THE INDEPENDENT VOICE OF HOSPITAL PHARMACY
IN THIS ISSUE:
News: Barcoding medicines should not be hindered says EAHP
Conference: Coverage from the Hospital Pharmacists Association of Ireland annual conference Report: Research unveils potential for new drug development in heart disease
Awards: Exclusive coverage of the finalists, the winners, the bold and the beautiful!
our brightest Star Atorvastatin is the market leading medication for treating cholesterol Atorvas速 (atorvastatin), now available from Rowex, the No. 1 generic company in cholesterol lowering medication in the Irish market
Manufacturing in Ireland from our Bantry base, we believe in investing in the best medicines for your patients Medicinal products subject to prescription. Further information and SPC available from Rowex Ltd., Bantry, Co. Cork.
Feature: Urinary Tract Infections and the role of the pharmacist Conference: Looking 'beyond the horizon' with the National Association of Hospital Pharmacy Technicians News: Patient access to new medicines welcomed
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PSI Baseline Study of Hospital Pharmacy practice underway P5
UCC Pharmacology Professor leads research team in genetic study of osteoporosis P6
The inaugural Irish Pharmacy Awards took place earlier this month at The Burlington Hotel and they have been deemed an oustanding success! There was certainly some significant celebrations as we presented 14 richly deserved awards to individuals and pharmacy teams.
The Irish Pharmacy Awards 2012 - The Finalists and Winners P9 Healthcare workers urged to admit mistakes at HPAI annual conference P18
National Association of Hospital Pharmacy Technicians annual conference P36
You represent the very centre of our healthcare system and the health of our nation is dependent on you. In so many cases you are our first port of call when something is wrong.
Regulars Feature - Urinary Tract Infections P24 Feature - The management of hypertension P30
Furthermore, the Awards themselves wouldn't have been possible without our fantastic sponsors. Let me take this opportunity to say a heartfelt 'Thank You' to:
Clinical Profiles P44
Actavis Academy Ireland;
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.
EDITOR Kelly Jo Eastwood email@example.com ACCOUNTS Lorraine Moore firstname.lastname@example.org
Of course there would be no winners announced on the if it weren't for the hard work of our esteemed judging panel, which is made up of 19 of the industry's business, pharmacy and professional leaders. The judges had a very difficult task ahead of them in examining the applications and nominations and the team at IPN Communications Ltd would like to thank them for their time and effort.
Feature - Treatment regimes for Dupuytren's Contracture P40
MANAGING DIRECTOR Natalie Maginnis email@example.com
Nominations were incredibly strong from across the country and alot of effort was made in ensuring that the very best of pharmacy practice has been recognised and was rewarded. This issue of HPN profiles all the finalists and winners within the hospital pharmacy categories. Getting access to that healthcare in a way that is affordable and effective is becoming increasingly difficult for many families in these hard financial times. The one area of dedicated, professional and accessible healthcare for all – is in our pharmacies and within hospital pharmacy departments.
Research points to the potential development for new heart disease drugs P22
PUBLISHER IPN Communications Ireland Ltd Carmichael House, Lower Baggot Street, Dublin 2 00353 (01) 6024715
Kelly Jo Eastwood
SALES MANAGER Debbie Graham firstname.lastname@example.org CONTRIBUTORS Yvonne Sheehan, President, NAHPT Professor Eoin O'Brien Sean Egan, Antimicrobial Pharmacist at Tallaght Hospital
McNeill Healthcare Ireland Ltd; Pfizer Healthcare Ireland; Pinewood Healthcare; Roche Products Ireland; Sanofi; Teva Pharmaceuticals Ireland and TTM Healthcare. I hope you enjoy this issue of the magazine, and for those of you who were able to attend on May 19th, I hope your night was a memorable one. Make sure you look out for our future issues with full details of the Irish Pharmacy Awards 2013!
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THE INDEPENDENT VOICE OF HOSPITAL PHARMACY
HPN • Issue 4
New systems must support barcoding medicines The future pan-European system of medicined verification must facilitate, and not hinder, barcoding of single dose medicines administered in hospitals.The request has been made by the European Association of Hospital Pharmacists in their response to a consultation on a regulatory instrument which will set out the requirements for the unique identification of medicines throughout the European supply chain. The system is required to be introduced under the 2011 Falsified Medicines Directive and is intended to safeguard the public against counterfeit products.
Dr Roberto Frontini
EAHP emphasised the positive role barcoding of the single dose of medicine can have in terms of patient safety. It enables bedside scanning and checking of the medicine immediately prior to its administration to the patient. Studies have suggested barcoding and checking
medicines in this way can reduce medication errors by as much as 40%. However hospital pharmacists have warned the Commission that choices made on the specification of anticounterfeiting systems could
have unintended consequences for the possibility of panEuropean barcoding of the single dose. This might include, for example, stipulating manufacturers apply a form of barcode for medicines packaging, such as linear code, that, due to size, may
not easily also be applied to single doses of medicine within blister packages. EAHP favours 2D GS1-compliant datamatrix codes for this reason. Dr Roberto Frontini, President of the EAHP said: â€œHospital Pharmacists in Europe feel very strongly about the patient safety benefits of single dose barcoding. It is therefore important that EAHP brings to the attention of all relevant policy makers in the medicines sector the advantages of introducing this approach. We also must ensure the achievement of single dose barcoding is not threatened by developments elsewhere, such as the forthcoming introduction of an anticounterfeit medicines verification system."
HPN presents Irish Pharmacy Awards The response in the form of submissions and nominations to the Irish Pharmacy Awards 2012 was overwhelming. This issue of HPN features all the finalists within our three hospital cageories, and importantly all the winners. In addition we have the official stamp of approval from Minister for Health Dr James Reilly who comments that "Irish Pharmacy Awards are an important
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opportunity for the pharmacy sector to recognise pharmacists and pharmacy personnel who have made a significant contribution to the improvement of patient care and pharmacy practice in Ireland. "I commend those pharmacists who are dedicated to innovation and excellence in patient care," he says. The entries ranged from
innovative e-learning developments to professionals who have endeavoured throughout their career to improve medication safety and compliance. Response to the night itself on may 19th was overwhelming, with over 450 attendees. Please turn to page 17 for full details.
Hospital pharmacy baseline survey The PSI is currently conducting a Baseline Study of Hospital Pharmacy Practice in Ireland. This study aims to provide an understanding of the nature and type of hospital pharmacy services currently being delivered nationally and also, (in a parallel phase), to review and report on the international profile of standards of hospital
pharmacy service and care delivery. The study also aims to ascertain the views of the profession in order to inform policy development in this critical area, which is a key concern of the PSI Council and central to the future development of the profession. The study is being carried out on behalf of the PSI by consultants
Horwath Bastow Charleton (HBC), and under the auspices of the Pharmacy Practice Development Committee, an advisory committee of the PSI Council. In addition, a Project Steering Group has been established, chaired by Dr. Ann Frankish, and comprising patient interest and hospital pharmacy practice expertise to oversee
the project and to ensure compliance with the stated objectives on behalf of the PSI. All Hospital Pharmacists are encouraged to participate in this survey, in order to obtain a reflective input from the profession and an accurate benchmark of hospital pharmacy services in Ireland.
Illegal Medicines Case The Irish Medicines Board (IMB) notes that James Bellamy, Director of Harmony Products Ltd, yesterday received a three year prison sentence and a fine of €100,000 at the Dublin Circuit Criminal Court. This followed his conviction for the illegal importation and wholesale of unauthorised prescription only medicinal products which were
later sold as ‘herbal viagra’ for erectile dysfunction. Harmony Products Ltd was also fined €150,000 with one year to pay or distress in default. The case was brought by the Director of Public Prosecutions following an investigation carried out by the IMB and An Garda Síochána.
Fellow awards at TCD Dr Ed Lavelle
Trinity College Dublin celebrated the beginning of the annual Trinity Week with the announcement of two Honorary Fellows, 16 new Fellows and 103 new Scholars of the College, a record number for the College. Dr Lorraine O'Driscoll from the School of Pharmacy was elected as a Fellow, as was Dr Ed Lavelle from the School of Biochemistry and Immunology. Other awardees included
President of Ireland, Michael D. Higgins, who received an Honorary Fellowship from the College for his commitment to education throughout the course of his career. The ceremony is one of the oldest and most colourful at Trinity College Dublin, dating back to the foundation of the College in 1592, and marks the beginning of the annual Trinity Week, a long established celebration of College life.
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UCC Professor leads researchers Professor Brendan Buckley, Clinical Professor at the School of Pharmacology, UCC is leading a research team amongst an international consortium of investigators from more than 50 large studies across Europe, North America, East Asia and Australia. of genetic variants have been robustly found to be associated with fracture risk.
Professor Brendan Buckley
Within the largest genetic study in osteoporosis performed to date, the researchers studied the relationship of genes with fracture in approximately 30,000 cases and 100,000 controls. Osteoporosis is a common and often devastating age-related disease. 50% of subjects that fracture their hip after 80 years
die within 12 months afterwards. Surprisingly, women older than 65 years are at greater risk of dying after hip fracture than after breast cancer. The disease is strongly genetically determined, but the genes responsible have been largely unknown. However, this situation has changed dramatically today.
According to the researchers study, published in the leading genetics journal Nature Genetics, variants in 56 regions of the genome have been discovered to influence the bone mineral density (BMD) of individuals. Fourteen of these variants were also found to increase the risk of bone fracture. This is the first time such a large number
The study pinpointed many factors in critical molecular pathways that are possible targets for new medicines to stop bone loss. Some of these have become available recently to treat the disease and others are in clinical trial. The potential is further highlighted by the identification in this study of genes encoding proteins that may be targets for future drugs that may stimulate new bone building. Just as interesting is the discovery of groups of individuals with genetic variants that protected them against developing osteoporosis or sustaining fractures.This study is part of the GEnetic Factors of OSteoporosis (GEFOS) project sponsored by the European Commission (FP7-HEALTH- F22008-201865-GEFOS). Additional information on the project can be found at http:// www.gefos.org/.
Motion welcomed for patient access The Irish Pharmaceutical HealthcareAssociation (IPHA) has welcomed the tabling of a motion at the Annual Conference of the Irish Medical Organisation (IMO) regarding patient access to new medicines. The IMO motion calls on the Minister for Health to ensure that new medicines, which have completed satisfactory
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pharmaceutical and economic evaluation, are immediately reimbursed on the StateDrug Schemes. Welcoming IMOâ€™s stance, David Gallagher, IPHA President said: "The research based pharmaceutical industry is constantly developing new and innovative medicines which offer great hope for the management
of chronic illnesses. As well as being in breach of the current agreement with the IPHA regarding the supply of medicines, the failure on the part of the HSE to fund new products that have successfully completed the HTA process, is denying Irish patients access to a growing range of treatments that are routinely available in
other countries. "I sincerely hope that Minister Reilly will take heed of this motion and instruct the HSE to immediately ensure that its agreement with the IPHA is adhered to and that Irish patients, regardless of income, can access new and often life changing treatments."
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Reduces Total Cholesterol and LDL Cholesterol1 Helps prevent cardiovascular events in patients at risk of first event1
Ireland has a NEW King of Hearts! Abbreviated prescribing information: Torvan 10 mg/ 20 mg/ 40 mg and 80 mg Film-coated tablets. Presentation: Torvan is supplied as film-coated tablets of 10 mg/ 20 mg/ 40 mg or 80 mg of atorvastatin. Indications: Torvan is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Used for the prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors. Dosage: The patient should be placed on a standard cholesterol-lowering diet before receiving atorvastatin and should continue on this diet during treatment with atorvastatin. The dose should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response. The usual starting dose is 10 mg once a day. Adjustment of dose should be made at intervals of 4 weeks or more. The maximum dose is 80 mg once a day. Atorvastatin is for oral administration. Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food. Contraindications: Hypersensitivity to the active substance or to any of the excipients of this medicinal product. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal. During pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures. Special warnings and precautions for use: Liver function tests should be performed before the initiation of treatment and periodically thereafter and in patients who develop any signs or symptoms suggestive of liver injury (monitor raised transaminase levels until they resolve). Should an increase in transaminases of greater than 3 times the upper limit of normal (ULN) persist, reduction of dose or withdrawal of atorvastatin is recommended. For patients with prior hemorrhagic stroke or lacunar infarct, the balance of risks and benefits of atorvastatin 80 mg is uncertain, and the potential risk of hemorrhagic stroke should be carefully considered before initiating treatment. Torvan should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis and a CK (creatine kinase) level should be measured before treatment. If CK levels are significantly elevated at baseline (> 5 times ULN), treatment should not be started. Patients with muscle pain, cramps, or weakness especially if accompanied by malaise or fever should have their CK levels monitored. Torvan must be discontinued if clinically significant elevation of CK levels (> 10 x ULN) occur, or if rhabdomyolysis is diagnosed or suspected. If muscular symptoms are severe and cause daily discomfort treatment discontinuation should be considered. The risk of myopathy may also be increased when administered with other medicinal products that have a potential to induce myopathy. In cases where co-administration of these medicinal products with Torvan is necessary, the benefit and the risk of concurrent treatment should be carefully considered. The concurrent use of atorvastatin and fusidic acid is not recommended, therefore, temporary suspension of atorvastatin may be considered during fusidic acid therapy. Exceptional cases of interstitial lung disease have been reported with some statins. If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued. Developmental safety in the paediatric population has not been established. Drug Interactions: CYP3A4 inhibitors, CYP3A4 inducers, Transport protein inhibitors, Gemfibrozil / fibric acid, derivatives, Ezetimibe, Colestipol, Fusidic acid, Digoxin, Oral contraceptives, Warfarin, Tipranavir, Ciclosporin, Lopinavir, Ritonavir, Clarithromycin, Saquinavir, Darunavir, Itraconazole, Fosamprenavir, Nelfinavir, Grapefruit Juice, Diltiazem, Erythromycin, Amlodipine, Cimetidine, Efavirenz, Rifampin, Gemfibrozil, Fenofibrate, Phenazone. Pregnacy and lactation: Torvan should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant. Undesirable effects: Common side effects include: nasopharyngitis, allergic reactions, hyperglycaemia, pharyngolaryngeal pain, epistaxis, constipation, flatulence, dyspepsia, nausea, diarrhoea, myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain, liver function test abnormal, blood creatine kinase increased, headache, abdominal pain, alanine aminotransferase increased, blood creatine phosphokinase increased, For further undesirable effects, please refer to the SPC. Shelf Life: 18 months. Marketing Authorisation Holder: Pinewood Laboratories Ltd, Ballymacarbry, Clonmel, Co. Tipperary. Marketing Authorisation Holder Numbers(s): PA 281/150/001 - 004. This medicine is a prescription only product. Further prescribing information is available on request. Date of revision: April 2012 References: 1. Torvan Summary of Product Characteristics, April 2012 Date of preparation: April 2012
Irelandâ€™s No. 1 Generic Healthcare Specialists
The good news is that innovation and dedication is well and truly alive throughout the island of Ireland. The bad news is that there is so much it has been incredibly difficult to choose the best. The Irish Pharmacy Awards 2012 were held on May 19th in The Burlington Hotel, Dublin and proved to be an ovberwhelming success. Over 400 of the pharmacy industry's professionals gathered for an evening of celebration and recognition and the comments post-event were inspiring. Joan Peppard, President of the Hospital Pharmacists Association of Ireland, and a member of our elite judging panel comments, "It has been wonderful to witness first hand the work being undertaken throughout hospital pharmacy recognised. "The significant contribution to patient safety and the multidisciplinary approach evident in all the submissions has been extremely noteworthy. The judging panel expect that these awards
will inspire further work and recognition of hospital pharmacy practice in a collaborative patient-focussed environment." Minister for Health Dr James Reilly placed his own stamp of approval on the Irish Pharmacy Awards, exclusively telling HPN, "These awards are an important opportunity for the pharmacy sector to recognise pharmacists and pharmacy personnel who have made a significant contribution to the improvement of patient care and pharmacy practice in Ireland. I commend those pharmacists who are dedicated to innovation and excellence in patient care.' He states: We are living in a time of significant challenge and change, particularly in health services. Irish people are living longer but are at greater risk of developing chronic diseases. As pharmacists well know, our patients increasingly take a more complex range of medicines. In our health system, change is necessary and we must work together to ensure that our patients continue to receive healthcare which is safe, of high quality, equitable and sustainable. "
Over the forthcoming pages we feature the finalists within each of our Hospital Award categories and the fantastic winners who were announced on the night itself. There are some truly oustanding examples of , not to mention individual endeavours to greatly enhance the wellbeing and health of hospital patients throughout Ireland. The team at Hospital Pharmacy News are thrilled to introduce these submissions and would like to congratulate the teams and hospital pharmacists involved with each project submission. The Irish Pharmacy Awards showcase the best of hospital pharmacy inviting projects that demonstrate results in improving and progressing the pharmaceutical profession and experience for patients and customers in a total of fourteen categories. IPN Communications Managing Director Natalie Maginnis comments: "When we launched this Awards at the start of 2012 I was confident that the oustanding service provided by Ireland's pharmacists and pharmacy teams, across both hospital and community settings, would be recognised."
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Hospital Pharmacy of the Year Sponsored by Roche Products (Ireland) Limited
Ciaran Meegan (Team Lead) Pharmacy: Mater and Peamount Hospitals Ciaran Meegan, Michelle McGuirk, Maria Creed, Mater Hospital, Debbie Murray, Peamount Hospital. Pharmacy Department at Mater Hospital Project Overview: The team have developed an e-learning programme which will raise understanding of high-risk drugs and the dangers that can be posed when these are administered or prescribed. The online health and safety course identifies the top ten medicines and drug groups that can result in harm, as well as how errors in prescription and medication might occur and how these can be avoided. It highlights the importance of educating professionals in high-risk drugs across all care sectors, from the prescription of the product to its administration and dispensation. The e-learning programme also reinforces the importance of reporting any errors relating to medication.
Muireann Ni Shuilleabhain (Team Lead) Pharmacy: South Infirmary, Victoria University Hospital, Pharmacy Department Muireann Ni Shuilleabhain, Chief Pharmacist with her Pharmacy Department, South Infirmary-Victoria University Hospital Project Overview: The team's focus has been to bring the Pharmacy Department into the wider spectrum of the hospital organisation and the entire team has worked enthusiasticly and passionately to achieve this goal. 2012 witnessed two patient safety and staff efficiency projects coming to fruition. One project focuses on a pharmacist medicines reconcilliation service whilst the other looked at increasing efficiences achieved with restructuring an existing model of pharmaceutical care. The commitment of both these projects has resulted in very positive results in terms of patient safety, measurable cost savings and enhanced working relationships.
John O'Bryne (Team Lead) Pharmacy: Tallaght Hospital, Pharmacy Department Members of the pharmacy team at Tallaght Hospital including Evelyn Deasy (Pharmacy Education and Research Manager), Ann Allen (Clinical Pharmacy Services Manager), Michelle Fitzsimons (Senior Clinical Pharmacist) and Jennifer Hayde (Senior Clinical Pharmacist) Project Overview: Managing patient medication at points of transfer into or out of the hospital setting is a central element to patient safety and care and at Tallaght Hospital pharmacy department, the last five years has witnessed a programme of research and process improvement to improve patient safety and medicines management. The team at Tallaght have developed Ireland's first electronic medication reconcilliation tool (TEAMS), providing clear information to GPs and community pharmacists concerning a patients discharge medication list and medications which were stopped or changed during hospitalisation. The service, just one of several innovated by the team, has been highly commended by community pharmacy colleagues.
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The Winner of the Hospital Pharmacy of the Year Award: Muireann Ni Shuilleabhain and team, South Infirmary Victoria University Hospital Pharmacy Department.
On accepting t he Award, Muireann commented
I am delighted that all of our hard work and innovation at the Pharmacy Department at the South Infirmary Victoria University Hospital has been acknowledged. The staff really deserve this award as they are a high performing team in this time of limited resources. "The Irish Pharmacy awards ceremony was a very positive experience for us. Hospital pharmacists are generally modest about their achievements. There are many hospital pharmacies doing challenging and innovative work throughout the country and I would encourage hospital pharmacy teams to partake in the award process in the future. The participation process has boosted morale in our department and raised our profile in the hospital.
"Thanks to the organisers at IPN for creating such a glittering night at the Burlington ballroom, and to Roche Pharmaceuticals for sponsorship of this Hospital Pharmacy Award.
Dr Osamu Okuda, Managing Director of Roche said
Sean Dowling and Muireann Ni Shuilleabhain with the Hospital Pharmacy of the Year Award
Through our work with pharmacists, we are privileged to witness their commitment to the health and wellbeing of their patients every day. We are pleased to recognise this commitment in partnership with Irish Pharmacy News, and honour their professionalism through the sponsorship of these awards. Congratulations to South Infirmary, Victoria University Hospital Department, Cork, Hospital Pharmacy Team of the year.
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Hospital Pharmacist of the Year Sponsored by Roche Products (Ireland) Limited
Tim Delaney Pharmacy: Health Services Executive Nomination Overview: Tim Delaney is the Medication Safety Programme Lead for the Health Services Executive in Ireland. Tim has extensive experience in pharmacy and healthcare management having held positions as the Head of Pharmacy in Adelaide Hospital (1989-1994), Chief executive Officer, Adelaide Hospital (1994-1998) and Chief Pharmacist, Tallaght Hospital (1998-2010). He was a member of the Management Team in Tallaght Hospital, with responsibility for Pharmacy, Process Improve, Medical Physics and Clinical Engineering and Catering. Whilst in Tallaght Hospital, Tim established Ireland's first Medication Safety Programme in the acute healthcare setting, providing a national blueprint for the reporting of medication safety incidents for the purpose of organisational learning and systems improvements.
Oisin O'Halaoin Pharmacy: Midland Regional Hospital, Tullamore Nomination Overview: Oisin is predominantly a hospital pharmacist based within the Midland Regional Hospital in Tullamore but is also a member of the Green Party and within this context he campaigns tirelessly for Ireland to clean itself up. A tutor for the Irish Centre for Postgraduate Continuing Education Oisin has a passion for enhancing the profile of hospital pharmacy, standing for election last year to the Pharmaceutical Society of Ireland. Oisin was instrumental in overseeing the relocation of the hospital pharmacy department within Tullamore to a new, larger space whilst ensuring minimal distruption to their services and patients.
Mairead Galvin Pharmacy: Naas General Hospital/School of Pharmacy, Trinity College Nomination Overview: Mairead works within the hospital pharmacy department at Naas General Hospital. Within her role she has been key in researching antimicrobials and works as part of the multidisciplinary antimicrobial stewardship team. She has worked passionately within medicine reconcilliation to improve medicine safety and compliance within the hospital setting. She has published research into the area of sources of pre-admission medication information and has been described as constantly eager to promote the role of the hospital pharmacist within the context of the wider healthcare team, often taking on research and pilot projects in addition to her day-to-day work within Naas General Hospital.
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The Winner of the Hospital Pharmacist of the Year Award: Tim Delaney, Health Services Executive.
Speaking after the event, which he sadly couldn't attend, Tim told Hospital Pharmacy News
I am delighted to receive this Award and I see it as an affirmation of my work in medication safety, which is gratifying. I have been fortunate in my hospital pharmacy career to have worked with many excellent colleagues, both pharmacists and technicians whose enthusiasm, intelligence and hard work made so many developments possible. However I would like to dedicate this award to the first pharmacis I recruited when I became a Chief Pharmacist. Denise Ward Molloy worked with me for twelve years in the Adelaide and Tallaght Hospital. She played a key role in the forging of one team from three as we moved from our three small city centre hospitals to one large one. Her untimely death, just one week before this ceremony, leaving her husband David and two boys bereft, reminds us of how precious and unpredictable life is. I dedicate this award to her memory.
Dr Osamu Okuda, Managing Director of Roche said
John O'Byrne from Tallaght Hospital Pharmacy Department accepts the Hospital Pharmacist of the Year Award on behalf of Tim Delaney from Rory Lee, Business Unit Director, Roche Products (Ireland)
Through our work with pharmacists, we are privileged to witness their commitment to the health and wellbeing of their patients every day. We are pleased to recognise this commitment in partnership with Irish Pharmacy News, and honour their professionalism through the sponsorship of these awards. Congratulations to Tim Delaney, Hospital Pharmacist of the Year.
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Hospital and Community Pharmacy Alliance Award Sponsored by Hospital Pharmacy News Cliona Hayden, Eimear O'Dwyer and Fiona McGrehan (Team Lead) Pharmacy: Our Lady's Hospice and Care Services Pharmacy Department Cliona Hayden and Eimear O'Dwyer Project Overview: The 'Palliative Meds Info Service' is a specialist service which responds to telephone and email enquiries from health professionals caring for patients with life-limiting illnesses throughout Ireland. Pharmacists at Our Lady's Hospice identified the need for providing practice-based medicines information to these healthcare professionals and this is the first palliative meds information service in Ireland. The service provides hospice based expertise to practitioners in the community, including GPs and community pharmacists to help overcome regional inequalities in the availability of hospice services throughout Ireand.
Niamh O'Hanlon and Peter McElwee Pharmacy: St Vincents University Hospital Pharmacy Department Project Overview: Peter and Niamh have, over a number of years, developed a mutually beneficial relationship working across the hospital and community pharmacy interface, liaising to clarify prescriptions from St Vincents and to establish patient medication safety. Decisions regarding a patients medical treatment whilst in hospital and which will have a direct impact on the patients care back ihn the community are advised through this liaison and with true multidisciplinary working. The relationship has greatly enhanced Peter's ability to work as a community pharmacist and has helped in advising his own prescribers and allows the hospital pharmacy team to discharge patients with confidence back into the community.
Oisin O'hAlmhain Pharmacy: Midland Regional Hospital Pharmacy Department, Tullamore Project Overview: Oisin through his work in the Pharmacy department at Tullamore Hospital, Co. Offally, liaises with community pharmacy by giving ‘Patient Medication Profiles’ to patients when they leave the hospital. These are cards that contain details of all the medication the patient is on and are for patients to stick on their fridge at home and bring with them to the pharmacy whenever they go to pick up their medication. This ensures that the patient has advanced knowledge of what they are on and that the pharmacist has quick access to the information that has been provided by the hospital to the patient.
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The Winner of the Hospital & Community Pharmacy Alliance Award: Cliona Hayden, Eimear O'Dwyer and Fiona McGrehan, Our Lady's Hospice and Care Services Pharmacy Department, including Ms Veronica Treacy and Ms Aveen Murray.
Emer O’Dwyer accepted the award on the night and told HPN
We are delighted to have won the Hospital and Community Pharmacy Alliance Award.
"While this kind of award is a mark of achievement for the work that we have been doing, it is also a great way to promote the service to both community and hospital pharmacists around the country. "We provide the service to help pharmacists provide the best care to their patients with palliative care needs. Having won the award presents us with an opportunity to promote and expand the service and improve the quality of palliative care that is given in all care settings.
Debbie Graham, Sales Manager of Hospital Pharmacy News states
I was absolutely delighted with the calibre of the finalists and highlighting the importance of hospital pharmacy liaising with community colleagues. "The winning entrants, Cliona Hayden and Eimear O’Dwyer from Our Lady’s Hospice are very deserving and provide a service that raises the bar, providing an essential accessibility that helps so many across Ireland.
Veronica Treacy and Aiveen Murray with the Hospital and Community Pharmacy Alliance Award
Veronica Treacy and Aiveen Murray accept the award from Debbie Graham, Sales Manager, Hospital Pharmacy News
HPN • Issue 4
16 Awards Social
Irish Pharmacy Awards 2012 The Guests Over 450 of the pharmacy industry's great and good turned up to The Burlington Hotel in Dublin for the inaugural Irish Pharmacy Awards. The night was hailed as the biggest success of the pharmacy calendar for 2012 with guests in their droves excited about booking their place at the 2013 extravanganza!
1) Compere Sybil Mulcahy,
TV3 The Morning Show 2)
Jonathan Irwin, Chief Executive, Jack and Jill Foundation, Ireland and Senator Mary Ann O'Brien, MD, Lily O'Briens Chocolates
3) Patricia Ging, Michelle McGuirk, Mariosa Kieran, Mater Hospital Pharmacy Department 4) Rhona Murray and Dr Martin Henman, School of Pharmacy, Trinity College, Dublin 5) Joan Peppard, President, HPAI (and Judge) and John Peppard 6)
Colm O'Sullivan, Niamh O'Sullivan, Mairead Galvin, Ronan Fingleton, Naas General Hospital Pharmacy Department
7) Keith O'Neill and Dr Anne Marie Healy, School of Pharmacy, Trinity College Dublin 8)
Edward McGettrick, Locum, Brian Kehoe, David Murphy Pharmacy, Emer Curran, Cappagh Hospital and Derina Deveny, Health Express
Mater Hospital pharmacist Patricia Ging who was one of two winners in our High/Low Charity Game
10) Muireann NiShuilleabhain and Andrew Desmond, South Infirmary Victoria University Hospital
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Healthcare workers urged to admit mistakes and to ignore a mother's concern at their peril “To err is human, to cover up is unforgivable but to refuse to learn is inexcusable,” Conference told. Healthcare workers can and do make mistakes but it is how they act when this happens and how they learn from it that is key, the Hospital Pharmacists Association of Ireland (HPAI) Annual Conference has heard. Keynote speaker Mrs Margaret Murphy, External Lead, Patients for Patient Safety Programme, WHO Patient Safety, gave a presentation explaining how negative patient experiences can be used as a learning tool in the health service with the aim of avoiding reoccurrence and promoting full disclosure when things go wrong. Mrs Murphy’s 21-year-old son Kevin died after a series of delays and errors in diagnosing his illness in the Irish health service, and she now acts as a patient advocate and speaks about Kevin’s death and her family’s experience after his death. “Every point of contact in the health service failed him,” Mrs Murphy told the Conference, explaining how her family were”
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driven” down the litigation route, which they didn’t want, in an effort to arrive at the truth and gain an understanding of what had happened, “after being met with denial, collegiality, defensiveness and inappropriate behaviour”. “Our main purpose in all of that was learning. We couldn’t change the past. We couldn’t undo the event but we certainly had a hope that healthcare could use it and prevent reoccurrence,” she told delegates, stressing that full disclosure is vital and is not about apportioning blame. LISTEN TO THE PATIENT “The patient is present through the entire continuum of care. They are the only individual who is there from A to Z and we are not mining the knowledge and information they have and the contribution they can make to the process,” Mrs Murphy pointed out. She urged hospital pharmacists and all healthcare workers to use
the patient experience and learn from it. While acknowledging that things have begun to change for the better since her son’s death, she stressed there is still a long way to go.
Concluding, Mrs Murphy summed up her argument quoting Sir Donaldson: ”To err is human, to cover up is unforgivable but to refuse to learn is inexcusable.”
THE DIFFERENCE BETWEEN LIFE AND DEATH
Quoting Sir Liam Donaldson, Chair, WHO Patient Safety, Mrs Murphy said the five most dangerous words in healthcare are “it could not happen here”. “Don’t ever be seduced by the notion that it can’t happen to you,” she warned the hospital pharmacists, adding that she only realised from listening to other speakers at the Conference how much contact hospital pharmacists had with patients. Mrs Murphy said her key message to the conference was “simple measures save lives, it is not always the complicated stuff”, and “You ignore at your peril the concerns of a mother. The umbilical cord is never totally severed.”
This year’s HPAI Annual Conference highlighted the high level of research in the sector, with 98 poster presentations submitted for appraisal. Common themes included promoting better medication safety and highlighting the role of the hospital pharmacist in reducing medication errors within the hospital setting and in the community. HPAI President Ms Joan Peppard said hospital pharmacists play a vital role in the Irish healthcare system and are making significant contributions to improving medication safety and patient care, by working with their hospital healthcare colleagues in a multidisciplinary, collaborative way.
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20 News She also highlighted the success of antimicrobial pharmacists in helping contribute to the reduction in MRSA and C. Difficile cases reported in Irish hospitals. 2
“Hospital pharmacists are highly trained healthcare professionals and can contribute more to the hospital setting in terms of improving patient care and delivering cost efficiencies.
We are keen to work with our hospital colleagues and the HSE on progressing and expanding our role within the hospital sector,” she commented. Just under 200 delegates attended the weekend Conference. The Hospital Pharmacists Association of Ireland (HPAI) is a non profit-making voluntary group that exists to further the development of hospital pharmacy practice, assists in the provision of continuing pharmaceutical education for its members, represents hospital pharmacists at national level on issues of relevance to hospital pharmacy and seeks to advance the professional welfare of its members.
It runs an annual conference with educational workshops, keynote speakers, research and audit poster exhibition and the organisation's AGM. This year’s conference took place on 20th22nd April 2012 in the Crowne Plaza Hotel, Santry.
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1) Niamh Ennis, SJH; Niamh Keady SVUH; Aisling Beakey; Beaumont Hospital; Aedan O'Callaghan; JCMH; Kieran Reynolds; Aine Walsh; Claire Mullins MMUH; Laura Gale; Tallagh Hospital 2) President of the HPAI Joan Peppard presents a cheque for 1,000 (Euros) to the Pharmacy Benevolent Fund 3) Aisling O' Donnell and Rory O'Donnell, Vice president Irish Pharmacy Union and Joan Peppard; President of HPAI 4) Pat Norris, Baxter Healthcare Ltd with Lisa Kelly, MRH and Poster Competition winner 5) Marie Murray, St Michael's Hospital and Marie Keane, Limerick Regional Hospital 6) Fergal O'Shoughnessy, Coombe Hospital 7) Chairperson Maria Creed, MMUH
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Potential to develop new drugs to tackle heart disease Researchers from the Royal College of Surgeons in Ireland (RCSI) and the University of Bristol have discovered that oral bacteria that escape into the bloodstream can cause blood clots and trigger life-threatening growths on heart valves. Further research arising from this study could lead to new drugs to tackle infective heart disease.
Dr Steve Kerrigan
Dr Steve Kerrigan, School of Pharmacy, was the RCSI collaborator on the study which is being presented at the Society for General Microbiology's Spring Conference which takes place in the Convention Centre Dublin this week. The bacteria Streptococcus gordonii is a normal inhabitant of the mouth and contributes to plaque that forms on the surface of teeth. If these bacteria enter into the blood stream through bleeding gums they can start to wreak havoc by masquerading as human proteins. The researchers have discovered that S. gordonii is able to produce a molecule on its surface that lets it mimic the human protein fibrinogen - a blood-clotting factor. This
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activates the platelets, causing them to clump inside blood vessels. These unwanted blood clots encase the bacteria, protecting them from the immune system and from antibiotics that might be used to treat infection. Platelet clumping can lead to growths on the heart valves (endocarditis), or inflammation of blood vessels that can block the blood supply to the heart or brain. Dr Helen Petersen who is presenting the work said that better understanding of the relationship between bacteria and platelets could ultimately lead to new treatments for infective endocarditis. "In the development of infective endocarditis, a crucial step is the bacteria sticking to the heart valve and then activating
platelets to form a clot. We are now looking at the mechanism behind this sequence of events in the hope that we can develop new drugs which are needed to prevent blood clots and also infective endocarditis," she said.
components of the S. gordonii molecule that mimics fibrinogen, so we are getting closer to being able to design new compounds to inhibit it. This would prevent the stimulation of unwanted blood clots," said.
Infective endocarditis is treated with surgery or by strong antibiotics - which is becoming more difficult with growing antibiotic resistance. "About 30% of people with infective endocarditis die and most will require surgery for replacement of the infected heart valve with a metal or animal valve," said Dr Petersen.
The team are also looking more widely at other dental plaque bacteria that may have similar effects to S. gordonii. "We are also trying to determine how widespread this phenomenon is by studying other bacteria related to S. gordonii. What our work clearly shows is how important it is to keep your mouth healthy through regular brushing and flossing, to keep these bacteria in check," stressed Dr Petersen.
Dr Steve Kerrigan, RCSI commented: "Our team has now identified the critical
Streptococcus gordonii is a bacteria that affects the mouth
Protelos is proven to be an effective long term 1st line treatment option in postmenopausal osteoporosis to reduce vertebral and hip fractures, by rebalancing bone turnover in favour of bone formation 1
Protelos (strontium ranelate) abbreviated prescribing information: Please refer to the Summary of product Characteristics before prescribing. Presentation: Sachet containing 2g of strontium ranelate granules for oral suspension. Indication: Treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures. Dosage and Administration: The recommended daily dose is one 2g sachet once daily by oral administration at bedtime, preferably at least two hours after eating. The granules in the sachets must be taken as a suspension in a glass of water. Due to the nature of the treated disease, strontium ranelate is intended for long-term use. Generally, calcium and vitamin D supplements are advised in women with low dietary intake. Elderly (>65): No dosage adjustment is required in relation to the elderly. Renal Impairment: No dosage adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance). Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30Â ml/min). Hepatic Impairment: As strontium ranelate is not metabolised, no dosage adjustment is required in patients with hepatic impairment. Paediatric Population: The safety and efficacy of Protelos in children aged below 18 years have not been established. No data are available. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions: VTE: Protelos is associated with an increased risk for venous thrombo-embolic events (VTE). The cause of this finding is unknown. Protelos should be used with caution in patients at increased risk of VTE, including patients with a past history of VTE. Skin reactions: Cases of severe hypersensitivity syndromes, including, in particular, drug rash with eosinophilia and systemic symptoms (DRESS), sometimes fatal, have been reported with use. Interaction with laboratory test: Strontium interferes with colorimetric methods for the determination of blood and urinary calcium concentrations. Therefore, in medical practice, inductively coupled plasma atomic emission spectrometry or atomic absorption spectrometry methods should be used to ensure an accurate assessment of blood and urinary calcium concentrations. Excipient: Protelos contains a source of phenylalanine which could be harmful for people with phenylketonuria. Interactions: Food, milk and derivative products, and medicinal products containing calcium may reduce the bioavailability of strontium ranelate, therefore, administration of Protelos and such products should be separated by at least two hours. It is preferable to take antacids at least two hours after Protelos, however, when this dosing regimen is impractical due to the recommended administration of Protelos at bedtime, concomitant intake remains acceptable. Protelos therapy should be temporarily suspended if a patient is on a course of oral quinolone or tetracycline antibiotics as it may hinder their absorption. Fertility, pregnancy and lactation: Protelos is only intended for use in postmenopausal women. There are no data from the use of strontium ranelate in pregnant women. Physicochemical data suggest excretion of strontium ranelate in human milk. Protelos should not be used during breast-feeding. No effects were observed on males and females fertility in animal studies. Undesirable effects: Overall incidence rates for adverse events with strontium ranelate did not differ from placebo and adverse events were usually mild and transient. The most common adverse events (frequencies versus placebo) consisted of nausea (7.1% vs. 4.6%), and diarrhoea (7.0% vs. 5.0%), which were generally reported at the beginning of treatment with no noticeable difference between groups afterwards. Other adverse events included: headache (3.3% vs. 2.7%), memory loss (2.5% vs. 2.0%), disturbance of consciousness (2.6% vs. 2.1%), dermatitis (2.3% vs. 2.0%), eczema (1.8% vs. 1.4%), venous thromboembolism (2.7% vs. 1.9%), increases in blood creatinine kinase (1.4% vs. 0.6%). Other adverse reactions where frequency was unknown include: Severe hypersensitivity skin reactions including Stevens-Johnson syndrome and DRESS; alopecia; oral mucosal irritation; bronchial hyperreactivity, hepatobiliary disorders, bone marrow failure insomnia, dyspepsia, gastroesophageal reflux, constipation, flatulence and hepatitis. Undesirable effects associated with hypersensitivity skin reactions include pyrexia, lymphadenopathy and eosinophilia. See Summary of Product Characteristics for further details. Presentation: Box containing 28 sachets. Legal Category: POM. Marketing Authorisation Numbers and Holder: EU/1/04/288/001-006, Les Laboratoires Servier, 50, rue Carnot 92284 Suresnes cedex France. Date of Preparation or Last Review: December 2011. Full prescribing information is available from: Servier Laboratories, Block 2, West Pier Business Campus, Old Dunleary Road, Dun Laoghaire, Co. Dublin. Tel: (01) 6638110, Fax: (01) 6638120. Date of Preparation of Item: December 2011. 1. Protelos Summary of Product Characteristics
24 Urinary Tract Infection
The Management of Urinary Tract Infection Sean Egan is currently the Antimicrobial Pharmacist at Tallaght Hospital in Dublin and has been in this position for five years. In his role, he aims to drive quality improvement in antimicrobial usage. He first registered as a pharmacist in 2003, and has worked as a Clinical Pharmacist in the hospital setting in Ireland and the UK since registration. He graduated from the University of Nottingham School of Pharmacy. Egan also has an MSc from Trinity College Dublin and, has completed Green-Belt certification in Six Sigma process improvement methodology. INTRODUCTION Urinary tract infections (UTIs) are among the most common infections encountered. UTIs are more common in women, with the lifetime risk of UTI among women being reported as 60% [1-3]. UTIs are usually caused by transfer and invasion of patient bowel flora such as enterobacteriaceae (for example E.coli, Klebsiella pneumoniae or Proteus mirabilis) or enterococci (Enterococcus faecium or Enterococcus faecalis) translocating into the urinary system via the ascending transurethral route (most commonly), the bloodstream, the lymphatics or by direct extension. Typically E. coli is identified in 80-90% of positive urine samples processed in Irish microbiology laboratories. Urinary tract infection may be classified as either uncomplicated, complicated or urosepsis. Risk factors for UTIs include pregnancy, poorly controlled diabetes mellitus, urological surgery, ureteral obstruction, increasing age and transient short-term catheterisation. DEFINITIONS UNCOMPLICATED UTIs Uncomplicated UTIs include simple cystitis and acute pyelonephritis. Cystitis is defined as inflammation of the urinary bladder and associated symptoms include frequency, dysuria, urgency, haematuria, suprapubic pain and change in the smell of the urine. This accounts for the vast majority of patients with UTI, and is usually treated successfully in the community setting. Pyelonephritis is defined as bacterial infection of the kidney
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substance. Acute pyelonephritis is distinguished from simple cystitis by symptoms including fever, rigors, nausea, vomiting and flank pain. The symptoms of cystitis may or may not occur in patients with acute pyelonephritis. While these symptoms are characteristic, confusion and other non-specific signs and symptoms can make diagnosis difficult, particularly in elderly patients. The risk of mortality is increased in pyelonephritis, and some patients may require hospitalisation for treatment. Both of these types of infection should be distinguished from asymptomatic bacteriuria which is the presence of bacteria in urine without signs or symptoms of infection. This may be common in some cohorts of the population, including nursing home patients and does not typically require treatment (however pregnant women with asymptomatic bacteriuria should be treated with antibiotics as they are at much higher risk of complications). COMPLICATED UTIs Complicated UTIs are associated with a structural or functional urological abnormality, or immunosuppression, which alters the natural defence system and exposes the patient to an increased risk of infection. Patients with indwelling catheters, men, diabetics and pregnant women are also classified as complicated as their treatment requires an alternative and more cautious approach compared to uncomplicated cystitis. Typically, urine culture in patients with indwelling urinary catheters will reveal the presence of a potential Gram-negative urinary pathogen. However, this commonly reflects catheter colonisation rather than infection, and positive microbiological identification should not generally be treated without other signs of infection.
On the other hand, bacteriuria is commonly associated with both short-term and long-term catheterisation and the duration of catheterisation is an important risk factor for the development of catheter associated bacteriuria.
may increase the risk of infection. Moreover, factors which affect the body’s immune function will also increase infection risk. Risk factors for UTI include;
Urinary tract infection is less common in men, and may be associated with diabetes mellitus. UTI in men requires a longer duration of treatment as there is a higher risk of progression to pyelonephritis or associated prostatitis. Likewise, all diabetic patients are at higher risk of progression to urosepsis and need a longer treatment course.
Urosepsis is a systemic infection of the bloodstream with an associated inflammatory response to infection caused by UTI. This is more common with complicated UTIs and pyelonephritis, and is associated with a mortality rate of 13-30%. Early diagnosis and initial broad-spectrum antibiotic treatment of urosepsis is vital. The treatment of complicated UTI, pyelonephritis and UTI in pregnancy and children is usually undertaken under specialist supervision or in the hospital setting. The remainder of this article with therefore largely focus upon the general principles of diagnosis and treatment of urinary tract infection, with a particular focus on the rationale for antibiotic agent choice in the treatment of uncomplicated UTI. RISK FACTORS FOR A UTI Physiologically, the urinary tract and kidney are designed to flush away any bacterial overgrowth which might cause infection. In principle, anything which increases the chance of urinary bacterial colonisation or reduces the urinary system's ability to void properly
• Urinary tract procedures • Diabetes mellitus • Immunocompromised state • Structural or functional urological abnormalities • Sexual activity DIAGNOSIS Diagnosis of a urinary tract infection may be made by the presence of clinical signs of infection, and urinary microbiological testing. This may be challenging in some patient groups, such as elderly patients with dementia as a good clinical history may be difficult, and bacteriuria will be common. Urine dipstick testing in the medical centre can help to differentiate patients who have urinary tract infection from those without UTI, including those with asymptomatic bacteriuria. Testing for urinary nitrites and leukocytes can act as a useful negative screen, as inability to detect both together suggests a UTI is unlikely 95% of the time. However dipstick testing is unreliable in pregnancy, children under three years and patients with complicated UTIs – these patients need urine culture in the laboratory. LABORATORY DETECTION Laboratory detection can take the form of direct microscopy or culture. Microscopy measures the
25 amount of red and white blood cells in urine, which can indicate infection. In addition it may be possible to quantify the number of bacteria present. The presence of both blood cells and bacteria in urine is highly suggestive of infection. More commonly, semi-quantitative culture of urine to identify bacteria is used to aid UTI diagnosis. This technique counts the number of colony forming units of bacteria per ml of urine. The bottom third of the urethra is likely to be colonised with bacteria in most patients, which is why a midstream urine sample should be used. There will, therefore likely be bacteria in any urine sample, but this may just correspond to urethral colonisation rather than UTI. Semi-quantitative culture aims to differentiate between colonisation and infection by using a cut-off point of 100,000 colony forming units per ml. Samples which yield the presence of below this concentration for one or more species of bacteria per urine sample may indicate bacterial colonisation. With the exception of catheter colonisation, a sample with more than 100,000 colony forming units per ml is indicative of infection. The infecting species is also identified at this point and, where a significant result is found antibiotic susceptibility testing is performed.
URINARY PATHOGEN ANTIBIOTIC SUSCEPTIBILITY IN IRELAND
NEW TRENDS IN ENTEROBACTERIACEAE RESISTANCE
UTI is usually caused by bacterial translocation from the patients bowel and the potential infecting pathogen may range from enterobacteriacea to enterococci, staphylococci or candida. However, the vast majority of infections are caused by the enterobacteriaceae â€“ Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis, and the enterococci - Enterococcus faecium or Enterococcus faecalis. When devising empiric antibiotic guidelines, an awareness of changes in the resistance patterns of these key species is paramount.
Fully sensitive enterobacteriaceae will usually be successfully treated with penicillins, cephalosporins, trimethoprim, cotrimoxazole, nitrofurantoin or the fluoroquinolones, such as ofloxacin or ciprofloxacin. Unfortunately, amoxicillin resistance levels have rendered this agent redundant for empiric therapy across Ireland. However the remaining agents still have a potential place in therapy.
Currently, national data on the resistance patterns to these pathogens in urinary samples is, unfortunately lacking, and we have to rely on data extrapolated from patterns derived from blood culture isolates. These are not directly applicable to UTI treatment in the community because they often reflect resistance patterns in sicker, largely hospitalised patients, who will be more likely to have received antibiotics and exhibit infection with more resistant organisms. Nevertheless, this data provides us with useful directly comparable data with which to benchmark trends both nationally and internationally. A number of important trends have emerged.
Historically, enterobacteriaceae have overcome amoxicillin treatment through the evolution and spread of the beta-lactamase class of enzymes, which hydrolyse this drug. Mankind fought back with the discovery of betalactamase inhibitors, such as clavulanic acid, which prevented penicillin hydrolysis. Co-amoxiclav remains a useful option for the treatment of most UTIs. However, the enterobacteriaceae have continued to evolve new resistance mechanisms, such as cephalosporinases or extendedspectrum beta-lactamases (ESBLs), which allow them to overcome antibiotics, such as co-amoxiclav and cephalosporins. This has begun to manifest itself in Ireland over the past 5 years. An examination of resistance trends amongst E. coli bloodstream isolates nationally over the past decade reveals in increase in the
Antibiotic Feb 04 Feb 05 Feb 06 Feb07 Feb 08 Feb 09 Feb 10 Total Ď‡2 p-value First line antibiotics Trimethoprim %S 69.5% 72.0% 69.9% 69.5% 69.5% 72.5% 71.2% 70.6% 0.726
N 518 578 658 717 868 848 889 5076
Nitrofurantoin %S 92.8% 87.0% 88.4% 89.5% 89.3% 87.8% 91.1% 89.4% 0.319 Ampicillin
N 97 123 155 687 853 838 888 3641 %S 50.1% 53.2% 47.6% 47.9% 48.1% 50.2% 50.3% 49.5% 0.408 N 525 588 660 728 877 838 890 5106
Second line antibiotics Cephalexin
94.0% 93.3% 89.9% 92.5%
N 83 104 138 146 159 162 - 812
Cephradine %S 88.4% 89.6% 85.8% 85.1% 87.8% 86.5% 84.7% 86.6% 0.137
N 432 471 513 565 704 666 885 4236
Ciprofloxacin %S 95.7% 95.0% 93.8% 92.4% 88.2% 90.0% 85.2% 90.8% <0.05
N 510 575 645 706 861 842 881 5020
Co-amoxyclav %S 87.6% 87.8% 81.6% 82.9% 89.2% 82.1% 88.0% 85.2% <0.05
N 525 588 662 730 879 862 899 5145
incidence of ESBL-producing organisms and, currently just over 1 in 20 isolates identified in blood-cultures in hospitalised patients produce ESBL and may be resistant to cephalosporins and co-amoxiclav . This new form of resistance has also been accompanied by co-resistance to fluoroquinolones and trimethoprim in some bacterial strains, meaning that conventional agents may not be as universally efficacious as in previous decades. Whilst data on resistance to bloodstream isolates provides us with a useful picture of underlying trends in our sicker patients, good practice in the formulation of an evidence based empiric policy needs to be informed by resistance patterns in urinary isolates. Unfortunately, national data on resistance patterns amongst urinary bacterial isolates is not available. However, a recent survey published by five hospital microbiology laboratories in the Cork and Kerry regions (Cork University Hospital, Mercy University Hospital, Kerry General Hospital, Bons Secours Hospital Cork and Bons Secours Hospital Tralee) provides a useful insight into more regional data . Data on positive urine samples, which originated in general practice were compared on the same month each year from 2004-2010, and trends in infecting pathogen and resistance rates were analysed. Enterobacteriaceae accounted for 88% of positive samples and enterococci accounted for a further 5%. Antimicrobial resistance patterns were analysed for these two groups of organisms. Ampicillin was tested in place of amoxicillin and the sensitivity result for ampicillin may be regarded as comparable. Similar analysis of laboratory testing of GP urine samples at Tallaght hospital demonstrates a comparable pattern of resistance . National empiric guidelines for the treatment of infection in general practice were produced by a working group of the Health Protection Surveillance Centre/Strategy for the Control of Antimicrobial Resistance in Ireland (SARI) in November 2011. These guidelines recommend that nitrofurantoin and trimethoprim be used empirically as first-line agents for the treatment of UTI. Data from the Cork/Kerry study reveal that sensitivity to these two agents remained high in 2010 at 89% for nitrofurantoin and 71% for trimethoprim.
Table 1. Percent of Enterobacteriaceae and Enterococcus sp sensitive (%S) to 1st line antibiotics by month and year of sample (N=5152, not all samples were tested for all antibiotics)
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26 Urinary Tract Infection
Trimethoprim resistance has increased in the period since 2004. Traditionally, a cut-off point of 80% sensitivity has been used to guide the utility of an agent for empiric UTI efficacy in the hospital setting. In this study, trimethoprim fell below this cut-off point â€“ however the authors point out that these results will be biased towards patients with persistent UTI postantibiotics, as urine culture is usually only utilised in the minority of patients treated in primary care. Trimethoprim sensitivity rates are likely to be much higher in the general community population, and they suggested that empiric trimethoprim should continue to be used in their region as per national guidelines . Figure 2. (Above) National Empiric Antibiotic Treatment Guidelines for UTI.  Low sensitivity rates to ampicillin support the view that amoxicillin should not be used empirically for UTIs. These guidelines also include a separate section on the
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diagnosis and treatment of UTI in long-term care residents over the age of 65 years, and include recommendations for the treatment of patients with catheter associated UTIs. USE OF BROADER-SPECTRUM AGENTS EMPIRICALLY FOR UNCOMPLICATED UTI It is possible that individual pockets of trimethoprim resistance may exist in other regions of Ireland, and the existence of such data may preclude the application of national guidelines to local use. However it is unlikely that a similar co-resistance pattern to nitrofurantoin will also be found. Empiric therapy with one or both drugs should be possible in most patients who are not contraindicated to nitrofurantoin or trimethoprim. The oral cephalosporins cefalexin and cefradine remain useful second-line agents, but it should be noted that they do not have activity against enterococci. Co-amoxiclav and ciprofloxacin are much more broad-spectrum
than agents discussed to date. Whilst both will likely be effective against most UTIs, usage also exposes patients to additional and arguably unnecessary ecological collateral damage. Co-amoxiclav, quinolones and cephalosporins have been implicated as agents which are more likely to encourage the emergence of antimicrobial resistance or Clostridium difficileassociated diarrhoea than trimethoprim or nitrofurantoin. They should therefore be considered as second-line agents on the basis of their risk-benefit profile in this setting. TREATMENT OPTIONS FOR MORE RESISTANT ENTEROBACTERIACEA IN PRIMARY CARE Whilst national empiric guidelines will work for the majority of patients, the treatment of infection caused by more resistant infecting pathogens may increasingly require the use of less conventional therapy. Enterobacteriaceae which produce cephalosporinases or extendedspectrum beta-lactamases
may not be treatable with cephalosporins or co-amoxiclav. Amongst the samples processed in the laboratory at Tallaght Hospital, activity appears to be retained to nitrofurantoin in the majority of patients, and this remains a useful therapeutic option. In a small number of patients, nitrofurantoin may be contraindicated or coresistance to this drug may be present. In these circumstances, alternative oral agents are limited and clinicians are beginning to rediscover antibiotic choices which were formally used in Ireland but have fallen out of favour until recent times. Fosfomycin tromethamine is a phosphonic acid antimicrobial agent which retains activity against a wide range ofenterobacteriaceae, including those that produce extendedspectrum beta-lactamases (ESBLs) . This drug is unlicensed in Ireland and the UK but has been used extensively across Europe and North America for some time. A German brand of the product called Monuril is currently available from the specialist wholesaler
Medisource, and this comes in a 3000mg (3g) sachet format. It is licensed in Germany for the treatment of acute uncomplicated UTI in women aged from 12 to 65 years. The drug is given as a 3g one off “mega-dose”, and patients should be advised to mix this in a glass of water before swallowing. They should also be advised that although this drug only requires a one-off dose, it may take a number of days for symptomatic relief to emerge as the drug is excreted via the urinary system over time. The side-effect profile of this drug is comparable to other antibiotics, with diarrhoea occurring in 2.4-9% of cases. Serious adverse events are rare and are isolated to limited case-reports. These include angioedema, aplastic anaemia, asthma exacerbations, cholestatic jaundice, hepatic necrosis and toxic megacolon. Pivmecillinam hydrochloride may also be used as an agent to treat UTI in an era of increasing beta-lactam and cephalosporin resistance . This drug is licensed in the UK and has been used in some centres to fill the clinical need for an oral agent used to treat multidrug-resistant enterobacteriaceae. There is less experience of using the drug against isolates which produce ESBLs, and some authors have suggested that it should be used in combination with co-amoxiclav as it displays synergy when given with clavulanic acid. Currently, pivmecillinam susceptibility testing is not widely available in Irish microbiology laboratories. There is a significant clinical need for more oral agents which retain activity against enterobacteriaceae. In the absence of activity against drugs such as nitrofurantoin, fosfomycin or pivmecillinam, clinicians increasingly need to fall back on intravenous antibiotic options which require much greater healthcare utilisation and are far from ideal from a patient perspective. Without further drug discovery in this field, it is likely that the treatment of UTI may increasingly require intravenous therapy in some patients. USUAL DURATION OF ANTIBIOTIC TREATMENT Uncomplicated cystitis in women should respond to three days therapy of an antibiotic which retains activity to the infection organism, although some guidelines recommend up to 5 days of nitrofurantoin. UTI
antibiotic treatment courses in diabetics, pregnant women and men are longer with seven to 14 days being required. Pyelonephritis may require 14 days therapy, although a seven day treatment course may be possible with ciprofloxacin. WHO CAN BE TREATED SYMPTOMATICALLY? Balakrishnan et al  recommend that for non-pregnant female patients with mild dysuria and no underlying risk factors, referral to the general practitioner for antibiotic therapy may not be necessary. In such patients, it is likely that antibiotic therapy will only shorten the duration of UTI symptoms by up to one day. In this cohort of patients ensuring adequate hydration should result in resolution of symptoms. Use of urine alkalinising agents may also be of benefit for these patients, however a robust evidence base to support their use is not present. Where use of these agents could be recommended, care should be taken to avoid use in conjunction with interacting agents such as ACE-inhibitors, potassium-sparing diuretics, or lithium. Patients with a history of persistent UTI may benefit from drinking cranberry juice, as it inhibits bacterial adhesion to the urinary tract epithelium and can prevent infection . Heterogeneity between studies has meant that the optimal dose and duration of cranberry juice consumption is yet to be fully determined. Cranberry juice interacts with warfarin and should be avoided in patients taking this medicine. Balakrishnan et al recommend that all pregnant women, diabetics, men, children under 16 or patients with underlying heart or renal disease should be referred to their GP for treatment. They also recommend that patients with cloudy or smelly urine, haematuria, thirst and unexplained weight-loss should also be referred. This is not an extensive list for referral however, nor is it possible to outline every scenario where GP referral should occur. Careful clinical judgement on a case-by-case basis should also occur in the pharmacy, with consideration of the possibility of other differential diagnoses. In addition to the factors outlined by Balakrishnan et al, referral of patients to their GP if there is the possibility of progression to upper urinary tract infection should also occur. This would include the immunocompromised, any
patient with flank pain, increased temperature, nausea and vomiting or flu like symptoms, patients with indwelling urinary catheters, those who have had recent urological procedures, or patients with underlying structural urological abnormalities. All patients with persistent urinary symptoms should also be referred. OVERALL CONCLUSIONS Urinary tract infection is one of the most common infection types encountered in primary care. Antibiotic choice has become more complicated in recent times with the evolution of greater Gram-negative resistance, and it is likely that unless new licensed oral treatment options come to market in Ireland, we will increasingly need to rely on older unlicensed agents or intravenous options. This has implications for patients, community pharmacists, GPs and secondary/tertiary healthcare providers. The way we use antibiotics for the treatment of UTI in primary care also has important implications for preventing the emergence of resistance to these agents, especially those which have activity against Gram-negative pathogens. Good practice both in the diagnosis and prescription of antibiotics, with a special emphasis on ensuring optimal agent choice, dose and duration are vital in helping to preserve antibiotic utility into the future. REFERENCES 1. Grabe M, Bjerklund-Johansen TE, Botto H, Wullt B, Cek M, Naber, K.G et al.. Guidelines on Urological Infections. The Netherlands: European Association of Urology, 2011. ISBN 978-90-79754-96-0. 2. Kumar, P. and Clark, M (Eds). 2008. Clinical Medicine. 6th Edition. London: Elsevier Saunders Limited 3. Kalpana, G., Hooten, T.M., Naber, K.G., Wullt, B., Colgan, R., Miller, L.G., Moran, G.J et al.. International Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women: A 2010 Update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clinical Practice Guidelines, 2011;52: e103-e118.
Resistance/EuropeanAntimicrobial ResistanceSurveillanceSystemEARSS/ EARSSSurveillanceReports/2011Re ports 5. A Brennan, A Sheahan, O Murphy, L Cronin, M Kelly, M Coughlan, B O’Reilly, L Barry, S O’Connell. Cork and Kerry study looks at antibiotic susceptibility in urine samples - EpiInsight – Disease Surveillance Report of the HPSC Vol 13 Issue 2. Feb 2012. Available at http://ndsc.newsweaver. ie/epiinsight/1mn862vqdrs?a=1&p=20 966705&t=17517774 6. Cullen IM, Manecksha RP, McCullagh E, Ahmad S, O’Kelly F, Flynn RJ, McDermott T et al. The changing pattern of antimicrobial resistance within 42,033 Eschericia coli isolates from nosocomial, community and urology patientspecific urinary tract infections, Dublin 1999-2009. BJU Int. 2011 Aug 24. doi: 10.1111/j.1464-410X.2011.10528.x. [Epub ahead of print] 7. Bradley CP, Carey B, Murphy M, O’Connor N, Cunney R, Byrne S Sheehan A, on Behalf of SARI/ HSE. Guidelines for Antimicrobial Prescribing in Primary Care in Ireland, November 2011. Available at http://www.hpsc.ie/hpsc/A-Z/ MicrobiologyAntimicrobialResistance/ InfectionControlandHAI/Guidelines/#d. en.3334 8. Falagas ME, Kastoris AC, Kapaskelis AM, Karageorgeopolis DE. Fosfomycin for the treatment of multidrug resistant, including extended-spectrum beta-lactamase producing, Enterobacteriaceae infections: a systematic review. Lancet Infectious Diseases. 2010;10:43-50 9. Pallett, A. and Hand, K.. Complicated urinary tract infections: practical solutions for the treatment of multi-resistant Gram-negative bacteria. Journal of Antimicrobial Chemotherapy, 2010;65:iii25-iii33 10. Balakrishnan I, Hill V. Dealing with Urinary Tract Infections. The Pharmaceutical Journal. 2012 pages 687-690 11. Jepson RG, Craig JC. Cranberries for preventing urinary tract infections. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD001321. DOI: 10.1002/14651858. CD001321.pub4.
4. The Health Protection Surveillance Centre/ Health Service Executive. EARS-Net Report Quarter 3 2011. Available at http://www.hpsc.ie/ hpsc/A-Z/MicrobiologyAntimicrobial
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28 Out and About
Record hospital pharmacists attend EAHP congress On the occasion of its 40th Anniversary, the European Association of Hospital Pharmacists (EAHP) has recently recorded the highest number of attendees at its annual Congress so far. In total 3,700 conference delegates registered and attended over the three day event in Milan between 21st and 23rd March, listening to keynote speeches, taking part in seminars, and enjoying associated sponsor events.
The theme of the Congress was “Special patient groups – hospital pharmacists creating standards for care” with the 3 keynote speakers addressing the topics of: limits of treatment; the management of risk and life safety; and, drug safety in geriatric patients. Professor Umberto Veronesi, the internationally recognised Italian surgeon and oncologist, opened the Congress with an address on the modern advances being
1) Conor Delaney, Pfizer 2) Actavis delegates at the Nerviano Plant 3) Richard Kay Pharmashelve Ltd 4) Conference Centre, Milan 5) Connor Sadler Actavis, Eileen Fitzgerald, Mayo General Hospital and Caroline Fitzgerald, Actavis 6) Damian Griffin and Celia Serra, Accord Generics 7) Zaldoun al-Hilali (UAE) James Donohoe (Ireland) and Daniel Morkla (UK) Hospira 8) Jane Strong Tallagh Hospital, Caroline Fitzgerald Actavis and Marie Keane, Limerick Regional 2
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made in many areas of treatment such as stem cell research, the move towards multi-disciplinary models of health provision, and nanotechnology. He then outlined some of the many potential future roles of pharmacists as in palliative care, pain management and the use of opiods, clinical trials and clinical decision-making. Elsewhere at the Congress, amongst the many other events, the preliminary results of the 1
EAHP pan-European survey of current hospital pharmacy practicewere presented, a lively panel discussion was held on the future of hospital-based small scale production and an educational seminar took place on the involvement of the hospital pharmacist in chronic infections.
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NICE guideline will revolutionise the way we manage Hypertension Written by Eoin O’Brien, Professor of Molecular Pharmacology, The Conway Institute, UCD
Professor Eoin O’Brien
These admonitions apply equally to Ireland. Indeed, the Irish population aged 65 years or older has been estimated to have grown by around 107,771 persons in the period 19962011, to represent in total about 14% of the general population. Nearly 25% of persons in this group will be over 80 years, the majority of whom will have isolated systolic hypertension. CONVENTIONAL BP MEASUREMENT
The National Institute for Health and Clinical Excellence (NICE) has just published a draft for consultation of its 2011 guideline for the Clinical Management of Primary Hypertension in Adults. The NICE guidelines are recommendations for the care of patients with a variety of illnesses, so that best clinical practice is achieved in primary and secondary care in the NHS. The stated mission of NICE is to “base [its] clinical guidelines on the best available research evidence, with the aim of improving the quality of healthcare”. To achieve this, NICE uses predetermined and systematic methods to identify and evaluate the evidence relating to specific review questions. This body has gained such respect and scientific credibility over the years that its guidelines influence national policy on healthcare delivery
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across the world. Consequently, the hypertension guideline is going to have a profound effect on how high blood pressure (BP) will be diagnosed and managed in primary care in the UK and Ireland in the future. Introducing the need for change, the guideline reminds us at the outset that at least one quarter of the adult population of the UK has hypertension, and that this figure rises to more than 50% in people over the age of 60 years. Moreover, as the demographics of the UK shift towards an older, more sedentary and obese population, the prevalence of hypertension and its requirement for treatment will continue to rise. We are also reminded that high blood pressure is the major cause of stroke and that bringing BP down to normal prevents this catastrophic complication.
High BP continues to be diagnosed in primary care and in hospital clinics using the traditional technique of measurement with a mercury sphygmomanometer and stethoscope (or more lately with automated devices), despite the fact that this technique has been shown to be grossly inaccurate. Since Riva-Rocci and Korotkoff gave us the technique of conventional BP measurement (CBPM) over a century ago, we have landed men on the moon, encircled Mars, invented the automobile and aeroplane and, most importantly, revolutionised the technology of science with the microchip. Why, we might ask, has medicine ignored scientific evidence and technological advances for so long so as to perpetuate a grossly inaccurate measurement technique in both clinical practice and hypertension research? It is a salutary thought that if (as conservative estimates show) whitecoat hypertension is present in 20% of the population when BP is measured conventionally in primary care,
and if masked hypertension is present in 10% of patients whose BP is measured in similar circumstances, it follows that hypertension is being misdiagnosed in as many as a third of all patients attending for routine BP measurement. NICE recommends ABPM for diagnosis and treatment of hypertension Now all must change. The NICE guideline confirms the inaccuracy of conventional measurement: “These findings suggest that the current practice of using a series of CBPM alone for the diagnosis of hypertension leads to inaccurate diagnosis” and that “the current practice of using CBPM to define hypertension will lead to drug treatment being offered to a substantial number of people who are normotensive”. The guideline has no hesitation therefore in stating emphatically that 24-hour ambulatory blood pressure measurement (ABPM) “should be implemented for the routine diagnosis of hypertension in primary care”. To be specific, the guideline stipulates: “If the first and second BP measurements taken during a consultation are both higher than 140/90mmHg, offer 24-hour ambulatory blood pressure monitoring to confirm the diagnosis of hypertension.” The authors recognise, however, that this recommendation will have profound implications for the diagnosis of hypertension and that it must be based on very robust evidence. NICE undertook, therefore, the most detailed cost-benefit analysis ever conducted for ABPM and
conventional measurement. This led the authors of the RAMBLER study to conclude that “ABPM appears to have a significant impact on decisionmaking of general practitioners and on the medical management of patients with hypertension in the community”. The RAMBLER II Study using the dabl interpretive reporting system and central analysis to assess the feasibility of ABPM in more than 100 primary care practices is presently being analysed.
this showed clearly that the use of ABPM would result in substantial savings to the NHS. “This analysis suggests that ABPM is the most costeffective method of confirming a diagnosis of hypertension in a population suspected of havingmeasurement >140/90mmHg… This conclusion was consistent across a range of age/gender stratified subgroups.”
“considerable challenges”. Some of the problems recognised by NICE are the training of healthcare professionals, the provision of sufficient numbers of validated ABPM devices and the need for staff to be “trained in their use and the interpretation of data generated by the reports”.
IMPLEMENTATION OF NICE RECOMMENDATIONS
The same problems face clinical practice in Ireland but, unlike the UK, ABPM has become increasingly available in primary care, often with the support of the pharmaceutical industry. Indeed, Ireland was the first European country to show that ABPM could be used effectively in primary care to achieve better blood pressure control in patients with hypertension.
The NICE guideline readily admits that implementation of a recommendation — which means in effect that some 13 million patients with high blood pressure in the UK will have to be offered ABPM not only to confirm the diagnosis, but also for the follow-up assessment of treatment efficacy — will present
The RAMBLER study in 2006 showed that ABPM allowed patients with inadequate blood pressure control to be identified and, in some cases, prevented from unnecessarily commencing antihypertensive medication, and that blood pressure control was improved in those managed with ABPM compared with
The recommendation of NICE will be applied, quite rightly, to practice in Ireland. We should anticipate, therefore, the consequences for clinical practice.
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Although general practitioners in Ireland use ABPM more than their colleagues in the UK, the reality is that the new Minister for Health, Dr James Reilly, will have to make funding available forthe widespread use of the technique in primary care. However, he should not see this as a deterrent, but rather welcome it as a means for preventing stroke and heart attack, with the potential for enormous savings in the future. If blood pressure control was achieved in Ireland, some 5,000 strokes per annum could be prevented! However, the daunting reality is that less than a third of patients on treatment have their blood pressure controlled. THE ROLE OF PHARMACIES IN PROVIDING ABPM Whereas primary care practices will be the main providers of ABPM (provided adequate reimbursement is made available) pharmacies are now proving to be valuable alternative providers. Indeed recent commentaries in the Journal of the American Medical Association have deplored the underutilisation of highly skilled pharmacists in the provision of health care and have shown, moreover, that when
pharmacists become engaged in the management of hypertension BP control improves. Recently ABPM has been introduced to pharmacists in Ireland using the dabl system (www.dablhealth. com) of analysis and reporting. (see Figure 1) If ABPM in a pharmacy is normal the patient is instructed to bring the report to his/her general practitioner at their next attendance but if the ABPM is reported as abnormal instruction is given to make an appointment as soon as possible. To-date the feedback from patients and referring general practitioners is very positive. The advantages of ABPM in pharmacies are: Greater availability of ABPM to the public Ready access to a local and convenient pharmacy Provision of an interpretative report to the patient who is informed as to the degree of blood pressure control Close collaboration between the pharmacist and the patient’s general practitioner Provision of a trend report (See Figure 2) to patients having a repeat ABPM so as to indicate the response to blood pressure lowering medication Availability of data to provide demographic information on national blood pressure trends. One of the major features of being able to engage hypertensive patients in the management of their illness is how much more compliant with management and treatment they become when they are actively informed as to the state of their blood pressure control. Pharmacists can play a major role in this process.
ch to op a io o r id p p
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
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). 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.
➞ ➞ ➞
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.
Insights into anti-dementia prescribing Professor David Williams of the Department of Geriatric Medicine, RCSI
Medicine, RCSI, and Dr Kathleen Bennett, Senior Lecturer in Pharmacoepidemiology and Statistician in the Department of Pharmacology and Therapeutics, TCD, conducted an analysis of the national prescription of antidementia medications database.
A study carried out by researchers within the Royal College of Surgeons of Ireland and Trinity College has shown insights into prescribing trends of anti-dementia drugs in Ireland. Despite clear guidance existing on dosage escalation, the study shows this is not being implemented in the majority of cases. Linda Brewer and Professor David Williams of the Department of Geriatric
They found that approximately 70% of patients remained on the initial dosage prescribed with no up-titration over time. "With regard to donepezil, most patients (80 per cent) were commenced on 5mg and over half of these patients remained on this introductory dose,” the researchers found. Overall, adherence to antidementia medications was low (at less than 60 per cent), which may reflect poor surveillance of drug compliance in this cohort, according to the research team.
Some 40,000 people in Ireland have dementia and anti-dementia medications (cholinesterase inhibitors and NMDA receptor antagonists) are widely prescribed, with studies of these drugs reporting improvements in cognitive scores, function and behaviour to varying degrees, which can delay the need for nursing home care. The HSE Primary Care Reimbursement Service (PCRS) pharmacy database contains prescription information for
the majority of the over 70s in Ireland and, therefore, includes most beneficiaries of antidementia treatment, they noted. The researchers analysed prescribing patterns from 2006 to 2010 of commonly-prescribed anti-dementia medications (donepezil, rivastigmine, galantamine and memantine) using the database, which contains prescription information for 1.2 million people. Drug dosages, duration and adherence were also examined.
New data for Twynsta New data show that TWYNSTA®, a once daily, single pill combination of the angiotensin II receptor blocker (ARB) telmisartan and the calcium channel blocker (CCB) amlodipine, leads to rapid and sustained blood pressure (BP) reductions that can bring most patients with previously uncontrolled hypertension on RAS inhibitor monotherapy to BP goal effectively within 4 weeks.
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The results from the TEAMSTA Switch study, presented at the 22nd Annual Scientific Meeting of the European Society of Hypertension (ESH) in London, show that TWYNSTA® delivers prompt BP control in the majority of patients with uncontrolled hypertension on RAS blocker monotherapy (i.e. angiotensin II receptor blockers, angiotensinconvertingenzyme inhibitors or direct renin inhibitors) and provides further
confirmation of its excellent efficacy in controlling high blood pressure. Despite decades of persistent efforts, in Europe the BP control of patients who suffer from hypertension is only approximately 30%. “This study clearly shows that the combination of an ARB with a CCB is a highly effective way
of optimising blood pressure control in the majority of people” said the lead author of TEAMSTA Switch, Professor Bryan Williams, Professor of Medicine at the University of Leicester.
Whatâ€™s the best treatment? Life writes the questions. We pursue the answers. Our innovations help millions of people by alleviating their suffering and improving their quality of life. We give them hope.
We Innovate Healthcare
36 NAHPT Conference 2012
'Beyond the Horizon' On the 28th April 2012 the National Association of Hospital Pharmacy Technicians held their annual conference and AGM at the Crowne Plaza Hotel, Northwood, Santry, Dublin.
contribution of the pharmacy team can make to positive patient outcomes.
The programme included a number of motivating presentations that demonstrated how improvements can be made in pharmacy services and patient care optimised by extending the role of the pharmacy technician.
The poster exhibition demonstrated clear evidence of pharmacy technician’s input and value adding activities within pharmacy practice. The judges on the day said the standard is being raised each year and it is becoming more difficult to choose a clear winner in each category.
Highlights of day included Tanya Creaner, Chief Pharmacy Technician, Craigavon Hospital who gave an overview of the pharmacy technician’s roles and responsibilities within the Southern Health and Social Care Trust NI while Dr. Tamasine Grimes focussed on how the
Ms Marie McLaughlin, University Hospital Galway, was the overall winner of the Actavis Academy Poster Award. Her poster was titled “Towards a leaner dispensary service. The UHG Experience” Eleanor Muir, St James’s Hospital was runner up with a highly commended poster.
The student first place winner was Ciara Eagleton for her poster entitled ”To Evaluate the information generated by the Implementation of a Specific Intravenous Immunoglobulin Prescription in the University Hospital Galway." Second place and highly commended went to Elaine Gahan. Both students are from AIT Athlone. We would like to thank all delegates who attended and participated in our conference and to thank all the pharmaceutical companies who support us and help us provide a professional, educational networking event for all pharmacy technicians. Yvonne Sheehan President NAHPT 2011-2013
1) Lorna Morris and Jennifer Henry AIG Athlone
5) Damian Griffin Accord Generics and Laura Lyons Mator Public Hospital NAHPT Editor
9) Eithne Oogan Sligo Hospital, Paul Wellwood, Dara Duff, Dawn Johnston Medisource
6) James Donohoe Hospira, Ann O'Brien Mater Public Hospital and Mark Kelly Hospira
10) Actavis Poster Competition Caroline Fitzgerald presenting to Ciara Eagleton AIT, highly commended student
2) Caroline Fitzgerald and Connor Sadlier Actavis Caroline Fitzgerald, Ciara Eagleton, Elaine Gahan and Diane Patterson, both students are undertaking the add on degree year at Athlone Institute of Technology.
4) Padraig Cahil Pfizer, Yvonne Sheehan President NAHPT and Caroline Reidy Pfizer
7) Rosemary Dwyer Naas General, Joanne Phelan Waterford Regional Hospital and Fran Glynn NAHPT Vice President 8) Jurgan Wegner Pinewood, Miriam William and Bridin O'Rourke IT Students Carlow
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12) Caroline Fitzgerald Actavis presenting to Elaine Gahan AIT student winner
11) Winner of the Actavis Draw, Emma Hutton Carlow IT and Caroline Fitzgerald from Actavis
13) Carina O'Reilly, Ilona Rusiecka and Catherine Earely IT Carlow
18) Caroline Fitzgerald Actavis presenting to runner up Eleanor Muir St James Hospital
14) Emmett Moran Vice President IACPT, Sarah Smyth and Diane Patterson AIT Course Co-orinator
19) Thomas Colgan, Sharon Rice, Tara Byrne United Drug, Elaine Murphy Intrapharma
15) Caroline Fitzgerald Actavis presenting to overall winner Marie McLaughlin 16) Bernie Love Connolly Hospital, Sean Gaffney Chugai, Aoife Noonan IT Carlow and Irene Roycroft Naas Hospital
20) Avril Duignan, Trisha Hayes Fresenius Kabi, Tania O'Sullivan and Lydia Meyler Bon Secours Hospital Tralee 21) Ciara Devlin Gerard Labs, Wendy Abbey, Amanda King and Tony Toomey Pharmasource
17) Eithne Oogan Sligo Hospital, Paul Wellwood, Dara Duff, Dawn Johnston Medisource (2)
HPN â€˘ Issue 4
EAHP Annual Academy Seminar The European Association of Hospital Pharmacists (EAHP), in combination with the Panhellenic Association of Hospital Pharmacists (PEFNI),recently held its 7th Annual Academy Seminar to assist hospital pharmacists in learning from European and Global best practice. The event also gave practical guidance to attendees about how to implement change in their hospital pharmacy.
Delegates attending the EAHP Annual Academy Seminar.
The weekend of themed lectures and workshops took place in Thessaloniki, Greece between 20th and 22nd April 2012. 40 pharmacists participated from 14 countries, and were mainly heads of pharmacies or deputies from the new EU-Countries and EU candidate countries. The overall topic of the 2012 weekend was: "What do we need to know about building or reconstructing a hospital pharmacy?" Topics covered included: production engineering; quality and risk management; how to set up new facilities; hospital
pharmacy logistics; use of automatic picking systems; and latest developments in medicine barcode technology. Participants were guided and informed about these subjects by prominent individuals in hospital pharmacy including: Technology Consultant Winfried Scheirer; Barbara Wimmer, a Head of Drugs Information and Clinical Pharmacy in an Austrian hospital; HolgerKnoth, Head of Pharmacy at Carl Gustav Carus University Hospital in Dresden; and, Michael Beranek, a consultant in Good Manufacturing Practice. All participants received certificates of education accredited by the Accreditation Council for Pharmacy Education (ACPE) on completion of the course.
Green award for Temple Street Pictured at the 2012 Green Awards is Stephen Wheeler, Managing Director of Airtricity presenting the Green Leadership Award to Padraig Ryan, Sustainability Officer, Children's University Hospital Temple Street.
Children’s University Hospital, Temple Street has been recognised with two prestigious accolades at the 2012 Green Awards for its success in implementing a holistic approach to environmental management. Temple Street was a finalist in both the Green Healthcare and Green Leadership categories, as well as making it into the top 10 of the 300 entries, ‘the best of the best’. The hospital was honoured with the Green Healthcare Award for
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the structured approach that it has implemented over the past number of years towards environmental areas including waste, water and energy management. To add to this award, Padraig Ryan received the 2012 Green Leadership Award for his role in implementing and embedding a culture of sustainability within the hospital. He was commended for going that extra mile to promote the hospital’s sustainability agenda.
Get them back in the swing of things
Restore the natural rhythm of life for patients with depression l First
Line treatment for depression1 l Improves mood and daytime functioning1,3
circadian rhythms1,2 l Respects sexual life1
Valdoxan (agomelatine) abbreviated prescribing information: Please refer to the Summary of Product Characteristics before prescribing. Presentation and composition: Valdoxan 25 mg film-coated tablets. Indication: Treatment of major depressive episodes in adults. Dosage: Adults: The recommended dose is 25 mg once daily taken orally at bedtime. After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime. Liver function tests should be performed in all patients at initiation of treatment and then periodically after around six weeks (end of acute phase), after around twelve and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated. Valdoxan tablets may be taken with or without food. Elderly (>65y): Efficacy has not been clearly demonstrated in the elderly (≥ 65 years). Only limited clinical data is available on the use of Valdoxan in elderly patients ≥ 65 years old with major depressive episodes. Therefore, caution should be exercised when prescribing Valdoxan to these patients. Paediatric Population: The safety and efficacy of Valdoxan in children aged below 18 years have not been established. No data are available. Administration: taken as a single dose at bedtime. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms. Properties: Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. Agomelatine resynchronises circadian rhythms in animal models of circadian rhythm disruption. Agomelatine increases noradrenaline and dopamine release specifically in the frontal cortex and has no influence on the extracellular levels of serotonin. Contraindications: Hypersensitivity to the active substance or to any of the excipients, Hepatic impairment (eg cirrhosis or active liver disease), Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin). Fertility, pregnancy and lactation: For Valdoxan, no clinical data on exposed pregnancies are available. Caution should be exercised when prescribing Valdoxan in pregnancy. It is not known whether Valdoxan is excreted into human milk. If treatment with Valdoxan is considered necessary, breastfeeding should be discontinued. Precautions: Valdoxan should not be used in elderly patients with dementia with depressive symptoms as safety and efficacy has not been established in this group. Valdoxan should be used with caution in patients with a history of bipolar disorder, mania or hypomania and should be discontinued if a patient develops manic symptoms. Valdoxan contains lactose. The combination of Valdoxan and alcohol is not advisable. Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. If any patient develops symptoms suggesting hepatic dysfunction liver function tests should be performed. Caution should be exercised when Valdoxan is administered to patients with pretreatment elevated transaminases (> the upper limit of the normal ranges and ≤3 times the upper limit of the normal range), preferably by laboratory tests within the first 3 weeks of treatment.The decision whether to continue the patient on therapy with Valdoxan should be guided by clinical judgement pending laboratory evaluations. If jaundice is observed therapy should be discontinued. Caution should be exercised when prescribing Valdoxan for patients with hepatic injury risk factors e.g. obesity/overweight/non-alcoholic fatty liver disease, substantial alcohol intake or concomitant medicinal products associated with risk of hepatic injury.Drug Interactions: Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/19 (10%). Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine. Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure. Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated. Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold increased exposure of agomelatine. While there was no specific safety signal in the 800 patients treated in combination with oestrogens, caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e.g. propranolol, grepafloxacine, enoxacine) until more experience has been gained. In vivo, agomelatine does not induce CYP450 isoenzymes. Agomelatine inhibits neither CYP1A2 in vivo nor the other CYP450 in vitro. Therefore, agomelatine will not modify exposure to medicinal products metabolised by CYP 450. Adverse Events: In clinical trials, over 3,900 depressed patients have received Valdoxan. Adverse reactions were usually mild or moderate and occurred within the first two weeks of treatment. The most common adverse reactions were nausea and dizziness. These adverse reactions were usually transient and did not generally lead to cessation of therapy. Adverse reactions are listed below using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), Common: headache, dizziness, somnolence, insomnia, anxiety, migraine, nausea, diarrhoea, constipation, upper abdominal pain, hyperhidrosis, back pain, fatigue, increases (>3 times the upper limit of the normal range) in ALAT and/or ASAT (i.e. 1.1% on agomelatine 25/50 mg vs. 0.7 % on placebo), anxiety. Uncommon: paraesthesia, blurred vision, eczema. Rare: erythematous rash, hepatitis. Frequency not known: suicidal thoughts or behaviour, agitation, restlessness, irritability, mania/hypomania, pruritis, aggression, nightmares, abnormal dreams. Overdosage:: There is limited experience with agomelatine overdose. Signs and symptoms of overdose included epigastralgia, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis and malaise. No specific antidotes for agomelatine are known. Management of overdose should consist of treatment of clinical symptoms and routine monitoring. Medical follow-up in a specialised environment is recommended. Presentation: Pack of 28 tablets of Valdoxan 25 mg See Summary of Product Characteristics for further details. Legal Category: POM. Marketing Authorisation Numbers and Holders:: EU/1/08/499/003 Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex-France. Date of Preparation or Last Review: December 2011. Full prescribing information is available from:: Servier Laboratories, Block 2, West Pier Business Campus, Old Dunleary Road, Dun Laoghaire, Co Dublin. Tel: (01) 6638110, Fax (01) 6638120. Date of Preparation or Last Review: February 2012. 11 12 MC1 VAL PA. References: 1. Valdoxan Summary of Product Characteristics Dec 2011 2. Hickie I.B. & Rogers N.L The Lancet 2011; DOI:10.1016/S0140-6736(11)60095-02 3. Lemoine P. et al J Clin Psychiatry 2007; 68:1723-32 4. Kasper S. & Hamon M. 2009; The World Jnl of Bio Psy. 10(2):117-126
Innovation in the treatment of depression4
1 tablet daily at bedtime1
Treatment Regimes for Dupuytren's Contracture Dupuytren's contracture is a relatively common disorder characterized by progressive fibrosis of the palmar fascia. It is a benign, slowly progressive fibroproliferative disease of the palmar fascia. Initial tendon thickening is painless and often goes unnoticed and undiagnosed. Joint stiffness and a loss of full extension develop insidiously over decades.
As the scarring process progresses, nodules form on the palmar fascia and the finger gradually loses its flexibility, with contractures that draw one or more fingers into flexion at the metacarpophalangeal (MP) joint. The term Dupuytren disease (DD) is also used for this disorder, as the fingers are not always held in a fixed flexion deformity. A thickening, or nodule, develops in the palm of the hand near the base of the ring or little finger. Sometimes a pit, or indentation, may form in the palm or on the finger. Other nodules may develop and create a cord, or band, that extends
from the palm into the finger. This cord tightens and pulls the finger into a bent position toward the palm causing some discomfort. It becomes hard to straighten the finger. The thickened tissue may pull the finger into a completely bent position. It may even get so bad that you cannot use your fingers. Any of the fingers may be affected, but it is most common in the ring finger or little finger. Pain is not common with Dupuytren's. If the condition gets worse quickly, the fingers can become bent within a few weeks or
months. But this is rare. It is more common for a finger to take several years to reach the bent position. An epidemiological study on Dupuytren’s disease in Bosnia and Herzegovina (D Zerajic and V Finsen. BMC Musculoskelet Disord, 2004) examined the hands of 1,207 men and women over the age of 50 years. It reported that prevalence was highly age-dependent, ranging from 17% for men between 50-59 years to 60% in the oldest men. The prevalence among women was lower. The great majority
only had palmar changes without contracture of the digit. As the disease progresses, excess collagen continues to build up and may eventually form into a rope-like cord under the skin. Recurrence is a feature of the hand condition Dupuytren’s contracture. However, new treatments offer the possibility of reduced contractures and an improved range of motion. STEROID INJECTIONS According to Mr David Warwick, Consultant Hand Surgeon with Southampton UJniversity Hospitals NHS Trust, a steroid injection can be effective in causing nodules in the palm to shrink. This can be painful and the skin can lose some of its thickness through atrophy. The Ketchum et al (J Hand Surg, 2000) study found that intralesional injections with the steroid triamcinolone acetonide, directly into the area of disease, could modify its progression with an average of 3.2 injections per nodule resulting in approximately 97% of hands showing regression of disease as exhibited by a softening or flattening of the nodule(s). Although some patients had complete resolution of the nodules, most experienced definite but incomplete resolution in the range of 60 80% Radiotherapy (RT) can prevent progression of Dupuytren’s contracture. It is unknown
Issue 4 • HPN
whether there is a dose response and which dose is sufficient. After a mean followup of 13 years, radiotherapy has been found to be effective in prevention of disease progression and improves patients’ symptoms in earlystage Dupuytren’s contracture (N Betz et al. Strahlenther Onkol, 2010).
by Dias (J Hand Surg Br, 2006) but had a high incidence of post-operative patient-reported complications of 46%. A higher complication rate was seen in those patients with worse initial deformities. The rate of contracture recurrence or persistence was 15%.
RECURRENCE Dupuytren’s disease has a high recurrence rates, especially when a patient has so called Dupuytren’s diathesis. The term diathesis relates to certain features of Dupuytren's disease and indicates an aggressive course of disease.
The initial description of Dupuytren’s disease diathesis included 4 factors: • the patient is below the age of 50 years old • positive family history • both of the hands are affected
SURGICAL TREATMENT The mainstay of treatment for Dupuytren’s contracture is hand surgery. For patients with significant fixed flexed posture (contracture) of the fingers from a Dupuytren's contracture, when nonsurgical treatments have failed, surgical procedures can remove the scarred tissue to free the fingers and release the tendons. These procedures can return function to a disabled hand. Minor nodule formation and/or skin thickening of the palm is not a reason to operate. Sometimes the surgeon can release the scarred tissue by carefully cutting it with a needle. This procedure is referred to as a needle aponeurotomy or needle fasciotomy. Surgery is usually considered when fingers are already bent by more than 15 to 20 degrees and the use of the hand has become restricted. Fasciotomy is indicated for isolated metacarpophalangeal joint contracture and can be done as an open procedure or percutaneously (needle fasciotomy) in the outpatient setting. Percutaneous needle fasciotomy results in good short-term improvement, but the recurrence rate is often high (AL van Rijssen AL. J Hand Surg Am, 2006). Surgery for Dupuytren’s contracture achieved a high rate of full, or almost full, correction in 75% of patients in a study
HPN • Issue 4
• ectopic lesions (Peyronie’s disease, Knuckle pads and Ledderhose disease).
of disease, plantar fibrosis, knuckle pads and radial side involvement.
In a study of Hindocha et al. they reevaluated these 4 factors and modified them. The original factors of family history, bilateral Dupuytren’s disease, and ectopic lesions now include 2 additional factors: male gender and age at onset of younger than 50 years. The presence of all new Dupuytren’s disease diathesis factors in a patient increases the risk of recurrent Dupuytren’s disease by 71% compared with a baseline risk of 23% in those Dupuytren’s disease patients with none of the earlier-described factors. In another study the prognostic value of diathesis was evaluated. They concluded that presence of diathesis can predict recurrence and extension. A scoring system was made to evaluate the risk of recurrence and extension containing the following values: bilateral hand involvement, little finger surgery, early onset
Issue 4 • HPN
Xiapex is a powder and solvent that are made up into a solution for injection. It contains the active substance collagenase clostridium histolyticum. Xiapex is to be used in patients with cords in their palms that are thick enough to be felt through the skin. The European Commission granted a marketing authorisation valid throughout the European Union for Xiapex to Pfizer Limited on 28 February 2011. With surgery, the proposal is to correct contracture but recurrence is a common problem and injection with collagenase has shown early clinical promise for mild disease limited to the metacarpophalangeal joint. The treatment with collagenase
is different for the MCP joint and the PIP joint. In a MCP joint contracture the needle must be placed at the point of maximum bowstringing of the palpable cord. The treatment consist of one injection with 0.58 mg 0.25 ml. collagenase clostridium histolyticum. The needle must be placed vertical on the bowstring and there is a 3-point distribution of each total injection volume. For the PIP joint the needle must be placed not more than 4 mm distal to palmar digital crease to 2-3 mm depth. The injection for PIP also consist of one injection but filled with 0.58 mg collagenase clostridium histolyticum/ 0.20 ml. The needle must be placed horizontal to the cord and there is a 3-point distribution of each total injection volume. After the injections the patient’s hand is wrapped in bulky gauze dressing and must be elevated for the rest of the day. After 24 hours the patient returns for passive digital
extension to rupture the cord. Moderating pressure for 10-20 seconds ruptures the cord. The Collagenase Option for the Reduction of Dupuytren’s (CORD I) study (L Hurst et al. NEJM, 2009) found that collagenase clostridium histolyticum significantly reduced contractures and improved the range of motion in joints affected by advanced Dupuytren’s disease. Overall, the range of motion in the joints was significantly improved after injection with collagenase, as compared with placebo (from 43.9 to 80.7 degrees vs. from 45.3 to 49.5 degrees). The primary endpoint of CORD I was the percentage of patients achieving a reduction in contracture of the selected primary joint to five degrees or less, approximately 30 days after the last injection of that joint.
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44 Clinical Profiles
Xiapex available in Ireland
Xiapex, a product of Pfizer Healthcare Ireland is now indicated in Ireland for the treatment of Dupuytren’s contracture in adult patients with a palpable cord. Xiapex is comprised of a mixture of Class I (AUX-I) and Class II (AUX-II) clostridial collagenases in a defined mass ratio. Collagenases are proteinases that hydrolyze collagen under physiological conditions. Injection of Xiapex into a Dupuytren’s cord, which is
European Congress on Osteoporosis and Osteoarthritis (ECCEO)
Pack Size Change
Clonmel Healthcare would like to advise that Aceomel has changed from a 56 pack to a 60 pack. Aceomel is indicated for: Heart Failure Myocardial Infarction
Issue 4 • HPN
collagen in a complementary manner.
painful and debilitating condition, and for over 20 years we have been searching for; a treatment that would allow us to alter the course of the disease, rather than just manage the symptoms. The results today are it, and could totally change the way we treat osteoarthritis. For the first time we
have a treatment that can slow the development of this debilitating disease and could reduce or even eliminate the need for expensive and painful joint replacement surgery.”
Type 1 Diabetic Neuropathy
contact Clonmel Healthcare on 01-6204000 if you require any additional information on Aceomel.
Dosage: Adult: Inject 0.58mg into cord; injected volume depends on type of joint treated (see SPC). Elderly: As per adults. Children: Under 18 years, not indicated. Full prescribing information and references available from Pfizer Healthcare Ireland. Telephone: (01) 4676500
New data presented shows that, for the first time, scientists have identified a treatment that can significantly slow the development of the debilitating joint disease, osteoarthritis. The study of 1,683 people showed that Protelos® (strontium ranelate), reduced the deterioration of the protective tissue (cartilage) of the knee joint by a third (p=0.0.018). It indicated that for every three years of treatment, progression of the disease slowed by one year. It was also shown to significantly reduce pain (p=0.028) in people with the disease and to improve their ability to move around in their daily life (p=0.045). The data was presented at the European Congress on Osteoporosis and Osteoarthritis (ECCEO) in France.“This is a major breakthrough”, commented Professor Cyrus Cooper, lead investigator on the trial and Professor of Rheumatology at the University of Southampton and Professor of Musculoskeletal Science at the University of Oxford, UK. “Osteoarthritis is a
Aceomel 12.5mg, 25mg, 50mg tablets:-
comprised mostly of interstitial collagen types I and III, results in enzymatic disruption of the cord. The two classes of collagenases have similar but complementary substrate specificity. Both collagenases effectively cleave interstitial collagen but at different sites on the molecule; additionally, they prefer different conformations (triple helical versus denatured or cleaved). These differences account for the ability of the two classes of enzymes to digest
Full prescribing information for Aceomel is available on request or go to www.clonmel-health. ie . This Product is subject to medical prescription. Please
New Fresubin® Jucy replaces ProvideXtra®
Fresubin® is delighted to announce a new member to the family, Fresubin® Jucy 200ml Drink. Fresubin® Jucy Drink is a juice style, high energy 300kcal oral nutritional supplement containing 8g (100%) whey protein with a high nutritional value. It is an excellent tasting alternative to milk supplements. Fresubin® Jucy is suitable for patients with: • Increased energy and protein needs • Dislike or fatigue of milky oral nutritional supplements • Fat malabsorption Fresubin® Jucy Drink is enriched with all vitamins, essential trace elements and calcium. In addition, it is fat and fibre free, gluten free and clinically free from lactose and cholesterol.
Inspra® (eplerenone) approved for expanded use in chronic heart failure patients in Ireland.
CATT trial highlights serious safety concerns around unlicensed ocular bevacizumab use versus Lucentis
Fresubin® Jucy Drink 200ml will replace ProvideXtra®Drink 200ml, and will be substituted by Fresubin Jucy Drink as stock of flavours sells through in wholesalers. The GMS code and price for both
is the same. Fresubin® Jucy Drink is available in a variety of flavours including Apple, Orange, Pineapple and Blackcurrant, which taste best when chilled. It is not
suitable for infants under the age of one year. Versatile, Fresubin® Jucy Drink can be frozen and enjoyed as ice cream.
Inspra (eplerenone), a selective aldosterone antagonist/ mineralocorticoid receptor (MRA) has been approved in Ireland for a new therapeutic indication to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA II chronic heart failure (CHF) and left ventricular systolic dysfunction (LVEF ≤ 30%), in addition to standard optimal therapy. This is in addition to eplerenone’s current European indication as a treatment for post-myocardial
infarction heart failure with left ventricular systolic dysfunction again, alongside standard therapy. The approval is based on the findings of the EMPHASIS-HF trial, the main results of which were published in New England Journal of Medicine (NEJM) in January 2011. In the EMPHASIS-HF trial, eplerenone reduced the relative risk of cardiovascular (CV) death or heart failure (HF) hospitalisation by 37% (p<0.001) compared to placebo in CHF (NYHA class II)
patients already receiving current standard therapy. There were also statistically significant reductions in other secondary endpoints of all-cause mortality (24%; p=0.008), CV mortality (24%; p=0.012), all-cause hospitalisation (23%, p<0.001) and HF hospitalisation (42%; p<0.001). In 2011, Black and colleagues polled their Medscape advisors to find out which study or event had a major impact on the field of cardiology. The EMPHASIS-HF study was voted the most impactful.
Two-year data from the CATT (Comparison of Age-related macular degeneration Treatment Trials) study of 1,107 patients with age-related macular degeneration (AMD) has identified a 30% higher risk in overall serious systemic adverse events with unlicensed intravitreal bevacizumab versus Lucentis (p=0.004). The results also highlight reports of arteriothrombotic events, systemic hemorrhage, congestive heart failure, venous thrombotic events, hypertension and vascular death that were more frequent in bevacizumab-treated patients (p=0.07). These events have
been previously associated with systemic anti-VEGF treatment.
have reinforced safety and pharmacovigilance concerns surrounding the substitution of off-label bevacizumab (Avastin) for the licenced therapy Lucentis (ranibizumab) as a treatment for a range of ophthalmology conditions.
Lucentis is licenced in three areas of ophthalmology – age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME) and for visual impairment due to macular oedema secondary to retinal vein occlusion (RVO). However, some clinicians have been substituting off-label bevacizumab, a different molecule used in the oncology setting, for Lucentis and this practice has raised a series of safety concerns worldwide. The CATT study results
“The apparent differential safety risk between the two medicines may be due to differences in the molecules and their commercial formulation. This underscores the importance of drug design and development with the patient and disease process in mind”, said Dr Greg Hays, Medical Director Novartis Ireland.
HPN • Issue 4
Jim Breslin The Minister for Health, Dr James Reilly has announced a number of changes to the Board of the HSE, including three new members. They are Mr Jim Breslin, Secretary General of the
Department of Children and Youth Affairs Ms Frances Spillane, Head of the National Human Resource and Work Force Planning Unit in the Department of Health and Mr Tony O’Brien, Chief Operating
Officer of the Special Delivery Unit who replaces Dr Martin Connor on the board.
Steve Turley & Robin Bhattacherjee Lundbeck’s Steve Turley (pictured right) and Actelion’s Robin Bhattacherjee (pictured left) have been appointed as Chair and Vice-Chair of the European Medicines Group (EMG).
Mr Turley, who has been elected for the 2012-2013 term of office, replaces UCB’s Matthew Speers after he stood down following his two year stewardship. The new Chair said a priority of the Group would be
“addressing the challenges faced by medicines” not appraised by NICE or a national commissioning body, which are then “subject to variations in local decision making processes about levels of access”.
Dr Ruth Barrington Vhi Healthcare has announced that Minister for Health Dr James Reilly TD has appointed Dr Ruth Barrington to the board of Vhi Healthcare.
Dr Barrington is chief executive of Molecular Medicine Ireland, a charitable company established by NUI Galway, the RCSI, Trinity College, UCC and UCD to accelerate the translation
of scientific advances into new therapies, devices and diagnostics to improve the health of patients and the population.
Dr Ambrose McLoughlin Dr Ambrose McLoughlin has been appointed as the new Secretary General at the Department of Health.
effect. Previously, he was Registrar and Chief Executive of the Pharmaceutical Society of Ireland (PSI).
His appointment took immediate
Dr McLoughlin replaces Mr
Michael Scanlan, who served in the same position for seven years.
Brendan K. Farrell Medical diagnostics company, Crescent Diagnostics Ltd., which has developed proprietary predictive test for osteoporosis, has announced the appointment of Brendan K. Farrell as CEO.
Issue 4 • HPN
Brendan has over 30 years international experience in the diagnostics industry with extensive expertise in marketing and sales, licensing
and acquisitions, fund-raising, investor relations and general management.
Your patent expiry solution
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The evoluTion of Generics The evolution of Generics
Gemcitabine 100 mg/ml concentrate for solution for infusion Accord has developed a ready to use formulation of Gemcitabine: Gemcitabine 100 mg/ml Concentrate for Solution for Infusion which allows to calculate a more precise total volume of concentrate required to prepare a given dose, as shown in the table:
100 mg/ml formulation (Accord)
Aware of the higher concentration of the product before the preparation of solution for infusion (concentration 100 mg/ml as compared to 38 mg/ml after the preparation of solution for infusion in the originator) warning texts have been included in product cartons and labels to avoid any potential confusion by personnel dispensing, handling and preparing Gemcitabine concentrate for solution for infusion.
”: Concentration must be noticed
Warning text “caution, new concentration overdose may occur.
Text “Must be diluted before use”: Gemcitabine concentrate for solution for infusion must be diluted. The total quantity of the Gemcitabine concentrate for solution for infusion required for an individual patient should be diluted into at least 500 ml of sterile sodium chloride 9 mg/ml (0.9%) solution to a final concentration of 0.1 to 5 mg/ml.
100 mg/ml highlighted: 100 mg/ml concentration is highlighted by a coloured box on both main faces of carton, on top flap and on product label. This is highlighted across the different product presentations.
1000 mg/10 ml “Must be diluted before use” This text has been made more prominent on the main face of the carton and on label. Bold text has been applied.
“100 mg/ml” coloured box “caution, notice new concentration (100 mg/ml)” This text has been included in carton and label, right below the name of the product and it’s repeated on both main faces of the carton. Bolded text has been applied.
Concentrate for Solution for Infusion is available in different presentations:
Each presentation is differentiated by: •
including horizontal running lines: one line represents the lowest fill volume and for each next fill volume there is one additional bolded line.
each presentation has a different colour strip alongside the product name box, matching with the same colour of boxed text also included.
1500 mg/15 ml 2000 mg/20 ml
Accord Gemcitabine Solution SPC available on IMB database
200 mg/2 ml Accord Healthcare Ireland Ltd, 24-26 Bullford Business Campus, Kilcoole, County Wicklow, Ireland Tel. +353 (0)1 2592020
IN THIS ISSUE: News: Barcoding medicines should not be hindered says EAHP - Conference:Coverage from the Hospital Pharmacists Association of...
Published on Jun 29, 2012
IN THIS ISSUE: News: Barcoding medicines should not be hindered says EAHP - Conference:Coverage from the Hospital Pharmacists Association of...