Austrlian Journal of Pharmacy March 2013

How to support hypertension management

VITAMINS & SUPPLEMENTS Advising on complementary medicines

GENERICS Explaining the dollars and sense AUSTRALIAN JOURNAL OF PHARMACY

Packs a punch TO DISCOVER WHICH GENERIC COMPANY OFFERS YOU MORE, TURN TO PAGE 12

IN SIDE

FLU SHOTS GUILD ON PHARMACYLED VACCINATIONS

KEARNEY REPORT UK PAPER HINTS AT PHARMACY’S FUTURE

SANSOM REVIEW CPD & PI MIXED REACTIONS EARN 5.5 CREDITS TO REPORT THIS ISSUE

FEBRUARY 2013

BLOOD PRESSURE

VOL 94

CONTENTS

32

FEBRUARY 2013 VOL.94 NO.1113 The complete professional and business journal for pharmacists

40

FEATURES PROFESSIONAL 32 | HYPERTENSION

Pressure mounts on hypertension action New research has confirmed the role of the pharmacist in reducing blood pressure via a combination of medicines review and patient engagement.

OVER THE COUNTER 40 | VITAMINS & SUPPLEMENTS

Complementing patient support with knowledge Consumers want the advice of their pharmacist when it comes to complementary medicines.

BUSINESS 45 | GENERICS

Preparing for the rising tide of price disclosure Profitability from generics is a short-term bonus that should be invested in preparation for leaner times.

EDUCATION

AJPCPD

Accreditation number: CX130002 Upon successful completion of the associated assessment, the activities in this issue have

REGULARS NEWS AND REVIEW

PRODUCT NEWS

04 News

38 OTC

been accredited for 2.75 hours of Group 2 CPD

08 Wry side of the counter

(or 5.5 CPD credits) suitable for inclusion in an

10 Editorial

BUSINESS

individual pahrmacist’s CPD plan.

14 Political capital

44 Company news

16 Pharmacy Guild of Australia

51 Retail management

54 | DISEASE STATE MANAGEMENT

Anxiety and social phobia disorder 60 | CLINICAL PHARMACY

Dispersible aspirin tablets repacked into dosette boxes: Caution in practice 64 | THERAPEUTIC INSIGHT:

Therapeutic insight: the statins 67 | CURRENT DRUG INFORMATION

18 Pharmaceutical Society of Australia 20 Pharmacy Board of Australia

EVENTS r 14A Offshore Refresher

PROFESSIONAL

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22 Consumer health promotions

of Pharmacy Annual Conference

23 Practice updates

r "11 r $BMFOEBS

26 Rural matters 28 Medication in review

71 | SELF ASSESSMENT The cover image was supplied by Pharmacor and is linked to the Pharmacor advertorial on 12.

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

3

NEWS AND REVIEW

Sparks fly over Sansom review T

for the newer anticoagulant medicines,

those with reduced kidney function.’

but would like to see further economic

‘I am keen to give patients and

modelling to show the value of these

clinicians certainty about how these

new anticoagulants, in light of the

newer anticoagulants fit into treatment,

additional information now available.’

so I had the matter considered by

‘Mindful of the need to finalise its

the PBAC at the first opportunity, on

recommendation as soon as possible,

13 December 2012,’ Ms Plibersek said.

the Committee will allow the sponsor of

‘The Committee has advised me

dabigatran and the sponsors of other

here were mixed reactions to the

Goods Administration (TGA) to review

that based on the new information

new oral anticoagulants to make a late

pre-Christmas (2012) release of the

the safety information for dabigatran

that has arisen about this drug’s use

submission to the March 2013 meeting.

Sansom Review of Anticoagulant

and to continue doing so regularly.

in clinical practice, it is now concerned

Therapies in Atrial Fibrillation.

Since the previous 2011 PBAC

‘It’s important the companies have

about whether dabigatran represents

the opportunity to respond to the

recommendation, the TGA has issued

value for money at the price offered by

Committee’s comments, and provide

Society of Australia and NPS

two safety advisories for dabigatran

the company.

the data and economic modelling

MedicineWise endorsed the review,

relating to increased risk of bleeding

Medicines Australia reacted angrily

especially for people over 75 years, and

advised me that it is of a mind to rescind

to its recommendation that further

the need to monitor kidney function.

its March 2011 recommendation for

research was needed before new oral

This highlights the need for caution

dabigatran. ‘The PBAC feels there is an

While the Pharmaceutical

anticoagulant medicines, like dabigatran (Pradaxa) could be listed on the PBS. Indeed, Medicines Australia chief executive Dr Brendan Shaw went so far as to describe findings in the Sansom Review (as they relate to the listing of new anticoagulants) as a two-year bureaucratic merry-go-round.

‘The government’s expert committee reviewed Pradaxa almost two years ago.

The government then ordered a review of that decision. Now it’s demanding a review of that review.’

But, according to the Minister for Health, Tanya Plibersek, recent findings necessitated reassessing the new oral anticoagulants.

‘Australia is a world leader in health technology assessment and we make no apology for thoroughly assessing the effectiveness and costeffectiveness of new drugs; balancing access to new medicines while also protecting public safety.’

The review concluded that: ‘the net benefit of NOACs in clinical practice and the subsequent impact on costeffectiveness is uncertain at this stage and the PBAC should review its March 2011 advice to list dabigatran on the Pharmaceutical Benefits Schedule’.

The Minister also said that as a result of the safety questions raised in the

in prescribing this drug for some

‘Because of this, the PBAC has now

appropriate place in clinical treatment

…but tick from PSA

P

SA national president Grant Kardachi has welcomed the Sansom Review’s recommendations for shared care and collaboration between health professionals in the management of anticoagulation therapy in patients with atrial fibrillation (currently affecting 300,000 Australians).

‘This report, and the involvement of pharmacists in implementing its important recommendations, will make a significant difference to AF patients.

‘Atrial fibrillation is a significant contributor to the incidence of strokes that are associated with high morbidity and mortality,’ Mr Kardachi said.

‘The report makes a number of very positive recommendations which when implemented will better utilise the skills and services of pharmacists.’

Mr Kardachi said one such recommendation was the use of point-of-care testing (PoCT) for the measurement of INR values, which

review, she had asked the Therapeutic THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

4

patients—specifically the elderly and

determine appropriate dosing, as an option for warfarin management, particularly in the community setting.

‘The report highlights that this could involve a collaborative sharedcare arrangement between a patient’s medical practitioner and other health professionals with whom the patient has regular and convenient contact and specifically points to pharmacists in this regard,’ Mr Kardachi said.

‘Further the report recommends a nationally endorsed shared-care model for warfarin monitoring and management between health practitioners be developed which once again provides opportunities for pharmacists to be part of the collaborative approach.

‘Pharmacists could potentially become more involved in the identification of people with AF, helping to implement guidelines, educate patients, improve the use of anticoagulant medications and monitor patients.’

Clinical adviser at NPS

it requested,’ Ms Plibersek said. ■ The Sansom review was undertaken by Emeritus Professor Lloyd Sansom AO, former chair of the PBAC.

MedicineWise Dr Danielle Stowasser says that oral anticoagulant medicines, including warfarin and the newer anticoagulants, play an important role for people with atrial fibrillation.

‘The Sansom Review highlights important issues including the need for optimising warfarin treatment, the importance of establishing national guidelines for the use of anticoagulant medicines, and the uncertainty that surrounds the overall benefit of the new oral anticoagulants,’ says Dr Stowasser.

‘Warfarin has been used successfully for over 50 years and remains the mainstay of anticoagulant therapy.

‘All medicines have both risks and benefits, and in the case of anticoagulants—old and new—there are safety issues with all of them.’

To help address these safety issues, NPS MedicineWise (by the time you read this) will have launched an educational program (called: Achieving Good Anticoagulant Practice) for health professionals and for consumers explaining the optimal use of oral anticoagulants—including both warfarin and the newer oral anticoagulants. ■

NEWS AND PSAREVIEW

Electronic script workshops C

ommunity pharmacy has evolved as the ‘first’ computerised health profession by embracing connectivity through broadband for health and by integrating Electronic Transfer of Prescription (ETP) in the workflow. Pharmacists will now be able to take the next step in the pharmacy ehealth journey said the Pharmacy Guild of Australia.

ETP is the cornerstone of electronic medication management and gives community pharmacists time to provide additional focused care for patients.

Funding has been provided under the Fifth Community Pharmacy Agreement (5CPA) for the Electronic Transfer of Prescription Education Program. The Program aims to educate the community pharmacy workforce about electronic medication management and specifically the role of ETP in Australia’s ehealth landscape.

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facilities has recently been released by the

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Guiding principles for medication

The guiding principles have been developed under the lead of the National

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On-premises visits from the ehealth team are designed to provide community pharmacies with the knowledge necessary to start using ETP. Pharmacies will also be assisted with the signup process to be ‘ehealth enabled’ and formulating an action plan to engage prescribers in their local area to register to participate in ETP. To be eligible your pharmacy must meet one or more of the following conditions: UIF QIBSNBDZ IBT SFDFOUMZ

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laxoSmithKline (GSK) has initiated

by the recall,’ advised Acting Chief Health

a retail level recall of 10 batches of

Officer of NSW Dr Tony Penna. ‘To confirm the relevant batch number,

The new document does not provide

r .BDLBZ 2VFFOTMBOE

clinical practice guidelines for particular

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health conditions or procedures and is

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not intended to be used as accreditation

* The dates for 2013 will be

standards or a comprehensive policy and

released on the Guild website.

procedure manual for services.

Rather, the guiding principles

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RACFs to develop, implement and

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evaluate locally specific policies and procedures to support those involved

To register your interest visit: https://

in assisting residents with using and

pharmacyguild.wufoo.eu/forms/

managing their medicines.

onpremise-visit-expression-of-interest/

Ventolin and Asmol inhalers recall Ventolin and Asmol Inhalers due to

A

revised version of the Australian

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Revised guidelines for RACF medication management

immediate medical attention.’

The 17 guiding principles cover matters such as the operations of medicines advisory committees, nurse initiated medicines, medication charts, dose administration aids and medicine reviews.

The Pharmacy Guild has advised

Affected batches are: 7&/50-*/ CBUDI OVNCFST ,/

all pharmacists involved in supply

a fault in the delivery mechanism leading

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and servicing of residential facilities

to an inconsistent dose.

and the batch number will be found on the

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to familiarise themselves with the

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bottom of the canister label. If they identify

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revised principles with consideration

of the active medication, salbutamol, may

that they have one of the affected inhalers,

,-

of application to current local

not be delivered in full. In some cases,

it can be returned to their pharmacy for a

approximately one third of the normal dose

free replacement. Should people using

other delivery forms of Ventolin and Asmol

may be delivered per puff of the inhaler.

the affected batches of Ventolin or Asmol

or other respiratory medicines. â–

‘People who use Ventolin or Asmol

inhalers experience a worsening of their

This batch recall does not affect any

arrangements. â– The new principles are available at: www.health.gov.au/internet/main/

inhalers should check the batch number to

asthma or have concerns about the use

www.tga.gov.au/safety/alerts-

publishing.nsf/Content/D9282D3CCC0BF2

see if the inhaler they are using is affected

of their inhaler, they are advised to seek

medicine-ventolin-asmol-121224.htm

BCCA257AA00007134A/$File/Guiding%20 principle

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

5

NEWS AND REVIEW

NZ pharmacists able to prescribe P

harmacists in New Zealand will now be offered specialist postgraduate training to prescribe medications.

The new pharmacist prescriber practice was developed by the Pharmacy Council of New Zealand with the support of Health Workforce New Zealand.

‘The pharmacist prescriber will be able to prescribe from around a list of 1800 medicines, however, only within their area of expertise and practice, and in collaboration with a medical practitioner. So if a pharmacist is working in a gout clinic then you will identify those medicines that fall in your area of practice and prescribe those.

‘The safeguard here is that the initial diagnosis and the overall clinical care of the patient rests with the medical practitioner,’ said Pharmacy Council of New Zealand chair Andrew Bary.

According to Mr Bary after ‘wide and repeated consultation with all stakeholders’, the Pharmacy Council has developed a prescribing competency framework, and prescribing competencies against which the pharmacist prescribers will be assessed during their training.

‘This whole new area of practice is all about integrative care and is the opposite of fragmentative care.’

The Pharmacy Council has prescribed the qualification for the pharmacist prescriber scope of practice to be a universitybased post-graduate qualification.

Accreditation standards for the

prescribed qualification have been developed and will be used to accredit the qualification for the scope.

A guidance statement regarding the prerequisite postgraduate qualification for entry into the pharmacist prescribing has been produced, Mr Bary said.

Despite concerns about a potential conflict of interest, Mr Bary said the Ministry of Health in New Zealand: ‘has clearly set out that a pharmacist prescriber cannot hold any interest in a pharmacy. This is a priority and a non-negotiable condition right from the start’.

Last year, Health Workforce New Zealand provided

SPF 50+ hits shelves

S

Symbion and Apotex join forces

A

n expanded Pharmacy Choice program will now give access to a selected range of generic PBS

medications, as part of a five-year strategic agreement between Symbion and Apotex.

Under the agreement, Apotex will be the first-line supplier of generic PBS medicines, producing a comprehensive range of Pharmacy Choice branded private label products for its 700+ members and the independent market.

The move was a logical extension of the program’s ongoing success, said Symbion CEO Patrick Davies: ‘Our customers have been telling us that they want to be able to offer their patients continuity of brand from the dispensary as well.’

Apotex managing director Roger Millichamp said the agreement was a reflection of their combined strengths: ‘The proven competencies of both Apotex and Symbion around product quality, patent expiry pipeline, wholesale service delivery and retail support provide the foundation for the commercial imperatives that lie ahead for retail pharmacy. ■

every two hours as they may rub off through towelling, swimming or perspiration. Sunscreens that are

unscreens sold in Australia now

damage) and UVB (sunburn causing)

not water-resistant may need to be

include products authorised to

radiation. Despite the higher SPF, new

used more often.

display a Sun Protection Factor

50+ sunscreens should be used in the

(SPF) rating of up to 50+.

SPF50+ sunscreens offer greater protection against both UVA (causes skin

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

6

funding assistance towards course costs for a capped number of pharmacists who are eligible to undertake the university based pharmacist prescribing qualification. This funding is for the purposes of a demonstration project.

Health Workforce New Zealand have also confirmed the commencement of the regulatory process required to implement designated prescribing rights for pharmacists under the Medicines Act 1981.

The Ministry of Health aims to align implementation of designated prescribing rights with the date that the first pharmacist prescribers graduate.

The program has 14 pharmacists who have completed the new postgraduate certificate in pharmacist prescribing, which builds on the postgraduate diploma in clinical pharmacy.

Seven of the pharmacists who undertook the training worked in hospitals, while the other half worked in primary care. ■

same way as the 30+ sunscreens.

All sunscreens should be applied liberally and re-applied

The Therapeutic Goods Administration has already accepted applications from sunscreen suppliers and manufacturers for these new products to be added to the shelves.

Products that meet the old standard, SPF 30+, will continue to be available.

Pharmacy Guild of Australia national president Kos Sclavos said: ‘While the SPF indicates the level of UV protection, people with sensitive skin and children need to consider other factors when selecting a sunscreen, and everybody should continue to be smart about their exposure to the sun.’ ■

THAN OTHER PATCHES

*1-3

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PHASE 1 RAPID INITIAL DELIVERY P

4

4

Stop smoking aid. Contains nicotine.

References: 1. DeVeaugh-Geiss AM et al. Clinical Therapeutics 2010;32(6):1140–48. 2. Chen LH et al. Direct comparison of bioavailable nicotine from three marketed transdermal patches.

10th Annual Conference of the SRNT Europe 2008. 3. Fant RV et al. Pharmacol Biochem Behav 2000;67:479–82. 4. Nicabate Approved Product Information.

Nicabate® and Smart Control™ are trade marks of the GlaxoSmithKline group of companies. Nicorette ® is a trademark of Johnson and Johnson. Nicotinell® is a trademark of Novartis.

11/12 GSK00683/UC/AJP

NEWS AND REVIEW THE WRY SIDE OF THE COUNTER

At the mercy of pedants Pharmacy tales by David Pay*

‘H

ello,’ I said, juggling the telephone like a Dagwood dog between the edge of my chin and my shoulder. It was the beginning of June and, in other parts of the country, bodies would be plunging down ski slopes.

On the telephone, head office’s minion complained to me: ‘Rejected script… authority for Prolia… $298… more care needed… fix it up.’

‘When was it dispensed?’

‘March.’ The minion was brusque and indignant. She recited the date, prescription number and patient’s name.

‘I only started here a fortnight ago,’ I said.

She hesitated for a moment, contemplating the winter of her discontent. ‘Well, fix it anyway. That’s what we pay you for.’

I don’t mind a challenge. I’m one of those people who begins his day with black coffee and a glance at the morning paper. I start at the back…at the cryptic crossword.

I try the chess problem. I try the backgammon problem. Then I turn to the front page. Like a detective, I enjoy puzzling things out. I would make a good Sherlock Holmes… or a Charlie Chan. I like Charlie Chan— he has superior aphorisms.

Honourable father say: Investigation best way to find answer. So, with the minion in mind, I investigated. I began by opening up the patient’s history and immediately found the entry for Prolia Injections. The claim seemed, to me, to be in tip-top shape—date, doctor, authority number, etc—so I checked the pharmacist’s initials.

‘Who dispensed this?’ I asked

the dispensary technicians, both of whom had been drawn by curiosity to my computer screen. ‘Who’s ‘DT’?’

They both shrugged. ‘Gone,’ said one of them.

Charlie Chan: Bad alibi like dead fish—cannot stand test of time.

‘Gone where?’

They looked at me oddly, apparently not familiar with the precept of role playing.

My next step was to get a feel for Prolia, a product with which I was not familiar, and I discovered it to be a six-monthly subcutaneous injection for postmenopausal osteoporosis for which an authority from the Pharmaceutical Benefits Scheme is required (no repeats). Why had the claim been rejected? Very odd. Always very hard winter when honourable cheese run after mouse.

Next I telephoned the Health Insurance Commission. ‘Ah-hah,’ said a disembodied voice, the euphemistically dubbed consultant.

‘The prescription was written on February 28th using a Steamline Code… needed a phone authority.

Doctors could only use the Steamline Code for Prolia after March 1st.’

‘One day… but it wasn’t dispensed until half way through March.’

The consultant’s tone was patient.

‘It was still written in February.’

I decided to speak to the prescriber.

The way things were going it would probably turn out to be a relative of the evil genius Dr Fu Manchu. How wrong can you be? The doctor was female and exceptionally affable.

I put her in the picture. ‘The owner is concerned about being up the spout for $298.’

She was mortified. ‘Really sorry.

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

8

I’m trying to remember what happened… my computer would have picked up the Streamline Code automatically. A day early? Why?… unless one of my girls ran the updates a day early… extremely unlikely.’

She hesitated for a moment and then adopted a decisive manner.

‘Never mind. I’ll fix it with the department.’ And she disappeared off into the ether.

In the interim I tried to find the fabled pharmacist, DT; a vain ambition as it turned out.

‘But I do seem to remember something,’ ventured one of technicians. ‘I do remember a box asking for codes for an authority and the computer didn’t want to accept what I was entering. So I pressed the close button. And it all went away.

No problem.’

‘What d’you mean no problem…

That key stroke cost us $298.’

By now the telephone was ringing and the benign version of Dr Fu Manchu was back on the line. ‘Sorry. The Department says you should have picked up the date anomaly on your computer, so it’s your problem. I can’t write a new authority because the patient will need another supply in September and they’ll disallow it… too early.’

‘All a bit pedantic if you ask me.’

She sighed. ‘Perhaps tomorrow will be a better day.’

I smiled inwardly. Confucius say, sleep only escape from yesterday. O * David Pay is a former community pharmacy owner and continues to do locum work.

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DermAid. What a relief!

Always read the label and use only as directed. If symptoms persist, please see your healthcare professional.

References: 1. Woodford R & Barry BW. Report on vasoconstrictor study on hydrocortisone preparations. School of Pharmacy,Portsmouth Polytechnic and School of Pharmacy, University of Bradford. England 1985 2. D07A – Plain Topical Corticosteroids Market, MAT Units & Dollars, June 2012. Ego Pharmaceuticals Pty Ltd. 21-31 Malcolm Road, Braeside 3195 Australia. ph: +61 3 9586 8800 Toll Free: 1800 033 706. ‘Ego’ and ‘DermAid’ are trademarks of Ego Pharmaceuticals Pty Ltd. 1012 Ego© ask@egopharm.com www.egopharm.com EGO00185 7/12

NEWS AND REVIEW EDITORIAL

THE AJP IS 100% OWNED BY PDL PHARMACIST MEMBERS

Members of PDL receive the AJP every month at no charge. This is PDL’s way of sharing with its members the benefits of owning Australia’s most authoritative and influential pharmacy journal.

Isaac Bober, editor, AJP

Advancement of pharmaceutical knowledge

‘T

he more things change, the more they stay the same,’ or so said Jean-Baptiste Alphonse Karr, and he might well have been talking about this very journal.

You see, when the Australian (or Australasian) Journal of Pharmacy was launched in January 1886—making it Australia’s oldest (after the Bulletin closed in 2008), continually-published journal of record/commentary—it was positioned as being ‘dedicated to the advancement of pharmaceutical knowledge’.

More than 126 years later the AJP is still dedicated to the advancement of pharmaceutical knowledge. Flick through one of the first issues of the journal and compare it with the issue you’re reading right now and the bones of the thing are the same.

To that end, I’d like to pay homage to all the editors who’ve worked on the AJP before me and in particular to my immediate predecessor, Matthew Eton, who lived and breathed pharmacy. He’s handed over the title in good health and now it’s up to me and the rest of the team at APPco to continue his good work.

Going forward, all of us here at the AJP are looking forward to ensuring the title

maintains its position as the journal of pharmacy. To do that, we’ll continue to bring you the same informative and insightful copy we always have and a whole lot more.

This year, if the conversations I’ve been having with pharmacists and industry representatives are anything to go by, is going to be an interesting one. For one, there’s an election coming up and just what the two sides have in mind for pharmacy remains to be seen.

Obviously there are more issues confronting the industry than the election, but I’ll refrain from clambering up onto my soap box just yet…

It’s worth reminding you that the AJP is your magazine. Since 2000, APPco (which publishes the AJP) has been owned lock, stock and barrel by PDL and it, in turn, is owned by its member pharmacists, and that means you.

So, as is traditional with every new editor taking over a title, I’d like to know what you like, don’t like about your magazine. Is there something else you’d like to see in the AJP? Drop me a line at Isaac.Bober@appco.com.au and let me know.

THERE’S AN ELECTION COMING UP AND JUST WHAT THE TWO SIDES HAVE IN MIND FOR PHARMACY REMAINS TO BE SEEN

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

10

EDITORIAL AND ADVERTISING OFFICES Level 5, 8 Thomas Street, Chatswood NSW 2067 TELEPHONE: (02) 8117 9500 FACSIMILE: (02) 8117 9511 WEB SITE: www.appco.com.au Editor: Isaac Bober (02) 8117 9542 EMAIL: isaac.bober@appco.com.au Managing Editor: David Weston Associate Editor: Janet Doyle Education Editor: John Chapman Journalist: Jayamala Gupte Feature writers: Steven Chong, Lisa Offord ADVERTISING INQUIRIES National Sales and Marketing Manager: Nicole Barry (02) 8117 9522 nicole.barry@appco.com.au Advertising Account Managers: Jeff Johnston (02) 8117 9523 jeff.johnston@appco.com.au Amanda Bennetts (02) 8117 9525 amanda.bennetts@appco.com.au Art Director: Steve Wilson www.wetdog.com.au Production and Advertising Co-ordinator: Lee Priday BOARD OF DIRECTORS John R Coppock (Chairman) FPS, FAICD, FACPPM Paul Naismith, BPharm, MPS David Mattingly David Weston, BA, DiplM-Lib, DipEdPub Robert Scanlon, PhC, FPS, MACPP, MSHPA NON-PDL MEMBER SUBSCRIPTIONS Within Australia $180 pa GST inclusive All other addresses AUD$240 pa Single copies: Within Australia $15.00 GST inclusive Overseas $25 (includes postage) Inquiries (03) 9810 9900 The Australian Journal of Pharmacy is published each month by the Australian Pharmaceutical Publishing Company Pty Ltd. ACN 004 082 053 Registered office: 40 Burwood Road, Hawthorn Vic 3122 Tel: (03) 9810 9900 Fax: (03) 9819 1706 Printed and bound by DAI Rubicon ISSN 0311-8002 © 2013 APPCo Pty Ltd. All AJP material is copyright.

Reproduction in whole or in part is not permitted without the written permission of the publisher.

Circulation: 18,415 September 2012 Australia’s largest circulating pharmacy publication

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PHARMACOR COVER ADVERTORIAL

How to support hypertension management

VITAMINS & SUPPLEMENTS Advising on complementary medicines

GENERICS Explaining the dollars and sense

VOL 94

FEBRUARY 2013

BLOOD PRESSURE

AUSTRALIAN JOURNAL OF PHARMACY

Packs a punch TO DISCOVER WHICH GENERIC COMPANY OFFERS YOU MORE, TURN TO PAGE 12

IN SIDE

FLU SHOTS GUILD ON PHARMACYLED VACCINATIONS

KEARNEY REPORT UK PAPER HINTS AT PHARMACY’S FUTURE

SANSOM REVIEW CPD & PI MIXED REACTIONS EARN 5.5 CREDITS TO REPORT THIS ISSUE

Make sure it’s

Pharmacor ESTABLISHED IN 2007 THE COMPANY AIMS TO TAKE ON THE MAJOR PLAYERS AND BECOME A HOUSEHOLD NAME.

O

ne of Australia’s fastestgrowing pharmaceutical companies, Pharmacor, wants to be seen as more than just a

But ensuring the ‘right look’ is only part of the brand’s attraction.

‘Here at Pharmacor we know how tough it’s becoming, as a pharmacist,

generics supplier. Indeed, the company

to turn a profit—I’m a registered

born and bred on Sydney’s Northern

pharmacist—and that’s why we’ve

Beaches wants its

negotiated hard with our

products to be considered

suppliers to ensure the

as an alternative brand,

best possible pricing.’

While other generics

offered in the first instance by pharmacists when a

suppliers pull their sales

customer presents with

forces off the road and

an ailment.

put them behind a phone and a fax, Pharmacor has

And to do that, Pharmacor has focussed heavily on

kept its rep’s on the road. But it’s also

packaging design, making its over the

set up a call centre to cater for time-poor

counter (OTC) range of medicines look

pharmacists, thus offering its customers

every bit as slick as the ‘innovator’ brands.

the best of both forms of service.

Its Ethical range, however, maintains a clinical and discreet appearance as

‘We’re only a small team but we pride ourselves on having a committed sales

befitting the nature of

team that gets out and

prescription medicines.

meets with our clients face-to-face as often as

PREMIUM BRANDING

possible,’ says JP.

‘Pharmacists shouldn’t be on the back foot or

ON DISPLAY

embarrassed when

The launch of Gastrex

recommending a generic

(December 2012), the

product, nor do we want

bioequivalent of the

the general public feeling

segment innovator

they’ve somehow been sold down into

(Imodium®*), sees Pharmacor go head-

buying an inferior product. Hence we put

to-head with both Imodium®* and one

a lot of effort into our packaging to ensure

other generic. Gastrex is only the second

pharmacists and assistants alike are proud

bioequivalent generic in this segment.

to recommend “the alternative brand”,

‘We’re both excited and proud to

says director at Pharmacor, Jean Pierre

be offering Gastrex to pharmacists,

Salama (who prefers to be known as JP).

because it’s great value, packaged

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

12

‘WHAT I LIKE ABOUT PHARMACOR IS: ONE, IT’S AUSTRALIAN-GROWN AND OPERATED; TWO, THAT THE PRICE IS THE PRICE IS THE PRICE; AND THREE, THE HIGH QUALITY OF THE PRODUCT.’ OLEY VIENGKHOU, CAMPSIE PHARMACY

PHARMACOR COVER ADVERTORIAL

The right look at the right price!

Pharmacor offers branded generic OTC

Loratadine, Trust Cetirizine, Trust

together with the fluconazole capsule;

medicines in the following categories:

Fex—fexofenadine

Trust Nystatin Oral Drops; Sleepwell –

Analgesic Pharmacor was first to

Cold & Flu Trust Day Night Cold & Flu

doxylamine 25mg.

market with Mydol 15—paracetamol

Relief; Trust Sinus Pain Relief PE Day &

Other Along with Calcium

500mg, codeine phosphate 15mg. It

Night tablets

Supplements, Glucosamine tablets and

also offers: Trust Ibuprofen Plus Codeine;

Digestive health Gastrex—loperamide

a Topical Minoxidil preparation, one of

Trust Strong Pain—paracetamol

2mg; Trust Kolexeze—stool softener;

the brand’s best sellers has been Trust

500mg, codeine phosphate 10mg; Trust

Trust DeWorm—mebendazole 100mg;

Thrombix which is a low-dose enteric

Mydol—paracetamol 500mg, codeine

Stomach Ease—hyoscine

coated aspirin. Indeed, when a major

phosphate 10mg, doxylamine 5.1mg.

butylbromide 10mg.

brand went out of stock for an extended

Hayfever The three major

Schedule 3 medicines Trust Femzole—

period of time during 2012, Pharmacor

antihistamines at the core of every

fluconazole 150mg; Trust Femzole Duo

was able to make up the shortfall with

pharmacies Hayfever section: Trust

which includes a clotrimazole cream

Trust Thrombix.

‘What I like about Pharmacor is: one,

uniquely and very discreet’.

While Pharmacor’s OTC range all

it’s Australian-grown and operated; two,

carry the brand’s ‘Trust’ label, Gastrex

that the price is the price is the price; and

won’t. ‘We want it to be seen as a stand-

three, the high quality of the product,’

alone product,’ says JP.

says Mr Viengkhou.

‘Unlike some of its competitors that

‘That’s why we’ve aimed for discreet, yet premium-looking packaging, because

require you to bundle services to get a

diarrhoea can be an embarrassing ailment

better price, there’s no hidden agenda

that sufferers don’t want to scream about.’

with Pharmacor.’

In addition to the release of Gastrex,

MAKE SURE…

Pharmacor will also release later this year its Trust for Kids range of

▲ Pharmacist Oley Viengkhou says

If you’re looking for a service-oriented

paracetamol and ibuprofen liquids. This

Pharmacor’s budget-friendly, premium

generics supplier with a range of premium

adds to a strong portfolio of analgesic

quality medicines has helped his

products at budget-friendly pricing, then

products; in fact Pharmacor offers more

business grow.

Pharmacor should be at the top of your

than 20 OTC and 70-plus prescription branded generic medicines.

‘Our aim is to offer a “branded” generic alternative for every ailment,’ says JP.

‘to-call’ list. It’s Australian born and bred Pharmacy’s Oley Viengkhou says a

and run by pharmacists, so it knows what

combination of good old-fashioned

you’re looking for in a generic partner.

service and access to Pharmacor’s budget-friendly premium-quality

THE FRONTLINE Despite last year’s round of

medicines has helped his business grow.

‘There are nine pharmacies in Campsie

Pharmaceutical Benefits Scheme

[south-west Sydney, NSW] two of which—

(PBS) price cuts and the extraordinary

as well as a chemist warehouse—are

competition his pharmacy faces (a story

within 50 metres of my pharmacy. Throw in

that’s mirrored the country over), Campsie

PBS price cuts and it is tough going.

www.pharmacor.com.au Ph: 1300 138 805

*Imodium is a registered trademark of Johnson & Johnson and has no affiliation with Pharmacor Pty Ltd.

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

13

NEWS AND REVIEW POLITICAL CAPITAL

UK’s path to the future Stephen Greenwood, AJP political columnist and consultant with Greenwood Government Relations Pty Ltd

A NEW UK REPORT ON THE FUTURE OF COMMUNITY PHARMACY HAS RELEVANCE TO AUSTRALIAN PHARMACY.

I

f you were asked what are the five forces that will shape Australian pharmacy in the future, what would you say? You could point to the Pharmaceutical Society of Australia’s draft Vision for Pharmacists’ Practice developed in 2011. Or the Pharmacy Guild’s practical Roadmap templates which strategically compartmentalise in the four-quadrant Community Pharmacy Matrix plans for future directions.

But if you don’t wake worrying about whether your vision or fourquadrant matrix can be explained to your bank manager, you might like to know what is happening in the UK about the future of pharmacy. It is important, as what happens in the UK could well happen here.

Late last year a team from the well-regarded UK firm of consultants at AT Kearney developed a major analysis entitled ‘The Future of Community Pharmacy: Building a Sustainable Industry’. The study looks at key challenges including the squeeze on healthcare budgets, intensifying competition and patient demand for convenience and expertise. The report identifies business strategies that pharmacies should follow and seven enablers the consultants believe will be crucial for the sector’s future.

Sound familiar? It ought to because pharmacy in Australia is under almost as much pressure as the government tries to bring in that elusive surplus and possibly gouge

more savings out of a sector with more pharmacies failing in the last year than in the past 10!

Consultant reports about pharmacy are a dime a dozen.

Sometimes the work is excellent but often it is shallow, assumes the worst, misunderstands the behindthe-scenes politics and paints an unnecessarily bleak picture. So why should the Kearney Report be any different and what makes it compelling reading?

The answer lies in the quality of the research and the in-depth interviews, experience and insights undertaken with pharmacy leaders, government policy-makers, tertiary institutions and research institutes.

The Kearney Report draws on research from many organisations and the contributors read like a Who’s Who of pharmacy leaders and thinkers in the UK. Back to the five forces that will determine your future. The consultants identify the following: 1. The squeeze on healthcare budgets The UK government is curbing healthcare spending and the ‘NHS has to find efficiencies of 20% of its £100m budget’ at a time when chronic health conditions are on the rise and the population is ageing. The consultants expect the rate of growth in the NHS to continue to slow down. But by 2050 there will be one-in-four people over 65 as the population reaches 77 million. Pharmacy must transition

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

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‘into a model of care that promotes prevention and shifts delivery from secondary to primary settings’.

Pharmacy will have to do more with less as their ‘main source of income (generics buying profits)’ reduces because the UK ‘Department of Health will be quick to claw back… any extra profits… as the era of generic blockbusters in primary care begin to tail off in 2013 onwards’.

The UK civil service is ‘counting on a further 25% efficiency improvement in pharmacy productivity’.

The consultants argue that the squeeze on profits will cause an average drop per pharmacy of 35% in earnings by 2016 as buying profits fall.

2. Intensifying competition Pharmacists’ futures in the UK will be determined by a ‘ferociously competitive’ market. The crazy UK policy of introducing more than 1200 new 100-hour licences to improve patient access resulted in most new licences going to the multiples and supermarkets which aggressively entered the market.

That has meant that ‘the combined market share of the large players and the supermarkets is now 52.5%’. As a result, entry regulations were revised in 2012 but there is a message there for Australia about deregulation and market power.

The consultants consider that as pricing strategies become more aggressive and manufacturers move to direct distribution it will cause an average drop in pharmacy profitability of 9%.

3. Transformation of the supply chain Globally, margins are tight across

manufacturing. As a result more manufacturers look to retain margin by following Pfizer’s example of alternative distribution arrangements.

This will change the nature of community pharmacy forever and, in a country like Australia with its vast distances, threaten the viability of the pharmacy network and therefore the distribution arrangements for the Pharmaceutical Benefits Scheme (PBS).

4. Emergence of new alternative channels Since the emergence in 2005 of internet pharmacy, ‘technological advances and a growing demand for convenience means that physical pharmacies are no longer the only show in town’. Across Europe online and mail-order pharmacy regulations have become more liberalised.

Germany, according to Kearney, has 1500 licenced contractors operating now—remarkable given that ‘online pharmacy is still in its infancy’.

Remote dispensing machine trials have started in the UK and although consultants believe they are unlikely to replace real pharmacies, remote dispensing will be a factor in changing pharmacy’s future.

The consultants consider that these changes will result in an average drop in profitability of 9% by 2016.

5. Demand for convenience and expertise Patients continue to expect more from their pharmacy ‘with convenience and quality their main demands’—areas where there is room for improvement.

The consultants surveyed Primary

NEWS AND REVIEW POLITICAL CAPITAL

Care Trusts and found that patients thought that hours of opening ‘did not suit lifestyle needs’, ‘waiting times were too long’ and information and patient privacy could be better. In other words pharmacy needs more staff, better privacy and more consulting rooms, and all at a time when pharmacy revenues are in decline. Pharmacy must ‘deliver more with less, but also better’. That’s a hard ask.

SUPPLY CHAIN CHANGES Minor tweaks to dispensing won’t cut the mustard. Pharmacy has become large-scale business with streamlined supply chains. As a result, some chains have invested in automation and other large players have invested in centralised dispensing, sometimes using robotics for repeat prescriptions. The US and the Netherlands have shown that central fill infrastructures massively reduce labour costs and improve patient care as pharmacists have more time to spend in quality interactions with patients, and supply chain efficiencies from optimised deliveries. ‘The independents could struggle to find an alternative option unless wholesalers step in as dispensing service providers. In the Netherlands, for example, wholesalers have chosen to provide these services and have forward-integrated into the value chain, providing pre-prepared repeat prescriptions to all players in the market’.

Could that happen in Australia?

The consultants argue that independent pharmacies may have to revisit the co-operative model if wholesalers do not emerge as dispensing service providers.

MOVING FORWARD WHILE GOING BACKWARDS The combined impact of these five forces for change are estimated to result in an average profit reduction of 38% which will lead to a significant number of closures—as high as 7.5% of all UK pharmacies, or about 900 businesses. But the pain will be mainly felt by the independent operators as they have less ability than the large multiples or supermarkets to find revenue alternatives to the NHS, nor profit from economies of scale.

Some predict closures will go as high as 2000 over the next three years.

But if kept to 900, it is claimed that the ratio of people to pharmacies will bring access levels back to 2005 levels and be hardly noticed by the public.

Maybe‌ all these changes will be difficult and revolutionary.

MORE GOVERNMENT SAVINGS? So what can pharmacy do about For a government looking for it? The consultants suggest two efficiencies there are other options, strategies: such as moving 50% of repeat ‘1. Develop a more efficient supply prescriptions from 28 days to three function to reduce the overall cost months for the four main chronic of medicines distribution; and diseases (hypertension, diabetes, 2. Become a front-line point of care in hyperlipidemia and respiratory). This the healthcare system to optimise would reduce the number of items the use of medicines, manage dispensed in England in 2012 by more 3 8 t h o f flong-term s h o 1conditions, 2 3 0 0 1and 1 5promote 6 . p d f than P a40gmillion—equivalent e 1 2 6 / 1 to 0 /4%1 2 , self-care and healthy lifestyles.’ of all prescriptions in England. This

38

th

PSA Offshore Refresher Conference 2013 London 2 – 9 May 2013 Excellence in education www.psa.org.au

would reduce system costs, make home delivery more economically attractive and be far more convenient for some patients. However, under the current reimbursement system and apart from the health implications for reducing consumer contact with health professionals, it would reduce pharmacy income—presenting yet another argument for improving the alignment of incentives in the system.

You think that the Commonwealth Department of Health and Ageing hasn’t thought of that? Think again.

Ultimately, pharmacy has to become the front-line point of care if the health system is to be sustainable.

Pharmacy has all the right ingredients to become a valuable provider of healthcare services, including clinical skills, trusting patient relationships, unmatchable access and cost effectiveness.

This could well mean, supposes the Kearney team, that independent pharmacies, as we know them today, will largely cease to exist in the future. As they embrace change and a healthy-living focus, pharmacies ‘will require closer integration and, in some instances, co-location with health centres or GP practices, moving pharmaceutical care away from the high street’. Larger players are better placed to provide front-line care but the consultants consider that patient trust is an issue for them and for supermarkets, which will continue to be restricted in the type and extent of the services they offer given their business model.

FIT FOR THE FUTURE The consultants point to seven 1measures 1 : 5 3that : 5the 5 profession A M Aand EDT government need to focus on to make

the profession fit for its new purpose.

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Many of these ideas will resonate with pharmacists in Australia. To close our minds to these reforms would be folly. â–

London

NEWS AND REVIEW FROM THE GUILD

Pharmacist-led vaccination Kos Sclavos, national president, Pharmacy Guild of Australia

A NURSE-LED VACCINATION PROGRAM IN PHARMACIES WILL PAVE THE WAY FOR A PHARMACIST-LED PROGRAM.

C

ongratulations to our Welsh colleagues for the successful introduction of a pharmacist-led vaccination service.

It’s the latest country to allow approved pharmacists to administer vaccinations (and we’re talking the intradermal influenza vaccination).

Here, in Australia, the Pharmacy Guild has established a Vaccination Working Group which continues to work towards the necessary changes needed to implement a pharmacistled vaccination service. That said, the Pharmacy Guild is facing many stumbling blocks for a pharmacist-led vaccination team, but it is my personal view that in-pharmacy vaccination programs led by nurses should be encouraged and will pave the way for a pharmacist-led program.

Many of the reasons stated as to why pharmacists should not vaccinate are premises issues, and we have seen none of the stated issues emerge in the successful pharmacy programs by Priceline, Terry White Chemists, and some smaller independents. These programs are using a third party (ie. nurse immuniser) for vaccinations and it is my view their success shows that pharmacy is a suitable destination for vaccinations. Indeed, it’s estimated that last winter some 50,000 Australians received the flu vaccine in a community pharmacy.

Back in 2011, Charles Sturt University commenced vaccination training with its pharmacy students with the belief pharmacy-based

immunisation programs using pharmacist immunisers are inevitable in Australia given the international trend.

Because a nurse immuniser has to come into the pharmacy, a complex appointment system is sometimes needed to ensure patients receive the service when the nurse is available.

Both pharmacists and nurses have reported that customers like the convenience and the minimal waiting times of having in-pharmacy vaccinations. One can only imagine how much more efficient it will be when a number of pharmacist staff are credentialed to give the service.

In New Zealand our pharmacy colleagues have also implemented

IT’S ESTIMATED THAT LAST WINTER SOME 50,000 AUSTRALIANS RECEIVED THE FLU VACCINE IN A COMMUNITY PHARMACY. a successful pharmacist-led program (beginning in early 2012). Private paying patients between the age of 18 and 59 can now be vaccinated in community pharmacies with the intradermal influenza vaccination, Intanza 9µg, during the influenza season.

Almost 90 pharmacists in New Zealand completed the same immunisation training as other health professionals, allowing them to offer the service at their own premises.

The national program followed the success (in 2011) of a small number

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

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of pharmacies in Auckland, Waikato and the Bay of Plenty that were able to offer influenza vaccinations. This followed a successful two-year trial in Waikato where a community pharmacy provided influenza immunisation to individuals who were eligible for a subsidised immunisation but wouldn’t normally have received one.

In New Zealand vaccines are considered prescription medicines, but Medical Officers of Health can authorise people to administer them without a prescription if they are satisfied the person can carry out emergency treatment, knows how to safely handle immunisation products and equipment, has sufficient knowledge to ensure a patient can give informed consent and has the requisite interpersonal skills. The scheduling of the medicine is an issue that needs to be resolved in terms of a pharmacist-led implementation progress.

Vaccinators need to have completed the same immunisation training that other immunisation providers complete. That training is not difficult. Their clinical expertise and experience is assessed and their authorisation must be approved by a Medical Officer of Health.

Irish pharmacists, back in 2011, were given the green-light to administer the influenza vaccination after the Minister for Health announced pharmacists would be facilitated in participating in the seasonal influenza vaccination service for 2011. The legislation,

which gave effect to this, was signed in October 2011 and enables pharmacists to supply the influenza vaccine and adrenaline, both of which are prescription-only medicines, without the need for a doctor’s prescription.

In order to prepare pharmacists to deliver a flu vaccination service, the Guild’s sister organisation, the Irish Pharmaceutical Union, developed a vaccination training program.

The health service reimbursed pharmacists for administration of the vaccine to over-65s with a medical card (those on a low income), who are entitled to free medical services.

Patients older than 65 who did not have a medical card had to pay for the administration. And patients between the ages of 18 and 65 had to pay for both the vaccine and the administration.

In the United States all 50 states now allow pharmacists to vaccinate and the big corporate pharmacy groups are driving vaccination programs via marketing material. The numbers are not yet in for the recently completed vaccination period in the US, however, estimates suggest a significant number of patients who would otherwise not have received the vaccine did so because of the pharmacy initiatives.

This is a highly political issue, so we need to keep stating the success of pharmacist-led programs in other countries. We need to keep stressing how important it is these programs reach a greater audience because of their availability in pharmacies. We need to keep stressing the most efficient use of health resources would see pharmacists undertaking the administering of vaccinations. ■

Is treating mood symptoms enough?1

More pa tients ac hieved r emissio residual n if symptom s were a ddresse 1 d.

TREATING MOOD AND MORE † Targeting many off the symptoms of depression – DSM-IV4

† 2,3 3

PBS Information. Restricted Benefit. For the treatment of Major Depressive Disorder.

CYMBALTA is not PBS reimbursed for the treatment of Generalised Anxiety Disorder or Diabetic Peripheral Neuropathic Pain.

PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING. FULL PRODUCT INFORMATION IS AVAILABLE ON REQUEST FROM ELI LILLY. CYMBALTA (duloxetine HCl) 30 mg, 60 mg capsule. INDICATIONS: Treatment of Major Depressive Disorder (MDD), Diabetic Peripheral Neuropathic Pain (DPNP), Generalised Anxiety Disorder (GAD). CONTRAINDICATIONS: Known hypersensitivity to duloxetine or its excipients, co-administration with MAOI or within 2 weeks after discontinuing MAOI, patients with hepatic impairment, coadministration with potent CYP1A2 inhibitors. PRECAUTIONS: Clinical worsening and suicide risk, hepatotoxicity (from LFT elevations to liver failure), substantial alcohol consumption, narrow angle glaucoma, bipolar disorder*, history of mania, history of seizure disorder, hyponatraemia*, abnormal bleeding, increased blood pressure, orthostatic hypotension/syncope, serotonin syndrome*. OTHER PRECAUTIONS: Pregnancy, including neonatal symptoms with 3rd trimester use*, lactation, children and adolescents, slowed gastric emptying. INTERACTIONS: Concurrent use with serotonergic drugs, CYP1A2 inhibitors (e.g fluvoxamine), CYP2D6 substrates (e.g. thioridazine) and inhibitors, MAOI inhibitors*, St Johns Wort, warfarin. ADVERSE EFFECTS: Nausea, dry mouth, GI upset, anorexia, fatigue, dizziness, somnolence, tremor, sweating increased, flushing, vision blurred, insomnia, sexual dysfunction, palpitations, chills, musculoskeletal pain, headache, lethargy, paraesthesia, anxiety, sleep disorder, agitation, yawning, urinary frequency. Postmarketing events: restless legs syndrome, seizures on discontinuation, gynaecological bleeding. See full PI for others. DOSAGE AND ADMINISTRATION: MDD & DPNP 60 mg once daily; GAD 30 mg to 120 mg once daily. Start with lower dose or administer with food to improve initial tolerability. Lower dose in end stage renal disease.

Taper dose on discontinuation. Based on PI last amended on 19 Nov 2012. PBS Dispensed Price: 30 mg $38.22; 60 mg $50.42.

*Please note changes in Product Information.

References: 1. Paykel ES, et al. Psychol Med 1995;25(6):1171–1180. 2. Hirschfeld RMA, et al. Depress Anxiety 2005;21:170–7. 3. CYMBALTA Approved Product Information.

4. American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Text revision, Washington DC: American Psychiatric Association; 2000.

Eli Lilly Australia Pty Ltd, ABN 39 000 233 992, 112 Wharf Road, West Ryde, NSW 2114. 12/12 AUCYM00458 ELB0205/AJP

NEWS AND REVIEW FROM THE PSA

Connecting through collaboration Grant Kardachi, president, Pharmaceutical Society of Australia

THE GOAL OF COLLABORATION BETWEEN HEALTHCARE PROFESSIONS SHOULD ALWAYS BE TO IMPROVE PATIENT HEALTH OUTCOMES.

C

ollaboration in the healthcare environment does not begin and end with simple dialogue between the various professions within the sector. Rather it involves targeted and constructive strategies and polices so that these professions work together to achieve a single common objective—better patient outcomes.

This was the clear message that emerged from last November’s National Primary Health Care Conference at which a range of professions met to advance the concept of collaboration and examine the steps we need to take to achieve effective collaboration.

It was made clear that collaboration cannot just be for collaboration’s sake. The aim of collaborative engagement between the professions is to improve patient outcomes and if we do not strive to meet this objective we are letting everyone, including ourselves, down.

At the conference the PSA, the Pharmacy Guild and the Australian Medicare Local Alliance co-sponsored a session under the theme of ‘Pharmacy and general practice— integration and connection between frontline primary healthcare settings’.

A feature of this session was a panel discussion involving prominent pharmacists and GPs who canvassed examples of innovative consumercentred, team-based care featuring GPs and pharmacists.

The panel focused on three key areas:

r FYBNQMFT PG JOOPWBUJWF DPOTVNFS DFOUSFE UFBN CBTFE DBSF GFBUVSJOH (1T BOE QIBSNBDJTUT r IPX .FEJDBSF -PDBMT DBO GBDJMJUBUF DPMMBCPSBUJPO CFUXFFO QIBSNBDJTUT BOE (1T UP JNQSPWF DPOTVNFS IFBMUI PVUDPNFT BOE r IPX UP JNQSPWF UIF SFMBUJPOTIJQ CFUXFFO QIBSNBDJTUT BOE (1T

The outcomes of this meeting will help provide a guide as to how better to achieve the goals of collaboration.

An interesting point to emerge was that despite the best of intentions, we have not always gone about introducing new services in the best way. Indeed, some services could

INDEED, SOME SERVICES COULD HAVE BEEN BETTER IMPLEMENTED IF COLLABORATION HAD BEEN INCORPORATED INTO THE DEVELOPMENT STAGE have been better implemented if collaboration had been incorporated into the development stage early on.

Highly regarded GP Emil Djakic gave as an example the introduction of HMRs and highlighted that this service had been brought in with no consultation with GPs. He stressed that while GPs generally recognised it as a very valuable and effective service, consultation and collaboration with GPs in the early stages of its development and implementation would have made it even more effective and perhaps resulted in a broader uptake of the service.

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Another theme to emerge was that collaboration is becoming essential in the increasingly complicated medication world. With new medications coming on line all the time, pharmacists need to work closely with GPs to keep them abreast of developments and ensure their knowledge is current so their prescribing is appropriate to the needs of patients.

Just how pharmacists and GPs can work more closely was discussed in detail. Dr Djakic described the model he uses in his practice where a community pharmacist goes in for half a day a week to review medications and examines patient records to help maximise quality use of medicines and minimise possible medication misadventures.

Giving the pharmacist access to the full patient histories is an

important element in the success of this model. Without full access, the pharmacist would be unable to develop the clear picture of the patient’s history which is needed to make a professional assessment of their medication regimen.

I think this model provides a good balance to the models at the other end of the spectrum in which a full-time pharmacist is employed in a GP clinic as part of the team.

This is a very effective method which has proved to be extremely popular in those locations in which it has been implemented. We heard of

a clinic in Brisbane where this model sees the pharmacist brief the clinic GPs at their regular meetings and the result has been a renewed enthusiasm on the part of the doctors to broaden their knowledge of medicines.

Regardless of which model is chosen, the underlying principle of meeting increased patient health outcomes is the main game. To achieve this we must build into any model for such collaboration targets and objectives which specifically aim to achieve this objective.

In the past I have spoken of our health destination trial and I think this provides a good model for developing the right sort of collaboration.

Having a non-dispensing pharmacist counselling patients in the health services area of the pharmacy, and referring, where necessary, to a GP provides a firm basis to build an ongoing relationship.

There is nothing threatening in such an approach—it is clearly designed to improve patient outcomes.

I am confident that this year will see some major breakthroughs in the collaborative work between ourselves, GPs and Medicare Locals.

Our joint sponsorship of the session at the conference was a milestone in that three disparate healthcare organisations clearly agreed on the objectives we must aim for, and also that any hurdles to meetings such objectives can be ironed out through constructive dialogue.

Real collaboration has taken a great step forward and I look forward to further working with the Medicare Local network and GPs across Australia as we build on the achievements of recent times.

NEWS AND REVIEW FROM THE PBA

Registration renewals Steve Marty, chair, Pharmacy Board of Australia

THE LATEST NEWS ON PHARMACY BOARD OF AUSTRALIA ACTIVITY.

A

t the time of writing, more than 23,000 pharmacists had renewed their registration, while 347 notified the PBA that they no longer wished to be registered. A further 541 failed to respond to invoices and applications for renewal.

The names of those who had not renewed or had indicated that they no longer wished to be registered were removed from the register on 4 January and as such are no longer able to practise as pharmacists.

Employers should check the registration status of all pharmacists that they employ by using the online register check available at www. pharmacyboard.gov.au.

development of a new national paediatric medicines dosing resource.

The Australian Medicines Handbook Pty Ltd (AMH) has been engaged to develop and maintain the paediatric dosing resource, which will be available for sale from mid-2013.

The Board’s Guidelines on practicespecific issues—Guideline 1 (List

NATIONAL CHILDREN’S MEDICINES DOSING RESOURCE The Department of Health and Ageing is coordinating the

wide-ranging public consultation, the Board determined to continue the assignment of the accreditation functions under the National Law to the Australian Pharmacy Council for a period of five years from 1 July 2013.

The Board was conscious of the importance of providing certainty and continuity for education providers and to enable effective planning and efficient management by the Council. ■ disciplinary action by the Board or the Tribunal. [The intention here is to have the registrant serve a period of one month of suspension from

manager of the Terry White Chemist,

DECISION AND FINDINGS – 20 DECEMBER 2012

Wynnum Plaza (pharmacy) where

QCAT found the registrant had engaged

of ‘probation’ for 12 months to

11,799 packets of PSE were sold

in professional misconduct under the

27.01.14. The balance of the period

between 1 January 2008 and

National Law and in particular that:

of suspension—five months—will

31 March 2010. The registrant

r the registrant failed to establish

be added to any other disciplinary

Sarah Naghdi (registrant) was the

these sales.

In addition, the registrant was responsible for six of 11 covert sales of PSE made to staff of Queensland

therapeutic need upon sales of PSE; r UIF SFHJTUSBOU IBE MJUUMF PS OP

27.12.12 to 27.01.13 then a period

decision arising from action arising within that 12 month period.]

involvement in the direct sale of PSE at the pharmacy; r UIF WPMVNF BOE GSFRVFODZ PG 14&

Conditions were also imposed on the registrant’s registration for three years

Health during which ‘therapeutic need’

dispensed by the registrant was in

including:

was not assessed. As an example

breach of the Code, Standards and

r TVQFSWJTFE QSBDUJDF

of the extent of the registrant’s

Regulations; and

r NFOUPSJOH

conduct, the registrant also sold 30

r BT UIF NBOBHFS PG UIF QIBSNBDZ

to one customer in a single day on

the registrant had responsibility

two occasions.

for maintaining and upholding

The Board referred the registrant’s

standards of practice.

conceded she knew the pharmacy was

The registrant’s registration:

being targeted by drug runners; she was

r XBT TVTQFOEFE GPS B QFSJPE PG

relatively young and inexperienced at the time of her conduct and conceded she had engaged in inappropriate

r SFQPSUJOH CZ UIF NFOUPS UP UIF #PBSE r BEEJUJPOBM $1% JO FUIJDBM QSBDUJDF and communication modules; r NFNCFSTIJQ PG UIF 1IBSNBDFVUJDBM Society of Australia; and

conduct to QCAT. The registrant

r POMZ UP QSBDUJDF BU 2$11 BDDSFEJUFE pharmacies for three years .

six months from seven days after 20.12.12; r UP CF TVTQFOEFE BGUFS UIF SFHJTUSBOU

Ms Naghdi is not permitted to apply to Queensland Health for unrestricted

dispensing. The registrant also

has served one month for an

PSE until after completion of

maintained she was now aware of her

operational period of 12 months

supervision, mentoring and additional

responsibilities and was determined to

during which time the registrant

CPD as above and was also ordered to

act appropriately.

must not be the subject of any

pay the Board’s costs.

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

20

REVIEW OF ACCREDITATION ARRANGEMENTS Following a review which included

Professional misconduct

was responsible for about 40% of

INDUSTRY CAMPAIGN The Office of the Fair Work Ombudsman has advised it is commencing a national education and compliance campaign for community pharmacy which aims to promote and assess compliance with Commonwealth workplace laws including the Fair Work Act 2009, Fair Work Regulations 2009 and the Pharmacy Industry Award 2010. Information is available via a dedicated webpage www.fairwork. gov.au/pharmacy. Fair Work inspectors will undertake assessment of samples of pharmacy employers between April and July 2013.

of References) state that a current paediatric reference available from an Australian source (including a teaching hospital) must be accessible to pharmacists. The Board will monitor the progress in the development of this new resource and advise the profession further in future communiqués.

Up to 60% of adrenaline auto-injector carriers can’t demonstrate proper administration technique 1

Help your customers be prepared for anaphylaxis Demonstrate a simple 2-step operation with an EpiPen® Adrenaline Auto-Injector training device1–3

2 ➜

1

➜ Form fist around EpiPen® and pull off BLUE SAFETY RELEASE

Push ORANGE end hard into outer thigh so it 'clicks' and hold for 10 seconds‡

BLUE U SAFETY S RELEASE S

so it 'clicks' cclicks c s a and d hold o d for o 10 0 seco seconds ds‡

‡

Form fist around EpiPen and®pull off Push ORANGE end hard into outer thigh After administration of EpiPen Adrenaline Auto-Injector always seek medical attention – call 000. ® Lay person flat. If breathing is difficult allow to sit, but not stand.

Check they have been prescribed 2 pens4 Prompt administration of an EpiPen® Adrenaline Auto-Injector can be life-saving5,6

PBS Information: Authority Required. Refer to PBS Schedule for full authority information.

BEFORE PRESCRIBING, PLEASE REVIEW APPROVED PRODUCT INFORMATION AVAILABLE ON REQUEST FROM ALPHAPHARM. MINIMUM PRODUCT INFORMATION EpiPen® Adrenaline Auto-Injector 0.3mg/0.3mL EpiPen® Jr. Adrenaline Auto-Injector 0.15mg/0.3mL. The following are not a complete listing: Indication: For the emergency treatment of anaphylaxis (acute severe allergic reaction) due to insect stings or bites, foods, drugs or other allergens.

Contraindications: Contraindications are relative, as this product is intended for use in life-threatening emergencies. Certain arrhythmias, cerebral arteriosclerosis, vasopressor drug contraindication, shock (except anaphylactic shock), certain types of general anaesthesia. Precautions: Sulfite allergy, intravenous administration, ventricular fibrillation, prefibrillatory rhythm, tachycardia, myocardial infarction, cardiovascular disease, organic heart disease, cardiac dilation, cerebral arteriosclerosis, prostatic hypertrophy, elderly, individuals with diabetes, hypertension, narrow angle glaucoma, hyperthyroidism, organic brain damage, psychoneurosis, phenothiazine-induced circulatory collapse, Parkinsonism. Avoid injection into hands, feet, ears, nose, buttocks, genitalia. Use in Pregnancy: Pregnancy Category A. Excreted in breast milk. Use with caution when maternal blood pressure is in excess of 130/80. Interactions: CNS medicines, alpha and beta adrenergic blockers, some general anaesthetics, hypoglycaemic agents. Adverse Effects: Anxiety, restlessness, tachycardia, respiratory difficulty, tremor, weakness, dizziness, headache, dyspnoea, cold extremities, pallor, sweating, nausea, vomiting, sleeplessness, hallucinations, flushing of face and skin. Psychomotor agitation, disorientation, impaired memory, potentially fatal ventricular arrhythmias, severe hypertension which may lead to cerebral haemorrhage and pulmonary oedema. Angina may occur in patients with CAD. Dosage: Single intramuscular injection into anterolateral aspect of thigh, repeat as directed if symptoms recur or have not subsided. Adults > 30kg: EpiPen® Auto-Injector (0.3mg adrenaline) Children 15 – 30kg: EpiPen® Jr Auto-Injector (0.15mg adrenaline). The prescribing physician may choose to prescribe more or less than this amount; please refer to relevant guidelines.

References: 1. Kemp SF, et al. Allergy 2008;63:1061–1070. 2. EpiPen® Consumer Medicine Information, March 2011. 3. Therapeutic Goods Administration approved EpiPen® and EpiPen® Jr label (15 March 2005). 4. Pharmaceutical Benefits Schedule. Accessed June 2012. 5. NPS RADAR. Adrenaline (EpiPen®) Auto-Injector for acute anaphylaxis. www.npsradar.com.au Accessed June 2009. 6. Schwirtz A, et al. J Asthma Allergy 2010;3:159–167.

EpiPen® is a registered trademark of Mylan, Inc. EpiPen® and EpiPen® Jr. are distributed in Australia by Alphapharm Pty. Limited. ABN 93 002 359 739, Level 1, 30 The Bond, 30–34 Hickson Road, Millers Point, NSW, 2000. Medical Information Phone: 1800 028 365, www.alphapharm.com.au ALP0268/AJP inCeptiv

PROFESSIONAL PRACTICE UPDATES

+ Consumer health

promotions

The following information provides resources to pharmacists interested in leveraging off increased consumer interest in a particular health concern that has an official national health day, week or month. Read AJP’s weekly email newsletter, AJP on Friday, for more information about upcoming health promotions.

Event this m s onth International CHD Awareness Month HeartKids February 2013 www.heartkids.org.au

World Cancer Day Cancer Council Australia 4 February 2013 www.cancer.org.au

WA Sexual Health Week Know important signs and symptoms

O

varian Cancer Awareness Month was officially launched in Sydney on 31 January, to be followed by a month of publicity for Ovarian Cancer Australia’s KISS (Know the Important Signs and Symptoms) campaign throughout February.

‘And to celebrate Teal Ribbon Day on Wednesday, 27 February, Ovarian Cancer Australia will be hosting a special Afternoon Teal in Melbourne, and one in Perth the day after, on Thursday, 28 February,’ says Annabel Davies, chief operating officer for Ovarian Cancer Australia.

‘With these events, Ovarian Cancer Australia aims to raise awareness of ovarian cancer in the community and the media, and grow our network of supporters,’ she says.

‘Ovarian Cancer Australia will have special guest speakers, and a panel Q&A discussion with some of our celebrity ambassadors, an ovarian cancer survivor and our new CEO, Alison Amos.’

Ms Davies says that the symptoms of ovarian cancer are quite vague, so ‘many women visit their local pharmacy for advice, rather than see their GP. ‘Ovarian Cancer Australia urges pharmacists to be aware of the signs and symptoms of ovarian cancer, and if women present with these symptoms and they are new or unusual for them, and persist for two weeks or more, pharmacists should urge women to make an appointment with their GP. ‘Pharmacists can also direct women to Ovarian Cancer Australia’s

website where they can download a Symptom Diary to help them track their symptoms. Pharmacists can also inform women who have been diagnosed with ovarian cancer that they can access a range of support and information resources through Ovarian Cancer Australia.’

Symptoms of ovarian cancer include abdominal or pelvic pain; increased abdominal size or persistent abdominal bloating; needing to urinate often or urgently; and difficulty eating or feeling full quickly.

W: www.ovariancancer.net.au E: admin@ovariancancer.net.au T: 1300 660 334 FB: www.facebook.com/ OvarianCancerAustralia Tw: https://twitter.com/OvarianCancerOz

Party hard (but safely)

T

he Cancer Council Queensland’s SunSmart Party will continue to go strong until 28 February, celebrating summer and encouraging consumers to be SunSmart. All SunSmart Parties support the two-in-three Australians diagnosed with skin cancer before they turn 70, says Katie Clift, spokesperson for the Council.

Community members, organisations and businesses can host a SunSmart Party until 28 February by registering their party online, having ‘a whole lot of summer fun’ and raising funds to go to skin cancer research, prevention and early detection programs, as well as patient support services.

The campaign is being promoted via social media, on its own website and in local media.

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

22

WA AIDS Council 11–17 February 2013 www.wasexualhealthweek.com.au

Sunnies for Sight Brien Holden Vision Institute February 2013 www.brienholdenvision.org/be-involved/sayeye-campaign/sunnies-for-sight.html

‘The good news is that skin cancer remains the single most preventable type of cancer,’ Ms Clift said. ‘By getting involved and hosting or attending a SunSmart Party, people will see how easy it is to incorporate SunSmart habits into everyday life and special events.

‘Pharmacies can help us spread the word by letting their customers know about our new fundraising initiative.

‘It’s important to let customers know that if a new mole appears or spots change in shape, colour or size, people should see their GP immediately.’

Ms Clift says that since the late 1990s, the incidence of melanoma has decreased in those younger than 60.

‘We believe these figures most likely reflect the success of public health campaigns aimed at reducing levels of unsafe exposure and promoting sun protection.’

Pharmacies, especially those in Queensland, can use the SunSmart Party campaign and SunSmart messages to engage not just with regular customers, but also tourists, particularly those from countries with less harsh conditions.

‘It’s important to let tourists know that here in Queensland, we have the highest rates of skin cancer in the

world,’ Ms Clift said. ‘When the UV index is 3 and above, sun protection is required—here in Queensland the UV index is 3 and above all year round, so being SunSmart is essential in all seasons.

‘To reduce skin cancer risk when out and about, people should slip on protective clothing, slop on minimum SPF30+ broad spectrum, water resistant sunscreen, slap on a broad-brimmed hat, seek shade when out and about and slide on wrap-around sunnies.’

W: www.sunsmartparty.org.au E: fundraising@cancerqld.org T: 1300 65 65 85 P: http://pinterest.com/sunsmartparty/

Decide and discuss

D

onateLife Week 2013 (24 February–3 March) will have a theme of ‘Make your wish count— discover, decide, discuss organ and tissue donation.’

According to spokesperson Bree Cullen, there will be many community events taking place around the country, from community walks to talks, film competitions, sporting events, university outreach, engagement with Indigenous communities and information sessions with culturally and linguistically diverse communities.

‘These events provide a great opportunity for the community to discover the facts about organ and tissue donation, to make and register an informed decision and, most importantly, to discuss those wishes with the family.’

Ms Cullen says that the Organ and Tissue Authority is also working in partnership with a range of community organisations through its Community Awareness Grants program.

She suggested pharmacies could promote discussion of organ donation by displaying DonateLife materials on countertops or in

PROFESSIONAL PRACTICE UPDATES

front windows; by placing posters ‘It’s a conversation that can be in noticeboards, in staff rooms, rest prompted by situations like writing a rooms and kitchens; and including will, travelling overseas or celebrating a information on DonateLife Week significant birthday. It’s a conversation events in any communications, that families can have around the such as newsletters or intranet. dinner table.

They could organise events such as ‘Families that have discussed and morning teas or lunches, encourage know each other’s donation wishes are colleagues to use the screen saver or more likely to uphold those wishes.’ email signature images located in the Ms Cullen told the AJP that 80% of organisation’s online supporters’ kit, Australians were willing to become and even add text about the week organ donors, and 78% tissue donors; onto pay slips. encouragingly, 77% of Australians More than anything else, they have now discussed their donation can engage with their customers, wishes with family members. colleagues and staff about organ ‘But this is a conversation that donation, helping to normalise needs to be repeated because 44% of discussion of the topic.

Australians are still unsure about the ‘In the same way that people let donation wishes of their loved ones.’

W: www.donatelife.gov.au family members know if, for example, T: 02 6198 9800 they want to get buried or cremated F: 02 6198 9801 when they die, talking about your G u i l d donation P h a r wishes m 1 2 with 3 5 family 4 1 7members 2 2 . p d f FB:Pwww.facebook.com/DonateLifeAustralia a ge 1 1 9 / 1 2 / 1 2 , Tw: https://twitter.com/#!/donatelifetoday is an important conversation to have.

New Therapeutic Guidelines

T

wo new Therapeutic Guidelines—Cardiovascular 6 and Analgesic 6—are now available in an electronic format in eTG complete for computers, and miniTG for mobile devices.

With new cover designs for both guidelines, Analgesic 6 focuses on the clinical aspects of assessment and management of acute and chronic pain in adults and children. The content has been extensively reviewed and updated by a multidisciplinary expert group. The emphasis 5throughout : 3 5 : 0 is 3 onPsafe M and effective use of analgesics.

This topic has new sections on the assessment of acute pain and recurrent or chronic pain.

Appendix 1 includes several tools for assessing pain severity.

Cardiovascular 6 provides clear and concise recommendations for the assessment and reduction of cardiovascular disease risk and the management of a range of cardiovascular conditions. All topics have been extensively reviewed and updated by two expert writing groups. ■ www.tg.org.au

PROFESSIONAL PRACTICE UPDATES

Burden of osteoarthritis second to cancer M

usculoskeletal conditions like lower back pain and osteoarthritis are now second only to cancer as the leading cause of disease burden in Australia, according to the findings of a Global Burden of Diseases (GBD) 2010 study.

Professor Lyn March, who led the international Musculoskeletal Expert Group for the study from Royal North Shore Hospital and University of Sydney, said: ‘The study shows that in Australasia, musculoskeletal conditions account for 15.3% of the total burden of death and disability, just behind cancer at 16.2% and ahead of heart disease (13.8%) and mental health and substance abuse (13%).

‘These are all important health issues and recognised as national health priorities by the Australian government but to date MSK has not received an equitable level of priority.’

Prof Lyn March’s team has been working for the past four years to identify all the studies of arthritis and musculoskeletal conditions from around the world.

‘This study provides the clearest evidence to date of the huge and growing burden on the health of Australians from musculoskeletal conditions,’ said Prof March.

‘It shows that lower back pain is the leading cause of disability and osteoarthritis is one of the fastest growing conditions.’ Australian data was drawn from Australian health surveys.

‘When the disability component alone is looked at, which reflects the pain and suffering of people living with the conditions and the enormous associated economic impact in productivity losses and need for health

services—the MSK category is the leader at 27.4%, followed by all mental health and substance abuse at 22.4%,’ Prof March said.

‘We need clear and urgent action from our state and federal governments to improve prevention and management of musculoskeletal conditions to keep people moving and living without pain and disability, which is critical as our population ages.’

Ainslie Cahill, CEO Arthritis Australia, echoed the call for urgent action: ‘Arthritis and musculoskeletal conditions are by far the leading causes of disability

MIMS supports PSS

T

he development and expansion of the Pharmacists’ Support

launched early in 2013.

John Coppock, president of PSS,

PSS largely functions through the generous work of volunteers as PSS expands there is a greater need for administration and background support for the volunteers. Mr Coppock noted that training of the volunteers is a significant

said: ‘PSS plans to use communications

cost but it is essential to ensure the

further boost through a second generous

technology to develop novel ways of

quality of the service.

donation of $2000 from MIMS.

providing support to pharmacists. A PSS

Service (PSS) has been given a

Donations to the work of PSS are

website will be available to pharmacists

tax deductible. Anyone wishing to

develop a Pharmacists’ Support

across time zones, day and night and will

support the work of PSS by making a

Service website which will include a

equip pharmacists with information and

donation should direct their donation

host of resources and information to

links to a range of resources’.

to PSS c/o 381 Royal Pde, Parkville

The donation is being used to

support and assist pharmacists.

Mr Coppock also noted PSS does not

3052. Donations can also be made over

The website will enable PSS to

underestimate the value of a listening ear

the phone using a credit card through

broaden its outreach to pharmacists

from a colleague and that the telephone

the PSA (Victorian Branch) office on

throughout Australia. Currently the

service will also be expanded across

(03) 9389 4000 or by direct deposit into

service only has funds available to

all states of Australia when adequate

the PSS bank account BSB 083170 and

provide a telephone service between

ongoing funding becomes available.

account number 145988064 (please

8am and 11pm to Victoria, Tasmania,

He also reported that PSS is working

send your name and contact details so

South Australia and the Northern

towards expansion into both Western

that a receipt can be issued). ■

Territory. A website with links to useful

Australia and Queensland during 2013.

information will provide pharmacists

Mr Coppock said he hopes that the

throughout Australia with a valuable

generosity of MIMS will set a precedent

resource that they can access 24

to be followed by other organisations

discreet support on 1300 244 910 between

hours a day. The PSS website will be

involved with the pharmacy profession.

8.00 am and 11.00 pm every day of the year.

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

24

and chronic pain in Australia. The focus must be on preventing such debilitating effects. We want to see equitable access to effective treatments and professional support for all Australians struggling with arthritis no matter where they live’.

The Australian Bone and Joint Decade national action network, an alliance of organisations and professional bodies caring for people with musculoskeletal conditions including the Australian Rheumatology Association, Arthritis Australia and the Australian Physiotherapy Association, has launched a call to action for our state and national governments

to address the prevention and control of the growing burden of musculoskeletal conditions.

GBD 2010 was published and released in the medical journal The Lancet in December (2012) was funded globally by the Bill and Melinda Gates Foundation and was conducted by a consortium of international experts including the IHME, University of Washington Seattle, the School of Public Health, University of Queensland and the World Health Organisation. The GBD 2010 involved nearly 500 researchers from 300 institutions in 50 countries.

The MSK Expert Group, led by Prof March from the University of Sydney received funding from the Commonwealth Government Department of Health and Ageing and the Institute of Bone and Joint Research at Royal North Shore Hospital. ■

Pharmacists requiring assistance can contact PSS for anonymous and

PROFESSIONAL PRACTICE UPDATES

Shingles reduces quality of life

A

survey by Chronic Pain

that up to 50% of Australians aged over

pain for many older Australians,’ said

Australia has revealed the

50 years with shingles may develop

Dr Coralie Wales, president at Chronic

painful truth of shingles. The

PHN. In people aged 50 years and

Pain Australia.

‘Chronic pain from shingles is

older people get,’ said Professor Dominic Dwyer, medical virologist at the Centre for Infectious Diseases and Microbiology Laboratory Services, Westmead Hospital and University of Sydney.

‘People need to be aware that those in their sixties, seventies and older are particularly at risk of developing PHN,

ongoing pain many people experience

over, PHN is estimated to affect more

following the shingles rash has a

than 41,000 Australians, with 23,100

common and debilitating, particularly

and many are suffering silently at home

profound effect on their wellbeing.

cases occurring in those aged 60–79

amongst those in their 60s, 70s and

in pain. Our seniors deserve more. They

years. PHN is difficult to treat and may

older, yet it is not well-known by the

deserve recognition and support when

persist for years.

general public,’ she added.

living with this debilitating condition,

Two out of three (67%) of those surveyed with postherpic neuralgia (PHN) reported having to limit their time

The impact of PHN on mood and

One patient surveyed decribed

going out and socialising. More than

wellbeing was also particularly noticeable

shingles as: ‘like a corkscrew was

half (52%) had to limit walking and a

amongst those surveyed. Two-in-three

being screwed into the site of the

similar number (57%) were unable to

people (69%) with PHN reported feeling

scabs for up to six months’.

sleep properly.

anxious or down. Those with PHN were

‘PHN can be very distressing

which is likely to become more prevalent with Australia’s growing older population.’

The results of the survey were released to support the launch of a national awareness campaign

also twice as likely to report a negative

because of its severity and the abnormal

endorsed by Chronic Pain Australia and

of neuropathic pain which can develop

outlook on life compared to those whose

sensations associated with nerve

Painaustralia and supported by CSL

from damage to the nerves as a result

pain resolved with the shingles rash

damage,’ said leading pain medicine

Biotherapies, called ‘The Painful Truth:

of infection with the herpes zoster virus,

(shingles patients with PHN 45% vs

specialist and director at Pain Australia,

It’s not just shingles’. ■

which causes shingles.

shingles patients without PHN 22%).

Professor Michael Cousins.

increases with age, and it is estimated

on a significant source of ongoing

PHN is a chronic and debilitating form

3 8 2 5 S t The u drisk e nand 1 severity 2 3 5 5of0PHN 9 5 3 . pdf

P a gsurvey e 1helps2shine 0 / a1 spotlight 2 / 1 2 , ‘This

9 :‘Shingles 5 4 : 1should 4 not A Mbe dismissed A E D T as

For more information, visit

an inconsequential skin condition that

www.chronicpainaustralia.org.au

Kick-start your career in pharmacy with a

FREE PSA Student Membership

PSA3825

If you’re a pharmacy student, a free PSA Student Membership will open the door to discounts on more than 200 textbooks, access to workshops, conferences, Australian Pharmacist online, networking opportunities at early career pharmacist social events, and much more.

P: 1300 369 772 » membership@psa.org.au » www.psa.org.au

PROFESSIONAL RURAL MATTERS

Keep taking the tablets Professor Patrick Ball, Charles Sturt University with Dr Lisa Pont, University of Sydney

AS INDIVIDUALS WE CAN’T CHANGE HOW ALL PHARMACISTS PRACTICE, BUT WE CAN CHANGE FOR THE BETTER OWN PATCH OF PHARMACY PRACTICE.

S

o it is February and Christmas is a distant memory, perhaps with the support of pharmacologically modulated, liquid dosage forms.

The New Year resolutions have already been broken and abandoned, so it is back to the pharmacy, but what has really changed?

Well…the government has realised our real value and given us Medicare numbers to charge up all of our cognitive services.

The Pharmaceutical Society and the Pharmacy Guild have patched up all their differences and are pulling together for the future of the profession. Point-of-care testing is complementing our activities and helping patients follow medical advice between doctors’ appointments. Oh, and all pigs are fully fuelled and ready for take-off.

Will it be more of the same for 2013? What will it take to break the mould and reinvent pharmacy? If the national organisations can’t change the world for us, what can we do?

It is generally accepted that about 90% of what happens in any sphere is orchestrated by about 10% of people. So what if we could increase that to 12% or 15%? How much more could we achieve?

Change only really happens when it is actively attempted, but do the changes have to be revolutionary? Do they have to make massive amounts of extra, unpaid work for us?

We still wait for government to recognise what we do now—why doesn’t this happen?

We all give our time regularly to many of our clients but anything we do must be documented. As far as policy-makers are concerned, if it was not documented, it did not happen.

Must we carry a notebook and write everything down and then transfer it?

We actually have more tools than ever but we have to become meticulous about using them and documenting every intervention, every piece of advice etc.

Documentation with paper is dead information, but in the age of the smart phone most of us may have as much or more computing

DO WE HAVE TO ACCEPT THE STATUS QUO, OR CAN WE CHANGE THINGS OURSELVES? power in our pocket than in the desktop machine at the shop.

A number of tools and ‘apps’ already exist and huge amounts can be done just by compiling spreadsheets and ticking boxes, but this needs to be done straight into an electronic environment. ‘Cloud’ technology also means any such data can be easily backed up and protected, whatever happens to the device.

As previously noted in this column, one of the most pressing issues in rural health today is chronic disease state management

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

26

and adherence to therapy. Yes, this is a national issue, but it’s particularly relevant to rural areas because development of a disease complication will usually result in referral to distant specialists, hospital treatment and expense and separation from family and friends.

Evidence continues to tell us that our patients are non-adherent.

Adherence rates to medicines are as low as they are for diet and lifestyle advice (such as reducing dietary salt, alcohol consumption and increasing exercise).

Keeping to the theme of being guided by evidence, one thing we can do that does add value is to keep repeating the right messages to people at every workable opportunity.

If we do this, the proportion of our clients who do change and become adherent, both to

medication and to lifestyle advice, can often become free of all manifestations of their condition.

They cannot be considered to be ‘cured’ because, in most cases, any lapse back into their old ways will bring the condition straight back, so the changes have to be ‘for life’. But if the changes can be maintained, any potential complications of their condition will be long-delayed or prevented.

Even for those in whom we fail to help achieve radical change, evidence shows that almost any improvement will bring future

benefits and reduced complications.

A major cause of non-adherence is failure to ensure adequate supply. This is often compounded during holiday periods by changes to routine and a lack of forward planning. Many of us use automated email and SMS recall systems for prescription repeats and so on, but do we use this technology to the full?

How about holiday/travel checklists? Would our elderly clients being visited by their grandchildren benefit from having a wristwatch with medication reminders programmed into it?

Or their mobile phone calendar programmed to alarm when their medication is due?

Preventing one person with diabetes progressing to foot surgery saves thousands of dollars.

Preventing one from going onto dialysis will save the government your salary for two years. Apart from the better patient outcomes, the potential savings to the public health system are enormous.

Individually, we cannot make the fundamental changes which we look to the national organisations to deliver on. But individually are we really powerless? Do we have to accept the status quo, or can we change things ourselves? Many of us already are. All of the activities discussed above are being done by at least someone, somewhere and many are becoming established practices.

As a profession, though, we must keep and report the records. So is 2013 going to be a good year or an unlucky one? ■

Contact your territory manager today or contact Customer Service on 1800 008 757

Plus

*Compared to topical single anti-fungal agents. Canesten PlusÂŽ is a pharmacist medicine only.

Always read the label. Use only as directed. If symptoms persist consult your healthcare professional. Your pharmacist’s advice is required.

ASMI 2114 - 0912

PROFESSIONAL MEDICATION IN REVIEW

Interview crucial to HMR success Debbie Rigby, consultant pharmacist and chair, Australian Association of Consultant Pharmacy

WITH REPORTS OF VARIABILITY IN THE LENGTH AND QUALITY OF HMRs BEING CONDUCTED, IT IS TIMELY TO REINFORCE THE PURPOSE AND STEPS REQUIRED FOR AN EFFECTIVE HMR.

O

ne of the aims of a home medicines review (HMR) is to achieve safe, effective and appropriate use of medicines by detecting and addressing medicine-related problems that interfere with desired patient outcomes. This cannot be achieved without a conversation with the consumer about their medicines and health beliefs and preferences.

The patient interview needs to be conducted by an accredited pharmacist with the skills, knowledge and attitudes required for this advanced level practice.

HMR GOALS The clinical goals of a HMR include reducing medication-related problems, optimising pharmacotherapy and ensuring positive patient outcomes

from their medicines. They can be summarised as follows: r *NQSPWFE RVBMJUZ PG DBSF BOE CFUUFS DPOUSPM PG DISPOJD DPOEJUJPOT r *NQSPWFE RVBMJUZ PG MJGF r .BJOUFOBODF PS JNQSPWFNFOU PG

where appropriate. Overall, the service will take around 2–3 hours; and sometimes longer for inexperienced practitioners and complex cases.

A HMR is a comprehensive medication review—much more than medicine use review (MUR) or MedsCheck (see Table One). It cannot be done in 20 minutes in the GP surgery or community pharmacy.

Experienced accredited pharmacists agree that the home interview takes at least one hour, and sometimes longer.

These all need to be addressed during the patient interview and subsequent clinical assessment.

The HMR home interview should include at least the following information-gathering steps:

INTERVIEW STEPS The information gathered with the patient during the home interview is critical to the quality of a HMR. Providing the GP with a compelling patient-related reason for changes to the medication regimen is more likely to meet with success, compared to a theoretical ‘cut and paste’ from drug information texts or guidelines.

There are four main dimensions that are crucial in assuring safe and appropriate pharmacotherapy: ageing and safety; co-morbidities; polypharmacy; and adherence.

r $POTJEFS GSBJMUZ PG QBUJFOU BOE EJTDVTT

JOUFSBDUJPOT r 3FEVDFE IFBMUIDBSF DPTUT r #FUUFS VTF PG NFEJDJOFT

Behavioural counselling, motivational interviewing, education and advice can be used as effective communication during a HMR. TIMELINES A HMR service consists of a patient interview, clinical assessment and HMR report writing, plus a discussion with the referring general practitioner

TABLE ONE: "JNT PG B IPNF NFEJDJOFT SFWJFX DPNQBSFE UP .FET$IFDL )PNF NFEJDJOFT SFWJFX BJNT

.FET$IFDL BJNT

"DIJFWF TBGF FGGFDUJWF BOE BQQSPQSJBUF VTF PG NFEJDJOFT CZ

*EFOUJGZ QSPCMFNT UIBU UIF DPOTVNFS NBZ FYQFSJFODF

EFUFDUJOH BOE BEESFTTJOH NFEJDBUJPO SFMBUFE QSPCMFNT UIBU

XJUI UIFJS NFEJDJOFT

JOUFSGFSF XJUI EFTJSFE DPOTVNFS PVUDPNFT )FMQ UIF DPOTVNFS MFBSO NPSF BCPVU UIFJS NFEJDJOFT

CZ QSPWJEJOH BEWJDF PO UIF NBOBHFNFOU PG UIFJS NFEJDJOF

JODMVEJOH IPX NFEJDJOFT BGGFDU NFEJDBM DPOEJUJPOT *NQSPWF UIF FGGFDUJWF VTF PG NFEJDJOFT CZ DPOTVNFST

VOEFSTUBOEJOH BCPVU NFEJDJOFT 'BDJMJUBUF DPPQFSBUJWF XPSLJOH SFMBUJPOTIJQT CFUXFFO

&EVDBUF DPOTVNFST BCPVU IPX UP CFTU VTF BOE TUPSF

NFNCFST PG UIF IFBMUIDBSF UFBN JO UIF JOUFSFTUT PG DPOTVNFS

UIFJS NFEJDJOF

1SPWJEF NFEJDJOF JOGPSNBUJPO UP UIF DPOTVNFS BOE PUIFS IFBMUIDBSF QSPWJEFST JOWPMWFE JO UIF DPOTVNFS T DBSF

THE AUSTRALIAN JOURNAL OF PHARMACY VOL. 94 FEBRUARY 2013

28

VOEFSTUBOEJOH PG TFSWJDF r %JTDVTT UIF QBUJFOU T FYQFSJFODF PG UIFJS NFEJDJOFT JODMVEJOH QFSDFJWFE FGGJDBDZ BOE TJEF FGGFDUT r (BUIFS BTTFTT BOE EJTDVTT QBUJFOU

USFBUNFOU HPBMT r $PNQMFUF PG B QBUJFOU NFEJDBUJPO QSPÃ MF CZ UBLJOH B DPNQSFIFOTJWF NFEJDBUJPO IJTUPSZ r *EFOUJGZ BEEJUJPOBM NFEJDJOFT JODMVEJOH PWFS UIF DPVOUFS BOE DPNQMFNFOUBSZ NFEJDJOFT OPU JODMVEFE PO UIF (1 SFGFSSBM r 4ZTUFNBUJDBMMZ EFUFSNJOF UIF QBUJFOU T CBTJD VOEFSTUBOEJOH PG UIFJS NFEJDJOFT BOE NFEJDBUJPO EFWJDFT JODMVEJOH XIBU UIFZ BSF GPS UIF FYQFDUFE CFOFÃ UT BOE UIF JNQMJDBUJPOT PG GBJMJOH UP UBLF UIFN BT SFDPNNFOEFE r "QQSBJTF ESVH VUJMJUZ BOE QBUJFOU BEIFSFODF BOE QFSTJTUFODF r &TUJNBUF UIF NBHOJUVEF PG CFOFÃ U WFSTVT IBSN JO SFMBUJPO UP FBDI NFEJDBUJPO

*NQSPWF UIF DPOTVNFS T RVBMJUZ PG MJGF BOE IFBMUI PVUDPNFT

IFBMUI BOE XFMMCFJOH

r 1BUJFOU DPOTFOU BOE DPOÃ SNBUJPO PG

TJHOT BOE TZNQUPNT

GVODUJPOBM TUBUVT r 3FEVDUJPO JO "%3T BOE ESVH

*NQSPWF DPOTVNFS BOE IFBMUI QSPGFTTJPOBM LOPXMFEHF BOE

r *OUSPEVDUJPO BOE FTUBCMJTI SBQQPSU

r *EFOUJGZ OFFE GPS EFQSFTDSJCJOH PS BEEJUJPOBM NFEJDJOFT r (BUIFS JOGPSNBUJPO PO BEWFSTF FGGFDUT PG QPUFOUJBMMZ JOBQQSPQSJBUF NFEJDBUJPOT r 6TF FYQMJDJU DSJUFSJB UPPMT UP JEFOUJGZ UIF NPTU DSJUJDBM JTTVFT BOE QSJPSJUJTF JOUFSWFOUJPOT UP JNQSPWF RVBMJUZ PG DBSF BOE QBUJFOU TBGFUZ r "TTFTT TFEBUJWF BOUJDIPMJOFSHJD

PROFESSIONAL

Source: International Journal of Clinical Pharmacy 2012;34:510–4.

MEDICATION IN REVIEW

CO-MORBIDITIES

POLYPHARMACY

Contraindicationsa,b

Validity of indications, duration of treatment a,c

Compliance with care guidelines and recommendationsa,b

Drug-drug interactions, duplication b

Response to therapy (effectiveness)a,c Untreated conditionsa,b Adverse drug reactions a,c

Kidney functiona

Sedative, anticholinergic and serotonergic load b

CMR

Dosing times, intervals and drug forms b,c

Drug doses

a,b

Criteria for potentially inappropriate medications15-17,b

AGEING AND SAFETY and serotonergic load. r *EFOUJGZ QBUJFOU TJHOT BOE TZNQUPNT JOEJDBUJWF PG ESVH ESVH ESVH EJTFBTF PS ESVH GPPE JOUFSBDUJPOT r "TTJTU DPOTVNFST UP NBLF JOGPSNFE decisions via decision aids. r *EFOUJGZ QSBDUJDBM JTTVFT TVDI BT TXBMMPXJOH EJGGJDVMUJFT BCJMJUZ UP SFBE MBCFMT BOE XSJUUFO JOGPSNBUJPO r %FNPOTUSBUF BOE BQQSBJTF BENJOJTUSBUJPO UFDIOJRVFT PG SFTQJSBUPSZ EFWJDFT r %JTDVTT TUPSBHF DPOTJEFSBUJPOT PG NFEJDJOFT r &YQMBJO NPOJUPSJOH SFRVJSFNFOUT GPS CMPPE HMVDPTF MFWFMT CMPPE QSFTTVSF */3 TMFFQ EJBSJFT r 0SHBOJTF SFRVJSFNFOUT GPS BOZ BEEJUJPOBM TVQQPSU FH EPTF BENJOJTUSBUJPO BJET DPOUJOFODF BJET DPMMFDUJPO BOE EFMJWFSZ TFSWJDFT r $PODMVEF XJUI B TVNNBSZ PG UIF BHSFFNFOU XJUI UIF QBUJFOU BCPVU UIF USFBUNFOU BOE BO FYQMBOBUJPO PG XIBU XJMM IBQQFO OFYU

Ability to use as instructed c Medication-related concerns Drug costs b,c

ADHERENCE

interview is critical for the next phase of a HMR—the clinical assessment.

Without this information the quality and likely uptake of recommendations to the GP is of limited value.

"TDFSUBJO BMM DVSSFOU NFEJDBUJPOT *EFOUJGZ QBUJFOUT BU IJHI SJTL PG PS FYQFSJFODJOH BEWFSTF ESVH reactions. &TUJNBUF MJGF FYQFDUBODZ JO IJHI SJTL QBUJFOUT %FĂ OF PWFSBMM DBSF HPBMT JO UIF DPOUFYU PG MJGF FYQFDUBODZ %FĂ OF BOE DPOĂ SN DVSSFOU JOEJDBUJPOT GPS POHPJOH USFBUNFOU %FUFSNJOF UIF UJNF VOUJM CFOFĂ U GPS EJTFBTF NPEJGZJOH NFEJDBUJPOT &TUJNBUF UIF NBHOJUVEF PG CFOFĂ U WFSTVT IBSN JO SFMBUJPO UP FBDI NFEJDBUJPO 3FWJFX UIF SFMBUJWF VUJMJUZ PG EJGGFSFOU ESVHT *EFOUJGZ ESVHT UIBU NBZ CF EJTDPOUJOVFE *NQMFNFOU BOE NPOJUPS B ESVH NJOJNJTBUJPO QMBO XJUI POHPJOH

FRAMEWORK Australian medical specialists have proposed a framework with 10 sequential steps to assist in making decisions about the appropriateness of therapy in older people. The framework features an individualised appraisal of drug-related risk, expected lifespan, care goals, verification of diagnoses, likely time to benefit, and benefit–risk thresholds of individual medicines and their relative utility.

The information gathered at the

SFBQQSBJTBM PG ESVH VUJMJUZ BOE QBUJFOU BEIFSFODF CZ B TJOHMF OPNJOBUFE DMJOJDJBO

PATIENT CONVERSATION One aspect of a HMR that differentiates the service from a prescription review is the patient interview. Prescription reviews can be helpful in identifying anomalies and highlighting patients who may need a more comprehensive medication review. As a stand-alone tool their benefits are relatively limited

as they do not normally allow for a full discussion with the patient.

Patient-centred care was first defined in medical literature in 1970 as ‘to understand the complaints offered by the patient and the symptoms and signs found by the doctor, not only in terms of illness, but also as expressions of the patient’s unique individuality, their expressions, conflicts, and problems’.

From a pharmacist’s perspective, patient-centred care includes involving patients in decisions about medicines and supporting adherence.

It represents a shift in thinking about patient care in terms of medications and diseases toward thinking in terms of people and their problems.

Medication therapy should take into account patients’ individual needs and preferences. During a HMR interview, the patient should be given an opportunity to express their thoughts, feelings and expectations.

Communication skills essential for the patient interview include: questioning; listening; explaining; reflecting; using silence appropriately; and developing rapport.

A HMR is more than just gathering an up-to-date medicines list. This is useful to both the consumer and the GP and can be provided by a MedsCheck. During the HMR, medicines should be seen in the context of the patient’s medical condition, history and treatment.

The conversation with the patient may have an aspect of shared decision making. Many patients want more information and involvement in decisions about treatment, care or support than they experience in a standard consultation with their GP or picking up scripts in a pharmacy.

Embedding shared decision making into the home interview may be a challenge; but it is one that will differentiate a HMR as a valued service.

By exploring the patient’s beliefs and attitudes the conversation may be more likely to result in genuine

agreement, with the patient taking the medicine as prescribed.

PATIENT BELIEFS Patients may be reluctant to ask questions about medications during medical visits. A US study showed that: less than 1% of the medication questions asked by medical practitioners were open-ended; nearly half of all patients were not asked any questions about how their medications were helping; and more than twothirds of the patients were not asked any questions about barriers or side effects. Also, medical practitioners rarely asked about contraindications, allergies, or drug interactions.

The HMR home interview should allow patients to have a genuine opportunity to raise questions and express their views, which are taken into account in treatment decisions.

Patient health beliefs are influential in determining medication adherence.

Educational interventions alone are insufficient to improve medication adherence and persistence.

If you start out with a non-educated, non-compliant patient and all you do is educate them, then all you end up with is an educated, non-compliant patient.

People change their behaviour when they are motivated to do so and that happens when you speak to their feelings. About 20% of the variance in adherence behaviour can be attributed to a patient’s beliefs about chronic medications.

SUMMARY The interview is a critical, value-limiting step of the HMR service, requiring mastery of communication techniques with a focus on patient-centred care.

The interview provides an opportunity for a structured, critical examination of a patient’s medicines with the objective of reaching an agreement with the patient about treatment, optimising the impact of medicines, and minimising the number of medication-related problems. â–

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PROFESSIONAL FEATURE F E A T U R| EDIABETES | H Y P EMANAGEMENT RTENSION

Pressure mounts on hypertension action KEY POINTS Evidence of the mortality and morbidity due to hypertension has added weight to calls for a national action plan to improve early detection and management of heart, stroke and blood vessel disease.

Blood pressure targets have been revised to be slightly less aggressive than in the past, with a renewed emphasis on absolute risk rather than on individual risk factors.

Research has reinforced the value of the pharmacist in reducing blood pressure via medication review and engaging with patients and treating doctors in a collaborative healthcare setting yet mechanisms to get pharmacists working as primary care team members are lacking.

Although combination therapy can help with compliance, for most patients a combination of antihypertensives from two or more pharmacological classes is needed.

THE SILENT KILLER MAY BE NO MORE VOCAL A RISK FACTOR THAN CHOLESTEROL BUT ITS MORE WIDESPREAD PRESCRIBING, POOR ADHERENCE AND GREATER DISEASE BURDEN DROWNS OUT ANY OTHER HEALTH CONDITION. STEVEN CHONG REPORTS ON HOW PHARMACISTS CAN BETTER SUPPORT HYPERTENSION MANAGEMENT.

I

t’s official! Evidence established over two decades by an international research consortium including Harvard, the University of Queensland and the World Health Organization, published across a dedicated triple-issue Lancet extravaganza and funded by the World Bank and Gates Foundation has found that high blood pressure is the biggest global risk factor for disease.1 While not exactly ‘new’ news— high blood pressure has been cast as developed countries’ leading health villain long before World Hypertension Day began in 2005— the key findings from the landmark Global Burden of Disease Study 2010 (GBD 2010) show how modernity is now exacting the same toll on the health of the rest of the world.

In just 20 years since 1990, high blood pressure jumped from fourth place to first in leading risk

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factors for poor health worldwide, overtaking childhood underweight, indoor air pollution and smoking.2 Hypertension saddles the globe with the largest burden of death and disability, followed by tobacco and alcohol. In Australasia, obesity is literally the heaviest burden, followed by tobacco then hypertension.3 But in terms of premature death, cardiovascular disease (CVD) is still number one, worldwide and in Australia.4 ‘Having high blood pressure increases your risk of heart disease, which this study has also shown to be the leading cause of premature death in Australasia,’ said Dr Robert Grenfell, National Cardiovascular Health Director at the Heart Foundation (NHF) upon Lancet’s

PROFESSIONAL FEATURE | HYPERTENSION

publication of the GBD 2010 at the end of last year.5 ‘One in three Australians aged 30 to 65 have been told by a doctor they have high blood pressure—that’s 3.5 million people,’ pointed out Dr Grenfell, who urged those who haven’t been told to see a GP for a check up.

However, he added that the other top risk factors of obesity and smoking also contribute to CVD as well as a range of other conditions.

‘This adds even more evidence to an already overwhelming case for a national action plan to improve early detection and management of heart, stroke and blood vessel disease.’

HEART AND HYPERTENSION INITIATIVES The NHF joined forces with the Stroke Foundation in June to launch the Hearts and Minds Campaign for a funded national CVD action plan that includes 11 proposals including GP-led screening, reduction of salt and saturated fat levels in commonly eaten foods, and an active travel strategy to encourage walking, cycling and public transport use.6 Pharmacists were noticeably absent from the plan and salt reduction in food was the focus of the NHF during World Hypertension day on 17 May.7 However, a few days later the NHF was a partner with other health NGOs in the release of revised Guidelines for the Management of Absolute Cardiovascular Disease Risk.8 The Guidelines are an update to the 2009 version that introduced the Absolute CVD Risk Calculator [see AJP 2012;Feb 92:30–34, 2013;Jan 93:26–30] to primary healthcare to roll all the risk factors, and their dynamic interplay, into a single figure. In the 2012 edition, primary prevention was covered as well as recommendations on lipid and blood pressure lowering [see box below].

However, blood pressure targets were also updated to be slightly less aggressive than in the past.9

In a nod to the primacy of hypertension, people with a level of at least 160/100mmHg will be treated for their blood pressure regardless of their Absolute Risk. The new target for people with chronic kidney disease has been increased to ≤140/90mmHg from 130/80mmHg, and the target for people with microor macroalbuminuria has been increased to ≤130/80mmHg from 125/75mmHg.8 The level for people with diabetes remains ≤130/80mmHg and Dr Grenfell told the AJP that new data was showing a need for relaxation.

‘There would have been a substantial number of borderline people, say with a systolic BP between 140 and 160mmHg, who could have been told they were hypertensive and treated overjudiciously with not much benefit,’ Dr Grenfell says of the original 2009 Guidelines and there is only modelling to estimate how large that population might be.

‘Most people over 50 years old, however, have at least 2–3 risk factors, most commonly high blood pressure,’ he adds.

Dr Montgomery, Associate Professor of General Practice at the University of WA, is a GP based in Fremantle who welcomes the renewed emphasis on absolute risk rather than individual risk factors, as he says: ‘The right patients are likely to get better treatment, and sometimes the new Guidelines will spare expense and side-effects in people less likely to benefit from reflex prescribing of antihypertensives.’

BETTER DIAGNOSIS THROUGH 24-HOUR MONITORING Both Dr Grenfell and Dr Montgomery point out contention within the healthcare profession over the past year about a year-old consensus position statement from the NHF and High Blood Pressure Council of Australia (HBPRCA) on the role of 24-hour ambulatory blood pressure monitoring (ABPM).10

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PROFESSIONAL FEATURE | HYPERTENSION

As expected a year ago [see AJP Feb 2012;92:30–34], the statement confirms that ABPM—where BP readings are taken in intervals over a 24-hour period of normal daily activity—is a more accurate assessment of blood pressure. The HBPRCA promoted ABPM in its public campaigns for World Hypertension Day in May and it was further highlighted during the International Society of Hypertension’s biennial Scientific Meeting in Sydney they hosted in September.11,12 With GPs the traditional first port of call for a BP test and hypertension the most diagnosed and managed condition in general practice, the advent of ABPM could be a big deal and the Australian medical journals have devoted much space to it.13–15 ‘There has been some debate about the value of an ABPM approach because the medical community believes very firmly in using an Absolute Risk approach to determine the likelihood of a heart event,’ said Dr Grenfell on the publication of the statement last January. ‘However, the Heart Foundation believes that this approach provides a tool that can assist in determining if a person’s blood pressure is elevated, where the status is uncertain, which can then be used to identify if treatment is necessary. ‘The wider use of ABPM, although justified, is limited by its current availability and cost, which is due in part to the lack of medical subsidy in Australia. This needs review through the Medicare Benefits Schedule,’ Dr Grenfell said.10 Dr Montgomery, who was invited to comment on a recent US study16 of pharmacists that used ABPM in its methodology, agrees the lack of an MBS item number will hinder uptake up ABPM in Australia. ‘Some patients would spend about $80–$100 to access it and although a good BP monitor for home use could cost around the same, they have it

IN PRACTICE

Practice points for blood pressure lowering from Guidelines for the Management of Absolute CVD Risk18 1. If blood pressure is not responding to pharmacotherapy, reassess for: r OPO BEIFSFODF r VOEJBHOPTFE TFDPOEBSZ DBVTFT PG SBJTFE CMPPE QSFTTVSF r IZQFSUFOTJWF FGGFDUT PG PUIFS ESVHT r USFBUNFOU SFTJTUBODF EVF UP TMFFQ BQOPFB r VOEJTDMPTFE VTF PG BMDPIPM PS SFDSFBUJPOBM ESVHT r VOSFDPHOJTFE IJHI TBMU JOUBLF QBSUJDVMBSMZ JO QBUJFOUT UBLJOH "$& JOIJCJUPST PS BOHJPUFOTJO SFDFQUPS CMPDLFST

r AXIJUF DPBU SBJTFE CMPPE QSFTTVSF r UFDIOJDBM GBDUPST BGGFDUJOH NFBTVSFNFOU BOE

CKD.

2. If dual therapy at higher doses does not sufficiently reduce blood pressure, add an additional agent.

3. If combination therapy does not sufficiently reduce blood pressure, consider specialist advice.

4. Treatable secondary causes for raised blood pressure should be considered before commencing blood pressure drug therapy.

5. The following combinations should generally be avoided: r QPUBTTJVN TQBSJOH EJVSFUJD QMVT FJUIFS "$& JOIJCJUPS PS "3# r CFUB CMPDLFS QMVT WFSBQBNJM

for years of use compared to just the once,’ he told the AJP.

[HMRs] are a good mechanism for pharmacist collaboration and can be useful ‌ in terms of improving adherence.

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r WPMVNF PWFSMPBE FTQFDJBMMZ XJUI

COMMUNITY PHARMACISTS RESEARCHED The pharmacy study Dr Montgomery reviewed took place in Iowa City among five primary care clinics and involved 179 adult patients with uncontrolled hypertension who had already received up to three antihypertensive agents for the past four weeks. Similar to a MMR, pharmacists reviewed patient data and interviewed them, then discussed individual treatment recommendations with doctors who could adjust medications as needed.16 The study had high follow-up rates, with 87% of patients having ABPM assessments every two months until nine months. The co-management model reduced systolic and diastolic BP more than usual-care controls by an average 11/4mmHg—a ‘clinically important’ reduction

commented Dr Montgomery17—and perhaps more remarkably, doctors in the co-management group implemented 96% of pharmacists’ recommendations.

Dr Montgomery said implications may be limited for Australia because the pharmacists in Iowa were in collaborative healthcare clinics and although the Super Clinics could yet turn out to be similar, mechanisms to get pharmacists working as primary care team members were still lacking. ‘It would be good to see it replicated in other settings, but they were seeing the patient one-on-one rather than over a counter and the BP readings were ambulatory, but also, you would have to ask, in our health system “Who would pay for it?�’ he told the AJP. As a GP, Dr Montgomery does find it useful if pharmacists stock home BP machines to demonstrate or sell to customers. ‘The common dilemma for doctors is you take a BP reading and find it’s high but are not sure if it’s truly hypertension of just the white-coat effect. The evidence isn’t solid but my gut feeling is there may be less of that in a pharmacy and, or of course, in the patient’s home. Home machines are economical and fairly easy to use, but patients often worry about accuracy so it’s good for them to test and compare results on other machines.’ The updated Guidelines mention a Cochrane review of self-monitoring trials which were associated with a reduction in 2.5/1.8mmHg) reduction in blood pressure, ‘and may be a useful adjunct strategy’, providing a potential growing market for retail pharmacists.

Patients’ homes are the heart of HMRs and Dr Montgomery agrees that these are a good mechanism for pharmacist collaboration and can be useful with carefully selected patients in terms of improving adherence.

However, he feels the evidence for pharmacist interventions such as

First line treatment of hypertension in pregnancy1 Before prescribing please refer to approved Product Information.

Approved Product Information is available from Aspen Pharmacare.

PBS Information: This product is listed on the PBS as: antihypertensive, centrally acting agent.

Aldomet速 Minimum Product Information - Indication: Hypertension (mild, moderate to severe). Dosage: Adults Starting dose 250mg two or three times a day in the first 48 hours. The daily dosage may then be increased or decreased, at intervals of not less than two days. The maximum recommended daily dosage is 3g. Children Initial dosage is 10mg/kg of body weight daily in two to four doses. The daily dosage is then increased, or decreased. The maximum dosage is 65mg/kg or 3.0g daily, whichever is less. Contraindications: Patients with active hepatic disease (acute hepatitis and active cirrhosis); hypersensitivity (including hepatic disorders associated with previous methyldopa therapy) to any component of these products; patients on monoamine oxidase (MAO) inhibitors. Precautions: Rarely- acquired haemolytic anaemia; reversible reduction of the granulocytes count; reversible thrombocytopenia; jaundice; fatal hepatic necrosis. Lithium, Other Antihypertensive Drugs, Iron, Monoamine Oxidase (MAO) Inhibitors. Adverse reaction: Sedation, oedema, nausea, liver disorders, rash. Significant adverse effects have been infrequent. PBS dispensed price effective 23/01/12: $15.80.

References: 1. Therapeutic Guidelines: Cardiovascular 2008.

Aspen Australia is a group of companies including Aspen Pharmacare Pty Ltd, ABN 51 096 236 985.

All sales and marketing requests to: Aspen Pharmacare Australia Pty Ltd, St Leonards NSW 2065. Tel. +61 2 8436 8300 aspen@aspenpharmacare.com.au www.aspenpharma.com.au

Tick the box for Aspen Quality

PROFESSIONAL FEATURE | HYPERTENSION

dose administration aids (DAAs), medication reminders and fixeddose combinations is not that strong, echoing similar concerns in the updated Guidelines for the Management of Absolute CVD Risk.18 ‘These tools can be useful but the patient has got to want to use them.

My only vague concern is people may be choosing a combination simply because one exists rather than there being evidence for it.

For instance, I would get better results using chlorthalidone instead of a thiazide diuretic but most combination products with a diuretic will use hydrochlorothiazide. But the status quo is that I can’t choose ACE inhibitor with chlorthalidone instead of a thiazide. If it were all as simple as atorvastatin and amlodipine combinations then I would think it’s fine in principle, but they’re not always the right or best combination.’

ADHERENCE THROUGH COMBINATION THERAPY Consultant pharmacist Debbie Rigby recently compiled further recent evidence for fixed-dose combinations and HMRs for improving adherence and persistence where CVD or its risk factors commonly copresent with other conditions in Multiple Morbidities: How pharmacists can make a difference through medication reviews [see also AJP Jan 2013;93:26–30].19 ‘In addition to substantial improvements in adherence and persistence, fixed-dose combinations improve BP control and reduce adverse effects,’ Multiple Morbidities states.19

‘Home [BP] machines are economical and fairly easy to use…’

However, it is the improvements on hard endpoints, such as cardiovascular events or hospital readmissions, which are most compelling.

‘For most patients, a combination of antihypertensive agents from two or more pharmacological classes is needed. Up to four antihypertensives in combination may be necessary to achieve BP targets,’ says Ms Rigby.

‘But despite considerable evidence for multidrug therapy, most people with treated blood pressures above target get one or two classes prescribed. The Heart Foundation’s updated 2010 guidelines on BP management now advocate the use of two medications as initial therapy for most antihypertensive patients.’

As to which medications, apart from being up to the prescriber, it depends on the individual and Ms Rigby points to a large meta-analysis20 that showed similar efficacy to prevent cardiovascular events among all classes.

However, Ms Rigby points out ACE inhibitors and ARBs should not be used in combination to treat hypertension and treatment should always be individualised according to concomitant risk factors and diseases [see Table One].

ACE inhibitor/ARB

Calcium channel blocker Beta blocker

21 regions, 1990–2010: a systematic analysis for the GBD 201. Lancet 2012;380(6859):2197–223.

5. Heart Foundation. Media release. High blood pressure is world’s largest health risk, 14.12.2012.

6. Heart Foundation. Federal advocacy: Hearts and Minds campaign. www.heartfoundation.org. au/driving-change/Pages/federal-advocacy.aspx, accessed 13.12.2012.

7. Heart Foundation. Cutting salt could save 6,000 lives a year. Media release, 17.5.2012.

8. National Vascular Disease Prevention Alliance.

Media release. New guidelines and treatment procedures for heart attack and stroke risk.

22.5.2012.

9. National Vascular Disease Prevention Alliance.

Media release. 10 things to know about the NVDPA Guidelines.

10. Heart Foundation. Media release. Ambulatory blood pressure monitoring statement released.

6.2.2012.

11. HBPRCA. Media release. Do you know if you have high blood pressure? 15.5.2012.

12. HBPRCA. Media release. High blood pressure can cut short your life. 15.5.2012.

13. NHF and HBPRCA ABPM Consensus Committee. Ambulatory blood pressure monitoring. Aust Family Physician 2011;40(11):877–9.

14. Neal BC, Irwig L. Not much need for ABPM. Med J Aust 2011;195(11):634–5.

15. Campbelll DJ. Not much need for ABPM. Med J Aust 2012;196(4):241.

injury and risk. Lancet 2012;380(9859):2053–4.

16. Weber CA, Ernst ME, Sezate GS, et al.

2. Watts C, Cairncoss S. Should the GBD risk

Pharmacist-physician comanagement of

factor rankings be used to guide policy? Lancet

hypertension and reduction in 24-hour

2012;380(9859):2060–1.

ambulatory blood pressures. Arch Intern Med

3. Lim SS, Vos T, Flaxman AD, et al. A comparative

2010;170:1634–9.

risk assessment of burden of disease and injury

17. Montgomery B. ACP Journal Club. Pharmacist-

attributable to 67 risk factors and risk factor clusters

physician hypertension comanagement reduced

in 21 regions, 1990–2010: a systematic analysis for

24-hour ambulatory blood pressure. Ann Intern

the GBD 2010. Lancet 2012;380(9589):2224–60.

Med 2011;154(4):JC2–9.

18. National Vascular Disease Prevention Research Alliance. Guidelines for the Management of

Antihypertensive 2

Practice Point

Calcium channel blocker

Effective in presence of diabetes or dyslipidaemia

Stroke Foundation 2012.

Thiazide diuretic

Effective in presence of heart failure or post-stroke

19. Rigby D. Multiple Morbidities: How

Beta blocker

Recommended post-MI and in heart failure

pharmacists can make a difference through

Beta blocker

Recommended in presence of coronary heart disease

medication reviews. Pfizer Australia P/L, 2012.

Thiazide diuretic Thiazide diuretic

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

36

adjusted life years for 291 diseases and injuries in

1. Horton R. GBD 2010: Understanding disease,

TABLE ONE: Combinations for hypertension19 Antihypertensive 1

4. Murray CJL, Vos T, Lozano R, et al. Disability-

Not recommended in diabetes or metabolic syndrome

Absolute Cardiovascular Disease Risk. National

20. Turnbull F, Neal B, ALgert C, et al. Blood pressure lowering treatment trialists’ collaboration.

Arch Intern Med 2005;165(12):1410–9.

PRODUCT PRODUCT NEWS NEWS

DRUG ALERTS

Faulty crutch recall

T

he Therapeutic Goods Administration (TGA) has recalled some batches

of the Making Life Easy and Independent

OTC PRODUCTS

Natural origins

B

eiersdorf’s Nivea Visage has a new Pure & Natural skincare

range. Containing at least 95%

Living Superstore (MLE) Forearm Crutch

ingredients from natural origin, all six

Ergo Grip (tall and adult).

products in the range are designed to

A potential fault in the plastic component that links the arm cuff with the crutch stem

leave skin feeling naturally beautiful.

The range—three face creams, a

in the affected batches has led to reports of

cleansing lotion, a cleansing toner

the arm cuff separating from the crutch.

and wipes—combines Nivea’s effective ingredients that work in

active ingredients organically grown

is a natural source of vitamin E and

breakage of the plastic component

harmony with skin. It’s also free

and certified.

provides intense moisturisation. The

during use could result in the user falling

from parabens, silicones, artificial

and being injured.

colorants and mineral oils, with all the

While no injuries have been reported,

Beiersdorf Pure & Natural range contains organic argan oil, which

range retails from $7.50–$12.99.

1800 103 023

The affected batch numbers are: t .-& 'PSFBSN $SVUDI &SHP (SJQ 5BMM 251097-1202-1; and 251097-1203-1. t .-& 'PSFBSN $SVUDI &SHP (SJQ "EVMU 234354-1202-1; and 234354-1203-1.

The batch number can be found on a white sticker affixed to the leg of the

" XIJUFS GVUVSF

)JHI TUSFOHUI LSJMM PJM

P

F

rocter & Gamble’s Oral-B

1500mg is designed to assist

combines two ingredients—

crutch just below the hand grip.

stabilised stannous fluoride and

www.tga.gov.au/safety/alerts-device-mle

sodium polymetaphosphate.

forearm-crutch-121213.htm

aulding High Strength Krill Oil

new toothpaste Pro-Health

with joint inflation, PMS management and maintaining healthy cholesterol levels. It has high potency per capsule

Stabilised stannous fluoride

so consumers need not take any more

acts on bacteria to reduce

)FBU QBDL TBGFUZ BMFSU

P

down by acid and helps

to the risk of burns resulting from use

protect enamel against

of wheat or grain-filled heat packs (heat

further tooth decay and

packs), after the TGA received reports of

cavities. in the making,

t CFJOH IFBUFE JO NJDSPXBWFT GPS MPOHFS UIBO

Oral-B Pro-Health

t CFJOH SFIFBUFE CFGPSF CFJOH BMMPXFE UP DPPM QSPQFSMZ BOE t BHFJOH DBVTJOH GJMMJOHT UP ESZ PVU BOE become combustible.

thrombotic effects. It can therefore help with temporary relief from the pain of arthritis, Pro-Health

Krill oil is also a rich source of high-

42% reduction in

quality protein and antioxidants which

enamel loss versus ordinary fluoride

toothpaste

toothpaste after 15 days.

targets cavities,

It forms a protective

gingivitis, plaque, sensitivity, enamel, tartar, whitening and breath,

barrier that helps prevent food acids from damaging enamel.

There is also 57% reduction in gingival bleeding versus an

remind consumers to carefully follow

oral health and whitening benefits in

ordinary fluoride toothpaste after

manufacturer’s instructions and

one product

six months.

Pro-Health is formulated with

Achieve up to 71% reduction in

packs that are listed on the Australian

whitening ingredients that remove

bad breath after three weeks versus

Register of Therapeutic Goods. Heat

surface stains and prevent stain

ordinary fluoride toothpaste and

packs are classified as low-risk (Class 1)

build up to keep teeth whiter with

upto 56% greater tartar inhibition

medical devices.

up to 96% reduction in surface

after six months, according to the

www.tga.gov.au/newsroom/media-2012-heat

staining in two weeks, according to

manufacturer.

QBDLT IUN

the manufacturer.

www.oralb.com.au

recommends the purchase of heat

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

osteoarthritis and premenstrual symptoms.

provides up to

providing a number of therapeutic

The TGA asks pharmacists to

38

which have anti-inflammatory and anti-

More than 15 years

t CFJOH IFBUFE BOE QMBDFE PO PS JO CFEEJOH UIF UJNF TQFDJGJFE CZ UIF NBOVGBDUVSFS

Krill oil contains omega-3 fatty acids

It builds up minerals worn

harmacists should alert consumers

burns resulting from heat packs:

than two capsules daily.

damaging acid.

play a beneficial role in the prevention of disease. It retails $45.99 for 50 capsules. www.faulding.com.au

PRODUCT PRODUCT NEWS NEWS

OTC PRODUCTS

Transparently natural

Reduces acute bronchitis and sinusitis

A

B

ccording to a Jigsaw research survey, 71% of women use natural products in

lackmores Kaloba is a TGAregistered complementary medicine

Meets demands of a busy life

N

their household yet only 35% choose to use

for the treatment of acute bronchitis and

natural facial skincare. Of these women,

acute sinusitis. Kaloba has been used in

more than 60% said they had concerns

Europe since 1999 and is now available

potency stress and energy formula in a

around the affordability of their product, and

in pharmacies here. Preliminary evidence

convenient one-a-day tablet.

ature’s Own has launched Executive Performance—a high

more than 40% said it is still

suggests that Kaloba may treat acute

hard for them to know what is

bronchitis and acute sinusitis as a result of

Performance assists with energy levels and

genuinely natural.

the following properties:

helps to support the nervous system during

r BOUJWJSBM JNNVOF NPEVMBUJOH

times of stress. It also supports healthy

r BOUJCBDUFSJBM BOE

brain function including concentration,

r TFDSFUPNPUPSZ

memory and maintenance of normal mood.

dermatologists

It has approved doses (for acute bronchitis)

of Statistics, 35% of males and 42% of

to develop

for children older than two years* and may

females feel rushed or pressed for time.

naturally-inspired

hasten recovery by helping to reduce acute

As people try to cram more into their

products with

bronchitis symptoms.

already busy lives, many are turning to

Johnson & Johnson has collaborated with an integrated panel of specialists and

Each tablet of Nature’s Own Executive

According to the Australian Bureau

efficacious

supplements for help to maintain their

formulas.

*Children under the age of 6 years should

energy levels, making energy and stress

Working with

only be treated with Blackmores Kaloba

the number one segment

experts in

after consultation with a doctor.

in vitamin and mineral

integrative

www.blackmores.com.au

supplements.

Lifting its lax(ative) image

go hand-in-hand

T

o invigorate its image, Norgine has

energy and vitality

launched a new campaign for its banner

portfolio, Executive

medicine, biochemistry and micronutrients, the Neutrogena

‘Energy and stress and as part of our

brand focuses on developing a line that

product Movicol. A new visual, Colin the

Performance offers

could fully leverage the benefits of its

Python, represents the shape of an intestine

Australians help

natural ingredients.

(colon) and the feeling that occurs when

with balancing

constipated, whether it’s faecal impaction or a

the demands of

simple discomfort.

a busy life,’ said

Neutrogena Naturals was created with an average of 95% naturally derived ingredients and without the use of

According to consumer

Luke Fitzgerald,

sulfates, parabens, petrochemicals,

research, most sufferers

director of Sanofi

dyes, or phthalates.

of constipation feel ‘big or

Consumer

pregnant’. Therefore, Colin the

Healthcare, the

Naturals offers women transparency in the

Python’s image aims at being

manufacturers of

natural skincare category with packaging

empathetic to the consumer. It

Nature’s Own.

that outlines ingredients and sources to

was chosen as an endearing

help clearly communicate and dispel any

new mascot for Movicol and his

essential B vitamins for energy

potential confusion.

name is, well, self explanatory.

production, including niacin which is

Johnson & Johnson’s Neutrogena

Executive Performance contains

Bionutrients are nutrients that the skin

Norgine has started a

already uses to promote healthy function of

merchandising campaign in

of the brain and nervous system, and

the skin and Neutrogena Naturals includes

pharmacies and hopes this will help it to

thiamine which also plays a role in the

five classes of bionutrients, essential

‘jazz up’ the laxative aisle. Movicol has

maintenance of mood.

omega fatty acids, vitamins and minerals to

an RRP: $8.99 for 8 sachets and $19.99 for

help support and renourish skin.

30 sachets.

comes in 30 tablet packs.

1800 678 380

www.movicol.com.au

1800 451 453

also essential for the normal functioning

Nature’s Own Executive Performance

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

39

OVER THE COUNTER FEATURE | VITAMINS & SUPPLEMENTS

$PNQMFNFOUJOH QBUJFOU TVQQPSU XJUI LOPXMFEHF WHETHER SOME PHARMACISTS LIKE IT OR NOT, CONSUMERS WANT THEM TO HELP WITH ADVICE ON COMPLEMENTARY MEDICINES, WRITES -*4" 0''03%.

T

he growing wave of interest in complementary medicines such as vitamins and supplements provides pharmacists with an opportunity to offer evidence-based advice to information-hungry consumers.

Research pharmacist and herbalist Dr Lesley Braun has little doubt that self-care using over-the-counter complementary medicine products is likely to increase in the coming years, chiefly due to the ageing of the population and increased prevalence of chronic diseases.

Dr Braun observes that since chronic diseases do not have a conventional cure, more people will search for other strategies to improve their symptoms, reduce disease exacerbations and improve their overall quality of life.

And complementary approaches are a fertile hunting ground for such approaches, she says.

Evidence indicates that pharmacy customers want their pharmacists to be more involved in advising about complementary medicines.

However, there are barriers still preventing pharmacists from playing this role—and education, Dr Braun says, is the key. ‘Pharmacists are not really well recognised as being information

KEY POINTS Consumers want their pharmacists to be more involved in advising about complementary medicines.

Education is the major barrier preventing pharmacists from playing the role of the learned intermediary.

Vitamins and supplements, and the broader complementary medicines range, are the largest OTC category and the fastest growing.

sources in this area and, to be honest, pharmacists need to step up and make themselves available in that way. ‘Also, they need to become more familiar with the evidence to be able to give an informed opinion and the opinion needs to encompass not just the safety issues but also whether there are potential benefits as well,’ she said.

Dr Braun said at the very least pharmacists should have a good understanding of the most popular complementary medicines.

According to Dr Braun’s research, multivitamins and fish oils

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

40

supplements are especially popular, followed by vitamin C, glucosamine and B complex supplements.

Probiotics, CoQ10, ginkgo biloba, St Johns wort and valerian also feature in a list of top 10 complementary medicines taken by pharmacy customers. ‘But obviously there are those complementary medicines with supportive evidence that pharmacists should know about regardless of whether they are popular or not,’ Dr Braun said.

Dr Braun said the book she co-authored Herbs & Natural Supplements: An Evidence-based Guide contained the complementary medicines practitioners should know.

and the nutritionals: r JPEJOF r [JOD r DPFO[ZNF 2 r Ă TI PJMT r WJUBNJO % r HMVDPTBNJOF

FILLING A GAP The following complementary medicines have been chosen

by Dr Braun because ‘they have supportive evidence and fill a gap in practice because they are either safer and/or more effective than pharmaceutical treatments, or offer something unique, such as probiotics’: r QZHFVN r IPOFZ r IPSTFDIFTUOVU r HJOLHP CJMPCB r LBWB LBWB r QFQQFSNJOU r QSPCJPUJDT r UFB USFF r WJUFY r CMBDL DPIPTI r CBDPQB r QFMBSHPOJVN ,BMPCB BOE r FDIJOBDFB

r DIPOESPJUJO BOE r 4".F

There were a number of approaches pharmacists could take in order to provide their customers with the information they needed, she said. ‘It depends really on the environment in which they work in and the type of clientele they are seeing. If they are in an area where there are a lot of elderly people, for example, they should get to know those high-quality supplements which would be of most benefit to those patients. ‘If they are in an environment where there are young families, they could be focusing on pregnancy support. ‘If they are specialising in disease states—say diabetes or hypertension—they could look closely at the complementary medicine

OVER THE COUNTER FEATURE | VITAMINS & SUPPLEMENTS

approaches within these areas, as well as, of course, providing those very important diet and lifestyle health promotion messages,’ she said.

There are some pharmacists who will choose to outsource the expertise and employ a naturopath to work within the store. And then there are others who decide to continue to learn and become natural medicine specialists, Dr Braun added.

EXPERT ADVICE Blackmores director of education Pam Stone said there was a great opportunity for pharmacists to promote their services and role as being a destination to receive accurate and evidence-based information about complementary medicines.

‘Education is the key to helping pharmacists translate evidence into practice and to integrating complementary healthcare into the total patient care model.

‘Through the Blackmores Institute, we will offer accredited training for pharmacists and other healthcare professionals to

‘There is still a lot of growth potential because penetration is still nowhere near maturity…’

FILOMENA MAIESE

support their understanding of the benefits of complementary medicine, and we will promote the inclusion of complementary medicine in continuing professional development programs for healthcare professionals,’ she said.

RESPONSIBILITY FOR KNOWLEDGE Ms Stone said pharmacists had a responsibility to be educated and knowledgeable about complementary medicines so they can guide customers and patients in the ‘right way’.

‘My big aspiration is to provide this education in a way that imbeds it into the patient model so it supports them in their role as pharmacists in store,’ she said.

‘Not just getting theoretical education, they have to interpret into how it works for the patient, in a way that shows them how complementary medicine works alongside prescribed medication, and so on—a method that is realistic and therefore applicable in a pharmacy setting.

‘Because that is sometimes what is missing…they may read the

research on fish oil or ginkgo, but when confronted with the patient with multiple medications, they may not be confident using it with that patient because the information is not presented in a way that allows them to understand interactions or appropriate doses and so on.

Ms Stone said there was very good evidence on a range of complementary medicine ingredients and good evidence on a wider range of ingredients, which still require more studies.

She said ingredients with very good evidence included fish oils, coenzyme Q10, glucosamine, ginkgo and herbs such as St John’s wort and certain extracts of valerian.

‘There is a range of ingredients and herbs that are supported by strong scientific evidence but equally we don’t disregard traditional evidence.

‘Traditional evidence is very valid if it is strong enough and there is a wide range of that evidence and products are replicating the doses used traditionally,’ she said.

Ms Stone said by the year 2050, 25% of the population would be older than 65. Preventing age-related conditions is a top priority, she said.

‘Prevention is really the domain of complementary medicine and, as customers get more knowledgeable about this whole area, it would be good if pharmacists could meet this knowledge in terms of directing people towards which complementary medicines to use to support their health and wellbeing.

‘Complementary medicine is big business for pharmacy and the more knowlegable they are the more they can create a healthier destination for their patients and everyone wins,’ Ms Stone said.

CHANNEL YOUR ENERGY Australian Self-Medication Industry marketing and business development director Filomena Maiese said industry figures suggested the

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

41

OVER THE COUNTER FEATURE | VITAMINS & SUPPLEMENTS

PROMOTING BETTER HEALTH

Sugarcoating

vitamin and misleading content in some,

in reading the levels, so I encourage

but increased levels of hidden sugars.

consumers to seek advice from a trained,

It is pointless having the expertise if your

Some of the lolly-type products were

customers don’t know about it. One way

found to contain more than 50% sugar.

of educating the public about pharmacy’s role is to get involved in a health promotion.

A concern about children’s vitamin and supplements prompted a Queensland pharmacy group to join forces with

The analysis provided Malouf Pharmacies director Ian Malouf with the

ensure that the most suitable product at the correct dose is provided.

‘It is important that when consuming

opportunity to position the group as a

any vitamin or supplement that the levels

trusted healthcare destination.

of nutrients are of benefit for the purpose

Mr Malouf was quoted in a media

that it is being taken.’

It was also reported in the media that all

a marketing company and launch a

release: ‘Although consumers are

message to parents about the contents of

becoming aware of the negative impact

18 Malouf pharmacies no longer stocked

the products they were buying.

that sugar can have on their family’s

children’s vitamin supplements that

health and wellbeing, they need to

contained high levels of sugar.

A simple analysis of what was claimed on the labels of certain kid’s vitamin

be extremely careful when selecting

supplements (from the ‘contains’ section,

vitamins, especially for children,’ he said.

back of pack) not only revealed a lack of

‘We can’t expect parents to be expert

complementary medicine category would continue growing from strength to strength.

‘Nielsen data tells us that vitamins and minerals have become the single biggest front-of-shop category for pharmacy,’ she said. ‘Twenty-one per cent of front of shop is vitamins, minerals, supplements which makes them the biggest proportion of front of shop.’

According to Ms Maiese, of the top 10 categories it is the fastest growing, at 16%.

‘When you compare this with total front of shop at 6%, you can see where this category is going—it is now the biggest, and it is the fastest growing, so this tells us it is going to continue to get bigger.’

Ms Maiese explained the growth of this category was being driven by consumers who were ‘voting with their feet’.

‘What we have seen in the past few years is consumer penetration going up to 80%—so that’s 80% of Australian consumers using complementary therapies.

‘What this tells us is the consumer sees the value and the importance of having complementary therapy as part of their overall health regime.

‘What we need to do is adapt

our offer to that demand. There are many opportunities here for pharmacy because the consumer can benefit from extra help in this category,’ she said.

Pharmacy is still the main channel of distribution of complementary medicines at just above 50% and a big driver of this was convenience and the breadth of range, she said.

‘Also, pharmacy stands as the best channel to provide holistic advice,’ she said. ‘Pharmacists can have a conversation with a consumer about their prescription medication, their OTC therapies, as well as their complementary medicine, in one conversation.’

EVIDENCE BRINGS GROWTH Ms Maiese said industry figures revealed the therapies that were driving growth within complementary medicines are those that have built up strong evidence over time.

‘Some of the biggest segments are fish oil, calcium, folate, St John’s wort, probiotics and the multi’s,’ she said. ‘These have and are continuing to build a strong evidence base and they are getting a lot of recommendation as a result.’

Bearing in mind these trends, Ms Maiese outlined some opportunities

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

42

knowledgeable pharmacy professional to

The children’s vitamin supplement market is worth $38m a year, according to AC Nielsen MAT April 2012.

and considerations for pharmacies.

‘The first thing is to acknowledge the consumer wants these products: they want to have natural therapy as part of their overall healthcare solution and they want to go somewhere where they can get broad holistic advice,’ she said.

‘Consumers want to know how certain natural products fit in with their existing healthcare regime and they will go to someone with knowledge such as pharmacy and general practitioners, as well as naturopaths for that advice.’

However, when it comes to complementary medicines, consumer research has also highlighted the mixed bag of knowledge and expertise in pharmacy.

‘There are different ways pharmacy can build up expertise: you can import the expertise by getting a complementary medicine practitioner

in store, or you can build the expertise within the existing staff,’ she said.

‘With that knowledge will come a bit more confidence and comfort in recommending complementary therapies.’

Rather than going in boots and all, Ms Maiese suggests treading carefully and doing a bit of research of your own.

‘The aim would be to build up a repertoire of products and categories that you are comfortable recommending,’ she said.

‘And this does require quite a bit of investment in time in building up your knowledge base around your complementary product ranges.’

Ms Maiese said from a retail management point of view it was also vital to understand your demographic when it comes to complementary medicine range decisions.

‘If you are thinking about building your complementary medicine offer, look at the demographic in your local area to identify what your lead complementary medicine categories should be.

‘Build the right range in terms of products and quality offer and build the right knowledge around these offers,’ she said.

And if by now you are thinking you may have left your run a little too late, don’t be concerned.

‘There is still a lot of growth potential because penetration is still nowhere near maturity and the only way we are really going to harness this growth is to ensure that the consumer gets the right advice, the right product and they have the right experience,’ Ms Maiese said. ■

Useful complementary medicines information sources include: Natural Standard: www.naturalstandard.com Natural Medicines Comprehensive Database: www.naturaldatabase.therapeuticresearch.com US National Institutes of Health National Center for Complementary and Alternative Medicine (NCCAM): www.nccam.nih.gov MedlinePlus: Drugs, Supplements & Herbal Information: www.nim.nih.gov/medlineplus National Herbalists Association of Australia: www.nhaa.org.au Dietitians Association of Australia: www.daa.asn.au Complementary Healthcare Council: www.chc.org.au

Our TV ADVERTISING draws customers to your store.

Our TRAINING

enables you to give them the best advice.

Our COMMITMENT

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THE BENEFITS OF PROBIOTICS FOR KIDS ARE NOW FEATURED ON TV! Take advantage of this nation-wide advertising by the probiotic experts to strengthen your health advice in store and help more of your customers’ children!

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For children who get sick often, the probiotic strains in Inner Health Immune Booster for Kids have been clinically shown to reduce the frequency and severity of cold and flu symptoms.

Inner Health for Kids and Inner Health Immune Booster for Kids are only available from Pharmacies and Health Food stores, where your customers can receive informed advice; and you can be sure they come back to you, not a nearby supermarket.

www.ethicalnutrients.com.au BEST PRODUCTS BEST EDUCATION Industry Pulse independent research shows Ethical Nutrients, yet again, Ind BEST SERVICE as a the leading supplier to Pharmacy providing unparalleled service excellence and product training for the 3rd consecutive year!

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YOUR NATURAL BUSINESS PARTNER

BUSINESS COMPANY NEWS

Chemmart breaks 300 C

hemmart is on-track to become Australia’s largest community pharmacy brand with the recent signing of its 305th store in Williams Landing, Victoria. The Victorian store is one of 56 pharmacies that joined the brand in 2012.

Executive director at Chemmart, Jonathan Layton expressed his pleasure at breaking through the 300 stores barrier so soon after a strategic decision to focus on expansion of its member network.

‘With newly signed stores now opening weekly, we will be the largest community pharmacy brand in Australia by early 2013.

Our greatest presence is in Queensland, followed by Victoria and South Australia.

‘Over the past 12 months we have opened one new pharmacy

every 10 days. Our goal now is to reach 400 stores by 2015.’

Mr Layton said that like many other community pharmacy brands, Chemmart is expanding its range of wellbeing products and services to meet the needs of consumers. And it’s proving to gain traction, he says.

‘Our most recent brand health study indicates a significant

increase in the awareness of the professional services Chemmart Pharmacies provide.

‘Heavy investment in the training and education of our pharmacists and staff via the establishment of Chemmart College and our ongoing professional development programs has certainly paid off,’ Mr Layton said. ■

Brands by the numbers Rise and fall of major pharmacy brands—national Chemmart

2011

2012

214

305 104

Discount Drug Stores

90

Soul Pattinson

89

88

Amcal & Amcal Max

299

291

Guardian Pharmacy

193

156

National Pharmacies

59

55

Priceline Pharmacy

216

202

eRX and MediSecure OK to talk

T

he Australian Competition

result in cost savings and reduction in

of Health and Ageing and will further

and Consumer Commission

prescription transcription errors.’

promote the update and utilisation of

(ACCC) has granted eRX Script

The Commonwealth Department of Health and Ageing has provided

(ETP) by pharmacies and general

enter into a contract with MediSecure

funding to ensure electronic

practitioners across Australia.’

to facilitate the interoperability

prescriptions can be accessed by

between the two electronic prescription

all pharmacies, irrespective of the

solution will commence with the

exchange systems.

exchange service with which it was

January release of an update for Fred

originally lodged.

users to enable the the two exchanges

While eRX and MediSecure don’t currently ‘talk to each other’,

According to general manager

‘Deployment of the interoperability

to link. Further deployments will occur

chairman at ACCC Rod Sims said the

enterprise solutions at Fred IT

as other vendors come online with their

granting of the interim authorisation

Group David Freemantle: ‘The

software updates.

would allow electronic prescriptions

interoperability of the eRx and

to be accessed by all pharmacies,

MediSecure prescription exchanges

pharmacy once again demonstrates

regardless of the originating

will help to ensure pharmacists can

the great willingness and desire of

prescription exchange service.

dispense ePrescriptions electronically

pharmacists to adopt innovative and

whether they were generated by eRx

effective ehealth solutions. With over

or MediSecure’.

65% of pharmacies using eRx, we

‘Allowing the parties to implement the agreement under an interim authorisation is likely to increase the use of electronic prescriptions. This will

‘This was considered to be a key policy objective by the Department

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

44

Electronic Transmission of Prescriptions

Exchange with interim authorisation to

‘The continued uptake of ETP in

continue to make great strides in the use of this important ehealth initiative.’ ■

New president at ASMI

T

he Australian SelfMedication Industry (ASMI) has appointed Mark Sargent as its new president following the retirement of Lindsay Forrest from the role. Both Ralf Dahmen (secretary) and Trevor Norman (treasurer) were announced as co-vice presidents (Trevor Norman was re-elected).

The executive director at ASMI, Dr Deon Schoombie congratulated the newly-elected team, stating Mr Sargent’s vast experience would help him to guide the association through the many policy and regulatory issues facing the industry this year.

‘There are a number of key policy and regulatory issues that will be extremely important for the industry over the coming year. These include business reform at the TGA, reviews into medicines labelling and packaging, a new trans-Tasman regulatory model, reform of complementary medicines, fresh approaches to medicines scheduling and promotion, and the advancement of consumer self-care,’ said Mr Sargent.

Dr Schoombie added: ‘We are very fortunate to have the services of these two vastly experienced figures [Ralf Damen and Trevor Norman] in the industry and I look forward to continuing to work with them in these important roles. ■

BUSINESS FEATURE | GENERICS

Preparing for the rising tide of price disclosure KEY POINTS Profits from generics are shortlived with the price disclosure mechanism designed to inevitably claw back pharmacy margins and profitability of generics suppliers.

■ Eventually pharmacy will receive less remuneration per script than when government began the PBS reform process, including price disclosure, in 2007 while business costs continue to rise with inflation.

■ Price disclosure has a big impact on suppliers of substitutable medicines and may lead to decisions such as discontinuing some low-volume and unprofitable molecules.

■ The future is still positive for those pharmacies that can adapt to the changing remuneration model or have already.

■

PROFITABILITY FROM GENERICS IS A SHORT-TERM BONUS THAT SHOULD BE INVESTED IN PREPARATION FOR LEANER TIMES, WRITES MARK NICHOLSON.*

W

hile the atorvastatin and rosuvastatin 25% price reduction on 1 December 2012 was not technically a weighted average disclosed pricing (WADP) reduction it has increased awareness and heightened concern about the WADP price reductions that will occur every four months (1 April, 1 August and 1 December).

Up until the atorvastatin and rosuvastatin price reduction, the impact of the advised price reductions at each start date has been more than offset by new profit streams resulting from new patent expiries (ie. substituting new generic medicines for originator medicines). Patent expiries will of course continue

The WADP process

but, once the high-volume molecules reach their end point in the price reduction process, pharmacy’s average gross profit dollars per script will decline from where it is today.

This article is designed to help owners and managers forecast the impact of these cuts on their business and encourage them to invest in changes required to ensure their ongoing viability, growth and profitability.

GENERICS AND THE PBS The government’s recently released 2012 annual report on PBS expenditure and prescriptions notes a PBS spend of more than $7.5bn for about 195 million scripts. Table One shows the top 10 drugs by

Weighted average disclosed pricing

government cost, together with an indication of which medicines are currently off patent and when their next price cut is due.

The top 10 drugs account for more than 30% of the PBS expenditure and there are only three that are currently off patent.

Atorvastatin is comfortably the highest funded molecule followed by rosuvatatin. It is not known when rosuvastatin will be off patent but when it does it will be warmly welcomed by pharmacy as the generic equivalent will provide short-term gross profit dollars to offset the future price cuts to atorvastatin and other key molecules.

One of the often stated reasons by government to implement the WADP mechanism is to create headroom for new PBS listings. Table Two details the new drugs listed on the PBS from 1 December 2012. It appears the new listings to be dispensed by community pharmacies are alternatives to drugs already listed, while new medicines that represent a new cost to the PBS are hospital-based medicines.

While this is good news for health consumers and taxpayers, if this trend continues over time and no new ‘blockbusters’ are listed on the PBS, community pharmacy’s share of the PBS spend may well decrease.

government which then calculates the

(WADP) was designed to ensure the

weighted average price. Based on that

majority of this price difference was

information, government reduces the

Price disclosure started in August

and strength. The pharmacy, in turn,

clawed back by the government on

price paid (ex-manufacturer) for those

2007 as a long-term response to the

pays the medicine’s purchase price to

behalf of the Australian taxpayer and

medicines to the average market price

market price of medicines coming off

the manufacturer/wholesaler.

health consumer with both the generic

(subject to a minimum 10% difference).

and originator manufacturers being paid

This is an ongoing process with the

patent. Under the Australian system of

When medicines come off patent

cycle from patent expiry to first price-cut

less for their product over time.

remuneration, the Federal Government

generic manufacturers compete for

pays pharmacies a fixed price for a

market share by offering competitor

particular Pharmaceutical Benefits

brands to pharmacy for a lower price

medicine manufacturers submit sales

months) and then subsequent price cuts

Scheme (PBS) medicine by molecule

than the list price paid to the originator.

information (net of discounts) to the

occurring annually.

Under this price disclosure regime,

taking about 18 months (maximum 21

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

45

BUSINESS FEATURE | GENERICS

TABLE ONE: 5PQ ESVHT CZ HPWFSONFOU DPTU m 1#4 FYDMVEFT 31#4

Drug 1

Atorvastatin

Product

Condition

No.

Government

Avge Govt

Patent

Next Price

treated

Prescriptions

Cost

Payment/Rx

Expiry Date

Cut date

593,307,859

$56.46

Off Patent

1/12/13

Lipitor

High Cholestorol

10,507,613

2

Rosuvastatin

Crestor

High Cholestorol

6,729,477

359,207,846

$53.38

Future

3

Ranibizumab

Lucentis

Vision loss

145,018

307,816,693

$2,122.61

Future

4

Adalimumab

Humira

Autoimmune disease

111,611

198,802,937

$1,781.21

Future

5

Esomeprazole

6

Fluticasone with Salmeterol

7

Olanzapine

Nexium

Ulcers, reflux

5,677,991

168,095,363

$29.60

Future

Seretide &

Asthma & anti-inflammatory

3,007,412

169,267,494

$56.28

Future

Zyprexa

Anti-psychotic

938,882

159,545,861

$169.93

Off Patent

1/08/13

2,427,196

133,172,362

$54.87

Off Patent

1/04/13

72,658

127,752,968

$1,758.28

Future

1,695,976

117,857,405

$69.49

Future

8

Clopidogrel

Plavix

Heart disease

9

Etanercept

Enbrel

Autoimmune disease

10

Tiotropium Bromide

Spiriva

Pulminary disease

THE RISE AND FALL OF GENERIC PROFITS The molecules coming off patent in 2013 include irbasartan (Avapro), irbasartan/HCTZ, montelukast sodium (Singulair), candesartan cilexetil (Atacand), and candesartan cilexetil + hydrochlorthiazide (Atacand Plus). The current total PBS spend on these molecules is estimated at around $245m compared to the $885m spend on the top three PBS medicines that are now off patent: atorvastatin ($593m), olanzapine ($159m) and clopidogrel ($133m).

These three molecules which now have generic alternatives are among the top 10 list in

Table One. Table Three calculates the average number of scripts (all strengths) processed in each of the estimated 5,250 pharmacies across Australia. Of course, some pharmacies will do more and some less so you may want to review your own pharmacy’s data and use it as a reference against the calculations in the subsequent tables.

Table Four provides an estimate of the current differences between the costs to pharmacy of the generic drug versus the historical amount funded by the government (ie. the cost of the originator’s drug).

Much has been made of these short-term windfall differences by

Accurately forecasting profit reduction is difficult due to the number of variables impacting the final price reduction.

UIBU FOTVSFT QIBSNBDZ EPFT UIF HPWFSONFOU T JOJUJBM AIFBWZ MJGUJOH CZ DPOWFSUJOH QBUJFOUT UP HFOFSJD NFEJDJOFT r UIF FWFOUVBM TJHOJĂ DBOU TBWJOHT UP HPWFSONFOU UISPVHI BO PSEFSMZ CVU BHHSFTTJWF QSJDF SFEVDJOH NFDIBOJTN JF 8"%1

UIBU DBQJUBMJTFT PO UIF IJHI DPOWFSTJPO SBUFT BOE UIF MPX DPTUT PG HFOFSJD NBOVGBDUVSFST XJUIJO B SFBTPOBCMZ TIPSU QFSJPE PG UJNF r HPWFSONFOU BDIJFWF TBWJOHT WJB SFEVDFE NBSL VQ QBZNFOUT UP QIBSNBDZ PO NBOZ NFEJDJOFT BT SFEVDFE PS

$PNNVOJUZ QIBSNBDZ

"MUFSOBUJWFT QSFWJPVTMZ BWBJMBCMF

r QIBSNBDZ T FWFOUVBM OFU GVOEJOH QFS QSFTDSJQUJPO GPS NFEJDJOFT XJUI HFOFSJD FRVJWBMFOUT XJMM CF

Aflibercept

Eye

Yes

Yes

Paraffin compound eye ointment

Dry eye syndrome

Yes

Yes

JOUSPEVDUJPO PG HFOFSJDT .PSF

Sodium hyaluronate

Dry eye syndrome

Yes

Yes

PO UIJT CFMPX

Atenolol

High Blood Pressure

Yes

Yes

Ezetimibe

High Cholestorol

Yes

Yes

Naloxone hydrochloride

Opoid overdose

Yes

Yes

Rivaroxaban

Deep vein thrombosis

No

?

Aprepitant

Chemotherapy related

No

?

Temozolomide

Brain cancer

No

?

Mycophenolate sodium

Lupus related kidney inflammation

No

?

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

46

r UIF TIPSU UFSN QSPĂ U JODFOUJWF

UIF QSJDF QBJE CZ HPWFSONFOU JT

TABLE TWO: /FX 1#4 MJTUJOHT GSPN %FDFNCFS $POEJUJPO

various commentators, but little commentary discusses:

MFTT UIBO SFDFJWFE CFGPSF UIF

ESTIMATING PROFIT REDUCTION

BY SCRIPT Accurately forecasting profit reduction is difficult due to the number of variables impacting the final price reduction. These include:

BUSINESS FEATURE | GENERICS

r FBDI NBOVGBDUVSFS T TFMM QSJDF

TABLE FOUR: &YBNQMF %JTDPVOU $BMDVMBUJPO

BOE WPMVNF

"UPSWBTUBUJO NH

r NBOVGBDUVSFS T PGG JOWPJDF

Current List Price (excl. premium free incentive)

JODFOUJWFT

$51.00

0MBO[BQJOF NH

$MPQJEPHSFM NH

$124.71

$50.15

Less:

r UIF WPMVNF QVSDIBTFE CZ QIBSNBDZ JO UIF Ă STU NPOUI

Dispense fee

$6.52

$6.52

$6.52

GPMMPXJOH UIF MJTUJOH PG B

Mark-up

$4.50

$10.74

$4.50

DPNQFUJUPS CSBOE BT UIJT JT

Funded price to pharmacy for medicine cost

$39.98

$107.45

$39.13

75%

80%

70%

&TUJNBUFE HFOFSJD QVSDIBTF QSJDF EJTDPVOU

Example generic price to pharmacy for medicine cost

$10.00

$21.49

$11.74

FYDMVEFE GSPN DBMDVMBUJPOT BOE r UIF NJY PG EJGGFSFOU WPMVNFT BOE

Estimated generic purchase price discount %

QSJDFT BUUBDIFE UP FBDI QSPEVDU TUSFOHUI GPS FBDI NPMFDVMF

Nonetheless, Table Five provides an indicative estimate of how significant the price reductions will be and the extrapolation of total profit reduction, using

the script numbers derived on an average basis within Table Three. Hence, across the three molecules the annualised loss

of profit for the respective script volumes totals $70k. Bear in mind that atorvastatin’s price cut will not be until December 2013 and

TABLE THREE: 4DSJQUT QFS QIBSNBDZ ‡ "WFSBHJOH $BMDVMBUJPO "UPSWBTUBUJO Total scripts funded by government

10,507,613

Number of pharmacies in Australia ď€?ď€Ąď€™ď€˜ď€€ď€?ď€?ď€“ď€€ď€•ď€˜ď€€ď€Žď€™ď€—ď€™ď€žď€–ď€™ď€Ąď€€ď€„ď€‚ď€ƒď€„ď€€ď€šď€œď€&#x;ď€? ď€Łď€˘ď€€ď€ƒď€€ď€€ď€„ď€‚ď€ ď€ƒď€„ď€ ď€ƒď€„ď€€ď€€ď€ƒď€‚ď€Œď€„ď€‡ď€€ď€?ď€’ď€€ď€€ď€“ď€•ď€›ď€™ď€€ď€ƒ Average number of scripts per pharmacy p.a.

0MBO[BQJOF

$MPQJEPHSFM

938,882

2,427,196

5,250

5,250

5,250

2,001

179

462

will therefore not be truly felt until 2014.

Additionally, the cuts will continue annually until the difference between the price the government pays and the average price pharmacy pays is less than 10%.

Table Six forecasts how these ongoing price cuts may unfold and what the annualised loss of

BUSINESS FEATURE | GENERICS

TABLE FIVE: Estimated profit reduction using script volume from Table Two Atorvastatin 40mg Estimated generic substitution rate

Olanzapine 7.5mg

80%

50%

Clopidogrel 75mg 60%

Estimated generic purchase price discount (per Table Three)

$29.99

$85.96

$27.39

Date of next price reduction

1/12/13

1/08/13

1/04/13

Possible price reduction *

$23.99

$42.98

$16.43

Example number of scripts per pharmacy p.a.

Example annualised total profit reduction per pharmacy based on above script volume

2,001

179

462

$48,000

$7,693

$7,593

Total = $69,686 * Price reduction estimate calculated by multiplying substitution rate by price discount.

The above is illustrative only and eventual price reductions could be less or more.

profit is by the third price cut. At this time (2015) the Pharmacy Guild of Australia will hopefully have negotiated a new five-year agreement with the government of the day, hence the remuneration variables may change.

It should be noted that the forecast calculations assume that there will not be further

improvements in trading terms (ie. generics buy-prices will remain static). Competition among generics manufacturers may bring further price improvements which will help pharmacy owners but it also means future cuts will be greater and, in turn, accelerated the clawback of wholesaler discounts.

As an aside, this will ultimately exert significant pressure on local manufacturing operations which carry higher costs than their overseas counterparts.

Not unlike the low-price warehouse pharmacies in a pricecentric market, the eventual winners in the generics price game will be those with the

TABLE SIX: Estimated profit reduction timeline using assumptions in Tables Four and Five Forecast price movement based on assumptions Date

Atorvastatin 40mg

Olanzapine 7.5mg

Clopidogrel 75mg

Price

Price

Price

30/11/12

$67.54

1/12/12

$51.00

Reduction $14.92

1/04/13

Reduction

$124.71 $78.41

$50.15 $46.30

1/08/13 1/12/13

$24.91

$54.00

$43.26

Total Estimated reduction including mark-up due to

$6.57

$13.49

$2.63

$10.75

1/08/15 $18.29

$16.12 $5.52

1/04/15 1/12/15

$27.45

$24.41

1/08/14 $19.39

$22.70 $26.09

1/04/14 1/12/14

Reduction

$1.10 $47.63

$81.46

$36.66

WADP and 25% non WADP reduction on 1/12/2012 Average number of scripts from Table Three Example forecast annual loss by

2,001

179

462

$95,329

$14,580

$16,948

1 December 2015 from 30/11/2012 1. Price excludes premium-free incentive and future increases to the dispensing fee.

2. Price reduction estimates are inclusive of mark-up loss and assumes current net into store price remains constant.

3. Price reduction estimate calculated with reference to variables arising from previous examples.

4. Average number of scripts is for all strengths rather than just the specific strength listed hence the total loss on molecule calculation should not be relied upon.

5. The above is illustrative only and eventual price reductions and loss per individual pharmacy could be less or more.

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

48

lowest costs and supply chain control (unless government provides subsidies similar to motor vehicle manufacturers).

Hence, over time it is possible that high-cost manufacturers could withdraw products in low-volume molecules if they become unprofitable and may contemplate moving manufacturing operations to low-cost countries (eg. New Zealand and Pharmac).

SCRIPT PROFIT DECLINE Table Seven compares the price and gross profit pharmacy made on atorvastatin/Lipitor before WADP in 2007, then immediately prior to its availability as a generic in March 2012, and finally against the forecast position from Table Six after the expected December 2015 price cut.

This table highlights that pharmacy owners will eventually make less per script in dollar terms for medicines with generic alternatives than they achieved in 2007 before the introduction of WADP. For many this will comprise the dispense fee ($6.42 but indexed annually), the premium-free incentive ($1.62) and the mark-up of 15%.

Hence, as the approved price comes down then so does the mark-up component.

business F e at u r e | g e n e r i c s

Table seven: Comparison of Pharmacy Gross Profit – Atorvastatin 40mg

Dispense value including dispense fee

Atorvastatin

Atorvastatin

Atorvastatin generic

originator (Lipitor)

originator (Lipitor)

estimated

40mg 2007

40mg 1/04/2012

1/12/2015

$78.07

Premium free incentive

$67.54

$18.29

$1.59

$1.62

Total

$78.07

$69.13

$19.91

Estimated net purchase cost including wholesaler discount

$62.72

$53.70

$10.00

Gross Profit $

$15.35

$15.43

$9.92

Gross Profit %

20%

22%

50%

Therefore, over an eightyear period (2007–2015) the average remuneration per script will have fallen in real terms while business costs continue to rise with inflation. Clearly, pharmacy owners should not get carried away with the short-term benefits flowing from generics and understand it is an immediate and one-off opportunity to reduce debt and invest in business innovation to ensure long-term sustainability.

Equally, any consideration to buy a pharmacy business should take into account the future profits and cashflows of the business rather than what has been produced historically.

A new perspective— now and beyond Having strategies to combat the negative impact of WADP is essential for all pharmacies.

These strategies will vary, should be specific, achievable and uncomplicated. Consider the following as a guide: 1. All good businesses are

are inadequate then growth is required (organic or through acquisition/merger/medical centre) or space reduced. If sales are okay but profit is low

Therefore, over an eightyear period (2007–2015) the average remuneration per script will have fallen in real terms while business costs continue to rise with inflation.

underpinned by efficient and effective reporting systems that allow strategic change to be measured and managed.

then margins, product mix, store layout, staff skill-set and so on will require reviewing.

3. Growth strategies for most community pharmacies will revolve around service innovation, training and marketing of specialty categories and services, whether as a branded pharmacy or an independent.

4. Use capable advisers who understand your business and industry to stress test your chosen market position, strategies to get there and your action plan.

WADP is a systemic change to the Industry which is now only just starting to be felt and properly understood by pharmacy owners. Despite the significant price cuts in the future for key molecules, the underlying remuneration per script compares favourably with many foreign countries (eg.

NZ). Hence, WADP should be viewed more as an eventual

‘resetting of the base’ rather than the creation of a base that is structurally unsustainable.

At JR Pharmacy we are working with clients on strategies to replace an estimated loss of $2.00 per script by December 1, 2015 across the pharmacy’s total script volume (ie. for 60,000 prescriptions, this equals $120,000) while also considering the inevitable inflationary rise in overheads.

Business models that are already structurally unstable through low net profit to sales (<7%), high debt, high rent to gross profit dollars or both may inevitably fail if they are unable to adapt to the changing prescription remuneration model.

But for those that can adapt or already have, then the future should be positive and full of opportunity. Some strategies, such as investing in pharmacists, may seem counter intuitive (ie. possible increase in wages costs) but this can ensure governmentfunded program income, health solution services income and scheduled medicines sales are maximised while differentiating against warehouse discount models.

Ageing and overweight populations with complex health problems need support with health solutions in the form of both medicines and advice, while healthy ageing Australians want assistance to stay that way.

For those pharmacies that can meet the changing expectations of Australian consumers in a changing retail and PBS landscape, the future can be as bright as the past. n

2. F inancial success is defined by good sales/profit per square metre (sq m) and appropriate expenses per sq m. If sales The Australian journal of Pharmacy vol.94 February 2013

50

* Mark Nicholson is managing partner at leading pharmacy accountants and business advisers, JR Pharmacy Services, (07) 3222 8444 mnicholson@pitcherpartners.com.au.

BUSINESS RETAIL MANAGEMENT

Changing something established Bruce Annabel, pharmacy business adviser and Adjunct Professor of Pharmacy Management, QUT. bannabel@jr.com.au

MAKING A DECISION TO IMPROVE DISPENSARY EFFICIENCY IS A CRUCIAL FIRST STEP THAT MANY TRADITIONAL COMMUNITY PHARMACIES MUST TAKE TO PREPARE FOR LOOMING THREATS TO DISPENSARY PROFITABILITY.

T

aking action to manage the potential risks is preferable to doing nothing at all.

Doing nothing is the worst decision you can make. The successful innovators in any industry, and community pharmacy is no different, never choose the status quo and do nothing in the face of risks and challenges.

Innovation is defined by the Oxford English Dictionary as ‘Change something established by introducing new methods, ideas or products’ and there is nothing more established (some might say entrenched) in the traditional community pharmacy model as the dispensary process, roles, layout/design and failure of owners/managers to recognise the inefficiencies.

UNCOVER INEFFICIENCIES Most dispensaries I observe take an

inordinate length of time to handle most aspects: from script-in, keying in, picking, replenishment, transfer and checking, through to script-out.

Close observation of these processes will uncover the time delay of distance the script has to travel, time it sits around between processes at busy times (as there aren’t enough, or the right staff rostered on) and the

bearing higher staff and floor/ wall space costs and increasingly frustrated customers waiting much longer than necessary and detracting from their experience.

CHOOSE TO ACT! I have explained the crucial need for such dispensary innovation to many owners. Most acknowledge my points yet far too many fail to act, usually in fear of making a mistake and/or not wishing to challenge the status quo in their own pharmacy.

However, doing nothing in the face of the fundamental changes occurring throughout our economy and consumer environments, not to

…MOST PHARMACIES CAN SAVE A LOT OF TIME BY IMPLEMENTING INNOVATIVE CHANGES THROUGHOUT THE WHOLE DISPENSARY bottlenecks at script-out caused by so many functions (script-in, waiting, script-out, primary care enquiry, S2/3 requests, counselling and cash and wrap) being squashed into a tiny area—causing the process to get bogged down yet again.

The result is stressed-out pharmacists, pharmacy owners

mention the looming 2013 weighted average disclosed price (WADP) cuts is the worst decision owners can make.

TRY THESE METRICS Today the average gross profit dollars earned per script dispensed by traditional community

FIGURE ONE: Cost of dispensing in community pharmacies Pharmacy

Script volume

CPS

City strip

Turnover $7m

110,000

$13.40

Comment

City strip

$3.2m

67,000

$7.65

Efficient in all aspects.

City strip

$2.1m

32,000

$9.61

Efficient roles & systems. Process not addressed

Shopping centre

$6.9m

81,000

$8.55

Efficient in all aspects except layout.

Shopping centre

$9m

110,000

$10.84

Roles/roster efficient.

Provincial

$4.3m

50,000

$11.13

Efficient systems/processes.

Provincial

$2.4

37,000

$9.61

Roles/roster needs attention.

Inefficient process, layout, roles and systems.

pharmacies is about $14 (this varies depending on pharmacy location and generic substitution level) including fees, mark-up, wholesaler discount (shrinking), rebates, bonus stock and generic supplier discounts.

I termed this RPS—Revenue Per Script.

Last year I calculated the average cost incurred to dispense a prescription to be $9.56. This was based on data collected from 39 pharmacies after allocating all pharmacy overheads between the dispensary, scheduled medicines and retail sections. These costs included everything to do with running the dispensary such as wages, owner commercial salary, on-costs, rent, IT, continuing professional development, fixtures and fittings, stationery, light and power, bank charges and so on. I termed this CPS—Cost Per Script.

Therefore, community pharmacies, on average, earn net profit per script of $4.44—the PPS or Profit Per Script.

These three figures are averages and vary depending mostly on how efficiently the dispensary is operated rather than location, which still has an effect, albeit much less.Figure One offers a small selection from among the pharmacies on which I have based my cost-of-dispensing analysis.

For each of these pharmacies the RPS is higher than the CPS. This delivers bottom line net profits per script and makes up the great majority of the total pharmacy net profit after scheduled medicines and retail sales are added in.

CONTINUED ON PAGE 52

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

51

BUSINESS RETAIL MANAGEMENT

BENEFITS FOR ALL The work done by Glenn The point of knowing RPS and CPS Guilfoyle and Peter Feros, both is as follows: experts in dispensary process 1. As WADP cuts begin to exceed and efficiency, and previously new generic discounts entering published in the AJP, indicates the market, the RPS may slowly that most pharmacies can save fall, perhaps beginning December a lot of time by implementing 2013. innovative changes throughout 2. CPS will continue rising if the the whole dispensary. status quo remains (ie. wages, According to Peter Feros the on-costs and rent in particular difference in script processing time always rise). between efficient and inefficient 3. The gap between the two may dispensaries is more than two therefore narrow over time, thus minutes. By being able to save just impacting net profits, cash flow, one minute per script on average— pharmacy valuation and for some, equating to a saving of 60c per even viability. script—a pharmacy will reduce their 4. By beginning to work on improving CPS, thus helping to bridge some dispensary efficiencies now of the gap that may be lost to WADP community pharmacies will reduce cuts in the future. their CPS, thus helping to maintain Putting that in perspective, if the 3 7 6 1 CPEx p o 1 2 3 5 5 1 0 0 0 . p d f Pa ge 1 2 0 / 1 2 / 1 2 , the gap between costs and revenue current net profit per script for the per script.

35 pharmacies is $4.44 and that falls CONTINUED FROM PAGE 51

to, say $3.66, in 2014 the saving of this 60c would bridge most of the gap these pharmacies otherwise stand to lose through WADP. REMEMBER… Gravity shelves, drawers and robot systems, while helpful in most circumstances and dependent on individual needs, will only deliver a small proportion of this saving.

The trick is to address the whole dispensary to gain the benefits that are clearly available.

Another crucial goal when attempting to lift dispensary efficiency is to reduce customer waiting time. Let’s face it: no-one likes to wait needlessly so successfully minimising dispensing times will also minimise customer frustration, while impressing existing 1 0 : 0 3 : 1 1 AM AEDT customers and giving them another reason to come back.

A STEP FURTHER But why stop there? Take these ideas together and aim to offer the fastest dispensary service in the market area. In achieving the goal you will have gained the opportunity to promote it as a powerful point of difference.

The efficiency dividend is a saving of the cost of time—time that pharmacists can use to engage customers by offering health solutions, providing remunerated services, bolstering solution sales and generally delighting the customer, thus creating another powerful point of difference.

So now is the time to crack the established status quo of your community pharmacy’s entrenched dispensary systems by making innovative decisions for the future. ■

EVENTS

CALENDAR OF EVENTS CPD by the Sea–NSW Convention 22–24 FEBRUARY Novotel, Manly Pacific Manly NSW www.cpdbythesea.com.au

NSW Annual Therapeutic Update 1–3 MARCH Crowne Plaza, Terrigal NSW Pharmaceutical Society of Australia, NSW T: (02) 9431 1100 F: (02) 9431 1150 E: nsw.branch@psa.org.au

Arthritis NSW Health Professionals Education Day 16 MARCH 2013 Kolling Institute, Royal North Shore Hospital, Reserve Road, St Leonards, Sydney, NSW 2065 Time: 9am–4pm Cost: $180 (after 31/12/12) Lunch provided.

T: (02) 9857 3300 E: Jenny Ly: jly@arthritisnsw.org.au www.arthritisnsw.org.au

The Australian Pharmacy Professional Conference (APP2013) 21–24 MARCH Gold Coast Convention and Exhibition Centre, Qld The Pharmacy Guild of Australia, Qld branch T: (07) 3831 3788 F: (07) 3831 9246 E: events@qldguild.org.au www.appconference.com

PSA Refresher engages expert speakers

T

NHS Trust. She was responsible for gastroenterology and hepatology patients in Brighton, and created a digestive diseases ward where surgical, gastroenterology and hepatology patients are cared for on the same ward.

Ms St Clair-Jones chairs the

he 38th Pharmaceutical Society

the development of PAIN (Pharmacist

of Australia’s Offshore Refresher

Analgesia Interest Network) and is chair

Gastroenterology and Hepatology Interest

Conference will focus on the best

of the United Kingdom Clinical Pharmacy

Group of the UK Clinical Pharmacy

outcomes in pharmacy practice from

Association Pain Management Group.

Association and is an honorary lecturer at

both a clinical and business aspect.

He was co-opted to the Council of The

both University of Brighton and University

The line-up of clinical experts

British Pain Society for several years

College London Schools of Pharmacy.

includes Dr Tony Mastroianni who

before becoming an elected council

will discuss topics covering: ‘Perils of

member in 2011.

mood disorders and their treatments’;

For more information on the

Anja St Clair-Jones will discuss:

38th Pharmaceutical Society of

‘Kids behaving badly and then

‘Hepatology—love your liver’. Ms St

Australia’s Offshore Refresher Conference

growing up—an overview of ADHD

Clair-Jones is a qualified pharmacist who

to London from 2–9 May, email:

and other childhood disorders’; ‘Be

established a surgical pharmacist team in

info@impactevents.com.au, call

spooked—does treatment work for

Brighton and Sussex University Hospitals

(03) 95353600 or visit www.psa.org.au

anxiety disorders?’; ‘Eyes wide shut—a psychiatrist’s perspective of sleep’; and ‘Understanding psychopathy (do we just lock up and throw away the key?)’.

Dr Mastroianni is a consultant psychiatrist in the rehabilitation unit of the Sydney Forensic Hospital, a conjoint

Turn knowledge into practice

A

t its 24th Annual Conference, the

efficiency; and CPD standards and

Australian College of Pharmacy

guidelines update.

will continue the tradition of

In addition, the program will feature

lecturer at the University of NSW, a

assisting pharmacists to convert

more intensive sessions for those who

supervisor of senior psychiatric registrar

knowledge into practice.

‘specialise’ in an area of practice or who

training, and a specialist in adult ADHD

The 2013 program is aligned with

and its co-morbidity. He has extensive

the College’s three faculties—clinical,

experience working in the criminal

business and compounding—and

program for compounders; a review

The 38th Pharmaceutical Society of Australia Refresher Conference 2013

justice system with chronic psychotic

features sessions covering:

of anticoagulants; an update on eye

and affective mental illness, substance

Clinical—cardiovascular disease,

care; complementary medicines; and

2–9 MAY 2013 London, UK Pre-conference: 28 April–2 May, Bath Extended pre-conference: 23–28 April, Cornwall Post-conference: 9–13 May, Hanbury Manor, or 9–14 May Lisbon and North Portugal Extended post-tour: 13–17 May, Oxford and Cotswolds www.psa.org.au

abuse disorders and personality

women’s health, multiple morbidities

business planning.

disorders. His private practice is in

and auto-immune conditions, new

general adult and forensic psychiatry

drugs, depression and anxiety, sleep

based in Sydney.

apnoea, asthma and COPD; Business

ConPharm 13

‘Build a winning team’ at APP13

7–9 JUNE 2013 Hilton, Adelaide, SA T: (02) 61202800. E: aacp@aacp.com.au www.aacp.moodle.com.au

The Australian College of Pharmacy’s 24th Annual Conference & Exhibition 5–8 JULY Brisbane Convention & Exhibition Centre www.knowledgeintopractice.com.au

want to drill deeper into a specific topic.

These sessions will include a full day

The College conference will be held at the Brisbane Convention

and personal development—PBS

& Exhibition Centre from 5–8 July. Cost

Roger Knaggs and Anja St Clair-

reform, retailing, social marketing,

$395. For more information, visit www.

Jones. Mr Knaggs will speak on pain

using the Cloud, innovation and

knowledgeintopractice.com.au

Delegates will hear from UK speakers

management; he was instrumental in

T

information to their patients and customers.

The course is informed by the latest evidence-base available and provides

he Australian Chef de Mission for

attending his session on Saturday,

independent advice about CAM products.

the 2012 London Olympic Games

23 March from 4:05–5:15pm.

The course will be held on Sunday, 24

Nick Green will be presenting at the

Commencing immediately after the

March, 2–6pm to Monday, 25 March

Pharmacy Guild’s Australian Pharmacy

APP conference is a short course in

8:30am–5:30pm. For further information

Professional Conference (APP2013).

integrative medicine to provide pharmacy

visit www.integramedshortcourses.com.

Delegates can share Mr Green’s

practitioners with additional knowledge

journey and see how they can ‘Build

and skills to deliver evidence-based

a winning team’ in their pharmacy by

complementary medicine (CAM)

www.appconference.com

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

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EDUCATION D I S E A S E S TAT E M A N A G E M E N T

Associate Professor Louis Roller BPharm, BSc, MSc, PhD, FPS, Dip Ed, teaching associate, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University Dr Jenny Gowan PhD, Grad Dip Comm Pharm, FPS, FACPP, AACPA, consultant pharmacist, MediCom Medication Management Services; teaching associate, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University

Anxiety and social phobia disorder After reading this article, the learner should be able to: t EFGJOF UIF WBSJPVT UZQFT PG BOYJFUZ t EFGJOF TPDJBM BOYJFUZ

ANXIETY DISORDERS ARE OFTEN DISMISSED OR MISDIAGNOSED, YET CAN BE GENERALLY READILY TREATED.

t EFTDSJCF UIF OPO QIBSNBDPMPHJDBM USFBUNFOUT PG BOYJFUZ t EFTDSJCF UIF QIBSNBDPMPHJDBM USFBUNFOUT PG TPDJBM BOYJFUZ t SFGFS QBUJFOUT XJUI TPDJBM BOYJFUZ t DPVOTFM QBUJFOUT XJUI TPDJBM BOYJFUZ BQQSPQSJBUFMZ

Competencies addressed: 1.3, 1.4, 4.1, 4.2, 6.1, 7.1, 8.1

Accreditation number: CX130002C Upon successful completion of the associated assessment, this activity has been accredited for 1 hour or Group 2 CPD (or 2.0 CPD credits) suitable for inclusion in an individual pharmacistâ&#x20AC;&#x2122;s CPD plan.

A

nxiety is a mood state characterised by apprehension and somatic symptoms of tension in which an individual anticipates impending danger, catastrophe, or misfortune.

The future threat may be real or imagined, internal or external. It may be an identifiable situation or a more vague fear of the unknown (eg. a general sense of impending doom). The body often mobilises itself to meet the threat; muscles become tense, breathing is faster, and the heart beats more rapidly.

Anxiety may be distinguished from fear both conceptually and physiologically, although the two terms are often mistakenly used interchangeably.1

ANXIETY DISORDER Anxiety is an uncomfortable inner feeling of fear or imminent disaster.

The criterion for anxiety disorder as defined by the International Classification of Health Problems and Primary Care, 1985 is: generalised and persistent anxiety or anxious mood, which cannot be associated with, or is disproportionately large in response to a specific psychosocial stressor, stimulus or event.2

Anxiety is a normal and necessary human emotion that helps us avoid dangerous situations or heightens our ability to face them. Occasionally, anxiety can become so intense, misplaced or so chronic that it

TABLE ONE: DSM-IV classification of anxiety disorders3,4,7 1. Generalised anxiety disorder (GAD) 2. Anxiety disorder due to general medical disorder 3. Panic disorder with/without agoraphobia 4. Agoraphobia without history of panic disorder 5. Specific phobia 6. Social phobia 7. Obsessive compulsive disorder 8. Post-traumatic stress disorder 9. Acute stress disorder 10. Substance induced anxiety disorder

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becomes maladaptive. When anxiety symptoms interfere with an individualâ&#x20AC;&#x2122;s ability to function effectively or significantly undermines their quality of life, then that individual has an anxiety disorder. Anxiety disorders are among the most common conditions seen in medicine and are often dismissed or misdiagnosed, yet they can be generally readily treated.3 The most common response to a stressor is anxiety. People who live through events that are beyond the normal range of human suffering, such as natural disasters (bushfires, floods, drought) and manufactured disasters (wars, rape, murder, torture, kidnappings, child abuse, domestic abuse, severe bullying at work, etc) sometimes develop a severe set of anxiety-related symptoms known as post-traumatic stress disorder.4,5 There are, however, people who are constantly anxious to the extent that it is abnormal and interferes with their lives. They suffer from an anxiety disorder, a problem that affects 5â&#x20AC;&#x201C;10% of the population. The symptoms of anxiety, which are psychological or physical in manifestation, can vary enormously from feeling tense or tired to panic attacks.2â&#x20AC;&#x201C;4 A common method of assessing anxiety and its level of seriousness is the Hamilton Anxiety Scale (HAS or HAMA) which is a 14â&#x20AC;&#x201C;26 item test measuring the severity of anxiety symptoms. It is also sometimes called the Hamilton Anxiety Rating Scale (HARS).The HAS is used to assess the

EDUCATION

AJP CPD CONTINUING PROFESSIONAL DEVELOPMENT

severity of anxiety symptoms present in children and adults. It is also used as an outcome measure when assessing the impact of anti-anxiety medications, therapies, and treatments and is a standard measure of anxiety used in evaluations of psychotropic drugs.6 The classification of anxiety has undergone many changes since Freud coined the term â&#x20AC;&#x2DC;anxiety neurosisâ&#x20AC;&#x2122;.

These changes reflect a move away from theory based on psychodynamic classifications to theoretical, phenomena-based systems such as the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).7 The most recent edition of the DSM-IV recognises the subcategories of anxiety disorders listed in Table One. The DSM-IV also defines criteria for a panic attack and agoraphobia.

It is important to recognise that these are not the only illnesses which exhibit anxiety symptoms. These symptoms are commonly found in other disorders such as depression, schizophrenia, somatoform disorders, organic disorders and disorders of the personality.3,4,7,8 Symptoms and treatment Anxiety symptoms may be primary or secondary to other psychiatric or

D I S E A S E S TAT E M A N A G E M E N T

TABLE THREE: Levels of anxiety and effects on health and behaviour3,12,11,12,21 Mild anxiety

" IFJHIUFOFE TUBUF PG BMFSUOFTT XIJDI JT OFDFTTBSZ EVSJOH TUSFTTGVM QFSJPET PG EBJMZ MJWJOH 0QFOOFTT UP DIBOHJOH TUJNVMJ BOE BCJMJUZ UP TPMWF QSPCMFNT XJUI QFBL FGGJDJFODZ

Moderate anxiety

4FMFDUJWF JOBUUFOUJPO %FDSFBTFE QFSDFQUJPO PG UIF FOWJSPONFOU -BDL PG DPODFOUSBUJPO 0CTFSWBCMF CFIBWJPVS .VTDVMBS UFOTJPO WBSJPVT TJHOT PG UFOTJPO BMUFSBUJPO JO QIZTJPMPHJDBM GVODUJPOJOH

Severe anxiety

/BSSPXFE QFSDFQUVBM Ă FME BSSPXFE DPHOJUJWF GVODUJPOJOH DBO POMZ BUUFOE UP POF UIJOH BU B UJNF CFJOH Ă YBUFE BU B DFSUBJO QPJOU PS / QSFPDDVQJFE JOUFOTFMZ XJUI EFUBJM 0CTFSWBCMF CFIBWJPVS * OBQQSPQSJBUF SFTQPOTFT BJNMFTT BDUJWJUZ SBQJE QVMTF JODSFBTFE IFBSUCFBU IZQFSWFOUJMBUJPO JODSFBTFE TFOTJUJWJUZ UP QBJO EFDSFBTFE BCJMJUZ UP IFBS BOE TFF * OBQQSPQSJBUF SFTQPOTFT BJNMFTT BDUJWJUZ SBQJE QVMTF JODSFBTFE IFBSUCFBU IZQFSWFOUJMBUJPO JODSFBTFE TFOTJUJWJUZ UP QBJO EFDSFBTFE BCJMJUZ UP IFBS BOE TFF

Panic

" TFOTF PG JNQFOEJOH EPPN 'FFMJOHT DBO PWFSXIFMN UIF QFSTPO XIP DBO CFDPNF AGSP[FO BOE IJHIMZ EJTPSHBOJTFE 5IF TFOTF PG AMPTT PG DPOUSPM PWFS TFMG BOE UIF FOWJSPONFOU 'FFMT GSBOUJD EFTQFSBUF TVGGFST EJNJOJTIFE TFOTBUJPO BOE QFSDFQUJPO %JTJOUFHSBUJPO PG QFSTPOBMJUZ

physical disorders. For secondary anxiety, treatment of the underlying problem is the initial approach, although there may need to be shortterm symptomatic treatment, for which non-pharmacological therapy is often effective. Definition of various anxiety disorders has importance

TABLE TWO: Psychological and physical signs and symptoms of anxiety3,4,9,11,12 Psychological

Physical

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MOTOR TENSION r NVTDMF UFOTJPO BDIJOH r UFOTJPO IFBEBDIF r USFNCMJOH TIBLJOH UXJUDIJOH r SFTUMFTTOFTT r UJSFEOFTT GBUJHVF AUTONOMIC ACTIVITY r ESZ NPVUI r QBMQJUBUJPOT UBDIZDBSEJB r TXFBUJOH DPME DMBNNZ IBOET r ĂĄ VTIFT DIJMMT r EJGGJDVMUZ JO TXBMMPXJOH PS AMVNQ JO UISPBU r EJBSSIPFB BCEPNJOBM EJTUSFTT r GSFRVFODZ PG NJDUVSJUJPO r EJGGJDVMUZ CSFBUIJOH TNPUIFSJOH GFFMJOH r EJ[[JOFTT PS MJHIU IFBEFEOFTT

because of the implications for specific treatment. There is often co-morbidity, with several anxiety disorders occurring together, or with substance use or dependence and depression.

In these instances, each disorder must be addressed, although some treatments will be suitable for several disorders. For many anxiety disorders, psychological therapies such as cognitive behavioural therapy (CBT) are the most appropriate initial choice.

Brief counselling may be as effective as benzodiazepines in the management of some anxiety disorders.3,4,7,8 Although cognitive approaches for the treatment of anxiety disorders may be as effective as drugs (and have fewer adverse effects), the problem for patients can be difficulty of access.

Those patients with more severe or persistent anxiety disorders usually need medication as well.

Anxiety symptoms may be very prominent in depressive disorders and unresponsiveness to anti-anxiety therapy may result from the patient having a depressive illness and also in

need of antidepressant treatment.3,4,7 Subsyndromal anxiety disorders are a variety of anxiety states which do not meet the diagnostic criteria for an anxiety disorder. These may be associated with intermittent mildto-moderate increases of anxiety, or a mild or temporary response to some life stressor. This would include mild transient stress reactions.

Subsyndromal anxiety disorders usually respond to brief counselling, reassurance and relaxation strategies.

They do not normally warrant the use of anxiolytic medications.3,4,7,8 There is much evidence to suggest that fear and anxiety reactions differ psychologically and physiologically.

Anxiety is a future-oriented mood state, characterised by apprehension because we cannot predict or control upcoming events.9 Fear, on the other hand, is an immediate emotional response to current danger characterised by strong escapist action tendencies and, often, a surge in physiological sympathetic activity.10â&#x20AC;&#x201C;12 Anxiety and pain/pain and anxiety

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EDUCATION D I S E A S E S TAT E M A N A G E M E N T

The relationship between anxiety and pain is a common experience in clinical settings.13 For example, anxiety levels have been shown to predict pain severity and pain behaviour in acute and chronic pain patients.14,15 Anxiety reduction techniques and anxiolytic drugs have been reported to be successful in ameliorating pain associated with medical procedures.16 Experimental studies have confirmed the enhancing effect of anxiety on pain for different components and measures of pain, eg. ratings of pain intensity18 and unpleasantness17 pain threshold18 and pain discrimination.19â&#x20AC;&#x201C;21 Generalised anxiety disorder Generalised anxiety disorder (GAD) comprises excessive anxiety and worry about various life circumstances and is not related to a specific activity, time or event such as trauma, obsessions or phobias. There is an overlap between GAD and other anxiety disorders. General features of GADs are persistent, unrealistic and excessive anxiety and worry about a number of life circumstances for six months or longer.8,10 The diagnostic criteria for GAD in the DSM-IV 7 requires three or more of the following: r JSSJUBCJMJUZ r SFTUMFTTOFTT r ALFZFE VQ PS APO FEHF r FBTJMZ GBUJHVFE r EJGGJDVMUZ DPODFOUSBUJOH PS ANJOE HPJOH CMBOL r NVTDMF UFOTJPO PS r TMFFQ EJTUVSCBODF

Clinical features can be divided into

TABLE FIVE: 1TZDIJBUSJD BOE PSHBOJD EJTPSEFST UIBU NBZ QSPEVDF BOYJFUZ 1TZDIJBUSJD

0SHBOJD

depression presenile dementia drug or alcohol dependence drug or alcohol dependence withdrawal schizophrenia

%36( 3&-"5&% amphetamines, other sympathomimetics, bronchodilators, excess caffeine, levodopa, digoxin, lignocaine, antipsychotic agents, thyroxine, many others, $"3%*07"4$6-"3 angina, arrhythmias, mitral valve prolapse &/%0$3*/& hyperthyroidism, phaeochromocytoma, hypoglycaemia, carcinoid syndrome, insulinoma /&630-0(*$"epilepsy, acute brain syndrome 3&41*3"503: asthma, COPD, acute respiratory distress, pulmonary embolism

psychological and physical symptoms (see Table Two) with the symptoms and signs according to bodily systems as shown in Table Three. Levels of anxiety and their effects on health and behaviour are shown in Table Four.

Table Five illustrates the psychiatric and organic disorders that may produce anxiety.

SOCIAL ANXIETY DISORDER Social anxiety disorder, (also known as social phobia), is distinguished by a fear of public humiliation or embarrassment. It is one of several phobic disorders, which are all typified by excessive, specific, and consistent fear and avoidance of an object, activity, or situation. People with social phobia may avoid doing activities in public such as eating or speaking, as well as using public bathrooms. Ultimately, someone with social phobia fears that people they do not know may judge them, which would cause them to have

TABLE FOUR: 4ZNQUPNT BOE TJHOT BDDPSEJOH UP CPEZ TZTUFNT /FVSPMPHJDBM

dizziness, headache, trembling, twitching, shaking, paraesthesia

$BSEJPWBTDVMBS

palpitations, tachycardia, flushing, chest discomfort

(BTUSPJOUFTUJOBM

nausea, indigestion, diarrhoea, abdominal distress

3FTQJSBUPSZ

hyperventilation, breathing difficulty, air hunger

$PHOJUJWF

fear of dying, difficulty concentrating, â&#x20AC;&#x2DC;mind going blankâ&#x20AC;&#x2122;, hypervigilance

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

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anxiety. Most commonly, social phobia develops between early adolescence and age twenty five.22â&#x20AC;&#x201C;26 Non-generalised social anxiety disorder Non-generalised social anxiety disorder involves more specific phobias such as public speaking, speaking to strangers, eating in public and even using public toilets. Models of social phobia emphasise the fact that sufferersâ&#x20AC;&#x2122; views of how they are coming across to others fall short of their belief about what these others expect from them.27

male-to-female prevalence is 2:3.

Social anxiety disorder usually begins early at about 14â&#x20AC;&#x201C;16 years of age.4, 23,24 A history of shyness and behavioural inhibition throughout childhood is common. Unless effectively treated, the clinical course is often that of a chronic, unremitting, and lifelong disorder. The phobic situation(s) is avoided or is endured with intense anxiety or distress. There are two subtypes of this disorder:8 HFOFSBMJTFE TPDJBM BOYJFUZÂ&#x2021;GFBS PG OVNFSPVT TPDJBM TJUVBUJPOT JODMVEJOH CPUI QFSGPSNBODF BOE

Symptoms and treatment The most common symptoms seen in social anxiety disorder include blushing, muscle twitching, shaking, and stuttering and other typical symptoms of anxiety. Panic attacks may occur in either specific phobias (fear of animals, fear of blood, injury, fear of flying, height, and others) or social anxiety disorder.

However, social anxiety disorder is differentiated from panic disorder and agoraphobia (fear of being in an open, crowded, or public place) by involving the fear of humiliation and social scrutiny, rather than the fear of having a panic attack.4,23.24 The lifetime prevalence of social anxiety disorder is estimated to be about 4â&#x20AC;&#x201C;5% of the population.39 The

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Treatment is quite different for the two types of disorder.

As social anxiety disorder commences during adolescence, it can seriously interfere with development of normal social skills and abilities to form interpersonal relationships. This can lead to functional disabilities that can persist for a life-time. Hence, social anxiety disorder may inhibit academic and employment potential. Sufferers are less likely to marry, and a majority report moderate-to-severe impairment in their abilities to carry

EDUCATION

AJP CPD

D I S E A S E S TAT E M A N A G E M E N T

CONTINUING PROFESSIONAL DEVELOPMENT

out daily activities. Some 70–80% of individuals will exhibit one or more psychiatric illness during their lives which includes depression, general anxiety disorder, panic disorder, body dysmorphic disorder and alcohol and substance abuse.4,23–26 Social anxiety is known to have a genetic basis; however, environmental influences may also contribute to the condition such as anxious behaviour modelling in parents and parental overprotection. Shyness in children, which is associated with later development of social anxiety disorder has been linked to a specific genetic polymorphism of the serotonin transporter promoter region.4,12,27 It would seem that non-generalised anxiety disorder may mainly involve disturbances in noradrenergic system functioning, while there is good evidence for dopinergic and serotonergic dysfunction in the generalised form. Pharmacological challenge studies indicate that serotonin type-2 receptors are hypersensitive in patients with social anxiety disorder, and other studies have found specific neural pathways to be activated in this condition.3,12,27 Treatment of social anxiety disorder requires early detection and appropriate diagnosis to prevent its lifelong functional consequences.

Sufferers are often reluctant to seek help and when they do, they are often misdiagnosed and inappropriately treated. In recent times, the use of medications has been established as first-line therapy.8 MEDICATIONS The efficacy, tolerability and safety of selective serotonin reuptake inhibitors (SSRIs) support these agents as first-line treatment.

Benzodiazepine clonazepam and certain monoamine oxidase inhibitors (representing both reversible and non-reversible inhibitors) may also be of benefit. Treatment of social phobia may need to be continued for several

months to consolidate response and achieve full remission.8,12,27 SSRIs have shown benefit in longterm treatment trials, while longterm treatment data from clinical studies of clonazepam are limited but support the drug's efficacy. There is also evidence for the effectiveness of exposure-based strategies of CBT, and controlled studies suggest that the effects of treatment are generally maintained at long-term follow-up.

In light of the chronicity and disability associated with social phobia, as well as the high relapse rate after shortterm therapy, it is recommended that effective treatment be continued for at least 12 months.28 Specific medications Tricyclic antidepressants (TCAs): amitriptyline, clomipramine, dothiepin, doxepin, imipramine, nortriptyline, trimipramine.

Imipramine has been found to be ineffective for social anxiety disorder, and TCAs are now not recommended for this condition.6,29 Selective serotonin re-uptake inhibitors (SSRIs): citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline are all likely to be effective. Controlled-release paroxetine effectively treated the symptoms associated with social anxiety disorder and was well tolerated, with few patients stopping treatment due to adverse events.30 Reversible monoamine oxidase inhibitors: moclobemide was found to be effective and well tolerated in the long-term treatment of social anxiety disorder with or without co-morbid anxiety disorder.31 Irreversible monoamine oxidase inhibitors: phenelzine and tranylcypromine have demonstrated marked efficacy for social anxiety disorder, but due to their many potential problems (mainly food and drug interactions) should be

reserved for non-SSRI responder or non-moclobemide responders.32

initially, increasing according to tolerability and patient response to a maximum of 300mg daily

Serotonin noradrenergic re-uptake inhibitors (SNRIs): venlafaxine.

A study evaluating the anxiolytic efficacy, safety and tolerability of a flexible dose of venlafaxine extended release (ER) compared with placebo and paroxetine in the short-term treatment of generalised social anxiety disorder found that both active treatments were generally well tolerated and were associated with a similar incidence of adverse events.33 Benzodiazepines: are advantageous treatments for anxiety disorders because they work quickly. However, benzodiazepines can vary in terms of efficacy across anxiety disorders.

Benzodiazepines have been found to be a superior treatment in social anxiety disorder. While benzodiazepines are effective in the treatment of generalised anxiety disorder, other treatments such as SSRIs may be more effective. Among the benzodiazepines, clonazepam is the best studied, although there is reason to expect that all benzodiazepine anxiolytics would be effective for this condition.6,34,35 Beta-blockers: reduce peripheral autonomic symptoms of anxiety, but they are not effective in treating generalised anxiety disorder.

However, they are useful for nongeneralised social phobia involving performance-related situations.36 Therapeutic Guidelines: Psychotropic8 recommends the following regimens for treating social anxiety disorder: Generalised social anxiety disorder First-line pharmacological treatment When medication is needed, SSRIs are preferred. Efficacy has been established for fluvoxamine, paroxetine and sertraline. Any of the following SSRIs are suggested: 1. fluvoxamine 100mg orally, daily

OR 1. paroxetine 10mg orally, daily initially, increasing according to tolerability and patient response to a maximum of 60mg daily OR 1. sertraline 25mg orally, daily initially, increasing according to tolerability and patient response to a maximum of 200mg daily.

Second-line pharmacological treatment The following treatments would in general only be used after unsuccessful trials of at least one first-line treatment. However, these treatments should be considered firstline for those who responded well to them previously. Some patients only respond to second-line therapy.

Benzodiazepines can be used in the treatment of patients who do not have a history of alcohol or other substance abuse (a common comorbidity with social anxiety disorder) or significant co-occurring depression. Clonazepam is the only benzodiazepine for which efficacy in generalised social anxiety disorder has been clearly demonstrated: clonazepam 0.25–2mg orally, twice daily is recommended.

Non-generalised social anxiety disorder For non-generalised social anxiety disorder (including performance anxiety) the goal of pharmacological treatment is to reduce the specific physiological symptoms (manifestations of sympathetic overactivity) of tremor, palpitations, sweating, which are distressing or unpleasant during a particular task.

Beta blockers are widely used for this purpose: propranolol 10–40mg orally, 30–60 minutes before the social event or performance is recommended.

Propranolol should be avoided

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in patients with asthma or severe peripheral vascular disease and some patients with heart failure. It should be used cautiously in patients with diabetes. Propranolol does not directly relieve the mental aspects of social phobia.

Alternatively, a short-acting benzodiazepine could be used just before the performance situation.

However, adverse effects include sedation, impaired coordination or disinhibition, all of which may impair performance:

scheduling and identifying and challenging dysfunctional thoughts can be used as a brief form of psychological intervention in patients with a variety of diagnoses, particularly in primary care settings. ■

chronic pain. Mol Psychiatry 2001; 6:256–60.

Gourley DR. Textbook of therapeutics: drug and

14. Kain ZN, Sevarino F, Alexander GM. et al.

disease management, 8th edition. Williams &

Preoperative anxiety and postoperative pain in

Wilkins, 2006.

women undergoing hysterectomy—a repeated

28. Van Ameringen M, Allgulander C, Bandelow B,

measures design. J Psychosom Res 2000;

et al. WCA recommendations for the long-term

49:417–22.

treatment of social phobia. CNS Spectr 2003 Aug;

15. van den Hout JH, Vlaeyen JW, Houben RM,

8(Suppl 1);40–52.

Two useful websites for health

et al. The effects of failure feedback and pain-

29. Federoff IC, Taylor S. Psychological and

professionals or to which patients

related fear on pain report, pain tolerance,

pharmacological treatments of social phobia: a

might be referred are:

and pain avoidance in chronic low back pain

meta-analysis. J Clin Psychopharmacol 2001; 21:

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patients. Pain 2000;92: 247–57.

311–24.

www.beyondblue.org.au

16. Swiss Federal Institute of Technology Zurich.

30. Lepola U, Bergtholdt B, St Lambert J, et al.

A step forward in targeted pain therapy. Science

Controlled-release paroxetine in the treatment

1. Vandenbos GR. American Psychological

Daily, 24 January 2008. www.sciencedaily.com

of patients with social anxiety disorder. JClin

1. alprazolam 0.25–0.5mg orally, as a

Association Dictionary of Psychology. Washington

accessed 28/11/12.

Psychiatry 2004;65(2):222–9.

single dose

DC: American Psychological Association, 2007.

17. Strahl C, Kleinknecht RA, Dinnel DL. The role

31. Stein DJ, Cameron A, Amrein R, et al.

OR

2. Sylvers S, Laprarie J, Lilienfeld. S. Differences

of pain anxiety, coping, and pain self-efficacy in

Moclobemide is effective and well tolerated in

1. lorazepam 0.5–1mg orally, as a

between trait fear and trait anxiety: implications

rheumatoid arthritis patient functioning. Behav

the long-term pharmacotherapy of social anxiety

single dose.

for psychopathology. Clinical Psychology

Res Ther 2000 Sep;38(9):863–73.

disorder with or without comorbid anxiety disorder.

Review 2011;31(1):122–37.

18. Casten RJ, Parmelee PA, Kleban MH, et al.

Int Clin Psychopharmacol 2002 Jul;17(4):161–70.

3. Murtagh J. General practice, 5th edition.

The relationships among anxiety, depression,

32. Muller JE, Koen L, Seedat S,

Sydney: McGraw Hill, 2011.

and pain in a geriatric institutionalized sample.

Stein DJ. Social anxiety disorder: current

4. Barlow DH, Durand VM. Abnormal psychology:

Pain1995;61(2):271–6.

treatment recommendations. CNS Drugs

an integrative approach, Sixth edition. Belmont

19. Rhudy JL, Meagher MW. Fear and anxiety:

2005;19(5):377–91.

CA: Thomson Wadsworth, 2011.

divergent effects on human pain thresholds. Pain

33. Allgulander C, Mangano R, Zhang J,

5.Cantor C. Evolution and posttraumatic stress:

2000; 84(1):65–75.

et al. Efficacy of Venlafaxine ER in patients

disorders of vigilance and defence. Routledge,

20. Lee JE, Watson D, Frey-Law LA.Psychological

with social anxiety disorder: a double-blind,

2005.

factors predict local and referred experimental

placebo-controlled, parallel-group comparison

6. Hamilton M. A rating scale for depression.

muscle pain: A cluster analysis in healthy adults.

with paroxetine. Hum Psychopharmacol 2004;

Journal of Neurology, Neurosurgery and

Eur J Pain 2012 Nov. [Epub ahead of print]

19(6):387–96.

Psychiatry 1960;23:56–62.

21. Janssen SA, Arntz A. No interactive effect of

34. Davidson JR. Use of benzodiazepines in social

7. American Psychiatric Association. Diagnostic

naltrexone and benzodiazepines on pain during

anxiety disorder, generalised anxiety disorder, and

and statistical manual of mental disorders, 4th Text

phobic fear. Behav Res Ther 1999;37:77–86.

posttraumatic stress disorder. J Clin Psychiatry

Revision. (DSM-IV-TR) Washington DC: American

22. Schneier FR, Johnson J, Hornig CD, et al.

2004;65 Suppl 5:29–33.

Psychiatric Association, 2002.

Social phobia. Comorbidity and morbidity in an

35. Jefferson JW. Benzodiazepines and

8. Therapeutic Guidelines: Psychotropic version 6.

epidemiologic sample. Arch Gen Psychiatry 1992

anticonvulsants for social phobia (social anxiety

Therapeutic Guidelines Limited, 2008.

Apr;49(4):282–8.

disorder). J Clin Psychiatry 2001;62 Suppl 1:50–3.

9. Barlow DH. Anxiety and its disorders: the nature

23. Kring A, Johnson S, Davison GC, Neale JM.

36. Schneier FR. Pharmacotherapy of social

and treatment of anxiety and panic, 2nd edition.

Abnormal psychology, 11th Edition. New York:

anxiety disorder.Expert Opin Pharmacother

New York: Guilford Press, 2002.

John Wiley & Sons, 2009.

2011;12(4):615–25.

10. Roy-Byrne PP, Craske MG, Stein MB. Panic

24. Lampe LA. Social phobia. Australian Doctor

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disorder. Lancet; 2006; 368: 1023–32.

21 May 2004, 35–42.

2013.

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psychology: the problem of maladaptive

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13. Grachev ID, Fredickson BE, Apkarian AV.

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2012] available from: www.health.gov.au/

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internet/main/publishing.nsf/Content/46AB

neuronal marker N-acetyl aspartate to perception

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7A3FEF9664E4CA2575D2000A6D09/$File/

distinguishes closely interrelated characteristics of

27. Helms RA, Quan DJ, Herfindal ET,

mhaust2.pdf .

NON-PHARMACOLOGICAL TREATMENT In generalised social anxiety disorder, cognitive behavioural therapy incorporating exposure-based therapy, social skills training and cognitive therapy is the treatment of choice. However, for many people CBT alone is not sufficient to reduce symptoms to a manageable level, so a combination of pharmacological and psychological treatment is needed.

CBT is an empirical psychological treatment. It is based on two key principles: cognitions may control feelings and behaviour; and behaviours affect thought patterns and emotions. CBT aims to identify, challenge and modify maladaptive, automatic or core thoughts, beliefs, perceptions and behaviours. This occurs over a series of clinical interviews, and cognitive and behavioural tasks. Acute treatment typically takes between 12 and 20 weekly sessions. Follow-up booster sessions at three or six months are often useful. CBT may be effective alone or it may aid pharmacotherapy in acute treatment and reduce relapse risk after drugs are discontinued.

Benzodiazepines can interfere with the effectiveness of CBT. Elements of CBT such as activity

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

58

EDUCATION

AJP CPD

D I S E A S E S TAT E M A N A G E M E N T

CONTINUING PROFESSIONAL DEVELOPMENT

and hesitantly, anxiously and

r %PFT UIF QBUJFOU IBWF SFTQJSBUPSZ

with negative body language,

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no eye contact, stuttering

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and blushing, hands you r 9BOBY BMQSB[PMBN

4DFOBSJP

NBZ DBVTF IZQPYBFNJB r $BVUJPO XJUI ESVHT UIBU JOIJCJU

prescriptions for:

$:1 " NFUBCPMJTN

UBCMFUT NH CE GPS BOE

Paroxetine is a selective serotonin

You have known Adam Littlemouse

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reuptake inhibitor with a half-life of about

(34 years old, average weight and

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24 hours (which may be increased in older patients); it is extensively

height) for some time.

Based on your discussion

metabolised via the P450 (CYP 2D6)

to come to the pharmacy except on

with the doctor, it was

isoenzyme system and is approved

rare occasions to get his medications

thought that Adamâ&#x20AC;&#x2122;s

for the treatment major depression,

for his asthma which he has had since

level of anxiety was

of social anxiety disorder/ social

childhood. Despite this, you have gained

pretty extreme and at

phobia, generalised anxiety disorder,

He lives alone and is even too â&#x20AC;&#x2DC;shyâ&#x20AC;&#x2122;

least a short-term treatment

his trust and he will sometimes talk to you in a halting and self-deprecating

with a benzodiazepine might be useful as

manner. You know that he spends most

well as the SSRI.

post-traumatic stress disorder.36â&#x20AC;&#x201C;38 Factors to consider with paroxetine: r .FEJDJOF GSFF JOUFSWBM NBZ CF

Adam would need to be counselled on

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of his free time alone and probably does

is going to be there. Even though this

not have many, if any, friends. Both his

meeting is seven days away, his stomach

the appropriate use of the medications

parents are deceased and he is an only

turns raw with anxiety and fear floods

and encouraged to reduce his red wine

child. He does not smoke, but he does

over him again. He knows that in front

to perhaps one glass with his dinner.

admit to drinking a â&#x20AC;&#x153;fairâ&#x20AC;? amount of red

of the boss heâ&#x20AC;&#x2122;ll stammer, hesitate, his

Adam declined your offer of

wine every night.

face will turn red, he wonâ&#x20AC;&#x2122;t remember

Consumer Medication Information

You are assured that his asthma is

what to say, and everyone will witness his

(CMIs) leaflets as he felt it would

under reasonable control. He has been

embarrassment and humiliation. He has

alarm him further. Counselling

taking Seretide (fluticasone/salmeterol)

seven miserable days of anxiety ahead

included emphasis on the benefits

250/25mcg MDI bd, and he always has a

of him to think about it, ruminate over it,

of the two medications plus the

Ventolin MDI handy.

worry about it, over-exaggerate it in his

implications of the Cautionary and

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mind, again and again and again.

Advisory Labels 1,9,12 and B.

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Recently, when he came to collect his asthma medication, he confided in

The worst part of all this from Adamâ&#x20AC;&#x2122;s

you hesitantly and with great difficulty,

point of view is that these meetings occur

but with great patience and empathy

all the time and all he really wants to do is

on your part, admitted that he did not

go home and keep out of everyoneâ&#x20AC;&#x2122;s way.

want to go to work because a meeting

Adam is describing and living a typical

is scheduled the next week. He knows

social anxiety disorder set of symptoms.

that these meetings always involve

You realise that straight counselling will

co-workers talking with each other about

not help the situation, but you do indicate

their current projects. Just the thought of

to him that his condition is a real condition

speaking in front of co-workers raises his

and can be treated successfully with

anxiety. Sometimes he canâ&#x20AC;&#x2122;t sleep the

either medications and/or psychotherapy.

night before because of the anticipatory

You ascertain from Adam that he

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prescribed follow.

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Alprazolam has a short-intermediate

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half-life ranging from 6â&#x20AC;&#x201C;27 hours

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and is approved for the treatment of

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anxious patients with some symptoms of depression (short term); panic

OUTCOMES

disorder.36â&#x20AC;&#x201C;38

The outcome of all this is that some three

Factors to consider with alprazolam: r 3FHVMBS VTF GPS NPSF UIBO m XFFLT

months later, Adam is not taking the alprazolam any more. However, he is still

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taking the paroxetine, he has reduced

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his drinking significantly and feels much

r #FXBSF TVEEFO EJTDPOUJOVBUJPO PG

anxiety that builds up. Finally, the

would like help. You recommend a

meeting is over. A big wave of relief spills

particular GP who you know has had

over him as he begins to relax. But the

some success in treating such patients.

memory of the meeting is still uppermost

He agrees to make an appointment on

in his mind.

the proviso that you contact the doctor

r .POJUPS QBUJFOU GPS QIZTJDBM BOE

to inform her of his situation. This you

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he said with a smile when he came into

himself and that everyone in the room

readily agree to and talk to the doctor.

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your pharmacy to pick up his medications.

saw how afraid he was when he spoke,

About a month later Adam returns (he

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and how stupid he acted in their presence.

kept putting off making an appointment

At next weekâ&#x20AC;&#x2122;s meeting, his employer

as he felt he would make a fool of himself)

He is convinced he made a fool of

MPOH UFSN USFBUNFOU

less anxious, more confident and more positive about life generally. He started

r #FXBSF PG TFEBUJPO FTQFDJBMMZ XIFO BMDPIPM JT DPOTVNFE

some cognitive behavioural sessions with a â&#x20AC;&#x2DC;really niceâ&#x20AC;&#x2122; psychologist and that too is

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helping. â&#x20AC;&#x2DC;Work doesnâ&#x20AC;&#x2122;t seem so bad now,â&#x20AC;&#x2122;

The above scenario is purely hypothetical and not based on any real people or events.

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

59

EDUCATION CLINICAL PHARMACY

Dispersible aspirin tablets repacked into dosette boxes: Caution in practice Martina Mylrea BEd, BSc, MEd (Learning Technology); Sherryl Robertson BAppSc (Chem) Hons, PhD; Alison Haywood BPharm, PhD; Beverley Glass BPharm, BTech (Marketing) Hons, BSc (Chem) Hons, PhD Edited by Cassie Fersterer, Society of Hospital Pharmacists of Australia#

After reading this article, the learner should be able to: t EFTDSJCF UIF JNQBDU PG repackaging dispersible aspirin into dosette boxes, as demonstrated in this study; t QSPWJEF B SFDPNNFOEBUJPO BT to whether dispersible aspirin should be repackaged into dosette boxes, based on the results of this study.

Competencies addressed: 1.4, 2.5, 4.2, 4.3

Accreditation Number: S2012/79 This activity has been accredited for 1 hour of Group 2 CPD (or 2 CPD credits) suitable for inclusion in a pharmacistâ&#x20AC;&#x2122;s CPD plan (if selfassessment questions are completed after reading the journal article).

THIS STUDY AIMED TO DETERMINE THE STABILITY OF ACETYLSALICYLIC ACID IN TABLETS REPACKED INTO DOSETTE BOXES, A PRACTICE OFTEN UNDERTAKEN BY PATIENTS.

C

ompliance aids have been developed to assist patients better manage their medicines by organising individual doses according to the prescribed dosing schedule throughout the day. While well-sealed dose administration aids (DAAs) such as the WebsterPak are commonly used by community and hospital pharmacists to repackage medicines, it is not known which compliance aids are used by patients in their homes. Many of these aids, such as the dosette box or pill organiser are readily available under a variety of brands, but do not have adequate airtight seals.

Removal of medicines from primary packaging and repacking into a compliance aid invalidates the stability guaranteed by the manufacturer. Only a small number of medicines (eg. atenolol, paracetamol, frusemide prochlorperazine and clozapine) have been investigated for stability following repacking into DAAs by pharmacists.

Llewelyn et al studied the stability of sodium valproate, which is known to be hygroscopic when repacked into DAAs and stored under various temperature and humidity

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

60

conditions. The results highlighted that accelerated conditions of temperature and humidity must be taken into account, as well as the fact that different countries (and even within countries) may experience variable temperature, humidity and light conditions. These studies have been performed using well-sealed DAAs commonly used by pharmacies in Australia.

Elmasry et al reported on the quantitative analysis of mebeverine, mesalazine, sulphasalazine and dispersible aspirin stored in a monitored dosage system, highlighting not only that the tablets were stored together, but also the differences in terms of safety and risk between medications

repacked under the supervision of a pharmacist and those being repacked into compliance aids by patients.

Low-dose aspirin is prescribed for primary prevention of stroke and acute myocardial infarction in older people. A recent study reported that low-dose aspirin (acetylsalicylic acid [ASA]) was a cost-effective option in primary prevention and that the majority of health systems are more than willing to pay for any additional quality-adjusted life year gained. Tablet splitting or dividing has been an accepted practice for many years as a means of obtaining the prescribed dose of a medication and for cost-saving purposes. The storage of split tablets is not well discussed in the literature and anecdotal evidence suggests that many patients split tablets in advance and then store these in bottles that previously contained the same medication, a different medication or some other substance, or in a

FIGURE ONE: Hydrolysis of aspirin to salicylic acid

COOH

O

COOH OH

OCCH 3 Water / moisture

Aspirin (ASA)

Salicylic Acid

EDUCATION

AJP CPD

CLINICAL PHARMACY

CONTINUING PROFESSIONAL DEVELOPMENT

compliance aid such as a dosette box. Due to stability concerns, patients are generally advised that if only half a tablet is used, the unused half should be discarded, particularly with medicines that are known to be unstable, when exposed to light and air.

ASA is rapidly hydrolysed to salicylic acid (SA) on exposure to moisture (see Figure One) and the limit of the SA content in dispersible ASA tablets is 3%. Chromatographic methods have been described to determine ASA in pharmaceutical formulations and biological fluids.

Investigators using reversephase high-performance liquid chromatography (HPLC) have recommended a short time limit for the determination of ASA between sample preparation and analysis in order to prevent degradation. The lack of exact data on the stability of these samples in an HPLC autosampler prior to analysis is the limitation of these assays. Studies

by Kees et al, Gandhimathi et al and Montgomery et al have also been limited by their lack of specificity and data relating to robustness in terms of the stability of samples for HPLC injection. Other limitations include the use of mobile phases, which are complex and not cost effective, and the use of chloroform (environmentally inappropriate solvent) for the extraction of ASA. Considering the above repacking practices and that ASA is rapidly hydrolysed to SA on exposure to moisture, this study aimed to determine the stability of ASA in dispersible tablets repacked into dosette boxes, a practice often undertaken by patients.

METHOD High performance liquid chromatography The Varian ProStar HPLC system consisted of a 240 quaternary solvent delivery module, 210 autosampler

…anecdotal evidence suggests that many patients split tablets in advance and then store these in bottles that previously contained the same medication, a different medication or some other substance

and a photodiode array detector. A Pursuit XRs C18 (5µm, 250 x 4.6mm) reverse-phase column (at 40ºC) was selected as the stationary phase. The mobile phase was water:methanol:phosphoric acid (1M (35:60:5) )and the detection wavelength was 235nm. An injection volume of 20µL was used with a flow rate of 1mL/min. Data were analysed using Varian Star Chromatography Workstation. The method was validated for accuracy, precision, linearity and range, sensitivity, robustness (solution stability) and specificity.

Storage conditions The following four storage conditions were investigated: refrigeration (5±3°C); controlled room temperature (25ºC; 60% relative humidity [RH]); accelerated (40°C; 75% RH) simulated by a climate chamber conformant to the International Conference on Harmonisation requirements; and ‘in-use’ with natural variations in daylight exposure and internal temperature fluctuations (23–26°C; 45–60% RH).

Dispersible aspirin 300mg tablets (Solprin, Reckitt Benckiser) whole and split (halved along the tablet score line) were removed from the primary (foil) packaging and immediately repacked into dosette boxes and stored for one week at each of the four storage conditions.

For the controls, Solprin 300mg tablets in primary (foil) packaging) were also stored under the same four conditions. All of the Solprin tablets tested had the same batch numbers and an expiry date of one year from the time of analysis. The stored tablets were tested for drug content (ASA) and the degradation product (SA) at days 0 and 7.

Standard and sample solutions Standard solutions of ASA (2–30µg/ mL) and SA (2–10µg/mL) were

prepared. For each assay (in triplicate), 20 tablets were selected at random, removed from the primary packaging and finely crushed using a mortar and pestle.

A sample equivalent to 300mg of aspirin was then transferred to a 50mL volumetric flask and extracted with a solution of methanol:formic acid (98:2). Extracted tablet samples were sonicated for three minutes each and filtered through 0.2µm syringe filter. Further dilution with mobile phase resulted in a solution containing approximately 15µg/mL aspirin. All samples were protected from light during extraction and stored in amber vials and analysed using the stability-indicated HPLC method.

RESULTS High performance liquid chromatography Several extraction media (eg. acetonitrile, methanol, ethanol, mobile phase) were evaluated to achieve the best extraction recovery of ASA. Single tablets (in triplicate) were dissolved in each extractant, filtered, diluted with mobile phase and analysed immediately. The ASA per cent recovery for the extractants was: acetonitrile (80%), methanol (99%), ethanol (95%) and mobile phase (water:methanol:phosphoric acid 35:60:5) (95%). Methanol produced the best extraction recovery, and the addition of formic acid 2% improved the peak shape.

The method proved to be valid for accuracy, precision, linearity (correlation coefficients greater than 0.9999 for both ASA and SA) and sensitivity.

Robustness (solution stability) Due to the susceptibility of ASA to hydrolysis, sample solutions may degrade during the extraction process or sample preparation for HPLC analysis. This may be attributed to the water containing

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EDUCATION CLINICAL PHARMACY

Specificity As per International Conference on Harmonisation guidelines, forced degradation studies were performed on tablet samples under the stress conditions of light, heat, humidity, acid/base hydrolysis and oxidation. The conditions used in this study were designed to avoid complete, but achieve no less than 5% degradation of the active pharmaceutical ingredient, ASA. Other than SA, no major degradation products were observed, when ASA was subjected to acid/ base, oxidative and photolytic stress.

A summary of the amount of ASA remaining after exposure to various stress conditions of light, heat, humidity, acid/base hydrolysis and oxidation is presented in Table One. Peak purity test results confirmed that the ASA peak was homogeneous and pure in all the analysed stress samples, confirming that the ASA was unaffected by the presence of the degradant SA or tablet excipients.

TABLE ONE: Summary of forced degradation results Stress condition

Time

Assay of ASA

Acid hydrolysis (HCl 1 M)

4 hours

91%

Base hydrolysis (NaOH 1 M)

1 hour

34%

Oxidation (H2O2 6%)

24 hours

8%

–

78%

UV (300–400nm)

400 watt h/m2

–

VIS (400–800nm)

2.4 million lux h

–

Photolytic degradation

ACA = acetylsalicylic acid. UV = ultraviolet. VIS = visible.

mobile phase and that the sample was maintained in the HPLC autosampler prior to analysis.

Therefore, an assessment was made of the stability of the sample solutions prepared in the following manner. A tablet was extracted, diluted and maintained in the HPLC autosampler under laboratory conditions (25 ± 2ºC), it was then repeatedly analysed by HPLC over an eight-hour period.

Extracted tablet sample solutions on the HPLC autosampler when subjected to repeat sampling after five hours showed a 2% decrease in concentration of the analyte, ASA. These results informed all analyses, where samples were always extracted, diluted and analysed within the five-hour time period and usually within two hours to ensure stability of the analyte.

Aspirin is rapidly hydrolysed to SA on exposure to moisture…

Storage conditions Aspirin is rapidly hydrolysed to SA on exposure to moisture and the limit of SA content in aspirin tablets is prescribed by the British Pharmacopoeia (BP) to be 3% w/v. Aspirin content is required

to be within 95–105% of the labelled amount.

The dispersible aspirin tablets kept in the primary packaging and stored under the four storage conditions retained potency with no significant degradation to SA. All tablets repacked into dosette boxes, except those tablets stored at accelerated conditions complied with the BP requirement that the aspirin content should be within 95–105% of the labelled amount (see Table Two). This highlights that both temperature and moisture accelerate the degradation of aspirin.

There is concern that the content of the degradant SA exceeded the BP limit (3%) under the accelerated storage conditions for the aspirin tablets repacked into dosette boxes.

The accelerated storage condition showed SA to be present in more than double (6.7%) the specified limit (see Table Two). For all other storage conditions the amount of SA did not exceed the limit. However, when compared to the results for the original packaging, a greater percentage of SA was present, confirming the original packing to be effective in protecting the aspirin from degradation. No additional degradation was associated with splitting tablets, with similar results

TABLE TWO: Effect of exposure to various storage conditions on the stability of ASA in repacked dispersible aspirin tablets Mean % ASA remaining (SD, n = 3) Storage condition t=0

Packaging

WHOLE TABLET

WHOLE TABLET

SPLIT TABLET

–

101 ± 0.2

–

<0.005*

Dosette box

100 ± 0.4

103 ± 0.3

0.2

25°C; 60% RH

Original foil

100 ± 0.1

–

<0.005

–

40°C; 75% RH

Dosette box

93 ± 0.6

91 ± 0.1

6.7

–

40°C; 75% RH

Original foil

101 ± 0.03

–

<0.005

–

‘In-use’

Dosette box

100 ± 0.1

99 ± 0.3

0.5

–

‘In-use’

Original foil

102 ± 0.1

–

<0.005

–

Refrigeration (5 ± 3°C)

Dosette box

100 ± 0.1

100 ± 0.2

0.2

–

Refrigeration (5 ± 3°C)

Original foil

101 ± 0.3

–

<0.005

–

25°C; 60% RH

ASA = acetylsalicylic acid. BP = British Pharmacopoeia. RH = relative humidity. SA = salicylic acid. * As determined by the limit of quantitation (0.3g/mL).

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SPLIT TABLET

Mean % SA (n = 3) – 0.2

EDUCATION

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CONTINUING PROFESSIONAL DEVELOPMENT

FIGURE TWO: Dosette box and aspirin dispersible tablets after storage under accelerated conditions (40°C; 75%RH) for seven days in a dosette box (left) and in the original packaging (right). for the ASA and SA content across the four storage conditions.

With regards to the physical attributes, the aspirin tablets removed from the original packaging exhibited signs of physical degradation within seven days of being repacked into dosette boxes and stored at accelerated conditions (see Figure Two). The tablets swelled, became soft, disintegrated easily and developed a pink discolouration.

DISCUSSION A simple and cost-effective HPLC method was developed to quantitate ASA in dispersible aspirin tablets that is accurate, precise, sensitive and specific. The extraction method using methanol resulted in an extraction recovery of 99% and was superior to other solvents.

In addition, methanol presented an environmentally safe option compared to chloroform used by Montgomery et al.

Our study also presents important information on the robustness of the HPLC method, which ensures the stability of ASA in the samples prior to analysis.

This stability-indicating method can therefore be used to determine ASA in dispersible aspirin tablets repacked into dosette boxes.

The tablets swelled, became soft, disintegrated easily and developed a pink discolouration.

Although our results concur with Elmasry et al in terms of the aspirin content when stored under standard conditions, these authors did not specify the exact temperature conditions, conduct the stability study under accelerated conditions, or monitor the amount of the degradant, SA. However, they highlighted the risk associated with patients using dosette boxes to manage medicines and their work presents a valuable insight into the implications of storing different medicines together in a compliance aid.

These results are also in agreement with the findings of a study highlighting that discolouration in aspirin tablets was due to exposure to high humidity. Dispersible tablets are listed as an example of solid dosage forms that should not be repacked into compliance aids, according to guidelines, such as the Professional Practice Standards and Dose Administration Aids Service.

In conclusion, while the ASA content of the dispersible aspirin tablets remained within specifications at room temperature, there were changes in the physical appearance under accelerated storage conditions.

KEY REFERENCES

improving patients care. AMJ 2011;4(4):183–9.

Llewelyn V, Mangan M, Glass BD. Stability of sodium valparote repackaged into dose adminstratrion aids. Journal of Pharmacy and Pharmacology 2010;62:838–43.

Glass B, Haywood A, Llewelyn V, Mangan M. Compliance aids and medicine stability: new evidence of quality assurance. Current Drug Safety 2009;4(1):74–8.

Glass BD, Mangan M, Haywood A. Prochlorperazine tablets repackged into dose administration aids: can the patient be assured of quality? J Clin Pharm Ther 2009;34(2):161–9.

Bowen L, Mangan M, Haywood A, Glass BD. Stability of furosemide tablets repackaged into dose administration aids. Journal of Pharmacy Practice and Research 2007:37(3)178–81.

Haywood A, Mangan M, Glass BD. Stability implications of repackaging a paracetamol tablet into a dose administration aid.

Journal of Pharmacy Practice and Research 2006;36(1):25–8.

Competing interests: None declared. # This review is a secondary publication of an article originally published as ‘Stability of dispersible aspirin tablets repacked into dosette boxes’, Journal of Pharmacy Practice and Research 2012;42(3):204–7.

Some key references are listed at the end of this article and a full list of references are provided in the original publication.

Perks S, Robertson S, Haywood A, Glass BD. Clozapine repackaged into dose administration aids: a common practice in Australian hospitals.

Int J Pharm Prac 2012;20(1):4–8.

Haywood A, Llewelyn V, Robertson S, Glass BD. Dose administration aids: pharmacists’ role in

ERRATUM The Clinical Pharmacy continuing professional development article published in the AJP’s December 2012 issue identified the wrong authors. It should have noted that article was authored by Christopher Freeman BPharm, DradDipClinPharm; W Neil Cottrell BScPharm(Hons), MScPharm, PhD; Greg Kyle BPharm, MClinPharm, PhD; Ian D Williams MBBS, FRACGP; Lisa Nissen BPharm, PhD. The error resulted from not replacing the authors of the previous clinical pharmacy CPD article published in October 2012. The AJP apologises unreservedly to the authors and readers for this error.

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EDUCATION THERAPEUTIC INSIGHT

Therapeutic insight: the statins After reading this article, the learner should be able to: t EFTDSJCF UIF DVSSFOU SFTFBSDI JOUP FYJTUJOH BOE QPUFOUJBM UIFSBQFVUJD VTFT PG TUBUJOT t EFTDSJCF UIF DVSSFOU SFTFBSDI JOUP NFUBCPMJD BDUJPOT BOE FGGFDUT PG TUBUJOT t UIF DVSSFOU SFTFBSDI JOUP BEWFSTF FGGFDUT PG TUBUJOT Competencies addressed: 1.3.1, 4.2, 6.2.2, 6.2.3

Accreditation Number: CX130002E This activity has been accredited for 0.25 hours of Group 2 CPD (or 0.5 CPD credits) suitable for inclusion in a pharmacistâ&#x20AC;&#x2122;s CPD plan (if selfassessment questions are completed after reading the journal article).

AJP EDUCATION EDITOR JOHN CHAPMAN REVIEWS THE LATEST EVIDENCE ON STATIN USE.

T

he use of statins to reduce levels of low density lipoprotein cholesterol (LDLC) and very low density lipoprotein cholesterol (VLDLC) is now well accepted both for patients with coronary artery disease (CAD) and for primary prevention,1 although the economic basis for primary prevention in the absence of compelling risk factors is unclear.2 Statins also improve lipid profiles and reduce testosterone levels in women with polycystic ovary syndrome (PCOS) but there is, as yet, no evidence that their use improves menstrual regularity or spontaneous ovulation.3 This is not surprising as there appears to be a growing consensus that insulin resistance (IR), hyperinsulinaemia and type 2 diabetes, suggesting progressively dysfunctional insulin metabolism, play a key role in the development of PCOS and its accompanying metabolic derangements.10,11 There is growing evidence of the role of adipose tissue in the development of chronic inflammatory states associated with metabolic syndrome.4â&#x20AC;&#x201C;6 Adipose tissue was originally thought to be simply an energy-storage organ.

It is now recognised as an active participant in energy homoeostasis and physiological functions such as immunity and inflammation, particularly in the case of central adipose tissue.5 Macrophages, as

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

64

components of adipose tissue, also actively contribute to its activities.

Adipose tissue is known to express and secrete a variety â&#x20AC;&#x2DC;adipokinesâ&#x20AC;&#x2122; (humoural factors)â&#x20AC;&#x201D;leptin, adiponectin, resistin and visfatin as well as cytokines and chemokines such as tumour necrosis factoralpha, interleukin-6 and monocyte chemoattractant protein-1. The release of adipokines by either adipocytes or adipose tissueinfiltrated macrophages results in a chronic sub-inflammatory state that may play a key role in the development of insulin resistance and type 2 diabetes, as well as the increased risk of cardiovascular disease associated with obesity.5 STATINS AND INFLAMMATION Lyngdoh et al noted the pleiotropic effects of statins across a range of studies, particularly as regards the involvement of C-reactive protein (CRP).12 Elks and Francis5 suggested that systemic inflammation in metabolic syndrome may involve CRP and some pro-inflammatory cytokines, with the nuclear factorkappaB pathway also believed to play a role. Inflammation of central adipose tissue leads to adipokine production and secretion into the general circulation. This contributes to the overall inflammatory condition and the probable association is strengthened by recent work.12 Dietary components

may also contribute to central adiposity and the inflammation seen in this condition.4 Nishimura, Manabe and Nagai13 highlighted the ability of adipose tissue to secrete humoural factors (adipokines) and to produce proinflammatory cytokines. Obesity is therefore likely to contribute to the low-level systemic inflammation that is seen in metabolic syndrome and associated chronic pathologies such as atherosclerosis. Recent studies have also shown that obesity induces chronic local inflammation in adipose tissue; and that cells of the innate immune system (particularly macrophages) are crucially involved in adipose inflammation and systemic metabolic abnormalities. It is now clear that the adipocyte is an active participant in the generation of the inflammatory state in obesity.

Lyngdoh et al found that individuals on statins have lower CRP levels; conversely, no effect was found for IL-1 , IL-6 and TNF- levels.12 STATINS AND OSTEOARTHRITIS The findings regarding inflammatory processes in general and CRP in particular have stimulated interest in other conditions where inflammation is thought to play a part. Clockaerts et al have reported that statin use is associated with more than a 50% reduction in overall progression of osteoarthritis of the knee, but not of the hip.15 STATINS AND MYOPATHY, MYOSITIS AND RHABDOMYOLYSIS Myopathy, myositis and, more rarely, rhabdomyolysis are associated with statin use.16 An observational study by Nichols and Koro suggests that statin initiation was associated with an approximate doubling of the risk for any myopathic event but not with an increased risk of rhabdomyolysis.17 These findings might be treated with caution as the study did not control for dose

EDUCATION

AJP CPD

THERAPEUTIC INSIGHT

CONTINUING PROFESSIONAL DEVELOPMENT

of statin prescribed and focused on simvastatin and lovastatin only.17 The effects of statins on muscle appear to be dose related with higher doses increasing the likelihood of these side effects, and are more common with simvastatin in doses of 80mg.16,26 The muscle problems observed in statin-treated patients may be related to impairment of mitochondrial function and muscle calcium homeostasis.25 STATINS, MILD COGNITIVE IMPAIRMENT AND DEMENTIA Results in this area are mixed although a recent observational study suggests that ‘Statins may slow the rate of cognitive decline and delay the onset of Alzheimer’s disease (AD) and all-cause dementia in cognitively healthy elderly individuals, whereas individuals with Minor Cognitive Impairment (MCI) may not have comparable cognitive protection from these agents’.19 It should be noted that systematic reviews in 2010 did not support the use of statins for prevention.20–21 STATINS AND CANCER PREVENTION Results in this area are mixed, however more recent work suggests that there is an association between statin use and a reduction in cancer-related mortality.23 Other studies have shown a significant negative association between prior statin use and a diagnosis of adenomatous polyps22 and an association for statin usage in preventing prostate cancer.24 Further progress will depend on results from well-designed clinical trials.

STATINS AND TYPE 2 DIABETES Statin use is associated with an increased risk of diabetes and with increases in hepatic transaminases, although the absolute risk of diabetes is low compared with the risk-reduction benefit of the cardiovascular effects of statins.18

STATINS AND FOOD INTERACTIONS Evidence has been available for some time regarding the effect of the elements present in grapefruit (and Seville oranges), resulting in inhibition of small-intestine CYP3A4 and the subsequent increase in the bioavailability of statins resulting in increased blood level of these drugs,27 particularly simvastatin, lovastatin and atorvastatin. Although commentary has largely focused on CYP3A4 inhibition in the small intestine there may well be further factors at play in the liver.28 Research is also being undertaken on the concomitant intake of soluble fibre and statin bioavailability29 and we will consider this at a later date.

Statin bioavailability may also be affected by hepatic enzyme induction (eg. phenytoin) or inhibition (eg. macrolide antibiotics). ■

causation? Nutr Metab Cardiovasc Dis 2004;

analysis of the ginkgo evaluation of memory

14: 228–32.

study. Journal of Stroke and Cerebrovascular

8. Bergman RN, Van Citters GW, Mittelman SD,

Diseases: The Official Journal Of National Stroke

Dea MK, Hamilton-Wessler, M, Kim SP et al.

Association 2012;21(6):436–44.

Central role of the adipocyte in the metabolic

20. Muangpaisan W, Brayne C. Systematic

syndrome. J Invest Med 2001; 49: 119–26.

review of statins for the prevention of vascular

9. Ehrmann, D.A., Polycystic ovary syndrome.

dementia or dementia. Geriatrics & Gerontology

N Engl J Med, 2005. 352(12): p. 1223–36.

International 2010;10(2):199–208.

10. Halperin IJ, et al. The association between

21. McGuinness B, O’Hare J, Craig D, Bullock R,

the combined oral contraceptive pill and insulin

Malouf R, Passmore P. Statins for the treatment

resistance, dysglycemia and dyslipidemia

of dementia. Cochrane Database of Systematic

in women with polycystic ovary syndrome:

Reviews 2010, Issue 8. Art. No.: CD007514. doi:

a systematic review and meta-analysis of

10.1002/14651858.CD007514.pub2.

observational studies. Human Reproduction

22. Broughton T, Sington J, Beales I. Statin

2011; 26(1): 191–201.

use is associated with a reduced incidence of

11. Moran LJ, et al. Impaired glucose tolerance,

colorectal adenomatous polyps. International

type 2 diabetes and metabolic syndrome in

Journal of Colorectal Disease. 2012:1–8.

polycystic ovary syndrome: a systematic review

23. Nielsen SF, Nordestgaard BG, Bojesen SE.

and meta-analysis. Human Reproduction Update

Statin use and reduced cancer-related

2010; 16(4): 347–63.

mortality. New England Journal of Medicine

12. Lyngdoh T, Vollenweider P, Waeber

2012;367(19):1792–802.

G, Marques-Vidal P. Association of statins

24. Zhang Y, Zang T. Association between statin

with inflammatory cytokines: a population-

usage and prostate cancer prevention: a refined

based Colaus study. Atherosclerosis

meta-analysis based on literature from the years

1. Jain M, Rosenberg M. Meta-analysis:

2011;219(1):253–8.

2005–2010. Urologica Internationalis. 2012;

Lowering LDL-C levels using statins reduces

13. Nishimura S, Manabe I, Nagai R. Adipose

Article in press. Epub 9 Oct 2012.

major vascular events regardless of baseline

tissue inflammation in obesity and metabolic

25. Sirvent P, Fabre O, Bordenave S,

risk. Ann Intern Med 2012;157(8):JC4-2. doi:

syndrome. Discovery Medicine 2009; 8: 55–60.

Hillaire-Buys D, Raynaud De Mauverger E,

10.7326/0003-4819-157-8-201210160-02002.

14. Boppidi H, Daram SR. Non-alcoholic fatty

Lacampagne A, et al. Muscle mitochondrial

2. Taylor F, Ward K, Moore THM, Burke M, Davey

liver disease: hepatic manifestation of obesity

metabolism and calcium signaling impairment

Smith G, Casas JP, Ebrahim S. Statins for the

and the metabolic syndrome. Postgrad Med

in patients treated with statins. Toxicol Appl

primary prevention of cardiovascular disease.

2008;120(2):E01–7.

Pharmacol 2012;259(2):263-8. doi: 10.1016/j.

Cochrane Database of Systematic Reviews

15. Clockaerts S, Van Osch GJVM, Bastiaansen-

taap.2012.01.008. Epub Jan 17.

2011, Issue 1. Art. No.: CD004816. DOI:

Jenniskens YM, Verhaar JAN, Van Glabbeek F,

26. Silva M, Matthews ML, Jarvis C, Nolan NM,

10.1002/14651858.CD004816.pub4.

Van Meurs JB, et al. Statin use is associated

Belliveau P, Malloy M. Metaanalysis of

3. Raval AD, Hunter T, Stuckey B, Hart RJ.

with reduced incidence and progression of knee

drug-induced adverse events associated

Statins for women with polycystic ovary

osteoarthritis in the Rotterdam study. Annals Of

with intensive-dose statin therapy. Clin Ther

syndrome not actively trying to conceive.

The Rheumatic Diseases 2012;71(5):642–7.

2007;29:253–60.

Cochrane Database of Systematic Reviews

16. Rallidis LS, Fountoulaki K, Anastasiou-

27. Paine MF, NH O. Clinical relevance of the

2011, Issue 10. Art. No.: CD008565. DOI:

Nana M. Managing the underestimated risk

small intestine as an organ of drug elimination:

10.1002/14651858.CD008565.pub2.

of statin-associated myopathy. International

drug-fruit juice interactions. 2007 [14 Dec

4. Antuna-Puente B, Feve B, Fellahi S,

Journal Of Cardiology 2012;159(3):169–76.

2012]; February(3). Available from: www.ncbi.

Bastard JP. Adipokines: the missing link

17. Nichols GA, Koro CE. Does statin therapy

nlm.nih.gov/pubmed/17269895#

between insulin resistance and obesity.

initiation increase the risk for myopathy? An

28. Mandery K, Balk B, Bujok K, Schmidt I,

Diabetes Metab 2008; 34: 2–11.

observational study of 32,225 diabetic and

Fromm MF, H G. Inhibition of hepatic uptake

5. Elks CM, Francis J. Central adiposity, systemic

non-diabetic patients. Clinical Therapeutics

transporters by flavonoids. Eur J Pharm Sci

inflammation, and the metabolic syndrome.

2007;29(8):1761–70.

[online]. 2012 [14 dec 2012]. Available from:

Curr Hypertens Rep 2010; 12: 99–104.

18. Ito MK. Dyslipidaemia: management using

www.ncbi.nlm.nih.gov/pubmed/22394605.

6. Nishimura S, Manabe I, Nagai R. (2009) Adipose

optimal lipid-lowering therapy. The Annals Of

29. Zhou SF. Drugs behave as substrates,

tissue inflammation in obesity and metabolic

Pharmacotherapy 2012;46(10):1368–81.

inhibitors and inducers of human cytochrome

syndrome. Discovery Medicine 2009; 8: 55–60.

19. Bettermann K, Arnold AM, Williamson J,

P450 3A4. Curr Drug Metab [online]. 2008

7. Esposito K, Giugliano D. The metabolic

Rapp S, Sink K, Toole JF, et al. Statins, risk of

[14 Dec 2012]; 9(4):310–22]. Available from:

syndrome and inflammation: association or

dementia, and cognitive function: secondary

www.ncbi.nlm.nih.gov/pubmed/18473749.

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Lyrica helps control my neuropathic pain

PBS

LISTED

LYRICA

1

MARCH 1 2013

PBS Information: This product is not listed on the PBS. RPBS Information: Authority required “For the treatment of refractory neuropathic pain not controlled by other drugs”.

Before prescribing, please review full Product Information available from www.pfizer.com.au

Minimum Product Information LYRICA® (pregabalin) capsules. Indications: Neuropathic pain in adults; adjunctive therapy in adults with partial seizures with or without secondary generalisation. Contraindications: Hypersensitivity to pregabalin or excipients. Precautions: Pregnancy; lactation; dizziness; somnolence; history of substance abuse*; congestive heart failure; galactose intolerance; withdrawal symptoms; renal impairment; peripheral oedema; creatine kinase elevation; weight gain; blurred vision; hypersensitivity reactions; increased risk of suicidal thoughts or behaviour. See full PI. Interactions: CNS depressants; alcohol; lorazepam; oxycodone; medications causing constipation. See full PI. Adverse effects: Most common: dizziness, somnolence. Others include: blurred vision, fatigue, weight gain, dry mouth, headache, ataxia, peripheral oedema, impaired balance, diplopia, sedation. Post-marketing, serious: angioedema, allergic reaction, loss of consciousness, mental impairment, congestive heart failure, keratitis, pulmonary oedema. See full PI. Dosage and Administration: 150 to 600 mg orally/day given as 2 divided doses. Neuropathic pain: start at 150 mg/day, increase to 300 mg/ day after 3 to 7 days. If needed, increase to a maximum of 600 mg/day after a further 7 days. Epilepsy: start at 150 mg/day, increase to 300 mg/day after 7 days. Maximum dose of 600 mg/day may be given after a further week.

Renal impairment: reduce dose. See full PI. V11212. Reference: 1. LYRICA Approved Product Information. 1 June 2010. Pfizer Australia Pty Ltd. ABN 50 008 422 348. 38-42 Wharf Road, West Ryde, NSW 2114. Medical Information: 1800 675 229. ®Registered trademark. P7029 S&H 01/13 PFILY0450E_FP_FEB_AJP

*Please

note changes to Product Information.

EDUCATION

AJP CPD

C U R R E N T D R U G I N F O R M AT O N

CONTINUING PROFESSIONAL DEVELOPMENT

John Chapman BPharm, BCom, PGDipClinHospPharm, FACP (HC) MPS, education editor AJP. john.chapman@appco.com.au.

No interaction from aripiprazole with either lithium or valproate T

After reading these articles, the learner should be able to: t EFTDSJCF UIF SFTVMUT PG SFDFOU QVCMJTIFE TUVEJFT t DPOTJEFS JNQMJDBUJPOT PG UIFTF TUVEJFT UP UIFJS QSBDUJDF Competencies addressed: 6.2, 7.1, 7.2

Accreditation number: CX130002D Upon successful completion of the associated assessment, this activity has been accredited for 0.5 hours of Group 2 CPD (or 1.0 CPD credits) suitable for inclusion in an individual pharmacistâ&#x20AC;&#x2122;s CPD plan.

he antipsychotic, aripiprazole, plus lithium or valproate demonstrates rapid and significant improvement in manic symptoms that is sustained over the long term.

A previous report showed that therapeutic doses of either lithium or valproate had no clinically significant effects on the pharmacokinetics of aripiprazole. The investigators aimed to determine the effects of co-administration of aripiprazole on the steady-state pharmacokinetics of lithium or valproate in healthy subjects.1 Two similarly designed, openlabel, single-sequence studies were conducted. Healthy subjects received daily oral doses of either lithium (450mg every 12 hours) or valproate (500mg every 12 hours) on days one to seven.

Following day seven was a twoday washout period, and on day 10, subjects began receiving oral doses of aripiprazole (10mg once daily) for two days. Aripiprazole was then titrated from 10 to 20mg once daily to establish tolerance of aripiprazole. On day 14, the dose was escalated and subjects received aripiprazole 30mg once daily for 13 days. Beginning on day 20, subjects

received lithium (450mg every 12 hours) or valproate (500mg every 12 hours) concomitantly with aripiprazole 30mg once daily through day 26. Serial blood samples for serum lithium or valproate concentration determination were collected for up to 12 hours postlithium or valproate administration on days seven and 26.

valproate. The majority of subjects (76.9% for aripiprazole plus lithium and 68¡4% for aripiprazole plus valproate) reported adverse events, but this adverse event profile is consistent with what has been observed in other studies.

It was concluded: â&#x20AC;&#x2DC;The addition of aripiprazole to either lithium or valproate had no clinically

THE ADDITION OF ARIPIPRAZOLE TO EITHER LITHIUM OR VALPROATE HAD NO CLINICALLY MEANINGFUL EFFECTS ON THE PHARMACOKINETICS OF EITHER DRUG. The lithium study enrolled 32 healthy subjects (72% completed the study), and the valproate study enrolled 48 healthy subjects (58% completed the study). In both studies, the 90% confidence intervals for the ratios of population geometric means, with and without aripiprazole, were contained within 80% and 125% for both the Cmax and AUCĎ&#x201E;, respectively. Furthermore, the addition of aripiprazole did not change the median Tmax of lithium or valproate (four hours).

Thus, the addition of aripiprazole did not affect the steady-state pharmacokinetics of lithium or

meaningful effects on the pharmacokinetics of either drug.

In addition, co-administration of aripiprazole with lithium or valproate demonstrated no unexpected safety signals in healthy subjectsâ&#x20AC;&#x2122;. â&#x2013; 1. Boulton DW, Kollia GD, Mallikaarjun S, et al. Lack of a pharmacokinetic drugâ&#x20AC;&#x201C;drug interaction between lithium and valproate when co-administered with aripiprazole Journal of Clinical Pharmacy and Therapeutics 2012;37:565â&#x20AC;&#x201C;70.

Available in Australia AripiprazoleÂ&#x2030;"CJMJGZ "SJQJQSB[PMF ()

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 FEBRUARY 2013

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EDUCATION C U R R E N T D R U G I N F O R M AT I O N

Warfarin management after discharge from hospital W

arfarin is recognised as a high-risk medication for adverse events, and the risks are particularly heightened in the period immediately following a patient’s discharge from hospital. This qualitative study aimed to explore the experiences of Australian patients and healthcare professionals of warfarin management in the postdischarge period and identify the benefits and deficiencies of existing systems, to inform the development of a model for a new collaborative post-discharge warfarin management service.1 Healthcare professionals, professional organisation representatives and patients recently discharged from hospital taking warfarin (consumers) were recruited via purposive, criterion-based sampling within two Australian states. Semistructured telephone interviews were conducted between August and October 2008 using standard discussion guides.

Data were manually analysed to identify emergent themes using a phenomenological approach.

Forty-seven participants were involved in the telephone interviews. Three major themes emerged:

(i) appropriate warfarin education is integral to effective warfarin management; (ii) problems occur in communication along the continuum of care; and (iii) home-delivered services are valuable to both patients and

Although high-quality warfarin education and effective communication at the hospital– community interface were identified as important in postdischarge warfarin management, deficiencies were perceived within current systems. The role of homedelivered services in ensuring timely follow-up and promoting continuity of care was recognised.

1. Stafford L, van Tienen EC, Peterson GM, et al. Warfarin management after discharge from hospital: a qualitative analysis. Journal of Clinical Pharmacy and Therapeutics 2012;37:410–14.

Available in Australia Warfarin sodium—Coumadin, Marevan

Inhaled glucocorticoids for persistent asthma in prepubertal children associated with reduction in attained adult height

T

he use of inhaled glucocorticoids for persistent asthma causes a temporary reduction in growth velocity in prepubertal children.

The resulting decrease in attained height one to four years after the initiation of inhaled glucocorticoids is thought not to decrease attained adult height.

The investigators measured adult height in 943 of 1041 participants (90.6%) in the Childhood Asthma Management Program; adult height was determined at a mean (±SD) age of 24.9±2.7 years. Starting at the age of 5–13 years, the participants had been randomly assigned to receive 400µg of budesonide, 16mg of nedocromil, or placebo daily for 4–6 years.

The investigators calculated differences in adult height for

healthcare professionals.

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Previous studies exploring anticoagulation management in other settings have identified similar themes. Post-discharge management should therefore focus on providing patients with a solid foundation to minimise future problems.

It was concluded: ‘Addressing the three identified facets of care within a new, collaborative post-

discharge warfarin management service may address the perceived deficiencies in existing systems.

Improvements may result in the short- and longer-term health outcomes of patients discharged from hospital taking warfarin, including a reduction in their risk of adverse events’. ■

each active treatment group, as compared with placebo, using multiple linear regression with adjustment for demographic characteristics, asthma features, and height at trial entry.1 Mean adult height was 1.2cm lower (95%) in the budesonide group than in the placebo group and was 0.2cm lower (95%) in the nedocromil group than in the placebo group. A larger daily dose of inhaled glucocorticoid in the first two years was associated with a lower adult height (−0.1cm for each microgram per kilogram of body weight). The reduction in adult height in the budesonide group as compared with the placebo group was similar to that seen after two years of treatment (−1.3cm). During the first two years, decreased growth

velocity in the budesonide group occurred primarily in prepubertal participants.

It was concluded: ‘The initial decrease in attained height associated with the use of inhaled glucocorticoids in prepubertal children persisted as a reduction in adult height, although the decrease was not progressive or cumulative’. ■ 1. Kelly HW, Sternberg AL, Lescher R, et al, Effect of inhaled glucocorticoids in childhood on adult height. N Engl J Med 2012;367:904–12.

Available in Australia Budesonide—Budamax, Entocort, Pulmicort, Rhinocort, Rhinocort Hayfever, Symbicort Turbuhaler Nedocromil sodium—Tilade CFC-Free

EDUCATION C U R R E N T D R U G I N F O R M AT I O N

Administration of interferon beta to patients with MS not associated with reduction in progression of disability

I

nterferon beta is widely prescribed to treat multiple sclerosis (MS), however, its relationship with disability progression has yet to be established.

A retrospective cohort study based on prospectively collected data (1985â&#x20AC;&#x201C;2008) was carried out to investigate the association between interferon beta exposure and disability progression in patients with relapsing-remitting MS.1 Patients with relapsing-remitting MS treated with interferon beta (n = 868) were compared with untreated contemporary (n = 829) and historical (n = 959) cohorts.

The main outcome measure was time from interferon beta treatment eligibility (baseline) to a confirmed and sustained score of six on the Expanded Disability Status Scale (EDSS) (range, 0â&#x20AC;&#x201C;10, with higher scores indicating higher disability).

The median active follow-up times (first to last EDSS measurement) were as follows: for the interferon beta-treated cohort, 5.1 years for the contemporary control cohort, four years; and for the historical control cohort, 10.8 years.

The observed outcome rates for reaching a sustained EDSS score of six were 10.8%, 5.3%, and 23.1% in the three cohorts, respectively.

Exposure to interferon beta was not associated with a statistically significant difference in the hazard of reaching an EDSS score of 6 when either the contemporary control cohort (hazard ratio, 1.30) or the

historical control cohort (hazard ratio, 0.77) were considered.

It was concluded: â&#x20AC;&#x2DC;Among patients with relapsing-remitting MS, administration of interferon beta was not associated with a reduction in progression of disabilityâ&#x20AC;&#x2122;.

An editorial that discusses the issues involved has been published.2 â&#x2013;

Echinacea may cause allergic reactions in children younger than 12

T

he Medicines and Healthcare products Regulatory Agency (12 August 2012) (MHRA) is

in general catch fewer colds.

This move by the MHRA follows precautionary advice from the

advising parents and carers not to give

European Herbal Medicinal Products

oral products containing echinacea

Committee (HMPC) and from the UK

to children under 12 years due to the

Herbal Medicines Advisory Committee

risk of rare allergic reactions that may

(HMAC) who concluded that the use

sometimes be severe. Echinacea

of echinacea in children younger than

species are herbal ingredients

12 presents a low risk of rare allergic

traditionally used mainly to relieve

reactions that could be severe and the

symptoms of the common cold and

perceived benefits of the products are

influenza type infections.

not outweighed by the potential risks in

Due to the risk of rare allergic reactions that may be severe and other

this age-group.

Possible side effects of oral

side effects, the MHRA is advising

echinacea products include:

parents and carers not to give oral

r BMMFSHJD SFBDUJPO TVDI BT TXFMMJOH

products containing Echinacea to

IJWFT PS SBTIFT

children under 12 years. If they have any

r TXFMMJOH PG UIF TLJO EVF UP ĂĄVJE

1. Shirani A, Zhao Y, Karim ME, et al. Association

concerns, they should seek the advice of

r TXFMMJOH PG UIF GBDJBM BSFB 2VJOLF T

between use of interferon beta and progression

their general practitioner or pharmacist.

of disability in patients with relapsingâ&#x20AC;&#x201C;remitting

Children aged 12 years or older and

multiple sclerosis. JAMA 2012;308:247â&#x20AC;&#x201C;56.

adults can continue to use oral products

2. Derfuss T, Kappos L. Evaluating the potential

containing echinacea. Risks of side

benefit of interferon treatment in multiple

effects in older children and adults are

sclerosis. JAMA 2012;308:290â&#x20AC;&#x201C;1.

reduced because they weigh more and

PFEFNB

r TISJOLJOH PG UIF BJSXBZT PG UIF MVOHT XJUI PCTUSVDUJPOT CSPODIPTQBTN BOE r BTUINB BOE MJGF UISFBUFOJOH SFBDUJPOT BOBQIZMBDUJD TIPDL â&#x2013;

Thiazolidinediones associated with increased risk of bladder cancer among adults with type 2 diabetes

P

atients with type 2 diabetes have

control studies that reported incident

of pioglitazone specifically (pooled RR

a 40% increased risk of bladder

bladder cancer among people with

1.22,) showed significant associations

cancer. Thiazolidinediones,

type 2 diabetes who ever (vs never) were

with bladder cancer. No significant

especially pioglitazone, may increase

exposed to pioglitazone (main outcome),

association with bladder cancer was

the risk. The investigators conducted a

rosiglitazone or any thiazolidinedione.

observed in the two RCTs that evaluated

systematic review and meta-analysis

Of the 1787 studies identified, the

rosiglitazone use (pooled RR 0.87).

It was concluded: â&#x20AC;&#x2DC;The limited

to evaluate the risk of bladder cancer

investigators selected four RCTs, five

among adults with type 2 diabetes taking

cohort studies and one case-control

evidence available supports the

thiazolidinediones.1

study. The total number of patients was

hypothesis that thiazolidinediones,

2,657,365, of whom 3,643 had newly

particularly pioglitazone, are associated

databases (including MEDLINE, Embase

diagnosed bladder cancer, for an overall

with an increased risk of bladder cancer

and Scopus) and sources of grey

incidence of 53.1 per 100,000 person-

among adults with type 2 diabetesâ&#x20AC;&#x2122;. â&#x2013;

literature from inception through March

years. The one RCT that reported on

2012 for published and unpublished

pioglitazone use found no significant

1. Colmers IN, Bowker SL, Majumdar SR, et al.

studies, without language restrictions.

association with bladder cancer (risk

Use of thiazolidinediones and the risk of bladder

They included randomised controlled

ratio [RR] 2.36). The cohort studies of

cancer among people with type 2 diabetes: a

trials (RCTs), cohort studies and case-

thiazolidinediones (pooled RR 1.15) and

meta-analysis. CMAJ 2012;184:E675-E683.

They searched key biomedical

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EDUCATION C U R R E N T D R U G I N F O R M AT I O N

Effect of influenza vaccines on warfarin therapy W

arfarin is a widely used anticoagulant, well-known for its interactions with medications and foods. Vaccinations, particularly the influenza vaccine, have been thought to potentially interfere with anticoagulation response in those on chronic warfarin. The objective of this study was to systematically review the literature to assess the validity and clinical significance of this association.(1) A primary literature search was performed using MEDLINE (1966– June 2011) and EMBASE (1980– June 2011). Additional studies were obtained by performing a manual bibliographical review of literature from the initial results and by searching the Cochrane Database of Systematic Reviews.

All English-language, peerreviewed publications identified were evaluated. Reviews, case studies and trials reporting anticoagulation response using an unconverted prothrombin time ratio were excluded.

Thirty-one abstracts were initially reviewed, and seven studies were identified for inclusion in this review. Significant changes in mean international normalised ratio post-vaccination between the study and comparator groups were documented in one trial. Through subgroup analysis, another study noted that elderly patients spent more time in the sub-therapeutic range postvaccination when compared with baseline INR levels. No other significant changes in mean INR levels were documented following

influenza vaccination. Adverse bleeding events reported after immunisation were limited and minor in nature.

It was concluded: ‘Overall, our review does not indicate a

1. Kuo AM, Brown JN, Clinard V. Effect of influenza vaccination on international normalized ratio during chronic warfarin therapy. Journal of Clinical Pharmacy and Therapeutics 2012;37:505–9.

Available in Australia Warfarin sodium—Coumadin, Marevan

Tiotropium reduced exacerbations in poorly controlled asthma

I

nhaled glucocorticoids and long acing beta-agonists (LABAs) are the treatment of choice for asthma suffers.

However, some patients with asthma have frequent exacerbations and persistent airflow obstruction despite treatment.

In two replicate, randomized, controlled trials involving 912 patients with asthma who were receiving inhaled glucocorticoids and LABAs, the investigators compared the effect on lung function and exacerbations of adding tiotropium (a total dose of five µg) or placebo, both delivered by a soft-mist inhaler once daily for 48 weeks. All the patients were symptomatic, had a post-bronchodilator forced expiratory volume in one second (FEV1) of 80% or less of the predicted value, and had a history of at least one severe exacerbation in the previous year.

The patients had a mean baseline FEV1 of 62% of the

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consistent, clinically relevant effect of influenza vaccines on international normalized ratio of patients on chronic warfarin therapy. Isolated reports of variations in international

normalized ratio following influenza vaccination are likely due to other factors’. ■

predicted value; the mean age was 53 years. At 24 weeks, the mean (±SE) change in the peak FEV1 from baseline was greater with tiotropium than with placebo in the two trials: a difference of 86±34 ml in trial one and 154±32

It was concluded: ‘In patients with poorly controlled asthma despite the use of inhaled glucocorticoids and LABAs, the addition of tiotropium significantly increased the time to the first severe exacerbation

...THE ADDITION OF TIOTROPIUM SIGNIFICANTLY INCREASED THE TIME TO THE FIRST SEVERE EXACERBATION AND PROVIDED MODEST SUSTAINED BRONCHODILATION ml in trial two. The pre-dose (trough) FEV1 also improved in trials one and two with tiotropium, as compared with placebo: a difference of 88±31 ml and 111±30 ml, respectively.

The addition of tiotropium increased the time to the first severe exacerbation (282 days versus. 226 days), with an overall reduction of 21% in the risk of a severe exacerbation (hazard ratio, 0.79). No deaths occurred; adverse events were similar in the two groups.

and provided modest sustained bronchodilation’. ■ COMMENT: For pharmacists wishing to read more in this area, there is a useful review online in Medscape. Registration is FREE and simple. See: www.medscape.com/pharmacists 1. Kerstjens HAM, Engel M, Dahl R, et al.

Tiotropium in Asthma Poorly Controlled with Standard Combination Therapy. N Engl J Med Sep 3 2012.

Available in Australia Tiotropium bromide—Spiriva

EDUCATION

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CPD INFORMATION AJP 2013;94(1113) February 2013 Disease State Management

Anxiety and social phobia disorder Accreditation number: CX130002C Accredited for 2.0 Group 2 CPD credits upon achieving 75% or more in the assessment.

Clinical Pharmacy

Integrating pharmacists into general practice Accreditation number: S2012/79 Accredited for 2.0 Group 2 CPD credits upon achieving 75% or more in the assessment.

Therapeutic Insight

Accreditation number: CX130002E Accredited for 0.5 Group 2 CPD credits upon achieving 75% or more in the assessment.

Current Drug Information

Accreditation number: CX130002D Accredited for 1.0 Group 2 CPD credits upon achieving 75% or more in the assessment.

SUBMITTING ANSWERS

Disease State Management, Therapeutic Insight and Current Drug Information t 14" NFNCFST DBO TVCNJU BOTXFST POMJOF GPS UIFTF TFDUJPOT BU XXX QTB PSH BV BOE GPMMPX UIF MJOL UP TVCNJU BOTXFST t 1IBSNBDZ (VJME PG "VTUSBMJB NFNCFST SFHJTUFSFE NZ$1% VTFST DBO TVCNJU BOTXFST POMJOF BU XXX NZDQE PSH BV DMJDL PO UIF ANZ$1% MPH JO CVUUPO UP BDDFTT ZPVS BDDPVOU and assessment. t "VTUSBMJBO $PMMFHF PG 1IBSNBDZ NFNCFST DBO TVCNJU BOTXFST POMJOF GPS UIFTF TFDUJPOT BU XXX BDQ FEV BV VOEFS $1% "DUJWJUJFT Clinical Pharmacy t "MM AJP SFBEFST DBO TVCNJU BOTXFST UP this section at http://cpd.shpa.org.au/ scripts/cgiip.exe/WService=SHPACP/ ccms.r?PageId=10003.

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ANSWERS FROM DECEMBER 2012 Disease State Management

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Disease State Management Anxiety and social phobia disorder AJP 2013;94(1113): 54â&#x20AC;&#x201C;59. This unit attracts 2.0 Group 2 CPD credits. Accreditation number CX130002C. Each question has only one answer.

1. Choose the INCORRECT answer. Anxiety is not considered abnormal except when it occurs: A JO JOUFSQFSTPOBM SFMBUJPOTIJQT B JO TJUVBUJPOT UIBU NPTU QFPQMF DBO IBOEMF XJUI MJUUMF EJGGJDVMUZ C JO UIF BCTFODF PG QIZTJPMPHJDBM TZNQUPNT TVDI BT SBQJE IFBSUCFBU D JO DPOKVODUJPO XJUI QIZTJPMPHJDBM TZNQUPNT TVDI BT JSSFHVMBS IFBSUCFBU E prior to a visit to the dentist.

2. Choose the CORRECT answer. A man feels uncomfortable and on edge most of the time. He tends to snap at people, is unable to relax, and has difficulty in sleeping. He is most likely suffering from: A agoraphobia.

B schizophrenia.

C manic depression.

D HFOFSBMJTFE BOYJFUZ EJTPSEFS E a panic disorder.

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C QBOJD BUUBDLT D NBOJD TUBHF PG CJ QPMBS EJTFBTF E major mood disorder.

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on Friday

5. Choose the INCORRECT answer.

The following medications are used appropriately in the treatment of generalised anxiety disorder (often in combination with non-pharmacological therapies): A buspirone.

B BNJUSJQUZMJOF C diazepam.

D WFOMBGBYJOF E DJUBMPQSBN 6. Choose the INCORRECT answer. The DSM-IV for the diagnosis of social anxiety disorder includes the following: A B NBSLFE BOE QFSTJTUFOU GFBS PG POF PS NPSF TPDJBM PS QFSGPSNBODF TJUVBUJPOT JO XIJDI UIF QFSTPO JT FYQPTFE UP VOGBNJMJBS QFPQMF PS UP QPTTJCMF TDSVUJOZ CZ PUIFST B UIF JOEJWJEVBM GFBST UIBU IF PS TIF XJMM BDU JO B XBZ PS TIPX BOYJFUZ TZNQUPNT

UIBU XJMM CF IVNJMJBUJOH PS FNCBSSBTTJOH C FYQPTVSF UP UIF GFBSFE TJUVBUJPO BMNPTU JOWBSJBCMZ QSPWPLFT BOYJFUZ XIJDI NBZ UBLF UIF GPSN PG B QBOJD BUUBDL D the person does not recognise that the GFBS JT FYDFTTJWF PS VOSFBTPOBCMF E UIF GFBSFE TPDJBM PS QFSGPSNBODF TJUVBUJPOT BSF BWPJEFE PS FOEVSFE XJUI JOUFOTF BOYJFUZ PS EJTUSFTT 7. Choose the INCORRECT answer. The DSM-IV for the diagnosis of social anxiety disorder includes the following: A UIF BWPJEBODF BOYJPVT BOUJDJQBUJPO PS EJTUSFTT JO UIF GFBSFE TPDJBM PS QFSGPSNBODF TJUVBUJPO T JOUFSGFSFT TJHOJGJDBOUMZ XJUI UIF QFSTPO T OPSNBM SPVUJOF PDDVQBUJPOBM GVODUJPOJOH PS TPDJBM BDUJWJUJFT PS SFMBUJPOTIJQT B UIFSF NBZ NBSLFE EJTUSFTT BCPVU IBWJOH the phobia.

C JO JOEJWJEVBMT ZPVOHFS UIBO EVSBUJPO JT VTVBMMZ TIPSU MJWFE D the fear or avoidance is not due to the EJSFDU QIZTJPMPHJDBM FGGFDUT PG B ESVH PS B HFOFSBM NFEJDBM DPOEJUJPO E UIF GFBS JT OPU BDDPVOUFE GPS CZ PUIFS NFOUBM EJTPSEFST 8. Choose the INCORRECT answer. Currently, effective medication treatment of social anxiety disorder includes the following: A imipramine 25mg tds.

B QBSPYFUJOF o NH EBJMZ C QIFOFM[JOF GSPN NH CE D QSPQSBOPMPM o NH QSJPS UP B TPDJBM FWFOU XIFSF UIFSF JT TZNQBUIFUJD PWFSBDUJWJUZ E NPDMPCFNJEF o NH EBJMZ 9. Cognitive behaviour therapy will generally include all the following, except: A UFMMJOH UIF QBUJFOU UP HSPX VQ B FEVDBUJPO BCPVU UIF OBUVSF PG BOYJFUZ BOE TPDJBM QIPCJB C BOYJFUZ NBOBHFNFOU BOE EF BSPVTBM TUSBUFHJFT TVDI BT IZQFSWFOUJMBUJPO DPOUSPM BOE QSPHSFTTJWF NVTDVMBS SFMBYBUJPO D DPHOJUJWF DIBMMFOHJOH BOE DPHOJUJWF restructuring.

E graded exposure to feared situations.

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Health promotions are supported with clinical tips written by popular pharmacy academics and practitioners. These tips are practical reminders that can help pharmacists and assistants to better engage customers about their health concerns and demonstrate your pharmacyâ&#x20AC;&#x2122;s ability to offer more than simply a convenient dispensing service.

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Clinical Pharmacy Dispersible aspirin tablets repacked into dosette boxes: Caution in practice AJP 2013;94(1113):60–63. This unit attracts 2.0 Group 2 CPD credits. Accreditation number S2012/79.

1. Choose the INCORRECT statement.

A Removal of medicines from primary packaging into a dose administration aid (DAA) means you can no longer be assured of the expiry date of the medicines given by the manufacturer.

B WebsterPaks are well-sealed devices and as such the repackaging of medicines into them does not invalidate the stability guaranteed by the manufacturer.

C Splitting a tablet originally stored in a blister pack invalidates the stability guaranteed by the manufacturer.

D Manufacturer’s expiry dates on medications apply when the medications are stored according to the manufacturer’s recommendations.

2. Which statement(s) is/are CORRECT? Choose all that apply. i. Aspirin is hydrolysed to salicylic acid on exposure to light.

ii. Aspirin is hydrolysed to salicylic acid on exposure to moisture. iii. There is an allowable limit of 3% salicylic acid content in dispersible aspirin tablets. iv. Aspirin content should be within 90% to 110% of the labelled amount.

A ii, iii, iv C ii,iii B i, iii D All statements are correct.

3. Which statement(s) is/are CORRECT with respect to the method of this study?

Choose all that apply.

A There were a total of four storage conditions investigated.

B Dispersible aspirin tablets, were removed from the foil packaging and repacked into dosette boxes and stored for one week at each of the storage conditions.

C The ‘control’ tablets were kept in their original packaging and stored under the same conditions for the same

amount of time.

D Split tablets were halved using tablet cutters along the score line.

4. Which statement(s) is/are CORRECT with respect to the results of this study? Choose all that apply.

A Dispersible aspirin tablets packed into dosette boxes showed signs of physical degradation when stored at room temperature.

B The only major degradation product that was found was salicylic acid.

C There was significant salicylic acid detected in the dispersible aspirin tablets repackaged into dosette boxes and stored at accelerated conditions, but it remained within acceptable limits in all four storage conditions.

D All dispersible aspirin tablets kept in their original packaging retained potency in all four storage conditions.

5. What conclusions can be drawn after reading the results of this study and the author’s recommendations? Choose all that apply.

A Dispersible aspirin tablets should not be stored in dosette boxes.

B Dispersible aspirin tablets should not be stored in dosette boxes but can be safely stored in WebsterPaks.

C Dispersible aspirin tablets stored at room temperature in dosette boxes are safe if they are used within seven days.

D Dispersible aspirin tablets undergo physical degradation when stored in dosette boxes.

E Once the humidity goes over 60%, dispersible aspirin should not be packed into dosette boxes.

F It’s safe to put dispersible aspirin in a dosette box as long as it is refrigerated.

Therapeutic Insight The statins AJP 2013;94(1113):64–65. This unit attracts 0.5 Group 2 CPD credits. Accreditation number CX130002E. Each question has only one answer.

1. Choose the CORRECT answer. Use of statins is associated with: A a reduction in levels of LDLC and VLDLC in coronary artery disease.

B a reduction in levels of LDLC and VLDLC in primary prevention.

C an improvement in lipid profiles for patients with PCOS. D All of the above.

2. Choose the INCORRECT answer. Myopathy, myositis and rhabdomyolysis are associated with the use of statins:

A as a group effect.

B in a dose-related relationship.

C only in the case of high-dose (80mg) simvastatin.

D possibly as a result of impairment of mitochondrial function and muscle calcium homeostasis.

3. Choose the INCORRECT answer. Adipose tissue is now recognised as: A simply a storage tissue.

B an active participant in energy homoeostasis and physiological function.

C a tissue known to express and secrete a variety of ‘adipokines’ (humoural factors).

D a tissue known to express and secrete a variety of cytokines.

4. Choose the INCORRECT answer. Use of statins is associated with: A an increased risk of diabetes.

B increases in hepatic transaminases.

C a reduction in cancer-related mortality.

D a significant slowing of the rate of cognitive decline in elderly individuals with MCI.

5. Choose the CORRECT answer. Various studies involving statins have suggested that: A statins may be useful in reducing the progression of osteoarthritis of the knee.

B statins may play a role in reducing systemic inflammation resulting from CRP. C statins appear to have little effect in preventing or slowing cognitive impairment in the elderly.

D All of the above.

Current Drug Information AJP 2013;94(1113):67–70. This unit attracts 1.0 Group 2 CPD credit. Accreditation number CX130002D. Each question has only one answer.

1. Choose the INCORRECT answer. Two similarly designed, open-label, single-sequence studies conducted to determine the effects of co-administration of aripiprazole on the steady-state pharmacokinetics of lithium or valproate in healthy subjects, showed: A the addition of aripiprazole did not affect the steady-state pharmacokinetics of lithium or valproate.

B the adverse event profile seen was not different to that seen in other studies.

C The addition of aripiprazole lowered the median Tmax of lithium and valproate (at four hours).

D The addition of aripiprazole demonstrated no unexpected safety signals in healthy subjects.

2. Choose the INCORRECT answer. A study to measure adult height in 943 of 1041 participants in the Childhood Asthma Management Program, determined at a mean (±SD) age of 24.9±2.7 years, showed:

A during the first two years, decreased growth velocity in the budesonide group occurred primarily in prepubertal participants.

B the dose of inhaled glucocorticoid in the first two years was not associated with changes in adult height.

C reduction in adult height in the budesonide group compared with the placebo group was similar to that seen after two years of treatment.

D decreased growth velocity in the budesonide group was neither progressive nor cumulative.

3. Choose the INCORRECT answer. A retrospective cohort study based on prospectively collected data (1985–2008) carried out to investigate the association between interferon beta exposure and disability progression in patients with relapsing-remitting MS showed: A exposure to interferon beta was not associated with a statistically significant

THE AUSTRALIAN JOURNAL OF PHARMACY VOL.94 JANUARY 2013

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difference in the hazard of reaching an EDSS score of 6.

B the median active follow-up time (first to last EDSS measurement) was shortest for the historical control cohort.

C the observed outcome rates for reaching a sustained EDSS score of six were greatest for the historical control cohort.

D the hazard of reaching an EDSS score of 6 was greatest for the contemporary control cohort.

4. Choose the INCORRECT answer. A systematic review and meta-analysis carried out to evaluate the risk of bladder cancer among adults with type 2 diabetes taking thiazolidinediones showed: A one RCT reporting on pioglitazone found no significant association with bladder cancer.

B two RCTs evaluating rosiglitazone use showed no significant association with bladder cancer.

C the study included only cohort studies and RCTs. D only the cohort studies of thiazolidinediones and of pioglitazone specifically showed significant associations with bladder cancer.

5. Choose the CORRECT answer. A study involving 912 patients with asthma who were receiving inhaled glucocorticoids and LABAs, and in whom the investigators compared the effect on lung function and exacerbations of adding tiotropium, showed: A the study focused on patients whose FEV1 was at or close to predicted value.

B patients included in the study were receiving inhaled corticosteroids OR LABAs but not both.

C trough FEV1 was not affected by the addition of tiotropium.

D the addition of tiotropium increased the time to the first severe exacerbation.

TGA registered 6 Dec 2012

Introducing ÂŽ Kaloba

Blackmores KalobaŽ is clinically proven to relieve symptoms of acute bronchitis and acute sinusitis and has been shown XS WMKRM½GERXP] MQTVSZI VIGSZIV] XMQI SJ EGYXI FVSRGLMXMW2-4 The use of KalobaŽ is associated with a high level of patient satisfaction3,5 KalobaŽ is well tolerated and suitable for both children over the age of 2 years* and adolescents with acute bronchitis1-3,5

for the treatment of acute bronchitis and acute sinusitis1

KalobaÂŽ has been used extensively in Europe since 1999 and is now available in Australian pharmacies

Clinical evidence for KalobaÂŽ in acute bronchitis

KalobaÂŽ significantly improves recovery time and relieves symptoms in acute bronchitis Within 4 days, onset of treatment effect was felt by:2

% 68.8 of adults taking

33.3%

of adults taking placebo

vs.

KalobaÂŽ

p<0.0002

Figure 1. Proportion of patients experiencing treatment effect at day 42

Adult patients2Adult patients2 100

84.4% 84.4% p<0.0001

40 20

60 40

100

100

77.7 80

%

80

30%

30%

20

Patients (%)

60

80 Patients (%)

Patients (%)

80

p<0.0001

60 40 20

Patients (%)

100

5 Children and adolescent Children and patients adolescent patients5

77.7

%

p<0.0001

p<0.0001

60 40 20

19.6%

19.6% p<0.0002

0

0 Placebo (n=60) Placebo (n=60) Kaloba (n=64) Kaloba (n=64)

0

0 Kaloba (n=103)Kaloba Placebo (n=103) (n=97) Placebo (n=97)

Figure 2. Patients with acute bronchitis assessed by physicians as completely recovered or showed major improvement at day 7.2,5

Adapted from Chuchalin et al, 2005.2 A randomised, double-blind, placebo-controlled trial using a design with planned interim analyses in 124 adults with acute bronchitis present )48 hours and a bronchitis severity score (BSS). Primary endpoint: /EPSFE WMKRM½GERXP] HIGVIEWIH &77 JVSQ FEWIPMRI XS HE] ZW TPEGIFS T 2

Adapted from Kamin et al, 2010..5 A randomised, double-blind, placebo-controlled multicenter trial in 200 patients aged 1â&#x20AC;&#x201C;18 years with acute bronchitis present )48 hours and a bronchitis severity score (BSS). Primary endpoint: /EPSFE WMKRM½GERXP] HIGVIEWIH &77 JVSQ FEWIPMRI XS HE] ZW TPEGIFS T 5

SJ TEXMIRXW [IVI ZIV] WEXMW½IH SV WEXMW½IH [MXL /EPSFEŽ compared with 47.7% taking placebo3 8LI XSPIVEFMPMX] TVS½PI SJ /EPSFEŽ was similar to placebo over 7 days in children, adolescents and adults with acute bronchitis with no serious adverse events reported2,3,5 *Children under the age of 6 years should only be treated with Blackmores KalobaŽ after consultation with a doctor.

References: 1. Kaloba Consumer Medicine Information. 2. Chuchalin AG et al. Explore (NY) 2005;1:437â&#x20AC;&#x201C;45. 3. Matthys H, Heger M. Curr Med Res Opin 2007;23:323â&#x20AC;&#x201C;31. 4. Bachert C et al. Rhinology 2009;47:51â&#x20AC;&#x201C;8. 5. Kamin W et al. Int J Clin Pharmacol Ther 2010;48:184â&#x20AC;&#x201C;91.

www.blackmores.com.au/kaloba