May/June 2011 Issue 1
THE INDEPENDENT VOICE OF HOSPITAL PHARMACY
Your Partner in Hospital Pharmacy D el iver ing Cre serv atin ice g va & ch lue oice in P har ma ceu tica ls
Medicine Shortages Come Under the Spotlight
Profile: Oisin goes Green in our Hospital Pharmacist Profile
Cre atin g va
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har ma ce
in P har ma ceu tica ls.
The Role of Pharmacy in the Management of Type 2 Diabetes
rod uct s
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me na in hospital pharma ceu ticals. Broad
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Diazemuls* Docetaxel* Epirubicin* Floxapen* Gemcitabine* Irinotecan* Paclitaxel* Piperacillin/Tazobactam* Rapilysin*
Date of Preparation April 2011. AADHCP-009-01
IN THIS ISSUE:
We are renowned for our extensive product pipeline and consistent product launches tailored specifically to the needs of the hospital sector in Ireland. For more information contact us today at contact @actavis.ie
*All of the above medicines are subject to medical prescription. Full prescribing information is available on request from Actavis Ireland Ltd, Euro House, Little Island, Co. Cork.
Actavis Ireland Ltd Euro House Euro Business Park Little Island Co. Cork T 1890 33 32 31 F 021 461 90 49 @ firstname.lastname@example.org
creating value in pharmaceuticals
Hospital Pharmacists Association Annual Conference hears Greater Collaboration is Key
Titration is important
Abbreviated Prescribing Information: For full prescribing information refer to the Summary of Product Characteristics. Name: Ebixa Active Substance: Memantine Hydrochloride. Indication: Treatment of patients with moderate to severe Alzheimer’s disease. Dosage & Administration: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient. Treatment is orally either as tablets (10 mg) or solution (5mg/pump) taken with or without food at the same time every day. The solution should only be dosed onto a spoon or into a glass of water using the pump. Maintenance dose is 20mg/day, (two tablets or 2ml solution [4 downward pumps] once daily). Treatment starts with 5mg/day (half a tablet or 0.5 ml solution [1 downward pump] once daily) for the first week; the 2nd week 10mg/day (one tablet or 1 ml solution [2 downward pumps] once daily); the 3rd week 15mg/ day (one and a half tablets or 1.5ml solution [3 downward pumps] once daily) and the 4th week 20mg/day (two tablets or 2ml solution [4 downward pumps] once daily). Moderate renal impairment 10mg/day (one tablet or 1 ml solution [2 downward pumps] once daily), if well tolerated after 7 days the dose can be titrated up to 20mg/day (two tablets or 2 ml solution [4 downward pumps] once daily). Severe renal impairment- dose is 10 mg/day (one tablet or 1 ml solution [2 downward pumps] once daily). Mild-moderate hepatic impairment- no dose adjustment. Severe hepatic impairment- no data available: Not recommended. Children & Adolescents: Not recommended. Contraindications: Hypersensitivity to the active substance or any of the excipients. Pregnancy and Lactation: Pregnancy: Memantine should not be used in pregnant women unless clearly necessary. Lactation: Memantine should not be used in women who are breastfeeding. Special Warnings and Precautions for use: Caution is recommended in patients with epilepsy. Caution is advised in patients with raised urine pH as this may elevate plasma levels. Clinical trial data are limited on patients with recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension and patients with these conditions should be closely supervised. Avoid concomitant use of NMDA antagonists (see also interactions). Oral solution only: Patients with rare hereditary problems of fructose intolerance should not take Ebixa 5mg/pump oral solution as it contains sorbitol. Tablets are lactose free. Patients should be warned to take special care if driving and using machines as Ebixa has minor to moderate influence on these tasks. Interactions: Effects of L-Dopa, dopaminergic agonists and anticholinergics may be enhanced. Effects of barbiturates and neuroleptics may be reduced. Concomitant administration of Ebixa with antispasmodic agents e.g. dantrolene and baclofen can modify their effects, dose adjustments may be necessary. Increased plasma levels could occur with concomitant use of cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine. Coadministration with hydrochlorothiazide (HCT) may lead to a reduced serum level of HCT. Concomitant use of NMDA antagonist- amantadine, ketamine, dextromethorphan or phenytoin should be avoided. Close monitoring of prothrombin time or INR is advisable for patients treated concomitantly with oral anticoagulants. Adverse reactions: Common (≥1/100 to <1/10) headache, somnolence, hypertension, constipation, dizziness, dyspnoea and drug hypersensitivity. Uncommon reactions (≥1/1,000 to <1/100): cardiac failure, fatigue, fungal infections, confusion, hallucinations (mainly in severe Alzheimer’s disease), venous thrombosis/ thromboembolism, vomiting, gait abnormal. Very rare (<1/10,000): seizures. Not known: Isolated cases of pancreatitis and psychotic reactions have been reported post-marketing. Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. In post-marketing experience these events have been reported in patients treated with memantine. Overdose: Symptomatic treatment. Elimination: Mainly in unchanged form via the kidneys. Legal Category: POM. Marketing Authorisation Holder: H.Lundbeck A/S, Ottiliavej 9, DK-2500 Valby, Denmark. Marketing Authorisation Numbers: EU/1/02/219/005 Ebixa 5mg/pump oral solution-50ml bottle. EU/1/02/219/006 Ebixa 5mg/ pump oral solution-100ml bottle. EU/1/02/219/007 Ebixa film-coated tablets 10mg, 28 pack size. EU/1/02/219/008 Ebixa film-coated tablets 10mg, 56 pack size. Further information may be obtained from: Lundbeck (Ireland) Ltd., 7 Riverwalk, Citywest Business Campus, Dublin 24. Date of Preparation: January 2011
approved from the moderate stage of alzheimer’s Disease onwards3
Dosage: From start to maintenance3
Availability of Medicines under the Spotlight at IPU Conference Page 4
Compensation levels lead to new guidance in administering drugs Page 6
Welcome to the inaugural issue of Hospital Pharmacy News; Ireland’s first and only bi-monthly publication aimed at the Hospital Pharmacy market. Through this medium we aim to provide you with the most comprehensive and up-to-date news and views on what is current and topical in the pharmacy industry.
Profile: Oisin shows in ‘green’ side in Hospital Pharmacist Profile Page 8
Clinical Feature: Medication Safety at points of transfer in and out of Hospital, by Dr Tamasine Grimes Page 24 Hospital Pharmacy Profile: We Meet the Team at Tullamore Page 38 Clinical Feature: The Generics and Biosimilars Markets throughout Ireland Page 40 ORAL SOLUTION
Before FIRST use
you must prime the pump with
Out and About Picture Page Special Page 50 downward pumps and discard the liquid
Clinical Profiles Page 52 Appointments Page 56
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 Carmichael House, Lower Baggot Street, Dublin 2 00353 (01) 6024715
downward pump per day
downward pumps per day
downward pumps per day
downward pumps per day
Coverage from the Annual Hospital Pharmacists Association Conference Page 14
MANAGING DIRECTOR Natalie Maginnis email@example.com EDITOR Kelly Jo Eastwood firstname.lastname@example.org
SALES MANAGER Lisa Sheridan email@example.com Contributors Dr Laura Sham Mr Donal Og O'Donovan Dr Stephen Byrne Dr Tamasine Grimes Andy Croft
Kelly Jo Eastwood
Let’s make no mistake; Hospital Pharmacists have by no means escaped the tightening wrath of our economic crisis. The effects of budget cuts continue to ripple throughout the health service as a whole, impacting dangerously on the wellbeing of Ireland’s population. People are living ‘cheaper’ and this has a knock-on effect. Research shows that 38% of those at risk of poverty and 47% of those living in consistent poverty report having a chronic illness compared to 23% of the general population. Whilst suffering cutbacks, Pharmacists are having to maintain standards and continue to offer the highest possible levels of care; a big ask when staff numbers are on the decline and locum cover is nearly non-existent. However the wealth of benefits Pharmacists can bring to this declining state are immense. Ireland is at the forefront of pharmaceutical research; our Schools of Pharmacy are often nodded to by counter-parts in the rest of Europe and this industry can remain strong in the face of economic adversity by cross-collaborative working, determination and stealth. Key to this is enhanced partnerships between Community and Hospital Pharmacy, an issue referred to by key opinion leaders numerous times this year. According to Minister Reilly, further cuts are anticipated and therefore pharmacy as a whole is going to have to huddle even closer to brave the storm. One hand must know what the other is doing to ensure a streamlined marriage. Hospital Pharmacists work closely with other members of the pharmacy team such as Technicians as well, and we will be working closely with the relevant organisations throughout Ireland to keep you aware of future developments and changes to current working practices. Hospital Pharmacists are at the forefront of medication safety, deliverance and drug-related technology, to name but a few areas of expertise. It is imperative therefore they perform at the highest level possible. We at HPN aim to bring you the latest in clinical pharmaceutical research, written by local experts and industry leaders, as well as the newest and up-to-the-minute news on issues ranging from generics and biosimilars to education development and general interest. We are always keen to hear your views and ideas so please get in touch by emailing me at: firstname.lastname@example.org or via telephone on: 00447876548989. Meantime, we hope you enjoy the issue.
ART DIRECTED Smart Page Design
ACCOUNTS Susan McBride email@example.com
References: 1. Jones et al. 2007. Intl J Geriatr Psychiatry 22: 258-362. 2. Massoud et al 2010. Current Neuropharmacology 8;69-80. 3. Ebixa Summary of Product Characteristics.
Titration is important1,2
SALES AND EVENTS ORGANISER Cliona Dudgeon Cliona.firstname.lastname@example.org 004428 90801195
THE INDEPENDENT VOICE OF HOSPITAL PHARMACY
HPN • May/June 2011
Alarm over Medicines Shortages Necessary steps are needed to ensure the availability of prescription medicines to patients, delegates at this month’s Irish Pharmacy Union Annual Conference have heard. One of the key issues discussed at the conference was the concern over availability of key medicines. An average of 40 medicines have been out of circulation and unavilable to patients in Ireland over the last few weeks according to the IPU. Speaking to delegates, Pharmacist Caitriona O’Riordan from County Cork added that was is needed is “the adoption in Ireland of a public service obligation to maintain the uninterrupted supply of prescription medicines to patients to be taken.”
Catriona O’Riordan, Cork Pharmacist
It is the responsibility of the Irish Medicines Board, the HSE and the Department of Health to ensure the availability of prescription
medicines to patients. In most European countries medicines’ distribution is carried out as part of a public service function whereby pharmacies and patients can rely completely on manufacturers to supply the product and quantities needed - this does not happen in Ireland. Ms O’Riordan said: “It is not good enough that stocks of medicines run out and vulnerable patients have to wait to get their medication. The current system is fragile and is not consistent. It can leave a cancer patient waiting for up to two weeks for oral chemotherapy medication. Pharmacists want an assurance that manufacturers will maintain
supply of all the prescription medicines we require for our patients in an efficient, timely, safe and reliable manner. This requires the intervention of the powers that be in the state to make sure this happens. We are calling for immediate action in this regard.” Pharmacists report that the following medicines are not available to patients at the moment include: • An important anti-asthmatic medicine for children
• Some anti psychotics • Some antibiotics
A state-of-the-art electronic reporting system (TEAMS), which enables the production of electronic patient discharge summaries, has won the Public Service Category in the InterTradeIreland Innovation Award. In 2004, the Hospital’s paperbased discharge summary was replaced by an electronic discharge summary describing a patient's diagnosis and procedures. While this was used throughout the hospital, it was not guaranteed to be accessible to community clinicians such as GPs and pharmacists. As the Hospital handles 25,000 inpatient discharges per year, the
potential benefits of developing an electronic system were significant. The TEAMS system was implemented in the AMNCH in October 2010 and since its introduction has delivered significant improvements in the accuracy of information on patient medical records and brought greater efficiencies in billing and hospital administration. The TEAMS system represents
the first application in Ireland to provide medication reconciliation to GPs, community pharmacists and patients and gives individualised risk factor data for two major areas of public health: cardiac risk and paediatric obesity. There are also financial benefits to the system as no other product automatically pre-fills private health insurance forms and raises invoices, reducing turnaround.
Hospital Services Portal Cahill May Roberts’ have introduced a new range of online services, designed specifically with hospital pharmacies in mind, as a one-stop’-shop’ for all of your supply needs. This document is designed to help you discover and use the services within as quickly and easily as possible. Key functions of this new Hospital Services Portal include online ordering. Hospital pharmacists can search through, and order products via the companys’ online ordering facilities. These orders are placed on their live system immediately on order entry (and stock indicators are live). Order May/June 2011 • HPN
delivery will be scheduled exactly as telesales / DOE orders are currently. In addition, pharmacists can query their database of historic sales transactions on their account. Developed exclusively with hospital pharmacies in mind, this
function allows you to search the financial transactions on your account using the PO number (or part of) you used during ordering (this includes all ordering methods, not just online ordering). It will return all invoices / credits associated with this PO reference to make your search easier.
Whilst the Pharmaceutical Society of Ireland earlier this month announced the results of the 2011 election, the only Hospital Pharmacist in the running has voiced concern and disappointment at his non-election. Oisin O’hAlmhain, Hospital Pharmacist at Tullamore Hospital told Hospital Pharmacy News that he is now deeply worried the voice of his colleagues won’t be heard, with the news that only one member will represent the profession of the PSI Board. Returning Officer Dr Ambrose McLaughlin, PSI Registrar deemed the following Pharmacists to be elected:
• Ms Leonie Maria Clarke • Mr Ignatius Noel Stenson • Mr John David Corr and; • Mr Keith O’Hourihane. Leonie Clarke has extensive experience in many areas of pharmacy practice, in particular the pharmaceutical industry, administrative and academic pharmacy. In recent years Leonie
has worked as a pharmaceutical consultant to a wide range of clients, advising on issues such as compliance with legislation, education, quality management and corporate governance in the sector. Meanwhile Mr John Corr of Corr’s Pharmacy in Coolock, Dublin, is a previous Chairman of the Irish Pharmacy Union and Mr O’Hourihane is of Achille Pharmacy in Co Mayo.
Read Oisin’s comments on this issue, and much more in this month’s personal profile, pages 8-11.
• Certain anti-hypertensives
TEAMS eliminates paper chain The accolade was won by The Adelaide and Meath Hospital, Dublin and its’ development involved collaboration between Trinity College’s School of Pharmacy & Pharmaceutical Sciences and the School of Medicine along with ERGO Software Group. The new contentrich patient information system aims to dramatically reduce the paperwork involved and reduce errors in prescriptions.
PSI Election Results
Cahill May Roberts’ encourage any feedback you might have so please feel free to share with them via email@example.com or through the feedback icon displayed on top right of the screen.
SOS to Shift Attitudes As a part of their SOS Save our Skin campaign, La Roche-Posay, commissioned a team to research the behaviour and attitudes of Irish adults towards the sun and their awareness of sun related risks. Research was conducted by UCD Smurfit School of Business on 451 people. The survey sample size is statistically viable and proportionally representative of the country. The team surveyed 451 Adults (47% male, 53% female) and the findings reveal some alarming statistics with regard to safety in the sun in Ireland. Although awareness is increasing and behaviour in the sun is improving, this campaign is still as urgent as ever, in particular when it comes to men. Over 50% of respondents admitted family is the biggest influence on their use and chosen level of sun protection factor. La Roche-Posay is calling on the public to adopt safe behaviour in the sun when abroad as well as in Ireland, to get their moles/ suspicious lesions checked and to check their partner’s moles. With increasing incidences of skin cancer in Ireland, over 8100 new cases diagnosed in 2009*, we all need to be more aware of the harmful effects of the sun, even in Ireland, and to always protect the whole family to prevent sun damage. Minister for Health Dr James Reilly launches the SOS campaign with Alannah and Shane Cullen.
HPN • May/June 2011
Claims for Minors hit €8.3m Research by InjuriesBoard.ie has shown children aged 3-7 are over three times more likely to have an accident that results in a personal injury claim than infants aged 3 or less. In 2010, 615 minors were awarded compensation totaling €8.5million, or an average of €13,839.90. Awards ranged in value from €500 to over €170,000. Motor related accidents (at 79%) accounted for four times as many injuries as public liability (21%). Professor Alf Nicholson, Consultant Paediatrician, Temple Street Children’s Hospital said: “Injuries are a serious public health problem in Europe and
more children over the age of one die of injuries than all other diseases combined. For every child that dies from an injury, 160 are admitted to hospital and over 2,000 are seen in the emergency department – deaths are just the tip of the iceberg.”
Pictured is Professor Alf Nicholson, Consultant Paediatrician, Temple Street Children’s Hospital, Patricia Byron, Chief Executive, InjuriesBoard.ie and 8 year old Sarah Morris, patient at Temple Street Children’s Hospital.
EC Approves Alliance Alliance Pharma, the pharmaceutical company based in Chippenham, has revealed that the European Commission has approved its deal with Reckitt Benckiser. Alliance Pharma's wholly owned subsidiary Alliance Pharmaceuticals now has permission to acquire the Irish rights to the Anbesol and Ashton & Parsons brands.The acquisition is unconditional and was expected to complete on 26 April 2011. On completion, Alliance will pay £2.55m in cash. The company
intends to fund the acquisition by drawing a loan from the £20m Revolving Credit Facility (RCF) that was put in place in November 2010 to fund acquisitions. The RCF is not currently used. The acquisition is expected to be earnings enhancing for Alliance in the current financial year. Anbesol is used to treat mouth ulcers, teething pains and denture irritation. Ashton & Parsons is used in infants to relieve pain and stomach upset caused by teething.
The Future in Flu Research? A new mobile phone application has been developed to help monitor the spread of infectious diseases such as flu. The FluPhone app allows phones to "talk" to each other, recording how many people each user meets and using Bluetooth technology it anonymously records interactions between phone owners. When the phones come into close proximity, the app records this and automatically sends the data to researchers. The app has been developed by researchers at the University of Cambridge Computer Laboratory, one of seven institutions working on a study to reduce the impact of epidemics. A basic version of the FluPhone app was used in a three-month pilot study in Cambridge in 2010. May/June 2011 • HPN
A New Filgrastim Biosimilar in Ireland
Study leaders Professor Jon Crowcroft and Dr Eiko Yoneki hope that their most recently-collected data could be used to simulate social interaction during an epidemic or pandemic. Prof Crowcroft explained that epidemiologists traditionally monitor how a disease spreads by asking patients to keep diaries of their movements and social contacts. Dr Yoneki added: "The data was a valuable insight into how human communities are formed, how much time people spend together, and how frequently they meet. Such data show complex networklike structures, which is very useful for understanding the spread of disease."
Errors lead to Fresh Guidance The Clinical Indemnity Scheme has issued fresh guidance to Hospital Pharmacists involved in the administering of drugs, following new research which shows a high level of claims for compensation as a result of medication errors. Figures show that between 2004 and 2010 a total of 124 claims were made and of these, 33 involved the prescribing of a medicine known to cause severe allergic reaction. This error alone led to fatalities in four patients, two of which were accounted for by the administration of pencillincontaining products. A breakdown of the statistics show 35,510 events relating to medication safety ranging from near-misses to more serious events between 2004 and 2010. The guidelines include the following safety tips: > Ensure patients understand their allergies and are aware of medications to avoid. >
Check the allergy status of drugs immediately before prescribing, dispensing or administering medication: the failure to consider allergies at this stage is a “crucial contributory factor”.
Check reliable references for cross- allergies, such as the Irish Medicines Board (imb. ie): lack of knowledge on which medications contain
allergens is common among health professionals.
Document allergies to medication: lack of reliable information regarding a patient’s allergy history at the point of prescribing, dispensing or administering medication can result in errors.
> Put computerised prescribing systems to good use: these can minimise the risk of errors if configured to take into account information on allergies. >
Improve treatment of anaphylaxis: rapid, evidence based treatment can minimise the impact on the patient. Without it, results can be fatal.
Officials have also issued a series of safety steps for health professionals who believe a patient has an allergy or intolerance, but the history is inconsistent with this. These include amending all existing records, where appropriate, to minimise the chance of an error occurring in future.
(filgrastim) A new era in G-CSF therapy
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HPN • May 2011
8 Oisin O’hAlmhain
Oisin’s Going Green for Ireland
If I see something that needs to change, I’m going to try and change it
Lifetime Ambitions Oisin completed his preregistration training as a pharmacist in Letterkenny General Hospital, Donegal in 197 and continued to work there as a pharmacist for a further two years, while studying for a postgraduate diploma in clinical pharmacy through the Robert Gordon University, Aberdeen. It was from here in 1999 that he set off on a personal ambition of getting involved in voluntary work across the water. Oisin headed for
Kitovu Hospital, Masaka, Uganda through a scheme organised by the now defunct Irish Government Agency for Personal Services Overseas (APSO). “This was the culmination of an interest in Africa and development issues, which started with hearing stories of my mother’s work as a teacher in Zambia in the 1960’s,” he says. “The time was right after gaining a few years within pharmacy under my belt at Letterkenny and it was a wonderful and very insightful experience.”
Within Tullamore Hospital Oisin is in direct contact with patients on a daily basis, as well as managing other clinical pharmacists. He works on an orthopaedic unit with between 30-60 beds and an acute stroke unit.
is almost like an entirely different job.
The Bleak Future?
He says: “There is a lot more patients now attending hospital and a lot more generally going on for us as a profession; now having access to lab results and therefore ensuring patients’ drug treatment regimes are correct and appropriate.
Looking at the changes in pharmacy during his time in the profession, Oisin laments that, while the basics of the job have not altered, the way it’s carried out
“Over the time I have been in Tullamore, I have expanded clinical pharmacy services from a one pharmacist operation to a comprehensive service where
Life for Hospital Pharmacist Oisin O’hAlmhain is never dull. After hanging up his pharmacists’ coat at Tullamore Hospital a few weeks ago he put on his scrubs and climbed into the Liffey. 'Why' is of course the question on everyone’s lips; but quite obviously it was because he felt it needed a good clean. Oisin is a full-time Hospital Pharmacist and full-time Green Party politician, combining in his life at the same time his two greatest passions. “If I see something that needs to change, I’m going to try and change it,” he tells HPN. And sometimes that means getting your hands dirty, as Oisin tries to encourage Ireland to clean herself up. May/June 2011 • HPN
HPN • May/June 2011
10 Oisin O’hAlmhain most patients have their inpatient stay, “This has involved innovative use of technology and novel approaches to problem solving. Keeping the lines of communication open between hospital and community pharmacists, and between other disciplines has always been central to this.” Oisin, a member of the European and American College of Clinical Pharmacy, has tutored for the Irish Centre for Continued Postgraduate Education and enjoys working with the varied students who come through the doors at Tullamore Hospital, not just from European countries, but internationally as well. He firmly believes the focus for the future is on safety; safety of patients and the safety of medicines. “With the recession hitting Ireland so hard we now have much less staff,” he reflects. “Some years ago we finally got the numbers of staff needed during the ‘boom’ years and this streamlined our jobs to such a great extent, we were able to offer much enhanced services to our patients. “Unfortunately it’s such an opposite situation at the moment. Many staff are now taking maternity leave and we have no cover. Salaries have been cut along with the rest of the public health service so in all it doesn’t make for a great picture for pharmacy in the future.”
Non-Election Issue Oisin also stood for election this year to the Council of the Pharmaceutical Society of Ireland. Disappointingly, as HPN was going to press we learned Oisin had not received enough votes but having adequate hospital pharmacy representation is something he still feels very strongly about. He told us: “I am a firm believer in using evidence-based research to achieve the best outcomes for patients, and for pharmacy services in general. I think my experience in this area and in direct patient care would have made me a useful addition to the Council. “The Pharmaceutical Society needs to be held accountable as a public body, which is answerable
May/June 2011 • HPN
to us Pharmacists, the experts in medication. We need to elect pharmacists to the Council who will maintain this accountability and ask the appropriate questions. I would be such a Pharmacist.
I have been ‘Green’ since I was a teenager, I think it’s hugely important. In fifty years we could all be up to our ankles in the North Atlantic. We can improve greatly in Ireland in terms of waste and I have been very active within my local community in trying to achieve this.
“Prior to the Hospital Act in 2007 there were four to five hospital pharmacists on the Council but now there is only one. As we are a smaller profession it’s obviously harder to get the votes, I would have needed 20% of the total votes to get in but that in turn means it’s even more important than ever that we are adequately represented.”
Going Green Not content with busying himself at the Pharmacy Department in Tullamore, Oisin is also a Green Party politician, who recently managed to gain 2% of the General Election vote in Dublin South Central. Environmental issues are close to Oisin’s heart and bring forth a lot of passion in his desire to point Ireland’s population in the direction of cleaning themselves up. “I have been ‘Green’ since I was a teenager, I think it’s hugely important. In fifty years we could all be up to our ankles in the North Atlantic. We can improve greatly in Ireland in terms of waste and I have been very active within my local community in trying to achieve this. “This month is National Spring Cleaning Month so just a few weeks ago I was climbing into the Liffey to help clean it out. I think it’s important the Irish people become interested in cleaning their own areas and we as a Party are hoping to introduce legislation to improve the environment.” So with all this going on, it probably seems difficult for Oisin to picture where he might see himself in ten years but the Dublin Hospital Pharmacist has very clear thoughts. “In ten years I’d like to think maybe I’ll be in the Dail, or even Health Minister perhaps,” he smiles. “If I see something that needs to change, I’m always going to try and change it. Sometimes the only way to do that is to run for office, so watch this space.”
“The Pharmaceutical Society needs to be held accountable as a public body”
HPN • May/June 2011
Pay Cuts Need to Challenge Cuts in pharmacists’ payments are entrenching, rather than challenging, failed patterms of primary care delivery. As a result, pharmacy’s ability to deliver primary care cost-effectively is being undermined by arbitary and ill-conceived cuts in payments. This was one of the profund statements made at the recent Irish Pharmaceutical Union National Conference. IPU President Mr Darragh O’Loughlin told delegates that “the challenge for public policy is to ensure that pharmacy is enabled and not disabled.” From July 2009 to March 2011 pharmacists suffered cuts in payments of 32% or €153m. On 31 March a further cut amounting to €36 million in a full year was announced. “I sincerely hope, and IPU is working to ensure, that the latest cut marks the end of an ad hoc series of cuts to pharmacy payments” Mr O’Loughlin said. IPU President Mr Darragh O’Loughlin.
It is time for a constructive patient-focused approach to be taken by the Government
Referring to the detailed submission in January to the Minister entitled ‘Time for a New Approach’ O’Loughlin said “the IPU clearly demonstrated that there is no scope for further unilateral and arbitrary cuts. It is time for a constructive patientfocused approach to be taken by the Government and the HSE. Pharmacists are ready to provide the modern 21st century professional pharmacy service that patients need. We have clearly said that additional efficiencies and savings can be achieved
by adopting a new approach. This approach would involve a substantial and direct engagement with IPU within a defined period of time to review all existing, administrative, and contractual payment arrangements. “Continuing uncertainty caused by FEMPI and rising interest rates are red flags for our businesses.” Turning to the issue of competition in the Irish pharmacy sector Mr O’Loughlin said that “there has been ill-informed comment recently about a supposed need to increase competition among Irish pharmacies. In fact, Ireland already has the most liberal and competitive pharmacy market in the European Union.” In 2005, the European Free Trade Association (EFTA) completed a Europe-wide study of the regulation of professions, including pharmacists, and found that Ireland had the most deregulated pharmacy market of all 25 EU member states. Similarly, a separate study, published that same year by the European Commission, concluded that Ireland has the least regulated pharmacy market in Europe.
HSE Board Changes Major changes are afoot. Health Minister Dr James Reilly has, just this month, announced major alterations to the board of the Health Service Executive, indicating his intention to accept the resignations by all current board members. The Minister has also announced plans to legally abolish the board structure by the end of this year. Minister Reilly will put in place an Interim Board for the HSE which will involve senior figures from the Department of Health and from the executive of the HSE.
May/June 2011 • HPN
Mr Frank Dolphin, the outgoing chairman of the board, has accepted the Minister’s request to remain as Chairman of the new Interim Board.
said it was his intention that the new board would allow for “greater integration and less duplication in the delivery of health care services to patients”.
Commenting on the imminent announcement of the new Interim Board membership, Minister Reilly
He added “there is a pressing need to reform services to the benefit of patients and those people in need
of the services”. Once the legal requirement for the existence of the board is removed and the board abolished, a new corporate governance structure will be put in place which will make the health services more directly accountable to the Minister for Health who in turn is accountable to people through the Oireachtas.
HPN • May 2011
Further Reductions Likely –
Martina McCabe pharmacy technican AMNCH and Elaine Conyard President of the Hospital Pharmacy Assocation.
Secretary General comments at HPAI Annual Conference
Greater collaboration between all members of the healthcare team, particularly among community and hospital pharmacy settings, is key to an improved experience for both healthcare professionals and patients. These were the words of Mr Michael Scanlan, Secretary General at the Department of Health as he address the Annual Hospital Pharmacists Association Conference earlier this month. Focusing on how Pharmacists can deliver at the interface of care, Mr Scanlan outlined the influence of hospital-initiated drugs on those medications used and/or dispensed within the community, reflecting the need for great cross-care pathway working and communication. One of the main issues, he pointed out, is for Pharmacists to clearly define the conditions of use for a drug, such as clarifying the condition and length of therapy, whilst keeping treatment tightly controlled.
Health Information Bill Referring to the Health Information Bill currently being prepared, Mr Scanlan outlined how this will facilitate the development of electronic patient records in the near future. The Bill will provide an enabling framework with objectives running at two-fold:
Michael Scanlon, Secretary General at the Department of Health, Elaine Conyard, President of the Hospital Pharmacy Assocation, Marita Kinsella, Chief Pharmacist
For the introduction of a unique health identifier for patients, healthcare professionals and healthcare organisations, and;
To facilitate greater linkages between electronic health record systems.
It is proposed that such a Bill will include ways to positively encourage healthcare workers to report adverse events quickly and inform the patient and their families of any errors which occur, in the anticipation of reducing medication errors. It is proposed that such a Bill will include ways to positively encourage healthcare workers to report adverse events quickly and inform the patient and their
May/June 2011 • HPN
families of any errors which occur, in the anticipation of reducing medication errors. Referring to an April 2010 ESRI Bulletin, which showed an improvement in mortality figures since 2000, Mr Scanlan highlighted the possibility of this being attributed to better drugs and better prescribing. Healthcare professionals should focus on the positive, rather than the negative, he added. Aims should reflect keeping people healthy, not in need of healthcare, getting the best value, and deliver the highest quality services. “Waiting times are more important than waiting numbers,” but he did note that as health took an early hit on cost-cutting last year, subsequent reductions are likely to reduce year on year, making identifiable areas for saving increasingly difficult. Essentially therefore, value services and outcomes will be top of the agenda for decision-makers. Delegates from the Hospital Pharmacists Association and allied professionals met at the Crowne Plaza Hotel in Dublin at the start of April for the two-day event, which highlighted areas for discussion ranging from workshops on the aspects of compounding to CPD for Pharmacists.
Research Standards Research is alive and well within Hospital Pharmacy, reports Eileen Butler. A total of 62 poster presentations were entered into this years’ Poster Competition, with some authors submitting as many as three entries. The standard each year continues to increase. While the country’s aseptic services pharmacists compete with the antimicrobial stewardship pharmacists for poster numbers, other strong themes emerging from this year’s
competitions included therapeutic drug monitoring and improving safety around insulin. A number of hospitals have been working to redesign their discharge prescriptions. Below is an outline of the Categories and successful entries:
Category 1: Research - Sponsored by GlaxoSmithKline 1st - Statin optimisation in Type 2 Diabetes Mellitus Outpatients.
Helen Danaher, Mater Misericordiae University Hospital, Dublin.
2nd - Methadone prescribing in the secondary care setting.
Muireann O’Connor, St James’s Hospital, Dublin.
Category 2: Audit - Sponsored by B.Braun 1st - A review of pharmacist cancelling dangerous prescriptions process at the MMUH.
Jennifer Brown, Mater Misericordiae University Hospital, Dublin.
2nd - The use of prophylactic antibiotics in preventing surgical site infection (SSIs) in caesarean section patients.
K Tutty, South Tipperary General Hospital.
Category 3: Innovation in Practice / Professional Development - Sponsored by anonymous donor 1st - Development and implementation of a nutritional chart in the Mater Misericordiae University Hospital.
Jennifer Brown, Mater Misericordiae University Hospital, Dublin.
2nd - Reducing medication errors using the Patient’s Own Drug (POD) system and an Integrated Discharge Prescription.
Sinead Murray, St Vincent’s Private Hospital, Dublin 4.
Category 4: Intern Pharmacist Project 2009-2010: Mary Harte Award A baseline audit of vancomycin dosing and therapeutic drug monitoring at AMNCH. Breda Bourke, AMNCH, Tallaght.
Category 5: Pharmaceutical Technician competition - Sponsored by Baxter Healthcare A re-audit of the turnaround time for urgent medication orders brought to the pharmacy reception. Martina McCabe, pharmaceutical technician, AMNCH.
under the spotlight with Lorraine Horgan, Head of Professional Development and Learning at the Pharmaceutical Society of Ireland. Lorraine looked across the water at the Ontario model of CPD as one which Ireland may form a base from in the future from the perspective of having a general register with minimum threshold competence. This will be a self-directed, reflective model where the pharmacist will log their learning in an electronic portfolio, she said. It will not consist of CPD points or hours of learning, as these models have been shown to be unsuccessful and do not increase competence. The Institute of Pharmacy in delivering CPD services, will be able to confer fellowships, and allow for such recognition by other professions. The structure will include a general competency (entry level on the register), specialist professional competency (MSc hospital pharmacy, special interest groups, peer networking), Advanced practitioner 1 (Pharm D, leadership & mgt, mentoring, delivers seminars) and Advanced practitioner 2 (PhD, advanced research, expert @ conferences).
The Future of CPD The future of Continuing Professional Development came
HPN • May/June 2011
Try a different name in the bedroom tonight...
€10,000 Bursary for CTS Clinics Carpal Tunnel Syndrome (CTS) is the most common focal neuropathy with a high prevalence of 6% in men and 9% in women. Currently, patients are referred to a rheumatologist where they can wait up to two years for an initial assessment and another year for neurophysical investigation. This current situation was highlighted in Cork University Hospital’s winning entry for the Dr Bernard Connor Innovation Bursary which was sponsored by Abbott to recognise and celebrate pioneering work in rheumatology in Ireland.
Dr John Ryan, Cork University Hospital.
Entitled ‘A rapid access assessment and management clinic for carpal tunnel syndrome’, the bursary submission outlined the intention of providing a more patient-centric delivery of healthcare, reducing waiting times by providing a same day rheumatology assessment, neurophysiological testing and occupational therapy review. This innovative approach will enable an enhanced clinical decision-making pathway by using a combined expert approach as proven by published UK orthopaedic departments.
patient information leaflets regarding diagnosis and treatment for patients. Dr John Ryan, Consultant Rheumatologist, Cork University Hospital commented: "We were delighted to have been awarded the Dr Bernard Connor Innovation Bursary for 2010. This significant bursary has greatly benefited our initiative in providing a multidisciplinary assessment for patients with carpal tunnel syndrome. We are pleased that our effort in providing a more patient centred delivery of healthcare has been made possible through the support of Abbott".
The €10,000 bursary will be used to develop this rapid access clinic for CTS as well as assist in developing occupational therapy services for patients. It will also be used to develop
The bursary, which is now in its fifth year of existence, was chaired by Dr John Donohoe, President, Royal College of Physicians of Ireland and Chairperson of the adjudicating panel, he said: “This
year the name of the bursary was changed to the Dr Bernard Connor Innovation Bursary and the purpose of this was to highlight the importance of innovation in continuing to provide a high level of patient care in the future. This has certainly been demonstrated by the exceptional calibre of entries to this year’s bursary which made the judging process quite difficult. I would like to congratulate Cork University Hospital on their winning entry and hope that this bursary of €10,000 will be of significant benefit to their project”.
Assuring Supply Chain Safety The PSI (Pharmaceutical Society of Ireland), the pharmacy regulator, has published final guidelines on the sourcing, storage and disposal of medicines within retail pharmacy businesses (pharmacies) which aim to assure the safety and integrity of the medicine supply chain by improving traceability and management of medicine stocks. “As pharmacies are the final link in the chain of supply of medicines, from manufacturers to patients, all medicines sold or supplied from pharmacies must firstly be sourced from appropriate manufacturers and wholesalers,” said PSI Head of Communications Kate O’Flaherty. “They should also be stored in accordance with the relevant marketing authorisation, to assure the safety, quality and efficacy of such products. In addition, the disposal of waste or out-ofdate medicines in pharmacies must be carried out in a manner which protects public health and does not result in any risk to the
environment. Compliance with the regulations and the guidelines is therefore essential for patient safety to be maintained and the integrity of the supply chain to be protected.” The guidelines in relation to the sourcing of medicinal products aim to ensure that medicines are sourced from appropriate authorised suppliers and that there is a traceability within the system to prevent counterfeit medicines entering the supply chain, and to facilitate rapid responses to product recalls or withdrawals. Medicines should be stored in
appropriate physical premises and conditions, including in particular those medicines requiring refrigeration or storage in a Controlled Drugs safe. The guidelines also state there should be appropriately robust stock management procedures in place, including date checking procedures and procedures for managing controlled drugs, refrigerated medicines, ‘exempt’ medicines and veterinary medicines. The guidelines regarding disposal aim to ensure that public health and the environment are
adequately protected and that pharmacists and pharmacy owners are cognisant of their obligations under other waste legislation. In addition, important requirements around the destruction and disposal of controlled drugs are clarified, and the guidelines highlight that patients and the public should be facilitated in regard to the management of waste medicines. The guidelines in full are available to view and download from the PSI website www.thePSI.ie.
…all the performance at a fraction of the cost for patients with erectile dysfunction. Dosage
Levitra per pack of 4
Previous MSP of Levitra
Abbreviated Prescribing Information Levitra® film-coated tablets Levitra® film-coated tablets (vardenafil as hydrochloride trihydrate). See full Summary of Product Characteristics (SmPC) before prescribing. Classification for Sale or Supply: Prescription only which may not be renewed. Presentation: Each tablet contains 5, 10 or 20mg of vardenafil (as hydrochloride trihydrate), orange round tablets, marked with the BAYER cross on one side and 5, 10 or 20mg on the other. Indication: Treatment of erectile dysfunction in adult men. To be effective, sexual stimulation is required. Not for use by women. Dosage and Administration: Adult men: 10mg approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20mg or decreased to 5mg. Maximum recommended dose: 20mg. Max dose frequency: once daily with or without food A high fat meal may delay onset of activity. Elderly men: no dosage adjustment required, though increase to a maximum 20mg dose should be carefully considered depending on individual tolerability. Children and adolescents: not indicated below 18 years of age. Mild and moderate hepatic impairment, severe renal impairment: Consider a starting dose of 5mg. Max dose recommended in patients with moderate hepatic impairment: 10mg. With other medicinal products: In combination with erythromycin or clarithromycin, the dose of Levitra® should not exceed 5mg. Contraindications: Hypersensitivity to vardenafil or to any of the excipients; avoid nitrates or nitric oxide donors (e.g amyl nitrite) in any form; patients who have loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION); men for whom sexual activity is inadvisable (e.g. severe CVS disorders); severe hepatic impairment; end-stage renal disease requiring dialysis; hypotension; recent stroke or MI; unstable angina; known hereditary retinal degenerative disorders; concomitant use of potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) in men older than 75 years; concomitant use of potent HIV protease inhibitors e.g. indinavir. Warnings and Precautions: Undertake a medical history and physical exam to diagnose erectile dysfunction and determine potential underlying causes. Consider cardiovascular status, since there is a degree of cardiac risk associated with sexual activity. Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure. Use with caution in patients with anatomical deformation of the penis or conditions which predispose to priapism (e.g. sickle cell anaemia, multiple myeloma or leukemia). Combination with other treatments for erectile dysfunction is not recommended. Concomitant use of alpha(α)-blockers and vardenafil may lead to symptomatic hypotension. Concomitant vardenafil should only be initiated if the patient has been stabilised on α-blocker therapy. Patients on stable α-blocker therapy: vardenafil therapy to be started at a dose of 5mg and consider a time separation of dosing. In patients taking an optimised dose of vardenafil, α-blockers should be initiated at the lowest dose. Stepwise increase in α-blocker dose may be associated with further lowering of blood pressure. Avoid concomitant use with potent CYP 3A4 inhibitors (e.g. itraconazole and ketoconazole (oral use)). Give no more than 5mg vardenafil when given concomitantly with erythromycin or clarithromycin. Avoid grapefruit juice (increases plasma concentrations of vardenafil). Prolongation of QTc interval - avoid use in at-risk patients. Advise patients that in the case of sudden visual defects or NAION to stop taking Levitra® and consult a physician. Tolerability of the maximum dose of 20mg may be lower in elderly patients (≥ 65 years old). Benefit-risk assessment is needed in patients with bleeding disorders. Interactions: Effects on vardenafil: inhibitors of CYP 3A4 may reduce vardenafil clearance. Effects of vardenafil: coadministration with nitrates is contraindicated. Concomitant treatment with α-blockers should be initiated only if the patient is stable on α-blocker therapy. Pregnancy and lactation: not indicated for use in women. Effects on ability to drive and use machines: patients should be aware of how they react to Levitra® before driving or operating machinery. Undesirable Effects: Very common: flushing, headache. Common: dizziness, nasal congestion, dyspepsia, and nausea. Uncommon: somnolence, increased lacrimation, visual disturbances, chromatopsia, conjunctivitis, blurred vision, tachycardia, palpitations, hypertension, hypotension, orthostatic hypotension, dyspnoea, epistaxis, abnormal LFTs, GGTP raised, photosensitivity, face oedema, rash, increased blood creatine phosphokinase, myalgia, back pain. Rare: hypersensitivity, anxiety, syncope, seizure, transient global amnesia, increased intraocular pressure, angina pectoris, myocardial ischaemia, laryngeal oedema, muscle rigidity, priapism, erections increased (prolonged or painful). Frequency unknown: NAION, visual defects sudden deafness, myocardial infraction. Serious cardiovascular events, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia have been reported post marketing in temporal association with another medicinal product in this class. Marketing Authorisation Numbers: EU/1/03/248/001-012. Marketing Authorisation Holder: Bayer Schering Pharma AG, 13342 Berlin Germany. Further information available from: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18. Tel: (01) 2999 313. Date of preparation: August 2009. References: 1. Saenz de Tejada I, Int J Impot Res 2001: 13 (5) 282 - 290. 2. Levitra SmPC. 3. MIMS July 2010. Urtext number: 06.10.00037.ie. Date of preparation: June 2010.
May/June 2011 • HPN
HPN • May 2011
Alumni Award for Gerald Dr Gerald Farrell, Managing Director of Lilly Ireland has been awarded the NUI Galway Alumni Seavite Award for Science at the annual 2011 awards which recognise individual excellence and achievements among the University’s 80,000 graduates worldwide.
Take the quicker route to recovery
Since its inception eleven years ago an impressive roll call of other luminaries include Michael D. Higgins, Ciaran FitzGerald, Sean O’Rourke, Prof. Rose Anne Kenny, Prof. Orla Conneely, Prof. Frank Gannon, Dr. Luke Clancy and Grainne Seoige. Dr Farrell, a native of Castlerea, Co Roscommon, graduated from University College Galway in 1981 with a Bachelor of Science in Botany. He then went on to obtain his doctorate in Plant Biotechnology at University College Cork. Following a postgraduate assignment with Agriculture Canada in New Brunswick, Canada he joined Lilly Ireland in 1989 and was appointed Managing Director in 2003. Dr Farrell also plays an active role in the Irish Pharmaceutical Healthcare Association where he served as President from 2008 to 2010. Presenting the award, President of NUI Galway, Dr James J. Browne said: “Dr Farrell has made a significant impact on the Irish and international stage in both his role as Managing Director of Lilly Ireland and as President of the industry body, the Irish Pharmaceutical Healthcare Association and Dr Farrell is a deserving winner of the Award for Science.”
Pictured at the NUI Galway Alumni Awards (from left to right): Host RTÉ’s Siún Nic Gearailt, Dr James J Browne, NUI Galway President, Dr Gerald Farrell, Managing Director, Lilly Ireland, Kaye Mulrooney, Seavite and Maureen Gilvarry, Chairperson Alumni Board. Thanking the University Dr Gerald Farrell said: “It’s a great honour to receive this award for science, it’s even more of a pleasure as it comes from my alma mater, NUI Galway. My career has been
firmly rooted in science and through my work with Lilly Ireland in the discovery, development and launch of new medicines for human disease, I have been able to continue my contribution to the
Simple Daily ZiThromax® 500mg dosage1
Treatment regimen for susceptible respiratory infections1
ZiThromax® strongly binds to tissues and has a half-life of 2-4 days1
• Short 3 day treatment regimen in comparison with clarithromycin2
sector. I would like to thank NUI Galway for this great recognition.”
Spotlight on Care What are ‘excellent levels’ of patient care and how can ‘excellence’ be defined? The answers of these, and many other, questions are to be examined when the 40th European Symposium on Clinical Pharmacy takes place in Dublin later this year. Hosted by the Hospital Pharmacists Association of Ireland, the Irish Pharmacy Union, the Pharmaceutical Society of Ireland and by the European Society of Clinical Pharmacy, the conference will be held from the 19th to the 21st October 2011. The Symposium will further highlight how patient care at an May/June 2011 • HPN
‘excellent level’ is at the core of clinical pharmacy. Over the years many studies have been performed that have documented, from different perspectives, the financial and health-related benefits of clinical pharmacy. Nevertheless, as care becomes more complex and financial constraints grow, there are still challenges attached to linking the
care provided to definitive endpoints, like reductions in mortality and morbidity. Delegates are invited to learn how to connect care and outcomes through the rational use of IT, the construction of optimal pathways in chronic disease and in diverse patient populations and settings.
ZITHROMAX™ (azithromycin) ABBREVIATED PRESCRIBING INFORMATION (Republic of Ireland) Abbreviated Prescribing Information for ZITHROMAX: Presentation: Capsules containing 250mg azithromycin. Powder for oral suspension containing 200mg/5ml azithromycin after reconstitution. Indications and dosage: Upper and lower respiratory tract infections, skin and soft tissue infections and otitis media: 500mg once daily for 3 days. Uncomplicated sexually transmitted diseases caused by Chlamydia trachomatis or susceptible Neisseria gonorrhoea: Single 1g dose. Use in the elderly: Normal adult dosage is recommended. Use in children: Once daily for 3 days. Less than 3 years (up to 15kg), 10mg (0.25ml) per kg per day; 3 - 7 years, 5ml per day; 8 - 11 years, 7.5ml per day; 12 - 14 years, 10ml per day. There is no information on children under six months of age. See Summary of Product Characteristics (SPC) for further information on dosage recommendations according to age and weight range. Administration: ZITHROMAX should be administered as a single daily dose. ZITHROMAX Capsules, at least 1 hour before or 2 hours after food. ZITHROMAX oral suspension should be administered to children using the spoon provided in the pack, or the oral dosing syringe provided in the 15ml pack only. Refer to SPC for appropriate dosing instructions. Contra-indications: Hypersensitivity to azithromycin or other macrolide antibiotics or excipients such as lactose. Severe hepatic impairment. Patients receiving ergot derivatives. Special Warnings and Precautions: Severe renal impairment (creatinine clearance <10ml/min). Serious allergic reactions (angioneurotic oedema and anaphylaxis (rarely fatal)). Superinfection. Increased risk for cardiac arrhythmia as seen with other macrolide treatment. Clostridium difficile associated diarrhoea (CDAD). Caution in diabetic patients. Pregnancy and lactation: Not recommended. Drug Interactions: Antacids, ergot derivatives, terfenadine, theophylline. Monitor patients on concurrent coumarin-type oral anticoagulants, digoxin or ciclosporin. Undesirable Effects: Zithromax is well tolerated with a low incidence of side-effects.
Common side-effects: Nausea, vomiting, diarrhoea, abdominal discomfort (pain/cramps). Uncommon side-effects: Loose stools, flatulence, digestive disorders, anorexia, dyspepsia; dizziness/vertigo, somnolence, headache, convulsions (which have also been found to be caused by other macrolides), syncope; allergic reactions including pruritus and rash; arthralgia; vaginitis. Legal Category: S1A. Package quantities: 250mg capsule: pack of 6, or pack of 4, (PA 19/47/1); powder for oral suspension: 15ml bottle (600mg); 22.5ml bottle (900mg) (PA 19/47/2). Product Authorisation Holder: Pfizer Limited, Sandwich, Kent. Further information on request: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. Ref: ZX 7_0 Date of preparation: November 2008. References: 1. ZITHROMAX® SmPc. 2. Robert. N. Swanson, Treatment in Respiratory Medicine 2005, Vol.4 No.1: 31-39. Pfizer Healthcare Ireland 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. Date of preparation: January 2011 ZIT/2011/003
20 Dr Ledwidge
Superaspirins to the Fore
Importance of CPD is Highlighted
Synthesis and characterization of two of novel aspirin pro-drugs—or “superaspirins”—suggest not only can efficacy and safety of conventional aspirin be improved, but therapy failure with aspirin due to gastrointestinal (GI) side effects may be reduced. This raises the possibility of new applications of aspirin beyond secondary prevention of CV disease. Irish researchers presented the findings at the recent American Cardiology College’s 60th Annual Meeting. While treatment with conventional aspirin can significantly reduce incidence of CV events, MI, or stroke in patients with previous CV events, treatment failure is common, noted Dr Mark T. Ledwidge, MD and colleagues from the School of Pharmacy at Trinity College and St. Vincents University Hospital, Dublin, Ireland. Novel pro-drug approaches may solve the dual challenge of efficacy and tolerability. Dr Ledwidge
Using in vitro and in vivo models of platelet aggregation, the investigators evaluated comparative efficacy of three novel aspirin pro-drugs (ST0701, ST0702, ST0703) vs. conventional aspirin at equimolar doses. The
comparative topical effects of high doses of the pro-drugs and conventional aspirin were also examined over 3 days in rat and rabbit models of GI injury. Compared with conventional aspirin, two of the prodrugs were significantly more effective in attenuating platelet aggregation in human platelet rich plasma in response to adenosine diphosphate, collagen, and arachidonic acid, Dr. Ledwidge noted. Additionally, ST0702 was more effective (P<0.05) at inhibiting lipoprotein(a) than either niacin or aspirin. It also attenuated low-density lipoproteins (LDL) and triglycerides. However, unlike niacin, ST0702 did not raise plasma PgD2, the arachidonic acid metabolite that is believed to cause flushing. This may
be due to aspirin release from ST0702 or its pharmacokineticpharmacodynamic profile. In vivo preclinical studies demonstrated that at equimolar doses, one of the agents was more effective than aspirin in inhibiting thromboxane B2 production. At high doses (30mg/kg/day for 3 days), conventional aspirin produced significant ulceration in in-vivo models of GI injury; in contrast, the pro-drugs caused no damage at equimolar doses.
Hospital Pharmacy Technicians in the NAHPT (National Association of Hospital Pharmacy Technicians) are certainly ‘Stepping Up’ following the organisation’s Annual Conference, which was held at the Clarion Airport Hotel in March. Several key issues for Technicians were brought to the fore during the meeting, including the use of finger-print recognition in medicines management and the ongoing importance of Continuing Professional Development.
Issues with Clozapine Compliance Clozapine, for the treatment of patients suffering from schizophrenia, despite being introduced in Finland in 1970, was not prescribed in Ireland until 1993. In addition, it has never been used as a first-line medicine.
Looking further into this issue, Pharmacist Tanya Appleby and Technician Jennifer Mackay, both from Tallaght Hospital outlined issues surrounding the importance of compliance. Compliance levels are low as patients don’t turn up for or collect their prescriptions. “It is essential to build a rapport with patients,” they commented. The treatment of schizophrenia patients is to reduce the risk of symptoms on a three-tiered basis:
1st – atypical treatment Onlezepine or respiradone trialing 6-8 weeks and then decide if working or not before changing to;
Main Picture. Back Row: Jennifer O Mara, Maire McLoughlin, Rebekah Corrigan, Eglina Corrigan Front Row: Laura Lyons, Fran Glynn President N.A.H.T.P, Yvonne Sheehan Vice President N.A.H.T.P 1. Aisling Scollan, Patrick Tehan Fannin, Jurate Godeliauskaite 2. Avril Duignan, George Aubrey Fresenius Kabi 3. Ann O Brien Shane Murphy Rowax
The next issue of Hospital Pharmacy News sees the first in a series of articles by Dr Ledwidge on the Pharmacy Management of Cardiology, including recent research and topical issues for Hospital Pharmacy staff.
4. Aoife Conroy, Mena Sheridan Allphar 5. Ciara Devlin Gerrard 6. Caroline Lowry, Jackie Boyle Abbott, Sinead Shanley Abbott, Kate Garden 7. Cathemm Field , AJ Calter Braun
The 'Universal' Health System
Increased efficiency, quality and transparency of costs are among the key benefits of a universal healthcare system, according to a leading Dutch ophthalmologist speaking at the annual conference of the Irish College of Ophthalmologists in Cavan. Addressing over 100 delegates from the Irish and International ophthalmic community, Mr. Stevie Tan of the Academic Medical Centre in Amsterdam, Netherlands, outlined his experience of the Dutch system of universal healthcare and the potential implications of such a system for the delivery of eye services in Ireland. Explaining the shift towards a universal healthcare market in the Netherlands, Mr. Tan said, “Strict government regulation with fixed May/June 2011 • HPN
prices and budgets during the 1980s led to increasing waiting lists and lack of innovations. Costs were expected to increase due to ageing of the population and expanding treatment options. The major goal of the reform was to establish a universal insurance and introduce a healthcare market. Insurance companies became key players and healthcare providers were incentivised to increase efficiency, deliver service and quality and to innovate.” Also addressing this year’s
Paul Moriarty, President of the ICO and keynote speakers Prof Charles Normand, Chair of Health Policy and Managment ,TCD and Mr Stevie Tan of the Academic Medical Centre Amsterdam. Photo: Leon Farrell/Photocall Ireland.
conference was Dr. Niamh Collins, a registrar of ophthalmology at the Midwestern Regional Hospital, who presented findings of a new
study focusing on the price of sight and Age-related macular degeneration (AMD) treatment in Ireland.
HPN • May/June 2011
22 NAHPT Conference
8. Declan Jordan Lilly - Daiichi-Sankyo
Tanya noted the side effects of Clozapine, such as dose dependency, drooling and drowsiness but also highlighted how Pharmacists and healthcare professionals can help with managing these.
For example patients suffering constipation should be advised to take regular exercise and water and avoid laxatives.
7. work life balance
Medicines Management – Spoonful of Sugar On the issue of Medicines Management (MM), ward-based Pharmacy Technician Parampreet Bahia from Guys and St Thomas’s Hospital in the UK outlined her experiences on the ward. She told the conference that, within six hours of a hospital admission, the Pharmacy Technician on the ward will reconcile and get two confirmations on the drug chart, liaise with the (on-duty) pharmacist on clinical screening and can dispense from the ward itself, using the Omnicell system of fingerprint recognition.
3. patient education 14
13. Julie Jorgan 14. Mark Kelly Hospire, Diane Patterson 15. Martina Lynch, Carole Caflerky 16. Paddy Lavelle Far Page
18. Padraig Cahill Pfizer, Richard Coonan Pfizer, Niamh McAvliffe 19. Paul Boland Medis Source, Dawn Johnston Medis Source, Dera Duff 20. Sarah Wall Alchemy, Gerdaline Whelan Alchemy, Yvonne Sheehan Vice President N.A.H.P.T 21. Sheila Mcann, Caroline Hoey, Pharmacy Techs
May/June 2011 • HPN
“Motivation equals energy and direction,” commented Paddy. She outlined seven key points:
2. not asking patient for their own meds
11. Jean Baptiste, Elaine Murphy IntraPharma, Keith Noblett
22. Yvonne Kavanagh Teva, Ann-Marie McGrath
3rd – Clozapine. It is only used if others are tried and failed, if patient suffers EPS. It is not first line treatment due to different blood problems it can cause. Neutropenia can occur in 2% of all patients.
10. James Donohoe, Mark Kelly of Hospira, and Kate Gargan
17. Conor Sadlier Activis, Elaine Conyard president HPAI, Fran Glynn Presidient NAHPT, Caroline Fitzgerald Activis
taught us how to say ‘no’ nicely and how to break down dreaded tasks into manageable portions.”
The ‘Spoonful of Sugar’ Report published in 2007 in the UK showed:
9. Fiona Richardson, Naomi McMahon, Terri- Sue Cosgrove Pinewood
12. Jennifer Mackey, Imelda Fitzgerald, Emily Traecy
2nd – typical/older drugs Haloperidol or chloperazine, however these have EPS (extrapyramidal symptoms);
as the main problems with medicines management, and from this the problem of original pack dispensing arose. Parampreet noted it is essential for Pharmacists to document all problems with medicines management reconciliation and all hospitals must have Standard Operating Procedures in place.
1. Mindset 2. the work itself 18
5. environment 6. health
Paddy went through each of the above identifying what decreases energy and what delegates can do to increase energy and motivation. Delegates were given examples of how to improve each to get the most out of positive thinking such as advice on limiting tasks so as not to drain energy, breaking various tasks down into smaller, more manageable chunks so as not to dread items on the agenda and she outlined the importance of assertive communications. The morning presentations finished with Caitriona Gowing, Senior Clinical Pharmacist at Tallaght Hospital speaking about the importance of CPD for pharmacy technicians. What is CPD? – anything that helps you become a better Pharmacy Technician, she noted. The cycle ranges from self-appraisal to personal planning, to having an action plan, and finally, documenting and evaluating evidence.
The AGM of the National Association of Hospital Pharmacy Technicians was held in the afternoon, when three new committee members were elected. Fran Glynn, Senior Pharmacy Technician, Naas Hospital, continues as President of the NAHPT for a third year.
Pharmacy Technicians can identify learning needs through a number of measures including self analysis, reflection on actions and comparisons to standards.
An updating of Standard Operating Procedures came out top as the winner of the Poster Presentation at the Conference.
A talk from Paddy Lavelle on ‘maximising motivation in times of uncertainty’ was particularly interesting and Patterson added: “Lavelle’s talk was inspirational tackling, as it focused on issues such as assertive communications and people’s mindsets towards tasks. She
Blathnaid McIntyre of Tallaght Hospital’s Pharmacy Department detailed her work in shadowing and observing the cleaning practises at the Aseptic Unit. Her recommendations and the updating of the SOP were approved and came into practise
Conference attendee Diane Patterson from the Athlone Institue of Technology commented that, although Bahia’s job was non-existent in Ireland, her address to conference had given a useful insight into this side of the profession.
agt the Unit from March of this year. The poster competition gives entrants the opportunity to showcase their department or vision, or to represent changes. The poster competition was sponsored by Actavis Ireland and Blathnaid commented after her win: “Tallaght Hospital has always been very strongly represented in this competition so I’m delighted with the win.” Runners-up in the poster competition, winning the ‘Student Prize’ was a group from Carlow
I.T., First Year Pharmacy Technician Course. The group, which included Margret Maralit, Barry Nolan, Emily McCormack and Agata Mudryk under the guidance of Dr. Martina McGuinness designed the poster as part of a project in an ‘Effective Communications Module’ at the college.
Winner Blathnaid Mc Intyre with Caroline Fitzgerald, Hospital Business Manager, Actavis Ireland pictured in front of Mc Intyre’s winning poster.
HPN • May/June 2011
24 Adverse Drug Events & Medical safety
Medication Safety at Points of Transfer into and out of Hospital Dr Tamasine Grimes Research Pharmacist, AMNCH, Tallaght Hospital, Dublin 24 Senior Lecturer, School of Pharmacy and Pharmaceutical Sciences, Trinity College, Dublin 2
Grimes T/ Hospital Pharmacy News/ April 2011/ D
Doctor Tamasine Grimes
May/June 2011 • HPN
Introduction Managing patients’ medication(s) at points of transfer into or out of hospital (e.g. admission or discharge) is central to patient safety and high quality care. There is a wealth of international evidence to show that patients are at risk of experiencing a medication error as they move between care settings and this may result in morbidity or mortality and in increased use of healthcare resources. Medication reconciliation (Med Rec) is a process recommended at points of transfer of care to minimise the opportunity for miscommunication and medication error. It is mandated internationally by a number of patient safety agencies and policy makers, including: The Institute for Healthcare Improvement (IHI) in the United States (US); the National Institute for Health and Clinical Excellence (NICE), the National Patient Safety Agency (NPSA) and the Care Quality Commission in the UK. In Ireland in 2008, the Department of Health and Children’s Report from the Commission for Patient Safety and Quality Assurance, Building a Culture of Patient Safety, recommended that healthcare organisations prioritise the implementation of formal Med Rec systems at all points of transfer of care. They defined this as a “process of obtaining a complete and accurate list of each patient’s current medications from all available sources at all points of contact and verifying and reconciling medications to reduce medication errors”. Since then, the Medication Safety Forum and the Patient First Initiative, both of which are tasked with implementing the recommendations of Building a Culture of Patient Safety, have included Med Rec as a key priority in their programme of work. The mandate to ensure safe management of medication at points of transfer of care is clear.
Figure 1: Patient journey between primary and secondary care
Figure 1: Patient journey between primary and secondary ca
There are a number of steps in the Med Rec process: verification; clarification; reconciliation and transmission. It is important that all steps are undertaken and completed so that those who deliver care to the patient before, during and after the transfer of care can be fully informed regarding the patient’s medication usage and enabled to prescribe, dispense and implement therapeutic changes appropriately. This relates to all involved in managing the patient’s medication, including the patient themselves, the hospital doctor, nurse or pharmacist, the community pharmacist, GP and other health professionals. A number of developments are unfolding in hospitals across Ireland to more readily enable Med Rec. These range from the undertaking of research to understand the baseline situation, the re-design of drug Kardexes or discharge prescriptions and summaries to enable clearer communication and the development of service, allowing the clinical pharmacist and other members of the pharmacy team to become more involved in the medication management processes at
admission and discharge. Over the past five years in AMNCH, Tallaght, we have overseen a programme of research and process improvement aiming to improve medication safety at admission and discharge and to investigate and facilitate implementation of Med Rec. This has involved collaboration with colleagues in the Pharmacy Department and across the hospital in AMNCH and in Naas General Hospital (NGH), and partners in the Schools of Pharmacy in Trinity College Dublin (TCD), the University of London and the Royal College of Surgeons in Ireland, along with colleagues in the School of Medicine, TCD. This article describes the research undertaken and the developments implemented over the past five years and our ongoing programme of research and development for the years ahead.
Prevalence of medication reconciliation in adults discharged from acute, public hospitals in Ireland Although it is recognised internationally that error
in the communication and documentation of medication details on admission or discharge is common, here-to-fore there has been little evidence to characterise the situation in the adult Irish population. We undertook a study to assess the prevalence of medication reconciliation on discharge from acute hospital care and to determine the factors associated with success in achieving Med Rec. The study was performed across two hospitals, AMNCH and NGH, between 2006 and 2008. The patient’s medication use across the entire inpatient episode, from admission to discharge, was assessed. This involved review of admission medication lists, documentation in the healthcare record and discharge medication lists, principally the discharge prescription and discharge summary. Over 1200 patients were recruited to the study and almost 10,000 medications were surveyed. The study identified that Med Rec was achieved for every second patient discharged from the hospital, whilst the remainder experienced at least one nonreconciliation(1). We found that the majority of these non-
reconciliations carried the potential to cause moderate to severe patient harm and a small number may have resulted in unplanned readmission to hospital within three months of discharge. The most common reasons for nonreconciliation were omission of medication, failure to communicate an intentional discontinuation or withdrawal of a medication and errors in communication of essential information, e.g. dose or frequency. It was identified that non-reconciliation of medication lists at admission persisted through the inpatient episode and beyond discharge. Patients using an increasing number of medications and those who experienced chronic rather than acute illness were a greater risk of experiencing non-reconciliation, indicating that the implementation for formal Med Rec processes should be prioritised to these patients. Processes which involved a higher transcription burden, that is those that required the prescriber/ clinician to document medication lists again and again, were associated with more frequent non-reconciliation. In particular, the traditional handwritten system whereby the
HPN • May/June 2011
26 Adverse Drug Events & Medical safety discharging doctor handwrites a list of drugs on a discharge prescription and on a discharge summary, was shown to result in error more frequently. The recommendations from this study were that Med Rec processes should be undertaken at both the admission and discharge interfaces, and that strategies to reduce the transcription burden in the discharge prescribing process should be explored and implemented. In AMNCH, use of an electronic patient management system with a prescription module facilitates this, whilst in NGH revision of the discharge prescription and summary form have resulted in improvements to patient safety.
Admission Med Rec – building the pre-admission medication list Undertaking Med Rec at admission is required to identify any drug- related morbidity contributing to the patient’s condition and to facilitate safe decision making regarding ongoing therapy and appropriate changes to that therapy. Elucidating the list of medication a patient was using before admission (the preadmission medication list (PAML)), particularly for patients admitted via A&E, can be challenging not least because the patient is unwell and may not be best placed to reliably report their medication use. It is important that clinicians know how best to retrieve this information, both with regard to speed of access and confidence in the accuracy and reliability of information received. We undertook a study between AMNCH and NGH to identify the availability and the accuracy of PAMLs garnered from a variety of sources (personal communication with the GP, community pharmacist or nursing home staff, reference to referral letters from GPs or nursing homes, reference to previous inpatient documentation, reference to data held by the Primary Care Reimbursement Service, reference to patient’s own drugs)(2,3). This study involved a random selection of 134 adult patients, who were using at least three regular medicines and were admitted via A&E. Having regard to both the accuracy of the list and the ease of access to information, we identified that for the majority of patients, contacting the community pharmacy was the most efficient route, followed by contacting the GP. For nursing home patients, personal
May/June 2011 • HPN
communication with the nursing home staff is recommended. We identified that for GMS patients, the information held on the Primary Care Reimbursement Services Database was a very reliable source of PAML and the findings support the undertaking of further work to identify the challenges and facilitators to making this information available in the acute clinical setting.
Admission Med Rec – the role of the clinical pharmacist Research undertaken internationally provides evidence to support the role of the clinical pharmacist in managing medications at admission, in particular obtaining accurate medication histories and undertaking admission Med Rec. Despite this, a recent Irish survey found that in very few adult public hospitals were clinical pharmacists involved in the admission medication management process(4). We undertook a study between AMNCH and NGH to identify the prevalence of Med Rec between the PAML and the drugs prescribed following admission and to assess the contributions made by the clinical pharmacist to patient care and medicines management. A Med Rec service was provided by clinical pharmacists to randomlyselected patients within 24-hours of admission. Differences between the medications on the PAML and the admission Kardex were identified and investigated to determine whether they were therapeutically rational and intentional. If not, the non-reconciliation and recommendations for change were documented in the patient’s healthcare record, coupled with verbal communication with the prescriber if deemed urgent or necessary. We found that the clinical pharmacist contributed to the medicines management of the majority (97%) of patients: in some cases this involved simply endorsing the Kardex to facilitate supply, whilst in others the pharmacist intervened where medication error or unintentional changes were identified(5). Just under half (46%) of patients were affected by an unintentional unresolved medication change at 48-hours into their admission, of which 60% were omissions. The majority (93%) of these were judged to have the potential to cause minor harm: none were judged to cause severe harm. The findings support
27 the need to improve systems of communication between the prescriber and the clinical pharmacist and to explore the benefits of enabling the clinical pharmacist to make changes to the patient’s admission drug Kardex when unintentional nonreconciliations are identified. Further research is ongoing in NGH to assess the role of the clinical pharmacist attending posttake ward rounds and the effect this has on the prevalence of Med Rec on admission.
Development and implementation of a tool within the electronic patient record to facilitate Med Rec on admission and discharge from hospital In 2004, AMNCH’s paper-based discharge summary was replaced by an electronic discharge summary system (TEAMS) describing a patient's diagnosis, procedures and discharge prescription. The system interfaces with the hospital’s patient demographic system (iPMS). While this was used throughout the hospital, it was not guaranteed to be accessible to community clinicians such as GPs and pharmacists. As the hospital handles 25,000 inpatient discharges per year, the potential benefits of enhancing the electronic system to facilitate greater information provision and communication were considerable. We developed a tool within this system to facilitate electronic Med Rec. This included an electronic platform to capture the patient’s PAML, available at any networked or wireless PC in the hospital. This list forms the first step in building the discharge medication list, facilitating ease of reconciliation between the preadmission and discharge lists and ready identification and correction of any unintentional changes to the patient’s medication before they leave hospital. The system produces a structured discharge medication list, categorised as ongoing medication, stopped medication and withheld medication, together with brief reasons for any changes made. This information is included in each of the discharge prescription and the discharge summary, ensuring that the hospital, the patient, the GP and the community pharmacist are all working with identical information. The discharge summary is transmitted electronically, using Healthlink, to GPs ensuring their immediate
IV DRUGS / ONCOLOGY Product
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3B Fingal Bay Business Park Balbriggan Co. Dublin Tel: 00353 1 8413030 Fax: 00353 1 8496949 Preparation May 11 HPN • May 2011
28 Adverse Drug Events & Medical safety
May/June 2011 • HPN
The Technician/ Pharmacist AIMM (Tech-AIMM) study The IMM service introduced previously involves delivery of pharmaceutical care by pharmacist/ technician teams. Notable elements of the service include assessment, selection and use of patient’s own drugs (PODs) during the inpatient episode, delivery of medication reconciliation on admission and discharge and provision of medication supplies on discharge. In AMNCH, we intend to investigate the benefits of including the pharmacy technician in the delivery of multi-disciplinary medicines management at admission and discharge. We also seek to understand whether use of PODs during the patient’s stay and provision of medication on discharge results in positive patient outcomes and/ or economic benefits. Following completion and reporting of the AIMM study, the Tech-AIMM study will commence in 2012.
a a uni qu e
Medication error and miscommunication occur frequently at points of transfer of care and it is important that we ensure that the systems we have in place and the services we deliver anticipate potential vulnerabilities, minimise opportunity for error and ensure patient safety as our patients move from their home to hospital and back again. In the recent past, a great deal has been learned regarding medication safety at admission and discharge from acute hospital care in Ireland. Evidence based practice can readily be implemented in every hospital to facilitate Med Rec. The Irish evidence base to support the role of the pharmacist in contributing to patient care and the system changes necessary to maximise safe practices at these points of care continues to expand.
Grimes TC, Duggan CA, Delaney TP, Graham IM, Conlon KC, Deasy E, Jago-Byrne MC, O’ Brien P. Medication details documented on hospital discharge: crosssectional observational study of factors associated with medication non-reconciliation. British Journal of Clinical Pharmacology (2011);71(3):44957. Fitzsimons M, Grimes T, Galvin M. Sources of pre-admission medication information: Observational study of the accuracy and availability. International Journal of Pharmacy Practice (In Press). Grimes T, Fitzsimons M, Galvin M, Delaney T, Flanagan S, Evaluation of dispensing records from the Primary Care Reimbursement Service as a source of pre-admission medication information, Pharmacoepidemiology and Drug Safety (In Press). Grimes T, Duggan C, Delaney T. Pharmacy services at admission and discharge in adult, acute, public hospitals in Ireland. International Journal of Pharmacy Practice (2010);18(6):346-52. Galvin M, Grimes T, Fitzsimons M, Jago-Byrne MC, Clinical pharmacy input into the admission medication reconciliation process in Ireland. , Pharmacoepidemiology and Drug Safety (2010),19,(6):649. Scullin C. Scott MG. Hogg A. McElnay JC. An innovative approach to integrated medicines management. Journal of Evaluation in Clinical Practice (2007):13(5):781-8.
PowerfulonPain reducedriskof opioid-induced constipation
Targin® tablets contain an opioid analgesic TARGIN® 5mg/2.5mg, 10mg/5mg, 20mg/10mg and 40mg/20mg prolonged release tablets Prescribing Information Republic of Ireland Presentation: Film-coated, oblong, prolonged release tablets containing oxycodone hydrochloride and naloxone hydrochloride, marked OXN on one side and the oxycodone strength on the other. Colours: Blue - 5mg (oxycodone hydrochloride)/2.5mg (naloxone hydrochloride), white - 10mg (oxycodone hydrochloride)/5mg (naloxone hydrochloride), pink - 20mg (oxycodone hydrochloride)/10mg (naloxone hydrochloride) and yellow - 40mg (oxycodone hydrochloride)/20mg (naloxone hydrochloride). Indications: Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Dosage and administration: Adults over 18 years: Usual starting dose for opioid naïve patients is Targin® 10mg/5mg, taken orally at 12-hourly intervals. Patients requiring a higher dose are recommended Targin 20mg/10mg tablets. Targin 5mg/2.5mg is intended for dose titration when initiating opioid therapy and individual dose adjustment. The dosage is dependent on the severity of the pain and the patient’s previous history of analgesic requirements. Patients already receiving opioids may be started on higher doses of Targin depending on their previous opioid experience. The maximum daily dose of Targin is 80mg oxycodone hydrochloride and 40mg naloxone hydrochloride. Targin tablets are not intended for the treatment of breakthrough pain. For the treatment of breakthrough pain, a single dose of “rescue medication” should amount to one sixth of the equivalent daily dose of oxycodone hydrochloride. Please refer to the SmPC for further details on dose titration. Targin tablets must be swallowed whole and not broken, chewed or crushed which leads to a rapid release and absorption of a potentially fatal dose of oxycodone. Children under 18 years: Not recommended. Contraindications: Hypersensitivity to the active substances or excipients, any situation where opioids are contraindicated, severe respiratory depression with hypoxia and/or hypercapnoea; severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, non-opioid induced paralytic ileus, moderate to severe hepatic impairment. Precautions and warnings: Respiratory depression, elderly or infirm, opioid-induced paralytic ileus, severely impaired pulmonary function, hypothyroidism, adrenocortical insufficiency, toxic psychosis, cholelithiasis, prostate hypertrophy, alcoholism, delirium tremens, history of alcohol and drug abuse, pancreatitis, hypotension, hypertension, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, pre-existing cardiovascular diseases, head injury (due to risk of raised intracranial pressure), epileptic disorder or predisposition to convulsions, patients taking MAO inhibitors, renal impairment, mild hepatic
Increasingly it is recognised that a collaborative approach to medication management and pharmaceutical care, involving prescribers, pharmacists and patients, can improve the quality and safety of medication use. Delivery of a multidisciplinary integrated medicines management (IMM) service to hospital inpatients in Northern Ireland resulted in decreased length of hospital stay (by two days), decreased rate of readmission over a twelve month period, increased time to readmission (by 20 days), and improved quality of prescribing(6). At present in AMNCH, we are undertaking a study to assess the benefits of delivering an IMM type service, adapted locally to AMNCH (AIMM). This before and after study is being undertaken in adult patients receiving medical care. Control patients receive the standard ward based clinical
pharmacy service, including medication history taking. Intervention patients receive the AIMM service, comprising team based clinical pharmacy services, and clinical pharmacist led medication reconciliation on admission and discharge, with the pharmacist enabled to make changes to the Kardex and compile the discharge prescription. We are measuring the effect this has on the prevalence of medication reconciliation, the quality of prescribing and the time to- and frequency of- A&E visits and unplanned readmission. The study commenced in April 2010, patient recruitment will be completed in May 2011 and the findings will be presented in Spring 2012.
The AMNCH Integrated Medicines Management (AIMM) study
access to this information. The system is accessible on the hospital network at any stage day or night, and this facilitates immediate availability of information regarding previous inpatient episodes for readmitted patients, and the importation of previous medication lists to a current episode, as appropriate. The benefits accruing from the implementation of this system upgrade are currently being investigated and will be reported in 2012. Further planned developments include integration of the system for use in the A&E and outpatient settings and investigation of the challenges and facilitators to communicating via Healthlink with community pharmacists.
ch to op a io o r id p p a
In AMNCH, we intend to investigate the benefits of including the pharmacy technician in the delivery of multi-disciplinary medicines management at admission and discharge.
impairment, pre-operative use or within the first 12 – 24 hours post–operatively. Not suitable for the treatment of withdrawal symptoms. Not recommended in cancer associated with peritoneal carcinomatosis or sub-occlusive syndrome in advanced stages of digestive and pelvic cancers. Interactions: Substances having a CNSdepressant effect (e.g. alcohol, other opioids, sedatives, hypnotics, anti-depressants, sleeping aids, phenothiazines, neuroleptics, anti-histamines and anti-emetics) may enhance the CNS-depressant effect of Targin (e.g. respiratory depression). Interaction with coumarin anticoagulants may increase or decrease INR. Pregnancy and lactation: Not recommended. Side-effects: Common adverse drug reactions are decreased/loss of appetite, restlessness, headache, vertigo, decrease in blood pressure, abdominal pain, diarrhoea, dry mouth, constipation, flatulence, vomiting, nausea, dyspepsia, increased hepatic enzymes, hiccups, altered mood, decreased activity, psychomotor hyperactivity, agitation, dysuria, pruritus, skin reactions, hyperhidrosis, dizziness, drug withdrawal syndrome, feeling hot and cold, chills, asthenic conditions. Some side-effects which are uncommon but could be serious are hypersensitivity, confusion, depression, halluc-inations, disturbance in attention, somnolence, speech disorder, convulsions, syncope, visual disturbances, palpitations, angina pectoris, tachycardia, increase in blood pressure, dyspnoea, respiratory depression, biliary colic, erectile dysfunction, urinary retention, peripheral oedema, abdominal distension and chest pain. Please refer to the SPC for further details of other uncommon side-effects and oxycodone class-effects. Tolerance and dependence may occur. It may be advisable to taper the dose when stopping treatment to prevent withdrawal symptoms. Legal category: CD (Sch2) POM. Package quantities: Blisters of 56 tablets. Marketing Authorisation numbers: PA913/025/001-4. Marketing Authorisation holder: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK. Member of the Napp Pharmaceutical Group. Further information is available from: Mundipharma Pharmaceuticals Limited, Millbank House, Arkle Road, Sandyford, Dublin 18, Tel: +353 (0)1 2063800. Date of preparation: April 2011. (UK/UNA-11115).
➞ ➞ ➞
Targin® provides pain relief that is as effective as oxycodone alone1 Targin® reduces the risk of opioid-induced constipation when compared to oxycodone alone1 Targin® is GMS re-imbursable Targin® is indicated for severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.
References: 1. Simpson K, Leyendecker P, Hopp M, et al. Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin 2008;24(12):3503-3512. 11144TRG
Adverse events should be reported to Mundipharma Pharmaceuticals Limited on 1800 991830
® The Napp device (logo) is a Registered Trade Mark. ® Targin is a Registered Trade Mark. © 2010-2011 Napp Pharmaceuticals Limited.
HPN • May 2011
30 Dr Stephen Byrne
The Prescribing ‘Cascade’ Seven out of ten older people in nursing homes in Ireland are getting at least one inappropriately prescribed medicine, shows recent research. A cross-border research team led by Dr Stephen Byrne, Senior Lecturer in Clinical Pharmacy at University College Cork, found that 630 older people in long-term care in Northern Ireland and the Cork area were receiving an average of 11 medicines each. Half of them were prescribed 8-14 daily medicines each. Dr Byrne said that inappropriate prescribing is a global problem and internationally research has demonstrated this problem in all healthcare sectors from primary care to secondary care and in long term care facilities. “Potentially inappropriate prescribing can lead to both minor
and serious adverse drug events for older people. One of the most common instances is the risk of falls and fractures, leading to extended hospitalisation. “The administrations in Ireland, North and South, could make a valuable contribution by announcing decisive action to reduce potentially inappropriate prescribing. “This could include protocol driven medication reviews to ensure that pharmacists, GPs, consultants and nurses work closely with one another and with older people and their relatives to ensure patients receive the medicines they need. The issues surrounding potentially
inappropriate prescribing can only be managed through a multidisciplinary approach," Dr Byrne added. The research study, funded by the Centre for Ageing Research and Development in Ireland (CARDI), found that in nursing homes in the Republic of Ireland, 73% of residents were receiving at least one potentially inappropriate medicine. In Northern Ireland, that figure was 67%. Within the study, nearly one fifth (19%) of the sample were receiving three or more potentially inappropriate medicines. The cost of the inappropriate medicines per older person
worked out at about €356 in the Republic of Ireland and €170 in Northern Ireland. Commenting on the research, Dr Roger O’Sullivan, Director of CARDI said: “We are delighted to have supported this research. It has come up with unambiguous findings on a subject of great importance for older people.”
is “Inappropriate prescribing of medicines – Implications for older people and health budgets”. Both documents are available in full at www.cardi.ie.
The full research report is entitled “An evaluation of the inappropriate prescribing in long stay elderly facilities in the greater Cork and Northern Ireland regions using the STOPP and Beers criteria”. A research brief, which draws on the research report and other information collated by CARDI,
An Ageing Nation Drug use amongst the elderly is extremely common, accounting for over 60% of all prescription items dispensed by Community Pharmacists. The elderly are prescribed approximately 4.5 times more prescription items per head than younger adults aged 15-59 (Information Centre, 2008). The population of the UK is ageing and this trend is projected to continue. By 2033, 23% of the population will be aged 65 and over compared to 18% aged 16 or younger. The classes of medicine used most commonly in the elderly include: cardiovascular drugs, anti-infectives, analgesics, hypoglycaemics, psychotropic drugs and anti-rheumatics.
Dr. Stephen Byrne, School of Pharmacy, UCC main investigator in CARDI study.
May/June 2011 • HPN
Benzodiazepines are a group of drugs that are sometimes used to treat anxiety, sleeping problems and other disorders. Examples include: diazepam (trade name Valium®), lorazepam (trade name Ativan®), chlordiazepoxide, (trade names Librium® and Tropium®),
oxazepam, temazepam, nitrazepam, flurazepam, loprazolam, lormetazepam, clobazam and clonazepam. Benzodiazepines work by affecting the way certain brain chemicals (neurotransmitters) transmit messages to certain brain cells. In effect, they decrease the 'excitability' of many brain cells. This has a calming effect on various functions of the brain. Adverse drug reactions (ADRs) are common in the elderly - they are prescribed large numbers of medications (median 6 in a recent study) – with increased risk of due to multiple co-morbidities, reduced physiological reserves and altered drug handling. Common ADRs are falls, sedation, cognitive impairment which links
the topic to major national agenda items such as falls, depression, and dementia. ADRs create health needs in primary and secondary care, for example, about 35% of hospital admissions of older people have inappropriate prescribing and in a third of these ADR is responsible for presentation, making ADRs one of the commonest problems in acute medicine.
“By 2033, 23% of the population will be aged 65 and over compared to 18% aged 16 or younger.”
HPN • May/June 2011
Do Pharmacists have a Role to Play in the Treatment of Type-2 Diabetes Mellitus? Written by: Dónal Óg O’Donovan BPharm (Hons) MPSI; Dr Stephen Byrne BPharm (Hons) PhD MPSI; Dr Laura Sahm BPharm (Hons) PhD MPSI
The Diabetic Patient Diabetes Mellitus (DM) is a chronic disease and is a growing problem globally. It is estimated that the number of patient suffering from DM will rise from 135 million in 1995 to 300 million in 2025 People who suffer from DM have a life-expectancy which is eight years shorter than those without the disease. Type 2 Diabetes Mellitus (T2DM) results from defects in insulin secretion, with insulin resistance also being a major factor. Glycemic control is fundamental to the management of T2DM patients. Glycosylated haemoglobin (HbA1c) is a biochemical measurement that gives a weighted average of
the blood glucose concentration over the previous 120 days. By measuring the degree of glycation it is possible to get a reliable indicator of diabetic control. HbA1c is now recognised as the monitoring test of choice for assessing medium-long term glycaemic control in DM
patients. If a patient has a high HbA1c then it indicates that the patient has consistently had poor glycaemic control over the past 3 months. For diabetic patients, poor glycaemic control in the long term is associated with micro and macrovascular complications, which are costly to treat and lead to a reduced quality of life for the patient. The United Kingdom Prospective Diabetes Study (UKPDS) demonstrated that for every 1% reduction in HbA1c there is a 21% drop in risk for any diabetes-related endpoint, a 21% reduction in deaths related to diabetes, and a 37% reduction in microvascular complications. The National Institute for Health and Clinical Excellence (NICE) recommend a general target of HbA1c of 6.5% for T2DM patients. This level may occasionally be set above 6.5% in order to reduce the incidences of side-effects such as hypoglycaemia, or in order not to impact on the patient’s quality of life, but it is recommended that the actual level set for each individual patient should only be set in consultation with their doctor and the patient should be involved in the process. Setting a target HbA1c of <6% is not recommended due to increased risk of severe hypoglycaemia, which could prove harmful to the patient. Recently there has been interest in broadening the role of the pharmacist beyond the traditional dispensing and distributing medication, to include a greater role in public health. The pharmacy profession is being recognised as having a strategic position in health promotion due to the pharmacists’ in-depth knowledge of the rational use of drugs. The role of the pharmacist as part of a multidisciplinary team is a valuable one. Pharmacists are now a vital part of the healthcare team and are playing more of a role in the
May/June 2011 • HPN
clinical outcomes of drug therapy. Intervention programs which have involved pharmacists have been proven successful, generating benefits that are ten times greater than the costs. This review examines the contributions of pharmacists to the long term outcomes of patients with T2DM by improving their control and management. The studies included in this systematic review were identified through a search of Cochrane Library Databases, Medline, Embase, PsycINFO, ERIC, Dissertation and Sociological Abstracts, CINAHL and PubMed®. Studies which took place in the community, outpatient, primary care and hospital (secondary care) settings were all included. Twenty-three papers in total are included in this review.
Types of Intervention
Most of the studies involved pharmacist education of the patient about their T2DM. Three studies referred to “medication counselling”, while other studies involved the pharmacist monitoring and managing the patient’s medication. In some studies the pharmacist was allowed to amend the patient’s medication using a pre-agreed algorithm whilst others relied on the pharmacist discussing the case with the physician before any medication changes were made.
Thirteen studies reported that there was an improvement in patient’s lipid profile. Total Cholesterol (TC) levels decreased in five studies (range of decrease: 0.4 – 0.6 mmol/L). When looking at low-density lipoproteincholesterol (LDL-C), seven studies reported a decrease in patient’s values (range of decrease: 0.2 – 0.7mmol/L). Two further studies reported an increase in the number of patients with optimal LDL-C values (defined as <100mg/dL, based upon American Diabetic Association guidelines, both studies involved were based in America). Six studies reported a decrease in patients’ triglyceride (TG) levels. High-density lipoprotein (HDL-C) was reported to have increased in two studies. (HDL-C is cardioprotective so it is desirable to have as high a level as possible.) Finally, two studies reported an increase in the rate of LDL-C measurement among patients, while another study reported an increase in the rate of full-lipid profiling.
In terms of patient contact with the investigator during the study, most studies involved clinical visits or scheduled consultations at regular intervals, but some studies involved telephone contact. A further study involved a pharmacist-managed primary care clinic while another study took place in a “physician-supervised, pharmacist-managed primary care clinic”. The follow-up varied between the studies. Mean follow-up was 12.0±8.3 months. Minimum followup was 4.0 months and maximum follow-up was 42.0 months.
HbA1c All 23 studies reported that pharmacist intervention was very successful at reducing HbA1c in T2DM patients. There was a mean reduction in HbA1c of 1.5% (Standard Deviation (SD) ±0.8%). In all cases the reduction in HbA1c between baseline values and final values was statistically significant (p<0.05). In two studies, it was not possible to extract exact data on HbA1c reduction, but in these cases the number of patients with HbA1c ≤7% was reported. In both of these studies, pharmacist intervention was successful at increasing the number of patients with HbA1c ≤7%.
Cardiovascular System and BMI It was also found that patients subject to pharmacist interventions experienced cardiovascular benefits. These included reductions in systolic blood pressure and diastolic blood pressure. Another study reported that patients in the intervention group experienced a statistically significantly greater reduction in their Body Mass Index (BMI) than patients in the control group. In addition, two studies reported that pharmacist-managed patients had statistically significantly increased use of daily aspirin. Daily aspirin is recommended in T2DM patients by NICE due to their increased risk of CVD.
HPN • May/June 2011
34 Diabetes Diabetes-related Complications and Health Issues One study reported that microalbuminuria was significantly reduced in pharmacist-managed patients, and two studies reported an increase in the frequency of screening. Five studies reported an increase in the number of patients receiving retinal examinations. Six studies reported an increase in the number of patients receiving regular foot examinations. One study reported an increase in the number of pharmacist-managed patients being referred for “dietary instruction”. Two studies indicated an increase in the influenza vaccination rate in pharmacistmanaged patients.
35 of non-adherence (as measured by the Brief Medication Questionnaire (BMQ)) were shown in one study. Another study measured patients’ knowledge about the disease, its complications and also about their medication. They reported a significant increase in knowledge in the patients who received a pharmacist intervention compared with control patients. A further study reported a significant increase in the mental component score of the 12-Item Short Form Health Survey (SF-12) in pharmacist-managed patients. One study indicated an increase in quality of life in pharmacistmanaged patients as measured by the EuroQol-5D (EQ-5D) questionnaire.
Economic Benefits Mental Health and Medication Issues Significant improvements in wellbeing (as measured by the 12-item Well Being Questionnaire (WBQ12)) and a decrease in the risk
Doctor Stephen Byrne May/June 2011 • HPN
The economic benefits of the pharmacist intervention were measured in three studies. A decrease in costs per patient was reported in all three studies, for the duration of the intervention; which ranged from US $415 to $1,200.
Discussion The results of these studies have shown that interventions by a pharmacist are successful in reducing HbA1c in patients with T2DM and that pharmacist interventions in T2DM patients can lead to reductions in mortality, morbidity and cost of treatment. Most of the interventions revolved around education of the patient and counselling in some form. Community and hospital pharmacists are particularly well positioned to provide this service to their patients so it could be argued that pharmacists are already having a beneficial effect on glycemic control to some degree. We feel that it is also reasonable to assume that the improvement was due to the regular contact between the patient and the pharmacist. In the Irish healthcare system although there is no obligation on the patient to return to the same pharmacy, many patients choose to have a regular pharmacy which will encourage this effect.
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HPN • May 2011
36 Diabetes Pharmacists are ideal for undertaking interventions in T2DM patients because of their specific training in pharmacology and medication management. Hospital pharmacists will be able to advise on the most appropriate oral anti diabetic drugs and liaise with their counterparts in the Community setting to ensure seamless care of the patient. As many T2DM patients have a lot of medications and have a complex dosing regimen, the pharmacist is well placed to educate the patient about their medication and clarify their regimen to help improve adherence. The benefits of pharmacist intervention were also evident
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through improvements in T2DM patient’s general health. Improvements were seen in blood pressure, lipid profile and also to BMI. The beneficial effects of pharmacist interventions on quality of life and medication adherence are noteworthy. The complications associated with T2DM can have an adverse effect on patient’s quality of life. This means that any improvement in quality of life may indicate a lower instance of complications. The reported decrease in risk of non-adherence found in these studies will ultimately result in better glycemic control. In turn this will lead to a reduction in complications
associated with T2DM and a better quality of life for the patient, as well as decreased burden of the disease on the health service.
Conclusion Type 2 DM is an ongoing cause for concern in industrialized nations. The majority of the cost associated with treating diabetes comes from the complications that develop over time, as a result of poor glycemic control.
diabetes will be reduced. This means a lower cost in the disease treatment, improved quality of life for the patient and a reduced burden on society as a whole. Pharmacists, with their specialised knowledge can be successfully used to reduce HbA1c and many of the other complications associated with T2DM.
It has been proven that by improving the glycemic control of patients and keeping their HbA1c as close to their target as possible, the complications associated with
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38 Hospital Profile
Pharmacy Offers Much More at Tullamore Ease of access to medicines and space to move freely within a busy environment was once but an ambition for the Hospital Pharmacy team at Tullamore Hospital. Working within the confines of a listed building and limited space for storage and shelving, the opening of a brand new and technologically advanced pharmacy department couldn’t have materialised quick enough. However at the start of this year those dreams were realised and now everyone, from Lead Pharmacists, to Technicians, to Students and, perhaps most importantly, Patients, are reaping the benefits.
carry out hospital pharmacy tasks in a more efficient manner. “Ergonomically this current situation works better for all the pharmacy staff; everything is within easy reach, no more tedious bending down or reaching up and it would be an under-statement to say we now have more floor space per square foot. This is a major issue for Hospital Pharmacy departments.”
Upwards and Onwards Previously, the pharmacy team at Tullamore were operating within an approximate quarter of the space they now have. The old building was not only listed but restrictive in terms of space and shelving solutions. The new environment brings with it improved services for patients; a key philosophy not just for the pharmacy department, but for Tullamore Hospital as a whole. Oisin continues: “We have witnessed a small increase in staff since the new department opened. Now, every patient is seen by a pharmacist within inpatients. When I first started here in 2002, I was the only pharmacist so over the years this has been an exceptional improvement.
Shirley Armitage, Senior Pharmacist, Oisin O’hAlmhain, Lead Pharmacist and Tadhd Reddan, Pharmacy Intern.
The Midland Regional is one of only a few purpose-built, standalone hospital buildings outside Dublin and originally opened on a phased basis between May 2007 and December 2008.
Chief Pharmacist Oisin O’Halmhain told Hospital Pharmacy News of the team’s delight that they can now operate in a more efficient and standard-bearing environment.
In just March of this year the former Taoiseach, Mr Brian Cowen officially opened the E150m building and heads have been turning in the pharmacy sector for the new Hospital’s modern and technologically advanced
He says: “We all now have the privilege of conducting our work more efficiently and with more space. The layout within the new Pharmacy Department is exceptionally more modern and improved on our previous facilities and this in turn has allowed us to
Hospital have access to update a special central patient records system. The Pharmacy Department at Tullamore hosts a number of students, locally and foreign on an annual basis, in addition to accepting a number of Pharmacy Technicians each year from Athlone University.
The old pharmacy storage
Never one to rest on his laurels, Oisin and his team already have great plans underfoot to continuously develop the pharmacy department so that it constantly meets the ever changing demands of the 21st century. Next and high on their agenda is the procurement of a Pyxas Automated Dispensing Machine, an almost ATM of the Pharmacy development. This service would allow the Pharmacists to access medicines out-of-hours and to offer an out-of-hours prescription service; even further still enhancing the quality of pharmacy-based patient care within Tullamore.
The new storage unit
“Patients are seen on a ‘priority’ basis; we need to ensure their medication is correct on admission and upon leaving the hospital and with the new advances this new pharmacy department has brought us I am delighted to report that we can now offer a much improved service for our patients in this regard.” The new department has been specifically designed to be completely compliant with the latest infection control guidelines and has been developed in such a way that boxes never need be stored on the ground. Additional room is always available now for storage of medicines. The clinical pharmacists working within the specialised general and oncology pharmacy services at the Pharmacy students Nial Claffey and Therese Doolan.
May/June 2011 • HPN
HPN • May/June 2011
40 Biosimilars & Generics
The Irish Generic Market
Andy Crofts, Healthcare Markets Editor, Espicom Business Intelligence Ltd, looks at the market of Generics in Ireland while HPN focuses on Biosimilars
Unlike Germany, the Netherlands or the UK, Ireland has never been a Why So Low? major user of generic pharmaceuticals. A survey by the National Centre for Usage is low in large part due to the pricing and reimbursement Pharmacoeconomics published in April 2009 found that in 2008 generics system. Current prescribing rules accounted for 18.3% of GMS prescriptions by volume and 7.9% by value, stipulate that the pharmacist must dispense exactly what the doctor equal to 67.1 million euros. The vast majority of these are sold as branded has written on the prescription; products; unbranded generics accounted for only 2.4% by volume and 0.2% unlike in many markets where generics are widely-used, a by value. A further 18.7% was spent on branded drugs for which a generic generic or other equivalent product equivalent is available in 2008, equal to 163.4 million euros, indicating that cannot be substituted in Ireland. considerable savings are already possible through greater generic utilisation. Since 1972, the wholesale price of medicine must not exceed the This overall pattern has changed little in recent years; there has been little, aaverage wholesale price in nine if any, growth in the position of generics in the market. They accounted other European countries. These Austria, Belgium, Denmark, for 7.1% by value in 2003 and 8.2% in 2007, so the 2008 figure actually are Finland, France, Germany, the represented a slight fall. This trend is also seen in other markets, and is largely Netherlands, Spain and the If a drug is not available in due to increased uptake of newer, more expensive, branded treatments. UK. these markets, the price will be Pharmaceutical production in Ireland is dominated by the branded industry, set by negotiation between the and the HSE. Under but a few major generic companies also have small manufacturing operations. manufacturer the 2006-2010 agreement, price Multinational generic players with Irish facilities include Mylan (Gerard increases are allowed only in circumstances and by Laboratories), Stada Arzneimittel (Clonmel Healthcare), Teva Pharmaceuticals exceptional negotiation with the HSE. Finally, Ireland, and Wockhardt (Pinewood Healthcare). Other companies, such as all drugs supplied to the General Services (GMS) scheme Iceland’s Actavis, do not manufacture in Ireland, but have established sales Medical are subject to a rebate to the operations. Ireland’s membership of the EU makes it relatively easy to supply government, equal to 3.53% of the generics from overseas. wholesale price.
There are, however, no specific stipulations regarding the price of generics or original products for which generic competition is available. While many older patent-expired branded products are still popular in the market, the preferred method of addressing the issue since at least 2007 has been to negotiate - or impose price cuts with their manufacturers, rather than stimulate generic competition. Lower prices all round cuts the drug bill at a point in time, but this does not provide much incentive for greater generic use, or indeed much incentive for generic suppliers to approach the market. The most recent price cut was in October 2010, when the prices of the most commonly prescribed off-patent drugs were cut by up to 40%. This followed major cuts in the price of nearly 300 branded drugs in February 2010. In March 2007, around 600 medicines were reduced in price by around 20%. These comprised older patentexpired brands for which a generic
May/June 2011 • HPN
Figure 2: Technical development and production of a biopharmaceutical
(or second identical brand) is available. In January 2009, these drugs saw a further reduction of an average of 15%.
Changes planned for 2011? Patent expiries can be a major spur to generic usage; blockbusters such as Lipitor (atorvastatin) are losing protection around the world, and generic alternatives can often be very much cheaper. However, if the system of pricing and reimbursement does not favour generic usage, then uptake will remain low and older expensive brands will continue to be prescribed. As part of a far wider healthcare costcutting drive, the government unveiled major reform plans in June 2010, aimed at reducing the overall drugs bill and increasing the use of generics. The plans have two main components: 1. Pharmacists should be
permitted to substitute a prescribed brand product with a generic, provided that the generic is deemed interchangeable. This essentially means that the generic would have to have the same active ingredient, in the same strength. Doctors would be able to specify no substitution if required. In all other cases, the patient would be given the option of taking the original brand, but would then have to pay any price difference. A regularly-updated list of interchangeable medicines would be maintained, and some products such as biologics or those with a narrow therapeutic index would be excluded. This would be used in hospitals and under the GMS/other public reimbursement schemes. The government plan noted that hospitals should have a suitable governance structure in place to facilitate the appropriate use of interchangeable medicines. 2. Substitution reforms would go hand in hand with pricing reforms. A single reference price would
be set for a group of medicines, typically at the lower end of the range. Reimbursement within this group would only be made at this price level, meaning again that if a patient wanted a higher priced product, they would have to pay the difference themselves. The system would be overseen and regularly reviewed by the HSE. These plans were due to come into effect in 2011, but at the time of writing no date for implementation has been set, presumably due to the political difficulties experienced by the government, which finally fell in the general election of February 2011. However, the new government and new health minister have indicated they will implement the plans – or something very similar, as they also plan to abolish the HSE – given the state’s need to rein in public expenditure over the next few years. Given this, generics look set to become far more widely-used in a short space of time, if the experience of other countries is any guide.
The Market of Biosimilars Generic medicines have made a major contribution to affordable and accessible healthcare for over 20 years, saving the European Union (EU) alone an estimated €20 billion annually. By 2010 biopharmaceuticals, grew 12-15% per year. They represent one of the fastest growing segments of the pharmaceutical industry, and there are more than 200 of them on the market today. Some 300 more are being investigated in clinical trials. Biopharmaceuticals can now also be produced by manufacturers other than the originator when the relevant patents have expired. These new biotechnological medicines are most commonly known as ‘biosimilar medicines’. In other texts they may be named ‘similar biological medicinal products’, ‘biosimilars’, ’followon biologics‘ or ‘biogenerics’. Biosimilar medicines are therefore a subset of biopharmaceuticals,
HPN • May/June 2011
42 Biosimilars & Generics
43 medicines > Affordable prices > Sustainable fi nancing > Reliable health and supply systems
Figure 4: Stages of development of a biosimilar medicine
Table 4: Value of Top 10 Biologics, Ireland INSERT EXCEL DOCUMENT HERE with comparable safety and efficacy to originator reference medicinal products. The main difference between the two is that biosimilar medicines will be less expensive. To gain approval, biosimilar medicines have to demonstrate that they are as safe and effective as the originator reference product. Biosimilar medicines are evaluated for their similarity and comparability with the reference product. This evaluation is customised to each biosimilar product and the active substance it contains, together with the methods used for development and the clinical use of the product. One key aspect to be considered is the variation of potency and purity of the product which should be within the limits displayed by the reference product.
Development Processes The biosimilar development process uses the latest analytical and clinical technologies, including some that may have not been available to assess the reference product at the time it was first approved. Once the medicine is approved, specific monitoring is required for biopharmaceuticals to assure continued safety and efficacy. In addition to the specific monitoring, data is collected through pharmacovigilance activities. The data collected is used to prepare periodic safety update reports (PSURs). These reports review the risk-benefit of medicines, at frequent intervals after the product is first approved and marketed. Pharmacovigilance is not specific to biosimilar medicines but applies to all medicinal products.
May/June 2011 • HPN
Biosimilar medicines now offer a major opportunity to provide greater access to affordable healthcare for several life-saving medicines, at least equally significant to the emergence of generic medicines over the past two decades.
very robust regulatory systems now in place in the EU allow full confidence in biosimilar medicines.
marketing if there are specific issues identified during the approval process.
Biopharmaceuticals Biosimilar Medicines
Biosimilar competition resulting in just a 20% price reduction on five off –patent biopharmaceutical medicines could save the EU over €1.6 billion per year.
Biopharmaceuticals have been available for over twenty years. They fall into different classes:
Since 2004, there has been acceleration in this new field of pharmaceutical development, with the first five biosimilar medicines gaining European regulatory approval in 2006 and 2007. Biosimilar medicines are approved by the European Commission (EC) through the European centralised procedure, which is overseen by the European Medicines Agency (EMEA). The term ‘biosimilar medicine’ is derived from the EU legislation governing this approval process. As is the case for all medicines, European regulations and guidelines are in place to ensure the quality, safety and efficacy of biosimilar medicines, and also to avoid unnecessary clinical testing. Pharmacists have a leading role in ensuring that the most appropriate medicines are made available to the right patients in the right way, and at the right time. A prime responsibility is the evaluation and supply of new medicines within their national regulatory and reimbursement framework. Biosimilar medicines are an emerging source of affordable biopharmaceuticals which pharmacists can critically appraise, referring to data published on the EMEA website, in order to support clinical decisions and health provider (payer) expectations. The
Hormone products e.g. growth hormone for growth hormone disorders, erythropoietin for the anaemia of kidney disease, and insulin for diabetes Immunomodulators e.g. betainterferon for multiple sclerosis Monoclonal antibodies (MABs) e.g trastazumab for breast cancer Blood coagulation modulators e.g. factor VIII and IX for blood disorders such as haemophilia Enzymes e.g. for the treatment of metabolic disorders such as Gaucher disease Vaccines. Both originator reference products and biosimilar medicines are made under carefully controlled conditions to ensure the products are consistent, and manufactured to the required quality. This is known as Good Manufacturing Practice (GMP). In the European Union, GMP inspections for all biopharmaceuticals (both originator and biosimilar medicines) are coordinated by the EMEA and performed by National Regulatory Agencies. There are three levels: Routine GMP inspections of manufacturing sites to ensure that medicines are produced safely and correctly; Pre-Approval Inspections (PAI) for GMP compliance prior to the approval of new medicines for
On 1 May 2007 the EMEA launched a new database designed to facilitate the exchange of information on compliance with GMP within the European medicines network. The database, called EudraGMP, can be accessed by national competent authorities, the European Commission and the EMEA. Biosimilar medicines are made by specialist organisations. They may be a dedicated but separate part of a large pharmaceutical company, a stand-alone biotechnology company, or a partnership between the two, which has benefits in terms of reducing development costs. The development and manufacture of these products is a complex field which is expensive, requires particular expertise and carries a degree of commercial risk. Not all biopharmaceuticals will necessarily become available as a biosimilar medicine. The cost of development, production, and also the size of the market (number of patients) have to be taken into account by a potential manufacturer. Industry must be able to develop and produce the biosimilar medicine at a cost that allows them to market competitively at lower prices than the reference product.
Most European countries have or are developing strategies to address each of these factors. Strategies to increase the affordability and availability of medicines to more patients include promoting competition and enhancing the availability of generic medicines. Biosimilar medicines need to be included in these strategies. Since a clear legal and regulatory environment has been established, a clear market pathway for biosimilar medicines needs to be established in each individual Member State to enable access to these medicines as soon as possible after their marketing approval. Indeed, the way countries determine which medicines are selected and used needs to be adjusted to ensure biosimilar medicines are made fully available. Factors include marketing authorisation approval, agreement on price and on how the biosimilar medicines are reimbursed and gaining the acceptance of clinicians and patients in using biosimilar medicines as part of their practice and treatment. Access for patients to biosimilar medicines is not automatic; it requires proactive steps to be taken by all relevant stakeholders.
four times more medicines than when they were 30. It is estimated that the European population aged over 60 will increase from under 22% to more than 25% between 2000 and 2015. This equates to an additional 50 million people in Europe aged over 60. Current estimates for Europe show that the related expenditure on medicines is growing at more than twice that of the growth of GDP (Gross Domestic Product). Not surprisingly, the effective management of healthcare costs is key for all governments. Biopharmaceuticals are some of the world’s most expensive medicines. On average, they cost much more per patient as conventional pharmaceuticals. They cost many thousands of euros or more per patient per year for the whole life treatment of some rare metabolic disorders. They are also often used to treat long-term conditions such as diabetes, cancer, anaemia of chronic kidney failure and multiple sclerosis, with a corresponding impact on clinical practice. As a consequence, payers must try to fund the treatments considered best for the patient by their clinicians, while ensuring value for money and the management of finite resources.
These budgetary pressures can result in patients not being treated in accordance to national guidelines. For example, in France, around two-thirds of pre-dialysis patients would be expected to be on erythropoietin (EPO), but figures show that less than half receive the treatment.
The use of medicines increases as people age, with those over 60 years using on average three to
The improved affordability of healthcare that could result from the use of biosimilar medicines
Irish Values Total
is real. It has been estimated that 20% reduction in price of five biopharmaceuticals off patent, or imminently off patent, would save the EU over €1.6 billion per year.
Identification As required by law for all medicines in the EU, every biosimilar medicine will either have an invented or brand name, or the name of the active substance together with the company name. Every biosimilar medicine is consequently clearly identified by its unique name, which has to be formally accepted by the EMEA prior to its approval. The first two biosimilar medicines in Europe bear invented names (Omnitrope® and Valtropin®). Both contain the same active substance, somatropin. Somatropin is the scientific name for this active substance. The scientific name is usually called the INN (International Non-proprietary Name) or generic name. The INN is also approved by the EMEA during the scientific evaluation of the biosimilar medicine. The name of a medicine and the name of its active substance are very important for the clear identification, safe prescription and dispensing as well as for monitoring the safety in use of the medicine.
Traceability All pharmaceutical and biopharmaceutical manufacturers use a variety of techniques to be able to trace their medicine at all times. This includes unique
labelling, batch numbering and packaging. Effective traceability also covers systems which track the way medicines reach the patient via the supply chain, and how medicines taken by or administered to patients are recorded and can be traced back in case adverse reactions occur during the treatment.
Interchangeability Interchangeability refers to the medical/pharmaceutical practice of switching one medicine for another that is equivalent, in a given clinical setting. The regulatory scientific data, published via the EPAR (European Public Assessment Report), should guide the decisions regarding interchangeability. If an originator company changes its manufacturing process of their product, interchangeability between the pre and post-change products is presumed so long as it is supported by comparability data. For scientific consistency, the same approach should be taken for biosimilar medicines. It is important to reiterate that biosimilar medicines match their reference product in terms of quality, safety and efficacy. A demonstration of therapeutic equivalence is required in order to adopt the posology (dose recommendations) of the reference product. The extensive comparability and post-marketing data will therefore demonstrate that it is safe and efficacious to switch dose for dose from the reference product to the biosimilar medicine.
Retail Hospital Total MAT/2/2011 EURO MAT/2/2011 EUROS 136,630,738 78,509,926 215,140,664
Value of Top 10 Biologics, Ireland
Access to Biosimilars The World Health Organisation (WHO) states that access to medicines depends on four factors. > Rational selection and use of
Attributions: European Generic Medicines Association
HPN • May/June 2011
44 AVRO Congress Reports Key Research
Congress Reports Findings from Key ARMD Research
Good News for Diabetic Vision Impairments of bevacizumab compared to Lucentis. Lucentis showed statistically significantly greater reduction in retinal thickness compared to bevacizumab and significant differences in favour of Lucentis were seen on a number of secondary endpoints including absence of fluid on OCT and absence of dye leakage on angiography.
From Left to Right Avril Daly, Fighting Blindness. Professor Stephen Beatty, Whitfield Clinic, Waterford. Dr Greg Hays, Novartis Ireland.
Results of three important studies looking at drug treatment in agerelated muscular degeneration have been reported at the recent AVRO (Association for Research in Vision and Ophthalmology) Congress.
As an organization representing people with age-related macular degeneration in Ireland, we have been greatly anticipating the results of this study,
May/June 2011 • HPN
The long-awaited studies contrasted the use of the Novartis licensed treatment Lucentis, with Roche’s cancer drug bevacizumab, in wet Age Related Macular Degeneration. The CATT (Comparison of Age-related macular degeneration Treatment Trials): Lucentis-bevacizumab Trial, a two-year, multicenter, randomized, clinical trial was designed to evaluate the relative efficacy and safety of Lucentis (ranibizumab) and bevacizumab for the treatment of wet AMD. “As an organization representing people with age-related macular degeneration in Ireland, we have been greatly anticipating the results of this study," said Avril Daly CEO, of Fighting Blindness. "Patient led organizations, such as Fighting Blindness, are concerned only with proven safety and efficacy in all treatment options. It is essential that the results of this study are discussed in detail between patients and doctors so that patients can make informed decisions on the treatment options open to them and the potential risks”. However, while CATT may provide useful information regarding the relative effectiveness of the two medicines, intravitreal bevacizumab remains unlicensed for ophthalmic use. There are also aspects of this study design that may weaken the comparison of bevacizumab to
Lucentis, particularly in relation to evaluating relative safety: • The study is not powered to demonstrate differences in rates of rare and life threatening events (such as stroke and myocardial infarction) between bevacizumab and Lucentis (NICE workshop report, 13 July 2010) •
In the study, one intravitreal injection of bevacizumab is repackaged in glass vilas in an asceptic filling facility. The vials are for single use only. [CATT Manual of Procedures, section 4] However, when unlicensed intravitreal bevacizumab is used in every-day clinical practice, a single-use vial for intravenous infusion is invariably compounded into several smaller doses for use, thus multiple eyes are treated from a single vial – increasing the risk of contamination and subsequent infection/ inflammation.
In terms of efficacy, it was shown in CATT that Lucentis PRN (ProReNata -Treatment as Needed) dosing was as efficacious as Lucentis monthly dosing, supporting the need for an individualised dosing regimen. Unlicensed bevacizumab PRN failed to meet primary endpoint of non-inferiority compared to Lucentis, despite patients receiving a higher number of injections
Safety Issues With regard to safety, there was a statistically significant increased risk of systemic serious adverse events, associated with hospitalisations, with bevacizumab compared to Lucentis, (24.1% v 19% respectively). A higher number of deaths occurred among bevacizumab treated patients. This reflects findings in recent studies. The Curtis / Duke study which found a 28% increased risk of stroke and 11% increased risk of overall mortality with Avastin compared to Lucentis in the secondary analysis. Also shown at ARVO was an analysis done at John Hopkins University by Gower et al (involving 78,000 Medicare patients) indicated that the use of bevacizumab showed an 11% higher risk in overall mortality and a 57% higher risk of hemorrhagic cerebrovascular accident than Lucentis.
with ATEs occurring in 12.4% of bevacizumab treated patients compared to 1.4% of Lucentis treated patients. Commenting on these results, Professor Stephen Beatty, Retinal Specialist at the Institute of Eye Surgery at Whitfield Clinic in Waterford, says: “These results support our belief that Lucentis is the most appropriate treatment for wet AMD and that there may be differences in the safety profile of Lucentis and bevacizumab when used in the eye”. Lucentis was specifically designed and licensed for treatment of the eye, and is manufactured to the highest standards for intra-ocular use. Currently, Lucentis is licensed for wet age-related macular degeneration (AMD) in more than 85 countries, and is licensed in the European Union for the treatment of vision loss due to diabetic macular edema (DME). “Lucentis has a well established safety profile and Novartis systematically monitors the safety and tolerability of Lucentis for licensed indications on an ongoing basis. To date there is more than 750,000 patient-treatment years of exposure globally with Lucentis.” commented Dr Greg Hays, Medical Director at Novartis Ireland.
A third study presented at ARVO, by Barros-Perreira et. al., assessed plasma VEGF levels one month after Lucentis or bevacizumab treatment in AMD patients. VEGF levels were significantly decreased one month after IVT bevacizumab, whilst there was no significant reduction in plasma VEGF levels one month after IVT Lucentis. Authors conclude these differences could lead to distinct differences in the systemic safety profiles of these drugs. These three studies follow data published or presented in 2010 and 2011, including a recent study by Carneiro et al (Ophthalmologica 2011), which reported that bevacizumab may be an independent and significant predictor for new arterial thromboembolic events (ATEs),
Meanwhile, Ireland’s Diabetic Macular Edema (DME) patients now have access to Lucentis (ranibizumab). The treatment is now available to treat patients with visual impairments due to DME, a major cause of blindness in the working-age population and affects approximately 2% of people in Ireland with diabetes. “For people with diabetes, one of their greatest fears is sight loss and the impact that this would have on their independence and ability to perform day-today activities such as driving,” commented Kieran O’Leary, CEO, Diabetes Federation of Ireland. “An agent such as Lucentis, that can restore vision for a person with DME to a level that enables them to continue to drive safely, is a welcome advance in treatment.” Pivotal data shows that Lucentis treatment results in rapid, superior and sustained vision gains compared to laser therapy. Lucentis is the first licensed pharmacological therapy to significantly improve both vision and vision-related quality of life in patients with visual impairment due to DME.
"Lucentis has a well established safety profile"
In the RESTORE study, more than double the percentage of Lucentis treated patients, versus laser, achieved visual acuity (VA) levels required for driving (53% vs 23.6%) at 12 months. This study also showed that patients treated with Lucentis alone gained an average of 7 letters in VA at 12 months compared to baseline, while laser-treated patients gained
Kieran O’Leary, Diabetes Federation of Ireland.
an average of 0.9 letters as measured on a standard ETDRS eye chart. These results are further supported by an independent US study examining Lucentis for the treatment of DME compared to standard of care, conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net). Lucentis was well tolerated in DME clinical studies and its safety profile was consistent with the well-established profile in patients with wet age-related macular degeneration (wAMD). Incidence of arterial thromboembolic events in DME clinical trials was similar in Lucentis and control arms. Ocular adverse events were similar to those seen in wAMD trials. “Lucentis will offer an entirely new pharmacological approach to treatment for visual impairment due to DME compared to laser therapy, the current standard of care,” commented Mr. Mark Cahill, Consultant in ophthalmic surgery, Royal Victoria Eye and Ear Hospital.
HPN • May/June 2011
Spring Meeting for Thoracic Society The Irish Thoracic Society recently held their Spring Meeting. The event was sponsored by Boehringer Ingelheim and featured talks from
Paris and the USA. Pictured below are some of those who attended.
Following a heavy schedule of discussions surrounding issues of medicine shortages, reductions in pharmacists payments and future roles of the profession in vaccine delivery, delegates at the Irish Pharmacy Union Annual Conference let their hair down at a Gala Dinner, held in the exquisite Lyrath Estate, Kilkenny.
1) Prof Charles Gallagher Consultant Respiratory Physician St Vincents Hosp Speaker, Maureen Mason Boehringer Ingelheim, Dr Aidan O' Brien Consultant Respiratory Physician Mid Western Regional Hosp, Gillian Hession Boehringer Ingelheim. 2) Prof JJ Gilmartin Consultant Respiratory Physician Merlin Park Hosp, Dr Anthony O’Regan Consultant Respiratory Physician UCHG, Prof Ulrich Specks Mayo Clinic USA Speaker.
2) Avril Ryan, Teva Pharmaceuticals and Sara Jane Gavin, McCabes Pharmacy Sandyford Dublin. 3) Paul Moran, Teva Pharmaceuticals, Aideen Kenny, Teva Pharmaceuticals, Sarah Corry, Teva Pharmaceuticals and Fergus McCauley Pharmexx Ireland
The Royal College of Physicians is throwing its’ weight behind a new campaign aimed at helping the Irish population combat the growing problem of carrying excess weight and obesity. Safefood’s ‘Stop the Spread’ campaign is a
2) Mr Tim Delaney, National Programme Lead, Medication Safety, is pictured with Mr Shaun Flanagan, Chief Pharmacist, Corporate Pharmaceutical Unit, HSE and Dr Ambrose McLoughlin, PSI.
4) Dr Mark Ledwidge, Chair, Dr Leonara O’Brien and Mr Peter Weedle. 5) Delegates at the conference.
May/June 2011 • HPN
1) Ms Adrienne Lynn, HSE, Professor Donal O’Shea, Consultant Endocrinologist at St Columcille's Hospital and St Vincent's University Hospital Dublin and Dr. Cliodhna Foley-Nolan, Director, Human Health & Nutrition, safefood.
two-year, all-island initiative and the launch was held at the Royal College of Physicians Dublin headquarters. Speakers included Dr Cliodhna-Foley Nolan, Director of Human Health & Nutrition, safefood, Professor Donal O’Shea,
Consultant Endocrinologist at St Columcille's Hospital and St Vincent's University Hospital Dublin and Ms. Velma Burns, Associate Director, Millward Brown Lansdowne research company.
2) Speakers at the event; Dr. Cliodhna Foley Nolan, Director, Human Health & Nutrition, safefood; Ms. Velma Burns, Millward Brown Landsdowne research; and Professor Donal O’Shea, Consultant Endocrinologist at St Columcille's Hospital and St Vincent's University Hospital Dublin.
3) Elaine Conyard, Sinead McCool and Kate Mulvenna.
Photographs from Maxwells Photography
Giving Weight to the Obesity Epidemic
Speakers included Dr Ambrose McLoughlin, Professor Colm Bergin, Mr Tim Delaney and Dr Joe Clarke, with issues discussed ranging from funding and resource utilisation in medicines management to medication safety and prescribing. 1
1) Dr Helen Flint, Medication Management Programme Leader and Dr Ambrose McLoughlin, PSI.
1) Ger Gahan IPU, Dermot McConn and Wendy McGlashen.
Pharmacy Liaisons in Clinical Care The Royal College of Physicians recently hosted an Introduction Course for Pharmacy Liaisons in the Clinical Care Programmes. The event was held in Association with the Health Service Executive and the Pharmaceutical Society of Ireland.
3) Dr Marcus Butler Consultant Respiratory Physician St Vincents Hosp, Dr Dave Curran Consulatant Respiratory Physician Mercy Hospital Cork, Dr Terry O’Connor President Irish Thoracic Society Mercy Hosp Cork, Eamonn Murphy Boehringer Ingelheim. 4) Dr Terry O’Connor President Irish Thoracic Society Mercy Hosp Cork, Prof Ulrich Specks Mayo Clinic USA speaker, Prof Loic Guillevin Hopital Cochin Paris speaker, Prof Charles Gallagher St Vincents Hosp speaker.
IPU Delegates Dine in Style
3) Mr Mark Neal, Pharmaceutical Society of Northern Ireland and Mr. John Dardis, Chairman, safefood.
HPN • May/June 2011
48 Clinical Profiles UniPhar the Distance
Pharmasource is a new initiative from the UniPhar Group, which provides Pharmacists’ exempt medicinal products, manufactured specials and bespoke procurement requirements. Pharmasource will attain on a Pharmacists’ behalf, difficult to
Positive news for Exenatide from CHMP
Ebixa 10mg Tablets – New Lactose Free Tablet & Consequential Tablet Colour Change
Melfen Tablets Change
Eli Lilly and Company, together with Amylin Pharmaceuticals, Inc and Alkermes, Inc. have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the marketing authorisation of exenatide for prolonged release suspension for injection for the treatment of type 2 diabetes in combination with common oral therapies in the European Union. This application to the European regulatory authorities is for use of exenatide for prolonged release as a once-weekly 2-mg dose to improve glycaemic control in adults who have not achieved adequate glycemic control on maximally tolerated doses of these oral therapies. If approved, exenatide for prolonged release
procure quality assured medicines and those that are in short supply or have been discontinued.
For further information contact your UniPhar Wholesale representative or
A free phone, free fax and online ordering service will be provided by experienced and knowledgeable pharmaceutical technicians.
Free phone 1800 440 440.
would be the first once-weekly type 2 diabetes treatment.
HbA1c, a measure of average blood sugar over three months, between 1.5 and 1.9% after six months. Further, the exenatide for prolonged release submission was built upon more than five years of market experience with BYETTA® (exenatide) injections, the twicedaily form of exenatide that is available in more than 70 countries worldwide.
If approved, the treatment is planned to be marketed in the European Union under the proposed brand name BYDUREON® (exenatide 2 mg powder and solvent for prolonged release suspension for injection). The positive opinion was reached after the CHMP review of the submission package, including data from the DURATION phase III clinical trials in which treatment with exenatide resulted in improvements in glycaemic control, with weight loss in most patients, with just one dose per week. In the data submitted, exenatide for prolonged release showed statistically significant improvements in glycaemic control based on reduction of
Following a recent communication issued to all relevant healthcare professionals in January of this year, Lundbeck Ireland Limited would like to highlight that from March 2011, Ebixa 10mg Tablets have changed colour and shape.
tapered oblong, biconvex tablet to a tablet which is oval shaped and pale yellow to yellow in colour. The new Ebixa 10mg Tablets are film-coated with a breaking line and engravings “1 0” on one side and “M M” on the other side.
The tablet formulation of Ebixa has been changed and is now lactose free. As a consequence of this, the Ebixa 10mg Tablet has changed from a white centrally
The current Summary of Product Characteristics and Patient Information Leaflet for Ebixa can be accessed online at www. medicines.ie.
Clonmel Healthcare would like to inform you that Melfen 200mg and 400mg Tablets are being changed from a pink sugar coated tablet printed with a Clonmel logo and code 178 or 179 to a white filmcoated tablet that is unprinted.
PA Holder: Clonmel Healthcare Ltd., Clonmel, Co. Tipperary.
Please note that the cartons will have “NEW FORMULATION” printed on them also.
May/June 2011 • HPN
Exenatide for prolonged release belongs to the class of glucagonlike peptide1(GLP-1) receptor agonists. In a once-weekly dose, a continuous release of exenatide is delivered using Medisorb®, a biodegradable microsphere technology developed by Alkermes.
Gilenya recommended in EU
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Gilenya® (fingolimod) 0.5 mg daily as a disease modifying therapy in patients with highly active relapsing-remitting multiple sclerosis (MS) despite treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS.
the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI), a measure of disease activity.
The CHMP recommendation forms the basis for a European Commission licensing decision, which is expected in approximately three months.
“More than 500,000 people in the EU live with MS, a debilitating neurological condition that involves an unpredictable, lifelong progression of complex symptoms,” commented John Golding, President, European Multiple Sclerosis Platform (EMSP). “The first available oral MS treatment that offers significant efficacy for appropriate patients is a welcome alternative.”
“We're pleased with today's recommendation by the CHMP because it means patients in Europe with highly active relapsing-remitting MS could soon benefit from Gilenya's significant efficacy in a once-daily capsule,” said Loretto Callaghan, Managing Director of Novartis Pharmaceuticals Ireland.
(the study’s primary endpoint) was 2.94% in Protelos patients compared to 0.20% in patients receiving alendronate (p<0.001). This greater effect on bone formation was further amplified after 12 months of treatment. Protelos also significantly increased both the bone formation rate and the mineral apposition rate compared to alendronate over six and 12 months of treatment. The bone-forming efficacy of Protelos is linked to its innovative dual mechanism of action which rebalances bone turnover in favour of the formation of newer and stronger bone. This is not the case with bisphosphonates as they have been shown to actually suppress the bone formingsurface. Speaking from ECCEO in Valencia, Professor Moira
O’Brien, President of the Irish Osteoporosis Society said; “This is welcome news for Irish people with osteoporosis, of which it is estimated there are approximately 300,000. Osteoporosis is a major health problem in Ireland and prevalence is increasing at an alarming rate due to increased life expectancy. We now have the scientific evidence to show that bone formation is significantly greater in patients on strontium ranelate, than those on alendronate. This improvement in bone formation observed confirms that this well-tolerated drug is a strong alternative for doctors treating patients with osteoporosis, resulting in potentially better patient outcomes.”
Novartis is launching a new pre-filled syringe formulation of the asthma treatment Xolair® (omalizumab) in Ireland. Xolair prefilled syringe which is available in 75 or 150 mg doses, removes the need for healthcare professionals to wait 20 minutes while the medicine, currently supplied as a lyophilized or “freeze-dried” powder, is reconstituted. The option of two doses for the prefilled syringe also allows more accurate dosing and less wastage.
patients can benefit greatly from Xolair treatment.” said Dr Greg Hays, Medical Director, Novartis Ireland.
“A small number of the total asthma population have severe persistent allergic asthma, for this subset of the population the disease is very debilatating with patients spending on average 33 days in hospital. Many of these
Xolair pre-filled syringe solution for injection was approved by the European Commission based on an open-label, parallel arm study conducted in 155 adults who had mild to moderate asthma, allergic rhinitis or perennial rhinitis
and were susceptible to allergic disease (or ‘atopic’), but were otherwise healthy. This study compared the pre-filled syringe formulation of Xolair to the marketed lyophilized formulation. Results showed that the effects on IgE were comparable between both formulations. The pre-filed syringe formulation of Xolair was shown to be bioequivalent to the marketed lyophilized formulation, with comparable effects on free and total IgE and no difference in adverse events. In addition, a supportive open-label safety study in 155 patients using Xolair liquid formulation demonstrated a safety profile equivalent to Xolair lyophilized formulation.
The CHMP opinion was based on the largest clinical trial programme submitted to date for a new MS drug, and included data from clinical studies showing significant efficacy in reducing relapses,
Greater bone-forming activity with Protelos
Protelos® (strontium ranelate) has significantly greater boneforming activity than the commonly prescribed bisphosphonate, alendronate, according to results of the largest-ever biopsy study in post-menopausal women presented recently at the European Congress on Osteoporosis and Osteoarthritis (ECCEO011-IOF) in Valencia. Through its unique dual impact on both bone formation and resorption, Protelos substantially reduces fracture risk, the primary goal of osteoporosis treatment. In this international, double blind study of 268 women, Protelos has a significantly greater effect on mineralising surface compared to alendronate. After six months, mineralising surface, expressed as a percentage of bone surface
If you have any queries on the above, please do not hesitate to contact the Lundbeck Medical Department at (01) 4689800 or email email@example.com.
Pre-filled syringe of Xolair in Ireland
Clinical trials and experience in patients who are inadequately controlled on high doses of inhaled glucocorticosteroids and long-acting beta2-agonists have shown that Xolair reduces asthma exacerbations, and reduces the need for emergency medical treatment.
HPN • May/June 2011
Speeding Referral to Diagnosis
Tony O'Brien Tony O’Brien has been appointed to work in a co-leadership capacity with the HSE’s National Director of Clinical Strategy & Programmes as part of the ongoing development of the Clinical Strategy and
Programmes Directorate. Mr O’Brien will have a particular focus on the implementation of the programmes within the health care system and will have responsibility for the budget and staffing
associated with the Directorate. Tony has been Director of BreastCheck since 2002 and Chief Executive of the National Cancer Screening Service (NCSS) from its establishment in 2007
Dr Basil Elnazir Dr Basil Elnazir has been appointed as the new Chairperson of the Asthma Society of Ireland Medical Committee. Dr Elnazir is a Consultant Respiratory
Paediatrician at the Adelaide and Meath incorporating the National Children’s Hospital. Dr Elnazir specialises in respiratory and allergic disorders in children. Having served on the Asthma
Society Paediatric Advisory Council, he has worked closely with the Asthma Society of Ireland over the last number of years.
Kathleen Lynch T.D Prof O'Byrne
The beginning of this year marked the start of a National Lung Cancer Awareness Campaign providing a timely reminder that lung cancer is the leading cause of cancer-related death in Ireland. Currently over 75% of lung cancer cases present in the late stage of the disease. To mark the awareness campaign, Lilly will be supporting education classes, in association with the Irish Cancer Society, to focus on signs and symptoms of lung cancer, the importance of rapid access referral, and the Irish Thoracic Society guidelines for diagnosis and treatment of lung cancer. In addition, Lilly will be running a poster campaign advising the general public of the signs and symptoms of the disease. In response to the problem of late diagnosis, eight rapid access centres were established by the National Cancer Control Programme in designated cancer care centres across Ireland over the past number of years to speed up the process from referral to diagnosis. Professor Ken O’Byrne, Consultant Oncologist, St. James’s Hospital said: “With 75% of patients presenting to their GP at the late stage of the disease, it is imperative that symptom recognition is vastly improved. Referrals to rapid access centres will help speed up the process from referral to diagnosis which is essential to improve patient outcomes. An important element in the process of diagnosis is the significant progress being made with the development of targeted therapies. This will help identify the type of lung cancer a patient has and therefore enable them to be put on the correct type of treatment.” May/June 2011 • HPN
More than 1,700 Irish people are diagnosed with the disease annually and survival rates are low, with only 12% of all patients surviving five years or longer after diagnosis, however survival rates can be improved by early diagnosis and referral. Better symptom recognition is another essential component for improving patient outcomes. Symptoms of lung cancer may include one or several of these symptoms: development of a cough, coughing up blood, breathlessness and wheezing, fatigue and weight loss, chest pain, repeated bouts of pneumonia, hoarseness, pain in the shoulder, arm or hand.
2. Physiological assessment through pulmonary function tests to find out if pulmonary function can support invasive tests and/or radical treatment. 3. Radiological assessment through contrast enhanced CT scan of thorax and upper abdomen to level of adrenals to establish the clinical stage of the cancer. 4. Airway assessment through bronchoscopy to provide staging information and route for diagnosis.
The Irish Thoracic Society guidelines outline a number of assessments that are needed to inform the appropriate course of treatment for lung cancer, these include:
5. Tissue diagnosis through biopsy or needle aspiration. This is often obtained at bronchoscopy (central masses) or by transthoracic needle aspiration/ core biopsy (peripheral lesions) but may be confirmed by cytology/histology from other sites such as lymph glands, skin nodules or pleural fluid.
1. Initial clinical assessment to determine performance status, co‐morbidity and weight loss.
Norma Cronin, Health Promotion Manager, Irish Cancer Society commented: “Our annual lung
cancer awareness campaign is an important platform for us to raise awareness of the key challenges facing diagnosis and treatment. “It is essential that early referral from the GP to rapid access clinics in the designated cancer care centres takes place to ensure the best possible outcome for the patient. We hope that education initiatives such as this one will lead to a significant improvement in the referral, diagnosis and treatment of lung cancer.”
Minister of State Kathleen Lynch T.D. has been appointed to the position of Minister for Older People. Minister Lynch’s priority will be to complete and
implement the National Positive Ageing Strategy as outlined in the Programme for Government. Her responsibilities also include ensuring the supply of more and
better care for older people in the community and in residential settings, a further priority of this Government.
Lisa Sheridan Lisa Sheridan is Advertising Manager with Hospital Pharmacy News. Lisa’s background is in Print and Directory Advertising, having worked for Independent
News and Media for six years befiore joining the advertising team at Hospital Pharmacy News and Irish Pharmacy News. Lisa can be contacted at lisa@
irishpharmacynews.ie. Tel Dublin office 01 4429763
Kelly Jo Eastwood Kelly Jo Eastwood has joined the team of the Editorial Department at Hospital Pharmacy News. With over eleven years experience working within the health and pharmacy publishing
market, Kelly Jo was previously Managing Editor with Medical Communications, responsible in her role for overseeing five monthly magazines throughout Northern Ireland, Scotland, England and
Wales. Kelly Jo is employed as Editor of Hospital Pharmacy News. She can be contacted at: firstname.lastname@example.org. Tel: 00447876548989.
Cliona Dudgeon IPN is delighted to introduce their newest team member, Cliona Dudgeon. Cliona joins the IPN team as a Sales and Events Assistant.
She joins the team after spending the last year working as a Marketing and Events Assistant within the Fir Trees Hotel. Prior to this, Cliona worked on the North West Music Festival as part of the events team, as well as a small
stint with the Riverdance production team in 2008. She graduated from the University of Ulster in 2010 with a degree in Leisure, Events and Cultural Management.
HPN • May/June 2011
Published on Dec 31, 2011
Published on Dec 31, 2011
IN THIS ISSUE: Medicine Shortages Come Under the Spotlight - The Role of Pharmacy in the Management of Type 2 Diabetes - Profile: Oisin goes...