Clinical Care 2014

The

Clinical Care Journal

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The latest developments in Irish healthcare // February 2014

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

BUILDING A BETTER HEALTH SERVICE

IMPROVING QUALITY, ACCESS AND COST EFFICTIVENESS OF SERVICES CARDIOLOGY // EPILEPSY // RHEUMATOLOGY

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Contents

Contents 5: Effectiveness of Service: Dr Aine Carroll, the HSE’s National Director of Clinical Strategy & Programmes explains the restructuring and realignment of clinical programmes.

9:

Geriatrics: Dr. Diarmuid O’Shea, outlines the challenges facing the National Clinical Programme for Older People – and its achievements.

13: Ophthalmology Virtual departments of ophthalmology are among a range of new initiatives under the National Clinical Programme for Ophthalmology, as Mr. Paul Moriarty tells Maureen Browne.

17: Audiology: The universal newborn screening programme is in the final stage of implementation according to Ms. Aisling Heffernan, Programme Manager, HSE National Clinical Programme for Audiology.

20: Respiratory COPD: COPD Outreach Centres have been established to improve care and reduce hospital admissions, according to Prof. Tim McDonnell, Clinical Lead and Consultant Respiratory Physician.

25: Radiology: 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. Maureen Browne reports.

27: CARDIOLOGY: Over 80 per cent of STEMI patients are now being treated in PPCI centres and the thrombolysis rate has dropped to 10 per cent, Prof. Kieran Daly tells Maureen Browne.

31: Epilepsy: Dr. Colin Doherty, National Clinical Lead of the Clinical Programme on Epilepsy, outlines the progress in delivering a new model of care for patients with chronic epilepsy.

35: Renal Programme: Kidney transplants, home haemodialysis and home peritoneal dialysis are being accessed by increased numbers of patients according to Dr. Liam Plant.

39: Paediatrics: Prof. Alf Nicholson explains the major developments within the HSE National Clinical Programme for Paediatrics and Neonatology.

47: obstetrics: Ireland has the lowest number of obstetricians per 1,000 females in the OECD and needs four new maternity hospitals, writes Maureen Browne.

50: Diabetes: A retinopathy programme for the early identification of eye disease in patients with diabetes will be rolled out soon, according to Dr. Ronan Canavan.

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Contents

57: Rheumatology: Seven new consultant rheumatologists have been appointed under the HSE National Clinical Programme for Rheumatology, according to Prof.

Oliver Fitzgerald.

61: MENTAL HEALTH: With new staff and new capacity, community mental health teams will contribute to community care, according to Dr. Ian Daly, National Clinical Lead and Executive Director, HSE Dublin South City and South West.

65: Asthma: The new model of care should result in 10 per cent fewer hospital admissions and a 90 per cent reduction in asthma deaths, according to Prof. Pat Manning, Clinical Lead of the National Clinical Programme for Asthma.

69: stroke: New consultant neurologists, nurses, therapists and psychologists have been appointed and eight new stroke units have been opened, says Prof. Peter Kelly, Joint Clinical Lead of the National Stroke Programme 73: HEART FAILURE: New heart failure units are showing outcomes as good as any of those seen internationally, according to Prof. Ken McDonald, HSE National Clinical Lead for Heart Failure.

77: Anaesthesia: Dr Bairbre Golden, Director of the HSE National Clinical programme in Anaesthesia explains the programme's approach.

82: DERMATOLOGY: Waiting lists for outpatient dermatology are down by 47 per cent, reports Maureen Browne.

83: Primary Care: The HSE National Clinical Care Programmes depend on the primary care services. Maureen Browne reports.

88: clinical leads: The clinicians leading up the HSE Clinical Programmes.

Clinical Care Journal The

Managing Editor: Maureen Browne Staff Editor: Mary Connaughton Editorial Assistant: Valerie Jordan Design & Layout: Leon Hayden Advert Design: Jennifer Reid Illustrations & Photography: iStock Photo, Thinstock Photo Production Manager: Mary Connaughton Production Assistant: Jennifer Reid Sales Director: Paul Clemenson

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 Š2014. 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

Improving quality, access and cost

effectiveness of services Dr. Aine Carroll, HSE National Director of Clinical Strategy & Programmes explains to Maureen Browne how the Clinical Programmes are being re-structured and re-aligned and examines some of their achievements.

D

r. Aine Carroll, HSE National Director of Clinical Strategy & Programmes, said that the original aim of the HSE National Clinical Programmes was to improve the quality, access and cost effectiveness of services.

“When you look at high level quality improvement initiatives throughout the world you see a synergy with what we are doing. For example, the triple aim of The Institute of Medicine is often quoted – to improve the patient experience of care, to improve the overall health of the population and to reduce costs of care. The aims of the HSE Clinical Programme and the aims of The Institute are well aligned, but I think we have gone a step further. The Programmes are designing services that provide timely, efficient, effective and equitable care and value for money. But more importantly for the patients, they are patient centred.

“The aims of the Programmes are about quality, access and value. When I took up this post a year ago we knew we had to restructure the Programmes. There were

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33 Programmes and supporting initiatives and whilst excellent work had been done in terms of individual programmes, there was now a need to restructure to facilitate integration and alignment.

“Then new structures were introduced in the HSE, which meant that the Programmes also needed to be aligned with these new Divisions. Now our restructuring affords us the opportunity to both re-align with the HSE structures and integrate right across the new Divisions and to ensure that improving patient experience and clinical leadership are at the heart of what we are providing in the health services.

“We are working with our main stakeholders to decide what the integrated Programmes will look like. It is very important to work with the new National Directors about how they see the Programmes. Translating clinical strategy into frontline services is extremely challenging and I think this restructuring affords us a really strong mechanism to

I think the HSE and the professional organisations have been very courageous and committed to maintain their focus on improved services in what are challenging times.”

ensure that what we are designing gets turned into improved patient experience at the frontline.

“I am the Project sponsor of this work and I hope that it will be completed by the second quarter of 2014.

“I have been liaising with a number of different countries and I am aware that all healthcare organisations are struggling with the increased complexity and costs of healthcare. We have been able to prioritise three main areas - patient flow, chronic disease prevention and management and aging demographics - which are likely to provide the most in terms of improved patient experience and improved value for money. This will enable us to plan for healthy ageing and will allow us to assist those who are living with the consequences of chronic disease.

The new divisions will afford us a really good structure to develop an integrated approach to management of these three areas. These three areas are also in keeping with the priorities of other countries from a European and indeed world perspective.

“The National Clinical Programmes are going to be a key driver for real meaningful change for patients. Very often reform refers to restructuring , but in the Programmes reform we are talking

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FEATURE Interview

about real meaningful reform for patients and hopefully, if we plan correctly, people won’t end up as patients at all – they will remain well and have access to appropriate services as they require them.

“I think in many areas we are well ahead of other countries. The programmes are a partnership between the HSE and the Forum of Postgraduate Training Bodies.

They are also a partnership between the Allied Health Professionals and the HSE (with the Irish Association of the Directors of Nursing and Midwifery and the Therapy Professions Committee).

Most importantly, they are a partnership with patients. We have placed patients at the centre of what we are trying to achieve and we have appropriate and meaningful patient input at all levels. The partnerships we have with key stakeholders are incredibly powerful and will deliver meaningful change for patients.

“I think the HSE and the professional organisations have been very courageous and committed to maintain their focus on improved services in what are challenging times. It is very gratifying to see those commitments sustained and it is gratifying that we have support at the highest level –from the Minister for Health, Dr. Reilly, Minister White and Minister Lynch, the HSE Director General, Mr. Tony O’Brien and the Secretary General of the Department of Health, Dr. Ambrose McLoughlin. We have political and health service support along with the support of clients and staff. With this level of engagement I feel we will see positive changes in how we provide services."

Dr. Carroll said The HSE National Clinical Programmes were already nationalising existing best practice, engaging patients, aligning stakeholders, implementing new services, reducing the length of hospital stay, cutting waiting lists and saving considerable money.

There had, she said, been a revolution in healthcare from 1970 when there was an emphasis on doing things cheaper, to 1980 when it moved to doing things right, to 1990 when the focus was on doing the right things right (evidence based medicine) to 2010 when we had the National Clinical Programmes.

Dr. Carroll said that there were a number of significant achievements of the Programmes to date.

PICTURED: Dr Aine Carroll

The National Clinical Programme for Acute Medicine had introduced the National Early Warning Score (NEWS) which received a public service excellence award from the Taoiseach, the total length of stay had been reduced by 21 per cent between 2005 and 2012 with the introduction of Acute Medical Assessment Units in every acute hospital and overnight length of stay had been reduced by eight per cent between 2005 and 2012.

The National Clinical Programme for Epilepsy had received an international nursing award for its description of the new national epilepsy service of Ireland.

In the National Clinical Programme for Rheumatology/MSK, physiotherapy led musculo-skeletal clinics were reducing waiting lists by up to 70 per cent and 10,000 new patients had been triaged and treated from orthopaedic and rheumatology waiting lists in one year.

The National Clinical Programme for COPD had developed a COPD outreach model of care and pulmonary rehabilitation model of care, bundles of care and patient information materials, the average length of stay had been reduced from 9.1 days in 2009 to 7.6 in December 2012. Pulmonary rehabilitation was available in 37 sites, in 2012 access to pulmonary rehabilitation in 56 per cent of the sites had exceeded the target set and further work was ongoing to target areas without access.

The National Clinical Programme for Medicines Management had identified an additional two drugs as part of the “Preferred Drugs Initiative,” and the programme was aiming to secure €20 million in savings this year.

Work by the National Clinical Programme for Stroke meant that 27 out of 28 hospitals admitting patients with stroke requiring acute care now had a stroke unit, an increase form 18 in July 2010. Thrombolysis was available in all Model 3 and Model 4 hospitals, either directly or via ambulance access protocols.

Thrombolysis rates had increased from

2.4 per cent in 2007 to 9.5 per cent in 2013 exceeding targets and leaving Ireland with one of the highest rates in the world. (UK is five per cent, Sweden 6.6 per cent and USA 2.4 per cent) There was a 2.5 per cent increase in patients discharged to home in 2011 a two per cent decrease in case fatality in 2011 and 2012 and a 2.9 per cent increase in stroke nursing home admission.

The National Clinical Programme for Diabetes had commenced the national diabetes retinopathy screening and aimed to screen 30 per cent of the diabetic population this year. A national model of care to deliver CS11 therapy to children with Type 1 diabetes under five years had been developed and implemented.

The Retrieval & Transport Medicine Programme had extended neonatal retrieval to 24/7 nationally in 2013.

Paediatric retrieval was due to begin a five day daytime service in 2013 and the implementation of a national model for adult retrieval designed to support hospital groups was planned for early this year in Dublin, Cork and Galway, providing a seven day daytime service.

The National Clinical Programme for Audiology had introduced national screening of 99 per cent of children within four weeks of birth and the national Clinical Programme for Acute Coronary Syndrome had four 24/7 PCI centres operational.

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Geriatrics FEATURE

Shift Focus from Life Expectancy to

Healthy Life Expectancy The challenge facing the National Clinical Programme for Older People now is twofold, to implement the acute model of care for older people in our localities and to get working on a similar model for older people in the community, says Dr Diarmuid O’Shea, National Clinical Lead for the Programme for Older People and Consultant Physician in Geriatric Medicine at St. Vincent’s University Hospital, Dublin.

He looked at the achievements and challenges facing the Programme in an interview with Maureen Browne.

T

he National Clinical Programme for Older People (NCPOP) is one of over 30 clinical programmes that are being run jointly by the HSE and the RCPI. The rationale behind the National Clinical Programme for Older People (NCPOP) is partly based around our current and projected changing ageing demographic. It primarily aims to support the older person’s right to access the most appropriate care in the right place in a timely fashion.

Changing Demographics This increase in population of those over the age of 65, the increase in prevalence of chronic illness, the increased focus on integrated care and the evidence that specialist geriatric care improves outcomes mandates that we have a system of care in place for both the acute hospital sector and the community that will support the care of all of us as we age. As this cohort of us will live longer, the numbers of those

over 85 will also increase and, are likely to require higher intensity levels of care.

Comprehensive Geriatric Assessment A recent Cochrane review shows that Comprehensive Geriatric Assessment (CGA), which is a co-ordinated multidisciplinary assessment that identifies medical, physical, social and psychological problems, followed by the formation of a plan of care including appropriate rehabilitation, improves outcome for those older people admitted to hospital. This is the case only if they

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In Ireland, and indeed around the world, there is an acknowledged need to improve the flow and process of people through the acute hospital sector.”

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FEATURE Geriatrics

added years healthy ones. We should change the focus from life expectancy to healthy life expectancy. So we all individually have a personal responsibility to personal health promotion and disease prevention – exercise, healthy eating, social connectivity and mental health well being. There is, however, a collective responsibility to health care provision. This societal and governmental responsibility is pivotal, and the NCPOP is one part of this response.

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The Planning Imperative In the 2011 census the total population was 4.6 million, with 535,400 over the age of 65 years. This is a 14.4% increase since 2006. The total number of those over 65 years is projected to increase to 885,600 in 2026, reaching 1.3 million by 2041.

This will be coupled with a fall in the ratio of “working age” relative to retired people from 5.7 in 2011 to 2.6 in 2041, culminating in significant challenges and opportunities in ensuring not just health care provision, but pension provision, provision of community services and long-term care services.

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In 2026, even to keep the number in long-term care in the region of 4%, we will require an increase to in the region of 35,000 nursing home beds.”

are admitted to a specialist ward, with a specialist geriatrician led multidiciplinary team, and have a CGA. Care in the Community In Ireland, and indeed around the world, there is an acknowledged need to improve the flow and process of people through the acute hospital sector. There is also a need to support people in the community more compassionately and efficiently.

Increasing emphasis on supporting people in the community, reducing delays in discharge of people from the acute hospital to either home with community supports or to long-term care, whichever is the wish of the person, requires a number of approaches. Firstly, it will need attention to the assessment process. It will also require financing of the provision of this care and a rethink and revision of the legal processes underlying the mechanisms of accessing these supports.

Can the processes be made simpler, and can they happen in the community and the nursing home, as well as in the acute hospital sector?

The NCPOP is looking to improve integration and communication between hospital and community services, advocate for better secondary and community care services, better transitions across services for people and better flow through the acute hospital.

Health Promotion and Disease Prevention In 1945 life expectancy was around 60 years. There was a small disparity in male and female life expectancy between the 1930s and 1950s. This gender gap was 5.7 years in 1980 and in 2005 was down to 4.8 years. While we know that today a man can expect to live in Ireland until the age of 77, and a woman until nearly 81 years, the real challenge is to make these

The pensions of today’s pensioners are paid out by the revenue that is paid by today’s workers. As long as the ratio of workers to pensioners remains somewhat stable the system is sustainable. However if the ratio of pensioners to workers increases existing levels of payments and retirement ages can only be maintained if current workers make higher contributions.

While the national figures are helpful, there is variation in the ageing demographics around the country with regards to the pattern of ageing. So while nationally there was a 22% increase in those between 65 – 69 years, and a 22% increase in those over the age of 85 years between 2006 and 2011, this was different in parts of Dublin, Kerry, Cork, Tipperary, Galway and Donegal.

Thus a good understanding of your local area demographics is a key factor in this planning imperative.

As 95% of people live in the community, the length of time the total number of people requiring home help or home care packages will likely increase in time. The

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Geriatrics FEATURE

total number of people in long-term care is approximately 22,400. In 2026, even to keep the number in long-term care in the region of 4%, we will require an increase to in the region of 35,000 nursing home beds.

Any service developments, which can help older people, increase their healthy life expectancy and reduce their dependency on home services or nursing home care, will be beneficial. This is where the acute model of care for older people admitted to hospital will help – a specialist geriatric service.

What is a Specialist Geriatric Service?

Older people admitted to hospital, if they are admitted to a specialist service, are more likely to get out of hospital, more likely to get out quickly, more likely to go home, less likely to go into a nursing home and less likely to functionally decline when in hospital.

A Specialist Geriatric Service (SGS) consists of a Specialist Geriatric Team (SGT), dedicated Specialist Geriatric Wards (SGWs), a rehabilitation service and team, ambulatory day care service, outreach to long-term care, timely access to home supports and long term care.

The NCPOP conducted a survey in 2011 of the 36 or so acute hospitals providing acute care and found that only 30% had a dedicated ward, while only 40% had a day hospital. In fact 24% of the acute hospitals had none of the elements that would define a specialist geriatric service.

SGS Model of Care Minister Lynch launched the Model of Care for Specialist Geriatric Services in the acute setting in December 2012 in the RCPI with the HSE. We are up and running in what are undoubtedly challenging times. We work closely with all the clinical care programmes, especially the Acute Medicine Programme, which appointed a large group of consultants including some dually accredited general and geriatric physicians who are leading the change in delivery of care provision for acutely ill older adults in hospital.

This needs now to be complemented by the development of acute hospital based services for older people that will meet their needs, specialist wards, with

geriatrician led specialist teams, with access to community services and timely access to rehabilitation and long-term care.

The development of a similar model for older people in the community led by general practitioners will be the next challenging step.

None of these services or clinical programmes can function without adequate funding and provision of home care services, expansion of rehabilitation beds on and off the acute hospital site and further investment in the provision of long-term care.

All of these together will result in the older person being more likely to get out of hospital quickly if admitted, they will be less likely to functionally decline, they will be more likely to get home and less likely to go into a nursing home.

The Challenge Among the many recommendations in The Francis Reports of 2010 and 2013 in the United Kingdom, the clear statement that care of older patients should be a marker of good care and a focus for quality improvement initiatives, was very welcome indeed. We should, for many reasons, adopt this finding alone as the main goal for all of the clinical programmes as this will ensure high quality care for all.

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If they are admitted to a specialist service, they are more likely to get out of hospital, more likely to get out quickly, more likely to go home, less likely to go into a nursing home.� commitments, to mention but a few.

Our ethos must be to improve how we work together in our local areas. We can do this by recognizing that care of the older person is the ultimate marker of quality care, and by ensuring that we have specialist geriatric services in all acute hospitals. We should demonstrate that it can be done even in these challenging times, so that as the economic tide turns in our favor further benefits can be accrued.

Our challenge now is twofold to implement the acute model of care for older people in our localities and to get working on a similar model for older people in the community.

All medical and allied health professional groups should ensure that ongoing education and training in matters relating to care of older people are to the forefront of their continuing professional development programmes.

Workforce planning for the future needs to recognize and plan for meeting the needs that the changing ageing demographic will bring to the face of hospital care. This type of workforce planning should occur in all healthcare professions. One concrete example is that we currently have 85 appointed consultant geriatricians this will need to increase to at least 140 by 2021 if we are maintain current services, and that does not take it account the evolution and progression of service provision in terms of acute medicine, outreach, stoke and subspecialty

PICTURED: Dr Diarmuid O’Shea

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Renewed Hope A breakthrough oral medication for patients with metastatic castration-resistant prostate cancer

ZYTIGA® ▼ 250 mg Tablets PRESCRIBING INFORMATION ACTIVE INGREDIENT(S): Abiraterone acetate. Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATION(S): Taken with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. The treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

DOSAGE & ADMINISTRATION: Adults: 1000 mg (4 tablets) single daily dose. Not with food as this increases the systemic exposure (take dose at least two hours after eating; no food for at least one hour post-dose).

Swallow whole with water. Take with recommended dose of prednisone or prednisolone of 10 mg daily. Medical castration with LHRH analogue should be continued during treatment in patients not surgically castrated. Children: No relevant use. Hypokalaemia: In patients with pre-existing, or who develop hypokalaemia during treatment with Zytiga, consider maintaining potassium level at ≥4.0 mM. Patients who develop Grade ≥ 3 toxicities (hypertension, hypokalaemia, oedema and other non-mineralocorticoid toxicities) stop treatment and start appropriate medical management. Do not restart Zytiga until symptoms of the toxicity have resolved to Grade 1 or baseline. Renal impairment: No dose adjustment, however no experience in patients with prostate cancer and severe renal impairment; caution advised.

Hepatotoxicity: If hepatotoxicity develops (ALT or AST >5x upper limit of normal - ULN), stop treatment immediately until liver function returns to baseline; restart Zytiga at 500 mg (2 tablets) once daily and monitor serum transaminases at least every 2 weeks for 3 months and monthly thereafter (see Special warnings & precautions). If hepatotoxicity recurs on reduced dose, stop treatment. If severe hepatotoxicity develops (ALT or AST 20xULN), discontinue Zytiga and do not restart. Hepatic impairment: Mild (ChildPugh class A) - no dose adjustment required. Moderate (Child-Pugh class B) - approximately 4x increased systemic exposure after single oral doses of 1,000 mg. Moderate/Severe (Child-Pugh class B or C) – no clinical data for multiple doses. Use with caution in moderate impairment, benefit should clearly outweigh risk. CONTRAINDICATIONS: Pregnancy or potential to be pregnant. Hypersensitivity to active substance or any excipients.

Severe hepatic impairment (Child-Pugh Class C). SPECIAL WARNINGS & PRECAUTIONS: Zytiga may cause hypertension, hypokalaemia and fluid retention due to increased mineralocorticoid levels. Cardiovascular: Caution in patients with history of cardiovascular disease. In patients with a significant risk for congestive heart failure (history of cardiac failure, uncontrolled hypertension, ischaemic heart disease) consider an assessment of cardiac function before treating (echocardiogram). Safety not established in patients with left ventricular ejection fraction < 50% or NYHA Class II to IV (pre-chemotherapy) and III or IV (post-chemotherapy) heart failure. Before treatment cardiac failure should be treated and cardiac function optimised. Correct and control Hypertension, hypokalaemia and fluid retention pre-treatment. Caution in patients whose medical conditions

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might be compromised by hypertension, hypokalaemia or fluid retention e.g. heart failure, severe or unstable angina pectoris, recent myocardial infarction or ventricular arrhythmia, severe renal impairment. Monitor blood pressure, serum potassium and fluid retention and other signs and symptoms of congestive heart failure before treatment, then every two weeks for 3 months, and monthly thereafter. Consider discontinuation if there is a clinically significant decrease in cardiac function. Hepatotoxicity & Hepatic impairment: Measure serum transaminases pre-treatment and every two weeks for first three months, then monthly. If symptoms/signs suggest hepatotoxicity, immediately measure serum transaminases. If ALT or AST > 5x ULN, stop treatment and monitor liver function. Restart treatment after liver function returns to baseline; use reduced dose (see dosage and administration). No clinical data in patients with active or symptomatic viral hepatitis. Corticosteroid withdrawal: Monitor for adrenocortical insufficiency if prednisone or prednisolone is withdrawn. Monitor for mineralocorticoid excess if Zytiga continued after corticosteroids withdrawn. Bone density: Decreased bone density may be accentuated by Zytiga plus glucocorticoid.

Prior use of ketoconazole: Lower response rates may occur in patients previously treated with ketoconazole for prostate cancer. Hyperglycaemia: Use of glucocorticoids could increase hyperglycaemia, measure blood sugar frequently in patients with diabetes. Use with chemotherapy: Safety and efficacy of concomitant use of Zytiga with cytotoxic chemotherapy not established. Intolerance to excipients: Not to be taken by patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Take sodium content into account for those on controlled sodium diet. Potential risks: Anaemia and sexual dysfunction may occur in men with metastatic castration resistant prostate cancer including those taking Zytiga. Skeletal Muscle Effects: Cases of myopathy reported. Some patients had rhabdomyolysis with renal failure. Caution is recommended in patients concomitantly treated with drugs known to be associated with myopathy/rhabdomyolysis. SIDE EFFECTS: Very common: urinary tract infection, hypokalaemia, hypertension, diarrhoea, peripheral oedema.

Common: hypertriglyceridaemia, cardiac failure (including congestive heart failure, left ventricular dysfunction and decreased ejection fraction), angina pectoris, arrhythmia, atrial fibrillation, tachycardia, dyspepsia, increased alanine aminotransferase, increased aspartate aminotransferase, rash, haematuria, fractures (includes all fractures with the exception of pathological fracture). Other side effects: adrenal insufficiency, myopathy, rhabdomyolysis. Refer to SmPC for other side effects. FERTILITY/ PREGNANCY/ LACTATION: Not for use in women. Not known whether abiraterone or its metabolites are present in semen. A condom is required if the patient is engaged in sexual activity with a pregnant woman. If the patient is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method.

Studies have shown that abiraterone affected fertility in male and female rats, but these effects were fully reversible. INTERACTIONS: Caution with drugs activated by or metabolised by CYP2D6 particularly when there is a narrow therapeutic index e.g. metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecanide, codeine,

oxycodone and tramadol. Avoid strong inducers of CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John’s wort). Zytiga is a CYP2C8 inhibitor (in vitro data). Examples of medicinal products metabolised by CYP2C8 incl paclitaxel, repaglinide. No clinical data are available on the use of Zytiga with CYP2C8 substrates. Food (see Dosage & Administration). LEGAL CATEGORY: POM PRESENTATIONS, PACK SIZES, PRODUCT LICENCE NUMBERS: One bottle containing 120 tablets.

EU/1/11/714/001. MARKETING AUTHORISATION HOLDER: JANSSENCILAG INTERNATIONAL NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK. © Janssen-Cilag Ltd 2013. Prescribing information last revised: 21 August 2013. PIVER21082013.

Item number: PHIR/ZYT/0813/0003. Date of preparation: August 2013.

This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse reactions related to this medicinal product. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’, in addition to the traditional post-paid ‘yellow card’ option.

FREEPOST Pharmacovigilance Section Irish Medicines Board Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.imb.ie e-mail: imbpharmacovigilance@imb.ie Adverse events should also be reported to Janssen-Cilag Ltd on +44 1494 567447.

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Ophthalmology

FEATURE

A network of virtual departments of ophthalmology.

The HSE National Clinical Programme for Ophthalmology wants to see new multidisciplinary screening and treatment models for children and virtual departments of ophthalmology surrounding each surgical hospital in the country. Maureen Browne reports.

T

he HSE National Clinical Programme for Ophthalmology wants to see new multidisciplinary screening and treatment models for children, virtual departments of ophthalmology surrounding each surgical hospital in the country and dedicated treatment centres for cataracts, according to Mr. Paul Moriarty, Clinical Lead of the National Clinical Programme and Consultant Ophthalmic Surgeon, specialising in oculo platics at the Eye & Ear Hospital, Dublin.

He said the country’s ophthalmic services are facing the twin challenges of a vastly increased demand for services and funding new and expensive treatments.

The philosophy behind the National Clinical Programme is to try and get as much as possible of chronic eye disease out of a hospital setting and into the community.

“At present ophthalmic services are heavily

delivered in hospitals and we would prefer to see it more community based. To have all these services delivered in hospital is an inappropriate use of manpower and means that surgeons do not have time to carry out surgery.

by nurses under the community scheme.

Those identified as requiring further assessment and/or intervention are then seen either in hospital or by Community Ophthalmic Physicians, who often work in isolation in single person clinics.

“We engaged with Prof. Charles Normand, Edward Kennedy Chair in Health Policy and Management in TCD to look at the big picture in ophthalmology – the numbers requiring service, how we could improve the delivery of certain elements of the service and children’s screening.

“If you look at an area like South Dublin and Kildare, the birth rate has increased hugely over the last five years and unfortunately the system has reached saturation, with a lot of children waiting to be treated following school screening,” said Mr. Moriarty.

“We have identified five main areas which we are prioritising – children’s screening and treatment, eye problems in diabetic patients, AMD, glaucoma and cataracts.”

Children are generally screened and evaluated in the school setting around the age of four and a half to five and a half. Screening is generally carried out

“To try and get around this, we are seeking to introduce a pilot study for that area which would use a combination of orthoptist and optometrist to screen the children, because at present there is a certain level of false positives coming though the system. This would also help with the after care of those children who then require treatment. Rather than doctors doing all the supervision, we

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FEATURE Ophthalmology

believe a combined multidisciplinary team of orthoptist; optometrist and community eye doctors would be best practice. We also think having a larger inclusion of other healthcare professions could make the system work more effectively.

“Our analysis has revealed that this initiative would require additional resources in terms of personnel and funding. We are currently exploring various options on how to deliver this in a way that provides value both to the patient and the system.

“Some hospitals have stopped taking direct referrals for these children because they cannot treat them within the appropriate timeframe. Children with refractive problems, where they are long sighted or one eye develops differently need to be treated before the age of six or six and a half. Our aim is to identify these children by age four or four and a half years as this will give us a critical window of time within which to effectively treat and manage these children.”

Another major group being targeted by the Programme are diabetics and this can be seen as one of the success stories of the National Clinical Programmes. Universal diabetic retinopathy is being rolled out over the next three years and this will be followed by an annual screening. Those who fail will be referred to hospital clinics and a certain amount of money has been ring fenced for this initiative.

The Programme is also looking at patients with Age Related Macular Degeneration, cataracts and glaucoma.

“AMD was always there but as the population ages its prevalence is increasing. Over the last five years because of the advance of Anti VEGF Treatments becoming available the number of cases seen nationally has increased from about 500 a year to 7,500 a year. However, there has been no increase in our budget to finance the increasing numbers seeking treatment. The cost of drugs for treatment

}

are quite substantial.

“The treatment of macular oedema in diabetic patients may squeeze our budget further; the number of patients in this category has mushroomed overnight and their treatment involves not just drug costs, because while they have to have treatment every six weeks, they have to be reassessed every three months with a large battery of testing which takes time and manpower.

“At present, all regional centres do their own programmes, but I think that in future it would be better to keep more of these treatments in the community. We would use more of the outlying hospital centres and I would see community eye doctors working not in isolation but in groups to deliver the treatment arm to diabetics, AMD and pre and post-op cataract evaluation. This will involve restructuring organisations where people work and will require leadership – but it is the right way to go for patients.

“The other big group is glaucoma and a small number of patients with glaucoma need specialist care but the vast majority need watchful waiting and monitoring with a simple drop treatment.

“We have been looking at shared care models with our optometry colleagues and consultants in hospital might end up doing virtual clinics where data is downloaded from other areas and they can give advice on the future patient care. For example, Dublin South and Kildare might have the RVEEH as a centre with satellite community centres where doctors work in groups with good equipment and links back to the hospital for advice. This model works well in Sligo and Letterkenny where they have a good computer system between the two centres. Transport links are not great and they do a significant amount of remote referrals.

“Because of the age demographics the number of patients requiring cataract surgery is growing all the time and we

In the medium term we need to set up one or two specialised cataract surgical centres, which would be dedicated only to cataracts.”

have virtually reached saturation with the existing surgical facilities. I know that the Mater Hospital has put 400 cataracts out to tender to get their waiting lists under control. In the medium term we need to set up one or two specialised cataract surgical centres, which would be dedicated only to cataracts and not involved in teaching or other peripheral work. A centre like that could get through 80 – 100 cases a week.

“The demographics of care are against us – with our high birth rate, increasing cohort of older people, high tech treatments and new drugs.

“Virtually all cataract patients are now treated as day patients so there has been huge savings in bed costs but most of this have been instantly absorbed by the cost of treatment for AMD. We need to be mindful of the fact that by treating cataracts in a timely fashion we keep people out of nursing homes, maintain their quality of life and independence which ultimately results in large savings to the state.

“In order to make progress we have to build up community links, we need vastly improved patient records and links between different centres so we end up with a virtual department of ophthalmology surrounding each surgical hospital. We also need to put in dedicated cataract surgical centres to cope with the numbers and we need to roll out shared care programmes between optometry and medical staff for the care of glaucoma and probably shared care for cataracts, on the lines of what is happening in Sligo and the North West. There is an excellent programme there where optometrists can refer patients into Mr. Paul Mullaney and using his data sets they take part of aftercare with the hospital. We are all for using the health care professions who are most appropriate and trying to keep patients in the community.

“With limited resources and growing numbers we have reached crisis point, but I am optimistic about the future – through the clinical programme we will be making a case to the HSE for the future direction of eye care in the best interests of patients.”

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In DMARD-IR AnD TnF-IR RA PATIenTs, WHEN COMBINATION WITH MTX IS NOT AN OPTION...

THINK ROACTEMRA1

RoActemRA, in combination with methotrexate (mtX), is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DmARDs) or tumour necrosis factor (tNF) antagonists. In these patients, RoActemRA can be given as monotherapy in case of intolerance to mtX or where continued treatment with mtX is inappropriate. RoActemRA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.2 ABRIDGED PRESCRIBING INFORMATION. (For full prescribing information, refer to the Summary of Product Characteristics [SmPC]). RoActemra® (Tocilizumab) 20mg/ml Concentrate for Solution for Infusion.

Indications: (i) In combination with methotrexate (MTX), for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more DMARDs or TNF antagonists. In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. (ii) As monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX, for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients ≥ 2 years of age, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Dosage and Administration: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA or sJIA and all patients should be given the Patient Alert Card. RA Patients: Recommended posology is 8mg/kg diluted to a final volume of 100ml, given once every 4 weeks by iv infusion over 1 hour. For patients weighing > 100kg, doses > 800mg per infusion are not recommended. No data on doses above 1.2g. Dose adjustments: Dose modification, interruption or in some cases discontinuation of RoActemra recommended in the event of raised liver enzymes, low absolute neutrophil count (ANC) or low platelet count (see SmPC for details). In patients not previously treated with RoActemra, initiation not recommended in patients with an ANC below 2 x 109/l. Closely monitor renal function in patients with moderate to severe renal impairment as RoActemra has not been studied in these patients. No data in patients with hepatic impairment. sJIA Patients: No data in patients < 2 years of age.

Posology: 8mg/kg diluted to a final volume of 100ml for patients ≥ 30kg or 12mg/kg diluted to a final volume of 50ml for patients < 30kg once every 2 weeks by iv infusion over 1 hour. Check patient’s weight at each visit – refer to SmPC. In the event of raised liver enzymes, low ANC or low platelet count, interrupt/discontinue RoActemra dose or modify/stop concomitant MTX and other medications where appropriate - see SmPC for details. Reduction of RoActemra dose due to laboratory abnormalities not studied in sJIA patients. Clinical improvement is generally seen within 6 weeks of starting RoActemra; reconsider continued therapy if no improvement is seen in this timeframe. Contraindications: Hypersensitivity to any component of the product; active, severe infections. Warnings and Precautions: Serious (sometimes fatal) infections reported in patients receiving immunosuppressive agents including RoActemra. Do not initiate in patients with active infection. If serious infection develops interrupt therapy until infection controlled. Caution in patients with history of recurring/chronic infections, or other underlying conditions (e.g. diverticulitis, diabetes and interstitial lung disease) which may predispose patients to infection. Vigilance for the timely detection of serious infection recommended. Advise all patients and parents/guardians of sJIA patients to contact their healthcare professional immediately when symptoms suggestive of an infection appear. Screen for latent TB prior to starting therapy. Treat latent TB with standard anti-mycobacterial therapy before initiating RoActemra. Risk of false negative tuberculin skin and interferon-gamma TB blood test results, especially in severely ill/immunocompromised patients. Advise patients to seek medical attention if sign/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever) suggestive of TB infection occur during or after treatment with RoActemra.

Viral reactivation (e.g. hepatitis B) reported with biologic therapies for RA. Patients screening positive for hepatitis excluded from clinical trials. Events of diverticular perforations as complications of diverticulitis reported uncommonly with RoActemra in RA patients. Exercise caution in patients with a history of intestinal ulceration or diverticulitis. Evaluate patients with symptoms of complicated diverticulitis promptly. Serious hypersensitivity reactions reported - may be more severe and potentially fatal in patients who have experienced hypersensitivity reactions during previous infusions even if they have received premedication with steroids and anti-histamines. Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction with RoActemra. If an anaphylactic reaction or other serious hypersensitivity/serious infusion related reaction occurs, stop administration of RoActemra immediately and discontinue therapy permanently. Use with caution in patients with active hepatic disease or hepatic impairment. Not recommended in patients with baseline ALT or AST > 5 x ULN; use with caution in patients with ALT or AST > 1.5 x ULN. Monitor ALT and AST levels for RA and sJIA patients according to SmPC – other liver function tests including bilirubin should be considered where indicated. If raised, follow dosage recommendations in SmPC for RA and sJIA patients. Risk of neutropenia may be increased in patients previously treated with a TNF antagonist. Continued therapy not recommended in patients who develop an ANC < 0.5 x 109/l or platelet count < 50 x 103/μl. In patients not previously treated with RoActemra, initiation not recommended where ANC is below 2 x 109/l. Caution in patients with low platelet count; monitor neutrophils and platelets in RA and sJIA patients according to SmPC. If reduced, follow dosage recommendations in SmPC for RA and sJIA patients.

Elevations in lipid parameters seen - refer to SmPC. Assess lipid parameters according to SmPC if elevated, manage patients according to local guidelines for hyperlipidaemia. Potential for central demyelination with RoActemra currently unknown; physicians should be vigilant for symptoms of new onset disease. Immunomodulatory medicines may increase malignancy risk in RA patients. Do not give live and live attenuated vaccines concurrently with RoActemra as safety not established – refer to SmPC for further details on immunisations. RA patients should have CV risk factors managed as part of usual standard of care. Not recommended for use with other biological agents. Macrophage activation syndrome (MAS) is a serious life-threatening disorder that may develop in sJIA patients – RoActemra has not been studied in patients during an active MAS episode. Advise patients experiencing dizziness not to drive or use machines until dizziness resolved. Product contains 26.55mg sodium per 1200mg. Drug Interactions: In RA patients, levels of simvastatin (CYP3A4) were decreased by 57% one week following a single dose of tocilizumab to levels similar to or slightly higher than those observed in healthy subjects. Monitor patients taking medicines which are individually adjusted and metabolised via CYP450 3A4, 1A2 or 2C9 when starting or stopping RoActemra, as doses may need to be increased to maintain therapeutic effect. The effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy. Refer to SmPC for further details on the effects of RoActemra on cytochrome CYP450 and drug interactions generally. Fertility, Pregnancy and Lactation: No adequate data from use in pregnant women. Animal study showed an increased risk of spontaneous abortion/embryo-foetal death at high dose. RoActemra should not be used during pregnancy unless clearly necessary. Women of childbearing potential should use effective contraception during and up to 3 months after treatment. No lactation data in humans. A decision on whether to continue/discontinue breastfeeding or RoActemra therapy should be made taking into account the relative benefits to the child and mother. Refer to SmPC. Side Effects and Adverse Reactions: RA: ADRs occurring in patients with RA receiving tocilizumab as monotherapy or in combination with MTX or other DMARDs: Very Common (≥ 1/10): upper respiratory tract infections and hypercholesterolaemia. Common (≥ 1/100 - <1/10): cellulitis, pneumonia, oral herpes simplex, herpes zoster, abdominal pain, mouth ulceration, gastritis, rash, pruritus, urticaria, headache, dizziness, hepatic transaminases increased, weight increased, total bilirubin increased, hypertension, leucopenia, neutropenia, peripheral oedema, hypersensitivity reactions, conjunctivitis, cough and dyspnoea. sJIA: In general, the ADRs were similar to those seen in RA patients. Infections – Serious infections of varicella and otitis media reported, in addition to infections for RA. Infusion reactions – Hypersensitivity reactions requiring treatment discontinuation occurred in < 1% of patients. Other events occurring within 24 hours of infusion in 16% of patients included, but were not limited to rash, urticaria (considered serious), diarrhoea, epigastric discomfort, arthralgia and headache. IgG – decreased levels during therapy. Other – decreases in neutrophil and platelet counts, hepatic transaminase elevations, lipid parameter increases and anti-tocilizumab antibodies observed.

Serious or Potentially Serious: active tuberculosis, invasive pulmonary infections, interstitial lung disease (including pneumonitis and pulmonary fibrosis), gastrointestinal perforations (as complications of diverticulitis), serious hypersensitivity reactions. Refer to SmPC for a complete listing of adverse events for RA and sJIA. Legal Category: Limited to sale and supply on prescription only. Presentations and Marketing Authorisation Numbers: 80mg of tocilizumab in 4ml (20mg/ml) pack of 1 (EU/1/08/492/001); 200mg of tocilizumab in 10ml (20mg/ml) pack of 1 (EU/1/08/492/003); 400mg of tocilizumab in 20ml (20mg/ml) pack of 1 (EU/1/08/492/005). Marketing Authorisation Holder: Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom. RoActemra is a registered trade mark. Further information is available from Roche Products (Ireland) Limited, 3004 Lake Drive, Citywest, Naas Road, Dublin 24. Telephone: (01) 4690700. Fax: (01) 4690791. Date of Preparation: January 2013. p17/01/13. Copyright © 2013 by Roche Products (Ireland) Ltd. All rights reserved. References: 1. Nisar MK et al. The role of tocilizumab monotherapy in the management of rheumatoid arthritis: a review. Int. J. Clin. Rheumatol. (2012) 7(1): 9-19. 2. SmPC. RoACTEMRA (tocilizumab) Summary of Product Characteristics, 13 December 2012.

ClinicalCare2014.indd 15

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Product name and PA number: Nicorette® 2mg Gum, Nicorette® 15mg Invisi Patch and Nicorette® 10mg Invisi Patch . PA Number: PA 823/49/1,3,14 and 24, PA 823/49/21-22. PA Holder: McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland. Classification: Products are not subject to medical prescription. Further information is available upon request.

IRE/NI/14-0602

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Science inAudiology Progress FEATURE

©TongRo Images/thinkstock.com

Significant progress in hse national clinical Programme

for audiology.

The universal newborn screening programme is in the final stage of implementation nationally and the national adult and paediatric bone anchored programme is established, according to the Programme Manager HSE National Clinical Programme for Audiology, Ms. Aisling Heffernan. Maureen Browne reports.

S

ignificant progress has been made in the last 12 months by the HSE’s National Clinical Programme for Audiology (ACCP).

The universal newborn screening programme is in the final stage of implementation nationally. The national adult and paediatric bone anchored programme is now established, running from six acute sites.

In March of 2013, Dr. Gary Norman, an audiologist, was appointed National Clinical Lead for Audiology.

Said Ms. Heffernan: “We are delighted that part of Dr. Norman’s commitment is to provide diagnostic follow up for babies who fail the screen as he can share his clinical expertise with audiology staff

on the ground.”

A recruitment process is underway for four Assistant National Leads for Audiology - and these should be in post by early 2014, giving a coverage of one clinical lead per million of the population.

The HSE Executive Lead of the Programme is Mr. Brian Murphy, who was one of the people instrumental in establishing the National Clinical Programme for Audiology in 2011.

The newborn hearing screening

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Babies screened now will not miss any significant exposure to language.”

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FEATURE Audiology

programme has been rolled out to almost all the country.

“Between April 2012 and July 2013, we screened 62,000 babies and 94 cases of permanent hearing impairment were identified or 1.5 per thousand, which is in keeping with international reports. We have a detailed list of key performance indicators and 99 per cent of babies are being offered a screen. We would expect that approximately three per cent of babies will fail the screening test and will be referred onto the audiology services for more in depth assessment; the majority of babies will pass the screening test,” said Ms. Heffernan.

“One of the important aspects of being able to pick up permanent hearing impairment at an early stage is that babies can be fitted with hearing aids earlier and they can be placed on the waiting list for cochlear implants, where appropriate.

HSE audiologists have received special training in early assessments and fitting tiny hearing aids.

“Research has shown that the first six months of a baby’s life are critical for language acquisition. Prior to the rollout of the screening, children would have been typically two years old before being assessed and fitted with hearing aids.

Babies screened as part of the newborn screening programme, will not miss any significant exposure to language

PICTURED: Ms. Aisling Heffernan

and we would hope that children with significant hearing impairments will have developmentally-appropriate language skills when they enter school.”

For those parents of children with a hearing impairment who opt for Irish sign language as the primary communication mode for their child, language immersion can start earlier. This newborn screening programme will lead to each child with a permanent childhood hearing impairment reaching their full potential.

“A considerable amount of work has been done with Beaumont Hospital in Dublin on the development of a business case, for the provision of bilateral cochlear implants to children. The UK NICE guidelines recommend offering bilateral implants to all children; however, Beaumont Hospital is currently funded to provide unilateral implants. There are about 300 children with unilateral implants and we are progressing a plan to assess whether they would benefit from a second one.”

Ms. Heffernan said that the national bone anchored hearing aid programme (BAHA) was rolled out to six sites at the end of 2012 and during the beginning of 2013. Because of their ear structure, chronic infections or active middle ear disease, some people are unable to benefit from behind the ear aids. With bone anchored hearing aids, an implant is inserted into the bone behind the ear so

PICTURED: Mr. Brian Murphy

}

A recruitment process is underway for four Assistant National Leads for Audiology- one for each HSE region - and these should be in post by the early 2014.” that a special hearing aid can be attached.

“The BAHA programme is going really well and is a good example of an initiative whereby the money follows the patient. There is funding to provide for approximately 100 processors each year.

“We are now also introducing a repair service for the BAHA processors, which is unique in Europe. We have experts from each of the six sites on a working group and have done a lot of work to standardise our assessment forms and to have a national policy for the programme.”

The ACCP sponsored 10 students to undertake an MSc in Audiology in the UK and a year of clinical competence training and assessment in Ireland.

These students are now taking up posts in the HSE. There will be 17 additional audiology posts added to the workforce by early 2014; this equates to a 23 per cent increase in staffing.

The ACCP worked closely with the Higher Education Authority to select a higher education institute to commence an MSc programme in Audiology. University College Cork has been selected and the ACCP/HEA and UCC are working together on funding requirements.

The Department of Expenditure and Reform approved a unified career structure for audiology in August 2013.

This will remove the confusing division between audiologists and audiological scientists and provide a clear career pathway for audiologists.

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Pr Di is flu as Pa sh co pr or of ch Pa Ca he SP Dr rig

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The recommendations from The National Audiology Review Group report (2011) continue to provide the objectives for improving and sustaining a quality audiology service for adults and children in Ireland.

18 | CLINICAL CARE

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IE_S

Help your

patients with COPD

to see how good life can be

Seretide 500 Diskus (salmeterol/fluticasone propionate) is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

TM

TM

SeretideTM DiskusTM – Each dose provides Seretide 500 Diskus 50/500 microgram/dose inhalation powder, pre-dispensed. (salmeterol xinafoate and fluticasone propionate) Abridged prescribing information (see SPC for full prescribing information).

Presentations: Seretide 500 Diskus 50/500 microgram/dose inhalation powder, pre-dispensed. Each dose provides 50 mcg salmeterol (as salmeterol xinafoate) and 500 mcg of fluticasone propionate. Therapeutic Indications: Seretide 500 Diskus is indicated for the symptomatic treatment of patients with COPD with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. Seretide is indicated in the regular treatment of asthma where use of a combination (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate. Dosage and administration COPD: Adults Seretide 500 Diskus (50 mcg of salmeterol and 500 mcg fluticasone propionate) – one puff twice daily. Asthma: (See SPC for further details regarding dosage and administration for Asthma). Contra-indications: Hypersensitivity. Warnings and Precautions: Seretide should not be used to treat acute asthma symptoms for which a fast- and short-acting bronchodilator is required. Patients should not be initiated on Seretide during an exacerbation. Serious asthma-related adverse events and exacerbations may occur during treatment with Seretide.

Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen. Treatment with Seretide should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under physician supervision. For patients with COPD, cessation of therapy may also be associated with symptomatic decompensation and should be supervised by a physician. As with all inhaled medication containing corticosteroids, Seretide should be administered with caution in patients with pulmonary tuberculosis, severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, uncorrected hypokalaemia, thyrotoxicosis or patients predisposed to low levels of serum potassium. Paradoxical bronchospasm: substitute alternative therapy. Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods, but are less likely than with oral steroids. Concomitant treatment with ketoconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided unless the benefits outweigh the potentially increased risk of systemic side effects. Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. It is important, therefore, for asthma patients that the dose of inhaled steroid is titrated to the lowest dose at which effective control is maintained. Monitor height of children on prolonged inhaled steroid therapy. Transfer from oral steroids: special care needed, monitor adrenal function. Do not stop abruptly. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Patients with COPD: Be vigilant for possible development of pneumonia or other lower respiratory tract infections. If a patient has experienced pneumonia, treatment with Seretide should be re-evaluated. Drug Interactions: Avoid beta-blockers.

Care with co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir). Fertility, Pregnancy and Lactation: Balance risks against benefits. Undesirable effects: Very common (≥1/10): Nasopharyngitis, headache. Common (³1/100 and <1/10): Candidiasis of mouth and throat, pneumonia, bronchitis, hypokalaemia, hoarseness/dysphonia, sinusitis, contusions, traumatic fractures, arthralgia, myalagia. See SPC for other possible undesirable effects. PA Holder: GlaxoSmithKline (Ireland) Limited, Stonemasons Way, Rathfarnham, Dublin 16, Ireland trading as Allen & Hanburys. PA Number: PA 1077/46/3 Drug classification: S1B. Package quantities: Seretide 500 Diskus is available in 60 dose Diskus. Seretide and Diskus are registered trademarks of the GlaxoSmithKine group of companies. All rights reserved. Date of Preparation of API: August 2012. API Code: IE/SFC/0027/12. Further information available from: Allen & Hanburys Ltd., Stonemasons Way, Rathfarnham, Dublin 16.

GSK Respiratory Health – We live and breathe it. www.health.gsk.ie

IE_SFC_0041_13_Seretide_COPD_Ad_210x297.indd 1 ClinicalCare2014.indd 19

IE/SFC/0041/13

Adverse events should be reported directly to the IMB; Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.imb.ie, e-mail: imbpharmacovigilance@imb.ie.

Adverse events should also be reported to GlaxoSmithKline on Free phone 1800 244 255, Fax 01 4938839 or e-mail ireland.drugsurveillance@gsk.com.

Date of preparation: September 2013

Ref. 1: Seretide Diskus Summary of Product Chracteristics. www.medicines.ie. Accessed 20th September 2013.

15.10.2013 11:32:18 09:38:46 04/02/2014

© istock/thinkstock.com

FEATURE Respiratory/COPD

Reducing COPD hospital admissions The HSE has established COPD Outreach Centres throughout the country to improve patient care and reduce hospital admissions, Prof. Tim McDonnell, Clinical Lead of the Programme and Consultant Respiratory Physician at St. Vincent’s University Hospital and St. Michael’s Hospital, Dublin tells Maureen Browne.

E

leven of the 12 Chronic Obstructive Pulmonary Disease (COPD) Outreach Centres which were planned by the HSE National COPD Programme for 2013 are now in place, according to Prof. Tim McDonnell, Clinical Lead of the Programme and Consultant Respiratory Physician at St. Vincent’s University Hospital and St. Michael’s Hospital, Dublin.

by outreach teams from the hospital.

The means that patients do not need to be admitted to hospital when they have an exacerbation or if they are admitted it may allow patients to be discharged earlier through the outreach programme management.

Many of these services have been up and running for some time and it is hoped to have the remaining service in place shortly.

It is hoped to reduce COPD admissions to hospital by 1,500 a year through the outreach programme and the pulmonary rehabilitation programme for COPD. These initiatives aim to improve exercise tolerance, quality of life and reduce dyspnoea for patients.

The outreach programmes are run by a Senior Respiratory Physiotherapist and a Clinical Nurse specialist. The programme facilitates patients with exacerbations of COPD to be treated in the community

The Programme plus the increased awareness of COPD as a public health problem has resulted in the average length of stay for patients with COPD admissions being brought down from 9.1

20 | CLINICAL CARE

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Respiratory/COPD

FEATURE

}

One in four people in Ireland over the age of 35 are likely to be diagnosed with COPD, requiring treatment during their lifetime.”

days in 2009 to 7.8 days in 2012. This is mainly due to the work of the National Clinical Programme and its initiatives (Outreach Programme, Pulmonary Rehabilitation Programme, clinical pathways etc) and the increased awareness of COPD as a public health issue.

Extrapolating from Canadian figures, approximately one in four people in Ireland over the age of 35 are likely to be diagnosed with COPD, requiring treatment during their lifetime. This condition is a large cause of morbidity and mortality in Ireland, with approximately 1,500 deaths and 12,000 admissions a year from the disease.

In 2011, there were approximately 5,000 fewer bed days used by COPD patients than in 2009. Some of this was due directly to initiatives supported by the Clinical Programme, which had encouraged people to see if they could make changes in their own practices.

The Medical Assessment Units have also helped.

“There’s a greater awareness of COPD. People are examining how they can make improvements in their management and there is a new awareness about best management practices,” said Prof.

McDonnell.

“Pulmonary rehabilitation is now accessible in 25 acute hospitals and in 15 centres in the community, but I know there is still a capacity issue

© iStock/thinkstock.com

Prof. McDonnell said the Programme was working to save 50 lives a year from COPD, through a number of measures to decrease morbidity and mortality, including obtaining a correct and earlier diagnosis and allowing the institution of correct treatment based on best practice guidelines at an earlier stage in the disease course.

there. Pulmonary rehabilitation is a comprehensive programme for patients with respiratory disability built around a structured exercise programme in conjunction with a dedicated education and self-management programme. We really need to build up capacity. The COPD Programme has established a model of care for pulmonary rehabilitation which is on the HSE website, there are also training materials/ resources and DVDs for patients. The website www.livingwithCOPD.ie is also a useful resource for both patients and health professionals.

“We as healthcare professionals are always reviewing how best the care of patients who become acute admissions can be managed. We have had a reasonable roll out of the bundle of care for patients with COPD exacerbation to ensure safer management and hopefully reduce their length of stay in hospitals. There are about ten items in the bundle, which we think will optimise the care of patients with COPD exacerbations. This is available in all Emergency Departments and in Medical Assessment Units. It reminds people how optimal care may be delivered but it needs constant re-enforcement.

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FEATURE Respiratory/COPD

© istock/thinkstock.com

COPD Support Ireland – was launched in October with pharmaceutical support.

This is very important from the point of view of the Programme, as it will hopefully allow us to get adequate patient input. We need to hear the voice of patients in deciding how we need to go forward. We want to get their views on what we are doing and if they think it is the correct way to go. Patients’ views must be central to all we are doing.”

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If proper support in the shape of tools and resources were available to GPs, it would assist them greatly in caring for their patients.”

“Things are improving, but there are cost constraints and worries on the horizon about what is going to happen. I believe there is still much the clinical programmes can do to assist in care of patients.

COPD patients is already taking place there. If proper support in the shape of tools and resources were available to GPs, it would assist them greatly in caring for their patients.

“We know there are more patients with COPD out there and arguably admissions are going to increase. We know that we still have a problem. In 2009, we had the highest rate of admission for COPD in the OECD. The reasons for this are not clear, but we do know it is not good to have so many COPD patients requiring hospital admission.

“Spirometry has to be a priority for us.

We have done a number of pilot projects on spirometry assessment with GPs, one in the Midlands and one in Gorey, Co. Wexford. A spirometry course has been developed by IARS for practice nurses and is accredited by DIT. The difficulty is that practice nurses are already busy. But we need to find a way to optimise this and generally deliver more spirometry results to primary care.

“We would like to make more progress on primary care services for patients with COPD. There is a lot of pressure on primary care and clearly a lot of care for

“An advocacy group for patients with COPD has been set up. This group –

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 working group 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 the COPD programme manager. All the various clinical representatives feedback information and get advice from their representative bodies.

This facilitates 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.

PICTURED: Prof. Tim McDonnell

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IE/RESP/0024/13. Date of preparation: July 2013.

Over 40 years in respiratory medicine and we’re still leading the way.

GSK Respiratory Health – We live and breathe it www.health.gsk.ie ClinicalCare2014.indd 23

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al

Radiology

FEATURE

Improving outcomes and patient journeys through the system One of the goals of the National Clinical Programme for Radiology is to show a small expenditure in radiology can bring about cost savings for the wider healthcare system. Maureen Browne reports.

T

he National Clinical Programme for Radiology is co-led by Dr. Peter Kavanagh, Consultant Radiologist, Connolly Hospital Blanchardstown, Dublin and Dr. Niall Sheehy, Consultant Radiologist, St. Jamesâ&#x20AC;&#x2122;s Hospital, Dublin. The Programme was established to address issues of quality, access and value for patients and users of diagnostic imaging.

There are significant cost benefits with these improvements â&#x20AC;&#x201C; while the tests themselves are rarely inexpensive; using them in an efficient, targeted manner will reduce overall costs for the health service.

The National Radiology Programme aims to show how a small expenditure in radiology can reduce much larger costs across the wider health service. 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 six per cent of health spending in Ireland.

The National Radiology Programme is currently rolling out access to the iRefer

radiology guidelines to all hospitals in the country.

the referral guidelines is an important first step in building closer links with GPs.

The guidelines were developed by the Royal College of Radiologists in the UK to help clinicians, radiologists, radiographers and other healthcare professionals to determine the most appropriate imaging procedures for a wide range of clinical problems. Practical guidance is based on the best available evidence, together with expert consensus for clinical applicability. The guidelines were reviewed and adopted by the Faculty of Radiologists, the National Clinical Programme for Radiology and the National Radiation Safety Committee of the HSE.

The National Radiology Programme has also commenced work on developing relative value units (RVU) for imaging procedures listed under NIMIS code which can be used across all patient level costing (PLC) acute hospital sites.

Access to the guidelines has already been rolled out to public hospitals. The next phase will focus on the independent hospitals. The Programme will then work with representatives from the Irish College of General Practitioners (ICGP) to make the guidelines available for GP use.

The National Clinical Programme for Radiology has begun to work with the new Primary Care Division to develop plans to improve GP direct access to ultrasound investigations. The rollout of

The National Radiology Programme has regular meetings with all key stakeholders as radiology services occupy 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.

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The National Radiology Programme is currently rolling out access to the iRefer radiology guidelines to all hospitals in the country. â&#x20AC;?

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Choose BRILIQUE™ instead of clopidogrel for your ACS patients...

...89 more lives could be saved in Ireland each year * 1

As measured by CV deaths (PLATO study)2

Recommended in the ESC Guidelines3-5

*Based on Republic of Ireland HIPE (Hospital In Patient Enquiry) figures. Based on all eligible patients receiving BRILIQUE instead of clopidogrel and CV mortality results from the PLATO study.

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. Co administration of ticagrelor with moderate CYP3A4 inhibitors (e.g. cyclosporine, diltiazem) is discouraged, as this may lead to an increase in exposure of ticagrelor, if use is unavoidable, appropriate patient monitoring is 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 cyclosporine. 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 product information available 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: 07/13. BRILIQUE is a trade mark of the AstraZeneca group of companies. Reference 1: HIPE (Hospital In Patient Enquiry) Casemix data- Ready Reckoner 2013 (2011 costs and activity). 2: Wallentin L, Becker RC, Budaj A, et al.

Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Eng J Med 2009;361:1045-57. 3: Steg G and James SK et al. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J 2012 Aug 24. OI:10.1093/eurheartj/ehs215. 4: Hamm CW et al. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2011 32(23):2999-3054. 5: Wijns W et al. ESC Guidelines on Myocardial Revascularisation. European Heart Journal (2010) 31, 2501–2555 doi:10.1093/eurheartj/ehq277. Approval id: 71122.011.

Date of preparation: October 2013

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FEATURE

©cornstock/thinkstock.com

Cardiology

All planned PPCI Centres now opened Over eighty per cent of STEMI patients in Ireland are now being treated in PPCI centres and the rate of thrombolysis has dropped to approx 10%, according to Prof.

Kieran Daly, Clinical Lead of the HSE National Clinical Programme for Acute Coronary Syndrome and Consultant Cardiologist at University College Hospital, Galway. Maureen Browne reports.

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A heartbeat portal has now been set up within the HIPE system which can take cardiac data. ”

A

ll the planned Primary Percutaneous Coronary Intervention Centres (PPCI) have now been opened throughout the country, according to Prof. Kieran Daly, Clinical Lead of the HSE National Clinical Programme for Acute Coronary Syndrome and Consultant Cardiologist at University College Hospital, Galway.

Centres which provide 24/7 service are now operational in the Mater Hospital, St James’s Hospital, and St. Vincent’s University Hospital Dublin, University Hospital Galway, Cork University Hospital and the Mid Western Regional Hospital in Limerick and there is a 9 - 5 centre in Waterford. The 24/7 PPCI Centres are staffed by more than five interventionist cardiologists and have an on-call rota of nursing, technical and radiological staff and at least two cath labs.

“Our aim was to get these centres open and to implement a standardised national protocol for the diagnosis and treatment of ST-Segment Elevation Myocardial Infarction (STEMI) patients and we have achieved this.” said Prof. Daly.

Over eighty per cent of STEMI patients are now been treated in PPCI centres and the rate of thrombolysis has dropped to approx 10%” said Prof. Daly.

STEMI patients who are within 90 minutes travel time from first medical contact (ECG diagnosis) are taken directly to a PPCI Centre for acute intervention to open blocked arteries.

If they are outside this timeframe, they are taken first to the nearest emergency Department, where they are assessed for thrombolysis and then transferred as soon as possible to the PPCI centre for further assessment.

There are approximately 2,000 STEMIs in Ireland annually and it is expected that the new protocols will save about 8,000 bed days nationally each year.

Patients brought to PPCI Centres 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 been transferred from a regional hospital they go back there, if they are brought directly

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FEATURE Cardiology

}

©cornstock/thinkstock.com

The 24/7 PPCI Centres are staffed by more than five interventionist cardiologists and have an on-call rota of nursing, technical and radiological staff and at least two cath labs. ”

by ambulance from home they go back to the hospital nearest their home for mobilisation and cardiac rehabilitation.

“All STEMI units, particularly those which are open 24/7 have problems in terms of staffing and maintaining rotas.

As the programme expands, people are out of bed at night more frequently. That is an ongoing issue and trying to get resources to support this is a problem, as of course securing financial resources is a problem with all programmes. Trying to work out of existing resources when you take a unit and implement a 24/7 service is a major strain on staffing, so all credit to technical, nursing, NCHD and consultant staff for getting behind it and taking on something that was not resourced in a way we would have liked.

“The National Ambulance Service and the Dublin Fire Brigade have also got behind this service in a big way and are very enthusiastic about it. We have ongoing training programmes in place to help them to take on a level of

PICTURED: Prof. Kieran Daly

responsibility which they didn’t have before.”

between 15 and 20 per cent but it should not be more than that.”

Ambulances nationally have been equipped with ECG machines and staff have been 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-toone conversation with the primary PCIB Centre and make a decision about where to take the patient.

A major development of the Programme this year has been in the area of data collection. It was accepted from the beginning that data collection was essential for audit and analysis and a heartbeat portal has now been set up within the HIPE system which can take cardiac data. This follows on from the Heartbeat Programme put in place by Dr. Siobhan Jennings and Brendan Kavanagh.

“Data is being collected now. It is not yet complete from all centres because of a shortage of staff but this is something which we are trying to address. We should have complete data going forward from 2014 and that means we can audit, analyse and see where we are going.”

“For remote areas a big factor has been the input from the helicopter service, either the Emergency Air Ambulance Service in Athlone or the Coastguard Helicopter Service. This has been most effective in bringing people from remote areas, such as the north west or south west, to a Primary Percutaneous Intervention Centre (PPCI). It has been very effective and done within good timelines, so that people who couldn’t get to a PPCI centre within 90 minutes travel time by road can do so by helicopter.

The extent of its use can be demonstrated by the fact that the PPCI Centre in University College Hospital, Galway took over 60 helicopter transfers in the first six months of this year.”

Prof. Daly said that there were issues about inappropriate referrals to some PPCI Centres. “Some Units get more inappropriate referral than others and it is something we are dealing with through ongoing education and good communications. The experience is that most programmes will expect false positives (inappropriate admissions) of

Looking to the year ahead, Prof. Daly said he wanted to bring the number of inappropriate referrals to a minimum, to make sure data collection in the HIPE portal was 100 per cent so that proper audit could be introduced. There were also staff requirements which they hoped to have included in the 2014 HSE National Service Plan.

“The focus of the Programme up to now has been on STEMIs, but much larger numbers of people are non STEMIs. We have about 6,000 of those cases each year and we are now looking at protocols for risk stratifying non STEMIs. There are various models out there, the GRACE score and the TIMI score and we are looking at developing a unifying risk score to ensure that all referrals to angiography units are appropriate.”

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IE/RESP/0024/13. Date of preparation: July 2013.

Over 40 years in respiratory medicine and we’re still leading the way.

GSK Respiratory Health – We live and breathe it www.health.gsk.ie ClinicalCare2014.indd 30

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©Photodisc/thinkstock.com

Epilepsy FEATURE

Major innovations

in epilepsy care

IE/RESP/0024/13. Date of preparation: July 2013.

Dr. Colin Doherty, National Clinical Lead of the HSE Clinical Programme on Epilepsy and Consultant Neurologist at St. James’s Hospital, Dublin tells Maureen Browne about a new model of care for patients with chronic epilepsy.

S

ignificant progress has been made in the delivery of a new model of more effective care for patients with chronic epilepsy, according to Dr. Colin Doherty, National Clinical Lead of the HSE Clinical Programme on Epilepsy and Consultant Neurologist at St. James’s Hospital, Dublin.

A Nurse Led Ambulatory Service has been introduced, integrated care pathways providing for standardised seizure management in the community, primary care and acute hospitals have been implemented and a new ‘state-of-the-art’ Epilepsy Monitoring Unit to facilitate complex epilepsy surgery has been developed in Beaumont Hospital, Dublin.

Epilepsy is a chronic disease characterised 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 of whom are under 16 years), only about 70 per cent are well controlled on medication, leaving about 12,000 - 15,000 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 for social,

vocational and occupational aspirations.

Dr. Doherty said the backbone of the delivery of chronic disease management for epilepsy at the hospital interface and at proposed outreach clinics in intellectual disability institutions, maternity hospitals and in the future possibly primary care centers, was the recruitment of a cohort of nurse specialists who would be trained up to Advanced Nurse Practitioner (ANP) level such that they would have their own cohorts of epilepsy patients whom they would manage autonomously, including prescribing and changing AEDs. This would provide us with a new

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The record is now a national tool and as far as I am aware may be the only record of its kind in the world being used across geographic and institutional boundaries.”

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FEATURE Epilepsy

pictured: Dr Colin Doherty

revisit the nursing issues at Waterford and Tralee in 2015.

“At this stage, many of the nurses are in training and thus the full gamut of services envisaged are still a long way off.

Central to the success of this is the use of the Electronic Patient Record developed

by Mary Fitzsimons and her team at Beaumont. The record is now a national tool and as far as I am aware may be the only record of its kind in the world being used across geographic and institutional boundaries.”

The outline of the advanced nurse practitioner roles was nominated for and won an international nursing award for innovation.

}

“The result of surveying all patients with epilepsy attending a large GP practice in Dublin using our protocol (specifically our checklist for managing stable disease in the community) revealed that only ten per cent required referral back to the service. This I believe provides us with some of the data required to push for wider use of the checklist, a process that starts with engaging with the Practice Nurse Association in terms of dissemination and training.”

tier of expertise, freeing up Neurologists and Epileptologists to concentrate on diagnosis, diagnostic difficulty and the most refractory epilepsy cases. Nearly two-thirds of the nurses envisaged in the programme had now been appointed. The full quota was in place in Dublin NE, Mid Leinster, Galway and Limerick and the appointment of the nurses in Sligo had been approved.

SOPs and Integrated care pathway for acute seizure management have also been developed and are now in active use. These provide standardised approaches to everything from primary care referral, seizure management in the community, approaches to the diagnosis and management of chronic epilepsy all the way to a specific integrated pathway for managing seizures in the emergency room.

The outline of the advanced nurse practitioner roles was nominated for and won an international nursing award for innovation.”

“Unfortunately, no nurses have been appointed in Cork. Given the lack of any ability to appoint nurses to Cork University Hospital, we have asked that the resources ring fenced for the nurses be redirected somewhat. Instead of five nurses for the south covering Waterford, CUH, the Mercy, and Tralee we are asking that two nurses be appointed urgently to CUH. The remaining monies for nurses will then be reconfigured to support a new neurophysiology position in CUH and a new neuropsychologist with some sessional support for a second epileptologist at Beaumont. We will

“Largely there is a move towards delivering the same kind of care across geographical and institutional borders, which I believe is unique in European or US epilepsy care so far. The existence of high-level guidelines such as NICE and SIGN has not led to the kinds of coherent evidence based treatment that was initially hoped. Instead, there is no substitute for on-the-ground work with each unit to try and promote standardised, evidence-based care.

“As an example, our SOP on

management of epilepsy in women covers everything from contraception and AEDs, preconceptual care through the development of outreach clinics in the maternity hospitals, the management of seizures during labour and on to postmenopausal issues. The SOP has been reviewed by the College of Obstetrics and Gynaecology and the National Clincal Programme for Obstetrics and Gynaecology and its main provisions have been rolled out in two maternity hospitals in Dublin with a third to come on line later this year.

“The last version of the Integrated Care Pathway for Seizure Management in the ED includes checkboxes that required the ED staff to demonstrate that they have placed the patient on a particular pathway, which is again unique in European or US epilepsy care. Importantly, over 12 months follow-up there was no excess morbidity or mortality in the early discharged epilepsy group.”

Dr. Doherty said a ‘state-of-the-art’ digital hub for multi-angle video EEG monitoring had been developed at Beaumont Hospital, Dublin to assist in complex epilepsy surgery. A consultant neurophysiologist as well as three new technical staff had been recruited to the service. “A key innovation was the development of a similar four bedded unit in CUH with two monitored beds that would be connected by a virtual private network, using the same technology and standard operating procedures to have a truly national service for complex epilepsy.

We are optimistic that the unit will open early in 2014.

“The programme in conjunction, with Beaumont hospital, secured emergency funding for another important surgical intervention, Vagal Nerve Stimulator implantation, and we have also jointly submitted a business case for funding the programme properly over the next five to ten years. During the last three years, regional management of VNS follow-up has been devolved to CUH and St James’s and most recently to Galway.”

Dr. Doherty said the nurse-led programme that has been running for years in the two main paediatric

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Epilepsy

“The model of care outlines a proposal to manage the national cohort of paediatric epilepsy using the expertise of regional paediatric physicians working off a common base of Paediatric SOPs in paediatric departments regionally instead of relying solely on primary care for community management of this complex group of patients. This network remains in the planning phase and needs the thrust of the new national paediatric programme to come to fruition. The National Epilepsy Care programme has a ‘Cradle to Grave’ remit and strongly supports the development of such a network.

“In preparation for the new hospital department, the National Clinical Programme for Epilepsy has in conjunction with epilepsy Ireland developed a new nursing post for transitioning patients from paediatric to the adult service. This nurse will work part-time in epilepsy Ireland providing expert guidance to parents and young people with epilepsy and part-time in the new paediatric hospital developing protocols for transition clinics. This post is expected to be appointed in early 2014.”

Turning to Information management and the Electronic Patient Record,

Dr. Doherty said the opportunity and necessity to use healthcare data/ information intelligently had never been greater. “High quality data and information management are essential for: providing evidence about how well health services are performing; informing the design of service improvement and development; scanning the horizon to predict what will happen; and promoting more proactive healthcare delivery. In this regard, the business intelligence generated from healthcare data is an essential tool in the transformation of healthcare, which aims to improve quality, safety and efficiency of patient care.

“Internationally, exploitation and meaningful use of information and communication technology (ICT) is recommended to support integrated health services. In this regard, the epilepsy programme is a leader nationally with the implementation and use of an electronic patient record (EPR) in a number of regional epilepsy centres including University Hospital Limerick, University

College Hospital Galway, St James’s, Beaumont and Connolly hospitals Dublin. This secure web-based EPR is facilitating the sharing and exchange of clinical information across traditional organisational boundaries. Regardless of geographical location, authorised personnel involved in epilepsy care can have access to patient records.

“The technology is now supporting a range of in-patient and out-patient services as well as outreach clinics in the intellectual disability sector and maternity care. The EPR is on course to become the repository for healthcare records for all those with epilepsy who interact with the health service in Ireland. To date, more than 3,000 individual patients with epilepsy have their epilepsy care record in the EPR. As well as supporting the delivery of a range of epilepsy services, the EPR allows efficient interrogation and analysis of large volumes of patient information and is therefore a key asset in terms of business intelligence for the national epilepsy programme.”

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There is a move towards delivering the same kind of care across geographical and institutional borders, which I believe is unique in European or US epilepsy care so far.”

©Photodisc/thinkstock.com

hospitals had laid the foundations for the structure of the National Epilepsy Care Programme. The addition of three extra candidate ANPs positions to the current complement of clinical nurse specialists brought the total number of nurses dealing with chronic epilepsy care to nine for the million or so citizens under the age of 16 years. “The advent of the new children’s hospital will see the development of the largest single epilepsy department on the site of St James’s Hospital. New Departments of Neurophysiology and a new two bedded EMU fitted out to the same specifications, with two paediatric neurophysiologists and a complement of highly trained neurophysiology measurement scientists will be at the heart of the management of complex epilepsy at the new hospital. A satellite service with ANP input will be provided in CUH.

FEATURE

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Renal Programme FEATURE

Increased numbers being transplanted and on home haemodialysis.

Of the 3,876 adults with EndStage Kidney Disease (ESKD) at the end of 2012, a total of 2079 (54 per cent) now have a functioning kidney transplant, as have 50 (62 per cent) of the 81 children with this condition, according to Dr. Liam Plant, National Clinical Director of the HSE National Renal Office and Consultant Renal Physician, Cork University Hospital. Maureen Browne reports.

I

n 2012, there were over 160 kidney transplants performed by the National Renal Transplant Unit at Beaumont Hospital and an increased proportion (31) was from living donors. Of the 3,876 adults with End-Stage Kidney Disease (ESKD) at the end of 2012, a total of 2,079 (54%) now have a functioning kidney transplant, as have 50 (62%) of the 81 children with this condition.

able to manage their own care and fit their treatment times around their everyday lives, which can be more difficult for those receiving Centre-based therapies. They are also less costly than Centre-based therapies. In 2012 the number of patients accessing Home Dialysis therapies increased by 12.3 per cent, compared with an increase of 0.2 per cent in those accessing Centre-based therapies.

The total number of patients on Centrebased Haemodialysis in Ireland has changed relatively little over the last 18 months, because of the higher proportion of people who have been transplanted and the increased number who have accessed Home Haemodialysis and Home Peritoneal Dialysis, according to Dr. Liam Plant, National Clinical Director of the HSE National Renal Office and Consultant Renal Physician, Cork University Hospital.

“Despite this, the total number of Centre-based haemodialysis treatments delivered remains enormous at almost 250,000 treatments per annum, with direct attributable costs approximating to €100 million. This has been substantially reduced by improved procurement practices and by mid-2014 we will have completed a project to replace all of the haemodialysis equipment in each of the 14 HSE Units with new state-of-the art machines. Total travel by patients accessing these therapies exceeds 13.7 million km per annum.

“Our strategic objective for ESKD care is to maximise the proportion of patients with a functioning kidney transplant and to increase access to Home Dialysis therapies (for suitable patients). Home Dialysis therapies offer many positive lifestyle benefits, such as patients being

“We are particularly pleased by the continued expansion of the National Home Haemodialysis Programme. There are now five units – in Dublin, Waterford, Cork and Galway – training patients for

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FEATURE Renal Programme

Home Haemodialysis. At present, we have 40 patients using this therapy. These patients have more control over their lives, can dialyse when they wish, and report an improved quality of life. Switching to Home Haemodialysis has meant that, collectively, they are travelling 135,000 km less per annum to access care. In Ireland, the average distance that a patient lives from their Centre Haemodialysis unit is 27 km. Not having to make this journey, to-and-fro, on 156 days each year, greatly improves their lives.

“The fact that 40 people are on Home Haemodialysis has reduced (by about 6,500) attendances at the Centre Haemodialysis units, with a reduction in costs of €1 million per annum.

The national target is to increase to 80 the number of patients on Home Haemodialysis over the next 2 years.”

Dr. Plant said that the National Renal Office is now in the process of completing the commissioning four contracted Satellite Haemodialysis units located in Dublin and its environs. This project had been delayed over the last 18 months, but should soon provide a more dispersed integrated network of haemodialysis sites to facilitate patient care. On Dublin’s Southside there will be units located in Tallaght and Sandyford, with a unit at Northern Cross on Dublin’s Northside and another unit in Drogheda. This will bring to seven the total number of contracted Satellite Haemodialysis units in use in Ireland.

“We are also planning to locate additional units in the south east and in the Midlands. Our aim is to have more widely dispersed and proportionally smaller units, so that patients will have less distance to travel, with less risk of overcrowding at the Acute Centre based units, and with a concomitant reduction in costs and increase in value.”

A uniform linked-up national IT platform for kidney disease management (the Kidney Disease Clinical Management System) has also been introduced. Said Dr. Plant: “This platform standardises the collection, presentation and recording of the key data needed to optimise care for patients with

kidney disease. In addition, it provides a real-time archive for audit of activity and outcomes, for quality assurance programmes, and will eventually form the basis for the National Renal Registry.

We have been rolling it out across the country. It is now operational in Cavan, Letterkenny, Sligo, Castlebar, Galway, Tralee, Cork and Waterford and has just been introduced in Tullamore. Next it will be activated in Beaumont and Limerick, Following which, all the remaining Renal Units in the country will be linked up.

It means, for example, that if a patient comes to Beaumont Hospital for a kidney transplant in the middle of the night, all that patient’s medical information from their parent unit will be immediately available in a clearly standardised and recognisable format. This has required an enormous effort from multiple local teams and from the KDCPMS Project Team and our partners in Mediqal Health Informatics.”

The Renal Office has also just initiated a project to develop Clinical Guidelines for the assessment and management of Acute Kidney Injury and Chronic Kidney Disease, which will be developed in concordance with the methodologies endorsed by the National Clinical Effectiveness Committee.

Chronic Kidney Disease (CKD) Stage 3-5 afflicts approximately 10 per cent of adults aged over 45 years in Ireland, with a further 10 per cent having less advanced stages. It leads to a dramatic increase in the risk of cardiovascular disease. ESKD in Ireland is projected to increase by between 550 and 875 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 ageing of the population. Diabetes, which affects one in 20 people in Ireland, has been responsible for 15 per cent 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 hospital/ 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. � To 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 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.

PICTURED: Dr Liam Plant

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in the ongoing battle against serious childhood diseases.

www.immunisation.ie

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Paediatrics and Neonatology Programme FEATURE

Major developments in Paediatrics and Neonatology Programme There have been some major developments in the past year in the HSE National Clinical Programme for Paediatrics and Neonatology. Maureen Browne reports.

T

here have been six major developments in the last 12 months in the HSE National Clinical Programme for Paediatrics and Neonatology, including the introduction of a Children’s Charter and GP algorithms for all common conditions, agreement on national guidelines for non specialist surgery and the implementation of 24/7 neonatal transport and insulin pump therapy for under fives with Type 1 diabetes mellitus.

Prof. Nicholson said that from the beginning, policy development had been from the ground up so that rather than coming up with policy documents the Clinical Leads visited the country’s 19 paediatric departments and 35 sub specialty centres to ascertain from them

the best way to plan for the future. Their feedback is now being used to provide a framework for a national model of care for newborns, children and young people in Ireland.

He said that the Children’s Charter, which he sees as a very important development has been developed by the National Advocacy Unit HSE in collaboration with the Clinical Programme. It is aimed at ensuring that children’s voice and

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The HSE has given approval for the appointment of an additional consultant neonatologist as part of an enhancement to this extended service.”

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The Clinical Paediatrics and Neonatology Programme was established in June 2011 by the Clinical Strategy and Programmes Directorate of the HSE and the Faculty of Paediatrics, Royal College of

Physicians of Ireland. Prof. Alf Nicholson (Paediatric Programme) and Prof. John Murphy (Neonatal Programme) are Joint National Leads.

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YOU KNOW EFFICACY: Greater reductions in HbA1c vs. once-daily insulin detemir2

REASSURANCE: The only basal insulin recognised for long-term cardiovascular safety1 SIMPLICITY: A true once-daily basal insulin1,3,4 LANTUS IS THE ONLY BASAL INSULIN RECOGNISED FOR LONG-TERM CARDIOVASCULAR SAFETY1,5

ORIGIN is a unique, six-year landmark cardiovascular outcomes trial, evaluating Lantus vs. standard care in pre- and early diabetes.*5 *Lantus is not indicated for use in patients with pre-diabetes

OVER 10 YEARS OF ESTABLISHED EFFICACY & SAFETY PROFILES1,4–11 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 Job Code: IE.GLA.13.10.02a. Date of preparation: November 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. Lantus SmPC. 2. Meneghini L, et al. Diabetes, Obes and Metab 2013;DOI:10.1111/dom.12083:1–8. 3. Porcellati F, et al. Diabetes Care 2007;30:1261–63.

4. Rosenstock J, et al. Diabetologica 2008;51:408–16. 5. Gerstein HC, et al. N Eng J Med 2012;367:319–28. 6. Gerstein HC, et al. Diabet Med 2006;23:736–42.

7. Aschner P, et al. Lancet 2012;379:2262–9. 8. Yki-Järvinen H, et al. Diabetologia 2006;49:442–51. 9. Riddle MC, et al. Diabetes Care 2003;26:3080–6. 10. Schreiber SA,code: et al. Diabetes Job xxxxxxTechnol Ther 2008;1(2):121–7. 11. DeVries JH, et al. Diabetes 2012;61(Suppl 1):A552–3.

Date of preparation: December 2012

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Paediatrics and Neonatology Programme

FEATURE

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There are 87,400 in patient paediatric discharges annually. The average length of stay in hospital is 3.6 days. The Programme suggests that with improved OPD facilities and expanded diagnostics this inpatient number should decrease.â&#x20AC;?

experience of health care is central to identifying health needs and improving their experience of services and informing the design, delivery and evaluation of the paediatric and neonatal programmes.

understanding. They have the right to informed participation in all decisions involving their health care and every child shall be protected from unnecessary medical treatment and investigation.

The wide ranging Charter providing for access to safe and effective care, stipulates that children be treated with dignity and respect, tact and understanding at all times, taking account of any disability or special need and taking into consideration the religious beliefs and cultural background of the child and the family. Children are entitled to have their privacy respected, receive appropriate information, and be allowed to participate in decision making regarding their care.

Children shall have full opportunity for play, recreation and education suited to their age and condition and shall be in an environment designed, furnished, staffed and equipped to meet their needs.

It states that children shall be admitted to hospital only if the care they require cannot be equally well provided at home or on a day basis. They will have the right to have their parents or parent substitute with them as much as possible.

They shall be cared for by staff whose training and skills enable them to respond to the physical, emotional and developmental needs of children and families. Continuity of care should be ensured by the team caring for children.

Children and their parents shall have the right to be informed in a manner appropriate to their age and

The Charter states that promoting health among children and young people, disease prevention, and supporting and empowering parents and children to self manage long-term health conditions and to mitigate physical and emotional stress is a priority.

Another very important childcare development is the implementation of a 24/7 neonatal transport service. The HSE has given approval for the appointment of an additional consultant neonatologist as part of an enhancement to this extended service.

It had been estimated that the neonatal transport service would undertake 150 neonatal transports each year but this has been greatly exceeded and the programme is now completing 300 retrievals annually.

The NNTP is serviced by neonatal teams from the three Dublin NICUs. The Transport Team consists of the

neonatal registrar, neonatal nurse and National Ambulance Service (NAS) personnel and Air Corps pilot and it is available daily to conduct transports anywhere within the country or overseas as required. The service has a custom fitted neonatal designated ambulance and another back up ambulance. There is an NNTP transport incubator module and equipment placed in each of the three NICUs and a further module for air transport housed with the Irish Air Corps.

Insulin pump therapy has been introduced for under fives with Type 1 diabetes mellitus. Dr. Stephen O'Riordan has been leading on the implementation of this process. Prof. Nicholson said this needed extension of the model of care to all children and adolescents with diabetes and the development of a national diabetes audit.

GP algorithms for all common conditions were formally launched at ICGP AGM in May 2013. In addition, 25 neonatal algorithms have been developed with the aim of ensuring safe, effective and efficient care of a high standard. They are clear, concise and up to date. They are currently undergoing a consultation process with the appropriate bodies and feedback is awaited. Methods of incorporating these into clinical practice will be further explored in due course.

CLINICAL CARE | 41

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LILLY INSULINS & PENS MEETING THE NEEDS OF YOUR PATIENTS WITH DIABETES

RANGE OF DEVICES WHICH ARE EASY TO USE, AND OFFER SOLUTIONS FOR YOUR PATIENTS WITH DIABETES

HUMULIN® VIAL, CARTRIDGE, AND KWIKPEN™. HUMULIN IS HUMAN INSULIN (PRB) REPUBLIC OF IRELAND ABBREVIATED PRESCRIBING INFORMATION. Presentation Humulin S is a sterile solution of 100IU/ml human insulin available as either 10ml vial or 3ml cartridge. Humulin I is a sterile suspension of 100IU/ml isophane human insulin available as either 10ml vial, 3ml cartridge, or 3ml KwikPen. Humulin M3 is a sterile suspension of 100IU/ml human insulin in the proportion of 30% soluble insulin and 70% isophane insulin available as either 10ml vial, 3ml cartridge, or 3ml KwikPen. Uses Treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis. Dosage and Administration All Humulin preparations should be given by subcutaneous injection. Only Humulin S may be given intravenously. Resuspension Humulin S does not require resuspension. Humulin I and Humulin M3 require resuspension immediately before use. Please see Summaries of Product Characteristics or Patient Information Leaflets for details on how to do this. Mixing of insulins (vials only): Humulin S may be administered in combination with Humulin I. The shorter-acting insulin (Humulin S) should be drawn into the syringe first, to prevent contamination of the vial by the longer-acting preparation (Humulin I). It is advisable to inject immediately after mixing. Warnings and Special Precautions Some patients taking human insulin may require a change in dosage from that used with animal-source insulins. If an adjustment is needed, it may occur with the first dose or during the first several weeks or months. Treatment with human insulin may cause formation of antibodies, but titres of antibodies are lower than those to purified animal insulin. Product Authorisation Numbers and Holder Humulin S: PA 0047/058/003 and PA 0047/058/005. Humulin I: PA 0047/059/003 and PA 0047/059/006. Humulin I KwikPen: PA 0047/088/001. Humulin M3: PA 0047/069/002 and PA 0047/069/004. Humulin M3 KwikPen: PA 0047/092/001. Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, England. HUMULIN® (human insulin [prb]) is a registered trademark of Eli Lilly and Company. KWIKPEN™ is a trademark of Eli Lilly and Company. HUMALOG® VIAL, CARTRIDGE, AND KWIKPEN™ HUMALOG IS INSULIN LISPRO (HUMAN INSULIN ANALOGUE). Presentation Humalog is a sterile solution of 100U/ml insulin lispro available as either 10ml vial, 3ml cartridge, or 3ml KwikPen. Uses Treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus. Dosage and Administration Humalog may be given shortly before meals and, when necessary, soon after meals. Humalog should be given by subcutaneous injection or by continuous subcutaneous infusion pump. If necessary, Humalog may also be administered intravenously, for example, for the control of blood glucose levels during ketoacidosis, acute illness, or perioperatively. Humalog takes effect rapidly (approximately 15 minutes) and has a shorter duration of activity (2 to 5 hours) as compared with soluble insulin. Warnings and Special Precautions Usage in pregnancy: Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/newborn. Insulin lispro should be used in children only when an advantage is expected compared to soluble insulin, for example, in the timing of the injection in relation to meals. Marketing Authorisation Numbers and Holder Humalog vial: EU/1/96/007/002. Humalog cartridge: EU/1/96/007/004. Humalog KwikPen 3ml: EU/1/96/007/031. Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands. HUMALOG® (insulin lispro) is a registered trademark of Eli Lilly and Company. KWIKPEN™ is a trademark of Eli Lilly and Company. HUMALOG® MIX25™ CARTRIDGE AND KWIKPEN™. HUMALOG MIX50™ CARTRIDGE AND KWIKPEN. HUMALOG IS INSULIN LISPRO (HUMAN INSULIN ANALOGUE). Presentation Humalog Mix25 is a white, sterile suspension of 100U/ml 25% insulin lispro solution and 75% insulin lispro protamine suspension available as either 3ml cartridge or 3ml KwikPen. Humalog Mix50 is a white, sterile suspension of 100U/ml 50% insulin lispro solution and 50% insulin lispro protamine suspension available as either 3ml cartridge or 3ml KwikPen. Uses Treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Dosage and Administration Humalog Mix25 or Humalog Mix50 may be given shortly before meals and, when necessary, can be given soon after meals. Humalog Mix25 or Humalog Mix50 should only be given by subcutaneous injection. The rapid onset and early peak of activity of Humalog itself is observed following the subcutaneous administration of Humalog Mix25 or Humalog Mix50. The duration of action of the insulin lispro protamine suspension component is similar to that of a basal insulin. Warnings and Special Precautions Usage in pregnancy: Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/newborn. Administration of insulin lispro in children should be considered only in case of an expected benefit when compared to soluble insulin. Marketing Authorisation Numbers and Holder Humalog Mix25 cartridge: EU/1/96/007/008. Humalog Mix25 KwikPen 3ml: EU/1/96/007/033. Humalog Mix50 cartridge: EU/1/96/007/006. Humalog Mix50 KwikPen 3ml: EU/1/96/007/035. Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands.

HUMALOG® (insulin lispro) is a registered trademark of Eli Lilly and Company. MIX25™, MIX50™, AND KWIKPEN™ are trademarks of Eli Lilly and Company. LILLY INSULINS GENERAL INFORMATION. See Summaries of Product Characteristics for additional information, including time-action profiles of all formulations. Dosage and Administration (general) The dosage or type of insulin should be determined according to the requirements of the patient. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. Vials are packed with instructions regarding dose preparation and administration, and these should be carefully followed. Lilly insulin cartridges are to be used with a CE marked pen according to the instructions provided by the device manufacturer. Patients should be advised to always keep a spare syringe and vial, or a spare pen and cartridge. Prefilled pens are packed with instructions on how to use them. These directions should be followed carefully. Do not use if, after resuspension, the insulin remains at the bottom, if there are clumps in the insulin, or if solid white particles stick to the bottom or wall giving the container a frosted appearance. Contra-indications Hypersensitivity to the active ingredient or to any of the excipients. Hypoglycaemia. Warnings and Special Precautions (general) Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand, type, species, and/or method of manufacture may result in the need for a change in dosage. For fast-acting insulins, any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole day, particularly nocturnal/fasting glucose control. Changes in early warning symptoms of hypoglycaemia may occur on transfer between different types of insulin products. Insulin requirements may be reduced in the presence of renal impairment or hepatic impairment. However, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.

Insulin requirements may be increased during illness or emotional disturbances. Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin. If the combination is used, patients should be observed for signs and symptoms of heart failure and pioglitazone discontinued if any deterioration occurs.Pregnancy and Lactation Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Patients should be advised to inform their doctors if they are pregnant or contemplating pregnancy. Driving, etc The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating machinery).

Undesirable Effects Hypoglycaemia is the most frequent undesirable effect of insulin therapy. Local allergy is common and usually resolves. Systemic allergy is rare but potentially more serious since severe cases may be life-threatening. Lipodystrophy is uncommon.

For full details of these and other side-effects, please see the Summary of Product Characteristics, which is available at http://www.medicines.ie/. Legal Category POM. Date of Preparation or Last Review February 2011 (internal review June 2013) Full Prescribing Information is Available From Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL. Telephone: Basingstoke (01256) 315 000. E-mail: ukmedinfo@lilly.com or Eli Lilly and Company (Ireland) Limited, Hyde House, 65 Adelaide Road, Dublin 2, Republic of Ireland, Telephone: Dublin (01) 661 4377. E-mail: ukmedinfo@lilly.com Adverse events and product complaints should be reported. To report an adverse event or a product complaint about a Lilly medicine, please call Lilly on: 01 664 0446. Adverse events and product complaints may also be reported to the Irish Medicines Board. Reporting forms and information can be found at www.imb.ie then click “Online Reporting”.

IEHMG00107a. July 2013

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Paediatrics and Neonatology Programme FEATURE

A considerable amount of work has been done on the establishment of national guidelines for non-specialist surgery. The Programme is now close to finalising a document following extensive discussions with all stakeholders. This will look at how face surgery should be delivered to children and if it should be delivered in a tertiary centre, a regional centre or a local hospital.

Access to consultant opinion is a problem and a major issue for GPs is the difficulty and time it may take to obtain a consultant opinion on a child.

Many OPD waiting lists are in excess of two months. Prof. Nicholson said that a set time for consultant phone advice is one option that works well in the North East. Certainly most paediatricians will use one or two urgent slots per clinic for urgent referrals from GPs but these slots needed to be protected and properly ringfenced. A system whereby urgent but not emergency conditions could be seen by a consultant within a week of referral would be useful. The patient could be seen by a consultant and after one visit discharged or be further assessed in an outpatient clinic at a future date.

“Ambulatory paediatrics is a modern model of service provision. It is perhaps best defined by its principle objectives

}

The fundamental objective of the programmes is to improve access to health care for children.” which are to provide the best care available in as convenient a manner as possible to the child and their family.

These objectives are supported firstly by early consultant input and secondly by making every effort to limit the time spent in hospital. The register of permanent consultant posts shows that there are 25 consultant neonatology appointments. This complement is less than the recommended number which should be one neonatologist per 2,000 births (BAPM 2010). Based on 74,000 births annually there should be 37 neonatology appointments.”

The data collected from the site visits about neonatal actives would imply that there are 11 level 1 units, 4 level 2 units and 4 level 3 units. This categorisation provides a basis for the short to medium term planning of newborn care.

Prof. Nicholson said the Paediatric Emergency Transport (PETS) is a definite priority for the programmes.

Outreach education sessions are very popular and there has been significant

liaison with the National Transport Lead and Intensivists in Temple Street and Crumlin hospitals.

The fundamental objective of the programmes is to improve access to health care for children. The overarching aims of the programmes are to provide maximal care to children at the point of first contact, to improve the interface between primary and secondary care of children, to deliver parity of esteem between hospital and non-hospital services for children and to develop an agreed model of care for newborns, children and young people in Ireland.

The challenges to the programme are: � To keep children out of hospital. � To smooth patient flow through the system. � To improve the primary care of children. � To make the system more patientcentred and more equitable avoiding 'post-code disadvantage'. � To achieve change in times of great austerity.

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FEATURE Paediatrics and Neonatology Programme

Overall, there has been a 16 per cent increase in the 0 - 15 years age group since 2000 according to CSO, however, within the age groups, the increases vary quite a lot with the 0 - 4 year age group showing a 34 per cent increase, the 5 - 9 year age group has increased by 20 per cent and the 10 - 15 year age group has increased by just 1 per cent.

and family involvement in the planning of child and adolescent services.

Said Prof. Nicholson: “The rapid rise in the number of children under four years in this country is particularly striking.

It has important implications for child health and acute paediatric services. It would be expected that the Irish health service would need to spend a greater proportion of its budget on children compared with other national health services who have smaller proportions of children. One would also anticipate that additional resources would have been put in place to deal with this additional quantum of children. Healthy children need strong community paediatrics with immunisation, screening, nutrition and developmental/cognitive assessment. Ill children need a seamless acute hospital service.

The need for consistent and standard levels of clinical and corporate governance in paediatric units.

“Children under the age of 15 years now account for 23 per cent of the total population in Ireland, making it one of the highest in Europe.”

The establishment of the acute paediatric retrieval service are both high priorities.

There are 87,400 in patient paediatric discharges annually. The average length of stay in hospital is 3.6 days. The Programme suggests that with improved OPD facilities and expanded diagnostics this inpatient number should decrease.

There are 1,600 ICU admissions with the average length of stay being seven days.

There were almost a quarter of a million (243,748) paediatric ED attendances in 2011.

Prof. Nicholson said that a number of overall reflections based on their discussions with child health professionals across the country include: The need for an increased focus on health promotion, support for parenting and improving child and young person wellbeing.

The need for greater child, young person

The need for data which reflected the quality of service provision across the country. Quality metrics should be part of the clinical activity within all units.

This was essential for continual quality improvement.

An increasing child population had increased levels of referrals from primary care for both scheduled and unscheduled care. This consequently increased waiting times for scheduled care and increased the number of children and young people seen out of hours. The facilities available for children and young people while in the emergency departments were often not appropriate (e.g. lack of audio-visual separation between and adults and children).

The need to develop a national plan for the delivery of neonatal care.

The need to look at different models of acute care delivery (rapid response/ paediatric assessment unit and short stay observation unit proposals and the role of the general paediatrician should to be reviewed and expanded).

The need for a National Service Framework (NSF) for children and young people in Ireland (akin to the NSF developed in Scotland, Wales and Northern Ireland).

“A consultant-delivered paediatric service is a key element for delivering better patient care in Ireland. In a consultantdelivered service the consultant paediatrician is clinically responsible for the care the patient receives during the course of treatment. In essence it means that the consultant will either provide hands-on care or closely supervise, in the clinical setting, all aspects of the care received by the child. In order to achieve this level of care there is a need

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The rapid rise in the number of children under four years in this country is particularly striking. It has important implications for child health and acute paediatric services.” to increase the number of consultant general paediatricians. Formal manpower planning is required to ensure that graduates of the paediatric training programme have the skills and expertise required to meet the health care needs of children attending Irish health services in the future,” he said.

To facilitate Prof. Nicholson and Prof.

Murphy in carrying out their roles, a multi-disciplinary Working Group and a Clinical Advisory Group were established.

The Working Group meets every 6 - 8 weeks and is co-chaired by Prof.

Nicholson and Dr. Murphy with Ms. Grace Turner as Programme Manager.

The Paediatric Clinical Advisory Group has broad representation and is chaired

by Prof. Hilary Hoey (Dean of the Faculty of Paediatrics). It meets on a bi-monthly basis.

The Neonatal Clinical Advisory Group, under Chairman Prof. Martin White, also meets on a bi-monthly basis.

All recommendations from the Working Group are agreed by the Clinical Advisory Groups, Directors of Nursing and Midwifery Reference Group, Therapy Managers Advisory Group and other stakeholders prior to implementation.

The Programme has been actively engaging with the Paediatric Patient Reference Group which has been established to allow the inclusion of the voice and experiences of children and their families in service development initiatives. The Programme has a general practitioner representative and liaises with the Irish College of General Practitioners in relation to paediatric primary care issues.

44 | CLINICAL CARE

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in the ongoing battle against serious childhood diseases.

www.immunisation.ie

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While you take care of your patients our Full Cover Scheme takes care of the bills

For full details and to find out about our Schedule of Benefits for Professional Fees call our dedicated Medical Relations team on 1890 44 44 44 or email medical.relations@vhi.ie

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Obstetrics FEATURE

Ireland needs four new

© istockphotokstockphoto.com

maternity hospitals

Despite government acceptance of the need for four new maternity hospitals, there seems little prospect of any early move for the Rotunda Hospital, which is on its present site since 1757 or the Coombe Women & Infant’s University Hospital which was opened on its present site in 1967, writes Maureen Browne.

W

hile there have been major developments in the clinical practice of obstetrics and gynaecology in Ireland in recent years, there has been no movement on the long planned and long demanded replacement of the country’s three stand alone maternity hospitals and there seems little prospect of progress on this in the immediate future.

Six years ago the KPMG Independent Review of Maternity and Gynaecology Services in the Greater Dublin Area said that the poor infrastructure in the three Dublin maternity hospitals posed risks to both the health and safety of women and infants and recommended

that the three hospitals be co-located beside adult acute services.

Last year the Minister for Health announced that the National Maternity Hospital, which opened in 1894 was to be relocated on the campus of St. Vincent’s University Hospital in Elm Park, Dublin. An indicative sum of €150 million was approved from the HSE’s Capital Plan to allow this project to proceed.

While this is very welcome news, the country’s economic situation makes it unlikely that the Rotunda or the Coombe will be replaced in the short to medium term.

CLINICAL CARE | 47

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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

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 or history of liver tumours, 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, anaphylactic reactions. 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,

3830_IMNXT_A4_Ad_v.indd 1 ClinicalCare2014.indd 48

carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, nevirapine, griseofulvin and St John’s Wort.

Implanon NXT may also interfere with the metabolism of other 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 PRODUCT AUTHORISATION NUMBER: PA 61/28/1. PRODUCT AUTHORISATION HOLDER: Organon Ireland Limited, P.O. Box 2857, Drynam Road, Swords, Co. Dublin, Ireland. DATE OF REVISION OF PRESCRIBING INFORMATION: August 2012 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 Limited 2012.

All rights reserved. Date of preparation: October 2013.

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.

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

www.talkoptions.ie

WOMN-1097684-0000

Discreet subdermal method 2

03/10/2013 12:20 04/02/2014 11:33:44

FEATURE

© iStock/thinkstock.com

Obstetrics

The Department said the proposed relocation of the National Maternity Hospital addressed a key recommendation in the 2008 KPMG Report that Dublin maternity hospitals should be located alongside adult acute services.

The Department stated that colocation of maternity hospitals with adult acute services was the optimal solution for the provision of hospitalbased maternity services, as it could provide access to the full range of medical and surgical specialties and clinical support services in sufficient volume and complexity to provide added value. This was particularly important for high-risk mothers and babies.

WOMN-1097684-0000

However, there seems little prospect of any early move for the Rotunda Hospital, which is on its present site since 1757 and the Coombe Women & Infant’s University Hospital which was opened on its present site in 1967.

The KPMG report said that the age and condition of the three Dublin maternity hospitals varied, however

there were significant estate issues at all three hospitals, with the National Maternity Hospital having the most concerning issues.

The report said that they believed that it was fortunate that there had not been a serious untoward incident due to the mixed quality of facilities.

They said that each of the re-located Dublin maternity hospitals should be in a position to accommodate 10,000 births a year, of whom 8,000 would in consultant/midwife units and 2,000 in co-located Midwifery Led Units (MLUs) The HSE also wants to replace the existing Limerick Maternity Hospital with a new hospital on the campus of University Hospital, Limerick at Dooradoyle.

There is an international tend away from stand-alone maternity services and towards co-location with adult services or tri-location with adult and paediatric services. The KPMG report said that co-location provided many clinical, operational and financial

benefits to both maternity and adult services in terms of access to surgical capacity, other specialist services, including imaging, pathology and wider consultant opinion.

In the absence of immediate plans to start building the new maternity hospitals it is vital that facilities in all 19 maternity hospitals around the country are maintained to a standard where they are suitable for mothers and babies.

Ireland also urgently needs an increase in the number of consultants. The country has the lowest number of obstetricians per 100,000 females in the OECD countries – Greece has nine times as many consultants as we have.

}

The country has the lowest number of obstetricians per 100,000 females in the OECD countries.”

CLINICAL CARE | 49

12:20

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© istockphoto/thinkstockphoto.com

FEATURE Diabetes

Reducing the risk of sight loss

in diabetic patients The HSE National Clinical Programme for Diabetes can report that the first phase of the country’s national retinopathy programme for the early identification of eye disease in people with diabetes is well under way, according to Dr. Ronan Canavan, Consultant Endocrinologist at St Vincent’s University Hospital and St Columcille’s Hospital, Dublin and Clinical Lead of the National Clinical Programme for Diabetes.

Maureen Browne reports.

T

he first phase of the country’s national retinopathy programme for the early identification of eye disease in people with diabetes is well under way, according to Dr. Ronan Canavan, Consultant Endocrinologist at St Vincent’s University Hospital and St Columcille’s Hospital, Dublin and Clinical Lead of the National Clinical Programme for Diabetes.

“This is the culmination of seven years of work and marks very significant progress.

The National Diabetic Retinopathy Framework was written by Dr. Orlaith O’Reilly and launched in 2007 under the Diabetes Expert Advisory Group.

Following a successful pilot, active recruitment of patients is now going on in a broad number of areas of the country and early next year should include all areas

of the country. The National Cancer Screening Service, which is managing the project, is now sending out some 3,000 invitations for screening each week.

“The NCSS is monitoring the quality of the overall service and the number of invitations being taken up and the first patients that may otherwise have been missed have gone forward for ophthalmology review and treatment.

We are expecting good results.

“There is a list of patients identified through the Medical Cards, Long Term

}

There are 17 integrated nursing posts in the process of being recruited.”

50 | CLINICAL CARE

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Diabetes

FEATURE

Illness Scheme and the Drug Repayment Scheme and there is also a process for GPs to refer in patients who may not have been identified. I would encourage people to go to the website www.diabeticretinascreen.ie where the process for patients to check if they have been put forward to go on to a register is explained as patients still have to give consent to be included on the register.”

The objective of the screening is to ensure earlier treatment and to reduce the risk of sight loss and Dr. Canavan said that the real challenge will arise next year when NCSS will complete the invitation to all patients identified in the process with funding for screening and treatment hopefully secured but still to be confirmed.

While only a small proportion will go on to treatment that will represent a significant part of the financial challenge.

The programme is on track for 30 per cent of the 150,000 people with diabetes identified in the country to be screened this year, and depending on budget allocations, the remainder will be able to complete screening in 2014.

The cost of screening 30 per cent of the population in 2013 was estimated at €3.1 million and it was costing approximately €1.8 million in 2013 to treat screened patients. The figures for 2014 will represent a steady increase in costs for screening and a major additional cost for treatment.

Dr. Canavan said that the clinical guidelines for the treatment of diabetic retinopathy drawn up two years ago needed to be revised in terms of new treatments and their effectiveness and some significant costs involved in new treatments had still to be fully assessed.

The Programme would like to use the

© iStock/thinkstock.com

“Our plans are to stay on track to have the entire diabetic population offered and completed screening in 2014, but cost estimates are a significant challenge.

Retinopathy screening is a game changer in terms of the diabetic programme delivering real change for patients. In other countries it has been shown that programmes on these lines can reduce the risk of sight loss and blindness and be cost effective.”

}

The challenge was to offer insulin pumps to every child who would benefit from one.” screening register to assist the further delivery of the diabetes services. Dr. Canavan said that a register could allow the Programme to plan and budget to ensure that services were delivered throughout the country and to follow the impact of changes as patients access services.

Earlier Diabetes Programme plans involved the appointment of 16 podiatrists.

Less than eight were employed up to the first half of 2013, but the appointment

of the remaining eight has being actively pursued and it is hoped to have these remaining posts appointed by the end of 2013.

“There was a reduction in bed days associated with diabetic foot ulcers of 2,061 bed days per year in 2012. The first podiatrists were employed in 2011 and we attributed the savings to these appointments despite having only half the number of podiatrists

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FEATURE Diabetes

in post. We would like to see these savings channelled towards the appointment of more podiatrists.

Group and if anything this has deteriorated, while patient numbers continue to increase dramatically.

“This bed day reduction translates into savings of €430,000 and we would be disappointed if that money was not being re-invested on additional podiatrists on the ground. However, we are trying to restart the stalled podiatrists’ appointment process. We hope to have a further eight appointed in 2013 and we will be looking for additional posts in 2014 and 2015.”

“It is a body of work for the Programmes to get across how much diabetes is increasing and patients are not being seen in the preferred location and we need to have the most value for money where uncomplicated patients are seen in primary care and the more complex patient are seen in secondary care.”

Dr. Canavan said that there were 17 integrated nursing posts in the process of being recruited. Eight had started and active recruitment was on going for the remainder. The purpose of these nurses is to deliver on integrated Type 2 diabetes care. This involves the uncomplicated Type 2 diabetes patients receiving full care in the community, while complicated Type 2 Diabetes would be shared between primary and secondary care. “I am very aware of the concern in primary care dealing with numbers and with the education of GPs who traditionally may have been discouraged from seeing patients with diabetes. A programme priority is to advocate for resources in diabetes of which a significant proportion should be directed to patients in primary and integrated care to allow the integrated model of care to work.”

}

The programme is on track for 30 per cent of the 150,000 people with diabetes identified in the country to be screened this year.”

Dr. Canavan said that in the area of paediatric diabetes, which had been lead

by Dr. Stephen O’Riordan, there was a policy that all children of five years and under with Type 1 Diabetes should have access to insulin pump therapy. There had been some success through procurement and through the work of Dr. O’Riordan and his team on delivering this. The challenge was to offer insulin pumps to every child who would benefit from one. Some significant progress had been made in the five and under age categories. There were some areas of Limerick and Galway that would need increased secondary care resources for paediatric diabetes.

In the area of gestational diabetes, new gestational diabetes guidelines were being developed and Prof. Fidelma Dunne was leading a working group looking at the feasibility of a national screening programme for gestational diabetes.

In the model of care, each nurse will be responsible for a general population of 75,000 or approximately a quarter of an Integrated Service Area (ISA) area.

Their appointment is to support practice nurses in delivering education in support of diabetic patients. “Our plan is for an additional 17 nurses to be appointed each year for a four year period, to enable the programme to be fully rolled out. We are at present assessing the impact of the appointment of the first 17 nurses.

“While it is our goal to get as much new resources as possible into primary care, it must be recognised that there are deficits in secondary care due to staff restrictions.

Diabetes nurses and dieticians who are leaving the service are not being replaced.

When the Diabetes Programme was started there was a deficit in secondary care identified by the Expert Advisory

PICTURED: Dr. Ronan Canavan

54 | CLINICAL CARE

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DemonstrateD Powerful PaIn relIef1,a for the symptomatic relief of1

30-60mg once daily

rheumatoid arthritis ankylosing spondylitis

90mg

90mg

acute Gouty arthritis

120mg

once daily

90mg once daily

arCoXIa® (etoricoxib) ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing. Present entat entatIon Ion Tablets: 30mg, 60 mg, 90 mg and 120 mg tablets each containing 30mg, 60 mg, 90 mg or 120 mg of etoricoxib respectively.

InDICatIons Symptomatic relief of osteoarthritis, rheumatoid arthritis (RA), ankylosing spondylitis (AS) and the pain and signs of inflammation associated with acute gouty arthritis. The short-term treatment of moderate pain associated with dental surgery. Base the decision to prescribe a selective COX-2 inhibitor on an assessment of the individual patient’s overall risks. DosaGe anD aDmInIstratIon Take orally with or without food. Onset of action may be faster when administered without food, and should be considered when rapid relief is needed. Osteoarthritis: 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy. Rheumatoid arthritis: 90 mg once daily. Ankylosing spondylitis: 90mg once daily. For acute pain conditions, etoricoxib should be used only for the acute symptomatic period. Acute gouty arthritis: 120 mg once daily limited to a maximum of 8 days. Postoperative dental surgery pain: 90 mg once daily, limited to a maximum of 3 days. Some patients may require additional postoperative analgesia. Each dose above is the maximum recommended dose for each condition and should not be exceeded. As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, use for the shortest duration possible and use the lowest effective daily dose. Re-evaluate periodically the patient’s need for symptomatic relief and response to therapy, especially in osteoarthritis patients. Hepatic insufficiency: mild (Child-Pugh score 5-6): regardless of indication, do not exceed a dose of 60 mg daily; moderate (Child-Pugh score 7-9): regardless of indication, do not exceed 30 mg once daily. Renal insufficiency: No dosage adjustment necessary for patients with creatinine clearance ≥ 30 ml/min. ContraInDICatIons History of hypersensitivity to any component of this product. Active peptic ulceration or gastro-intestinal (GI) bleeding. Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria or allergic type reactions after aspirin or NSAIDs including COX-2 inhibitors. Pregnancy and lactation. Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10). Estimated creatinine clearance <30 ml/min. Children and adolescents under 16 years of age. Inflammatory bowel disease. Congestive heart failure (NYHA II-IV). Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled. Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease. PreCautIons anD warnInGs Gastro-intestinal effects Upper GI complications (perforations, ulcers or bleedings), some with fatal outcome have occurred in patients taking etoricoxib. Caution is advised in patients most at risk of developing a GI complication with NSAIDs: elderly, those on any other NSAID or aspirin concomitantly, or those with a prior history of GI disease. There is a further increase in the risk of GI adverse effects (GI ulceration or other GI complications) when etoricoxib is taken together with aspirin (even at low doses). A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials. Cardiovascular Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially MI and stroke), relative to placebo and some NSAIDs. As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, use for the shortest duration possible and use the lowest effective daily dose. Re-evaluate periodically the patient’s need for symptomatic relief and response to therapy, especially in those with osteoarthritis. Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with etoricoxib after careful consideration. COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thromboembolic diseases because of their lack of antiplatelet effect. Therefore antiplatelet therapies should not be discontinued. Renal effects Consider monitoring renal function in patients with pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis. Fluid retention, oedema and hypertension Exercise caution in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and pre-existing oedema from any other reason, as fluid retention, oedema and hypertension have been observed in patients taking etoricoxib. All Nonsteroidal Antiinflammatory Drugs (NSAIDs), including etoricoxib, can be associated with new onset or recurrent congestive heart failure. Take appropriate measures, including discontinuation of etoricoxib where there is clinical evidence of deterioration in the condition of these patients. Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses. Therefore, hypertension should be controlled before treatment with etoricoxib (see section 4.3) and special attention should be paid to blood pressure monitoring during treatment with etoricoxib. Blood pressure should be monitored within two weeks after initiation of treatment and periodically thereafter. If blood pressure rises significantly, consider alternative treatment. Hepatic effects Elevations of ALT and/or AST (>3 times the upper limit of normal) have been reported in approximately 1% of patients treated in trials with etoricoxib 30mg, 60 mg and 90 mg for up to one year. Monitor any patient with symptoms /signs of liver dysfunction or in whom an abnormal liver function test has occurred. Discontinue etoricoxib if signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (3 times the upper limit of normal) are detected. General Take appropriate measures and consider discontinuation, if during treatment, patients deteriorate in any of the organ system functions described above. Maintain appropriate medical supervision when treating the elderly and patients with renal, hepatic or cardiac dysfunction with etoricoxib. Use caution when initiating treatment in patients with considerable dehydration. Rehydrate patients prior to starting therapy with etoricoxib. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported very rarely, associated with the use of NSAIDs and some selective COX-2 inhibitors. Discontinue at the first signs of skin rash, mucosal lesions or any other signs of hypersensitivity as hypersensitivity reactions (anaphylaxis, angioedema) have been reported. Etoricoxib may mask fever. ‘Arcoxia’ tablets contain lactose: do not use in patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. InteraCtIons Interactions (pharmacodynamic): Oral anticoagulants: Exercise caution when coadministering with warfarin and other oral anticoagulants. Closely monitor the prothrombin time INR when therapy with etoricoxib is initiated or the dose changed in patients receiving oral anticoagulants or similar agents, particularly in the first few days. Diuretics, ACE-inhibitors and Angiotensin II Antagonists: NSAIDS may reduce the effect of diuretics and antihypertensive drugs. In some patients with compromised renal function, the co-administration of an ACE inhibitor or AIIA and cyclo-oxygenase inhibitors may result in further deterioration of renal function including possible acute renal failure, which is usually reversible. Administer cautiously, especially in the elderly. Patients should be adequately hydrated. Consider monitoring renal function at initiation of therapy and periodically thereafter. Aspirin: etoricoxib can be used concomitantly with aspirin at doses used for cardiovascular prophylaxis (low dose aspirin). However, concomitant administration of low dose aspirin with etoricoxib may result in an increased rate of GI ulceration or other complications compared to use of etoricoxib alone. Concomitant administration of etoricoxib with doses of aspirin above those for cardiovascular prophylaxis, or with other NSAIDS is not recommended. Ciclosporin/tacrolimus: monitor renal function when etoricoxib and either ciclosporin or tacrolimus is used in combination. Interactions (pharmacokinetic) The effect of etoricoxib on the pharmacokinetics of other drugs: Lithium: the plasma concentration of lithium is increased by NSAIDS, therefore monitor and adjust blood lithium and lithium dosage if necessary. Methotrexate: adequate monitoring is recommended for methotrexate-related toxicity when etoricoxib and methotrexate are

ClinicalCare2014.indd 55

Postoperative moderate Dental surgery Pain

once daily, maximum 3 days.

once daily, maximum 8 days.

administered concomitantly. Oral Contraceptives (OC): Administration of etoricoxib 60 mg with an OC containing 35 mcg ethinyl estra estra-diol (EE) and 0.5 to 1 mg norethindrone for 21 days increased the steady state AUC0-24hr of EE by 37%. Administration of etoricoxib 120 mg with the same OC, concomitantly or separated by 12 hours, increased the steady state AUC0-24hr of EE by 50 to 60%. Consider this increase in EE concentration when selecting an oral contraceptive for use with etoricoxib. An increase in EE exposure can increase the incidence of adverse events associated with oral contraceptives. Hormone Replacement Therapy: 120 mg etoricoxib administered with 0.625 mg Premarin™ (Wyeth) for 28 days increased the mean steady state AUC0-24hr of unconjugated estrone (41%), equilin (76%) and 17-ß-estradiol (22%). Although the clinical significance is unknown, take into consideration the increase in estrogenic concentration when selecting HRT as the increase in estrogen exposure might increase the risk of adverse events associated with HRT. Digoxin: Patients at high risk of digoxin toxicity should be monitored for an increase in digoxin Cmax when etoricoxib and digoxin are administered concomitantly. Effect of etoricoxib on drugs metabolised by sulfotransferases: Etoricoxib is an inhibitor of human sulfotransferase activity, particularly SULT1E1 and has been shown to increase the serum concentrations of ethinyl estradiol. It may be prudent to exercise care when administering etoricoxib concurrently with other drugs primarily metabolised by human sulfotransferases (e.g. oral salbutamol and minoxidil). Effect of etoricoxib on drugs metabolised by CYP isoenzymes: Based on in vitro studies, etoricoxib is not expected to inhibit cytochromes P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4. In a study in healthy subjects, daily administration of etoricoxib 120 mg did not alter hepatic CYP3A4 activity as assessed by the erythromycin breath test. Effects of other drugs on the pharmacokinetics of etoricoxib: The main pathway of etoricoxib metabolism is dependent on CYP enzymes. CYP3A4 appears to contribute to the metabolism of etoricoxib in vivo. Ketoconazole: a potent inhibitor of CYP3A4, dosed at 400 mg once a day for 11 days to healthy volunteers did not have any clinically important effect on the single-dose pharmacokinetics of 60 mg etoricoxib (43% increase in AUC). Voriconazole and Miconazole: Co-administration of either oral voriconazole or topical miconazole oral gel, strong CYP3A4 inhibitors, with etoricoxib caused a slight increase in exposure to etoricoxib, but is not considered to be clinically meaningful based on published data. Rifampicin: Co-administration of etoricoxib with rifampicin, a potent inducer of CYP enzymes, produced a 65% decrease in etoricoxib plasma concentrations, an interaction which may result in recurrence of symptoms. Antacids: Antacids do not affect the pharmacokinetics of etoricoxib to a clinically relevant extent. PreGnanCY anD laCtatIon Pregnancy: contra-indicated in the first, second and third trimesters of pregnancy Lactation: contra-indicated. Fertility: Use of etoricoxib is not recommended in women attempting to conceive. sIDe effeCts The following undesirable effects were reported at an incidence greater than placebo in clinical trials in patients with OA, RA, AS or chronic low back pain treated with etoricoxib 30mg, 60mg or 90mg up to the recommended dose for up to 12 weeks, in MEDAL Program studies for up to 3½ years, in short term acute pain studies for up to 7 days or in post-marketing experience: [Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare ( ≥1/10,000 to <1/1000) Very rare ( <1/10,000) not known (cannot be estimated from the available data)] Infections and infestations: Common: alveolar osteitis Uncommon: gastro-enteritis, upper respiratory infection, urinary tract infection. Blood and lymphatic system disorders: Uncommon: anaemia (primarily associated with gastrointestinal bleeding), leukopenia, thrombocytopenia. Immune system disorder: Uncommon: hypersensitivity ** Rare: angioedema, anaphylactic/anaphylactoid reactions including shock. Metabolism and nutrition disorders: Common: oedema/fluid retention Uncommon: appetite increase or decrease, weight gain. Psychiatric disorders: Uncommon: anxiety, depression, mental acuity decreased, hallucinations. Rare: confusion, restlessness. Nervous system disorder: Common: dizziness, headache. Uncommon: dysgeusia, insomnia, paraesthesia/hypaesthesia, somnolence. Eye disorders: Uncommon: blurred vision, conjunctivitis. Ear and labyrinth disorders: Uncommon: tinnitus, vertigo Cardiac disorders: Common: palpitations, arrhythmia Uncommon: atrial fibrillation, tachycardia, congestive heart failure, non-specific ECG changes, angina pectoris, myocardial infarction*. Vascular disorders: Common: hypertension. Uncommon: flushing, cerebrovascular accident*, transient ischaemic attack, hypertensive crisis, vasculitis. Respiratory, thoracic and mediastinal disorders: Common: bronchospasm Uncommon: cough, dyspnoea, epistaxis. Gastro-intestinal disorders: Very common: abdominal pain Common: Constipation, flatulence, gastritis, heartburn/acid reflux, diarrhoea, dyspepsia/epigastric discomfort, nausea, vomiting, oesophagitis, oral ulcer.Uncommon: abdominal distention, bowel movement pattern change, dry mouth, gastroduodenal ulcer, peptic ulcers including gastrointestinal perforation and bleeding, irritable bowel syndrome, pancreatitis. Hepatobiliary disorders: Common: ALT increased, AST increased.

Rare: hepatitis, hepatic failure, jaundice. Skin and subcutaneous tissue disorders: Common: ecchymosis Uncommon: facial oedema, pruritus, rash, erythema, urticaria. Rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, fixed drug eruption. Musculoskeletal and connective tissue disorders: Uncommon: muscular cramp/spasm, musculoskeletal pain/stiffness. Renal and urinary disorders: Uncommon: proteinuria, serum creatinine increased, renal failure/renal insufficiency. General disorders and administration site conditions: Common: asthenia/fatigue, flu-like disease. Uncommon: chest pain. Investigations: Uncommon: blood urea nitrogen increased, creatine phosphokinase increased, hyperkalaemia, uric acid increased. Rare: blood sodium decreased. The following serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for etoricoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome. * Based on analyses of long-term placebo and active controlled clinical trials, selective COX-2 inhibitors have been associated with an increased risk of serious thrombotic arterial events, including myocardial infarction and stroke. The absolute risk for such events is unlikely to exceed 1% per year based on existing data (uncommon). ** Hypersensitivity includes the terms “allergy”, “drug allergy”, “drug hypersensitivity”, “hypersensitivity”, “hypersensitivity NOS”, “hypersensitivity reaction” and “nonspecific allergy”. PaCKaGe QuantItIes 30 mg and 60 mg Tablets: packs of 28 tablets. 90 mg Tablets: packs of 5 and 28 tablets. 120 mg Tablets: packs of 7 and 28 tablets. legal Category: POM. marketing authorisation numbers: Tablets 30 mg PA 1286/7/1, Tablet 60 mg PA 1286/7/2, Tablet 90 mg PA 1286/7/3, Tablet 120 mg PA 1286/7/4. marketing authorisation holder: Merck Sharp & Dohme Ireland (Human Health) Limited, Red Oak North, South County Business Park, Leopardstown, Dublin 18.

Date of revision: April 2013. © Merck Sharp and Dohme Ireland (Human Health) Limited 2013. All rights reserved. Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin 18 or from www.medicines.ie.

Date of preparation: May 2013 references: 1. Arcoxia SPC. a. Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. Due to cardiovascular risks, the shortest duration possible and the lowest effective daily dose of ARCOXIA® should be used.1 b. The recommended dose for osteoarthritis is 30 mg once daily. An increased dose of 60 mg once daily may increase efficacy. The dose for osteoarthritis should not exceed 60 mg daily.1

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

MUSC-1084536-0000

osteoarthritisb

for the short-term treatment of1

04/02/2014 11:34:06

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04/02/2014 11:34:15

© iStock/thinkstock.com

Rheumatology FEATURE

New consultant

rheumatologists appointed

The HSE National Clinical Programme for Rheumatology has succeeded in having seven new consultant rheumatologists appointed, Prof. Oliver Fitzgerald Clinical Lead of the Programme and Consulant Rheumatologist at St. Vincent's University Hospital Dublin tells Maureen Browne.

T

he National Clinical Programme for Rheumatology is a joint initiative between the HSE and the RCPI. Prof. Oliver FitzGerald, Clinical Lead of the Programme and Consultant Rheumatologist at St. Vincent’s University Hospital, Dublin said the Programme has achieved a number of its objectives, but it is still a work in progress and more needed to be done.

To date the programme has succeeded in having seven new consultant rheumatologists appointed. “In effect we have seven additional consultants on the ground, although one is working in a temporary capacity and has not got a permanent post yet. We have new consultants in Tallaght, in Crumlin, in Navan, in Kerry and in Galway. We had an additional consultant in Limerick who took up post in 2012, but then resigned.

The local rheumatologists in Limerick subsequently decided not to look for an

additional rheumatologist but instead to seek somebody who would cover their general medicine commitment. This has been agreed and they have now been taken off their ‘general call’. This means that each is spending 50 per cent more time on rheumatology which is the equivalent of a full time consultant.

“We also have the first UCD Chair in Rheumatology. Prof. Gerry Wilson took up the Bresnihan Chair in July 2013.

This was not part of the Programme but is none-the-less linked to it. Another chair in rheumatology was advertised by TCD and following interviews nobody

}

We certainly need to encourage and work with local hospitals as much as possible to support their new consultants.”

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Rheumatology FEATURE

© iStock/thinkstock.com

needed to be seen by a rheumatologist or orthopaedic surgeon. “I think that ultimately we will need more physiotherapists. We are currently working on the development of a care pathway for regional MSK pain which hopefully will better define for GPs the kind of patients who need to be seen by a consultant and those who can be successfully managed in primary care or

by MSK physiotherapists.”

The model of care document for Rheumatology services is to be circulated shortly for a second time. Any feedback will be taken on board and then the document will be ready for publication.

The Programme will be able to sign off on this once final views and input have been received from the Irish Society of Rheumatology, the Irish Rheumatology Health Professionals Society, the Directors of Nursing and the GP groups.

}

Once the waiting lists are at a manageable level, the programme will focus on the next phase which involves the MSK physiotherapists working more between primary and secondary care.”

was appointed, so they will have to readvertise that post.

“We are not over the hump yet. Broadly there have been difficulties in getting support teams, administrative support and clinical space to allow these new consultants to carry out their work.

We certainly need to encourage and work with local hospitals as much as possible to support their new consultants.

“Another initiative we have been working hard on is the appointment of 24 musculo-skeletal (MSK) physiotherapists between the orthopaedic and the rheumatology programmes. They are assessing and where appropriate treating patients on the rheumatology and orthopaedic waiting lists. Our reports show that in about 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 most cases by referral to a physiotherapist.

“The MSK physiotherapists have been taking up posts throughout the country, since last year and 22 of 24 are now in post. The majority have been in place for approximately a year, and the initial data in relation to reducing waiting list for Rheumatology services is looking very good. Between them, the MSK physiotherapists have seen about 18,000 patients up to September this year.

Unfortunately we do not yet have up to date waiting list figures but based on the 2009 figures we expect that this activity would result in a reduction in waiting lists for orthopaedics and rheumatology of about 25 per cent. Each of the new physiotherapists should see about 1,000 patients a year.”

“The other aspect on which we have been working is the development of web based high tech authorisation form for biologics which will include some clinical outcome measurements. This form, which was developed in collaboration with the Primary Care Reimbursement Service, is being piloted in St. Vincent’s and Connolly hospitals. Once the pilot is completed and any necessary changes made, we are hoping that we will be in a position to roll this out nationally within a short period of time.”

PICTURED: Prof. Oliver Fitzgerald

Once the waiting lists are at a manageable level, the programme will focus on the next phase which involves the MSK physiotherapists working more between primary and secondary care. GPs might first refer to the physiotherapist who would assess patients and judge if they

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It’s time to change your ideas about ORENCIA® Sustained protection from structural damage1

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. Anaphylaxis or anaphylactoid reactions can occur and can be life threatening. Orencia should be discontinued permanently 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 infections (including herpes simplex, oral herpes and herpes zoster), rhinitis, pneumonia, influenza Uncommon (≥ 1/1,000 to < 1/100): tooth infection, onychomycosis, sepsis, musculoskeletal infections, skin abscess, pyelonephritis, basal cell and squamous cell carcinoma, skin papilloma, thrombocytopenia, hypersensitivity, depression, anxiety, sleep disorder (including insomnia), 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, erythema, hyperhidosis, arthralgia, amenorrhea, menorrhagia, influenza-like illness, weight increase. Rare: Tuberculosis, 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, Watery Lane, Swords, Co Dublin. Tel: 1-800-749-749 or medical.information@bms.com. DATE OF PREPARATION: September 2013. Job No.: 427IE13PR08462-01

Reference: 1. Westhovens R, et al. Disease remission, radiographic non-progression and normalization of function achieved at year 1 are sustained long-term in a majority of patients: 5-year outcomes with abatacept in biologic-naïve patients. ACR/ARHP Scientific Meeting 2009. 16–21 October, Philadelphia, PA. Poster 1657.

© 2013 Bristol-Myers Squibb Company Date of approval: October 2013 427IE13PR08468-01 IROC-133468-04

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Mental Health FEATURE

Care to be developed through communityand mental health teams New staff are in place and there is now capacity in the service to a greater degree than before to develop community care through the operations of community mental health teams, Dr. Ian Daly, the National Clinical Lead of the HSE Programme for Mental Health and Executive Director, HSE Dublin South City and South West, tells Maureen Browne.

M

any of the staff required for the HSE National Clinical Programme for Mental Health have taken up post and there is now capacity in the service to a greater degree than before to develop community care through the operations of community mental health teams, according, to Dr. Ian Daly, the National Clinical Lead and Executive Director, HSE Dublin South City and South West.

“A second step taken is in the organisation of training. Cross-disciplinary training in targeted clinical interventions is now well advanced for most of our front line staff. These interventions aim to provide integrated medical and psychosocial treatments, which have proven efficacy, to individuals presenting with serious mental health disorders. Many such disorders are complicated by significant co-morbidities which adversely affect general health and, indeed, longevity. Such co-morbid presentations conform to chronic disorder categorisations.

“The third part of our strategy is designed to overcome some of the disadvantages of sector-based mental health. The approach here is to link groups of community mental health teams in order to ensure sufficient volume so to create tiers of expertise. Through the creation of these tiers at health area, regional and national levels, all closely connected to front-line teams, we can develop a comprehensive framework of care that brings the necessary level of expertise to each individual case and to ensure that the generalist and specialist components of mental health service delivery are in optimal accord.”

Current priorities lie in implementation.

“There has been a very positive response to the Programmes around the country.

Many hundreds of staff members around the country are receiving training in one or other of a number of interventions, in general, those for which there is the strongest evidence. In addition to participation in the training objectives considerable local initiative has been invested in seeking to identify local pathways and solutions in line with the principles of the Programmes.

“A year ago community mental health team development was tentative. The process has accelerated considerably and owes much to the creation of a Mental Health Directorate with a strong national

}

Cross-disciplinary training in targeted clinical interventions is now well advanced for most of our front line staff.”

Models of care designed to effectively manage chronic health conditions are relatively few in healthcare generally.

They require a combination of models, some which are relatively precise – around diagnosis and the recommending of therapies – and others which represent empirical, multi-component approaches that serve to ensure adherence and to improve self-management. Combining the delivery of evidence-based interventions with the promotion of ‘self-efficacy’ in managing long-term disorders, and incorporating these within a broad range of recovery outcomes, are the targets for clinical interventions.

Adequate team structures are essential to the success of such interventions.

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FEATURE Mental Health

NEW

}

The process has accelerated considerably and owes much to the creation of a Mental Health Directorate with a strong national mandate.” mandate. This gives us the opportunity to provide, through these teams, a service offering that is more comprehensive and that ensures greater continuity. In order for that to happen, teams need to be structured so as to optimally respond to a wide range of potential demand. The risk is that a one-size-fits-all process can come to dominate this form of healthcare delivery. Even if they work in groups, healthcare practitioners typically work as individuals and there are few proven, practised pathways through which multicomponent interventions are effectively blended to optimal benefit.

The Clinical Care Programmes in Mental Health are designed to facilitate solutions to these dilemmas. They are based on a (partial) compartmentalisation of the work of community teams designed around three broadly described work streams – the provision of broad-based, comprehensive care to those with serious mental disorders such as psychosis; a range of specific psychotherapies for those with complex psychological conditions such as eating disorders, emotionally unstable personality disorders or posttraumatic stress disorders; and the development of volume-based responses to the so-called common mental health problems.

The latter programme – for future development – is designed as a solution set for disorders such as anxieties, depressions and related conditions which have a lifetime occurrence in about 20% of the population, about 5% of whom suffer significant disability. Such conditions can be optimally managed through combinations of stepped-care and collaborative care arrangements, located in primary care or intermediate between primary care and mental health services and accompanied by specialist mood disorder services for those with

severe, intractable or co-morbid disorders.

“Within each of these three work streams an initial clinical programme has been developed – an Early Intervention for Psychosis Programme, an Eating Disorder Management Programme and a Programme for the Management of SelfHarm (and Suicide Risk) presenting to Hospital Emergency Departments.

Envisaged within the Programmes is a progressive shift in service orientation from a restricted concern with the treatment of primarily ‘severe and enduring disorders’ at relatively late stages of presentation towards the identification of such disorders at earlier stages of development. Since about 75% of lifelong mental health disorders have their onset before age 25 years, this will necessarily entail the adoption of youth-friendly service delivery models and the development of closer working relationships between Child and Adolescent and General Adult services. As part of a prevention strategy the Programmes also envisage the development of partnership relationships with fully accredited voluntary and community agencies to ensure more widely available support.

Dr. Daly said it was important to understand that any single clinical programme did not represent a comprehensive solution for that disorder or group of disorders. The programmes are incremental steps towards developing an overall care model that is guided by established evidence and that offers personalised care aiming at optimal individual recovery. Each individual clinical programme represents a solution set for one part of the overall challenge of mental disorder. All of the programmes will require further development, modification and extension in a process that is likely to take place over some years.

“The utilisation of a wider range of interventions combined with a focus on earlier diagnosis and greater levels of effective community support will help to promote recovery, enhance vocational participation and improve personal well-being and functioning. A recovery paradigm, that is, recovery from, in and beyond mental disorder is becoming mainstream in many mental healthcare systems around the world. Recovery may be viewed as a set of outcomes relating to well-being and quality, independence and functional capacity, or as a process where hope and the attainment of personal meaning and positive life fulfilment are seen as a priority. From a social movement perspective, it reflects a striving for emancipation that has been increasingly evident among those with physical disabilities in recent years.

“Measurement of programme effectiveness and efficiency will look at cost offsets, as, for instance, in reduced hospitalisation, and at providing enhanced care on a cost-effective basis. The lack of adequate IT represents a particular challenge according as an increasingly dispersed national model of care delivery is developed.

“A final aim of the Programmes is the development of national oversight, reflecting clinical and academic interests in order to drive national standards, to progressively manage and reduce variation, to promote innovation in service delivery and to afford us opportunities for larger-scale population and translational research programmes.”

“It would be fair to say that this current round of programmes is primarily targeted at frontline services. There is an equally important need to develop tertiary capacity for difficult cases and to develop regional and national centres of expertise.

Successive rounds of programme development will address these objectives.

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COMBINATION

NEW

Rapid onset* and long lasting efficacy**

50/5 µg 125/5 µg 250/10 µg

The NEW asthma maintenance treatment

INNOVATION

Modern aerosol device with a patient-facing dose counter1 * Open label study, significant increase in FEV1 5 mins after dosing (p=o.oo1) (Aalbers et al: Onset of Bronchodilation with fluticasone/formoterol combination versus fluticasone/salmeterol in an open-label, randomised study; Adv Ther 2012) ** 6-12 month open label study, significant improvement in spirometric secondary endpoints vs baseline (Mansur et al, Long Term Safety and Efficacy of fluticasone/formoterol combination therapy in Asthma; JAMP -Vol 25, No0, 2012 p1-10)

flutiform is indicated for the regular treatment of asthma in adults and adolescents (12 years and over), where use of a combination product (inhaled corticosteroid [ICS] and long-acting ß2-agonist [LABA]) is appropriate. flutiform 250/10µg indicated in adults only. flutiform® (FLUTICASONE PROPIONATE AND FORMOTEROL FUMARATE) PRESSURISED INHALATION SUSPENSION. Prescribing Information Ireland. Please read the Summary of Product Characteristics before prescribing.

Presentation: Pressurised inhalation suspension, in a pressurised metered dose inhaler (pMDI), containing fluticasone propionate and formoterol fumarate dihydrate at strengths of 50 µg/5 µg, 125 µg/5 µg or 250 µg/10 µg per actuation. Indications: Regular treatment of asthma where the use of a combination product (inhaled corticosteroid and long-acting ß2-agonist) is appropriate: For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting ß2-agonist (SABA), or for patients already adequately controlled on both an inhaled corticosteroid and a long-acting ß2-agonist (LABA). flutiform 50 µg/5 µg and 125 µg/5 µg per actuation are indicated for use in adults and adolescents 12 years and above. flutiform 250 µg/10 µg per actuation is only indicated for use in adults. Dosage and administration: For inhalation use. The patient should be shown how to use the inhaler correctly by a physician or other healthcare professional. Patients should be given the strength of flutiform containing the appropriate fluticasone propionate dose for their disease severity (note that flutiform 50 µg/5 µg per actuation is not appropriate in patients with severe asthma). The appropriate strength should be taken as two inhalations, twice-daily (normally in the morning and evening) and used every day, even when asymptomatic. flutiform should not be used in children under 12 years. Prescribers should be aware that in asthmatics, fluticasone propionate is as effective as some other inhaled steroids when administered at approximately half the total daily microgram dose. Total daily dose can be increased if asthma remains poorly controlled by administering a higher strength inhaler.

Appropriate doses of the ß2-agonist and inhaled corticosteroid (ICS) in separate inhalers, or the ICS alone, should be prescribed if a patient requires doses outside the recommended dose regimens. Patients should be assessed regularly and once asthma is controlled, treatment should be reviewed and stepped down to the lowest effective dose, or an ICS alone. It is extremely important to regularly review patients as their treatment is stepped down. ICSs alone are first line treatment for most patients. flutiform is not intended for initial treatment of mild asthma. For patients with severe asthma the ICS therapy should be established before prescribing a fixed-dose combination product. Patients on flutiform must not use an additional LABA. An inhaled SABA should be taken for immediate relief of asthma symptoms arising between doses. The AeroChamber Plus® spacer device is recommended in patients who find it difficult to use inhalers; re-titration should always follow the introduction of a spacer device. Patients should be advised to contact their prescriber when the flutiform dose indicator is getting near zero.Contra-indications: Hypersensitivity to any of the active substances or excipients. Precautions and warnings: flutiform should not be used for the first treatment of asthma, to treat acute asthma symptoms or for prophylaxis of exercise-induced asthma. It should not be initiated during an exacerbation, during significantly worsening or acutely deteriorating asthma, and should not be stopped abruptly. Patients should use their flutiform maintenance treatment as prescribed, even when asymptomatic. If a patient experiences serious asthma-related adverse events or exacerbations, they should continue treatment but also seek medical advice. Patients should be reviewed as soon as possible if there is any indication of deteriorating asthma control. In the case of sudden and progressive deterioration, which is potentially life-threatening, an urgent medical assessment should be carried out. Use with caution in patients with: pulmonary tuberculosis; quiescent tuberculosis; fungal, viral or other infections of the airway; thyrotoxicosis; pheochromocytoma; diabetes mellitus (consider additional blood sugar controls); uncorrected hypokalaemia; predisposition to low levels of serum potassium; impaired adrenal function (monitor HPA axis function regularly) ; hypertrophic obstructive cardiomyopathy; idiopathic subvalvular aortic stenosis; severe hypertension; aneurysm or other severe cardiovascular disorders. There is risk of potentially serious hypokalaemia with high doses of ß2-agonists or concomitant treatment with ß2-agonists and drugs that can induce or potentiate a hypokalaemic effect. Particular caution is recommended in unstable or acute severe asthma and other conditions when the likelihood for hypokalemia adverse effects is increased. Monitoring of serum potassium levels is recommended during these circumstances. Formoterol may induce prolongation of the QTc interval. Caution must be observed when treating patients with existing prolongation of QTc interval. flutiform should be discontinued immediately if there is evidence of paradoxical bronchospasm. Systemic effects with an ICS may occur, particularly at high doses for prolonged periods or when combined with potent CYP3A4 inhibitors, but are less likely than with oral corticosteroids. Use of a spacer device may also cause an increased systemic exposure. Increased exposure can be expected in patients with severe hepatic impairment. Prolonged

ClinicalCare2014.indd 63

NEW

fluticasone propionate/formoterol A POWERFUL PARTNERSHIP

treatment with high doses of corticosteroids may result in adrenal suppression and acute adrenal crisis, particularly in adolescents and children or potentially as a result of trauma, surgery, infection or rapid dose reduction. Patients should be advised that flutiform contains a small amount of ethanol; however this negligible amount does not pose a risk to patients. flutiform is not recommended in children under 12 years of age. Interactions: Caution is advised in long-term co-administration with strong CYP3A4 inhibitors (e.g. ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, ketoconazole and telithromycin); co-administration should be avoided if possible. Ritonavir in particular should be avoided, unless the benefits outweigh the risks of systemic side-effects. Caution is advised with use of non-potassium sparing diuretics (e.g. loop or thiazide), xanthine derivatives, glucocorticosteroids, L-Dopa, L-thyroxine, oxytocin, alcohol or other adrenergic drugs. There is an increased risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons. Hypokalaemia may increase the risk of arrhythmias in patients being treated with digitalis glycosides. Concomitant use of ß-adrenergic drugs can have a potentially additive effect. Extreme caution should be taken when using formoterol fumarate with drugs known to prolong the QTc interval, such as tricyclic antidepressants or MAOIs (and for two weeks following their discontinuation), as well as antipsychotics (including phenothiazines), quinidine, disopyramide, procainamide and antihistamines. Concomitant use of an MAOI or a similar agent, such as furazolidone or procarbazine, may precipitate hypertensive reactions. ß-blockers and formoterol fumarate may inhibit the effect of each other. ß-blockers may produce severe bronchospasm in asthma patients, and they should not normally be treated with ß-blockers including those that are used as eye drops to treat glaucoma.

Under certain circumstances, e.g. as prophylaxis after myocardial infarction, cardioselective ß blockers could be considered with caution Pregnancy and lactation: flutiform is not recommended during pregnancy. It should only be considered if benefits to the mother outweigh risks to the foetus. It is not known whether fluticasone propionate or formoterol are excreted in breast milk; a risk to the breast feeding infant cannot be excluded. A decision should be made on whether to discontinue breastfeeding or discontinue/abstain from flutiform. Side-effects: Potentially serious side-effects: hyperglycaemia; depression; aggression; behavioural changes (predominantly in children); paradoxical bronchospasm; agitation; vertigo; palpitations; ventricular extrasystoles; angina pectoris; tachycardia; hypertension; dyspnoea; peripheral oedema; Cushings Syndrome; adrenal suppression; growth retardation; cataract and glaucoma; hypersensitivity reactions and QTc interval prolongation. Please consult the SPC for details of non-serious side-effects and those reported for the individual molecules. Legal category: POM Package quantities: One inhaler containing 120 actuations 50 µg/5 µg, 125 µg/5 µg, 250 µg/10 µg Marketing Authorisation numbers: PA 1688/13/1-3 Marketing Authorisation holder: Mundipharma Pharmaceuticals Limited, Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland. Member of the Mundipharma Pharmaceutical Group. For medical information enquiries, please contact info@mundipharma.ie Date of preparation: January 2013 Reference: 1. flutiform Summary of Product Characteristics ® FLUTIFORM is a registered trademark of Jagotec AG, and is used under licence. ® AEROCHAMBER and AEROCHAMBER PLUS are registered trade marks of Trudell Medical International. © 2012 Mundipharma Pharmaceuticals Limited.

Adverse events should be reported. Reporting forms and information can be found at http://www.imb.ie/EN/Safety--Quality/Online-Forms/Human- Medicine-Adverse-Drug-Reaction.aspx Adverse events should also be reported to Mundipharma Pharmaceuticals Limited on 01 206 3800/1800 991830 (outside office hours).

IRE/FL-12042

04/02/2014 11:34:48

IE/RESP/0024/13. Date of preparation: July 2013.

Over 40 years in respiratory medicine and we’re still leading the way.

GSK Respiratory Health – We live and breathe it www.health.gsk.ie ClinicalCare2014.indd 64

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FEATURE

© iStock/thinkstock.com

Asthma

A National Model of Care for

IE/RESP/0024/13. Date of preparation: July 2013.

The HSE National Clinical Programme for Asthma (NAP) anticipates that it can achieve reductions of ten per cent or more per year in acute hospital admissions and 90% reduction in asthma deaths through implementation of its Model of Care over the next few years, according to Prof. Pat Manning, Consultant Respiratory Physician and the Programme’s National Clinical Lead. Maureen Browne reports.

Asthma treatment.

T

he HSE National Clinical Programme for Asthma (NAP) has made significant progress in 2013 on its key deliverable for the year which was the development of a National Model of Care for the treatment of the disease, according to Prof. Pat Manning, Consultant Respiratory Physician and the Programme’s National Clinical Lead.

This model of care takes into account the care and treatment of patients with asthma through primary care to secondary care and back again to primary care.

During the year, the draft document was sent out to stakeholders for comment.

These have now been received and the document is being readied for sign off as planned by end of Q4 2013.

“The NAP National Model of Care (MOC) for Asthma details how physicians, nurses, and other health care professionals can work effectively 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,” said Prof. Manning.

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

}

A priority has been Emergency Department nurses and nurses working in the Medical Assessment Units.

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Help your

patients with asthma to see how good life can be

Seretide (salmeterol/fluticasone propionate) is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate.

TM

Note: Seretide 50 microgram /100 microgram strength is not appropriate in adults and children with severe asthma.

TM

SeretideTM (salmeterol xinafoate and fluticasone propionate) Abridged prescribing information (see SPC for full prescribing information).

Presentations: SeretideTM DiskusTM – Each dose provides 50 mcg salmeterol (as salmeterol xinafoate) and 100 mcg, 250 mcg or 500 mcg respectively of fluticasone propionate. SeretideTM EvohalerTM - Each inhalation provides 25 mcg salmeterol (as salmeterol xinafoate and 50 mcg, 125 mcg or 250 mcg respectively of fluticasone propionate. Therapeutic Indications: Seretide is indicated in the regular treatment of asthma where use of a combination (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate. Seretide 500 Diskus is indicated for the symptomatic treatment of patients with COPD with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. Dosage and administration: Adults and adolescents 12 years and over: Asthma: Seretide Diskus – one puff b.d. of: Seretide 100 or Seretide 250 or Seretide 500 (each containing 50 mcg of salmeterol and 100 mcg, 250 mcg or 500 mcg respectively of fluticasone propionate). Seretide Evohaler – two puffs b.d. of: Seretide 50 or Seretide 125 or Seretide 250 (each containing 25 mcg of salmeterol and 50 mcg, 125 mcg or 250 mcg respectively of fluticasone propionate). A short term trial of Seretide may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma for whom rapid control of asthma is essential. In these cases, the recommended initial dose is one puff of Seretide 100 Diskus or two puffs of Seretide 50 Evohaler.

Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. Regular review of patients as treatment is stepped down is important. In general inhaled corticosteroids remain the first line treatment for most patients. Seretide is not intended for the initial management of mild asthma. Lowest strength Seretide (50 Evohaler or 100 Diskus) is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed combination can be used in patients with severe asthma. Children 4-11 years: Seretide 100 Diskus (50 mcg salmeterol and 100 mcg fluticasone propionate) – one puff b.d.. Seretide 50 Evohaler (25mcg salmeterol and 50mcg fluticasone propionate)- two puffs twice daily. Adults: COPD: Seretide 500 Diskus (50 mcg of salmeterol and 500 mcg fluticasone propionate) – one puff b.d.. Contraindications: Hypersensitivity. Warnings and Precautions: Seretide should not be used to treat acute asthma symptoms for which a fast- and short-acting bronchodilator is required. Patients should not be initiated on Seretide during an exacerbation. Serious asthmarelated adverse events and exacerbations may occur during treatment with Seretide. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen. Treatment with Seretide should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under physician supervision. For patients with COPD, cessation of therapy may also be associated with symptomatic decompensation and should be supervised by a physician. As with all inhaled medication containing corticosteroids, Seretide should be administered with caution in patients with pulmonary tuberculosis, severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, uncorrected hypokalaemia, thyrotoxicosis or patients predisposed to low levels of serum potassium. Paradoxical bronchospasm: substitute alternative therapy. Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods, but are less likely than with oral steroids. Concomitant treatment with ketoconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided unless the benefits outweigh the potentially increased risk. Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. It is important, therefore, for asthma patients that the dose of inhaled steroid is titrated to the lowest dose at which effective control is maintained. Monitor height of children on prolonged inhaled steroid therapy and the dose should be reduced to the lowest dose at which effective control is maintained. Transfer from oral steroids: special care needed, monitor adrenal function. Do not stop abruptly. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Patients with COPD: Be vigilant for possible development of pneumonia or other lower respiratory tract infections. If a patient has experienced pneumonia, treatment with Seretide should be re-evaluated. Drug Interactions: Avoid beta-blockers. Care with co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir). Fertility, Pregnancy and Lactation: Balance risks against benefits. Undesirable effects: Very common (≥1/10): Nasopharyngitis, headache. Common (≥1/100 and <1/10): Candidiasis of mouth and throat, pneumonia, bronchitis, hypokalaemia, hoarseness/dysphonia, sinusitis, contusions, traumatic fractures, arthralgia, myalagia. See SPC for other possible undesirable effects. PA Holder: GlaxoSmithKline (Ireland) Limited, Stonemasons Way, Rathfarnham, Dublin 16, Ireland trading as Allen & Hanburys. PA Numbers: Seretide Diskus PA 1077/46/1-3 Seretide Evohaler PA 1077/46/4-6. Drug classification: S1B. Package quantities: Seretide Diskus is available in 60 dose Diskus. Seretide Evohaler is available in 120 inhalations Inhaler. Seretide, Evohaler and Diskus are registered trademarks of the GlaxoSmithKine group of companies. All rights reserved. Date of Preparation of API: August 2012. API Code: IE/SFC/0026/12. Further information available from: Allen & Hanburys Ltd., Stonemasons Way, Rathfarnham, Dublin 16.

SeretideTM 50 EvohalerTM 25 microgram/50 microgram/dose pressurised inhalation, suspension.

SeretideTM 125 EvohalerTM 25 microgram/125 microgram/dose pressurised inhalation, suspension.

SeretideTM 250 EvohalerTM 25 microgram/250 microgram/dose pressurised inhalation, suspension. (salmeterol xinafoate and fluticasone propionate) Abridged prescribing information (see SPC for full prescribing information).

Presentations: Each inhalation provides 25 mcg salmeterol and 50 mcg, 125 mcg or 250 mcg respectively of fluticasone propionate.

Therapeutic Indications: Seretide is indicated in the regular treatment of asthma where use of a combination (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate. Dosage and administration: Please refer to SPC for full dosage and administration details and for details on the use and cleaning of the inhaler. Seretide Evohaler is for inhalation use only. Patients should be made aware that Seretide Evohaler must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Seretide they are receiving remains optimal and is only changed on medical advice. Adults and adolescents 12 years and over: two puffs twice daily of Seretide 50, 125 or 250. A short term trial of Seretide may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma for whom rapid control of asthma is essential. In these cases, the recommended initial dose is two puffs of Seretide 50 Evohaler. Once control of asthma is attained, consideration should be given to whether patients should be stepped down to an inhaled corticosteroid alone. Regular review of patients during step down is important. In general inhaled corticosteroids remain the first line treatment for most patients. Seretide is not intended for the initial management of mild asthma. Seretide 50 Evohaler is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed combination can be used in patients with severe asthma. Children 4-11 years: Two puffs twice daily of Seretide 50 Evohaler. The maximum licensed dose of fluticasone propionate delivered by Seretide in children is 100mcg twice daily. Contraindications: Hypersensitivity to the active ingredients or any of the excipients. Warnings and Precautions: Seretide should not be used to treat acute asthma symptoms for which a fast- and short-acting bronchodilator is required. Patients should not be initiated on Seretide during an exacerbation. Serious asthmarelated adverse events and exacerbations may occur during treatment with Seretide. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen. Treatment with Seretide should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under physician supervision. As with all inhaled medication containing corticosteroids, Seretide should be administered with caution in patients with pulmonary tuberculosis, severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, uncorrected hypokalaemia, thyrotoxicosis or patients predisposed to low levels of serum potassium. Paradoxical bronchospasm: substitute alternative therapy. Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods, but are less likely than with oral steroids. It is important, therefore, that the dose of inhaled steroid is titrated to the lowest dose at which effective control is maintained. Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. Transfer from oral steroids: special care needed, monitor adrenal function. Do not stop abruptly. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Monitor height of children on prolonged inhaled steroid therapy and the dose should be reduced to the lowest dose at which effective control is maintained. Concomitant treatment with ketoconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided unless the benefits outweigh the potentially increased risk. Physicians should remain vigilant for the possible development of pneumonia and other lower respiratory tract infections in patients with COPD. If a patient with severe COPD has experienced pneumonia the treatment with Seretide should be re-evaluated. Drug Interactions: Avoid beta-blockers. Potential additive effect with concomitant use of other beta-adrenergic containing drugs. Potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, itraconazole, telithromycin) should be avoided unless benefits outweigh potential risk. Fertility, Pregnancy and Lactation: Balance risks against benefits. Undesirable effects: Very common (≥1/10): Nasopharyngitis, headache. Common (≥1/100 and <1/10): Candidiasis of mouth and throat, pneumonia, bronchitis, hypokalaemia, throat irritation, hoarseness/ dysphonia, sinusitis, contusions, muscle cramps, traumatic fractures, arthralgia, myalagia. See SPC for other possible undesirable effects.

Overdose: There are no data on overdose with Seretide. If Seretide therapy has to be withdrawn due to overdose of the beta agonist component, consider appropriate replacement steroid therapy. PA Holder: GlaxoSmithKline (Ireland) Limited, Stonemasons Way, Rathfarnham, Dublin 16, Ireland trading as Allen & Hanburys. PA Numbers: PA 1077/46/4-6. Drug classification: POM. Package quantities: 120 inhalations Inhaler.

Date of Preparation of API: August 2013. API Code: IE/SFC/0039/13. Further information available from: Allen & Hanburys Ltd., Stonemasons Way, Rathfarnham, Dublin 16.

Ref. 1. Seretide Diskus and Evohaler Summary of Product Characteristics. www.medicines.ie. Accessed 20th September 2013.

Adverse events should be reported directly to the IMB; Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.imb.ie, e-mail: imbpharmacovigilance@imb.ie.

Adverse events should also be reported to GlaxoSmithKline on Free phone 1800 244 255, Fax 01 4938839 or e-mail: ireland.drugsurveillance@gsk.com.

IE_SFC_0040_13_Seretide_Asthma_Ad_210x297.indd 1 ClinicalCare2014.indd 66

GSK Respiratory Health – We live and breathe it. www.health.gsk.ie

IE/SFC/0040/13

Date of preparation: September 2013

09.10.2013 04/02/2014 17:10:05 11:34:55

with about 21 per cent of children affected.

Asthma is often under-diagnosed and uncontrolled, creating a substantial burden of ill-health to 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 exacerbation-related treatment costs.

Prof Manning went on to say that “our overarching aim of 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 hours services and at hospital ED and in patient admission services.

Prof. Manning said that the MOC focus is: On Asthma Check development at primary care level which outlines the step-by-step process for implementation of guideline based asthma management 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 and reduce exacerbations and improve asthma care. � To improve access to hospital based

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Implementation of the Model of Care by clinicians and managers is and will be supported by a range of other ancillary documents describing care pathways, clinical guidelines and other decisionmaking tools.

“The initial focus of the work of the NAP has been primarily on two main areas. Firstly, 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 and this has been implemented. Our second

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There are approximately 450,000 people with doctor-diagnosed asthma in Ireland (over 1 in 8 of the population).”

PICTURED: Prof. Pat Manning

major focus was 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 we are delighted that the MOC is now complete,” said Prof.

Manning.

“Another area of work this year has been the educational programme for nurses both in primary and secondary care. A priority has been Emergency Department nurses and nurses working in the Medical Assessment Units. “We are focusing on education of nurses with skills training on asthma and the implementation of the national asthma guidelines, which are based on international best practice for acute and ongoing asthma management “We also have a programme in place for practice nurses in primary care and by the end of 2013; we hope to have 300 practice nurses trained. This will mean that we will have about 50 per cent of practice nurses trained.”

During 2013, the NAP has developed in conjunction with the Irish College of General Practitioners, a e-learning modular case-based programme on asthma care.

CLINICAL CARE | 67

2013

7:10:05

�

specialist asthma service from secondary care services and primary care through Scheduled/Rapid access asthma services (adult/paeds), and access to specialist asthma therapies.

To improve links through CNS/ Asthma nurse specialist within the community services To develop and implement a standard referral pathway to asthma services To develop structured assessment and review protocols throughout the system To establish uniform discharge protocols To 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.)

FEATURE

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04/02/2014 11:35:02

Only one oral anticoagulant has demonstrated superiority in preventing ischaemic stroke vs. well controlled warfarin in patients with AF*1–5

Ischaemic stroke devastates Pradaxa® protects

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 gastro-intestinal 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. No relevant use of Pradaxa in the paediatric population in the indication. 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, if considered a significant risk factor for major bleeding. This may include 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 anticoagulants 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,

101202 BIP SPAF - Master ClinicalCare2014.indd 68 Ad A4_V11_Irish.indd 1

tacrolimus, dronedarone; prosthetic heart valves requiring anticoagulant treatment.

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 reuptake 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. Concomitant use of ticagrelor. 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 medicinal products which may increase the risk of haemorrhage. The use of fibrinolytic medicinal products 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. Contains Sunset Yellow (E110) which may cause allergic reactions. Interactions: Anticoagulants and antiplatelet aggregation medicinal products; P-gp inhibitors e.g. amiodarone, quinidine, verapamil, clarithromycin, ticagrelor 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 to <1/10): anaemia; epistaxis; gastrointestinal haemorrhage; abdominal pain; diarrhoea; dyspepsia; nausea; skin haemorrhage; genitourological haemorrhage, including haematuria. 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 July 2013.

References 1. Connolly S, Ezekowitz MD, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361:1139–1151. 2. Connolly S, Ezekowitz MD, et al. Newly identified events in the RE-LY trial. N Engl J Med 2010; 363:1875– 1876. 3. Patel MR, Mahaffrey KW, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365:883–891. 4. Patel MR, Mahaffrey KW, et al.

Supplementary appendix to Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

N Engl J Med 2011; 365:883–891. 5. Granger CB, Alexander JH, et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2011; 365:981–992. *AF=Atrial fibrillation Date of preparation: October 2013 Job code: IRE/DBG-131322

For more information, including an educational pack, go to www.pradaxa.ie/SPAFeducationalpack or call the Pradaxa® information line on 1850 946100

21/10/2013 16:00 04/02/2014 11:35:03

© istockphoto/thinkstockphoto.com

Stroke FEATURE

Saving stroke

patients

Consultant neurologists with training in stroke have been allocated to seven hospitals, 51 new nurses, therapists and psychologists have been appointed and eight new Stroke Units have been established, according to Prof. Peter Kelly, Consultant Neurologist at the Mater Hospital, Dublin and Joint Lead of the HSE National Clinical Programme for Stroke. Maureen Browne reports.

I

t is estimated that about 10,500 new strokes and TIA events occur each year in the Republic of Ireland, according to Prof. Peter Kelly, Consultant Neurologist at the Mater Hospital, Dublin and Joint Lead of the HSE Clinical Stroke Programme. This is based on the results of a 2006 population based epidemiological study in Dublin North City of stroke and transient ischaemic attack.

Of these 10,500 patients, about 6,500 are discharged from hospital with a primary diagnosis of stroke. The remaining numbers are made up of patients who are not admitted to hospitals, (about ten per cent of the total in the population study) patients with TIA, or patents who were coded in HIPE with a primary diagnosis other than stroke such as those with recurrent stroke or a secondary diagnosis of stroke.

Prof. Kelly said that the 2006 stroke audit was a landmark study and had indicated widespread deficiencies in hospital care for stroke patients. “Following that, under the direction of Minister Harney we had a new cardiovascular strategy launched in 2010 and for the first time had an integrated strategy on stroke included

in it. It is from this document that the current National Clinical Programme for Stroke derives its guidance.

“Beginning in 2010, it was agreed that the HSE would provide protected funding of approximately €4.5 million per annum for stroke services within the overall budget.

This has rolled over since then, so despite the overall budgetary cutbacks the concept of protecting funding for stroke was maintained and has been very welcome.”

Prof. Kelly said the original goal of the Programme was to do a three year plan and a clinical and business case was put together and signed off by the HSE Management Team in 2010. The metrics were to be viewed and judged again at the end of 2013. “The primary measurement source was to be HIPE, so we are waiting to see the HIPE figures for 2013 which we expect to have in the second quarter of 2014.”

In 2013, since a considerable amount of the work in the three year programme was front loaded in 2011 and 2012, there was a concentration on consolidating the work of 2011 and 2012.

There have been a number of significant achievements in 2013. It had been agreed that there would be 57 new nurses and therapists and some psychologists and 51 of these are now either in post or being appointed. Some posts could not be filled because of a lack of candidates and discussions are still ongoing with health managers on getting the very small remaining number of posts advertised.

Consultant neurologists with training in stroke have been specifically allocated between Beaumont and Our Lady of Lourdes Hospitals, the Mater and Cavan Hospitals and to Cork University Hospital and St. James’s Hospital.

A consultant neurologist has been appointed to Sligo General Hospital and is due to take up post next year. These posts are shared with the Neurology Programme and have a dual role for general neurology and stroke. “Between 10 and 15 consultant geriatricians have been appointed around the country, again on a shared basis with the Acute Medicine Programme. The division of responsibilities within their departments is being left to the discretion of the local teams in geriatric medicine, but their

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Stroke

appointment should improve capacity within geriatric medicine.

“The 2006 audit and population study showed that less than 1 per cent of ischemic stroke patients received thrombolysis. This increased to 3.3 per cent in a study done by the HSE in early 2009, before the start of the Stroke Programme. For the first quarter of 2012, the Programme aimed at a target of 7.5 per cent nationally. An audit was carried out in the first quarter of 2012, midway through the implementation timeframe.

The results from this audit were cross checked with the data entered on the National Stroke Register. The results showed that in the first quarter of 2012 there were 1,246 patients with ischemic stroke treated of whom 118 were reported back by the hospital as having been thrombolised, giving a national rate of 9.5 per cent. This was ahead of the goal for the end of 2013. The figure returned by the Stroke Register was 10.8 per cent but we have taken the figure of 9.5 per cent as being more reliable, but it is reassuring that they are relatively close.

“The significance of this can be gauged from the fact that in 2012 the thrombolysis rate was 8 per cent and in Ontario, which was the best performing province, it was 9.6 per cent. With the exception of the UK, (predominantly England, Wales and Northern Ireland) which showed a national rate of 11 per cent in its national audit, the Irish rate is the best I have seen reported in the literature. Rates are improving over time internationally in many jurisdictions, but we have had a significant increase over a very short period of time. Again our role in the programme is not to provide treatment but to advise, support and facilitate and the credit goes to our colleagues around the country who are providing these services, often out of hours and with a degree of personal cost.

“The three year goal of the Stroke Clinical Care Programme was to open nine new Stroke Units in hospitals which take stroke patients through their Emergency Departments. Eight of these have been opened and discussions on the ninth are ongoing with management in Cork University Hospital. New Units

have been opened in Drogheda, Cavan, Mullingar, Limerick, the Mercy Hospital in Cork and in Wexford and Roscommon.

We have been informed that some beds have become available in Roscommon and these have been designated for stroke rehabilitation.

“We estimate now that 27 of the 28 acute hospitals in which stroke units were planned now have a stroke unit. However this is based on self-reported data from the hospitals and with staff movement, people leaving and changing positions, there may be some fluidity in the position as reported back to us, so we wish to validate the numbers independently.

Therefore, we are carrying out a national audit in partnership with the HSE, the IHF and the RCPI. This will be a very detailed audit to validate the current stage of services following the first three years of the Programme. It will be carried out in 2014.”

According to the National Stroke Register the percentage of patients entered as having been treated in a stroke unit in 2012 was 60 per cent – up from the figure of one per cent in 2006 revealed in the Irish Stroke Audit six years previously.

Prof. Kelly said other initiatives of the Programme included early supported discharge initiatives. They are based on the idea that ambulatory patients who could be treated at home may require some ongoing intensive rehabilitation.

Services can be delivered to them, usually in their home from a dedicated team that links in with the hospital, with the hospital and community service straddling two care settings. Pilot projects have been introduced in the Mater, Tallaght, Galway and Mullingar and the feedback is that the Mater, Tallaght and Galway are working very well, probably because they serve a critical mass of population within a relatively close geographical space. “One of the learning points from the pilots is that it may be more difficult and may not be the most appropriate care model to attempt to provide the service in rural areas because of the dispersion of the population. It is probably best applied to locations where community rehabilitation is sparse and the population relatively condensed but we are still on a learning

FEATURE

curve with this initiative. The pilot in the Mater is the most developed and in 2012, its first full year of operation, the average length of stay for patients treated reduced by one third and the programme team estimated that about €134,000 in hospital costs was saved based on acute bed days savings.

“In 2013, the TRASNA Telemedicine Stroke Service began with an initial implementation between the Mater and Cavan and that is working well in practice. We are now beginning discussions with hospitals nationally to ascertain how this would work with the new hospital groups.

“Over the next few months there are two new pilot projects on atrial fibrillation screening in the community being introduced in co-operation with GPs and hospitals in the west of Ireland. We have high hopes for these two projects, because we consider this screening very important and of course partnership with our GP colleagues is very important for stroke prevention in the long term.

“A collaborative survey is also going on with the IHF and the ESRI looking at costs, savings and clinical need for the provision of rehabilitation services for stroke patients in the community. A report on this is expected in 2014.

“A range of additional pathways and protocols have also been worked out and disseminated throughout the country and are available on the HSE website.

“A total of €180,000 was distributed nationally to acute hospitals to promote the development of rapid access for transient ischemic attacks to be used according to what the local clinicians felt was the most effective way. The aim is to shorten the length of acute hospital stay for these patients. We will be collating the feedback from around the country and the experience of acute hospitals and expect that this will continue through 2014.”

Prof. Kelly said the flagship project for 2014 will be the new stroke audit and the continued development of ongoing workstreams and pilot projects.

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®

A daily response1 For a destructive disease2

ADENURIC 80 mg and 120 mg film-coated tablets: Abbreviated Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Film-coated tablets containing 80 mg or 120 mg febuxostat. Also contains lactose monohydrate. Use: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis) in adults. Dosage and administration: Oral use with or without food. Recommended dose is 80 mg once daily. If serum uric acid is > 6 mg/ dL (357 µmol/L) after 2-4 weeks, 120 mg once daily may be considered. Elderly: No dose adjustment required. Renal impairment: No dosage adjustment necessary in patients with mild or moderate renal impairment. Efficacy and safety not fully evaluated in patients with severe renal impairment. Hepatic impairment: Recommended dosage in patients with mild hepatic impairment is 80 mg. Limited information available in patients with moderate hepatic impairment. Efficacy and safety has not been studied in patients with severe hepatic impairment. Children and adolescents: Safety and efficacy in children under 18 has not been established. Organ transplant recipients: No experience therefore not recommended. Contra-indications: Hypersensitivity to the active ingredient or to any of the excipients.

Warnings and precautions: Cardio-vascular disorders: Not recommended in patients with ischaemic heart disease or congestive heart failure. Product allergy/hypersensitivity: Advise patients of signs/ symptoms of allergic/hypersensitivity reactions and monitor closely for symptoms. Stop treatment immediately if serious reactions occur, including Stevens-Johnson syndrome, and do not re-start febuxostat at any time. Acute gouty attacks (gout flare): Do not start treatment until an acute attack of gout has completely subsided. As with other urate lowering medicinal products, gout flares may occur during initiation of treatment. At treatment initiation flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended. If a gout flare occurs during treatment, do not discontinue.

Manage the gout flare concurrently as appropriate. Continuous treatment decreases frequency and intensity of gout flares. Xanthine deposition: As with other urate lowering medicinal products, in patients in whom the rate of urate formation is greatly increased (e.g. malignant disease and its treatment, Lesch-Nyhan syndrome), the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract. As there has been no experience, febuxostat is not recommended for use in these populations. Mercaptopurine/azathioprine: Not recommended in patients concomitantly treated with mercaptopurine/azathioprine. Where combination cannot be avoided, monitor patients closely. Dose reduction for mercaptopurine/ azathioprine is recommended. Theophylline: Use with caution in patients concomitantly treated with theophylline. Monitor theophylline levels in patients starting febuxostat therapy. Liver disorders: Liver function test is recommended prior to the initiation of therapy and periodically thereafter based on clinical judgement. Thyroid disorders: Caution in patients with alteration of thyroid function. 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: Mercaptopurine/azathioprine: On the basis of the mechanism of action of febuxostat on xanthine oxidase inhibition concomitant use is not recommended. No data is available regarding the safety of febuxostat during cytotoxic chemotherapy. Theophylline: Inhibition of XO may cause an increase in the theophylline level. Caution advised if these substances are given concomitantly, monitor theophylline levels in patients starting febuxostat therapy. Naproxen and other inhibitors of glucuronidation: Can be co-administered with naproxen with no dose adjustments necessary. Inducers of glucuronidation: Monitoring of serum uric acid is recommended 1-2 weeks after start of treatment with a potent inducer of glucuronidation. Cessation of treatment of an inducer might lead to increased plasma levels of febuxostat. Colchicine/indometacin/hydrochlorothiazide/warfarin: Can be co-administered with

colchicine or indomethacin with no dose adjustments necessary. No dose adjustment necessary when administered with hydrochlorothiazide. No dose adjustment necessary for warfarin when administered with febuxostat. Desipramine/CYP2D6 substrates: Co administration with other CYP2D6 substrates is not expected to require any dose adjustment for those compounds. Antacids: May be taken without regard to antacid use. Pregnancy and lactation: Do not use during pregnancy or breast-feeding.

Effect on fertility unknown. Side-Effects: Clinical Studies and post-marketing experience: Common (1-10%): Gout flares, headache, diarrhoea*, nausea, liver function test abnormalities*, rash, oedema.

Uncommon (0.1–1%): Blood thyroid stimulating hormone increased, diabetes mellitus, hyperlipidemia, decrease appetite, weight increase, decreased libido, insomnia, dizziness, paraesthesia, hemiparesis, somnolence, altered taste, hypoaesthesia, hyposmia, atrial fibrillation, palpitations, ECG abnormal, hypertension, flushing, hot flush, dyspnoea, bronchitis, upper respiratory tract infection, cough, abdominal pain, abdominal distension, gastro-oesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort, cholelithiasis, dermatitis, urticaria, pruritus, skin discolouration, skin lesion, petechiae, rash macular, rash maculopapular, rash papular, arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis, renal failure, nephrolithiasis, haematuria, pollakiuria, proteinuria, erectile dysfunction, fatigue, chest pain, chest discomfort, blood amylase increase, platelet count decrease, WBC decrease, lymphocyte count decrease, blood creatine increase, blood creatinine increase, haemoglobin decrease, blood urea increase, blood triglycerides increase, blood cholesterol increase, haematocritic decrease, blood lactate dehydrogenase increased, blood potassium increase. Rare (0.1-0.01%): Pancytopenia, thrombocytopenia, anaphylactic reaction**, drug hypersensitivity**, blurred vision, weight decrease, increase appetite, anorexia, nervousness, tinnitus, pancreatitis, mouth ulceration, hepatitis, jaundice**, Stevens-Johnson Syndrome**, angioedema**, generalized rash (serious)**, erythema, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash pruritic**, rash erythematous, rash morbillifom, alopecia, hyperhidrosis, rhabdomyolysis**, joint stiffness, musculoskeletal stiffness, tubulointerstitial nephritis**, micturition urgency, thirst, blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase. *Treatment-emergent non-infective diarrhoea and abnormal liver function tests in combined Phase III studies more frequent in patients concomitantly treated with colchicine. **Adverse reactions coming from post-marketing experience. Rare serious hypersensitivity reactions including Stevens-Johnson Syndrome and anaphylactic reaction/shock have occurred in post-marketing experience. Hypersensitivity reactions to febuxostat can be associated with the following symptoms: skin reactions characterised by infiltrated maculopapular eruption, generalised or exfoliative rashes, also skin lesions, facial oedema, fever, haematologic abnormalities such as thrombocytopenia, and single or multiple organ involvement (liver and kidney including tubulointerstitial nephritis). Gout flares commonly observed soon after treatment start and in first months. Frequency decreases after time. Gout flare prophylaxis is recommended. Please consult the SmPC for further information. Pack sizes: 80 mg and 120 mg tablets: 28 film-coated tablets. Legal category: POM. Marketing authorization number: EU/1/08/447/001 & 003. Marketing authorization holder: Menarini International Operations Luxembourg S.A., Avenue de la Gare, L-1611 Luxembourg, 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, Glenageary, Co. Dublin or may be found in the SmPC. Last updated: January 2013.

References: 1. Adenuric SmPC. December 2012. 2. McQueen, F.M., et al. Nat Rev Rheumatol, 2012.

8(3): p. 173-81.

ADENURIC® is a trademark of Teijin Limited, Tokyo, Japan Abbreviated prescribing information is up to date at time of printing; updated prescribing information will be available at www.medicines.ie Date of item: September 2013 13Aden003a

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FEATURE

Heart failure units

reducing risk of readmission

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The new heart failure units which have been opened in hospitals throughout the country are working very well and showing outcomes which are as good as any of those seen internationally, Prof. Ken McDonald, Consultant Cardiologist at St. Vincent’s University Hospital in Dublin and the HSE National Clinical Lead for Heart Failure tells Maureen Browne.

.

T

he new structured heart failure units established in acute hospitals throughout the country have resulted in the chances of discharged patients being re-admitted over the following three months moving from one in three to one in ten, according to Prof.

Ken McDonald, Consultant Cardiologist at St. Vincent’s University Hospital in Dublin and the HSE National Clinical Lead for Heart Failure.

“The units which have been opened are working very well and showing outcomes which are as good as any of those seen internationally,” said Prof. McDonald.

Heart failure units are part of hospital cardiology units which are dedicated to looking after patients whose primary reason for admission is heart failure.

These units have a significant impact on the intermediate and clinical course of patients. From the outset it has been shown that a structured coordinated

©istockphoto/thinkstock.com

Heart Failure

multidisciplinary approach to care could shorten length of stay in hospital and reduce the likelihood for immediate readmission within three months of discharge.

The major thrust of the Programme has been to develop heart failure units in admitting hospitals. There are now 11 active units and by the end of 2014 it is hoped that this will be increased to 14 or 15. Prof. McDonald believes that all hospitals with an Emergency Department should have a heart failure unit or be linked to a hospital with a unit.

“We have shown that the structure is sound and effective and what we now need are resources to enable us to expand these further nationally.

Heart failure is one of the commonest causes of medical admission in people over 65 in this country and the outcome

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3 1

Agents Tablet

OLMESARTAN

AMLODIPINE

HYDROCHLOROTHIAZIDE

20mg

5mg

12.5mg

40mg

5mg

12.5mg

40mg

10mg

12.5mg

40mg

5mg

25mg

40mg

10mg

25mg

Konverge Plus 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/5 mg/25 mg and 40 mg/10 mg/25 mg film-coated tablets (olmesartan medoxomil /amlodipine [as amlodipine besilate]/hydrochlorothiazide) Prescribing information Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Filmcoated tablets containing: 20 mg olmesartan medoxomil, 5 mg amlodipine, 12.5 mg hydrochlorothiazide or 40 mg olmesartan medoxomil, 5 mg amlodipine, 12.5 mg hydrochlorothiazide or 40 mg olmesartan medoxomil, 10 mg amlodipine, 12.5 mg hydrochlorothiazide or 40 mg olmesartan medoxomil, 5 mg amlodipine, 25 mg hydrochlorothiazide or 40 mg olmesartan medoxomil, 10 mg amlodipine, 25 mg hydrochlorothiazide. Uses: Treatment of essential hypertension. Indicated as add-on therapy in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation. Also as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component formulation (hydrochlorothiazide or amlodipine). Dosage: Oral administration. Adults (18-65 years): Recommended dose is 1 tablet daily. Add –on therapy: administer in patients whose blood pressure is not adequately controlled on olmesartan medoxomil and amlodipine taken as dual-component combination. Step-wise titration of the dosage of the individual components recommended before changing to the triple-component combination. When clinically appropriate, direct change from dual-component combination to triple-component combination may be considered. Substitution therapy: dose to be based on the doses of the individual components of combination at time of switching. Maximum daily dose of 40 mg/10 mg/25 mg. Elderly: Caution, monitor blood pressure frequently especially at maximum dose. Increase dosage with care. Extreme caution, including more frequent monitoring of blood pressure, recommended in patients aged 75 or older. Patients with mild to moderate renal impairment: Maximum dose 20 mg/5 mg/12.5 mg and monitor potassium and creatinine levels. Caution in patients with mild to moderate hepatic impairment; maximum daily dose 20 mg/5 mg/12.5 mg; monitor blood pressure and renal function closely. Use with caution in patients with impaired liver function. Initiate amlodipine at the lowest dose and titrate slowly. Contra-indicated in severe hepatic impairment. Children and adolescents under 18 years: Not recommended. Contra-indications: Hypersensitivity to any component, to dihydropyridine derivates or to sulfonamide-derived substances. Severe renal impairment. Refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic hyperuricaemia. Severe hepatic insufficiency, cholestasis or biliary obstruction. Second or third trimesters of pregnancy. Severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle, haemodynamically unstable heart failure after acute myocardial infarction. Warnings and Precautions: Correct intravascular volume depletion before administering Konverge Plus or maintain close medical supervision. 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. Special caution in patients with aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Not recommended in patients with primary aldosteronism. May impair glucose tolerance. In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required. Increases in cholesterol and triglyceride levels. Thiazides may precipitate hyperuricaemia or frank gout. Periodic determination of serum electrolytes should be performed. Can cause fluid or electrolyte imbalance (including hypokalaemia, hyponatraemia and hypochloraemic alkalosis). Risk of hypokalaemia with cirrhosis of the liver, brisk diuresis, inadequate oral intake of electrolytes, concomitant therapy with corticosteroids or ACTH. Hyperkalaemia, risk factors include renal impairment, and/or heart failure. Close monitoring of serum potassium in patients at risk of hyperkalaemia is recommended. Concomitant use of potassium containing and sparing products should be undertaken with caution and potassium levels monitored frequently. May cause intermittent and slight elevation of serum calcium. Discontinue before carrying out tests for parathyroid function. May increase urinary excretion of magnesium. Dilutional hyponatraemia may occur in oedematous patients in hot weather. Not recommended for combination use with lithium. Changes in renal function in susceptible individuals with heart failure. Amlodipine associated with increased reports of pulmonary oedema. Treat patients with heart failure with caution. Use amlodipine with caution in patients with congestive heart failure. Do not initiate during pregnancy. Discontinue as soon as possible if pregnancy occurs. Increase dosage with care in the elderly. Photosensitivity reactions have been reported with thiazide diuretics. Excessive blood pressure decrease in patients with ischaemic heart disease or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma. Exacerbation or activation of systemic lupus erythematosus with the use of thiazides. The blood pressure lowering effect of olmesartan medoxomil is somewhat less in black patients than non-black patients. Interactions: Not recommended for concomitant use with lithium, drugs affecting potassium levels. Caution with baclofen, NSAIDs, amifostine, other hypertensive agents, alcohol, barbiturates, narcotics, antidepressants, CYP3A4 inhibitors, CYP3A4 inducers, calcium salts, cholestyramine and colestipol, digitalis glycosides, non-depolarizing skeletal muscle relaxants, anticholinergic agents, antidiabetic medicinal products, betablockers and diazoxide, pressor amines, medicinal products used in the treatment of gout, amantadine, cytotoxic agents, salicylates, methyldopa, ciclosporin, tetracyclines, grapefruit juice, dantrolene, simvastatin. Pregnancy and Lactation: Do not use in the first trimester and discontinue as soon as possible if pregnancy occurs. Contraindicated in second and third trimesters of pregnancy. Not recommended during lactation. Side Effects: Konverge Plus: Common (≥ 1/100 <1/10): upper respiratory tract infection, nasopharyngitis, urinary tract infection, dizziness, headache, palpitations, hypotension, diarrhoea, nausea, constipation, muscle spasm, joint swelling, pollakiuria, asthenia, peripheral oedema, fatigue, blood creatinine increased, blood urea increased, blood uric acid increased. Olmesartan: Common: urinary tract infection, hypertriglyceridaemia, hyperuricaemia, dizziness, headache, cough, bronchitis, pharyngitis, rhinitis, diarrhoea, nausea, abdominal pain, dyspepsia, gastroenteritis, arthritis, back pain, skeletal pain, haematuria, peripheral oedema, fatigue, chest pain, influenza-like symptoms, pain, blood urea increased, hepatic enzymes increased, blood creatine phosphokinase increased. Amlodipine: Common: dizziness, headache, somnolence, flushing, nausea, abdominal pain, ankle swelling, fatigue, oedema.

Hydrochlorothiazide: Very common (≥1/10): hypertriglyceridaemia, hypercolesterinaemia, hyperuricaemia. Common: hypokalaemia, glycosuria, hypercalcaemia, hyperglycaemia, hypomagnesaemia, hyponatriaemia, hypochloraemia, hyperamylasaemia, confusional state, dizziness, diarrhoea, nausea, constipation, abdominal pain, meteorism, gastric irritation, vomiting, blood creatinine increased, blood urea increased. For less frequent side effects see SmPC. Pack Sizes: Blister containing 28 film-coated tablets. Legal Category: POM. Product Authorisation Numbers: PA 865/19/1-5. Product Authorisation Holder: Menarini International Operations Luxembourg S.A, 1 Avenue de la Gare, L-1611 Luxembourg. Marketed by: A. Menarini Pharmaceuticals Ireland. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin or may be found in the SmPC. Date of Preparation: January 2013.

Abbreviated prescribing information is up to date at time of printing; updated prescribing information will be available at www.medicines.ie.

Co-promoter: DAIICHI SANKYO IRELAND LTD., Riverside One, Sir John Rogerson Quay, Dublin 2, Ireland.

Date of item: September 2013. 13Kon055

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Heart Failure

for people managed by specialist multidisciplinary care in a structured unit is considerably better than when they are treated on a more ad hoc basis.

Heart failure is one of the major chronic diseases with which the Irish healthcare system has to contend. In Ireland there are about 100,000 patients with heart failure and the condition is the primary or component diagnosis of about 20,000 hospital admissions annually nationally, with an average length of stay of about ten days. Middle aged adults today have a 20% to 30% lifetime risk of developing heart failure.

Once patients have been admitted to hospital with heart failure, they have a high chance of re-admission and reducing this re-admission rate is obviously very important for patient welfare and the healthcare economy.

“Internationally, it is regarded as a huge cost on the health services and Ireland is no different. We are focussing on the diagnosis and treatment of heart failure to try and make patients’ lives a bit more comfortable, to improve outcomes and to reduce the economic cost.”

UK figures – and there is no reason to believe that Irish ones are different – show the direct healthcare costs of heart failure are 2% of the total health budget, with indirect costs such as family, loss of earnings and nursing home costs equating to a further 2%.

Patients with heart failure are predominantly elderly, so as the population ages, the numbers of patients with heart failure can also be expected to increase. It is a male dominated condition but will be seen more and more in women as the population ages. Work in St. Vincent’s University Hospital has shown that the average age of patients with heart disease in the community is 78.

The prevalence of heart failure is also increasing because of the improved survival from major cardiovascular events such as myocardial infarction and the continued poor management of risk factors for heart failure, particularly hypertension. Also contributing to the

FEATURE

}

In Ireland there are about 100,000 patients with heart failure and the condition is the primary or component diagnosis of about 20,000 hospital admissions annually nationally, with an average length of stay of about ten days.”

increasing prevalence of the heart failure syndrome is 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 HSE Programme is also working on pilot studies to see how they can best link with primary care colleagues. Like other Programmes, much of the progress here depends on agreement on the GPs contract to allow a focus on greater chronic disease management in the community.

Heart failure is an active area in terms of new pharmacology and device therapy, but there is still a major focus on prevention. As the HSE National Clinical Programme for Heart Failure evolves, it is believed that clinicians will focus as much on prevention as treatment strategies both locally and nationally.

Results of the Stop-HF study, carried out by Prof. McDonald and colleagues at St. Vincent’s Hospital on more than 1,300 people, showed that a screening and management programme could be effective in preventing heart failure.

Prof. McDonald said that they found that blood test screening followed where necessary by targeted care of people at risk could significantly reduce the incidence of heart failure and in particular, hospital admissions for this and other cardiovascular conditions.

received standard care from their doctors.

“We found that a significantly lower number of patients in the intervention group compared to the control group required hospitalisation for heart failure or left ventricular dysfunction and they had lower rates of emergency hospitalisation for major cardiovascular events,” said Prof.

McDonald.

This study, sponsors of which included by St Vincent's Screening to Prevent Heart Failure, (STOP-HF) the Heartbeat Trust and the HSE was presented at the American College of Cardiology conference in San Francisco and published simultaneously in the Journal of the American Medical Association (JAMA).

Therapy for heart failure is also improving and it is generally accepted that with structured organised care, significant improvements can be made which will improve quality of life for the patient, reduce hospital needs, free up beds for other conditions and save money in terms of what heart failure costs the exchequer.

The study enrolled patients without symptoms over 40 years of age with risk factors for heart failure and divided them into an intervention and control groups.

Patients in the intervention group were screened for blood levels of B-type nartriuretic peptide. (BNP) These patients received specialised care if it was necessary, while the control group patients

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®1

with

r a no l a z i ne

For stable angina patients inadequately controlled on beta blockers or calcium antagonists2 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 CYP2B6 substrates. Monitor digoxin levels following initiation and termination of Ranexa. Limit dose of simvastatin to 20mg once daily in patients taking Ranexa. Limit dose of atorvastatin and consider clinical monitoring 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. Drugs transported by the Organic Cation Transporter-2 (OCT2): Plasma exposure of metformin increased in subjects with type 2 diabetes mellitus when co-administered with Ranexa. The exposure of other OCT2 substrates may also be affected. 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 breastfeeding. 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, paraesthesia, blurred vision, visual disturbance, diplopia, 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, coordination abnormal, gait disturbance, parosmia, impaired hearing, peripheral coldness, orthostatic hypotension, throat tightness, pancreatitis, erosive duodenitis, oral hypoaesthesia, angioedema, allergic dermatitis, urticaria, cold sweat, rash, acute renal failure, urinary retention, 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: June 2013.

Reference: 1. Chaitman, B.R., et al. JAMA, 2004; 291(3): p. 309-16.

2. Ranexa® Summary of Product Characteristics, April 2013.

Date of item: September 2013

Abbreviated prescribing information is up to date at time of printing; updated prescribing information will be available at www.medicines.ie

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Anaesthesia FEATURE

Strong collaboration in

Anaesthesia.

1

The HSE National Clinical Programme in Anaesthesia (NCPA) believes it has got the focus and attention on key anaesthesia requirements and their essential role in the delivery of a safe and quality service to patients, particularly in the peri-operative environment, Dr. Bairbre Golden, Director of the Programme and Consultant Anaesthetist at the UPMC Beacon Hospital in Dublin tells Maureen Browne.

pictured: dr. Bairbre Golden

O

ne of the key achievements of the HSE National Clinical Programme in Anaesthesia (NCPA) is the improved partnership approach between anaesthesia and healthcare management. At this point, a very strong collaboration has been established, according to Dr. Bairbre Golden, Director of the Programme and Consultant Anaesthetist at the UPMC Beacon Hospital in Dublin.

She said a strong working relationship existed between the Programme, the College of Anaesthetists of Ireland (CAI) and the Irish Standing Committee of the Association of Anaesthetists of Great Britain and Ireland (ISC-AAGBI).

“One of my objectives was to raise the profile of Anaesthesia. We felt that people did not recognise what anaesthetists did or our essential role in governance and quality assurance of peri-operative care. A lot of work has been done around service delivery, the management of the theatre and pre-admission and how intrinsic this is to achieving day surgery admissions, ultimately leading to decreased LOS.

“Twelve months later we believe we have got the focus and attention on key anaesthesia requirements and their essential role in the delivery of a safe and quality service to patients, particularly in the peri-operative environment.

“We continue to work closely with a number of other Clinical Care programmes, including Critical Care, Surgery (Acute, Elective and Orthopaedic) Obstetrics & Gynaecology, Emergency Medicine, Acute Medicine and Transport Medicine. It is that ability to rapidly interface with the other Programmes and the multidisciplinary teams in other care groups which are the foundation of the Programme and on which its success has been built, both for anaesthesia and in my view across the broader clinical care structure.

}

The programme is also working on the development of a national audit tool for anaesthesia.

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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: Topical treatment of mild to moderate acne vulgaris, particularly inflammatory lesions, in adults and adolescents aged 12 years and above. Dosage and administration: Adults and adolescents: Apply once daily in the evening, to the entire affected area. Excessive application will not improve efficacy, but may increase the risk of skin irritation. Frequency of application should be reduced or temporarily interrupted if excessive dryness or peeling occurs. An effect of the treatment may be seen in 2-5 weeks.

Treatment should not exceed more than 12 weeks of continuous use. Children under 12 years: Safety and efficacy has not been established. Elderly: No specific recommendations. After washing gently with a mild cleanser and fully drying, apply a thin film of gel. If the gel does not rub into the skin easily, too much is being applied. Hands should be washed after application. 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, lips, other mucous membranes and areas of irritated or broken skin. Apply with caution to sensitive areas of skin. In case of accidental contact, rinse well with water. Use with caution in patients with a history of regional enteritis, ulcerative colitis, a history of antibiotic-associated colitis or in atopic patients. At first, an increase in peeling and reddening will occur in most patients. Depending upon the severity of these side effects, patients can use a non-comedogenic moisturiser, temporarily reduce the frequency of application or temporarily discontinue use however; efficacy has not been established for less than once daily dosing frequencies. Caution with concomitant topical acne therapy because a possible cumulative irritancy may occur. Discontinue if severe local irritancy occurs. Exposure to sun or sunlamps should be avoided or minimised. If this is not possible, patients should be advised to use a sunscreen and wear protective clothing. Do not use if a patient has sunburn. 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. Avoid contact with hair, fabrics, furniture or carpeting.

Patients with a recent history of systemic or topical clindamycin or erythromycin use are more likely to have pre-existing anti-microbial resistance. Cross-resistance may occur with other antibiotics such as lincomycin and erythromycin when using antibiotic monotherapy. Drug Interactions: Caution with concomitant topical antibiotics, medicated or abrasive soaps and cleansers, soaps 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. Do not use in combination with erythromycin-containing products. Caution with concomitant use of neuromuscular blocking agents as clindamycin may enhance the action of these. Avoid concomitant use of tretinoin, isotretinoin and tazarotene as their efficacy may be reduced and irritation may increase. If combination treatment is required, the products should be applied at different times of the day (e.g. one in the morning and the other in the evening). Simultaneous use with topical sulphonamide-containing products may cause skin and facial hair to temporarily change colour (yellow/orange). Pregnancy and Lactation: Safety in human pregnancy, lactation and fertility is not established. Balance risks against benefits. Should not be applied to the breast area. Undesirable effects: Erythema, Peeling, Dryness, Burning Sensation, Pruritus, Headache, Application Site Photosensitivity or Pain. 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/0002/13. Date of preparation: March 2013.

Date of preparation: November 2011. IE/CBP/0021/11

C

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C A U D

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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

KE

Adverse events should be reported. Reporting forms and information can be found at www.medicines.ie/yellowcardreporting.aspx.

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

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.

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Anaesthesia

shortly. An analysis of this data will be a priority for 2014 and they will be working with all key stakeholders to develop an education profile. There has been strong support for this from the HSE nursing leadership and the leadership of the College of Anaesthesia.

“Our governance structure continues to underpin the Anaesthesia Programme and the Working and Advisory Groups are very active and very well attended. Our lay representative and our multidisciplinary colleagues have been active in influencing the way in which we have delivered the Programme objective and made our outputs stronger.”

“From this we will develop an educational framework for anaesthesia nursing. At present there is a programme in place which goes up to Masters level but nurses with a Masters tend to be in leadership positions and our Programme will be for the education of nurses delivering anaesthesia.

A web-site page for the Programme has been created, under the leadership of John Cahill (it is part of the HSE site) and with the support of Cormac Cullen, www.hse.ie/anaesthesia/. A protocol and process has been agreed for its maintenance to ensure integrity and accuracy. They are now working to develop a secure, password-enabled protected site for healthcare professionals where anaesthetists and anasethetic nurses can put up protocols and exchange information.

Date of preparation: November 2011. IE/CBP/0021/11

8:55:12

The programme is also working on the development of a national audit tool for anaesthesia. “John Cahill is working with the ESRI to see if HIPE data can be used for an audit system. A basic audit will identify the number of anaesthetics given nationally, the complexity profile of the patients and the variation between anaesthesia type (Regional vs. GA) and age profiles. This information can drive the quality agenda as we will be able to make strategic decisions based on the workload in different units. Our aim is to have a feasible National Anaesthesia Audit System proposal for pilot in 2014.”

“The NCPA is continuing to develop the Pre-Admission Model of Care and it is hoped that the working document will be sent out for consultation with all key stakeholders shortly. Once this is signed off, it will constitute a framework document for those involved in preadmission or who want to set up a pre-admission process. We want all those involved to achieve a service which is sustainable in the long term.”

The programme has completed and signed off on a pathway of care for critically ill patients in obstetrics. This was a joint collaboration between the Obstetrics and Gynaecology, Critical Care and

Anaesthesia national programmes.

Dr Golden said, at the request of Prof. Eilis McGovern of the HSE MET (Medical Education and Training), a manpower planning project had been undertaken for anaesthesia resources. This is a joint collaboration, which is being led

by Dr David Mannion of the College of Anaesthetists of Ireland, and involves the NCPA, CAI and ISC-AAGBI. In collaboration with our colleagues in the NCPS, work continues on The Productive Operation Theatre Programme (TPOT)—a skill set to help people address issues in the hospital which are causing delays within the theatre suite, facilitate greater access to surgical services and promote quality and patient-safety within the peri-operative setting.

The NCPA, in collaboration with other interests has also developed a model of care for a National Adult Transport and Retrieval Service for critically ill patients. It is collaborating with the National Transport Medicine Programme, the National Clinical Programmes in Paediatrics, Neonatology, Critical care, Emergency Medicine, Acute and Elective Surgery Acute Medicine and others. A national Steering Group has been set up and work is ongoing.

}

The NCPA, in collaboration with other interests has also developed a model of care for a National Adult Transport and Retrieval Service for critically ill patients.

© iStock/thinkstock.com

Since she took up her appointment, Dr. Golden has personally visited almost every hospital in the country with an Anaesthetic Department,

S

mg ry ve s. a ty en ed ly a en he g. in ng nt If ts ld se m:

“We have strong, multi-disciplinary, representative Working and Advisory Groups that meet on a very regular basis, with Anaesthesia Programme Leads and Anaesthesia Nurse Leads appointed in all hospitals performing surgery throughout the country.

FEATURE

Dr Golden said that they are continuing to work with their nursing colleagues under the leadership of Aileen O’Brien, National Lead for Anaesthetic Nurses on a survey on anaesthesia nurse competencies, which should be completed

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12 weeks of psoriatic arthritis control for

Play without pause

After 2 starter doses, 1 dose of Stelara® every 12 weeks can reliably control the signs and symptoms of psoriatic arthritis.1 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): Plaque psoriasis: 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. Psoriatic arthritis: Alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. DOSAGE & ADMINISTRATION: Under the guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis or psoriatic arthritis. Subcutaneous injection. Avoid areas with psoriasis. For self-injecting patients ensure appropriate training, follow-up and monitoring during treatment. Plaque psoriasis, 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). Psoriatic arthritis, adults & elderly: 45 mg at week 0 followed by a 45 mg dose at week 4, then every 12 weeks. Alternatively, 90 mg may be used in patients with a body weight >100 kg. 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

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to increase the risk of malignancy. No studies in patients with a history of malignancy or in patients who develop malignancy while receiving STELARA. Monitor all patients, in particular those older than 60, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment for non-melanoma skin cancer. 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 appropriate therapy should be instituted and, STELARA discontinued immediately. Immunotherapy: Not known whether STELARA affects allergy immunotherapy. Latex sensitivity: Needle cover contains natural rubber (latex), may cause allergic reactions. SIDE EFFECTS: Common: dental infections, upper respiratory tract infection, nasopharyngitis, dizziness, headache, oropharyngeal pain, diarrhoea, nausea, pruritus, back pain, myalgia, arthralgia, fatigue, injection site erythema, injection site pain, antibodies to ustekinumab. Other side effects include: cellulitis, serious hypersensitivity reactions (including anaphylaxis, angioedema). Refer to SmPC for other side effects. FERTILITY: The effect of ustekinumab has not been evaluated. PREGNANCY: Should be avoided. Women of childbearing potential: Use effective contraception during treatment and for at least 15 weeks post-treatment.

LACTATION: Limited data in humans. INTERACTIONS: In vitro, STELARA had no effect on CYP450 activities. Vaccinations: Live vaccines should not be given concurrently with STELARA, and should be witheld for at least 15 weeks after last dose of STELARA. STELARA can resume at least 2 weeks after such vaccinations. No data on secondary transmission of infection by live vaccines in patients receiving STELARA. Concomitant immunosuppressive therapy: Psoriasis: The safety and efficacy of STELARA in combination with other immunosuppressants, including biologics, or phototherapy have not been evaluated. LEGAL CATEGORY: Prescription Only Medicine. PRESENTATIONS, PACK SIZES, PRODUCT LICENCE NUMBER: STELARA 45mg: 1 x 0.5ml pre-filled syringe. EU/1/08/494/003. STELARA 90mg: 1 x 1.0ml pre-filled syringe. EU/1/08/494/004. MARKETING AUTHORISATION HOLDER: JANSSEN-CILAG INTERNATIONAL NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER INFORMATION IS AVAILABLE FROM: JanssenCilag Ltd, 50 – 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK. © Janssen-Cilag Ltd 2013. Prescribing information last revised: 09/2013. PIVER: 0913.

Reporting suspected adverse reactions is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’, in addition to the traditional post-paid ‘yellow card’ option.

FREEPOST, Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2.

Tel: +353 1 6764971, Fax: +353 1 6762517 Website: www.imb.ie, e-mail: imbpharmacovigilance@imb.ie Adverse events should also be reported to Janssen-Cilag Ltd on +44 (0)1494 567447.

Reference: 1. Stelara SMPC Date September 2013 available from www.medicines.ie Date of preparation: September 2013. PHIR/STE/0913/0002a

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© F1online/thinkstock.com

FEATURE Dermatology

Dermatology outpatient waiting lists down Recent analysis of waiting list figures show a significant reduction in the length of time patients are now waiting for an outpatient dermatology appointment. Maureen Browne reports.

A

nalysis of outpatient dermatology waiting list figures in Ireland up to and including October 2013 has revealed a 47 per cent - 3,540 patients - decrease in the number of patients waiting longer than one year for an outpatients' appointment, according to the HSE National Clinical Programme on Dermatology.

The HSE says that since its initiation of the National Clinical Programme in Dermatology in 2010, the following improvements in service delivery have been realised: � The removal of waiting list 'backlog'. � The introduction of a standard pathway for a patient that includes referral management and an active discharge policy. � The ability to meet the National Cancer Care Programme guidelines and HIQA standards for skin cancer. � Greater supports in place for consultant dermatologists working in isolation in a single handed unit. � Increased clinical governance through

the introduction of both clinical outcome and activity measures.

The HSE says The National Clinical Programme for Dermatology provides guidance for the facilitation of selfmanagement and primary care management of patients with skin problems as appropriate. It also aims to provide a range of other highly specialist skills in tertiary centres.

The overall aim of the Programme is to “significantly reduce the waiting lists for Dermatology services and introduce standardised care”.

According to the HSE this is achieved through the following initiatives: 1. Improved referral management such as restriction of GP referrals for low priority lesions and some rashes.

Restriction of surgical removal of certain low priority lesions. These proposals are being developed in consultation with the GP member of the implementation group.

2. Improved management of return

patients: Active discharge policies.

Development of nurse review clinics.

3. Critical consultant appointments in areas that have a very low ratio of dermatologists per head of population. This has been an overarching aim of the Southern Irish Association of Dermatologists group for many years.

4. Clarification of regional/hospital 'catchment' areas for Dermatology.

5. Critical appointment of consultants with dermatologic surgery expertise to deal with the growing number of skin cancers in Ireland. This is being done in conjunction with the NCCP.

}

The overall aim of the Programme is to significantly reduce the waiting lists for Dermatology services and introduce standardised care.”

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Primary Care FEATURE

Primary care vitally important

to future developments of Clinical Programmes

Much of the future development of the HSE National Clinical Care Programmes is dependent on how the primary care services are resourced and supported to manage chronic disease in the community, writes Maureen Browne.

I

t is recognised that much of the future development of the highly successful HSE National Clinical Care Programmes is dependent on new arrangements which will see much of chronic disease managed and cared for in the community.

the country’s GPs, which will involve greater support and resources for family doctors who are already struggling to deal with their current workload. The GPs will be the cornerstone of the ambitious strategy to treat over 90 per cent of patients in the community.

However, GPs would say they are

}

State spending on PCCs is understood to have been slashed from €17.5 million in 2011 to €6.1 million in 2012.”

© iStock/thinkstock.com

The transfer of a significant amount of chronic disease management from hospital to the community, including some complex cases, would free up the hospitals to deal with more acute patients, which is

a basic tenet of the Programmes, in line with good medical practice and would significantly reduce current unacceptable waiting lists in many specialties. It could also be expected to result in a significant reduction in overall costs, which are set to spiral in line with our ageing population.

This is going to require a new deal with

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For the treatment of idiopathic Parkinsonâ&#x20AC;&#x2122;s disease as monotherapy or as an adjunct to levodopa

Legal Category: POM. Marketing Authorisation Holder: Teva Pharma GmbH, Germany. Marketing Authorisation Numbers: EU/1/04/304/003 Tablets 1mg 28 pack. Further information may be obtained from Lundbeck (Ireland) Ltd., 7 Riverwalk, Citywest Business Campus, Citywest, Dublin 24, Ph: 01-4689800 email: medi@lundbeck.com AZ2/6/13

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5:34

© Ingram Publishing/thinkstock.com

Primary Care FEATURE

certainly not in a position to take on additional work. The increasing demand for GP services, a shortage of GPs, the recession, long waiting lists for public hospital specialist appointments and the fact that more and more disease can now be managed in the community have all contributed to the increasing burden on general practice.

The transfer of further services to the community will require the full implementation of the long promised new primary care infrastructure, with integrated multi-disciplinary primary care teams including general practitioners, nurses, physiotherapists, occupational

therapists , dental services, community mental health services, child and adolescent mental health services, early intervention teams and doctor-on-call services working in Primary Care Centres.

The HSE has stated that 484 Primary Care Teams were in place by end of 2013.

The government’s Primary Care Strategy argues that in a developed primary care system, up to 95 per cent of people’s day-to-day health and social care needs can be met in the primary care setting thereby avoiding the need for them to go to hospital.

However, this is predicated on a network

of Primary Care Centres throughout the country. These centres, if fully operational should be able to deliver the kind of reform needed. However, their development has been dogged by lack of resources.

While there are about 100 PCCs around the country it is estimated that only slightly more than half of these are fully operational. Thirty four centres have been opened since March 2011. However State spending on PCCs is understood to have been slashed from €17.5 million in 2011 to €6.1 million in 2012, with a further reduction last year. The Minister has announced that a further 16 Primary Care

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Could your patients be at risk?

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ASK AB O

Alcohol is a direct cause of more than 30 diseases.* Why not discuss drinking habits with your patients today? You could uncover vital information about their health and risk of disease.

A T H E F U LL P

*Global Status Report on Alcohol and Health, World Health Organization, 2011. SEL7/3/13

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Primary Care

FEATURE

Mr. Hennessy said that by the best reckoning primary care and social inclusion provided services to about 3.5 million people each year.

© Digital Vision/thinkstock.com

A successful system would see primary care managing the majority of patients who required a routine straightforward level of urgent or planned care, with treatment being delivered at home or a close to home as possible. Hospital and specialist services managing the minority of patient who required emergency and complex planned care, where the relevant expertise is concentrated and long stay providing residential care for those who needed it.

“The obvious priority is to have all services working a single integrated system and for patient journeys through the system to be as seamless and as delay free as possible.”

This is the obvious priority. The current year will see how far and how quickly we can move towards it realisation.

Centres are to be build under a €115 million public private partnership.

The Primary Care Directorate was established in 2013 to lead the implementation of primary care reform.

Mr. John Hennessy, HSE National Director Primary Care, spelled out his vision for the development of services at last Autumn’s Annual Conference of the Health Management Institute of Ireland.

He said many services previously accessible in hospitals were now possible in local communities and central to the modernisation of the health service was the development of a greater range and volume of community based services to accommodate these changes.

Priorities which were now being worked on to deliver the commitment that 90 per cent of care would be provided in primary settings included: � Targeted investment to address gaps in key primary care services – e.g. chronic illness management, ophthalmology and diagnostics. � Improving the primary care infrastructure in the form of better Primary Care Centres and ICT enabled communications.

� Extending the coverage of Community Intervention Teams (with an increased emphasis in the greater Dublin area) to facilitate hospital avoidance and resolve delayed discharge problems. � Facilitating the discharge of complex patients to primary care – this must be done safely and in accordance with clinical governance standards. � Providing for demographic pressures and demand-led growth in medical cards and local schemes. � Reducing costs in areas like generic prescribing for drugs and medicines and introducing reference pricing for commonly prescribed products. � Expanding programmes that worked in social inclusion such as the needle exchange and methadone replacement programmes and targeting specific funding to address disadvantaged groups and increasing levels of homelessness. � Reporting primary care activity in a way that fairly reflected the scale of the work.

Mr. Hennessy said the overall objectives were the positioning of primary care so that it fulfilled its potential as a central part of the health care system and was strong on productivity, results and achieving targets.

}

By the best reckoning primary care and social inclusion provided services to about 3.5 million people each year.”

PICTURED: Maureen Browne

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FEATURE Clinical leads

Clinical LEADS The clinicians heading up the HSE Clinical Programmes are:

Dr Aine Carroll HSE National Director Of Clinical Strategy & Programmes

Dr Ronan Canavan National Clinical Lead HSE National Diabetes Programme

Dr Diarmaid O’Shea National Clinical Lead HSE National Programme For Older People

Prof Oliver Fitzgerald National Clinical Lead HSE National Programme On Rheumatology

Mr Paul Moriarty National Clinical Lead HSE National Programme For Ophthalmology

Dr Ian Daly National Clinical Lead HSE National Programme On Mental Health

Ms Aisling Heffernan Programme Manager HSE National Audiology Clinical Care Programme

Prof Pat Manning National Clinical Lead HSE National Asthma Programme

Prof Tim McDonnell National Clinical Lead HSE National Copd Programme

Prof Peter Kelly and Dr Joe Harbison Joint National Clinical Leads HSE Stroke Programme.

Prof Ken McDonald National Clinical Lead HSE Heart Failure Programme Dr Bairbre Golden Director HSE National Clinical Programme For Anaesthesia

PICTURED: Dr Colin Doherty

PICTURED: Prof Pat Manning

PICTURED: Dr Diarmaid O’Shea

PICTURED: Dr Ronan Canavan

Dr Peter Kavanagh and Dr Niall Sheehy Joint National Clinical Leads HSE National Radiology Programme Prof Kieran Daly National Clinical Lead HSE National Acute Coronary Syndrome Programme Dr Colin Doherty National Clinical Lead, HSE National Programme On Epilepsy Dr Liam Plant National Clinical Director HSE National Renal Office Prof Alf Nicholson and Prof John Murphy Joint National Clinical Leads HSE National Programme For Paediatrics & Neonatology - Prof Nicholson (Paediatrics) Prof Murphy (Neonatology)

88 | CLINICAL CARE

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The

Clinical Care Journal

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The latest developments in Irish healthcare // February 2014

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BUILDING A BETTER HEALTH SERVICE

IMPROVING QUALITY, ACCESS AND COST EFFICTIVENESS OF SERVICES CARDIOLOGY // EPILEPSY // RHEUMATOLOGY

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