Page 1

Issue 11

HOSPITAL PHARMACY NEWS IRELAND THE INDEPENDENT VOICE OF HOSPITAL PHARMACY

Hospital Pharmacy Awards 2013

The Winners Issue

IN THIS ISSUE:

HELP CONTAIN THE HELP CONTAIN THE DANGER DANGER IN IN mmCRPC CRPC

News: Hospital pharmacists develop new Aseptic Compounding guidelines Page 5

XTANDI is a direct approach to treating metastatic castration – 1-3 XTANDIprostate is a direct approach treating metastatic resistant cancer post to – docetaxel . XTANDIcastration directly – 1-3 resistant prostate cancer postsignalling – docetaxel . XTANDI & potently targets AR receptor at three stepsdirectly of the potently targets ARandrogen receptor signalling at three steps of the AR&pathway: Blocking binding; preventing nuclear AR pathway:of Blocking preventing nuclear translocation the AR; androgen impairingbinding; DNA binding – preventing 1-5 DNA binding – preventing translocation of theexpression. AR; impairing modulation of gene modulation of gene expression.1-5 Take hold of mCRPC in a brand new way. Take hold of mCRPC in a brand new way.

Report: The ongoing war against Clostridium difficile Page 8 Feature: Budget impact analysis on rheumatoid arthritis Page 15 Awards: Exclusive coverage of the winners from the Hospital Pharmacy Awards 2013! Page 16

XTANDI (enzalutamide) soft capsules.Prescribing Prescribing XTANDI (enzalutamide) 4040 mgmg soft capsules. Information:Please Pleaseread read thethe Summary Summary ofof Product Product Information: Characteristics (SPC) before prescribing.Presentation: XTANDI Characteristics (SPC) before prescribing.Presentation: XTANDI 40 mg soft capsules each containing 40 mg of enzalutamide. 40 mg soft capsules each containing 40 mg of enzalutamide. Indications: XTANDI is indicated thetreatment treatmentofofadult adult Indications: XTANDI is indicated forfor the men with metastaticcastration castrationresistant resistantprostate prostatecancer cancer men with metastatic whose disease has progressed on or after docetaxel therapy. whose disease has progressed on or after docetaxel therapy. Dosage and administration: The recommended dose is Dosage and administration: The recommended dose is 160 mg enzalutamide (four 40 mg capsules) as a single oral 160 mg enzalutamide (four 40 mg capsules) as a single oral daily dose. For further details please refer to the SPC. daily dose. For further details please refer to the SPC. Contra-indications: Hypersensitivity to the active substance Contra-indications: to the or to any of the Hypersensitivity excipients. Women whoactive are, orsubstance who may or to any of pregnant. the excipients. Women and who warnings: are, or whoCaution may become, Precautions become, warnings: Caution should pregnant. be used in Precautions administering and XTANDI to patients with a should be of used in administering XTANDI tofactors. patients history seizures or other predisposing Thewith risk aof history of seizures or other predisposing factors. The risk of seizure may be increased in patients receiving concomitant seizure may be increased patients receiving concomitant medicinal products that in lower the seizure threshold. Caution medicinal products that lower thesevere seizurerenal threshold. Cautionas is required in patients with impairment is required in patients withstudied severeinrenal impairment as enzalutamide has not been this patient population. enzalutamide not been in this population. Caution is has required in studied patients withpatient moderate hepatic Caution is required patientssorbitol with (E420). moderate hepatic impairment. XTANDIincontains Patients with impairment. XTANDI contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not raretake hereditary problems of fructose intolerance should not this medicinal product. Interactions: Co-administration takewith thiswarfarin medicinal product. Interactions: Co-administration and coumarin like anticoagulants should be with warfarin and coumarin like anticoagulants should be avoided. If XTANDI is co administered with an anticoagulant avoided. If XTANDI co administered an anticoagulant metabolised by is CYP2C9, additional with monitoring should be conducted.by CYP2C8 playsadditional an important role in theshould elimination metabolised CYP2C9, monitoring be of enzalutamide in an theimportant formationrole of itsinactive metabolite. conducted. CYP2C8and plays the elimination Strong inhibitors gemfibrozil) (e.g. rifampicin) of enzalutamide and(e.g. in the formationorofinducers its active metabolite. of CYP2C8 are(e.g. to gemfibrozil) be avoided or used with(e.g. caution during Strong inhibitors or inducers rifampicin) of CYP2C8 are to be avoided or used with caution during XTD 13008IE XTD 13008IE

enzalutamidetreatment. treatment. IfIf patients patients must must be be co co administered enzalutamide administered strongCYP2C8 CYP2C8 inhibitor, inhibitor, the the dose dose of of enzalutamide enzalutamide should a astrong should bereduced reducedtoto80 80mg mgonce once daily. daily. CYP3A4 CYP3A4 plays plays aa minor be minor role role in in themetabolism metabolism ofof enzalutamide enzalutamide and and no no dose dose adjustment the adjustment isis necessary when XTANDI is co administered with inhibitors necessary when XTANDI is co administered with inhibitors or or inducersofofCYP3A4. CYP3A4.Enzalutamide Enzalutamide isis aa potent potent enzyme inducers enzyme inducer inducer and increases the synthesis of many enzymes and transporters; and increases the synthesis of many enzymes and transporters; therefore, interaction with many common medicinal products therefore, interaction with many common medicinal products that are substrates of enzymes or transporters is expected. that are substrates of enzymes or transporters is expected. The reduction in plasma concentrations can be substantial, The reduction in plasma concentrations can be substantial, and lead to lost or reduced clinical effect. There is also a risk of and lead toformation lost or reduced clinical effect. There is also a risk of increased of active metabolites. Food has no clinically increased formation active metabolites. Foodtohas no clinically significant effect onofthe extent of exposure enzalutamide. significant the extent of exposurewithout to enzalutamide. In clinical effect trials, on XTANDI was administered regard to Infood. clinical trials, XTANDI was administered without regard to Pregnancy and lactation: Enzalutamide is not for use in food. Pregnancy and lactation: Enzalutamide is not for are, useor in women. Enzalutamide is contraindicated in women who women. Enzalutamide is contraindicated in women who are, or who may become, pregnant. If the patient engages in sexual who may become, pregnant. If the patientpotential, engagesa in sexual intercourse with a woman of childbearing condom intercourse with a woman childbearing a condom and another form of birth of control must bepotential, used during and for and another form of birth control must be used during(≥and for 3 months after treatment. Side effects: Very Common 1/10): 3 headache, months after Side(≥ effects: Very Common (≥ 1/10): hottreatment. flush; Common 1/100 to < 1/10): neutropenia, headache, hot flush; Common 1/100 to <disorders, 1/10): neutropenia, visual hallucinations, anxiety,(≥ cognitive memory visual hallucinations, anxiety, disorders, memory impairment, hypertension, drycognitive skin, pruritus, fractures, falls; impairment, pruritus, fractures, falls; Uncommon hypertension, (≥ 1/1,000 todry< skin, 1/100): leucopenia, seizure, Uncommon (≥ 1/1,000 to < 1/100): seizure, amnesia, disturbance in attention. Pleaseleucopenia, refer to the SPC for amnesia, in attention. Please refer to the SPC for further disturbance details of other side effects. Legal category: POM/ S1A Marketing numbers: further details ofAuthorisation other side effects. LegalEU/1/13/846/001. category: POM/ Marketing Authorisation holder: Astellas Pharma Co., S1A Marketing Authorisation numbers: EU/1/13/846/001. Ltd, 5 Waterside, Citywest holder: Business Astellas Campus,Pharma Dublin Co., 24. Marketing Authorisation Ph +353 1467 1555 Citywest Business Campus, Dublin 24. Ltd, 5 Waterside, Ph +353 1467 1555

References: References:1.1.XTANDI XTANDISummary SummaryofofProduct ProductCharacteristics, Characteristics, 2013. 2013. 2.2. Tran Tran CC etetal.al.Science Science2009; 2009;324(5928): 324(5928):787–790. 787–790. 3.3.Hu 5(5): 753–764. HuRRetetal. al.Expert ExpertRev RevEndocrinol EndocrinolMetab. Metab.2010; 2010; 5(5): 753–764. 4.4. Scher Scher HH etetal. al.NNEngl EnglJ JMed. Med.2012; 2012;367(13): 367(13):1187–1197. 1187–1197. 5.5.Heinlein CA, Chang C. Androgen receptor in prostate cancer. Heinlein CA, Chang C. Androgen receptor in prostate cancer. Endocr EndocrRev. Rev.2004: 2004:25; 25;276 276– –300. 300. Date of preparation: November 2013. Date of preparation: November 2013.

This medicinal product is subject to additional This medicinal product subject to additional monitoring. This will allow is quick identification of monitoring. This will allow quickprofessionals identification new safety information. Healthcare are of new safety information. Healthcare professionals requested to report Adverse events associated withare requested report Adverse events associated this drug toto the IMB or to Astellas Pharma Co Ltd with at this drug to the IMB or to Astellas Pharma Co Ltd at irishdrugsafety@astellas.com irishdrugsafety@astellas.com See section 4.8 of SPC for instructions on how to report See section 4.8 of SPC for instructions on how to report adverse reactions. adverse reactions.

CPD: Quantifying the economic costs of communications inefficiency in Irish hospital pharmacy Page 23 Feature: Cardiovascular risk factors in Women Page 42


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DENZAPINE Suspension offers an exclusive treatment option for: • Difficult to treat patients • Patients with swallowing problems • New patients - simple initiation DENZAPINE Abbreviated prescribing information. Clozapine 25mg, 50mg, 100mg, 200mg Tablets. 25mg, 50mg, 100mg: Round flat yellow bevel edged tabs marked with strength over a pressure sensitive breakline. 200mg: Large, oval-shaped yellow tablet, with strength on one side and a breakline on the other. ALSO DENZAPINE ORAL SUSPENSION: Clozapine 50mg/ml. Free-flowing yellow suspension. Indications: Treatment-resistant schizophrenia in patients unresponsive to or intolerant of conventional neuroleptics. Psychotic disorders occurring during the course of Parkinson’s disease, if standard treatment has failed. Adult: Schizophrenia: Initially 12.5mg once or twice on first day increasing by 25-50mg increments up to 300mg daily within 2-3 weeks; may be further increased in 50-100mg increments at half-weekly or, preferably, weekly intervals. Usual range: 200-450mg /day given in divided doses. Max. 900mg daily. Parkinson’s initially 12.5mg/day in the evening. Increase by 12.5mg increments with max, 2 increments a week up to 50mg once daily. Usually range: 25 -37.5mg/day. Max. 50mg/day, exceptionally 100mg/day. Elderly: Initially 12.5mg daily increasing gradually in increments of 25mg daily. Child: Not recommended. Contraindications: Patients unable to undergo regular blood tests. History of granulocytopenia/agranulocytosis (except if from chemotherapy). Impaired bone marrow function. Uncontrolled epilepsy, alcoholic and other toxic psychoses, drug intoxication, comatose conditions. Circulatory collapse and/or CNS depression. Severe renal or cardiac disorders. Active liver disease associated with nausea, anorexia or jaundice; progressive liver disease, hepatic failure. Paralytic ileus. Lactation. Special warnings: Can cause agranulocytosis, Initiation restricted to WBC counts>3500/mm3 and neutrophil count >2000/mm3). Monitor these counts weekly for first 18 weeks and at least 4 week intervals thereafter including 4 weeks after complete discontinuation (see SPC). Discontinue immediately if neutropenia or agranulocytosis. Caution: CVD or family history of QT prolongation, risk factor for stroke, liver disorders, prostatic enlargement, narrow-angle glaucoma. Reported: Myocarditis, pericarditis/ pericardial effusion, cardiomyopathy, impairment of intestinal peristalsis, neuroleptic malignant syndrome, hyperglycaemia, thromboembolism. Withdraw gradually over 1-2 weeks. Pregnancy. Driving/using machinery. Contains lactose. Drug interactions: Contraindicated: Drugs causing agranulocytosis (co-trimoxazole, chloramphenicol, sulphonamides, pyrazolone analgesics e.g. phenylbutazone, penicillamine, carbamazepine, cytotoxic agents); avoid depot antipsychotics, drugs causing electrolyte imbalance, drugs prolonging QT, alcohol. Caution: CNS depressants, drugs with anticholinergic, hypotensive, or respiratory depressant effects, norepinephrine, epinephrine, CYP1A2 inhibitors (caffeine) and inducers (omeprazole), smoking, fluvoxamine, paroxetine, carbamazepine, phenytoin, rifampicin, CNS – active agents. See SPC. Adverse reactions: Leucopoenia/decreased WBC/neutropenia, eosinophilia, leukocytosis, weight gain, drowsiness, dizziness, blurred vision, headache, tremor, rigidity, akathisia, extra pyramidal symptoms, seizures, tachycardia, ECG changes, hypertension, postural hypotension, syncope, GI disorders, dry mouth, elevated liver enzymes, urinary incontinence/retention, fatigue, fever, temperature regulation disturbances. Pack Size: 84 x 25mg tablets, 50 x 50mg tablets, 84 x 100mg tablets, 50 x 200mg tablets, 100ml x 50mg/ml. Supply of DENZAPINE is restricted to pharmacies registered with the DMS. Product Authorisation Numbers: DENZAPINE 25mg, 50mg, 100mg and 200mg tablets PA 126/235/1, 3, 2 and 4, DENZAPINE 50mg/ml suspension PA 126/235/5. Full prescribing information is available on request or go to www.clonmel-health.ie. Legal Category: Medicinal product subject to medical prescription. Marketing Authorisation Holder: Clonmel Healthcare Limited, Waterford Road, Clonmel, Co. Tipperary. Date last revised: April 2013. - 2013/ADV/CLO/030 References: 1. MIMS April 2013


3

Issue 11

Contents

Foreword

Global pharmacy workforce memorandum signed in Dublin P4

Editor

Irish group of hospital pharmacists develop and launch Aseptic Compounding guidelines P12

Welcome to Issue 11 of Hospital Pharmacy News, our exclusive winners issue, featuring all those who enjoyed success at the inaugural Hospital Pharmacy Awards.

Kelly Jo Eastwood

Poster presentation shows 5-year savings impact for rheumatoid arthritis P15

The Hospital Pharmacy Awards truly are the gold standard of best practice.

5

Nominations were incredibly strong from across the country, representing the very best hospital pharmacy practice has to offer.

All the winners and news from the inaugural Hospital Pharmacy Awards 2013 P16

The standard of the entries was exceptional and our esteemed judging panel had an incredibly difficult time making the final decision. But make it they did, and on pages 16 through to 33 we profile those that topped their list.

HPE Live in Birmingham P36

Hospital Pharmacy News will continue to champion hospital pharmacy and we believe that the future looks bright. With support, and with the right investment, pharmacy departments can grasp the opportunity to change the way services and medicines are delivered, improving patient health.

Regulars Clinical - Marketing authorisation for Boehringer's Giotrif P10

8

Feature - COPD - A new approach to treatment P38

Ireland is fortunate to have countless individuals and teams who work tirelessly to ensure extremely high levels of pharmaceutical care and improve clinical outcomes for patients. We are extremely proud to be able to showcase these.

Feature - Cardiovascular risks for women P42

We would like to thank our very generous sponsors for their support.

Clinical Profiles P48 46

Appointments P50

Hospital Pharmacy News is Circulated to all independent, multiple and hospital pharmacist, pre reg pharmacists, students pharmacy student’s offi cial bodies, government officials and departments, Pharmacy Managers, Manufactures, Wholesalers. Buyers of pharmacy groups and healthcare outlets. Circulation is free to all pharmacists Subscription rate for Hospital Pharmacy News 60euro plus vat per year All rights reserved by Hospital Pharmacy News. All material published in Hospital Pharmacy News is copyright and no part of this magazine may be reproduced, stored in a retrieval system of transmitted in any form without written permission. Pharmacy Communication Ireland have taken every care in compiling the magazine to ensure that it is correct at the time of going to press, however the publishers assume no responsibility for any effects from omissions or errors.

PUBLISHER IPN Communications Ireland Ltd Clifton House, Lower Fitzwilliam Street, Dublin 2 (01) 669 0562

SALES MANAGER Debbie Graham debbie.hpn@btconnect.com Mobile: 0044 7450274112

Elsewhere, innovation continues to show evidence as the Hospital Pharmacists Association of Ireland launch National Guidelines for Aseptic Compounding in Irish Hospital Pharmacy Practice. These guidelines reflect the translation of international good manufacturing practices (GMP) into a clear and concise document to support aseptic compounding in Irish hospital pharmacy departments. They represent an important body of work and will be a valuable asset in the continually evolving and improving quality of service from Irish hospital pharmacy departments. Turn to page 12 for the full details. Finally, may I take this opportunity on behalf of the whole team at Hospital Pharmacy News to wish you all a very happy, and prosperous New Year.

CONTRIBUTORS Morgan O'Connell Catherine Waldron

MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com

ART DIRECTED BY Smart Page Design

EDITOR Kelly Jo Eastwood kelly@hospitalpharmacy.ie

www.pharmacynewsireland.com www.facebook.com/ HospitalPharmacyNews

ACCOUNTS Julie Daly cs.ipn@btconnect.com

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HPN • Issue 11


4 News

Legal avenue for hospital pharmacy 'common training framework' EAHP President Dr Roberto Frontini

specialties of the medical and dental professions could benefit from such cross-border qualification recognition.

The European Association of Hospital Pharmacists (EAHP) has publicly congratulated Members of the European Parliament (MEPs) for their scrutiny of legislation governing qualification recognition across national borders. In particular, MEPs achieved an opportunity to improve recognition of specialised qualifications in pharmacy, veterinary medicine and nursing. Thanks to amendments secured by the European Parliament there will now be a formal legal

avenue for specialisations such as hospital pharmacy to create a ‘common training framework’ across countries. National regulators of professional qualifications (‘competent authorities’) and professional associations in at least 10 countries can now establish a competence-based framework for automatic recognition of a specialist qualification. In the previous Directive on professional qualification recognition (Directive 2005/36/EC), only

The final vote of the European Parliament on reforms to professional qualification recognition legislation took place on 9 October 2013, completing a two-year process of review. The text now needs to be formally approved by Member States before coming into law. The vote in Council is expected before the end of the year. Member States will then have until the end of 2015 (two years) to implement the provisions introduced by the revised Directive into national legislation. EAHP President Dr Roberto Frontini said,“The recently completed review of the Professional Qualifications Directive showed the European Parliament at its best: picking up on missed issues in a Commission proposal and working across party groupings and countries to improve and

enhance a legal text. Hospital pharmacists owe a debt of gratitude to the lead and shadow rapporteurs of the Parliament for navigating through the hundreds of issues on this all-encompassing legal file. In doing so they picked up on the need to lift restrictions in the Commission text preventing specialties of pharmacy from making use of the common training framework tool. "With this approving vote from the European Parliament the onus now falls upon EAHP, its members and relevant national authorities to start the process of competency-alignment to form a mutual qualification recognition framework. With this in place, health systems and patients across Europe will be able to benefit from greater mobility amongst highly skilled and experienced health professionals who are dedicated to improving patient outcomes and patient safety.”

MRSA rates drop but long way still to go Rates of MRSA in Ireland have halved since 2006, but there is still a long way to go, in particular concerns over HIQA hospital hygiene reports. The Minister for Health, Dr James Reilly TD has launched the Second National Clinical Guideline - Prevention and Control Methicillin-Resistant Staphylococcus aureus (MRSA). This guideline was quality assured by the National Clinical Effectiveness Committee (NCEC). The NCEC recommended the guideline to the Minister, who endorsed it.

Issue 11 • HPN

The Minister said “We must continue to systematically address the prevalence of MRSA in Ireland. This guideline is a significant step and I am pleased to launch it.” Both the Minister and the Department of Health welcome the ongoing HIQA hospital hygiene reports and note the concerns raised in these, and indeed, previous reports about hand hygiene practices particularly among medical staff. Tackling the twin problems of healthcare associated infections

and antimicrobial resistance is a global challenge and a major patient safety priority at national level. Healthcare associated infections are one of the leading causes of preventable harm experienced by patients in modern healthcare and cause a significant burden of mortality, morbidity and increased costs. This National Clinical Guideline: Prevention and Control Methicillin-Resistant Staphylococcus aureus (MRSA) provides practical guidance on prevention and control measures for MRSA to improve patient

care, minimise patient morbidity and mortality and to help contain healthcare costs. The guideline has been developed for all healthcare staff involved in the care of patients, residents or clients who may be at risk of or may have MRSA in acute hospitals, obstetrics and neonates, nursing homes/long stay residential units and the community. Copies of the report are available at http://www.dohc.ie/ publications/MRSA_Report.html


5

National guidline for Aseptic Compounds Hospital pharmacists develop National Guidelines for Aseptic Compounding in Irish Hospital.

national guidelines for aseptic manufacturing in Irish Hospital Pharmacies.

A local group of hospital pharmacists have compiled their knowledge of aseptic compounding to develop an innovative set of guidelines for Irish hospital pharmacy departments.

Joan Peppard, immediate past President of HPAI comments: "Most hospital pharmacies are already adhering to the practice outlined in this guidance document. However, by having supportive guidance, a national framework to self-audit is now available to Irish hospital pharmacists. This will ensure, that all hospital pharmacy units will continue to maintain the high quality service for patients needs."

Hospital pharmacy departments with compounding facilities were invited by the Hospital Pharmacist Association of Ireland (HPAI) to contribute to a project to develop

Michael Fitzpatrick and Veronica Treacy, St James's Hospital, pictured at the launch of the HPAI Aseptic Compounding guidelines.

Undergraduate award for pharmacy student The RCSI Dean of Medicine and Health Sciences (Professor Hannah Mc Gee) is pictured at the Annual White Coat Ceremony with Mr Joseph Sweeney as he receives the Servier Medal for best experienced researcher from Ms Aoife Mc Auliffe, Medical and Regulatory Affairs Manager for Servier (Ireland).

Pictured (l-r) is Prof Fergal O'Brien, Professor of Bioengineering and Regenerative Medicine; Joseph Sweeney, Undergraduate award winner; and Dr Orlaith Brennan, Lecturer in Physics.

Joseph conducted his research as part of his fourth year undergraduate studies at the School of Pharmacy under the supervision of Professor Fergal J. O Brien (Professor of Bioengineering and Regenerative Medicine) and Dr. Orlaith Brennan (Department of Anatomy). The research dissertation was titled: "Investigation of the

influence of a mineral supplement on tissue level bone density and mechanical strength following estrogen deficiency in a rat ovariectomy model of early stage postmenopausal osteoporosis". This research dissertation also won the Medical Sciences category of the Google Undergraduate Awards 2013. The President of Ireland will present Joseph with the medal for winning this category at the UA Summit 2013, which will be held in Dublin from the 13th-15th of November 2013. Joseph's research was one of almost 4000 pieces of coursework submitted to The Undergraduate Awards* this year, from 182 thirdlevel institutions internationally.

New route for the development of anti-diarrhoeal drugs Gastroenterology research carried out by the RCSI (Royal College of Surgeons in Ireland) in conjunction with Trinity College Dublin and Johns Hopkins University in Baltimore, Maryland has uncovered a new route for the development of anti-diarrhoeal drugs. The new route directly targets cells and molecular processes that control water movement into the intestine and may help with the development of a new class of anti-diarrhoeal medication.

The research found that drugs which act on a protein called Farnesoid X Receptor (FXR) in the tissue of the intestine can stop water moving in to the gut. By switching off the water movement in to the gut, this can prevent diarrhoea occurring. Dr Stephen Keely, Associate Director of Molecular Medicine, RCSI and lead researcher, said â&#x20AC;&#x2DC;Diarrhoeal diseases are common and debilitating but safe and effective drugs for their treatment

are still lacking. Our research has found that FXR is an important regulator of intestinal function and has excellent potential for the development of a new class of anti-diarrhoeal drugs." In Ireland, diarrhoea is the main reason for approximately 40,000 visits to gastroenterology clinics annually. Epidemics of acute infectious diarrhoea are common, and many illnesses such as inflammatory bowel disease, digestive disorders and irritable

bowel syndrome cause disruptions to the normal functioning of the intestine and lead to diarrhoea. These conditions have a large financial burden to society both in terms of healthcare and lost hours of work. The research found that drugs which target the FXR protein, target the cells lining the intestine, and because of this they may have broader efficacy and fewer side effects than many anti-diarrhoeals currently available on the market.

HPN â&#x20AC;˘ Issue 11


6 News

Global Pharmacy Workforce Observatory Memorandum signed in Dublin

Left to Right: Mr Luc Besancon, Dr Michel Buchmann, Mr Martin Astbury and Mrs Helen Gordon

The International Pharmaceutical Federation (FIP) and the Royal Pharmaceutical Society (RPS) signed a Memorandum of Understanding to support the establishment of a Global Pharmacy Workforce Observatory, in Dublin recently.

aim to establish a permanent contemporary workforce databank under the Global Pharmacy Workforce Observatory (GPWO).

This initiative is based on the data and case studies from the 2009 and 2012 FIP Global Pharmacy Workforce Reports (www.fip.org/ educationreports). FIP and RPS

The Global Workforce Observatory (GPWO) – an online database platform for global workforce intelligence that will be hosted by the RPS on behalf of FIP and

The FIP and RPS will work together to promote and develop the following, via the GPWO Project Team:

specifically the FIP Education Initiative (FIPEd). The database platform will be accessible and utilised by FIP Member Organisations and FIP Institutional Members (AIM) as a membership benefit.

this will be a significant resource for workforce development. We see this as a high profile collaboration and extend our thanks to the RPS for providing the support required to make this work”.

The GPWO Project Team will be accountable to FIPEd for the quality and progression of the project and will produce an annual report on progress and use for both RPS and FIPEd. The Director of the FIPEd Education Development Team will assume day-to-day responsibility for the project, on behalf of FIPEd and the FIPEd Steering Committee will assume responsibility of providing oversight on the quality and progress of the project. The Royal Pharmaceutical Society will provide expertise and strategic support for this important global project.

Mrs Helen Gordon, Chief Executive of the RPS, says “We at the RPS recognise the importance that workforce intelligence plays for the better planning of healthcare, and in this case, pharmaceutical care, to our nations. We see this as a strategic issue for a professional leadership body, and the RPS has no doubt about the benefit of collaborating with FIP in this project. Workforce intelligence is vital for workforce development, and workforce development is the cornerstone of professional advancement”.

Mr Luc Besancon, General Secretary and CEO of FIP welcomes this collaboration; “FIP is clear that we need to provide access to accurate and useful workforce data for our members. We know that knowledge about the global workforce is needed by both our members and by our United Nations partners, for whom

Almost ¤70m drug savings achieved Pharmaceutical companies that make and supply original branded medicines in Ireland have delivered savings of almost ¤70 million in the first half of 2013, according to the Irish Pharmaceutical Healthcare Association (IPHA).

major price reductions agreed between the industry and the Government. Proper recognition needs to be given to these savings. Meanwhile, the new system of reference pricing and generic substitution should bring down the price of generics."

Responding to reports that the Troika had singled out the cost of branded medicines, as well as generic medicines, as being too high in Ireland, IPHA Commercial Affairs Director Orlaith Brennan said: “Generic medicines are up to 50% more expensive in Ireland than the European average. However, original branded medicines produced by IPHA companies are now at or below the European average as a direct result of a series of

Ms Brennan pointed out that the current agreement has delivered over ¤68.5 million in savings to the State in the first 6 months of 2013 and has in place mechanisms to deliver ¤400 million over the course of the agreement. IPHA member company products are at or below the European average.

Issue 11 • HPN

“Last week IPHA companies implemented a third series of price reductions for many off

patent medicines as part of the agreement, which will see the cost to the State and patients reducing further. As a result of a series of price reductions agreed by IPHA companies between 2008 and 2013, the pharmaceutical per item cost to the State has reduced by nearly 30%, resulting in savings in the region of ¤554 million. Since the economic crisis enveloped this country necessitating the Troika bailout programme, IPHA companies have worked with the State to ensure that they played their part in implementing a reform programme. This is reflected in the very significant savings that have been delivered to the State, Ms Brennan concluded.

The GPWO project plan has currently been prepared and a GPWO Memorandum of Understanding between FIP and RPS has been agreed and was formally signed at FIP’s 73rd Annual Congress in Dublin on 1st September; both Chief Executives, together with the President of FIP, Dr Michel Buchmann and the President of the RPS, Mr Martin Astbury, were present at this event.


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• Excellent penetration in lung1 and skin2 tissue • Statistically superior clinical efficacy versus vancomycin in nosocomial pneumonia due to MRSA in the ZEPHyR trial3 • Comparable clinical and microbiological success to vancomycin in culture-proven MRSA patients with cSSTI4 See Summary of Product Characteristics before prescribing Zyvox 2mg/ml Solution for Infusion (containing 2mg/ml linezolid). Zyvox 600mg Film-Coated Tablets (containing 600 mg linezolid). Zyvox 100mg/5ml Granules for Oral Suspension (containing 20mg/ml linezolid). Indications: Zyvox is indicated for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram positive bacteria (specific therapy against Gram negative organisms must be initiated concomitantly if a Gram negative pathogen is documented or suspected). Zyvox is also indicated for the treatment of complicated skin and soft tissue infections only when microbiological testing has established that the infection is known to be caused by susceptible Gram positive bacteria. Zyvox should only be used in patients with known or possible co-infection with Gram negative organisms if there are no alternative treatment options available. Linezolid should only be initiated in a hospital environment and after consultation with a relevant specialist such as a microbiologist or infectious diseases specialist. Dosage/Route of administration: Dose: 600mg IV or orally, twice daily for all indications. Duration 10-14 days. The solution for infusion should be administered over a period of 30 to 120 minutes. No dose adjustment is required for the elderly, or patients with any degree of renal or hepatic insufficiency. Linezolid should be given after dialysis in patients receiving such treatment. The maximum treatment duration is 28 days. Children (<18 years): Not recommended as there are insufficient data to establish dosage recommendations. Film-coated tablets and oral suspension may be taken with or without food. Contraindications: Patients hypersensitive to linezolid or any of the excipients. Patients taking any drug which inhibits monoamine oxidases A or B or within two weeks of taking any such drug. Linezolid should not be administered to patients with the following, unless there are facilities available for close observation and blood pressure monitoring: a) Patients with uncontrolled hypertension, phaeochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder, acute confusional states or b) Patients taking any of the following medications: Serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), directly and indirectly acting sympathomimetic agents, vasopressive agents, dopaminergic agents, pethidine or buspirone. Breast-feeding should be discontinued prior to and throughout administration. Precautions: Linezolid should be used with special caution in patients with severe renal or hepatic insufficiency and only when the anticipated benefit is considered to outweigh the theoretical risk. All patients should be advised to report symptoms of visual impairment, such as changes in visual acuity, changes in colour vision, blurred vision, or visual field defect, prompt evaluation is recommended with referral to an ophthalmologist if necessary. If patients are taking Zyvox for longer than the recommended 28 days, their visual function should be regularly monitored, the continued use of Zyvox in these patients should be weighed against the potential risks. There may be an increased risk of neuropathies when linezolid is used in patients currently taking or who have recently taken antimycobacterial medications for the treatment of tuberculosis. It is recommended that complete blood counts should be monitored weekly as myelosupression has been reported in patients receiving linezolid. In cases with a known outcome, haematologic parameters have risen towards pre-treatment levels upon discontinuation of linezolid. Close monitoring is recommended in patients with preexisting risk factors for myelosuppression , those who are receiving concomitant medications that may decrease haemoglobin levels, depress blood counts or adversely affect platelet count or function; those on therapy >10-14days, or with severe renal insufficiency. Patients who develop signs and symptoms of lactic acidosis such as recurrent nausea and vomiting, abdominal pain, low bicarbonate level or hyperventilation require immediate medical attention. In complicated skin and soft tissue infections linezolid should only be used in patients with known or possible co-infection with Gram negative organisms if there are no alternative treatment options available In these circumstances treatment against Gram negative organisms must be initiated concomitantly. Antibiotic-associated diarrhoea and antibiotic-associated colitis, including pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in association with the use of nearly all antibiotics including linezolid and may range in severity from mild diarrhoea to fatal colitis. Therefore, it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of linezolid. If antibiotic-associated diarrhoea or antibiotic-associated colitis is suspected or confirmed, ongoing treatment with antibacterial agents, including linezolid, should be discontinued and adequate therapeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in this situation. Treat superinfections if they develop. Convulsions have been reported to occur in patients when treated with Zyvox. In most of these cases, a history of seizures or risk factors for seizures was reported. Patients should be advised to inform their physician if they have a history of seizures. Spontaneous reports of

serotonin syndrome associated with the co-administration of linezolid and serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs) have been reported. Co-administration of linezolid and serotonergic agents is therefore contraindicated except where administration of linezolid and concomitant serotonergic agents is essential. In those cases patients should be closely observed for signs and symptoms of serotonin syndrome such as cognitive dysfunction, hyperpyrexia, hyperreflexia and incoordination. If signs or symptoms occur physicians should consider discontinuing either one or both agents; if the concomitant serotonergic agent is withdrawn, discontinuation symptoms can occur. Suspension contains sodium, sucrose and mannitol; avoid in phenylketonuria and sucrose intolerance; Solution contains glucose and sodium. Limit tyramine-rich foods. Linezolid reversibly decreased fertility and induced abnormal sperm morphology in adult male rats at exposure levels approximately equal to those expected in humans; possible effect of linezolid on the human male reproductive system are not known. Interactions: Linezolid is not recommended for administration to patients on concomitant medications that might put them at risk from MAO inhibition unless under close observation and monitoring is possible. It is recommended that doses of drugs with a vasopressive action, including dopaminergic agents, should be carefully titrated to achieve the desired response when co-administered with linezolid. Rifampicin decreased the linezolid Cmax and AUC by a mean 21% [90% CI, 15, 27] and a mean 32% [90% CI, 27, 37], respectively in a study. The mechanism of this interaction and its clinical significance are unknown. Pregnancy: Linezolid should not be used during pregnancy unless necessary. Driving: Patients should be warned about the potential for dizziness or symptoms of visual impairment whilst receiving linezolid and advised not to drive if affected. Side effects: Haematological abnormalities (see precautions above). Common side effects: headache, candidiasis, oral candidiasis, vaginal candidiasis, fungal infection, metallic taste, diarrhoea, nausea, vomiting, abnormal liver function tests, increased AST, ALT or alkaline phosphatise, increased BUN, increased LDH, creatine kinase, lipase, amylase or non fasting glucose, decreased total protein, albumin, sodium or calcium, increased or decreased potassium or bicarbonate, increased neutrophils or eosinophils, decreased haemoglobin, haematocrit or red blood cell count, increased or decreased platelet or white blood cell counts. Uncommon side effects: localized or general abdominal pain, chills, fatigue, fever, injection site pain, phlebitis / thrombophlebitis, localized pain, leucopenia, neutropenia, thrombocytopenia, eosinophilia, dizziness, hypoaesthesia, insomnia, paraesthesia, blurred vision, tinnitus, hypertension, constipation, dry mouth, dyspepsia, gastritis, glossitis, increased thirst, loose stools, pancreatitis, stomatitis, tongue discolouration or disorder, dermatitis, diaphoresis, pruritis, rash, urticaria, vulvovaginal disorder, polyuria, vaginitis, increased total bilirubin, increased creatinine, increased sodium or calcium, decreased non fasting glucose, increased or decreased chloride, increased reticulocyte count, decreased neutrophils. Rare side effects: arrhythmia (tachycardia), transient ischaemic attacks and renal failure. The following adverse reactions to linezolid were considered to be serious in rare cases: localised abdominal pain, transient ischaemic attacks and hypertension.and renal failure. Post marketing experience: There have been reports of antibiotic-associated colitis, including pseudomembranous colitis, potentially associated with life-threatening complications, anaemia, pancytopenia, sideroblastic anaemia, myelosuppression, lactic acidosis (see SPC section 4.4), hyponatraemia and anaphylaxis. Nervous system disorders: Peripheral neuropathy, convulsions, serotonin syndrome (see SPC sections 4.3 and 4.5). Peripheral neuropathy has been reported in patients treated with Zyvox; these reports have primarily been in patients treated for longer than the maximum recommended duration of 28 days (see SPC section 4.4). Eye disorders: Optic neuropathy, optic neuritis, loss of vision, changes in visual acuity, changes in colour vision, changes in visual field defect (see SPC section 4.4). Reports of angioedema, alopecia, superficial tooth discolouration, toxic epidermal necrolysis, bullous skin disorders such as those described as Stevens-Johnson syndrome have been received. Packaging quantity: Zyvox Infusion 300ml bag, 10 bags. Zyvox 600mg tablet, 10 tablets. Zyvox Granules for Oral Suspension 150ml bottle, 1 bottle. Marketing Authorisation Numbers: 300ml bag: PA 822/143/2. 600mg tablet: PA 822/143/4. 150ml bottle: PA 822/143/1. Legal Classification: S1A. The Marketing Authorisation Holder: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at EUMEDINFO@ pfizer.com. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500. Date of Preparation of P.I.: October 2013. Ref: ZY 10_0

ReFeReNCeS: 1. Boselli e, et al. Crit Care Med 2005;33:1529-1533. 2. Gee t, et al. antiMiCroB aGents CheMother 2001;45:1843-1846. 3. Wunderink r. et al, Clin infeCt dis 2012; online Jan 12. 4. itani kM, et al. aM J surG 2010;199:804-816

Date of Preparation: October 2013 ZYX/2013/022/1


8 Report

The ongoing war against Clostridium difficile While advances have been made and battles won in the area of hygiene awareness, clinicians are being advised to remain vigilant in the overall war against Clostridium difficile infection (CDI). In an exclusive interview, HSE Assistant National Director of Health Protection Dr Kevin Kelleher tells Hospital Pharmacy News about the challenges facing Irish doctors. In an era when hospital-acquired infections (HAIs) are under scrutiny because of an increased focus on patient safety and preserving scarce resources, Clostridium difficile infection (CDI) remains a stubborn stumbling block in the bid to eradicate HAIs. The use of antibiotics has long been implicated in the development of CDI-associated diarrhoea in the patient population because of the way in which some ‘good’ bacteria are killed by antibiotic use, allowing C.difficile bacteria to proliferate and cause infection. Less than one in 20 of the healthy adult population carry a small amount of C.difficile and do not experience any adverse effects from it.1 However the common symptoms — such as stomach cramps, nausea, fever and loss of appetite, accompanied by the hallmark diarrhoea — pose diagnostic problems for the clinician in distinguishing CDI from other infections with a similar symptomatic profile. But if left untreated, CDI can lead to the development of colitis (inflammation of the bowel) and the onset of serious illness.2 Diagnostic challenges The detection of toxin A/B from faecal samples by immunoenzymatic techniques has been at the core of laboratory CDI diagnosis for more than two decades. Toxin enzyme immunoassays (EIAs) are faster and easier to perform than culture or cytotoxin assays and negate the need for a dedicated technician or special equipment, providing for a laboratory to refer results more quickly. However — if used as standalone assays — immunoenzymatic kits for C.difficile v’s gold-standard methods are seen as suboptimal in terms of specificity and sensitivity. Commercial EIA systems show high specificity but low-tomoderate sensitivity and the Issue 11 • HPN

positive and negative predictive values of all kits vary, depending on the prevalence of the condition being detected.2 In this context, and to facilitate accurate laboratory diagnosis, if the prevalence of C.difficile toxins in stool samples is relatively low — <10 % — then the positive, predictive values of these assays is too low (<50 %) to represent a reliable diagnosis and optimal clinical management. 2 Due to these findings, it has been “strongly recommended” in an expert review of anti-infective therapy that a two-step diagnostic algorithm involving a highly sensitive, rapid screening method should be used to identify positive samples.2 Aside from laboratory diagnosis, in the more severe forms of C.difficile endoscopy and radiology can serve as helpful tools, while lower GI endoscopy can be utilised to visualise colonic mucosa and identify pseudomembranes or inflammation.2 Low albumin level, high white blood cell count and immunosuppression are associated with more severe forms of CDI.2 Prior to thorough clinical investigation, according to guidance, there is a certain cohort of patients who may show up on the clinician’s radar in terms of their risk for developing CDI.

Dr Kevin Kelleher, Assistant National Director of Health Protection, HSE

However, even when the initial infection has been successfully tackled, the rate of recurrence represents one of the most challenging aspects of CDI management for clinicians. An expert review of anti-infective therapy2 asserted that after successful first-line treatment with standard therapies, 20-to-30 % of patients could experience recurrence within 30 days of the discontinuation of initial therapy.

These include:

The risk factors for recurrences are similar to the risks associated with initial infection:2

• The elderly;

• Stay in an intensive care unit;

• Patients who have undergone bowel surgery;

• Prolonged period in an acute hospital setting;

• Those who have spent considerable time in an acute hospital setting or other healthcare facilities, such as a nursing home;

• Serious underlying illness;

• Those who have a serious illness;

• Renal impairment;

• Patients with a weakened immune system, such as those who are undergoing treatment for cancer; and

• Disruption of normal colonic microflora via exposure to antibacterial agents; and

• Those who have recently completed or are still on a course of antibiotics.1

• Advanced age (that is, over 65 years old);

• Compromised immune system;

• Previous CDI. Recurrence has been identified as relating to a combination of

three different factors, namely: Intestinal presence of C.difficile spores; suboptimal host immune response; and failure to reestablish colonic microflora. Taken in combination, these factors bring into stark reality the challenges to specialists in their efforts to prevent recurrence; however the identification of patients at a higher risk of recurrence presents obvious benefits in terms of improved treatment pathways in recurrent C.difficile infection.2 Irish incidence New cases of C.difficile became notifiable in Ireland in May 2008. Between that time and December 2012, 8,669 new cases were reported to the Computerised Infectious Disease Reporting system. However in January 2012, case definition was revised to make both new and recurrent cases notifiable. The data showed that during 2013, there were 1,619 new CDI cases notified, as well as 180 recurrent cases and 25 for which there was no case type information. This equated to a national crude incidence rate of 35.3 new CDI cases per 100,000 of the population, according to the Health Protection Surveillance Centre (HPSC).3


9 According to 2012 data, the majority of new cases were in females at 61% and in older age groups and the mean age was 67 years old but the 75-to-84 years age group had the highest number of cases, at 45%.3

illness but without CDI.3 Costs rose further for CDI patients with co-morbidities: in patients with inflammatory bowel disease (IBD), overall costs were $22,873 per patient, compared with $15,762 for non infected patients with IBD.3

Antimicrobial stewardship

The future

Dr Kelleher elaborated that all healthcare facilities should have an active antimicrobial stewardship programme to encourage wise prescribing:

The HPSC also reported that in 2012, 26 severe cases of CDI were notified, representing 1.5% of the overall incidence of infection. According to data for that year, 64% (n=1,117) experienced onset of CDI symptoms in a healthcare facility, with 77% of these (n=854) occurring in the reporting hospital. Notably, however, 30% of all cases of CDI experienced onset of symptoms in the community — up from 27% from 2011 and 2010.3

The right treatment

“This should include local antimicrobial prescribing guidelines to include a restrictive antimicrobial list and efforts to minimise the frequency, duration and number of antimicrobial agents prescribed,” he told Hospital Pharmacy News.

As for the future, it is seen as likely that DNA sequencebased methods are set to be increasingly applied to studies of the epidemiology of C.difficile — this is primarily to be driven by the continuing decreased cost of this method and high discriminatory power.2

Information on changing testing practices is being collected on a quarterly basis from this year onwards and this will enable more robust comparisons of CDI rates, said the HPSC.93 Economic impact CDI takes a significant toll on healthcare costs, a consideration acutely relevant in terms of ever-pressurised health budgets. European estimates show that the potential costs of managing CDI are as high as ¤3 billion per annum. Bearing in mind the ageing population, it is estimated that by 2050, more than 134 million Europeans will be 65 years of age or older.(4) Due to the fact that CDI is most prevalent in the older population, the economic strain placed by CDI is expected to increase dramatically.4 CDI prolongs hospital stays and prevents return to normal activities. While it is impossible to accurately measure the exact financial impact of this on a societal level, the impact on hospital costs comes to light when it is considered that an extra one-to-three weeks is spent in the hospital setting.3 Other factors such as infection prevention and control measures, laboratory testing, litigation, decontamination, cohort isolation and ward closures can also contribute significantly to the economic impact.4 A German study has found that patients with CDI incurred an additional cost of treatment compared to other patient types and this ranged from ¤4,067 to ¤9,276 per patient episode due to increased length of hospital stay. Furthermore, a recent US review compiled from 13 studies showed that in 2008, treating primary CDI ranged from $9,822 to $13,854 — this was in comparison to a cost range from $6,950 to $9,008 for controls with similar underlying

Defining the right treatment options presents yet another challenge for clinicians. Treatment can include discontinuing antibiotics in an effort to allow intestinal flora to regenerate; however, the patient’s clinical status can often preclude this. In terms of pharmacological therapies, the HPSC has highlighted “some advantages” of fidaxomicin over vancomycin in CDI treatment and indicated that after consultation with a specialist consultant and microbiologist, it may be used: “As an alternative to vancomycin for adults with mild-to-moderate or severe CDI; in patients at high risk of recurrence or with first recurrence; and where concominant antibiotic use is unavoidable.”3 Of the three treatments available — fidaxomicin, vancomycin and metronidazole — there are two Phase-3 clinical trials comparing fidaxomicin and vancomycin.5,6 However, no clinical trials have been conducted to date comparing fidaxomicin and metronidazole.3 In relation to metronidazole the report states “Expert opinion would consider fidaxomicin to have similar advantages to vancomycin”.3 However the Centre added that fidaxomicin has not yet been tested in pregnant or breastfeeding women or patients with a history of IBD.3 Speaking exclusively to Hospital Pharmacy News, HSE Assistant National Director of Health Protection Dr Kevin Kelleher spoke about the importance of appropriate prescribing habits in CDI prevention: “Recent, prolonged and/or multiple antibiotic use predisposes patients and/or residents to CDI and are a major risk factor for recurrent infection,” he explained. “Antibiotics disturb the normal colonic microbiota, thereby permitting C.difficile to cause infection. Almost all antibiotics have been associated with CDI, though some of the broaderspectrum agents are more likely to predispose to infection, for example fluoroquinolones, clindamycin and third-generation cephalosporins.”

“In addition, hospitals should implement the core high-impact interventions for antimicrobial stewardship, as outlined in the national guidelines. These include clinical review and direct prescriber feedback, antimicrobial surveillance and audit, restricted availability of antimicrobials and pre-authorisation.” Ireland does not currently have a national referencing laboratory for typing and antibiotic testing and this has resulted in limited data on the molecular epidemiology of C.difficile strains here. “However,” Dr Kelleher pointed out, “a 2009 national one-month prevalence study of 139 strains from 211 patients reported Irish ribotype distribution for the first time. Sixteen different ribotypes were found, with 027 (19 %); 106 (13 %); 078 (9 %); 044 (9 %); 014 (8 %); and 001 (7 %) the most common. At present, Irish hospitals submit specimens to reference laboratories in the UK.” Dr Kelleher outlined his take-home message for preventing the spread of C.Diff in the acute setting: “Focus on CDI prevention,” he stressed. “This can be done by sensible antibiotic prescribing; good infection prevention and control practices, which include hand hygiene, as per the WHO’s ‘5 Moments’; monitoring CDI rates on your wards and the root cause analysis of CDI cases for potentially modifiable risk factors; and prompt management of patients with suspected potentially infectious diarrhoea,” he said. He also pointed out that C.difficile spores are resistant to alcohol hand-rubs, creating a need for vigilance in regular hand-washing. Dr Kelleher concluded by urging the use of the SIGHT mnemonic UK protocol,(3) which provides a useful framework for managing suspected infectious diarrhoea cases, and he encouraged physicians to consult the multiple resources available to healthcare workers on the issue.

Future therapeutic approaches — mirrored by new treatment options and strategies already available — should be based on a two-pronged approach: eliminating the infection in spite of continuing concominant antibiotic therapy, and reducing the risk of recurrence.2 S Suspect that a case may be infective where there is no clear alternative cause for diarrhoea I Isolate the patient if in a healthcare facility (e.g., hospital, nursing home) with contact precautions. Consult with the infection prevention and control team where available while determining the cause of the diarrhoea G Gloves and aprons must be used for all contacts with the patient and their environment. Instruct the patient and carers/family members in hand hygiene and when they need to use PPE H Hand washing with soap and water should be carried out after each contact with the patient and the patient’s environment T Test the stool for C.difficile toxin, by sending a specimen immediately. If the patient is unwell/unstable, contact the consultant microbiologists/ID physician for advice.

References • HPSC report available at http:// www.hpsc.ie/hpsc/A-Z/Gastroenteric/ Clostridiumdifficile/Factsheets/ File,2946,en.pdf. Accessed October 2013 • ‘Epidemiology, Diagnosis and Treatment of Clostridium Difficile Infection.’ Basetti, Villa, Pecori, Arzese, Wilcox. Disclosures: Expert Review of Anti-infective Therapy. 2012;10(12):14051423. • ‘Surveillance, Diagnosis and Management of Clostridium Difficile in Ireland: Update of 2008 Guidance.’ HPSC, February 2013, revised June 2013. Accessed October 2013 • Kuijper et al, ‘Clostridium DifficileAssociated Disease in North America and Europe.’ Clin Microbiol Infect 2006 Oct; 12 Suppl 6:2-18. • Louie et al, Fidaxomicin versus Vancomycin for Clostridium difficile Infection. N Engl J Med 2011 ; 364;5 ; 422-431 • Cornely O A et al; Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet 2012 ; 12 ; 281 – 289

HPN • Issue 11


10 News

Boehringer Ingelheim’s Giotrif® (afatinib), receives European marketing authorisation Giotrif (afatanib)

and improving lung cancer related symptoms, making it an important addition to our treatment options in UK." Around 80 – 85% of lung cancers are NSCLC, of which about 10% also have the EGFR mutation. NSCLC is often linked to smoking, but some people are diagnosed with it having never smoked. NSCLC patients who have never smoked are more likely to have an EGFR mutation.

Boehringer Ingelheim have announced that the European Commission has granted marketing authorisation for Giotrif® (afatinib), as first line treatment of Epidermal Growth Factor Receptor (EGFR) TKInaïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). Giotrif® (afatinib), the first irreversible ErbB family blocker is a new, once-daily, oral treatment which targets EGFR.14 Giotrif® (afatinib) irreversibly blocks oncogenic signalling from all homo and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4, blocking the key pathways that help cancer cells grow, migrate and metabolise. Data from the pivotal LUX-Lung 3 trial, the largest global phase III trial in patients with EGFR mutation positive advanced lung cancer, comparing Giotrif® (afatinib) to pemetrexed/cisplatin chemotherapy in the first line setting showed that patients taking Giotrif® (afatinib) as a first line treatment lived for an average of 11.1 months without their tumour growing (known as progression free survival, PFS) versus 6.9 months for those treated with pemetrexed/ cisplatin (HR 0.58; p<0.001). Issue 11 • HPN

The European marketing authorisation for Giotrif® (afatinib) was based on data from the pivotal LUX-Lung 3 trial, the largest global phase III trial in patients with EGFR mutation positive advanced lung cancer, comparing Giotrif® (afatinib) to pemetrexed/ cisplatin chemotherapy in the first line setting. Almost 70% of patients who took part in this study had never smoked.

Dr Sanjay Popat, The Royal Marsden NHS Foundation Trust

Furthermore, patients with the most common types of EGFR mutation (accounting for 90% of all known EGFR mutations) Giotrif® (afatinib) provided patients with progressionfree survival of 13.6 months compared to 6.9 months with pemetrexed/cisplatin (HR 0.47; p=0.001). The marketing authorisation of Giotrif® (afatinib) follows recent guidance from the National Institute for Health and Care Excellence (NICE) highlighting the clinical need for EGFR testing to detect the mutation

in untreated patients with advanced or metastatic NSCLC. "Its novel mode of action allows Giotrif® to block EGFR and other members of the ErbB Family of receptors that play a key role in the growth and spread of cancers associated with a high mortality such as lung cancer," said Dr. Sanjay Popat, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust, London and clinical investigator in the LUX-Lung 3 trial. "Clinical data demonstrates Giotrif® efficacy in delaying tumour growth

In LUX-Lung 3, in addition to an improvement in progression-free survival, Giotrif® (afatinib) was associated with a significantly delayed time to deterioration in global health status, quality of life, and disease related symptoms including cough and dyspnoea versus pemetrexed/ cisplatin. Side-effects seen with Giotrif® (afatinib) were manageable through dose reductions and supportive care, with 8% of patients discontinuing due to Giotrif® (afatinib) related side effects, compared to 12% in the pemetrexed/cisplatin arm.6 The most common side effect was diarrhoea with 1.3% of patients discontinuing treatment due to this.


12 Guideline Report

National Guidelines for Aseptic Compounding in Irish Hospital Practice A local group of hospital pharmacists have compiled their knowledge of aseptic compounding to develop an innovative set of guidelines for Irish hospital pharmacy departments. Hospital pharmacy departments with compounding facilities were invited by the Hospital Pharmacist Association of Ireland (HPAI) to contribute to a project to develop national guidelines for aseptic manufacturing in Irish Hospital Pharmacies. The National Guidelines for Aseptic Compounding in Irish Hospital Pharmacy Practice reflect the translation of international good manufacturing practices (GMP) into a clear and concise document to support aseptic compounding in Irish hospital pharmacy departments. These guidelines represent an important body of work and will be a valuable asset in the continually evolving and improving quality of service from Irish hospital pharmacy departments. The compounding of medicines in a controlled environment enables compounding of complex and/or hazardous drugs such as chemotherapy or other drugs that could pose a risk to patients and to staff if prepared at ward level. It reduces the risk of error, whilst providing a high quality, flexible service. Local production at hospital level facilitates treatment at relatively short notice to meet patient requirements. It also allows participation in clinical trials, which is important for patient treatment options. Given the requirements for quality and safety when handling such drugs, it is important that the underpinning principles of GMP are incorporated into standard practices in these units. Regulations surrounding Good Issue 11 • HPN

Manufacturing Practice (GMP) outline what is required for licensed manufacturing units, to manufacture licensed drugs. Officials who inspect pharmaceutical manufacturing facilities worldwide (PIC/S) have published guidelines for good practice for the preparation of medicines in hospitals. Individual countries like the UK and USA have their own national guidelines. Aseptic compounding in Irish Hospital Pharmacy is exempt from holding a Manufacturer’s Authorisation provided certain criteria are met (Medicinal Products (Control of Manufacture) Regulations, 2007. Section 5 – S.I. No. 539 of 2007). However, professionally, the ethos of GMP is paramount to ensure that all products compounded are of high quality, safe and effective. Below we have summarised some of the main principles of these guidelines, but they can be obtained in full by contacting the HPAI at www.hpai.ie PREMISES AND EQUIPMENT The general requirements for premises and equipment are seven-fold and encompass:  Premises and equipment should be appropriately designed, built, used, maintained and upgraded, ensuring that they are suitable for the intended activities and to minimise the risk of errors. The capacity should be sufficient to enable a logical workflow and appropriate segregation of activities.  In order to reduce the risk of contamination, for example by cross contamination or by the accumulation of dust and dirt, appropriately designed premises and equipment, as well as careful and suitable working techniques should be used. The

design should enable thorough cleaning. Special care should be taken when samples are taken or when equipment is cleaned and, where applicable, disinfected after repair or maintenance.

to desribe the composition, specifying all starting and other materials used and laying down all processing and packaging operations as well as quality control tests and release.

 Adequate measures should be taken against the entry of insects and other animals (pest control).

c) Records

 Washing and cleaning activities should not themselves be a source of contamination.  Production, storage and quality control areas should be accessible to authorised personnel only.  Environmental conditions (temperature, humidity, light) during production, quality control and storage (including cold storage) should be defined and monitored and, if necessary, controlled. Monitoring results should be documented, assessed and retained. When conditions fall outside the defined limites, adequate corrective action should be taken.  All areas should be clean, orderly and well lit. DOCUMENTATION Quality relevant data, including risk assessments, should be documented. The term 'documentation' summarises particularly: a) Specification There should be appropriately authorised and dated specifications for sarting materials, packaging materials and finished products, where appropriate, they should also be available for intermediate or bulk products. b) Product specific instructions There should be processing, packaging, quality control and release instructions available

Processing, packaging and quality control documents, which record the quality relevant facts of the history of a medicinal product during preperation. d) General procedures and additional documentation Instructions for the performance of standardised operations and other evidence which document the history and the quality of a medicinal product. Examples are the description of receipt of goods, sampling, reference samples of prepared products, testing, release, rejection, calibration, cleaning, disinfecting, performance of hygiene activities, personnel training and operation of equipment.  All specifications, instructions and procedures should be approved, signed and dated by the Responsible Person or by a person appointed by the Responsible Person. Effective and review dates should be defined.  All written documents should be legible, clear, unambiguous and up to date. Electronic records should be adequately protected against unauthorised changes and against data loss. The readability of electronically stored data needs to be guaranteed over the whole retention period.  The totality of these documents should ensure the complete traceability of the preperation process of a medicinal product.  Any alteration made to a document should be signed


13

Claire Browne, Deirdre Behan, Jane Martin and Louise McDonnell

Fiona Begley, Mary Coyle and Maria Tallon

Frances Moloney, Grant Carroll and Lisa Hammond

Joan Peppard pictured at the launch of the Aseptic Compounding Guidelines

and dated.The alteration should permit the reading of the original information. The reason for alterations should be evident. Equivalent measures should be applied to electronic records.

 Equipment and material used for all operations should be suiable for the intended use.

 Records should be retained for a sufficient period to satisfy national legislative requirements. In any case, records should be retained at least one year after the expiry date of the relevant finished product. Procedures and preperation instructions (including prescriptions) should be retained at least five years after their use. PRODUCTION Production operations should guarantee the required quality and should be performed and supervised by competent people.

 Production should be performed by trained personnel  Starting materials should be approved before use. The identity, weight and volume of all starting materials should be independently checked by a second person or by a validated computerised system (e.g. barcode)  Production should be performed based on a written instruction, in which all relevant processes are laid down in detail.  To avoid mix-ups, all necessary technical and organisational measures should be taken.  The process steps which have been performed should be recorded.

 Products and materials should be protected against microbial and other contamination at all preperation steps.  At all times during preperation, all products should be identified. Labels or indications on containers and equipment should be clear, and unamibguous.  At all times during preperation, the operational status (e.g. cleaned, in use) of rooms and equipment should be clear. QUALITY CONTROL  Quality control ensures that all requirements related to quality are met.

 In particular it ensures that the necessary tests are carried out and that products are only released if they comply with the quality requirements.  The extent to which quality control tests are performed should take into account stability information and physical properties and should be defined on the basis of a risk assessment.  Quality control and release activities should be independent of preperation activities. * The Guidelines are not intended to place any restraint upon the development of alternate systems, new concepts or new technologies, which provide a level of quality assurance at least equivalent to those set out in the guidelines.

HPN • Issue 11


14 Clinical

Invokana receives marketing authorisation in EU for treatment of adults with Type 2 Diabetes of type 2 diabetes is enormously complex and canagliflozin will be a welcome addition to our diabetic treatment options.” “This marketing authorisation represents a major milestone in Johnson & Johnson’s longstanding commitment to diabetes. INVOKANA® will pave the way for Janssen as part of our goal to develop and provide new therapeutic options for adult patients with type 2 diabetes”, comments Dr. Leisha Daly, Country Director, Janssen Ireland. In Ireland, the prevalence of type 2 diabetes continues to be on the rise. Despite there being a number of treatments currently available, many patients are still not able to achieve and maintain long-term control of their blood sugar. Type 2 diabetes is a progressive disease that, if left uncontrolled, can lead to debilitating complications. Janssen has announced earlier this month that it has received marketing authorisation for Invokana® (canagliflozin) in the European Union for the treatment of adults with type 2 diabetes mellitus.1 Canagliflozin is an oral, once-daily medication, which belongs to a new class of medications called sodium glucose co-transporter 2 inhibitors. Canagliflozin will provide a new treatment option for the management of adults with type 2 diabetes. The kidneys make an important contribution to balancing blood glucose. As glucose is filtered from the blood into the kidneys it is reabsorbed back into the bloodstream. An important carrier responsible for this reabsorption is called sodium glucose co-transporter 2 (SGLT2).2 Canagliflozin selectively inhibits SGLT2, and, as a result, promotes the loss of glucose via the urine, lowering blood glucose levels in adults with type 2 diabetes.3 Dr. Maeve Durkan, MB.Bch.BAO. LRCPI&SI (NUI), FACP,Mmed. Ed, Consultant in Diabetes, Endocrinology & Metabolism & Dean of Academy, NUI Galway School of Medicine & UL GEMS commented on the announcement, “The arrival of new agents in type 2 diabetes, such as canagliflozin, promises to make a real difference to patients’ lives. Management

Issue 11 • HPN

The Marketing Authorisation Application submission was supported by a comprehensive global Phase 3 clinical programme, which enrolled more than 10,300 patients in nine studies, and is one of the largest late-stage development programmes for an investigational pharmacological product for the treatment of type 2 diabetes submitted to health authorities to date. It assessed the efficacy and tolerability of canagliflozin across the spectrum of adult type 2 diabetes management, in patients who need further glucose control as a single agent (monotherapy), in combination with metformin, and in combination with other glucoselowering agents, including insulin. Three studies have compared canagliflozin to current standard treatments.4-6 Two studies compared canagliflozin to sitagliptin and one study compared canagliflozin to glimepiride. The Phase 3 programme also included three large studies in special populations: older patients with type 2 diabetes, patients with type 2 diabetes who had moderate renal impairment, and patients with type 2 diabetes who were considered to be at high risk for cardiovascular disease.7-9 The International Diabetes Federation estimates that in 2011, 366 million people were living with diabetes (type 1 and 2), and the diabetes population is expected to grow to over 550 million in less

The arrival of new agents in type 2 diabetes, such as canagliflozin, promises to make a real difference to patients’ lives. Management of type 2 diabetes is enormously complex and canagliflozin will be a welcome addition to our diabetic treatment options.

than 20 years.10 The World Health Organisation estimates that 90% of the diabetes population have type 2 diabetes.11 One in 10 deaths in adults in Europe can be attributed to diabetes (~600,000 people in 2011).10 If left uncontrolled, type 2 diabetes can lead to serious long-term microvascular and macrovascular complications such as coronary heart disease (leading to heart attack) and stroke, nerve disease leading to amputation, retinopathy resulting in blindness and nephropathy causing end-stage renal disease.12 Improved glycaemic control has been demonstrated to reduce the onset and progression of these complications.13 References: 1 Marketing Authorisation: http://www. ema.europa.eu/docs/en_GB/document_ library/Summary_of_opinion_-_ Initial_authorisation/human/002649/ WC500150105.pdf 2 Marsenic O. et al. Glucose Control by the Kidney: An Emerging Target in Diabetes. Am J Kidney Dis 2009; 53: p875-883. 3 Sha S et al. Canagliflozin, a novel inhibitor of sodium glucose cotransporter 2, dose-dependently reduces calculated renal threshold for glucose excretion and increases urinary glucose excretion in healthy subjects. Diabetes Obes Metab 2011;13(7):669672.

4 Lavalle-González FJ et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013 Sep 13. [Epub ahead of print] 5 Schernthaner G et al. Canagliflozin Compared With Sitagliptin for Patients With Type 2 Diabetes Who Do Not Have Adequate Glycemic Control With Metformin Plus Sulfonylurea: A 52-week randomized trial. Diabetes Care. 2013; 36(9):2508-15 6 Cefalu WT, Leiter LA, Yoon KH, et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, doubleblind, phase 3 non-inferiority trial. The Lancet. Published online before print July 12, 2013, doi:10.1016/S01406736(13)60683. 7 Bode B et al. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract. 2013;41(2):72-84. 8 Yale J et al. Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease. Diabetes, Obesity and Metabolism. 3 March 2013. Published ahead of print, DOI: 10.1111/dom.12090. 9 Neal B et al. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)-A randomized placebo-controlled trial. Am Heart J. 2013;166(2): 217-223. 10 International Diabetes Federation. About Diabetes. Available http:// www.idf.org/diabetesatlas/5e/europe. Accessed November 2013. 11 Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: Diagnosis and classification of diabetes mellitus. Geneva, World Health Organization, 1999 (WHO/NCD/NCS/99.2) available at http://whqlibdoc.who.int/hq/1999/ who_ncd_ncs_99.2.pdf. Accessed November 2013. 12 World Health Organization, Media Centre, Diabetes, Fact sheet Number 312. Available at: http://www.who.int/ mediacentre/factsheets/fs312/en/. Accessed September, 2013. 13 Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011. Available at: http://www.cdc. gov/diabetes/pubs/factsheet11.htm. Accessed November 2013.


Introduction of an infliximab biosimilar (CT-P13): A five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland McCarthy G1, Ebel Bitoun C2, Guy H3 and Gommers JW4

PMS22

1Department

of Rheumatology, Mater Misericordiae, University Hospital, Dublin, Ireland 2Hospira, Meudon La Foret, France 3WG Consulting Healthcare Limited, High Wycombe, United Kingdom 4Hospira, Royal Leamington Spa, United Kingdom

• A biosimilar medicine is a biological medicine that is developed to be similar to an existing biological medicine (the ‘reference medicine’), in that it has the same mechanism of action and active substance as it’s reference medicine, and is used in treating the same disease.1 • Biosimilars have similar efficacy and safety profiles to the originator biologics such that their introduction into Ireland is expected to increase competition, lower prices and improve the affordability of costly therapies.

Figure 1. Annual total cost per patient 30,000 25,000 Total cost (€)

Objectives

20,000 15,000 10,000

First year

5,000

Subsequent years

0

• The objective of this study sought to estimate the budget impact of introducing an infliximab biosimilar (CT-P13) as a treatment option for rheumatoid arthritis (RA) patients in Ireland.

Epidemiology • The annual population in Ireland receiving treatment with a biologic was based on Irish national population statistics and UK published literature including: prevalence and incidence of RA; proportion of patients eligible for treatment with a biologic; and proportion of patients receiving treatment with a biologic (Table 1). Table 1. Prevalent and incident population receiving treatment with a biologic Epidemiology parameters 4,582,769 Total population of Ireland2 3 0.8% Prevalence 4 10% % eligible for treatment with a biologic 3,4,5 100% % receiving treatment with a biologic Annual prevalent population receiving treatment with a biologic 0.082% % of population5 No. of patients 3,776 0.03% Incidence3 4 10% % eligible for treatment with a biologic 100% % receiving treatment with a biologic3,4,5 Annual incident population receiving treatment with a biologic 0.003% % of population5 No. of patients 119 • After the first year, an annual population growth rate of 1.1% was assumed.6 Market uptake • The infliximab biosimilar was compared against the following current treatment strategies; etanercept, adalimumab, infliximab, certolizumab, golimumab, rituximab, abatacept, and tocilizumab. • The proportion of patients receiving these current treatment strategies were derived from interviews conducted with clinicians in the UK.7 • Maximum conversion (100%) of all existing and new infliximab patients to the infliximab biosimilar was assumed for years one to five to identify the maximum potential savings which could be achieved. • Table 2 below shows the current patient distribution assumed among different treatments for the prevalent and newly diagnosed population (for year 1 only). Table 2. Current proportions of patients on treatment and percentage being transferred to the infliximab biosimilar Existing patients receiving New patients to initiate treatment with a biologic treatment with a biologic (year 1) % Shift to % Shift to Treatment % No. Infliximab No. % No. Infliximab No. biosimilar biosimilar Etanercept 34% 1,284 0% 1,284 34% 41 0% 41 Adalimumab 34% 1,284 0% 1,284 34% 41 0% 41 Infliximab 13% 491 100% 0 13% 15 100% 0 Certolizumab 9% 340 0% 340 9% 11 0% 11 Golimumab 3% 113 0% 113 3% 4 0% 4 Rituximab 4% 151 0% 151 4% 5 0% 5 Abatacept 0% 0 0% 0 0% 0 0% 0 Tocilizumab 3% 113 0% 113 3% 4 0% 4 Infliximab 0 491 0 15 biosimilar Total 3,776 3,776 119 119 • Corresponding patient numbers over 5 years in a world without and with the introduction of the infliximab biosimilar were derived by combining the market shares in Table 2 with the percentage of new and existing patients eligible for treatment with a biologic in Table 1.

• Outcomes are reported as the annual and cumulative budget impact over five years. • In addition, an analysis has been performed to explore the potential savings that could be achieved when varying the conversion of existing infliximab patients to the infliximab biosimilar. The conversion percentages analysed were 25%, 50% and 75%.

Results • In year one, 3,776 prevalent and 119 incident patients entered the model. • Of these, 13% received the infliximab biosimilar with the total cost per patient calculated as €15,754 in the first year of treatment and €12,789 in subsequent years. • The drug acquisition cost for the infliximab biosimilar was assumed to discount infliximab by 20%. • Annual budget saving estimations following the introduction of the infliximab biosimilar were €579,631, €1,165,400, €1,177,553, €1,189,463 and €1,201,137 for years one to five, with an overall budget saving of €5,313,184 (Figure 2). Figure 2. Annual budget savings as a result of the introduction of the infliximab biosimilar for the treatment of RA in Ireland Estimated net budget saving (€)

• An Excel-based budget impact model was developed over a five-year time horizon. The model was based on the following inputs and assumptions:

1,400,000 1,200,000 1,000,000 800,000 600,000 400,000 200,000 0 Year 1

Year 2

Year 3

Year 4

Year 5

• The total cost of treating a new patient with the infliximab biosimilar for 1 year is €15,754. The estimated overall budget saving of €5,313,184 is therefore equivalent to treating an extra 337 new patients with the infliximab biosimilar for one year. • When setting the percentage conversion of existing infliximab patients to the infliximab biosimilar as 25%, 50% and 75% compared to the 100% assumed, the overall budget savings are as follows; €1,678,037, €2,889,753 and €4,101,468 compared to €5,313,184 (Figure 3). Figure 3. Overall budget savings as a result of varying the conversion of existing infliximab patients to the infliximab biosimilar Estimated net budget saving (€)

Methods

6,000,000 5,000,000 4,000,000 3,000,000 2,000,000 1,000,000 0 25%

50%

75%

100%

Percentage conversion of existing infliximab patients to the infliximab biosimilar

Conclusions • Introducing an infliximab biosimilar as a treatment option for RA patients in Ireland represents a cost saving of up to €5,313,184 over five years; equivalent to treating an extra 337 new patients with a biosimilar for one year.

References

• The total cost per patient was based on UK published literature and where this was not available assumptions were made. The total cost per patient included drug acquisition, administration, and monitoring costs.

1. European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. EMA/CHMP/BMWP/403543/2010. Committee for Medicinal Products for Human Use (CHMP). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf (accessed 30.01.13). 2012b. 2. European Commission. Eurostat 2012. Available from: http://epp.eurostat.ec.europa.eu/portal/page/portal/eurostat/home/ (Accessed 30/04/13). 3. Assumptions used in estimating a population benchmark. NICE 2012a. Available from: http://www.nice.org.uk/usingguidance/commissioningguides/raadults/raserviceassumptions.jsp (Accessed 09/01/13). 4. Kobelt G, et al. Access to innovative treatments in rheumatoid arthritis in europe. Lund University 2009 1-92. 5. Assumptions used in estimating a population benchmark. NICE 2012b. Available from: http://www.nice.org.uk/usingguidance/commissioningguides/biologicaltherapies/AssumptionsUsedInEstimatingAPopulationBenchmark.js p (Accessed 09/01/13). 6. Index mundi. Ireland Population growth rate 2012. Available from: http://www.indexmundi.com/ireland/population_growth_rate.html (Accessed 11/06/13). 7. Hospira. Data on file (market research). 2012.

• The annual total cost per patient for the first and subsequent years across the different treatment strategies are shown in Figure 1.

Acknowledgements

EMEA/INF/13/0022 Date of preparation: September 2013

WG Consulting were commissioned by Hospira to undertake this analysis.

Drug acquisition, administration and monitoring costs


16 Award Winners

Celebrating hospital pharmacy success - The Hospital Pharmacy Awards 2013 industry and manufacturers, and with the right investment by the HSE, pharmacy departments can grasp the opportunity to change the way services and medicines are delivered, improving patient health. We would like to thank our very generous sponsors for their support of these awards and to the judges, who gave up so much of their valuable time. The quality and independence of our judging panel underpins the credibility of these Awards.

The 2013 Hospital Pharmacy Awards were a great success, with over 300 pharmacy professionals attending to recognise and celebrate the outstanding achievements within this sector. The event, a first for hospital pharmacy in Ireland, was organised by Hospital Pharmacy News, and took place at the Crowne Plaza Hotel, Santry on September 21st, 2013. Finalists were selected from over 200 nominations from all aspects of hospital pharmacy, for a total of 10 awards. The evening champions excellence in all aspects of hospital pharmacy, with awards ranging from Innovation and Service to Hospital Pharmacy Technician of the Year, and has firmly established itself as the highlight of the year for the many hospital pharmacy teams in Ireland.

Yvonne Sheehan, Hospital Pharmacy Technician at Tallaght Hospital and President of the National Association of Hospital Pharmacy Technicians, echoed these sentiments stating:

"The Hospital Pharmacy Awards was a fantastic night and I would like to congratulate you all on the organisation of such a successful event. Caroline Monahan was deligthed with her award for best Hospital Pharmacy Technician and I think her award is sitting on the mantle piece at home."

Issue 11 â&#x20AC;˘ HPN

- Louise Duggan, Novartis

- Orla Johnston, Pharmacy Department, Beaumont Hospital Ireland is fortunate to have countless individuals and teams who work tirelessly to ensure extremely high levels of pharmaceutical care and improve clinical outcomes for patients. Hospital Pharmacy News will continue to champion hospital pharmacy and we believe that the future looks bright. With support, from us and partnerships with

"On behalf of the pharmacy department of Naas General Hospital, I would like to express the heartiest of congratulations to your team on a truly successful night for the pharmacy awards. Thank you so much for making us feel like we make a difference and to be recognised for it." - Ann Pilkington, Pharmacy department, Naas General Hospital

"We just wanted to say "Thank you" for a great event. All of the pharmacy team at Beaumont really enjoyed themselves!"

As Amanda Fitzpatrick, Chief Pharmacist at St Patrick's University Hospital, told us after the event:

"I was very pleased to attend the Hospital Pharmacy News awards ceremony. It was a great occasion to celebrate the many achievements in hospital pharmacy. It has certainly got me thinking.Thank-you for organising such a worthwhile event."

"Congratulations to you and your team at the Hospital Pharmacy News for such a successful event. We were delighted to be involved and had a great opportunity to network with some really important customers. I must admit the venue and the food was superb."

The Hospital Pharmacy Awards 2014 will take place on September 20th in the Burlington Hotel, Dublin. Make sure and catch the next issue of Hospital Pharmacy News for all the details.


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18 Award Winners

Hospital Pharmacy Team of the Year Award Investing in education and the health of the nation

Hospital Pharmacy Team of the Year winners St Vincent's University Hospital Pharmacy Department: Jacinta Dean, Elizabeth Collis, Claire Kingston, Richella Knox, Zulema Gonzales, Myra Tyrell, Fionnuala Kennedy, Ciaran Muldowney, with Caroline Reidy, Hospital Key Account Manager, Pfizer Healthcare Ireland

The winners of the Hospital Pharmacy Team of the Year Award were crowned at the team from St Vincent's University Hospital. Fionnuala Kennedy, Chief II Clinical Pharmacy Manager told Hospital Pharmacy News: "The team at St Vincent's University Hospital are delighted within this award. It is a great recognition for all the staff here, especially following the JCI accreditation process, which has been incredibly tough. "We would also like to thank

and pay tribute to all the hard work that went into the event, it really has been a great evening and excellent to recognise the contribution of hospital pharmacists to patient care in Ireland. Weâ&#x20AC;&#x2122;re not very good at getting our contribution recognised ourselves!" St Vincent's University Hospital is a Joint Commission International (JCI) accredited hospital and is the only public hospital in Ireland to achieve this distinction. JCI is an international organisation

which inspects and accredits healthcare institutions world-wide according to published standards, which strive towards excellence in healthcare. The pharmacy staff have been pivotal in ensuring that SVUH achieved accreditation and the reputation of the pharmacy department was greatly enhanced as a result. Caroline Reidy, Hospital Key Account Manager with Pfizer Healthcare Ireland, commented:

"Pfizer Healthcare Ireland is very proud to sponsor the Hospital Pharmacy Team of the Year Award. The hospital pharmacy department provides a significant service in delivering medicines management within the secondary care setting that truly enhances patient and medication safety. We are delighted to sponsor this award in recognising pharmacy teams that are leading the way in delivering such a critical service in hospital while putting the patient first."

The 2014 Hospital Pharmacy Awards take place on September 20th, 2014 in the Burlington Hotel. Further details on the award categories to follow. Issue 11 â&#x20AC;˘ HPN


Award Winners 19

Hospital Innovation and Service Award Investing in education and the health of the nation

Winners of the Innovation and Service Development Award, Mary Oâ&#x20AC;&#x2122;Toole, Elaine Burke, Sinead Flynn, Esther Courtney, Mark Donohue, Novartis Market Access Lead and Alison Dunne

The emergence of a new Clozapine Clinic in Galway University Hospital ensured the success of the pharmacy department in scooping the Hospital Innovation and Service Development Award. The service has evolved over the years to bring the multidisciplinary team and the patient together to improve patient care. The clinic provides care for over

150 psychiatric patients. The majority of these are outpatients. Allison Dunne, Chief Pharmacist at Galway University Hospital on accepting the award, stated: "Winning the Hospital Pharmacy News Innovation Award in 2013 gave our clozapine clinic team recognition within the psychiatry department in Galway University Hospital.

"It also afforded us a platform from which to promote the benefits of our clinic to managers at both a local and national level. We felt very proud to win the award and it has strengthened the bond between us as a multidisciplinary team."

Awards and this category in particular as it serves to highlight and promote the lengths hospital pharmacists are going to in order to offer a better standard of care for their patients."

Mark Donohue, Novartis Market Access Key Account Manager told us: "Novartis are very proud to be associated with the Hospital Pharmacy

The 2014 Hospital Pharmacy Awards take place on September 20th, 2014 in the Burlington Hotel. Further details on the award categories to follow. HPN â&#x20AC;˘ Issue 11


20 Award Winners

Hospital Pharmacist of the Year Award Investing in education and the health of the nation We Innovate Healthcare The winner of the Hospital Pharmacist of the Year Award, Patricia Ging, Chief II Pharmacist at the Mater Misericordiae University Hospital, is the pharmacist for Heart and Lung Transplantation and Pulmonary Hypertension services in the hospital. Since assuming this role in 2008 she has worked exceptionally hard to develop and enhance the role of the pharmacist in these diverse services. Patricia told Hospital Pharmacy News: "I was astounded to even be nominated given the huge talent and innovation ongoing throughout my colleagues and peers in Ireland. That said I am delighted to accept this award. My role wouldn't be what it is without the dedication and support of the whole team within the pharmacy department at MMUH." Rory Lee, Business Unit Director, Oncology, Roche Products Ireland, said: "Roche’s aim as a leading healthcare company is to create, produce and market innovative solutions of high quality for unmet medical needs. The three Roche values Integrity , Courage and Passion are central to how we want to behave as individuals, and collectively as an organisation. "We are delighted to support the Hospital Pharmacist of the Year , that awards a pharmacist who demonstrates these values of Integrity Courage and Passion in today’s challenging hospital environment. Many congratulations to Patricia Ging."

Hospital Pharmacist of the Year Award winner Patricia Ging with award sponsor Rory Lee, Business Unit Director, Oncology, with Roche Products Ireland Ltd Issue 11 • HPN

The 2014 Hospital Pharmacy Awards take place on September 20th, 2014 in the Burlington Hotel. Further details on the award categories to follow.


Award Winners 21

Hospital Pharmacy Technician of the Year Award Investing in education and the health of the nation The Hospital Pharmacy Technician of the Year Award was won on the night by Caroline Monaghan, from the Tallaght Hospital. Caroline commented: "I have had such a fantastic night so far and this has topped it all off. I really didn't expect to win this award tonight, I was happy to enjoy the celebration with my colleagues. This award will stand pride of place within our pharmacy department. I would really like to pay tribute to the work being carried out by all hospital pharmacy technicians throughout Ireland." Caroline has been described as having 'a vision for the future of pharmacy and will work constantly to bring about these quality improvements,' understanding how important pharmacyâ&#x20AC;&#x2122;s role is in shifting from pill to patient and that being at ward level helps improve patient care. Paul Boland, Managing Director of Medisource comments: "Medisource are delighted to sponsor the HPN Hospital Pharmacy Technician of the Year award and convey many congratulations to Caroline for her well deserved win. "Our mission is to explore all avenues in tracking down unlicensed medicines to assist in continuing patient care, and our emphasis is on personal communication to ensure that medicines are sourced and delivered within the required timeframe and that such sourcing is done only through verified and legitimate distribution channels within regulations. We offer a global reach and commit to significant local stockholding so that your patient doesnâ&#x20AC;&#x2122;t have to suffer a break in treatment."

Carolyn Monahan, Hospital Pharmacy Technician of the Year, Paul Boland, Managing Director, Medisource

The 2014 Hospital Pharmacy Awards take place on September 20th, 2014 in the Burlington Hotel. Further details on the award categories to follow.

HPN â&#x20AC;˘ Issue 11


CPD 6: LEANS MANAGEMENT Biography - Matthew Hamilton is Policy Deployment Officer at Leading Edge Group. He has worked as a policy analyst and programme manager on health reform and e-learning projects in Ireland, Australia, Central America and the Caribbean. He is currently a Health Economics Masters candidate at NUI Galway.

60 Second Summary Currently, the full economic costs of communications inefficiencies in Irish hospital medicines management and the economic value of alternative strategies to address these inefficiencies is not known. This knowledge gap has meant that pharmacists, hospital administrators and policymakers make decisions about allocating scarce resources to communications improvement strategies such as process redesign and information technology without having a solid basis to assess the resource claims of these projects. As a contribution to addressing this issue, Leading Edge Group sponsored a research project that included a pharmacy level survey of Irish hospital pharmacists, a literature review and the development of a prototype discrete event simulation of the hospital medicines supply process. The current experience of Irish hospital pharmacists relating to communications efficiency in medicines management has direct practical implications from the point of view of how to economically evaluate communications improvement projects in hospital medicines management. Bearing each of the above messages in mind, Leading Edge Group is currently developing a diagnostic tool that it is hoped can help finance managers, pharmacists and hospital administrators to assess the comparative economic impacts of alternative projects to improve the communications efficiency of Irish hospital medicines management.

1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice. 2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area. 3. PLAN - If I have identified a knowledge gap - will this article

satisfy those needs - or will more reading be required? 4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result? Have I identified further learning needs? 5. WHAT NEXT - At this time you may like to record your learning for future use or assessment. Follow the 4 previous steps, log and record your findings.

Published by HPN, sponsored by Pfizer Healthcare Ireland. Copies can be downloaded from www. irishpharmacytraining.ie Disclaimer: All material published is copyright, no part of this can be used in any other publication without permission of the publishers and author. Pfizer Healthcare Ireland has no editorial oversight of the CPD programmes included in these modules.

The economic costs of communications inefficiency in Irish hospital pharmacy Hospitals worldwide are frequently characterised by their large size, complex organisation and use of increasingly specialised professionals and technologies. This combination of size, complexity and specialisation has made it increasingly challenging for hospitals to consistently deliver the accurate, clear, timely and appropriately targeted communication upon which safe, quality and efficient patient care depends. Poor or inefficient communication has been cited as a major source of medical error that can result in unnecessary patient deaths and injuries and significant waste of scarce

healthcare resources. However, credible economic estimates of the value of better communications in hospitals are largely lacking. As recently as 2010, a paper by Ritu Agarwal and colleagues claimed to provide the first national (US) estimate of the cost of communication inefficiency in hospitals. These financial costs were estimated to be equivalent to 1.97% of hospital revenues or over $4 million a year for a typical 500 bed hospital. However, this estimate may well be an underestimate as the analysis was restricted to estimating the direct financial costs of nurse and doctor time allocated to communication that is â&#x20AC;&#x153;wastedâ&#x20AC;? and of the cost of increased length of

patient stay attributable to poor care coordination and discharge planning. As conceded by the authors, this financial analysis falls someway short of providing an economic estimate of the full range of the impacts of poor communication within hospitals that they themselves identified. For example, the authors did not seek to derive economic estimates for medical errors, inferior patient experience and increased stress and decreased job satisfaction for hospital employees arising from communication inefficiencies. Communication failings in hospitals environments can arise from deficiencies in

Continuous Professional Development Modules are sponsored by Pfizer Healthcare Ireland Pfizer Healthcare Ireland has no editorial oversight of the CPD programmes included in these modules.


CPD 6: LEANS MANAGEMENT

patient harm have been estimated to occur in 9-16% of hospitalisations and hospital medicines management is a complex process involving an estimated 30-40 steps and multiple healthcare professionals, with scope for error and inefficiency at each stage.

information elicitation and ease of use of communications medium, the use of unacceptable abbreviations and illegible content, the consistency between performed and recorded care, differing interpretations of the purpose of communication amongst different clinical professionals or unnecessary interruptions of planned activities by hospital staff. The working environment can also contribute to such errors as lack of access to a computer may result in lack of access to drug and patient information and a lack of appropriate feedback mechanisms can leave doctors unaware of when they have made prescribing errors . The medium of communication also appears to be a relevant factor, with some errors potentially more likely in phone based communication than in face to face communication.

A large proportion of medical errors due to communications breakdown occur in the hospital medicines management process. These errors can have significant consequences, with adverse drug events (which include both medication errors and adverse drug reactions resulting in patient harm) having been identified as the principal cause of morbidity and mortality as a result of medical treatment, with a quarter of these events being assessed as preventable.

Currently, the full economic costs of communications inefficiencies in Irish hospital medicines management and the economic value of alternative strategies to address these inefficiencies are not known. This knowledge gap has meant that pharmacists, hospital administrators and policymakers make decisions about allocating scarce resources to communications improvement strategies such as process redesign and information technology without having a solid basis to assess the resource claims of these projects. Furthermore, in the current national context of significantly reduced public healthcare expenditure, disinvestment decisions are being made without adequately accounting for the consequences of these decisions in terms of degraded communications quality and the flow on impact on health and economic outcomes.

Poor communication has been identified as potentially the most significant cause of medical errors and these errors are both common and have economically significant impacts.

As a contribution to addressing this issue, Leading Edge Group sponsored a research project that included a pharmacy level survey of Irish hospital pharmacists, a literature review and the development of a prototype discrete event simulation of the hospital medicines supply process.

As noted in 2009 by Ciara Kirke and colleagues, patient safety events resulting in

The initial phase of this project concluded in September and one striking aspect of was

the self-reported experience of the pharmacists who were surveyed in the run up to attending the Pfizer National Hospital Pharmacy Forum in May. Some of the main findings from this survey incluided: • 61% of respondents felt that inefficient communication between the pharmacy and other parts of the hospital had an impact on medicines management within their hospital, with the remaining 39% unsure and no respondents saying that there was no impact • respondents identified issues such as doctors not using e-mail, communications not reaching staff members and lack of follow up and learning from incidents as examples of communications inefficiencies • respondents estimated that successfully addressing communication inefficiencies would save on average between 30 minutes a day (for research pharmacists) to just over an hour a day (for basic grade pharmacists) of staff time for each of 11 categories of pharmacy staff member • 80% of respondents said there was no named individual explicitly responsible for the quality of communications in medicines management in their hospital, 10% said there was and 10% were unsure • pharmacy staff spent most time (45%) communicating with nurses, followed by doctors (28%) but would give slightly more priority (38%) to improving communication with doctors than to improving communication with nurses (38%)

Continuous Professional Development Modules are sponsored by Pfizer Healthcare Ireland Pfizer Healthcare Ireland has no editorial oversight of the CPD programmes included in these modules.


CPD 6: LEANS MANAGEMENT

Another striking finding there was wide variability in the availability of key metrics within hospital pharmacies. Some pharmacies have detailed data available on costs and outcomes, while others do not, with the practical implication that the quantity and nature of work that is required to develop a pharmacy level estimate of the potential benefits of communication improvement projects may vary considerably. As an example of how diverse the picture is:

baseline report on Irish hospital pharmacy by the Pharmaceutical Society of Ireland (2013) such as:

o 50% of survey respondents reported not having information about the length of time from prescription issue to medication reaching the patient in their pharmacy, while 41% had this information available and updated on at least a daily basis

• limited involvement of pharmacists in patient care teams

o 59% of survey respondents reported not having metrics relating to the number of missed doses available within their pharmacy, while 4.4% had this information available and updated on at least an hourly basis o 41% of survey respondents reported not having information about the number of prescription errors available, while 50% had this information available and updated on at least a daily basis o 41% of respondents reported not having information about the monetary value of wasted medications available, 47% had this information available on an annual basis and 12% had this information available and updated instantaneously Many of these findings emphasise some of the issues highlighted in the

• relatively low levels of automation and communication between systems compared to other countries • inadequate technology and low IT skills amongst hospital pharmacy staff • under-developed links beyond the hospital

• the need for innovative solutions relating to training and role redesign • concerns over impact of unfilled pharmacy staff vacancies The current experience of Irish hospital pharmacists relating to communications efficiency in medicines management has direct practical implications from the point of view of how to economically evaluate communications improvement projects in hospital medicines management. When it comes to identifying solutions, technology (including better data and analytics) and process improvement (including training) appear to be the two categories of improvement projects that best match the preferences of pharmacy staff. Survey respondents would allocate the greatest proportion (28%) of any new resources available for improving communications in medicines management to improved communication technologies followed by staff

training (19%), redesigning processes (18%) and improved data and analytics (17%) Process improvement approaches may comprise a combination of training, role redesign, reorganisation of workplace layout and changes in how data is measured and communicated that is often undertaken within an explicit framework such as Lean. Lean is a management philosophy originally developed for manufacturing environments by the Toyota Motor Corporation that is increasingly being deployed in healthcare settings. Lean approaches seek to involve staff in identifying and solving problems in order to eliminate any step in a process that does not add value to patients. Lean incorporates techniques such as mapping processes, improving visual controls and implementing rapid improvement projects so as

to improve the efficiency with which information, people, equipment and medications interact within hospital processes Although some practical challenges have been identified to translating Lean implementations into tangible efficiency improvements , there is some emerging evidence that such gains being generated. Lean implementations have been credited with helping to achieve outcomes such as decreasing incidence of ventilator-associated pneumonia, improving patient access to clinical services, reducing catheter related bloodstream infections and reducing turnaround times for pathology reports. Process redesign strategies to improve communications efficiency in medicines management may include projects such as making greater use

Continuous Professional Development Modules are sponsored by Pfizer Healthcare Ireland Pfizer Healthcare Ireland has no editorial oversight of the CPD programmes included in these modules.


CPD 6: LEANS MANAGEMENT

of multidisciplinary case conferences, which was identified as one of the most effective interventions to reduce prescription error in a 2009 systemic review of inappropriate prescribing in the elderly by Kaur and colleagues and promoting exchanges between pharmacists and doctors to add feedback about prescribing errors formally to medical teams and develop the prescribing knowledge of doctors. A 2009 study by Jonathon Karnon and colleagues found that all five pharmacy process improvement strategies they examined, such as pharmacist led medicines reconciliation or use of standardised forms in conjunction with nurse taking of medication history, were cost-effective against baseline. Greater use of information and communication technology in healthcare has also been identified as having the potential to produce beneficial health and efficiency outcomes such as reducing mortality and morbidity, supporting greater adherence to treatment regimes, reducing waiting times, patient stay and travel times, avoiding costly inpatient visits and laboratory tests, improving knowledge transfer amongst medical practitioners and improving patient satisfaction. Yet despite such significant potential benefits, the rate of adoption of such technology in healthcare is low and the promised general benefits of this technology on quality of care and costs have not yet been established. A number of review articles have pointed to the generally unsatisfactory quality of the health economic evaluations of these technologies that have

appeared in the academic literature to date. There is also a suggestion that studies that rely on a relatively weaker evidence base than achieved in randomised studies may be more likely to report positive findings about these technologies. Medicines management technologies such as e-prescribing have been shown to reduce many errors that occur in hand written prescriptions, including dosage errors. A review of the literature relating to computerized physician ordered entry systems concluded that implementing these systems is associated with major reductions in prescribing errors. However, e-prescribing can also introduce new errors during the process of entering and retrieving information. Furthermore, implementation of new technologies such as electronic health records has been associated with a range of unintended consequences such as increasing the administrative burden on clinical staff, reducing the quantity/quality of time clinicians interact with patients, making paper based records more difficult to access and introducing delays in transcription of data. A 2011 major review of health information technology in medicines management concluded that although the evidence base for these technologies is substantial and varied, the economic literature is this area is sparse. This review identified the need for well-planned studies with broad input from many stakeholders to help better understanding the true worth of these technologies with

studies that integrate costs and consequences likely to be especially valuable. Despite the availability of potential solutions to communications inefficiency in hospital medicines management, and a clearly acknowledged need to do better, the low level of recent improvement projects attempted in medicines management communication in Irish hospitals, probably reflects the difficulty of securing resources for such projects in the current economic climate. Only one third of hospital pharmacies surveyed had implemented improvement measures addressing the quality of communication between the pharmacy and other parts of the hospital in the last two years. Improving this rate of participation in improvement initiatives will likely be important in achieving efficiency gains within the hospital pharmacy. To assist greater use of improvement projects, Leading Edge Group is currently developing a diagnostic tool that it is hoped can help pharmacists and hospital administrators to assess the comparative economic impacts of alternative projects to improve the communications efficiency of Irish hospital medicines management. Encouragingly, the recently complete first phase of the Leading Edge Group research project in this area demonstrated that it is feasible to use a technique called discrete event simulations to improve our understanding of the economic value of communication in Irish hospital medicines

management. This technique is closely aligned to the process mapping and process redesign work that Leading Edge Group has deployed in hospital pharmacies in Ireland and Canada and has the benefit of enabling medicines management improvement investment / disinvestment decisions to be assessed using quality adjusted life years (QALY) measures that make these projects more readily comparable with economic evaluations of direct medical treatments. However, given the high degree of variability in the quality of data available within Irish hospital pharmacies, a key current challenge is developing an approach that has widespread applicability in multiple hospital pharmacy settings. It is also likely that the diagnostic tool currently under development is likely to be best deployed in conjunction with pharmacy level process mapping, time and motion studies and mining of current data systems. In the longer term there is scope to go beyond evaluating the economic impact of specific improvement projects by developing a national dataset that provides a credible national estimate of the cost of communications inefficiencies in Irish hospital medicines management and by establishing national quality benchmarks in the area of communication efficiency in Irish hospital medicines management.

Continuous Professional Development Modules are sponsored by Pfizer Healthcare Ireland Pfizer Healthcare Ireland has no editorial oversight of the CPD programmes included in these modules.


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P11/11/12


28 Award Winners

Hospital Pharmacy Representative of the Year Award Investing in education and the health of the nation The Hospital Pharmacy Representative of the Year Award was won on the night by Caroline Fitzgerald of Actavis. Since joining Actavis in 2008, Caroline has completely dedicated herself to developing and growing the Actavis hospital business unit. Her commitment is not just to meet the target expectations of the company but to ensure 100% service is delivered to the hospital pharmacist. Caroline said: "I am honoured to accept this Award. I really feel that the work I do is easy as it is a true passion. The hospital pharmacists and their teams that I deal with on a daily basis make it a joy to want to assist them in every way possible to make their job easier in providing excellent quality of care to their patients." Debbie Graham, Advertising and Sales Manager with Hospital Pharmacy News said: "The team at Hospital Pharmacy News are very proud to support this award as it underpins the true value pharmacy representatives and their companies bring to the industry. Caroline has worked tirelessly within this profession and I am honoured to be able to present her with this award in celebration of her endeavours and dedication."

Debbie Graham, Advertising and Sales Manager, Hospital Pharmacy News, with Caroline Fitzgerald, Actavis

The 2014 Hospital Pharmacy Awards take place on September 20th, 2014 in the Burlington Hotel. Further details on the award categories to follow. Issue 11 â&#x20AC;˘ HPN


Award Winners 29

Oncology Pharmacist of the Year Award Investing in education and the health of the nation BD PhaSeal™

The BD Oncology Pharmacist of the Year Award was won on the night by Fionnuala King, Chief Pharmacist at St James's Hospital.

joined the staff of St James’s Proven safe handlingFionnuala Hospital in 2000, and has been lead for Oncology/Haematology and of hazardous drugs Pharmacist palliative care. Her nomiator described her as 'dedicated to her patients, her team and consistently providing comprehensive pharmaceutical care to this patient cohort.

'She focuses on patient safety , and 1 also efficiency and effectiveness of drug therapy. She is the “go to” person amongst her colleagues, both within the hospital and external for up to date information on oncology. Fionnuala thinks outside the box and will look for simple solutions and trial before fully implementing. Fionnuala commented: "I was so delighted that my colleagues thought highly enough of me to nominate me for this award. It is an honour and a delight to work within such a close team, when everyone has the same dedication and work attitude that you have and it makes achieving goals that bit easier. Patiet care and enhancing and improving patient care is what we are all here to do and these awards represent a unique opportunity to not only reward those at the coal face but also tor recognise them for their endeavours." Paul Boland, Managing Director of Medisource, presented the award to Fionnuala on behalf of BD, the sponsor. He commented: "BD are delighted and honoured to sponsor the Oncology Pharmacist of the Year Award, as it offers this field of hospital pharmacists the opportunity to showcase their hard work and dedication whilst rewarding those who endeavour to enhance and improve the quality of life for this group of patients. Many congratulations to Fionnuala on a well deserved win. Congratulations also must go all of the finalists for their exceptional work and innovation." Pictured receiving her award from Paul Boland, Managing Director, Medisource is Fionnuala King, St Jame's Hospital

The 2014 Hospital Pharmacy Awards take place on September 20th, 2014 in the Burlington Hotel. Further details on the award categories to follow. HPN • Issue 11


30 Award Winners

Aseptic Hospital Unit of the Year Award Investing in education and the health of the nation

Caroline Fitzgerald, Hospital Business Manager, Actavis Ireland, Jennifer Brown and Brid Ryan, Mater Misericordiae University Hospital and Tony Hynds, Actavis Ireland

The Aseptic Compounding Unit (ACU) of the Mater Misericordiae University Hospital (MMUH) won the Aseptic Hospital Pharmacy Unit of the Year Award. The team at MMUH has been using electronic manufacturing software (ASCRIBE) for several years in the manufacture of cytotoxic chemotherapy. This has been complemented by publishing version controlled chemotherapy protocols on the hospital intranet to give oncology/haematology staff access to up to date clinical protocols and ensure the safe Issue 11 â&#x20AC;˘ HPN

The MMUH Aseptic Unit has taken the first step in introduced a fully integrated system for the prescribing, manufacture and administration of cytotoxic chemotherapy.

on cloud nine. It is great to be recognised for the work that we do. As hospital pharmacists we are not very good at recognising and congratulating ourselves so thank you to Actavis and to Hospital Pharmacy News for providing us with this opportunity."

Team lead Brid Ryan commented after collecting their award: "We have all worked very hard and shown real dedication over the past number of years to ensure we are providing the best in aseptic compounding. However to win this award tonight has put us

Caroline Fitzgerald, Hospital Business Manager with Actavis Ireland, told Hospital Pharmacy News: "Actavis is delighted to support the Hospital Pharmacy Awards and are proud to sponsor the Aseptic Hospital Unit of the Year Award.

and accurate treatment of patients.

"With 2 EU cytotoxic sites of manufacture we pride ourselves on our robust supply chain & can be a partner you can trust. Actavis sell an affordable quality oncology range of products to Irish aseptic units. "Many congratulations to the whole team at the Mater Misericordiae University Hospital on their very deserving win & to our Finalists Beaumont Hospital, St Jamesâ&#x20AC;&#x2122;s Hospital & Mayo General Hospital. We would like to thank everyone for their submissions & welcome more for our 2014 award"


Award Winners 31

Antimicrobial Project of the Year Award Investing in education and the health of the nation The Gerard Laboratories Antimicrobial Project of the Year Award was won by Anne Hartnett and her team from the University Hospital Limerick. Anne and her team developed a unique iPhone application to promote and support rational prescribing of antimicrobial agents for adults. Information is available for common infections and includes advice on: investigations to carry out; probable pathogens involved and empiric antimicrobial therapy. Patients benefit from timely and appropriate antimicrobial therapy, reduced antimicrobial resistance and better health outcomes. Anne commented after accepting her award: "The field of antimicrobial is evolving constantly and requires the constant hard work of an entire team to ensure our departments keep up with the changes. The iPhone application that we have developed is a real team effort and so I am delighted to accept this award on behalf of our team within the hospital. We have had an immensely enjoyable night." Ciara Devlin, Hospital Manager with Gerard Laboratories said: "As a company we are delighted to be involved with the Hospital Pharmacy Awards and commend the positivity they bring to the hospital pharmacy profession. Congratulations to all of the finalists within this category who are all undertaking sterling work and, importantly, many congratulations to the overall winner, Anne, and her team."

Winner of the Antimicrobial Award Anne Hartnett, University Hospital Limerick, with Ciara Devlin, Hospital Manager, Gerard Laboratories

The 2014 Hospital Pharmacy Awards take place on September 20th, 2014 in the Burlington Hotel. Further details on the award categories to follow.

HPN â&#x20AC;˘ Issue 11


32 Award Winners

Hospital Pharmacy Manager of the Year Award Investing in education and the health of the nation One of the key ingredients for any successful team, is a successful manager. Mariosa Kieran demonstrated to the judging panel of the Hospital Pharmacy Awards that she has all of the attributes required as she walked off with the Hospira Hospital Pharmacy Manager of the Year Award. MarĂ­osa has successfully operated in three managerial roles in the Mater Misericordiae University Hospital pharmacy department over the last year, Medicines Information Service Manager, Clinical Pharmacy Service Manager and Deputy Head of Pharmacy Services. MarĂ­osa has overseen the pharmacy department involvement in the relocation of a number of wards and departments from outdated clinical configurations to the new, state of the art, Whitty Building. Mariosa comments: "I was so proud to have been nominated by my team for this award as it is so wonderful and different to be acknowledged for work that we take for granted to do every day. Winning this award is the icing on the cake and I would like to thank the judges, and of course Hospital Pharmacy News." Dennise Broderick, Country Manager with Hospira commented: "Mariosa is obviously an extremely dedicated leader and manager and it is with great pride that I present her with this award tonight. Hospira are delighted to be involved with the Hospital Pharmacy Awards, which we see as a vital platform for rewarding excellence within this field."

Winner Mariosa Kieran, Mater Misericordiae University Hospital is pictured receiving her award from Dennise Broderick, Country Manager, Hospira

Issue 11 â&#x20AC;˘ HPN

The 2014 Hospital Pharmacy Awards take place on September 20th, 2014 in the Burlington Hotel. Further details on the award categories to follow.


Award Winners 33

Lifetime Achievement Award Investing in education and the health of the nation The Evolution of Generics

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Winner of the Lifetime Achievement Award Andrew Barber along with Damian Griffin, National Sales Manager, Accord Healthcare Ireland

The Lifetime Achievement Award was amongst the most prestigious on the night. The judging panel were so impressed with the calibre of nominations for this category that it was deemed only fair to present the accolade to both nominees, whom they described as 'equally deserving." Dr Andrew Barber was the first to be presented with his award on the night. He told Hospital

Pharmacy News: "This is such a surprise and yet such an honour. I would like to pay tribute to Professor Meegan and also to my entire pharmacy team at Galway University Hospital. Our ethos is, and has always been, very much that of teamwork and thus I salute them." Professor Ciaran Meegan of the Mater Misericordiae University Hospital, was the second recipient of the

Ciaran Meegan, Lifetime Achievement winner with Damian Griffin, National Sales Manager, Accord Healthcare Ireland

accolade. He told us: "Hospital pharmacy is changing and evoloving on a constant basis. It is imperative that we, as pharmacy professionals, continue to change also and to meet challenges head on, turning them into opportunities. These awards are a fantastic way to recognise all the innovation that is ongoing in this industry." Damian Griffin, National Sales Manager with Accord

Healthcare Ireland, stated: "Accord Healthcare Ireland are delighted to be associated with the Hospital Pharmacy Awards, and in particular with our sponsorship of the Lifetime Achievement category as we have a firm belief and passion for all that it stands for. "Both Professor Meegan and Dr Barber are worthy recipients of this accolade and on behalf of the whole company I offer them sincere congratulations

HPN â&#x20AC;˘ Issue 11


34 Feature

Special report from the ECTRIMS Congress Written by: Written by Danielle Barron, Editor, Irish Medical News This year's ECTRIMS Congress broke records with regards to the levels of attendance and research presented. The capital city of Denmark, Copenhagen, played host to the 2013 event, which was attended by a wide variety of stakeholders, all of whom are working with patients with MS in some capacity. This year the meeting heard further evidence that brain volume loss correlates with long-term disability in multiple sclerosis (MS), following new analyses of data from studies involving fingolimod. A media briefing entitled “Addressing Key Challenges in Multiple Sclerosis” looked at the role of the immunomodulator fingolimod in addressing key aspects of the disease and its impact on the brain. “Brain volume loss in neurological disorders and MS: A role for Gilenya” was the title of the fascinating presentation given by Dr Sven Schippling, senior physician and deputy head of the MS clinic at the Department of Neuroimmunology and MS Research, University Hospital Zurich, Switzerland. Dr Schippling explained that he would outline the clinical relevance of brain atrophy, and how a drug such as fingolimod could be targeted against brain volume loss in MS. “Time is brain”, he began, explaining that this sentence is well-known from stroke medicine. “Time is brain holds true for all of us here in this room, because every single one of us loses brain as we speak. Simply by getting older we lost brain tissue.” The clinician used images to illustrate the difference between a young brain and an older one that has lost volume. “There are diseases, such as Alzheimer’s disease, where

Issue 11 • HPN

neurodegeneration plays a role very early on, and is essentially the hallmark of the disease. This also means that by atrophy, clinical signs and symptoms become overt and increase over time. Depending on the grade of atrophy, patients with more severe atrophy over time have the most severe phenotype of the disease,” he said. In MS, one part of the disease is inflammation, which can be depicted on T2-weighted MRI. What has been missing, however, is the “second phase” of the disease, Dr Schippling said. “That second phase is neurodegeneration. Maybe we did not speak about this second phase because we did not have the treatments to target it.” Dr Schippling used several MRI images of a patient’s brain to illustrate the extent of not only inflammation, but also the shrinking of her brain. “The brain atrophy that affects all of us, occurs in MS at a rate of five to 10 times higher than the normal ageing population. While we might lose somewhere between 0.1 and 0.15 per cent each year, an MS patient loses up to 0.75 per cent each year with the disease,” he said. The neurologist explained that brain volume loss is actually a measure of neuro-axonal damage, so there is not only a loss of myelin, but also a loss of axons and neuronal cells.

The brain atrophy that affects all of us, occurs in MS at a rate of 5 to ten times higher than the normal ageing population. allow the clinician and the neuroscientist assess the amount of atrophy in daily practice and new methods such as serial registration of MRI images allow the delineation of brain shrinkage over time. Dr Schippling explained that recent data has shown that MS comes with atrophy, even in the very early disease stages.

“We also have good evidence that CNS atrophy correlates nicely with clinical outcomes,” he added.

“While you might think that it progresses over time, you have to keep in mind that the overall normalised brain volume is also dropping over time. When you factor in the normalised brain volume loss, the true rates of atrophy are virtually the same, be it a case of CIS, be it relapsing, or be it a progressing patient.”

Brain atrophy not only occurs in later disease stages, Dr Schippling continued, explaining that even patients with CIS and relapsing/remitting forms of the disease are susceptible to brain volume loss.

EDSS scores help assess the clinical disability of the patient and studies have proved that shrinking of the grey meta volume leads to higher EDSS scores, on average, explained Dr Schippling.

In order to reliably depict the extent of atrophy, measures must be developed that will

“Thinning of the cortical grey matter comes with higher degrees of disability,” he said,

adding that this is both motor disability and overall disability, such as visual impairment. Dr Schippling then continued by telling the audience that trials have shown that relapse rates in placebo cohorts have been decreasing steadily over time. “This is because when the first drugs became available or were tested in Phase III trials, we had no alternative treatment available - basically everyone in the trials was on treatment. These days we have effective treatments already, so only the patients not responding enter the trials. There is a certain selection bias towards more benign patients as regards relapse rates,” he explained, asserting that the addition of the McDonald criteria means that MS is now being diagnosed earlier. Disability outcomes are what matters to patients - being able to see and walk, he added. The data on addressing brain volume loss for forthcoming therapies is inconsistent, if even available, continued the neurologist. “This is also due to the fact some of them simply don’t work on brain atrophy.” Fingolimod has been studied in three Phase III trials, the FREEDOMS, FREEDOMS 2 and TRANSFORMS studies, and Dr Schippling outlined its effects on brain atrophy. “Interestingly when you look at baseline as a proof of concept, the lower the brain volume, the higher the EDSS, or in other words, the higher the EDSS the lower the brain volume. The higher the age, the lower the brain volume - this is a fact, we know that age impacts on brain atrophy. The higher the lesion load at baseline, this is predictive for future disability and also for increased brain atrophy,” he explained adding that the data in this instance is very robust.


35 The data from the three trials shows that patients on fingolimod have significantly reduced rates of brain atrophy when compared to beta interferon 1a, as in the case of the TRANSFORMS study, or as compared to patients on placebo in both FREEDOMS studies. Patients who switched from interferon beta 1a to fingolimod after one year in the TRANSFORMS trial had a significant decrease in their brain atrophy rates following the switch, Dr Schippling added. “When patients switch from beta interferon 1a to fingolimod, they get an additional benefit - be it reduced relapse rates, be it reduced number of T2 lesions

on MRI, or be it reduced brain atrophy.” These measured differences translate into “clinical reality”, he continued. He explained that there was a significant reduction in disability progression with fingolimod over the two years of 37 per cent in the FREEDOMS trial. “We as clinicians and neuroscientists will be asked what is the biological mechanism by which this happens. Fingolimod passes the blood brain barrier to a significant extent and by that can exert its effect on local cells that play a role in the pathology of MS.”

Dr Schippling concluded by saying that MS is not only an inflammatory disease, but also a degenerative disease to a significant extent. “This is important because we believe that brain atrophy is the ultimate correlate of disability in MS. Fingolimod is interesting not only because of its oral application, but also because of its dual method of action on both the peripheral immune system and central nervous system cells. It is the only approved therapy with consistent and robust impacts on brain atrophy rates, having been shown in three phase III trials, and its efficacy is mirrored by clinical outcome measures and disability progression.”

Dr Sven Schippling

News

Research programme to tackle diabetes burden Professor Patricia Kearney of University College Cork is one of the first recipients of the HRB Research Leader Awards. Her award, in partnership with the National Clinical Programme in Diabetes (NCPD), is to lead a project titled: Improving Care for People with Diabetes: A Population Approach to Prevention and Control.

costs of current care models and develop a lifestyle intervention for prevention of diabetes during pregnancy’. Many of the HRB research programmes are addressing areas which have traditionally been under-funded, but are crucial, such as health economics and biostatistics. All the research leaders will create a solid foundation of expertise and evidence to deliver better health, reduced health care costs and new approaches to care that benefit patients, care providers and the economy.

The investment of ¤9 million will address strategic gaps and leadership capacity in population health and health services research in Ireland. All of the research programmes within the HRB programme are specifically focused on delivering relevant and timely evidence that can be used in health care decision-making and are designed in consultation with leading healthcare decision makers. Working in partnership with the National Clinical Care Programme in Diabetes, Prof Kearney aims to improve patient care and reduce the preventable clinical, financial and societal burden of diabetes. According to Prof Kearney, ‘Diabetes is a common, disabling and deadly condition.

Professor Patricia Kearney

In Ireland it is estimated that nearly one in 10 adults have diabetes, many of whom are undiagnosed. Currently diabetes costs the state almost ¤580 million per annum and this will rise significantly in coming decades. Given the stated changes to move more care of diabetes into primary care, this programme of work will address specific gaps by determining the real prevalence and incidence of diabetes in Ireland, define the

The six new HRB Research Leaders will deliver research programmes which will: • Develop an internationally recognised research group focusing on the design and evaluation of effective behavioural interventions that will improve our health (Dr Molly Byrne, Lecturer and Health Psychologist, NUI, Galway). • Focus on the need to maximise prevention and treatment strategies for the increasing numbers living with chronic conditions such as diabetes (Professor Patricia Kearney, Research Professor at

University College Cork). • Assess the impact of online psychological interventions for people with multiple illnesses including chronic pain (Dr Brian McGuire, Senior Lecturer, Clinical Psychology, NUI, Galway). • Improve the national infrastructure to be able to accurately count and compare the costs and cost effectiveness of non-acute health services in Ireland (Prof Ciaran O Neill, Professor of Health Economics at NUI, Galway). • Assess the costs and benefits of personalised healthcare interventions to assist decision making in a time of resource constraints (Professor John Forbes, a health economics expert based at University of Limerick). • Use mathematical modelling and statistical techniques to integrate large health information datasets to improve decision making in relation to provision of health care interventions (Professor Cathal Walsh, Professor in Statistics at Trinity College Dublin).

HPN • Issue 11


36 News

Hospital pharmacists gather at HPE Live within the budgetary constraints which everyone faces. The keynote address was delivered by Professor Arthur Lipman of the Department of Pharmacotherapy at the College of Pharmacy, University of Health Sciences Center in the United States, who guided delegates through the latest advances in pain management.

Overall, the programme included over 40 speakers in a packed day covering issues including medicine reconciliation with primary care, anti-microbial stewardship, the implementation of smart pumps, preventions of sharps injuries and the challenges of mental illnesses for pharmacy.

Professor Arthur Lipman

The HPE LIVE launch event took place in Birmingham on 29 October 2013, bringing together over 500 healthcare professionals who specialise in pharmacy services - including 115 chiefs, directors or heads of pharmacy - and a packed hall of exhibitors made up of the

leading innovators in this sector. The event included 4 conference streams, with special emphases across all sessions on new processes and technology to assure patient safety, and the approaches needed to deliver improved patient outcomes

Delegates at HPE Live 2013

Hospital Pharmacy European Summit Change is a constant in the modern world, and the European hospital pharmacy profession not only wishes to keep pace with change, but to lead that change and ensure that it is patients and their outcomes from healthcare that are the ultimate beneficiaries. Accordingly, EAHP is compiling

a Summit, to be held on 14 & 15 May 2014, to set out the future direction of the profession, how it can further serve the patient, and enhance collaboration with other health professionals. The Summit’s outcomes, in defining hospital pharmacy competencies, highlighting best

practices, and proposing service metrics and implementation frameworks, is designed to provide a long term foundation for the achievement of EAHP’s mission of continuously improving hospital pharmacy in Europe in the patient interest.

is the input of the intended beneficiaries: patients. We also want to hear the views and opinions of colleague health professionals. Use the side links to learn more about the event, and how your organisation can be involved!

Key to the success of the Summit

IPHA Annual Meeting The importance of partnership in healthcare and of exploring new opportunities of working together, was the theme of the 20 Irish Pharmaceutical Healthcare Association (IPHA) Annual meeting. IPHA President Francis Lynch told delegates that as an industry, the best way of meeting the Issue 11 • HPN

challenges of effective and affordable healthcare delivery is through partnership and dialogue. he said. Mr. Lynch outlined how the latest supply agreement between the State and IPHA which was just over a year old and will run until 2015, was already expected to deliver direct savings of around

¤130 million in 2013 alone.”, he further added.

about reform and better outcomes for patients.

Among the other contributors to the meeting were Secretary General of the Department of Health Dr. Ambrose McLoughlin who highlighted the importance of stakeholders from across all aspects of healthcare working more closely together to bring

HSE Director of Health and Wellbeing, Dr. Stephanie O’Keeffe, Prof. John Higgins who headed up the Strategic Board for Hospital groups and Prof. Michael Barry the Clinical Director of the National Centre for Pharmacoeconomics also contributed to the meeting.


Clinical 37

Data presented at EASD support safety profile of Trajenta® (linagliptin) Boehringer Ingelheim and Eli Lilly and Company announced that results from two different pooled analyses of clinical studies support previous observations that the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin was shown to be well tolerated in a broad range of adults with Type 2 Diabetes (T2D). 1,2 These data were presented at the 49th European Association of Diabetes (EASD) Annual Meeting. GENERAL SAFETY ANALYSIS Findings from a pooled comprehensive analysis of safety data in 22 linagliptin clinical trials with 7,400 people with T2D (4,810 received linagliptin, 2,590 received placebo) included the following: • Linagliptin was well tolerated overall and across all age groups studied, with a low incidence of hypoglycemic events • Overall incidence of adverse events (AE) or serious adverse events (SAE) with linagliptin was similar to placebo (AE 56.5 percent versus 61.2 percent, and SAE 4.8 percent versus 6.3 percent, respectively) • The incidence of AEs with linagliptin compared to placebo remained similar irrespective of the age category (≤65 years, 65-74 years, ≥75 years) “Drug tolerability is an important consideration in the selection of appropriate treatments for people with Type 2 Diabetes, as often different populations will have drug contraindications and require dose adjustments to manage their disease,” said Prof. Nikolaus Marx, Professor of Medicine and Cardiology, University Hospital of Aachen, Germany. “The results presented support the safety profile of linagliptin.” RENAL SAFETY IN THE ELDERLY Results from a post-hoc analysis of pooled data from seven clinical trials including 1,293 people with T2D aged 65 years or older showed: • Linagliptin was well tolerated providing clinical efficacy in an elderly population with renal function ranging from normal to severe renal impairment

Drug tolerability is an important consideration in the selection of appropriate treatments for people with Type 2 Diabetes, as often different populations will have drug contraindications and require dose adjustments to manage their disease. • Overall renal function was not significantly altered by treatment with linagliptin from baseline to week 24, versus placebo • Patients taking linagliptin achieved a HbA1c reduction of -0.6 percent from baseline and –0.8 mmol/L for fasting plasma glucose (both values placebocorrected) • The overall incidence of AEs with linagliptin was similar to placebo (71.3 percent versus 72.8 percent, respectively) • Incidence of investigatordefined hypoglycaemia was not higher in patients who received linagliptin compared to those receiving placebo (21.3 percent versus 24.7 percent), with most events occurring in the trials that included a sulphonylurea or basal insulin as background therapy • Renal and urinary AEs were experienced by 5.5 percent and 4.3 percent of linagliptin and placebo patients, respectively. “The data presented from these analyses supplement the already established evidence demonstrating that linagliptin is a well-tolerated treatment for a broad range of people with Type 2 Diabetes,” said Professor Klaus

Professor Klaus Dugi

Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “This should provide physicians further assurance when treating different patient types with linagliptin.” ABOUT LINAGLIPTIN Linagliptin (5 mg) is marketed in Ireland as Trajenta® (linagliptin), as a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D. Linagliptin should not be used in patients with Type 1 Diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).3,4 The U.S. Food and Drug Administration (FDA), European

Medicines Agency (EMA) and several other regulatory authorities worldwide have approved linagliptin for the treatment of adults with T2D as a monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment, or in combination with metformin, metformin + sulphonylurea, and as add-on therapy to insulin with or without Metformin when patients are inadequately controlled by their current therapy and diet and exercise. With linagliptin, no dose adjustment is required regardless of renal function or hepatic impairment.

HPN • Issue 11


38 Feature

CPD: Have you REDD® the IMB Drug Safety Newsletter lately? review of the individual modules prior to release.

Morgan O'Connell, B.Sc. (Pharm.), M.Sc., M.P.S.I., PG Cert ODE (Open)

Caroline Waldron, B.Sc. (Pharm.), Ph.D., M.P.S.I., PG Cert ODE (Open)

iaCME is an independent accredited provider of CPD, established and run by innovative Irish healthcare professionals, (Pharmacists and a Doctor) who have considerable experience in the area of pharmacovigilance, quality management and CPD. They have been producing accredited online resources since 2011. The IMB Drug Safety Newsletter (DSN) is a valuable source of Safety information and using it as a CPD resource would help to address a key recommendation of the Report of the Commission on Patient Safety and Quality Assurance (2008), i.e. to learn from previous adverse events that have occurred. iaCME utilise the content from the IMB’s Drug Safety Update to deliver defined learning objectives. The IMB is in agreement with the use of its DSN for the purpose of CPD and has contributed to Issue 11 • HPN

The overall focus of each module is on reducing risks to patient safety by applying learnings from new and emerging safety information, as highlighted in the Drug Safety Update. iaCME formats the content using multimedia and adapts it to an appropriate template on the iaCME website (free of charge) to make it more engaging and to provide additional resources to explore individual topics in a more practice focussed way for those who wish to do so. The modules are accredited by the ICGP for doctors; there is, as yet, no accreditation procedure for any CPD for pharmacists but the modules are structured to equip pharmacists with evidence of engaging with relevant CPD in a manner specifically chosen to match the goals of the new Pharmacy CPD structure. This involves a four step process Read, Evaluate, Discuss (optional) and Document. Online Discussion forums provide an opportunity for peer learning through sharing ideas/experiences or asking questions. Documentation includes a Certificate, which can be printed or saved (remains always available on the website) but also templates for reflection as well as personal blog space for reflection, recording or peer interaction. This article will show how you might use the IMB DSN as a CPD resource. Like the actual DSN itself, it is, of course text based and so does not have the impact of the online version nor does it provide the optimal tools for using the DSN as a CPD activity. It is based on DSN 55 but does not contain all of the content in that edition – the original Newsletter is available at http:// www.imb.ie/images/uploaded/ documents/Drug%20Safety%20 Newsletter%2055%20(amended). pdf (Accessed Oct 18, 2013) NSAIDs are linked with a small increased risk of arterial thromboembolic events (such as myocardial infarction or stroke), particularly if used at high dose and for long-term treatment. Accordingly, class labelling recommends that NSAIDs be used at the lowest effective dose for the shortest period of time necessary to control symptoms. EU review by the

Pharmacovigilance Risk Assessment Committee (PRAC), of various studies relating to Diclofenac has found that, overall, compared with placebo, allocation to diclofenac or a coxib caused around three additional major vascular events per 1000 participants per year, with one such event causing death; in high-risk individuals, about seven or eight more would have a major vascular event, of which two would be fatal. Although the risk is likely to be dose-dependent, the PRAC considered that cardiovascular thrombotic risk cannot be excluded across all doses of diclofenac, especially in patients with pre-existing co-morbidities.

relief but also to a variable and unpredictable risk of side effects due to morphine’s action on the brain and respiratory centre.

Key Message

Key Message

• Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic risks associated with the use of diclofenac, similar to that for selective COX-2 inhibitors

• Codeine-containing medicines should only be used to treat acute, moderate pain in children older than 12 years of age, and only if it cannot be relieved by other analgesics such as paracetamol or ibuprofen, because of the risk of respiratory depression associated with codeine use.

• Diclofenac is now contraindicated in patients with established congestive heart failure (New York Heart Association, NYHA, classification II– IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease. Patients with these conditions should have their treatment reviewed.

Available (limited) data suggest that there is a reduced ability to metabolise codeine in younger children but that the enzyme system responsible for the metabolism of codeine can be considered to be fully matured by the age of 12.1 There have been reports of children who received codeine for pain control after tonsillectomy or adenoidectomy (or both) for obstructive sleep apnoea and who developed rare, but life-threatening adverse events, including death.

• Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, and smoking) should only be treated with diclofenac after careful consideration of the benefit-risk balance.

• As there seems to be a particular risk of developing serious and life-threatening adverse reactions (including loss of consciousness and respiratory depression) in those paediatric patients, who might already have compromised airways and who require pain relief following tonsillectomy and/ or adenoidectomy, Codeine is now contraindicated in all patients younger than 18 years of age for pain relief following tonsillectomy and/or adenoidectomy for Obstructive Sleep Apnoea Syndrome (OSAS).

• As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically.

• Codeine is contraindicated in patients of any age who are known to be CYP2D6 ultra-rapid metabolisers. (Up to approximately 10% of Caucasians are CYP2D6 ultrarapid metabolisers, but prevalence differs according to racial and ethnic group.1)

Codeine is converted into morphine (which is responsible for its pharmacological effects) by the cytochrome P450 enzyme CYP2D6. There are many genetic variations of CYP2D6, which affect the extent of this conversion in individuals. Different plasma morphine concentrations in patients’ blood leads not only to different levels of pain

• Use of codeine is contraindicated in breastfeeding women due to an increased risk for the child if the mother is an ultra-rapid metaboliser. • Codeine is not recommended in children with neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections,


39 multiple trauma or extensive surgical procedures. Symptoms of morphine toxicity may be increased in these patients. • Codeine use for all patients should be at the lowest effective dose for the shortest period of time and the duration of treatment should be limited to 3 days. Healthcare professionals are reminded that patients may respond differently to codeine. Those caring for patients taking codeine should be advised to seek medical advice if symptoms of toxicity occur. Dianette is authorised as a treatment for acne and other

QUIZ AND REFLECTION PROMPTERS After the Quiz, some reflection prompters are presented to assist you in embedding any learnings from the article into your practice. Quiz: 1. DSN 55 alerts HCPs to the possibility of which of the following risks associated with Diclofenac? a. Hypertension b. Hypotension c. Arterial Thrombotic Events d. QT Prolongation 2. In patients with ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or congestive heart failure, which of the following applies? a. diclofenac is contraindicated.

The IMB would not recommend that these products be administered to patients, pending the finalisation of the regulatory procedure. The IMB has not considered the advice as yet and, in the absence of concerted action at EU level, will await further regulatory action.

hormone related conditions. The progestogen content of Dianette (i.e. cyproterone acetate), suppresses ovulation and, therefore also has a contraceptive effect, although it is not authorised as a contraceptive in its own right. An EU review of Dianette has concluded that the benefits continue to outweigh the risks, provided that a number of measures are taken to minimise the well known risk of thromboembolism. Key Message: • Dianette should now be used solely in the treatment of moderate to severe acne

related to androgen sensitivity or hirsutism in women of reproductive age. For the treatment of acne, Dianette should only be used when alternative treatments, such as topical therapy or oral antibiotic treatment have failed. • Since Dianette is a hormonal contraceptive, women should not take this medicine in combination with other hormonal contraceptives. • It is important that healthcare professionals and women using Dianette are aware of the risk of VTE in order to prevent complications and serious adverse

b. diclofenac should be used at the lowest effective dose for the minimum duration, up to a maximum of 3 days.

5. Which of the following are now contraindications to the use of codeine(Select all that you think apply)?

c. diclofenac should only be commenced after consideration of each individual's risk factors for cardiovascular events.

Children under the age of 18

3. Which of the following are potential symptoms of morphine toxicity? (Select all that you think apply)?

Children under the age of 18 for pain relief following tonsillectomy and/or adenoidectomy for Obstructive Sleep Apnoea Syndrome (OSAS)

a. Somnolence

Any patients known to be CYP2D6 ultra-rapid metabolisers.

b. Reduced levels of consciousness.

Women who are breastfeeding.

c. Lack of appetite

Children under 12

d. Nausea and vomiting

6. What are the two authorised indications for Dianette in Ireland?

e. Constipation f. Respiratory depression g. 'Pin-point' pupils 4. Which enzyme is responsible for the conversion of codeine to morphine?

We are not going to list the answers to the quiz. If you are not absolutely sure of the answers you should review the article one more time. Better still re-read the original newsletter or try the online multimedia module available on the iaCME website free of charge. Even if you are sure you know the answers to all of the questions,

7. DSN 55 draws attention to which of the following as potentially serious side effects with Lariam (Mefloquine)?

outcomes and to facilitate a timely and correct diagnosis of VTE. Educational materials will also be available soon to highlight risk factors for VTE include increasing age, smoking and immobility. The 55th Edition of the IMB Drug Safety Newsletter contains more detailed information on the above topics together with some information on the working of the Pharmacovigilance Risk Assessment Committee and synopses of recent safety communications sent to HealthCare professionals.

Neurological degeneration 8. Which of the following statements is correct? Lariam has a long half-life and consequently, adverse reactions may occur and persist up to several months after discontinuation of the drug. Lariam has a short half-life so stopping treatment will result in rapid subsidence of any side-effects. 9. The recent EU Review has shown that compared with crystalloid solutions, while there is a greater benefit in using HES, the risk/benefit ratio is not favourable. True or False? a. True b. False 10. The EU PRAC has recommended suspension of HES authorisations. What is the IMB position on this advice?

Cardiovascular disorders Neuropsychiatric disorders

quizzes do not of themselves mean that your professional ability and practice has been advanced by the knowledge you have gained. You can assist the assimilation of your learnings into your practice by using the reflection template below. You can keep a record of the completed template (including the time spent on reflection as

well as engaging with Part 1 of the article) as evidence of your CPD. An online version of the template is available on the iaCME website and would be useful for record keeping.

HPN • Issue 11


40 Feature Topic 1: DICLOFENAC:

Topic 2: CODEINE

THE SAME CARDIOVASCULAR PRECAUTIONS NOW APPLY FOR DICLOFENAC AS FOR SELECTIVE COX-2 INHIBITORS.

RESTRICTED USE AS AN ANALGESIC IN CHILDREN AND ADOLESCENTS

Do you understand why changes have been made to diclofenac contraindications and warnings?

Actions required to enhance your practice:

Additional Learning Needs?

Do you know the cardiovascular conditions that would contraindicate the use of diclofenac in patients with such conditions? Do you know the risk factors for cardiovascular events that might affect the use of diclofenac? Are you aware of the new guidance on dose and duration of diclofenac therapy and why this advice is important? Do you need to review existing patients being treated with diclofenac? When and what do you need to review? Can you prepare your practice for future new patients requiring or receiving diclofenac? Any Other Thoughts/Reflections? Record of Any Discussions held with colleagues:

Issue 11 â&#x20AC;˘ HPN

Do you understand the background to the new restriction on the use of codeine as an analgesic in children and adolescents? Do you know the specific uses of codeine that are contraindicated in the case of children/ adolescents under the age of 18? Do you understand why this contraindication has been introduced? Do you know the lower age for which codeine may be used in children and what warnings apply for use in children over that age? Do you know the conditions specifically referenced as circumstances where codeine is not recommended in children? Do you know the recommendation regarding codeine in breastfeeding? Do you know the recommendation regarding codeine in patients known to be CYP2D6 ultra-rapid metabolizers? HCPs are reminded that patients may respond differently to codeine. Those caring for patients taking codeine should be advised to seek medical advice if symptoms of toxicity occur. Do you know the symptoms of codeine/morphine toxicity? Do you know how they could be confused with symptoms of sleep apnoea? Should you set up a review of any of your patients already receiving codeine? What can you do for potential future candidates for codeine treatment?

Actions required to enhance your practice:

Additional Learning Needs?


The first biosimilar monoclonal antibody (mAb) for use in gastroenterology

Gain a fresh perspective INFLECTRA™ is the world’s first biosimilar mAb. Designed with equivalent efficacy, safety and quality to reference infliximab1,2 to increase the treatment options for your gastroenterology patients. Change your perception. Choose INFLECTRA™. Abbreviated indications: Crohn’s disease (CD): adult patients with moderately to severely active CD who have not responded despite a full and adequate course of therapy with a corticosteroid and/or immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Adult patients with fistulising, active CD who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric patients (aged 6 to 17 years) with severe, active CD who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.

Abbreviated Prescribing Information – INFLECTRA▼ (Infliximab) powder for concentrate for solution for infusion Please refer to full Summary of Product Characteristics (SmPC) before prescribing. Presentation: Vial containing 100 mg of infliximab powder for concentrate for solution for infusion. Indications: 1) Rheumatoid arthritis in adult patients with active disease with inadequate response to disease-modifying antirheumatic drugs (DMARDs) or adult patients with severe, active and progressive disease not previously treated with methotrexate (MTX) or other DMARDs 2) Adult Crohn’s disease a) In patients with moderately to severely active Crohn’s disease who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have contraindications for such therapies. b) In patients with fistulising, active Crohn’s disease who have not responded despite conventional treatment (including antibiotics, drainage and immunosuppressive therapy). 3) Paediatric Crohn’s disease Severe, active Crohn’s disease in patients aged 6 to 17 years, who have not responded to conventional therapy including corticosteroid, immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. 4) Ulcerative colitis In both adult patients with moderate to severely active ulcerative colitis, and children and adolescents aged 6 to 17 years with severely active ulcerative colitis and an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine; or who are intolerant to or have contraindications for such therapies. 5) Ankylosing spondylitis In adult patients with severe active ankylosing spondylitis who have responded inadequately to conventional therapy. 6) Psoriatic arthritis In adult patients with active and progressive psoriatic arthritis when response to previous DMARD therapy has been inadequate. 7) Psoriasis In adult patients with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to systemic therapy including cyclosporine, MTX or PUVA. Dosage & Administration 1) Rheumatoid arthritis 3 mg/kg as an intravenous (IV) infusion repeated 2 and 6 weeks after initiation, then every 8 weeks. Inflectra must be given concomitantly with MTX. 2) Moderately to severely active Crohn’s disease 5 mg/kg IV infusion repeated 2 weeks after initiation. If a patient does not respond after 2 doses, no additional dose should be given. 3) Fistulising, active Crohn’s disease 5 mg/kg IV infusion repeated 2 and 6 weeks after initiation. If a patient does not respond after 3 doses, no additional dose should be given. 4) Ulcerative colitis 5 mg/kg IV infusion repeated 2 and 6 weeks after initiation, then every 8 weeks. 5) Ankylosing spondylitis 5 mg/kg IV infusion repeated 2 and 6 weeks after initiation, then every 6 to 8 weeks. If a patient does not respond by 6 weeks, no additional dose should be given. 6) Psoriatic arthritis 5 mg/kg IV infusion repeated at 2 and 6 weeks after initiation, then every 8 weeks. 7) Psoriasis 5 mg/kg IV infusion repeated 2 and 6 weeks after initiation, then every 8 weeks. If a patient shows no response after 14 weeks no additional dose should be

Ulcerative colitis (UC): adult patients with moderately to severely active UC who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Paediatric patients (aged 6 to 17 years) with severely active UC who have had inadequate response to conventional therapy including corticosteroids and 6-MP or AZA or who are intolerant or have medical contraindications to such therapies.

given. Administer IV over 2 hours initially and monitor for infusion-related reactions. Contraindications: Hypersensitivity to infliximab, to other murine proteins, or to any excipients. Tuberculosis (TB) or other severe infections such as sepsis, abscesses, and opportunistic infections. Moderate or severe heart failure (NYHA class III/IV). Warnings and Precautions: Caution in patients with or at risk of infusion reactions and hypersensitivity. Do not administer in patients with infections, and/or invasive fungal infections. Monitor for TB and do not use in patients with TB. Test for latent/ active TB prior to initiation of therapy. Do not use Inflectra in patients with active TB, patients with latent TB must not be initiated on Inflectra therapy until initiation with anti-TB therapy. Monitor closely for infections, including TB before, during and for six months post-treatment. Patients with fistulising Crohn’s disease with acute suppurative fistulas must not initiate therapy until source of infection, specifically abscess, is excluded. Test for HBV infection before initiating treatment. Consult expert in treatment for HBV-positive patients. Closely monitor carriers of HBV during and after therapy. In patients with HBV reactivation, stop Inflectra and initiate appropriate therapy. Pregnancy should be avoided during therapy, and for at least 6 months after last infusion. Adverse effects: Viral infection, bacterial infection, TB, fungal infection, meningitis, opportunistic infection, parasitic infection, hepatitis B reactivation, lymphoma, non-Hodgkin’s lymphoma, Hodgkin’s disease, leukaemia, melanoma, hepatosplenic T-cell lymphoma, Merkel cell carcinoma, allergic respiratory symptom, anaphylactic reaction/shock, lupus like syndrome, serum sicknesslike reaction, vasculitis, sarcoid-like reaction, depression, insomnia, amnesia, agitation, confusion, somnolence, nervousness, apathy, headache, vertigo, dizziness, hypoaesthesia, paraesthesia, seizure, neuropathy, transverse myelitis, demyelinating disorders, conjunctivitis, keratitis, periorbital oedema, hordeolum, endophthalmitis, transient visual loss, tachycardia, palpitation, cardiac failure, arrhythmia, syncope, bradycardia, cyanosis, pericardial effusion, myocardial ischaemia/ infarction, hypotension, hypertension, ecchymosis, hot flush, flushing, peripheral ischaemia, thrombophlebitis, haematoma, circulatory failure, petechia, vasospasm, URTI, sinusitis, lower respiratory tract infection, dyspnoea, epistaxis, pulmonary oedema, bronchospasm, pleurisy, pleural effusion, interstitial lung disease, abdominal pain, nausea, gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation, intestinal perforation/stenosis, diverticulitis, pancreatitis, cheilitis, hepatic function abnormal, transaminases increased, hepatitis, hepatocellular damage, cholecystitis, jaundice, liver failure, psoriasis (new onset or worsening), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia, bullous eruption, onychomycosis, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation, Toxic Epidermal Necrolysis, Stevens-Johnson syndrome, erythema multiforme, furunculosis, arthralgia, myalgia, back pain, urinary tract infection, pyelonephritis, vaginitis, infusion related reaction, pain, chest pain, fatigue, fever, injection site reaction, chills, oedema,

impaired healing, granulomatous lesion, autoantibody positive, complement factor abnormal. The SmPC should be consulted for further details of adverse effects Legal category: POM Marketing Authorisation Number/Pack: EU/1/13/854/001 (1 vial); EU/1/13/854/002 (2 vials); EU/1/13/854/003 (3 vials); EU/1/13/854/004 (4 vials); EU/1/13/854/005 (5 vials) Marketing Authorisation Holder: Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW. Further information is available on request from: Hospira Ireland Ltd, Unit 15, The Park, The Hyde Building, Carrickmines, Dublin 18, Ireland Date of preparation: October 2013 (IE/INF/13/0003)

Adverse events should be reported. Reporting forms and information can be found at www.imb.ie Adverse events should also be reported to Hospira UK Ltd. Telephone Medical Information: +44 (0) 1926 834400 6-MP = 6-mercaptopurine AZA = Azathioprine References: 1. INFLECTRA™. European Public Assessment Report (EPAR). Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/ medicines/002778/human_med_001677.jsp&mid=WC0b01ac058001d124. [Accessed September 2013]. 2. EMA. Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. May 2012. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2012/06/WC500128686.pdf [Accessed September 2013]. IE/INF/13/0020 November 2013


42 Feature

Cardiovascular risk factors in Women Written by Dr Darren Mylotte and Dr Kieran Daly Consultant Cardiologist/Senior Lecturer in Medicine, Cardiology Department, University College Hospital, Galway

Ischaemic heart disease (IHD) remains the leading killer of both men and women in developed nations. World Health Organisation data reveal that in Europe 55% of female deaths and 43% of male deaths are attributable to cardiovascular disease (CVD).1

Heightened physician and patient awareness of the risk factors contributing to CVD and their control with primary and secondary prevention strategies has led to a reduction in disease prevalence and mortality. The magnitude of this regression is smaller in women.

The notion that IHD is a male disease has led to the underestimation of disease burden in women. When ageadjusted data are considered, cardiovascular disease is more common in males.

Overall, the burden of disease remains high and could be further reduced by recognition and aggressive management of those at risk.

In blood plasma, lipids such as cholesterol and triglycerides bind to protein molecules to form lipoproteins. These lipidrich molecules may give rise to atherosclerotic plaque formation. The atherosclerotic potential of each lipoprotein depends on their physical size and concentration in the plasma.

The evaluation and treatment of IHD in women represents a unique and demanding challenge for clinicians. An understanding of gender-related differences in the clinical manifestations, pathophysiology and treatment of IHD is essential to reduce disease prevalence and adverse outcomes. This review will focus on the identification and

Low-density lipoprotein (LDL) carries most of the cholesterol in blood plasma. There is a strong positive correlation between total and LDL cholesterol levels and cardiovascular risk.2 This relationship holds true for patients with and without established CVD and in both males and females. The fundamental role of LDL in the

However, the prevalence of heart disease in the population >65 years is roughly equivalent between the sexes, owing to the higher proportion of women in this group. More women than men have died annually from IHD since 1984.

Issue 11 â&#x20AC;˘ HPN

treatment of cardiovascular risk factors in women. PLASMA LIPIDS

development of atherosclerosis and consequently the requirement to reduce levels cannot be overstated. Current guidelines recommend reducing LDL cholesterol levels to <3mmol/l in highrisk patients. Women tend to have less atherogenic lipoprotein subclass profiles than men. Elevated triglyceride levels are more common in women. Hypertriglyceridaemia is associated with the development of atherosclerotic disease but the extent of this correlation is not clearly defined. It is a more potent independent risk factor in women.3 A triglyceride value of >1.7mmol/l is considered to be a marker of increased risk although concentrations of <1.7mmol/l are not deemed a goal of therapy. Large-scale clinical trials have


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

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

As measured by CV deaths (PLATO study)2

Recommended in the ESC Guidelines3-5

*Based on Republic of Ireland HIPE (Hospital In Patient Enquiry) figures. Based on all eligible patients receiving BRILIQUE instead of clopidogrel and CV mortality results from the PLATO study. BRILIQUETM 90MG FILM-COATED TABLETS (ticagrelor) Abridged Prescribing Information (For full details see Summary of Product Characteristics (SmPC)) Use: Adults aged 18 years and older, co-administered with acetylsalicylic acid (ASA) daily: for the prevention of atherothrombotic events in patients with acute coronary syndromes (unstable angina, non-ST-segment elevation myocardial infarction [NSTEMI] or ST-segment elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Presentation: 90mg ticagrelor film-coated tablets. Dosage and administration: Treatment should be initiated with a single 180mg loading dose (two tablets of 90mg) and then continued at 90mg twice daily. Following an initial dose of ASA, patients should also take a daily maintenance dose of 75-150mg of ASA with Brilique, unless ASA is specifically contraindicated. Treatment is recommended for up to 12 months unless discontinuation is clinically indicated. Premature discontinuation of treatment or lapses in therapy should be avoided. Patients treated with clopidogrel can be directly switched to Brilique. For oral use. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active pathological bleeding. History of intracranial haemorrhage. Moderate-to-severe hepatic impairment. Co-administration with strong CYP3A4 inhibitors (e.g. ketoconazole). Precautions: Due to the increased risk of non-fatal or non-life threatening bleeding, use with caution in patients at an increased risk for bleeding (e.g. recent trauma or surgery, bleeding disorders or recent gastrointestinal bleeding) or those on concomitant medication that may increase bleeding risk (e.g. NSAIDs, anticoagulants) within 24 hours of taking Brilique. Brilique should be stopped 7 days prior to elective surgery if the antiplatelet effect is not desired. Use with caution in patients with an increased risk of bradycardic events (e.g. patients on digoxin), as asymptomatic ventricular pauses have been observed with Brilique, a history of asthma and/or COPD, a history of hyperuricaemia or gouty arthritis. Creatinine levels may increase during treatment with Brilique. Renal function should be checked after one month and thereafter according to routine medical practice, paying special attention to patients ≥ 75 years, patients with moderate-to-severe renal impairment and those receiving concomitant treatment with an ARB. Co administration of Brilique is not recommended with a high maintenance dose of ASA (> 300mg) or with doses of simvastatin > 40mg. Co administration of ticagrelor with strong CYP3A4 inducers is discouraged, as this may lead to a decrease in exposure and efficacy of ticagrelor. Co-administration with CYP3A4 substrates with narrow therapeutic indices is not recommended. Co administration of ticagrelor with moderate CYP3A4 inhibitors (e.g. cyclosporine, diltiazem) is discouraged, as this may lead to an increase in exposure of ticagrelor, if use is unavoidable, appropriate patient monitoring is recommended. Concomitant use of ticagrelor with doses of simvastatin or lovastatin > 40mg not recommended. Caution with concomitant use of P-gp inhibitors or P-gp substrates with narrow therapeutic indices e.g. verapamil, quinidine and cyclosporine. Caution with concomitant administration of SSRIs. Brilique is not recommended during pregnancy and breastfeeding. Undesirable effects: Common: Dyspnoea, epistaxis, gastrointestinal haemorrhage, subcutaneous or dermal bleeding, bruising and procedural site haemorrhage. Other undesirable effects include intracranial bleeding, elevations of serum creatinine and uric acid levels. Consult SmPC for a full list of undesirable effects. Legal category: POM. Marketing Authorisation Number: EU/1/10/655/004. Market Authorisation Holder: AstraZeneca AB, S 151 85, Södertälje, Sweden. Further product information available on request from: Freephone 1800 800 899 or contact AstraZeneca UK Limited, Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU, United Kingdom. Abridged Prescribing Information prepared: 07/13. BRILIQUE is a trade mark of the AstraZeneca group of companies. Reference 1: HIPE (Hospital In Patient Enquiry) Casemix data- Ready Reckoner 2013 (2011 costs and activity). 2: Wallentin L, Becker RC, Budaj A, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Eng J Med 2009;361:1045-57. 3: Steg G and James SK et al. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J 2012 Aug 24. OI:10.1093/eurheartj/ehs215. 4: Hamm CW et al. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2011 32(23):2999-3054. 5: Wijns W et al. ESC Guidelines on Myocardial Revascularisation. European Heart Journal (2010) 31, 2501–2555 doi:10.1093/eurheartj/ehq277. Approval id: 71122.011. Date of preparation: October 2013

Cardiovascular


44 Cardiovascular Feature consistently demonstrated the efficacy of HMG Co-A reductase inhibitors (statins) in reducing LDL and triglyceride levels and subsequent cardiovascular risk.4 A large proportion of high-risk women are not treated aggressively enough to reach evidence-based lipid goals.5 FEMALE SEX HORMONES The low incidence of CVD in pre-menopausal women with normal ovulation compared with age-matched men is believed to derive from endogenous sex hormones. Animal studies have consistently demonstrated the anti-atherosclerotic effects of oestrogen.6 During the menopause, a woman’s oestrogen levels drop to approximately one-tenth that of her pre-menopausal years.7 The loss of ovarian hormones has a widespread adverse impact on many cardiovascular risk factors. Hormone replacement therapy (HRT) comprises oestrogen with or without a progestin. It is used for relief of menopausal symptoms and the prevention of post-menopausal osteoporosis. Observational studies have suggested that women taking HRT have better CVD risk factor profiles and a reduced incidence of coronary artery disease.8 However, recent large clinical trials of HRT

have not demonstrated a reduction in cardiovascular risk.9 Further research into the anti-atherosclerotic effects of HRT is warranted as alternative hormone and dosing regimens still offer the potential to reduce total cardiovascular risk. Currently, the use of hormone replacement solely for cardioprotection is not recommended. HYPERTENSION Hypertension represents an increasingly important medical and public health issue. Its prevalence rises with age, with >50% of people aged 60-69 years and >75% aged above 70 years affected.10 Observational studies involving over one million people have indicated that death from both IHD and stroke rises progressively and linearly from blood pressure (BP) levels as low as 115mmHg systolic and 75mmHg diastolic upwards.11 For every 20mmHg systolic or 10mmHg diastolic increase in BP there is a doubling of CVD mortality. The goal of anti-hypertensive therapy is to reduce cardiovascular and renal morbidity and mortality. Treating systolic BP and diastolic BP to targets that are <140/90mmHg is associated with a decrease in CVD

complications.12 In patients with hypertension and either diabetes or renal disease, the BP target is <130/80mmHg.13,14 Hypertension is less common in females than in males until the fifth decade of life, when the incidence of hypertension increases in females. The prevalence of hypertension in women is equal to or exceeds that in men during the sixth decade of life. The oral contraceptive pill (OCP) may cause a small increase in BP but the absolute risk is small.15 BP levels return to baseline within three months of OCP discontinuation. The effect of the menopause on BP is controversial. A menopause-related rise in BP has been attributed to a variety of factors, including oestrogen withdrawal, overproduction of pituitary hormones and weight gain. Longitudinal studies have not documented a rise in BP with menopause, while cross-sectional studies have found significantly higher BP in post menopausal versus premenopausal women.16 There is ongoing debate about the effect of HRT on BP. The Women’s Health Initiative (WHI) found an average 1mmHg increase in systolic BP in 8,000

patients randomised to receive conjugated equine oestrogen and medroxyprogesterone acetate as compared with a placebo group.17 In a crosssectional analysis of 100,000 women in the WHI cohort, aged 50-79 years, current HRT use was associated with a 25% greater likelihood of hypertension compared with past use or no prior use.18 Current evidence indicates that the sex of the patient should not influence the decision to treat hypertension to pre-defined treatment goals. The response to anti-hypertensive medications is similar among the sexes. Caution must be exercised when using angiotensin converting enzyme inhibitors and angiotensin receptor blockers in women of childbearing age as both are teratogenic. GLUCOSE Hyperglycaemia is associated with an elevated risk of developing IHD and other atherosclerotic diseases.19,20 Patients with type 1 diabetes have a two- to three-fold increased risk of developing CVD. This is almost exclusively confined to those who have developed diabetic nephropathy.21 All patients with type 2 diabetes, regardless of renal status, are at increased risk of CVD. The prevalence of diabetes is increasing in both men and women. Studies have reported a significantly higher cardiovascular mortality for diabetic women compared to diabetic men.22 The age-adjusted risk of developing CVD doubles in diabetic versus non-diabetic women. Thus, it seems that diabetes negates the ‘female advantage’ which confers lower IHD prevalence on the majority of women. SMOKING Smoking-related death accounts for half of all deaths in longterm tobacco smokers. Over 50% of these deaths are due to CVD.23 The CVD risk is related to the number of cigarettes smoked daily and the duration of exposure. Cigarette smoking is more prevalent in women. Globally, the number of cigarette

Issue 11 • HPN


45 smokers is falling; however, the magnitude of decline is less dramatic in women. While the adverse effects of smoking are present in both men and women, they are believed to be slightly more pronounced in women, further reducing their innate protection from CVD.24 OBESITY Population studies have demonstrated a consistent link between being overweight and total mortality. CVD accounts for the excess mortality among obese subjects.25 Metabolic risk factors tend to cluster in obese patients: insulin resistance, glucose intolerance, low high-density lipoprotein (HDL), small LDL particles, high triglycerides and hypertension. The metabolic syndrome is a clustering of these risk factors and is more prevalent in women than in men with CVD.26,27 The four-year relative risk of cardiac events is doubled for women with the metabolic syndrome compared to those with a normal metabolic profile.28 GENDER DIFFERENCES IN RESPONSE TO THERAPY Evidence-based pharmacotherapy is essential to reduce morbidity and mortality associated with CVD. Emerging data concerning gender-related differences in the pathogenesis and response to treatment of CVD demonstrate a need for the individualisation of management strategies. Female representation in studies on IHD has risen since the 1980s; however, primary and secondary preventative regimens are largely based on evidence derived from principally male cohorts. Gender-specific physiological differences exist, including lower body mass index and smaller organ size in women compared with men, resulting in larger distribution volumes in males. Women have a larger proportion of body fat, which may increase the distribution volume for lipophilic drugs. Pharmacokinetic studies have demonstrated differences in the activity of drug-metabolising enzymes between the sexes. The enzymes of the cytochrome P450 system, which is

responsible for the metabolism of many cardiovascular drugs, may account for gender-specific response to treatment. The Physician’s Health Study showed that aspirin significantly reduced the risk of myocardial infarction but not stroke or cardiovascular mortality in men.29 In the Women’s Health Study, aspirin did not reduce the risk of myocardial infarction or cardiovascular mortality in women. A significant reduction in the risk of stroke was observed however.30 The contrasting response to long-term aspirin prescription demonstrates the need for gender-specific prescription. CONCLUSION CVD kills more women than all other disease entities combined; it is underdiagnosed and undertreated resulting in significantly poorer outcomes in women. Improved understanding of gender-related differences in risk factor profiles and treatment will further reduce cardiovascular morbidity and mortality in women. REFERENCES 1. World Health Statistical Information System 2004. www.who. int/whosis/ 2. Smith GD, Shipley MJ, Marmot MG, Rose G. Plasma cholesterol concentration and mortality. The Whitehall Study. J Am Med Assoc 1992; 267: 70-6. 3. Hokanson JE, Austin MA. Plasma triglyceride level is a risk factor for cardiovascular disease independent of high-density lipoprotein level: a meta-analysis of population-based prospective studies. J Cardiovasc Risk 1996; 3: 213-9. 4. Schaefer EJ, Brousseau ME. Benefits of reducing lowdensity lipoprotein cholesterol concentrations to <100mg/dL. Prev Cardiol 2000; 3: 136-9. 5. Grundy SM, Cleeman JL, Merz CN et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004; 110: 227-39. 6. Adams MR, Kaplan JR, Manuck SB et al. Inhibition of coronary artery atherosclerosis by 17-beta estradiol in ovariectiomized monkeys: lack of an effect of added progesterone. Atherosclerosis 1990: 10: 1051-7.

7. Paolitte R, Cosignani PG, Kenemans P et al. Menopause: problems and interventions in the United States. In: Paoletti R, Cosignani PG, Kenemans P et al (eds). Women’s Health and Menopause. Norwell, MA: Kluwer Academic Publishers, 1997; pp9-14. 8. Grodstein F, Stampfer, Colditz GA et al. Postmenopausal hormone therapy and mortality. New Engl J Med 1997; 336: 1769-75.

its treatment in postmenopausal women: baseline data from the Women’s Health Initiative. Hypertension 2000; 36: 780-9. 19. Pyorala K, Laakso M, Uusitupa M. Diabetes and atherosclerosis: an epidemiological view. Diabetes Metab Rev 1987; 3: 463-524. 20. Laakso M, Lehto S. Epidemiology of macrovascular disease in diabetes. Diabetes Rev 1997; 5: 294-315.

9. Clarke SC, Kelleher J, LloydJones H et al. A study of hormone replacement therapy in women with ischaemic heart disease: the Papworth HRT Atherosclerosis study. BJOG 2002; 109: 1056-62.

21. Borch-Johnsen K, Kreiner S. Proteinuria: value as predictor of cardiovascular mortality in insulin dependent diabetes mellitus. Br Med J (Clin Res Ed) 1987; 294: 1651-4.

10. Burt VL, Whelton P, Roccella EJ et al. Prevalence of hypertension in the US adult population. Results from the Third National Health and Nutrition Examination Survey, 1988-1991. Hypertension 1995; 25: 305-13.

22. Barrett-Connor EL, Cohn BA, Wingard DL, Edelstein SL. Why is diabetes mellitus a stronger risk factor for fatal ischaemic heart disease in women than in men? The Rancho Bernardo study. J Am Med Assoc 1991; 265: 627-31.

11. Lewington S, Clarke R, Qizilbash N et al. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Prospective Studies Collaboration. Lancet 2002; 360: 1903-13.

23. MacKenzie TD, Bartecchi CE, Schrier RW. The human costs of tobacco use (2). New Engl J Med 1994; 330: 975-80.

12. Hansson L, Zanchetti A, Carruthers SG et al. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet 1998; 351: 1755-62. 13. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care 2003; 26: S80-2. 14. National Kidney Foundation Guideline. K/DOQI HEARTWISE SUMMER 2007 clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Kidney Disease Outcome Quality Initiative. Am J Kidney Dis 2002; 39: S1-S246. 15. Chasan-Taber L, Willett WC, Manson JE et al. Prospective study of oral contraceptives and hypertension among women in the United States.Circulation 1996; 94: 483-9. 16. Rosenthal T, Oparil S. Hypertension in women. J Hum Hypertens 2000; 14: 691-704. 17. Manson JE, Hsia J, Johnson KC et al. Estrogen plus progestin and the risk of coronary heart disease. New Engl J Med 2003; 349: 523-34.

24. Prescott E, Hippe M, Schnohr P et al. Smoking and risk of myocardial infarction in women and men: longitudinal population study. Br Med J 1998; 316: 1043-7. 25. Calle EE, Thun MJ, Petrelli JM et al. Body-mass index and mortality in a prospective cohort of U.S. adults. New Engl J Med 1999; 341: 1097105. 26. Grundy SM. Metabolic complications of obesity. Endocrine 2000; 13: 155-65. 27. Grundy SM, Cleeman JI, Merz CN et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004; 110: 227-39. 28. Marroquin OC, Kip KE, Kelley D et al. The metabolic syndrome modifies the cardiovascular risk associated with angiographic coronary disease in women: a report from WISE. Circulation 2004; 1009: 714-21. 29. Steering Committee of the Physicians’ Health Study Research Group. Final report on the aspirin component of the ongoing Physicians’ Health Study. New Engl J Med 1989; 321: 129-35. 30. Ridker PM, Cook NR, Lee I-M et al. A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. New Engl J Med 2005; 352: 1293304.

18. Wassertheil-Smoller S, Anderson G, Psaty BM et al. Hypertension and

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46 Out & About

Hospital Pharmacy Awards 2013

1

The inaugural Hospital Pharmacy Awards were held on September 21st, 2013 in the Crowne Plaza Hotel, Santry. The evening proved to be a tremendous success, with over 300 pharmacy professionals in attendance from across Ireland to witness the first ever crowned winners of categories ranging from Hospital Pharmacist of the Year to Antimicrobial Project of the Year.

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5

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47

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12 1. 2. 3. 4. 5.

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13 Michael Boucher Hayes, Keith Dunning, Daniel Sweeney, Annalisa Deeney, Patrycia Kavezewska, Stephen Boucher, Ciara Bannon, Marguerite Keys, Patricia Donaghy, Anna Lisa Mullen, Michelle Blake, Julie McGeehin, Edel Bradley, Anne Machniewski, Joanne English and Tom Ferrie, Letterkenny General Hospital. Louisa Conlon, Gareth Dooley, Catherine Field, Maria Creed, Brid Ryan, Laura Lyons, Jennifer Brown, Louise Fitzsimons, Gavan Meegan, Noor Sako, Dearbhla Murphy, Geraldine Reid, Michelle McGuirk, Patricia, Ging and Ronnie Maxwell, Mater Hospital. Damien Griffin and Daniel Green, Accord Healthcare Ireland. Fergil Colohan, Ger Colohan, Karen Hurley and Dello Gill, Portiuncula Hospital, Mena Sheridan, Allphar, Caroline Fitzgerald and Conor Sadlier, Actavis. Allison Dunne, Elaine Burke, Elaine Callinan, Mary O’Toole, Elaine Maloney, Sinead Flynn and Esther Courtney, Galway University Hospital.

11

14 6. Ann O'Leary and Mary Leahy, Bon Secours Hospital, Tralee. 7. Andrew and Mary O’Neill Barber, Galway Univesity Hospital. 8. Veronica Treacy, Anne Marie Fahey and Bernard Carr, St James's Hospital. 9. Anna Radomski and Professor Marek Radomski, Head, School of Pharmacy, Trinity College Dublin. 10. Dr Laura Sahm, School of Pharmacy, University College, Cork, Elizabeth Barron, Mercy University Hospital and Professor Stephen Byrne, Head, School of Pharmacy, University College, Cork. 11. Richella Knox, Nyra Tyrell, Elizabeth Collis, Zulema Gonzalez, St Vincents Hospital. 12. Yvonne Sheehan, John Tormey, National Association of Hospital Pharmacy Technicians. 13. Ingrid Walsh, Grainne Carney and Carole Cafferky, Sanofi. 14. Caroline Monaghan and John McLoughlin, Tallaght Hospital.

HPN • Issue 11


48 Clinical Profiles FANNIN SOLE DISTRIBUTOR FOR DISTACLOR

Fannin Ltd will become the sole distributor for Distaclor® within the Republic of Ireland from the 1st of December, 2013.

Distaclor is available in pharmacies nationwide.

For further information on Distaclor please see www.fannin.eu/ Distaclor

• Acute bacterial meningitis

Ref 1. Meroponia Summary of Product Characteristics

Distaclor is a broad spectrum antibiotic which aids in fighting secondary bacterial respiratory infections. Distaclor is available in the following formats: • Distaclor LA 500mg tabs • Distaclor LA 375mg tabs • 125mg/5ml Distaclor Suspension • 250mg/5ml Distaclor Suspension

CLONMEL HEALTHCARE ARE DELIGHTED TO ANNOUNCE THE LAUNCH OF MEROPONIA 500MG AND 1G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Meroponia powder for solution for injection or infusion is indicated for the following infections in adults and children over 3 months of age: 1 • Pneumonia, including community acquired pneumonia and nosocomial pneumonia • Broncho-pulmonary infections in cystic fibrosis • Complicated urinary tract infections • Complicated intra-abdominal infections • Intra and post-partum infections • Complicated skin and soft tissue infections

TASECTAN® IS PRESENTED AT UNITED EUROPEAN GASTROENTEROLOGY (UEG) WEEK IN BERLIN

LAUNCH OF TELMISARTAN CLONMEL 20MG, 40MG AND 80MG FILM-COATED TABLETS.

Meroponia 500mg and 1g powder for solution for injection or infusion is available in a 10 vial pack.

In October a new study on Tasectan® was presented at UEG in Berlin by Prof Bueno.

Telmisartan Clonmel 20mg, 40mg and 80mg Tablets are indicated for: 1 • The treatment of essential hypertension in adults. • Reduction of cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease or type 2 diabetes mellitus with documented target organ damage.

PA 126/225/1-2 PA Holder: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary. Prescription only medicine. Date Prepared: December 2013. 2013/ADV/ MER/105

Full prescribing information is available on request or alternatively please go to www.clonmel-health. ie. Product is subject to medical prescription. Please contact Clonmel Healthcare on 01-6204000 if you require any additional information on Meroponia.

Tasectan® is new medical device indicated for the treatment of diarrhoea in adults, children and infants. It was launched on the Irish market in early 2013. Since its launch it has been recognised by Irish healthcare professionals as a safe and effective treatment for diarrhoea.

Telmisartan Clonmel Film-coated tablets are available in a 28 pack.

Issue 11 • HPN

Meroponia may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection

15,000 gastroenterologists from 125 different countries including Ireland attended UEG in Berlin. Tasectan is available from Ocean Healthcare, United Drug and Uniphar. For more information visit www.diarrhoea.ie or contact Ocean Healthcare 01 2968080. Prof Bueno is an internationally recognised expert on gastroenterology and R&D. Over

Telmisartan Clonmel is GMS reimbursable. Full prescribing information is available on request or alternatively please go to www.clonmel-health. ie. Product is subject to medical prescription.

Please contact Clonmel Healthcare on 01-6204000 if you require any additional information on Telmisartan Clonmel


49 HOSPIRA SHARES RESULTS FROM TWO OPEN-LABEL EXTENSION STUDIES FOR BIOSIMILAR INFLIXIMAB

Hospira, Inc, the world's leading provider of injectable drugs and infusion technologies, has shared the results of two open-label extension studies of CT-P13 (infliximab), one in patients with rheumatoid arthritis, the other in patients with ankylosing spondylitis, which were presented at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego. Hospira's CT-P13, branded as Inflectra™, was approved by the European Medicines Agency (EMA) in September 2013 as a biosimilar to reference product, Remicade® (infliximab). Inflectra is not currently approved for use in

the United States. In one study, 302 of 455 patients with rheumatoid arthritis who completed the Phase III PLANETRA study entered into the open-label extension phase. Of these, 158 were continuously treated with Inflectra (maintenance group) and 144 were switched from Remicade to Inflectra (switch group) for one additional year. The maintenance group and the switch group at weeks 78 and 102 were similar as measured by American College of Rheumatology (ACR) ACR20/50/70, DAS28-CRP, DAS28-ESR, EULAR-CRP, and EULAR-ESR response rates. Overall incidence of treatmentemergent adverse events (TEAE) was similar in both groups.

In the other study, 174 of 210 patients with ankylosing spondylitis who completed the Phase I PLANETAS study entered into the open-label extension phase. Of these, 88 were continuously treated with Inflectra (maintenance group) and 86 were switched from Remicade to Inflectra (switch group) for one additional year. The maintenance group and the switch group at weeks 78 and 102 were similar as measured by ASAS20/ASAS40, ASAS partial remission, and ASDAS-CRP rates. In this study, the adverse event profile for CTP13 was generally consistent with the originator.

POSITIVE RESULTS FROM PHASE 3 TRIAL OF XTANDI

Astellas Pharma Inc. and Medivation, Inc. announced, following review by the Independent Data Monitoring Committee (IDMC), positive results from a planned interim analysis of the Phase 3 PREVAIL trial of XTANDI (enzalutamide) in more than 1,700 men with metastatic castration-resistant prostate cancer (mCRPC) that

have progressed despite androgen deprivation therapy and who have not received chemotherapy. Given the observed benefits in the trial’s ’s co-primary endpoints of overall survival and radiographic progression-free survival, and considering the observed safety profile, the IDMC concluded enzalutamide demonstrated a favorable benefit-risk ratio.

The IDMC recommended the study be stopped and patients treated with placebo be offered enzalutamide. Additional data from the Phase 3 PREVAIL results, including safety data, will be submitted for presentation at an upcoming medical conference.

DAIICHI SANKYO´S ONCE-DAILY EDOXABAN MEETS PRIMARY EFFICACY ENDPOINT

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced results recently from the phase 3 ENGAGE AF-TIMI 48 study. This clinical trial found that the investigational, oral, once-daily direct factor Xa-inhibitor edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin for the prevention of stroke or systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). Once-daily edoxaban also demonstrated significant reductions in major bleeding compared to warfarin, achieving superiority for the principal safety endpoint. Results from ENGAGE AF-TIMI

48 were presented today as a late-breaking clinical trial at the American Heart Association (AHA) Scientific Sessions 2013 in Dallas and published online in the New England Journal of Medicine.

for warfarin (hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; p<0.001 for non-inferiority), and significantly reduced major bleeding by 20% (2.75% vs. 3.43% per year, respectively) (HR, 0.80; 95% CI, 0.71 to 0.91; p<0.001 for superiority). The edoxaban 30 mg treatment arm had an annual incidence of stroke or SEE of 1.61% versus 1.50% for warfarin (HR, 1.07; 97.5% CI, 0.87 to 1.31; p=0.005 for non-inferiority), and significantly reduced major bleeding by 53% (1.61% vs. 3.43% per year, respectively) (HR, 0.47; 95% CI, 0.41 to 0.55; p<0.001 for superiority).

PFIZER ANNOUNCES FURTHER LIPITOR PRICE REDUCTION

At the end of last year Pfizer announced a further price reduction to Lipitor (atorvastatin) which came into effect on November 1st. 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.

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 community drug schemes.”

“Pfizer has decided to reduce the price of Lipitor to the reference price to ensure that we can fairly compete against other

New legislation came into effect last year which allows pharmacists to substitute medicines that have been designated interchangeable

ENGAGE AF-TIMI 48 compared two edoxaban treatment arms, 60 mg and 30 mg, with warfarin in 21,105 patients with NVAF for a median of 2.8 years. This represents the largest and longest trial with a novel anticoagulant in patients with atrial fibrillation performed to date. The edoxaban 60 mg treatment arm had an annual incidence of stroke or SEE of 1.18% versus 1.50%

by the Irish Medicines Board. Atorvastatin was deemed interchangeable in August 2013. In addition, the Department of Health and HSE have introduced a reference price; the amount the state will refund a pharmacist for a group of medicines that are interchangeable. If a patient’s medicine is at or below 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.

HPN • Issue 11


50 Appointments

Aisling Quinlan PharmaConex are delighted to announce that Aisling Quinlan has now joined the team in their Shannon office. With over three year’s experience in customer service / administration roles having worked both in Ireland and Australia , Aisling should prove to be a very capable addition to the Locum team. Her most recent role was a customer facing one with added administration duties, skills which should transfer very well with those required of a Locum Co-ordinator. Working closely with Nicola she will be able to assist both locums and clients equally in a timely and efficient manner. Her email address is a.quinlan@ pharmaconex.com and she can be reached on the same number as Nicola 061 530202.

Thomas J. Lynch Bristol-Myers Squibb has announced that its Board of Directors has elected Thomas J. Lynch, Jr., M.D. to the Board, effective January 1, 2014. Dr. Lynch will serve as a member of the Science and Technology Committee of the Board of Directors.

Catherine Cullen Catherine Cullen, has joined Eurosales International as Marketing Manager . Catherine joins with over 16 years experience within pharmacy and FMCG retail. Since Graduating from Queens University Belfast , Catherine has spent eight years with Boots Ireland in marketing, followed by a year in Sona Nutrition , four years with Insomnia Coffee Company as Brand Manager , before moving to homestore+more . Catherine is also a post graduate of the University of Ulster Jordanstown , and holds a Diploma in Public Relations from the PRII.

David Johnston David Johnston has left his role as chief financial officer of AVEO Pharmaceuticals to join ImmunoGen in the same role. Johnston's switch comes after more than six years at AVEO having joined the company from his role as senior VP of finance corporate planning and analysis at Genzyme.

Feargal Ó Móráin Minister for Research and Innovation Seán Sherlock TD has announced the appointment of Mr Feargal Ó Móráin as the new Irish co-chair to the US-Ireland R&D Partnership Steering Group. The announcement coincides with a visit by the US co-chair to the Steering Group, Dr. Kerri-Ann Jones, Assistant Secretary of State for the United States Bureau of Oceans and International Environmental and Scientific Affairs.

Mike Nally Merck Sharp and Dohme (MSD) has announced that Mike Nally is to take on the role of Managing Director of the company's operations in the UK and Ireland. Nally will take over the role on January 1, 2014, moving from his current position as Managing Director of MSD in Sweden. He replaces Deepak Khanna who has been appointed to a new senior VP role at MSD where he will lead the company's oncology efforts across Europe.

Send your appointments announcements to Hospital Pharmacy News Have you taken up a new position recently or moved job roles? Get in touch to feature your new appointment on this page. Contact Kelly Jo Eastwood on 0044 7876548989 / E-mail: kjeastwood@hotmail.com or Debbie Graham on 0044 / E-mail: debbie.hpn@btconnect.com

Issue 11 • HPN


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Part of the Intas Group, Accord Healthcare is a young and dynamic pharmaceutical company, involved in the development, manufacturing and distribution of pharmaceutical products to over 50 markets around the world. The groupâ&#x20AC;&#x2122;s vision is to be involved in all the aspects of bringing pharmaceuticals to patients. Our activities today encompass

the entire pharmaceutical value chain and so create a truly integrated offering. By being vertically integrated and owning all steps of the process, Accord can bring high quality medicines to patients faster, more economically and with greater efficiency than our rivals.

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HOSPITAL PHARMACY NEWS - ISSUE 11 - 2014  
HOSPITAL PHARMACY NEWS - ISSUE 11 - 2014  

IN THIS ISSUE: News: Hospital pharmacists develop new Aseptic Compounding guidelines - Report: The ongoing war against Clostridium diffi cil...

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