrasias are confirmed. Caution should be used in patients who have moderate to severe alcoholic hepatitis and Enbrel should not be used in patients for the treatment of alcoholic hepatitis. Discontinue temporarily if significantly exposed to varicella virus. Live vaccines should not be given concurrently with Enbrel. Paediatric patients should have received all vaccines recommended in current immunization guidelines prior to starting Enbrel. Treatment with Enbrel may result in the formation of autoantibodies. Enbrel is not recommended for the treatment of Wegener’s granulomatosis. There have been reports of hypoglycaemia in Enbrel patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients. There have been reports of Inflammatory Bowel Disease (IBD) and uveitis in JIA patients being treated with Enbrel. Caution should be exercised when treating the elderly and with particular attention to occurrence of infections. Pregnancy & Lactation: Enbrel is not recommended in pregnant or breast-feeding women. Undesirable Effects: Adults: The most commonly reported adverse reactions are injection site reactions, infections, allergic reactions, development of autoantibodies, itching, and fever. See SmPC for less commonly reported side effects. TNFantagonists, such as Enbrel, affect the immune system and their use may affect the body’s defenses against infection and cancer. Serious

infections affect fewer than 1 in 100 patients treated with Enbrel.

Reports have included fatal and lifethreatening infections and sepsis.

Various malignancies have also been reported with use of Enbrel, including cancers of the breast, lung, skin and lymph glands (lymphoma).

Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with Enbrel use. There have been rare reports of lupus, lupus-related conditions, and vasculitis. Rate of new malignancies was similar to that expected for the population studied. Fatalities associated with serious infections, pancytopenia, aplastic anaemia and interstitial lung disease have also been reported. Paediatrics: Generally as for adults, except the following were more common: headaches, nausea, vomiting and abdominal pain. In addition the following were reported as severe events: varicella, appendicitis, gastroenteritis, depression/personality disorder, cutaneous ulcer, oesophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus and soft tissue and post operative wound infection. There have been post-marketing reports of IBD and uveitis in JIA patients, including cases indicating a positive re-challenge.

Legal Category: POM. Package Quantities: Enbrel Pre-filled Syringe: Each carton contains 4 pre-filled syringes containing either 25 mg or 50 mg of Enbrel and 4 alcohol swabs. Enbrel Pre-filled Pen (MYCLIC): Each carton contains 4 pre-filled pens containing 50 mg of Enbrel and 4 alcohol swabs. Enbrel Powder: Each carton contains 4 vials of Enbrel 25 mg powder, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs. Enbrel Paediatric (10 mg): Each carton contains 4 vials of Enbrel 10 mg powder, 4 prefilled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs. European Marketing Authorisation Numbers: Enbrel Pre-filled Syringe 25 mg: EU/1/99/126/013 Enbrel Pre-filled Syringe 50 mg: EU/1/99/126/017 Enbrel Pre-filled Pen (MYCLIC) 50 mg: EU/1/99/126/020 Enbrel Powder 25 mg: EU/1/99/126/003 Enbrel Paediatric 10 mg: EU/1/99/126/022.

European Marketing Authorisation Holder: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. For full prescribing information see the Summary of Product Characteristics. Further information is available on request from: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, telephone: +353 1 467 6500. Medical Information: 1 800 633 363.

API Reference Number: EN 4_0 Date of Prescribing Information: August 2012 References: 1. Enbrel SPC July 2010 2. Remicade SPC 3. Humira SPC 4. Orencia SPC 5. Mabthera SPC 6. Simponi SPC 7. Singh J et al. CMAJ: 2009.DOI;10.1503 8. Hetland ML et al. Arthritis & Rheumatism. Vol 62, no 1, January 2010.

Date of preparation: September, 2012 ENB/2012/137

13/03/2013 17:29:11

Rheumatology FEATURE

Major improvements in rheumatology

© hemera/thinkstockphoto.com

There has been a 57 per cent increase in new outpatient activity by consultant rheumatologists around the country without any increase in resources or major changes in practice since the establishment of the HSE Clinical Programme on Rheumatology three years ago, according to Prof.

Oliver FitzGerald, Clinical Lead of the Programme and consultant rheumatologist at St. Vincent’s University Hospital, Dublin.

Maureen Browne reports.

P

rof. Fitzgeraldsaid the increased activity appeared to have occurred because of the focus on waiting lists, because of the sharing of views and initiatives and because everybody involved is determined to tackle the lengthy waiting times. It was very encouraging.

The major development in 2012 has been the appointment of specialised musculoskeletal physiotherapists. “We had approval for 24 posts, we have filled 22 of them and they are now working their way through both the orthopaedic and rheumatology lists so as to assess and treat these patients as expediently as possible.

“The first of these physiotherapists was appointed in February of 2012 and between then and the end of the year approximately 10,000 patients had been seen, which is a very significant achievement. Even more so as many of the physiotherapists only took up post in the early autumn and it took them a little while to get going.

“We have detailed reports which show that in 80 per cent of those assessed by the physiotherapists it was found that it was not necessary for them to attend a consultant and they could be managed in many cases by referral for physiotherapy.

So far 80 per cent (or 8,000) of those taken off the waiting list have been orthopaedic

patients and 20 per cent (or 2,000) have been rheumatology patients.”

Prof. FitzGerald said that they were expecting each of the new physiotherapists to see 1,000 patients each per year, which should result in a further 24,000 people being taken off the waiting list in 2013.

He said the next phase of the Programme would take place when the waiting lists were brought down. Then the specialised physiotherapists would start to move more into the interface between primary and secondary care, so that they would be the first point of call for referrals. GPs would refer first to physiotherapists who would assess patients and judge if they needed to be seen by a rheumatologist or orthopaedic surgeon. We should see physiotherapists moving into this interface by the end of the year.Prof. FitzGerald said that he has also been involved with the “Fit for Work” initiative, a pan European programme which is looking at the level of work-related disability, related to musculoskeletal disease.

Studies have found that there are very poor outcomes for patients on long-term waiting lists. The longer a patient is on a waiting list, the longer they are out of work. “We spend about €350 million each year on work related disability payments to patients with musculoskeletal disease. If we could get a fraction of these patients treated and back to

CLINICAL CARE | 73

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13/03/2013 17:29:14

ENBREL

is Different A unique mechanism of action •

Enbrel is the only fully human soluble tumour necrosis factor (TNF) receptor 1,2,3,4,5,6

•

It works differently than MAB’s 1

No neutralising antibodies •

1

Enbrel is not associated with the production of neutraIising antibodies in humans

Enbrel has a short half life (<3 days) •

1

The half-life of anti-TNF agents should be taken into account if a treatment break is required

Efficacy •

Registry data and Cochrane Review data support efficacy & safety of Enbrel 7,8

ABBREVIATED PRESCRIBING INFORMATION Enbrel® etanercept Before prescribing Enbrel® please refer to full Summary of Product Characteristics (SmPC). Presentation: Enbrel Pre-filled Syringe: Enbrel 25 mg and 50 mg solution for injection in pre-filled syringe. Each prefilled syringe contains either 25 mg or 50 mg etanercept. Enbrel Pre-filled Pen (MYCLIC®): Enbrel 50 mg solution for injection in pre-filled pen.

Each pre-filled pen contains 50 mg etanercept. Enbrel Powder: Enbrel 25 mg powder and solvent for solution for injection. Each vial contains 25 mg etanercept and each pre-filled syringe contains 1 ml water for injections. Enbrel Paediatric: Enbrel 10 mg powder and solvent for solution for injection for paediatric use. Each vial contains 10 mg etanercept and each pre-filled syringe contains 1 ml water for injections.

Uses: Adults: Moderate to severe active rheumatoid arthritis (RA), in combination with methotrexate, when response to DMARDS, including methotrexate (unless contraindicated), has been inadequate. Enbrel can be given as monotherapy in the case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Severe, active and progressive RA without prior methotrexate treatment. Enbrel alone or with methotrexate has been shown to reduce the rate of progression of joint damage measured by X-ray and to improve physical function. Patients with moderate to severe plaque psoriasis (PP) who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporine, methotrexate or PUVA. Active and progressive psoriatic arthritis (PsA) when response to DMARDS has been inadequate. Enbrel has been shown to improve physical function in PsA patients, and to reduce the progression rate of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of PsA. Severe active ankylosing spondylitis (AS) when response to conventional therapy has been inadequate. Children aged 2-17 years: Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis from the age of 2 years when inadequate response to, or intolerant of methotrexate. Psoriatic arthritis from the age of 12 years when inadequate response to, or intolerant of methotrexate. Enthesitis-related arthritis from the age of 12 years when inadequate response to, or intolerant of, conventional therapy. Children aged 6-17 years: Chronic severe psoriasis when inadequately controlled by, or intolerant to, other systemic therapies or phototherapies. Dosage: By subcutaneous injection. Adults: RA – 25 mg twice weekly or 50 mg once weekly PP - 25 mg twice weekly or 50 mg once weekly for up to 24 weeks, or 50 mg twice weekly for up to 12 weeks followed by 25 mg twice weekly or 50 mg once weekly for a further 12 weeks if needed. Continuous therapy may be appropriate for some adult patients. Discontinue if no response after 12 weeks. For retreatment: 25 mg twice weekly or 50 mg once weekly for up to 24 weeks.

AS and PsA – 25 mg twice weekly or 50 mg once weekly. Children aged 2-17 years: Juvenile idiopathic arthritis (JIA) – 0.4 mg/kg (maximum per dose 25 mg) twice weekly with an interval of 3 – 4 days or 0.8 mg/kg (maximum per dose 50 mg) once weekly. Discontinuation of treatment should be considered in patients who show no response after 4 months.

Children aged 6-17 years: Plaque psoriasis in children aged 6-17 years – 0.8 mg/kg (maximum per dose 50 mg) once weekly for up to 24 weeks.

Discontinue if no response after 12 weeks. For re-treatment: 0.8 mg/kg (maximum per dose 50 mg) once weekly for up to 24 weeks. Contraindications: Hypersensitivity to any of the ingredients, sepsis or risk of sepsis, active infections. Warnings and Precautions: Enbrel should be initiated and supervised by specialist physicians experienced in the

ClinicalCare2013_1_104.indd 74

diagnosis and treatment of RA, JIA, PsA, AS, PP or Paediatric PP. Patients treated with Enbrel should be given the Patient Alert Card. Use carefully in patients predisposed to, or with history of, infection due to underlying diseases other than RA (e.g. advanced or poorly controlled diabetes) or with history of blood dyscrasias, pre-existing or predisposition to demyelinating disease or congestive heart failure. Cases of active tuberculosis have been reported, therefore all patients should be evaluated for both active and inactive TB prior to being treated with Enbrel. If active TB is diagnosed, Enbrel should not be initiated. Caution should be used when administering Enbrel to patients identified as carriers of hepatitis B virus and there have been reports of worsening hepatitis C in patients receiving Enbrel. Use with caution in patients with a history of hepatitis C. Whether treatment with Enbrel might influence the development and course of active and/or chronic infections is unknown. Concurrent administration of Enbrel and anakinra has been associated with increased risk of serious infections and neutropenia, and is therefore not recommended. In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events, and is therefore not recommended. Use caution when considering combination therapy with sulfasalazine.

Reports of various malignancies have been received in the postmarketing period, therefore with current knowledge, a possible risk for the development of lymphomas, leukaemia or other haematopoietic or solid malignancies in patients treated with a TNF-antagonist cannot be excluded. Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNFantagonists (initiation of therapy ≤ 18 years of age) in the postmarketing setting. Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including Enbrel.

Post-marketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Enbrel has not been studied in combination with other systemic therapies or phototherapy for the treatment of psoriasis. Monitor closely if patient develops new infection during treatment. Discontinue treatment if serious infection or allergic reaction develops or if blood dyscrasias are confirmed. Caution should be used in patients who have moderate to severe alcoholic hepatitis and Enbrel should not be used in patients for the treatment of alcoholic hepatitis. Discontinue temporarily if significantly exposed to varicella virus. Live vaccines should not be given concurrently with Enbrel. Paediatric patients should have received all vaccines recommended in current immunization guidelines prior to starting Enbrel. Treatment with Enbrel may result in the formation of autoantibodies. Enbrel is not recommended for the treatment of Wegener’s granulomatosis. There have been reports of hypoglycaemia in Enbrel patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients. There have been reports of Inflammatory Bowel Disease (IBD) and uveitis in JIA patients being treated with Enbrel. Caution should be exercised when treating the elderly and with particular attention to occurrence of infections. Pregnancy & Lactation: Enbrel is not recommended in pregnant or breast-feeding women. Undesirable Effects: Adults: The most commonly reported adverse reactions are injection site reactions, infections, allergic reactions, development of autoantibodies, itching, and fever. See SmPC for less commonly reported side effects. TNFantagonists, such as Enbrel, affect the immune system and their use may affect the body’s defenses against infection and cancer. Serious

infections affect fewer than 1 in 100 patients treated with Enbrel.

Reports have included fatal and lifethreatening infections and sepsis.

Various malignancies have also been reported with use of Enbrel, including cancers of the breast, lung, skin and lymph glands (lymphoma).

Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with Enbrel use. There have been rare reports of lupus, lupus-related conditions, and vasculitis. Rate of new malignancies was similar to that expected for the population studied. Fatalities associated with serious infections, pancytopenia, aplastic anaemia and interstitial lung disease have also been reported. Paediatrics: Generally as for adults, except the following were more common: headaches, nausea, vomiting and abdominal pain. In addition the following were reported as severe events: varicella, appendicitis, gastroenteritis, depression/personality disorder, cutaneous ulcer, oesophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus and soft tissue and post operative wound infection. There have been post-marketing reports of IBD and uveitis in JIA patients, including cases indicating a positive re-challenge.

Legal Category: POM. Package Quantities: Enbrel Pre-filled Syringe: Each carton contains 4 pre-filled syringes containing either 25 mg or 50 mg of Enbrel and 4 alcohol swabs. Enbrel Pre-filled Pen (MYCLIC): Each carton contains 4 pre-filled pens containing 50 mg of Enbrel and 4 alcohol swabs. Enbrel Powder: Each carton contains 4 vials of Enbrel 25 mg powder, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs. Enbrel Paediatric (10 mg): Each carton contains 4 vials of Enbrel 10 mg powder, 4 prefilled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs. European Marketing Authorisation Numbers: Enbrel Pre-filled Syringe 25 mg: EU/1/99/126/013 Enbrel Pre-filled Syringe 50 mg: EU/1/99/126/017 Enbrel Pre-filled Pen (MYCLIC) 50 mg: EU/1/99/126/020 Enbrel Powder 25 mg: EU/1/99/126/003 Enbrel Paediatric 10 mg: EU/1/99/126/022.

European Marketing Authorisation Holder: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. For full prescribing information see the Summary of Product Characteristics. Further information is available on request from: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, telephone: +353 1 467 6500. Medical Information: 1 800 633 363.

API Reference Number: EN 4_0 Date of Prescribing Information: August 2012 References: 1. Enbrel SPC July 2010 2. Remicade SPC 3. Humira SPC 4. Orencia SPC 5. Mabthera SPC 6. Simponi SPC 7. Singh J et al. CMAJ: 2009.DOI;10.1503 8. Hetland ML et al. Arthritis & Rheumatism. Vol 62, no 1, January 2010.

Date of preparation: September, 2012 ENB/2012/137

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rel. sis. rel, ma). ave ery ing brel and the ns, lso the and ere lity cal ive and ge. ge: 50 ach d 4 25 vial ton for an mg: 017 der 22. ed, ing her nd, blin 63. on:

SPC AJ: 62,

Rheumatology FEATURE

work a considerable amount of money can be saved. Working with the musculoskeletal physiotherapists, we are hoping to prioritise patients, get them back to work and get them off long term disability.

“The Fit for Work programme is also trying to get professionals to change the focus regarding work from what patients are not able to do to what they are able to do. For example a patient with acute back pain might not be fit for heavy lifting but might be quite fit for other less physical work. We are looking at the concept of developing a ‘fit note’ rather than a sick note, which might be more positive, and which is in place in the UK.” Prof. FitzGerald said that there had been some progress on the provision of additional consultant posts, but it was much slower than they would have wished. The rheumatology programme had received funding for seven additional consultant posts. All but one was through the interview process and the interview for the final post will take place shortly. Two consultants had taken up their posts, another is working in a temporary locum position and the remainder were awaiting contracts.

“It is critical that we proceed and get all these appointments made this year. In 2013 we will be seeing more emphasis on outpatient targets and getting outpatient waiting lists down to nine months, then six months and finally three months. We will be asking people to work hard to achieve these targets, but in some locations it will be impossible for consultants and their teams to achieve these targets without additional resources being put in place. This needs to be sorted out very soon and I hope that the recruitment pause will not interfere further with our filling these posts.”

In addition, progress had been made on the two new academic posts. The first academic post in rheumatology in UCD will be filled later this year and the person taking up this post will have some clinical sessions in the Mater and St. Vincent’s.

The model of care developed by the

Programme went out last year to the various reference groups, including the Irish Society of Rheumatology, the Irish Rheumatology Health Professionals Society, the Directors of Nursing and the GP groups. Comments were received back and incorporated into a new draft of the model. Prof. FitzGerald hoped that the Rheumatology Programme will shortly be in a position to sign off on these. The model will then go out again to the reference groups for final sign off.

“We have also spent a fair bit of time working on care pathways for various aspects of rheumatology. So far the three main areas of focus have been on management of patients with regional musculoskeletal pain, Methotrexate monitoring and how best to provide education regarding osteoarthritis in primary care. The regional musculoskeletal pain pathway is proceeding nicely and we hope we will be able to sign off on that within the next month or so and then send them out to the various groups for their views.”

The Programme is also working on how best properly monitor patients on drugs such as Methotrexate, who are not being adequately monitored and which puts them at risk. “We are trying to define how they should be monitored, who should carry out the monitoring and how frequently it should be done. This work is due to be finished shortly.”

The third area which the Programme is focusing on is patient education and information relating to osteoarthritis in primary care. Focus is on the type of information which should be available, how it should be distributed, the available pathways and how they work. When this work is completed they will move on to others.

spent nationally.

“One of the early things we discovered was that we had very little data on the use of these drugs. “We don’t know who is prescribing them, whether it is rheumatologists or gastroenterologists, and we don’t know if the drugs are being used effectively and efficiently. We have been working with the Primary Care Reimbursement Service to develop a web-based high tech authorisation tool. By using this tool, the information will all be automatically captured and it will also be possible to include information relating to diagnosis and some relevant clinical outcome measures. This will give us an excellent handle on usage.

“The development work has now been completed and we want to pilot the webbased system in two centres, before we launch it, hopefully in quarter 2 of 2013” Prof. FitzGerald said he would like to acknowledge the people who had worked on and supported the Rheumatology Programme. In particular, he wished to thank Dr. Barry White who had set up the Programme (it was one of the first Programmes established) and also the many people who had given of their time.

In particular he wanted to thank the Programme Manager, Sharon Morrow who had been with the Programme since the beginning bit who has recently been appointed Director of Operations at Tallaght Hospital “and who has been fantastic, working tirelessly on the programme’s behalf ”.

PICTURED: Prof. Oliver Fitzgerald

Prof. FitzGerald chairs the HSE Group on Biologics Medications Management, which was asked to look at the very high cost in relation to biologic drug use. Biologics are predominantly used for patient with inflammatory joint disease. They are very expensive, costing about €15,000 per patient per year, with more than €100 million being

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Calcichew New Pack A4_Layout 1 03/07/2012 15:30 Page 1

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Their strength is our forte CALCICHEW-D3 FORTE CHEWABLE TABLETS PRESCRIBING INFORMATION. (Please refer to full Summary of Product Characteristics when prescribing). Presentation: Chewable tablet containing 1250mg calcium carbonate (equivalent to 500mg of elemental calcium) plus 400IU colecalciferol (equivalent to 10 micrograms vitamin D3). Uses: Prevention and treatment of vitamin D/calcium deficiency. Supplementation of vitamin D and calcium as an adjunct to specific therapy for osteoporosis, in pregnancy, in established vitamin D dependent osteomalacia and in other situations requiring therapeutic supplementation of malnutrition. Dosage and administration: Oral (suck or chew). Adults and elderly: Two tablets daily. Children: Not intended for use in children. Hepatic impairment: No dose adjustment required. Renal impairment: Should not be used in patients with severe renal impairment.

Contraindications: Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria, severe renal impairment, renal stones, hypervitaminosis D, hypersensitivity to ingredient(s) Precautions: Monitor serum calcium and creatinine levels, particularly in patients on cardiac glycosides or diuretics and in patients with high tendency to calculus formation. Use with caution in patients with impaired renal function. Take into account risk of soft tissue calcification. Avoid in patients with phenylketonuria or sugar intolerance.

ClinicalCare2013_1_104.indd 76

Prescribe with caution in patients with sarcoidosis. Use with caution in immobilised patients. Additional doses of calcium or vitamin D should only be taken under close medical supervision. Interactions: Tetracyclines (take 2 hours before, or 4 to 6 hours after Calcichew-D3 Forte), bisphosphonates or sodium fluoride (take 3 hours before Calcichew-D3 Forte), Quinolone antibiotics (take two hours before or after), levothyroxine (take four hours before or after), thiazide diuretics, corticosteroids, cardiac glycosides, ion exchange resins (cholestyramine), laxatives (paraffin oil). Calcichew-D3 Forte should not be taken within 2 hours of eating foods high in oxalic acid (e.g. spinach and rhubarb) or phytic acid (e.g. whole cereals). Side effects: Hypercalcaemia, hypercalciuria, constipation, dyspepsia, flatulence, nausea, abdominal pain, diarrhoea, pruritus, rash, urticaria. Very rarely (usually only seen on overdose) milk-alkali syndrome. Use in pregnancy and lactation: Can be used in case of calcium and vitamin D deficiency. Daily intake in pregnancy should not exceed 1500mg calcium and 600IU colecalciferol (15 micrograms vitamin D3). Avoid overdose as permanent hypercalcaemia affects developing foetus. Calcium and vitamin D3 pass into breast milk so consider this when giving additional vitamin D to the child. Pharmaceutical precautions: Do not store above 30°C. Keep container tightly closed to protect from moisture. Legal category: Pharmacy

product. Product Authorisation No: 535/1/3. Product Authorisation holder: Shire Pharmaceuticals Ltd., Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP UK. Distributed in Republic of Ireland by: Cahill May Roberts, P.O. Box 1090, Chapelizod, Dublin 20, Republic of Ireland.

Further information is available on request. Date of revision: May 2011.

CALCICHEW is a registered trademark of Shire Pharmaceuticals Ltd in the Republic of Ireland.

Adverse events should be reported to the Pharmacovigilance Unit at the Irish Medicines Board (IMB) (imbpharmacovigilance@imb.ie).

Information about adverse event reporting can be found on the IMB website (www.imb.ie). Adverse events may also be reported to Shire Pharmaceuticals Ltd on +44 1256 894000.

Reference: 1. MIMS May 2012.

Date of preparation: June 2012.

Item Code: IRE/BU/CDF/12/0007. *According to IMS unit sales data April 2012.

13/03/2013 17:31:29

Ophthalmology FEATURE

Reducing the number of cases of

preventable blindness

The HSE National Clinical Programme on Ophthalmology aims to move a considerable amount of care away from hospital centres and into the community, according to Mr. Paul Moriarty, Clinical Lead of the Programme and Consultant Ophthalmic Surgeon at the Eye & Ear Hospital, Dublin. This will involve re-balancing manpower into the community while maintaining surgical services in the hospitals. Maureen Browne reports.

M

r. Moriarty was President of the Irish College of Ophthalmologists from 2009 to 2011 and it was during that term that he began the work towards getting a clinical programme for ophthalmology established. Under the auspices of the College the programme aims to reduce the number of annual cases of preventable blindness and vision impairment to maintain vision and to extend and prolong, to the greatest extent possible, the length of time those who have vision impairment can continue to live independently. It is a continuous process rather than a one-off project.

© hemera/thinkstockphoto.com

The programme aims to ensure rapid access to the acute hospital network for appropriate conditions and to ensure that as many procedures as possible are carried out as day-cases. Protocols and guidelines aimed at reducing the number of inappropriate referrals are also being explored.

Mr. Moriarty said that remarkable changes in life expectancy at birth have been achieved in the last century with half of all those born in 2000 expected to live to the age of 100 should current trends continue. Healthcare too has become much more effective with advances in medicine ensuring that despite people suffering from more chronic disease early diagnosis and better treatments have resulted in much improved outcomes.

These advances however, posed a myriad of challenges for the state with increasing pressure on the health service to deliver advancing medicine to an expanding and aging population.

“A great challenge now lies before the healthcare profession – making medicine better, making medicine safer and improving the patient experience and all of this to be achieved in a contracting budgetary environment.”

The research for the ophthalmology programme has been undertaken as a three stage process firstly involving an analysis of the existing service provision; what is currently being done by whom, where and at what cost. The second stage involves a systematic review of all the published literature on service

provision including skill mix, skill substitution and emerging technologies and stage three will involve modelling alternative patient pathways in Ireland.

Mr. Moriarty said there were five main areas of work within the Programme –Diabetic Retinopathy, Cataracts, Glaucoma, Age Related Macular Degeneration and Child Vision Screening. These were the blocks with the largest numbers in the system.

The retinopathy screening was being rolled out under the National Cancer Control Service (NCCP). In the first year it aimed to screen one third of diabetics and at the moment work was going on to deal with the downstream patients who would emerge from the

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Ophthalmology FEATURE

screening needing treatment and extra personnel would be required for that.

“At the end of the day, we are looking at eight centres, but for the first year we will be rolling out six.”

Another area of significant focus is Age Related Macular Degeneration (AMD) and glaucoma. The incidence of both is increasing with the increasing age profile of the population.

“At the moment, there is a proposal by Professor Colm O’Brien and Mr Paul Connell from The Mater Hospital looking at joint surveillance between the hospital and the community.”

Mr. Moriarty said that the surgical system is probably reaching capacity as far as cataracts are concerned. “We have 95 per cent utilisation of surgical cataract facilities and the numbers have increased by about 40 per cent. The use of day surgery has improved the throughput but we have reached the situation where we are going to have to put in extra capacity somewhere in the system. One of the things we are looking at is a single dedicated theatre in Dublin, which would exclusively provide cataract services five days a week. There would be no teaching; it would just deal with the waiting lists.

We estimate between16 and 20 cases could be done a day, so about 3,500 operations could be done a year, which would cover the backlog and add in a little comfort space when the Dublin numbers are reduced. If this proves successful, we would probably open a second unit in Cork or Limerick.”

A pilot project has been started in the North West, with Mr Paul Mullaney form Sligo General Hospital where community eye doctors and designated optometrists do the initial referral electronically and then care for the patients post op, referring patients back for a second consultation if they meet the clinical criteria.

Mr. Moriarty said that vision screening for children is done by a very diffuse

}

All the Clinical Programmes are expected to save money and already we have delivered 40 per cent more within our existing budget. group of nurses in school clinics and it is very hard to keep screening standards up, as so many do not have sufficient screening volume to maintain their expertise and in some area there are large number of false positives emerging. “We are looking at screening being much more concentrated and being supervised by orthoptists who would do the training supervision and audit the outcomes of screening. They would not be delivering the screening, but would be leading it and, quality assuring it.

screening and treatment for glaucoma and diabetic retinopathy would be done and patients referred into the hospital only if necessary.

Children who were detected with problems would be followed up by orthoptists in the hospital and in the community and then, if necessary, medically reviewed by the community eye doctor. If they have medical problems they would remain under the care of the doctor. If those children have refractive problems they would be managed by the orthoptist and the optometrist where appropriate until they reached the age of six. If they need squint surgery or if they fail to improve, they would be referred back to the doctor.”

Mr. Moriarty said that in each of the HSE regions he hoped to have a Director of Eye Care who would look after balancing the delivery of care between the community and the hospital.

Mr. Moriarty said that at present there were very long waiting lists across the country. “We are looking at the mechanics and the costs of rolling this out in Dublin and Kildare as waiting lists are worst there.

“Macular degeneration is an increasing problem in Ireland, due to the increase in the number of older people in the country. When these patients get into the programme, they are there permanently and the main difficulty is that hospitals are being overloaded with patient numbers. In the future model we see community clinics with small groups of eye doctors and the necessary equipment where the routine

“This will only work if we have proper ICT systems that enables information to be accessed from the community and the hospital and we do not have this at the moment. We are looking at an open source programme called Open Eye, which is being used in the UK. We will need to get funding its implementation and ongoing maintenance.”

“With competition for budgets and staff in the different administrative areas, it is very difficult to get that balance and while I am Clinical Lead, each hospital should have a Director of Eye Care who would supervise budgets in the hospital and the community. We will probably need to rebalance our training and manpower. We need a new Medical Consultant Ophthalmologist, who would be more specialised and who could take over part of this work. A lot of work in the community does not need surgical delivery but does need higher training.

“We also need to implement a central purchasing system, which I believe could result in considerable savings.

All the Clinical Programmes are expected to save money and already we have delivered 40 per cent more within our existing budget. With the country’s changing age profile and the increasing demand, I think we will be doing well if we deliver more efficient care for increasing numbers within the same budget.”

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Symptomatic anaemia management from start to stability1

ABRIDGED PRESCRIBING INFORMATION (For full prescribing information, refer to the Summary of Product Characteristics [SmPC]) MIRCERA® (methoxy polyethylene glycol-epoetin beta) 30, 50, 75, 100, 120, 150, 200, 250 micrograms (µg)/0.3 ml Solution for Injection in Pre-Filled Syringe Indication: Treatment of symptomatic anaemia associated with Chronic Kidney Disease (CKD) in adult patients. Dosage and Administration: Initiate treatment under supervision of a physician experienced in the management of patients with renal impairment. Administer either subcutaneously (sc) or intravenously (iv) in order to increase haemoglobin (Hb) to not greater than 12 g/dl. Mircera can be injected subcutaneously in the abdomen, arm or thigh. Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins. Haemoglobin variability should be addressed through dose management, with consideration for the Hb target range of 10 - 12 g/dl. A sustained Hb level of greater than 12 g/dl should be avoided. Hb rises of greater than 2 g/dl over a four week period should be avoided. Monitor patients closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia. Monitor Hb every two weeks until stabilised and periodically thereafter. Erythropoiesis Stimulating Agent (ESA)-naïve patients: In patients not on dialysis, 1.2µg/kg once a month by single s.c injection until Hb >10g/dl. Alternatively, in patients on dialysis or not on dialysis, 0.6µg/kg once a fortnight by single iv or sc injection. Increase dose by approximately 25% if Hb rise < 1g/dl/ month. Further increases of 25% can be made at monthly intervals until Hb target is reached. Patients treated once a fortnight whose Hb concentration is >10g/dl may receive MIRCERA once monthly using the dose equal to double the previous once a fortnight dose. Converting from current ESA: start MIRCERA as a single iv or sc injection once monthly at next scheduled dose. Current weekly darbepoetin alfa < 40µg or epoetin < 8000IU start monthly MIRCERA 120µg; current weekly darbepoetin alfa 40 - 80µg or epoetin 8000 - 16000IU start monthly MIRCERA 200µg; current weekly darbepoetin alfa >80µg or epoetin >16000IU start monthly MIRCERA 360µg. If dose adjustment is required to maintain Hb >10g/dl, increase monthly dose by 25%. For ESA naïve patients and patients converting from current ESAs: If Hb > 2g/dl/ month or Hb rising towards 12g/dl, decrease dose by 25%. If Hb continues to rise interrupt therapy until Hb levels decrease and restart at a dose 25% lower than the previously administered dose. Dose adjustments should not be made more frequently than once a month. Not recommended for patients under 18 years. Due to limited treatment experience, regular Hb monitoring and strict adherence to dose adjustment guidance is recommended for patients on peritoneal dialysis. Treatment with MIRCERA can be interrupted at any time. If one dose of MIRCERA is missed, administer the missed dose as soon as possible and restart MIRCERA at the prescribed dosing frequency. No adjustments of the starting dose nor of the dose modification rules are required in patients with hepatic impairment. No dose adjustment is required in patient’s ≥ 65 yrs old. Contraindications: Hypersensitivity to methoxy polyethylene glycol-epoetin beta or any of the excipients. Uncontrolled hypertension. Warnings and Precautions: The safety and efficacy of Mircera in other indications including anaemia with cancer has not been established. Monitor iron status prior to and during treatment. Supplementary iron therapy recommended in patients if serum ferritin < 100 µg/l or transferrin saturation below 20%. Failure to respond to treatment should be investigated: correct iron, folic acid or vitamin B12 deficiencies (refer to SmPC for details on these and other possible reasons for failure to respond). Discontinue therapy if Pure Red Cell Aplasia (PRCA) is diagnosed and do not switch patients to another ESA. PRCA caused by anti-erythropoietin antibodies has been reported in association with all ESAs, including MIRCERA. These antibodies have been shown to cross-react with all ESAs. Patients suspected or confirmed to have antibodies to erythropoietin, should not be switched to MIRCERA. Discontinue Mircera treatment in patients with Hepatitis C who experience a paradoxical decrease in haemoglobin and develop severe anaemia associated with low reticulocyte counts and perform PRCA testing. Epoetins are not approved in the management of anaemia associated with hepatitis C. Blood pressure may rise during treatment with Mircera. Blood pressure should be controlled before, at initiation of and during treatment with MIRCERA. If high blood pressure is difficult to control, dose must be reduced or administration discontinued. Maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration. In clinical trials, an increased risk of death, serious cardiovascular events including thrombosis or cerebrovascular events including stroke was observed when ESAs were administered to target a haemoglobin of greater than 12g/dl.

Caution in patients with haemoglobinopathies, seizures, bleeding, recent bleeding requiring transfusion, or with platelets > 500 x 109/l. ESAs are growth factors and there is a concern that they could stimulate the growth of any type of malignancy. Misuse of MIRCERA in healthy people may lead to an excessive increase in Hb and may be associated with life-threatening cardiovascular complications. To improve traceability of ESAs, clearly record the trade name of the administered ESA in the patient file. Mircera contains less than 1 mmol sodium (23mg) per ml. i.e. essentially sodium free. Drug Interactions: No interaction studies performed. Fertility, Pregnancy and Lactation: No data in humans. Caution when prescribing to pregnant women. Breast Feeding: Assess the risk benefit with lactating mothers. Fertility: Studies in animals have shown no evidence of impaired fertility. The potential risk to humans is unknown. Side Effects and Adverse Reactions: Common (≥1/100 - <1/10): Hypertension. Data from a controlled clinical trial with epoetin alfa or darbepoetin alfa reported an incidence of stroke as common. Platelet counts below 100 x 109/l were seen in 7% of patients treated with Mircera and 4% of patients treated with other ESAs. Post-marketing experience: As with other ESAs, cases of thrombosis including pulmonary embolism have been reported, frequency unknown. Cases of thrombocytopenia have been spontaneously reported, frequency unknown. Hypersensitivity reactions, including cases of anaphylaxis, have been reported, frequency unknown. Neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRSA) has been reported, frequency unknown. In cases of PRCA, therapy with Mircera must be discontinued. Refer to SmPC for details of all adverse reactions. Serious or Potentially Serious: Anaphylactic reactions, serious cardiovascular events and cerebrovascular events. Legal Category: Limited to sale and supply on prescription only. Presentation and Marketing Authorisation Numbers: Pre-filled syringe: 30, 50, 75, 100, 120, 150, 200 and 250 μg solution in 0.3 ml (Pack size of 1) EU/1/07/400/017, 008, 009, 010, 020, 011, 012 and 013. Marketing Authorisation Holder: Roche Registration Ltd., 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, UK. Further information is available from Roche Products (Ireland) Limited, 3004 Lake Drive, Citywest, Naas Road, Dublin 24. Telephone: (01) 4690700. Fax: (01) 4690791. MIRCERA is a registered trade mark. Date of Preparation: September 2012.

Reference: 1. MIRCERA Summary of Product Characteristics May 2012. p03/09/12

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Mental Health FEATURE

Promoting self-esteem, self-efficacy and personhood The HSE Clinical Care Programme (CCP) on Mental Health is moving to implementation as over 400 new posts in psychiatry arrive, according to the Programme’s Clinical Lead, Dr. Ian Daly, Executive Director, HSE Dublin South City and South West.

Maureen Browne reports.

T

hese posts, in the three disciplines of psychology, social work and occupational therapy, have been allocated to strengthen community teams and their allocation is contingent on Clinical Care Programme implementation.

“Our CCP subgroups have identified national standards for service delivery and care within each of the three programme areas. We are now talking about implementation with Executive Clinical Directors, Clinical Leads and local management teams. Lessons can be learnt from existing local initiatives which have worked well and which will help to inform others about the necessary organisational planning.”

A Programme Plan, developed last year as a background to CCP development, outlines relevant aims and principles. The promotion of self-esteem, self-efficacy and personhood, and incorporating these within a broad range of recovery outcomes, will be a target for clinical interventions. A second objective, based on established best practice and best use of existing clinical evidence, will shift the clinical focus of care from a primarily ‘severe and enduring’ focus towards the identification of mental disorders

at early stages of development. Mental health services will also be encouraged to develop partnerships with voluntary and community agencies in order to ensure a more broadly based care and support structure for vulnerable people.

The proposed organisational structure implies the creation of expertise and the development of areas of specialism within the broadly generalist framework of community mental health teams as outlined in the government policy document A Vision for Change.

The first CCP area is directed towards serious mental disorders, including psychotic disorders, which require extensive and sometimes long term care and support. This year’s programme is directed towards the management of first episode psychosis presentations. A second CCP area concerns the management of complex psychological conditions, and this year’s programme deals with eating disorders. The third CCP area deals with the management of common mental health problems, and this year’s programme is directed towards the management of self-harm behaviours presenting to Emergency Departments.

In the Psychosis Programme, additional

specialist capacity is being embedded in each of the Community Mental Health Teams, of which about 90 in adult and in C&A are prescribed in the government policy document A Vision for Change.

Within each Health Area these CMHT specialist members will come together on a part-time basis along with senior clinical representatives for purposes of training and clinical supervision and for certain specified clinical interventions.

In accordance with the literature, procedures for early identification, early referral and rapid screening of possible psychosis cases will be developed and these will be matched with an enhanced range of phase-specific interventions which will include Family Interventions for Psychosis, CBT for Psychosis, and Supported Employment schemes.

In the Eating Disorders Programme, an organisational structure similar to the Psychosis Programme will ensure specialist capacity at each level of service delivery, including for early or mild to moderate cases.

“This service structure reflects the fact that, in order to improve long-term outcome in eating disorders, there is, as the academic literature increasingly suggests, “a need to minimise the time

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FEATURE Mental Health

of untreated symptoms early in the illness”. Interventions will range from the provision of simple advice and support to ‘stepped’ levels of disorderrelevant psychological therapies including specific cognitive behavioural and family therapies.”

The third Programme targets the 12,000 people who present each year to Emergency Departments following Suicide or Self-harm behaviours.

Approximately 23 per cent represent those who repeat, and they represent a clear target group for preventive intervention. Triage and Assessment will be standardised and a stepped range of interventions, matched to need, will be developed. Assertive follow-up of this group will aim to reduce the rate of re-presentation.

Dr. Daly said that each of the CCPs proposes a relatively small set of coordinated actions to ensure integrated care. None aims to be fully comprehensive or to represent any final set of options in relation to the treatment of these conditions.

However, there is robust evidence for the effectiveness of CCPs in improving mental and physical outcomes. Clinical advisory groups had been established which extensively reviewed the original Programme document and which developed more detailed technical documentation. These were now at a point of being approved by the Irish College of Psychiatrists, the Irish College of General Practitioners, Allied Health Professional groups and Service User Representative groups.

Greater emphasis had been given to the inclusion of primary care in each of the areas of clinical activity.

“Psychiatric morbidity is one of the more common reasons for consulting General Practitioners and approximately one in six people yearly will attend their GP for primarily psychiatric reasons.

The development of mental health services within Primary Care represents an important future challenge and the

}

The third Programme targets the 12,000 people who present each year to Emergency Departments following Suicide or Self-harm behaviours.”

appointment of a Primary Care Mental Health Lead by the College of General Practitioners is to be welcomed. In addition to the development of services within primary care, the promotion of collaborative working relationships between Primary Care and Mental Health services is essential to the success of these programmes. Difficulties in accessing mental health services and uncertainties in the allocation of primary responsibilities to prevent gaps in clinical care will need to be addressed.

Access to psychotherapeutic and psychosocial interventions, whether in primary or specialist services, needs to be improved.”

The proposal to screen for early psychosis has allowed for the development of a research project relating to the use of omega oils in prodromal psychosis.

“There is some interesting suggestive evidence that omega oil can delay or offset the development of a full psychosis. Cork Consultant Psychiatrist, Dr. Maeve Rooney, who has been working with us, has obtained a Stanley Foundation grant to pursue this work, which will to be rolled out in conjunction with the Programme.

(The Stanley Foundation is the largest nongovernmental funding organisation in the US for research in the area of mental health).This is a benign intervention, as it is essentially a food supplement, and there is a real possibility that this intervention, simple and benign as it is, may hold real benefit for this atrisk group. Training for those who will be involved in the research is underway and approval has been received from the Irish College of Psychiatry.”

Clinical programme development offers both opportunity and challenge to existing practice models. “CCPs in

mental health offer the opportunity to improve outcomes across both physical and mental health domains. The reduction in avoidable complications is likely to be reflected in real savings rather than false cost control that isat the centre of many policy makers’ decisions. They also challenge us to reflect on our current service delivery models. For instance, we recognise that if we want to intervene early in mental health disorders we must bear in mind that we are looking at disorders where 75 per cent have an onset before age 25 years. A successful engagement with the so-called “chronic diseases of the young” requires models of care delivery that are relevant to the needs and contexts of young people with more emphasis on outreach and on individually tailored treatments.”

Possibly the greatest challenge to successful programme implementation lies in the resource and staffing shortages that have been so marked in recent years. Despite the excellent government commitment to new posts over the last two budgets, continued staffing losses from the service remain greater.

“Nevertheless, we must continue to review the balance between hospital and community staffing levels from the perspective of alignment with the more fundamental goals of ‘a specialty that specialises in the doctor-patient relationship’ as the psychiatry historian Edward Shorter has put it, one where ‘neurochem’ and ‘neurochat’ augment each other as the optimum form of care.

The underlying purpose of the clinical programmes is to create opportunities within psychiatric practice for delivering a broader range of interventions embracing the biological, psychological and psychosocial, each based on firm evidence and together creating synergies in this challenging area of clinical endeavour.”

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“I’m getting there, but each day is still a struggle” Maria, age 35.

Seroquel XR a next step for MDD * *Indicated for add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy.

Prior to initiating treatment, clinicians should consider the safety profile of Seroquel XR. Seroquel XR™ Abridged prescribing information (For full details see summary of product characteristics (SmPC)) Presentations: Prolonged-release tablets containing 50mg, 150mg, 200mg, 300mg and 400mg of quetiapine (as quetiapine fumarate). Uses: Schizophrenia including preventing relapse in stable schizophrenic patients who have been maintained on Seroquel XR. Treatment of bipolar disorder: treatment of moderate to severe manic episodes in bipolar disorder; treatment of major depressive episodes in bipolar disorder; prevention of recurrence in patients with bipolar disorder, whose manic or depressive episode has responded to quetiapine treatment. Add on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. Prior to initiating treatment, clinicians should consider safety profile of Seroquel XR. Dosage and Administration: Ensure that patients receive clear information on the appropriate dosage for their condition. Administer once daily, without food. To be swallowed whole, not split, chewed or crushed. Adults: Treatment of Schizophrenia and moderate to severe manic episodes in bipolar disorder: To be administered at least one hour before a meal. The daily dose at the start of therapy is 300 mg on Day 1 and 600 mg on Day 2. Recommended daily dose is 600 mg, if clinically justified the dose may be increased to 800 mg daily. Adjust dose within the effective dose range of 400 mg to 800 mg per day, depending on clinical response and tolerability. For maintenance therapy in schizophrenia no dosage adjustment necessary.

Treatment of depressive episodes in bipolar disorder: Administer at bedtime. Daily dose for the first four days is: 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Recommended daily dose is 300 mg. In clinical trials, no additional benefit was seen in the 600 mg group compared to 300 mg group. Individual patients may benefit from a 600 mg dose. Doses greater than 300 mg should be initiated by physicians experienced in treating bipolar disorder. In the event of tolerance concerns, clinical trials have indicated that dose reduction to a minimum of 200mg could be considered. For preventing recurrence in bipolar disorder: Patients who have responded to Seroquel XR for acute treatment of bipolar disorder should continue on Seroquel XR at the same dose administered at bedtime. Dose can be adjusted depending on clinical response and tolerability within the dose range of 300 mg to 800 mg/day. Use lowest effective dose for maintenance therapy. For add-on treatment of major depressive episodes in MDD: Administer at bedtime, daily dose at the start of therapy is 50mg on Day 1 and 2 and 150mg on Day 3 and 4. Use lowest effective dose for treatment, starting with 50mg/day. The need to increase the dose from 150 to 300mg /day should be based on individual patient evaluation. Elderly: Use with caution. Rate of dose titration may need to be slower and daily therapeutic dose lower than in younger patients. Patients should be started on 50mg/day and can be increased by 50mg/day to an effective dose. Efficacy & safety not evaluated in patients > 65 years with depressive episodes in framework of bipolar disorder. In elderly patients with major depressive episodes in MDD, dosing should begin at 50mg/day on Day 1-3 increasing to 100mg/day on Day 4 and 150mg/day on Day 8. Use lowest effective dose, starting from 50 mg/day. If dose increase to 300 mg/day is required this should not be prior to Day 22 of treatment. Children & Adolescents: Not recommended. Renal Impairment: No dose adjustment required. Hepatic Impairment: Use with caution. Patients should be started on 50mg/day and can be increased by 50mg/day to an effective dose, depending on clinical response and tolerability. Contra-indications: Hypersensitivity to quetiapine fumarate or excipients. Concomitant administration of cytochrome P450 3A4 inhibitors, e.g. HIV-protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin and nefazodone. Precautions and warnings: Children and adolescents (10-17yrs): not recommended if <18yrs old. Refer to SmPC for specific precautions and warnings relating to this patient group. Suicide/suicidal thoughts or clinical worsening: Refer to SmPC for information including recommendations on supervision and monitoring of all patients, particularly those at high risk. Extrapyramidal Symptoms (EPS): In clinical trials, quetiapine associated with increased incidence of EPS vs. placebo in patients treated for major depressive episodes in bipolar disorder and MDD. Quetiapine has been associated with akathisia and is most likely to occur in first few weeks of treatment – in these patients dose increase may be detrimental. Tardive dyskinesia (TD): If signs and symptoms of TD appear consider dose reduction or discontinuation. Symptoms of TD can worsen or even arise after discontinuation of treatment.

Somnolence and dizziness: quetiapine has been associated with somnolence and related symptoms, e.g. sedation. In clinical trials for bipolar depression and MDD onset was usually within the first 3 days of treatment and predominantly of mild to moderate intensity. If somnolence intensity is severe, patients may need more frequent contact for a minimum of 2 weeks after onset or until symptoms improve. Treatment discontinuation may need to be considered. Advise caution in patients regarding somnolence & dizziness (see below).

Cardiovascular: Use with caution in known cardiovascular disease (consider slower titration), cerebrovascular disease, or other conditions predisposing to hypotension. Possible initial orthostatic hypotension (and related dizziness) during the dose titration period (if it occurs consider lower dose or slower titration). Seizures: Caution where history of seizures. Neuroleptic malignant syndrome (NMS): NMS has been associated with antipsychotic treatment, including quetiapine. In the event of NMS discontinue treatment and give appropriate medical treatment. Severe neutropenia: has been uncommonly reported in clinical trials. Possible risk factors include preexisting low white cell count and history of drug-induced neutropenia. Discontinue quetiapine if neutrophil count < 1.0 x 109/L. Observe patients for sign/symptoms of infection and follow neutrophil counts until they exceed 1.5 x 109/L. Weight: weight gain should be monitored & managed as appropriate. Hyperglycaemia: Hyperglycaemia and /or development or exacerbation of diabetes (occasionally associated with ketoacidosis or coma) has been reported rarely, including some fatal cases. Observe for signs & symptoms of hyperglycaemia & regularly monitor patients with diabetes or risk factors for developing diabetes for worsening glucose control. Monitor weight gain regularly. Lipids: Increases in triglycerides, LDL and total cholesterol and decreases in HDL cholesterol observed in clinical trials – manage lipid changes as clinically appropriate. Metabolic risk: Possible worsening of the metabolic risk profile in individual patients, which should be managed as clinically appropriate. QT Prolongation: reported at therapeutic doses and in overdose. Exercise caution in patients with cardiovascular disease or family history of QT prolongation, and when quetiapine is prescribed with medicines known to increase QT interval or with concomitant neuroleptics, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia. Withdrawal: Acute withdrawal symptoms have been described after abrupt cessation of quetiapine. Gradual withdrawal (over at least 1 –2 weeks) is advisable. Elderly patients with dementiarelated psychosis: Not approved for treatment of dementia – related psychosis. Use with caution in patients with risk factors for stroke.

Dysphagia: has been reported with quetiapine. Use with caution in patients at risk for aspiration pneumonia. Pancreatitis: Pancreatitis has been reported. In many, but not all cases, patients had confounding risk factors. Venous Thromboembolism: cases have been reported, all possible VTE risk factors should be identified before & during treatment and preventive measures taken. Lactose: Contains lactose, patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interactions: Use with caution with other centrally acting drugs and alcohol. CYP3A4 inhibitors such as ketoconazole are contraindicated. Grapefruit juice (concomitant use not recommended). Hepatic enzyme inducers such as phenytoin & carbamazepine can significantly increase quetiapine clearance – refer to SmPC. Concomitant use with thioridazine caused an increased clearance of quetiapine with approx. 70%. Observe caution when used concomitantly with medicinal products known to cause electrolyte imbalance or to increase QT interval. Fertility, Pregnancy & lactation: Safety and efficacy not established – refer to SmPC. Effects on ability to drive: Advise patients not to drive or operate machinery until individual susceptibility known. Undesirable effects: Very Common: Dizziness, somnolence, headache, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin. Common: Leucopenia, decreased neutrophil count, eosinophils increased, hyperprolactinaemia, decreases in total T4, free T4, and total T3, increases in TSH, increased appetite, syncope, extrapyramidal symptoms, tachycardia, palpitations, vision blurred, orthostatic hypotension, rhinitis, dyspnoea, constipation, dyspepsia, vomiting, mild asthenia, peripheral oedema, irritability, pyrexia, elevations in serum transaminases (ALT, AST), elevations in gamma-GT levels, blood glucose increased to hyperglycaemic levels, abnormal dreams and nightmares, dysarthria, suicidal ideation and suicidal behaviour. For a full list of undesirable effects (that also includes data for children/ adolescents) refer to SmPC. Pharmaceutical precautions: No special requirements. Legal category: POM. S1A Marketing Authorisation Numbers: Seroquel XR 50mg, 150mg, 200mg, 300mg and 400mg PA 970/18/8-12 Marketing Authorisation Holder (MAH): AstraZeneca UK Ltd., Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU. Further product information available on request from: The MAH (address above), Freephone -1800 800 899. Abridged Prescribing Information prepared: 05/12. Seroquel XR is a trademark of the AstraZeneca group of companies.

Date of preparation: June 2012 URN: 12/0231

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Audiology FEATURE

Universal newborn hearing screening

programme roll out

M.

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It is hoped to complete the roll out of a universal newborn hearing screening programme to the entire country this year as well as increasing the number of audiology posts by 23 per cent, as part of. the HSE Audiology Clinical Care Programme (ACCP), according to its Programme Manager, Ms. Aisling Heffernan. Maureen Browne reports.

T

he HSE has now recruited a full-time National Clinical Lead for the Programme.

Dr. Gary Norman, an audiologist who previously worked in Beaumont Hospital, Dublin and more recently in the UK, takes up his post on March 1st. He will have a 50 per cent management and 50 per cent clinical commitment to the HSE. Dr. Norman succeeds interim National Clinical Lead, Prof. John Bamford, the internationally distinguished clinician,

academic and retired honorary professor from the University of Manchester. A further four Assistant National Leads will be appointed over the next few months. One will be assigned per region to give coverage of one per million of the population.

The HSE Executive Lead is Mr. Brian Murphy, National Primary Care and Social Inclusion Services Manager, who was one of those instrumental in establishing the ACCP in 2011

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FEATURE Audilology

following the report of the National Audiology Review Group (NARG).

The work undertaken by the NARG constituted the most extensive examination to date of audiology services in Ireland. It examined audiology services provided to children and adults nationwide and undertook an extensive public consultation and assessed the needs of the population.

It found that better use of existing resources, coupled with additional funding, improved education and training, and integration of audiology services across hospital and community settings would deliver better value for money and represented a long term investment in providing the best possible care, with improved health and social outcomes.

The key recommendations made by the NARG included: �T he implementation of a National Newborn Hearing Screening Programme. � I mprovements in hearing aid and ear mould services. �A restructuring of services and staffing to provide better integrated teams, with enhanced communication between professionals and patients. �T he appointment of a national clinical lead for audiology and four regional clinical leads to deliver the modernisation programme, and to implement new care pathways and improved clinical governance. �A workforce review to confirm the extent of the required uplift of numbers of audiology professionals. �E stablishment of within-country training for audiology professionals, with professional registration.

The NARG reported that permanent bilateral hearing impairment of a moderate or greater degree is present from birth in 1 to 1.2 per 1,000 babies born. This prevalence increases during the early years of life to about 2 to 2.5 per 1,000. Additionally about 0.4 to 0.6 per 1,000 children are born

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Thus, some 3,000 – 4,500 preschool and school age children in Ireland will have a permanent hearing impairment with potential consequences for communication, literacy, academic achievement, social and emotional development and later employability.”

with a unilateral hearing loss of a moderate or greater degree. If so called “mild” hearing impairments are included, the total prevalence at school entry (unilateral and bilateral, mild to profound) is thought to be of the order of 3 – 4 per 1,000. Thus, some 3,000 – 4,500 preschool and school age children in Ireland will have a permanent hearing impairment with potential consequences for communication, literacy, academic achievement, social and emotional development and later employability.

In addition, international evidence suggests that lack of appropriate and timely intervention increased the likelihood of undue parental distress and increased later costs in health, education and social care.

The report also stated that permanent acquired hearing loss of a significant

degree affects some eight per cent of the adult population. In the over 70 age group, this increases to some 50 per cent. This means that about a quarter of a million adults in Ireland have a permanent hearing impairment and would benefit from good quality hearing aids, after care, and access to rehabilitative services. Additional population needs that involve audiology services include balance disorders, the symptoms of which are the commonest reason for GP visits by patients over the age of 75, and tinnitus, with UK figures suggesting that it is experienced by some 36 per cent of adults.

Ms. Heffernan said that last year the universal newborn hearing screening programme was rolled out in the HSE South, the HSE Dublin North Leinster and the HSE Dublin North

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HH_C

Your Audiology Partner

7 Steps to Better Hearing ONE

TWO

THREE

FOUR

FIVE

SIX

SEVEN

Full Case History

Step 1 involves our audiologists carrying out a full case history. This includes a brief medical history, establishing areas of difficulty, attitude to hearing instruments, advisable conditions and one’s need for medical referral.

Otoscopy and Tuning

Step 2 is Otoscopy and Tuning.

Otoscopy is performed to BSA standards and reveals the condition of the outer ear canal and the tympanic membrane.

Sound Field Testing

Step 3 is Sound Field Testing.

This test gives us statistical information on the ability to hear words reproduced both in loud and quiet surroundings.

Full Audiometric Test

Step 4 is a full audiometric test conducted according to BSA procedures. This test includes air conduction and bone conduction testing and hearing thresholds are recorded.

Amplification Experience

Step 5 allows the patient to experience hearing amplification with instruments which are prescription programmed to match the patient’s hearing loss.

Hearing Aid Fitting

Step 6 requires the patient to return for their hearing aid fitting. This consultation includes guiding and training the patient on how to use their hearing aids.

Follow-Up Check

Step 7 is the follow-up and checking of the rehabilitation process. The audiologist will assess the patient’s ability to hear better in predetermined difficult situations.

Freephone 1800 66 77 11 • www.hiddenhearing.ie Artane · Athlone · Bray · Cashel · Coole · Cork · Dublin · Dundalk · Ennis · Galway · Kilkenny · Killarney · Letterkenny Limerick · Navan · Newbridge · Sligo · Terenure · Waterford · Wexford · + 60 Clinics Nationwide HH_ClinCareA4_2.indd 1 ClinicalCare2013_1_104.indd 87

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FEATURE Audiology

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By the end of this year we will have an extra 17 posts in audiology which is a 23 per cent increase on our present complement of 72 posts.”

East. Funding had been provided this year to roll it out to the HSE West.

“With full rollout, about 75,000 babies a year will have a hearing screen. We expect that about 150 newborns will be diagnosed per year with a hearing impairment. There are three steps in the screening programme and if the baby does not pass the three tests she or he will be referred to audiology services for more in depth hearing assessment.”

Ms. Heffernan said that research had shown that the first six months of a baby’s life are critical for language acquisition, yet up to now they would be two years old before being assessed and fitted with hearing aids. “Now we will be picking them up and fitting hearing aids by three-four months of age so that they will not be missing any significant exposure to language and we would hope that children with significant hearing impairment will have developmentally-appropriate language skills when they enter school.”

Audiologists have received special training in early assessments and fitting tiny hearing aids.

The Programme is also developing a memorandum of understanding between the different statutory and voluntary organisations which provide services to persons with hearing impairment. These include the HSE audiology services and speech and language services, the cochlear implant service in Beaumont, Deaf Hear and the Department of Education Visiting Teachers of the Deaf. This memorandum of understanding will cover detailed care pathways and

facilitate the organisations pooling information and information packs for families.

“Another major development is the national bone anchored hearing aid programme. We have six HSE funded sites where these surgical procedures will be carried out.” Because of their ear structure, some people are unable to have normal hearing aids fitted. With bone anchored hearing aids an implant is inserted into the bone behind the ear so that a hearing aid can be screwed on.

“Up to now this has only been done on an ad hoc basis, but we will now have a structured funded programme. “We have very stringent guidelines about referral to this programme. Approval will have to be given by the HSE in advance of carrying out each procedure and it will be a real example of money following the patient,” said Ms. Heffernan.

PICTURED: Aisling Heffernan

PICTURED: Brian Murphy

The Audiology Programme has also tackled the difficulties posed by the fact that there was no training programme for audiology in Ireland.

“People have to go abroad for training in audiology. We have done a lot of work with the Higher Education Authority (HEA) and will soon be issuing a joint callout to all the higher education institutes (HEI) in Ireland to ascertain which could provide an accelerated MSc programme in Audiology. Hopefully a HEI will be selected by the summer and the new programme will commence in 2014. The selected HEI will also provide CPD training and research.

“This year we have sponsored ten students to do an accelerated MSc in audiology, including a year of clinical placement in Ireland. By September of this year, they will be fully qualified.

“Audiology was prioritised again this year by the Department of Health and we received new funding for additional posts. By the end of this year we will have an extra 17 posts in audiology which is a 23 per cent increase on our present complement of 72 posts.”

D

PICTURED: Prof. John Bamford

88 | CLINICAL CARE

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IE_CB

DUAC UNDERSTANDS WHATâ&#x20AC;&#x2122;S IMPORTANT TO PATIENTS THE

HALLEN

Duac Once Daily 10mg/g and 50mg/g Gel (clindamycin and anhydrous benzoyl peroxide) Abridged prescribing information (Please refer to SPC before prescribing). Presentations: 1g of gel contains 10mg clindamycin as clindamycin phosphate and 50mg anhydrous benzoyl peroxide as hydrous benzoyl peroxide. Therapeutic Indications: Mild to moderate acne vulgaris, particularly inflammatory lesions. Dosage and administration: Adults and adolescents: Apply once daily in the evening, to affected areas after the skin has been thoroughly washed, rinsed with warm water and gently patted dry. Children under 12 years: Safety and efficacy has not been established. Elderly: No specific recommendations. Treatment should not exceed more than 12 weeks of continuous use. Contra-indications: Known hypersensitivity to clindamycin, lincomycin, benzoyl peroxide or any of the excipients in the formulation. Warnings and Precautions: Avoid contact with mouth, eyes, mucous membranes and abraded or eczematous skin. Apply with caution to sensitive areas of skin. In the event of accidental contact with the eyes, bathe with copious amounts of water. Use with caution in patients with a history of regional enteritis, ulcerative colitis, a history of antibiotic-associated colitis or in atopic patients. The frequency of application should be reduced if excessive irritation or dryness develops. If prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment should be discontinued immediately, as the symptoms may indicate antibiotic-associated colitis. Diagnostic and treatment options for colitis should be considered. May bleach hair or coloured fabrics.

Exposure to sun or sunlamps should be minimised. Patients should be advised that 4-6 weeks of treatment may be required before the full therapeutic effect is observed. Cross-resistance may occur with other antibiotics such as lincomycin and erythromycin when using antibiotic monotherapy. Local recommendations about antibiotic use and prevalence of acquired resistance should be taken into consideration. Drug Interactions: Caution with concomitant topical antibiotics, medicated or abrasive soaps, cleansers and cosmetics that have a strong drying effect, and products with high concentrations of alcohol and/or astringents, as a cumulative irritant effect may occur. Avoid simultaneous application of Duac Once Daily Gel and topical acne preparations containing vitamin A derivatives. Potential synergism exists between clindamycin and gentamycin. Pregnancy and Lactation: Safety in human pregnancy is not established. Balance risks against benefits. Not recommended during lactaction. Undesirable effects: Erythema, Peeling, Dryness, Burning, Pruritus. For less frequent undesirable effects, please see SPC. Legal Category: POM, S1A. PA Holder: GlaxoSmithKline (Ireland) Ltd, Stonemasons Way, Rathfarnham, Dublin 16, Trading as Stiefel. PA Number: PA 1077/120/001. Further information available from: GlaxoSmithKline (Ireland) Limited, Stonemasons Way, Rathfarnham, Dublin 16. Telephone: 01 4955000. Job number: IE/CBP/0008/11. Date of preparation: July 2011

References: 1. Langner A et al. BJD 2008;158,122-129 2. Summary of Product Characteristics for DuacÂŽ, available from www.medicines.ie. Accessed November 2011.

3. Lookingbill et al. JAAD 1997;37:590-5.

IE_CBP_0021_11_Duac_advert_A4_nov2011.indd 1 ClinicalCare2013_1_104.indd 89

Date of preparation: November 2011. IE/CBP/0021/11

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Duac works fast, starting to work in just 2 weeks1 Duac is a once daily treatment2 Duac is generally well-tolerated2,3

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Radiology

A pivotal service inof many the management conditions A number of models are currently under review in the HSE Clinical Programme on Radiology, with the focus on improving access to radiology. These include: extended day working (8am to 8pm), direct GP access for selected tests, weekend cover, and insourcing/outsourcing arrangements where demand exceeds capacity. The Programme is co-led by Dr Peter Kavanagh, Consultant Radiologist, Connolly Hospital Blanchardstown, Dublin and Dr Niall Sheehy, Consultant Radiologist, St James’s Hospital, Dublin. Maureen Browne reports.

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Delays in diagnosis may prevent the patient from being appropriately treated, costing the health service more and reducing the quality of life of the patient.”

The Radiology Programme was established to address issues of quality, access and cost for patients and users for diagnostic imaging and is particularly focussed on reducing the waiting lists for diagnostic imaging.

Currently demand for radiology studies is rising at a rate of about 5% per annum internationally. The increasing use of radiology is of great benefit to patients and clinicians not only through its enhanced diagnostic capability, but also through its ability to treat patients with minimally invasive interventional procedures, an important branch of modern radiology. There are significant cost implications with these improvements – while the tests themselves are rarely inexpensive, using them in an efficient, targeted manner will reduce overall costs for the health service. One of the goals of the National Radiology Programme is to show that a small expenditure in radiology can bring about much larger cost savings for the larger healthcare system. Apart from the financial benefits, the effective use of radiology is strongly associated with improved outcomes and faster patient journey times through the system.

Currently, it is estimated that spending on radiology averages 6% of health spending in Ireland. The vast majority

FEATURE

of patients will have some diagnostic imaging test during the course of their treatment, and many will undergo multiple radiology investigations. An estimated total of 3.5 million tests are conducted in Ireland per annum. As an expensive resource, it is important that is applied appropriately and used efficiently.

For example, there are about 80,000100,000 MRI examinations done in the public system per annum. Approximately 20,000-30,000 of these will be on inpatients. The average turnaround time for in-patient MRI is up to 4 days; this indicates that there is potential for a significant reduction in bed-days per admission through improvements in radiology efficiency and resources.

The Programme, co-led by Dr Peter Kavanagh, Consultant Radiologist, Connolly Hospital Blanchardstown, Dublin and Dr Niall Sheehy, Consultant Radiologist, St James’s Hospital, Dublin, has identified three important areas of work that can be facilitated by the programme towards this objective with the engagement of service providers (radiology department personnel), service users (GPs, Hospital Clinicians) and service payers (Hospital Administration & HSE Management). The three work streams are: • Data and Performance Measurement • Clinical Protocols and working with Clinicians • Quality Improvement Radiology occupies a pivotal position in the management of many conditions and shares a high level of interdependency with other specialties. Therefore an integrated approach with the other Clinical Programmes is key. The workstreams are currently underway and include the following: Data and Performance Measurement “Key Performance indicators are regarded as essential tools in today’s competitive health care environment. They form the raw materials necessary to evaluate and improve departmental processes.

“Performance indicators require the availability of data from which to measure a variety of parameters” says Dr Niall

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FEATURE Radiology

Sheehy. “Structured and standardised information makes our data collection easier, the subsequent analysis of which will be used to support the quality of service delivered. In order to meet these requirements the Programme is working with key stakeholders to establish: 1. Provision of a central repository for the data; 2. HIQA approved standardised structure of the data; 3. Daily feeds of anonymised data into the repository; 4. A Web Portal for specialty controlled access to and review of the data; 5. Web portal to have capability for authoring and addition to the dataset elements.”

evidence. We also hope that it will serve to prevent inappropriate use and promote the appropriate utilisation of radiology tests, and thus reduce unnecessary patient irradiation.”

Once data has been validated and clinically appropriate KPI reports, defined by the Radiology Programme (which will be selected in accordance with evidence-based international best practice standards) can be generated on a hospital-by-hospital basis for performance measurement. This benchmarked performance measurement will enable the Programme to support hospitals/hospital groups in developing greater efficiencies through quality improvement initiatives.

The Radiology Programme conducted a survey to assess current levels of access to radiology services for General Practitioners. Radiology departments were asked to respond to a number of questions regarding their arrangements for GP direct access to diagnostic imaging. While almost all locations had a facility for GP patients to access general x-ray, the access reduces proportionately as the level of complexity of the test increases, such that modalities like CT and MRI were largely inaccessible for the majority of GPs in Ireland.

Ultrasound occupied an intermediate position, with significant variation in access between different hospitals and in different regions. However, some locations had direct access arrangements in place. The Programme is working in cooperation with the Primary Care Clinical Programme to review the survey results and make recommendations on the future potential and requirements for GP direct access to diagnostic imaging.

“The introduction of the national referral criteria is an important first step in building closer links with GPs, giving a baseline from which to develop GP Clinical Protocols for the most common diagnostic tests” said Dr Kavanagh.

Clinical Protocols and working with Clinicians The Radiology Programme approved and adopted National Referral Criteria for diagnostic imaging in 2012. The iRefer guidelines “Making the best use of clinical radiology” published by the Royal College of Radiologists, UK, was reviewed and adopted by the Faculty of Radiologists, the National Radiology Programme and the National Radiation Safety Committee, HSE in 2012. “These guidelines are produced to help clinicians, radiologists, radiographers and other healthcare professionals to determine the most appropriate imaging investigation(s) for a wide range of clinical problems” said Dr Kavanagh. “We hope they will be a supportive tool to help direct clinical management and/or add confidence to the clinical diagnosis as additional

These guidelines will be launched nationally in 2013. Clinicians, health facilities and GPs will be asked to participate in the review of the referral criteria pertinent to their area of practice, with the intention of adapting them for ongoing local adoption, where appropriate. The Radiology Clinical Programme is currently organising access to the iRefer guidelines in an interactive ‘on line’ environment which will be accessible to hospitals, GPs and other health care facilities later in 2013.

Quality Improvement For an increasing number of conditions, it is often not possible for the clinician to

confidently make the diagnosis until after they have availed of radiology investigations and have the results of those tests to hand.

Delays in diagnosis may prevent the patient from being appropriately treated, costing the health service more and reducing the quality of life of the patient.

Therefore, delays in the delivery of radiology services should be avoided where possible. This also requires senior clinical decision-makers and radiologists to work together in co-ordinating activities whereby referrals can be optimally matched with available resources, e.g., morning GP clinics, breast screening clinics proceeding with the presence of a sub-specialty radiologist to provide the radiology elements, preferably all during the same patient visit. Such arrangements are clearly more feasible in elective/out-patient settings.

By increasing access to diagnostics – particularly the cross-sectional imaging modalities (ultrasound, CT and MRI) – this leads a more efficient health service by addressing three key objectives: • Admission prevention, • Faster diagnosis and treatment, and • Early discharge.

The real net savings, therefore, will not only be deliverable by radiology; but by overall process improvement and enhanced access to diagnostics, which can realise significant savings across the entire acute system in reduced admissions, reduced Average Length Of Stay (AvLOS), early discharge etc., (all of which are yet to be fully quantified).

The radiology programme plans to establish a Quality Improvement Programme in 2013. A number of models are currently under review, with the focus on improving access to radiology. These include: extended day working (8am to 8pm), direct GP access for selected tests, weekend cover, and insourcing/ outsourcing arrangements where demand exceeds capacity. Allied to this review, the forthcoming announcement of hospital groupings will be a strong influencing factor in the planning of future Radiology service provision.

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STROKE PREVENTION

The only licensed oral anticoagulant to show superior efficacy to warfarin for prevention of both ischaemic and haemorrhagic stroke – Pradaxa® 150mg b.d.1-3 Pradaxa® is licensed for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors.1,4 Pradaxa® 150mg b.d. Superior prevention of stroke and systemic embolism (p=0.0001) with similar rates of major bleeding vs warfarin.1,5,6 Pradaxa® 110mg b.d. Similar prevention of stroke and systemic embolism with significantly lower rates of major bleeding vs warfarin (p=0.003).4-6 Prescribing Information (SPAF - Ireland) PRADAXA® (dabigatran etexilate) Capsules containing 110 mg or 150 mg dabigatran etexilate (as mesilate) Action: Direct thrombin inhibitor Indication: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more of the following risk factors: Previous stroke, transient ischaemic attack, or systemic embolism (SEE); Left ventricular ejection fraction < 40 %; Symptomatic heart failure, ≥ New York Heart Association (NYHA) Class 2; Age ≥ 75 years; Age ≥ 65 years associated with one of the following: diabetes mellitus, coronary artery disease, or hypertension Dose and Administration: Renal function should be assessed by calculating CrCL prior to initiation to exclude patients with severe renal impairment (CrCL < 30 ml/min). Recommended daily dose 300 mg taken as one 150 mg capsule twice daily. Therapy should be continued long term. In case of intolerability to dabigatran, patients should be instructed to immediately consult their doctor. Elderly: Aged ≥ 80 years 220 mg taken as one 110 mg capsule twice daily; 75 – 80 years consider 220 mg taken as one 110 mg capsule twice daily. As renal impairment may be frequent in the elderly (> 75 years), assess renal function by calculating CrCL prior to initiation to exclude patients with severe renal impairment (CrCL < 30 ml/min). Renal function should also be assessed at least once a year or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate. Patients with an increased risk of bleeding: closely monitor clinically looking for signs of bleeding or anaemia. Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient. A coagulation test may help identify increased risk patients. Patients with gastritis, oesophagitis, or gastroesophageal reflux consider 220 mg taken as one 110 mg capsule twice daily due to the elevated risk of major gastrointestinal bleeding. Renal impairment: contraindicated in severe renal impairment (CrCL < 30 ml/min); patients with renal impairment and a high risk of bleeding consider 220 mg taken as one 110 mg capsule twice daily. Close clinical surveillance is recommended in patients with renal impairment. As above assess renal function prior to initiation to exclude patients with severe renal impairment and assess renal function at least once a year or more frequently as needed. Concomitant verapamil 220 mg taken as one 110 mg capsule twice daily; Pradaxa and verapamil should be taken at the same time. No dose adjustment required but close clinical surveillance in patients < 50 kg. Not recommended if liver enzymes > 2 Upper Limit of Normal (ULN). If switching from Pradaxa to parenteral anticoagulant wait 12 hours after the last dose of Pradaxa; if switching from parenteral anticoagulants to Pradaxa then Pradaxa should be given 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment; if switching from Pradaxa to VKA adjust the starting time of the VKA based on CrCL; if switching from VKA to Pradaxa stop VKA and give Pradaxa once INR <2.0. Cardioversion patients can stay on Pradaxa whilst being cardioverted. Not recommended aged < 18 years. Pradaxa should be swallowed whole with water, with or without food. Patients should be instructed not to open the capsule as this may increase the risk of bleeding. Contraindications: Hypersensitivity to any component; severe renal impairment (CrCL < 30 ml/min); active clinically significant bleeding; lesion or condition at significant risk of major bleeding such as current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; concomitant treatment with any other anticoagulant agent e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under the circumstances of switching therapy to or from Pradaxa or when UFH is given at doses necessary to maintain an open central venous or arterial catheter; hepatic impairment or liver disease expected to have any impact on survival; concomitant systemic ketoconazole, cyclosporine, itraconazole, tacrolimus, dronedarone. Warnings and

Precautions: Not recommended if liver enzymes > 2 ULN. Haemorrhagic risk: Close clinical surveillance (signs of bleeding or anaemia) is recommended throughout the treatment period, especially when haemorrhagic risk is increased or risk factors combined.

Factors which may increase haemorrhagic risk: age ≥ 75 years; moderate renal impairment (CrCL 30 – 50 ml/min); P-glycoprotein inhibitor co-medication; body weight < 50 kg; acetylsalicylic acid (aspirin); NSAID; clopidogrel; selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs); other drugs which may impair haemostasis; diseases/procedures associated with a risk of bleeding such as coagulation disorders, thrombocytopenia or functional platelet defects, recent biopsy, major trauma, bacterial endocarditis, oesophagitis, gastritis or gastroesophageal reflux. The measurement of dabigatran related anticoagulation may be helpful to avoid excessive high exposure to dabigatran in the presence of additional risk factors. Patients who develop acute renal failure must discontinue Pradaxa. If severe bleeding occurs, discontinue treatment and investigate the source of the bleeding. Avoid or use with caution agents which may increase the risk of haemorrhage. The use of fibrinolytic agents for the treatment of acute ischaemic stroke may be considered if the patient presents with a dTT, ECT or aPTT not exceeding the ULN according to the local reference range. Avoid concomitant administration with P-gp inducers. Patients on dabigatran etexilate who undergo surgery or invasive procedures are at increased risk for bleeding therefore surgical interventions may require the temporary discontinuation of dabigatran etexilate; prescribers should consult the Summary of Product Characteristics for further information. Procedures such as spinal anaesthesia may require complete haemostatic function. The risk of spinal or epidural haematoma may be increased in cases of traumatic or repeated puncture and by the prolonged use of epidural catheters.

After removal of a catheter, an interval of at least 2 hours should elapse before the administration of the first dose of dabigatran etexilate; these patients require frequent observation for neurological signs and symptoms of spinal or epidural haematoma. Treat with caution patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events. Myocardial infarction. The safety and efficacy of Pradaxa has not been studied in patients with prosthetic heart valves. Therefore use of Pradaxa is not recommended in these patients. Contains Sunset Yellow (E110) which may cause allergic reactions. Interactions: Anticoagulants and antiplatelet aggregation agents; Strong P-gp inhibitors e.g. amiodarone, quinidine, verapamil, clarithromycin co-administration (close clinical surveillance); verapamil co-administration - reduce Pradaxa dose to 220 mg (see above); not recommended for concomitant treatment posaconazole, protease inhibitors including ritonavir and its combinations with other protease inhibitors; avoid with P-gp inducers e.g. rifampicin, St John’s wort, carbamazepine, phenytoin; SSRIs or SNRIs. Dabigatran etexilate and dabigatran are not metabolised by cytochrome CYP450 system, therefore related medicinal product interactions not expected. Pantoprazole and other proton-pump inhibitors (PPI) were co-administered with Pradaxa in clinical trials and concomitant PPI treatment did not appear to reduce the efficacy of Pradaxa. Ranitidine administration together with Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran. Fertility, pregnancy and lactation: Avoid pregnancy during treatment. Do not use in pregnancy unless clearly necessary. Discontinue breast-feeding during treatment. Undesirable effects: Most commonly reported adverse reactions are bleedings occurring in total in approximately 16.5 % in patients with atrial fibrillation treated for the prevention of stroke and SEE. Common (≥ 1/100, <1/10): anaemia; epistaxis; gastrointestinal haemorrhage; abdominal pain; diarrhoea; dyspepsia; nausea; hepatic function abnormal/liver function test abnormal; genitourological haemorrhage (150 mg). Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes: 110 mg 60 capsules 150 mg 60 capsules Legal category POM MA numbers: 110 mg EU/1/08/442/007 (60 capsules) 150 mg EU/1/08/442/011 (60 capsules) Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information.

Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Hyde Building, The Park, Carrickmines, Dublin 18. Prepared in September 2012.

20513 BIP SPAF - Consultant Clinical Care Ad_V8_297x210_A4_Irish.indd 1 ClinicalCare2013_1_104.indd 94

References: 1. Boehringer Ingelheim. Pradaxa® 150mg hard capsules Summary of Product Characteristics. 2. Patel MR, Mahaffrey KW, Garg J, et al.

Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365:883-891. 3. Patel MR, Mahaffrey KW, Garg J, et al. Supplementary appendix to Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365:883-891. 4. Boehringer Ingelheim. Pradaxa® 110mg hard capsules Summary of Product Characteristics. 5. Connolly S, Ezekowitz MD, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361:1139-1151. 6. Connolly S, Ezekowitz MD, et al. Newly identified events in the RE-LY trial. N Engl J Med 2010; 363:1875-1876.

Date of preparation: September 2012 Job code: IRE/DBG-121576f◆

For more information, including an educational pack, go to www.pradaxa.ie/SPAFeducationalpack or call the Pradaxa® information line on 1850 946100

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© istockphoto/thinkstockphoto.com

Stroke FEATURE

Major developments

in stroke care in Ireland Ireland now has 28 Stroke Units in acute hospitals around the country, stroke rehabilitation units are being developed in four additional hospitals and the national thrombolytic rate is now one of the best internationally, according to Prof. Peter Kelly, Consultant Neurologist at the Mater Hospital Dublin and Joint Lead of the HSE Clinical Stroke Programme.

Maureen Browne reports.

I

reland now has 28 Stroke Units in acute hospitals around the country, stroke rehabilitation units are being developed in four additional hospitals, the national thrombolytic rate is now one of the best internationally, a telemedicine programme is been rolled out to support complex thrombolytic decision making in non acute hospitals and an early discharge support initiative is improving clinical outcomes and making significant bed savings.

These are among the main developments of the HSE Clinical Stroke Programme, according to Prof. Peter Kelly, Consultant Neurologist at the Mater Hospital Dublin and Joint Lead of the Programme.

He said a further Stroke Unit is awaiting a decision to open by local management, which will bring the number up to 29.

This compares to a total of 18 hospitals which reported they had a stroke unit when the Programme was started in 2010.The stroke units, which also include specialised rehabilitation units, are located in hospitals which accept patients with emergency strokes and

those who are potentially eligible for thrombolysis.

In its initial phase, it is hoped that the Stroke Programme will allow over 350 poor outcomes (lives saved or dependency avoided) to be averted each year and prevent a similar number of people from having strokes annually.

Stroke is the third biggest killer disease in Ireland – causing more deaths each year than breast cancer, prostate cancer and bowel cancer combined. Ten thousand people will suffer a stroke in Ireland this year and of these, over 2,000 will die, while one in five Irish people will have a stroke at some time in their lives.

Strokes not only cause enormous mortality and morbidity, but they are also a major drain on the health services’ budget, costing an estimated €1 bn year in Ireland. Prof. Kelly is the neurology lead for the Programme, Dr. Joe Harbison is the geriatrician lead, Mayo GP, Dr. Pat Durcan is the GP lead and Carmel Brennan – described by Prof. Kelly as “the driving force” is the Project Manager. The multidisciplinary

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An Experience Beyond the Best

TEL: +353 21 4845900 WEB: www.hayfieldmanor.ie EMAIL: enquiries@hayfieldmanor.ie www.facebook.com/hayfieldmanor www.twitter.com/hayfieldmanor Hayfield Manor, Perrott Avenue, College Road, Cork

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Stroke FEATURE

ethos of stroke treatment is a core principle and is at the heart of the programme, permeating planning and implementation.

Prof. Kelly said that one of the first pieces of work done in the Programme was to ensure a clinical governance structure that was robust at all levels from national to local. With this in mind, they encouraged the formation of local stroke teams which would be multidisciplinary with clinical and non clinical management and hospital and community representation at each hospital and the surrounding community services.

“By the end of last year, it was reported to us that all hospitals with the exception of one, had developed a local stroke team, which means that about 94 per cent are reporting that they have teams in place, which is the first step towards robust governance at local level.

“This is a change in practice on the ground. We hope to broaden and deepen this over the next two years by encouraging these teams to meet regularly and action local improvement initiatives.

“At regional level we currently have two regional leads per HSE region within the national Programme. In addition, about 2010, initial networks were formed in Dublin Mid Leinster and in the West, so we have two network leads, one in each of these regions.

“This means that in the Programme we have two leads for hospital care and one for primary care and a clinical regional governance unit. The appointment of Dr. Durcan has greatly strengthened the national governance discussions and structures of the programme and we now have a three way conversation between primary care, neurology and geriatrics.”

More formal networks will depend on the final configuration of the national hospital network by the Minister for Health. However, many hospitals are

working as de facto networks with referral pathways which are working very well. Prof. Kelly said they were very pleased with the success so far of the Programme’s thrombolysis initiative, which was one of the core aims of the Programme.

“A survey conducted in mid 2010 showed that only 50 percent of hospitals reported providing a 24/7 thrombolytic service for patients with acute stroke This is an important treatment, which can result in very dramatic improvement in disability and reduce mortality.

}

In its initial phase, it is hoped that the Stroke Programme will allow over 350 poor outcomes (lives saved or dependency avoided) to be averted each year and prevent a similar number of people from having strokes annually.”

“This is in conjunction with a range of approaches including better physician education, the creation of ambulance access approaches, key targeted additional consultants, nurse education protocols and more recently we have established the beginnings of a telemedicine project to cover all hospitals in the State on a 24/7 basis.

“The national thrombolytic rate has increased from 2.6 per cent in 2007 to 9.5 per cent in the first quarter of 2012, according to the best data available to us and based on an audit carried out by the office of Dr. Philip Crowley, HSE National Director of Quality & Care.

“The Irish rate is one of the best internationally and indeed may have increased since the audit was carried out.

Our rate of 9.5 per cent has exceeded our target of 7.5 per cent for the end of 2012.”

This has all been facilitated by new fast track protocols which have been worked out with the National Ambulance Service and implemented in many hospitals throughout the country.

Five consultant neurologist posts have been created jointly between the HSE Clinical Stroke Programme and the HSE National Neurology Programme of which four have been filled and one has been re-advertised following an initial failure to recruit a consultant. In addition, a number of stroke geriatricians

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FEATURE Stroke

Hospital alone. That is equivalent to creating one and a half beds in the system or taking a patient with an average length of stay of 3.5 days; it would mean being able to take in about 150 additional patients each year to the hospital. It also fulfils the national and ministerial goals of making better use of community services. Clinical outcomes have been excellent and personal outcomes also very good. So it is a ‘win’ as far as patient satisfaction, clinical outcomes and economics are concerned.”

have been appointed to certain strategic hospital locations around the country and many posts have been created jointly with the Acute Medicine Programme

entered every day. “The register gives us information on the quality and journey of care so that we can identify risks and if we are doing a good job.”

“We welcome these appointments which are contributing to the improvements we have seen. We have also negotiated for 55 nursing, therapy and psychology posts and at the time of the recruitment pause at the end of the summer, 41 of these had been filled. Also additional speech and language and occupational therapists have been appointed. We would expect that the recruitment pause will be relaxed early this year and we will be aiming to fill the remainder of these posts, in conjunction with the Regional Directors and local management teams.”

Another piece of work being carried out by the Programme is an Early Support Discharge Service to improve access of patients recently discharged form hospital to community rehabilitation.

In co-operation with Prof. Miriam Wiley of the Economic & Social Research Institute, (ESRI) the Programme has established a national stroke register. Prof. Kelly said that effectively this was done without any budget and it has been very successful so far, with about 85 per cent of hospitals in the state participating and the numbers increasing all the time. Over 2,500 patients have been entered on the register and additional patients are being

“The Community Rehabilitation Service is being supported to take patients who can be safely rehabilitated in their homes, take them out of hospital earlier, thus freeing up beds for other acute patients and improve ED waiting times.

The early support discharge service started initially in Dublin north city, based from the Mater Hospital, with a team led by Una Cunningham.

“In the first year of operation it accepted about one fifth of patients from the Mater, cutting the length of stay by a quarter. We estimate that even after investment costs for staff, equipment and running costs, there was a monetary bed day saving of about €160,000. We estimate that on average somewhere in the region of 450 bed days have been saved by the service in the Mater

A National Telemedicine Programme (TRASNA) to provide rapid access to stroke and neurological assessment has been developed between the Programme and an ICT team of colleagues in Cork.

The first clinical consultation was carried out successfully recently between doctors in the Mater and in Cavan General Hospital.

“TRASNA supports complex decision making for thrombolysis between doctors in remote emergency rooms and in acute hospitals. For example, it means that I can review a patient scan over the NIMIS or an alternative system and aid doctors locally to make decisions regarding thrombolysis. We anticipate rolling this our across the North East, and Dublin Mid Leinster, where it will replace the existing pilot which has been running there for the last two years.

The pilot was quite successful but the new system will be more sustainable and standardised nationally.”

An education programme for stroke management is being led by Imelda Noone, an Advanced Nurse Practitioner in St. Vincent’s University Hospital in Dublin. This is being developed and rolled out to stroke specialist nurse therapists and all healthcare staff dealing with patients with stroke, again with the aim of improving the quality of the experience that patients have with the health service.

© creatas/thinkstockphoto.com

}

The multidisciplinary ethos of stroke treatment is a core principle and is at the heart of the programme, permeating planning and implementation.

The early discharge support system is now being rolled out in Galway and in Tallaght and there are plans to extend it further this year and in 2014.

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STROKE PREVENTION

The only licensed oral anticoagulant to show superior efficacy to warfarin for prevention of both ischaemic and haemorrhagic stroke – Pradaxa® 150mg b.d.1-3 Pradaxa® is licensed for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors.1,4 Pradaxa® 150mg b.d. Superior prevention of stroke and systemic embolism (p=0.0001) with similar rates of major bleeding vs warfarin.1,5,6 Pradaxa® 110mg b.d. Similar prevention of stroke and systemic embolism with significantly lower rates of major bleeding vs warfarin (p=0.003).4-6 Prescribing Information (SPAF - Ireland) PRADAXA® (dabigatran etexilate) Capsules containing 110 mg or 150 mg dabigatran etexilate (as mesilate) Action: Direct thrombin inhibitor Indication: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more of the following risk factors: Previous stroke, transient ischaemic attack, or systemic embolism (SEE); Left ventricular ejection fraction < 40 %; Symptomatic heart failure, ≥ New York Heart Association (NYHA) Class 2; Age ≥ 75 years; Age ≥ 65 years associated with one of the following: diabetes mellitus, coronary artery disease, or hypertension Dose and Administration: Renal function should be assessed by calculating CrCL prior to initiation to exclude patients with severe renal impairment (CrCL < 30 ml/min). Recommended daily dose 300 mg taken as one 150 mg capsule twice daily. Therapy should be continued long term. In case of intolerability to dabigatran, patients should be instructed to immediately consult their doctor. Elderly: Aged ≥ 80 years 220 mg taken as one 110 mg capsule twice daily; 75 – 80 years consider 220 mg taken as one 110 mg capsule twice daily. As renal impairment may be frequent in the elderly (> 75 years), assess renal function by calculating CrCL prior to initiation to exclude patients with severe renal impairment (CrCL < 30 ml/min). Renal function should also be assessed at least once a year or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate. Patients with an increased risk of bleeding: closely monitor clinically looking for signs of bleeding or anaemia. Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient. A coagulation test may help identify increased risk patients. Patients with gastritis, oesophagitis, or gastroesophageal reflux consider 220 mg taken as one 110 mg capsule twice daily due to the elevated risk of major gastrointestinal bleeding. Renal impairment: contraindicated in severe renal impairment (CrCL < 30 ml/min); patients with renal impairment and a high risk of bleeding consider 220 mg taken as one 110 mg capsule twice daily. Close clinical surveillance is recommended in patients with renal impairment. As above assess renal function prior to initiation to exclude patients with severe renal impairment and assess renal function at least once a year or more frequently as needed. Concomitant verapamil 220 mg taken as one 110 mg capsule twice daily; Pradaxa and verapamil should be taken at the same time. No dose adjustment required but close clinical surveillance in patients < 50 kg. Not recommended if liver enzymes > 2 Upper Limit of Normal (ULN). If switching from Pradaxa to parenteral anticoagulant wait 12 hours after the last dose of Pradaxa; if switching from parenteral anticoagulants to Pradaxa then Pradaxa should be given 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment; if switching from Pradaxa to VKA adjust the starting time of the VKA based on CrCL; if switching from VKA to Pradaxa stop VKA and give Pradaxa once INR <2.0. Cardioversion patients can stay on Pradaxa whilst being cardioverted. Not recommended aged < 18 years. Pradaxa should be swallowed whole with water, with or without food. Patients should be instructed not to open the capsule as this may increase the risk of bleeding. Contraindications: Hypersensitivity to any component; severe renal impairment (CrCL < 30 ml/min); active clinically significant bleeding; lesion or condition at significant risk of major bleeding such as current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; concomitant treatment with any other anticoagulant agent e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under the circumstances of switching therapy to or from Pradaxa or when UFH is given at doses necessary to maintain an open central venous or arterial catheter; hepatic impairment or liver disease expected to have any impact on survival; concomitant systemic ketoconazole, cyclosporine, itraconazole, tacrolimus, dronedarone. Warnings and

Precautions: Not recommended if liver enzymes > 2 ULN. Haemorrhagic risk: Close clinical surveillance (signs of bleeding or anaemia) is recommended throughout the treatment period, especially when haemorrhagic risk is increased or risk factors combined.

Factors which may increase haemorrhagic risk: age ≥ 75 years; moderate renal impairment (CrCL 30 – 50 ml/min); P-glycoprotein inhibitor co-medication; body weight < 50 kg; acetylsalicylic acid (aspirin); NSAID; clopidogrel; selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs); other drugs which may impair haemostasis; diseases/procedures associated with a risk of bleeding such as coagulation disorders, thrombocytopenia or functional platelet defects, recent biopsy, major trauma, bacterial endocarditis, oesophagitis, gastritis or gastroesophageal reflux. The measurement of dabigatran related anticoagulation may be helpful to avoid excessive high exposure to dabigatran in the presence of additional risk factors. Patients who develop acute renal failure must discontinue Pradaxa. If severe bleeding occurs, discontinue treatment and investigate the source of the bleeding. Avoid or use with caution agents which may increase the risk of haemorrhage. The use of fibrinolytic agents for the treatment of acute ischaemic stroke may be considered if the patient presents with a dTT, ECT or aPTT not exceeding the ULN according to the local reference range. Avoid concomitant administration with P-gp inducers. Patients on dabigatran etexilate who undergo surgery or invasive procedures are at increased risk for bleeding therefore surgical interventions may require the temporary discontinuation of dabigatran etexilate; prescribers should consult the Summary of Product Characteristics for further information. Procedures such as spinal anaesthesia may require complete haemostatic function. The risk of spinal or epidural haematoma may be increased in cases of traumatic or repeated puncture and by the prolonged use of epidural catheters.

After removal of a catheter, an interval of at least 2 hours should elapse before the administration of the first dose of dabigatran etexilate; these patients require frequent observation for neurological signs and symptoms of spinal or epidural haematoma. Treat with caution patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events. Myocardial infarction. The safety and efficacy of Pradaxa has not been studied in patients with prosthetic heart valves. Therefore use of Pradaxa is not recommended in these patients. Contains Sunset Yellow (E110) which may cause allergic reactions. Interactions: Anticoagulants and antiplatelet aggregation agents; Strong P-gp inhibitors e.g. amiodarone, quinidine, verapamil, clarithromycin co-administration (close clinical surveillance); verapamil co-administration - reduce Pradaxa dose to 220 mg (see above); not recommended for concomitant treatment posaconazole, protease inhibitors including ritonavir and its combinations with other protease inhibitors; avoid with P-gp inducers e.g. rifampicin, St John’s wort, carbamazepine, phenytoin; SSRIs or SNRIs. Dabigatran etexilate and dabigatran are not metabolised by cytochrome CYP450 system, therefore related medicinal product interactions not expected. Pantoprazole and other proton-pump inhibitors (PPI) were co-administered with Pradaxa in clinical trials and concomitant PPI treatment did not appear to reduce the efficacy of Pradaxa. Ranitidine administration together with Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran. Fertility, pregnancy and lactation: Avoid pregnancy during treatment. Do not use in pregnancy unless clearly necessary. Discontinue breast-feeding during treatment. Undesirable effects: Most commonly reported adverse reactions are bleedings occurring in total in approximately 16.5 % in patients with atrial fibrillation treated for the prevention of stroke and SEE. Common (≥ 1/100, <1/10): anaemia; epistaxis; gastrointestinal haemorrhage; abdominal pain; diarrhoea; dyspepsia; nausea; hepatic function abnormal/liver function test abnormal; genitourological haemorrhage (150 mg). Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes: 110 mg 60 capsules 150 mg 60 capsules Legal category POM MA numbers: 110 mg EU/1/08/442/007 (60 capsules) 150 mg EU/1/08/442/011 (60 capsules) Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information.

Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Hyde Building, The Park, Carrickmines, Dublin 18. Prepared in September 2012.

20513 BIP SPAF - Consultant Clinical Care Ad_V8_297x210_A4_Irish.indd 1 ClinicalCare2013_1_104.indd 99

References: 1. Boehringer Ingelheim. Pradaxa® 150mg hard capsules Summary of Product Characteristics. 2. Patel MR, Mahaffrey KW, Garg J, et al.

Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365:883-891. 3. Patel MR, Mahaffrey KW, Garg J, et al. Supplementary appendix to Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365:883-891. 4. Boehringer Ingelheim. Pradaxa® 110mg hard capsules Summary of Product Characteristics. 5. Connolly S, Ezekowitz MD, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361:1139-1151. 6. Connolly S, Ezekowitz MD, et al. Newly identified events in the RE-LY trial. N Engl J Med 2010; 363:1875-1876.

Date of preparation: September 2012 Job code: IRE/DBG-121576f◆

For more information, including an educational pack, go to www.pradaxa.ie/SPAFeducationalpack or call the Pradaxa® information line on 1850 946100

13/12/2012 16:59 13/03/2013 17:32:27

For the treatment of bipolar I disorder*

NEW Legal Category: POM. Marketing Authorisation Holder: N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands. Marketing Authorisation Numbers: EU/1/10/640/002 Sycrest 5 mg sublingual tablets, 60 pack. EU/1/10/640/005 Sycrest 10 mg sublingual tablets, 60 pack. Further information is available on request from: Lundbeck (Ireland) Ltd., 7 Riverwalk, Citywest Business Campus, Dublin 24 or from www.medicines.ie. Date of Preparation: July 2012. *Sycrest is licensed for the the treatment of moderate to severe manic episodes in bipolar I disorder.

SY5/10/12

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SciencePrimary in Progress Care FEATURE

New primary care programme being developed.

The HSE primary care programme will change the emphasis of care from acute episodic care to structured, proactive care using “bundles of care” where appropriate.

Maureen Browne reports.

T

he scope of the HSE Clinical Care Programmes cover the whole of the patient journey from self management and prevention through to primary, secondary and tertiary care. These programmes provide a national, strategic, and co-ordinated approach to patient care across the spectrum of services from acute to community care.

Dr Aine Carroll. HSE National Director of Clinical Strategy & Programmes said the HSE was at present finalising the restructuring of the Clinical Programmes and the development of a Primary Care Programme. The primary care programme will change the emphasis of care from acute episodic care to structured, proactive care using “bundles of care” where appropriate.

“Over the next year, we will be paying particular attention to the management of long term conditions. We will have a dedicated primary care programme which will be GP led and look at how primary care and prevention underline all programmes and the whole of the patient journey from beginning to end,” said Dr. Carroll.

“The Programmes are all about the right services at the right time for the right person, regardless of where that is and as close to home as possible.

“Don Berwick talks about a need for a change in our professionalism – his father was an old fashioned country

physician, and my father was a country GP. My father finds it difficult to understand why I would choose a management position even for a defined period of time. Don Berwick tells how he used to watch his father going out in the middle of the night, and I recall my father putting chains on the tyres and heading up the mountains of Mourne in winter to deliver a baby or attend an ill patient. This was the professionalism of Freidson, an old-fashioned professionalism which is very much still in existence, and which is based on the idea of knowledge, altruism and self regulation. As Berwick describes so well, things are completely different now and much more complex with so many things being interdependent.

There is a pervasive hazard of change, of power and control and we also have the added complexity of significant technology and change capacity about how systems can deal with those additional challenges.

“Don Berwick came up with some top tips. The first was to keep patients first always. We think we do that but we don’t always. His second tip was to stop re-structuring. The third was to strengthen the health care system as a whole and not some specific aspect of it, such as the acute service or the community service. This is something I completely support. In order to do

that in the Irish healthcare system, we are going to have to reinvest in general practice and primary care.

“We are heading down the road of Hospital Trusts and he said – and I think we should be very cognisant of this – don’t put your faith in market forces. We can learn from the mistakes in the NHS. Berwick advises to avoid supply driven care and the whole area of institutional self-interest like the plague. He also talks about an integrated approach and that is what the programmes are all about.”

A number of developments in primary care have been approved. Eighteen Diabetes Nurse Specialists will be based in primary care for 80 per cent of the time with an added resource of Nurse Specialists for sentinel practices that will be involved. This will also facilitate the fast tracking of patients to hospital where required.

Approval is also awaited from Ministers Reilly and White to appoint 250 frontline staff, as part of the €20 million allocated to primary care.

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07768 Alcohol Advice_07268 Alcohol Facts 01/11/2012 09:46 Page 1

Alcohol Fast Facts

Weekly Low Risk Drinking Guidelines1 • up to 14 standard drinks for women

• up to 21 standard drinks for men

A standard drink in Ireland has about 10 grams of pure alcohol in it.

This equates to one of the following:

half a pint of beer, or small glass of wine (12.5% volume), or pub measure of spirits (35.5ml)

The average Irish drinker consumed 11.9 liters of pure alcohol in 2010. This equates to 482 pints of lager or 125 bottles of wine or 45 bottles of vodka. 2

Reported OECD average alcohol consumption per drinker is 9.4 litres, with Ireland ranked fifth for consumption.3

Reducing the amount of alcohol consumed typically reduces the risk for many health conditions and will reduce the annual and lifetime risk of an alcohol-related death. 4, 5

Even for some chronic diseases, such as liver cirrhosis and depression, reduction in alcohol consumption can be associated with rapid improvements in health. 4

LU1/6/12

The estimated overall cost to Irish society of problem alcohol use is €3.7 billion, 32% of which can be attributed to healthcare. 6

References: 1. http://www.hse.ie/eng/services/ healthpromotion/alcohol/ accessed September 2012 2. Steering Group Report on a National Substance Misuse Strategy February 2012. 3. OECD Healthdata 2011 4. Alcohol in Europe: A Public Health Perspective (2006) Peter Anderson and Ben Baumberg 5. Rehm et al Addiction, 106 (Suppl. 1), 11-19 6. Byrne, S. (2010) Costs to Society of Problem Alcohol Use in Ireland, Dublin: Health Service Executive.

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Lundbeck (Ireland) Ltd, 7 Riverwalk, Citywest Business Campus, Citywest, Dublin 24.

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Clinical leads FEATURE

Clinical LEADS The doctors heading up the HSE Clinical Programmes are: Cardiologist, Galway University Hospital and Professor of Cardiology at NUIG.

Care of the elderly Dr Diarmuid O’Shea, Consultant Physician in Geriatric Medicine at St Vincent’s University Hospital, Dublin.

Obstetrics and gynaecology Prof. Michael Turner. UCD Professor of Obstetrics and Gynaecology, Consultant Obstetrician/Gynaecologist, Coombe Women & Infants' University Hospital and St Vincent’s University Hospital, Dublin.

Palliative care Dr Karen Ryan. Palliative Medicine Consultant, St Francis Hospice, Dublin.

Joint lead stroke (geriatrician) Dr Joe Harbison, Consultant Stroke Physician, St James’s Hospital, Dublin.

Diabetes Dr Diarmuid Smith, Consultant Endocrinologist, Beaumont Hospital, Dublin.

Radiology Dr. Niall Sheehy, Consulant Radiologist, St. James's Hospital, Dublin Dr. Peter Kavanagh, Consultant Radiologist, Connolly Hospital, Dublin

Joint lead stroke (neurology) Prof. Peter Kelly, Consultant Neurologist, Mater Hospital Dublin.

Primary care Dr Joe Clarke, GP, Slane, Co. Meath.

PICTURED: Dr Karen Ryan

Acute coronary syndrome Prof. Kieran Daly, Consultant

PICTURED: Prof. Louise Barnes

Heart failure Prof. Ken McDonald, Consultant Cardiologist, St Vincent’s University Hospital, Dublin.

COPD Dr Tim McDonnell, Consultant Respiratory Physician, St Vincent’s University Hospital and St Michael’s Hospital, Dublin.

PICTURED: Prof. Oliver Fitzgerald

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FEATURE Clinical leads

Pictured: Dr Pat Manning

Asthma Dr Pat Manning, Consultant Respiratory Physician, Midlands Regional Hospital, Mullingar.

Mental health Dr Ian Daly, Executive Clinical Director, HSE Dublin South City and South West.

Epilepsy Dr Colin Doherty, Consultant Neurologist, St James’s Hospital, Dublin.

Dermatology Prof. Louise Barnes, Consultant Dermatologist, St James’s Hospital Dublin.

PICTURED: Prof. Michael Turner

PICTURED: Mr David Moore

Neurology Prof. Tim Lynch, Consultant Neurologist, Mater Hospital, Dublin.

Rheumatology Prof. Oliver Fitzgerald, Consultant Rheumatologist, St Vincent’s University Hospital, Dublin and Newman Clinical Research Professor at St Vincent’s University Hospital and the Conway Institute, University College Dublin.

Joint lead acute medicine Prof. Shane O’Neill, Clinical Director, Beaumont Hospital, Dublin.

Joint lead acute medicine Prof. Garry Courtney, Consultant Physician, St Luke’s Hospital, Kilkenny.

Emergency medicine Dr Una Geary, Consultant in Emergency Medicine, St James’s Hospital, Dublin.

Critical care Dr Michael Power, Intensive Care Consultant, Beaumont Hospital, Dublin.

Home IV programme Prof. Colm Bergin, Consultant in Infectious Diseases, St James’s Hospital, Dublin.

Elective Surgery Prof. Frank Keane, Former President and Council Member, Royal College of Surgeons in Ireland.

PICTURED: Mr Paddy Kenny

The Productive Theatre Mr. Declan Magee, Consultant Surgeon, St. Columcille’s Hospital, Loughlinstown, Co. Dublin.

The Productive Ward Mr. Mark White, Nursing Services.

Audit Programme Mr. Ken Mealy, Consultant in General Surgery with special interest in gastrointestinal surgery, Wexford General Hospital.

Pathology Dr. Gerard Boran, Consultant Pathologist in Tallaght Hosptial.

Blood Transfusion Programme Clinical Lead: Dr William Murphy, IBTS. Healthcare Acquired Infection Dr. Fidelma Fitzpatrick, Consultant Microbiologist, Beaumont Hospital and Health Protection Surveillance Centre Dublin.

Orthopaedics Mr. Paddy Kenny, Consultant Orthopaedic Surgeon in Cappagh and Connolly Hospitals.

Mr. David Moore, Consultant Orthopeadic Surgeon in Tallaght Hospital.

Home IV (OPAT) Dr. Susan Clarke, Consultant, St. James’s Hospital, Dublin.

104 | CLINICAL CARE

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IE_DUTT_0012_12_Combodart_Advert_A4_Golf_May2012

02.05.2012

12:25

Side 1

A single step forward in BPH management

Combodart provides: Symptom relief as rapid as tamsulosin monotherapy1,2

Start with

Superior Symptom improvement Vs tamsulosin or dutasteride monotherapy1,2 In moderate BPH patients

After more than 50 years of combined oral contraceptives…

COMBODART ABRIDGED PRESCRIBING INFORMATION (API). (Please refer to the full Summary of Product Characteristics before prescribing) PRESENTATIONS: Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, (equivalent to 0.367 mg tamsulosin). INDICATION: Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. POSOLOGY & ADMINISTRATION: Adults (including elderly): The recommended dose is one capsule (0.5 mg/ 0.4 mg) taken orally approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. Contact with the contents of the dutasteride capsule contained within the hard-shell capsule may result in irritation of the oropharyngeal mucosa. Where appropriate, Combodart may be used to substitute concomitant dutasteride and tamsulosin hydrochloride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from dutasteride or tamsulosin hydrochloride monotherapy to Combodart may be considered. Renal impairment: The effect of renal impairment on dutasteridetamsulosin pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment. Hepatic impairment: The effect of hepatic impairment on dutasteride-tamsulosin pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of Combodart is contraindicated. CONTRAINDICATIONS: Combodart is contraindicated in: women, children and adolescents; patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, tamsulosin (including tamsulosin-induced angio-edema), soya, peanut or any of the other excipients; patients with a history of orthostatic hypotension: patients with severe hepatic impairment. SPECIAL WARNINGS & PRECAUTIONS: Combodart should be prescribed after careful benefit risk assessment and after consideration of alternative treatment options including monotherapies. In two 4-year clinical study, the incidence of cardiac failure (a composite term of reported events, primarily cardiac failure and congestive cardiac failure) was higher among subjects taking the combination of dutasteride and an alpha blocker, primarily tamsulosin, than it was among subjects not taking the combination. Digital rectal examination, as well as other evaluations for prostate cancer or other conditions which can cause the same symptoms as BPH, must be performed on patients prior to initiating therapy with Combodart and periodically thereafter. Combodart causes a decrease in mean serum PSA levels by approximately 50%, after 6 months of treatment. Patients should have a new baseline established after 6 months of treatment with Combodart and PSA should be monitored regularly thereafter. Any confirmed increase from the lowest PSA levels while on Combodart may signal the presence of prostate cancer (particularly high grade cancer) or non-compliance to therapy with Combodart and should be carefully evaluated, even if those values are still within the normal range for men not taking α 5 reductase inhibitor (see SPC section 5.1). The relationship between dutasteride and high grade prostate cancer is not clear. Men taking Combodart should be regularly evaluated for prostate cancer risk including PSA testing (see SPC section 5.1). Results of one clinical study (the REDUCE study) in men at increase risk of prostate cancer revealed a higher incidence of Gleason 8 – 10 prostate

cancers in dutasteride treated men compared to placebo. The relationship between dutasteride and high grade prostate cancer is not clear. Men taking Combodart should be regularly evaluated for prostate cancer risk including PSA testing (see SPC section 5.1). As with other alpha-blockers, a reduction in blood pressure can occur during treatment with tamsulosin, as a result of which, rarely, syncope can occur. Intraoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin and may lead to increased procedural complications during the operation. Breast cancer has been reported in men taking dutasteride. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Dutasteride is absorbed through the skin, therefore, women, children & adolescents must avoid contact with leaking capsules. Caution should be used in the administration of Combodart to patients with mild to moderate hepatic impairment. The treatment of severely renally impaired patients (creatinine clearance of less than 10 ml/min) should be approached with caution. This medicinal product contains the colouring agent Sunset Yellow (E110), which may cause allergic reactions.

INTERACTIONS: There have been no drug interaction studies for Combodart. The following reflect information available on the individual components. Dutasteride: is mainly eliminated via metabolism and studies indicate that this metabolism is catalysed by CYP3A4 and CYP3A5. Longterm combination of dutasteride with drugs that are potent inhibitors of the enzyme CYP3A4 (e.g. ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase serum concentrations of dutasteride. Tamsulosin: Concomitant administration of tamsulosin hydrochloride with drugs which can reduce blood pressure, including anaesthetic agents and other alpha-1 adrenergic blockers could lead to enhanced hypotensive effects. Dutasteride-tamsulosin should not be used in combination with other alpha-1 adrenergic blockers. Caution should be used when dutasteride-tamsulosin is used in combination with cimetidine and with concomitant administration of warfarin and tamsulosin hydrochloride. Diclofenac may increase the elimination rate of tamsulosin. FERTILITY, PREGNANCY & LACTATION: Combodart is contraindicated for use by women. There have been no studies to investigate the effect of Combodart on pregnancy, lactation and fertility - the following statements reflect the information available from studies with the individual components; Fertility: Dutasteride has been reported to affect semen characteristics in healthy men. The possibility of reduced male fertility cannot be excluded. Effects of tamsulosin hydrochloride on sperm counts or sperm function have not been evaluated. Pregnancy: As with other 5 alpha reductase inhibitors, dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male foetus, inhibit the development of the external genitalia of the foetus. It is not known whether a male foetus will be adversely affected if his mother is exposed to the semen of a patient being treated with dutasteride (the risk of which is greatest during the first 16 weeks of pregnancy). As with all 5 alpha reductase inhibitors, when the patient's partner is or may potentially be pregnant it is recommended that the patient avoids exposure of his partner to semen by use of a condom. Lactation: It is not known whether dutasteride or tamsulosin are excreted in human milk. ABILITY TO DRIVE & USE MACHINES: No studies on the effects of Combodart on the ability to drive and use machines have

For more information on this and other GSK brands visit www.Health.gsk.ie

Clinical Care Cover 2013_final.indd 2

been performed. However, patients should be informed about the possible occurrence of symptoms related to orthostatic hypotension such as dizziness when taking Combodart.

UNDESIRABLE EFFECTS: DUTASTERIDE AND TAMSULOSIN CO-ADMINISTRATION: The following adverse events have been reported with an incidence of ≥1% during the four years of treatment in the CombAT Study (Combination of Avodart and Tamsulosin-study, a comparison of dutasteride 0.5mg and tamsulosin 0.4mg once daily for four years as co-administration or as monotherapy): Cardiac failure, impotence, altered (decreased) libido, ejaculation disorders, breast disorders (includes breast enlargement and/or breast tenderness), dizziness. Adverse Events identified through post-marketing experience (therefore the true incidence is unknown) with dutasteride monotherapy include allergic reactions, including rash, pruritus, urticaria, localised oedema, and angioedema, skin and subcutaneous tissue disorders. Uncommon: Alopecia (primarily body hair loss), hypertrichosis. The following adverse events related to tamsulosin monotherapy have been reported from both clinical trials and post marketing data: Common (≥1/100 <1/10); dizziness. Uncommon (≥1/1000 <1/100); palpitations, constipation, diarrhoea, nausea, vomiting, asthenia, headache, abnormal ejaculation, rhinitis, rash, pruritis, urticaria, postural hypotension. MA Number PA1077/118/001. Marketing authorisation holder GlaxoSmithKline (Ireland) Limited, Stonemasons Way, Rathfarnham, Dublin 16, Ireland. Legal category POM; S1A. Date of preparation of API: April 2012. Copy Approval Code: IE/COM/0021/12. Further information available on request from GlaxoSmithKline, Stonemasons Way, Rathfarnham, Dublin 16 Ireland. Tel: 01-4955000.

The recommended dose of Combodart is one capsule (0.5 mg/ 0.4 mg) taken orally approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. * vs either tamsulosin or dutasteride monotherapy † No significant difference was seen between combination and dutasteride monotherapy (RRR 19.6%, p=0.18) References: 1. Combodart Summary of Product Characteristics, 2010.

2. Roehrborn CG et al. Eur Urol 2010; 57: 123-131.

IE/DUTT/0012/12

®

Zoely—the pill made from an innovative combination of hormones is here.1,2 Zoely® 2.5 milligram nomegestrol acetate and 1.5 milligram estradiol film coated tablets.

Abbreviated Prescribing Information (Refer to Summary of Product Characteristics before prescribing) PRESENTATION: One blister containing 1 strip of 28 tablets (24 white film-coated tablets, each tablet containing 2.5 milligram nomegestrol acetate and 1.5 milligram estradiol (as hemihydrate) and 4 yellow placebo film-coated tablets). Three blisters per pack. USES: Contraception. DOSAGE: One tablet daily at about the same time. There is no pill-free week between strips. CONTRAINDICATIONS: Known or suspected pregnancy, presence or history of venous thrombosis (deep venous thrombosis, pulmonary embolism), arterial thrombosis (e.g. myocardial infarction) or prodromal conditions, severe hepatic disease with current abnormal liver function tests, liver tumor, cerebrovascular accident, pancreatitis associated with severe hypertriglyceridaemia, known or suspected sex-steroid sensitive malignancies, undiagnosed vaginal bleeding, history of migraine with focal neurological symptoms, hypersensitivity to any ingredients. PRECAUTIONS AND WARNINGS: All data below are based upon epidemiological data obtained with COCs containing ethinylestradiol. Zoely contains 17β estradiol.

As no epidemiological data are yet available with estradiol containing COCs, the warnings are considered applicable to the use of Zoely. The use of any COC (including Zoely) carries an increased risk of venous thromboembolism (VTE) compared with no use. The excess risk of VTE is highest during the first year a woman ever uses a combined oral contraceptive. Epidemiological studies have also associated the use of COCs with an increased risk of thromboembolism.

Extremely rarely, thrombosis has been reported to occur in other blood vessels, e.g. hepatic, mesenteric, renal, cerebral or retinal veins and arteries, in COC users. There is no consensus as to whether the occurrence of these events is associated with the use of COCs. Discontinue in the event of a thrombosis. The risk of venous thromboembolic events in COC users increases with age, positive family history and obesity. Also prolonged immobilisation, major surgery, any surgery to the legs, or major trauma where discontinuation is advisable. There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset of venous thrombosis. The risk of arterial thromboembolic complications or of a cerebrovascular accident in COC users increases with increasing age, smoking, dyslipoproteinemia, obesity, hypertension, migraine, valvular heart disease, atrial fibrillation, a positive family history. Other medical conditions, which have been associated with adverse circulatory events, include diabetes mellitus, systemic lupus erythematosus, hemolytic uraemic syndrome, chronic inflammatory bowel disease and sickle cell disease. Consider stopping if there is an increase in frequency or severity of migraine.

An increased risk of cervical cancer in long-term users of COCs has been reported however, the risk in users of Zoely is not available. Epidemiological studies reported that there is a slightly increased risk of having breast cancer diagnosed.

Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs. If a sustained clinically significant hypertension develops suspend use. The following conditions have been reported to occur or deteriorate with both pregnancy and COC use, but the evidence of an association with COC use is inconclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea; herpes gestationis; otosclerosis-related hearing loss.

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

Worsening of depression, Crohn’s disease and ulcerative colitis have been associated with COC use. Chloasma may occasionally occur. Monitor patients with diabetes. Zoely contains less than 65mg lactose, and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. USE IN PREGNANCY AND LACTATION: Not recommended during pregnancy. Not recommended during breastfeeding. INTERACTIONS: Interactions may lead to breakthrough bleeding and contraceptive failure. This may be seen with enzyme inducers such as phenytoin and phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, nevirapine, efavirenz riseofulvin and products containing St John’s Wort. Reduced absorption of etonogestrel may be seen with medical charcoal. Hormonal contraceptives may interfere with metabolism of other drugs, and therefore increase or decrease their plasma or tissue concentrations. UNDESIRED EFFECTS: Refer to SmPC for full details. Very Common: acne and abnormal withdrawal bleeding. Common: headache, migraine, weight gain, nausea, decreased libido, depression, depressed mood, mood altered, metrorrhagia, menorrhagia, breast pain, pelvic pain. Breast discharge may also occur. OVERDOSE: No serious effects have been reported. Symptoms may include nausea, vomiting and in young girls, slight vaginal bleeding. Treatment should be symptomatic. LEGAL CATEGORY: Prescription Only Medicine. MARKETING AUTHORISATION NUMBER: EU/1/11/690/002 MARKETING AUTHORISATION HOLDER: Theramex S.r.l., Via Messina 38, 20154 Milano, Italy Please refer to the full SmPC text before prescribing this product. Adverse events should be reported. Reporting forms and information can be found at www. imb.ie Adverse events with this product should also be reported to MSD Drug Safety Department on +44 (0) 1707 363773. Date of review: January 2012. Copyright © 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved.

References: 1. Dhont M. History of oral contraception. Eur J Contracept Reprod Health Care. 2010;15(S2):S12-S18. 2. Mansour D et al. The Eur J Contracept Reprod Health Care. 2011;16;6:430-443.

Further information is available on www.medicines.ie or on request from MSD, Pelham House, South County Business Park, Leopardstown, Dublin 18.

Date of preparation: January 2012

Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland

01-14-WOMN-1022638-0000

66% Relative Risk Reduction in AUR or BPH related surgery Vs tamsulosin at 4 years1,2

13/03/2013 17:46:31

The

Clinical Care Journal The latest developments in Irish healthcare // March 2013

The Clinical Care Journal // The latest developments in Irish healthcare

NEW PATHWAYS OF CARE

INTEGRATING ASSESSMENT, IMPROVEMENT & QUALITY

OPHTHALMOLOGY

EPILEPSY

PAEDIATRICS

REDUCING CASES OF PREVENTABLE BLINDNESS

SIGNIFICANT REDUCTION IN WAITING LISTS

THE LIFE BLOOD OF THE NATION

PLUS: ACS // DERMATOLOGY //RHEUMATOLOGY// STROKE

Clinical Care Cover 2013_final.indd 1

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