The Journal of the Irish Practice Nurses AssociationIssue 6 Volume 6 November/December 2013

GORD IN The PAeDIATRIc PATIeNT wITh DIsAbIlITyCaroline Flood

MANAGING PsORIAsIs IN PRIMARy cAReDr David Buckley

INsulIN INITIATION IN The cOMMuNITyHelena Farrell

sOcIAl MeDIA – PRAcTIce NuRses bewARe

Lisa Nolan

MeeTING RePORT: cOPD

James Fogarty

IPNA clINIcAl AwARDesc cVD PReVeNTION

GuIDelINesChristine Doherty

11/13 IR00131a

Marketing authorisation holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007, Lyon, France Marketing authorisation number: EU/1/06/357/007 (pre-filled syringe with two separate needles). Legal category: POM. Reference: 1. Health Protection Surveillance Centre. http://www.hpsc.ie/hpsc/A-Z/Hepatitis/HPV/Factsheet/. Accessed August 2013. 2. Gardasil® Summary of Product Characteristics. 3. Kjaer SK et al. A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (trypes 6/11/16/18) vaccine against high-grade cervical and external genital lesions. Cancer Prev Res 2009;2(10):868-878. 4. The Future II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. J Infec Dis 2007; 196(10): 1438-4615. 5. Joura E et al. Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: retrospective pooled analysis of trial data. BMJ 2012;344:e1401.Information about adverse event reporting can be found at www.imb.ie. Adverse events and inadvertent vaccination during pregnancy should also be reported to Sanofi Pasteur MSD by calling 00 44 1628 785291. Further information available upon request.

Why gamble?

Up to 80% of sexually active women become infected with an HPV type in their lifetime1

Most women under 45 years of age can gain some protection from Gardasil® against

HPV types 6, 11, 16 & 18 regardless of past or current infection2,3,4,5

GARDASIL_why gamble_strip_NOV13_03.indd 1 13/11/2013 15:29

Information about adverse event reporting can be found at www.imb.ie. Adverse events and inadvertent vaccination during pregnancy should also be reported to Sanofi Pasteur MSD by calling 00 44 1628 785291.

08/13 IR00150(1)

PNEUMOVAX® II solution for injection in a vial Pneumococcal Polysaccharide Vaccine Refer to Summary of Product Characteristics for full product information. Presentation: Pneumovax II is supplied as a single dose vial containing 0.5 millilitre of solution. Each dose contains 25 micrograms of each polysaccharide type derived from capsules of the 23 most prevalent pneumococci, dissolved in isotonic saline solution containing 0.25% phenol. Indications: For active immunisation against disease caused by the pneumococcal serotypes included in the vaccine. The vaccine is recommended for individuals 2 years of age or older in whom there is an increased risk of morbidity and mortality from pneumococcal disease. The specifi c at risk categories of persons to be immunised are to be determined on the basis of offi cial recommendations. The vaccine is not effective for the prevention of acute otitis media, sinusitis and other common upper respiratory tract infections. Dosage and administration: One single dose of 0.5 millilitre is administered by intramuscular or subcutaneous injection. Special dosing: It is recommended that pneumococcal vaccine is given at least two weeks before elective splenectomy or the initiation of chemotherapy or other immunosuppressive treatment. Vaccination during chemotherapy or radiation therapy should be avoided, and the vaccine should not be administered any sooner than three months after completion of such therapy. Persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after diagnosis is confi rmed. Revaccination: Healthy adults and children should not be revaccinated routinely. Revaccination at intervals of less than three years is not recommended because of an increased risk of adverse reactions. Revaccination may be considered for adults at increased risk of serious pneumococcal infection who were given pneumococcal vaccine more than fi ve years earlier or for those known to have rapid decline in pneumococcal antibody levels. Revaccination after 3 years may be considered for selected populations (e.g. asplenics) who are known to be at high risk of fatal pneumococcal infections and for children 10 years old or younger at high risk of pneumococcal infection. Contraindications: Hypersensitivity to any component of the vaccine. Warnings and precautions: As with any vaccine, adequate medical treatment, including epinephrine (adrenaline), and supervision should always be available in case of an acute anaphylactic reaction. It is not known whether the vaccine can cause foetal

harm or affect reproduction capacity when administered to a pregnant woman; the vaccine can be given to pregnant women only if clearly needed (potential benefi t outweighs potential risk). It is not known whether this vaccine is excreted in human milk; caution should be exercised when thevaccine is administered to a nursing mother. Vaccination should be delayed in the presence of signifi cant febrile illness or other active infection, except where delay involves greater risk.The vaccine should never be injected intravascularly. The vaccine should not be injected intradermally as injection by that route is associated with increased local reactions. If the vaccine is administered to patients who are immunosuppressed due to either an underlying condition or medical treatment (e.g. immunosuppressive therapy), the expected serum antibody response may not be obtained after a fi rst or second dose, so such patients may not be as well protected against pneumococcal disease as immunocompetent individuals. Required prophylactic pneumococcal antibiotic therapy should not be stopped after vaccination. The vaccine may not be effective in preventing infection resulting from basilar skull fracture or from external communication with cerebrospinal fl uid. As with any vaccine, vaccination with Pneumovax II may not result in complete protection in all recipients. Pneumovax II and Zostavax should not be given concurrently because concomitant use in a clinical trial resulted in reduced immunogenicity of Zostavax. Undesirable effects: Very common side effects: Fever and injection site reactions such as pain, soreness, erythema, warmth, swelling and induration. Other reported side effects that may potentially be serious include thrombocytopenia in patients with stabilised idiopathic thrombocytopenic purpura, haemolytic anaemia in patients who have had other haematologic disorders, leukocytosis, anaphylactoid reactions, serum sickness, angioneurotic oedema, Guillain-Barré Syndrome, radiculoneuropathy, febrile convulsions and injection site cellulitis. For a complete list of undesirable effects please refer to the Summary of Product Characteristics. Package quantities and basic NHS cost: Single pack containing one 0.5 millilitre single dose vial, basic NHS cost £8.32 (single). Marketing authorisation holder: Sanofi Pasteur MSD Limited, Mallards Reach, Bridge Avenue, Maidenhead, Berkshire SL6 1QP. Marketing authorisation number: PL 06745/0103 Legal category: POM Date of last review: August 2013

Are your patients at risk?

* See Immunisation Guidelines for Ireland www.immunisation.ie

Pneumococcal DiseaseVaccinate your at-risk patients and those 65 years and over against serious pneumococcal disease.

age 65+

chronic lung,liver, heart orrenal disease

weakenedimmunesystem

other at-risk groups*smoker

diabetesvis i t pneumo. ie

1

editorial

lessons to be learned using evidence based practice

The end of the year is nigh, and what a year it has been.

Amongst all the politics and austerity we are told that we can look forward to exiting the bailout by mid-December according to Michael Noonan.

However, the challenges and opportunities for healthcare will continue to arise into the New Year.

Due to the constraints on purse strings evidenced based practice has never been so important in order to justify spending on better healthcare in the community.

Take BreastCheck for example: the footfall towards the total turn out has risen to 70% of the target group screened. Despite this the desirability of screening 50-65 year olds, irrespective of risk factors, has come into question.

Dr Toqir Mukahtar, a researcher Oxford University explains that through her research review that “there is no discernible impact on mammography screening”.

She also states that “there is as much of a reduction in mortality for those unscreened as those screened in mammography screening”

On the other hand, Dr Ann O’Doherty, clinical director of BreastCheck argues that “until there is a more structured strategy at for example, molecular level, we need to continue the programme.”

Dr O’Doherty cites the Marmot report as part of her evidence describing it as one of “the most intensely examined and audited pieces of research available”. Dr O’Doherty insists on the importance of screening at population level as it reduces mortality in women by 20%.

Until otherwise stated it is imperative that we as practice nurses provide the most up to date information to all our female patients encouraging them to present for screening until the debate concludes.

Breast self-examination also plays its part in cancer reduction allowing the patient to take part in her role to maintain early detection of any breast abnormalities guided by the practice nurse or general practitioner. We also have a duty of care to remind women that mammography is not 100% sensitive of specific. The process is indeed a balance and a choice that Irish women have to make.

We cannot leave 2013 without mentioning midwifery healthcare. Although all practice nurses are not dual qualified when it comes to midwifery care we do come into constant contact with pregnant women. Primarily it is about recognising our remit of professional accountability and responsibility. If we do not hold a midwifery qualification should we be triaging a pregnant woman? Should we be checking blood pressure and testing urine to ease the pressure of our GP colleagues or should we allow holistic care to take over allowing less room for assumptions and errors in care.

The HIQA report into the death of Savita Halappanavar found: “a failure to provide the most basic patient care…and many missed opportunities which if acted upon, might have changed the outcome for her.” HIQA, 2013

In essence the whole scenario demonstrates how important it is to focus on safety, quality and standards of services provided by healthcare professionals. It is also about sharing information and reporting abnormalities to the relevant professionals and following through to the end. Responsibility cannot be diluted.

HIQA called upon the National Maternity Services strategy to ensure women receive “safe, high quality, and reliable care. No matter what the topic of care this engages practice nurses to participate in the best patient care available founded on evidence based care, improving all the time. An on-going process for all of us.

As practice nurses lets continue to contribute towards better health care for the nation in 2014.

Darina Lane

2

Issue 5 Volume 2 September / October2009

ContentsThe Journal of the Irish Practice Nurses Association

Issue 6 Volume 6 November / December 2013

Nursing in General Practice is published by GreenCross Publishing Ltd., 7 Upper Leeson Street, Dublin 4. Tel: 01 4410024 Fax: 01 5472388Email: maura@greenx.ie

DisclaimerThe views expressed in Nursing in General Practice are not necessarily those of the publishers, editor or editorial advisory board. While the publishers, editor and editorial advisory board have taken every care with regard to accuracy of editorial and advertisement contributions, they cannot be held responsible for any errors or omissions contained.

*GreenCross Publishing was established in 2007 and is jointly owned by Graham Cooke and Maura Henderson.

© Copyright GreenCross Publishing Ltd. 2013The contents of Nursing in General Practice are protected by copyright. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means – electronic, mechanical or photocopy recording or otherwise – whole or in part, in any form whatsoever for advertising or promotional purposes without the prior written permission of the editor or publishers

1 eDITORIAl

4 News

6 bRANch News

ReVIews

10 GORD IN The PAeDIATRIc PATIeNT wITh DIsAbIlITy Symptoms of GORD are a common problem amongst children with developmental

disability caroline Flood

27 MANAGING PsORIAsIs IN PRIMARy cARe The practice nurse has a vital role to play in

managing this very common condition Dr David buckley

32 INsulIN INITIATION IN The cOMMuNITy Clinical inertia is a widely recognized problem in diabetes management in the community

helena Farrell

17 IPNA clINIcAl AwARD

esc cVD PReVeNTION GuIDelINes christine Doherty

36 TechNOlOGy

sOcIAl MeDIA – AVOIDING The PITFAlls Nurses face a host of risks when it comes to social media

lisa Nolan

MeeTING RePORT

38 A bReATh OF FResh AIR COPDexchange.ie aims to encourage education and awareness of a condition which remains undiagnosed in many cases James Fogarty

40 AbsTRAcTs

42 PRODucTs

45 cROsswORD

EDITORMaura Henderson

CONSUlTING EDITORSDarina lane and Ruth Morrow

DESIGNERBarbara Vasic

PUBlISHERSGraham Cooke and Maura Henderson

NEW

5 Hours

of learning...

Limited Offer

On-line Course

Ultimate Cholesterol Lowering Plan©

Available now & FREE to all Health Professionals

HEART UK – the UK’s cholesterol charity, has just launched its Ultimate Cholesterol Lowering Plan© (UCLP©)on-line course – AVAILABLE NOW to all health professionals.

The UCLP© course is a must for health professionals searching for a credible, practical and realistic step-by-stepapproach to helping all patients lower their cholesterol.

The UCLP© is HEART UK’s very own cholesterol-lowering plan developed with support from seven leading healthexperts and an education grant from Alpro UK Ltd.

The UCLP© course will take you step-by-step through the UCLP© process. Each module covers the scientificevidence and, more importantly, how these learnings translate into daily practice for when advising your patient.

Supported by an education grant from Alpro UK Ltd

Learn about the UCLP© and how to apply itin your everyday practice:

Step 1 - Motivational InterviewingStep 2 - Heart-healthy foundation dietStep 3 - The four cholesterol-busting foods

Refresh your heart health and cholesterolknow-how:

Heart health status of the nationCholesterol metabolism basicsHealth screening and lipid-lowering drugs

Take it at your own pace

www.heartuk.org.uk/uclp

Pause and resume the courseat your convenience

No time constraints

For your FREE access visit us now at:

UCLP A4 AD v2_210x297mm 08/08/2013 13:55 Page 1

4

newsNurses and midwives most ethicalNurses and midwives are considered the most ethical when compared to other professions, and are ranked ‘high’ or ‘very high’ for honesty and ethics by 79% of the general public, it has been revealed.

The finding, part of a new study by Amárach Research, comes as the Nursing and Midwifery Board of Ireland (NMBI), the regulator, published its new draft ‘Code of Professional Conduct and Ethics for Registered Nurses and Registered Midwives’ as part of the inaugural Nurses Week 2013.

“This new Amárach Research shows nursing and midwifery to be viewed by the general public as ethical, trustworthy and extremely compassionate professions,” according to Dr Maura Pidgeon, Chief Executive Officer of the NMBI.

“The draft Code we have published is the next step in formalising these attributes by creating a framework of standards for the regulation, monitoring and enforcement of professional conduct. The intention is to guide nurses and midwives in their day-to-day practice and to help them to understand their responsibilities in caring for service users in a safe, ethical and effective way. The Code supports ethical and clinical decision-making, on-going reflection and professional self-development and informs the general public about

the professional care they can expect from nurses and midwives. I call now for interested stakeholders to give their views on this draft Code as part of our consultation process,” said Dr Pidgeon.

The draft Code’s five key principles include respect for the dignity of the person, professional responsibility and accountability, trust and confidentiality, quality of practice as well as collaboration with others. Each principle underpins the ethical values and related standards of conduct and practice. Together these guide the various relationships between nurses, midwives, service users and colleagues.

The NMBI’s consultation process is intended to get the views of the professions, the public and other stakeholders on the new draft Code, building on an earlier communications process involving focus groups, surveys and interviews. Stakeholder information sessions are being held in parallel with the call for written submissions on the draft code. The

consultation period runs until Friday, 10 January, 2014. The draft Code and consultation feedback forms for submission can be viewed on www.nmbi.ie. Submissions can be emailed to reviewofcode@nmbi.ie or sent in hard-copy by post to: Code Consultation, Nursing and Midwifery Board of Ireland, 18-20 Carysfort, Avenue, Blackrock, Co Dublin.

Chief Nursing OfficerappointedThe Minister for Health Dr James Reilly welcomed the appointment of Dr Siobhan O’Halloran as Chief Nursing Officer in the Department of Health recently. The position of Chief Nursing Officer has now been established at the level of Assistant Secretary in the Department, ensuring that the role of nursing and midwifery is represented at the highest level in terms of policy making for the health service. Commenting on Dr O’Halloran’s appointment Minister Reilly said “nurses and midwives form the bedrock of our health services. As we move to bring about radical change to improve our health services across the board, nurses and midwives are a vital group in achieving those reforms. It is imperative that their voice is heard at the highest level in the department and the appointment of the Chief Nursing Officer at Assistant Secretary level will achieve that aim.” Dr Siobhan O’Halloran was appointed to the post of Chief Nursing Officer following an open recruitment process conducted by the Public Appointments Service (PAS).

Dr Maura Pidgeon, chief executive Officer, NMbI.

siobhan O’halloran

Anxiety and Depression – GP open day

una butler ballycotton, Paul Gilligan ceO st. Patrick’s Mental health services , Professor Jim lucey Medical Director st. Patrick’s Mental health services and Margo hurley cork city Pictured at a GP and public information event on Anxiety and Depression at The River lee hotel, cork, hosted by mental health recovery service Dean clinic with Kathleen lynch TD, Minister of state at the Department of health and Department of Justice, equality & Defence with responsibility for Disability, Older People, equality & Mental health. hosted by community-based mental health recovery service Dean clinic cork, based at city Gate, Mahon

5

news

IrelandhasoneofthehighestratesofnursingapplicationsIreland continues to see an interest in nursing and midwifery well above the European average, it was revealed recently at the Annual Conference of the Nursing and Midwifery Board of Ireland (NMBI).

Dr Maura Pidgeon, Chief Executive Officer of the NMBI, said that CAO figures show the overall ratio of applicants to nursing places in Ireland is six to one, indicating a strong interest across Ireland amongst people keen to enter a dynamic and evolving part of Irish healthcare.

“Not only does demand outstrip nursing and midwifery vacancies in this country, Ireland shows a level of interest in these professions that is significantly higher than most other countries in Europe. In particular, the total number of mature applicants has been rising consistently since 2008.”

“The Amárach Research study also shows the strong desire on the part of the general public to expand the role of nurses and midwives to improve the Irish healthcare system. The nurse and midwife is central to quality care provision, and nurses and

midwives are becoming leaders across Irish healthcare. Their roles are evolving as they build new skills and expertise and this is very much reflected in the ongoing demand for careers in these areas.”

“Our job as statutory regulator at the NMBI is to protect the public in its dealings with nurses and midwives but also to protect the integrity of the practice of nursing and midwifery through the promotion of the highest standards of professional education, training, practice and professional conduct. Possess-ing attributes such as compassion, care and a sense of ethics are crucial in nursing and midwifery. In fact one of the things we are doing today is actually launching a new self-assessment tool to help people work out themselves if they have the right suitabil-ity for nursing and midwifery,” added Dr Pidgeon.

Entitled ‘Back to the future: Preserving the fundamentals of nurs-ing and midwifery and adapting to new futures in healthcare’, the NMBI conference explored the centrality of the patient within the care experience provided by nurses and midwives.

healthy travel campaignWhat did you catch this summer? Infectious disease expert Dr Jack lambert and travel writer Fionn Davenport are warning globetrotters not to be complacent about their health by launching the Healthy Travel awareness campaign on behalf of Sanofi Pasteur MSD.

A the launch of the campaign were lisa Mc laughlin, senior Manager, Marketing, sanofi Pasteur MsD, Ian Pitcher, business Development and Key Accounts executive, sanofi Pasteur MsD, Travel expert, Fionn Davenport, Dr Jack lambert, consultant in Infectious Diseases, Mater and Rotunda hospitals and university college Dublin, and model libby sheehy.

PerfectChristmaspresentfornursesanddoctors!For two decades, Dr Maurice Guéret has been examining the tonsils of the nation and prescribing his witty and original dose of good humour with lashings of healthy common sense. Dr Guéret is a direct descendant of the Cunningham family who used to operate a Wool and Drapery business in Newry town centre.

His popular Rude Health column in the Sunday Independent is a weekend feast for more than half a million readers and this collection features many of his very best columns alongside new pieces not published before. What The Doctor Saw includes a chapter about the life and work of his late grandfather, Dr Billy Coyne, who was Governor and Chief Psychiatrist at Dundrum Asylum in Dublin. That’s him on the cover of the book, aboard Neddy, the donkey from the Asylum’s Farm.

What The Doctor Saw has one hundred and forty pieces on topics that include Patient Bloopers, Execution by Hanging, Rude Consultants, The last Castrato, Honest Crisps, The Absurdity of Jogging, Men in Gardens, Papal Health, Irish Transsexuals, Tasers, Quacks, Cryogenics, Sigmund Freud’s Birthday, Dead

Snooker Players, Traveller Health, Australian Medical Slang, Medical Senators, Health Fascism, the Iveagh Baths and much more.

Host of RTE’s Saturday Night Show, Brendan O’Connor says ‘Dr Maurice Gueret is about the only Doctor I trust. His humanity is made bearable by a sharp edge, healthy cynicism and a real love for medicine. Buy This Book !”

International Bestselling Author Dr Paul Carson says the book “pulls together a collection of writings from Irish medicine’s sharpest, funniest and most incisive writer. At last, the Maurice Guéret compendium. I’ve read with envy many of his pieces over the years.”

Dr Maurice Gueret is a family doctor, a registered specialist in general practice, a member of the Society of Medical Writers and an exemplary dog walker.

Published by IMD, PO Box 5049, Dublin 6w. ISBN 978-0-9552701-8. €16.99.

Available in many Bookshops and also on-line at www.drmauricegueret.com

Author Biography and four sample chapters can be read at www.drmauricegueret.com

6

News for IPNA br ANches couNtry wIderegional news

cAVAN/MONAGhAN bRANch

MARGARET GEOGHEGAN

11 members from Cavan/Monaghan branch attended the 2013 Conference and AGM in Athlone. We all thoroughly enjoyed

it. Both the programme and exhibitions were excellent. A big thank you to the Dublin North branch for a job well done.

DONeGAl

BRIDGET BREEN

Our autumn season kicked off on September 25th at the Ramada Hotel in letterkenny. Chris Kenny kindly sponsored the evening. Fiona Boyle, Smoking Cessation Officer gave an overview of her work in the area, and the many ways she can help people to give up smoking. Clinics are held at a few district hospitals throughout the county. Fiona also gives telephone advise and, as you can imagine, is kept very busy.

This was followed by a very interesting talk by Dr McManus from the Education Centre, on healthy lifestyle and ways of getting people motivated to take more exercise and responsibility for their own health. Both speakers were well received, with 18 nurses in attendance.

October saw nine of us heading to Athlone for the AGM. It was a great weekend and compliments to the Dublin Branch for putting it all together in such a professional manner. The only missing person on the night was Sam Maguire.!!!

We came home happy as our colleague, Christine Doherty from Clonmany, received the Clinical Award. We are all so proud of her and her achievement in getting the prize. We now look forward to reading her article in this magazine (See page 17).

Another colleague, Patricia Gallagher from the Bayview Practice in Ballyshannon was our Donegal Representative for the Practice Nurse of the Year. She represented us well, but just didn›t come first. Many thanks to Patricia for the time and effort she put into her application. I hope she and Joe enjoyed their well deserved holiday afterwards. Congratulations to the winner and hope she continues to do well in general practice.

Our next meetings are November 14th and December 5th. Topics to be decided. louise will be sending out the texts regarding same.

Happy Christmas to you all.

KIlDARe

MARGARET ClANCY

Our first autumnal meeting was held 17th September. It was sponsored by Aoife Smith-Johnson from SMA. Carrie Powles from the National Cervical Screening Programme gave us a national update. This was well attended by the practice nurses.

The IPNA annual conference and AGM hosted by the Dublin north branch was entitled Old Issues-New Ideas. This excellent conference was very informative and educational. It was an ideal opportunity for new and established practice nurses to network Well done North Dublin branch!.

Our last branch meeting was held on 22nd October, and sponsored by Pamela large from Boehringer Ingelheim. Michelle Dunne, respiratory scientist, gave a short introduction to Spirometry. She showed us how to use a spirometer in general practice. It gave us a hands on opportunity to practise its use.

Our next meeting will be Tuesday 19th November, in Maudlins Hotel Naas at 19:45, which will be our branch AGM for 2013. All members welcome.

The Donegal women on tour! christine Doherty, cathy Mangan Fry, Grace Duffy, louise McKee, Patricia Gallagher, Pauline Kilcoyne, Mary F Doherty, bella stewart, and bridget breen.

Over 350 million patients treated with Clexane worldwide2

NOT ACTUAL SIZE

Clear visibility of expiry date

Colour-coded labelling and clear identification of CLEXANE® syringes by dose

Needle completely covered by the protection cap immediately after the injection

Automatic release of the safety mechanism when the plunger is fully depressed

Clear product identification

Designed to

protect against

needle stick

injuries1

References:1. CLEXANE® Summary of Product Characteristics. sanofi 2. Sanofi IMS data on file April 2012

CLEXANE® CONFIDENCE AT YOUR FINGERTIPS

New Clexane® and Clexane® Fortesafety lock syringes

CLEXANE® SYRINGES AND CLEXANE® FORTE SYRINGES PRESCRIBING INFORMATIONPresentation: Clear, colourless to pale yellow solution of either 100mg enoxaparin per 1ml (anti-factor Xa activity of 10,000IU/ml with reference to the WHO First International LMW Heparin Reference Standard) or 150mg enoxaparin per 1ml (anti-factor Xa activity of 15,000IU/ml). Clexane® Syringes: single dose pre-filled syringes containing either: 20mg enoxaparin in 0.2ml (2,000IU), 40mg enoxaparin in 0.4ml (4,000IU), 60mg enoxaparin in 0.6ml (6,000IU), 80mg in 0.8ml (8,000IU) or 100mg in 1ml (10,000IU). Clexane® Forte Syringes: single dose pre-filled syringes containing either: 120mg enoxaparin in 0.8ml (12,000IU) or 150mg in 1ml (15,000IU). Indications: Prophylaxis of thromboembolic disorders of venous origin, in particular those associated with orthopaedic or general surgery and in medical patients bedridden due to acute illness. Treatment of venous thromboembolic disease presenting with deep vein thrombosis, pulmonary embolism or both. Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin. Prevention of thrombus formation in the extracorporeal circulation during haemodialysis. Clexane 100mg/ml syringes only: Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI) in conjunction with thrombolytic drugs (fibrin or non-fibrin specific). Dosage & Administration: Prophylaxis: Patients with low to moderate risk of thromboembolism, e.g. general surgery, recommended dose of Clexane® is 20mg (2,000IU) once daily subcutaneously. Clexane® should be continued for 7 to 10 days or until risk of thromboembolism has diminished. Longer durations may be appropriate in some patients following hip replacement. Patients undergoing surgery, initial dose approximately 2 hours preoperatively. Patients with high risk of venous thromboembolism, e.g. orthopaedic surgery, the recommended dose is 40mg (4,000IU) once daily subcutaneously, initial dose being given approximately 12 hours preoperatively. Medical patients bedridden due to acute illness, the recommended dose is 40mg (4,000IU) once daily for a minimum of 6 days until return to full ambulation, for a maximum of 14 days. Longer durations may necessary if it is there is an ongoing significant risk of thromboembolic events beyond 14 days. Treatment: Subcutaneous administration either as a single injection of 1.5mg/kg (150 IU/kg) or as a twice daily injection of 1 mg /kg (100 IU/kg) usually for 5 days and until adequate oral anticoagulation is established. Unstable angina and non-Q-wave myocardial infarction recommended dose is 1mg/kg (100IU/kg) every 12 hours subcutaneously, administered concurrently with oral aspirin 100 to 325mg once daily. Treatment should be for minimum of 2 days and continued until clinical stabilisation, usual duration 2 to 8 days. Clexane 100mg/ml syringes only: Treatment of STEMI, the recommended dose is a single IV bolus of 30mg, plus a 1mg/kg SC dose followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses) for 8 days or until hospital discharge, whichever comes first. For dosage in patients ≥75 years of age, see elderly section. When used with a thrombolytic (fibrin specific or non-fibrin specific) Clexane® should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. All patients should receive aspirin 75 to 325mg once daily unless contraindicated. For patients managed with PCI: If the last Clexane® SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3mg/kg of Clexane® should be administered. During haemodialysis: 1mg/kg (100IU/kg) Clexane® introduced into arterial line of the circuit at beginning of dialysis. This dose is usually sufficient for a 4 hour session. If fibrin rings are found, e.g. after a longer session, a further 0.5 to 1mg/kg (50 to 100IU/kg) may be given. In patients with high risk of haemorrhage reduce the dose to 0.5mg/kg (50IU/kg) (double vascular access) or 0.75mg/kg (75IU/kg) (single vascular access). Elderly: Clexane 100mg/ml syringes only: For treatment of STEMI in patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12 hours (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses). For other indications, no dosage adjustment necessary unless kidney function is impaired. Children: Not recommended. Renal impairment: Dosage adjustment required for patients with severe renal impairment. Contraindications: Acute bacterial endocarditis; active major bleeding and conditions with a high risk of uncontrolled haemorrhage, including recent haemorrhagic stroke or subdural haematoma; thrombocytopenia in patients with positive in vitro aggregation test in presence of Clexane®; in jaundice; active gastric/duodenal ulcer; hiatal ulceration; threatened abortion or retinopathy; hypersensitivity to enoxaparin, heparin or other LMWH. Warnings and Precautions: Clexane® must not be administered by the intramuscular route. Different low

molecular weight heparins may not be equivalent; alternative products should not be substituted during therapy. Neuraxial haematomas may occur when Clexane® is used concomitantly with spinal/epidural anaesthesia. Haemodynamically unstable patients with pulmonary embolism may require alternative treatment. Use in patients with prosthetic heart valves has not been adequately studied and is not recommended. Clexane® should be used with care in hepatic insufficiency, history of thrombocytopenia, and conditions or patients with increased bleeding potential (such as those with peptic ulcers, recent ischaemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy, renal impairment, elderly and extremes of weight). Platelet counts should be measured prior to initiation of Clexane® and regularly during treatment. Heparins can suppress adrenal secretion of aldosterone leading to hyperkalaemia. Following vascular instrumentation adhere precisely to recommended dose intervals. If a closure device is used, the sheath can be removed immediately. If a manual compression method is used, sheath should be removed 6 hours after the last IV/SC enoxaparin sodium injection. If treatment is to be continued, the next scheduled dose should be given no sooner than 6 to 8 hours after sheath removal. The site of the procedure should be observed for signs of bleeding or haematoma formation. Pregnancy: Clexane® should be used during pregnancy only if the physician has established a clear need. Lactation: Advise avoidance of breast-feeding. Interactions: Discontinue unless essential agents affecting haemostasis, e.g. oral anticoagulants, thrombolytics, systemic glucocorticoids, NSAIDs, aspirin, clopidogrel. If the combination cannot be avoided, careful clinical and laboratory monitoring is recommended. Adverse Reactions: Bleeding, including retroperitoneal and intracranial, with or without the presence of associated risk factors, such as invasive procedures or use of medications affecting haemostasis. Thrombocytopenia, including rare cases of immuno-allergic thrombocytopenia with thrombosis. Elevation of liver enzyme levels and platelet count, and cutaneous or systemic allergic reactions (including anaphylactic/anaphylactoid reactions, and very rarely cutaneous vasculitis) have been reported. At site of injection: pain, haematoma, irritation, rarely hard inflammatory nodules and skin necrosis. Heparins can cause hypoaldsteronism which can increase in plasma potassium, and rarely, clinically significant hyperkalaemia. Rare reports of neuraxial haematoma when using spinal/epidural anaesthesia and post-operative indwelling catheter. Please consult SPC for full details of the recognised side effects with Clexane. Pharmaceutical Precautions: Do not mix with other injections or infusions. Do not store above 25°C. Do not refrigerate or freeze. PI revision: November 2012Product Licence numbers: PA 540/97/1: Clexane® Syringes; PA 540/97/2: Clexane® Forte Syringes.Legal category: POMMarketing Authorisation Holder: Sanofi-Aventis Ireland Ltd., Citywest Business Campus, Dublin 24, Ireland.Further information is available from: Sanofi 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com Tel.: (01) 4035600.

References:1. CLEXANE® Summary of Product Characteristics. sanofi 2. sanofi Data on file April 2012

Please refer to the Summary of Product Characteristics which can be found on IPHA @ http://www.medicines.ie/ before prescribing.

Information about adverse event reporting can be found at www.imb.ie Adverse events should be reported to the Sanofi Drug Safety Department

GBIE.ENO.13.06.01 Date of preparation July 2013

RRD01246 Clexane Sanofi A4 Ad_V6 (Resized).indd 1 8/8/13 3:00 PM

8

News for IPNA br ANches couNtry wIderegional news

KIlKeNNy

lEONIE FINNEGAN

Welcome back to all from the Kilkenny branch as we blitz through another season of flu vaccines!

Congrats to all the members of the Dublin Branch and the Committee members on a very successful, relevant and enjoy-able Conference. Very well done to you all. Our meeting held on the 23rd of October was both our AGM and educational meeting. A full update from our NEC was delivered to the branch by Mary Fogarty. A new definition of a Practice Nurse is currently sought. Patricia McQuillan has drafted one, which was discussed at our meeting and will be brought to the next NEC meeting. We thank Roisin Doogue for all her hard work and dedication as chairper-son nationally and welcome and support Siobhan Jordon into that role. We look forward to the new IPNA site e-learning hub and GreenCross Publishing’s, educational online support also, during the coming year.

Following election of officers at this AGM Helen Fogarty is welcomed as chairperson and Catriona lynch as secretary (with joint-secretary support of Sandra Blanchfield). Treasurers and NEC positions remain unchanged for this coming year. The in-

coming officers are offered much support from branch members and many thanks for taking these positions. leonie Finnegan stepped down as Chairperson and Una Stapleton as Secretary and both were thanked for their work and commitment over the last 4 years. Appreciation is also due to Patricia McQuillan for her role in communication and support which is ongoing. Also on this evening, sponsors Novartis, with Eoin Banville facili-tated our educational topic of COPD to be capably delivered Dr Breda Cushen, SPR, who is based in St luke’s Hospital Kilkenny. Breda gave us an excellent, very relevant and informative update on COPD.

Finally, on behalf of all members I would like to extend our heartfelt condolences to Helen Fogarty on the untimely passing of her brother Martin this summer

We are grateful to and wish to thank all our members for their on-going support, for education and networking, in our branch throughout the year and we wish each of you and all of us, a healthy, calm and happy run up to the fast approaching Christ-mas season!

NORTh DublIN

ANNE MARIE EllWOOD, ORlA DONNEllY

Our September meeting concluded our arrangements for the Conference. We hope that all those who attended enjoyed both the educational and social component of the conference. We enjoyed hosting it and all the hard work was rewarded by the large attendance. To all those who helped in any small way, we wish to

say a very big thank you. Our very best wishes to the Kerry branch for next year, if we can be of any help please do not hesitate to ask

Finally, we would like to wish our colleague lynn Cartwright the very best wishes as she returns to the UK. She will be missed by all.

sOuTh DublIN

KAREN CANNING

Firstly on behalf of our branch, I would like to congratulate two of our members, Anne O’Connor on the safe arrival of her daugh-ter Niamh and Margaret lynch on the safe arrival of her son Neil.

There was no October branch meeting due to the annual IPNA national conference. But we are looking forward to our November educational meeting. The guest speaker is Rita lawlor, PDC who will discuss professional development for Practice Nurses.

I would like to sincerely thank Anne O›Connor, the IPNA South Dublin branch and all involved in my nomination for Practice Nurse of the Year Award.

We were very pleased that 8 members of our IPNA South Dublin branch were able to attend and support this year›s annual IPNA conference.

It was very clear from the moment one walked through the doors of the Radisson Blu Hotel, Athlone the extent of planning our colleagues from the IPNA North Dublin branch had gone to in organising our national conference.

It was obvious who was part of the organising branch by their

royal blue sashes and the attention to detail throughout the conference was superb.

The Dublin colours were everywhere so we were left in no doubt as to which branch was the organising one!

The little touches were such a nice idea (county flags and a framed verse of a relevant county song on all the tables).

The lists of speakers and presentations were excellent.Unlike past years, this year›s keynote speaker gave a light-

hearted and amusing talk. This was a very good idea and I hope it becomes a tradition for future conferences. Another change to previous years was that there were no workshops, so no need for us to leave the main conference room.

To win Practice Nurse of the Year Award was the icing on the cake for me. I am totally overwhelmed. I would like to thank Anthony Carroll, SMA, for securing the educational bursary.

The hotel›s facilities were excellent – bedroom, conference facilities, dinner, wine, breakfast and lunch.

Well done to the IPNA North Dublin branch on hosting such a fabulous conference.

wIcKlOw

MARY FINNEGAN

We resumed our branch meetings after the summer break, on Monday 23rd September. We had an excellent topic that night:

9

News for IPNA br ANches couNtry wIde regional news

Acute and Chronic Pain Management, and our guest speaker was Dr Hugh Gallagher Consultant in Anaesthetic Medicine in SCH & SVUH. This was such an interesting topic, and an excellent talk giving rise to many questions from the floor at the end. The meeting was kindly sponsored by Peter Daly from Mundipharma.

We had no October meeting as the National IPNA Conference was held on 10th and 11th October. Five of our branch members attended the weekend, which was hosted by North Dublin Branch. This was an excellent weekend of speakers, and congratulations to all in the hosting branch for a very smoothly run weekend. The central location of Athlone was excellent too, allowing members to easily access the Conference from all over Ireland. The only tiny ‘complaint’ is that we missed the interactive clinical workshops of the previous Conferences, and would definitely like to see these included in future conference weekends. But, overall, it was a very enjoyable weekend, and a great opportunity to meet up with old friends and network with other branches.

We were also very proud to have one of our Wicklow members, Mary Sullivan, elected as National Treasurer on the NEC.

Our next meeting will be held on Monday 18th November in Bray. This will also be the Branch AGM. Yes, it’s that time of year again, where we hope to elect some new officers to the branch

committee!Our educational topic on the 18th will be the annual

Smeartakers update, which will be provided by Carrie Powell from Cervical Check. We are delighted that Carrie can provide this update for us at branch level, at one of our scheduled meetings, as it is so difficult for our members to find free days to attend further meetings, outside of their working hours.

St Vincent’s Private Hospital started a series of bi annual educational meetings for practice nurses, in our area, last year, and these have run successfully in March and November for the past 2 years. The next meeting is scheduled for Wednesday 27th November in SVPH from 6.30 – 9.30, and the topic will be Eating Disorders, which will be given by Dr Donal O’Shea from SCH & SVH. There will also be speakers from St John of God Hospital who will speak on Mental Health. These are always excellent meetings and we are very grateful to Mary Connolly, Director of Nursing in SVPH, for arranging and facilitating these meetings for our members.

We will have no branch meeting in December, and meetings will resume on Monday 13th January.

Can I close by wishing all our members a very happy, healthy, peaceful, worry free Christmas, and look forward to meeting you all at branch meetings over the coming few months.

NEC NEWS

IPNA cONFeReNce 2013The NEC would like to congratulate the North Dublin branch on hosting a very successful conference and to thank them for all their hard work on this.

Speakers’ presentations will be posted on the IPNA website as soon as possible.

IPNA AwARDs 2013Congratulations to all who won Awards at the recent IPNA Conference! The winners were as follows:

Practice Nurse of the Year 2013 – Karen canning (South Dublin Branch)IPNA Clinical Award 2013 (ESC CVD Prevention Guidelines 2012) – christine Doherty (Donegal Branch) Valerie Mangan IPNA loyalty Award 2013 – Pauline Mcloughlin (Sligo/leitrim Branch):

Well done also to the other nominees for the Practice Nurse of the Year Award who were as follows:Maura costello – Cavan/Monaghan Branch nomineePatricia Gallagher – Donegal Branch nomineebrid buckley – North Dublin Branch nomineesiobhan Jordan – South Tipperary Branch nominee

eleARNING FOR MeMbeRsThe new IPNA elearning platform was launched at the IPNA Con-ference. It is still being developed and all members will be contact-ed with details of how to access it as soon as these are available.

IPNA AGM 2013MotionsBoth motions that were proposed were ratified at AGM and have been sent to the Revenue Commissioners’ Charities Section for approval.

election of Nec OfficersThe following members were elected as NEC Officers:

siobhan Jordan (South Tipperary Branch) – National Chairpersoncora Goold (Cork Branch) – National Vice-ChairpersonMary sullivan (Wicklow Branch) – National Honorary TreasurerRuth Morrow (Cavan/Monaghan Branch) – National PRO

The NEC would like to thank the outgoing NEC Officers (Róisín Doogue and Bríd Buckley) most sincerely for all their work on behalf of the IPNA over the past year.

DATe FOR DIARyThe 2014 IPNA Annual Educational Conference / AGM will be held on Friday 17th and Saturday 18th October 2014 in the limerick Strand Hotel, hosted by the IPNA Kerry Branch.

Nec MeeTINGs 2014 Wednesday 5th February 2014, Ashling Hotel, D.8, 11am-3pmWednesday 7th May 2014, Ashling Hotel, D.8, 11am-3pmWednesday 3rd September 2014, Ashling Hotel, D.8, 11am-3pmFriday 17th October 2014, limerick Strand Hotel, time tbc

IPNA websITeThe IPNA website, www.irishpracticenurses.ie is updated constantly, so please log in regularly to get the latest news on study days, education, new comments in the Discussion boards and more. You will also find IPNA Policies, Articles of Association and Minutes of all NEC meetings to date in the Members Area.

IPNA ON TwITTeRIf you have a Twitter account you can follow the handle @PracticeNurses to receive IPNA news, reminders & useful information that is retweeted from other groups – directly to your timeline.

lisa Nolan, IPNA Administrator Tel: 042 9692403 email: admin@irishpracticenurses.ie

10

clinical review

IntroductionSymptoms of gastro-oesophageal reflux disease (GORD) are frequently observed in children with developmental disability.1,2 Gastro-oesophageal reflux (GOR) refers to the passage of gastric contents into the oesophagus, with or without regurgitation and vomiting, and is considered a normal physiological pro-cess.3 Conversely, GORD, refers to the troublesome symptoms and/or complications that develop secondary to persistent GOR.3 Children with developmental disability are at increased risk of developing GORD and generally experience a greater number of complications associated with the disease than their otherwise healthy counterparts.4 Thickening feeds represents one means by which symptoms of the disease may be managed in children,5 however, there is limited evidence to support this line of treatment in those with cerebral palsy, epilepsy, autism spectrum disorder and other forms of developmental disabil-ity. The potential side-effects associated with long-term use of feed thickeners should not be overlooked and the financial implications of their use in enteral feeds requires consideration. A lack of published recommendations and national guidelines for managing this patient group has led to variance in practice between dietitians who treat such children in Ireland.

GORD in developmental disability Episodes of GOR are usually caused by transient relaxations of the lower oesophageal sphincter (TlOSR), which normally allow excess gas to escape from the stomach.6,7 In those with developmental disability, the development of GORD is likely to be due to altered gastric motility, altered oesophageal motility, or an increase in the number of TlOSR, all of which may occur secondary to central nervous system and enteric nervous system dysfunction.2,8,9 Up to 75% of this patient group experience symptoms of the disease.2 Moreover, the type of GORD commonly observed in these children is severe and chronic in nature,7 and increases these patients’ risk of developing associated complications, which may include; erosive oesophagitis, Barrett’s oesophagus and adenocarcinoma.3 In children with neurological impairment, recurrent vomiting is the objective hallmark of GORD, although haematemesis, anaemia, rumination and regurgitation have also been observed in increased frequency in this patient group.2 Other signs and symptoms that may be indicative of GORD are outlined in Table 1.

Gastro-oesophageal reflux disease in the paediatric patient with disabilitycAROlINe FlOOD, BSC HUMAN NUTRITION & DIETETICS

11

clinical review

Table1. symptoms and signs that may be associated with gastro-oesophageal reflux*

symptoms signs

Recurrent regurgitation with/without vomiting

Oesophagitis

Weight loss or poor weight gain

Oesophageal stricture

Irritability in infants Barrett’s oesophagus

Heartburn or chest pain Recurrent pneumonia

Dysphagia laryngeal/pharyngeal inflammation

Odynophagia Apnoea spells

Wheezing Dental erosion

Stridor Feeding refusal

Cough Dystonic neck posturing (Sandifer syndrome)

Hoarseness Apparent life-threatening events

*Modified from Vandenplas et al., 20097

ManagementManagement of GORD generally involves aspects of positional, nutritional, and dietary modification, with use of pharmacological agents as required.7 Thickening feeds represents one dietary modification by which symptoms of GORD may be managed. Commercial thickening agents include carob bean gum, maltodextrin, modified maize or rice starch, sodium carboxymethyl cellulose, pectin and cellulose. In children with GOR who are otherwise healthy, it appears that feeds that are thickened with these agents reduce the frequency of overt regurgitation; however, they have not consistently been shown to reduce the actual number of oesophageal reflux episodes, as measured by oesophageal pH monitoring.5,10–13 Nonetheless, their use may provide a welcome improvement in symptoms for parents and carers of these children.7

Only one small trial has investigated the effectiveness of thickened feeds for managing GORD in children with developmental disability. Miyazawa et al.14 investigated the effects of a pectin-thickened enteral feed on symptoms of GORD and oesophageal parameters in 18 children with cerebral palsy. Results revealed a reduction in the number of vomiting and coughing episodes and improvements in some, but not all, oesophageal pH parameters.

A medical position statement commissioned by the European Society of Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) suggested that the lack of observed effect of some thickened formulas may be due to slower clearance of thickened acid refluxate from the oesophagus when ingested orally.15 Hence, in the study carried out by Miyazawa et al.,14 had the thickener been administered orally, it is possible that the results for oesophageal parameters and symptoms of GORD may have differed.

lack of clinical guidanceThere is no algorithm or clinical guideline available on the use of thickened feeds for managing GORD in children with developmental disability. The National Institute for Health and Clinical Excellence (NICE) have recently proposed the development of guidelines for managing GORD in children and young people.16 These guidelines aim to give special consideration to children with neurodevelopmental disorders; however, they are not due to be published until October 2014.

The lack of clinical guidance in this area has been highlighted by a recent survey of dietitians practising in Ireland who have

experience managing GORD in children with disability. The main finding from the survey was that significantly more dietitians working in tertiary (n=11) and general hospitals (n=11) than in the community (n=3) reported recommending thickened feeds to manage symptoms of GORD in these children (p<0.01, p<0.001 respectively). In addition to this, 20 dietitians reported observing thickened feeds being used in conjunction with enteral feeds in practice, and three reported observing these agents being used in post-pyloric feeds.

NICE guidelines for the prevention and control of healthcare associated infections in the community state that reconstituted feeds should be administered over a maximum period of four hours.17 Additionally, they state that administration sets and feed containers should be discarded after each feeding session when this approach to feeding is being undertaken. Despite this, only 7 out of 17 question respondents were of the opinion that giving sets should be changed every 4 hours when used with thickened enteral feeds. Of these dietitians, only three believed that the NICE guidelines are being implemented in practice where feed thickeners are being recommended. These findings further highlight the need for published guidelines in the area to promote consistent standards of care and to optimise treatment of GORD in this patient group.

Thickening agents in enteral feedsResults of the aforementioned survey that surround the use of thickened enteral feeds are also of concern. Children with developmental disability are at risk of undernutrition.18 Additionally, poor nutritional status is a risk factor for many infectious diseases.19 Therefore, children with developmental disability who are at increased risk of acquiring infections may be at further risk if proper aseptic technique is not being adopted when enterally fed. This may be further exacerbated if thickening agents are added to jejunal feeds, in which case, the stomach’s acid defences are being bypassed.

Conversely, if the NICE best practice guidelines for preventing infection in the community are to be implemented, the economic consequences of using thickening agents in enteral feeds becomes a major issue. Thickening agents themselves are relatively affordable, ranging from €3 to €8 (as per General Medical Scheme GMS prices; November

In those with developmental disability, the development of GORD is likely to be due to altered gastric motility, altered oesophageal motility, or an increase in the number of TlOsR.

12

clinical review

2012). However, if thickening agents are being administered with decanted enteral feed, best practice guidelines would necessitate changing giving sets and feed reservoirs every four hours, which vastly increases the cost of feeding. Case scenarios 1 and 2 outline the estimated cost difference of administering unthickened versus thickened enteral feed.

case scenario 1: administration of enteral feed (ready-to-use)example: 5 year old patient with cerebral palsy: estimated energy requirements: ~700kcalTotal feeding time: 14 hours @50ml/hr (standard 1kcal/ml fibre-enriched enteral feed)Total feeding volume: 700ml enteral feed

Item cost per item (€)*

Fibre-enriched enteral feed (200ml) 2.80

Fibre-enriched enteral feed (500ml) 7.00

Giving set 8.30

Daily total 18.10

Weekly total 134.20

*Price of feeds based on GMS prices (November 2012). Cost of giving set estimated from €250 for 30 giving sets. Weekly total includes cost of one syringe (~€7.50).

case scenario 2: addition of thickening agent to enteral feedingTotal feeding volume: 700ml decanted feed + 24g standard feed thickener per day (4 scoops per 200ml)

Item cost per item (€)*

Fibre-enriched enteral feed (200ml)

2.80

Giving set 8.30

Feed reservoir 2.20

Feed thickener (6.8g) 0.15

Total per 4 hour feed 13.45

Daily total 53.80

Weekly Total 384.10

*Price of enteral feeds and thickening agent based on GMS prices (November 2012). Estimate from feed thickener (135g box): €3.00. Cost of giving set estimated from €250 for 30 giving sets. Cost of feed reservoir estimated from €66 for 30 feed reservoirs. Total includes cost of one syringe (~€7.50).

Administering ready-to-use formula permits safe feed delivery over 24 hours without need to change giving sets and removes the need to use a feed reservoir. Therefore, in the previous case scenarios, using a thickening agent would increase the daily cost of enteral feeding by around €36 per day and €250 per week.

It is important to consider the financial burden that using these agents in enteral feeds places on families of children as well as the financial burden they are likely to place on the State. Anti-reflux medication ranges from €4 to €15,20 thus provision of appropriate medical agents appears to be a more appropriate strategy than recommending thickened enteral feeds to manage these childrens’ symptoms.

Thickened feeds: potential side-effects The long-term effects of consuming thickened feeds have not been investigated and the potential allergenicity of commercial

thickening agents warrants further research.7 Side-effects reported with short-term use include diarrhoea, increased coughing episodes and an increase in gastric emptying time.21-

24 In vitro studies suggest that the bioavailability and intestinal absorption of carbohydrates, fat, calcium, iron, zinc and copper may be reduced by feeds thickened with non-digestible carbohydrate.5,25 An increased risk of developing complications associated with GORD by using thickeners should also be considered. For instance, if thickened feeds only reduce symptoms of GORD but do not reduce actual oesophageal reflux (as indicated by the majority of studies), their long-term use in children has the potential to mask persistent GOR that could otherwise be treated with anti-reflux medication. In such a scenario, prolonged use of thickened feeds could further increase these children’s risk for developing serious complications associated with GORD.

Medical therapy for the management of GORD The North American Society of Paediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and ESPGHAN recommends that anti-secretory therapy should be optimised in children with GORD and neurological impairment (including those with developmental delay).7 Whilst the risk of side-effects also accompanies the use of anti-secretory medication, there are nutritional and clinical consequences of uncontrolled symptoms of GORD. At present, there is a greater evidence base to support the use of proton pump inhibitors in children with underlying disability and GORD than that which favours thickened feeds for managing these children.4,26,27 Additionally, where enteral feeding is indicated, medication represents a cheaper, more practical means by which symptoms can be managed.

conclusionFurther research is warranted to determine the effectiveness of thickened feeds in managing children with GORD and underlying disability. Until then, the potential side-effects associated with using thickened feeds should not be overlooked, nor should the serious financial burdens they place on families of these children when used in enteral feeds. Future guidelines that reflect the relevant literature are required in order to promote consistent standards of care and ultimately optimise the quality of treatment for GORD in children with a disability.

If thickened feeds only reduce the symptoms of GORD but do not reduce actual oesophageal reflux…their long-term use in children has the potential to mask persistent GOR.

ABRIDGED PRESCRIBING INFORMATIONViATIM® Suspension and solution for suspension for injection in a pre-fi lled syringe. Hepatitis A (inactivated, adsorbed) and Typhoid polysaccharide vaccine. Refer to Summary of Product Characteristics for full product information before prescribing. Additional information is available upon request. Presentation: Suspension and solution for suspension for injection in a pre-fi lled syringe. Available as a 1 millilitre single dose in a pre-fi lled, dual-chamber syringe, containing 25 micrograms of Salmonella typhi (Ty2 strain) capsular Vi polysaccharide and 160 antigen units of inactivated hepatitis A virus. Neomycin is used in the manufacturing process. Indications: For simultaneous active immunisation against typhoid fever and hepatitis A virus infection in subjects from 16 years of age. ViATIM is to be used on the basis of offi cial recommendations. Dosage and administration: A single 1 millilitre dose should be administered by slow intramuscular injection in the deltoid region. The vaccine is to be injected intramuscularly. ViATIM may be administered subcutaneously under exceptional circumstances (e.g. in patients with thrombocytopenia or in patients at risk of haemorrhage). Do not inject intravascularly. Also avoid administration into buttocks. The two vaccine components should only be mixed immediately prior to injection. To provide long term protection against infection caused by the hepatitis A virus, a booster injection of inactivated hepatitis A vaccine should be given 6 to 36 months later (preferably within 6-12 months). ViATIM may be used as a booster vaccine in subjects who have received an inactivated hepatitis A vaccine 6 to 36 months earlier, and who require protection against typhoid fever. Contraindications: Known hypersensitivity to the active substances, any of the excipients of ViATIM (including formaldehyde) or to neomycin (present in trace amounts as a residual of the manufacturing process). Vaccination should be delayed in subjects with an acute severe febrile illness. Warnings and precautions: As with all vaccines, appropriate facilities and medicines should be readily available in case of anaphylaxis or hypersensitivity following injection. ViATIM has a minor infl uence on the ability to drive and use machines. Immunogenicity of the vaccine may be impaired in immunosuppressed patients. The effect of ViATIM on individuals in the incubation period of hepatitis A is not known. Viatim does not protect against infection caused by Salmonella Enterica other than serotype typhi or against other known liver pathogens including Heaptitis A, C and E viruses. Viatim must not be mixed with any other vaccine in the same syringe. Interaction with other medicinal products: Concomitant administration of ViATIM and Td-IPV at 2 separate sites can be performed. Interaction studies with ViATIM and other inactivated vaccines have not been performed. However based on data from the concomitant administration of the monovalent vaccines with other inactivated vaccines at different injection sites, no interference with immune responses to any of these antigens would be expected. (Data based on typhoid Vi polysaccharide vaccine with diphtheria-tetanus (DT), tetanus-inactivated poliomyelitis (T-IPV), rabies, meningococcal polysaccharide A/C, hepatitis B, yellow fever and inactivated hepatitis A vaccine with hepatitis B vaccine). Fertility, pregnancy and lactation: Data on a limited number of exposed pregnancies indicate no adverse effects of ViATIM on pregnancy or on the health of the foetus/new born child. However, caution should be exercised when prescribing to pregnant women. As there are no data on the excretion of ViATIM in human breast milk, the decision to vaccinate a breast feeding woman should take into account the benefi t of breast-feeding to the child and the benefi t of ViATIM to the woman. Undesirable effects: Very common adverse reactions include: headache, myalgia, malaise, asthenia, injection site disorders (pain, induration, oedema, erythema). Common adverse reactions include: nausea, diarrhoea, arthralgia and fever. In post-marketing experience other adverse reactions have been reported and include: anaphylactic/anaphylactoid reactions, including shock, serum sickness and aggravation of asthma. No data on the safety of ViATIM in children and adolescents below 16 years are available. For a complete list of undesirable effects please refer to the Summary of Product Characteristics. Package quantities: Single dose prefi lled syringes in single packs. Marketing authorisation holder/Further prescribing information available from: Sanofi Pasteur MSD Limited, Block A, Second Floor, Cookstown Court, Old Belgard Road, Tallaght, Dublin 24 Marketing authorisation number: PA 544/37/1 Legal category: POM ® Registered Trademark Date of last review: October 2013

Information about adverse event reporting can be found at www.imb.ie Adverse events and inadvertent vaccination during pregnancy should also be reported to Sanofi Pasteur MSD by calling 00 44 1628 785291

ViATIM® protects for up to 36 months against both hepatitis A and typhoid fever.1

Avoiding contaminated food and water is good advice, but they don’t always remember it.

Let them know before they go!

HealthyTravel.ie

10/1

3 IR

0018

5(1)

(1) Sanofi Pasteur MSD, Viatim, summary of product characteristics, October 2012.

14

clinical review

References1. Shaw J, Weatherill S, Smith A. Tooth wear in children: an

investigation of etiological factors in children with cerebral palsy and gastroesophageal reflux. ASDC J Dent Child 1998;65:484–6, 439.

2. Sullivan P. Gastrointestinal disorders in children with neurodevelopmental disabilities. Dev Dis Res Rev 2008;14:128–36.

3. Sherman P, Hassall E, Fagundes-Neto U, Gold B, Kato S, Koletzko S, et al. A global, evidence-based consensus on the definition of gastroesophageal reflux disease in the pediatric population. Am J Gastroenterol 2009;104:1278–96.

4. Hassall E, Kerr W, El-Serag HB. Characteristics of children receiving proton pump inhibitors continuously for up to 11 years duration. J Pediatr 2007;150:262–7.

5. Horvath A, Dziechciarz P, Szajewska H. The effect of thickened-feed interventions on gastroesophageal reflux in infants: systematic review and meta-analysis of randomized, controlled trials. Pediatrics 2008;122:1268–77.

6. Blackshaw lA. New insights in the neural regulation of the lower oesophageal sphincter. Eur Rev Med Pharmacol Sc 2008;12:{Suppl 1} S33–S39.

7. Vandenplas Y, Rudolph C, Di lorenzo C, Hassall E, liptak G, Mazur l, et al. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr 2009;49:498–547.

8. Del Giudice E, Staiano A, Capano G, Romano A, Florimonte l, Miele E, et al. Gastrointestinal manifestations in children with cerebral palsy. Brain Dev 1999;21:307–11.

9. Andrew MJ, Sullivan PB. Feeding difficulties in disabled children. Paediatr Child Health 2010;20:321–6.

10. Huang R, Forbes D, Davies M. Feed thickener for newborn infants with gastro-oesophageal reflux. Cochr Dat Syst Rev 2002;:CD003211.

11. Craig W, Hanlon-Derman A, Sinclair C, Taback S, Moffatt M. Metoclopramide, thickened feedings, and positioning for gastro-oesophageal reflux in children under two years. Cochr Dat Syst Rev 2004;:CD003502.

12. Neu M, Corwin E, lareau SC, Marcheggiani-Howard C. A review of nonsurgical treatment for the symptom of irritability in infants with GERD. J Spec Pediatr Nurs 2012;17:177–92.

13. Carroll A, Garrison M, Christakis D. A systematic review of nonpharmacological and nonsurgical therapies for gastroesophageal reflux in infants. Arch Pediatr Adolesc Med 2002;156:109–13.

14. Miyazawa R, Tomomasa T, Kaneko H, Arakawa H, Shimizu N, Morikawa A. Effects of pectin liquid on gastroesophageal reflux disease in children with cerebral palsy. BMC gastroenterol 2008;8:11.

15. Aggett PJ, Agostoni C, Goulet O, Hernell O, Koletzko B, lafeber Hl, et al. Antireflux or antiregurgitation milk products for infants and young children: a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr 2002;34:496–8.

16. National Institute for Health and Clinical Excellence. Gastro-oesophageal reflux disease: recognition, diagnosis and management in children and young people Project Scope [Internet]. 2013 [cited 2013 May 3];Available from: http://guidance.nice.org.uk/index.jsp?action=byID&o=13656

17. National Institute for Health and Clinical Excellence (NICE). Infection: prevention and control of healthcare-associated infections in primary and community care. 2003; 46–7.

18. Marchand V, Motil KJ. Nutrition support for neurologically impaired children: a clinical report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr 2006;43:123–35.

19. Black RE, Allen lH, Bhutta Z a, Caulfield lE, De Onis M, Ezzati M, et al. Maternal and child undernutrition: global and regional exposures and health consequences. lancet 2008;371:243–60.

20. Primary Care Reimbursement Services (Health Service Executive) [Internet] [cited 2013 May 5]; Available from: http://www.sspcrs.ie/druglist/search.jsp

21. Chao H, Vandenplas Y. Effect of cereal-thickened formula and upright positioning on regurgitation, gastric emptying, and weight gain in infants with regurgitation. Nutrition 2007;23:23–8.

22. Orenstein SR, Shalaby TM, Putnam PE. Thickened feedings as a cause of increased coughing when used as therapy for gastroesophageal reflux in infants. J Pediatr 1992;121:913–5.

23. Vandenplas Y, Belli D, Benhamou P, Cadranel S, Cezard J, Cucchiara S, et al. A critical appraisal of current management practices for infant regurgitation-recommendations of a working party. Eur J Pediatr 1997;156:343–57.

24. Miyazawa R, Tomomasa T, Kaneko H, Morikawa A. Effect of formula thickened with locust bean gum on gastric emptying in infants. J Paediatr Child Health 2006;42:808–12.

25. Bosscher D, Van Caillie-Bertrand, Micheline Van Dyck, Kristien Robberecht H, Van Cauwenbergh, Rudy Deelstra H. Thickening Infant Formula With Digestible and Indigestible Carbohydrate: Availability of Calcium, Iron, and Zinc In Vitro. J Pediatr Gastroenterol Nutr 2000;30:373–8.

26. Cheung K, Tse P, Ko C, Chan Y, leung C, Chan K. Clinical efficacy of proton pump inhibitor therapy in neurologically impaired children with gastroesophageal reflux: prospective study. Hong Kong Med J 2001;7:356–9.

27. Böhmer C, Niezen-de Boer M, Klinkenberg-Knol E, Nadorp J, Meuwissen S. Gastro-oesophageal reflux disease in institutionalised intellectually disabled individuals. Neth J Med 1997;51:134–9.

What about them?

She’s offered protection from HPV types 6, 11, 16 and 18 through the national HPV vaccination programme in second level

Gardasil® – paves the way for cervical cancer and other HPV genital disease prevention1

• Most women under 45 years can gain some benefit from Gardasil® regardless of past or current infection1,2

• Gardasil is effective in preventing genital warts causally related to HPV 6, 11, 16 and 18 in males1

• Gardasil is indicated from 9-45 years of age in women and 9-26 years of age in men1

11/13 IR00132(1)

Information about adverse event reporting can be found at www.imb.ie. Adverse events and inadvertent vaccination during pregnancy should also be reported to Sanofi Pasteur MSD by calling 00 44 1628 785291. Further information available upon request.

ABRIDGED PRESCRIBING INFORMATION GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)). Refer to Summary of Product Characteristics for full product information before prescribing. Additional information is available on request. Presentation: Gardasil is supplied as a single dose pre-filled syringe containing 0.5 millilitre of suspension. Each dose of the quadrivalent vaccine contains highly purified virus-like particles (VLPs) of the major capsid L1 protein of Human Papillomavirus (HPV). These are type 6 (20 μg), type 11 (40 μg), type 16 (40 μg) and type 18 (20 μg). Indications: Gardasil is a vaccine for use from the age of 9 years for the prevention of premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types and genital warts (condyloma acuminata) causally related to specific HPV types. The indication is based on the demonstration of efficacy of Gardasil in females 16 to 45 years of age and in males 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents. Dosage and administration: The primary vaccination series consists of 3 separate 0.5 millilitre doses administered according to the following schedule: 0, 2, 6 months. If an alternate schedule is necessary the second dose should be administered at least one month after the first and the third dose at least three months after the second. All three doses should be given within a 1 year period. The need for a booster dose has not been established. The vaccine should be administered by intramuscular injection. Contraindications: Hypersensitivity to any component of the vaccine. Hypersensitivity after previous administration of Gardasil. Acute severe febrile illness. Warnings and precautions: The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination. As with all vaccines, appropriate medical treatment should always be available in case of rare anaphylactic reactions. The vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals. Syncope, sometimes associated with falling, can occur before or after vaccination with Gardasil

as a psychogenic response to the needle injection. Vaccinees should be observed for approximately 15 minutes after vaccination; procedures should be in place to avoid injury from faints. There is insufficient data to recommend use of Gardasil during pregnancy therefore the vaccination should be postponed until after completion of the pregnancy. The vaccine can be given to breastfeeding women. Gardasil will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to some limited extent against diseases caused by certain related HPV types. Vaccination is not a substitute for routine cervical screening. Individuals with impaired immune responsiveness, due to either the use of potent immunosuppressive therapy, a genetic defect, or other causes, may not respond to the vaccine. As with any vaccine, vaccination with Gardasil may not result in protection in all vaccine recipients. There are no safety, immunogenicity or efficacy data to support interchangeability of Gardasil with other HPV vaccines. Undesirable effects: Very common side effects include: headache and at the injection site, erythema, pain and swelling. Common side effects include bruising and pruritus at the injection site, pyrexia, nausea, and pain in the extremity. Rarely urticaria and very rarely bronchospasm has been reported. Idiopathic thrombocytopenic purpura, Guillain-Barré Syndrome and hypersensitivity reactions including, anaphylactic/anaphylactoid reactions have also been reported. For a complete list of undesirable effects please refer to the Summary of Product Characteristics. Package quantities: Single pack containing one 0.5 millilitre dose pre-filled syringe with two separate needles. Marketing authorisation holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007, Lyon, France Marketing authorisation number: EU/1/06/357/007 (pre-filled syringe with two separate needles). Legal category: POM. ®Registered trademark. Date of last review: Nov 2012.

References: 1. Gardasil® Summary of Product Characteristics. 2. Castellsague X, Munoz N, Pitisuttithum P et al. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24–45 years of age. Br J Cancer 2011; 105:28-37.

GARDASIL_she’s protected_A4_SEPT13_02.indd 1 08/11/2013 13:57

17

IPNA clinical award 2013

esc cVD Prevention Guidelines 2012chRIsTINe DOheRTy, PRACTICE NURSE AND MEMBER OF THE IPNA DONEGAl BRANCH

QuesTIONs:

1. What are the particular risk factors that caused Michael’s heart disease?

2. Name two other risk factors that lead to the development of heart disease?

3. Outline the non-pharmacological measures that you would discuss with Michael in order to control his condition in line with ESC 2012 guidelines.

4. What steps outlined in the ESC 2012 guidelines would help you motivate Michael to quit smoking if he had not yet done so?

5. What concerns do you have about Michael’s alcohol intake and what advice would you offer him?

6. Explain briefly the need for his new regime of medications and reasons for compliance.

7. What medications are proven to reduce cholesterol?

8. Explain briefly why such a high dose of a statin has been prescribed?

9. What blood tests would you repeat following commencement of this (statin) medication and why?

10. According to the new ESC 2012 guidelines what is the target for lDl cholesterol?

11. What is a normal blood sugar level and what follow up tests are required for Michael?

12. Today Michael’s BP was initially high. What is the target BP for patients with CVD according to the ESC 2012 guidelines? What follow up would Michael need to monitor his BP if it remained high?

cAse sTuDy Acute coronary syndromeMichael is a 46 year old man who has recently been discharged from hospital with a diagnosis of acute coronary syndrome.

He presented to the hospital initially complaining of 2 hour history of severe chest pain. Initially he thought it was indigestion and took some antacid. As there was no relief from the pain and it suddenly became worse and he also felt clammy and nauseated, his colleague brought him straight to A and E.Previous history: Indigestion and some shortness of breath on exertion in recent months

Medications: NilAllergies: Nil knownsmoking status: 20/day for 25 years approx.Alcohol history: Drinks in excess of 35units/week as

beer/wine.Family history: Father died suddenly 15 years

previously of a heart attack. Mother is a diabetic.

Michael was admitted for investigations and treatment. His admission ECG showed ST elevation in inferior leads. His troponin levels were elevated. He was taken to the coronary angiogram lab and had a coronary angiogram performed. His right coronary artery (RCA) was 90% blocked with minor disease in the other coronary arteries. A drug eluting stent was inserted into the RCA. Michael spent 2 days in the coronary care unit before transfer to a ward and then discharged home.

The results of his tests were as follows:ecG: STEMI (Inferior leads) which resolved

with q wave formation.echO: Area of dyskinesis in the right

ventricular wall. Ejection Fraction 55%

Angiogram: 90% narrowing RCA and minor disease in the other arteries.

cXR: Normal Troponin: 0.56Renal profile: Normalliver Profile: Normal Fbc: Hb 14.2Fasting lipids: Total Chol 6.2, Trigs 3.6, lDl 3.2, HDl

0.77mmol/lGlucose: 6.3mmol/l

his discharge medications are:Ramipril 1.25mg OD to increase to 2.5mgs after one weekbisoproplol 1.25mg OD to increase to 2.5mgs after one weekAspirin 75mg ODPrasugrel 10mgs ODAtorvastatin 80mgs OD

You are meeting Michael for the first time since his discharge. He is feeling a lot better, however, he is still shaken regarding his cardiac condition and what the future will hold. He is also confused about the need for so many tablets as he never took any before.

Today his BP is 152/96mmHg, heart rate is 78beats/min and regular. Weight 76kg and BMI 28kg/m2

What about them?

She’s offered protection from HPV types 6, 11, 16 and 18 through the national HPV vaccination programme in second level

Gardasil® – paves the way for cervical cancer and other HPV genital disease prevention1

• Most women under 45 years can gain some benefit from Gardasil® regardless of past or current infection1,2

• Gardasil is effective in preventing genital warts causally related to HPV 6, 11, 16 and 18 in males1

• Gardasil is indicated from 9-45 years of age in women and 9-26 years of age in men1

11/13 IR00132(1)

Information about adverse event reporting can be found at www.imb.ie. Adverse events and inadvertent vaccination during pregnancy should also be reported to Sanofi Pasteur MSD by calling 00 44 1628 785291. Further information available upon request.

ABRIDGED PRESCRIBING INFORMATION GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)). Refer to Summary of Product Characteristics for full product information before prescribing. Additional information is available on request. Presentation: Gardasil is supplied as a single dose pre-filled syringe containing 0.5 millilitre of suspension. Each dose of the quadrivalent vaccine contains highly purified virus-like particles (VLPs) of the major capsid L1 protein of Human Papillomavirus (HPV). These are type 6 (20 μg), type 11 (40 μg), type 16 (40 μg) and type 18 (20 μg). Indications: Gardasil is a vaccine for use from the age of 9 years for the prevention of premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types and genital warts (condyloma acuminata) causally related to specific HPV types. The indication is based on the demonstration of efficacy of Gardasil in females 16 to 45 years of age and in males 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents. Dosage and administration: The primary vaccination series consists of 3 separate 0.5 millilitre doses administered according to the following schedule: 0, 2, 6 months. If an alternate schedule is necessary the second dose should be administered at least one month after the first and the third dose at least three months after the second. All three doses should be given within a 1 year period. The need for a booster dose has not been established. The vaccine should be administered by intramuscular injection. Contraindications: Hypersensitivity to any component of the vaccine. Hypersensitivity after previous administration of Gardasil. Acute severe febrile illness. Warnings and precautions: The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination. As with all vaccines, appropriate medical treatment should always be available in case of rare anaphylactic reactions. The vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals. Syncope, sometimes associated with falling, can occur before or after vaccination with Gardasil

as a psychogenic response to the needle injection. Vaccinees should be observed for approximately 15 minutes after vaccination; procedures should be in place to avoid injury from faints. There is insufficient data to recommend use of Gardasil during pregnancy therefore the vaccination should be postponed until after completion of the pregnancy. The vaccine can be given to breastfeeding women. Gardasil will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to some limited extent against diseases caused by certain related HPV types. Vaccination is not a substitute for routine cervical screening. Individuals with impaired immune responsiveness, due to either the use of potent immunosuppressive therapy, a genetic defect, or other causes, may not respond to the vaccine. As with any vaccine, vaccination with Gardasil may not result in protection in all vaccine recipients. There are no safety, immunogenicity or efficacy data to support interchangeability of Gardasil with other HPV vaccines. Undesirable effects: Very common side effects include: headache and at the injection site, erythema, pain and swelling. Common side effects include bruising and pruritus at the injection site, pyrexia, nausea, and pain in the extremity. Rarely urticaria and very rarely bronchospasm has been reported. Idiopathic thrombocytopenic purpura, Guillain-Barré Syndrome and hypersensitivity reactions including, anaphylactic/anaphylactoid reactions have also been reported. For a complete list of undesirable effects please refer to the Summary of Product Characteristics. Package quantities: Single pack containing one 0.5 millilitre dose pre-filled syringe with two separate needles. Marketing authorisation holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007, Lyon, France Marketing authorisation number: EU/1/06/357/007 (pre-filled syringe with two separate needles). Legal category: POM. ®Registered trademark. Date of last review: Nov 2012.

References: 1. Gardasil® Summary of Product Characteristics. 2. Castellsague X, Munoz N, Pitisuttithum P et al. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24–45 years of age. Br J Cancer 2011; 105:28-37.

GARDASIL_she’s protected_A4_SEPT13_02.indd 1 08/11/2013 13:57

18

IPNA clinical award 2013

Q1.

Worldwide, cardiovascular disease (CVD) remains a significant cause of premature death.1 Health promotion in the primary and secondary prevention of CVD focuses on the modification of globally recognised risk factors. The WHO calculates that 80-90% of CVD deaths can be attributed to 1 or more major risk factors.15

Modifiable risk factors are:• Smoking – Michael smokes 20 daily for 25 years• Hypercholesterolaemia – Michael’s total cholesterol is

elevated at 6.2mmol/l, with raised triglycerides and lDl and low levels of cardioprotective HDl.

• Hypertension – Michael has grade 1 hypertension• Obesity – Michael has a BMI of 28kg/m2 with possible

abdominal adiposity (central obesity).• Alcohol consumption – Michael drinks >35 units per week • Impaired fasting glucose/type 2 diabetes – Michael’s fasting

plasma glucose is 6.3mmol/l.

Non-modifiable risk factors include age, gender and family history (Michael’s father had a fatal myocardial infarction).

Q2.

Two other risk factors that could lead to the development of heart disease are.1

Diet and exercise 1) Sub-optimal intakes of fruit, vegetables, fish and fibre.

Excess salt, saturated and trans-fats in the diet. 2) A sedentary lifestyle or irregular and inconsistent exercise.Psychosocial risk factors 1) low socio-economic status2) Work and family stressors3) Depression and anxiety4) Social isolation5) Hostility 6) Type ‘D’ personality.

Q3.

1. All patients should unequivocally be encouraged and supported to quit smoking(1,7,15).

2. Fruit, Vegetables, Fibre and Fish have cardioprotective benefits. 4-6 portions of fruit and vegetables and 30-45grams of fibre daily are recommended. Fish consumption of 1-2 servings per week have been shown to reduce CHD mortality by an impressive 36%(1,15).

3. A diet low in saturated and trans-fats (8,15). High fat diets contribute to obesity levels and cardiovascular and metabolic ill-health. Trans-fats offer no nutritional benefit, yet are commonplace in vegetable oils, fast foods and baking.

4. Reduce salt intake to <5grams daily. Processed foods, bacon and ham have a high salt content. Michael should be advised that 1g of salt is equivalent to 0.4g of sodium as this misunderstanding could lead to excess salt intake. Advise Michael to avoid salt alternatives due to raised potassium content. Although potassium is beneficial for blood pressure control, excess intake could be arrhythmogenic.10 Suitable substitutes are herbs and spices.

5. limit alcohol to 2 glasses a day (for males).1 Caution

Michael re: substituting alcohol with soft drinks due to the association with obesity and diabetes development.

6. Increase regular exercise – to optimise cardiovascular fitness, reduce weight, control BP, reduce risk of type 2 diabetes, improve HDl cholesterol and reduce lDl levels. Encourage participation in moderate intensity exercise for 30 minutes daily or a minimum of 2.5 hours weekly. low intensity exercise eg. walking may be advised initially if Michael has been sedentary.1,3,7

7. Manage weight – aim for a BMI of 18.5-24.9kg/m2.1 Obesity is becoming a worldwide crisis. Michael’s BMI of 28 qualifies him as obese. A waist circumference measurement of >94cm for males indicates central obesity, which has implications for type 2 diabetes development.1,12 Diet and exercise advice to manage weight will also benefit BP control, glucose and lipid levels.

8. Offer Michael tips to manage stressors in his work-life balance.1 Diet, exercise, peer support, adequate sleep and reduced alcohol dependence are important areas to consider.

Q4.

Smoking is prothrombotic and contributes significantly to premature death rates. Amounts of tobacco and duration of use are important factors contributing to irreversible plaque formation.1,2

ESC guidelines (2012) indicate that smoking cessation is the most important singular factor in secondary prevention, with significant reductions in mortality evident even after 6 months cessation.

Unfortunately, many patients often revert to smoking once the acute phase of their MI has passe.2)

Nurses must actively discourage smoking. Brief motivational interventions using the 5 As strategy should be used at each patient contact opportunity.1,3,6).]]

5 As Patient contact health promotion

Ask If the patient is a smoker, ask about amount and duration. If non-smoker, advise to avoid passive smoking

Advise Reiterate harmful effects of smoking, encourage total abstinence, reduction in cigarettes does not offer comparative benefits

Give oral, visual and written advice

Assess Readiness to quit. Is the patient at the pre-contemplative or contemplative stage?

Explore advantages and disadvantages of quitting

Assist Set date for quitting.Provide supportive, individualised care and counselling.

Re: managing withdrawal symptoms, NRT and patches and access to smoking cessation groups.

Arrange Follow-up visit to praise/encourage /offer support if patient is lapsing

Acknowledge success.Reflect on difficult areas.

20

IPNA clinical award 2013

Q5.

Alcohol has atherosclerotic effects, contributing to hypertension, CVA and cardiomyopathy. Alcohol excess can promote obesity and malnutrition and is associated with depression and cancer..7

Michael over-indulges in alcohol (>35 units/week). The potential for chronic ill-health exists, given his current lifestyle choices. Alcohol use should be discussed at primary care level and brief motivational interventions employed. Health promotion should focus on education and self-monitoring.

Instruct Michael regarding the daily alcohol limits (2 drinks/day for men) and the long-term health implications of excess consumption.1,7 It may be pertinent to encourage Michael to acknowledge triggers for his drinking habits. NICE (2010) advise the FRAMES formula(16):• FEEDBACK on the problem• RESPONSIBIlITY for change • ADVICE when required• MENU of choices to enable change• EMPATHY• SElF-EFFICACY

Q6.

Acei (Ramipril) are used extensively in primary and secondary CVD prevention. ACEi reduces post-MI mortality and has anti-hypertensive properties.1

longterm ACEi therapy is recommended in patients with large wall motion abnormalities. Michael has an area of dyskinesis in his right ventricular wall, although left ventricular systolic function is preserved, given his ejection fraction of 55%.2

ACEi preserves renal function in diabetic patients and reduces incidence of microalbuminuria and proteinuria.1 This may be relevant for Michael given his impaired fasting glucose and with a first degree relative with diabetes.

ACEi can precipitate hyperkalaemia.10 Therefore, check BP and electrolytes after 2 weeks. ACEi induced coughs may be avoided by changing to an ARB.

Betablockers in the post-MI period reduce longterm mortality, with greatest benefit achieved in patients at moderate-high risk.

bisoprolol has anti-arrhythmic and anti-hypertensive properties.1 This is advantageous for Michael given his diagnosis of inferior MI in the setting of possible hypertension (152/96mmHg).

Betablockers display anti-anginal qualities by reducing cardiac workload and cardiac O2 consumption.

Administration in a once-daily dose will also facilitate compliance where polypharmacy is an issue.

Aspirin and Prasugrel – Dual anti-platelet therapy is advised post MI.

Aspirin has shown positive results in secondary prevention and is recommended lifelong. It maintains the patency of the affected artery and reduces the extent of a re-infarction.2,3 A maintenance dose of 75mgs has similar benefits to higher doses without the risk of GI bleeding.

Prasugrel at 10mgs is recommended in the acute phase post-MI and where the patient has had angioplasty. Michael was stented to his RCA. Treatment is advised for 12 months.2

Poor compliance to longterm drug treatments is a very legitimate concern in secondary prevention. Nurses need to

be vigilant in exploring reasons for non-adherence and to continue to educate, support and empower patients to accept their diagnosis.14,15

Q7.

Raised plasma cholesterol, lDl and triglycerides levels and low cardioprotective HDl levels are recognised risk factors in CHD. Reducing lDl cholesterol by 1mmol can reduce CHD risk by 21%.4

Statins are first-line therapy for dyslipidaemia. ESC (2012) guidelines suggest that statins arrest atherosclerotic progression. Early studies have proven the efficacy of statins – the Scandinavian Simvastatin Survival Study 1994 documented notable reductions in total and lDl cholesterol with reductions in morbidity and mortality.5

Where statin intolerance develops, other drugs may be used – fibrates, Niacin or Ezetrol. Certain high-risk patients may require a combination of these therapies.

Q8.

Guidelines advocate intensive and immediate treatment (80mgs Atorvastatin) in the post-MI period.1

Statins inhibit cholesterol synthesis, thereby lowering levels of atherogenic lDls.1,4 An optimal target lDl of <1.8mmol/l is suggested as this has been attributed to a lower risk of recurrence of cardiovascular events.1,2

The use of the maximum tolerated dose of a statin must be balanced against the potential risk of adverse effects eg. Myositis or liver dysfunction.

Q9.

TesT RATIONAle AcTION

lipids 4-6 weeks after initiation of statin, a reduction in total and lDl cholesterol should be evident.1,2

Query compliance. Atorvastatin can be taken in the morning. Reiterate lifestyle advice. If target lDl achieved, consider reducing statin dose

liver tests To monitor for hepatic impairment.1

If elevated, discontinue/changestatin. Monitor for drug interactions e.g. avoid grapefruit, certain antibiotics (Clarithromycin)

cK (creatine Kinase)

If patient reports new myalgia. To monitor for development of myopathy. Avoid progression to rhabdomyolysis.4

If elevated, discontinue drug. Check for drug interactions.

Thyroid function

TFTs if not already completed to rule out secondary dyslipidaemia.4

If TFTs indicate hypothyroidism, commence Eltroxin.

Q10.

Asymptomatic individuals with elevated total and lDl cholesterol are risk assessed for the probability of developing CVD over a 10 year period. lifestyle (diet and exercise)

InnovatIve award-wInnIngosteoarthrItIs treatment!

Relieves pain and restores joint mobility1-3

Natural lubrication for arthritic joints4,5

Pain relief as effective as celecoxib1

Avoids heart and stomach risks1-3 common to most OA drug treatments6,7

FLEXISEQ™ with Sequessome Technology®

ThE SmART gEL ThAT LubRIcATESARThRITIc jOINTS

new

Pro Bono Bio International Trading Limited.For enquiries please contact: info@flexiseq.ie or 1 800 939149.

www.flexiseq.ie

References:1. Conaghan PG, Dickson J, Bolten W, Cevc G, Rother M. A multicentre, randomized, placebo-

and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology Advance Access published March 28, 2013 doi:10.1093/rheumatology/ket133.

2. Rother M, Conaghan PG. A multicentre, randomised, double-blind, placebo-controlled phase III trial comparing the efficacy and safety of epicutaneously applied ketoprofen in Transfersome® gel (IDEA 033) with drug-free Transfersome® gel (TDT 064) for pain associated with osteoarthritis of the knee. Manuscript submitted.

3. Stucki G et al. Ann Rheum Dis 2007;66(Suppl II):510.4. Data on file: Cantab Study Report: Caliper Lifesciences In vivo Bio-distribution Study.5. Cevc G, Schätzlein A, Richardsen H. Biochimica and Biophysica Acta, 2002;1564(1):21-30.6. Osteoarthritis: national clinical guideline for care and management in adults. London:

NICE, 2008. Available at: www.nice.org.uk/CG059.7. McKenzie S, Torkington A. Aust Fam Physician. 2010 Sep;39(9):622-5.

A Medical Device. Manufactured according to ISO 13485. Conforms to EU Medical Device Directive 93/42 EEC.

52157.01 PBB Flexiseq (ISR) 297x210 AW.indd 1 29/08/2013 09:15

22

IPNA clinical award 2013

modification is strongly advised to achieve a target TC of <5mmol/l.

Moderate risk individuals should aim for lDl cholesterol of <3mmol/l.

Control is tightened for patients with high risks to <2.5mmol/l. This may be achieved by intensive lifestyle advice +/ – statin addition.

Very high risk patients (previous cardiac event, with multi-morbidities or risk factors), should strive for a lDl of <1.8mmol/l or at least a 50% reduction in baseline lDl.1

Q11.

In Ireland, diabetes has increased by 13% since 1980s17 and is predicted to rise by 37% from 2005-2015.13 Hyperglycaemia increases risks of cardiovascular and microvascular (retinopathy, nephropathy and neuropathy) complications.

In asymptomatic patients, a diagnosis is confirmed by 2 abnormal results, either fasting plasma glucose or HbA1c

.13

Oral glucose tolerance testing (OGTT) is recommended where fasting levels exceed 5.6mmol/l or HbA1c is 5.7-6.4%. Target HbA1c is <7.0%.1 The following table classifies Michael’s potential results.

DIAGNOsIs ResulT

Impaired fasting glucose

Fasting glucose of 5.6 – 6.9 mmol/l on 2 separate occasions.

Impaired glucose tolerance

Post OGTT – 2 hour glucose 7.8 – 11.0 mmol/l.

Type 2 diabetes Post OGTT – 2 hour glucose of >11.1mmol/l.

Michael needs assessment for detection of symptoms associated with type 2 diabetes. He is at risk of metabolic syndrome and insulin resistance.11,12 having risk factors of hypertension, dyslipidaemia, raised BMI, established heart disease, first degree relative with diabetes and impaired fasting glucose.

Management of risk factors through diet and exercise can reduce HbA1c by 2%.13 Metformin, if tolerated, may need to be introduced as a first-line drug therapy. This drug is associated with reducing cardiovascular morbidity.13

Q12.

Michael has Grade 1 hypertension with BP of 152/96mmHg, however, this may simply be white coat hypertension.

Guidelines suggest a target BP for patients with CVD of 130-139/80-85mmHg. lower targets have not consistently been supported in research, except for patients with CVAs.

Persistently elevated BP needs to be confirmed by means of either1

1. Ambulatory BP monitoring – targets of 125-130/80mmHg.2. Home BP monitoring – target of 130-135/85mmHg.

If hypertension is confirmed, Michael needs advice regarding lifestyle modification, namely, smoking cessation, weight management, alcohol moderation, regular exercise, low-salt, low-fat diet with improved intake of fruit and vegetables (Dietary Approaches to Stop Hypertension (DASH) diet).9

Potassium in fruit and vegetables will help to reduce BP however, given that Michael is on ACEi also, it may be prudent to monitor serum electrolytes, to reduce risk of hyperkalaemia.10

Michael’s anti-hypertensive medications, Ramipril and Bisoprolol can be titrated to maximum tolerated doses. Combination therapy is more beneficial for BP control than simply maximising the dose of one drug.1

Conduct an ECG to rule out evidence of left ventricular hypertrophy (lVH) which is an independent CV risk.

Assess renal damage by checking urine to measure creatinine and glomerular filtration rate (GFR) and to detect microalbuminuria or proteinuria.

Ensure Michael’s compliance with therapy by clarifying any issues that may arise and offer support and counselling, as required, in the post-MI period.

References:1. The Fifth Joint Task Force of the European Society of

Cardiology (2012). European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. European Heart Journal, 33, 1635-1701.

2. Barton, J. (2013) Post-MI Drug Therapy. Cardiology Professional. 8 (1), 15-16.

3. Cox, J. (2011) Path to Recovery. Cardiology Professional. 6(1), 20-22.

4. Ford, H. (2013) Use of Statins to reduce the risk of cardiovascular disease in adults. Nursing Standard. 27(39), 48-56.

5. Grimes, D.S. (2012) An Epidemic of Coronary Heart Disease. QJM:An International Journal of Medicine. 105(6), 509-518.

6. Bennett, C., Perry, J. & lawrence, Z. (2009) Promoting Health in Primary Care. Nursing Standard. 23(47), 48-56.

7. Morton, K. (2013) Implementing Evidence-based Health Promotion Strategies. Nursing Standard. 27(33), 35-42.

8. Derbyshire, E. (2012) Trans-fats: Implications for Health. Nursing Standard. 27(3), 51-56.

9. Patience, S. (2012) Understanding the Relationship between Salt Intake and Hypertension. Nursing Standard. 27(18), 45-47.

10. Resuscitation Council UK (2011) Advanced life Support. 6th Edition. R.C.U.K., london.

11. Harkins, V. (2008)A Practical Guide to Integrated Type II Diabetes Care. HSE, Department of Health and Children, Irish College of General Practitioners and The Irish Endocrine Society. Downloaded on 08.08.2013 from http://www.hse.ie/eng/services/Publications/topics/Diabetes/A_Practical_Guide _to_Integrated_Type_II_Diabetes_Care.pdf

12. Alberti, G. & Zimmet, P. (2006) The IDF Consensus Worldwide Definition of the Metabolic Syndrome. International Diabetes Federation Taskforce on Epidemiology and Prevention. Downloaded on 08.08.2013 from http://www.idf.org/webdata/docs/IDF_Meta_def_final_pdf.

13. Anonymous (2011) Update on the Management of Type 2 Diabetes Mellitus. National Medicines Information Centre, St. James’s Hospital. 17(6) 1-8. Downloaded on 08.08.2013 from http://www.stjames.ie/GPs/HealthcareProfessionals/Newsletters/NMICBulletins/NMICBulletins2011/UpdateonDiabetes.2012.pdf

14. Alm-Roijer, C., Stagmo, M., Uden, G. & Erhardt, l. (2004) Better knowledge improves adherence to lifestyle changes and medication in patients with Coronary Heart Disease. European Journal of Cardiovascular Nursing. 3(4), 321-330

15. Cole, J.A., Smith, S.M., Hart, N. & Cupples, M.E. (2011) Systematic Review of the effect of diet and exercise lifestyle interventions in the secondary prevention of Coronary Heart Disease. Cardiology Research and Practice. Article ID 232351, 1-25.

16. National Institute for Health and Clinical Excellence. (2010) Alcohol-Use Disorders: Preventing Harmful Drinking. Public Health Guidance No. 24. NICE, london.

17. Hunter, N. (2013) Cutting Irish Cardiac Deaths. Cardiology Professional. 8(2), 10.

Effective. Convenient. Clean.

10µg 17ß-estradiol

Abbreviated Prescribing Information

Vagifem® 10 micrograms Vaginal Tablets. Refer

to the Summary of Product Characteristics before

prescribing. Qualitative and quantitative

composition: Each tablet contains estradiol

hemihydrate equivalent to 10 micrograms of

estradiol. Therapeutic indication: Treatment of

vaginal atrophy due to oestrogen deficiency in

postmenopausal women. Contraindications:

Known, past or suspected breast cancer, known, past

or suspected oestrogen dependent malignant

tumours (e.g. endometrial cancer), undiagnosed

genital bleeding, untreated endometrial hyperplasia,

previous or current venous thromboembolism (deep

venous thrombosis, pulmonary embolism), known

thrombophilic disorders (e.g. protein C, protein S, or

antithrombin deficiency), active or recent arterial

thromboembolic disease (e.g. angina, myocardial

infarction), acute liver disease, or a history of liver

disease as long as liver function tests have failed to

return to normal, known hypersensitivity to the active

substances or to any of the excipients, porphyria.

Special warnings: The dose of 17-estradiol is

very low and the treatment is local; however,

minimal absorption may be seen, especially during

the first two weeks of treatment. Pregnancy and

lactation: Vagifem® 10 micrograms is not indicated

during pregnancy and lactation. Dosage and

administration: Vagifem® 10 micrograms is

administered into the vagina, using the applicator.

Initial dose: One vaginal tablet a day for two

weeks. Maintenance dose: One vaginal tablet

twice a week. Treatment may be started on any

convenient day. Side effects: The most commonly

reported adverse events are headache, abdominal

pain, vaginal haemorrhage, vaginal discharge or

vaginal discomfort. Legal category: Only available

on prescription. For further information please

contact Novo Nordisk FemCare AG, Thurgauerstrasse

36/38, CH-8050 Zurich, Switzerland or the local

Novo Nordisk subsidiary. Vagifem® is a registered

trademark of Novo Nordisk FemCare AG.

Date of preparation: September 2012.

Reference:

1. Simon J et al. Obstet Gynecol 2008;112(5):1053–

1060. 2. Vagifem® 25μg Summary of Product

Characteristics. 3. Vagifem® 10μg Summary of

Product Characteristics.

4. Rioux JE et al. Menopause 2000;7(3):156–161.

5. Dugal R et al. Acta Obstet Gynecol Scand

2000;79:293–297.

* of local 17-estradiol

© 2012 Novo Nordisk FemCare AG

ID 4536, November 2012

Vagifem® 10µg – ultra low dose for vaginal atrophy1

A little goesa long way

Lowest effective dose* available2, 3

Significant long -term improvement in vaginal health1

Precise dose,3 locally administered,3 locally effective1

Effective.1 Convenient.4 Clean.5

Vaginal atrophy is a common and distressing symptom of the menopause, yet it is rarely discussed openly and only a minority of women seek medical help. The delicate lining of the vagina depends on oestrogen to stay thick and moist. After the menopause oestrogen levels drop dramatically from an average of 120 pg/mL to around 18 pg/mL.1 As oestrogen levels drop the skin and support tissues around the vagina become thinner and less elastic. Vaginal and cervical secretions also decrease, leading to reduced lubrication. This results in symptoms of vaginal dryness, soreness and itching. There may also be pain or bleeding during sexual intercourse. In addition, the pH of the vaginal secretions changes, from less than 4.5 in the premenopausal woman to over 6 in postmenopausal women.2 This affects the balance of microorganisms in the secretions and increases the risk of infection and inflammation.

Symptoms of vaginal atrophy• vaginal dryness • vaginal irritation • vaginal soreness • itching in and around the vagina • pain or bleeding during sexual intercourse • painful urination.

Vaginal dryness affects approximately 50% of postmenopausal women aged 50-60 years and about 70% of women over 70.5 Unlike hot flushes and night sweats which tend to resolve spontaneously over time, symptoms affecting the vagina often get worse and frequently need treatment. However, only one in four women with the condition seek medical help.6 This is partly due to a lack of awareness. Whereas hot flushes and night sweats are well known symptoms of the menopause,

many women may not be aware of a link between declining oestrogen levels and vaginal discomfort. In addition, many women are too embarrassed to discuss the problem, particularly with a male doctor. The International Menopause Society says that the impetus is upon the health professional to raise the topic of vaginal health. They suggest saying:

“Some women notice that they experience vaginal dryness during this time of life. I wonder if you are having any discomfort with intercourse?”

Managing postmenopausal vaginal atrophy

The average age of the menopause is 50 years. With life expectancy for women in Ireland now at 81.6 years, this means that an Irish woman experiences more than one third of her life after the menopause.3,4

Dr Hugh O’Connor, consultant obstetrician at Coombe Women & Infants University Hospital in Dublin said:

“Post menopausal women can suffer from vaginal dryness, irritation, urinary tract infection and painful intercourse. As time goes on vaginal prolapse is more common, as is stress incontinence.”

IR/V

F/10

13/0

016a

Dat

e of

pre

para

tion:

Oct

ober

201

3

Many women dismiss the symptoms of vaginal atrophy as an inevitable consequence of getting older. However, women do not have to put up with the discomfort and reduced quality of life as there are effective treatments available. A popular first line option is the use of a vaginal lubricant or moisturiser which can help if sex is uncomfortable. However, this is only a temporary measure and does not provide a long term solution.

Another option is systemic hormone replacement therapy (HRT) which relieves vaginal atrophy in about 75% of women. However, a quarter of women using systemic HRT still experience the symptoms

of urogenital atrophy and may need to be prescribed a combination of local and systemic therapy.7

The International Menopause Society recommends that local oestrogen is the best and most logical treatment for vaginal atrophy as it is safe, effective and with few contraindications.2 Local therapy avoids most systemic adverse events and is probably also more effective for vaginal problems. Local oestrogen therapy can be given as tablets, pessaries, cream or a vaginal ring. Vaginal tablets have the advantage of not being as messy as creamsand pessaries.

The International Menopause Society also recommends that clinicians should prescribe the lowest effective dose of oestrogen. From 1 October 2013 there will be an ultra low dose vaginal oestrogen tablet available in Ireland for the first time. Vagifem® 10 mcg (estradiol hemihydrate) contains 17ß estradiol - the same oestrogen that the body makes. Vagifem® was previously available as a 25 mcg dose but from 31 December 2013 this will be discontinued. Vagifem® 25 mcg was withdrawn from the UK two years ago.

Dr O’Connor said: “The vaginal symptoms of menopause can be very distressing and often women are too embarrassed to discuss them with friends or health professionals.” He added: “It is a silent crisis for many women. The health professional needs to ask direct questions.”Dr Hugh O’Connor, Coombe Women and Infants University Hospital, Dublin

Vagifem® 10 mcg is inserted using a preloaded disposable applicator which ensures precise dosing every time. The initial dose is one tablet inserted intravaginally once daily for two weeks followed by a maintenance dose of one tablet twice a week. Small amounts of oestrogen are released locally into the vaginal tissues. Women may continue to use Vagifem® 10 mcg for as long as symptoms persist.8

Vagifem® 10 mcg has undergone rigorous approval procedures in North America and the EU where clinical research has shown that the low dose is effective in treating symptoms of vaginal atrophy. A multi-centre double blind study found that Vagifem® 10 mcg was effective in significantly reducing urogenital symptoms such as vaginal dryness, soreness and itching as well as pain or bleeding associated with sexual intercourse over 12 weeks of treatment.9 The study also found that Vagifem® induces maturation of vaginal epithelial cells. Treatment increases the percentage of superficial cells, which usually lessen in postmenopausal women and reduces the number of parabasal cells, which are typically more prominent after the menopause. Vagifem® 10 mcg also changes the vaginal pH towards the more acidic ranges typical of non-menopausal women.

The British Menopause Society Council Consensus Statement states that low dose oestrogen preparations do not require added progestogen because systemic absorption of oestrogen is low without systemic effects and hormone levels remain within the postmenopausal range.10 However, because there is still some systemic absorption of oestrogen it potentially may be associated with the same risks as other forms of HRT and so carries the same warnings. Patients should be told to report any unusual vaginal bleeding straight away as it could be a warning sign of cancer of the uterus.

• Healthcare professionals should routinely talk to postmenopausal women about their urogenital health

• Treatment should be started early before irrevocable atrophic changes have occurred

• Treatment needs to be continued to maintain the benefits

• Local oestrogen preparations are effective and patient preference will usually determine the treatment used

• Additional progestogen is not indicated when low dose local oestrogen is used.

References: 1 Pandit L, Ouslander JG. Postmenopausal vaginal atrophy and

atrophic vaginitis. Am J Med Sci 1997;314:228–31. 2 Sturdee DW and Panay N on behalf of the International

Menopause Society Writing Group Climateric 2010 DOI: 10.3109/13697137.2010.522875

3 Menopause Information and Services Available to Women in Ireland, 2008, The Women’s Health Council

4 Women and Men in Ireland 2010 Central Statistics Office www.cso.ie

5 Rossin-Amar B. Gynécol Obstèt Fertil 2000;28:245-249 6 Cardozo L et al. Obstet Gynecol 1998;92:722–727. 7 Barnabei VM, Cochrane BB, Aragaki AK, et al. Menopausal

symptoms and treatment-related effects of estrogen and progestin in the Women’s Health Initiative. Obstet Gynecol 2005;105:1063– 73

8 Vagifem® 10 µg Summary of Product Characteristics 9 Simon J, Nachtigall L, Gut R, Lang E, Archer D, Utian W.

Effective treatment of vaginal atrophy with an ultra-low dose estradiol vaginal tablet Obstet Gynecol 2008 ; 112:1053-60

10 Pitkin J and Rees M on behalf of the British Menopause Society Council. Urogenital atrophy Menopause International 2008; 14:136-137. DOI:1258/mi2008.008022

IR/VF/1013/0016 Date of preparation: October 2013

Abbreviated Prescribing InformationVagifem® 10 micrograms vaginal tabletsEstradiol hemihydrate

PresentationVaginal tablet containing estradiol hemihydrate equivalent to estradiol 10 micrograms. Each tablet is inset in a disposable applicator.

IndicationTreatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women.

Posology and AdministrationAdministered intravaginally by use of an applicator. The applicator is inserted into the vagina until resistance is met (8-10 cm) and the tablet released by pressing the plunger. The applicator is then withdrawn and disposed of. Initial dose of 1 tablet daily for two weeks followed by maintenance dose of one tablet twice a week.

Contra-indicationsKnown, past or suspected breast cancer; known or suspected oestrogen-dependent malignant tumours; undiagnosed genital bleeding; untreated endometrial hyperplasia; previous or current venous thromboembolism (deep venous thrombosis (DVT) and pulmonary embolism); known thrombophilic disorders; active or recent arterial thromboembolic disease; acute liver disease or history of liver disease as long as liver function tests have failed to return to normal; hypersensitivity to ingredients; porphyria.

PrecautionsHRT should only be initiated for symptoms that adversely affect quality of life. Take personal and family medical history before initiation or reinstitution of therapy. Periodic check-ups are recommended. Physical examination and investigations including appropriate imaging tools should be carried out based on clinical needs of individual. Patients should be closely supervised if the following conditions are present, have previously occurred or have been aggravated during pregnancy or taking Hormone Replacement Therapy (HRT): leiomyoma or endometriosis; risk factors for thromboembolic disorders; risk factors for oestrogen-dependent tumours; hypertension; liver disorders; diabetes mellitus with or without vascular involvement; cholelithiasis; migraine or severe headache; systemic lupus erythematosus; a history of endometrial hyperplasia; epilepsy; asthma and otosclerosis. These conditions may recur or be aggravated during oestrogen treatment however due to very low absorption of estradiol during treatment with Vagifem® the recurrence or aggravation of the conditions is less likely than with systemic oestrogen treatment. Discontinue if contraindication discovered or if the following occur: jaundice or deterioration in liver function; significant increase in blood pressure; new onset of migraine-type headache; pregnancy. Women with an intact uterus with abnormal bleeding of unknown aetiology or if previously treated with unopposed oestrogens should be examined to exclude hyperstimulation/malignancy of endometrium before treatment initiation. A minor degree of systemic absorption may occur especially during the first two weeks of treatment with Vagifem®; an evaluation showed average plasma E2 concentrations remained within normal postmenopausal range. For repeated use treatment should be reviewed at least annually taking into account symptoms of endometrial hyperplasia/carcinoma. In women with an intact uterus, progestagen treatment is not necessary Characteristics: Section 4.4 in relation to endometrial hyperplasia and carcinoma). Vagifem® may be used in women with or without an intact uterus. Physical/gynaecological examination should be done if treatment is extended beyond one year. Bleeding or spotting appearing at any time on therapy should be investigated. Caution is advised in using this product in women who have undergone hysterectomy because of endometriosis as unopposed oestrogen may lead to premalignant or malignant transformation in the residual foci of endometriosis. Evidence suggests an increased risk of breast cancer in women taking combined oestrogen-progestogen and possibly oestrogen-only HRT that is dependent on the duration of taking HRT. HRT increases the density of mammographic images which may adversely affect the radiological detection of breast cancer. Long term (at least 5-10 years) use of oestrogen only HRT products has been associated with a slightly increased risk of ovarian cancer. HRT is associated with a 1.3-3 fold risk of developing

venous thromboembolism (VTE) especially in the first year of use. Risk factors for VTE include use of oestrogens, older age, major surgery, prolonged immobilisation, obesity, pregnancy/postpartum period, systemic lupus erythematosus cancer and personal/family history related to VTE/thromboembolic defects. Consider temporarily stopping HRT four to six weeks prior to surgery if prolonged immobilisation expected; do not restart until woman completely mobilised. Carefully consider benefit-risk of use of HRT in women on anticoagulant treatment. Discontinue HRT if VTE develops during treatment. Patients should contact the doctor immediately if they become aware of a potential thromboembolic symptom. A relationship between breast cancer risk, ovarian cancer risk and VTE with low dose local vaginal oestrogen is uncertain. No evidence of protection from HRT against myocardial infarction. Data shows no increased risk of coronary artery disease in hysterectomised women using oestrogen-only therapy. Combined oestrogen-progestogen and oestrogen-only therapy is associated with up to a 1.5-fold increased risk of ischaemic stroke. The overall risk of stroke in women who use HRT increases with age. A relationship between breast cancer risk, ovarian cancer risk, ischaemic stroke and VTE with low dose local vaginal oestrogen is uncertain. Oestrogens may cause fluid retention, monitor patients with cardiac or renal dysfunction. Women with pre-existing hypertriglyceridaemia should be followed closely during oestrogen replacement or HRT due to the link with pancreatitis in rare cases of high levels of plasma triglycerides. Oestrogens may increase plasma proteins including thyroid, corticoid and sex-hormone-binding globulin leading to increased circulating corticosteroids and sex steroid. The effect of estradiol on plasma binding proteins is likely to be less with local vaginal administration compared to systemic administration. HRT does not improve cognitive function. There is some evidence to demonstrate that there is an increased risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after the age of 65.

Pregnancy and lactationNot indicated

Undesirable effectsVery low rates reported (similar to placebo) of breast pain, peripheral oedema and postmenopausal bleedings; if do occur most likely to occur at the beginning of treatment. Other adverse events reported are: Common (≥1/100 to <1/10): headache, abdominal pain, vaginal haemorrhage, vaginal discharge or discomfort. Uncommon (≥ 1/1,000 to <1/100): vulvovaginal mycotic infection, nausea, rash, weight increased, hot flush and hypertension. Very rare (<1/10,000 patient years) spontaneous reports have been received for patients being treated with Vagifem® 25 mcg: breast or endometrial cancer, generalised hypersensitivity reactions, fluid retention, insomnia, migraine aggravated, DVT, diarrhoea, urticaria, rash (erythematous, pruritic), genital pruritis, endometrial hyperplasia, vaginal pain or irritation, vaginismus, vaginal ulceration, ineffective drug, weight gain, increase in blood oestrogen. Other side effects reported in association with systemic oestrogen treatment: myocardial infarction, congestive heart disease, stroke, gallbladder disease, skin and subcutaneous disorders (chloasma, erythema multiforme, erythema nodosum, vascular purpura, increase in size of fibroids, epilepsy, libido disorder, deterioration of asthma, probable dementia. The Summary of Product Characteristics should be consulted for a full list of side effects and further details of risk estimates.

PL Number PA 218/30/2Legal Category POM

For complete prescribing information please refer to The Summary of Product Characteristics which is available on www.medicines.ie or by email from info@novonordisk.ie or from Medical department, Novo Nordisk Limited, 2nd Floor, 2 Hume Street, Dublin 2, Ireland; www.novonordisk.ie.

Date created: September 2013

Information about adverse event reporting is available at www.imb.ie. Adverse events should be reported to the Novo Nordisk Medical department: Tel: 1850 665 665.

Vagifem® is a registered trademark of Novo Nordisk Femcare AG

% o

f pa

tient

s re

port

ing

vagi

nal d

ryne

ss

Premenopause

Age

Patients reporting vaginal dryness

Dryness increased significantly in late perimenopause and post menopause (p<0.001)

Dennerstein L et al. Obstet Gynecol 2000;96:351–8.

Premenopause Postmenopause51

Perimenopause

3%

0

10

20

30

40

50

21%

25%

32%

47%

LatePerimenopause

Postmenopause

Many women dismiss the symptoms of vaginal atrophy as an inevitable consequence of getting older. However, women do not have to put up with the discomfort and reduced quality of life as there are effective treatments available. A popular first line option is the use of a vaginal lubricant or moisturiser which can help if sex is uncomfortable. However, this is only a temporary measure and does not provide a long term solution.

Another option is systemic hormone replacement therapy (HRT) which relieves vaginal atrophy in about 75% of women. However, a quarter of women using systemic HRT still experience the symptoms

of urogenital atrophy and may need to be prescribed a combination of local and systemic therapy.7

The International Menopause Society recommends that local oestrogen is the best and most logical treatment for vaginal atrophy as it is safe, effective and with few contraindications.2 Local therapy avoids most systemic adverse events and is probably also more effective for vaginal problems. Local oestrogen therapy can be given as tablets, pessaries, cream or a vaginal ring. Vaginal tablets have the advantage of not being as messy as creamsand pessaries.

The International Menopause Society also recommends that clinicians should prescribe the lowest effective dose of oestrogen. From 1 October 2013 there will be an ultra low dose vaginal oestrogen tablet available in Ireland for the first time. Vagifem® 10 mcg (estradiol hemihydrate) contains 17ß estradiol - the same oestrogen that the body makes. Vagifem® was previously available as a 25 mcg dose but from 31 December 2013 this will be discontinued. Vagifem® 25 mcg was withdrawn from the UK two years ago.

Dr O’Connor said: “The vaginal symptoms of menopause can be very distressing and often women are too embarrassed to discuss them with friends or health professionals.” He added: “It is a silent crisis for many women. The health professional needs to ask direct questions.”Dr Hugh O’Connor, Coombe Women and Infants University Hospital, Dublin

Vagifem® 10 mcg is inserted using a preloaded disposable applicator which ensures precise dosing every time. The initial dose is one tablet inserted intravaginally once daily for two weeks followed by a maintenance dose of one tablet twice a week. Small amounts of oestrogen are released locally into the vaginal tissues. Women may continue to use Vagifem® 10 mcg for as long as symptoms persist.8

Vagifem® 10 mcg has undergone rigorous approval procedures in North America and the EU where clinical research has shown that the low dose is effective in treating symptoms of vaginal atrophy. A multi-centre double blind study found that Vagifem® 10 mcg was effective in significantly reducing urogenital symptoms such as vaginal dryness, soreness and itching as well as pain or bleeding associated with sexual intercourse over 12 weeks of treatment.9 The study also found that Vagifem® induces maturation of vaginal epithelial cells. Treatment increases the percentage of superficial cells, which usually lessen in postmenopausal women and reduces the number of parabasal cells, which are typically more prominent after the menopause. Vagifem® 10 mcg also changes the vaginal pH towards the more acidic ranges typical of non-menopausal women.

The British Menopause Society Council Consensus Statement states that low dose oestrogen preparations do not require added progestogen because systemic absorption of oestrogen is low without systemic effects and hormone levels remain within the postmenopausal range.10 However, because there is still some systemic absorption of oestrogen it potentially may be associated with the same risks as other forms of HRT and so carries the same warnings. Patients should be told to report any unusual vaginal bleeding straight away as it could be a warning sign of cancer of the uterus.

• Healthcare professionals should routinely talk to postmenopausal women about their urogenital health

• Treatment should be started early before irrevocable atrophic changes have occurred

• Treatment needs to be continued to maintain the benefits

• Local oestrogen preparations are effective and patient preference will usually determine the treatment used

• Additional progestogen is not indicated when low dose local oestrogen is used.

References: 1 Pandit L, Ouslander JG. Postmenopausal vaginal atrophy and

atrophic vaginitis. Am J Med Sci 1997;314:228–31. 2 Sturdee DW and Panay N on behalf of the International

Menopause Society Writing Group Climateric 2010 DOI: 10.3109/13697137.2010.522875

3 Menopause Information and Services Available to Women in Ireland, 2008, The Women’s Health Council

4 Women and Men in Ireland 2010 Central Statistics Office www.cso.ie

5 Rossin-Amar B. Gynécol Obstèt Fertil 2000;28:245-249 6 Cardozo L et al. Obstet Gynecol 1998;92:722–727. 7 Barnabei VM, Cochrane BB, Aragaki AK, et al. Menopausal

symptoms and treatment-related effects of estrogen and progestin in the Women’s Health Initiative. Obstet Gynecol 2005;105:1063– 73

8 Vagifem® 10 µg Summary of Product Characteristics 9 Simon J, Nachtigall L, Gut R, Lang E, Archer D, Utian W.

Effective treatment of vaginal atrophy with an ultra-low dose estradiol vaginal tablet Obstet Gynecol 2008 ; 112:1053-60

10 Pitkin J and Rees M on behalf of the British Menopause Society Council. Urogenital atrophy Menopause International 2008; 14:136-137. DOI:1258/mi2008.008022

IR/VF/1013/0016 Date of preparation: October 2013

Abbreviated Prescribing InformationVagifem® 10 micrograms vaginal tabletsEstradiol hemihydrate

PresentationVaginal tablet containing estradiol hemihydrate equivalent to estradiol 10 micrograms. Each tablet is inset in a disposable applicator.

IndicationTreatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women.

Posology and AdministrationAdministered intravaginally by use of an applicator. The applicator is inserted into the vagina until resistance is met (8-10 cm) and the tablet released by pressing the plunger. The applicator is then withdrawn and disposed of. Initial dose of 1 tablet daily for two weeks followed by maintenance dose of one tablet twice a week.

Contra-indicationsKnown, past or suspected breast cancer; known or suspected oestrogen-dependent malignant tumours; undiagnosed genital bleeding; untreated endometrial hyperplasia; previous or current venous thromboembolism (deep venous thrombosis (DVT) and pulmonary embolism); known thrombophilic disorders; active or recent arterial thromboembolic disease; acute liver disease or history of liver disease as long as liver function tests have failed to return to normal; hypersensitivity to ingredients; porphyria.

PrecautionsHRT should only be initiated for symptoms that adversely affect quality of life. Take personal and family medical history before initiation or reinstitution of therapy. Periodic check-ups are recommended. Physical examination and investigations including appropriate imaging tools should be carried out based on clinical needs of individual. Patients should be closely supervised if the following conditions are present, have previously occurred or have been aggravated during pregnancy or taking Hormone Replacement Therapy (HRT): leiomyoma or endometriosis; risk factors for thromboembolic disorders; risk factors for oestrogen-dependent tumours; hypertension; liver disorders; diabetes mellitus with or without vascular involvement; cholelithiasis; migraine or severe headache; systemic lupus erythematosus; a history of endometrial hyperplasia; epilepsy; asthma and otosclerosis. These conditions may recur or be aggravated during oestrogen treatment however due to very low absorption of estradiol during treatment with Vagifem® the recurrence or aggravation of the conditions is less likely than with systemic oestrogen treatment. Discontinue if contraindication discovered or if the following occur: jaundice or deterioration in liver function; significant increase in blood pressure; new onset of migraine-type headache; pregnancy. Women with an intact uterus with abnormal bleeding of unknown aetiology or if previously treated with unopposed oestrogens should be examined to exclude hyperstimulation/malignancy of endometrium before treatment initiation. A minor degree of systemic absorption may occur especially during the first two weeks of treatment with Vagifem®; an evaluation showed average plasma E2 concentrations remained within normal postmenopausal range. For repeated use treatment should be reviewed at least annually taking into account symptoms of endometrial hyperplasia/carcinoma. In women with an intact uterus, progestagen treatment is not necessary Characteristics: Section 4.4 in relation to endometrial hyperplasia and carcinoma). Vagifem® may be used in women with or without an intact uterus. Physical/gynaecological examination should be done if treatment is extended beyond one year. Bleeding or spotting appearing at any time on therapy should be investigated. Caution is advised in using this product in women who have undergone hysterectomy because of endometriosis as unopposed oestrogen may lead to premalignant or malignant transformation in the residual foci of endometriosis. Evidence suggests an increased risk of breast cancer in women taking combined oestrogen-progestogen and possibly oestrogen-only HRT that is dependent on the duration of taking HRT. HRT increases the density of mammographic images which may adversely affect the radiological detection of breast cancer. Long term (at least 5-10 years) use of oestrogen only HRT products has been associated with a slightly increased risk of ovarian cancer. HRT is associated with a 1.3-3 fold risk of developing

venous thromboembolism (VTE) especially in the first year of use. Risk factors for VTE include use of oestrogens, older age, major surgery, prolonged immobilisation, obesity, pregnancy/postpartum period, systemic lupus erythematosus cancer and personal/family history related to VTE/thromboembolic defects. Consider temporarily stopping HRT four to six weeks prior to surgery if prolonged immobilisation expected; do not restart until woman completely mobilised. Carefully consider benefit-risk of use of HRT in women on anticoagulant treatment. Discontinue HRT if VTE develops during treatment. Patients should contact the doctor immediately if they become aware of a potential thromboembolic symptom. A relationship between breast cancer risk, ovarian cancer risk and VTE with low dose local vaginal oestrogen is uncertain. No evidence of protection from HRT against myocardial infarction. Data shows no increased risk of coronary artery disease in hysterectomised women using oestrogen-only therapy. Combined oestrogen-progestogen and oestrogen-only therapy is associated with up to a 1.5-fold increased risk of ischaemic stroke. The overall risk of stroke in women who use HRT increases with age. A relationship between breast cancer risk, ovarian cancer risk, ischaemic stroke and VTE with low dose local vaginal oestrogen is uncertain. Oestrogens may cause fluid retention, monitor patients with cardiac or renal dysfunction. Women with pre-existing hypertriglyceridaemia should be followed closely during oestrogen replacement or HRT due to the link with pancreatitis in rare cases of high levels of plasma triglycerides. Oestrogens may increase plasma proteins including thyroid, corticoid and sex-hormone-binding globulin leading to increased circulating corticosteroids and sex steroid. The effect of estradiol on plasma binding proteins is likely to be less with local vaginal administration compared to systemic administration. HRT does not improve cognitive function. There is some evidence to demonstrate that there is an increased risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after the age of 65.

Pregnancy and lactationNot indicated

Undesirable effectsVery low rates reported (similar to placebo) of breast pain, peripheral oedema and postmenopausal bleedings; if do occur most likely to occur at the beginning of treatment. Other adverse events reported are: Common (≥1/100 to <1/10): headache, abdominal pain, vaginal haemorrhage, vaginal discharge or discomfort. Uncommon (≥ 1/1,000 to <1/100): vulvovaginal mycotic infection, nausea, rash, weight increased, hot flush and hypertension. Very rare (<1/10,000 patient years) spontaneous reports have been received for patients being treated with Vagifem® 25 mcg: breast or endometrial cancer, generalised hypersensitivity reactions, fluid retention, insomnia, migraine aggravated, DVT, diarrhoea, urticaria, rash (erythematous, pruritic), genital pruritis, endometrial hyperplasia, vaginal pain or irritation, vaginismus, vaginal ulceration, ineffective drug, weight gain, increase in blood oestrogen. Other side effects reported in association with systemic oestrogen treatment: myocardial infarction, congestive heart disease, stroke, gallbladder disease, skin and subcutaneous disorders (chloasma, erythema multiforme, erythema nodosum, vascular purpura, increase in size of fibroids, epilepsy, libido disorder, deterioration of asthma, probable dementia. The Summary of Product Characteristics should be consulted for a full list of side effects and further details of risk estimates.

PL Number PA 218/30/2Legal Category POM

For complete prescribing information please refer to The Summary of Product Characteristics which is available on www.medicines.ie or by email from info@novonordisk.ie or from Medical department, Novo Nordisk Limited, 2nd Floor, 2 Hume Street, Dublin 2, Ireland; www.novonordisk.ie.

Date created: September 2013

Information about adverse event reporting is available at www.imb.ie. Adverse events should be reported to the Novo Nordisk Medical department: Tel: 1850 665 665.

Vagifem® is a registered trademark of Novo Nordisk Femcare AG

% o

f pa

tient

s re

port

ing

vagi

nal d

ryne

ss

Premenopause

Age

Patients reporting vaginal dryness

Dryness increased significantly in late perimenopause and post menopause (p<0.001)

Dennerstein L et al. Obstet Gynecol 2000;96:351–8.

Premenopause Postmenopause51

Perimenopause

3%

0

10

20

30

40

50

21%

25%

32%

47%

LatePerimenopause

Postmenopause

Effective. Convenient. Clean.

10µg 17ß-estradiol

Abbreviated Prescribing Information

Vagifem® 10 micrograms Vaginal Tablets. Refer

to the Summary of Product Characteristics before

prescribing. Qualitative and quantitative

composition: Each tablet contains estradiol

hemihydrate equivalent to 10 micrograms of

estradiol. Therapeutic indication: Treatment of

vaginal atrophy due to oestrogen deficiency in

postmenopausal women. Contraindications:

Known, past or suspected breast cancer, known, past

or suspected oestrogen dependent malignant

tumours (e.g. endometrial cancer), undiagnosed

genital bleeding, untreated endometrial hyperplasia,

previous or current venous thromboembolism (deep

venous thrombosis, pulmonary embolism), known

thrombophilic disorders (e.g. protein C, protein S, or

antithrombin deficiency), active or recent arterial

thromboembolic disease (e.g. angina, myocardial

infarction), acute liver disease, or a history of liver

disease as long as liver function tests have failed to

return to normal, known hypersensitivity to the active

substances or to any of the excipients, porphyria.

Special warnings: The dose of 17-estradiol is

very low and the treatment is local; however,

minimal absorption may be seen, especially during

the first two weeks of treatment. Pregnancy and

lactation: Vagifem® 10 micrograms is not indicated

during pregnancy and lactation. Dosage and

administration: Vagifem® 10 micrograms is

administered into the vagina, using the applicator.

Initial dose: One vaginal tablet a day for two

weeks. Maintenance dose: One vaginal tablet

twice a week. Treatment may be started on any

convenient day. Side effects: The most commonly

reported adverse events are headache, abdominal

pain, vaginal haemorrhage, vaginal discharge or

vaginal discomfort. Legal category: Only available

on prescription. For further information please

contact Novo Nordisk FemCare AG, Thurgauerstrasse

36/38, CH-8050 Zurich, Switzerland or the local

Novo Nordisk subsidiary. Vagifem® is a registered

trademark of Novo Nordisk FemCare AG.

Date of preparation: September 2012.

Reference:

1. Simon J et al. Obstet Gynecol 2008;112(5):1053–

1060. 2. Vagifem® 25μg Summary of Product

Characteristics. 3. Vagifem® 10μg Summary of

Product Characteristics.

4. Rioux JE et al. Menopause 2000;7(3):156–161.

5. Dugal R et al. Acta Obstet Gynecol Scand

2000;79:293–297.

* of local 17-estradiol

© 2012 Novo Nordisk FemCare AG

ID 4536, November 2012

Vagifem® 10µg – ultra low dose for vaginal atrophy1

A little goesa long way

Lowest effective dose* available2, 3

Significant long -term improvement in vaginal health1

Precise dose,3 locally administered,3 locally effective1

Effective.1 Convenient.4 Clean.5

Vaginal atrophy is a common and distressing symptom of the menopause, yet it is rarely discussed openly and only a minority of women seek medical help. The delicate lining of the vagina depends on oestrogen to stay thick and moist. After the menopause oestrogen levels drop dramatically from an average of 120 pg/mL to around 18 pg/mL.1 As oestrogen levels drop the skin and support tissues around the vagina become thinner and less elastic. Vaginal and cervical secretions also decrease, leading to reduced lubrication. This results in symptoms of vaginal dryness, soreness and itching. There may also be pain or bleeding during sexual intercourse. In addition, the pH of the vaginal secretions changes, from less than 4.5 in the premenopausal woman to over 6 in postmenopausal women.2 This affects the balance of microorganisms in the secretions and increases the risk of infection and inflammation.

Symptoms of vaginal atrophy• vaginal dryness • vaginal irritation • vaginal soreness • itching in and around the vagina • pain or bleeding during sexual intercourse • painful urination.

Vaginal dryness affects approximately 50% of postmenopausal women aged 50-60 years and about 70% of women over 70.5 Unlike hot flushes and night sweats which tend to resolve spontaneously over time, symptoms affecting the vagina often get worse and frequently need treatment. However, only one in four women with the condition seek medical help.6 This is partly due to a lack of awareness. Whereas hot flushes and night sweats are well known symptoms of the menopause,

many women may not be aware of a link between declining oestrogen levels and vaginal discomfort. In addition, many women are too embarrassed to discuss the problem, particularly with a male doctor. The International Menopause Society says that the impetus is upon the health professional to raise the topic of vaginal health. They suggest saying:

“Some women notice that they experience vaginal dryness during this time of life. I wonder if you are having any discomfort with intercourse?”

Managing postmenopausal vaginal atrophy

The average age of the menopause is 50 years. With life expectancy for women in Ireland now at 81.6 years, this means that an Irish woman experiences more than one third of her life after the menopause.3,4

Dr Hugh O’Connor, consultant obstetrician at Coombe Women & Infants University Hospital in Dublin said:

“Post menopausal women can suffer from vaginal dryness, irritation, urinary tract infection and painful intercourse. As time goes on vaginal prolapse is more common, as is stress incontinence.”

IR/V

F/10

13/0

016a

Dat

e of

pre

para

tion:

Oct

ober

201

3

27

clinical review

The role of the practice nurse in managing psoriasis in primary care DR DAVID bucKley, MRCGP, DP DERMATOlOGY, MD, SOlAS DERMATOlOGY & lASER ClINIC, THE ASHE STREET ClINIC, TRAlEE, CO KERRY

Psoriasis is a chronic, common skin condition affecting about 3% of the Irish population. It can occur at any age and both sexes are affected equally. Approximately 50% of patients will have a first-degree relative with psoriasis, which shows that there is a

strong hereditary component. There are certain well-known triggering factors, including hormones, infection, drugs, alcohol and stress. It is probably more common that the psoriasis causes stress rather than vice versa.

The practice nurse has an important role in managing this chronic disease as patients need explanations, reassurance and education on how to manage the disease.

It has been more recently recognised that psoriasis can be linked to increased incidence of cardiovascular disease, with strokes and peripheral vascular disease being more common in patients with psoriasis. Psoriasis patients also have a higher incidence of hypertension, hyperlipidemia, central obesity, liver disease and type II diabetes. Adult patients with psoriasis should be screened for these conditions and strongly encouraged not to smoke and to keep alcohol consumption to a minimum

Psoriatic arthritisPsoriatic arthritis can occur in up to 5% of patients with psoriasis, although some patients with quiet severe psoriatic arthritis might only have mild skin manifestations of the disease. Conversely patients with severe psoriasis may have no psoriatic arthritis.

Psoriasis is a T-cell mediated disease in which the epidermis renews itself up to six times faster than normal in the affected areas, resulting in thickening and red scaling of the skin. Psoriasis may appear in traumatised skin such as a cut or burn – this is known as the Koebner phenomenon.

Nail changes are found in up to 60% of patients with psoria-sis, which can often help in clinching the diagnosis in unusual cases. Pitting and onycholysis (lifting of the nail from the nail bed) are the most common nail changes. Sometimes nails can be thickened, discoloured or may fall off as a result of psoriasis. It can be difficult and sometimes almost impossible to differen-tiate between nail psoriasis and fungal nail infection. Sending nail clipping for fungal stain and culture may be the only way to make the diagnosis. Some patients can have psoriasis infecting the nails with little or no skin involvement. Apart from systemic therapies, there is no effective treatment for nail psoriasis.

There are various clinical types of psoriasis, the most common being chronic plaque psoriasis, small plaque psoriasis, guttate psoriasis and flexural psoriasis

Guttate psoriasisGuttate usually presents in young adults and may be precipitated by a streptococcal sore throat. Small plaques of psoriasis can be distributed all over the body but mainly along the trunk and upper arms. Gutta is the latin word for teardrop, and this type of psoriasis looks like a shower of red scaly teardrops that have fallen down on the body. The rash can develop quite quickly over a couple of days but usually clears spontaneously after 6 or 12 weeks.

Treatment is usually with emollients or a 10% tar and 10% urea cream, which can be applied all over the affected areas twice a day. More severe protracted cases usually respond well to Dovobet or phototherapy.

Psoriatic arthritis can occur in up to 5% of patients with psoriasis, although some patients with quiet severe psoriatic arthritis might only have mild skin manifestations of the disease.

Effective. Convenient. Clean.

10µg 17ß-estradiol

Abbreviated Prescribing Information

Vagifem® 10 micrograms Vaginal Tablets. Refer

to the Summary of Product Characteristics before

prescribing. Qualitative and quantitative

composition: Each tablet contains estradiol

hemihydrate equivalent to 10 micrograms of

estradiol. Therapeutic indication: Treatment of

vaginal atrophy due to oestrogen deficiency in

postmenopausal women. Contraindications:

Known, past or suspected breast cancer, known, past

or suspected oestrogen dependent malignant

tumours (e.g. endometrial cancer), undiagnosed

genital bleeding, untreated endometrial hyperplasia,

previous or current venous thromboembolism (deep

venous thrombosis, pulmonary embolism), known

thrombophilic disorders (e.g. protein C, protein S, or

antithrombin deficiency), active or recent arterial

thromboembolic disease (e.g. angina, myocardial

infarction), acute liver disease, or a history of liver

disease as long as liver function tests have failed to

return to normal, known hypersensitivity to the active

substances or to any of the excipients, porphyria.

Special warnings: The dose of 17-estradiol is

very low and the treatment is local; however,

minimal absorption may be seen, especially during

the first two weeks of treatment. Pregnancy and

lactation: Vagifem® 10 micrograms is not indicated

during pregnancy and lactation. Dosage and

administration: Vagifem® 10 micrograms is

administered into the vagina, using the applicator.

Initial dose: One vaginal tablet a day for two

weeks. Maintenance dose: One vaginal tablet

twice a week. Treatment may be started on any

convenient day. Side effects: The most commonly

reported adverse events are headache, abdominal

pain, vaginal haemorrhage, vaginal discharge or

vaginal discomfort. Legal category: Only available

on prescription. For further information please

contact Novo Nordisk FemCare AG, Thurgauerstrasse

36/38, CH-8050 Zurich, Switzerland or the local

Novo Nordisk subsidiary. Vagifem® is a registered

trademark of Novo Nordisk FemCare AG.

Date of preparation: September 2012.

Reference:

1. Simon J et al. Obstet Gynecol 2008;112(5):1053–

1060. 2. Vagifem® 25μg Summary of Product

Characteristics. 3. Vagifem® 10μg Summary of

Product Characteristics.

4. Rioux JE et al. Menopause 2000;7(3):156–161.

5. Dugal R et al. Acta Obstet Gynecol Scand

2000;79:293–297.

* of local 17-estradiol

© 2012 Novo Nordisk FemCare AG

ID 4536, November 2012

Vagifem® 10µg – ultra low dose for vaginal atrophy1

A little goesa long way

Lowest effective dose* available2, 3

Significant long -term improvement in vaginal health1

Precise dose,3 locally administered,3 locally effective1

Effective.1 Convenient.4 Clean.5

Vaginal atrophy is a common and distressing symptom of the menopause, yet it is rarely discussed openly and only a minority of women seek medical help. The delicate lining of the vagina depends on oestrogen to stay thick and moist. After the menopause oestrogen levels drop dramatically from an average of 120 pg/mL to around 18 pg/mL.1 As oestrogen levels drop the skin and support tissues around the vagina become thinner and less elastic. Vaginal and cervical secretions also decrease, leading to reduced lubrication. This results in symptoms of vaginal dryness, soreness and itching. There may also be pain or bleeding during sexual intercourse. In addition, the pH of the vaginal secretions changes, from less than 4.5 in the premenopausal woman to over 6 in postmenopausal women.2 This affects the balance of microorganisms in the secretions and increases the risk of infection and inflammation.

Symptoms of vaginal atrophy• vaginal dryness • vaginal irritation • vaginal soreness • itching in and around the vagina • pain or bleeding during sexual intercourse • painful urination.

Vaginal dryness affects approximately 50% of postmenopausal women aged 50-60 years and about 70% of women over 70.5 Unlike hot flushes and night sweats which tend to resolve spontaneously over time, symptoms affecting the vagina often get worse and frequently need treatment. However, only one in four women with the condition seek medical help.6 This is partly due to a lack of awareness. Whereas hot flushes and night sweats are well known symptoms of the menopause,

many women may not be aware of a link between declining oestrogen levels and vaginal discomfort. In addition, many women are too embarrassed to discuss the problem, particularly with a male doctor. The International Menopause Society says that the impetus is upon the health professional to raise the topic of vaginal health. They suggest saying:

“Some women notice that they experience vaginal dryness during this time of life. I wonder if you are having any discomfort with intercourse?”

Managing postmenopausal vaginal atrophy

The average age of the menopause is 50 years. With life expectancy for women in Ireland now at 81.6 years, this means that an Irish woman experiences more than one third of her life after the menopause.3,4

Dr Hugh O’Connor, consultant obstetrician at Coombe Women & Infants University Hospital in Dublin said:

“Post menopausal women can suffer from vaginal dryness, irritation, urinary tract infection and painful intercourse. As time goes on vaginal prolapse is more common, as is stress incontinence.”

IR/V

F/10

13/0

016a

Dat

e of

pre

para

tion:

Oct

ober

201

3

28

clinical review

chronic plaque psoriasis Chronic plaque usually causes large red scaly plaques on the elbows and knees. Plaques are also commonly found on the lower back and the scalp. However, any part of the body can be affected including the face. Small plaque psoriasis causes a similar rash but as the name implies the plaques are smaller usually measuring only 2 – 4 cm in diameter. Many patients have learned to live with plaque psoriasis, particularly when it is localised to the elbows and knees and they can manage with simple emollients and clothing that will cover up the affected area. Younger patients and women might find it harder to live with this type of psoriasis and often require treatment (see Table 1).

Calcipotriol (Dovonex) is a vitamin D analogue and is often used as a first line treatment for more troublesome plaque psoriasis. However because of its slow onset of action, Calcipotriol is often combined with a potent topical steroid such as betamethasone (Dovobet) resulting in a much more rapid response, which encourages the patient to continue the treatment. It can take up to 6 or 12 weeks to clear psoriasis. Because the Dovobet contains a potent steroid it cannot be used on the face or flexures and is not licensed for children and teenagers under the age of 18. It is also best not to use it long term because of the risks of skin atrophy and systemic absorption. Most patients find that by using Dovobet once daily to the affected areas on the body for one month, it will give approximately 50% improvement in the appearance of the rash. Patients should then be weaned off Dovobet in the second month by using it only on Saturdays and Sundays and using Dovonex once daily on the other five days of the week. In the third month, Dovobet should be stopped completely and the patient should use Dovonex on its own seven days a week until the psoriasis clears. The ointment preparation is considered more potent but also more messy than the jel formulation. The maximum weekly dose of Dovonex is 100g/week in adults and it should not be used on more than 30% of the body surface area.

In children, Dovonex can be used in the mornings and Eumovate ointment applied at night to the rash on the body

for the first month. The child should then be weened off the Eumovate over the next month or two.

Although expensive, Dovonex is safe when used correctly, is convenient, clean and non-smelly for the patient, and can help clear psoriasis in 60% – 70% of patients with chronic stable plaque psoriasis and small plaque psoriasis. However, it does not work for all patients.

Dithranol has been on the market for almost two hundred years, and is known to have an anti-inflammatory and anti-proliferative effect for home use. Dithranol is best used as Dithrocrem, which comes in various strengths, from 0.1% up to 2%. This can be safely applied to plaques of psoriasis on the body and scalp once daily for 30 minutes, and then washed off. Patients are usually instructed to increase the strength of the Dithrocrem once weekly until they reach the high strength after five weeks (2%). Patients have to be careful to apply Dithranol only to the affected areas, as it will cause burning of uninvolved skin, particularly when the patient goes up to stronger strengths. Dithranol also causes temporary brown staining of the skin, and therefore is unsuitable for the face. The staining usually fades after a week or two once Dithranol is stopped. As Dithranol contains no steroid, it is safe (even weekly) in children. It can clear psoriasis in approximately 80% of patients, when used correctly, and it can result in long remission times. However, because it causes staining and takes longer for the patient to apply, it is usually reserved for second-line treatment.

Coal tar preparations can also be effective in psoriasis although they can be messy to use and smelly. Coal tar 10% is often combined with urea 10% and this ointment can be applied rubbing downwards twice a day to help clear psoriasis. Coal tar is often used in combination with other treatments, such as Calcipotriol (Dovonex, Dovobet) or dithranol. Tar is often used in combination with salicylic acid to descale the scalp (e.g. Cocois). Patients with more severe, extensive or resistant psoriasis or psoriatic arthritis should be referred on

Figure 1. Psoriasis is no laughing matter !!

Figure 2. chronic stable plaque psoriasis

Access your digital copy today!

www.mindo.ie

Did you know as a nurse you can also access our award winning medical newspaper

online at

30

clinical review

for hospital treatments, such as phototherapy or systemic therapies such as methotrexate, fumaric acid esters, or the new biological therapies such as Humira.

Face and flexuresPsoriasis on the face or flexures usually presents with more erythema and itch and less scale. Calcipotriol, potent steroids and Dithranol cannot be used on these areas but because the skin is thinner and less scaly often 1% hydrocortisone can help. An anti-yeast agent is often combined with 1% hydrocortisone for the face and flexures, which can give a more long-lasting clearance (e.g. Daktacort, Canesten HC). For more severe psoriasis affecting the face or flexures, tacrolimus (Protopic) can often be effective. Although not licensed for psoriasis, it is safe to use on these areas, usually twice a day for three weeks and once or twice a week thereafter until the psoriasis clears. Patients should be warned that it can cause a transient erythema, a slight burning of the skin in the first week which usually settles in the second and subsequent weeks. The

Psoriasis on the face or flexures usually presents with more erythema and itch and less scale.

weaker strength (0.03%) should be used in children from the age of 2 to 12 years of age, and the stronger strength (0.1%) should be used in adults.

The scalpScalp psoriasis can often cause itch and heavy flaking. Dark coloured clothes should be avoided as these make the scales shed more obvious. Although the hair can camouflage the psoriasis, it can also make the application of treatments more difficult. Thick plaques can be dislodged by using a tar and salicylic acid combination (e.g. Cocois) for the first week or two before using more targeted treatments such as calcipotriol combined with a potent topical steroid (Dovobet gel) or dithranol. Dovobet Gel, which is a combination of calcipotriol and betamethasone, should only be used overnight and washed out in the morning. After a week or two it can usually be reduced to 2 or 3 times a week. Scalp psoriasis often co-exists with seborrhoeic dermatitis, so an anti-fungal shampoo such as ketoconazole (Nizoral) or Ciclopiroxolamine (Stieprox shampoo) should be used once or twice a week on a regular basis.

summaryWhile psoriasis is rarely life threatening, it can cause a lot of distress, particularly in younger patients with more extensive disease. Fortunately the vast majority of patients with psoriasis can be managed in primary care and the practice nurse has an important role in managing this chronic disease.

References on request.For more information:Email: info@asctralee.comWebsite: www.skinlaserclinic.ie

© David Buckley 2012

Table 1. Management of chronic stable plaque psoriasis in general practice

chronic stable plaque psoriasis

body and scalp

Adults

Dovobet Ointment or Gel

Dithrocream

If no improvement

If no improvement

If no improvement

Refer for uVb or systemic Rx

Remission or substantial improvement

Dovonex + eumovate

No better

1% hydrocortisone

Protopic 0.1% in adults or 0.03% in children

Mild disease unconcerned patient

children <12

Face and Flexures

simple emollients

Dovonex cream

fl utiform® (FLUTICASONE PROPIONATE AND FORMOTEROL FUMARATE) PRESSURISED INHALATION SUSPENSION. Prescribing Information Ireland. Please read the Summary of Product Characteristics before prescribing.Presentation: Pressurised inhalation suspension, in a pressurised metered dose inhaler (pMDI), containing fl uticasone propionate and formoterol fumarate dihydrate at strengths of 50 µg/5 µg, 125 µg/5 µg or 250 µg/10 µg per actuation. Indications: Regular treatment of asthma where the use of a combination product (inhaled corticosteroid and long-acting ß2-agonist) is appropriate: For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting ß2-agonist (SABA), or for patients already adequately controlled on both an inhaled corticosteroid and a long-acting ß2-agonist (LABA). fl utiform 50 µg/5 µg and 125 µg/5 µg per actuation are indicated for use in adults and adolescents 12 years and above. fl utiform 250 µg/10 µg per actuation is only indicated for use in adults. Dosage and administration: For inhalation use. The patient should be shown how to use the inhaler correctly by a physician or other healthcare professional. Patients should be given the strength of fl utiform containing the appropriate fl uticasone propionate dose for their disease severity (note that fl utiform 50 µg/5 µg per actuation is not appropriate in patients with severe asthma). The appropriate strength should be taken as two inhalations, twice-daily (normally in the morning and evening) and used every day, even when asymptomatic. fl utiform should not be used in children under 12 years. Prescribers should be aware that in asthmatics, fl uticasone propionate is as effective as some other inhaled steroids when administered at approximately half the total daily microgram dose. Total daily dose can be increased if asthma remains poorly controlled by administering a higher strength inhaler. Appropriate doses of the ß2-agonist and inhaled corticosteroid (ICS) in separate inhalers, or the ICS alone, should be prescribed if a patient requires doses outside the recommended dose regimens. Patients should be assessed regularly and once asthma is controlled, treatment should be reviewed and stepped down to the lowest effective dose, or an ICS alone. It is extremely important to regularly review patients as their treatment is stepped down. ICSs alone are fi rst line treatment for most patients. fl utiform is not intended for initial treatment of mild asthma. For patients with severe asthma the ICS therapy should be established before prescribing a fi xed-dose combination product. Patients on fl utiform must not use an additional LABA. An inhaled SABA should be taken for immediate relief of asthma symptoms arising between doses. The AeroChamber Plus® spacer device is recommended in patients who fi nd it diffi cult to use inhalers; re-titration should always follow the introduction of a spacer device. Patients should be advised to contact their prescriber when the fl utiform dose indicator is getting near zero.Contra-indications: Hypersensitivity to any of the active substances or excipients. Precautions and warnings: fl utiform should not be used for the fi rst treatment of asthma, to treat acute asthma symptoms or for prophylaxis of exercise-induced asthma. It should not be initiated during an exacerbation, during signifi cantly worsening or acutely deteriorating asthma, and should not be stopped abruptly. Patients should use their fl utiform maintenance treatment as prescribed, even when asymptomatic. If a patient experiences serious asthma-related adverse events or exacerbations, they should continue treatment but also seek medical advice. Patients should be reviewed as soon as possible if there is any indication of deteriorating asthma control. In the case of sudden and progressive deterioration, which is potentially life-threatening, an urgent medical assessment should be carried out. Use with caution in patients with: pulmonary tuberculosis; quiescent tuberculosis; fungal, viral or other infections of the airway; thyrotoxicosis; pheochromocytoma; diabetes mellitus (consider additional blood sugar controls); uncorrected hypokalaemia; predisposition to low levels of serum potassium; impaired adrenal function (monitor HPA axis function regularly) ; hypertrophic obstructive cardiomyopathy; idiopathic subvalvular aortic stenosis; severe hypertension; aneurysm or other severe cardiovascular disorders. There is risk of potentially serious hypokalaemia with high doses of ß2-agonists or concomitant treatment with ß2-agonists and drugs that can induce or potentiate a hypokalaemic effect. Particular caution is recommended in unstable or acute severe asthma and other conditions when the likelihood for hypokalemia adverse effects is increased. Monitoring of serum potassium levels is recommended during these circumstances. Formoterol may induce prolongation of the QTc interval. Caution must be observed when treating patients with existing prolongation of QTc interval. fl utiform should be discontinued immediately if there is evidence of paradoxical bronchospasm. Systemic effects with an ICS may occur, particularly at high doses for prolonged periods or when combined with potent CYP3A4 inhibitors, but are less likely than with oral corticosteroids. Use of a spacer device may also cause an increased systemic exposure. Increased exposure can be expected in patients with severe hepatic impairment. Prolonged

treatment with high doses of corticosteroids may result in adrenal suppression and acute adrenal crisis, particularly in adolescents and children or potentially as a result of trauma, surgery, infection or rapid dose reduction. Patients should be advised that fl utiform contains a small amount of ethanol; however this negligible amount does not pose a risk to patients. fl utiform is not recommended in children under 12 years of age. Interactions: Caution is advised in long-term co-administration with strong CYP3A4 inhibitors (e.g. ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfi navir, saquinavir, ketoconazole and telithromycin); co-administration should be avoided if possible. Ritonavir in particular should be avoided, unless the benefi ts outweigh the risks of systemic side-effects. Caution is advised with use of non-potassium sparing diuretics (e.g. loop or thiazide), xanthine derivatives, glucocorticosteroids, L-Dopa, L-thyroxine, oxytocin, alcohol or other adrenergic drugs. There is an increased risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons. Hypokalaemia may increase the risk of arrhythmias in patients being treated with digitalis glycosides. Concomitant use of ß-adrenergic drugs can have a potentially additive effect. Extreme caution should be taken when using formoterol fumarate with drugs known to prolong the QTc interval, such as tricyclic antidepressants or MAOIs (and for two weeks following their discontinuation), as well as antipsychotics (including phenothiazines), quinidine, disopyramide, procainamide and antihistamines. Concomitant use of an MAOI or a similar agent, such as furazolidone or procarbazine, may precipitate hypertensive reactions. ß-blockers and formoterol fumarate may inhibit the effect of each other. ß-blockers may produce severe bronchospasm in asthma patients, and they should not normally be treated with ß-blockers including those that are used as eye drops to treat glaucoma. Under certain circumstances, e.g. as prophylaxis after myocardial infarction, cardioselective ß blockers could be considered with caution Pregnancy and lactation: fl utiform is not recommended during pregnancy. It should only be considered if benefi ts to the mother outweigh risks to the foetus. It is not known whether fl uticasone propionate or formoterol are excreted in breast milk; a risk to the breast feeding infant cannot be excluded. A decision should be made on whether to discontinue breastfeeding or discontinue/abstain from fl utiform. Side-effects: Potentially serious side-effects: hyperglycaemia; depression; aggression; behavioural changes (predominantly in children); paradoxical bronchospasm; agitation; vertigo; palpitations; ventricular extrasystoles; angina pectoris; tachycardia; hypertension; dyspnoea; peripheral oedema; Cushings Syndrome; adrenal suppression; growth retardation; cataract and glaucoma; hypersensitivity reactions and QTc interval prolongation. Please consult the SPC for details of non-serious side-effects and those reported for the individual molecules. Legal category: POM Package quantities: One inhaler containing 120 actuations 50 µg/5 µg, 125 µg/5 µg, 250 µg/10 µg Marketing Authorisation numbers: PA 1688/13/1-3 Marketing Authorisation holder: Mundipharma Pharmaceuticals Limited, Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland. Member of the Mundipharma Pharmaceutical Group. For medical information enquiries, please contact info@mundipharma.ieDate of preparation: January 2013

Reference:1. fl utiform Summary of Product Characteristics

® FLUTIFORM is a registered trademark of Jagotec AG, and is used under licence.® AEROCHAMBER and AEROCHAMBER PLUS are registered trade marks of Trudell Medical International. © 2012 Mundipharma Pharmaceuticals Limited.

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

IRE/FL-12042

A P O W E R F U L P A R T N E R S H I P

NEW

fluticasone propionate/formoterolfl utiform is indicated for the regular treatment of asthma in adults and adolescents (12 years and over),where use of a combination product (inhaled corticosteroid [ICS] and long-acting ß2-agonist [LABA]) is appropriate. fl utiform 250/10µg indicated in adults only.

Rapid onset* andlong lasting effi cacy**

COMBINATION

Modern aerosol device with a patient-facing dose counter1

INNOVATION

Modern aerosol device with a patient-facing dose counter

INNOVATION

* Open label study, signifi cant increase in FEV1 5 mins after dosing (p=o.oo1) (Aalbers et al: Onset of Bronchodilationwith fl uticasone/formoterol combination versus fl uticasone/salmeterol in an open-label, randomised study; Adv Ther 2012)** 6-12 month open label study, signifi cant improvement in spirometric secondary endpoints vs baseline (Mansur et al,Long Term Safety and Effi cacy of fl uticasone/formoterol combination therapy in Asthma; JAMP -Vol 25, No0, 2012 p1-10)

NEW

50/5 µg 125/5 µg 250/10 µg

The NEW asthma maintenance treatment

32

clinical review

Insulin initiation in the communityheleNA FARRell RGN, MSC DIABETES, BlACKROCK HAll PRIMARY CARE CENTRE, CORK, DIRECTOR OF HElENA FARREll CONSUlTANCY

Type 2 diabetes is a progressive condition, where beta cell function declines and fails, therefore requiring almost all individuals to be commenced on insulin therapy. There appears to be a very real clinical inertia within community care in relation to the initiation of

insulin and GlP-1 hormones in the community. This appears to be dependent on a number of variables, most notably cost, efficacy and side-effects. Also access to specialist supports such as access to a diabetes specialist nurse and consultant care has to be considered. This is not just unique to Ireland, it is a worldwide phenomenon. As with most insulin initiation and GlP-1 hormone initiation in the community, it is primarily for individuals with type 2 diabetes, so this article will focus on that population.

clinical inertiaClinical Inertia is a widely recognized problem in diabetes management within primary care, directly linked to poor glycaemic control and elevated HbA1c levels (Ziemer et al, 2005). lack of familiarity, education, training and over estimation of the care needed are all reasons cited by primary care physicians for not intensifying current treatment regimes or initiating insulin therapy (Philips et al, 2001). While non-adherence was cited as another contributory factor, this has been shown in many studies not to be as big an issue as clinical inertia (Reach, 2008, Giugliano et al, 2011). There is a general consensus amongst many primary care physicians that insulin therapy should only be commenced when absolutely necessary (Peyrot et al, 2005), despite the fact that there is evidence to

33

clinical review

suggest that by achieving good glycaemic control early in the course of diabetes, that long term vascular outcomes improve and potentially prolong beta-cell function (Niswender et al, 2002).

Role of general practiceTraditionally insulin initiation in type 2 diabetes has usually been commenced within a specialist setting and/or in secondary care. Due to type 2 diabetes reaching epidemic proportions, which is putting huge strain on an already over stretched secondary care service, there is a growing need for physicians within primary care to take on the management of what may have traditionally been viewed as more complex patients with type 2 diabetes.

Targets for HbA1c levels are not being met despite more drug regimes being made available. Type 2 diabetes is a progressive condition and this was shown through the UK Prospective Diabetes Study, which saw that those with type 2 diabetes had only 50% of normal insulin secretion at diagnosis and after six years had only less than 25% (UKPDS, 1998). Therefore the only way to achieve good glycaemic control in many of these patients is through the initiation of insulin.

Patient educationThere is no doubt that intensifying regimes and/or initiating insulin within the type 2 diabetes population requires a certain amount of support, confidence and knowledge, not just for the healthcare professional, but also the patient. The education that is involved is time consuming and intensive, which may be a barrier for both the healthcare professional and the individual concerned. A number of factors must be considered before commencing someone on insulin therapy or a GlP-1 hormone. Patient safety is an obvious primary concern with environmental and social factors also being taken into consideration. Do they live alone? Have they home support for e.g. home help, public health nurse etc. What is their health literacy like? What is their ability to understand and adhere to an insulin therapy regime?

One of the major barriers to insulin initiation is the individual’s own resistance or reluctance to commence insulin therapy. Many patients view commencing insulin therapy as a failure and subsequently there is a huge element of self-blame (Hunt et al, 1997). In one study, up to three quarters of participants viewed the initiation of insulin therapy as a ‘severe crisis’ in their condition (Ratzman, 1991). This may result in an individual go through the Five Stages of Grieving (Kubler-Ross, 2005). These are five emotional states of denial, depression, anger, bargaining and acceptance which an individual goes through not just when grieving for a loved one, but it is now well recognized that they also occur when grieving for a loss or their health or what they perceive as a worsening of their condition (Brown, 1985). Unless the healthcare professional acknowledges and understands these five stages and supports the individual, concerned this may lead to significant mental health issues such as depression, which may affect their adherence to an insulin regime (Kilbourne, 2005). There is a significant relationship between diabetes and depression, which may present another barrier to commencing insulin therapy (Robinson et al, 2008).

side effects of insulinThe side effects of insulin can also be a barrier to both patients and healthcare professionals commencing any regime. Hypoglycaemia, weight gain and complications are very real concerns and should be discussed with any individual when commencing insulin therapy to allay any fears that could

present a challenge to adhering to a regime. Other barriers to insulin initiation are concerns over restrictions to daily life that they suspect may arise when they are on insulin therapy, as well as an increase in the frequency of capillary blood glucose testing (Okazaki et al, 1999).

Needle phobia is another issue when commencing insulin therapy and its severity and prevalence can be underestimated amongst the healthcare profession. Up to 14% of people with diabetes can display some injection related anxiety, with up to 45% avoiding insulin injections (Zambanini et al, 1999). Needle phobia can be related to an underlying general anxiety disorder (GAD) which may need to be considered and addressed prior to commencing insulin therapy (Popkin et

al, 1988). Education about proper injection technique is also paramount to prevent issues such as lipohypertrophy which can affect insulin absorption and therefore adversely affect glycaemic control (Young et al, 1984). lipohypertrophy arises when a lump occurs under the skin due to an accumulation of fat from multiple insulin injections at that particular site (Rapini et al, 2007). Not changing needles and injecting at the same site repeatedly can contribute to the development of lipohypertrophy. The use of educational aids to assist an individual practising injection technique prior to the commencement of insulin therapy will ensure best practice, help allay any fears and allow for an open, honest discussion in relation to their overall diabetes management.

There is a real onus on healthcare providers to ensure that a patient fully understands the reasons why insulin therapy is being considered and the benefits to an individual’s health. Many people who have type 2 diabetes do not consider insulin therapy to be part of their management, only associating it with type 1 diabetes, and when the issue is raised with them, it can come as a huge shock. There is an opportunity when reviewing medication regimes or when educating an individual with type 2 diabetes on glycaemic control, to discuss their thoughts and perceptions, (known as health beliefs) in relation to insulin therapy, which effectively is facilitating and ‘sowing a seed’ towards self-efficacy and empowerment.

conclusionInsulin is a safe and effective way of achieving good glycaemic control in individuals with diabetes; unfortunately it is not initiated enough, used often enough or aggressively enough. The use of education when initiating insulin therapy within the community is essential in helping to increase self-efficacy in an individual with type 2 diabetes and also in coping with the

There appears to be a very real clinical inertia within community care in relation to the initiation of insulin and GlP-1 hormones in the community.

34

clinical review

complexities of the regime. Insulin therapy should be viewed as a normal and routine part of diabetes management, rather than being used as a threat for when a patient does not adhere with certain aspects of their care. Education helps to break down barriers and dispel many of the myths that are associated with insulin therapy.

ReferencesZiemer, David C., et al. “Clinical inertia contributes to poor diabetes control in a primary care setting.” The Diabetes Educator 31.4 (2005): 564-571.Phillips, lawrence S., et al. “Clinical inertia.” Annals of internal medicine 135.9 (2001): 825-834.Reach, G. “Patient non-adherence and healthcare-provider inertia are clinical myopia.” Diabetes & metabolism 34.4 (2008): 382-385.Giugliano, Dario, and Katherine Esposito. “Clinical inertia as a clinical safeguard.” JAMA: The Journal of the American Medical Association 305.15 (2011): 1591-1592.Peyrot, Mark, et al. “Resistance to Insulin Therapy Among Patients and Providers Results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study.” Diabetes Care 28.11 (2005): 2673-2679.Niswender, Kevin. Early and Aggressive Initiation of Insulin Therapy for Type 2 Diabetes: What Is the Evidence?. Clinical Diabetes 27.2 (2009): 60-68.UK Prospective Diabetes Study (UKPDS) Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352: 837–853, 1998Hunt lM, Valenzuela MA, Pugh JA: NIDDM patients’ fears and hopes about insulin therapy: the basis of patient reluctance. Diabetes Care20:292–298, 1997Ratzman KP: [The psychological aspects of diabetics with the

secondary failure of sulfonylurea therapy] (Article in German). Dtsch Med Wochenschr 116:87–90, 1991Kubler-Ross, Elisabeth, and David Kessler. On grief and grieving: Finding the meaning of grief through the five stages of loss. SimonandSchuster. com, 2005.Brown, Sharon A. “Diabetes and grief.” The Diabetes Educator 11.2 (1985): 53-57.Kilbourne, Amy M., et al. How does depression influence diabetes medication adherence in older patients?. American Journal of Geriatric Psych 13.3 (2005): 202-210.Robinson, N., J. H. Fuller, and S. P. Edmeades. Depression and diabetes. Diabetic medicine 5.3 (1988): 268-274.Okazaki K, Goto M, Yamamoto T, Tsujii S, Ishii H: Barriers and facilitators in relation to starting insulin therapy in type 2 diabetes (Abstract).Diabetes 48(suppl. 1):A319, 1999Zambanini, Andrew, et al. “Injection related anxiety in insulin-treated diabetes.”Diabetes research and clinical practice 46.3 (1999): 239-246.Popkin, Michael K., et al. Prevalence of major depression, simple phobia, and other psychiatric disorders in patients with long-standing type I diabetes mellitus. Archives of General Psychiatry 45.1 (1988): 64.Young, Robert J., et al. Diabetic lipohypertrophy delays insulin absorption. Diabetes Care 7.5 (1984): 479-480.Rapini, Ronald P.; Bolognia, Jean l.; Jorizzo, Joseph l. (2007). Dermatology: 2-Volume Set. St. louis: Mosby.

About the authorHelena Farrell RGN, MSc Diabetes, is the only freelance specialist nurse in diabetes working in the Republic of Ireland. She is based in Blackrock Hall Primary Care Centre, Cork. She is Director of Helena Farrell Consultancy (formerly Diabetes Insight).

In one study, up to three quarters of participants viewed the initiation of insulin therapy as a ‘severe crisis’ in their condition.

Up to 80% of sexually active women become infected with an HPV type in their lifetime1

Why gamble?

Most women under 45 years of age can gain some protection from Gardasil® against HPV

types 6, 11, 16 & 18 regardless of past or current infection2,3,4,5

Gardasil® – shows high efficacy for the prevention of cervical cancer and other HPV related genital diseases2

11/13 IR00131(1)

Information about adverse event reporting can be found at www.imb.ie. Adverse events and inadvertent vaccination during pregnancy should also be reported to Sanofi Pasteur MSD by calling 00 44 1628 785291. Further information available upon request.

ABRIDGED PRESCRIBING INFORMATION GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)). Refer to Summary of Product Characteristics for full product information before prescribing. Additional information is available on request. Presentation: Gardasil is supplied as a single dose pre-filled syringe containing 0.5 millilitre of suspension. Each dose of the quadrivalent vaccine contains highly purified virus-like particles (VLPs) of the major capsid L1 protein of Human Papillomavirus (HPV). These are type 6 (20 μg), type 11 (40 μg), type 16 (40 μg) and type 18 (20 μg). Indications: Gardasil is a vaccine for use from the age of 9 years for the prevention of premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types and genital warts (condyloma acuminata) causally related to specific HPV types. The indication is based on the demonstration of efficacy of Gardasil in females 16 to 45 years of age and in males 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents. Dosage and administration: The primary vaccination series consists of 3 separate 0.5 millilitre doses administered according to the following schedule: 0, 2, 6 months. If an alternate schedule is necessary the second dose should be administered at least one month after the first and the third dose at least three months after the second. All three doses should be given within a 1 year period. The need for a booster dose has not been established. The vaccine should be administered by intramuscular injection. Contraindications: Hypersensitivity to any component of the vaccine. Hypersensitivity after previous administration of Gardasil. Acute severe febrile illness. Warnings and precautions: The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination. As with all vaccines, appropriate medical treatment should always be available in case of rare anaphylactic reactions. The vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals. Syncope, sometimes associated with falling, can occur before or after vaccination with Gardasil as a psychogenic response to the needle injection. Vaccinees should be observed for approximately 15 minutes after vaccination; procedures should be in place to avoid injury from faints. There is insufficient data to recommend

use of Gardasil during pregnancy therefore the vaccination should be postponed until after completion of the pregnancy. The vaccine can be given to breastfeeding women. Gardasil will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to some limited extent against diseases caused by certain related HPV types. Vaccination is not a substitute for routine cervical screening. Individuals with impaired immune responsiveness, due to either the use of potent immunosuppressive therapy, a genetic defect, or other causes, may not respond to the vaccine. As with any vaccine, vaccination with Gardasil may not result in protection in all vaccine recipients. There are no safety, immunogenicity or efficacy data to support interchangeability of Gardasil with other HPV vaccines. Undesirable effects: Very common side effects include: headache and at the injection site, erythema, pain and swelling. Common side effects include bruising and pruritus at the injection site, pyrexia, nausea, and pain in the extremity. Rarely urticaria and very rarely bronchospasm has been reported. Idiopathic thrombocytopenic purpura, Guillain-Barré Syndrome and hypersensitivity reactions including, anaphylactic/anaphylactoid reactions have also been reported. For a complete list of undesirable effects please refer to the Summary of Product Characteristics. Package quantities: Single pack containing one 0.5 millilitre dose pre-filled syringe with two separate needles. Marketing authorisation holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007, Lyon, France Marketing authorisation number: EU/1/06/357/007 (pre-filled syringe with two separate needles). Legal category: POM. ®Registered trademark. Date of last review: Nov 2012.References: 1. Health Protection Surveillance Centre. http://www.hpsc.ie/hpsc/A-Z/Hepatitis/HPV/Factsheet/. Accessed August 2013. 2. Gardasil® Summary of Product Characteristics. 3. Kjaer SK et al. A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (trypes 6/11/16/18) vaccine against high-grade cervical and external genital lesions. Cancer Prev Res 2009;2(10):868-878. 4. The Future II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. J Infec Dis 2007; 196(10): 1438-4615. 5. Joura E et al. Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: retrospective pooled analysis of trial data. BMJ 2012;344:e1401.

GARDASIL_why gamble_A4_NOV13_01.indd 1 08/11/2013 14:07

36

technology

It’s probably safe to say that anyone who is not using social media by now is either afraid of it or doesn’t have the time for it.

While time is certainly an issue for many, a significant number of people remain intensely distrustful of social media. Worries about invasion of privacy, concern about personal security (particularly in relation to children)

and fear of cyber-bullying are all valid reasons to steer clear.Nurses face a whole host of additional risks if they are active

on social media sites: professionalism, ensuring appropriate nurse/patient relationships, legal/moral/ethical issues, being seen to give medical advice and maintaining patient confidentiality are all issues that should be considered.

We are used to maintaining patient confidentiality in the ‘real’ world. It was drummed into us during our training and for the most part is, thankfully, normal practice in healthcare settings. Talking about patients in lifts, corridors or the car park instinctively feels wrong so our default habit is to avoid it at all costs. Customs and practices related to patient privacy in healthcare settings are pretty much set in stone now.

However, the pace of our migration to the online world has been supersonic, so customs and practices there are still evolving and, quite frankly, leave a lot to be desired. One indicator of this is that of the 48 medical boards in the US, 44 have received complaints about violations of online professionalism.

There have been some spectacular online breaches of confidentiality from healthcare providers all over the world. Some are so blatantly negligent they are difficult to credit. Others may have been unintentional but they are breaches of privacy nonetheless.

For example:• Violations by healthcare professionals around the world have

included, a physician asking a patient for a date, another who labelled a patient lazy and ignorant for attending hospital repeatedly for treatment of uncontrolled blood sugars, a medical student who filmed a chest drain being inserted into a patient whose face was clearly visible, the sharing of a picture of a patient’s medical record on a healthcare employee’s Facebook account, a nurse assistant who took and shared a picture of a quadriplegic patient after he had had a bowel movement, discussions with colleagues on Facebook about specific patients and the sharing of a photo of a stab victim who later died.

If you wouldn’t say it using a loudspeaker at the GPO, don’t post it online.

Practice nurses and social media – how to avoid hidden pitfallslIsA NOlAN, HEAlTHCARE VIRTUAl ADMINISTRATOR AT ASlAN VIRTUAl ADMIN

37

technology

with the intention of posting them online. Make sure that no patient is in the background and that no patient notes are visible either. Someone could easily zoom in on that image and read the notes or patient’s name.

5) Changing details (like a name or age) doesn’t guarantee confidentiality.

Resources:There are a number of useful resources for nurses using social media. Here are some of the best ones.

The Nursing and Midwifery Board of Ireland has guidelines for nurses using social media. http://www.nursingboard.ie/en/publications_current.aspx

The ICGP has numerous factsheets and guidelines on the use of social media, all relevant to both GPs and Practice Nurses. http://www.icgp.ie/go/in_the_practice/it_faqs

The Nursing and Midwifery Council (UK) has guidelines on applying their Code to social networking sites. http://www.nmc-uk.org/Nurses-and-midwives/Advice-by-topic/A/Advice/Social-networking-sites/

The American Nurses Association has an extensive Social Networking Principles Toolkit at http://www.nursingworld.org/socialnetworkingtoolkit.aspx

CDC Social Media Tools, Guidelines & Best Practices http://www.cdc.gov/socialmedia/Tools/guidelines/

Nurse Together has a five minute YouTube clip entitled Social Media Guidelines for Nurses via www.nursetogether.com

We Nurses has a very useful set of links to guidelines for nurses using social media, via www.wenurses.co.uk

References and sources: www.FierceHealthcare.com www.medicalprotection.orgPhysician Violations of Online Professionalism and Disciplinary Actions: A National Survey of State Medical Boards – JAMA. 2012; 307(11): 1141-1142. doi:10.1001/jama.2012.330.

• An A&E doctor in the US posted an account of a shift on Facebook in 2011. Although she didn’t give names, she included enough detail about one patient’s injuries so that a third party was able to identify them. Although the doctor deleted her Facebook account as soon as she knew her patient had been identified, she was subsequently found guilty of unprofessional conduct, fired by the hospital and fined by her state medical board.

• I watched a discussion on Twitter last year where a doctor posted a picture of an x-ray on Twitter along with some clinical details and the patient’s age, and asked medical colleagues to give their opinions – basically he was crowdsourcing. Other doctors who were online at the time responded quickly, not with medical opinions, but suggesting that he had given too much information in his Tweet and therefore other patients who had been in his waiting room that day could potentially have identified the patient.

• A nurse in Scotland was suspended for posting pictures of patients having surgery on Facebook.

• In the US a patient took a video of another patient who was drunk, and posted the clip online. The hospital made huge efforts to have the video deleted, but were unsuccessful because it hadn’t violated that particular forum’s rules. The online debate about this case centred around free speech vs. the patient’s right to privacy.

There are ways to manage risks on social media. As is often the case, common sense is the most useful tool. If you wouldn’t say it using a loudspeaker at the GPO, don’t post it online. Venting about how busy you were today because one of your patients arrived at your surgery with a stab wound and subsequently had to be transferred to A&E by ambulance, is breaching confidentiality and possibly even putting them in danger if their assailant finds out what hospital they are in. Complaining about the trouble you are having getting a family with triplets to keep up with their vaccinations is basically identifying them to anyone else who was in your waiting room and noticed a parent with triplets. Posting a get well message to a patient on your Facebook timeline, or even via a message on their timeline, is another example of a violation of privacy, even though it might be well-meaning.

Remember, a momentary lapse of professionalism online is permanent and searchable, even if you later delete it.

In addition to following the usual rules of patient confidentiality, don’t forget:1) Texting and – mailing counts as ‘online activity’.2) Don’t rely on privacy settings to keep your online activity

contained to a specific audience. In fact, from 11th November Google will show users’ names and photos (along with any ratings and comments they may have made on particular products in the past) in internet adverts; i.e. endorsing marketers’ products – unless they specifically opt out. Facebook is also currently changing its policies so that all users will be discoverable via their Graph Search – unless they specifically opt out. Always assume that anything you post online is visible to everyone, both now and in the future.

3) Most of the teenagers and adults sitting in your waiting room right now have a smartphone and children are likely to have Nintendos that have inbuilt cameras. Are they taking pictures of other patients? How would your practice deal with this if another patient complained?

4) Be careful if taking team photos of you and your colleagues

Are [patients in your waiting room] taking pictures of other patients? how would your practice deal with this if another patient complained?

38

meeting report

A breath of fresh airCOPDexchange.ie aims to encourage education and awareness of a condition which remains undiagnosed in many cases

JAMes FOGARTy

COPD will be the third biggest killer in Ireland by 2020, a meeting of GPs and practice nurses heard recently. Dr Bob Rutherford, Consultant Respiratory Physician at Galway University Hospital, made the comments at the launch of a new learning resource

COPDexchange.ie. The independent educational resource, launched by

Boehringer Ingelheim, is aimed exclusively at Irish healthcare professionals (HCPs) caring for patients with COPD. HCPs can register for free on www.COPDexchange.ie for access to a suite of peer-reviewed materials designed to aid in the accurate diagnosis and effective management of one of Ireland’s leading causes of mortality. The website’s two educational modules are recognised for one CPD po int each, which are awarded to HCPs on successful completion. The Irish Nursing Board also recognises www.COPDexchange.ie for category one approval.

All content on COPDexchange.ie is developed in line with the latest Glo bal Initiative for Chronic Obstructi ve lung Disease (GOlD) guidelines, and a panel of respiratory experts hold editorial control to ensure that information provided is educational and independent.

Once registered, users have access to a suite of tools for HCPs including a smoking pack-years calculator, a downloadable Fletcher and Peto Chart and a COPD Assessment Test questionnaire.

The initiative follows the success of COPDexchange.co.uk, which provides similar resources for HCPs in the UK. Since going live in 2009, it has attracted more than 8,000 HCPs to register for continually updated educational content.

Diagnosis“We have a major problem here, but there are plenty of opportunities to deal with it,” Dr Rutherford explained.

COPD is a debilitating disease in almost every sense, which impacts on every aspect of the patient’s life. The number of known patients runs into the hundreds of thousands, how-ever, most disturbingly, half of patients are diagnosed with COPD only when they have developed severe or very severe symptoms.

After the age of 30, about 25ml to 30ml of lung capacity per year is lost naturally through ageing, but patients susceptible to COPD lose, on average, 60ml. However, while some can lose a lot less, others unfortunately lose up to 100ml per year.

“It is the third most common ca use of acute admissions to hospitals. It is a massive problem. The average length of stay for a hospital admission is six days, the average stay for a COPD patient is nine days,” Dr Rutherford told the audience.

“Many have lost half of their lung function by the time they are diagnosed and about 50 to 75 per cent are not diagnosed at all.”

Clearly this is not an acceptable situation for patients or healthcare professionals. The risk factors of the disease are well known: smoking, occupational and chemical fumes, and indoor air pollutants. While the majority of patients develop the disease due to a tobacco habit, a minority de velop COPD through exposu re to occupational and chemical fu mes, and indoor air pollutants.

cessationDr Derek Forde, ICGP Clinical le ad in COPD, also told the meeting that while some patients will doubt whether they can quit after a lifeti me of smoking, the importance of smoking cessation cannot be overestimated.

“It is never too late to stop,” he said. Dr Forde added that he uses the Fletcher Peto Curve as a tool to motivate patients to try smoking cessation.

“When you show smokers where they are heading, compared to where they will be if they stop smoking at 30 or 50, it is an eye-opener. A spirometer is useful in showing them their lung age. If a patient is 50 years of age and a smoker and you say ‘OK your lung age is 85’, they wake up and engage with you,” Dr Forde explains. “The basic fact is if you are not stopping smoking and you are susceptible to COPD, you are in big trouble.”

Dr Rutherford also emphasised the importance of smoking cessation.

“This is a very insidious condition and it is not until there is a 50 per cent reduction in capacity that all patients become symptomatic. Once you get to 30 per cent or 25 per cent you are at risk of dying. It is never too late to stop smoking. If you stop smoking at the age of 50, you will continue to lose lung function, but just at the normal rate. Even at the age of 70 it is still worth stopping; it is never too late to stop smoking.”

COPDexchange.ie provides free peer-reviewed resources, expert guidelines, and CPD accredited le arning content, which both Dr Forde and Dr Rutherford helped to create.

However, they both agree that the continued lack of a national screening programme is a stumbling block for treatment.

“If there was not the current impasse between the Department of Health and the ICGP clinical programmes, a COPD screening programme would be the next phase,” said Dr Forde. “If we were screening, spirometry would be the most important test. It is objective if it is done properly, it is

39

meeting report

affordable and it is safe.” The average spirometer only costs about €2,500.

Dr Rutherford suggested that the next logical step after screening is the establishment of specialised units, similar to the cancer centres of excellence, which would provide all facets of COPD treatment under one roof.

“If you are going to screen for so mething, you have got to be able to do something about it,” he expla ined. “If we had a national scre ening programme, I think it would lead to better uniformity of treatment – everyone being tested on the same inhalers, being interpreted in the same way and perhaps being put on the same medications.”

One of the biggest concerns for doctors treating COPD patients is exacerbations, and Dr Rutherford adds that patients who expe-rience a lot of exacerbations are on a steep downward curve.

“Each infection is another hit to the airway,” Dr Rutherford said. “Unfortunately, the worse your lung function, the more ex-acerbations you get, and each exacerbation is disastrous for that patient. For a start, there is an 8 to 9 per cent mortality rate for that particular admission, and 20 to 25 per cent are dead within one year. So it is significantly worse than a heart attack.”

ManagementThe strategies used in the management of COPD have changed in recent years, a move that Dr Forde welcomes.

“Up to recently, the main respiratory disease in primary care was asthma,” he explained. “Unfortunately many COPD patients followed an asthma-type management plan. This is not cor-rect, as evidence has shown that steroids increase instances of respiratory infection and pneumonia. More and more evidence suggests stopping the use of steroids early in the treatment of COPD, which is totally different to your asthmatics.”

Dr Rutherford echoed this, saying that inhaled steroids should never be given on their own to COPD patients due to the high risk of pneumonia. However, Dr Rutherford went on to to de-scribe the annual flu vaccine as a “critical intervention”, protect-ing not only against flu, but also significantly reducing the rates of pneumonia. He added that elective pulmonary rehab, while not reducing exacerbations, might reduce length of hospital stay and may even reduce mortality. For patients who experi-ence very frequent exacerbations, Dr Rutherford also recom-mends the use of azithromycin.

“In the 1980s and 1990s, Japanese patients developed a con-dition called panbronchiolitis and the mortality of this condi-tion was 80 per cent. Somebody put them onto azithromycin and it changed the landscape for this condition,” he added. “The mortality fell to five to 10 per cent.”

He also said that the most positive study ever on reducing exacerbati ons centred on azithromycin and he uses it regularly. However, if the patient still exacerbates on azithromycin, Dr Rutherford said he would discontinue the drug and place the patient on the PDE-4 inhibitor roflumilast.

Dr Forde also pointed to the use of the updated GOlD guide-lines issued this year. These guidelines help in the management of patients who are at varying levels of symptom severity, but may have the same spirometry reading. The guidelines also help identify patients earlier, heading off complications and exacer-bations in the future.

Dr Forde also recommended the use of the CAT test and the modified Medical Research Council (MRC) dys pnoea scale as well as use of exercise.

“For me it is all about moving and exercise, even if you are house bo und,” he said.

He added that given that there can be a number of co-mor-bidities with the more severe patients, drug compliance can be a problem.

“What makes COPD complicated is the overlap in symptoms,” he said. “In my practice with patients over 60, it is very rare that they will have only one disease. One condition is usually accompanied with others like diabetes, renal failure or heart failure.”

Practice Nurse, Ms Ruth Murrow, also discussed some of the other practicalities of running a COPD clinic.

“COPD has been historically perceived as difficult to manage with a poor prognosis as it is not as glamorous as asthma,” she added.

However, she said that COPD ma nagement in clinical practice is important and more emphasis should be placed on proper management to reduce exacerbations, hospitalisations, emergency department (ED) attendances and emergency GP visits.

Among the things a clinic can help with, she suggested, are an annnual physical examination with a spirometry test, inhaler technique and, of course, smoking cessation.

Clinical Nurse Specialist at GUH, Ms Marie Byrnes also discussed the COPD outreach programmes available around the country. In those, active treatment is provided by healthcare professionals in the patient’s own home for an acute exacerbation of COPD (AECOPD), an event which would require hospital care otherwise.

Her colleague, Ms Niamh Duignan, Senior Physiotherapist at Merlin Park, also discussed the importance of physiotherapy for COPD patients. She explained that, according to the UK’s standards authority, NICE, COPD patients with an MRC dyspnoea scale score of three to five benefit from pulmonary rehabilitation.

Ms Maria McNeill, Chief Respiratory Scientist, at the Midland Regional Hospital, Mullingar, also told the meeting that there would be great benefits from improving links between the hospital and primary care. She cited a study she was involved in where respiratory scientists performed spirometry in general practices. As well as being very popular with patients and GPs, the study also had the effect of reducing waiting lists and times.

While once the future looked bleak for COPD sufferers, the establishment of COPDexchange.ie and the mooted establishment of a screening programme means that this disease may finally get the attention it deserves.

“As we get more and more involved in chronic disease management,” said Dr Forde, “my view is that you are just not at the races unless you and your practice nurses are working as a team”.

Inhaled steroids should never be given on their own to cOPD patients due to the high risk of pneumonia

40

abstracts

Burden of illness and quality of life in patients being treated for seasonal allergic rhinitis: a cohort survey

small M, Piercy J,

Demoly P, Marsden h.

Allergic rhinitis is an inflammatory disease which is characterised by burdensome nasal and/or ocular symptoms. This study aimed to assess the impact of symptoms (number of symptom-free days (SFD) and quality of life (Qol)) in patients with seasonal allergic rhinitis (SAR) being treated with fluticasone furoate (FF), mometasone furoate (MF) or fluticasone propionate (FP).

In a cross-sectional, non-interventional, cohort analysis, primary care physicians and allergy specialists in France, Germany, and Spain were recruited via telephone interviews. Each physi-cian prospectively recruited 4 SAR patients – 2 receiving FF, 1 receiving MF and 1 receiving FP – during June 2009. Patients answered questions on symptoms and completed questionnaires on Qol (mini-rhinoconjunctivitis Quality of life Questionnaire, RQlQ) and burden of illness (Pittsburgh Sleep Quality Index). ClinicalTrials.gov identifier: NCT01199757.

A total of 540 patients were recruited during June 2009. 88 patients were subsequently found to be ineligible and excluded from the analyses. In the 4 weeks prior to assessment, patients reported a mean of 14.58 (+/-8.42) SFD. Patients receiving FF had more SFD (mean 15.45 +/-8.29) than patients receiving MF (adjusted mean difference – 1.22, 95% Confidence Interval (CI) [-3.16 to 0.72], p=0.434) or FP (adjusted mean difference – 1.95, 95% CI [-3.87 to – 0.03], p=0.092), although statistical significance was not achieved. The mean RQlQ score was 1.54 (+/-1.06). Patients receiving FF had a better quality of life in the previous week (mini-RQlQ score: mean 1.42, +/-1.04) than patients receiving MF (adjusted mean difference 0.28, 95% CI [0.03 to 0.52], p=0.052) or FP (adjusted mean difference 0.18, 95% CI [-0.05 to 0.41], p=0.244) Again, none of these results achieved statistical significance.

At the height of the allergy season, patients with SAR suffer symptoms approximately 50% of the time, and report an impact on their Qol. No significant differences were observed between FF, FP and MF related to SFD or Qol.

Investigation of poly (ADP-Ribose) polymerase-1 genetic variants as a possible risk for allergic rhinitis

Ozaydin A, Akbas

F,Aksoy F et alDepartment

of Medical Biology,

Cerrahpasa Faculty of Medicine,

Istanbul University , Istanbul,

Turkey .

Recent studies point toward the involvement of poly (ADP-ribose) polymerase-1 (PARP-1) in the pathogenesis of allergic airway inflammation, such as asthma and allergic rhinitis (AR). It has been suggested that inhibition of PARP-1 provides significant protection against systemic or tissue inflammation in animal models. The objective of this study was to investigate whether single-nucleotide polymorphisms of PARP-1 gene are associated with genetic susceptibility to AR. We studied the effect of promoter variations and Val762Ala polymorphism of the PARP-1 gene on the risk for developing AR in a case-control association study with 110 RA patients and 130 control subjects in a Turkish population. The polymorphisms of 410 C/T, – 1672G/A, and Val762Ala in the PARP-1 gene were analyzed using the polymerase chain reaction-restriction fragment length polymorphism method. Haplotype analysis of these groups was also per-formed. The results were statistically analyzed by calculating the odds ratio (OR) and their 95% confidence intervals using χ2 tests. The heterozygote genotype of the promoter polymorphism (-1672) was significantly found to be associated with susceptibility to AR (OR: 0.56) among the tested single-nucleotide polymorphisms. Haplotypes of PARP-1 – 410, – 1672, and 762 were not associated with an increased risk for AR. These results raise the possibility that the promoter (-1672) polymorphism of the PARP-1 gene may be a risk factor for AR.

Focus on: AlleRgy

Because congestion can impact your patients with allergic rhinitis any time of year... 85

%

of all

ergic

rhinit

is su

fferer

s

experi

ence

cong

estion

1

RESP

-107

9917

-000

0

NASONEX® 50 micrograms/actuation Nasal Spray, Suspension (mometasone furoate) [Phenylethyl alcohol-free formulation] ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing PRESENTATION: Nasal spray suspension containing mometasone furoate (as monohydrate) 50 micrograms per actuation. INDICATIONS: Adults and children aged 18 and over: Treatment of nasal polyps. Adults and children over the age of 12 years: For the treatment of the symptoms of seasonal allergic rhinitis or perennial rhinitis. Children 6 to 11 years of age: For the treatment of the symptoms of seasonal allergic rhinitis or perennial allergic rhinitis. In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with Nasonex may be initiated up to four weeks prior to the anticipated start of the pollen season. DOSAGE AND ADMINISTRATION: Nasal Polyposis: Adults and children aged 18 and over: The usual recommended starting dose for polyposis is two actuations (50 micrograms/actuation) in each nostril once daily (total daily dose of 200 micrograms). If after 5 to 6 weeks symptoms are inadequately controlled, the dose may be increased to a daily dose of two sprays in each nostril twice daily (total daily dose of 400 micrograms). The dose should be reduced following control of symptoms. If no improvement in symptoms is seen after 5 to 6 weeks of twice daily administration, alternative therapies should be considered. Efficacy and safety studies of Nasonex Nasal Spray for the treatment of nasal polyposis were four months in duration. Seasonal or Perennial Allergic Rhinitis: Adults and children over the age of 12 years: Two sprays (50 micrograms/spray) in each nostril once daily (total dose 200 micrograms). Once symptoms are controlled, dose reduction to one spray in each nostril (total dose 100 micrograms) may be effective for maintenance. If symptoms are inadequately controlled, the dose may be increased to a maximum daily dose of four sprays in each nostril (total dose 400 micrograms). Dose reduction is recommended following control of symptoms. Children 6 to 11 years of age: One spray (50 micrograms/spray) in each nostril once daily (total dose 100 micrograms). Clinically significant onset of action occurs in some patients within 12 hours after the first dose. Full benefit of treatment may not be achieved in the first 48 hours. Regular use is recommended to achieve full therapeutic benefit. CONTRAINDICATIONS: Hypersensitivity to any of the ingredients. Do not use in the presence of untreated localised infection involving the nasal mucosa. Patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred. PRECAUTIONS AND WARNINGS: Use with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections or ocular herpes simplex. There was no evidence of atrophy of the nasal mucosa following 12 months of treatment. Patients using Nasonex over several months or longer should be examined periodically for changes in the nasal mucosa. If localised fungal infection of the nose or pharynx develops, discontinuance of Nasonex therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing Nasonex. The concomitant use of additional therapy may provide additional relief particularly of ocular symptoms. There is no evidence of HPA axis suppression following prolonged treatment with Nasonex. Patients who are transferred from long-term administration of systemically active corticosteroids to Nasonex require careful attention. The safety and efficacy of Nasonex has not been studied for use in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities. Unilateral polyps that are unusual or irregular in appearance, especially if ulcerating or bleeding, should be further evaluated. Patients who are potentially immunosuppressed should be warned of the risk of exposure to certain infections. Rare cases of nasal septum perforation, increased intraocular pressure and/or cataracts have been reported following the use of intranasal corticosteroids. Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring patient to a paediatric specialist. Safety and efficacy of Nasonex Nasal Spray for the treatment of nasal polyposis in children and adolescents under 18 years of age have not been studied. Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. In a placebo-controlled clinical trial in which paediatric patients (n=49/group) were administered Nasonex 100 micrograms daily for one year, no reduction in growth velocity was observed. INTERACTIONS: A clinical interaction study was conducted with loratadine. No interactions were observed. PREGNANCY AND LACTATION Nasonex should only be used in pregnant women, nursing mothers or women of child-bearing age if the potential benefit justifies the potential risk to the mother, foetus or infant. SIDE EFFECTS: Adverse effects commonly reported in clinical trials in adult and adolescent patients include headache, epistaxis, pharyngitis, nasal burning, nasal irritation and nasal ulceration. Other less common and rarely reported side effects are listed in the SPC. PACKAGE QUANTITIES: 18g per bottle, supplied with a metered-dose manual spray pump actuator which delivers 50 micrograms per actuation. Legal Category: Prescription Only Medicine. Marketing Authorisation Number: PA 1286/38/1 Marketing Authorisation Holder: Merck Sharp & Dohme Ireland (Human Health) Limited, Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland. Date of Revision of Text: March 2013 Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin 18 or from www.medicines.ie. © Merck Sharp and Dohme Ireland (Human Health) Limited 2013. All rights reserved. Date of preparation: April 2013.

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

Reference: 1. Shedden A. Impact of nasal congestion on quality of life and work productivity in allergic rhinitis: findings from a large online survey. Treat Respir Med. 2005;4(6):438-445.

42

product news

PfizerlaunchesPfizerParacetamolandPfizerParaExtra in IrelandPfizer Consumer Healthcare is delighted to announce the introduction of a new range of analgesics to the Irish market. leveraging the strength of Pfizer, two new products are set to appear on retail shelves over the coming weeks with the launch of Pfizer Paracetamol and Pfizer ParaExtra.

Developed following extensive consumer research, Pfizer Paracetamol replaces the company’s existing Paracetamol 500mg product with an exciting new packaging design. Adding to the quality appearance and feel of the product, the packaging is being upgraded to metpol board for a sleeker and more sophisticated look. A pharmacy only 24-pack is available as well as a 12-count pack.

Choice in the analgesics category will be broadened for consumers with the introduction of Pfizer ParaExtra, a paracetamol and caffeine based capsule which provides rapid relief from pain.

Consumer research revealed that two-thirds of respondents expressed a liking for the new Pfizer Paracetamol packaging. Significantly, a massive 80 per cent said that they would be likely to buy the product with over half of these being positively influenced by the Pfizer branding.

As well as looking well, the range will be attractively priced ensuring that in today’s value-led environment, consumer demand will be strong for the new range.

Commenting on the launch, a spokesperson for Pfizer Consumer Healthcare said that this launch was a global first for the company in the branding of OTC medicines. “We are delighted to be introducing this product under the Pfizer brand – a brand which is well recognised and respected in Ireland and synonymous with cutting-edge medicines,” he added.

Pfizer Consumer Healthcare reminds pharmacists that full product details are available from their local Pfizer Consumer representative and on www.medicines.ie.

New56blisterpackforClonmelHealthcare Folic Acid 5mg Tablets Clonmel Healthcare would like to advise that Folic Acid 5mg Tablets are now available in blister packs of 56. These replace the previous packs of 250.

The formulation has also changed. The tablet is now around, yellow to orange yellow, speckled biplane tablet.

A GMS code for this new pack size has been available from November 1, 2013.

Full prescribing information for Folic Acid is available on request or go to www.clonmel-health.ie. This product is subject to medical prescription.

If you require any further information, please contact Clonmel Healthcare on 01 620 4000.

FlexiseqcreatesbigbuzzinIrishmarketThe buzz surrounding Flexiseq has certainly made the Irish pharmacy community sit up and take notice – it is the biggest selling OTC product Ireland has seen in years, with 15,000 tubes being sold per week, the company said.

With Arthritis CEO John Church publically welcoming the “innovative” new pain-relieving gel when it launched here in June, the company said it is no wonder pharmacists have described Flexiseq as the big hit of the summer.

The drug-free “wonder gel” is being heralded as a godsend by an increasing number of Ireland’s 450,000-plus osteoarthritis sufferers – particularly those at risk from the common gastrointestinal and cardiovascular side effects associated with NSAIDs, such as celecoxib and diclofenac.

Eamonn Brady, owner of Whelehan’s Pharmacy in Mullingar, said: “What I like about it is that it’s not a drug but it works.

“To have a drug-free way of relieving joint pains from osteoarthritis is great because we have many patients who are on a lot of medication and can’t use conventional painkillers, but because it’s drug free they can use Flexiseq.

“It’s rare that you get something like that – when I recommend it to somebody I can feel confident that it should give them relief.”

The innovative, award-winning OA treatment from Pro Bono Bio relieves pain and restores joint mobility without posing any risk to the patient’s heart and stomach thanks to Sequessome Technology.

It’s on sale in most pharmacists in Ireland, retailing at around €22 a tube or €58 for a three-pack – though keeping it in stock has been the big challenge for many shops around the country, the company said.

PockethydrationlaunchedinIrelandO.R.S®, a soluble tablet form of the standard oral rehydration salts formula is now available across Ireland. O.R.S is available in new great tasting blackcurrant, lemon and strawberry flavours.

O.R.S is one of the fastest growing OTC brands in the UK. The success comes from the brand expanding a traditional medical market for the ORS formula by introducing a convenient, great tasting soluble tablet which delivers the right balance of electrolytes, glucose and minerals formulated to quickly restore optimum hydration in a highly portable solution. This is driving new markets in the UK and Ireland in travel, sports, wellbeing and health and beauty.

Sports people involved in intensive training and plenty of sweating, from rugby to Gaelic football and running to gym classes, will appreciate the easy to prepare soluble tablets in handy 12 and 24 tablet tube packs.

Available to order in Ireland from Pharmed with the Recommended Retail Price for the 24 pack are €8.99 and €5.99 for the 12 pack.

For more information on O.R.S® including details on why the formula is so effective at maintaining an optimum fluid balance go to: www.ors.uk.com.

43

product news

PfizerannouncesfurtherLipitorpricereductionPfizer has announced a further price reduction to lipitor (atorvas-tatin). lipitor is now at the reference price across the dose range and most patients currently taking lipitor can continue to do so at no increased cost. lipitor is now priced at 15% of the original price making Ireland’s price among the lowest in the EU, and in fact the lowest on some strengths.

“Pfizer has decided to reduce the price of lipitor to the refer-ence price to ensure that we can fairly compete against other interchangeable atorvastatins,” said Mr John Molony, Director and Head of Established Products Business Unit, Pfizer Healthcare Ireland. “The price of lipitor has been steadily reducing since patent expiry in 2012. This is good news for patients who pay for their medicines themselves and it is good news for the state who pay for medicines supplied to patients under the GMS and com-munity drug schemes.”

New legislation came into effect earlier this year which allows pharmacists to substitute medicines that have been designated interchangeable by the Irish Medicines Board. Atorvastatin was deemed interchangeable in August 2013. In addition, the Depart-ment of Health and HSE have introduced a reference price; the amount the state will refund a pharmacist for a group of medi-cines that are interchangeable. If a patient’s medicine is at or be-low the reference price, they can continue to stay on their existing medicine at no increased cost. The reference price for atorvastatin has been set and comes into effect on November 1st 2013.

Mr Paul Reid, Managing Director, Pfizer Healthcare Ireland said “Pfizer supports competitive pharmaceutical markets and this legislation does not stipulate whether patients should receive a substitute medicine of any particular type, be it a brand or a generic, it stipulates that patients must be offered the medicine of lowest cost to the state or the patient and this applies to all patients.”

NewtreatmentoptionforADHDin children and adolescents as ShirelaunchesTyvenseShire Pharmaceuticals Ireland ltd has announced that its single-daily dose long-acting prodrug stimulant, Tyvense (lisdexamfetamine dimesylate), has been authorised by Irish Medicines Board for the treatment of ADHD in children aged six years and over when response to previous methylphenidate treatment is considered clinically inadequate.

Tyvense is the first stimulant prodrug to be launched in Europe for the treatment of ADHD. It provides a long duration of effect to help patients achieve control of their ADHD symptoms, said Shire. The prodrug is ingested in an inactive form and subsequently activated within the body, meaning that the active part of Tyvense is gradually released over time.

European guidelines recommend the use of ADHD medications that reduce the need for children to take medication through the course of the school day.

The most commonly prescribed medications for ADHD are stimulants. In Europe, the most frequently prescribed stimulant is methylphenidate. However, not all patients show a clinically adequate response to this treatment.

ActavislaunchUltracheckpregnancytestActavis Ireland is pleased to announce the launch of Ultracheck Pregnancy Test to the Irish market. The launch of Ultracheck not only adds to the extensive Actavis portfolio, but further strengthens the company’s over the counter offering, it said. Ultracheck is available in a single and double pack to all pharmacies in Ireland.

Tony Hynds, MD of Actavis Ireland said: “Actavis is delighted to introduce Ultracheck to the Irish market. With over 75,000 pregnancy test kits sold in pharmacy in the last 12 months, this launch represents an innovative addition to our growing OTC range and builds on our reputation of bringing choice and value to our customers.”

For further information on the Actavis OTC portfolio contact Actavis Ireland on 1890 33 32 31 or email on contact@actavis.ie.

Champix(varenicline)increasessmokingcessationinsubjectswithdepression–studyResults from a study recently published in The Annals of Internal Medicine reveals that patients with a past or present diagnosis of major depressive disorder treated with Champix were significantly more likely to quit smoking and maintain abstinence at the end of the treatment period than patients in the placebo group.

The study, “Effects of Varenicline on Smoking Cessation in Adults with Stable Treated Current or Past Major Depression”, was a double-blind, placebo-controlled, randomised clinical trial designed to assess the efficacy and safety of Champix for smoking cessation in patients with a history of major depressive disorder (MDD) in the past two years or under current stable treatment. A total of 525 male and female motivated to quit smokers, aged 18-75 years, were treated for 12 weeks and followed for an additional 40 weeks. Patients had a current or past diagnosis of MDD without psychotic features and were either on stable antidepressant treatment or had a successfully treated episode of MDD in the past two years.

The study met both the primary and secondary efficacy endpoints. Patients treated with Champix for 12 weeks showed significantly higher abstinence rates compared to patients treated with placebo. Efficacy results in this study are consistent with other varenicline trials.

Commenting on the study, Dr Declan O’Callaghan, Medical Director Pfizer Healthcare Ireland said: “This study offers important information which contributes to a further understanding of the clinical profile of Champix. The results suggest that Champix may be a suitable smoking cessation treatment for smokers with stable currently treated or past major depression.”

44

product news

Ground-breakinginnovationbringsstrip-freetestingtopeoplewithdiabetesThe latest technology in blood glucose monitoring, approved by the HSE, has been designed specifically for people with diabetes on insulin

Roche’s latest innovation in blood glucose monitoring, the new Accu-Chek Mobile system, brings the latest technology for people with diabetes to Ireland. The new system features innovative strip-free testing which has the significant advantage of requiring no handling or disposal of strips, making testing easier and more convenient.

With its all-in-one design and simple ‘4 step’ testing process, patients can monitor their blood glucose whenever and wherever they are. The increased convenience and ease of use for blood glucose monitoring has been shown to improve patient adherence.

Effective blood glucose monitoring remains a challenge for many people with diabetes in Ireland. Poor blood glucose management increases the likelihood of long-term health complications such as cardiovascular disease, nephropathy and retinopathy.

The Health Service Executive (HSE) prioritises improvements in diabetes management in Ireland to bring about better patient outcomes. Despite a period of austerity, the HSE is allowing innovations with clear patient benefits such as the Accu-Chek Mobile blood glucose monitoring system to be listed on the General Medical Services Scheme (GMS). This provides substantial cost-savings for the HSE and a great opportunity for people with diabetes in Ireland to benefit from state-of-the-art technology.

Jackie McGrath, diabetes specialist nurse, Naas General Hospital commented on the new system:

“I have had positive feedback from my patients who are using the new Accu-Chek Mobile system. A big advantage is the fact that there are no lancets or dirty strips to dispose of which makes it a good choice for people who are on the go.”

The Accu-Chek Mobile system features strip-free technology in the form of 50 tests on a continuous tape held on a cassette, meaning users no longer have to handle or dispose of single test strips. The system also provides six lancets in a drum with an integrated finger pricker, making the handling of single lancets obsolete. The new and advanced system also includes a PC-ready reports function. These reports offer a comprehensive overview of trends for both patients and caregivers to help them easily visualise and interpret blood glucose profiles. The new model also cuts handling steps by more than two thirds. Studies show the Accu-Chek Mobile system keeps readings accurate: 99.5% of the testing results were within strict accuracy limits.

The innovation of the new Accu-Chek Mobile system has already been awarded the prestigious Red Dot Design Award in both 2011 and 2012.

For more information on the Accu-Chek Mobile system please visit www.accu-chek.ie

Freephone Accu-Chek Careline: 1 800 709600.

New data show Novartis’ GilenyareducedbrainvolumelossbyonethirdinMSpatientsNovartis recently announced new data indicating that continued treatment with Gilenya (fingolimod) led to a reduction in brain volume loss in patients with relapsing forms of multiple sclerosis (MS), and was associated with a higher proportion of patients remaining free of disability progression. These data were presented at the ongoing 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark.

Brain volume loss is emerging as one of the best indicators of disability progression over the long-term in MS, and is a topic of much interest within the MS medical community. Increasingly, research focus is on treatments that will reduce the rate of brain volume loss. Gilenya is the only oral treatment for MS that has shown early and consistent slowing of brain volume loss, and the new data presented at ECTRIMS add to the growing evidence base of Gilenya’s efficacy in MS and reinforce the correlation between brain volume loss and disability progression over the long-term.

“The data presented today are very encouraging because they are from studies that took place over four years and show that Gilenya both reduces brain volume loss and slows the pace of disability progression for patients with MS,” said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals. “These are key treatment goals for patients with this chronic and debilitating illness.”

Key findingsCollective four-year results from the pivotal FREEDOMS and

FREEDOMS extension studies showed that patients who were treated continuously with Gilenya 0.5 mg experienced up to one-third less brain volume loss than patients who switched to Gilenya after receiving placebo for two years. Thus, delay in starting treatment with Gilenya by two years was associated with more brain volume loss.

Overall, patients who remained free of disease had consistently lower rates of brain volume loss compared to patients who experienced disease activity and MS progression. However, the benefit of Gilenya on brain volume loss was seen irrespective of whether patients were disease-free or had active disease. (Disease activity was evaluated by assessing measures that give a broad evaluation of MS: disability progression, relapses and new brain lesions detected on magnetic resonance imaging scans.)

A separate analysis of three key studies (FREEDOMS, FREEDOMS II and TRANFORMS) showed a correlation between disability progression and increased brain volume loss, and this correlation increased over time.

Higher baseline MRI lesion volume and baseline active lesions both predicted subsequent loss of brain volume during the studies but patients treated with Gilenya had less brain volume loss than those treated with placebo or IFN beta 1a IM, irrespective of baseline lesion volume and count.

MS patients with higher brain volume loss were more likely to experience disability progression.

45

crossword

Name:

Address:

Email:

Congratulations to the winner of last month’s crossword,

Colette Gibbons, c/o Dr P. Henaghan’s Surgery, Chapel Street, louisburgh, Co Mayo.

Please send your answers to the Editor, Nursing in General Practice, GreenCross Publishing, 7 leeson Street, Dublin 4. Closing date for entries: 31 December 2013.Winner will receive v50. Please note: the winners’ cheques will be sent out within 45 days.

Caltrate is a trademark. PA 172/38/1. Full prescribing information available from Pfizer Consumer Healthcare ltd., 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 or from www.medicines.ie

1 2 3 4 5

6 7

8

9 10

11 12 13

14

15 16

17

18 19 21

22 23

20

AcROss6 Untangle moss so I can enable the passage of fluid

through a porous membrane (7)7 Children’s respiratory problem in micro upsurge

(5)9 and 12 Down. She was barely recognisable on a

horse! (4,6)10 Pause can upset pot (8)11 Hog enthusiastic about gnu? (4-2)13 Dublin Area Rapid Transport, in short (4)15 Burden placed upon ourselves? (4)16 She .... .. a fever, and no-one could save her! (4,2)18 Heavy ref diagnosed as having pollen allergy (3,5)21 The 13 across runs through its capital (4)22 Skin disease prevalent where bees live? (5)23 The saw-bones patient? (7)

DOwN1 Attempt a written composition! (5)2 Just go by befuddled mugs (4,4)3 Assists immune deficiency illness? (4)4 Family, apple or Christmas (4)5 Oh! Pears sound foreign for domestics (2,5)8 Our ref riotously leads to public outburst (6)12 See 9 across.13 It requires guts to cause MOD undue difficulty (8)14 Can a D.T.I. cure an upset tummy? (7)17 Colour for putting on? Of course it is! (5)19 24, 36 and 48 inches, for example! (4)20 Access for an awkward pram? (4)

ANsweRs TO lAsT Issue’s cROsswORDAcROss: 6 lanolin, 7 limbo, 9 Echo, 10 Sculptor, 11 Tattoo, 13 Meet, 15 Bray, 16 Refuse, 18 Engaging, 21 Each, 22 Mummy, 23 Tonsils. DOwN: 1 Match, 2 Coronary, 3 Miss, 4 lisp, 5 Abdomen, 8 Cut off, 12 Turnip, 13 Masseuse, 14 Cranium, 17 Scalp, 19 Army, 20 Gaol.

Herceptin SC

Less waiting time More free time

All the benefits of Herceptin, now in a faster format1-4

p07/09/13

ABRIDGED PRESCRIBING INFORMATION (Early & Metastatic Breast Cancer Indication Only) (For full prescribing information, refer to the Summary of Product Characteristics [SmPC] HERCEPTIN¨ (trastuzumab) 600mg/5ml solution for injection Indications: Metastatic Breast Cancer (mBC): Treatment of patients with HER2 positive mBC: (i) as monotherapy following at least 2 chemotherapy regimens for mBC. Prior chemotherapy to include at least an anthracycline and a taxane, unless unsuitable for treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless unsuitable for treatments. (ii) in combination with paclitaxel for patients who have not received chemotherapy for mBC and where anthracyclines not suitable. (iii) in combination with docetaxel for patients who have not received chemotherapy for mBC. (iv) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive mBC, not previously treated with Herceptin. Early Breast Cancer (eBC): Treatment of patients with HER2 positive eBC (i) following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (ii) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. (iii) in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. (iv) in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy for locally advanced (including inflammatory) disease or tumours >2cm diameter. Herceptin should only be used in mBC or eBC patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Dosage and Administration: HER2 testing mandatory prior to Herceptin therapy. Only physicians experienced in cytotoxic chemotherapy should initiate Herceptin: The injection should be administered by a healthcare professional only. Herceptin subcutaneous (SC) formulation is not intended for intravenous (IV) administration and should be administered via a SC injection only. Check product labels to ensure correct formulation administered. Limited information available on switching from one formulation to another. Not recommended in patients <18 years of age. Dedicated PK studies in older people and those with renal or hepatic impairment have not been carried out. Refer to SmPC for dose reduction and missed doses. Treat mBC patients until disease progression. Treat eBC patients for 1 year or until disease progression; whichever occurs first. Recommended dose is 600mg/5ml irrespective of the patient’s body weight. No loading dose is required. This dose should be administered subcutaneously over 2-5 minutes every three weeks, refer to SmPC. Patients should be observed for six hours after the first injection and for two hours after subsequent injections for signs or symptoms of administration-related reactions. Refer to SmPC for chemotherapy combination dosing. Contraindications: Hypersensitivity to trastuzumab, murine proteins, hyaluronidase or any excipients. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. Warnings and Precautions: HER2 testing in a specialised laboratory mandatory to ensure adequate validation of test. No trial data available on re-treatment of patients with previous exposure to Herceptin in the adjuvant setting. Heart failure observed in patients receiving monotherapy or in combination with paclitaxel or docetaxel, particularly following anthracycline-containing regimens: may be moderate to severe, has been fatal. All candidates for treatment (especially those with prior anthracycline and cyclophosamide exposure) should undergo baseline cardiac assessment including history and physical examination, ECG, echocardiogram, and/or MUGA scan or magnetic resonance imaging. A careful risk-benefit assessment should be made. In all patients cardiac assessments should be repeated every 3 months during treatment and every 6 months following discontinuation until 24 months from the last dose. Anthracycline therapy should be avoided for up to 27 weeks after last dose of Herceptin. Formal cardiological assessment should be considered in patients with cardiovascular concerns following baseline screening. For patients who develop cardiac dysfunction monitoring should take place every 6-8 weeks. Consider discontinuing treatment in patients with asymptomatic decreased LVEF function if no clinical benefit seen. Caution in treating patients with symptomatic heart failure, history of hypertension, Coronary artery disease, and in eBC patients with LVEF of 55% or less. If LVEF drops 10 ejection fraction points from baseline and to below 50% treatment should be suspended, repeat LVEF assessment within 3 weeks. If LVEF does not improve or further declines, consider discontinuation, refer to SmPC. All such patients should be reviewed by cardiologist and followed up. If symptomatic cardiac failure develops during therapy, treat with standard medications.. Most patients in the pivotal trials who experienced heart failure improved with standard medication, refer to SmPC. mBC: Herceptin and Anthracyclines should not be given concurrently in the metastatic breast cancer setting. Increased risk of cardiotoxicity in patients who previously received anthracycline therapy. eBC: For eBC patients, cardiac assessment, as performed at baseline, should be repeated every 3 months

during treatment and every 6 months following discontinuation of treatment for duration of 24 months from the last dose. Further monitoring is recommended for patients receiving anthracycline containing chemotherapy and should occur yearly up to 5 years from the last dose or longer if a continuous decrease of LVEF is observed. In eBC, no data on patients with existing or a history of documented CHF (New York Heart Association Class greater than or equal II), history of MI, LVEF of <55%, other cardiomyopathy, hemodynamic effective pericardial effusion, cardiac arrhythmia requiring medical treatment, angina pectoris requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled hypertension. Therefore treatment not recommended. Herceptin and anthracyclines should not be given concurrently in the adjuvant treatment setting. In eBC adjuvant patients, the incidence of symptomatic and asymptomatic cardiac events increased when Herceptin (IV formulation) was administered after anthracycline-containing chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when Herceptin was administered concurrently with taxanes than when administered sequentially to taxanes. Most symptomatic cardiac events occurred within the first 18 months, regardless of the regimen used, refer to SmPC for further details.. In patients eligible for neoadjuvant-adjuvant treatment, low dose anthracycline regimens (maximum cumulative doses: doxorubicin 180 mg/m2 or epirubicin 360 mg/m2) can be administered concurrently with chemotherapy na•ve Herceptin patients. If patients have been treated concurrently with low dose anthracyclines and Herceptin in the neoadjuvant setting, no additional cytotoxic chemotherapy should be given after surgery. Experience of concurrent administration of anthracycline regimens is low, refer to SmPC for details. Neoadjuvant-adjuvant treatment is not recommended for patients older than 65 years of age refer to SmPC. Administration-related reactions (ARRs) are known to occur with Herceptin SC formulation. Pre-medication may reduce risk, refer to SmPC. Serious ARRs were not reported in the clinical trial however ARRs have been associated with the IV formulation. ARRs can be treated with an analgesic/antipyretic, or antihistamine. In rare cases, ARRs have resulted in fatal outcome. Patients experiencing dyspnoea at rest due to complications of advanced malignancy and co-morbidities may be at increased risk of fatal ARR and pulmonary events, therefore these patients should not be treated with Herceptin. Refer to SmPC for delayed (including fatal) ARR and pulmonary events. Severe pulmonary events have been reported with use of the IV formulation, occasionally fatal. Cases of interstitial lung disease reported: risk factors include prior or concomitant therapy with other anti-neoplastic therapies known to be associated with it such as taxanes, gemcitabine, vinorelbine and radiation therapy. Exercise caution for pneumonitis, especially in patients treated concomitantly with taxanes. Drug Interactions: No formal drug interaction studies have been performed. Effect of Herceptin on the pharmacokinetics of other antineoplastic agents: Pharmacokinetic data (PK) from studies BO15935 and M77004 in women with HER2 positive MBC suggest that exposure to paclitaxel and doxorubicin is not altered by Herceptin IV loading or maintenance dose, refer to SmPC. However Herceptin may elevate the overall exposure of one doxorubicin metabolite (7-deoxy-13 dihydro-doxorubicinone, D7D). The bioactivity of D7D and the clinical impact of the elevation of this metabolite is unclear. Study JP16003 in HER2 positive Japanese MBC patients suggest administration of Herceptin has no effect on the single dose PK of docetaxel. Study JP19959, a substudy of BO18255 performed in male and female Japanese patients with advanced gastric cancer studied the PK of capecitabine and cisplatin administered with or without Herceptin. Exposure to the bioactive metabolite 5 –FU of capecitabine was not affected by the concurrent use of cisplatin plus Herceptin. However, higher concentrations and a longer half-life of capecitabine were demonstrated when combined with Herceptin. The PK of cisplatin was not affected by concurrent use of capecitabine or by concurrent use of capecitabine plus Herceptin, refer to SmPC. Effect of antineoplastic agents on Herceptin pharmacokinetics: Study JPI6003 in Japanese HER2 positive MBC patients found no evidence of a PK effect on Herceptin with concurrent administration of docetaxel. Comparison of PK results from phase II & III clinical trials in HER2 positive MBC patients indicate that individual and mean Herceptin trough serum concentrations varied within and across studies however no clear effect of the concomitant administration of paclitaxel on the pharmacokinetics of Herceptin, refer to SmPC for further details. The administration of anastrozole did not appear to influence the pharmacokinetics of trastuzumab. Fertility, Pregnancy and Lactation: Avoid during pregnancy unless potential benefit for mother outweighs risk to foetus. Do not breast-feed during and for 7 months after last treatment. Cases of foetal renal growth and and/or function impairment in association with oligohydramnios (some associated with fatal pulmonary hypoplasia of the foetus) reported in pregnant women in the post-marketing setting. Use effective contraception during and for at least 7 months

after treatment has concluded. Advise women who become pregnant of potential foetal harm and manage with a multidisciplinary team. Side Effects and Adverse Reactions: Most serious and/or common adverse reactions (reported for IV and SC formulations) are cardiac dysfunction, ARRs, haematotoxicity (especially neutropenia), infections and pulmonary events. The safety profile of Herceptin SC formulation from the pivotal trial in eBC was overall similar to the known safety profile of the IV formulation. Adverse events reported more frequently for the SC formulation: serious adverse events which included post-operative wounds infections, ARRs, hypertension. The following adverse reactions have been reported with Herceptin IV monotherapy or in combination with chemotherapy in trials and in the post marketing setting: Very Common (≥1/10): febrile neutropenia, anaemia, neutropenia, leukopenia, hypertension, hypotension, dyspepsia, constipation, alopecia, mucosal inflammation, infusion related reactions, tremor, dizziness, headache, increased/decreased BP, irregular heart beat, palpitation, cardiac flutter, decreased ejection fraction, wheezing, dyspnoea (14%), diarrhoea, vomiting, nausea, lip swelling, hot flush, conjunctivitis, increased lacrimation, abdominal pain, erythema, rash, facial swelling, arthralgia, muscle tightness, myalgia, asthenia, chest pain, chills, fatigue, cough, epistaxis, rhinorrhoea, influenza-like symptoms, IRR, pain and pyrexia. Common (≥1/100 - <1/10): pneumonia (<1%), neutropenic sepsis, cystitis, herpes zoster, infection, influenza, nasopharyngitis, sinusitis, skin infection, rhinitis, upper respiratory tract infection, urinary tract infection, erysipelas, cellulitis, thrombocytopenia, , hypersensitivity, weight decreased/weight loss, anorexia, anxiety, depression, insomnia, abnormal thinking, peripheral neuropathy, paraesthesia, hypertonia, somnolence, dysgeusia, ataxia, dry eye, congestive cardiac failure (2%), supraventricular tachyarrhythmia, cardiomyopathy, hypotension, vasodilation, asthma, lung disorder, pharyngitis, pancreatitis, dyspepsia, haemorrhoids, constipation, dry mouth, hepatitis, liver tenderness, hepatocellular injury, acne, , dry skin, ecchymosis, hyperhydrosis, maculopapular rash, nail disorder, pruritus, dermatitis, arthritis, back pain, bone pain, muscle spasms, neck pain, renal disorder, breast inflammation/mastitis, peripheral oedema, malaise, , oedema and contusion. Serious or potentially serious: Severe infections, heart failure (New York Association [NYHA] class II-IV, hypertension, immunogenicity, pneumonitis, acute pulmonary oedema, renal failure and febrile neutropenia. Refer to SmPC for full listings of adverse events. Legal Category: Limited to sale and supply on prescription only. Presentation and Marketing Authorisation Number: EU/1/00/145/002 Pack of one 6mL vial containing 5mL of solution Marketing Authorisation Holder: Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom. Herceptin is a registered trade mark. Full prescribing information is available from Roche Products (Ireland) Limited, 3004 Lake Drive, Citywest, Naas Road, Dublin 24. Telephone: (01) 4690700. Fax: (01) 4690791. Date of Preparation: 09th September 2013.

References: 1. Ismael G, et al. Lancet Oncol. 2012; 13(9):869–878. 2. Jackisch C, et al. Oral presentation at the 8th European Breast Cancer Conference, Vienna,Austria 2012 (Abstract 1BA). 3. Pivot X, et al. Poster presentation at the 37th ESMO, Vienna, Austria 2012 (Poster 272P). 4. Herceptin (trastuzumab) combined IV and SC (vial) SmPC, August 2013. 5. Jackisch C, et al. Poster presentation at the 37th ESMO, Vienna, Austria 2012 (Poster 271P). 6. Pivot X, et al. Poster presentation at the 13th St Gallen Breast Cancer Conference, St Gallen, Switzerland 2013 (Poster 207).

Administer the standard of care in just 2 - 5 minutes compared to between 30 minutes to two hours with Herceptin IV1-4 Proven comparable efficacy and safety to I.V. Herceptin1, 2, 5 Simple, ready to use formulation, frees up clinic resources6

5549 Herceptin SC_press ad 395X273_AW.indd 1 18/09/2013 12:37