Page 1

Issue 8

THE INDEPENDENT VOICE OF HOSPITAL PHARMACY IN THIS ISSUE: News: Irish pharmacist presents at American College of Cardiology Page 5 Report: Medicines Reconcilliation a key priority Page 9 Awards: Launch of the inaugural Hospital Pharmacy Awards 2013 Page 11 News: The Sharps Directive and what it means for Hospital Pharmacists Page 24 Feature: Novel oral anticoagulant therapies – practical guidance Page 42

Full prescribing information is available from Boehringer Ingelheim Ireland Ltd, The Hyde Building, The Park, Carrickmines, Dublin 18. Date of preparation: February 2013 Job code: IRE/DBG-131038

Out & About: School of pharmacy retirements and gradulations Page 48

20855 BIP SPAF - HPN Ad_A5_Irish.indd 1

20/03/2013 15:28


In bipolar disorder find the right balance

NEW

*

Rapid efficacy with a fast-dissolving sublingual tablet1,2

Abbreviated Prescribing Information: For full prescribing information refer to the Summary of Product Characteristics. Name: Sycrest 5 mg & 10 mg sublingual tablets. Active Substance: Asenapine (as maleate). Indication: Treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Dosage: Treatment is twice daily (one dose to be taken in the morning and one dose in the evening). Monotherapy: starting dose is 10 mg twice daily, may be reduced to 5 mg twice daily according to clinical assessment. Combination therapy: starting dose is 5 mg twice daily, may be increased to 10 mg twice daily depending on the clinical response and tolerability in the individual patient. Paediatric population: No recommendation on posology can be made. Elderly patients: Use with care. Renal impairment: No dose adjustment required (no data in severe renal impairment CrCL < 15 ml/min). Hepatic impairment: Mild: no dose adjustment required; Moderate: caution; Severe: not recommended. Administration: Sublingual, only to be used by patients who can comply with instructions (due to poor bioavailability when taken orally). Use dry hands and do not remove the tablet until just before it is to be taken. Peel back the coloured tab and remove gently. Place the tablet under the tongue and allow it to dissolve completely. Do not chew or swallow. Avoid eating and drinking for 10 minutes after administration. When using Sycrest in combination with other medication, take it last. Contraindications: Hypersensitivity to the active substance or any of the excipients. Pregnancy and Lactation: Pregnancy: Sycrest should not be used in pregnant women unless clearly necessary and only if the potential benefit outweighs the potential risk to the foetus. Neonates exposed to antipsychotics (including Sycrest) during the third trimester should be monitored carefully for extrapyramidal/withdrawal symptoms. Lactation: Women taking Sycrest should not breast-feed. Special Warnings and Precautions for use: Elderly patients with dementia-related psychosis: Not recommended. Neuroleptic Malignant Syndrome: Sycrest must be discontinued if signs or symptoms develop. Seizures: Caution in patients with a history of seizures or a condition associated with seizures. Suicide: Closely supervise patients at high risk. Orthostatic hypotension: Caution in early treatment, in the elderly, in patients with cardiovascular/ cerebrovascular disease or with conditions predisposing to hypotension. Tardive dyskinesia: Discontinue Sycrest if signs or symptoms develop. Hyperprolactinaemia: Some reports have been received. QT interval: Caution in patients with known cardiovascular disease, family history of QT

prolongation or concomitant use of other QT-prolonging medicinal products. Hyperglycaemia and diabetes mellitus: Clinical monitoring is advised for at risk patients. Dysphagia: Some reports have been received. Body temperature regulation: Appropriate care is advised in patients at risk of an elevation of core body temperature. Severe hepatic impairment: Not recommended. Parkinson’s disease and dementia with Lewy bodies: These patients are at increased risk of adverse events (including NMS), benefits and risks should be carefully considered. Interactions: Caution: in combination with other centrally acting medicinal products; with CYP1A2 inhibitors (e.g. fluvoxamine), CYP2D6 inhibitors or substrates (e.g. paroxetine), antihypertensive agents, levodopa, dopamine antagonists. Avoid: Alcohol & eating / drinking for 10 minutes after administration. Adverse reactions: Very common (≥1/10): anxiety, somnolence. Common (≥1/100 to <1/10): weight increased, increased appetite, dystonia, akathisia, dyskinesia, parkinsonism, sedation, dizziness, dysgeusia, hypoaesthesia oral, ALT increased, muscle rigidity, fatigue. Uncommon (≥1/1,000 to <1/100): hyperglycaemia, syncope, seizure, extrapyramidal disorder, dysarthria, sinus bradycardia, bundle branch block, electrocardiogram QT prolonged, sinus tachycardia, orthostatic hypotension, hypotension, swollen tongue, dysphagia, glossodynia, paraesthesia oral, sexual dysfunction, amenorrhoea. Rare (≥1/10,000 to <1/1,000): neutropenia, neuroleptic malignant syndrome, accommodation disorder, pulmonary embolism, rhabdomyolysis, gynaecomastia, galactorrhoea. Not known (cannot be estimated from available data): allergic reactions, restless legs syndrome, nausea, oral mucosal lesions, salivary hypersecretion, drug withdrawal syndrome (neonatal). Other findings: Cerebrovascular events have been reported. Asenapine has anaesthetic properties – oral hypoaesthesia/ paraesthesia may occur directly after administration and usually resolve within 1 hour. Post marketing reports of serious hypersensitivity reactions (including anaphylactic reactions e.g. swollen tongue & throat) have been received. Overdose: Cardiovascular monitoring & supportive therapy. Close monitoring advised until patient recovers. Legal Category: POM. Marketing Authorisation Holder: N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands. Marketing Authorisation Numbers: EU/1/10/640/002 Sycrest 5 mg sublingual tablets, 60 pack. EU/1/10/640/005 Sycrest 10 mg sublingual tablets, 60 pack. Further information may be obtained from: Lundbeck (Ireland) Ltd., 7 Riverwalk, Citywest Business Campus, Dublin 24. Date of Preparation: January 2013. The person depicted is a model and is used for illustrative purposes only.

* Sycrest is licensed for the the treatment of moderate to severe manic episodes in bipolar I disorder. References: 1. McIntyre R, et al. A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disord 2009: 11: 673-686. 2. Sycrest Summary of Product Characteristics.

SY2/1/13


3

Issue 8

Contents

Foreword

EAHP survey reveals 99& of hospital pharmacists facing drug shortages P5

Editor

Patient safety threat as pharmacy still in ‘dark ages’ P6

This issue of Hospital Pharmacy News carry a wealth of news, features and special reports. Not least of which is an overview of the recent Sharpes Directive by EAHP Policy and Advocacy Officer Richard Price.

Medicines reconciliation a ‘key priority’ P9 Launch of the inaugural and prestigious Irish Hospital Pharmacy Awards 2013 P11 Out and about with the EAHP 18th Congress in Paris P48

Regulars

Kelly Jo Eastwood

States Richard; The main requirements of the Directive apply to employers whose main activity is the management, organisation or provision of healthcare, whether Government-provided (e.g. public hospitals) or privately-provided (e.g. nursing homes). Hospital pharmacies therefore fall directly within the Directive’s scope. The Directive’s requirements puts in place a new duty upon individual employees who receive a sharps injury whilst performing their work to notify the person responsible for safety and health in their workplace as soon as practicable. With the contentious issue of the Directive’s proposed ban on recapping now largely resolved through the issuing of a “clarification note” by the social partners, most of the Directive’s other requirements appear to have been broadly accepted by impacted stakeholders. As ever in the case of European Directives however, the proof of its impact will be in its implementation. To this end, the Directive includes provision for potential review of its implementation from 2015 onwards.

CPD - Quantifying communication across pharmacy P27 Adult ADHD - The new kid on the block P36 Novel oral anti-coagulant therapies by Professor James O’Donnell P42

Elsewhere we are excited to officially launch the first ever Hospital Pharmacy Awards!

Product Profiles P51

The Hospital Pharmacy Awards have been established to serve as the standard-bearer for professionalism and excellence throughout hospital pharmacy.

Clinical Profiles P52

The Hospital Pharmacy Awards are hosted by HPN to recognise outstanding examples of high standards, best practice, innovation and excellence throughout the hospital pharmacy profession in Ireland.

Appointments P54 Hospital Pharmacy News is Circulated to all independent, multiple and hospital pharmacist, pre reg pharmacists, students pharmacy student’s offi cial bodies, government officials and departments, Pharmacy Managers, Manufactures, Wholesalers. Buyers of pharmacy groups and healthcare outlets. Circulation is free to all pharmacists Subscription rate for Hospital Pharmacy News 60euro plus vat per year All rights reserved by Hospital Pharmacy News. All material published in Hospital Pharmacy News is copyright and no part of this magazine may be reproduced, stored in a retrieval system of transmitted in any form without written permission. Pharmacy Communication Ireland have taken every care in compiling the magazine to ensure that it is correct at the time of going to press, however the publishers assume no responsibility for any effects from omissions or errors.

PUBLISHER IPN Communications Ireland Ltd Carmichael House, Lower Baggot Street, Dublin 2 00353 (01) 6024715 MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com EDITOR Kelly Jo Eastwood kelly@hospitalpharmacy.ie ACCOUNTS Lorraine Moore cs.ipn@btconnect.com

SALES MANAGER Debbie Graham debbie.hpn@btconnect.com

Our esteemed panel of independent judges will be looking at the original contribution made in all of the categories with a special eye for how it is especially relevant to meeting the needs of the hospital population and/or colleagues within the profession. The judges will also expect to hear how the achievement contributes to the hospital pharmacy industry in overall vision and strategy. The winners will be announced during a glittering gala evening at the Crowne Plaza Hotel, Santry, on September 21st, 2013. Tickets are on sale now so book early to avoid disappointment! Page 11 starts our exclusive coverage of these prestigious awards so turn the page now to view the categories and criteria and get your pens ready for submitting or nominating.

CONTRIBUTORS Richard Price Professor James O'Donnell Matthew Hamilton Sean Owens Dr Sean O Domhnaill David Stead ART DIRECTED BY Smart Page Design

THE INDEPENDENT VOICE OF HOSPITAL PHARMACY HPN • Issue 8


4 News

Better links in health chain to benefit hospital pharmacists Acting PSI Registrar Ciara McGoldrick

There should be better links between hospital pharmacists and the services provided by primary care doctors and pharmacists in the community to improve patient outcomes, according to a new report published earlier this year by the PSI. Titled “Pharmaceutical Society of Ireland Baseline Study of Hospital Pharmacy”, the report was based on questionnaire responses from hospital pharmacists and heads of pharmacy departments, site visits and interviews at hospitals

around Ireland, and an analysis of international best practice, including practice in the EU, Australia, Canada and New Zealand. “A key issue that emerged from the report was realising a vision for pharmacy that fits into the wider healthcare delivery system in Ireland,” said Acting PSI Registrar/CEO Ciara McGoldrick. “Specifically, in the acute care setting, pharmacists wish to further develop hospital pharmacy services as an embedded part of integrated patient care services." Turn to page 16 for the full report.

Support in Common Training Frameworks The Internal Market Committee (IMCO) of the European Parliament has voted to allow Common Training Frameworks to be used for cross-border recognition of pharmacy and veterinary medicine specialties. At its meeting on 23 January

2013, IMCO Members of the European Parliament (MEPs) agreed a series of compromise amendments to lift restrictions that would prevent post-graduate specialties of automatically recognised professions from forming a common training framework.

A common training framework is a proposal from the European Commission that would allow nine countries or more to form a voluntary arrangement similar in effect to mutual automatic recognition for a qualification. Benefits of the proposal include the fact that not every country

in the European Union would need to participate, and that the recognition can be based on an agreed competence framework rather than upon requirements for strict agreement on the duration period of a qualification.

Tallaght pharmacy think pink The Pharmacy Staff of Tallaght Hospital raised ¤750.00 at their 'Think Pink' cake sale in aid of the Marie Keating Foundation. The department would like to thank everyone who kindly supported this event.

Issue 8 • HPN


5

Pharmacist presents research at ACC An Irish heart project presented landmark research results last month to the prestigious American College of Cardiology conference. The research was developed by Professor McDonald, consultant cardiologist at St Vincent’s University Hospital Dublin and Dr Mark Ledwidge, a pharmacist, both associated with the School of Medicine and Medical Science at UCD and co-founders of the Heartbeat Trust, a charity researching heart failure prevention. The Irish heart charity, Heartbeat Trust, sponsored St Vincent's Screening To Prevent Heart Failure (STOP-HF) study. The STOP-HF study, a randomised prospective study of more than 1,300 people, investigated whether screening, using a blood test, followed by targeted care of people at risk of heart failure can

Dr Mark Ledwidge with Dr Ambrose McLoughlin and Professor Ken McDonald

result in dramatically reduced disease burden and in particular hospital admissions for heart failure and other cardiovascular causes. The results presented today at the American College of Cardiology’s 62nd Annual Scientific Session in San Francisco found that a simple screening and management programme can be effective in preventing heart failure, according to the Irish research.

Providing hospital pharmacy services to meet the needs of complex patients – can the Basel Statements help? This is one of the key hospital pharmacy initiatives to be discussed at the upcoming International Pharmaceutical Federation Annual Congress being held in Dublin in August. Chair will be Betty Chaar from the University of Sydney, Australia. The theme of the 2013 conference- Towards a future vision for complex patients: Integrated care in a dynamic continuum - will address these developments, and the central role of the pharmacist in delivering patient care in an ever more challenging setting.

Hospital pharmacists face shortage problems The European Association of Hospital Pharmacists (EAHP) has published headline results of a recent survey that reveals 99% of responding hospital pharmacists say they have experienced difficulties with medicines shortages in the past year. With over 300 respondents from 27 countries, the survey also uncovered that 63% of hospital

pharmacists report medicines shortages to be a weekly, sometimes daily, occurrence. 77% consider that problem has become worse in the last year. Announcing the results at a reception in the European Parliament on access to medicines, EAHP President Dr Roberto Frontini said: “These headline results confirm what I have increasingly heard from

our members across Europe: that the shortages problem is widespread, doesn’t respect national borders, and urgently requires attention if patient care and health services are not to suffer. "Managing shortages and trying to source supply distracts pharmacists from other core tasks, places burden on support staff and can increase stress

and workload in the pharmacy environment with consequent impacts on the risk of error. Substitution of medicines in case of shortage of formulary drugs can also confuse doctors and nurses, further raising risks to patient safety." EAHP will publish the full results of its surveys at its forthcoming Congress in Paris, 13-15th March, 2013.

HPN • Issue 8


6 News

Irish Hospital Pharmacy in the Dark Ages threatens patient safety HPAI President Deirdre Lynch

The president of the Hospital Pharmacists’ Association of Ireland (HPAI) Deirdre Lynch has called on the Department of Health and HSE to work with the organisation to develop a national strategy for hospital pharmacy. She went on to say: “Ireland promotes itself as being a leading country in software development. It is not acceptable that patient safety is compromised by such antiquated systems.” Her call arises from the publication of a national baseline survey on hospital pharmacy by the Pharmaceutical Society of Ireland (the pharmacy regulator). "This report paints a very grim picture of Irish hospital pharmacy" said Ms Lynch. Automation and IT systems in Irish hospital pharmacies lag well behind other European countries, leaving Irish patients at a disadvantage when it comes to

Servier Award presentation Developing and Implementing an Environmental Monitoring Guideline in a Hosiyal Pharmacy Aseptic Compounding Unit was the winning project scooping the Servier Award at the recent Hospital Pharmacists Association of Ireland annual conference. Tadhg Reddan from the pharmacy department at Midland Regional Hospital in Tullamore was presented with the award at the conference venue in the Crowne Plaza, Santry.

Issue 8 • HPN

safety. Software is a very outdated DOS-based system, which carries a risk of losing valuable patient medication records and financial information.

“Modern IT systems greatly enhance patient safety by using barcode technology and electronic prescribing rather than handwriting. This helps to reduce mistakes and improves record

keeping. They also provide better financial information so that we can manage precious resources better” she said. The report describes Irish hospital pharmacies as unfit for purpose. Researchers found that premises were "small, cramped” and “outdated for the services they provide”. This was the first ever independent survey of Irish Hospital Pharmacy. Ms Lynch thanked the Pharmaceutical Society of Ireland for conducting the survey, commenting that it “yielded valuable information and should provide food for thought for the Department of Health and HSE”. The results of this survey are one of the main agenda items at the HPAI’s annual conference which takes place this weekend in Dublin. The national baseline survey on hospital pharmacy was conducted by the pharmacy regulator and published on their website: http:// www.thepsi.ie/tns/publications/ core-publications.aspx


The First and Only Oral Single-Drug Solution for DVT and PE Treatment Fast onset of efficacy with built-in simplicity

No injections1,2

No dietary restrictions1-3

No need for coagulation monitoring1,2 DVT = deep vein thrombosis. PE = pulmonary embolism.

Xarelto 15mg and 20mg film-coated tablets (Rivaroxaban). Please refer to full SmPC before prescribing. Presentation: Film-coated tablet containing 15mg or 20mg of rivaroxaban. Indication: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age â&#x2030;Ľ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults. Dosage and Administration: Prevention of stroke and systemic embolism: The recommended dose is 20 mg once daily, which is also the recommended maximum dose. Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE: The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE. Renal impairment: No dose adjustment is necessary in patients with mild renal impairment. Patients with moderate or severe renal impairment, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, the recommended dose is 15mg once daily. For the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE no dose adjustment is required, although a reduction of the dose from 20 mg once daily to 15 mg once daily should be considered if the patientâ&#x20AC;&#x2122;s assessed risk for bleeding outweighs the risk for recurrent DVT and PE. Hepatic impairment: Contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C. Contraindications: Hypersensitivity to the active substance or any of the excipients; clinically significant active bleeding; lesion or condition at significant risk of major bleeding; concomitant treatment with any other anticoagulant agent except under the circumstances of switching therapy to or from rivaroxaban or when unfractionated heparin is given at doses necessary to maintain a patent central venous or arterial catheter; hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C; pregnancy and breast feeding. Warnings and Precautions: Clinical surveillance in line with anticoagulation practice is recommended throughout treatment. Xarelto should be discontinued if severe haemorrhage occurs. Not recommended: in patients with severe renal impairment (creatinine clearance <15 ml/min); in patients receiving concomitant systemic treatment with strong concurrent CYP3A4- and P-gp-inhibitors, i.e.

azole-antimycotics or HIV protease inhibitors; in patients with increased bleeding risk; due to lack of data: in patients below 18 years of age, in patients with prosthetic heart valves, in patients with PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy; in patients concomitantly treated with dronedarone. Use with caution: in conditions with increased risk of haemorrhage; in patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) or with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations; in patients treated concomitantly with medicinal products affecting haemostasis or with strong CYP3A4 inducers. In patients at risk of ulcerative gastrointestinal disease prophylactic treatment may be considered. Although treatment with rivaroxaban does not require routine monitoring of exposure, rivaroxaban levels measured with a calibrated quantitative anti-Factor Xa assay may be useful in exceptional situations. Specific dose recommendations apply for patients with moderate to severe renal impairment. Xarelto contains lactose. Undesirable effects: Common: anaemia, dizziness, headache, eye haemorrhage, hypotension, haematoma, epistaxis, haemoptysis, gingival bleeding, gastrointestinal tract haemorrhage, gastrointestinal and abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting, pruritus, rash, ecchymosis, cutaneous and subcutaneous haemorrhage, pain in extremity, urogenital tract haemorrhage, renal impairment, fever, peripheral oedema, decreased general strength and energy, increase in transaminases, post-procedural haemorrhage, contusion, wound secretion. Uncommon: thrombocythemia, allergic reaction, dermatitis allergic, cerebral and intracranial haemorrhage, syncope, tachycardia, dry mouth, hepatic function abnormal, urticaria, haemarthrosis, feeling unwell, increases in: bilirubin, blood alkaline phosphatase, LDH, lipase, amylase, GGT. Rare: jaundice, muscle haemorrhage, localised oedema, bilirubin conjugated increased, vascular pseudoaneurysm (uncommon: in prevention therapy in ACS following percutaneous intervention). Frequency not known: compartment syndrome or (acute) renal failure secondary to a bleeding. Prescription only. Marketing Authorisation Holder: Bayer Pharma AG, D-13342 Berlin, Germany. MA numbers: EU/1/08/472/011-21. Further information available from: Bayer Ltd., The Atrium, Blackthorn Road, Dublin 18. Tel: 01 2999313. Date of Preparation: 11/2012.

References: 1. Xarelto [summary of product characteristics, 15mg]. Berlin, Germany: Bayer Pharma AG; 2012. 2. Xarelto [Placeholder for Summary of Product Characteristics, 20 mg tablet]. Berlin, Germany: Bayer HealthCare AG; 2012. 3. EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010(26);363:2499-2510. L.IE.GM.01.2013.0104 Date of Preparation: 01/2013


Sustain response. Reduce recurrence1,2

Treat C. difficile infection...

...and help release your patients from the threat of recurrence1,2 Abbreviated Prescribing Information - DificlirTM Presentation: DIFICLIR film-coated tablets containing 200 mg fidaxomicin. Indications: DIFICLIR is indicated in adults for the treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea. Posology: Adults including elderly: 200 mg administered twice daily for 10 days with or without food. Children: no data available. Renal and hepatic insufficiency: No dose adjustment is considered necessary (see special warnings and precautions) Contraindications: Hypersensitivity to active substance or any of the excipients. Special Warnings and Precautions: Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment, pseudomembranous colitis,

fulminant or life threatening CDI or concomitant inflammatory bowel disease. Co-administration of potent P-glycoprotein inhibitors, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone are not recommended. Drug interactions: DIFICLIR is both a substrate and may be an inhibitor of intestinal P-glycoprotein. DIFICLIR had a small but not clinically relevant effect on digoxin exposure. However, a larger effect on P-glycoprotein substrates with lower bioavailability or which are more sensitive to intestinal P-glycoprotein inhibition such as dabigatran etexilat cannot be excluded. Pregnancy and Lactation: Pregnancy: There are no data available. Animal studies did not indicate direct or indirect harmful effects. It is preferable to avoid the use of DIFICLIR during

pregnancy. Breast-feeding: It is unknown whether fidaxomicin and its metabolites are excreted in human milk. Although no effects on the breastfed newborns / infants are anticipated, a risk cannot be excluded. Undesirable Effects: The most common treatment related adverse reactions were vomiting (1.2%), nausea (2.7%) and constipation (1.2%). Uncommon adverse events reported in clinical trials included decreased appetite, dizziness, headache, dysgeusia, abdominal distension, flatulence, dry mouth, alanine aminotransferase increased. Consult DIFICLIR Summary of Product Characteristics for a full list of side effects. Legal Classification: Prescription Only Medicine (POM). Packs: Blister cards: 20 x 1 film coated tablets (10 x 2 cards) EU Number (PA Number): EU/1/111/733/001004. MA holder: Astellas Pharma Europe B.V.

References: 1. Cornely O.A. et al. Lancet Infect Dis 2012;12:281-89. 2.Louie T.J. et al. New Engl J Med 2011 ;364 :422-31

Sylviusweg 62, 2333 BE Leiden, The Netherlands. Date of Preparation of API: January 2013 Summary of product characteristics and further information from: Astellas Pharma Co Ltd, 5 Waterside, Citywest Business Campus, Naas Road, Dublin 24. Tel: 01 4671555 Adverse Events should be reported to Astellas Pharma Co. Ltd.

Dificlir/02 2013/384


4.1.8

Formulary

36.4% of respondents had a formulary in place, with 6.8% indicating development. Of those with a formulary, 21% indicated it was update 21% every two years, 29% more than two years, and another 29% st in another way – for the most part, these indicated that the updates w arising from particular requests by doctors, as new drugs were introd and/or when existing drugs were updated in terms of licensing and us

9

Report

Medicines Reconciliation A Key Priority 4 .2 Pha r m a c is t Sur v e y Findings In Hospitals 4.2.1

Perceptions regarding Services

There should be better links between hospital pharmacistsInand the services provided by primary care doctors and the pharmacist survey, we asked pharmacists what they thought o pharmacists in the community to improve patient outcomes, accordingofto a hospital new report published today to bypatient the outcome responsibility the pharmacist in relation practice in their hospitals. Pharmaceutical Society of Ireland (PSI). There should be better links between hospital pharmacists and the services provided by primary care doctors and pharmacists in the community to improve patient outcomes, according to a new report published by the Pharmaceutical Society of Ireland (PSI). The report also found that hospital pharmacist involvement in multidisciplinary ward-based activities is limited and should be further developed to optimise their role in the safe and costeffective use of medicines Titled “Pharmaceutical Society of Ireland Baseline Study of Hospital Pharmacy”, the report was based on questionnaire responses from hospital pharmacists and heads of pharmacy departments, site visits and interviews at hospitals around Ireland, and an analysis of international best practice, including practice in the EU, Australia, Canada and New Zealand. The study’s respondents identified medicines reconciliation - the process of ensuring that medicines prescribed on admission to hospital correspond to those that the patient was taking before admission - as a key area in which hospital pharmacists could and should be playing a more prominent role. The report also found that while most hospital pharmacists had some influence over prescribing medications, there was a desire for hospital pharmacy to do more within this current limited scope. “A key issue that emerged from the report was realising a vision for pharmacy that fits into the wider healthcare delivery system in Ireland,” said Acting PSI Registrar/CEO Ciara McGoldrick. “Specifically, in the acute care setting, pharmacists

wish to further develop hospital pharmacy services as an embedded part of integrated patient care services. Through the Pharmacy Ireland 2020 initiative, the PSI is driving the greater involvement of pharmacists in the delivery of these services in Ireland in line with international best practice.” “For example, the issue of medicines reconciliation is seen as a priority. The Patient Safety Commission specifically recommended formal medicines reconciliation in 2008; this has yet to materialise and it is important that this issue be progressed. But overall, there is clearly huge potential for further development in hospital pharmacy services, with many surveyed having postgraduate qualifications and experience in other sectors. Mandatory continuing professional development requirements and the new Irish Institute of Pharmacy will also further support development in this respect.”

 Not Applicable  Strongly Agree  Agree  Neither Agree nor Disagree  Disagree  Strongly Disagree

As canMessage: be seen, agree that hospital pharmacists sh Main Asmost can bepharmacists seen, most pharmacists agree that hospital pharmacists should be considered responsible and medication-relation accountable for responsible and accountable for patients’ outcom patients’ medication-relation outcomes, and also that hospital pharmacists pharmacists significantly influence theinprescribing significantly influence the prescribing practice their hospitals.practice in their ho

There was a belief amongst respondents that they did not have influence over general policy in hospitals. Appraisal The latter point was discussed also in the site visit interviews, both w of pharmacy staff by managers supports theservice drive toand/or improvean antimicr to be generally pharmacy staff.cramped, Where a clinical pharmacy was found to be rare and the with levels of automation overall healthcare services in place, there was more confidenceIreland,” that prescribing practice was influe recruitment embargo is seen and communication between added Ms McGoldrick. to be having a significant systems lagging well behind negative impact on hospital other countries. Access to The PSI commissioned pharmacy teams. While most hospital pharmacy services Horwath Bastow Charleton pharmacists were engaging in is restricted in most hospitals (now Crowe 24Horwath) in midCPD (Continuing Professional at present to weekday “office 2011 to conduct a study to Development) or CE (Continuing hours” and a key issue raised provide an understanding of Education), there was agreement in the report was the need for the nature and type of hospital that opportunities and variety clinical pharmacy services to be pharmacy services currently of CPD/CE activities were available in parallel with other being delivered in Ireland, limited, especially for specialist medical services when required. and to review and report on areas of practice. The career the international profile of the “This study has given us a structure and opportunities for standards of hospital pharmacy valuable and unprecedented progression for pharmacists are service and care delivery. Crowe insight into hospital pharmacy in also a source of concern within Horwath was assisted in this Ireland, following a similar report the profession. project by senior academic commissioned by the PSI in pharmacists in the University of The report outlined that 2010 on community pharmacy. Central Lancashire (UCLan) in respondents believed hospital All this facilitates a holistic view of pharmacy in this country and pharmacy premises in Ireland the UK.

HPN • Issue 8


10 News

Galway pharmacist lucky Boston escape Galway hospital pharmacist Diana Hogan-Murphy just after crossing the finish line at the Boston Marathon

Galway Hospital Pharmacist Diana Hogan-Murphy has been describing her ‘near miss’ experience, as she was caught up in the recent Boston Marathon explosion. Diana was taking part in the event after securing a qualifying time in the Dublin Marathon and only crossed the finish line an hour before the explosions occurred.

She said she felt “so lucky to escape unharmed” but efforts to contact friends and family failed as all Internet and phone coverage had been shut down in the area. The 36-year-old, who works as a clinical pharmacist at Cavan General Hospital, described the surrounding areas as a “fortress”, with police armed with machine guns at each corner.

“Nobody really knew what was happening and the finish line area became very congested with people starting to panic, then the second blast occurred five seconds later. The real panic then set in and everybody started sprinting past me away from the finish line, which was full of smoke. People were screaming and crying not really sure of what was happening,” she said.

“That evening, I attempted to get something to eat and left the building to be greeted by armed FBI agents, who screamed that I had to put my hands on my head. After a body search and identification, I was sent back to my apartment and was warned not to attempt to leave the block until at least Tuesday morning.”

Diana is an experienced runner having previously becoming the first person to complete a 250km self-sufficient ultra marathon on all seven continents.

Paula scoops One 4 All During the Hospital Pharmacists Association of Ireland annual conference last month, Actavis ran a competition to win a One 4 All voucher. Pictured is the winner Paula O’Neill, Chief Pharmacist at

Issue 8 • HPN

St Finbars Hospital, Douglas, Cork. Paula is pictured receiving her voucher from Caroline Fitzgerald and Conor ?? from Actavis. The winner was picked by current President of HPAI Deirdre Lynch.

Despite her ordeal, Ms HoganMurphy said that the Boston Marathon is one of the best in the world, with hundreds of thousands of supporters coming out to show their support.


Hospital Pharmacy Awards 2013!

Hospital Pharmacy Awards 2013

Recognising excellence throughout Hospital Pharmacy Excellence in Pharmacy

We at Hospital Pharmacy News are both delighted and proud to announce the launch of inaugural Hospital Pharmacy Awards 2013. The Hospital Pharmacy Awards serve to act as the standardbearer for professionalism and excellence throughout hospital pharmacy. The Hospital Pharmacy Awards are hosted by HPN to recognise outstanding examples of high standards, best practice, innovation and excellence throughout this pharmacy sector in Ireland. These awards have been set up to reward achievement above and beyond that required. This is because they not only recognize professional and academic excellence but also the value of hospital pharmacists who push themselves the extra mile; those whose achievement is bounded not by what they must do, but only by the very best they can do. So we seek to recognise individuals with the character and ability to excel, but we also offer an environment in which such individuals can prosper. This is created in many ways, but we know that these awards will help hospital pharmacists, and their teams, to keep working hard and to stretch themselves further, fostering innovation. There are a total of ten categories up for grabs?  Hospital Pharmacist of the Year  Hospital Pharmacy Team of the Year  Hospital Pharmacy Technician of the Year  Hospital Pharmacy Manager of the Year  Hospital Pharmacy Representative of the Year  Antimicrobial Project of the Year  Aseptic Unit of the Year  Oncology Pharmacist of the Year  Innovation Project of the Year  Lifetime Achievement Award All shortlisted submissions for the Hospital Pharmacy Awards will be put forward for consideration to our esteemed, prestigious judging panel. This panel comprises of a totally independent group of professionals from within as well as outside the hospital pharmacy industry, who will decide the winners of the coveted Hospital Pharmacy Awards 2013.

The judges will be looking at original contributions with a special eye for how each submission is especially relevant to meeting the needs of patients and/or colleagues within the profession. The judges will also expect to hear how the achievement contributes to the hospital pharmacy’s overall vision and strategy. The winners will be announced during a glittering gala evening at the Crowne Plaza Hotel, Santry on September 21st, 2013 in front of an audience of over 300 representatives from across the country. Natalie Maginnis, Managing Director of IPN Communications Ltd commented: “We’re extremely proud and are equally delighted to see the Hospital Pharmacy Awards 2013 come to life with the announcement of this first ever event featuring 10 award categories and showcasing all that is positive and innovative in this fast paced industry. The evening will be what we envisaged from the inception of the Awards; a unique celebration of Ireland’s hospital pharmacy profession. “We would also like to thank all of our sponsors for their tremendous support which enables the industry to come together for this fantastic occasion.” How to attend the gala evening Tables and individual tickets for the gala evening are on sale now. However, we anticipate a sell-out event in 2013 so please be sure to book your tickets promptly to secure your seats. For further details please visit our website at: www.pharmacynewsireland.com Or contact Awards Co-ordinator Kelly Eastwood directly at: kjeastwood@hotmail.com


Hospital Pharmacy Awards 2013

Hospital Pharmacist of the Year Award

Investing in education and the health of the nation Excellence in Pharmacy

Roche Products Ireland

This aim of this award category is to recognise those who, through their service to patient care, education or research, to the profession and to the society, are worthy of being rewarded. The judges will be looking for those individuals whom exhibit promising leadership, dedication and commitment to practice excellence and professional growth. This may be through hospital pharmacy activities or their experiential training in direct patient care, research or education. The winner will exhibit eagerness, dedication and a positive attitude toward the academic learning, the practice, and the profession of hospital pharmacy. This Award is open to any pharmacist working within a Hospital Pharmacy unit in Ireland Examples:  What campaigns have you/they been involved in within the last twelve months worthy of recognition?  What has been the measurable outcomes/success of these?  What benefits have others derived as a result of your/their innovation and hard work?  Give examples of their outstanding work and commitment to the betterment of the hospital pharmacy profession  Evidence of an ability to identify opportunities and develop them through initiative and excellent interpersonal skills  What additional groups and bodies do you/they subscribe to in assisting towards the future growth of the profession? Criteria:  You may enter more than one category but each individual entry can only be submitted for a maximum of two categories  You will need to submit a short summary of no more than 500 words with supporting information  Entries should generally cover the twelve month period from January 2012 – December 2012 Judging:  There will be three finalists selected from all applications submitted  Each finalist submission will be judged by our independent judging panel  Each finalist will be invited to attend the gala awards ceremony on September 21, 2013 at the Crowne Plaza Hotel, Santry where the winner will be announced  For further information please visit our website at www.pharmacynewsireland.com

Company Mission Statement Roche’s aim as a leading healthcare company is to create, produce and market innovative solutions of high quality for unmet medical needs. Roche products and services help to prevent, diagnose and treat diseases, thus enhancing people's health and quality of life. We do this in a responsible and ethical manner and with a commitment to sustainable development respecting the needs of the individual, the society and the environment. Roche was founded more than 100 years ago and since then our corporate culture has been characterised by our core values of integrity, courage and passion. This has made us a world leader in healthcare. The three Roche values Integrity, Courage and Passion are central to how we want to behave as individuals, and collectively as an organisation.

We Innovate Healthcare

One of Roche’s Pillars supporting our Vision is People - We achieve more by challenging ourselves to grow and develop. By creating an environment where people can flourish, where achievements are recognised and where we are accountable to one other and to Roche. We are happy to support the Hospital Pharmacist of the Year , that awards a Pharmacist who demonstrates these values of Integrity Courage and Passion in today’s challenging Hospital environment.

Issue 8 • HPN


Hospital Pharmacy Technician of the Year Award

Hospital Pharmacy Awards 2013

Investing in education and the health of the nation

Medisource

Excellence in Pharmacy

This Award category serves to recognise and salute those pharmacy technicians whose hard work quite often flies under the radar. If you know someone that has enriched the depth and broadened the scope of pharmacy technicians then this award category is for you. Hospital pharmacy technicians have a vital role to play in supporting the team within hospital pharmacy departments. In recognition of this, this award will be given to someone who have provided an outstanding support for the pharmacy profession within their department. We will be looking for those that have been able to demonstrate exemplary accomplishments which foster the advancement of patient care and/or the profession of pharmacy technicians. Judges will want to see professionalism / leadership, support for and participation in continuous professional development, with a commitment to safe, rational, economic pharmaceutical care within the pharmacy technician role. Examples:  Evidence of new innovation or new thinking which has enhanced the hospital pharmacy department within which they work  Excellent communication with staff and additional pharmacy team members  Examples of your/their expertise exceptional effort resulting in a milestone being achieved or target exceeded  Examples of collaboration whereby outstanding teamwork and/or leadership skills have ensured a task was completed regardless of challenges faced Criteria:  You may enter more than one category but each individual entry can only be submitted for a maximum of two categories  You will need to submit a short summary of no more than 500 words with supporting information  Entries should generally cover the twelve month period from January 2012 – December 2012 Judging:  There will be three finalists selected from all applications submitted  Each finalist submission will be judged by our independent judging panel  Each finalist will be invited to attend the gala awards ceremony on September 21, 2013 at the Crowne Plaza Hotel, Santry where the winner will be announced  For further information please visit our website at www.pharmacynewsireland.com

Company Mission Statement Medisource are delighted to sponsor the HPN Hospital Pharmacy Technician of the Year award. Medisource are a wholly Irish owned company with more than 20 experienced staff, including pharmacy technicians. Our mission is to explore all avenues in tracking down unlicensed medicines to assist in continuing patient care, and our emphasis is on personal communication to ensure that medicines are sourced and delivered within the required timeframe and that such sourcing is done only through verified and legitimate distribution channels within regulations. We offer a global reach and commit to significant local stockholding so that your patient doesn’t have to suffer a break in treatment. We invest heavily in our human resources so that we can provide live up to the minute information through one to one communications.

HPN • Issue 8


Hospital Pharmacy Awards 2013

Hospital Pharmacy Manager of the Year Award

Investing in education and the health of the nation

Hospira

Excellence in Pharmacy

A successful manager creates a productive environment to work in as well as the drive and impetus to make things happen. They must balance technical and management skills. This Award is aimed at any individual who has made a significant contribution in the past year to their pharmacy department, to those pharmacy managers who have been instrumental in driving the department forward. This could be through improving financial and clinical performance through effective medication management, inter department relations, reviews or clinical trials, developing a new service or development of staff The judges will be looking for that candidate who has exceeded expectations by an innovative approach, who plans, directs, revises, and modifies pharmacy procedures. Pharmacy Manager of the Year award recognises those who provide the most effective demonstration of their pharmacy management competence, no matter the scale of the hospital or department. Examples:  How have you/they made a personal contribution to the hospital pharmacy team as a whole?  How have you/they managed and handled the team over the last twelve months to improve the working of the pharmacy department?  Please give examples of challenges faced over the last twelve months and how they have been overcome  How does your/their management approach make them special and stand out from any other hospital pharmacy manager?  Demonstrate techniques for motivating staff and detail any major achievements worthy of the Hospital Pharmacy Manager of the Year Award Criteria:  You may enter more than one category but each individual entry can only be submitted for a maximum of two categories  You will need to submit a short summary of no more than 500 words with supporting information  Entries should generally cover the twelve month period from January 2012 – December 2012 Judging:  There will be three finalists selected from all applications submitted  Each finalist submission will be judged by our independent judging panel  Each finalist will be invited to attend the gala awards ceremony on September 21, 2013 at the Crowne Plaza Hotel, Santry where the winner will be announced  For further information please visit our website at www.pharmacynewsireland.com Company Mission Statement Hospira is a global speciality pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in speciality generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. Learn more at www.hospira.com Biosimilars Biosimilars that are licensed for the UK are high-quality, cost-effective alternatives to proprietary biopharmaceuticals. With patents for these biopharmaceuticals expiring, Hospira is expanding its competencies to develop, manufacture and market Biosimilars in order to meet the growing demand for lower cost alternatives. A 20% price reduction on 5 high-cost drugs resulting from Biosimilar competition could save the EU over ¤1.6 billion per year.

Issue 8 • HPN


Itâ&#x20AC;&#x2122;s about confidence

Hospira is one of the major companies producing and marketing biologics globally With over 14,000 employees in 70 countries Hospira Biologics is built on strong foundations of excellence in innovation, service and support

Global biologics producer â&#x20AC;&#x201C; built on foundations of excellence

Experienced manufacturer of biologics Hospira Biologics use their extensive biologics expertise to manufacture their marketed products both in their own facilities and through rigorously evaluated manufacturing partners

Extensive biologics manufacturing expertise

Proven efficacy and safety We work hard to ensure our products not only meet stringent efficacy and safety requirements, but also offer the practical features you find useful

Proven efficacy and safety combined with a range of additional benefits

Strong heritage of delivering more Hospira is a global company with a strong heritage of over 70 years, with access to the resources and skills needed to harness the very latest technological advances in biologics development. Date of preparation February 2013 IE/13/001

Our philosophy is simply to deliver more in everything we do


Hospital Pharmacy Awards 2013

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

Excellence in Pharmacy

There are many key elements to building a productive team, including communication and co-operation. Good communication means everyone is aware of their own responsibilities and what the team's goals are whilst co-operation leads to increased productivity. The judging panel will be looking for the pharmacy that can demonstrate a close working relationship internally and with the doctors, nurses and other members of the multi-disciplinary team to ensure that patients receive optimal pharmaceutical care while attending the hospital. Teams that have adopted a key role in monitoring and reviewing patients and their medications, providing medication counselling where appropriate and liaising with community pharmacy colleagues and GPs to promote seamless pharmaceutical care. This can also include pharmacists and technicians, who are involved in ongoing research projects, in teaching and tutoring undergraduate and postgraduate healthcare personnel and in clinical training that enhances the overall performance of their department. A team that excels is the one who, together, endlessly work to improve their efforts. They comprehend the importance of on-going improvements and how this helps support the overall objectives of the department. The Award is open to any hospital pharmacy team with a minimum of three team members Examples:  Display of how team members are motivated and keep each other in team spirit positively  What is the methodology for this particular team in tackling a particular project?  Describe a project the team worked on recently and how individual team members worked towards a shared goal  How do you identify each other’s strong skills and structure them to the betterment of the team as a whole?  Please give examples of your success from working together as a team Criteria:  You may enter more than one category but each individual entry can only be submitted for a maximum of two categories  You will need to submit a short summary of no more than 500 words with supporting information  Entries should generally cover the twelve month period from January 2012 – December 2012 Judging:  There will be three finalists selected from all applications submitted  Each finalist submission will be judged by our independent judging panel  Each finalist will be invited to attend the gala awards ceremony on September 21, 2013 at the Crowne Plaza Hotel, Santry where the winner will be announced  For further information please visit our website at www.pharmacynewsireland.com

Hospital Pharmacy Awards 2013 September 21st, 2013 Crowne Plaza Hotel, Santry For application/nomination forms please contact: Kelly Jo Eastwood on: 0044 7876548989 OR by email at: kjeastwood@hotmail.com For table sales and sponsorship enquiries please contact: Debbie Graham on: 0044 7450 274112 OR by email at: debbie.hpn@btconnect.com Issue 8 • HPN


THE FUSION OF ACTION, VISION AND STRENGTH Actavis, Inc. represents the powerful combination of Watson Pharmaceuticals and the Actavis Group. Together we share a broader commercial footprint, an expanded product portfolio and enhanced capabilities in Ireland and around the world. With 2 EU cytotoxic manufacturing sites, we are the partner you can trust.

Actavis Ireland Ltd. Euro House, Euro Business Park Little Island, Co. Cork T: 1890 33 32 31 F: 021 461 90 49 E: contact@actavis.ie NA -009h-01

www.actavis.ie


Hospital Pharmacy Awards 2013

Hospital Innovation and Service Award

Investing in education and the health of the nation Excellence in Pharmacy

Novartis

This award will be presented to a practising hospital pharmacist and/or team in recognition of a project which could easily be accomplished regardless of hospital size or staff, which need not be sophisticated, and which serves a useful purpose or has recently been published. The judges will be looking for significant innovation in practice, method or service directly or indirectly resulting in improved patient care and/ or advancement of the profession of hospital pharmacy. We know that many pharmacists have initiated exciting programmes in their hospitals and we would like to recognise them. This award is ultimately for the forward thinking hospital pharmacists who are sourcing new ways of overcoming challenges faced. Key to this is optimising the health status of the patients under the care of hospital team, targeting areas of need and effective health enhancement and promotion. Examples:  How and why was the project started and what were the key objectives?  Examples of how this particular innovation is unique and the development process in getting it to fruition  Examples of the fundamental changes made by this innovation and the practicality of its application  Examples of published work directly relevant to the innovation  Impact of the innovation on patient care and for the wider hospital pharmacy industry Criteria:  You may enter more than one category but each individual entry can only be submitted for a maximum of two categories  You will need to submit a short summary of no more than 500 words with supporting information  Entries should generally cover the twelve month period from January 2012 – December 2012 Judging:  There will be three finalists selected from all applications submitted  Each finalist submission will be judged by our independent judging panel  Each finalist will be invited to attend the gala awards ceremony on September 21, 2013 at the Crowne Plaza Hotel, Santry where the winner will be announced  For further information please visit our website at www.pharmacynewsireland.com

Company Mission Statement Novartis is the only healthcare company globally with leading positions in pharmaceuticals, eye care, generics, biosimilars, vaccines and diagnostics, OTC medicines and animal health. Novartis employs over 123,000 people worldwide. Approximately 1,200 people are employed in two manufacturing plants in Cork and commercial operations in Dublin. Novartis is committed to R&D in Ireland. In 2012 ¤4m was invested in R&D and over the last three years, 17 clinical trials have been conducted, in areas such as Oncology, Respiratory, Ophthalmology and Neurology. Located in Model Farm road Cork, Alcon's manufactures the world's leading intraocular lens for various countries around the globe. Alcon's AcrySof lenses are implanted in six of every 10 cataract surgery patients worldwide.

Issue 8 • HPN


Antimicrobial Project of the Year Award

Hospital Pharmacy Awards 2013

Investing in education and the health of the nation

Mylan

Excellence in Pharmacy

Due largely to the overuse and misuse of antibiotics, bacteria have become increasingly resistant to many of the compounds we rely on to treat serious infections in our hospitals. Antibiotic pharmacists have been shown to be effective in many situations and as they become more accomplished their role is greatly expanding to include direct intervention in patient treatment. The judges within this category will be looking for an innovative project promoting health development, it could ideally include reviewing antibiotic orders (including drug selection and duration of therapy), design and promotion of clinical practice guidelines, implementation and operation of antibiotic “switch “programmes and documenting the effectiveness of interventions. The winning project will show a clear indication of how the pharmacy profession can play a key role long side other professions in tackling the problem of antibiotic resistance. As with medicine, pharmacy is becoming increasingly specialised, with lead pharmacists playing key roles in clinical areas such as critical care, haematology, oncology and neonatology. The development of the antibiotic pharmacist role over the past decade is a reflection of this, coupled with the recognised need for prudent antimicrobial prescribing. Examples:  Examples of a dedication and commitment to expanding and enhancing the role of antimicrobial hospital pharmacists for the whole profession  Examples of particular project(s) carried out within the field of antimicrobial pharmacy and/or recent work published  Education and expansion of knowledge in order to provide greater volume of service  Training and teamwork with the great antimicrobial team and hospital staff Criteria:  You may enter more than one category but each individual entry can only be submitted for a maximum of two categories  You will need to submit a short summary of no more than 500 words with supporting information  Entries should generally cover the twelve month period from January 2012 – December 2012 Judging:  There will be three finalists selected from all applications submitted  Each finalist submission will be judged by our independent judging panel  Each finalist will be invited to attend the gala awards ceremony on September 21, 2013 at the Crowne Plaza Hotel, Santry where the winner will be announced  For further information please visit our website at www.pharmacynewsireland.com

Company Mission Statement To us, our mission isn't just words. It's a cause we've made personal. At Mylan, we are committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership.

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Hospital Pharmacy Awards 2013

Oncology Pharmacist of the Year Award

Investing in education and the health of the nation Excellence in Pharmacy

BD

Recognising those who provide quality patient care in relation to a patient’s oncologic diagnosis, prescribed treatment, age group and other identified needs and provides comprehensive pharmaceutical care to oncology patients to assure safe and effective drug therapy. The judging panel will be looking for a high calibre individual who can demonstrate organisation, management and quality of care and services that optimise outcomes in patients with malignant diseases. This person will be able to show how they coordinate the drug therapy process through drug selection, drug information, dosing, monitoring, outcomes management, and patient education/counselling. Examples:  Judges will want to see examples of where knowledge and expertise have been used to both inspire colleagues within the industry and/or enhanced the patient experience within the field of oncology  How have you/they shown inventive thinking and novel application of techniques to solve a problem, improve efficiency or develop a new concept?  How have you/they undertaken significant personal development and/or increased your/their knowledge and ability to the benefit of the wider hospital pharmacy team and the profession?  Examples of the overall contribution to pharmacy oncology which has directly or indirectly had an impact on service delivery and standards Criteria:  You may enter more than one category but each individual entry can only be submitted for a maximum of two categories  You will need to submit a short summary of no more than 500 words with supporting information  Entries should generally cover the twelve month period from January 2012 – December 2012 Judging:  There will be three finalists selected from all applications submitted  Each finalist submission will be judged by our independent judging panel  Each finalist will be invited to attend the gala awards ceremony on September 21, 2013 at the Crowne Plaza Hotel, Santry where the winner will be announced  For further information please visit our website at www.pharmacynewsireland.com

Hospital Pharmacy Awards 2013 September 21st, 2013 Crowne Plaza Hotel, Santry For application/nomination forms please contact: Kelly Jo Eastwood on: 0044 7876548989 OR by email at: kjeastwood@hotmail.com For table sales and sponsorship enquiries please contact: Debbie Graham on: 0044 7450 274112 OR by email at: debbie.hpn@btconnect.com Issue 8 • HPN


Aseptic Hospital Unit of the Year Award

Hospital Pharmacy Awards 2013

Investing in education and the health of the nation

Actavis

Excellence in Pharmacy

This award category is open to qualified, trained pharmacists and technicians engaged in the preparation of injectable and other sterile products for individual patient use. The judges will be looking for the unit that can best demonstrate safety and quality within their department while incorporating initiatives. This could be through SOPs, cost saving projects, clinical trials medication, interaction with other departments, identification and fulfilment to training needs or other. An aseptic hospital unit can be made up of pharmacists, technicians, assistants and support staff and this award is open to any number of team members working within this capacity to ensure that the products prepared are sterile and free from contamination. In addition, the judges will be looking at the team that offers an exceptional level of Good Clinical Practice and puts patient safety and efficacy at the heart of its objectives. Examples:  Have you/they displayed observation in following strict procedures to ensure accuracy and/or to improve accuracy within the aseptic unit?  Have you/they engaged in training, development and/or further education to ensure continuation in meeting patient needs? Judges will expect to see evidence and results  Can you show examples of reducing wastage by improving efficiency and effective team working?  Have you recently carried out any internal audits, with documented results completing an accurate assessment checklist to ensure smooth and effective running of the unit? Criteria:  You may enter more than one category but each individual entry can only be submitted for a maximum of two categories  You will need to submit a short summary of no more than 500 words with supporting information  Entries should generally cover the twelve month period from January 2012 – December 2012 Judging:  There will be three finalists selected from all applications submitted  Each finalist submission will be judged by our independent judging panel  Each finalist will be invited to attend the gala awards ceremony on September 21, 2013 at the Crowne Plaza Hotel, Santry where the winner will be announced  For further information please visit our website at www.pharmacynewsireland.com

Company Mission Statement "Actavis develops and manufactures pharmaceuticals of the highest quality. We meet current and future customer needs through smart investments in R&D. We deliver best-in-class service and superior value." Statement from Actavis Representative, Caroline Fitzgerald, Actavis is delighted to support the hospital pharmacy awards & are proud to sponsor the Aseptic Unit of the year Award. With 2 EU cytotoxic sites of manufacture we pride ourselves on our robust supply chain & can be a partner you can trust. Actavis sell an affordable quality oncology range of products to Irish aseptic units.

HPN • Issue 8


Hospital Pharmacy Awards 2013

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

Excellence in Pharmacy

Hospital Pharmacy News

This aim of this award category is to recognise the sales representatives who excel in customer service, knowledge of their product base and a commitment to their profession in terms of future growth and development. The winner of this category must stand out in business ethics and integrity. Judges will be looking for exceptional applicants that show creativity and an inspiring work ethic. Whether it’s interacting with customers, going that extra mile, running new initiatives or training and promotional campaigns, this person will be an integral part of their company’s business. Nominated individuals may stand out due to their excellent team morale and motivation boosting techniques; their involvement in staff education and training or may be known to hospital pharmacists and the wider pharmacy team as being a beacon of knowledge for the products which form their sales list. Examples:  How have you/they improved the company’s operation, resulting in positive sales growth and tangible results?  Can you/they demonstrate a commitment to outstanding customer/client service?  How have you/they shown a commitment to provide innovative and driven services?  How have you/they demonstrated a sales service above and beyond that from which is expected to motivate team members, clients and colleagues? Criteria:  You may enter more than one category but each individual entry can only be submitted for a maximum of two categories  You will need to submit a short summary of no more than 500 words with supporting information  Entries should generally cover the twelve month period from January 2012 – December 2012 Judging:  There will be three finalists selected from all applications submitted  Each finalist submission will be judged by our independent judging panel  Each finalist will be invited to attend the gala awards ceremony on September 21, 2013 at the Crowne Plaza Hotel, Santry where the winner will be announced  For further information please visit our website at www.pharmacynewsireland.com

Company Mission Statement Hospital Pharmacy News is proud to sponsor the Hospital and Community Pharmacy Alliance of the Year Award. Hospital Pharmacy News is dedicated to working with Ireland's pharmacy market as the industry's professionals strive to build on previous successes, creating a stronger future. For us, it's the ability to work with pharmacy's, their owners and management teams to plan for the long term, grow the industry and transfer wealth from one generation to the next. Team working is an essential aspect for success. Within Ireland we are witnessing more frequently multidisciplinary working between hospital and community pharmacists and their staff; with the ultimate goal of improving health initiatives for patients, whether that is in a hospital or community setting. Pharmacy has many unsung heroes, so this Award is a great opportunity for us to be able to support the ongoing dedication and commitment, and help showcase the businesses that are the foundations of the Irish pharmacy market. Hospital Pharmacy News is dedicated to helping pharmacy in Ireland continue to drive success, even in the face of obstacles, challenges and adversity. Issue 8 • HPN


Lifetime Achievement Award

Hospital Pharmacy Awards 2013

Investing in education and the health of the nation

Accord

Excellence in Pharmacy

The Lifetime Achievement Award recognises the career and achievements of a hospital pharmacist who has made an indelible impact on the pharmacy industry within Ireland as a whole. This award will be given to a hospital pharmacist that has made a major impact on the arena of pharmacy in Ireland and will honour those individuals who have made a difference. The award provides special recognition to those who have provided outstanding service over a sustained period of years to the pharmacy/pharmacy academic community. Sponsored in conjunction with the Jack and Jill Foundation – the HPN Awards nominated charity – we are looking for someone who’s pioneering influence and unique approach to the delivery of sophisticated patient care and enhancement is worthy of the Lifetime Achievement title. The Lifetime Achievement Award is the most prestigious of all awards presented at the HPN Awards. It does not merely signify the superior achievement embodied in a single work. Instead, it is an acknowledgement of superior achievement in an entire career. So, to prevent unseemly competition and to prevent the impression that there are any losers in this category, this is the only award that is not decided by a vote of our judging panel. Instead, a special sub-committee of our judging panel - a Lifetime Achievement Award Committee has been established consisting of five members from across a diverse area within pharmacy. This committee will consider all the recommendations made for this award.

Examples:  Made a positive impact on the pharmacy industry  25 years, or more, of sustained service to pharmacy  Earned recognition by other industry, training, education or academic groups;  The respect of professional peers Criteria:  You may enter more than one category but each individual entry can only be submitted for a maximum of two categories  You will need to submit a short summary of no more than 500 words with supporting information  Entries for this award may cover any time span and are open to those individuals working within hospital pharmacy in Ireland; either directly or indirectly Judging:  There will be three finalists selected from all applications submitted  Each finalist submission will be judged by our independent judging panel  Each finalist will be invited to attend the gala awards ceremony on September 21, 2013 at the Crowne Plaza Hotel, Santry where the winner will be announced  For further information please visit our website at www.pharmacynewsireland.com

The Evolution of Generics Hospital Pharmacy Awards 2013 September 21st, 2013 Crowne Plaza Hotel, Santry For application/nomination forms please contact: Kelly Jo Eastwood on: 0044 7876548989 OR by email at: kjeastwood@hotmail.com For table sales and sponsorship enquiries please contact: Debbie Graham on: 0044 7450 274112 OR by email at: debbie.hpn@btconnect.com HPN • Issue 8


24 Report

New European requirements on use of sharps in hospitals come into force May 2013 marks the date by which European Member States are required to have put in place new requirements arising from the 2010 EU Council Directive 2010/32/EU on the prevention of sharps injuries in the hospital and healthcare sector (commonly referred to as “the Sharps Directive”) Richard Price

New requirements on healthcare employers to undertake sharps injury risk assessment procedures

Background to the Directive The case for regulation in this area is well made in respect of the fact that injuries caused by needles and other sharp instruments are one of the most common and serious risks to healthcare workers. If the sharp instrument is contaminated by blood, there is the potential for transmission of infection. Such injuries can cause anxiety and distress to those affected and can, in the most serious cases, result in infection with blood-borne pathogens such as HIV or hepatitis B or Ci. The Directive was developed in an unusual procedure, coming as the result of an agreement by European “social partners”, that is the Hospital and Healthcare Employers’ Association (HOSPEEM) and the European Public Services Union (EPSU), in July 2009. Most other European Directives are developed through a process involving the European Commission, European Parliament and representatives of national governments. The Directive’s overall purposes are to “achieve the safest possible working environment” and “to prevent workers’ injuries caused by all medical sharps”.

Issue 8 • HPN

The main requirements of the Directive apply to employers whose main activity is the management, organisation or provision of healthcare, whether Government-provided (e.g. public hospitals) or privately-provided (e.g. nursing homes). Hospital pharmacies therefore fall directly within the Directive’s scope. The Directive’s requirements upon healthcare employers focus on assessing and mitigating against the risk of sharps injuries. Accordingly, the Directive requires all healthcare employers to have in place risk assessment procedures. The Directive stipulates that these assessment procedures should include exposure determination and “understanding the importance of a wellresourced and organised working environment”ii. Furthermore, these assessment procedures should also take into account “technology, organisation of work, working conditions, level of qualifications, work related psycho-social factors and the influence of factors related to the working environment”. Making use of the risk assessment activity to improve procedures and mandatory staff training Further to this, the Directive then requires risk assessments to be made use of for eliminating and reducing the risk of sharps injury. Accordingly, healthcare employers are expected to specify

and implement safe procedures for using and disposing of sharp medical instruments and contaminated waste. Additionally, the employer should regularly reassess these procedures and use the procedures as an integral part of training with healthcare workers. Beyond this, the Directive sets out a general expectation on employers to highlight different risks, give guidance on existing legislation, promote good practice and raise awareness about sharps injury issues. Recapping of syringes - strongly discouraged, but not quite a ban The original Directive of 2010 had set out a ban on the practice of recapping syringes. However, following publication of the Directive and further consultation with practitioners and employers potential difficulties with such a blanket ban were foreseen. Therefore the Social Partners (responsible for the Directive) issued a ‘clarification note’ to make clear that “The practice of recapping refers to needles without safety and protection mechanisms”. This has been interpreted to allow the limited continuation of recapping in so far as enabling pharmacists to carry out the necessary procedures to prepare medicinesiii. In addition to this, the Directive sets out a general expectation on employers to eliminate unnecessary use of sharps and to provide medical devices that incorporate safety-engineered protection mechanisms. When a Sharps injury occurs The Directive’s requirements puts in place a new duty upon individual employees who receive a sharps injury whilst performing their work to notify the person responsible for safety and health in their workplace as soon as practicable. At this point, the employer is required to take “immediate steps for the care of the injured

worker, including the provision of post-exposure prophylaxis and the necessary medical tests where indicated for medical reasons, and appropriate health surveillance”. The employer must also investigate the causes and circumstances and record the incident. The worker must provide the relevant information at the appropriate time to complete the details of the accident or incident. Where an employee may have been exposed to a bloodborne virus, employers must ensure they have immediate access to medical advice and counselling, where appropriate. With the contentious issue of the Directive’s proposed ban on recapping now largely resolved through the issuing of a “clarification note” by the social partners, most of the Directive’s other requirements appear to have been broadly accepted by impacted stakeholders. As ever in the case of European Directives however, the proof of its impact will be in its implementation. To this end, the Directive includes provision for potential review of its implementation from 2015 onwards. UK NHS European Office Briefing Document ‘Protecting healthcare workers from sharps injuries’, May 2013. Available at: http://www.nhsemployers.org/ SiteCollectionDocuments/Protecting_ healthcare_workers_from_sharps_ injuries_KL_20130507.pdf Accessed 15 May 2013 i

Council Directive 2010/32/EU Available at: http://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri= OJ:L:2010:134:0066:0072:EN:PDF Accessed 15 May 2013 ii

British Dental Trade Association Regulatory Update, February 2013 Available at: http://www.bdta.org.uk/ news/393/15/Regulatory-Update--February-2013.html Accessed 15 May 2013 iii


J A N S S E N

H I V

P O R T F O L I O

PREZI ST 800 m A g: Now o ne tab per da let y

PREZISTA: now one tablet per day in combination with other antiretrovirals for: • Treatment-naïve patients regardless of viral load 1 • Treatment-experienceed patients with no DRV RAMs, HIV-1 RNA <100,000 copies/ml and CD4 cell count ≥100 cells x 106/l 1

Prescribing Information. Prezista (darunavir) PREZISTA® 100mg/ml oral suspension and 75 mg, 150 mg, 400 mg, 600 mg and 800 mg film-coated tablets Active ingredient: Darunavir (as ethanolate). Oral suspension - 100mg/ml; Filmcoated tablets - 75 mg, 150 mg, 400 mg, 600 mg or 800 mg. See Summary of Product Characteristics (SmPC) before prescribing. INDICATIONS: PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. PREZISTA Oral suspension, 75 mg, 150 mg and 600 mg tablets may be used to provide suitable dose regimens: For the treatment of HIV-1 infection in antiretroviral treatment (ART) experienced adult patients (including highly pretreated). For the treatment of HIV-1 infection in ART-experienced paediatric patients from the age of 3 years and at least 15 kg body weight. PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens: For the treatment of HIV-1 infection in antiretroviral therapy (ART) naïve adults. For the treatment of HIV-1 infection in ART-experienced adults with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. Genotypic or phenotypic testing (when available) and treatment history should guide the useof PREZISTA. DOSAGE AND ADMINISTRATION: Therapy should be initiated by health care provider experienced in management of HIV. PREZISTA must be taken with food. ART-naïve adults: PREZISTA 800 mg once daily with ritonavir 100 mg once daily. ART-naïve children: Not recommended for use. ART-experienced adults with no DRV-RAMs: PREZISTA 800 mg once daily with ritonavir 100 mg once daily. All other ART-experienced adults: 600 mg PREZISTA/100 mg ritonavir twice daily. ART-experienced paediatric patients: ≥ 15 kg and < 30 kg: 375 mg (3.8ml) PREZISTA/50 mg (0.6ml) ritonavir ≥ 30 kg and < 40 kg: 450 mg (4.6ml) PREZISTA/60 mg (0.8ml) ritonavir > 40 kg: 600 mg (6 ml) PREZISTA/100 mg (1.2 ml) ritonavir. PREZISTA oral suspension can be used in patients unable to swallow PREZISTA tablets. Children < 3 years of age or < 15 kg body weight: Not recommended. Elderly: Limited information available. Use with caution. Hepatic impairment: Use with caution in patients with mild or moderate hepatic impairment and contraindicated in patients with severe hepatic impairment. Renal impairment: No dose adjustment required. CONTRAINDICATIONS: Hypersensitivity to active substance or any excipients. Severe hepatic impairment. Combination of rifampicin/ritonavir or lopinavir/ ritonavir with PREZISTA. Preparations containing St John’s wort. Active substances that are highly dependent on CYP3A for clearance. SPECIAL WARNINGS AND PRECAUTIONS: Regular assessment of virological response is advised. Perform resistance testing if lack of/loss of virological response. Do not use PREZISTA/rtv 800/100 mg once daily dose regimen in ART-experienced patients with one or more DRV-RAMs. Advise patients that current antiretroviral therapy does not cure HIV and precautions should be taken to avoid transmission. Do not use in children < 3 years of age or weighing < 15 kg. Severe skin reactions: Discontinue PREZISTA/rtv immediately if signs or symptoms of severe skin reactions develop. Stevens-Johnson Syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.

Rash: In clinical studies, mild to moderate rash more common in treatmentexperienced patients receiving both PREZISTA + raltegravir compared to patients on either PREZISTA or raltegravir alone. Patients with known sulphonamide allergy: Contains a sulphonamide moiety; caution advised. Hepatotoxicity: Drug-induced hepatitis has been reported. Patients with preexisting liver dysfunction including chronic active hepatitis B or C have increased risk of liver function abnormalities including severe/potentially fatal hepatic adverse events and should be monitored. Prompt interruption/discontinuation of treatment if liver disease worsens. Haemophiliac patients: Possibility of increased bleeding. Immune reactivation syndrome: An inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise in immune reactive patients with severe immune deficiency at start of combination antiretroviral therapy (CART). Other: Onset/exacerbation of diabetes mellitus or hyperglycaemia reported. Lipodystrophy and metabolic abnormalities. Consider measurement of fasting serum lipids and blood glucose and manage as appropriate. Patients with advanced HIV disease and/or long-term exposure to CART may develop osteonecrosis. Life-threatening/fatal drug interactions reported in patients treated with colchicine and powerful CYP3A and P-glycoprotein inhibitors. Patients with renal or hepatic impairment should not be given colchicine with DRV/r. PREZISTA 400 mg & 600 mg tablets contain sunset yellow FCF (E110) which may cause allergic reaction. INTERACTIONS: Refer to the SmPC for full details before initiating therapy. Interaction studies have only been performed in adults. Medicinal products that affect darunavir/ritonavir exposure: Darunavir/ritonavir must not be coadministered with medicinal products that are highly dependent on CYP3A4 for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events. Refer to “Contraindications” for more details. Medicinal products that are affected by the concomitant use of darunavir/ ritonavir: PIs: Lopinavir/ritonavir contraindicated. Saquinavir: not recommended. Indinavir: dose adjustment may be required. Atazanavir: can be used with darunavir/ritonavir. The efficacy and safety of the use of darunavir/ ritonavir and any other PI not established (e.g. fos (amprenavir), nelfinavir and tipranavir). Generally, dual therapy with PIs not recommended. NNRTIs: Efavirenz: if in combination with PREZISTA/rtv, the PREZISTA/rtv 600/100 mg twice daily regimen should be used. Clinical monitoring for CNS toxicity may be required. Etravirine, rilpivirine, nevirapine: no dose adjustment required. NRTIs: Tenofovir: monitoring of renal function may be required. No interactions expected with zidovudine, zalcitabine, emtricitabine, stavudine, lamivudine, didanosine and abacavir. Non-antiretroviral products: Do not use: phenobarbital, phenytoin, voriconazole, salmeterol, tadalafil (treatment of pulmonary arterial hypertension), boceprevir, telaprevir. Monitoring required/ possible dose adjustments: carbamazepine, clarithromycin, ketoconazole, itraconazole and clotrimazole, warfarin (monitor INR), calcium channel blockers, oestrogen hormone replacement therapy, cyclosporine, tacrolimus and sirolimus, methadone coadministration, parenteral midazolam, atorvastatin, rosuvastatin, pravastatin PDE-5 inhibitors, rifabutin, colchicine, bosentan. Maraviroc: dose should be 150 mg twice daily. Careful titration required: digoxin, SSRI’s. No dose adjustment: H2-receptor antagonists, proton pump inhibitors. Alternative or

Reference: 1. PREZISTA 800 mg. Summary of Product Characteristics, January 2013. Date of preparation: March 2013 | PHIR/PRE/0313/0001

additional contraceptive measures required: oestrogen-based contraceptives. Caution: artemether/lumefantrine, dexamethasone; sildenafil, tadalafil and vardenafil (treatment of erectile dysfunction). Not recommended: fluticasone, budesonide (unless potential benefit outweighs risk of systemic corticosteroid effects). PREGNANCY AND LACTATION: Use during pregnancy only if potential benefit justifies potential risk. HIV infected women must not breastfeed their infants under any circumstances. SIDE EFFECTS: Refer to SmPC for full details of side effects. Safety profile in children and adolescents is similar to that in adult population. Very common: diarrhoea. Common: lipodystrophy, hypertriglyceridaemia, hypercholesterolaemia, hyperlipidaemia, insomnia, headache, peripheral neuropathy, dizziness, vomiting, nausea, abdominal pain, increased blood amylase, dyspepsia, abdominal distension, flatulence, increased alanine aminotransferase, increased aspartate aminotransferase, rash, pruritus, asthenia, fatigue. Uncommon: thrombocytopenia, neutropenia, anaemia, immune reconstitution syndrome, drug hypersensitivity, diabetes mellitus, gout, anorexia, decreased appetite, weight changes, hyperglycaemia, insulin resistance, depression, confusional state, disorientation, anxiety, altered mood, sleep disorder, abnormal dreams, lethargy, paraesthesia, hypoaesthesia, somnolence, conjunctival hyperaemia, vertigo, myocardial infarction, angina pectoris, prolonged electrocardiogram QT, hypertension, dyspnoea, cough, pancreatitis, gastritis, gastrooesophageal reflux disease, aphthous stomatitis, retching, dry mouth, abdominal distension, flatulence, constipation, hepatitis, cytolytic hepatitis, hepatic steatosis, increased enzyme levels, allergic dermatitis, urticaria, hyperhidrosis, night sweats, alopecia, osteoporosis, myalgia, arthralgia, pain in extremity, renal failure, nephrolithiasis, increased blood creatinine, decreased creatinine renal clearance, proteinuria, bilirubinuria, erectile dysfunction, gynaecomastia, pyrexia, chest pain, peripheral oedema, malaise. LEGAL CATEGORY: POM.PRESENTATIONS, PACK SIZES, PRODUCT LICENCE NUMBER: 100mg/ml oral suspension: 1 bottle containing 200ml. EU/1/06/380/006. 75 mg tablets: 1 bottle containing 480 tablets. EU/1/06/380/005. 150 mg tablets: 1 bottle containing 240 tablets. EU/1/06/380/004. 400 mg tablets: 1 bottle containing 60 tablets. EU/1/06/380/003. 600 mg tablets: 1 bottle containing 60 tablets. EU/1/06/380/002. 800 mg tablets: 1 bottle containing 30 tablets. EU/1/06/380/007. MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER INFORMATION AVAILABLE FROM: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG, UK. ©Janssen-Cilag Ltd 2013 Prescribing information last revised: January 2013 | PIVER: 201301

Adverse events should be reported. Reporting forms and information can be found at www.imb.ie. Adverse events should also be reported to Janssen-Cilag Ltd on 0044 1494 567447


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CPD 3: LEANS MANAGEMENT Biography - Matthew Hamilton is Policy Deployment Officer at Leading Edge Group. He has worked as a policy analyst and programme manager on health reform and e-learning projects in Ireland, Australia, Central America and the Caribbean. He is currently a Health Economics Masters candidate at NUI Galway.

Matthew Hamilton

60 Second Summary Inefficiency in communication and collaboration was one of the principal themes to emerge from a workshop that continuous improvement specialist Leading Edge Group facilitated with about forty hospital pharmacists at the Hospital Pharmacist Association of Ireland conference in April last year. Underpinning Lean Pharmacy are the principles of focusing on patients (placing patient needs at the centre of every decision in a process and seeking to eliminate any step that does not add value to patients) and involving staff (supporting, training and trusting staff to identify and solve problems). An example of Lean Pharmacy deployment in an Irish hospital pharmacy setting that was previously featured in the Irish Pharmacy News is Galway University Hospital, where Leading Edge Group worked with pharmacy staff to help them achieve better communication with hospital colleagues and patients, a more empowered staff team and improved use of physical facilities through greater use of visual cues. A more systematic approach to improving communication and collaboration in healthcare settings may be achievable through a combination of mapping where failings and inefficiencies currently occur, assigning explicit responsibility for the effective flow of information across healthcare organisations to named individuals, by redesigning processes and by making better use of technology.

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

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

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

Quantifying and eliminating failings in communication and collaboration across the pharmacy chain In modern healthcare, achieving optimum communication and collaboration across the myriad specialised professions, organisations, technologies and processes involved in each patientâ&#x20AC;&#x2122;s care is an increasing challenge. Unsurprisingly, in such a complex environment it is common for communication and collaboration to be far from optimal, with significant avoidable costs as the result. A 2010 paper by Agarwal, Sands and Schneider estimates that a typical 500 bed hospital in the US loses over $4 million annually solely as a result of communication inefficiencies. This estimate

is likely to be conservative as was based on measuring only direct resource costs such as salaries and did not account for other economic burdens, such as the impact on patient care. Inefficiency in communication and collaboration was one of the principal themes to emerge from a workshop that continuous improvement specialist Leading Edge Group facilitated with about forty hospital pharmacists at the Hospital Pharmacist Association of Ireland conference in April last year. Pharmacists at the workshop applied aspects of the process improvement methodology

Lean Pharmacy to analysing the flow of information and medicines between suppliers, pharmacists, prescribers and patients, to identify where bottlenecks, frustrations and waste occurred and to describe potenrial redesigned processes that could eliminate or mitigate the identified inefficiencies. Participant pharmacists identified issues that both reached backwards to suppliers (relating to failings in communication and collaboration that contribute to stock shortages) and forward to other parts of the hospital (relating to time spent chasing down prescribers to confirm or modify prescriptions).

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


CPD 3: LEANS MANAGEMENT

and implementing rapid improvement projects are deployed in order to review the current state, to imagine and describe the ideal future state and to develop and implement a plan to achieve the ideal state and sustain continuous improvement within the hospital pharmacy. Underpinning Lean Pharmacy are the principles of focusing on patients (placing patient needs at the centre of every decision in a process and seeking to eliminate any step that does not add value to patients) and involving staff (supporting, training and trusting staff to identify and solve problems).

Many of the concerns of these Irish pharmacists about ineffective communication and collaboration are shared by their Canadian peers. Leading Edge Group has identified a number of common themes arising from its work supporting the deployment of Lean Pharmacy in Canada, including: • Defective (incomplete or unclear) communication. Pharmacists regularly have to contact the prescriber in order to clarify the request or to ascertain the patient allergy status. As a result there is unnecessary movement (chasing down the prescriber), the medication review is conducted with inadequate context regarding patients and

implementing the therapy is delayed.

respond to visual cues relating to declining stock levels.

• Episodic communication. In many instances, the receipt of medication orders in the pharmacy is a batch feed activity. Orders are faxed in batches from in-patient care areas or outlying facilities, or are handled in batches by the staff in the pharmacy, resulting in uneven distribution of work.

• Restricted-communication. The design of existing roles and processes often force pharmacists to undertake tasks within the pharmacy that could be performed by pharmacy technicians. As a result the capacity of pharmacists to share their expertise with other clinicians in other parts of the hospital is constrained with potential knock on effects on the quality of patient care.

• Inconsistent communication. There are differing approaches to how information is logged and communicated within pharmacy inventory management systems and staff members may have varying levels of understanding about how to appropriately

The suite of tools and processes that comprise Lean Pharmacy are designed to tackle these challenges. Mapping value streams, improving visual controls

Lean Pharmacy is part of a wider Lean approach to healthcare continuous improvement that has been credited with benefitting patients, improving staff morale and enhancing the financial performance of service providers, a combination that explains why Lean’s growing role in healthcare improvement initiatives has coincided with a growing imperative to improve performance whilst costs have become increasingly constrained. Additionally, a number of findings from Leading Edge Group’s Lean Pharmacy scoping analysis of the Irish community pharmacy sector last year may have relevance to hospital pharmacists, such as achieving: • Inventory levels that are appropriate to the level of demand, where wastage of drugs is minimized and time spent managing inventory is released for quality initiatives by pharmacists.

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


CPD 3: LEANS MANAGEMENT

The project was characterised problems and implement • How More time pharmacists An example of Lean Pharmacy the  for project   was  implemented   by: solutions within their to spend as members of the deployment in an Irish patient care teams handling constraints by using Lean hospital pharmacy setting - Taking out of the Prior  experience   with  implementing   The  project   was  characterised   Techniques   used  in  learning the  project   included:   complex medication-use Thinking. by:   that was previously featured classroom, relating Lean Lean   t hinking   h ad   c onvinced   t he   issues and advising members in the Irish Pharmacy News is Concepts to the everyday work conversations   about   ¥ Taking   learning  oAs ut  aoresult, f  the   the pharmacy¥ Prompting   ofhospital’s   the multidisciplinary teams Galway Hospital, Acting  Chief   Pharmacist   that   University pharmacy members onintroducing   current issues where Group –  Relating   staff  of opinions   and  team anxieties   classroom   team:Lean  concepts   Lean  regarding tools  and  concepts   to  Leading Edge medications andteam   prescribing. worked with pharmacy staff to  the   everyday  work  of  pharmacy   ¥ Implementing  an  ideas  board  and   the  pharmacy   would  empower   - Walking the process – Going  Have developed the to help them achieve better team   m embers   establishing   aily  ten   m inute   them  to  make  ongoing  improvements   to wheredeach step of a knowledge, skills and communication with hospital • Application of information improvement   m eetings   ¥ Walking   t he   p rocess   –   G oing   t o   despite   t he   c onstraints   w ithin   w hich   process happens and talking confi dence to lead process colleagues and patients, Technology and automation where   of  a  process  work on an ¥ Mapping   to customers about their key  team   processes   work.   ensure patient improvement a more empowered staff each  step   tothey   effectively experiences happens   to   basis; ongoing ¥ Facilitating   a  site  and visit  needs to  another   safety and to identify those team and improved use of and  talking   A   L ean   c onsultant   f rom   L eading   E dge   “customers”   a bout   t heir   most in need of the attention physical facilities through organisation  to  see  Lean  in  action   - Learning by doing – was  appointed  to  deliver  agreater   ofGroup   a pharmacist. use of visual cues. experiences   and  nHave eeds   a better understanding ¥ Mentoring  team  members  as  they   of needs, expectations and Developing team knowledge achievedby  doing  –the tailored  programme  of  training  aThese nd   results ¥wereLearning    developing   and  techniques executed  pby rojects  to   experiences of both patients planned   of Lean through a combination • mentoring   Print or electronic issue of allpharmacy   to  10-­‐12   hospital   team  ofknowledge   of  Lhospital ean   achieve   a  tidier,  safer   work   and staff in other implementing improvement prompting conversations prescriptions, eliminating time team  members,   primarily   pharmacy   techniques  by  implementing   environment   and   etter  stock   projects in thebhospital departments; spent deciphering handwriting. about staff opinions and technicians  and  pharmacists.   pharmacy. improvement   p rojects   i n   t he   management   anxieties, implementing an  Manage stock more hospital     ideas board and daily ten pharmacy   • Information on patient effectively with greater visibility The key outcomes achieved minute improvement ¥   meetings, of stock and less stock outs; medicines being stored and were empowered staff, mapping key team processes, accessed when needed by the improved customer service, an off-site visit to see Lean in relevant persons, to ensure  Utilise pharmacy space more better stock management, action and the mentoring of that the correct medications effectively. better workflow and better staff. are dispensed in the correct work space utilisation. volumes in order to deliver the A Lean Consultant from most efficient and safe service Leading Edge group was The pharmacy department Furthermore, a number of to the patient. appointed to deliver a tailored here was under significant issues raised by the recently programme of training and pressure to perform more released baseline report on mentoring to 10-12 hospital work with less staff. The • Pharmacy sensitive data Irish hospital pharmacy by pharmacy team members, hospital asked Leading Edge being available to assist the Pharmaceutical Society primarily pharmacy technicians to develop the capacity of with workforce and resource of Ireland highlight some of and pharmacists. the pharmacy team solve planning. The  key  outcomes  achieved  were   empowered   staff,  toimproved   customer   focus,  better  stock  management,  better  workflow  and  

Taking learning  out   of  the  classroom  

Walking the   process  

Learning by   doing  

better space  utilisation.      

Empowered staff  

Pharmacy team  m embers  have  m ade  process  improvement  an   ongoing  part  of  their  routine  work  

TYPE OF  OUTCOME  

Improved customer  focus  

Better stock  management     Better  workflow     Better  space  utilisation    

DESCRIPTION

Pharmacy team  members  have  spoken  to  their  customers  to  get  a   better  understanding  of  the  needs,  expectations  and  experiences  of   both  patients  and  hospital  staff  in  other  departments  

A Kanban  system  has  been  successfully  implemented  to   ensure  greater  visibility  of  stock  and  almost  eliminate  stock-­‐ outs  of  key  stock  items   Work  process  have  been  mapped  and  unnecessary  movement   of  people  and  transportation  of  products  have  been   eliminated   A  re-­‐organised,  tidier  and  more  visual  work  environment  has   created  space  savings  of  25%  

Continuous Professional Development Modules are sponsored by Pfizer Healthcare Ireland

LEADING ofEDGE   GROUP   -­‐  CANADA  included inLEADING   PfizerEHealthcare Ireland has no   editorial oversight the CPD programmes these modules. FURTHER  CONTACT   LEADING   DGE  GROUP   -­‐  IRELAND   EDGE  GROUP  -­‐  UK   Suite  800,  120  Eglinton  Avenue  East,   Charter  House,  Harbour  Row,   Centre  for  Value  Chain  Research,  Kent  Business   www.leadingedgescm.com  


CPD 3: LEANS MANAGEMENT

the enablers and barriers to better communication and collaboration across the pharmacy chain (from manufacturers to distributors to hospital pharmacies to hospital wards and units), in particular: • Relatively low levels of automation and communication between systems compared to other countries and inadequate technology • Under-developed links beyond the hospital • Limited involvement of pharmacists in patient care teams • The need for innovative solutions relating to training and role redesign Medicines management can mean different things to different people. The definition used in this survey is that used by the UK Audit Commission’s 2001 Spoonful of Sugar report: Medicines management in hospitals encompasses the entire way that medicines are selected, procured, delivered, prescribed, administered and reviewed to optimise the contribution that medicines make to producing informed and desired outcomes of patient care. To explore some of these issues further, Leading Edge Group will be conducting a survey of Irish hospital pharmacists in March and April to: • identify current strengths and weaknesses of communication and collaboration across the pharmacy chain

• identify priority areas for improvement • assess the current and potential future application of human process, technology and data analysis strategies to enable better communication and collaboration in Irish hospital pharmacy The purpose of this survey will be to provide an economic analysis of the impacts of communication and collaboration inefficiencies across the Irish hospital pharmacy chain. Such economic analysis may help hospital pharmacist to set priorities and to learn more about the communication and collaboration improvement strategies deployed or planned by their peers. It is also intended that this research will make a contribution to better understanding the economic impact of communication inefficiencies in Irish healthcare and to support the development of more systematic approaches to improving communications and collaboration in Irish hospital pharmacy. A more systematic approach to improving communication and collaboration in healthcare settings may be achievable through a combination of mapping where failings and inefficiencies currently occur, assigning explicit responsibility for the effective flow of information across healthcare organisations to named individuals, by redesigning processes and by making better use of technology. Such a more systematic approach has the potential to

improve the quality of hospital pharmacy services, use scarce resources more effectively and improve the working lives of hospital pharmacists. More details about Lean Pharmacy and how you can participate in the survey are available at http://www. leadingedgegroup.com/ consulting/zlean-pharmacy/ LEAN IN PHARMACY Pharmacy is an area of healthcare in which major health gain, improved financial performance and greater staff satisfaction are readily achievable through implementing Lean thinking. Leading Edge Group has produced resources to aid community pharmacists, hospital pharmacists and health service planners, policymakers and regulators to achieve these gains.

• Efficient Pharmacy Inventory

Practices are essential to the profitability of your pharmacy. Too much inventory is a major cause for insufficient cash flow. Don’t let profits sit on your shelves or expensive brand name drugs go out of date due to improper inventory levels. Remember inventory eats cash.

• LEAP Self Assessment Tool

– This self-assessment tool was developed in order to assist community pharmacists to identify key areas where initial process improvement efforts may need to focus in order to resolve the largest problem or worst bottlenecks. If in applying the this tool, a community pharmacy scores less than 30 “yes” responses, then it is likely to benefit from

implementing Lean. Less than 20 “yes” responses would indicate that there may be an urgent case to review internal processes in order to ensure future viability. If you are a pharmacist or are responsible for healthcare services that include pharmacy, talk to Leading Edge Group today about how we can help you achieve quality improvements and financial savings. Services we can provide include:

• Tailored training, mentoring

and consulting programmes to empower pharmacy team members in both community and hospital pharmacies to achieve improvements and overcome resource constraints by implementing Lean Thinking

• Preparation of advice,

analysis and reports for policymakers, regulators and service planners about tackling systemic issues to enable improved performance from the pharmacy sector

• Provision of introductory

training to Lean thinking and concepts through our range of online courses and workshops For specific queries, contact Leading Edge Group by email (info@leadingedgegroup.com) or phone on 021 4855863. Author Information: Matthew Hamilton is Policy Deployment Officer at Leading Edge Group. He has worked as a policy analyst and programme manager on health reform and e-learning projects in Ireland, Australia, Central America and the Caribbean. He is currently a Health Economics Masters candidate at NUI Galway.

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


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The NEW asthma maintenance treatment

INNOVATION

Modern aerosol device with a patient-facing dose counter1 * Open label study, significant increase in FEV1 5 mins after dosing (p=o.oo1) (Aalbers et al: Onset of Bronchodilation with fluticasone/formoterol combination versus fluticasone/salmeterol in an open-label, randomised study; Adv Ther 2012) ** 6-12 month open label study, significant improvement in spirometric secondary endpoints vs baseline (Mansur et al, Long Term Safety and Efficacy of fluticasone/formoterol combination therapy in Asthma; JAMP -Vol 25, No0, 2012 p1-10)

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

NEW

fluticasone propionate/formoterol A POWERFUL PARTNERSHIP

treatment with high doses of corticosteroids may result in adrenal suppression and acute adrenal crisis, particularly in adolescents and children or potentially as a result of trauma, surgery, infection or rapid dose reduction. Patients should be advised that flutiform contains a small amount of ethanol; however this negligible amount does not pose a risk to patients. flutiform is not recommended in children under 12 years of age. Interactions: Caution is advised in long-term co-administration with strong CYP3A4 inhibitors (e.g. ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, ketoconazole and telithromycin); co-administration should be avoided if possible. Ritonavir in particular should be avoided, unless the benefits outweigh the risks of systemic side-effects. Caution is advised with use of non-potassium sparing diuretics (e.g. loop or thiazide), xanthine derivatives, glucocorticosteroids, L-Dopa, L-thyroxine, oxytocin, alcohol or other adrenergic drugs. There is an increased risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons. Hypokalaemia may increase the risk of arrhythmias in patients being treated with digitalis glycosides. Concomitant use of ß-adrenergic drugs can have a potentially additive effect. Extreme caution should be taken when using formoterol fumarate with drugs known to prolong the QTc interval, such as tricyclic antidepressants or MAOIs (and for two weeks following their discontinuation), as well as antipsychotics (including phenothiazines), quinidine, disopyramide, procainamide and antihistamines. Concomitant use of an MAOI or a similar agent, such as furazolidone or procarbazine, may precipitate hypertensive reactions. ß-blockers and formoterol fumarate may inhibit the effect of each other. ß-blockers may produce severe bronchospasm in asthma patients, and they should not normally be treated with ß-blockers including those that are used as eye drops to treat glaucoma. Under certain circumstances, e.g. as prophylaxis after myocardial infarction, cardioselective ß blockers could be considered with caution Pregnancy and lactation: flutiform is not recommended during pregnancy. It should only be considered if benefits to the mother outweigh risks to the foetus. It is not known whether fluticasone propionate or formoterol are excreted in breast milk; a risk to the breast feeding infant cannot be excluded. A decision should be made on whether to discontinue breastfeeding or discontinue/abstain from flutiform. Side-effects: Potentially serious side-effects: hyperglycaemia; depression; aggression; behavioural changes (predominantly in children); paradoxical bronchospasm; agitation; vertigo; palpitations; ventricular extrasystoles; angina pectoris; tachycardia; hypertension; dyspnoea; peripheral oedema; Cushings Syndrome; adrenal suppression; growth retardation; cataract and glaucoma; hypersensitivity reactions and QTc interval prolongation. Please consult the SPC for details of non-serious side-effects and those reported for the individual molecules. Legal category: POM Package quantities: One inhaler containing 120 actuations 50 µg/5 µg, 125 µg/5 µg, 250 µg/10 µg Marketing Authorisation numbers: PA 1688/13/1-3 Marketing Authorisation holder: Mundipharma Pharmaceuticals Limited, Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland. Member of the Mundipharma Pharmaceutical Group. For medical information enquiries, please contact info@mundipharma.ie Date of preparation: January 2013 Reference: 1. flutiform Summary of Product Characteristics ® FLUTIFORM is a registered trademark of Jagotec AG, and is used under licence. ® AEROCHAMBER and AEROCHAMBER PLUS are registered trade marks of Trudell Medical International. © 2012 Mundipharma Pharmaceuticals Limited. Adverse events should be reported. Reporting forms and information can be found at http://www.imb.ie/EN/Safety--Quality/Online-Forms/Human- Medicine-Adverse-Drug-Reaction.aspx Adverse events should also be reported to Mundipharma Pharmaceuticals Limited on 01 206 3800/1800 991830 (outside office hours). IRE/FL-12042


32 Neurology

Multiple Sclerosis Author Biography: Sean Owens has been a community pharmacist for seven years and works with DocMorris pharmacy in Raheny, Dublin. Sean completed his MPharm at Queens University Belfast in 2004, and has worked in community pharmacy in greater Dublin since. In 2010 Sean returned to study Graduate Entry Medicine at UCD, and has two years of study remaining. His interests include cancer treatment, and in 2012 he will attend Emory University Atlanta to investigate triple negative breast cancer

Multiple Sclerosis (MS) is an immuno-inflammatory degenerative disease which attacks myelinated axons throughout the central nervous system (CNS) resulting in the formation of discreet plaques. MS is the most common chronic inflammatory disease of the CNS, affecting over 2 million people worldwide and is 3 times more common in women than in men1. Whilst the cause of MS is not yet fully understood, it is thought that multiple factors act together to trigger or perpetuate the disease. Research has not demonstrated genetic predisposition, however genetic susceptibility may act synergistically with environmental triggers such as exposure to viral infections (e.g. Epstein Barr Virus), vitamin D deficiency and a lack of exposure to sunlight. Equatorial countries have a lower incidence than those of increasing latitude, whilst incidence in Norway, where diets are high in vitamin D, is lower than should be expected1. Recent research has argued that the geographical spread of endemic helminths

(such as the tape worm) may in fact incur protective immunological properties which may also explain the geographical phenomenon; this offers rational for exciting new therapies (see below) 2.

conduction of nerve impulses which causes the classic presenting symptoms of MS (see below). Inducing T cell tolerance to myelin antigens is therefore a promising strategy for the future treatment of MS2.

PATHOLOGY

PRESENTATION

Demyelination of nerve axons throughout the CNS is thought to be mediated via activation of T cells in the periphery and the subsequent extravasation of these T cells into the CNS. There is subsequent secretion of pro-inflammatory cytokines such as interferon, interleukins and tumour necrosis factor which attack the myelin of the nerve resulting in plaque formation. Plaque formation disrupts

Approximately 20% of MS patients present with optic neuritis (inflammation of the optic nerve) as the first discreet demyelinating episode; over 40% will proceed to experience this at some point during the course of their disease2. As a community pharmacist it is important to be mindful of both presenting symptoms and at risk groups; a young female presenting with symptoms of optic neuritis would therefore warrant an immediate referral. Symptoms of optic neuritis include sudden partial or complete loss of vision, sudden blurred vision and pain with eye movement. Classic presenting symptoms of MS include: • motor symptoms – eg spasticity • optic neuritis • autonomic symptoms especially bladder, bowel and sexual dysfunction • cerebellar symptoms – eg lack of coordination and tremor • trigeminal neuralgia • pain - this may be primarily associated with the demyelination, or secondary to muscle spasticity • also depression, constipation and fatigue

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34 Neurology

DIAGNOSIS OF MS MS is classified as: • relapsing-remitting (RRMS) • secondary-progressive (SPMS) • primary-progressive (PPMS) • progressive-relapsing (PRMS) RRMS accounts for 85% of MS cases and is characterised by recurrent attacks whereby a variety of focal neurologic deficits appear in a distinct and unpredictable fashion. These may resolve either wholly or partially over a short period of time leaving little or no residual effect. Approximately 50% of RRMS patients convert to SPMS

within 10-15 years. This is characterised by continual disease progression and increasing disability over time. PPMS accounts for approximately 10% of MS cases, whereby function declines progressively without relapse. Sporadic relapse against a background of disease progression is typical of PRMS and accounts for around 5% of all MS cases2. MS was traditionally diagnosed on a clinical basis; evidence of disease activity separated in time and space was required to suggest the presence of lesions. Supporting evidence from magnetic resonance imaging of the brain and spinal cord, and cerebrospinal fluid

examination confirmed the diagnosis. However with recent advances in neurological imaging, the ‘McDonald criteria’ now allows diagnosis of MS with the onset of clinical symptoms such as optic neuritis. Visually-evoked potentials, which measure electrical activity in the brain, can also be useful but are not essential for diagnosis. Cerebrospinal fluid analysis is of use when MRI is contraindicated, not available or inconclusive, and is evaluated for oligoclonal bands, IgG titres and inflammatory markers. NOVEL PHARMACOTHERAPY Emergency treatment of an acute episode or flare-up of MS includes prompt administration of IV steroids, IV immunoglobulin or plasmapheresis. Although the evidence for the efficacy of steroids is still of much debate in the literature, most centres in Ireland still subscribe to their use. Chronic treatment of MS has an immunomodulatory arm aimed at modifying the underlying disease process and a symptomatic arm aimed at improving quality of life. Disease-modifying therapies include: • Interferon beta-1a (Avonex, Rebif) • Interferon beta-1b (Betaferon) • Glatiramer acetate (Copaxone) • Natalizumab (Tysabri) • Mitoxantrone (Novantrone) • Exciting new orally active agents Fingolimod (Gilenya) and Teriflunomide (Aubagio) Interferon beta-1b is licensed for RRMS and is administered every other day subcutaneously whilst interferon beta-1a is given weekly via intramuscular injections. Glatiramer acetate is a synthetic polypeptide also approved for RRMS, and can be used where depression is a concern when using interferon3. The drawbacks of these three therapies are their partial efficacy, modest effect on disease progression, expensive costs and unfavourable dosage and route of delivery.

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Natalizumab is indicated as a monotherapy for RRMS and has shown promise in delaying physical disability and reducing incidence of flare-ups (68% relapse rate reduction and a 42% reduction of progressive disability risk)4. However a small number of cases of progressive multifocal leukocephalopathy (PML), a rare viral infection of the white matter of the brain, associated with high mortality, was linked to natalizumab use and caused the FDA to withdraw this therapy in 2005. PML is caused by the ‘JC virus’ which may be present in the CNS but kept under control by the immune system, and is generally only seen in patients with severe immune deficiency e.g. transplant and AIDS patients. The risk of PML seems to increase with immunosuppression, JC virus sero-positivity and natalizumab treatment over 2 years. However so favourable were initial results with natalizumab a restriction program called TOUCH has been launched to allow the drug back into the market under close supervision1. Mitoxantrone is currently the only immunosuppressive agent approved for SPMS and PRMS, and has shown efficacy in reducing neurological disability and the frequency of clinical relapses. The main risks are cardiotoxicity (which increases with cumulative dosing) and secondary acute myeloid leukaemia. Fingolimod is famously the first FDA approved oral treatment for RRMS. It works by both reducing the peripheral circulatory lymphocyte load and by promoting lymph node sequestration of lymphocytes. This may in turn reduce lymphocyte migration into the CNS. Following early reports of cardiotoxicity, fingolimod has been relicensed to have the first dose administered in a hospital setting to monitor for potential bradycardia (which can be especially prevalent within the first 6 hours). For this reason it is also contraindicated in patients with ischaemic heart disease, cerebrovascular disease, heart failure and heart block. Unlike natalizumab, immunosuppression is not a primary concern as neither T cell


35

activation nor memory T and B cell responses are impaired 1. Teriflunomide, a prodrug analogue of leflunomide (an oral DMARD licensed for rheumatoid arthritis), is a new oral agent currently in phase III trials 1. It is thought to act by inhibiting T and B cell proliferation and was FDA approved in 2012 for RRMS. Unfortunately it has inherited leflunomide’s side effects and contraindications profile i.e. peripheral neuropathy, hepatoxocity, acute renal failure, interstitial lung disease and teratogenicity (a particular issue in young females). FUTURE PHARMACOTHERAPY BG-12, otherwise known as dimethyl fumarate and previously used off-licence in the treatment of psoriasis, has demonstrated benefits in patient reported quality of life for RRMS. Currently in phase III trials, if approved, BG-12 could become another valuable oral treatment option for RRMS patients. As with terflunomide, the main advantage, aside from oral delivery, is the wealth of existing patient experience and research in using this drug and its analogues5. Alemtuzumab, a monoclonal antibody licensed for B-cell chronic lymphocytic leukaemia, has recently been FDA approved for RRMS refractory to interferon therapy. Statins are still being investigated for therapeutic efficacy in RRMS, with a mechanism of action which may involve regulating T helper cells. However despite ongoing trials, hard evidence is lacking1. Like terflunomide, laquinimod is a tryptophan catabolite and in a phase II study it has been found to reduce the number of active MRI lesions in RRMS6. There is an increasing interest in utilising helminth mediated autoimmune regulation in autoimmune diseases. The proposed mechanism of action involves the ‘hygiene hypothesis’ whereby it is thought that abnormally high levels of sanitation in the developed world may contribute to disordered immune-regulation. Early evidence indicates that

helminthic therapy may augment immune-regulation in conditions such as inflammatory bowel disease or asthma. Phase I trials in animal models for MS appear safe and preliminary data has been encouraging2. As this field of research rapidly evolves with the emergence of more effective and specific therapies, new and unexpected side effects must also be anticipated- especially opportunistic CNS infections and immunosuppression related malignancies. Pharmacovigilance programs to monitor patients undergoing novel therapies may well become standard and the community pharmacist would be ideally placed to participate in this field. Other factors that may direct the course of future treatments include organ specific drug delivery, enhanced CNS bioavailability and pharmacogenomics. Compliance and cost will play a key role in the actual uptake of novel therapies, and the advent of a choice of oral therapies may dramatically change the mainstay of MS treatment for future generations1. ADJUNCTIVE PHARMACOTHERAPY MS comorbidities include: Depression, Fatigue, Spasticity, Bladder dysfucntion, Bowel dysfunction, Cognitive dysfunction, Pain, Paroxysmal symptoms, , Sexual dysfunction, Tremor, Heat intolerance, Optic neuritis. Depression Depression should be anticipated and treated appropriately if diagnosed, preferrably with SSRIs if suitable. Tricyclic antidepressants may also be used as their anticholinergic side effects may aid symptoms of bladder spasticity, chronic pain and hypersalivation. Fatigue Amantadine is an unlicensed medication to treat fatigue in MS, with methylphenidate, fluoxetine and modafinil second line options.

Analgesics, anticonvulsants, antidepressants, etc may in fact contribute to fatigue and may need adjusting as appropriate. Pain and spasicity Tricyclic antidepressants are the first-line option for primary pain with anticonvulsants such as carbamazepine, phenytoin and gabapentin well established second-line agents. Secondary pain as a result of spasticity requires antispasmodics such as baclofen, which is effective, inexpensive and easily titrated. Side effects include fatigue and weakness. Benzodiazepines and dantrolene sodium are second line agents, the latter less commonly employed due to interactions and hepatoxicity. Gabapentin is particularly useful in patients who experience spasticity and neuropathic pain. Pregabalin, phenytoin and topiramate are also all potential beneficial adjuncts. Tizanidine is a centrally acting alphaadrenergic agonist, which is also used to manage spasticity. With a similar profile as baclofen, it is more sedative and interacts with antibiotics such as ciprofloaxacin. Bladder dysfunction Bladder dysfunction is primarily treated with anticholinergics and intermittent catheterisation can also be used. The botulinum toxin (Botox) has recently been approved for the treatment of urinary incontinence due to detrusor overactivity refractory to anticholinergics. Constipation Constipation is common, and can be anticipated and treated prophylactically if needed. Initial treatment should include treatment of immobility, increased fluid and fibre intake follwed by stool softeners, bulk formers, or laxatives. Erectile dysfunction Erectile dysfunction is common in men with MS and may be treated with oral phosphodiesterase type 5 inhibitors such as sildenafil. Pharmacist role The psycho-social and increased risk of infection associated with autonomic dysfunction (ie bladder, bowel and sexual

dysfunction) should not be underestimated, and should be addressed sensitively rather than ignored. Patient education is of paramount importance and where consent has been given counselling should include family and carers. Rehabilitation is a key element in the treatment of MS and is often underutilised. Speech therapists, psychiatrists, occupational therapists, physiotherapists, nurses etc form the back bone for improving and maintaining quality of life for patients, and are frquently overlooked, or deemed overtly expensive. On the contrary, as well as improving the patient’s quality of life, the effective and anticipated use of these services can reduce the frequency of hospital stays. A multi-disciplinary team approach is key to helping patients, and the community phartmacist is in a prime position to play a central role4. REFERENCES 1 -Kieseiera B, Heinz W, Hartunga HP et al “The future of multiple sclerosis therapy” Pharmacological Research 2009;60(4):207–211 2 - J.O. Fleming “Helminth therapy and multiple sclerosis” International Journal for Parasitology Jan 2013 3 -Sorensen S “Balancing the benefits and risks of diseasemodifying therapy in patients with multiple sclerosis” Journal of the Neurological Sciences 2011;311(1):29–34 4 - Metz L, Patten S, McGowan D ”Symptomatic therapies of multiple sclerosis” Biomedicine & Pharmacotherapy 1999;53(8):371–379 5 - Kappos L, Gold R, Arnold D, et al “Effects of BG-12 on Quality of Life in Relapsing– Remitting Multiple Sclerosis: Findings From the Phase 3 Define Study” Value in Health 2012;15(7):557 6 - Platten M, Ho P, Steinman L. “Anti-inflammatory strategies for the treatment of multiple sclerosis – tryptophan catabolites may hold the key” Drug Discovery Today 2006 (3); 3: 401–408

HPN • Issue 8


36 Adult ADHD

Adult ADHD – The New Kid on the Block Dr. Seán Ó Domhnaill

and impulsivity as its primary features. The prevalence in childhood is between 3-6% with approximately 65% of patients continuing to display evidence of the condition, particularly the inattentive syndrome, in adulthood. DIAGNOSIS:

Dr. Seán Ó Domhnaill, MB DPM MRCPsych Dip. CBT, is a Consultant General Adult Psychiatrist working in St. Dympna’s Hospital, Carlow and pro bono Medical Director, Cuan Mhuire drug and alcohol treatment services. He is Managing Director of Psychiatric Court Services Limited and a Special Rapporteur for the Irish United Nations Association.

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INTRODUCTION: Attention Deficit Hyperactivity Disorder (ADHD) has been an area of contention among psychiatrists and paediatricians, not to mention between Child and Adolescent and Adult Psychiatry services for several decades. The condition is now well-recognised and accepted as representing a distinct set of clinical entities with inattention, hyperactivity

The American DSM was the first to provide operationalised diagnostic criteria after the condition was first acknowledged by the psychiatric community. The current DSM recognises the different syndromes of Attention Deficit Hyperactivity Disorder (I), the manifestation characterised by the inattention common to all variations of the clinical condition. The ADHD (H) corresponds to the Hyperkinetic Syndrome of ICD-10 and the mixed condition is common to both. DSM 1V requires 6 out of 10 attention-related items and/ or 6 out of 10 hyperactivityrelated symptoms or signs for the diagnosis. Where a patient

scores 6 or more on both scales, the combined condition is diagnosed. HISTORY OF TREATMENT: Since Still’s description of the children with “minimal brain dysfunction” in the hyperactive and inattentive children he examined after the 1920s pandemic of encephalitis, the lack of actual brain lesions has led to the realisation that the condition is associated with neurochemical aetiology. Bradley’s use of Benzedrine in the hyperactive and inattentive children he treated established psychostimulants as the first line treatment in children with this condition. ImmediateRelease preparations such as Methylphenidate (Ritalin) are easy to evaluate in children, once the initial anxiety about prescribing in the young is overcome by both parents and physicians. The treatments require baseline measurements of height and weight, pulse and blood pressure, with bi-annual


37

measurements thereafter, and common side-effects include headache, abdominal pain, dizziness and agitation. There is no such thing as a panacea, but it is a wonderful thing to watch the effect, within 30 minutes, of Methylphenidate on a child who was out of control just half an hour previously. The drug is very predictable after the first few doses and the effects tend to last for 3-4 hours, depending on individual factors. The Modified-Release preparations of Methylphenidate are useful where once-daily dosing is preferred or where teachers are uncomfortable with dispensing “serious” medication

for a variety of reasons. It is generally preferred to leave the evenings drug-free in children as they will often experience insomnia as a problem with these medications. The MR preparations last 8-12 hours, again very predictably after the first few doses. Behavioural Modification techniques, which should have been employed prior to medication anyway, are effectual. Children with ADHD tend to have difficulty with sustained sleep anyway, although the problem seems to disappear with time. The diagnosis, however, contrary to popular belief, is not quite so quick to resolve itself.

ADULT ADHD The continuity of ADHD symptoms in adulthood in two-thirds of patients is of note to primary and secondary care physicians. While the hyperactivity tends to reduce, at least in the absence of alcohol,

the impulsivity can definitely persist and fidgeting frequently replaces hyperactivity. Apart from the psychostimulant medications, there are also specific Noradrenaline ReUptake Inhibitors such as Atamoxetine (Strattera) which have recognised efficacy, as well as many other agents with minimal evidence to support their use. Atamoxetine tends to take 6 weeks to exert its effect and its maximum benefit is not seen until 10 weeks at the appropriate dose. The most common side-effects are dizziness, gastrointestinal upset, urinary retention of presumably anti-cholinergic origin, which tends to reduce over time, and the risk, albeit low, of hypertension. These drugs are nothing new since we have been prescribing their likes in the form of Reboxetine in the past without significant adverse reactions in the vast majority of cases. Additional agents are outlined in Table 1, but they are somewhat less frequently used. For the fearful, it is probably worth mentioning that psychostimulant abuse is uncommon in those prescribed Methylphenidate, while the patients with ADHD have a higher than predicted use of Cannabis and anxiolytics. Drug diversion is a real problem, but is minimised by the careful and short-term prescriptions issued.

HPN • Issue 8


38 Adult ADHD

As these agents are controlled drugs, there tends to be a careful eye kept on the prescription and it is a useful exercise to keep in regular contact with the General Practitioners and pharmacists of the patients prescribed these medications. A short phone-call can be very reassuring, and allows for the establishment of better relations between our community-based colleagues and ourselves. FORENSIC AND ADDICTION ISSUES My first experience with Adult ADHD was while attempting to interview a patient who was facing charges which would inevitably lead to a custodial sentence. He attended the interview accompanied by

his grandmother as both of his parents were dead from drug-related conditions. After ten minutes of fidgeting and squirming in the chair, he excused himself and I was given the opportunity to ask his grandmother was there any question that he might be using drugs! She reassured me quite calmly that he had always been like this, “hyper” his whole life and completely unable to sustain attention. His crimes had been carried out on very obvious impulse, with all the lack of planning and consideration of the likely consequences were he to be caught that would attend such impulsivity. He had stolen a car within 200 metres of home, on his way home! I contacted a senior academic

psychiatrist in Dublin and asked if they knew of anyone who dealt with ADHD in the adult population. The negative answer was accompanied by the very positive suggestion to “make it your own sub-specialty”. I have been treating patients with this condition for eight years now, many of them self-referred or recommended by INCADDS, the ADHD self-help group, others by their G.P.s, some by CAMHS teams, many by psychologists and some discovered by my own clinical recognition of the condition in patients previously diagnosed with the more common comorbidities; anxiety, depression, substance misuse and personality disorder.

The comorbidities are often the result of growing up in the adversity of having an undiagnosed or untreated ADHD and the evidence suggests that these children are more likely to be diagnosed with Conduct Disorder, Oppositional Defiant Disorder and, later, EmotionallyUnstable or Anti-Social Personality Disorder, none of which are likely to endear them to society. The evidence is clear that there is a significant overrepresentation of ADHD among the prison population, although the figures for Ireland have yet to be established and it is unlikely that the authorities would welcome the introduction of yet another controlled drug into our prison formularies.

Table 1. Common treatments for ADHD. Table 1. Common treatments for ADHD. Generic Preparations Methylphenidate I.R Methylphenidate M.R. Atamoxetine Reboxetine Venlafaxine XL Dexamfetamine

Usual Dose range 5-10mg t.i.d. 18-54mg o.d. 40-50mg b.d. 4-6 mg b.d. 75-225 mg 5-30 mg divided doses

Trade Names Ritalin Ritalin La, Concerta XL Strattera Edronax Efexor XL Multiple.

CONCLUSION:

Conclusion:

ADHD is a common condition affecting 3-6% of the population with a male to female preponderance of 3-4:1 in childhood and adolescence and an apparent prevalence of 2-4% in the adult population, albeit with equal prevalence among the sexes. Very few assessment/ diagnostic and treatment centres exist in the Irish Republic. There appear to be two private sector clinics and one assessment service, provided by a psychiatrist, in the Health Service Executive. Diagnosis is based on clinical assessment with neuropsychological testing being of great assistance in differentiating the various manifestations of the condition. When diagnosing this condition, it is useful to look also for co-morbid Autism, Asperger’s Syndrome, dyslexia, dyspraxia and the comorbidities which arise secondary to the condition, as listed above.

ADHD is a common condition affecting 3-6% of the population with a male to female preponderance of 3-4:1 in childhood and adolescence and an apparent prevalence of 2-4% in the adult population, albeit with equal prevalence among the sexes. Very few However, in these straitened times, it is important to show that there is a continued effort to address the common and relatively easilyassessment/diagnostic and treatment exist the Republic. There treated conditions in psychiatry or psychology, especially whencentres the quality of life for in those whoIrish come into treatment (and their families) can be so dramatically improved by simple application of well-established principles. appear to be two private sector clinics and one assessment service, provided by a The increasing acceptance of Adult ADHD by the psychiatric profession is Diagnosis reflected in the number of articles under review by Irish psychiatrist, in the Health Service Executive. is based oncurrently clinical and other psychiatric journals. Articles on Adult ADHD and on the differentiation between ADHD and Bipolar Disorder have appeared in assessment neuropsychological testing great assistance in peer reviewed Britishwith journals in the past few years and will soon appearbeing in the Irishof equivalent. differentiating the various of this thewillcondition. When diagnosing this The burgeoning use of the internet has lead manifestations to many self-diagnoses and continue to be the case. The shortage of doctors willing to treat the condition is a problem, but with increasing education around ADHD and its treatments, the future is looking brighter for those with condition, it is useful to look also for co-morbid Autism, Asperger’s Syndrome, this difficult but eminently treatable condition. dyslexia, dyspraxia and the comorbidities which arise secondary to the condition, as References upon request. listed above.

Issue 8 • HPN

However, in these straitened times, it is important to show that there is a continued


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Alendronate tablets are highly acidic, and must be taken before food and with at least 200ml of water, due to the risk of them causing ulceration and oesophagitis this an lead to poor compliance.

The SOluTiOn: BONASOL is a liquid formulation of alendronate, 70mg/100ml in a pleasant sugar-free solution, thus avoiding these complications. Bonasol Once Weekly is a unique medicine, developed and made in Ireland, for Europe and the world. Rx 100ml once weekly, before breakfast.

PACKAGE QUANTITIES: 4* 100ml clear plastic bottle with a tamper-evident closure POM. GMS MAH: XEOLAS PHARMACEUTICALS LIMITED PA 1572/1/1 MARKETED IN IRELAND BY: FANNIN LTD, FANNIN HOUSE, LEOPARDSTOWN, DUBLIN 18 For a copy of the SmPC or further medical information, please contact MedInfo@fannin.eu Adverse events should be reported to Fannin Ltd at 01 2907000 or pharmacovigilance@fannin.eu FN2012-10-005

Fannin


40 Research

A Model and Standards for Managing Medicines Shortages in Hospitals David M Stead SW Regional Medicines Procurement Specialist Pharmacist David.stead@UHBristol.nhs.uk

Risk Assessment Tool Alternative Timescale of Risk to Patient Available Shortage

Score

No alternative available

Over 6 weeks

Significant Risk

3

Alternative involves risk

4 to 6 weeks

Potential Risk

2

Alternatives available

Up to 2 weeks No risk

to shortages to mitigate the risk to patients. This included consideration of stock management across the region during a shortage.

The lack of availability of a medicine (a shortage) is becoming an increasing problem due to the increasing complexity and fragility of the globalised nature of the pharmaceutical supply chain and the current economic climate. Shortages can lead to suboptimal patient care and increase risk to patients by causing unpredictable changes to routine clinical practice.

which examined some of the reasons shortages occur, and also work by Amanda Baumer and colleagues which looked at the impact of drug shortages in acute care hospitals in the USA in financial terms. It was estimated that the cost of managing shortages was $99 million. Even allowing for extrapolation of self-reported data, a lower figure still represents a significant cost burden to the health economy.

In 2009, NHS South West, working within an ABPI Outreach programme, established a group to look at a model for managing shortages across an NHS region in England

It was recently estimated that pharmacy staff time wasted in chasing and resolving shortages in English Hospitals was between £3 and £5 million pounds a year.

The project team membership included ABPI, BAPW and BGMA representation together with pharmacists from both primary and secondary care and a clinician. The project lead was the Medicines Procurement Specialist Pharmacist from the South West. The project group was co-chaired by an NHS Trust Medical Director and a member of the ABPI Supply Chain Group.

The group agreed, therefore, that we would try to adopt a managed approach to shortages across the SHA which would fit in with the current DH/ CMU reporting systems and would also encourage Chief Pharmacists across the region to work for the benefit of the most clinically needy patients rather than simply looking at the needs of their own trust in isolation.

The group looked at earlier work undertaken by Liz Breen,

The process was designed to create an SHA wide response

Issue 8 • HPN

A regional group comprising the Procurement Specialist, Director of South West Medicines Information and Training, Senior Pharmacy Manager Chair of SW Procurement Group plus any specialist advisor (eg Paediatrics, Quality Assurance etc) will review the shortage, assess the risk (if not already done elsewhere) and agree and advise Senior Pharmacy Managers on the most appropriate course of action across the region The risk assessment tool, seen at the top of the page, was designed locally to provide us with a ‘traffic light’ system for managing shortages. Maximum Score is 27 (3x3x3) Red Risk Amber Risk Green Risk

Score over 9 Score 4 - 9 Score 1 – 3

A Red risk requires a response within 24 hours, an Amber risk within 7 days and a Green risk needs no response but will be monitored. The information gathered was managed by the Regional Specialist Procurement Pharmacist who would then provide this, together with a note

1

of what information is required of each trust (and the timescale) to Senior Pharmacy Managers. In order for this process to work effectively, it was imperative that timescales are met and, as such, each Senior Pharmacy Manager would identify a deputy to whom the form could be sent in his/ her absence. The proposed approach to stock management would mean that the limited stock would be available to patients with the greatest clinical need regardless of geography. The Regional Procurement Pharmacist wwould keep Senior Pharmacy Managers updated on the shortage as and when information was received from the Department of Health or the manufacturer. In the case of a shortage where there was no alternative product available an assessment should be made of current stock holding, availability of emergency stock and the need for restrictions in use and the development of a local trust communications plan. By collating this data at a regional level, not only could the stock available be managed appropriately, but the way in which trusts were implementing restrictions in use and developing a communication plan could be shared by all trusts Where a therapeutic alternative


41 may have been available, the alternate product would need a risk assessment and this could be undertaken nationally or regionally by a nominated pharmacist or clinician. Restrictions in use again needed to be considered. The project provided an excellent example of all parties working together for a common aim. The documentation has been used for shortages over the last 3 years and the resulting information has allowed movement of stock within the South West on three occasions thus preventing any significant delay in patient treatment. Given the current problems with shortages, it is felt that this process could be used on a country wide basis in the future. In addition, discussions are continuing with the ABPI, BGMA, DH and CMU looking at further improvements in shortage management. This project has now received the full support of the Chief Pharmaceutical Officer for England and in the past few weeks, a set of Standards for Managing Medicines Shortages in Secondary Care, supported by the NHS and the Royal Pharmaceutical Society of Great Britain, has been published and English Regions are being urged to adopt and develop these standards. OVERARCHING PRINCIPLES OF THE STANDARDS DOCUMENT

includes selling of medicines to third parties and stockpiling by individual Trusts when a shortage occurs. NHS Trust Chief Pharmacists should work collaboratively to ensure that such medicines as are available during a shortage are used for patients with the greatest clinical need. Trusts should seek to work on a (regional) basis to avoid duplication of work on risk assessments, procurement alternatives and production of clinical advice etc. Advice from QA and UKMI should be available nationally when required. The NHS should develop and manage a web site for medicines shortages information which must contain up to date information on all shortages, duration and recommended action where available. Standards for NHS Hospitals include: 1. All NHS hospitals must have an up to date, written policy for managing medicines shortages 2. A steering group of a senior pharmacist, nurse and doctor should be established to oversee medicines shortages. 3. When a shortage is identified, a designated senior pharmacist must conduct a fully documented risk assessment to evaluate the potential effect of the shortage. This assessment should take account of;

The Chief Pharmacist is responsible for taking a leadership role in developing strategies and procedures for managing all aspects of medicines shortages

The estimated length of the shortage

The Chief Pharmacist must ensure that no action is taken within the Trust which could exacerbate a medicines shortage within the NHS. This

4. Once a shortage is confirmed, the pharmacy must establish the stock on hand within its entire organisation and make an estimate of the time period

The availability of suitable alternative products The potential risk to patients.

this will cover. It is essential that this includes stock used through homecare or outpatient services provided by a third party. In order to manage this stock appropriately it is advisable to hold the limited stock in a single area. Working collaboratively (e.g. within a region), limited stocks can be shared based on clinical need. 5. Where limited stock leads to a restriction being placed on the use of a medicine, then this restriction should be approved by the trust Medical Director, with start and review dates, and should be communicated immediately to all relevant hospital staff. Communication of these restrictions is essential for ensuring patient safety and preventing medication errors. 6. Trusts should review their internal and external communications plans on a regular basis to ensure they are fit for purpose. The aim of the plan is to ensure that all hospital staff involved in the supply chain, and affected patients are made fully aware of the situation. It is critical that patients/carers are counselled when a medicine shortage is likely to delay or compromise care. 7. Where a potential alternative medicine is available, then a named senior pharmacist should carry out a fully documented risk assessment of the alternative. This work should be supported by regional and/or national QA advice and additional clinical information on alternative products should be obtained from regional/national MI services. 8. Once this assessment has been completes, then the steering group should agree the content of any resultant communication and must ensure that it reaches all appropriate

hospital staff, including those on shift work. 9. If any training is necessary as a result of the use of the alternative medicine, then the steering group must ensure that this takes place in a prompt and effective manner. 10. All medicines shortages have the potential to affect patient safety and should, therefore be recorded on the trust risk register and notified to the Safe Medicines Practice Division of the National Commissioning Board Authority. 11. Following the resolution of a medicines shortage, the steering group should meet and document the outcome, lessons learned and future actions and these should be communicated to all appropriate hospital staff. 12. NHS Trusts should keep an up to date log of shortages to include details of the shortage (this may help in identifying areas where shortages are most likely to occur), decisions taken, alternatives used and any new safeguards which have been introduced. Following the publication of the Standards, a small group is now looking at establishing an NHS owned Shortages Website which we hope to establish, with support from the industry, within the next 12 months.. REFERENCES 1.http://www.dh.gov.uk/en/Publications/ PublicationsPolicyAndGuidance/ DH_065198 2.http://www.dh.gov.uk/en/Publications/ PublicationsPolicyAndGuidance/ DN_082370 3http;//www.dh.gov.uk/en/Publications/ PublicationsPolicyAndGuidance/ DH_082840 4. Breen L. Pharm. J. May 24th 2008 p.631 5. Baumer A. et al Am. J. Health-Sys. Pharm. Vol. 61, Oct 1st 2004, p.2015

99% experience shortages Irish hospital pharmacists are having difficulties with medicines shortages, says new research. The European Association of Hospital Pharmacists has published headline results of a recent survey that reveals 99% of responding hospital

pharmacists say they have experienced difficulties in the past year. With over 300 respondents from 27 countries, the survey also uncovered that 63% of hospital pharmacists report medicines shortages to be a weekly,

sometimes daily, occurrence. EAHP President Roberto Frontini said: “These headline results confirm what I have increasingly heard from our members across Europe: that the shortages problem is widespread, doesn’t respect national borders, and

urgently requires attention if patient care and health services are not to suffer. I want to take this opportunity at the European Parliament to call on all partners to work together in identifying and enacting solutions.”

HPN • Issue 8


42 NCAS

Novel oral anticoagulants therapies - practical guidance relating to normal clinical practise

Prof James O’Donnell PhD, MD, FRCPI, PRCPath Professor of Haematology and Director Haemostasis Research Group, National Centre for Coagulation Disorders, Trinity College Dublin, Ireland

INTRODUCTION Accumulating data from a series of recent large randomised controlled trials has demonstrated the efficacy and safety of a number of novel oral anticoagulants (NOACs). The NOACs can be considered to fall into two principal categories - the direct factor Xa inhibitors (e.g. Rivaroxiban and Apixiban) and the direct thrombin inhibitors (e.g. Dabigatran). These drugs have already been licensed within Ireland for a variety of specific clinical indications (notably perioperative thromboprophylaxis, atrial fibrillation and the treatment of acute venous thrombosis). An estimated 5000 Irish patients are already being treated with these agents and this number is likely to continue to increase in the coming years. Notwithstanding the cost implications, the new oral anticoagulants offer several advantages over warfarin which include less drug-drug and drug-food interactions. Consequently, the NOACs demonstrate more predictable

Issue 8 • HPN

James O’Donnell obtained his MB from Trinity College Dublin, and completed his clinical haematology training in the Hammersmith and Royal Free Hospitals in London. He obtained a prestigious Medical Research Council Training Fellowship in 1998, and was awarded his PhD by Imperial College London in 2001. Prior to returning to Dublin, James spent three years as a Senior Lecturer and Principal Investigator in Imperial College, during which time he was funded through a Clinician Scientist award from the British Heart Foundation. His principal research interests include the role of carbohydrate structures in determining the biological activity of coagulation proteins; the molecular mechanisms through which coagulation is regulated at the feto-maternal interface; and the molecular basis of constitutional thrombophilia. Following his return to Ireland in 2005, he has since became the first clinician scientist to receive the prestigious Science Foundation Ireland President of Ireland Young Investigator award. In addition, he is Director of the large Haemostasis Research group in the Institute of Molecular Medicine in Trinity College. This group has already been successful in obtaining in excess of ¤5M in peer-reviewed grant awards over the past five years. Prof O’Donnell has more than 70 peerreviewed publications in high impact journals, (including 5 papers in Blood and 3 papers in the Journal of Biological Chemistry) and has given a series of invited presentations at leading international meetings including the American Society for Hematology and the ISTH congresses.

pharmacokinetics than warfarin so that routine anticoagulant monitoring and dose titration is not required for the vast majority of patients treated with these newer agents. This critical difference obviously offers major potential advantages for individual patients. However, the recent and expanding use of the different NOAC therapies poses a number of practical issues that need to be addressed within our healthcare system. In particular, despite the fact that warfarin therapy is associated with a narrow therapeutic window and a significant risk for major bleeding complications, we have now had more than 40 years of experience in using coumarins in the clinic. Consequently, most pharmacists and physicians have accumulated significant clinical experience in managing warfarin. In contrast, outwith the setting of major clinical trials, there is a striking paucity of experience or indeed published data with regards to optimal use of the specific NOAC therapies. This brief review seeks to

provide an overview of some of the key practical clinical questions that recurrently arise with respect to the expanding use of NOACs in current clinical practise. COMMENCING A PATIENT ON NOAC THERAPY In Ireland, the three NOAC therapies currently in use are Rivaroxaban (Xarelto®), Apixaban (Eliquis®) and Dabigatran etexilate (Pradaxa®) [Table 1]. Because these agents function as direct inhibitors for either FXa or thrombin, they rapidly produce a full therapeutic anticoagulant effect within four hours following oral administration. This rapid onset of action is in marked contrast to the delayed onset of significant anticoagulant effect associated with warfarin therapy. Warfarin functions as a vitamin K antagonist, and thereby inhibits hepatic synthesis of the procoagulant clotting factors II, VII, IX and X respectively. Since some of these factors have long plasma half lives,

the full anticoagulant effects of warfarin are not established until several days following the initiation of therapy. Moreover, warfarin therapy also inhibits the hepatic synthesis of vitamin-K dependant protein C and protein S respectively. Since protein C and protein S are critical anticoagulant proteins, the net effect for the first few days following warfarin initiation is actually paradoxically to increase the risk of thrombosis. Consequently, in routine clinical practise combined administration of both LMWH and warfarin is necessary until the INR has reached the target therapeutic range (typically INR≥2) for two consecutive days. Due to their rapid onset anticoagulant effect, and the fact that NOACs do not influence plasma protein C or protein S levels, overlapping use of LMWH is not typically required when a patient is being commenced upon NOAC therapy. As with any anticoagulant therapy, the NOACs inevitably are associated with inherent


Abbreviated Prescribing Information. Betaferon 250 microgram/ml, powder and solvent for solution for injection. See full Summary of Product Characteristics (SmPC) before prescribing. Presentation: Betaferon 250 microgram/ml, powder and solvent for solution for injection contains recombinant interferon beta-1b 250 microgram (8.0 million IU) per ml when reconstituted. Indications: Patients with a single demyelinating event with an active inflammatory process, if severity warrants treatment with i.v. corticosteroids, alternative diagnoses have been excluded and the patient is at high risk of developing clinically definite multiple sclerosis (MS). Relapsing remitting multiple sclerosis (RRMS) with two or more relapses in the last two years. Secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses. Dosage / administration: Adults: Initiate under the supervision of a physician experienced in the treatment of MS. Recommended adult dose: to obtain adequate efficacy, a dose of 250 microgram (1 ml reconstituted solution) injected subcutaneously every other day should be reached, usually with titration from a starting dose of 62.5 micrograms. Not recommended in RRMS with less than 2 relapses in the previous 2 years or in SPMS with no active disease in the last two years. Optimal dose/ treatment duration not yet fully clarified. If patient fails to respond, stop treatment. Children: Limited data in 12 to16 year olds. Not recommended in children under 12 years. Contraindications: Initiation during pregnancy, hypersensitivity to interferon-ß, human albumin or any of the excipients, current severe depression, suicidal ideation, decompensated liver disease. Precautions / Warnings: Use of cytokines by patients with pre-existing monoclonal gammopathy has been associated with development of systemic capillary leak syndrome, shock-like symptoms and fatal outcome. Pancreatitis has been observed rarely, often with hypertriglyceridaemia. Caution in patients with current or past depressive disorders especially those with antecedents of suicidal ideation. Advise patient that depression and suicidal ideation may occur and should be reported immediately. Monitor such patients closely and treat appropriately; consider cessation of Betaferon. Caution in patients with seizure history or taking anti-epileptics. Contains human albumin: potential risk for transmission of viral diseases and risk for transmission of CJD cannot be excluded. Regular thyroid function tests recommended in patients with history of thyroid dysfunction or as clinically indicated; normal laboratory monitoring of MS; full blood count, differential WBC, platelet count and blood chemistry including liver function tests (e.g. AST, ALT and γ-GT) prior to and regularly during therapy and periodically thereafter in absence of symptoms. Patients with anaemia, thrombocytopenia and/or leukopenia may require more intensive monitoring of blood counts. With neutropenia, monitor closely for fever or infection. Thrombocytopenia with profound decreases in platelet counts has been reported. In clinical trials, asymptomatic elevations of serum transaminases (mostly mild and transient) occurred very commonly. Severe hepatic injury, including hepatic failure, reported rarely with most serious events usually in patients exposed to other hepatotoxic drugs/substances or in presence of comorbid conditions. Monitor for hepatic injury. Closely monitor/investigate elevations in serum transaminases; consider discontinuation if levels increase significantly or clinical symptoms develop. Use with caution and closely monitor patients with severe renal failure and/or pre-existing significant cardiac disease, especially at start of treatment. There have been rare reports of worsening of cardiac status on initiation of Betaferon. Discontinue, if cardiomyopathy suspected to be related to Betaferon occurs. Serious hypersensitivity may occur e.g. bronchospasm, anaphylaxis, urticaria; if severe, discontinue and institute medical intervention. Reports of injection site necrosis, sometimes extensive and involving muscle fascia with possible scar formation. Occasionally debridement/skin grafting required and healing may take up to 6 months. Discontinue until healed in patients with multiple lesions. Patients with single lesions may continue if necrosis is not too extensive. Advise patient to consult physician if any break in the skin occurs. To minimise the risk, patients should use aseptic injection technique and rotate injection site with each dose. Incidence of injection site reactions may be reduced by use of an autoinjector. Periodically review self-administration procedure, especially after occurrence of injection site reactions. Potential for immunogenicity; Possibility of development of serum interferon beta-1b neutralising activity which may be associated with reduced clinical efficacy with regard to relapse activity; no new adverse events were associated with the development of neutralising activity. Decisions about continuing therapy should be based on clinical disease activity rather than neutralising activity status alone. Cross reactivity with natural interferon-ß occurs in vitro but has not been investigated in vivo. May affect ability to drive and use machines. Pregnancy: Initiation of treatment during pregnancy is contra-indicated. Increased risk of spontaneous abortion. If woman becomes pregnant or wishes to, discontinuation of treatment should be considered but may be associated with severe relapse. Inform women of potential hazards. Women of childbearing potential should use appropriate contraception. Lactation: potential for serious adverse reactions in nursing infants. Interactions: No drug interaction studies have been performed. Effect on drug metabolism unknown. Corticosteroid or ACTH treatment for up to 28 days has been well tolerated. Use with other immunomodulators other than corticosteroids or ACTH is not recommended. Use with caution in combination with products with a narrow therapeutic index and largely dependent on the hepatic cytochrome P450 system for clearance (possible reduced enzyme activity). Additional caution with co-medication which affects haematopoetic system. Undesirable effects: At the beginning of treatment adverse reactions are common but in general they subside with further treatment. The most frequently observed adverse reactions are a flu-like symptom complex and injection site reactions. Dose titration is recommended at the start of treatment in order to increase tolerability to Betaferon. Flu-like symptoms may be reduced by administration of nonsteroidal anti-inflammatory drugs. The incidence of injection site reactions may be reduced by the use of an autoinjector. Side effects observed in clinical trials with Betaferon very commonly (≥10%) and at a higher percentage than with placebo: infection, abscess, lymphocyte count decreased, white blood cell count decreased, lymphadenopathy, blood glucose decreased, depression, anxiety, headache, dizziness, insomnia, migraine, paresthesia, conjuctivitis, abnormal vision, ear pain, palpitation, vasodilatation, hypertension, upper respiratory tract infection, sinusitis, cough increased, dyspnoea, diarrhoea, constipation, nausea, vomiting, abdominal pain, alanine aminotransferase increased, aspartate aminotransferase increased, skin disorder, rash, hypertonia, myalgia, myasthenia, back pain, pain in extremity, urinary retention, urinary incontinence, dysmenorrhoea, menstrual disorders, metrorrhagia, impotence, injection site reaction, injection site necrosis, flu-like symptoms, fever, chills, sweating, malaise. Additional side effects identified during post-marketing experience: Very common: arthralgia; common: anaemia, tachycardia, hypothyroidism, blood bilirubin increased, weight increased, weight decreased, confusional state, menorrhagia, urticarial, pruritus, alopecia; uncommon: thrombocytopenia, gamma-glutamyl-transferase increased, hepatitis, blood triglycerides increased, confusion, suicide attempt, emotional lability, skin discoloration; rare: cardiomyopathy, thyroid disorders, hyperthyroidism, pancreatitis, hepatic injury, hepatic failure, anaphylactic reactions, anorexia, bronchospasm; frequency not known: capillary leak syndrome in preexisting monoclonal gammopahy. Prescription only. MA Number: EU/1/95/003/005. MA Holder: Bayer Pharma AG, D-13342 Berlin, Germany. Further information available from: Bayer Ltd., Tel 01 2999313 Date of preparation: August 2012.

L.IE.SM.02.2013.0131

Building a positive future


44 NCAS

TABLE 1

TABLE 1

bleeding risk. Consequently, prior to NOAC prescription it would seem be prudent to check baseline full blood count, renal function, liver function, and coagulation screen (PT and APTT). Rivaroxaban dose reduction is recommended for patients with creatinine clearance in the range 15-49mL/ min. Moreover, rivaroxaban therapy is not recommended in patients with creatinine clearance less than 15mL/min. Dabigatran is mainly (80%) eliminated via renal excretion and therefore unsurprisingly bioaccumulation occurs in the setting of renal impairment. Consequently, dabigatran therapy is not recommended if creatinine clearance is less than 30ml/min. CONVERTING A PATIENT FROM LMWH OR WARFARIN ONTO NOAC THERAPY For patients already being treated with LMWH, the heparin therapy can be discontinued and the NOAC simply commenced when the next dose of LMWH was scheduled. Many patients stabilized on long term warfarin therapy may prefer to continue with same. On the other hand, some patients on coumarin may decide to switch to either rivaroxaban or dabigatran respectively. For patients transitioning from warfarin therapy onto NOAC, the process is a little more complex than for those on LMWH, and differs according to the specific NOAC agent involved. [1] This is perhaps unsurprising given the longer half-life of warfarin effect, and the fact that only some of the NOACs (e.g. Rivaroxaban) have an effect on the INR. Importantly, the magnitude of this INR effect varies significantly depending upon the specific INR test employed. To convert from warfarin to rivaroxaban, the patient should be advised to discontinue their warfarin and the INR then checked on a daily basis. Once the INR has fallen below 3.0, rivaroxaban should be commenced at normal dosage. To convert from warfarin to dabigatran, the patient should again have their warfarin discontinued. Once the INR has fallen below 2.3,

Issue 8 • HPN

Dabigatran

Rivaroxaban

Apixaban

Trade name

Pradaxa

Xarelto

Eliquis

Target

Thrombin

Factor Xa

Factor Xa

Peak plasma levels

1.25 – 3 hours

2 – 4 hours

1 – 3 hours

Kidney excretion

80%

66%

25%

Half life

12-14 hours

9 – 13 hours

10 – 14 hours

Laboratory monitoring assays

Thrombin clotting time

Anti-Xa

Anti-Xa

Octaplex (50U/kg)

Octaplex (50U/kg)

Ecarin clotting time

Emergency bleeding dabigatran should be instituted at normal dosage. Based upon the published trial data, there is little evidence to suggest that these degrees of anticoagulant overlaps are associated any significant risk for increased bleeding. LABORATORY MONITORING OF NOAC ANTICOAGULANT EFFECTS For patients treated with coumarins, it is well established that regular INR monitoring and careful dose titration is essential in order to minimise the risk of recurrent thrombosis and bleeding. In contrast, because of their more predictable pharmacokinetic and pharmacodynamics properties, no routine coagulation monitoring is required for the majority of patients on NOAC therapies. However, in some cases laboratory testing to assess in vivo levels of

FEIBA (80U/kg)

anticoagulation for patients using NOACs may be necessary. Examples would include individuals requiring emergency surgery, or patients who present with significant bleeding complications. In these cases, two critical points should be considered in the first instance. First, the timing of the last dose of NOAC should be ascertained. Second, renal and liver function also need to be defined. In general, the Prothrombin Time (PT) is sensitive to rivaroxaban therapy, whilst the Activated Partial Thromboplastin Time (APTT) is sensitive to Dabigatran. However the sensitivities of the PT and APTT vary across different commercial assay methodologies2. In addition, the prolongation of PT and APTT are non-linear, so that these assays cannot provide accurate quantitative information on the plasma concentrations of rivaroxaban or dabigatran.

Nevertheless, if the PT and APTT are both normal, it is less likely that there are high plasma concentrations of rivaroxaban or dabigatran respectively. In tertiary referral centres, other specialised coagulation tests can be used to accurately determine plasma NOAC levels. In particular, the anticoagulant effects of rivaroxaban can be quantified using an anti-Xa assay. Similarly, dabigatran levels can be measured using the Thrombin Clotting Time (TCT) or the Ecarin Clotting Time. The TCT has a linear correlation with dabigatran concentrations and is significantly prolonged even in the presence of low levels of the drug. Consequently, a normal TCT infers that the residual plasma levels of dabigatran are minimal. Nevertheless, further studies will be necessary to determine whether any of these in vitro clotting assays play a useful role in predicting bleeding


m

mbrane yer

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The NEW transdermal fentanyl patch from Pfizer

Backing Film Solid reservoir Rate-controlling membrane Separate skin adhesive layer Protective liner

Up to 15% less expensive than brand leader2

Bioequivalent to original brand with additional benefits1 Fentadur 12, 25, 50, 75 and 100 micrograms/hour transdermal patch (fentanyl) Prescribing information (refer to Summary of Product Characteristics for full prescribing information). Presentation: Tan coloured transdermal patches releasing 12, 25, 50, 75 or 100 micrograms / hour of fentanyl. Indications: Severe chronic pain which can only be managed with opioid analgesics. Dosage: Adults. Initial dose: This should be based on patient’s opioid history taking into account possibility of developing tolerance, patient’s current general condition, medical status and the degree of severity of the disorder. Assess dosage regularly after each administration. If changing from another opioid to fentanyl refer to the SPC for initial recommended doses. For opiate naive patients initiate treatment with patches releasing 12 micrograms/hour fentanyl. Elderly or weak patients: recommend initiate opiate treatment with immediate release morphine and prescribe fentanyl after determination of optimal dose. Dose titration and maintenance: Replace patch every 72 hours. Titrate dose until analgesic efficacy attained. Treatment discontinuation should be gradual in order to prevent withdrawal symptoms. Elderly, cachectic or debilitated patients: Observe carefully for signs of fentanyl toxicity and reduce dose if necessary. Hepatic and renal impairment: Observe carefully for signs of fentanyl toxicity and reduce dose if necessary. Children: Do not use in children under 2 years (12 µg/h strength only) or 12 years (25 - 100 µg/h strengths) of age as experience is limited. Administer only to opioid-tolerant paediatric patients already receiving at least 30 mg oral morphine equivalent per day. Please refer to SPC for initial dosage. Dose titration and maintenance: If analgesic effect is insufficient administer supplementary morphine or another short-duration opioid. Dose adjustments should be done in 12.5 mcg/hour increments. Apply patch to a clean, dry and non-hairy area of skin on the upper body (chest, back, upper arm). Remove hair at application site using scissors instead of shaving. The skin area to which the patch is applied should be free of microlesions (e.g. due to irradiation or shaving) and skin irritation. Contraindications: Hypersensitivity to fentanyl or any of the excipients. Acute or postoperative pain. Severe impairment of central nervous system. Warnings and Precautions: Use only if patient has been adequately assessed medically, socially and psychologically. Do not change from one fentanyl containing product to another without counselling. Treatment should only be initiated by an experienced physician familiar with the pharmacokinetics of fentanyl transdermal patches and the risk of severe hypoventilation. Potential for serious or life-threatening hypoventilation exists even if the lowest dose is used when initiating therapy in opioid-naïve patients. It is recommended that Fentadur be used in patients who have demonstrated opioid tolerance. After a serious adverse reaction monitor patient for 24 hours following removal of patch. Do not divide or cut patch. As respiratory depression may occur patients must be observed for this effect. Respiratory depression may persist after the removal of the patch. Drug dependence may occur. CNS active substances may worsen the respiratory depression. Use with caution in patients with existing respiratory depression, chronic obstructive or other pulmonary disease, increased intracranial pressure, impaired consciousness, coma, brain tumours, hypotension, hypovolemia or bradyarrhythmias. Patients with hepatic or renal impairment should be observed and dose reduced if necessary. Patients with fever should be monitored for opioid adverse reactions. Do not expose application site to direct external heat sources. Elderly or cachectic patients should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary. Do not administer to opioid naïve paediatric patients. Potential for serious or life-threatening hypoventilation exists regardless of the dose of transdermal fentanyl administered. Use of fentanyl patches may lead to a positive doping test. Use of fentanyl patches as a doping agent may be hazardous to the health. Exercise caution in patients with myasthenia gravis as non-epileptic (myo)clonic reactions can occur. Abuse or intentional misuse of Fentadur may result in overdose and/or death.Dispose of used patches in accordance with guidance within SPC. Drug Interactions: Barbituric acid derivatives. Concomitant use of buprenorphine, nalbuphine or pentazocine not recommended. CNS depressants (e.g. opioids, antipsychotics, hypnotics, general anaesthetics, skeletal muscle relaxants, sedating antihistamines and alcoholic beverages). MAO-inhibitors. CYP3A4 inhibitors (such as itraconazole. ritonavir, ketoconazole, itraconazole or macrolide antibiotics).Pregnancy & Lactation: Do not use in pregnancy unless clearly necessary as safety in pregnancy is not established. Studies in animals have shown reproductive toxicity. Long-term treatment during pregnancy may cause withdrawal symptoms in the infant. Use during labour and delivery not advised as fentanyl passes into the placenta. Discontinue lactation at least 72 hours after removal of patch. Side Effects: Respiratory depression is the most serious side effect. Long term use can lead to development of tolerance and physical / psychological dependence. Withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety and shivering) may occur after switching from other opioids or following discontinuation of treatment. Very common (over 10%): constipation, dizziness, headache, nausea, pruritus, somnolence, sweating and vomiting. Common (1-10%): hypersensitivity, abdominal pain, anorexia, anxiety, asthenia, cold feelings, confusional state, conjunctivitis, depression, diarrhoea, drowsiness, dry mouth, dyspepsia, dyspnoea, erythema, fatigue, hallucinations, hypertension, influenza like illness, insomnia, itching, loss of appetite, malaise, muscle spasms, nervousness, oedema peripheral, palpitations, paraesthesia, rash, rhinitis, sedation, skin reactions at application site, stomach pain, tiredness, tachycardia, tremor, urinary retention, urinary tract infection, vertigo and yawning. Please refer to full SPC for other undesirable effects. Driving and operating machinery: May affect the ability to drive and use machines, especially at onset of treatment, following dosage change or if used with alcohol or antipsychotics. Overdose: Immediate management includes removing patch and physical / verbal stimulation of patient, followed by administration of an opioid antagonist such as naloxone. Respiratory depression due to overdose can persist longer than the effect of the opioid antagonist. Intensive care unit treatment may be required. If severe or persistent hypotension occurs consider use of hypovolemia with appropriate parenteral fluid therapy. Legal Category: CD (Schedule 2), POM (S1A).Marketing Authorisation holder: Pfizer Healthcare Ireland, Pfizer Building, 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. Package quantities and Marketing Authorisation numbers: Fentadur 12 µg/h., each pack contains 5 transdermal patches, PA 822/70/5. Fentadur 25 µg/h., each pack contains 5 transdermal patches, PA 822/70/1. Fentadur 50 µg/h., each pack contains 5 transdermal patches PA 822/70/2. Fentadur 75 µg/h., each pack contains 5 transdermal patches, PA 822/70/3. Fentadur 100 µg/h., each pack contains 5 transdermal patches, PA 822/70/4. Further information is available on request from: Pfizer Healthcare Ireland, Pfizer Building, 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. Medical Information Direct Line: 1 800 633 363. Date of Preparation: August 2012. Company reference: gxFE 2_0 IE References: 1. Data on file; Fentanyl Transdermal Patch Common Technical Document, Nov 2007. 2. www.hse.ie Date of preparation: Jan 2013 FENT/2013/003/1


46 NCAS

risk in patients treated with NOAC therapies. In addition, optimal target therapeutic ranges using these specific assays have not yet been defined. MANAGEMENT OF BLEEDING COMPLICATIONS Given the biochemical properties of the NOACs in terms of their ability to inhibit procoagulant factor Xa or thrombin respectively, it is perhaps not surprising that like other therapeutic anticoagulants they carry an inherent bleeding risk. Pending greater clinical experience in the real-world everyday usage, it is difficult to accurately quantify the absolute bleeding risk. Nevertheless, even on the basis of the results observed within the narrow confines of the published clinical trials, it is clear that some patients treated with these agents will inevitably present with significant bleeding complications. For minor or moderate bleeding complications (e.g. epistaxis or ecchymosis), withholding of NOAC therapy for one or more days may be sufficient to stop bleeding and enable further investigation if required. For major and life-threatening bleeding complications, NOAC therapy should be immediately ceased and the timing of the last dose of NOAC administration should be determined. If the last dose of dabigatran was recently administered, absorption may be significantly reduced by administration of activated charcoal. It is unclear whether charcoal is useful in reducing absorption of rivaroxaban. Close clinical monitoring of the patient, ideally within the setting of a High-Dependency or Intensive Care Unit is recommended. Packed cell transfusion is important in maintaining adequate circulatory volume. In addition, although they will not reverse the primary underlying NOAC anticoagulant effects, nevertheless platelet, plasma and fibrinogen infusions should be considered in order to minimise the effects of any secondary dilutional coagulopathy. Importantly, aggressive interventions (endoscopy, interventional

Issue 8 â&#x20AC;˘ HPN

radiology or surgery) should be directed towards identifying and treating the bleeding source. In a minority of extreme cases, acute haemodialysis may be useful in removal of dabigatran as only 35% is bound to plasma proteins. Since more than 92% of rivaroxaban in plasma is bound to albumin, it cannot be removed by dialysis. Emergency departments have acquired significant experience in the use of vitamin K, fresh frozen plasma and prothrombin complex concentrates (PCC) in order to reverse warfarininduced anticoagulant effects in patients who present with life-threatening bleeding complications. In contrast, there is little good data to determine optimal reversal strategies for the NOACs2,3. However, one small recent human volunteer study suggested that the effect of rivaroxaban therapy may be reversed following administration of a four factor PCC4. Pending the results of further clinical studies, it seems reasonable to consider 50IU/kg Octaplex for patients on rivaroxaban who present with life-threatening bleeding. In contrast, the same study reported that PCC had no significant efficacy in reversing the anticoagulant effects of dabigatran in healthy volunteers. However activated PCC (FEIBA 80U/kg) has been shown to correct thrombin generation parameters in vitro in plasma from healthy volunteers receiving single doses of dabigatran. Again, pending the results of further clinical studies, it seems reasonable to consider 80IU/kg FEIBA for patients on dabigatran who present with life-threatening bleeding. MANAGEMENT OF NOAC ADMINISTRATION AROUND ELECTIVE SURGERY? Management of anticoagulant therapies in patients undergoing major surgical procedures is a common clinical problem. For warfarin-treated patients, because of the long half life involved, warfarin treatment generally needs to be withheld for 3-4 days prior to surgery. Following surgery, even if warfarin therapy is commenced on day +1 postoperatively,

therapeutic anticoagulation levels will not typically be re-established for another 4 days. Cumulatively therefore, for patients on warfarin therapy peri-opertive management necessitates disruption of normal steady-state therapeutic anticoagulation for at least 7 days. Consequently, for patients at high thrombotic risk, peri-operative bridging anticoagulation with LMWH is generally required. In contrast to warfarin, the NOACs achieve full therapeutic anticoagulation within 4 hours of first dose administration and have short plasma half lives in normal individuals. Consequently, for most patients treated with NOACs, the necessary duration of interruption of NOAC therapy peri-operatively is much less1,5. NOAC therapy can be withheld for 1-2 days prior to the surgical procedure, depending upon the perceived bleeding risk associate with the operation. Clearly the plasma half life of the respective NOAC therapies may be significantly prolonged in patients with significant underlying renal and/or hepatic impairment. Consequently, NOAC treatment may need to be withheld for a longer period in this cohort of patients prior to any significant surgical intervention. In addition, laboratory testing using TCT, ECT or anti-Xa assays pre-operatively may be useful in such individuals in order to define that NOAC therapy has been adequately cleared pre-operatively. Post-operatively, provided that adequate haemostasis has been achieved and dependent upon the bleeding risk associated with the specific surgical procedure, NOAC therapy could be reinstituted 24 to 48 hours after the operation. In these circumstances, given the short interruption of NOAC anticoagulation, bridging LMWH anticoagulation may not be required. Alternatively, if there is significant concern regarding the risk of bleeding following surgery, LMWH may be used for several days prior to the reintroduction of NOAC therapy.

CONCLUSIONS In summary, the anti-Xa and direct thrombin inhibitors constitute important new therapeutic options. On the basis of the published literature, it is clear that they are safe and efficacious, and indeed may offer specific benefits over warfarin in relation to some specific clinical indications. However, given the rapidly increasing numbers of Irish patients being treated with NOACs, it is critical that all of the multidisciplinary team involved in providing care for these patients is educated regarding the individual properties of the different drugs, and their inherent associated bleeding risk. In addition, this bleeding risk must be discussed in full with any patient who is considering commencing NOAC therapy. Further clinical experience and highly powered clinical trials will be essential in order for us to define optimal ways to manage these patients around times of surgical intervention, or when they present with significant bleeding complications.â&#x20AC;&#x192; REFERENCES [1] Schulman S, Crowther MA. How I treat with anticoagulants in 2012: new and old anticoagulants, and when and how to switch. Blood. 2012 Mar 29;119(13):301623. [2] Makris M, Van Veen JJ, Tait CR, Mumford AD, Laffan M.Guideline on the management of bleeding in patients on antithrombotic agents. Br J Haematol. 2013 Jan;160(1):35-46. [3] Siegal DM, Crowther MA. Acute management of bleeding in patients on novel oral anticoagulants. Eur Heart J. 2012 Dec 7. [Epub ahead of print]. [4] Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation. 2011 Oct 4;124(14):1573-9. [5] Ortel TL. Perioperative management of patients on chronic antithrombotic therapy. Hematology Am Soc Hematol Educ Program. 2012;2012:529-35.


47

Re-alignment announced of Irish hospitals RCSI and the RCSI Teaching Hospitals Academic network (Beaumont Hospital, Connolly Hospital, the Cavan-Monaghan Hospital Group, the Louth-Meath Hospital Group and the Rotunda Hospital) have welcomed the announcement of the reconfiguration of Irish Hospitals by Minister for Health, Dr James Reilly TD. This re-alignment of Irish Hospitals, with their medical school partners, will create six Academic Health Centres in Ireland. This is an important development for Ireland and will lead to improvements in patient care, increase the research output of Irish medical schools and facilitate the rapid deployment of new discoveries into patient care. This development is consistent with the Strategy for Science, Technology and Innovation 2009-13, "A key priority is to develop a small number of centres of world significance in translational health research, each with strong foundations in both academia and the health services. Investment in such centres of excellence in translational medicine is required to extract full value from the resources that have been invested in basic biomedical sciences and biotechnology."

Professor Cathal Kelly, CEO, RCSI,

Academic Health Centres (AHCs) are an alliance of educational and healthcare institutions that combine the three major activities - health professional education, research and patient care. There is worldwide evidence of significant improvement in patients outcomes, efficiency of service and the economic impact (AHCs create an economic impact of over $500 Bn per annum in the USA), through the development of this model of health-care delivery. THE DEVELOPMENT OF THE RCSI TEACHING HOSPITAL NETWORK AHC WILL LEAD TO: For patients • Improved health outcomes and safety. • Improved and more streamlined access to services. • Better access to innovative treatments and clinical trials

For staff • Emphasis on innovation, encouragement of learning. • Increased opportunities for staff and students to be directly involved in education and research. • An enriched learning environment that will increase exposure to sub-specialties, specialist training, and translational medicine.

Professor Cathal Kelly, CEO, RCSI, welcoming the Government initiative commented: "RCSI welcomes this important initiative in the development of our healthcare services. The College looks forward to working even more closely with its hospital partners for the benefit of patients, clinicians and health professions in training."

Gold standards for Osteoporosis Osteoporosis is a growing public health problem. At present it is estimated that 300,000 people in Ireland have Osteoporosis. One in 5 men and 1 in 2 women over 50 will develop a fracture due to Osteoporosis in their lifetime. The disease can affect even children The gold standard for the treatment of osteoporosis , Bonasol is not only available in Ireland, but was developed and

is manufactured here also. The product was developed and registered by Irish company Xeolas Pharmaceuticals. They are a specialty pharmaceutical company developing innovative products for niche patient groups, including children and older patients. Their patient-inspired products are designed to be patient-friendly, to improve compliance with treatment

and ensure availability to those patients that need medicines the most. Their product development efforts are primarily focused on niche patient groups with special requirements including children, some elderly patients and patients in acute care environments.

the pre-breakfast aspect of the product - easier to remember and more pleasant to take first thing in the morning and it has compliance enhancing features making it more convenient and with reduced potential for administration error. Full prescribing information and references available from Fannin Ltd.

Bonasol’s appearance and flavour enhances and reinforces

HPN • Issue 8


48 Out & About

European Association of Hospital Pharmacists 18th Congress The 18th Congress of the European Association of Hospital Pharmacists (EAHP), was recently held in Paris with a unique spotlight on issues of inter-professional collaboration through its theme: “Improving patient outcomes: a shared responsibility”.

3

The 2013 congress saw the introduction of the Synergy satellite programme, run alongside the packed programme of speakers, workshops and seminars investigating hospital pharmacy operational, conceptual and therapeutic matters. EAHP also hosted a special welcome session for attendees from China and a session greeting a record number of student attendees. Full Congress report will be featured in next month’s issue of HPN.

4

1

5

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1: Damien Griffin and Girish Mistry, Accord Generics 2: James Donahoe, Denise Broderick Michelle Smith, Hospira Ireland 3: David Hobbart, Kerry General Hospital and Muireann Ain Shuilleabhan, SIVUH, Cork 4: Caroline Reidy, Pfizer and Caroline Soneira Chenio, Portlaoise General 5: Caroline Soneira Chenio, Portlaoise General, Anne Machniewski, Letterkenny General, Debbie Murray, Peamount Hospital and Padraig Cahil, Pfizer 6: Peter Seddon and Matt Jelley, Nova Labs Issue 8 • HPN


49 AbbVie launches in Ireland From the start of this year, Abbott has separated into two listed public companies and nearly 400 Irish staff in Sligo, Cork and Dublin began working for AbbVie, the newly established global researchbased pharmaceutical company. Building on Abbott’s 125-year heritage, AbbVie launches with more than 20 mid- to late-stage clinical programmes in the

pipeline. In 2013, the company will employ about 21,000 people worldwide, marketing medicines to more than 170 countries. “This is an exciting day for AbbVie and our 400 colleagues in Ireland,” said Ryan Quigley, general manager of AbbVie Ireland. “We look forward to working together with patients and healthcare partners to meet the healthcare needs in Ireland.”

Cork Hospital marathon appeal Olympic athlete Derval O’Rourke, patron of the Cork University Hospital (CUH) Charity, is asking participants in the Cork City Marathon, on the 3rd of June, to run in aid of the CUH Charity’s Intensive Care Unit (ICU) Appeal. Recognising that a critical illness can be one of the most stressful times for families of patients, the ICU Appeal’s first aim is to refurbish the visitor’s area on the ward and to develop a private area for family discussions. Registration can be made at www.corkcitymarathon.ie. To join the ICU Appeal Marathon Team (and receive your sponsorship pack) or for further information please contact icu@cuhcharity. ie or follow us on Facebook ICU RUN for LIFE or donate at www.mycharity.ie/event/ icurunforlife.

Importance of patient education Nearly two out of three people in four major European countries have no awareness of personalised medicine – despite the fact that this evolving discipline has vast implications for Europe’s healthcare issues and Europeans’ personal health. These statistics presented recently at the European Alliance for Personalised Medicine (EAPM) conference taking place in Dublin, in association with the Irish EU Presidency, were part of the PACE Cancer Perception Index that studied knowledge and attitudes about cancer treatment and care, the healthcare system and patient involvement. PACE, a Lilly Oncology initiative, stands for Patient Access to Cancer care Excellence. “Personalised medicine is a promising concept,” said Tonio Borg, European Union (EU) Commissioner for Health and Consumers. “As patients are divided into groups based on their individual, biological, genetic and genomic characteristics, medical interventions are tailored to those patients' needs.” “Hence, this new approach can help reduce the risk of undesirable adverse reactions and at the same time, make medicines more effective,” said Mr. Borg. HPN • Issue 8


50 News

Actavis unveils vibrant corporate rebrand Joan Peppard, former President, HPAI along with Caroline Fitzgerald, Actavis, at the recent EAHP Congress in Paris.

Developed at Actavis Headquarters in the US, the new green and blue logo bears the company name Actavis, topped off with a distinctive helix shape, which reveals a “W” shape emerging from a shaded “A,” a subtle historical reference to the Watson and Actavis heritage. “This new logo is a powerful and accessible visualisation that celebrates Actavis’ emergence as a global pharmaceutical leader, and visually defines the Company’s focus on growth and success in the future.” says Irene Sheehan, Marketing Director at Actavis Ireland.

May is a significant month for Actavis Ireland, as the Company completes the roll out of its new company logo and ‘branding’ to the Irish market. The distinctive new look and feel sees Actavis move from its existing orange colouring to a vibrant green, visually defining the company’s focus as it moves into a new period of growth following its acquisition by Watson Pharmaceuticals.

She continues “We look forward to showcasing this eye-catching new look and to introducing the new Actavis at national and international pharmaceutical events during the remainder of 2013. Our re-branded logo and colouring ensures stand out among our industry competitors and has been very positively received in this initial stage of the rollout. Our striking new look further enhances our collateral and positions Actavis positively to maximise the Company’s offering of product choice and value in Ireland over the coming months and years.”

New report on use of health system A report on the use of health services by older people in Ireland has found that social care services are likely to face rapidly growing pressures with ageing. As part of The Irish Longitudinal Study on Ageing (TILDA), the report was launched last month on the occasion of a conference also hosted by TILDA on ‘Meeting the challenge of an ageing Ireland’ for policy

Issue 8 • HPN

makers and researchers in ageing. The report was written by authors, Aoife McNamara, Prof. Charles Normand and Prof. Brendan Whelan. The study focused on the drivers of service use in hospital, primary, community and social care services. At the time of the survey almost 70% of the population were paying out of pocket costs for primary and

secondary care services. About 30% of the population had medical cards, providing free access to these services.

 Having a medical card increases the number of days in hospital, as does having medical insurance.

Key findings of the study are:

 Usage of GP service and numbers of nights spent in hospital are strongly affected by poor health (as indicated by self-rating, number of reported diseases and measures of disability).

 Age in itself is not a significant driver of health service use. Factors related to age such as declining health or higher levels of entitlement are more important.


Product Profiles ELIQUIS® (APIXABAN) LAUNCHED IN IRELAND

Eliquis® 2.5mg has been recently launched in Ireland for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. This is the first approved indication for ELIQUIS®, a new oral direct Factor Xa inhibitor developed by the alliance of Bristol-Myers Squibb and Pfizer Inc. ELIQUIS® is the only oral anticoagulant with a 12- to 24-hour post surgery initiation window, which may help physicians to

CLONMEL HEALTHCARE ANNOUNCE THE LAUNCH OF EFESTAD (DESLORATADINE) 5MG FILM-COATED TABLETS.

Efestad (Desloratadine) 5mg is indicated for the relief of symptoms associated with:

CLONMEL HEALTHCARE ANNOUNCE THE LAUNCH OF IBANDRONIC ACID CLONMEL (IBANDRONIC ACID) 150MG FILM-COATED TABLETS.

Ibandronic Acid Clonmel (Ibandronic Acid) 150mg is indicated for:1

• Allergic rhinitis • Urticaria1 Efestad Film-coated tablets are available in a 30 pack. Full prescribing information for Efestad is available on request or go to www.clonmel-health.ie .

51 observe and stabilize postsurgical patients before beginning treatment.i ELIQUIS® is dosed 2.5 mg twice daily, requires no routine platelet or liver monitoring, other than measurement of ALT as part of standard pre-operative Press Release: assessment, and requires Clonmelin Healthcare no dose adjustment indicated patients.i In Subject: New launch patients undergoing hip replacement surgery, the recommended duration of treatment is 32 to 38 days.i In patients undergoing knee replacement surgery,

Ibandronic Acid Clonmel Film-coated tablets are available in

Please contact Clonmel Healthcare on 01-6204000 if you require any additional information on Efestad. Efestad is the Clonmel brand of Desloratadine.

Product is subject to medical prescription. Ibandronic Acid Clonmel is GMS reimbursable from 1st February 2013.

a 1 pack.

To avoid ulceration and irritation of the stomach lining alendronic acid must be taken: Bonasol Once Weekly, a sugarfree orange-flavoured medicine, is a 70mg alendronic acid liquid approved for the treatment of postmenopausal osteoporosis

Please contact Clonmel Healthcare on 01-6204000 if you require any additional information on Ibandronic Acid Clonmel.

Full prescribing information for Ibandronic Acid Clonmel is available on request or go to ELI/2012/038/1 www.clonmel-health.ie . ThisDate of preparation: November 2012.

and reduces the risk of vertebral and hip fractures. Bonasol acts selectively on bone tissue without directly affecting bone formation, and the reduction of elevated bone turnover leads to continuous net gains in bone mass and decreased occurrences of vertebral and hip fractures.

BONASOL ONCE WEEKLY FOR POSTMENOPAUSAL OSTEPOROSIS

The approval of ELIQUIS® was based on the ADVANCE-2 and ADVANCE-3 clinical trials, part of the EXPANSE clinical trial program.i

References: This Product is subject to medical prescription. Efestad is GMS reimbursable from 1st February 2013.

• The treatment of osteoporosis in postmenopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

the recommended duration of treatment is 10 to 14 days.i

Take Tablets: � hour before breakfast or first food of the day With 200ml of water

In either a sitting or standing position (no going back to bed) 4 hours before other medication Take Bonasol Once Weekly: � hour before breakfast or first food of the day With at least 30ml of water Wait at least 30minutes before lying down again The product was developed and registered by a new Irish company, Xeolas Pharmaceuticals. It is a prescription only medicine. Full prescribing information and references available from Fannin Ltd. Email: medinfo@fannin.ie.

HPN • Issue 8


52 Clinical Profiles CYMALON GETS NEW LOOK FOR 2013

MONTELUKAST IS DAY ONE LAUNCH FOR ACTAVIS

Cymalon, the over-the-counter cystitis treatment from Actavis Ireland, has been re-launched with a new look for 2013. The new, eye-catching packaging refreshes the look of this wellestablished product, which offers fast, effective relief from a range of condition-related symptoms including: a burning sensation when passing water; the need to pass water frequently and a

Actavis Ireland is pleased to announce the introduction of Montelukast Paediatric (4 mg and 5 mg) and Montelukast Actavis (10 mg) on the first day of patent expiry. Delivering key products on Day One continues to be an important focus for Actavis Ireland and this latest launch - on 25th February - continues to underline Actavis’ position as the fastest growing

NEW DIARRHOEA TREATMENT LAUNCHED FOR THE WHOLE FAMILY

PFIZER HEALTHCARE IRELAND ANNOUNCES LAUNCH OF NEW FENTADUR® ANALGESIC PATCH

Ocean Healthcare is pleased to announce the launch of Tasectan on the Irish market. Tasectan Gelatin Tannate, is indicated for the treatment of diarrhoea. Tasectan has a unique mode of action that targets the source of diarrhoea. It is the only product suitable for use in infants, children and adults. Tasectan is available in

Dublin, October 8th 2012: Pfizer Healthcare Ireland recently announced the launch of Fentadur® transdermal patch, indicated for the management of severe chronic pain which can be adequately managed only with opioid analgesics. Fentadur® contains fentanyl and is available in five dosing strengths: Fentadur® 12 micrograms/ hour transdermal patch (1.38mg fentanyl) Fentadur® 25 micrograms/ hour transdermal patch (2.75mg fentanyl) Fentadur® 50 micrograms/ hour transdermal patch (5.50mg fentanyl)

Issue 8 • HPN

general discomfort in the lower abdomen area. A familiar sight on Irish pharmacy shelves and a popular choice among Irish cystitis sufferers1, Cymalon offers a complete 48hour course of treatment, with six lemon flavour sachets of granules, mixed to take as an oral solution. Cymalon contains citric acid which helps increase the secretion of urine and render it less acidic

pharmaceutical company on the Irish market1. Indicated for the treatment of asthma, Montelukast Paediatric is available in 4 mg and 5 mg x 28 chewable tablets and Montelukast Actavis 10mg, for adolescents and adults from 15 years of age, is available in packs of 28 film coated tablets. Subject to medical prescription, Montelukast is GMS reimbursable and available from all

capsules for adults and sachets for paediatric use. More information is available on www.diarrhoea.ie The launch of Tasectan will be supported by a heavyweight marketing campaign targeting consumers and healthcare professionals. The campaign will include Radio, Print and online advertising.

Fentadur® 75 micrograms/ hour transdermal patch (8.25mg fentanyl) Fentadur® 100 micrograms/ hour transdermal patch (11mg fentanyl) The dosing of Fentadur® is individual and based on the patient’s opioid historyi. It should also take into account the medical status of the patient, and the degree of severity of the disorderi. The required fentanyl dosage should be assessed regularly and titrated individually until analgesic efficacy is attainedi. If analgesia is insufficient at the end of the initial application period, the dose may be increased after 3 days until the desired effect is obtained for each patienti. Dose adjustment should

and sodium citrate which aids the treatment of the urinary tract infection. Cymalon (x six sachets) is available at a trade price of ¤4.51. For further information on the Actavis OTC Product portfolio please contact the Actavis OTC Account Manager Barry Doyle on (086) 0242 131.

wholesalers from February 25th. Montelukast Paediatric 4 mg is available at a trade price of ¤18.27 and the 5 mg at ¤18.71. Montelukast Actavis 10 mg has a trade price of ¤18.38. For further information on the Actavis portfolio please contact Actavis on 1890 33 32 31 or email on contact@actavis.ie

Tasectan is available from Ocean Healthcare and all wholesalers. For more information contact Ocean Healthcare 01 2968080 Tasectan Capsules 8s RRP ¤7.95 Tasectan Sachets Paediatric 10s ¤8.95

normally be performed in 12mcg/ hour or 25mcg/hour increments. The transdermal patch should be changed every 72 hours and a new skin area should be selected for each applicationi. Fentadur® is a prescription only medication and is GMS reimbursable. Full prescribing information is available on www.medicines.ie. Should you have any medical queries about Fentadur® please contact the Pfizer Medical Information Department Freephone 1800 633 363. An up to date approved Fentadur® Summary of Product Characteristics is available on www.medicines.ie.


53 MIRABEGRON RECEIVES POSITIVE CHMP OPINION FOR TREATMENT OF OVERACTIVE BLADDER SYMPTOMS

ASTELLAS PHARMA EUROPE Ltd. announced on October 19th that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of a marketing authorisation for BETMIGATM (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients

with overactive bladder (OAB) syndrome.

LAUNCH OF MONTELAIR CHEWABLE TABLETS

Clonmel Healthcare has announced the launch of Montelair (Montelukast) 4mg , 5mg Chewable tablets and 10mg Film-coated tablets.

inhaled corticosteroids and in whom 'as-needed' short-acting beta-agonists provide inadequate clinical control of asthma

Montelair (Montelukast) 10mg Film-coated Tablets are indicated for:1 • The treatment of asthma as add-on therapy in those patients, 15 years and older, with mild to moderate persistent asthma who are inadequately controlled on

The opinion now needs ratification by decision of the European Commission which is expected within the next 74-90 days. When approved, mirabegron will be the first in a new class of OAB treatment, offering healthcare professionals an alternative option to antimuscarinics (currently the only licensed oral treatment option) when treating patients with OAB.

• Adult asthmatic patients (15 years and over) in whom Montelair is indicated in asthma, Montelair can also provide symptomatic relief of seasonal allergic rhinitis. • The prophylaxis of asthma in patients in which the predominant component is exercise-induced bronchoconstriction.

Mirabegron is a once daily oral ß3-adrenoceptor agonist with a distinct mechanism of action compared to antimuscarinics, the current treatment standard.1 Mirabegron works by stimulating the ß33 receptors in the detrusor muscle of the bladder2 causing relaxation of the bladder muscle during the storage phase of the micturition cycle. This improves the storage capacity of the bladder without inhibiting bladder voiding.3

Also available, Montelair 4mg Chewable tablets for patients aged 2 to 5 years and Montelair 5mg Chewable tablets for patients aged 6 to 14 years. Montelair Chewable and Filmcoated tablets are available in a 28 pack. Please contact Clonmel Healthcare on 01-6204000 if you require any additional information on Montelair.

CHANGE TO NEORAL CONCENTRATE

Novartis Ireland Ltd have announced a forthcoming change to the packs of Neoral® (ciclosporin) Concentrate for Oral Solution and Sandimmun® (ciclosporin) Concentrate for Oral Solution.

Novartis now have approval for the inclusion of a 1ml oral syringe in each pack of Neoral Concentrate for Oral Solution and Sandimmun Concentrate for Oral Solution. This will be in addition to the existing 4ml syringe. This will allow the

most appropriate syringe to be selected for the dose of Neoral or Sandimmun prescribed.

TOVIAZ ASSOCIATED WITH IMPROVEMENTS IN BLADDER VARIABLES

Results from the Study of Fesoterodine In an Ageing population (SOFIA), published in the Journal of the American Geriatrics Society recently, show that Toviaz® (fesoterodine fumarate) is associated with statistically significant and clinically meaningful improvements in most bladder diary variables, and significantly greater

improvement in patient-reported outcomes, compared to placebo, in patients aged 65 years and older with overactive bladder (OAB) at week 12. The Toviaz® group showed significantly greater improvements in urgency episodes per 24 hours, the study primary endpoint, compared with placebo (a decrease from 8.5 to 4.6, and 8.8 to 6.3 respectively, at week 12,

P<0.001). Toviaz® was generally well-tolerated in all patients 65 years and older with OAB in the study. The efficacy and safety profiles of Toviaz® in the SOFIA trial support a favourable benefit-risk ratio of antimuscarinic drugs in older subjects with OAB reported in previous trials.

It is anticipated that stocks containing the 1ml syringes will be available within the next couple of months.

HPN • Issue 8


54 Appointments

Dr. Gary J. Nabel Sanofi is pleased to announce the appointment of Dr. Gary J. Nabel, M.D., Ph.D., to Chairman of the Strategic Development

and Scientific Advisory Council (SDSAC). Dr Nabel, currently Senior Vice President, Chief Scientific Officer and Deputy

to Dr Elias Zerhouni, President, Global R&D, will succeed Dr Richard Klausner.

Mark Borthwick The United Kingdom Clinical Pharmacy Association (UKCPA) has announced that Mark Borthwick, Consultant Pharmacist Critical Care, John

Radcliffe Hospital has been elected its new Chair. Mark says: "The UKCPA has been prominent in my professional development since the moment I

stepped into hospital pharmacy, so I am very excited at the opportunity to be involved in this organisation in such an influential role."

Michael Koenig At a recent meeting, the Supervisory Board of Bayer AG appointed Michael Koenig, currently a member of the Executive Committee of Bayer

MaterialScience and Head of the Polycarbonates business unit, to the Board of Management of the holding company effective April 1, 2013. He is to succeed Dr.

Richard Pott (59) effective June 1, 2013, upon Pott's retirement as of that date.

Professor Mark Ferguson The Board of Science Foundation Ireland (SFI) has appointed Professor Mark Ferguson as Director General of the organisation. Professor

Ferguson, a native of Northern Ireland, will take up the position on January 16th 2012. A leading academic for thirty years, Professor Ferguson is

also a co-founder of Renovo, a biotechnology company developing novel pharmaceutical therapies to prevent scarring and accelerate wound healing.

Professor Philip J O’Connell The Governing Authority of University College Dublin has announced the appointment of Professor Philip J O’Connell as Director of the UCD Geary

Institute, the university’s worldleading research centre for economics and social sciences. Professor O’Connell joins UCD from the ESRI where he

was Head of Social Research and Director of the European Migration Network in Ireland.

Seamas Donnelly Seamas Donnelly from the UCD School of Medicine and Medical Science, University

College Dublin, and St Vincent’s University Hospital is the first Irish based academic to be

appointed as editor-in-chief of the Quarterly Journal of Medicine (QJM).

Stephan Gemkow The supervisory board of Celesio AG has appointed Stephan Gemkow (52) as its new chairman. Gemkow succeeds Professor Dr Jürgen Kluge, who resigned from this position as of Issue 8 • HPN

18 December 2012. As a leading international trading company and provider of logistics and services in the pharmaceutical and healthcare sector, Celesio

takes a proactive and preventive approach to ensuring that patients receive the products and support that they require for optimum care.


Did you know?

YOU CAN ORDER YOUR EXEMPT MEDICINES ONLINE ...

... its only a click away www.cmrg.ie/alchemy • www.cmrg.ie/hospitals Retail

Hospital

Please contact Alchemy for Log on details

Market Leading Price Structures Alchemy is a comprehensive service for sourcing exempt medicinal products. We source and supply manufactured specialsextemporaneous products within 72 hours. We have a specialist team in place (pharmacists, technicians and telesales personnel) to guide you through the process in an ethical and professional manner from order to delivery. Full supplier verification ensures complete traceability of all our products. Source and supply short, discontinued, irregular and once off products. No extra delivery charges using customers current delivery arrangements*.

We have a large number of exempt medicines in stock and immediate access to a database of more than 650,000 medicines worldwide.

NEW WEB PORTAL allows you to easily place your order for exempt medicinal products electronically removing the need to fax your order through. This new site allows you to manage all aspects of the exempt medicines part of your business including: Checking the availability of stock, pricing and re-printing of invoices. To access our site visit: www.cmrg.ie/alchemy Contact details Cahill May Roberts, Pharmapark, Chapelizod, Dublin 20.

Provide a first class cold chain service.

Telesales: Hospital Retail

(071) 916 1801 (Option 1) (Option 2)

* Express emergency deliveries may incur a fee

Technical queries: (01) 630 5432 Fax: (071) 9161977

e: alchemy@cmrg.ie • w: www.cmrg.ie/alchemy • www.cmrg.ie/hospitals Retail

Hospital

HOSPITAL PHARMACY NEWS - ISSUE 8 - 2013  
HOSPITAL PHARMACY NEWS - ISSUE 8 - 2013  

IN THIS ISSUE: News: Irish pharmacist presents at American College of Cardiology - Report: Medicines Reconcilliation a key priority - Awards...

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