HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

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THE INDEPENDENT VOICE OF HOSPITAL PHARMACY HOSPITA PHARMAC NEWS IRELAND Issue 14 IN THIS ISSUE: News: Hospital pharmacists speak out about iMed Page 4 Profile: Actavis’s Caroline Fitzgerald – Pharmacy Rep of the ear Page 9 Feature Alcohol induced Brain Injury Page 20 Awards: Exclusive look at the Hospital Pharmacy Awards 2014 Finalists Page 22 CPD: Diabetic Foot Disease Page 25 Report: 11th Post ASCO meeting coverage Page 46 Working in partnership with the NHS Full Line Specials Manufacturer The trusted name for Specials www.novalabs.co.uk A division of the Nova Bio Pharma Group

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IN THIS ISSUE: News: Hospital pharmacists speak out about iMed - Profile: Actavis’s Caroline Fitzgerald – Pharmacy Rep of the Year - Feature Alcohol induced Brain Injury - Awards: Exclusive look at the Hospital Pharmacy Awards 2014 Finalists - CPD: Diabetic Foot Disease - Report: 11th Post ASCO meeting coverage

Transcript of HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

Page 1: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

THE INDEPENDENT VOICE OF HOSPITAL PHARMACY

HOSPITAL� PHARMACY�

NEWS IRELAND

Issue 14

IN THIS ISSUE:

News: Hospital pharmacists

speak out about iMed

Page 4

Profile: Actavis’s Caroline

Fitzgerald – Pharmacy Rep

of the Y�ear Page 9

Feature Alcohol induced

Brain Injury Page 20

Awards: Exclusive look at the Hospital Pharmacy

Awards 2014 Finalists Page 22

CPD: Diabetic

Foot Disease Page 25

Report: 11th Post ASCO

meeting coverage Page 46

Working in partnership with the NHS

Full Line Specials Manufacturer

The trusted name for Specials

www.novalabs.co.uk A division of the Nova Bio Pharma Group

A5 port ad artwork:Layout 1 22/8/14 11:46 Page 1

Page 2: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

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HPN • Issue 14

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Issue 14

Contents ForewordEditor Kelly Jo Eastwood

In leading news this issue, concern has been expressed that underfunding of hospital and mental health services is threatening patient care. The Irish Hospital Consultants Association (IHCA) has called for additional resources to be allocated to acute hospitals in the 2015 Budget, ensuring the delivery of safe, quality care to patients.

Commenting on its pre-budget submission, Dr Gerard Crotty, President of the IHCA said, “It is a major concern that budgets for acute hospitals have been cut to unrealistic levels such that, in the first five months of 2014, acute hospital expenditure was ¤104.8m over-budget. The vast majority of hospitals are grossly underfunded with some overspending by up to 21%. Funding for acute hospital services has been cut by almost one fifth compared with the resources in place in 2008. If increased resources are not provided in the 2015 Budget it will increase the risk that a growing number of patients will not be treated within a medically appropriate timeframe.”

In other news, Leonidas Tzimis has taken up the position of co-chair for users in the Planning Committee of the Integrating the Healthcare Enterprise (IHE Pharmacy). IHE is the organisation that enables users and developers of information technology for healthcare to achieve interoperability of systems through the precise definition of healthcare tasks, the specification of standards-based communication between systems required to support those tasks and the testing of systems to determine that they conform to the specifications.

Tullamore Hospital Pharmacist and President of EAHP, Joan Peppard has said, “For hospital pharmacy, as for any profession, you can either wait to be shaped by the future, or try to shape the future. It’s with this in mind that our organisation takes a pro-active and engaged view when it comes to the challenges of future technology in the hospital pharmacy environment.”

Turn to page 4 to read the news story in full.

The deadline for entries to the 2014 Hospital Pharmacy Awards has passed and as a team we have been overwhelmed by the quantity and quality of this year's entries. In total, 40 finalists have been selected for the 2014 Awards and these individuals and teams are showcased in the inside pages of this issue.

Well done to all those who have been shortlisted. Our esteemed judging panel now face a difficult decision; as we all know there can be only one winner on the night.

Preparations are well underway for the main event, which takes place on September 20th in the Hilton DoubleTree Hotel. It is not too late to book your place. To do so please contact me, Kelly Jo Eastwood on [email protected]

We look forward to welcoming you all for what promises to be a night of celebration and excellence.

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.

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

MANAGING DIRECTOR Natalie Maginnis [email protected]

EDITOR Kelly Jo Eastwood [email protected]

ACCOUNTS Pauline Magill [email protected]

CONTRIBUTORS Dr Helen McMonagle

Dr Harry Comber

ART DIRECTED BY� Smart Page Design

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

Hospital pharmacist takes on Ironman Championship P4

Actavis’ Caroline keeps customers at heart P9

Underfunding threatening patient care P14

The 2014 Hospital Pharmacy Awards Finalists P20

11th Post ASCO highlights discussed in Dublin P46

Regulars

Feature: Alcohol induced Brain Injury P20

CPD: Diabetic Foot Disease P25

Out and about P46

Appointments P50

4

6

46

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Issue 14 • HPN

L�aunch of Guideline on C. Diff

News

Don’t wait to shape the future

The Chief Medical Officer at the Department of Health, Dr Tony Holohan, has launched the 3rd National Clinical Guideline – Surveillance, Diagnosis and Management of Clostridium difficile Infection in Ireland. This guideline was quality assured by the National Clinical Effectiveness

Committee (NCEC).

This National Clinical Guideline together with the guidelines No. 2 on MRSA, provides practical guidance on prevention and control measures for clostridium to improve patient care, minimise patient morbidity and mortality and to help contain healthcare costs.

Tullamore Hospital Pharmacist Joan Peppard has congratulated Leonidas Tzimis on taking up the position of co-chair for users in the Planning Committee of

the Integrating the Healthcare Enterprise (IHE Pharmacy).

Integrating the Healthcare Enterprise (IHE) is the

Joan Peppard

organisation that enables users and developers of information technology for healthcare to achieve interoperability of systems through the precise definition of healthcare tasks, the specification of standards-based communication between systems required to support those tasks and the testing of systems to determine that they conform to the specifications. The work is managed by IHE Committees and supported by various national and international bodies and among them EAHP.

The IHE-Europe Connectathon (http://connectathon.ihe-europe.net) provides a unique opportunity for vendors to test the interoperability of their products in a structured environment with peer vendors. Participants test against multiple vendors using real world clinical scenarios

following IHE Integration Profiles specifications, across a variety of domains including Pharmacy, Radiology, Cardiology, Pathology, Patient Care Devices, Patient Care Coordination, Laboratory, and IT Infrastructure, along with those of their peer vendors. The next IHE European Connectathon will take place in Luxembourg, April 20-24, 2015.

Ms Peppard said: “For hospital pharmacy, as for any profession, you can either wait to be shaped by the future, or try to shape the future. It’s with this in mind that our organisation takes a pro-active and engaged view when it comes to the challenges of future technology in the hospital pharmacy environment.

“There is so much opportunity for improvement out there, but we must be present and active in the debates and discussion to ensure the best outcomes are achieved. That’s why I’m delighted that, Leonidas Tzimis, our representative within IHE, is able to take up this leading position, and ensure hospital pharmacy is at the centre of developments in IT interoperability in European healthcare systems. On behalf of all at EAHP I thank him again for his leadership in this area and commitment to the task.”

This includes the importance of organisations having an infection control and prevention programme in place with an emphasis on good hand hygiene, the use of Standard Precautions and antimicrobial stewardship.

This guideline has been developed for all healthcare staff involved

in the care of patients, residents or clients who may be at risk of or may have C. difficile in hospitals, nursing homes/long stay residential units and the community. The full guideline, summary version and presentation from the launch are available on the DOH website at www.dohc.ie

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HPN • Issue 14

mHealth applications must have oversight

The European Association of Hospital Pharmacists (EAHP) has responded to a consultation by the European Commission advising that any mHealth applications linked to the use of medicines must have levels of regulatory oversight, ideally involving pharmacist expertise, in order to ensure their safety.

The European Commission launched a consultation on mHealth in April 2014, asking healthcare professionals and patients for input on the health related applications of smartphone technology. One of EAHP’s key points was that the introduction of new technologies in the hospital setting has been an ever-present reality. Lessons learned include the need to understand the potential positive applications of a new technology at an early stage, and for Governments and health system managers to take a leadership role in achieving their realisation. This lesson, for example, is evident in the difficulties experienced in achieving bedside scanning as a patient safety measure within hospital systems - as medicines still do not typically contain a bar code to the single unit.

Another key point of EAHP’s response was to underline safety

needs when applying mHealth to any process involving medicines.

Kathy Stephenson, Macmillan Palliative Care Pharmacist at the Southern Trust on the issue of mHealth comments, “Technology offers many wonderful opportunities for enhancing services and potentially improving adherence to medicines, but we still need to recognise the limitations of such systems.

We have seen both positive and negative influences emerge from the internet over the last twenty years, so it is therefore essential that development of any mHealth app for patient use, relating to medications, is carried out in conjunction with highly specialist pharmacists experienced in use of each particular medication. They can ensure that the app appropriately directs users to a qualified health professional if there is concern about symptoms or side effects.

“A computer programme accessed via a mobile device can never replace the value of individual contact with a health professional, especially in matters of personal health, but it also needs to be balanced so that users do not become unduly concerned.”

Summer scholarship for pharmacy student

Third year pharmacy student Ezebuchi Nwafor has received an HRB Summer Student Scholarships for a research project he will conduct with his mentor Dr Christian Waeber.

Stroke is the 3rd leading cause of death in the world. However, the only available drug, which is used to dissolve the clot and restore blood flow to the affected area, is only used in ~4% of patients. Effective therapies are therefore needed. Ezebuchi’s project will focus on preconditioning, which is a process whereby a stimulus

below the threshold of damage is applied, leading to tissue resistance to the same, or different stimuli given beyond damage threshold.

He is planning to use primary cells derived from brain to test in vitro whether different preconditioning stimuli generate sphingosine-1-phosphate, or S1P, and whether this S1P makes these cells more resistant to a lack of oxygen and nutrients by acting on specific membrane receptors.

The goal of these studies, for which Dr Waeber received a Marie Curie Career Integration Grant, is to establish the importance of a new pathway providing protection against ischemia. Knowledge of the molecular interactions involved in this pathway may provide novel therapeutic targets for stroke, as well as for other conditions such as neurodegenerative disorders and cancer.

Dr Christian Waeber & Ezebuchi Nwafor

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Issue 14 • HPN

News

Beaumont Hospital, Dublin has launched a new Antimicrobial App, which will assist staff in their day to day work, prescribing, dispensing and administering antibiotics to patients.

The App will help hospital staff to select the most appropriate antibiotics for treating patients with infection, promote more consistent prescribing by almost 500 prescribing doctors and also provide ward pharmacists and nurses with additional information to administer and monitor

Kerrill Thornhill, Managing Director of Maithu IT solutions www.medicaleguides.com; Karen Burns, Consultant Microbiologist, Mary Regan, Antimicrobial Pharmacist and Professor Ed Smith, Consultant Microbiologist/Chair of Clinical Governance, Beaumont Hospital.

antibiotic use around the hospital.

The App makes almost 300 of pages of up-to-date prescribing information and guidance accessible on a handheld device and was developed over a twelve month period by Beaumont’s antimicrobial stewardship and clinical microbiology team, with extensive consultation with clinician colleagues.

As a tertiary hospital, with a number of specialties, such

as neurosurgery and kidney transplantation, the Beaumont Antimicrobial App also provides detailed information for staff on the most appropriate antibiotics for preventing and managing infections in these highly specialist areas.

Internationally, the issue of over prescription and incorrect use of antibiotics directly contributes to the threat of antimicrobial resistance (AMR) and the risk of antibiotic-related side effects, such as Clostridium difficile

infection. Indeed, the World Health Organisation (WHO) recently published its first Global Report on AMR.

In Ireland, the national clinical guideline on Clostridium difficile infection was published in June 2014 and emphasises the importance of prudent antimicrobial use as a means to reduce the risk of Clostridium difficile infection.

Having easy access to the local guidelines via the Beaumont Antimicrobial App will reduce the amount of time that doctors, nurses and pharmacists need to spend searching for information in bulky documents or on shared PCs. Staff will be able to access the most up-to-date information from their smartphone, allowing them to respond in a more efficient and consistent way to patients’ needs. The antimicrobial stewardship team at Beaumont will also be able to update the App, whenever new guidelines or information become available.

Beaumont develop antibiotics App

Inappropriate medication prescribingA new study from RCSI (Royal College of Surgeons in Ireland) and Trinity College Dublin, which examined the prevalence of potentially inappropriate prescribing (PIP) and prescribing omissions in older Irish adults, has found that 14% of people over the age of 65 has been prescribed at least one inappropriate form of medication in their lives and 30% have not been prescribed clinically indicated medications, at least once in their lives.

The research was carried out by RCSI’s Department of General Practice, the Health Research Board (HRB) Centre for Primary Care Research and Trinity College Dublin, using data from The Irish Longitudinal Study on Ageing (TILDA), and was recently published in the European Journal of Clinical Pharmacology.

Potentially inappropriate prescribing in older adults is a term used for medications that should be generally avoided in this age group and where doses or frequencies of administration that should not be exceeded.

Speaking on the findings, lead researcher Dr Rose Galvin, RCSI Department of General Practice and Programme Leader at the HRB Centre for Primary Care Research, said, “These figures of potentially inappropriate prescribing and omissions in patient’s medication are worrying. We found that the most frequently inappropriate prescribed drugs were non-steroidal, anti-inflammatory medications which were dispensed to patients with moderate-severe hypertension; and aspirin dispensed to those with no history of coronary, cerebral, or peripheral vascular symptoms.

“We also found that the most common prescribing omission were antidepressant drugs in the presence of patients with moderate to severe depressive symptoms that could last at least three months.”

The research revealed a direct correlation between both PIP and prescribing omission with polypharmacy, or the use of multiple medications by a single patient. The researchers

concluded that the application of a screening tool to assist prescribing decisions can reduce unnecessary medication, related adverse events, healthcare utilisation and cost.

Dr Galvin went on to say, “It is clear that Doctors and Pharmacists who dispense these

medications to patients must be extra-vigilant when dispensing and prescribing medicines to their patients. Better efforts should be directed to place particular focus on appropriateness of medication issued to patients both with respect to under and over-prescribing.”

Dr Rose Galvin

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Over 350 million patients treated with Clexane worldwide2

NOT ACTUAL SIZE

Clear visibility of expiry date

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

Needle completely covered by the protection cap immediately after the injection

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

Clear product identification

Designed to

protect against

needle stick

injuries1

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

CLEXANE® CONFIDENCE AT YOUR FINGERTIPS

New Clexane® and Clexane® Fortesafety lock syringes

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

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

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

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

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

GBIE.ENO.13.06.01 Date of preparation June 2013

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Issue 14 • HPN

Medicines Management in Palliative Care

L�ocal device to aid Coronary Disease

Registration for the Medicines Management in Palliative Care education programme is now open. The Medicines Management in Palliative Care education programme has been developed by the Palliative Meds Info service at Our Lady’s Hospice & Care Services (OLH&CS) for pharmacists seeking to improve their medicines management knowledge and skills in providing a service to patients with palliative care needs.

This year, the course is

delivered using an online learning component and the education day will be held on the 5th of November 2014 at Our Lady’s Hospice & Care Services, Education & Research Department. Online learning will be available from the 1st of October 2014

Course Content

• Gain up-to-date evidence-based knowledge of how and why medicines are used in pain and symptom management in palliative care,

with a focus on cancer and neurological illnesses.

• Understand the practical use and indications for a syringe pump in palliative care.

• Enhance communication skills with patients and colleagues to promote optimum pharmaceutical care of patients at end of life.

Who should attend?

Community pharmacists, hospital pharmacists, residential care pharmacists and other

health care professionals with a particular interest in medicines in palliative care.

Register Now: Click to view programme. Click here to register. Registration and online learning will be hosted by the Palliative Hub (Learning Platform). You will need to set-up an account to register for the programme.

Early Bird Discount (before 8 October) ¤90

Registration Fee (after 8 October) ¤100

Buccolam Oromucosal Solution RecallThe Health Products Regulatory Authority (the HPRA, formerly the Irish Medicines Board) advises that, as a precautionary measure, the company ViroPharma SPRL is recalling from pharmacies several specific batches of the Buccolam Oromucosal Solution products used to treat convulsive seizures in children and adolescents.

The reason for the recall is that an issue has been identified in relation to manufacturing controls in place at the manufacturing site. As a consequence, there was a theoretical risk of contamination at the manufacturing site.

This risk has been assessed as being very low. There is no evidence of any actual

contamination having occurred with the Buccolam products, and the potential contaminant has not been detected in any batch of Buccolam during product testing to date. Nevertheless, these batches of Buccolam are being recalled to pharmacy level as a precautionary measure.

Recall letters were issued by ViroPharma SPRL, to

wholesalers and hospital and community pharmacists on Tuesday, July 29th 2014. Pharmacists and wholesalers are being asked to return units from the above-listed batches, for replacement. The replacement batches were manufactured at a different manufacturing site and they are immediately available.

A new device that promotes the bypass of arterial obstructions, potentially removing the need for major surgery has been developed locally.

Worldwide, there are approximately three million open heart coronary bypass and peripheral artery bypass operations each year. These procedures involve major surgery with inherent risks of anaesthesia, ventilation, surgical trauma and potential complications such as kidney failure and wound infection. Around 20% of all patients requiring surgery are unable to undergo such bypass procedures because of the poor status of their arteries or co-existing illness that would make the risk of surgery too great.

Publishing in the latest issue of the prestigious journal Biomaterials, the research

project (led by Professor Noel Caplice in UCC with collaborators in the Mayo Clinic, USA) has developed a vascular cell delivery device and tested it successfully in a large animal model with similar sized arteries to humans. The device is inserted via a keyhole procedure through the artery to the site of obstruction and promotes micro-bypass of this obstruction over a four week period. This results in the return of normal heart function and a recovery of full exercise capacity.

Professor Noel Caplice, Director of the Centre for Research in Vascular Biology at UCC and Chair of Cardiovascular Sciences says, “If reproduced in humans this device would offer an alternative to open surgical bypass operations with implications for treatment of patients who are

currently inoperable. It also has the potential to reduce costs and time spent in hospital.” Professor Caplice is a practicing interventional cardiologist.

Plans are now in place to test this technology over the coming years in patients who require bypass surgery but would otherwise be deemed unfit for surgical intervention.

Professor Noel Caplice

News

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HPN • Issue 14

The hospital pharmacists’ partner of choice – Pharmacy Representative of the Y�ear Caroline Fitzgerald

Caroline Fitzgerald

Profile

The Hospital Pharmacy Representative of the Year Award offers the opportunity to test professional sales skills and to benchmark those skills against other leading representatives.

The 2013 Award was presented by Hospital Pharmacy News in recognising excellence in product knowledge and service to customers, to Caroline Fitzgerald, Actavis Hospital Business Manager, Ireland.

Pharmacy representatives are the ambassadors in their markets and are an integral part of a global team of people who further their company’s mission to encourage, advance and elevate the pharmaceutical industry.

“Caroline really is a forward-thinking person to have in our trade,” said one judge. “I am sure that she could give a lot of good advice to people entering the industry.”

Caroline offers problem solving capabilities and reliability, according to her customers. “We have an ambitious department that relies heavily on Caroline’s extensive knowledge and experience in the industry. She steers us with the right knowledge and advice.

“Caroline is an excellent communicator, who always follows up any queries and promptly responds with the required information. She is efficient at anticipating problems and offering solutions.”

What does Caroline believe are the key qualities needed to

work as an effective pharmacy representative within the hospital industry in Ireland?

“In my opinion there are a number of key qualities needed;

Trust – customers need to trust you, in order to buy from you;

Listening to your customer needs - so that you can meet them effectively;

Knowledge – knowing your industry so that customers may learn something new from you;

The backing of a good company with a proven track record of supply.”

Having worked in the charity sector as a Development Officer with ISPCC and the Irish Youth Foundation, Caroline moved on to pastures new joining an advertising agency in the role of Strategic Director. Upon entering the world of pharmaceuticals she began a career working with Pinewood Healthcare, before joining Actavis – a team she has been part of for the last six years.

“Every week in my job is different. There is never a dull moment,” she reflects. “In managing the Hospital Business Unit I am involved in pulling together the different areas of sales, marketing, regulatory, new product launches and corporate requirements. I work from home where possible and spend some time every week in our Cork office whilst also spending some time monthly travelling abroad for corporate meetings.”

Page 10: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

10

Issue 14 • HPN

Our mission is to be the hospital pharmacists' most trusted partner and we are focused in everything we do in order to meet this goal

Caroline Fitzgerald, Actavis

Profile

Managing medicines safely, effectively and efficiently is central to the delivery of high-quality care that is focused on the patient and gives value for money. Over the past two decades, growing evidence has demonstrated the positive impact of clinical pharmacy services on patient outcomes. Pharmacists’ clinical skills and expertise are an integral part of delivering better services to patients.

The role of the hospital pharmacist has changed dramatically in the past 20 years, evolving from preparation and supply of pharmaceuticals to become a more patient-centred healthcare service. Pharmacists

now play a key role in optimising medicines use and minimising risk associated with medicines.

One of the key challenges Caroline has noticed during her time working with Ireland’s hospital pharmacy departments is that of drug shortages and out of stocks, which pharmacists now face frequently.

Drug shortages are reported not just in Ireland but worldwide. The major cause appears to be economic and overcoming the drug shortages problem is currently a major challenge for the foreseeable future.

Hospital pharmacy within

Ireland is very different to what it was ten years ago,” Caroline continues. “Hospital pharmacists are under so much pressure; between their daily workload, issues with under-staffing, under-resourcing and endeavours to save yet more money, when it simply just isn’t there.

“All too often pharmacy departments spend so much time trying to source supply,” says Caroline. “At Actavis, we pride ourselves on good stock management to ensure we don’t have these issues and I personally spend a considerable amount of time on a monthly basis to ensure we live up to our reputation.

“Drug shortages and out of stocks is an area in which we have a proven track record in supporting our customers. Twice during the last two years we have responded to drug shortages by speeding up a drug launch to ensure supply in the Irish market with our product Doxorubicin.

“Furthermore, we supplied the market with Vinorelbine when there was no alternative available until the licenced product came back to the market.

“Our mission is to be the hospital pharmacists' trusted partner and we are focused in everything that we do in order to meet this goal. This means always having product, having value added products and services where possible, such as larger strengths or clearer packaging.”

And in looking to the future? Caroline has a clear objective for both the company and the industry in which she operates. “I am hopeful that hospital pharmacists across Ireland will, in time, have the benefit of having more time to carry out their job, and with less pressure.

“For the team at Actavis, our goal is simple; to ensure we are the partner of choice to these same pharmacists, having continuity of supply and fair prices.”

The Ballymascanlon House Hotel, Dundalk is the venue for the 7th All Ireland Pharmacy Conference on 26th and 27th January 2015.

The Conference is jointly organised and funded by a number of pharmacy organisations.

Its focus is to share good practice in pharmaceutical care and practice development across the primary and secondary care sectors. Pharmacists, technicians and qualified assistants will be encouraged to exchange ideas for pharmaceutical service development in the North and in

the Republic of Ireland.

On the evening of Monday 26th January 2015 the conference dinner will take place at 8.00pm and provides an opportunity to network with colleagues. The main conference proceedings will start at 9.30am on Tuesday 27th January 2015 with a keynote address by Professor Ian Bates entitled 'Steps to Excellence'. The remainder of the conference will involve panel discussions, parallel oral sessions and poster presentations.

Call for Abstracts

Abstracts are invited that deal

with a broad range of pharmacy practice, including (but not limited to) the following areas:

• Collaborative initiatives

• Leading innovation

• Medicines safety & management

• Service Development

Abstract Format

This year, conference abstracts should be submitted via the Irish Institute of Pharmacy website. Abstracts can only be considered where submitted in the agreed format, please see the Instruction for authors submitting abstracts.

Documents should be submitted in Word format, and we would be obliged if the following naming format could be used:

• Authors Name_First Three Words of Title

Applicants should clearly indicate the corresponding and presenting author(s) and whether they wish their abstract to be considered for poster or oral presentation (10 minutes plus 5 minutes for questions).

The closing date for receipt of abstracts is Friday 26th September 2014 and authors will be notified regarding acceptance by Friday 10th October 2014.

7th All Ireland Pharmacy Conference

Page 11: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

Aiming for a world without Hepatitis C

At Janssen, we have a mission to eradicate Hepatitis C. We are proud to play an integral role in this new era of treatment options for Hepatitis C patients.

In Ireland alone, it is estimated that between 20,000-50,000 people are infected with Hepatitis C.* Major advances in Hepatitis C treatment, together with existing treatment options, means a life without Hepatitis C is becoming more of a reality for many patients.

Janssen has a strong heritage in infectious diseases, with medicines for the treatment of Hepatitis C, HIV and Tuberculosis.

Our commitment in Hepatitis C:

• We will continue to develop treatments to provide the greatest chance of a life without Hepatitis C for our patients

• We will ensure these treatments are accessible to the patients that need them

• We will provide support to both healthcare professionals and patients through education and awareness

For us, there is no time to waste. Treating patients as soon as possible improves outcomes.

Patients are waiting…

Aiming for a world without Hepatitis C

At Janssen, we have a mission to eradicate Hepatitis C. We are proud to play an integral role in this new era of treatment options for Hepatitis C patients.

In Ireland alone, it is estimated that between 20,000-50,000 people are infected with Hepatitis C.* Major advances in Hepatitis C treatment, together with existing treatment options, means a life without Hepatitis C is becoming more of a reality for many patients.

Janssen has a strong heritage in infectious diseases, with medicines for the treatment of Hepatitis C, HIV and Tuberculosis.

Our commitment in Hepatitis C:

• We will continue to develop treatments to provide the greatest chance of a life without Hepatitis C for our patients

• We will ensure these treatments are accessible to the patients that need them

• We will provide support to both healthcare professionals and patients through education and awareness

For us, there is no time to waste. Treating patients as soon as possible improves outcomes.

Patients are waiting…

* Thornton et al. Determination of the burden of hepatitis C virus infection in Ireland. Epidemiol. Infect. 2011: doi: 10.1017/S0950268811001920 Date of preparation: June 2014 | PHIR/HEP/0514/0002a

Page 12: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

12

Issue 14 • HPN

Less DIsRUPTION More freedoM

NOW, Less Is More

INCIVO® ▼ 375mg film-coated tablets PRESCRIBING INFORMATIONACTIVE INGREDIENT(S): Telaprevir. Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATION(S): Only in combination with peginterferon alfa and ribavirin, for treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis): treatment naïve or previously treated with interferon alfa (pegylated or non-pegylated) alone or combination with ribavirin, including relapsers, partial and null responders. DOSAGE & ADMINISTRATION: Adults: Three 375 mg tablets, orally twice daily. Alternatively, two 375 mg tablets orally every 8 hours. Take tablets with food, swallow whole (total daily dose: 6 tablets) for 12 weeks, in combination with peginterferon alfa-2a or -2b and ribavirin. Refer to peginterferon alfa and ribavirin SmPC for specific dosage instructions. Total treatment duration of peginterferon alfa and ribavirin either 24 or 48 weeks refer to INCIVO SmPC All patients: Patients with HCV RNA > 1,000 IU/ml at week 4 or 12 should discontinue all therapy. In case of 48 weeks treatment, discontinue peginterferon alfa and ribavirin if HCV RNA detectable at week 24 or 36. Do not reduce or interrupt INCIVO treatment. Do not restart INCIVO treatment if discontinued for ADRs or insufficient virologic response. When taken twice daily, missed dose can be taken within 6 hours. When taken three times daily, missed dose can be taken within 4 hours. Otherwise skip dose and resume normal dosing schedule. Children: <18 years old - no data available. Elderly: Limited data ≥ 65 years old. Renal impairment: No dose adjustment . No data on moderate/severe renal impairment (CrCl < 50 ml/min) or haemodialysis. Hepatic impairment: Dose modifications not required in mild hepatic impairment (Child-Pugh A, score 5-6). Not recommended in moderate to severe impairment (Child-Pugh B or C, score ≥ 7) or decompensated liver disease. Peginterferon alfa and ribavirin are contraindicated in ChildPugh score ≥ 6. CONTRAINDICATIONS: Hypersensitivity to INCIVO tablets. Combinations with strong inducers of CYP3A and active substances highly dependent on CYP3A for clearance where resulting elevated plasma concentrations associated with serious and/or life-threatening events. Do not use with medicines such as: alfuzosin, amiodarone, bepridil, quinidine, astemizole, terfenadine, cisapride, pimozide, ergot derivatives, lovastatin, simvastatin, atorvastatin, sildenafil or tadalafil (only when used for treatment of pulmonary arterial hypertension), quetiapine, oral midazolam and triazolam, rifampicin, St. John’s wort, carbamazepine, phenytoin, phenobarbital. Concomitant Class Ia or III antiarrhythmics, except intravenous (IV) lidocaine. Refer to SmPCs for peginterferon alfa and ribavirin for their contraindications. SPECIAL WARNINGS & PRECAUTIONS: Rashes: Severe, potentially life-threatening and fatal skin reactions have been reported with INCIVO combination treatment; inform patients. Monitor all rashes for progression. Consider consultation with dermatology specialist for moderate rash (< 50% of body surface area). If rash severe (> 50% of body surface area), discontinue INCIVO immediately; consult dermatology specialist; peginterferon alfa and ribavirin may need to be discontinued. Discontinue INCIVO, peginterferon alfa and ribavirin if generalised bullous eruption, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson syndrome (SJS) /toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis, erythema multiforme suspected/diagnosed; consult dermatology specialist. Fatal cases have been reported in patients who continued to receive INCIVO combination treatment after developing TEN. Do not restart INCIVO if discontinued due to skin reaction. Anaemia: Incidence and severity of anaemia increased with INCIVO combination treatment. Regularly monitor haemoglobin prior to and during treatment. For management of anaemia, see SmPC for ribavirin. If ribavirin permanently discontinued, INCIVO must also be permanently discontinued. If INCIVO discontinued for anaemia, may continue treatment with peginterferon alfa and ribavirin. Do not reduce dose of INCIVO or restart if discontinued. Pregnancy and contraception: see ‘Pregnancy’ below, see also SmPC for ribavirin. Cardiovascular: Significance of modest increase in QTcF interval uncertain. Use with caution with Class Ic antiarrhythmics propafenone and flecainide and other QT-prolonging medicines. Avoid in patients with congenital QT prolongation, or family history of congenital QT prolongation or sudden death. Caution in patients with: history of acquired QT prolongation; persistent heart rate < 50 bpm; history of heart failure with reduced left-ventricular ejection fraction; medicinal products known to prolong QT interval. Clinical and ECG monitoring required. Monitor and correct electrolyte disturbances. Laboratory tests: Monitor HCV RNA levels at least at weeks 4 and 12. Prior to treatment, monitor complete blood count with white blood cell differential counts, electrolytes, serum creatinine, liver function tests, TSH, uric acid and at least at weeks 2, 4, 8 and 12. Combination with peginterferon alfa-2b: No clinical data on treatment-experienced patients and limited data in treatment-naïve patients. Thyroid disease: Risk of increased TSH. Monitor TSH levels before and during treatment. Possible dose adjustment of thyroid replacement therapy. No clinical data on re-treating patients who have failed HCV NS3-4A protease inhibitor-based therapy; in pre/peri/post-liver or other transplants; with HCV/HBV co-infection. Limited data in HIV/HCV co-infection. INCIVO is a strong inhibitor of CYP 3A4, refer to ‘Contraindications’ and ‘Interactions’. Tablets contain sodium. SIDE EFFECTS: Very common (> 1/10): anaemia, nausea, diarrhoea, vomiting, haemorrhoids, proctalgia, pruritus, rash. Common (> 1/100 to < 1/10): oral candidiasis, thrombocytopenia, lymphopenia, hypothyroidism, hyperuricaemia, hypokalaemia, dysgeusia, syncope, anal pruritus, rectal haemorrhage, anal fissure, hyperbilirubinaemia, eczema, swelling face, exfoliative rash, oedema peripheral, product taste abnormal. Serious side effects: DRESS, SJS, TEN, retinopathy, pre-renal azotemia with or without acute renal failure. Refer to INCIVO SmPC for other side effects. Refer to peginterferon alfa and ribavirin SmPC for associated side effects. PREGNANCY: Not recommended. Males and females (of childbearing potential) and their partners must use 2 effective non-hormonal contraceptives during treatment and for 2 months after INCIVO treatment ended. Refer to peginterferon alfa and ribavirin SmPC. LACTATION: Discontinue breast-feeding prior to therapy.

INTERACTIONS: Co-administration with CYP3A and/or P-gp inducers may markedly decrease telaprevir plasma concentrations; avoid use with mild/moderate CYP3A inducers. CYP3A and/or P-gp inhibitors may increase telaprevir plasma concentrations. INCIVO inhibits CYP3A4 and P-gp. Strong CYP3A4 inhibition is time dependant, intensifies over first 2 weeks and after discontinuation can take 1 week to disappear, may increase systemic exposure to substrates of CYP3A or P-gp. Refer to C/Is. Avoid domperidone. Rifabutin, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir, salmeterol, vardenafil not recommended. Inhaled/nasal fluticasone/budesonide not recommended unless benefit/risk positive. Avoid colchicine in renal or hepatic impairment. Caution with: Class Ic antiarrhythmics propafenone and flecainide, trazodone, systemic dexamethasone, abacavir, zidovudine, ethinylestradiol/norethindrone. Caution and clinical monitoring with IV lidocaine, clarithromycin, erythromycin, telithromycin, troleandomycin, ketoconazole, itraconazole, posaconazole, voriconazole, parenteral midazolam, amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil, bosentan, fluvastatin, pitavastatin, pravastatin, rosuvastatin, repaglinide, methadone. Clinical and concentration monitoring with: digoxin, dabigatran, atazanavir/ritonavir, tenofovir, disoproxil fumarate, cyclosporine, tacrolimus, sirolimus. Careful monitoring advised with warfarin (monitor INR), fentanyl and alfentanil; dose adjustment may be necessary. Use telaprevir 1,125 mg every 8 hours with efavirenz. Clinical relevance of changes unknown for alprazolam, escitalopram, zolpidem. LEGAL CATEGORY: Prescription only medicine. PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER- 375mg film-coated tablets; pack of 42 tablets (1 week) EU/1/11/720/002. MARKETING AUTHORISATION HOLDER: JANSSEN-CILAG INTERNATIONAL NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK. © Janssen-Cilag Ltd 2013. Prescribing information last revised: December 2013. PIVER1213.

This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse reactions related to this medicinal product. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’. Alternatively the traditional post-paid ‘yellow card’ option may also continue to be used.

FREEPOSTPharmacovigilance SectionIrish Medicines BoardKevin O’Malley HouseEarlsfort CentreEarlsfort TerraceDublin 2Tel: +353 1 6764971Fax: +353 1 6762517 Website: www.imb.ie e-mail: [email protected] Adverse events should also be reported to Janssen-Cilag Ltd on +44 (0)1494 567447

References: 1. INCIVO® Summary of Product Characteristics, December 2013. Available at: www.medicines.ie 2. Horsmans Y et al. EASL 2013; abstract 826. 3. Sievert W et al. J Hepatol 2013; 58(Suppl 1): S373.

Item prepared: December 2013. PHIR/INC/1113/0009.

# As part of combination therapy with peginterferon alfa and ribavirin for 24 or 48 weeks. † Compared to INCIVO® dosing every 8 hours.

The shortest course of PI therapy available with a siMple Morning and evening dose1#

More adherence3†

1#

FOR JUST

TWICE DAILY DOSING1

INCIVO BID Full Pg Advert Updated.indd 1 20/01/2014 10:17

HPAI Conference 2015

News

Phar-In consortium seek hospital pharmacist input

The HPAI annual education conference will take place from 17th to 19th April 2015 in the Crowne Plaza, Santry, Dublin. Registration will open in early 2015 (Date TBC; Note: earlier

than previous years).

Poster abstracts will be accepted from late 2014 (Date TBC) , so start thinking about possible entries.HPAI

membership is due at the start of January – please renew your membership before registration. You need to be a member of IMPACT to be a full HPAI member.

To contact the education subcommittee re any aspect of the HPAI Conference, please e-mail: [email protected]

New debate starts on access to Eudravigilance information

The European Medicines Agency (EMA) has opened a consultation on its proposed policy for permitting access to information held in its Eudravigilance database, and in so doing has started a fresh debate about suggested ‘censorship’ by the Agency.

The Eudravigilance database is of much interest to many scientists and researchers in the fi eld of medicine as it holds all suspected adverse drug reaction (ADR) reports on medicines in Europe. However, transparency campaigners are concerned

that the EMA’s proposed policy, that any publication that uses Eudravigilance data should be shown to the EMA before publication, amounts to a form of censorship. The EMA may then raise with authors what it believes to be “incorrect analyses, unsupported inferences, misleading statements” or personal data concerns. It will expect authors to address these before publication.

Further to this, an EMA panel will review individual research requests for access

to the database and may refuse permission if they are unconvinced that proposed research has a public health value or is confl ict with EMA public health and legal responsibilities.

Reasoning for the proposals includes the need to avoid scaremongering around the safety of drugs or misrepresentation of data. An EMA spokesperson said, “Publications can have major impact on use of medicines and public health and it is in everyone’s interest that they are

done with a clear understanding of the data.”

However Ben Goldacre, co-founder of the AllTrials campaign, described the proposals as “state censorship of scientifi c discussion and data analysis of public health data” and felt EMA could be in a position of confl icted interest if researchers highlight problems in EMA decisions. Others have highlighted the bureaucracy and cost involved in the proposals.

The consultation closes on 15 September 2014.

A consortium initiative called ‘Phar-In’, fi nancially supported by the European Commission and led in part by the European Industrial Pharmacists Group (EIPG), is currently investigating the needs and scope of pharmacist (and other health

professional) education in the area of biotechnology, including for hospital pharmacists.

As part of this investigation a survey of practising professionals is being conducted, the results of which will be used to formulate the

competencies and programmes of pan-European education programmes in biotechnology, including a distance learning Masters.

https://www.surveymonkey.com/s/pharin4

Replies are requested by 15th September.

EAHP encourages hospital pharmacists to respond to the survey in order to ensure wide input from hospital pharmacy to this project and its outcomes.

Page 13: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

Less DIsRUPTION More freedoM

NOW, Less Is More

INCIVO® ▼ 375mg film-coated tablets PRESCRIBING INFORMATIONACTIVE INGREDIENT(S): Telaprevir. Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATION(S): Only in combination with peginterferon alfa and ribavirin, for treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis): treatment naïve or previously treated with interferon alfa (pegylated or non-pegylated) alone or combination with ribavirin, including relapsers, partial and null responders. DOSAGE & ADMINISTRATION: Adults: Three 375 mg tablets, orally twice daily. Alternatively, two 375 mg tablets orally every 8 hours. Take tablets with food, swallow whole (total daily dose: 6 tablets) for 12 weeks, in combination with peginterferon alfa-2a or -2b and ribavirin. Refer to peginterferon alfa and ribavirin SmPC for specific dosage instructions. Total treatment duration of peginterferon alfa and ribavirin either 24 or 48 weeks refer to INCIVO SmPC All patients: Patients with HCV RNA > 1,000 IU/ml at week 4 or 12 should discontinue all therapy. In case of 48 weeks treatment, discontinue peginterferon alfa and ribavirin if HCV RNA detectable at week 24 or 36. Do not reduce or interrupt INCIVO treatment. Do not restart INCIVO treatment if discontinued for ADRs or insufficient virologic response. When taken twice daily, missed dose can be taken within 6 hours. When taken three times daily, missed dose can be taken within 4 hours. Otherwise skip dose and resume normal dosing schedule. Children: <18 years old - no data available. Elderly: Limited data ≥ 65 years old. Renal impairment: No dose adjustment . No data on moderate/severe renal impairment (CrCl < 50 ml/min) or haemodialysis. Hepatic impairment: Dose modifications not required in mild hepatic impairment (Child-Pugh A, score 5-6). Not recommended in moderate to severe impairment (Child-Pugh B or C, score ≥ 7) or decompensated liver disease. Peginterferon alfa and ribavirin are contraindicated in ChildPugh score ≥ 6. CONTRAINDICATIONS: Hypersensitivity to INCIVO tablets. Combinations with strong inducers of CYP3A and active substances highly dependent on CYP3A for clearance where resulting elevated plasma concentrations associated with serious and/or life-threatening events. Do not use with medicines such as: alfuzosin, amiodarone, bepridil, quinidine, astemizole, terfenadine, cisapride, pimozide, ergot derivatives, lovastatin, simvastatin, atorvastatin, sildenafil or tadalafil (only when used for treatment of pulmonary arterial hypertension), quetiapine, oral midazolam and triazolam, rifampicin, St. John’s wort, carbamazepine, phenytoin, phenobarbital. Concomitant Class Ia or III antiarrhythmics, except intravenous (IV) lidocaine. Refer to SmPCs for peginterferon alfa and ribavirin for their contraindications. SPECIAL WARNINGS & PRECAUTIONS: Rashes: Severe, potentially life-threatening and fatal skin reactions have been reported with INCIVO combination treatment; inform patients. Monitor all rashes for progression. Consider consultation with dermatology specialist for moderate rash (< 50% of body surface area). If rash severe (> 50% of body surface area), discontinue INCIVO immediately; consult dermatology specialist; peginterferon alfa and ribavirin may need to be discontinued. Discontinue INCIVO, peginterferon alfa and ribavirin if generalised bullous eruption, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson syndrome (SJS) /toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis, erythema multiforme suspected/diagnosed; consult dermatology specialist. Fatal cases have been reported in patients who continued to receive INCIVO combination treatment after developing TEN. Do not restart INCIVO if discontinued due to skin reaction. Anaemia: Incidence and severity of anaemia increased with INCIVO combination treatment. Regularly monitor haemoglobin prior to and during treatment. For management of anaemia, see SmPC for ribavirin. If ribavirin permanently discontinued, INCIVO must also be permanently discontinued. If INCIVO discontinued for anaemia, may continue treatment with peginterferon alfa and ribavirin. Do not reduce dose of INCIVO or restart if discontinued. Pregnancy and contraception: see ‘Pregnancy’ below, see also SmPC for ribavirin. Cardiovascular: Significance of modest increase in QTcF interval uncertain. Use with caution with Class Ic antiarrhythmics propafenone and flecainide and other QT-prolonging medicines. Avoid in patients with congenital QT prolongation, or family history of congenital QT prolongation or sudden death. Caution in patients with: history of acquired QT prolongation; persistent heart rate < 50 bpm; history of heart failure with reduced left-ventricular ejection fraction; medicinal products known to prolong QT interval. Clinical and ECG monitoring required. Monitor and correct electrolyte disturbances. Laboratory tests: Monitor HCV RNA levels at least at weeks 4 and 12. Prior to treatment, monitor complete blood count with white blood cell differential counts, electrolytes, serum creatinine, liver function tests, TSH, uric acid and at least at weeks 2, 4, 8 and 12. Combination with peginterferon alfa-2b: No clinical data on treatment-experienced patients and limited data in treatment-naïve patients. Thyroid disease: Risk of increased TSH. Monitor TSH levels before and during treatment. Possible dose adjustment of thyroid replacement therapy. No clinical data on re-treating patients who have failed HCV NS3-4A protease inhibitor-based therapy; in pre/peri/post-liver or other transplants; with HCV/HBV co-infection. Limited data in HIV/HCV co-infection. INCIVO is a strong inhibitor of CYP 3A4, refer to ‘Contraindications’ and ‘Interactions’. Tablets contain sodium. SIDE EFFECTS: Very common (> 1/10): anaemia, nausea, diarrhoea, vomiting, haemorrhoids, proctalgia, pruritus, rash. Common (> 1/100 to < 1/10): oral candidiasis, thrombocytopenia, lymphopenia, hypothyroidism, hyperuricaemia, hypokalaemia, dysgeusia, syncope, anal pruritus, rectal haemorrhage, anal fissure, hyperbilirubinaemia, eczema, swelling face, exfoliative rash, oedema peripheral, product taste abnormal. Serious side effects: DRESS, SJS, TEN, retinopathy, pre-renal azotemia with or without acute renal failure. Refer to INCIVO SmPC for other side effects. Refer to peginterferon alfa and ribavirin SmPC for associated side effects. PREGNANCY: Not recommended. Males and females (of childbearing potential) and their partners must use 2 effective non-hormonal contraceptives during treatment and for 2 months after INCIVO treatment ended. Refer to peginterferon alfa and ribavirin SmPC. LACTATION: Discontinue breast-feeding prior to therapy.

INTERACTIONS: Co-administration with CYP3A and/or P-gp inducers may markedly decrease telaprevir plasma concentrations; avoid use with mild/moderate CYP3A inducers. CYP3A and/or P-gp inhibitors may increase telaprevir plasma concentrations. INCIVO inhibits CYP3A4 and P-gp. Strong CYP3A4 inhibition is time dependant, intensifies over first 2 weeks and after discontinuation can take 1 week to disappear, may increase systemic exposure to substrates of CYP3A or P-gp. Refer to C/Is. Avoid domperidone. Rifabutin, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir, salmeterol, vardenafil not recommended. Inhaled/nasal fluticasone/budesonide not recommended unless benefit/risk positive. Avoid colchicine in renal or hepatic impairment. Caution with: Class Ic antiarrhythmics propafenone and flecainide, trazodone, systemic dexamethasone, abacavir, zidovudine, ethinylestradiol/norethindrone. Caution and clinical monitoring with IV lidocaine, clarithromycin, erythromycin, telithromycin, troleandomycin, ketoconazole, itraconazole, posaconazole, voriconazole, parenteral midazolam, amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil, bosentan, fluvastatin, pitavastatin, pravastatin, rosuvastatin, repaglinide, methadone. Clinical and concentration monitoring with: digoxin, dabigatran, atazanavir/ritonavir, tenofovir, disoproxil fumarate, cyclosporine, tacrolimus, sirolimus. Careful monitoring advised with warfarin (monitor INR), fentanyl and alfentanil; dose adjustment may be necessary. Use telaprevir 1,125 mg every 8 hours with efavirenz. Clinical relevance of changes unknown for alprazolam, escitalopram, zolpidem. LEGAL CATEGORY: Prescription only medicine. PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER- 375mg film-coated tablets; pack of 42 tablets (1 week) EU/1/11/720/002. MARKETING AUTHORISATION HOLDER: JANSSEN-CILAG INTERNATIONAL NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK. © Janssen-Cilag Ltd 2013. Prescribing information last revised: December 2013. PIVER1213.

This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse reactions related to this medicinal product. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’. Alternatively the traditional post-paid ‘yellow card’ option may also continue to be used.

FREEPOSTPharmacovigilance SectionIrish Medicines BoardKevin O’Malley HouseEarlsfort CentreEarlsfort TerraceDublin 2Tel: +353 1 6764971Fax: +353 1 6762517 Website: www.imb.ie e-mail: [email protected] Adverse events should also be reported to Janssen-Cilag Ltd on +44 (0)1494 567447

References: 1. INCIVO® Summary of Product Characteristics, December 2013. Available at: www.medicines.ie 2. Horsmans Y et al. EASL 2013; abstract 826. 3. Sievert W et al. J Hepatol 2013; 58(Suppl 1): S373.

Item prepared: December 2013. PHIR/INC/1113/0009.

# As part of combination therapy with peginterferon alfa and ribavirin for 24 or 48 weeks. † Compared to INCIVO® dosing every 8 hours.

The shortest course of PI therapy available with a siMple Morning and evening dose1#

MORE siMplicity2†plicity2†plicity MORE cOnvEniEncE† More adherence3†

1#

FOR JUST

TWICE DAILY DOSING1

INCIVO BID Full Pg Advert Updated.indd 1 20/01/2014 10:17

Page 14: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

14

Issue 14 • HPN

Underfunding threatening patient care

Concern has been expressed that underfunding of hospital and mental health services is threatening patient care. The Irish Hospital Consultants Association (IHCA) has called for additional resources to be allocated to acute hospitals in the 2015 Budget, ensuring the delivery of safe, quality care to patients.

The IHCA launched its pre-budget submission detailing seven key areas which the Association believes need to be addressed by the new Minister for Health in the upcoming Budget.

They stat that there is a pressing need to increase frontline acute hospital resources in the 2015 Budget otherwise the delivery of care to patients will be adversely affected leading to increased delays and growing numbers of patients on waiting lists. The total health budget provisions for acute hospitals and mental health services have been cut excessively during the past five years of austerity. Recent budgets have not been based on realistic estimates of patient demand. It is essential that increased funding for these frontline services is provided in the 2015 Budget, especially as the country’s economic circumstances continue to improve.

Commenting on its pre-budget submission, Dr Gerard Crotty, President of the IHCA said, “It is a major concern that budgets for acute hospitals have been cut to unrealistic levels such that, in the first five months of 2014, acute hospital expenditure was ¤104.8m over-budget. The vast majority of hospitals are grossly underfunded with some overspending by up to 21%. Funding for acute hospital services has been cut by almost one fifth compared with the resources in place in 2008. If increased resources are not provided in the 2015 Budget it will increase the

risk that a growing number of patients will not be treated within a medically appropriate timeframe.

“Alarmingly, there were 50,689 patients awaiting elective care in May 2014 representing a 5% increase on May 2013. It is clear that the deep acute hospital budget cuts have increased the number of patients awaiting treatment and it is essential that hospital budgets are based on more realistic estimates of projected demand. The Association strongly recommends that increased resources are provided in Budget 2015 in order to utilise the existing bed and theatre capacity to the optimum.”

Key statistics noted in the submission include the following:

• Total health spending in Ireland accounted for 8.9% of GDP which is significantly below the OECD average. Health spending, as a share of GDP is much lower

in Ireland than in other European Countries such as Austria, Denmark, France, the Netherlands, Germany and Switzerland where it accounts for 11% or more of GDP.

• Funding for acute hospitals has been cut by almost a fifth or around ¤873m since 2008, at a time when the number of in-patients and day-case patients has increased from 1.2m to 1.43m.

• In the first five months of 2014, 46 of the 49 acute hospitals were over budget, as reported in the HSE May 2014 Performance Report.

• The number of day-case patients treated in 2013 was 42% or 246,117 cases higher than in 2007. However, in the first 5 months of this year, 12,500 (-3.5%) fewer day-case patients were treated than in the same period last year. This has given rise to an

increase in elective waiting lists.

• The number of people awaiting elective care increased by 5% to 50,689, of which 4,649 were children, in the year to May 2014.

• The number of clinically discharged patients occupying acute hospital beds continues to be around 670, which is equivalent to Beaumont Hospital or University Hospital Galway being closed to new admissions throughout the year.

• Mental Health funding has been cut by almost ¤250m, or 25% since 2009, while simultaneously, Child and Adolescent Mental Health Services have reported an increase in the numbers on waiting lists to 3,029 cases, representing an 11% increase on the same period last year.

Dr Gerard Crotty

Page 15: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

3

Make the First Combination COUNTIn patients with RAS* wild-type mCRC, 1st line Erbitux + FOLFIRI achieved a median overall survival of 33.1 months, a 7.5 month increase over bevacizumab + FOLFIRI 1, **, $

mCRC just got very PERSONALTesting for RAS mutations can identify patients most likely to benefit from 1st line treatment with Erbitux

* RAS = KRAS + NRAS exons 2, 3, 4. ** The data analysis in ongoing. $ The primary endpoint of the trial,

objective response rate based on investigators’ read in patients with KRAS exon 2 wild-type tumours, was not met.

1. Stintzing S et al.: European Cancer Congress 2013 – Abstract: LBA17 & oral presentation.

Merck Serono Oncology | Combination is key™

Merck Serono is a division of Merck

ERB14-0078 April 2014

PRESCRIBING INFORMATION - UK AND IRELANDPlease refer to the Summary of Product Characteristics for further informationErbitux 5 mg/ml solution for infusion cetuximab.

Presentation: Glass vial containing 20 ml or 100 ml of Erbitux solution for infusion at a concentration of 5 mg/ml. Total: 100 mg or 500 mg Erbitux per vial.Indications:Treatment of Epidermal Growth Factor Receptor-expressing, RAS wild-type metastatic colorectal cancer (mCRC) in combination with irinotecan-based chemotherapy; in first-line in combination with FOLFOX (oxaliplatin, 5-FU and folinic acid) or as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. Treatment of squamous cell cancer of the head and neck (SCCHN) in combination with radiation therapy for locally advanced disease or in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.Dosage and administration: Administer Erbitux once a week. Adults: Initial dose: 400 mg/m2 infused over 120 min. Subsequent weekly doses: 250 mg/m2 infused over 60 min. Older people: no dose adjustment required, but experience limited in patients older than 75 years. Children: safety and efficacy have not been established. Administration must be supervised by a physician experienced in antineoplastic medicinal products. Administer intravenously with infusion pump, gravity drip or syringe pump using a separate infusion line. Do not exceed an infusion rate of 5 mg/min for the first dose and 10 mg/min for subsequent doses. Premedicate first infusion at least one hour before with an antihistamine and a corticosteroid. Premedication recommended for all subsequent infusions. Flush line with sterile 0.9% NaCl at end of infusion. Closely monitor patient throughout infusion and for at least 1 hour afterwards. Resuscitation equipment must be available. mCRC: Evidence of wild-type RAS status is required before initiating treatment. Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS and NRAS (exons 2, 3 and 4). Refer to product information for concomitantly used chemotherapeutic agents for dosage. Administer Erbitux first and do not administer concomitantly used chemotherapeutic agents earlier than 1 hour after end of Erbitux infusion. Continue treatment until disease progression. Locally advanced SCCHN: start Erbitux one week before radiation therapy and continue treatment until the end of the radiation therapy period. Recurrent/metastatic SCCHN: use in combination with platinum-based chemotherapy followed by Erbitux as maintenance therapy until disease progression. Do not administer chemotherapy earlier than 1 hour after the end of Erbitux infusion.Contraindications: Severe (grade 3 or 4) hypersensitivity to Erbitux. In combination with oxaliplatin-containing chemotherapy in patients with mutant RAS mCRC or for whom RAS mCRC status is unknown. Consider contraindications to concomitantly used chemotherapeutic agents or radiation therapy.Precautions: Discontinue infusion immediately and permanently in the event of severe infusion-related reactions (symptoms may include: bronchospasm; urticaria; increase or decrease in blood pressure; loss of consciousness or shock; rarely: angina pectoris; myocardial infarction or cardiac arrest) – emergency treatment may be required. Some of these reactions may be anaphylactic or anaphylactoid in nature or represent a cytokine release syndrome (CRS). Anaphylatic reactions may occur as early as within a few minutes of the first infusion. The risk is increased in patients with a history of allergy to red meat, tick bites of positive results of tests for IgE antibodies against cetuximab. A CRS typically occurs within one hour after infusion and is less commonly associated with bronchospasm and urticaria. It is normally most severe in relation to the first infusion. Monitor all vital signs closely for at least two hours for the first dose. If an infusion-related reaction occurs during the first 15 minutes, stop the infusion. Perform careful benefit/risk assessment including whether patient may have pre-formed IgE antibodies, before giving a subsequent infusion. If an infusion-related reaction develops later during the infusion or at a subsequent infusion, further management depends on its severity – see SPC. Warn patients of possible delayed-onset severe infusion-related reactions. Decrease infusion rate if mild or moderate infusion-related reaction occurs (symptoms may include: fever; chills; dizziness; dyspnoea) and use lower rate in all subsequent infusions. Closely monitor patients, particularly during the first administration and those with reduced performance status and pre-existing cardiopulmonary disease. Cases of interstitial lung disease have been reported, with most patients being from the Japanese population. Discontinue Erbitux if this is diagnosed.

Skin reactions are very common. Consider prophylaxis with oral tetracyclines (6-8 weeks) and topical 1% hydrocortisone cream with moisturiser. Skin reactions may become severe, especially in combination with chemotherapy. The risk of secondary infections is increased and cases of staphylococcal scalded skin syndrome, necrotising fasciitis and sepsis, in some cases with fatal outcome, have been reported. Interrupt treatment if patient experiences an intolerable or severe skin reaction (≥ grade 3 CTCAE). Only resume if reaction resolves to grade 2. With second or third instances of severe skin reactions, resume at lower dose (200 mg/m2, then 150 mg/m2). A fourth occurrence of severe skin reaction, or failure to resolve to grade 2 during interruption, necessitates permanent discontinuation of Erbitux. Determine serum electrolyte levels (e.g. magnesium, potassium, calcium) prior to, and periodically during Erbitux treatment and replete as appropriate. In combination with platinum-based chemotherapy, severe leukopenia or neutropenia may occur, leading to infectious complications such as febrile neutropenia, pneumonia and sepsis. Careful monitoring is recommended in such patients, particularly in those who experience skin lesions, mucositis or diarrhoea. An increased frequency of severe and sometimes fatal cardiovascular events and treatment emergent deaths has been observed in non-small cell lung cancer, SCCHN and colorectal carcinoma patients. In some studies (non-small cell lung cancer) association of these with age ≥ 65 years has been observed. When prescribing, take into account the cardiovascular and performance status of the patient and concomitant administration of cardiotoxic compounds such as fluoropyrimidines.Do not use Erbitux in colorectal cancer patients whose tumours have RAS mutations or for whom RAS tumour status is unknown. Promptly refer patients with symptoms of keratitis to an ophthalmology specialist. If ulcerative keratitis is confirmed, interrupt or discontinue Erbitux. Consider the benefits/risks of continuing treatment if keratitis is diagnosed. Use Erbitux with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye. Contact lens use is a risk factor for keratitis and ulceration.Only use in pregnancy if potential benefit justifies potential risk to foetus. Breast feeding is not recommended during Erbitux treatment or for up to 2 months after last infusion.Side effects: Very common: skin reactions (acne-like rash; pruritus; dry skin; desquamation; hypertrichosis; nail disorders); hypomagnesaemia; increase in liver enzyme levels; mild or moderate infusion-related reactions; mucositis, in some cases severe,which may lead to epistaxis. Common: headache; diarrhoea; nausea; vomiting; severe infusion-related reactions, in some cases fatal; conjunctivitis; fatigue; dehydration normally secondary to diarrhoea or mucositis; hypocalcaemia; anorexia which may lead to weight decrease. Uncommon: blepharitis; keratitis; pulmonary embolism; DVT, interstitial lung disease. Very rare: Stevens-Johnson syndrome/toxic epidermal necrolysis. Unknown frequency: superinfection of skin lesions; aseptic meningitis. Refer to product information of concomitantly used chemotherapeutic agents for side effects. In combination with fluoropyrimidines, the frequency of cardiac ischaemia and hand-foot syndrome was increased compared to that with fluoropyrimidines. In combination with capecitabine and oxaliplatin (XELOX) the frequency of severe diarrhoea may be increased.In combination with platinum-based chemotherapy, the frequency of severe leukopenia or neutropenia may be increased, leading to a higher rate of infectious complications such as febrile neutropenia, pneumonia and sepsis compared with platinum-based chemotherapy alone.Prescribers should consult the summary of product characteristics in relation to other side-effects.Legal category: POM. Basic NHS price:One vial of 100 mg/20 ml: £178.10. One vial of 500 mg/100 ml: £890.50. Marketing Authorisation Holder and Numbers:Merck KGaA, Darmstadt, Germany; EU/1/04/281/003, 005.For further information, including price queries, contact:UK: Merck Serono Ltd, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK Tel: 020 8818 7373.Republic of Ireland: Merck Serono, 4045 Kingswood Road, Citywest Business Campus, Dublin 24. Tel: 01 4687590.Date of preparation: January 2014. Job Bag No: ERB14-0002

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

In the Republic of Ireland information can be found at www.imb.ie. Adverse events should also be reported to Merck Serono Limited - Tel: +44(0)20 8818 7373 or email: [email protected]

Erbitux Advert April 2014 v2.indd 1 01/05/2014 08:05

Page 16: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

DEAR PHARMACIST,

Tipol Suppositories Paracetamol

are the only complete range of

Paracetamol Suppositories with

Dosing Tables by both Age

and Bodyweight for Newborns

(3kg and over), Infants, Children

and Adults. The Dosing Tables

are printed on the cartons and

patient information leafl ets

and allow for more accurate

dosing.

TIPOL SUPPOSITORIES

PARACETAMOL FOR MORE ACCURATE DOSING BY AGE

AND BODYWEIGHT.

Abbreviated Prescribing Information (see SPC for full details)Name of the Medicinal Products: Tefi n 75 mg Suppositories and Tefi n 150mg Suppositories. Tefi n Suppositories contain ibuprofen. Therapeutic Indications: For the symptomatic treatment of mild to moderate pain and fever. Posology and method of administration: See dosing tables. Tefi n suppositories should be put deep into the rectum after a bowel movement. They may be warmed up in the hands or dipped for a short time into warm water to improve their sliding properties. Contraindications Hypersensitivity to ibuprofen, aspirin or other NSAIDs or to any of the excipients, disorders of blood count, active gastric or duodenal ulcer or haemorrhage, cerebrovascular or other active bleeding, severe impairment of liver or kidney function, severe cardiac failure, patients in the last three months of pregnancy. Special warnings and precautions for use: Caution in the following groups: patients with gastrointestinal conditions, elderly, patients with cardiovascular hypertension, heart failure, porphyria, impaired renal function, hepatic dysfunction, hay fever, asthma or allergies, patients at risk for thrombotic events and patients with blood disorders. Pregnancy and breastfeeding: Caution in pregnancy and in breastfeeding. Interaction with other medicinal products and other forms of interaction: Caution in combination with the following active substances: Other NSAIDs including salicylate, digoxin, phenytoin, lithium, diuretics, ACE inhibitors, adrenergic beta-antagonists and angiotensin-II inhibitors, glucocorticoids, platelet aggregation inhibitors like acetylsalicylic acid and selective serotonin uptake inhibitors, methotrexate, ciclosporin, anticoagulant agents, sulphonylureas, tacrolimus, zidovudine, probenicid and sulphinpyrazone. Undesirable effects: Cardiac disorders, blood and lymphatic system disorders, nervous system disorders, eye disorders, ear and labyrinth disorders, gastrointestinal disorders, local irritation and bleeding, renal and urinary disorders, skin and subcutaneous tissue disorders, aggravation of infections and infestations, vascular disorders, hypersensitivity reactions, hepatobiliary disorders and psychiatric disorders. Overdose: Overdosing may lead to CNS-related disorders, gastrointestinal bleeding and dysfunction of liver and kidney. There is no specifi c antidote. Shelf life: 5 years. Special precautions for storage: Do not store above 25°C. Marketing authorisation holder: Carysfort Healthcare Limited, 93 Carysfort Park, Blackrock Co. Dublin, Ireland. Marketing authorisation number: PA 1684/1/1-2. Date of preparation: June 2014

Complete Dosing Tables available on request for your Dispensary.

Tipol Suppositories Paracetamol 75mg POM , 125mg P , 250mg P , 500mg P and Max 1000mg P all with 5 year shelf life.

Abbreviated Prescribing Information (see SPC for full details)Name of the Medicinal Products: Tipol 75 mg Suppositories, Tipol 125mg Suppositories, Tipol 250 mg Suppositories, Tipol 500mg Suppositories, Tipol Max 1000mg Suppositories. Tipol Suppositories contain paracetamol. Tipol 500mg Suppositories and Tipol Max 1000mg Suppositories contain Soya Lecithin. Therapeutic Indications: Symptomatic treatment of mild to moderate pain and/ or fever. Posology and method of administration: See dosing tables. Tipol suppositories should be put deeply into the rectum after bowel movement. They may be warmed up in the hands or dipped for a short time into warm water to improve their sliding properties. Elderly patients, infants, patients with chronic nutritional disorders, patients who are underweight, patients with liver or renal disease, patients taking excess alcohol or patients using medicines which are enzyme inducers are more likely to develop liver toxicity from paracetamol use. Children and adolescents: See dosing tables. Contraindications: Known hypersensitivity to paracetamol or to any other excipients. Tipol 500mg Suppositories and Tipol Max 1000mg Suppositories contain soya which may cause allergic reactions. Severe hepatocellular insuffi ciency (Child-Pugh ≥ 9). Special warnings and precautions for use: In the following disorders, use paracetamol with caution: hepatocellular insuffi ciency (Child-Pugh < 9), chronic nutritional disorder, underweight, chronic alcohol abuse, severe renal insuffi ciency (creatinine clearance below 10 ml/min), Gilbert’s syndrome (Meulengracht’s disease). High fever, evidence of secondary infection and symptoms persisting for more than three days should receive medical attention. Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage. Interaction with other medicinal produc ts and other forms of interaction Paracetamol should be used with caution with the following medications: warfarin and other coumarins, probenecid, liver inducers such as phenobarbital, phenytoin, carbamazepine and rifampicin, AZT (zidovudine), chloramphenicol, cholestyramine, chronic or acute alcohol intake, metoclopramide, domperidone and oral contraceptives. Undesirable effects: Increase in liver transaminases, changes of blood count such as thrombocytopenia and agranulocytosis, analgesic-induced bronchospasm, hypersensitivity reactions like erythema including urticaria and anaphylactic shock. Soybean lecithin may induce allergic reactions (Tipol 500mg Suppositories and Tipol Max 1000mg Suppositories contain soybean lecithin). Overdose: Elderly people, infants, persons with liver disease, chronic alcohol abuse and chronic nutritional disorders, people who are underweight and those concomitantly receiving other active substances which cause enzyme induction, are more at risk of intoxication. Shelf life: 5 years. Special precautions for storage: Do not store above 25°C. Marketing authorisation holder: Carysfort Healthcare Limited, 93 Carysfort Park, Blackrock Co. Dublin, Ireland. Marketing authorisation number: PA 1684/2/1-5. Date of preparation: June 2014.

DEAR PHARMACIST,Tefi n Suppositories Ibuprofen 75mg (8 months - 3 years / 7.5-15kg), 150mg (3 years - 9 years / 15-29kg) are the only Ibuprofen Suppositories on the GMS and Community Drug Schemes. The Dosing Tables by Age and Bodyweight are printed on the cartons and patient information leafl ets and allow for more accurate dosing.

MA Holder: UnitedDrugConsumer

Blackhall01 8405071

GMS Code 68183 P

GMS Code 68472 P

GMS Code 61734 P

GMS Code 62983 PMA Holder:

UnitedDrugConsumer

Blackhall01 8405071

Date: June 2014

Date: June 2014

Caryfort DPS.indd 3 25/06/2014 14:20:27

AquilantPharmaceuticals

Page 17: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

DEAR PHARMACIST,

Tipol Suppositories Paracetamol

are the only complete range of

Paracetamol Suppositories with

Dosing Tables by both Age

and Bodyweight for Newborns

(3kg and over), Infants, Children

and Adults. The Dosing Tables

are printed on the cartons and

patient information leafl ets

and allow for more accurate

dosing.

TIPOL SUPPOSITORIES

PARACETAMOL FOR MORE ACCURATE DOSING BY AGE

AND BODYWEIGHT.

Abbreviated Prescribing Information (see SPC for full details)Name of the Medicinal Products: Tefi n 75 mg Suppositories and Tefi n 150mg Suppositories. Tefi n Suppositories contain ibuprofen. Therapeutic Indications: For the symptomatic treatment of mild to moderate pain and fever. Posology and method of administration: See dosing tables. Tefi n suppositories should be put deep into the rectum after a bowel movement. They may be warmed up in the hands or dipped for a short time into warm water to improve their sliding properties. Contraindications Hypersensitivity to ibuprofen, aspirin or other NSAIDs or to any of the excipients, disorders of blood count, active gastric or duodenal ulcer or haemorrhage, cerebrovascular or other active bleeding, severe impairment of liver or kidney function, severe cardiac failure, patients in the last three months of pregnancy. Special warnings and precautions for use: Caution in the following groups: patients with gastrointestinal conditions, elderly, patients with cardiovascular hypertension, heart failure, porphyria, impaired renal function, hepatic dysfunction, hay fever, asthma or allergies, patients at risk for thrombotic events and patients with blood disorders. Pregnancy and breastfeeding: Caution in pregnancy and in breastfeeding. Interaction with other medicinal products and other forms of interaction: Caution in combination with the following active substances: Other NSAIDs including salicylate, digoxin, phenytoin, lithium, diuretics, ACE inhibitors, adrenergic beta-antagonists and angiotensin-II inhibitors, glucocorticoids, platelet aggregation inhibitors like acetylsalicylic acid and selective serotonin uptake inhibitors, methotrexate, ciclosporin, anticoagulant agents, sulphonylureas, tacrolimus, zidovudine, probenicid and sulphinpyrazone. Undesirable effects: Cardiac disorders, blood and lymphatic system disorders, nervous system disorders, eye disorders, ear and labyrinth disorders, gastrointestinal disorders, local irritation and bleeding, renal and urinary disorders, skin and subcutaneous tissue disorders, aggravation of infections and infestations, vascular disorders, hypersensitivity reactions, hepatobiliary disorders and psychiatric disorders. Overdose: Overdosing may lead to CNS-related disorders, gastrointestinal bleeding and dysfunction of liver and kidney. There is no specifi c antidote. Shelf life: 5 years. Special precautions for storage: Do not store above 25°C. Marketing authorisation holder: Carysfort Healthcare Limited, 93 Carysfort Park, Blackrock Co. Dublin, Ireland. Marketing authorisation number: PA 1684/1/1-2. Date of preparation: June 2014

Complete Dosing Tables available on request for your Dispensary.

Tipol Suppositories Paracetamol 75mg POM , 125mg P , 250mg P , 500mg P and Max 1000mg P all with 5 year shelf life.

Abbreviated Prescribing Information (see SPC for full details)Name of the Medicinal Products: Tipol 75 mg Suppositories, Tipol 125mg Suppositories, Tipol 250 mg Suppositories, Tipol 500mg Suppositories, Tipol Max 1000mg Suppositories. Tipol Suppositories contain paracetamol. Tipol 500mg Suppositories and Tipol Max 1000mg Suppositories contain Soya Lecithin. Therapeutic Indications: Symptomatic treatment of mild to moderate pain and/ or fever. Posology and method of administration: See dosing tables. Tipol suppositories should be put deeply into the rectum after bowel movement. They may be warmed up in the hands or dipped for a short time into warm water to improve their sliding properties. Elderly patients, infants, patients with chronic nutritional disorders, patients who are underweight, patients with liver or renal disease, patients taking excess alcohol or patients using medicines which are enzyme inducers are more likely to develop liver toxicity from paracetamol use. Children and adolescents: See dosing tables. Contraindications: Known hypersensitivity to paracetamol or to any other excipients. Tipol 500mg Suppositories and Tipol Max 1000mg Suppositories contain soya which may cause allergic reactions. Severe hepatocellular insuffi ciency (Child-Pugh ≥ 9). Special warnings and precautions for use: In the following disorders, use paracetamol with caution: hepatocellular insuffi ciency (Child-Pugh < 9), chronic nutritional disorder, underweight, chronic alcohol abuse, severe renal insuffi ciency (creatinine clearance below 10 ml/min), Gilbert’s syndrome (Meulengracht’s disease). High fever, evidence of secondary infection and symptoms persisting for more than three days should receive medical attention. Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage. Interaction with other medicinal produc ts and other forms of interaction Paracetamol should be used with caution with the following medications: warfarin and other coumarins, probenecid, liver inducers such as phenobarbital, phenytoin, carbamazepine and rifampicin, AZT (zidovudine), chloramphenicol, cholestyramine, chronic or acute alcohol intake, metoclopramide, domperidone and oral contraceptives. Undesirable effects: Increase in liver transaminases, changes of blood count such as thrombocytopenia and agranulocytosis, analgesic-induced bronchospasm, hypersensitivity reactions like erythema including urticaria and anaphylactic shock. Soybean lecithin may induce allergic reactions (Tipol 500mg Suppositories and Tipol Max 1000mg Suppositories contain soybean lecithin). Overdose: Elderly people, infants, persons with liver disease, chronic alcohol abuse and chronic nutritional disorders, people who are underweight and those concomitantly receiving other active substances which cause enzyme induction, are more at risk of intoxication. Shelf life: 5 years. Special precautions for storage: Do not store above 25°C. Marketing authorisation holder: Carysfort Healthcare Limited, 93 Carysfort Park, Blackrock Co. Dublin, Ireland. Marketing authorisation number: PA 1684/2/1-5. Date of preparation: June 2014.

DEAR PHARMACIST,Tefi n Suppositories Ibuprofen 75mg (8 months - 3 years / 7.5-15kg), 150mg (3 years - 9 years / 15-29kg) are the only Ibuprofen Suppositories on the GMS and Community Drug Schemes. The Dosing Tables by Age and Bodyweight are printed on the cartons and patient information leafl ets and allow for more accurate dosing.

MA Holder: UnitedDrugConsumer

Blackhall01 8405071

GMS Code 68183 P

GMS Code 68472 P

GMS Code 61734 P

GMS Code 62983 PMA Holder:

UnitedDrugConsumer

Blackhall01 8405071

Date: June 2014

Date: June 2014

Caryfort DPS.indd 3 25/06/2014 14:20:27

News

EAHP is inviting its Member Associations and individual hospital pharmacists and institutions to participate in potential submissions to the European Union (EU) for financial support for cross-border hospital pharmacy projects, particularly in the areas of medicines reconciliation, antimicrobial stewardship and paediatric interventions such as Therapeutic Drug Monitoring.

Three opportunities have been identified, and are described briefly below:

1. Health Programme Call 4: Adherence, frailty, integrated care and multi chronic conditions

EAHP is considering a bid for support in developing a cross-

border SOP for medication reconciliation in hospitals. This would build on the work of projects such as www.high5s.org and www.ismp-canada.org. The deadline for proposals to be submitted is 25th September 2014.

2. Health Programme Call 7: Healthcare associated infection in long-term care

EAHP is considering a bid for support in developing a cross-border SOP for antimicrobial stewardship in hospitals. This would build on the work of inititiaves such as the Antibiotic Resistance Prevention And Control (ARPAC) Project, with an emphasis on pharmacy-driven interventions. The deadline for proposals to be submitted is 25th September 2014.

3. Horizon 2020: Establishing effectiveness of health care interventions in the paediatric population

EAHP is considering a bid for support for projects that help

increase the effectiveness of health care interventions through Therapeutic Drug Monitoring (TDM) for high risk medications in the paediatric population. The deadline for proposals to be submitted is 14th October 2014.

Hospital pharmacists sought for EU projects

AquilantPharmaceuticals

Page 18: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

18

Issue 14 • HPN

Feature

Ireland cancer rates set to double by 2040 - Here's whyThe latest projections from the National Cancer Registry show that the number of new cancer cases being diagnosed each year in Ireland is expected to double by 2040.

A recent report authored by Alison Pearse, Researcher and ICE Postdoctoral Research Fellow at the National Cancer Registry Ireland, and Dr Harry Comber, recently retired Director of the Registry looked a bit more deeply at how the figures are calculated.

Three elements determine the projection of trends in cancer incidence: population change, cancer trends, and changes in exposure to risk factors.

POPUL�ATION CHANGE

An ageing population is the main factor driving an increase in cancer numbers. This is because the rate of ageing is much bigger than any changes in the rate of cancer.

The NCR projections use models of population change provided by the Central Statistics Office. These models make a number of assumptions about mortality, migration and fertility. Only the first of these is likely to have any major impact on future cancer numbers, as the others affect the younger population, where cancer cases are low. With the ageing of the population, and improved life expectancy, the median age of cancer patients at diagnosis will increase.

The projections indicate that almost 50% of people with invasive cancers will be aged over 70. As a result there will not only be more cancer patients, but they will be older on average.

CANCER TRENDS

The projections are also based on the assumption that current trends in cancer incidence will continue. For each cancer, we examined the incidence rates from 1994 to 2010 to find the current trend.

Non-melanoma skin cancer rates, for example, have been increasing since 2001. The projections show that this increase will continue in the future, and skin cancers will in fact be the most rapidly increasing cancers in the future. The primary risk factor for non-melanoma cancer of the skin is UV exposure, and evidence suggests that this steady increase is mainly due to recreational UV exposure, such as sunbeds.

But it doesn’t always follow that what is happening now will predict what will happen in the future. The rapid increase in prostate cancer cases in the 1990s and early 2000s, for example, was due to the widespread use of Prostate Specific Antigen (PSA) testing. This is a blood test which measures the level of the PSA protein in the bloodstream, and was introduced as a way to help with the diagnosis of prostate cancer. But this trend began to level off around 2004, when PSA testing was found to be less useful that previously thought, because many people with raised PSA levels do not have prostate cancer and some prostate cancers identified through testing are very slow growing and may not require treatment. Because of the large variations in trend for prostate cancer in the past two decades, the projections aren’t regarded as very reliable.

Another example of something that can affect cancer rates and therefore projected trends is screening. The introduction of screening for breast and cervical cancers led to a considerable increase in the number of cases that were diagnosed. Screening for colorectal cancer recently begun in Ireland and novel methods of screening for other cancers will probably appear in the next decade. While some screening may eventually bring about a reduction in health service costs, screening will initially increase case numbers and costs above what might be expected from natural increase.

L�IFESTY�L�E FACTORS

Four risk factors have been shown to determine the majority of the attributable risk of cancer (excluding non-melanoma skin cancer) in the UK: tobacco, diet (including food energy balance, obesity and physical activity), alcohol and reproductive factors. Three of these can be considered lifestyle-related. There are no equivalent calculations for Ireland, but given the similarity in lifestyle between the populations of Ireland and the UK, it is reasonable to assume that the distribution and prevalence of attributable risks due to these major factors are similar.

The link between exposure to these risk factors and cancer incidence can perhaps be most clearly seen with tobacco smoking. Smoking has been implicated as a causal factor in many cancers, and

is the cause of the overwhelming majority of lung cancer cases. Smoking prevalence in Ireland is high, although decreasing slowly, and more rapidly in males than females. Overall there has been a fall of about 9% in smoking prevalence for males and of about 8% for females since 1986.

The estimated increase in tobacco-related cancers in Ireland and between 2010 and 2040 is 110-115% in females and 83-91% in males. However, given the gradual decrease in female smoking rates in the 1990s, there is likely to be an eventual levelling-off in the number of female lung cancer cases. Men have much higher smoking rates overall, so although it is falling for both genders, it will still take longer for male rates to catch up.

What all this shows is that projections of cancer cases based on existing trends are limited in their ability to predict the future cancer burden. However, the overall conclusions from these projections are clear. Although we cannot modify the effects of demographic change, the majority of attributable cancer risk is due to a small number of well understood and potentially modifiable behaviours: UV exposure, smoking, alcohol consumption, diet and exercise.

THE PREVAL�ENCE OF PROSTATE CANCER

In the Ireland, prostate cancer incidence increased dramatically during 1994-2000, with the greatest rate of growth in men under 70. Incidence continued to rise in Ireland during 1994 to 2004 at 9% per annum. In Northern

Ireland (NI), by contrast, incidence only began to rise in the period from 2001 to 2003. Mortality from prostate cancer did not change in either region over this time.

Prostate cancer rates in Ireland are the highest in Europe and amongst the highest in the world In 2010, 3,125 men were diagnosed with prostate cancer in Ireland Irish men have a 1 in 8 chance of developing prostate cancer (to put this in context, Irish women have a 1 in 10 chance of developing breast cancer)

After skin cancer, prostate cancer is the leading cause of cancer in men. Prostate cancer is often a slow growing cancer, particularly in older men, and symptoms may not occur for many years. Prostate cancer is 90% curable if it is treated in its earliest stages.

There have been, and are currently, a number of research projects and trials conducted looking at the incidence of this particular cancer, its impact and PSA testing.

Prostate specific antigen (PSA) testing has been linked to increased incidence of prostate cancer in other countries. The use of PSA testing for prostate cancer detection is controversial. In the RoI there are no guidelines on PSA use. In NI, the UK National Screening Committee has recommended that PSA testing should not be used for prostate cancer screening, although an informed choice Prostate Cancer Risk Management Programme is in place.

The aim of a more recent project was to investigate reasons for the differences in prostate cancer incidence rates in Northern Ireland and the Republic of Ireland. In particular, the authors explored whether there were (1) different frequencies and patterns in use of PSA tests and (2) different practices regarding referral for biopsy in the two areas.

The project involved collection of data on PSA tests and prostatic biopsies conducted in Ireland during 1995 and 2005.

The results of the analyses showed that PSA testing is widespread in both jurisdictions, but especially in

Dr. Harry Comber

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19

HPN • Issue 14

Ireland where around half of men aged 50 and older were estimated to have had a PSA test in 2005 alone. The more extensive use of PSA testing in the RoI compared to NI is likely to be, in part, a result of different attitudes of GPs and clinicians towards PSA testing. Rates of prostatic biopsies also rose in both jurisdictions. This trend more closely coincided with recent trends in prostate cancer incidence in both the RoI and NI. Prostate cancer mortality rates began to decline before PSA testing became widespread; advances in treatment are the most likely explanation for these trends.

CANCER IN IREL�AND 1994-2011

Earlier last month, the National Cancer Registry published its most up-to-date report on cancer statistics within Ireland.

The report shows that more than 19,000 invasive cancer cases were

diagnosed on average each year in the period 2009-2011, with a lifetime risk of 1 in 3 for men and 1 in 4 for women. There were almost 9,000 deaths from cancer in 2011, making it the second most common cause of death after cardiovascular disease.

CANCER IN Y�OUNG PEOPL�E

12% of all cancers diagnosed in 2009-2011 were in people under 40. The commonest cancer in those aged under 15 was leukaemia. In men, testis was the commonest site of cancer in those aged 15-24 while non-melanoma cancer of skin was the most common cancer in those aged 25-39. In situ cancer of the cervix was the commonest cancer in women in both the 15 to 24 and 25 to 39 year age groups. The high incidence of both in situ and invasive cervical cancer in young women is due to opportunistic and, more recently, organised cervical cancer screening activity.

All-cancer mortality rates in those aged 0-39 have declined substantially since 1994, with an annual percentage fall of 2% in both men and women aged 25-39 years.

TRENDS IN IREL�AND AND UK

Trends in lung cancer incidence in Ireland were broadly similar to those in the UK. Male rates are declining, although less rapidly in Ireland, while female rates are increasing, but more rapidly in Ireland than in the UK. Melanoma incidence is increasing rapidly in both Ireland and the UK; both countries had higher incidence rates than the EU average in 2012. The incidence of female breast cancer is increasing in both Ireland and the UK; the rate of increase in Ireland is almost twice that in the UK, presumably due to the recent introduction of breast screening in Ireland. Invasive cervical cancer incidence is increasing in Ireland but is decreasing in the UK, where screening is well-established.

Prostate cancer incidence rates in Ireland continue to increase more rapidly than those in the UK and, in 2012, were over 1.5 times higher than in the UK. This is probably due to the widespread use of opportunistic PSA testing in Ireland from the mid 1990s onwards.

CANCER SURVIVAL�

Survival from all the common cancers improved in Ireland between the periods 1995-1999 and 2000-2007, but there was little change in the ranking of Ireland relative to other European countries. The exception to this was non-Hodgkin’s lymphoma, survival from which ranked 20th in Europe in 1995-1999 but 9th in 2000-2007. Survival from cancers of the ovary and kidney remains among the worst in Europe. For most cancers, 5 year survival rates in Ireland were fairly similar to those observed in the UK.

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Page 20: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

20

Issue 14 • HPN

Feature

Alcohol-Related Brain Injury – Irelands Forgotten Condition

The physical and behavioural consequences of heavy drinking and intoxication are, unfortunately, all too familiar to professionals working in Irish hospitals today.

The impact of our societal drinking practices will be more than apparent to those treating the one-in-four emergency-department patients whose admissions can be directly attributed to alcohol consumption 1.With 88 deaths a month in Ireland now being directly related to the use of alcohol2, the physical-health and economic burden of this universal problem cannot be refuted.

Among the growing numbers of patients presenting with alcohol-related injuries is a sub-group of people with a condition which remains largely undiagnosed and untreated. Up to 80% of people with a condition known as Alcohol- Related Brain Injury (ARBI) are diagnostically missed by attending medical practitioners and allied professionals.

The impact of ARBI on Irish society is substantial. For example, ARBI now accounts for 10% of the dementia population3 and for 12.5% of dementias in people under 654. It is thought that ARBI accounts for 21% of the homeless of population5 and up to 42% of the prison population6. There is a significant burden on our acute services with individuals with alcohol related cognitive impairment being significantly over represented in populations of in-patients who are hard-to

discharge. It is estimated that this equates, on average, to sixteen lost beds days per person affected7.

Worldwide autopsy studies have shown that approximately 0.4-2.8% of the general population will be affected8. Thus, a conservative estimate for Irish prevalence is approximately 18,320 affected individuals but it is hypothesised that numbers are likely to be closer to 128,2409.

“The low identification rates associated with this disorder serve to create a vicious cycle of repeated (and increasingly extended) hospital admissions, progressive deterioration, reducing prognosis and rising morbidity” says Dr. Helen McMonagle, the Alcohol Related Brain Injures Rehabilitation Coordinator with the Alcohol Forum in Donegal. “Despite having one of the highest rates of alcohol-consumption in the world, Irish professionals remain largely uninformed of this serious condition” she continues.

In order to increase awareness of Alcohol Related Brain Injury and provide a clearer understanding of good practices in relation to the identification and treatment of ARBI, the HPN has collaborated with Dr. McMonagle to bring together some of the key issues associated with this disorder.

DEFINING AL�COHOL� REL�ATED BRAIN INJURIES

Alcohol-Related Brain Injury (ARBD) is an umbrella term that describes a spectrum of neurological, neuropsychiatric and neuropsychological conditions that are associated with long-term alcohol misuse and related vitamin deficiencies. Brain Injury of this

kind can be broken down broadly into acute forms and chronic forms.

Acute forms of ARBI are severe and sudden in onset and include:

• alcohol-related withdrawal syndromes

• alcohol related black-outs

• Wernickes Encephalopathy

Chronic forms of ARBI are, by contrast, usually slow-developing but long-lasting. These include:

• Korsakoff Amnesic Syndrome

• Frontal Lobe Dysfunction

• Diminished Generalised Cognitive Functioning

The most commonly referenced ARBI is the acute form, Wernicke’s Encephalopathy. It consists of ophthalmoplegia (eye movement disorder) ataxia (wide-based gait) and confusion though only 16% of cases will feature all of these ‘classical’ signs. The syndrome is a medical emergency, and untreated, it leads to death in up to 20% of cases, or to Korsakoff-Amnesic Syndrome in 85% of survivors.

Korsakoffs Amnesic Syndrome is marked by a profound difficulty learning new information. As time passes, this means that there is an increasing period of time for which the person has no memory. To fill gaps in their memory, a person may start to ‘confabulate’ – construct detailed (but inaccurate) stories which may seem believable to the person and others.

What many professionals may not be aware of is that ARBI may be characterized by more subtle and much less specific cognitive damage. For example,

deterioration of executive functions such as reasoning, problem solving, memory, strategic planning, inhibition, implementation of feedback from others can be all be observed to varying degrees. This can have major implications for an affected persons social awareness, risk behaviour and ability to make use of substance misuse treatment.

HOW DOES AL�COHOL� DAMAGE THE BRAIN?

Alcohol related brain injury is caused by a combination of factors directly and indirectly associated with alcohol misuse. These factors serve to change the structure and biochemical processes at a neurological level.

Firstly, alcohol or ethanol is a neurotoxic substance. Repeated and excessive exposure to this toxin can cause changes to our brains. Secondly, those who are drinking alcohol excessively can become chronically dehydrated. This can cause cells in the brain to become inefficient, and eventually waste away.

In addition, alcohol can damage the linings of our stomach and intestines. This means nutrients from our food are not absorbed properly into our blood. One of these essential vitamins is Vitamin B1 (Thiamine). Thiamine is important because it converts carbohydrates into energy for our bodies. Lack of thiamine causes the cells and structures in our brains to become deprived of energy.

Individuals who become dependent on alcohol often begin to neglect their nutrition, substituting food for alcohol. They may also vomit frequently and experience regular diarrhoea. This further reduces the supply of essential nutrients to the body and the brain.

Withdrawal from alcohol and the process of detoxification requires increased levels of thiamine. However, the stores of thiamine may already be very low in the person who has been misusing alcohol due to the aforementioned factors. Repeated withdrawals or detoxes from alcohol without adequate supplementation with thiamine can cause serious damage the brain.

Dr Helen McMonagle BSc.MSc. D.CounsPsych

Alcohol Related Brain Injuries Rehabilitation Coordinator

Dr. McMonagle is a HCPC-registered psychologist with a special interest in substance misuse and cognitive impairment. Working with the Alcohol Forum, Dr McMonagle is setting a strategic direction for ARBI- specific care which is designed to strengthen the capacity of the health and social care system to meet the needs of people with ARBI, their families and carers. She is a graduate of The Queens University Belfast, The University of Wales and The University of Teesside. Dr. McMonagles professional vision is to work within a health service which views alcohol-related and substance-induced cognitive impairment as a national health priority.

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HPN • Issue 14

WHO’S AT RISK OF DEVEL�OPING AL�COHOL�-REL�ATED BRAIN INJURY�?

Everyone that drinks alcohol to excess is at risk. Studies have identified that the following groups of individuals are particularly vulnerable to developing ARBI:

• Those who have been drinking in a harmful way for 5-10 or more years.

• Men who are regularly drinking 35 or more standard drinks per week, and women regularly drinking 28 or more standard drinks per week.

• People who are experiencing frequent ‘memory blackouts’ while drinking.

• People who have a family history of ARBI.

• People over the age of 35.

• People who have alcohol-related liver damage.

• Individuals who have had numerous withdrawals or detoxifications.

• Individuals who are underweight or malnourished.

• People who have been admitted to hospital in the past year due to drinking.

CAN A PERSON RECOVER FROM AL�COHOL� REL�ATED BRAIN INJURY�?

The recovery outcome can be positive for those that have ARBI - over 75% of people have a chance of some sort of recovery if they are identified at an early stage. Twenty five per cent make a complete recovery, 25% make a significant recovery, 25% make a slight recovery and 25% make no recovery10. Thus the majority of people will have a better probability of recovery if they are identified at an early stage and an appropriate intervention offered. This raises the importance of thorough assessment on admission to hospital.

SIGNS AND SY�MPTOMS OF AL�COHOL� REL�ATED BRAIN INJURY�

Problems with memory and learning are the most common consequence of chronic alcohol use and Alcohol Related Brain Injury.

Memory

• Poor day-to-day memory

• Difficulty remembering recent events.

• Difficulties recalling previous life events

• Confabulation

Attention

• Distractible

• Slow information processing

• Multi-tasking problems: Finds it difficult to complete tasks with a lot of different steps

• Difficulties finishing tasks they have started

Executive Dysfunction

• Difficulties in solving problems and planning activities

• Difficulties with complex, abstract and flexible thinking e.g. finds it difficult to think about things from ‘different angles’

• Changes in levels of interest and motivation – the person seems to have ‘lost their spark’, lacks initiative and spontaneous behaviour

• They may have poor self- awareness and unable to judge their abilities accurately

• Changes in temperament e.g. may over-react to situations, appear unusually irritable, or experience abnormal mood swings

• May become unusually impulsive, disinhibited (e.g. socially inappropriate outbursts) or develop poor social skills.

Coordination

• Problems with balance and coordination, especially in the lower limbs, which can lead to increased falls and accidents.

WHAT TO DO IF SOMEONE Y�OU KNOW IS AFFECTED BY� AL�COHOL�-REL�ATED BRAIN INJURY�?

If there is a suspicion that someone is showing any of the indicators of Alcohol Related Brain Injury it is important to alert their G.P of another medical professional as they may need immediate hospital treatment. Providing a description of the symptoms you have noticed, how this has developed over the course of time and how this differs from how the person usually behaves.

The medical practitioner will want to examine the individual and they may arrange for tests to be carried out such as blood tests or a brain scan. Other neurological processes (e.g Alzheimers, Acquired Brain Injury) will need to be ruled out.

Eliminating alcohol from the system is one of the most important steps in recovering from alcohol-related brain injury. The person may require a medically assisted detoxification and a period of care within the hospital environment until physical

stabilisation is achieved.

A new report published in the UK, Alcohol and brain damage in adults - With reference to high-risk groups by the Royal College of Physicians, the Royal College of General Practitioners and the Association of British Neurologists provide specific recommendations around the parenteral and prophylactic use of Pabrinex® (a the brand name for an injection that contains the vitamins thiamine, riboflavin, pyridoxine, ascorbic acid and nicotinamide) which is considered essential in the prevention and treatment of ARBI. Ongoing thiamine treatment is referenced as a fundamental facet of long term treatment for chronic ARBI.

What will happen next will vary according to the individuals on-going needs and local service provision. They may need:

• Ongoing support for abstinence. This may include spending a period of time in an alcohol-free environment and support from a team of professionals from the local Drug and Alcohol Service.

• Dietary advice from a nutritionists and does of oral thiamine towards the upper limits of the BNF guidelines.

• An Occupational Therapy assessment which will examine how well a person can function in their daily lives (e.g self care, cooking etc.) and what supports they will need in order to live as independently as possible.

• A physiotherapy assessment to help a person with their balance and coordination.

• A cognitive assessment with a neuropsychologist after a prolonged period of abstinence. This assessment will be able to clarify the extent of cognitive impairment and preserved strengths.

• A multidisciplinary team when the person has complex needs. This team may consist of psychiatry, psychology, occupational therapy, dieticians, social work, medical practitioners and family. Drawing from different fields, the multidisciplinary approach ensures that rehabilitation accounts for the full spectrum of the persons rehabilitative needs.

Unfortunately, it is all too often that people with Alcohol Related

Injury are not offered a robust rehabilitative package until their condition is very advanced and opportunities for recovery have been lost. This is partially due to the stigma attached to the condition, deprioritization of those with alcohol misuse problems and a lack of resources/established care pathways in Ireland.

It is evident with the high rate of mortality and morbidity associated with this condition, there is a need for new and better methods to intervene at all points along the spectrum of ARBI and to forestall the occurrence of the disorder. Ultimately, local and national clinical commissioning groups should focus on the development of ARBI service responses which will result in robust preventative, treatment and rehabilitative strategies to halt the progression of ARBI.

REFERENCES

1. Alcohol Action Ireland; Retrieved from http://alcoholireland.ie/facts/health-and-alcohol/

2. Alcohol Action Ireland; Retrieved from http://alcoholireland.ie/facts/health-and-alcohol/

3. Lisham, W.A (1990). Alcohol and the brain. British Journal of Psychiatry 156:635–644, 1990

4. Harvey, R.J., Rossor, M.N., Skelton-Robinson, M. and Garralda, E. (1998) Dementia Research Group. Imperial College School of Medicine

5. Gilchrist, G, and Morrishon, DS (2005).Prevalence of alcohol related brain damage among homeless hostel dwellers in Glasgow. European Journal of PublicHealth, 15 (6). Pp. 587-588

6. Arbias: Acquired Brain Injury in the Victorian Prison System & Famularo-Doyle, Jo. "Homelessness, Acquired Brain Injury and Corrections Victoria." Parity 23.1 (2010): 18

7. Popoola A, Keating A, Cassidy E (2008); Alcohol, cognitive impairment and hard to discharge acute hospital inpatients. Ir J Med Sci 2008;177:141 –5

8. Harper C, Fornes P, Duyckaerts C, Lecomte D, Hauw JJ (1995) An international perspective on the prevalence of the Wernicke-Korsakoffsyndrome. Metabolic Brain Disease 1995; 10:17

9. McMonagle, H (2014). The Impact of Alcohol Related Brain Injury on Family and Society. Alcohol Forum National Conference, Lecture conducted in the National Convention Centre, Dublin.

10. Smith, I. and Hillman, A. (1999) Management of Alcohol Korsakoff Syndrome, Advances in Psychiatric Treatment, Vol. 5, pp. 271-278.

Page 22: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

22

The finalists

22

The finalistsAwardsHospital Pharmacy

2014

Hospira Hospital Pharmacy Manager of the Y�ear Award

Debbie MurrayPharmacy: Peamount Hospital

Nomination Overview: Debbie has successfully operated as a Manager within Peamount Hospital Pharmacy Department and at all times has made sure they provide a service that is effectively and professionally managed. She seamlessly carries out her work to the greatest enhancement of patient care and for the betterment of patients. She has improved the standards of the pharmacy department service, up-skilling capabilities of pharmacists, and significantly reducing financial expenditure on reference sources. She has been involved in a wide variety of multidisciplinary projects that have positively contributed to patient care and improved inter-department relationships such as the collaborative partnership with the Mater Misericoridae University Hospital where she has developed an innovative programme to improve the management of medicines and to enhance patient safety and standards of care.

John O’ByrnePharmacy: Tallaght Hospital

Nomination Overview: John has been responsible for leading the pharmacy department at Tallaght Hospital through the most difficult years in the history of the hospital, mitigating the impact of the recruitment embargo and taking hard prioritisation decisions using a democratic management style via the pharmacy management team. His steely perseverance with senior hospital management combining evidenced based results, excellent influencing skills and his own integrity allowed the pharmacy department to hold its course when other areas struggled.

Gemma TreacyPharmacy: Mater Misericordiae University Hospital

Nomination Overview: Gemma held the position of Acting Clinical Pharmacy Service Manager in 2013 stepping up from her role of Senior Clinical Pharmacist. During this time period the clinical service faced a number of challenges due to changes within the hospital and on a national level. Gemma’s management during this period transformed the challenges into an opportunity for the pharmacy department to improve their service provision. Despite the numerous challenges Gemma ensured that not only was a high standard of services maintained throughout, but that service expansions and improvements were achieved.

Issue 14 • HPN

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It’s about confidence

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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.

Hospira is one of the major companies producing and marketing biologics globally

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Date of preparation February 2013 IE/13/001

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The finalists

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The finalistsAwardsHospital Pharmacy

2014

Roche Oncology Pharmacist of the Y�ear Award

Felicity McDonnellTitle: Senior Clinical Pharmacist | Pharmacy: Tallaght Hospital

Nomination Overview: Felicity has been at the forefront of the oncology service in Tallaght Hospital since it commenced in 2004. She works on both the oncology day ward and the pharmacy aseptic unit. During this time her workload has doubled. Felicity has provided all the pharmaceutical supports required by these consultants in the set-up of a centre of expertise for breast care, lung, GI and GU cancers. She has been the constant in the oncology day ward that has seen many changes in nursing management. She participates in the induction training of all new doctors to the oncology service and ensures they have the skills required to run an efficient service.

Patricia HeckmannTitle: Chief Pharmacist, National Cancer Control Programme

Nomination Overview: Ms Patricia Heckmann came to the National Cancer Control Programme (NCCP) as the first Chief Pharmacist in 2012. Since her appointment, Patricia’s strength as an experienced hospital pharmacist combined with her strategic acumen, ICT knowledge, managerial and leadership skills have proven invaluable in progressing the medical and haematoncology programme within the NCCP. Patricia’s work to improve quality and patient safety impacts on patients receiving chemotherapy in the community and in the 26 public hospitals which provide this service. Under her leadership, protocols for 26 different indications have been completed and made available on the NCCP website.

Brid RyanTitle: Deputy Aseptic Compounding Services Manager | Pharmacy: Mater Misericoriae University Hospital

Nomination Overview: Brid has worked in Oncology services in the MMUH for seven years and has been instrumental in revolutionising oncology service provision within this hospital, a Centre for Excellence in Oncology in Ireland. She has brought CATO to implementation in the Pharmacy Department and incorporates a leadership role in advancing the oncology service with other aspects of her role. This includes clinical responsibilities such as ward round attendance and ward level service provision, oncology clinical trials cover and financial review for oncology drug use in the MMUH

Issue 14 • HPN

We Innovate Healthcare

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HPN • Issue 14HPN • Issue 13

Diabetic Foot DiseaseDiabetic foot disease is a broad spectrum of foot disorders involving the cutaneous, soft-tissue, and osseous structures. Acute conditions may manifest as deeply infected wounds with extensive structural damage necessitating immediate medical attention to avoid amputation. Peripheral neuropathy, tissue ischemia, and foot biomechanics play a role in the development of acute ulcerative conditions. Some common offending agents in acute infections include gram-positive cocci and gram-negative bacilli. Early recognition and treatment by a multidisciplinary healthcare team are necessary for complete therapeutic resolution in patients who present with acute conditions. Pharmacists play an integral role in assessing the appropriateness of therapeutic regimens, as well

as in educating patients upon discharge in order to prevent exacerbation of the condition.

Diabetic foot disease (DFD) is a spectrum of disorders involving the cutaneous, soft-tissue, and osseous structures of the foot. This includes the development of foot ulcers and infections that may develop into limb-threatening conditions. Early recognition and management of acute DFD are critical for the prevention of disease progression and amputation. This review is intended to educate pharmacists regarding the proper management of acute DFDs according to current guidelines.

Risk Factors and Pathophysiology

Diabetic Foot Ulcers (DFUs): The development of DFUs involves many etiological

factors that are important to monitor in diabetes patients. Peripheral neuropathy (PN), which is present to some degree in >50% of diabetes patients aged >60 years, is one of the most important factors in the development of DFUs.5 Profound PN leads to loss of protective sensation, and consequently to increased vulnerability to physical and thermal trauma. PN has been shown to increase the risk of DFU development sevenfold.3 Irregular mechanical loading of the foot that results in excessive plantar and heel pressure is another causative factor.6,7 Biomechanics, such as structural foot abnormalities (calluses and hammertoes) and reduced joint mobility, further alters the mechanical loading of the plantar surface and increases the risk of DFUs.7 Physical trauma, especially when repetitive, also increases the risk. In one study involving

1. REFL�ECT - 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. PL�AN - If I have identified a knowledge gap - will this article

satisfy those needs - or will more reading be required?

4. EVAL�UATE - 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.

Biography - Oluwaranti Akiyode, PharmD, BCPS, CDEAssociate Professor

Howard University College of PharmacyClinical Pharmacist

Bryan Sackey, PharmD Candidate 2015, BSHoward University

60 Second SummaryDiabetic foot disease is a broad spectrum of foot disorders involving the cutaneous, soft-tissue, and osseous structures. Acute conditions may manifest as deeply infected wounds with extensive structural damage necessitating immediate medical attention to avoid amputation.

The development of DFUs involves many etiological factors that are important to monitor in diabetes patients. Peripheral neuropathy (PN), which is present to some degree in >50% of diabetes patients aged >60 years, is one of the most important factors in the development of DFUs. Profound PN leads to loss of protective sensation, and consequently to increased vulnerability to physical and thermal trauma. PN has been shown to increase the risk of DFU development sevenfold. Irregular mechanical loading of the foot that results in excessive plantar and heel pressure is another causative factor.

Because acute DFD can rapidly progress to a limb-threatening condition, it is imperative for clinical pharmacists and healthcare professionals (HCPs) to assess the extent of disease and develop an appropriate patient-directed treatment algorithm. Early recognition of the patient’s acute condition through the use of proper diagnostic tools is essential.

Most hospitalisations in acute DFD are due to acute infection of a foot ulcer or exacerbation of a previous DFI. Because of the complexity of an acute DFD and its potentially life-threatening exacerbations, management requires prompt action by a multidisciplinary team.

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.

CPD 8: Diabetic Foot

CPDContinuing Professional

Development

CPDCPDCPDCPDBryan Sackey

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Issue 14 • HPN

common organisms in mild-to-moderate DFIs; they most commonly occur in patients who have not had antibiotics in the past month.11 Chronic infections are typically mixed GPC and GNB. The presence of ischemic and necrotic tissue is associated with obligate anaerobes. Methicillin-resistant S aureus and Pseudomonas aeruginosa infections usually occur in patients with chronic hospitalization and drug-resistant conditions.11,12

Clinical Presentation and Diagnostic Approach

Because acute DFD can rapidly progress to a limb-threatening condition, it is imperative for clinical pharmacists and healthcare professionals (HCPs) to assess the extent of disease and develop an appropriate patient-directed treatment algorithm. Early recognition of the patient’s acute condition through the use of proper diagnostic tools is essential. Upon patient presentation, the following must be assessed: physical presentation of the foot ulcer, presence of wound infection, tissue ischemia, and neuropathy or neuropathic osteoarthropathy.6,13

The Meggitt-Wagner classification is a well-known and validated system that HCPs can use to stage DFUs.14 This classification has been shown to be a good predictor of ulcer prognosis and determinant of whether amputation is warranted.15 MRI is the gold standard for detection of soft-tissue lesions, whereas x-ray may be appropriate when osseous involvement is suspected.11,16

Rapid progression of an acute DFI may lead to a limb-threatening condition; thus, early recognition of the infection’s severity is important. A patient with a wound infection usually presents with classic signs and symptoms of inflammation (tenderness, erythema, warmth, and/or pain).11 A purulent, potentially malodorous discharge from

the ulcer suggests a more extensive infection.11 Acute DFI typically manifests as cellulitis, deep-skin and soft-tissue infections, or acute osteomyelitis ( TABLE 1 ).17 According to the most recent Infectious Diseases Society of America guideline, a tissue culture must be obtained before empirical therapy is initiated, and the wound must be appropriately cleaned and debrided before specimens are obtained.11 A patient presenting with a local infection associated with signs of systemic inflammatory response syndrome must be hospitalized for critical care.11 Blood cultures are recommended for patients with signs of acute systemic illness.11

In the presence of neuropathy and insufficient vascularization, some of the classic signs and symptoms of a foot infection (pain and erythema) may be false-negative, so evaluation for tissue ischemia and PN is critical in acute DFD patients.11 The absence of pedal pulses may indicate lower-extremity ischemia.18 The patient’s vascular status should be determined via diagnostic tools such as Doppler ultrasound and tissue percutaneous oximetry.16 Tissue ischemia can be diagnosed as tissue percutaneous oximetry <30 mmHg or ankle blood pressure <50 mmHg.15 The ankle-brachial systolic pressure index is an unreliable assessment of ischemia in diabetes patients.18 The 10-g Semmes-Weinstein monofilament test and the Neuropathy Disability Score are useful diagnostic tools for neurologic examination in the clinical setting, and both may be used.19

Treatment

Most hospitalisations in acute DFD are due to acute infection of a foot ulcer or exacerbation of a previous DFI.5 Because of the complexity of an acute DFD and its potentially life-threatening exacerbations, management requires prompt action by a multidisciplinary team.11 The healthcare team

669 subjects with DFUs, 21% of ulcers were linked to rubbing from footwear, 11% to injuries, 4% to cellulitis complicating tinea pedis, and 4% to self-inflicted trauma (e.g., cutting toenails).8

Peripheral arterial disease (PAD), which is a major contributor to the development of DFU, is approximately twice as prevalent in diabetes patients.6 PAD reduces blood flow and ulcer healing, leading to tissue ischemia and a worsened DFU prognosis.9 One large study found that the ankle-brachial index—a common assessment of vascular dysfunction in PAD diagnosis—was strongly linked to the risk of foot ulceration.10 Management of fasting plasma glucose is also critical in diabetes patients; uncontrolled hyperglycemia has been shown to interfere with wound healing, resulting in endothelial dysfunction and development of PN.7 One study showed

that long diabetes duration (>10 years) and poor glycemic control (A1C >9%) were associated with DFUs.10

Diabetic Foot Infections (DFIs): DFIs develop in the presence of an ulcer or traumatic injury. A DFI typically begins superficially and spreads to deeper structures, leading to deep abscess, chronic ulcers, cellulitis, and osteomyelitis. Acute soft-tissue infections usually involve necrotizing fasciitis, malodorous discharge, and tissue loss; the presence of cyanotic discoloration usually signifies vascular interference.7 Acute DFIs warrant immediate therapeutic intervention to prevent gangrene and amputation. Etiological microorganisms of DFIs include gram-positive cocci (GPC), gram-negative bacilli (GNB), and anaerobic organisms. Staphylococcus aureus and beta-hemolytic streptococci are the most

CPD 8: Diabetic Foot

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HPN • Issue 14

must first assess the foot disease to classify the wound and determine whether there is an infection. The DFD classification which is based on often-used and validated classification systems for DFIs, is useful for determining whether an infection is limb-threatening (severe) or non–limb-threatening (mild-to-moderate).11 Uninfected wounds should not be cultured or treated with antibiotics. Mild infections are usually treated with oral antibiotics on an outpatient basis for 1 to 2

weeks; moderate infections usually involve either oral or parenteral antibiotics for 2 to 4 weeks.11 Immediate hospitalization is warranted for all patients whose infection is severe or complicated by critical limb ischemia.11

Upon hospitalisation, it is important to keep the patient medically stabilised (fluids, electrolytes, insulin, etc.). After site-appropriate deep culturing, empiric parenteral therapy should be initiated with broad-spectrum

antibiotics ( TABLE 3 ) and must be reevaluated daily. Once cultures are analyzed, more definitive therapy should be initiated. When possible, the patient may be switched to oral therapy for a total of 2 to 4 weeks of antibiotic therapy (including initial parenteral therapy). If there is no improvement or the condition worsens, reculturing and broadening of antibiotic therapy should be considered.11 Pharmacists play an integral role in this process by working with other HCPs

to select the most appropriate empirical therapy, dosage, and route of administration, as well as by monitoring the pharmacodynamic and pharmacokinetic properties of these medications. Urgent surgical consultation may be necessary when there is suspicion of limb ischemia and an extensive limb-threatening infection that is nonresponsive to parenteral antibiotic therapy. In the presence of critical limb ischemia and in patients with a history of PAD, revascularization may

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CPD 8: Diabetic Foot

be initiated after recognition of the infection (within 1-2 days).11 Amputation should be considered in patients with necrotizing fasciitis, gas gangrene, extensive soft-tissue loss, or severe osteomyelitis.20

Amputation is reserved for prevention of a life-threatening condition, and the decision to perform this procedure should be made only after a thorough patient-provider discussion.18

Many studies suggest that it is important to monitor blood glucose levels in hospitalized patients.11,18,21 In particular, because hyperglycemia is associated with poor wound healing, a correction would help eradicate the infection and increase the likelihood of a favorable outcome.11,21

Offloading techniques should be employed in all patients to prevent iatrogenic foot complications. Wound care, which includes incision, drainage, and debridement, should be performed on DFD patients to enable optimal healing of the ulcer.11 Sharp debridement of devitalized tissue may be necessary in noninfected neuropathic wounds.18 Dressings should be applied to promote wound healing, and appropriate selection is based on the type of wound: alginates, foams, or hydrocolloids for exudative wounds; films for dry wounds; hydrogels and saline gauze for dry or necrotic wounds.11 Granulocyte colony-stimulating factors such as Apligraf and Dermagraft have been shown to reduce the need for operative procedures and may be used as adjunctive therapy for wound closure in noninfected, nonischemic patients.11

Follow-up and Prevention

Appropriate discharge procedures should be in place to reduce the risk of readmittance for an acute exacerbation of DFD. Hospitalized patients who are

discharged and initiated on oral antibiotics must complete their regimen and follow up as directed so that therapeutic improvement of the condition can be evaluated. Upon discharge, the pharmacist must counsel patients on the importance of therapy adherence and potential side effects. Patients with PAD must optimize their therapy and be educated about risk factors (lipid abnormalities, smoking) in order to prevent future acute DFD. Pharmacists should also discuss foot-trauma preventive measures, such as daily inspections, appropriate footwear, and prompt reporting of any lesions, with patients. Blood glucose monitoring is critical for preventing acute DFD. In the United Kingdom Prospective Diabetes Study, a 1% mean reduction in hemoglobin A1C was associated with a 25% reduction in microvascular complications and a 36% reduction in amputations.22

Pharmacists must counsel patients on appropriate glucose monitoring, instill an attitude of medication adherence, and work with physicians to optimize the patient’s diabetes therapy. Therapeutic lifestyle changes, such as individualized diet and exercise, should be discussed with the patient. Lastly, it is important to involve the patient’s family and caregivers to facilitate a dynamic treatment approach.

REFERENCES

1. CD C. National Diabetes Fact Sheet: National Estimates and General Information on Diabetes and Prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2011.

2. Currie CJ, Morgan CL, Peters JR. The epidemiology and cost of inpatient care for peripheral vascular disease, infection, neuropathy, and ulceration in diabetes. Diabetes Care. 1998;21:42-48.

3. Reiber GE, Lipsky BA, Gibbons GW. The burden of diabetic foot ulcers. Am J Surg. 1998;176(suppl 2A):5S-10S.

4. Tennvall GR, Apelqvist J, Eneroth M. Costs of deep foot infections in patients with diabetes mellitus. Pharmacoeconomics. 2000;18:225-238.

5. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005;293:217-228.

6. Younes NA, Ahmad AT. Diabetic foot disease. Endocr Pract. 2006;12:583-592.

7. Altman MI, Altman KS. The podiatric assessment of the diabetic lower extremity: special considerations. Wounds. 2000;12(6 suppl B):64B-71B.

8. Macfarlane RM, Jeffcoate WJ. Factors contributing to the presentation of diabetic foot ulcers. Diabet Med. 1997;14:867-870.

9. Gregg EW, Sorlie P, Paulose-Ram R, et al. Prevalence of lower-extremity disease in the US adult population ≥40 years of age with and without diabetes: 1999-2000 National Health and Nutrition Examination Survey. Diabetes Care. 2004;27:1591-1597.

10. Lavery LA, Armstrong DG, Vela SA, et al. Practical criteria for screening patients at high risk for diabetic foot ulceration. Arch Intern Med. 1998;158:157-162.

11. Lipsky BA, Berendt AR, Cornia PB, et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54:e132-e173.

12. Clayton W Jr, Elasy TA. A review of the pathophysiology, classification, and treatment of foot ulcers in diabetic patients. Clin Diabetes. 2009;27:52-58.

13. Wukich DK, Armstrong DG, Attinger EC, et al. Inpatient management of diabetic foot disorders: a clinical guide. Diabetes Care. 2013;36:2862-2871.

14. Wagner FW Jr. The dysvascular

foot: a system for diagnosis and treatment. Foot Ankle. 1981;2:64-122.

15. Van Acker K, De Block C, Abrams P, et al. The choice of diabetic foot ulcer classification in relation to the final outcome. Wounds. 2002;14:16-25.

16. Ranachowska C, Lass P, Korzon-Burakowska A, Dobosz M. Diagnostic imaging of the diabetic foot. Nucl Med Rev Cent East Eur. 2010;13:18-22.

17. Bronze MS. Diabetic foot infections. Medscape. http://emedicine.medscape.com/article/237378-overview. Accessed March 3, 2014.

18. American Diabetes Association. Consensus Development Conference on Diabetic Foot Wound Care: 7–8 April 1999, Boston, Massachusetts. Diabetes Care. 1999;22:1354-1360.

19. Meijer JW, van Sonderen E, Blaauwwiekel EE, et al. Diabetic neuropathy examination: a hierarchical scoring system to diagnose distal polyneuropathy in diabetes. Diabetes Care. 2000;23;750-753.

20. Aragón-Sánchez J. Seminar review: a review of the basis of surgical treatment of diabetic foot infections. Int J Low Extrem Wounds. 2011;10:33-65.

21. Umpierrez GE, Hellman R, Korytkowski MT, et al; Endocrine Society. Management of hyperglycemia in hospitalized patients in non-critical care setting: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012;97:16-38.

22. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:854-865.

23. Micromedex Healthcare Series [Internet database]. Greenwood Village, CO: Thompson Micromedex. www.micromedexsolutions.com. Accessed March 3, 2014.

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IE.MIS.14.05.01Date of preparation: May 2013 www.sanofi .ie

A trusted partner in Irish Healthcare, with a strong heritage in Diabetes, Cardiovascular Disease, Oncology and Consumer Health.We are committed to supporting Irish Healthcare with innovative, holistic healthcare solutions.

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TO SUPPORTING HEALTHCARE IN IRELA

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2011152 Sanofi Commitment A4.indd 1 20/05/2014 16:13

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The finalists

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The finalistsAwardsHospital Pharmacy

2014Sanofi Hospital Pharmacy Team of the Y�ear Award

St James’s Hospital Medicines Management TeamTeam L�ead: Veronica Treacy, Director of Pharmacy | Team Members: Frances Jordan, Louisa Murray, Leonor O’Connor, Laura Mc Gillen, Lorraine Moylan, Carol Purcell, Tara Walsh, Senior Technicians; Colin McGill, Samuel Yesudoss, Kulbeer Singh, Sarah O’Reilly, Jonathan Murray, Ciara Floody, Bernie McEwan, Alan McManus, Basic Grade Technicians; Paddy Long, Paul Redmond, Stores Officers; Martin Holt, Pharmacy Porter; Sandra Conaty, Business Manager; Frances Farrell, Purchasing Officer; Jennifer Lawlor and Sinead O’Reilly, Clerical Staff

Nomination Overview: The senior technicians, purchasing and clerical staff at St James’s are involved in sourcing, ordering and receipting in orders. In these times of drug shortage issues this can be a challenging task. They are also often a valuable source of information for other hospitals and community pharmacies trying to source unusual medications / dressings and medical devices.

The Medicines Management staff in SJH has a wide range of skills and experience and has trained, mentored and inspired many student technicians and pharmacists over the years.

� e Pharmacy Department, Naas General HospitalTeam L�ead: Claire Domican, Acting Chief I Pharmacist | Team Members: Marie-Claire Jago-Byrne, Chief Pharmacist; Mairead Galvin, Deirdre Holland, Senior Clinical Pharmacists (on secondment); Aoife O’Flaherty, Niamh Fagan, Karen Mas Mollinedo ,Senior Clinical Pharmacists; Sharon Byrne, Stephanie Donoghue, Clinical Pharmacists; Ann Pilkingon, Senior Purchasing Technician; Fran Glynn, Deirdre Canning, Irene Roycroft, Senior Technicians; Aoife O’Toole, Pharmacy Technician; Aisling O’Brien , Pharmacy Attendant

Nomination Overview: The Clinical pharmacy team at NGH are currently the only team in Ireland to deliver a consultant led team based service

incorporating Medicine Reconciliation. The delivery of such a service represents an evolution from the traditional ward based service towards a more multidisciplinary patient focused approach which is the culmination of a series of research and audit in the field.

The structure of the technical team in the dispensary is designed and calculated to maintain the highest levels of efficiency within the working day. The team has been arranged into a planned and structured rota which offers rigidity and flexibility in equal measures.

Issue 14 • HPN

Temple Street Children’s University HospitalTeam L�ead: Reena Patel, Chief Pharmacist | Team Members: Mr Michael Curtin, Senior Pharmacist, Dispensary management & Specialist Paediatric ICU Pharmacy; Ms Michelle Kirranne, Senior Pharmacist, Dispensary management & Specialist Antimicrobial Pharmacy; Ms. Brenda O’Rourke, Senior Pharmaceutical Technician, Dispensary & Ward Services; Ms Gillian Cawley, Trainee Procurement Technician; Mr Paul Doyle, Purchasing Administration Officer; Ms Anne Hughes, Pharmacist Aide

Nomination Overview: The Pharmacy Team at Temple Street Children’s University Hospital is a cohesive team of three pharmacists and four support staff providing services to a 177 bed hospital, outpatient clinics and one of the busiest Emergency Departments in Europe. Every team member is encouraged to focus on what they can achieve in terms of

their contribution to patient care and to recognise its importance. In particular, the pharmacists exert flexibility and support each other both to facilitate service delivery and to ensure that they do not miss out on important opportunities external to the organisation.

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HPN • Issue 14

Mater Misericordiae University HospitalTeam Team: Maríosa Kieran, Clinical Pharmacy Service Manager | Team Members: Gemma Treacy, Deputy Clinical Pharmacy Service Manager/Directorates Liaison Pharmacist; Patricia Ging, Transplant / Pulmonary Hypertension Pharmacist (Chief 2); Nuala Scanlon, Antimicrobial Pharmacist (Chief 2); Helen Danaher, Senior Clinical Pharmacist; Catherine Boyle, Pharmacy Lead Infectious Diseases; Mairead Casserly, Senior Clinical Pharmacist / Pharmacy Education and Training Co-Ordinator; Joanna Carroll, Senior Clinical Pharmacist; Garreth Dooley, Senior Clinical Pharmacist – Oncology/Haematology Clinical Trials; Deirdre Lenehan, Senior Clinical Pharmacist – Antimicrobials; Mairead O’Connor, Senior Clinical Pharmacist – Infectious Diseases; Miriam O’Donovan, Senior Clinical Pharmacist; Brid Ryan, Deputy Aseptic Compounding Unit Manager; Louise Fitzsimons, Clinical Pharmacist / Medicines Safety; Brona Kehoe, Medicines Information / Clinical Pharmacist; Sarah Molony, Clinical Pharmacist; Jean-Anne Morrissey, Clinical Pharmacist; Dearbhla Murphy, Clinical Pharmacist; Nina Acosta, Clinical Pharmacist; Louisa Conlon, Pharmacy Intern

Nomination Overview: The Mater Misericordiae University Hospital (MMUH) Clinical Pharmacy team comprises of 18 Clinical Pharmacists, across four grades. The core role of the team is to maximise the therapeutic benefits of drugs to patients whilst minimising associated risks. This is provided through drug chart review, specialist ward round attendance, multidisciplinary team meetings, patient education and counselling, staff education provision, research, hospital committee membership and grand rounds presentations. The team are one of the driving forces of Clinical Pharmacy, both nationally and internationally. Innovative practices that they undertake that contribute to patient care include documentation in the patient’s medical notes and cancelling of dangerous prescriptions.

HIV Pharmacy Team Cork University HospitalTeam L�ead: Carmel Bogue | Team Members: Fiona Ahern, Marih O’Leary, Pharmacists; Carol Carey, Pharmacy Technician

Nomination Overview: The HIV pharmacy team in Cork University Hospital (CUH) is responsible for providing antiretroviral (ARV) medication to over 420 patients all over Munster. The pharmacy team works closely with Infectious Diseases (ID) consultants, doctors, a virologist and clinical nurse special ists to ensure the safe and appropriate supply of ARV medicines to HIV positive patients. Due to the pharmacy team remaining in their roles on a long term basis they develop a good rapport with patients. The pharmacy team members working within HIV services find their role rewarding and fulfilling on both a professional and personal level.

Saint John of God Hospital Pharmacy TeamTeam L�ead: Dolores Keating, Chief Pharmacist, Honorary Senior Clinical Lecturer, Royal College of Surgeons in Ireland | Team Members: Audrey Purcell, Caroline Hynes, Aoife Carolan, Senior Pharmacists; Linda Clarke, Pharmacy Technician; Lorna Dillon, Basic Grade Pharmacist; Geraldine Reid, Locum Senior Pharmacist

Nomination Overview: At SJOGH, the team care for people who have acute mental health problems. Their core values are hospitality, care, compassion, dignity, respect, justice and excellence .The development of pharmacy services in the hospital is guided by these values. Last year saw a number of significant developments in the field of mental health pharmacy led by the team at Saint John of God Hospital. The pharmacy team are a motivated, capable and cohesive team. Achievements over the last year are examples of how a group of excellent individuals can, as a team, become much more than the sum of its parts.

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The finalists

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The finalistsAwardsHospital Pharmacy

2014

MSD Multidisciplinary Working Award

Marie TierneyTitle: Antimicrobial Pharmacist; Secretary, Antimicrobial Stewardship Team | Pharmacy: Galway University Hospital | Team Members: Dr. Deirbhile Keady, Dr. Eithne McCarthy, Consultant Microbiologists, Chair Antimicrobial Stewardship Team, Consultant Leads for Antimicrobial Stewardshipl Dr. Martin Cormican, Dr. Úna NíRiain, Dr. Teck Wee Boo, Dr. Marianne Nolan, Consultant Microbiologists; Dr. Catherine Fleming, Dr. Helen Tuite, Infectious Diseases Consultants; Dr. David Gallagher, Consultant Medical Admissions Unit; Ms. Belinda Hanahoe, Surveillance Scientist

Submission Overview: GAPP (Galway Antimicrobial Prescribing Policy/Guidelines): Using Smartphone technology to implement multidisciplinary antimicrobial prescribing guidelines in a University Teaching Hospital and Hospital Group - The GAPP App is an outstanding example of a multidisciplinary initiative developed by the GUH Antimicrobial Stewardship Team (AST), with input from healthcare professionals and stakeholders in GUH and other hospitals within the West/North West Hospitals Group, in response to user demand.

The GAPP App harnesses Smartphone technology to deliver user friendly mobile prescribing guidelines and dosing calculators, with automatic updates, to guide and facilitate the care of patients in GUH. The password protected App is available free of charge to hospital staff.

Kathryn FeelyTitle: Specialist Pharmacist, Hepatitis C | Pharmacy: St Vincent’s University Hospital | Team Members: Sheila O’Toole, A Murphy, Carol McNulty, Clinical Nurse Specialists for Hepatitis C; Dr A McCormick, Dr D Houlihan, Dr M Iqbal, Hepatology Physicians

Submission Overview: Kathryn has been instrumental in providing and expanding the clinical pharmacy service to the hepatology team for many years and is at the forefront of liver pharmacy. Her knowledge and expertise are recognised by the many pharmacists in Ireland who come to her seeking advice on the appropriate therapeutic management of liver transplant patients, patients with liver disease and HCV patients. Kathryn was appointed as the HCV pharmacist for SVUH in 2013 and has used her extensive experience in hepatolgy to develop the HCV pharmacy service from scratch. Kathryn has also worked closely with the HCV pharmacists in other centres so that a consistent and robust service can be provided to all patients, no matter which HCV centre they attend.

Issue 14 • HPN

Amanda FitzpatrickTitle: Chief Pharmacist | Pharmacy: St Patrick’s University Hospital | Team Members: Elaine Mitchell Senior Clinical Pharmacist, Helen Lanigan Clozapine Pharmacist, Sandra Dowling Senior Pharmaceutical Technician, Izabela, Mandau Pharmaceutical Technician, Mary Anderson Biochemist, Michael Lane Biochemist, Frances Moynihan Clozapine Nurse / Phlebotomist, Anne Molloy CNMII, Edel Bennett Clozapine Nurse / Phlebotomist, Geraldine Cuniffe Clozapine Nurse /, Phlebotomist, Paula Keeshan Staff Nurse, Dr Seamus O’Ceallaigh Consultant, Psychiatrist, Prof Paul Fearon Consultant Psychiatrist and Clinical Professor of, Psychiatry, TCD, Prof Declan McLoughlin Consultant Psychiatrist and Research, Professor of Psychiatry, TCD

Submission Overview: Development and Introduction of a Multidisciplinary Care Plan for the Initiation of Clozapine - A shared document was developed to establish a best practice care plan and to assist communication with the multidisciplinary and wider team. Future plans are to expand the pathway to develop and enhance the physical monitoring carried out beyond the time frame of the Clozapine Initiation Pathway (CIP).

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The finalistsThe finalistsThe finalistsAwardsHospital Pharmacy

2014

Excellence in Patient Safety Award

Ciara Ni DhubhlaingPharmacy: St Patrick’s University Hospital | Team Members: Ciara Ni Dhubhlaing, Project Lead; Amanda Fitzpatrick, Chief I Pharmacist; Ailish Young Chief II Pharmacist; Elaine Mitchell, Senior Ward Pharmacist; Clare Butler, Senior Ward Pharmacist; Sandra O’Sullivan, Basic Grade Pharmacist

Project Overview: As the first step in introducing a comprehensive pharmacy medicines reconciliation process to SPUH to further the patient safety agenda and improve quality of care, it was agreed that medicines reconciliation on admission would be commenced. It was anticipated that this would highlight the frequency and severity of prescribing errors on admission and also reduce their impact on patient safety. A number of possible recording methods and their benefits and limitations were considered. A form was designed with team input and piloted on several wards. Changes were made as a result of patient information given during the pilot.

The results data illustrates the direct benefits of pharmacist intervention in medicines reconciliation on admission in improving patient safety and ensuring optimal treatment.

Aoife O’FlahertyTitle: Clinical Pharmacist | Pharmacy: Naas General Hospital

Project Overview: Since joining the team at Naas General Hospital Aoife O’Flaherty has worked tirelessly to improve patient care, patient medication safety, and communication between healthcare professionals and raise the profile of the pharmacy department within the hospital. As part of Aoife’s ongoing commitment to patient safety all patients newly prescribed stroke and cardiac medicines are counselled prior to discharge. As part of this service Aoife provides written information (including foreign languages) for patients and also applies to PCRS for funding (in the case of NOAC’s) to ensure seamless supply post discharge. Aoife has shown the best commitment to patient safety that it is possible to have.

Pharmacy DepartmentPharmacy: Mater Misericordiae University Hospital | Team Members: Professor Ciaran Meegan, Head of Pharmacy Services & Chair of Drug Safety Committee; Maria Creed, Drug Safety Facilitator; Louise Fitzsimons, Clinical and Medication Safety Pharmacist; Michelle McGuirk, Pharmacy Projects Co-ordinator; All Pharmacy Department staff, support and material proofing

Project Overview: The Mater Misericordiae University Hospital (MMUH) Pharmacy Department’s interest in patient safety has roots going back a decade. Where patient safety is concerned there can never be enough education – hence the initiatives undertaken for the betterment of all healthcare professionals in helping to up-skill them in medication safety processes. There has been continuous involvement from the pharmacy safety team since the inaugural Professional Completion Module was introduced for UCD medical undergraduates in 2010. The MMUH pharmacy safety team have created a sense of urgency with respect to medication safety, and as a result patient safety. This has galvanised the local safety culture in the MMUH and has been a source of inspiration nationally to the hospital pharmacy profession as a whole.

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Actavis Aseptic Unit of the Y�ear Award

Aisling CollinsTitle: Chief Pharmacist | Pharmacy: St James’s Hospital | Team Members: Team lead pharmacists (PTL) (on rotation): Sinead Smith; Sarah Jane Varden; Noel Gilligan; Edel O’Dea; Aileen Ryan. Senior pharmacists (in rotation):Eoin Minihane; Keelin McManus. Senior technicians (6 WTE): Siobhan Berry; Jane Kavanagh; Eleanor Muir; Sarah Mulhall; Ruth Molloy; Pamela Clarke; Margaret O’Reilly; Claire Farrelly. Basic grade technicians (6 WTE): Gillian Brady; Eithne Gorman (maternity leave); Helena Whelan; Claire Clancy; Kathrina Moloney; Niamh Small; Sarah O’Sullivan,QC technician: Greg Lee, Specialist cleaner: Diny Hibbert

Project Overview: The Aseptic Compounding Unit (ACU) in St. James’s Hospital compounds greater than 20,000 patient-specific products on site annually. The pharmacy ACU team in St. James’s Hospital is a highly motivated, hard-working and innovative group. The patient is at the centre of everything we do. The team appreciate, understand and contribute to the quality systems in the ACU in order to generate workflow processes that lead to a cost effective and efficient compounding unit and ensure the ultimate goal, i.e. the manufacture of medicinal products to a consistently high standard for every patient.

Evelyn GarveyTitle: Chief Pharmacist | Pharmacy: Midland Regional Hospital, Tullamore | Team Members: Éilis Crimmins, Senior Pharmacist; Nessa Fahy, Senior Pharmacist; Trish Scully, Senior Pharmaceutical Technician; Barbara Carroll, Pharmaceutical Technician, Carmel O’Meara, Pharmaceutical Technician; Audrey Moughty, Pharmaceutical Technician, Catriona Burke, Pharmaceutical Technician, Elaine Flynn, Pharmaceutical Technician, Niamh Cunningham, Pharmaceutical Technician, Caroline Colmey, Pharmaceutical Technician

Project Overview: Think Safety First – An Analysis of Aseptic Compounding Practice. Pharmacy staff prepare hazardous drugs in negative pressure isolators using needles and syringes. Operators have reported droplets leaking from vials during the compounding process. This is also reported in the literature. During batch production, vials may be punctured multiple times resulting in bung coring. This slows down the compounding process, and possess a risk to the quality of the final product. The team at Tullamore aimed to review compounding practice to reduce the risk of droplets leaking from vials, and bung coring.

AnneMarie DeFreinTitle: Chief II Pharmacist /Aseptic Manager | Pharmacy: St Vincents University Hospital | Team Members: Senior Onco/Haem Pharmacist Lisa Hammond, Senior Pharmacist Kate O’Mahony, Senior Aseptic Technician Nadia Campbell, Senior Aseptic Technician Trials Clare Donald

Project Overview: Together this small team implemented a range of new innovations across the unit and have looked to support our health service colleagues in delivering new drugs and new practices to their patients. This Department prepares all the chemotherapy (cytotoxic and non-cytotoxic) for administration to inpatients and day patients attending SVUH. Their submission to the Actavis Aseptic Hospital Unit of the Year Award 2014 is a recognition of the strong work commitment and patient delivery that the team in St. Vincent’s have delivered.

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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.

THE FUSION OF ACTION, VISION AND STRENGTH

www.actavis.ie

Actavis Ireland Ltd.Euro House, Euro Business Park Little Island, Co. CorkT: 1890 33 32 31 F: 021 461 90 49 E: [email protected] -009h-01

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for GenericsFirst

As the Leading Generic supplier in Ireland, we are proud to offer the medical community throughout the country the choice to prescribe and dispense quality generic treatments. In doing so, we are working with you to help your patients benefit from quality and cost-effective medications.

With over 30 years manufacturing healthcare products in Ireland, Pinewood Healthcare is one of the largest generic suppliers with a workforce of over 340 people. We are always committed to providing the Irish market with quality brands at inexpensive prices.

Quality Choice Value Service

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Pinewood Y�oung Hospital Pharmacist of the Y�ear Award

Caroline HynesPharmacy: Saint John of God Hospital

Nomination Overview: Caroline Hynes works as a Senior Pharmacist at Saint John of God Hospital. Caroline is a highly effective member of the pharmacy team and the wider multidisciplinary team at SJOGH. She is an efficient, hard-working, creative individual who upholds the mission and values of their organisation in her daily practice. Her achievements in her short career are remarkable. She is a supportive colleague who is a highly efficient dispensary worker and problem solver. She frequently manages the dispensary workload, meeting deadlines and prioritising effectively. Caroline is aware of the responsibilities of other pharmacy team members allowing them time to complete projects while covering the dispensary. Academically, Caroline is talented, she became only the second Irish-based pharmacist to become a Credentialled member of the College of Mental Health Pharmacy in the United Kingdom.

Colette MorrisPharmacy: Tallaght Hospital

Nomination Overview: Colette has been an excellent addition to the pharmacy department Tallaght Hospital and has at all times endeavoured to provide excellent patient care while maintaining a cheery demeanor. Recently, Colette has commenced work on the pharmacy department dispensary policies. She has embraced this work and has shown great insight, enthusiasm and common sense. Her work is facilitating a more stream-lined approach in the dispensary and is a valuable reference source to all staff. This work has also led her to become increasingly familiar with hospital and professional guidelines and she has used this knowledge to benefit the department as a whole. She is displaying all the characteristics of someone who will evolve into a leader in the profession over time.

Issue 14 • HPN

Brona KehoePharmacy: Mater Misericordiae University Hospital

Nomination Overview: Brona Kehoe works half time as a Medicines Information pharmacist in combination with her clinical pharmacist role. Having qualified from the Royal College of Surgeons in Ireland (RCSI) in 2010 with a B.Sc (Pharm) First-class honours, and on completion of the National Pharmacy Internship Programme (NPIP) MPharm in the MMUH, Brona joined the MMUH Pharmacy Department staff and went on to gain a distinction in the M.Sc in Hospital Pharmacy, Trinity College Dublin (TCD). In her short time within the pharmacy profession, Brona’s passion for her role as a hospital pharmacist combining her contribution to clinical pharmacy and Medicines Information services, in conjunction with her research and educational roles identify Brona as an inspirational young pharmacist dedicated to the future of her profession and the wellbeing of her patients.

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for GenericsFirst

As the Leading Generic supplier in Ireland, we are proud to offer the medical community throughout the country the choice to prescribe and dispense quality generic treatments. In doing so, we are working with you to help your patients benefit from quality and cost-effective medications.

With over 30 years manufacturing healthcare products in Ireland, Pinewood Healthcare is one of the largest generic suppliers with a workforce of over 340 people. We are always committed to providing the Irish market with quality brands at inexpensive prices.

Quality Choice Value Service

for GenericsFirst

As the Leading Generic supplier in Ireland, we are proud to offer the medical community throughout the country the choice to prescribe and dispense quality generic treatments. In doing so, we are working with you to help your patients benefit from quality and cost-effective medications.

With over 30 years manufacturing healthcare products in Ireland, Pinewood Healthcare is one of the largest generic suppliers with a workforce of over 340 people. We are always committed to providing the Irish market with quality brands at inexpensive prices.

Quality Choice Value Service

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2014

Medisource Hospital Pharmacy Technician of the Y�ear Award

Marie McLaughlinPharmacy: University Hospital Galway

Nomination Overview: Marie has been tasked with improving the GUH inventory management of medicines with two key goals of reduction of overall stock holding in the main pharmacy and reduce the number of ‘out of stocks’. Marie recognised that the two goals are not independent of each other in that the achievement of one may adversely affect the other. Marie has spent the last twelve months measuring the problem and devising a strategy to achieve the two key goals. Her task was part of and key to a larger ‘Lean’ project concerned with the main pharmacy’s activities, which continues to seek improvements in the hospitals overall quality of service and to reduce wastage of time, effort and money.

Yvonne SheehanPharmacy: Tallaght Hospital

Nomination Overview: Yvonne Sheehan was one of the first Pharmacy Technicians to be recruited to work in a hospital pharmacy and started working in the Meath Hospital in 1990. In 1994 Yvonne was involved in the introduction of the senior grade for Pharmacy Technicians. In 1997 Yvonne was on the founding committee of the National Association of Hospital Technicians (NAHPT), and since this time has held many positions on this committee including Union Liaison Officer, Chairperson and President of the Association. She is passionate about her own role and continues to make savings for the hospital in challenging economic times. Yvonne gives great support and encouragement to her colleagues and always strives to enhance and develop the role of the Pharmacy Technician in Tallaght Hospital.

Issue 14 • HPN

Tania O’SullivanPharmacy: Bon Secours Hospital, Tralee

Nomination Overview: Tania O’Sullivan joined the Pharmacy Department at Bon Secours Hospital Tralee in April 2006 as a pharmacy support assistant. She instantly brought a sense of life and vitality to the department. She excelled in her role and lost no time in furthering her education, completing the National Vocation Qualification of Pharmacy Technician from City and Guilds in 2010. Tania makes a significant contribution to the pharmacy team every day. She regularly participates in education initiatives in-house and attends events such as the Annual Pharmacy Technicians Education Conference in Santry, returning with informative feedback, keeping the department up to date with current best practice recommendations. She is seen as a true role model, and who enhances the department’s working environment with her sense of humour, camaraderie, and positivity.

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Carmel BoguePharmacy: Cork University Hospital

Nomination Overview: Carmel joined our pharmacy team in 2007. Since then she has brought experience and professionalism that has enriched the team. Carmel commenced a technician led non-stock supply of drugs to one of the hospital’s 35 bed wards. Carmel instigated this non-stock service with a passion and professionalism. In 2013 Carmel completed a Medicines Management Qualification. She uses this qualification to carry out medicines reconciliation and also checking patients own medicines for use on the medical ward. She is an outstanding team member and an invaluable support to the pharmacy department.

Caroline ConlonPharmacy: Our Lady’s Children’s Hospital Crumlin

Nomination Overview: Caroline is a dedicated, hard-working and innovative technician that has been working in the pharmacy department in Our Lady’s Children’s Hospital in Crumlin for 12 years. During this time, she has had a significant impact on both the running of the pharmacy department and on the many people she has worked with. She has been pivotal in the co-ordination and organisation of dispensary related activities and maintaining an efficient and safe pharmacy service. Caroline is a dedicated and enthusiastic team player and strives to deliver a high quality pharmacy service. Caroline leads by example and never shy’s away from any work task that needs to be completed.

Ann PilkingtonPharmacy: Naas General Hospital

Nomination Overview: In 2011, Ann Pilkington, Senior Pharmacy Technician, took up her new role in purchasing and procurement at Naas General Hospital. In 2013 Ann was selected to participate in The Health Information and Quality Authority’s (HIQA) program for education and training for frontline HSE staff. The object of the program is to provide support to the Irish health and social care system and to assist services and facilities to implement standards developed by HIQA. Ann has maintained a very high standard in her work. She delivers on all counts, efficiency, economy, professionalism and commitment.

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Hospital Pharmacy Representative of the Y�ear Award

Conor SadlierTitle: Key Account Manager | Company: Actavis

Nomination Overview: Conor works tirelessly on behalf of his customers to meet their demands and ensure Actavis always have product available to them. Internally to recognise this achievement he was promoted recently from Key Account Executive to Key Account Manager. Conor has been with Actavis for over 4 years and in that time has established strong relationships with their customers. He has a very strong customer service focused approach to his work. Everything he does is to ensure the customer is happy with our products, delivery and service. He goes the extra mile with training staff if there’s anything new within the Actavis portfolio.

He conducts his meetings in a professional manner to maximise his and his customers time and goes the extra mile with any query he gets managing it internally and liaising with the customer to always meet their needs.

Caroline ReidyTitle: Hospital Key Account Manager Specialty Care Business Unit | Company: Pfizer Healthcare Ireland

Nomination Overview: Caroline has been described as a keen and focussed professional who, along with Pfizer, supports innovation to help augment the safe use of medications in Irish hospitals including; intervention monitoring program designed with Irish hospital pharmacy departments used around the country in public and private hospitals; support towards e-learning medication safety programme; multilingual resource for pharmacists tool; promotion of safe practices undertaken to decrease risk (e.g. repackaging of products to lessen Sound Alike Look Alike Drug (SALAD) confusion and the Hospital Pharmacy Forum. The annual Pfizer hospital pharmacy forum run by Caroline and the Pfizer team provides a platform for hospital pharmacy to explore and develop pharmacy services. “She is a positive, dedicated and professional credit to both Pfizer, and her profession, and it’s always a pleasure to interact with her,” says her nominee.

THE INDEPENDENT VOICE OF HOSPITAL PHARMACY

Deirdre ConwayTitle: Senior Homecare and Pharmacy Specialist | Company: Baxter Healthcare Ltd

Nomination Overview: Deirdre has always ensured her customers know the reason for any stock problems and works tirelessly to ensure an alternative product is sourced, meaning the cancellation of multiple patients’ treatments was prevented. While stock outages can be frustrating, they are inevitable from time to time. Good initial communication and follow up information from the pharmacy representative is invaluable. Deirdre has worked closely with her customers this year on a number of projects, from the initial pilot stages, through work-arounds and fixes for high risk areas like Theatres and Accident and Emergency, to gradual roll-out. Her positive attitude, patience and reassurances have been much appreciated. She is always available at the end of the phone and responds to queries quickly. She always makes herself available if training for new products is required, and he nursing background means she is the ideal trainer at ward level.

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Are there medicines currently unavailable to your patient

in Ireland?

We can help...

www.medisource.ie | Call 1-890 2866366 | Fax 01 2866288 | Email [email protected]

227548-DPS-MEDISOURCE-AMA-IHCA.indd 2 05/09/2013 12:17:14Medisource Ad Sept 2013.indd 1 06/09/2013 10:06:11

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2014

Novartis Innovation and Service Development Award

Roisin DalyTitle: Chief Pharmacist | Pharmacy: Cavan Monaghan HospitalTeam Members: Diana Hogan Murphy, Senior Pharmacist; Judith Silao, Pharmacy; Martina McCabe, Pharmacy Technician

Submission Overview: Medicines management on medical wards – implementation of a pharmacy top up service. A pilot of a pharmacy top up service commenced on Medical 1 in February 2013 with one additional WTE pharmacy staff with the plan to roll out the service throughout the hospital. Several changes were identified and implemented to the service. These changes significantly reduced pharmacy time. Other benefits includes a reduction in medication errors, improved and safer patient care and a decrease in missed doses by patients.

Professor Ciaran MeeganPharmacy: Mater Misericordiae University Hospital | Team Members: Prof Ciarán Meegan, Ms Patricia Ging1, Ms Jennifer Brown1, Ms Maria Creed1, Ms Debbie Murray2, Prof Paul Gallagher3 . 1 Pharmacy Department MMUH, 2 Pharmacy Department Peamount Hospital, 3 School of Pharmacy RCSI

Submission Overview: An initiative between the Pharmacy Department, MMUH, Peamount Hospital and the School of Pharmacy RCSI, means that undergraduate pharmacy education in Ireland is undergoing an exciting and challenging transition from didactic learning delivered by academic staff to a patient centred clinical model delivered by hospital pharmacy practitioners. As a result of the partnership, undergraduate students receive lectures in therapeutics from hospital based clinical pharmacists, enhancing the contextualisation of material delivered. This synergistic collaboration has addressed an unmet need in Irish pharmacy undergraduate education.

Joan McGillycuddyPharmacy: Tallaght Hospital | Team Members: Joan McGillycuddy (Team Leader) Pharmacy staff, Consultants, NCHDs and Nurses

Submission Overview: Joan is Formulary Development Pharmacist and responsible for the continued development of the Tallaght Hospital Adult Medicines Guide and the development of the electronic version of this publication, the Tallaght Hospital Adult Medicines Guide App (The App) which was launched in October 2013. The new edition of the hard copy Adult Medicines Guide 2014/15, which was published in January 2014, now exceeds 500 pages of locally generated and approved recommendations, guidance and information which is essential to the non-specialist prescriber on a wide range of medicine related topics. The result is highly respected internal publication which is made available to many other hospitals on request.

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Novartis, leaders in innovation

Novartis, headquartered in Switzerland and is the only healthcare company with leading positions in pharmaceuticals, eye care, generics, vaccines, over the counter medicines and animal health. In Ireland, Novartis employs over 1,500 people in two manufacturing plants in Cork and commercial operations in Dublin, in Clonskeagh and Elm Park.

Innovation is key to Novartis. Novartis commitment to constantly invest in R&D (second highest investor in R&D worldwide - across all industries) feeds this innovation. As a result, Novartis is recognized for having an industry-leading pipeline with over 144 projects in clinical development of which, 30 are new molecules. One such molecule is Gilenya, the fi rst oral medication for relapsing , remitting multiple sclerosis which was launched in Ireland in 2012. As a result of having such a large pipeline, Novartis received three breakthrough therapy designations during 2013 from the US Food and Drug Administration (FDA) – among the highest number for any company. Already, in 2014, the FDA have also granted Novartis breakthrough therapy designation for Novartis cancer cell therapy CTL019 and fast track designation for LCZ696 in chronic heart failure with reduced ejection fraction. Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.

Novartis Research & Development in Ireland

Novartis is committed to R&D in Ireland. In 2013, ¤4m was invested in R&D and currently 26 clinical trials are being conducted in Ireland by Novartis, giving over 800 Irish patients earlier access to innovative medicines in cardiology, respiratory, ophthalmology, neurology, dermatology and oncology.

Loretto Callaghan, Country President and Managing Director of Novartis Ireland comments “At Novartis Ireland, our research is

driven by a clear scientifi c strategy. We focus on unmet medical needs. In Ireland we have a team of locally based medical advisors and a medical director who work closely with over forty of the country’s leading physicians across 20 different hospitals in Ireland. At the moment there are approximately 19 drugs being investigated in disease areas such as cancer, myeloproliferative disorders, multiple sclerosis, heart failure, age-related macular degeneration, respiratory conditions and psoriasis1.”

Google collaboration, extending Novartis’ lead in innovation

A further demonstration of Novartis’ leadership and investment in innovation is the recently announced Novartis-Google collaboration. Alcon, Novartis’ eye-care division, have in-licensed Google’s smart lens technology. The agreement is an important milestone, as it is a bringing together of Google’s expertise in miniaturization of sensors and batteries, together with Novartis and Alcon’s expertise in ophthalmology and vision correction. The collaboration is unique in the industry, and could bring together biology and technology in ways previously not imagined. This new technology has the potential to transform eye care and further enhance Alcon’s pipeline and global leadership in contact lenses and intraocular lenses. This also

helps Novartis take advantage of the opportunities that “wearable technologies” provide in disease management.

Innovations like wearable devices increase patient involvement in their own healthcare and connect patients more closely to their healthcare providers. In 2013, wearable devices generated ¤1.9 billion in revenues and it’s estimated that wearable technology represents a ¤7-37 billion market potential over the next fi ve years. Wearables can greatly improve patient disease management, but even more importantly, they have the potential to deliver therapeutic benefi t in eye care. This collaboration is a key step for Novartis to evolve technology to manage human disease.

Loretto Callaghan, Country President and Managing Director of Novartis Ireland adds, “With increasing pressures on the sustainability of healthcare systems worldwide, we need out of the

box thinking and to fully utilise the potential of new technology in healthcare. In Novartis, we support the vision of a sustainable healthcare system. We need a health system that empowers patients to make informed decisions about their health, that provides patients with early access to the best and safest medicines and supports innovation while balancing benefi t, risk and cost. Such a vision offers the most effective way to deliver the innovative medicines needed to tackle the current aging population and help to provide for a healthy and productive workforce”.

Innovation is critical to Novartis and to the future sustainability of healthcare in Ireland. Working with key stakeholders, like hospital pharmacists, on initiatives like the Hospital Pharmacy News Award in Innovation, is a key way to encourage this competency in the healthcare environment for the betterment of patients and healthcare in Ireland.

Company Profi le

Loretto Callaghan, Country President and Managing Directorof Novartis Ireland

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• Remicade is manufactured by MSD in Brinny, Co. Cork

• Over 1,700,000 patients treated1

• More than 13 years of market experience2

• Experience in a broad range of indications including CD, UC, RA, PSA and AS with a well-established safety and tolerability profile2

• Several thousand listed REMICADE (infliximab) clinical papers3

• Hundreds of registered clinical studies4

Remicade® 100mg Powder for Concentrate for Solution for Infusion (infliximab) Prescribing Information [Refer to full SPC text before prescribing Remicade (infliximab)] Indications: Rheumatoid Arthritis (RA): Remicade, in combination with methotrexate (MTX), is indicated for the reduction of signs and symptoms, as well as the improvement in physical function, in adult patients with active RA when the response to disease-modifying anti-rheumatic drugs (DMARDs), including MTX, has been inadequate; and in adult patients with severe, active and progressive disease not previously treated with MTX or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated. Adult Crohn’s Disease (CD): Remicade is indicated for the treatment of moderately to severely active CD in adult patients who have not responded to, or are intolerant of, a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; and fistulising active CD in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohn’s Disease (CD): Remicade is indicated for the treatment of severe, active CD in children and adolescents aged 6 to 17 years who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Ulcerative Colitis (UC): Remicade is indicated for the treatment of moderately to severely active UC in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric Ulcerative Colitis (UC): Remicade is indicated for treatment of severely active UC, in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Ankylosing Spondylitis (AS): Remicade is indicated for the treatment of severe, active AS, in adult patients who have responded inadequately to conventional therapy. Psoriatic Arthritis (PsA): Remicade is indicated for the treatment of active and progressive PsA, in adult patients when the response to previous DMARD drug therapy has been inadequate. Administration should be in combination with MTX or alone in patients who show intolerance to MTX or for whom MTX is contraindicated. A reduction in the rate of progression of peripheral joint damage in patients with polyarticular symmetrical subtypes of PsA has been measured by X-ray. Psoriasis (PsO): Remicade is indicated for the treatment of moderate to severe plaque PsO in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, MTX or PUVA. Dosage and administration: To improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded in the patient file. Remicade should be administered intravenously, initiated and supervised by physicians experienced in the diagnosis and treatment of RA, CD, UC, AS, PsA and PsO. Remicade should be administered intravenously over a 2 hour period. All patients administered Remicade should be observed for at least 1 to 2 hours post infusion for acute infusion-related reactions by appropriately trained healthcare professionals. Shortened infusions across adult indications: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Remicade (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour. If an infusion reaction occurs in association with a shortened infusion, a slower infusion rate may be considered for future infusions if treatment is to be continued. Shortened infusions at doses >6 mg/kg have not been studied. RA: 3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Adult moderately to severely active CD: 5mg/kg given as an intravenous infusion followed by an additional 5mg/kg infusion 2 weeks after the first infusion. If a patient does not response after 2 doses, no additional treatment should be given. Adult, fistulising, active CD: 5mg/kg intravenous infusion followed by additional 5mg/kg infusions at 2 and 6 weeks after first infusion. If a patient does not respond after 3 doses, no additional treatment should be given. UC: 5mg/kg given as an intravenous infusion followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks. Clinical response is usually achieved within 14 weeks of treatment (3 doses). AS: 5mg/kg given as an intravenous infusion followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. If a patient does not respond after 2 doses, no additional treatment should be given. PsA: 5mg/kg given as an intravenous infusion period followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. PsO: 5mg/kg given as an intravenous infusion followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks. If a patient shows no response after 4 doses, no additional treatment should be given. Readministration: Remicade can be readministered within 16 weeks following the last infusion. The safety and efficacy of readministration after a Remicade-free interval of more than 16 weeks has not been established in either CD or RA. The safety and efficacy of readministration in AS, other than every 6 to 8 weeks and in PsA and UC, other than every 8 weeks, has not been established. Readministration with one single Remicade dose in PsO after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen. Limited experience from retreatment, using a reinduction regimen suggests a higher incidence of infusion reactions, some serious, when compared to 8 weekly maintenance treatment. In case maintenance therapy is interrupted in any indication, and there is a need to restart treatment, Remicade should be reinitiated as a single dose followed by the maintenance dose recommendations. Paediatric population: CD (6 to 17 years): 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. If a patient does not respond by 10 weeks, no additional treatment should be given. UC (6 to 17 years): 5 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Available data do not support further infliximab treatment in paediatric patients not responding within the first 8 weeks of treatment. Contra-indications: Tuberculosis or other severe infections such as sepsis, abscesses and opportunistic infections; patients with a history of hypersensitivity to infliximab, other murine proteins or any of the excipients; patients with moderate or severe heart failure (NYHA class III/IV). Precautions and Warnings: Infusion reactions: Acute infusion reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion. If acute infusion reactions occur, the infusion must be interrupted immediately. Emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway must be available. Antibodies to infliximab may develop and have been associated with increased frequency of infusion reactions. Symptomatic treatment should be given and further Remicade infusions must not be administered. In clinical studies, delayed hypersensitivity reactions have been reported. Available data suggest an increased risk for delayed hypersensitivity with increasing Remicade-free intervals. Infections: Patients must be monitored closely for infections, including tuberculosis, before, during and up to 6 months after treatment with Remicade. Exercise caution with use of Remicade in patients with chronic infection or a history of recurrent infection. Patients should be advised of potential risk factors for infections. Suppression of TNFα may mask

Proud of our Heritage...

...Committed to our future

GAST

-112

0792

-000

0

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

symptoms of infection such as fever. Tuberculosis, bacterial infections including sepsis and pneumonia, invasive fungal, viral and other opportunistic infections, have been observed, some of which have been fatal. Infections were reported more frequently in paediatric populations than in adult populations. There have been reports of active tuberculosis in patients receiving Remicade. Patients should be evaluated for active or latent tuberculosis before Remicade treatment. All such tests should be recorded on the Patient Alert Card provided with the product. If active tuberculosis is diagnosed, Remicade therapy must not be initiated. If latent tuberculosis is diagnosed, treatment with anti-tuberculosis therapy must be initiated before initiation of Remicade. Patients on Remicade treatment should be advised to seek medical advice if symptoms of tuberculosis appear. An invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected in patients if a serious systemic illness is developed, a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage. Patients with fistulising CD and acute suppurative fistulas must not initiate Remicade therapy until possible source of infection is excluded. Hepatitis B (HBV) reactivation: Reactivation of HBV occurred in patients receiving Remicade who were chronic carriers. Some cases had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Remicade. Hepatobiliary events: Very rare cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis have been observed. Isolated cases of liver failure resulting in liver transplantation or death have occurred. Vaccinations: It is recommended that live vaccines not be given concurrently. Prior to initiating Remicade therapy it is recommended that paediatric patients be brought up to date with all vaccinations. Autoimmune processes: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Remicade and is positive for antibodies against double-stranded DNA, treatment must be discontinued. Neurological events: Anti-TNFα agents have been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of peripheral and CNS demyelinating disorders, including Guillain-Barré syndrome and multiple sclerosis. In patients with a history of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of Remicade therapy. Discontinuation of Remicade should be considered if these disorders develop. Malignancies and lymphoproliferative disorders: A risk of the development of lymphomas and other malignancies in patients (including children and adolescents) cannot be excluded. Caution is advised in patients with history of malignancy and in patients with increased risk for malignancy due to heavy smoking. Rare postmarketing cases of hepatosplenic T-cell lymphoma have been reported which were usually fatal. All Remicade cases have occurred in patients with CD or UC treated concomitantly with AZA or 6-MP. Caution should be exercised in patients with PsO and a medical history of extensive immunosuppressant therapy or prolonged PUVA treatment. Patients with UC at increased risk for, or with a prior history of dysplasia or colon carcinoma should be screened for dysplasia before therapy and at regular intervals throughout their disease course. Melanoma and Merkel cell carcinoma have been reported, periodic skin examination is recommended, particularly for patients with risk factors for skin cancer. Heart failure: Remicade should be used with caution in patients with mild heart failure (NYHA class I/II) and discontinued in face of new or worsening symptoms of heart failure. Others: Patients requiring surgery whilst on Remicade therapy should be closely monitored for infections. Haematologic reactions: Discontinuation of Remicade therapy should be considered in patients with confirmed significant haematologic abnormalities, including pancytopenia, leucopenia, neutropenia and thrombocytopenia. Special populations: Particular attention should be paid when treating the elderly (≥65 years) due to a greater incidence of serious infections seen in Remicade treated patients. Some of these had a fatal outcome. Interactions: No interaction studies have been performed. Combination of Remicade with other biological therapeutics used to treat the same conditions as Remicade, including anakinra and abatacept is not recommended. It is recommended that live vaccines and therapeutic infectious agents should not be given concurrently with Remicade Fertility, Pregnancy and Lactation: Women of childbearing potential should use adequate contraception and continue its use for at least 6 months after the last Remicade treatment. Administration of Remicade is not recommended during pregnancy or breast-feeding. Administration of live vaccines to infants exposed to infliximab in utero is not recommended for 6 months following the mother’s last infliximab infusion during pregnancy. Effects of infliximab on fertility and general reproductive function are unknown. Side-effects: Very Common ≥1/10: Viral infection, headache, upper respiratory tract infection, sinusitis, abdominal pain, nausea, infusion related reaction, pain. Common ≥1/100 to <1/10: Bacterial infections, neutropenia, leucopenia, anaemia, lymphadenopathy, allergic respiratory symptom, depression, insomnia, vertigo, dizziness, hypoaesthesia, paraesthesia, conjunctivitis, tachycardia, palpitation, hypotension, hypertension, ecchymosis, hot flush, flushing, lower respiratory tract infection, , dyspnoea, epistaxis, gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation,hepatic function abnormal, transaminases increased, new onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia, arthralgia, myalgia, back pain, urinary tract infection, chest pain, fatigue, fever, injection site reaction, chills and oedema. In phase 3 clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion related reaction. In post-marketing spontaneous reporting, infections are the most common serious adverse event. The most frequently reported opportunistic infections with a mortality rate of >5% include pneumocystosis, candidiasis, listeriosis and aspergillosis. Other less common and rarely reported side effects are listed in the SPC. Overdose: No case of overdose has been reported. Single doses up to 20mg/kg have been administered without toxic effects. Package Quantities: Type I vials, with rubber stoppers and aluminium crimps protected by plastic caps, containing a lyophilised powder (infliximab 100mg). Legal Category: POM Marketing Authorisation Number : EU/1/99/116/001 Marketing Authorisation Holder : Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands © Merck Sharp & Dohme Ireland (Human Health) Limited, 2013. All rights reserved. Date of Revision: July 2013 Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin 18 or from www.medicines.ie. Date of preparation: May 2014.References: 1. Data on file MSD PSUR 26, 2. Remicade SmPC, May 2014. 3. http://www.ncbi.nlm.nih.gov/pubmed/?term=Remicade+infliximab. Accessed 20 June 2013. 4. http://www clinicaltrials.gov/ct2/results?term=Remicade+Infliximab. Accessed 20 June 2013. AS = ankylosing spondylitis; CD = Crohn’s disease; PsA = psoriatic arthritis; RA = rheumatoid arthritis; UC = ulcerative colitis

Page 45: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

• Remicade is manufactured by MSD in Brinny, Co. Cork

• Over 1,700,000 patients treated1

• More than 13 years of market experience2

• Experience in a broad range of indications including CD, UC, RA, PSA and AS with a well-established safety and tolerability profile2

• Several thousand listed REMICADE (infliximab) clinical papers3

• Hundreds of registered clinical studies4

Remicade® 100mg Powder for Concentrate for Solution for Infusion (infliximab) Prescribing Information [Refer to full SPC text before prescribing Remicade (infliximab)] Indications: Rheumatoid Arthritis (RA): Remicade, in combination with methotrexate (MTX), is indicated for the reduction of signs and symptoms, as well as the improvement in physical function, in adult patients with active RA when the response to disease-modifying anti-rheumatic drugs (DMARDs), including MTX, has been inadequate; and in adult patients with severe, active and progressive disease not previously treated with MTX or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated. Adult Crohn’s Disease (CD): Remicade is indicated for the treatment of moderately to severely active CD in adult patients who have not responded to, or are intolerant of, a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; and fistulising active CD in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohn’s Disease (CD): Remicade is indicated for the treatment of severe, active CD in children and adolescents aged 6 to 17 years who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Ulcerative Colitis (UC): Remicade is indicated for the treatment of moderately to severely active UC in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric Ulcerative Colitis (UC): Remicade is indicated for treatment of severely active UC, in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Ankylosing Spondylitis (AS): Remicade is indicated for the treatment of severe, active AS, in adult patients who have responded inadequately to conventional therapy. Psoriatic Arthritis (PsA): Remicade is indicated for the treatment of active and progressive PsA, in adult patients when the response to previous DMARD drug therapy has been inadequate. Administration should be in combination with MTX or alone in patients who show intolerance to MTX or for whom MTX is contraindicated. A reduction in the rate of progression of peripheral joint damage in patients with polyarticular symmetrical subtypes of PsA has been measured by X-ray. Psoriasis (PsO): Remicade is indicated for the treatment of moderate to severe plaque PsO in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, MTX or PUVA. Dosage and administration: To improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded in the patient file. Remicade should be administered intravenously, initiated and supervised by physicians experienced in the diagnosis and treatment of RA, CD, UC, AS, PsA and PsO. Remicade should be administered intravenously over a 2 hour period. All patients administered Remicade should be observed for at least 1 to 2 hours post infusion for acute infusion-related reactions by appropriately trained healthcare professionals. Shortened infusions across adult indications: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Remicade (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour. If an infusion reaction occurs in association with a shortened infusion, a slower infusion rate may be considered for future infusions if treatment is to be continued. Shortened infusions at doses >6 mg/kg have not been studied. RA: 3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Adult moderately to severely active CD: 5mg/kg given as an intravenous infusion followed by an additional 5mg/kg infusion 2 weeks after the first infusion. If a patient does not response after 2 doses, no additional treatment should be given. Adult, fistulising, active CD: 5mg/kg intravenous infusion followed by additional 5mg/kg infusions at 2 and 6 weeks after first infusion. If a patient does not respond after 3 doses, no additional treatment should be given. UC: 5mg/kg given as an intravenous infusion followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks. Clinical response is usually achieved within 14 weeks of treatment (3 doses). AS: 5mg/kg given as an intravenous infusion followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. If a patient does not respond after 2 doses, no additional treatment should be given. PsA: 5mg/kg given as an intravenous infusion period followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. PsO: 5mg/kg given as an intravenous infusion followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks. If a patient shows no response after 4 doses, no additional treatment should be given. Readministration: Remicade can be readministered within 16 weeks following the last infusion. The safety and efficacy of readministration after a Remicade-free interval of more than 16 weeks has not been established in either CD or RA. The safety and efficacy of readministration in AS, other than every 6 to 8 weeks and in PsA and UC, other than every 8 weeks, has not been established. Readministration with one single Remicade dose in PsO after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen. Limited experience from retreatment, using a reinduction regimen suggests a higher incidence of infusion reactions, some serious, when compared to 8 weekly maintenance treatment. In case maintenance therapy is interrupted in any indication, and there is a need to restart treatment, Remicade should be reinitiated as a single dose followed by the maintenance dose recommendations. Paediatric population: CD (6 to 17 years): 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. If a patient does not respond by 10 weeks, no additional treatment should be given. UC (6 to 17 years): 5 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Available data do not support further infliximab treatment in paediatric patients not responding within the first 8 weeks of treatment. Contra-indications: Tuberculosis or other severe infections such as sepsis, abscesses and opportunistic infections; patients with a history of hypersensitivity to infliximab, other murine proteins or any of the excipients; patients with moderate or severe heart failure (NYHA class III/IV). Precautions and Warnings: Infusion reactions: Acute infusion reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion. If acute infusion reactions occur, the infusion must be interrupted immediately. Emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway must be available. Antibodies to infliximab may develop and have been associated with increased frequency of infusion reactions. Symptomatic treatment should be given and further Remicade infusions must not be administered. In clinical studies, delayed hypersensitivity reactions have been reported. Available data suggest an increased risk for delayed hypersensitivity with increasing Remicade-free intervals. Infections: Patients must be monitored closely for infections, including tuberculosis, before, during and up to 6 months after treatment with Remicade. Exercise caution with use of Remicade in patients with chronic infection or a history of recurrent infection. Patients should be advised of potential risk factors for infections. Suppression of TNFα may mask

Proud of our Heritage...

...Committed to our future

GAST

-112

0792

-000

0

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

symptoms of infection such as fever. Tuberculosis, bacterial infections including sepsis and pneumonia, invasive fungal, viral and other opportunistic infections, have been observed, some of which have been fatal. Infections were reported more frequently in paediatric populations than in adult populations. There have been reports of active tuberculosis in patients receiving Remicade. Patients should be evaluated for active or latent tuberculosis before Remicade treatment. All such tests should be recorded on the Patient Alert Card provided with the product. If active tuberculosis is diagnosed, Remicade therapy must not be initiated. If latent tuberculosis is diagnosed, treatment with anti-tuberculosis therapy must be initiated before initiation of Remicade. Patients on Remicade treatment should be advised to seek medical advice if symptoms of tuberculosis appear. An invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected in patients if a serious systemic illness is developed, a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage. Patients with fistulising CD and acute suppurative fistulas must not initiate Remicade therapy until possible source of infection is excluded. Hepatitis B (HBV) reactivation: Reactivation of HBV occurred in patients receiving Remicade who were chronic carriers. Some cases had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Remicade. Hepatobiliary events: Very rare cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis have been observed. Isolated cases of liver failure resulting in liver transplantation or death have occurred. Vaccinations: It is recommended that live vaccines not be given concurrently. Prior to initiating Remicade therapy it is recommended that paediatric patients be brought up to date with all vaccinations. Autoimmune processes: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Remicade and is positive for antibodies against double-stranded DNA, treatment must be discontinued. Neurological events: Anti-TNFα agents have been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of peripheral and CNS demyelinating disorders, including Guillain-Barré syndrome and multiple sclerosis. In patients with a history of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of Remicade therapy. Discontinuation of Remicade should be considered if these disorders develop. Malignancies and lymphoproliferative disorders: A risk of the development of lymphomas and other malignancies in patients (including children and adolescents) cannot be excluded. Caution is advised in patients with history of malignancy and in patients with increased risk for malignancy due to heavy smoking. Rare postmarketing cases of hepatosplenic T-cell lymphoma have been reported which were usually fatal. All Remicade cases have occurred in patients with CD or UC treated concomitantly with AZA or 6-MP. Caution should be exercised in patients with PsO and a medical history of extensive immunosuppressant therapy or prolonged PUVA treatment. Patients with UC at increased risk for, or with a prior history of dysplasia or colon carcinoma should be screened for dysplasia before therapy and at regular intervals throughout their disease course. Melanoma and Merkel cell carcinoma have been reported, periodic skin examination is recommended, particularly for patients with risk factors for skin cancer. Heart failure: Remicade should be used with caution in patients with mild heart failure (NYHA class I/II) and discontinued in face of new or worsening symptoms of heart failure. Others: Patients requiring surgery whilst on Remicade therapy should be closely monitored for infections. Haematologic reactions: Discontinuation of Remicade therapy should be considered in patients with confirmed significant haematologic abnormalities, including pancytopenia, leucopenia, neutropenia and thrombocytopenia. Special populations: Particular attention should be paid when treating the elderly (≥65 years) due to a greater incidence of serious infections seen in Remicade treated patients. Some of these had a fatal outcome. Interactions: No interaction studies have been performed. Combination of Remicade with other biological therapeutics used to treat the same conditions as Remicade, including anakinra and abatacept is not recommended. It is recommended that live vaccines and therapeutic infectious agents should not be given concurrently with Remicade Fertility, Pregnancy and Lactation: Women of childbearing potential should use adequate contraception and continue its use for at least 6 months after the last Remicade treatment. Administration of Remicade is not recommended during pregnancy or breast-feeding. Administration of live vaccines to infants exposed to infliximab in utero is not recommended for 6 months following the mother’s last infliximab infusion during pregnancy. Effects of infliximab on fertility and general reproductive function are unknown. Side-effects: Very Common ≥1/10: Viral infection, headache, upper respiratory tract infection, sinusitis, abdominal pain, nausea, infusion related reaction, pain. Common ≥1/100 to <1/10: Bacterial infections, neutropenia, leucopenia, anaemia, lymphadenopathy, allergic respiratory symptom, depression, insomnia, vertigo, dizziness, hypoaesthesia, paraesthesia, conjunctivitis, tachycardia, palpitation, hypotension, hypertension, ecchymosis, hot flush, flushing, lower respiratory tract infection, , dyspnoea, epistaxis, gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation,hepatic function abnormal, transaminases increased, new onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia, arthralgia, myalgia, back pain, urinary tract infection, chest pain, fatigue, fever, injection site reaction, chills and oedema. In phase 3 clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion related reaction. In post-marketing spontaneous reporting, infections are the most common serious adverse event. The most frequently reported opportunistic infections with a mortality rate of >5% include pneumocystosis, candidiasis, listeriosis and aspergillosis. Other less common and rarely reported side effects are listed in the SPC. Overdose: No case of overdose has been reported. Single doses up to 20mg/kg have been administered without toxic effects. Package Quantities: Type I vials, with rubber stoppers and aluminium crimps protected by plastic caps, containing a lyophilised powder (infliximab 100mg). Legal Category: POM Marketing Authorisation Number : EU/1/99/116/001 Marketing Authorisation Holder : Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands © Merck Sharp & Dohme Ireland (Human Health) Limited, 2013. All rights reserved. Date of Revision: July 2013 Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin 18 or from www.medicines.ie. Date of preparation: May 2014.References: 1. Data on file MSD PSUR 26, 2. Remicade SmPC, May 2014. 3. http://www.ncbi.nlm.nih.gov/pubmed/?term=Remicade+infliximab. Accessed 20 June 2013. 4. http://www clinicaltrials.gov/ct2/results?term=Remicade+Infliximab. Accessed 20 June 2013. AS = ankylosing spondylitis; CD = Crohn’s disease; PsA = psoriatic arthritis; RA = rheumatoid arthritis; UC = ulcerative colitis

Page 46: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

Issue 14 • HPN

46

Issue 14 • HPN

The finalists

46

The finalistsAwardsHospital Pharmacy

2014

Idis Hospital Pharmacist of the Y�ear Award

Dawn DavinTitle: Senior Pharmacist | Pharmacy: Tallaght Hospital

Nomination Overview: Dawn is a highly skilled and competent pharmacist and has excelled in the many areas that she has worked in over the years. She has amassed vast clinical knowledge, in particular in her areas of expertise of renal medicine and cardiology. Dawn endeavors to use this knowledge and skill to provide excellent patient care and to draft robust and up-to-date guidelines for the healthcare professionals working with her. As a clinical pharmacist, Dawn has also a keen interest in improving patient services. She has delivered talks on medications to patients enrolled in Tallaght Hospital cardiac rehabilitation programme and respiratory rehabilitation programme. Dawn constantly strives to promote the profession of pharmacy amongst all healthcare professionals and has participated in many multi-disciplinary projects and teams highlighting the role of the pharmacist and the contribution that they can make.

Jennifer BrownTitle: Pharmacy Head of Operations | Pharmacy: Mater Misericordiae University Hospital

Nomination Overview: Jennifer Brown was appointed as a Chief 1 Pharmacist Pharmacy Head of Operations in the Mater Misericordiae University Hospital (MMUH) in 2013. This is a new role both in the MMUH and in hospital pharmacy in Ireland. This innovative appointment provided an opportunity to forge a new position both within the pharmacy department and hospital wide. Jennifer assumed the role of hospital lead for the Prescriber’s Guide and drugs formulary on behalf of the Drugs and Therapeutics (D&T) Committee. Jennifer is held in high esteem by all colleagues, both within the pharmacy department and throughout the hospital. Her approachability and compassion ensure that pharmacy staff view her as an equitable, open-minded and empathetic manager. Her professionalism and high standard of work showcase the pharmacy department to the hospital’s senior management while also ensuring confidence and pride from her pharmacy colleagues.

Peter JacobTitle: Chief Pharmacist | Pharmacy: Beaumont Hospital Pharmacy Department

Nomination Overview: Peter has been instrumental in the development of hospital pharmacy services not only in Beaumont but also in Ireland during his 25 years of service as Chief Pharmacist in Beaumont. He has expanded the role of pharmacy staff throughout the hospital despite resource challenges. As a member of the HPAI Executive Committee, Peter was heavily involved in the initial career structure talks which are finally coming to a close. His “hands on attitude” has found him willing to work alongside staff when resources are limited. His “minding the shop” approach when staff shortages occur, finds him rolling up sleeves and doing pharmacist and technician work as needs be to get the job done and provide the service the pharmacy is committed to.

Page 47: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

47

HPN • Issue 14

News

Clinical oncology latest discussed in Dublin

Hospital Pharmacists and allied healthcare professionals gathered locally to discuss some of the latest research fi ndings in the fi eld of oncology.

Research included that from MSD, (known as Merck in the United States and Canada), recently announced new data from the company’s large ongoing Phase 1b study (KEYNOTE-001) evaluating pembrolizumab, MSD’s investigational anti-PD-1 antibody, as a single agent (monotherapy) in 411 patients with advanced melanoma. Following treatment with pembrolizumab, the estimated overall survival (OS) rate at one year was 69 percent across all patients studied, including 74 percent in patients without prior ipilimumab therapy (current standard therapy) and 65 percent in patients who had progressive disease on or following ipilimumab. At 18 months, the estimated OS was 62 percent. The median OS has not been reached, with some patients receiving treatment with pembrolizumab as monotherapy for more than two years.

“Melanoma is not a common cancer but each year about 720 people are diagnosed with this disease in Ireland,” said Dr Paul Donnellan, Consultant Medical Oncologist at Galway University Hospital. “Thankfully most patients have early stage disease and are cured by surgery. But for those with metastatic disease the prognosis and response rates to drug treatments have been abysmal. However we are now seeing some long term survivors with use of immunotherapy including anti-CTLA4 and anti-PD1 agents in particular. The phase 1 clinical trial of the anti-PD1 agent pembrolizumab (MK-3475) presented at ASCO this year makes it likely that we will soon have another very active drug to offer to our patients with metastatic malignant melanoma.”

The 11th Post ASCO Highlights Meeting was recently held in the Herbert Park Hotel, Ballsbridge, Dublin. The meeting was supported by Astellas, Roche, Merck Serono, BMS.

1: Prof. John McCaffrey, Mater Misericordiae University Hospital, Dr. Grainne O'Kane, Mater Misericordiae University Hospital, Prof. Des Carney, Mater Misericordiae University Hospital, Michael Rooney, Merck and Suzanne Ennis, Astellas Pharma Co. Ltd.

2: Oleh Martynyuk, AMNCH Tallaght Hospital, Salvador Figueroa, Roche Ireland and Nataliya Rozumna, Mater Misericordiae University Hospital.

3: Fionnuala King, St James’s Hospital, Suzanne Ennis, Astellas Pharma Co. Ltd, and Nuala Hannon, Hannon Oncology Education Ltd.

4: Liz Summersby and Niamh Thornton, Our Lady of Lourdes Hospital, Drogheda.

5: Sandra Reynolds, BMS, Niamh Devery, and Katrina Doherty, St. Vincent’s Private Hospital.

6: Eilish Duignan, and Anne Campbell, St. James’s Hospital.

7: Dr. Jennifer Westrup, UPMC Beacon Hospital, Dublin.

1

2

3

4

5

6

7

Page 48: HOSPITAL PHARMACY NEWS IRELAND - ISSUE 14 - 2014

48

Issue 14 • HPN

Biomarker findings from Crystal Study

News

Pharmacy researchers discover new biomarker

Merck Serono, the biopharmaceutical division of Merck, has announced new biomarker findings from a retrospective analysis of the completed Phase III study CRYSTAL that compared Erbitux® (cetuximab) plus FOLFIRI with FOLFIRI alone. The analysis involved a subgroup of patients with KRAS wild-type (exon 2) metastatic colorectal cancer (mCRC). An increase in median Overall Survival (mOS) was observed in patients with RAS wild-type tumours when Erbitux was added to FOLFIRI in 1st line mCRC.1

In this new analysis, 430 (65% of 666 patients) patient tumour

samples with wild-type KRAS (exon 2) status were assessed for additional RAS mutations (defined as mutations in exons 3 or 4 of KRAS and/or exons 2, 3 or 4 of NRAS). Of these, 367 were RAS wild-type, while

63 presented a mutation. The analysis shows a 27.7% increase in response rate (RR), a

3.0-month increase in median progression-free survival (PFS), and an 8.2-month increase in median overall survival (OS) in mCRC patients with RAS wild-type tumours receiving 1st line Erbitux plus FOLFIRI (n=178), compared with patients receiving FOLFIRI alone (n=189)

Local Scientists have made a significant discovery of a new biomarker which may help overcome resistance to newer and more targeted anti-cancer drugs, such as Herceptin, for HER2 positive cancers. These findings may also help the early identification of patients who will benefit more from these treatments.

The researchers, led by Professor Lorraine O’Driscoll, Associate

Professor of Pharmacology, Trinity, studied breast cancer cells and their extracellular vesicles (exosomes), which are 'packages' of information released out of cells. They discovered a molecule called Neuromedin U (NmU) which is strongly associated with resistance to the new anti-cancer drugs for HER2 positive cancers. This suggests NmU could be used as a biological marker to indicate the likelihood of responsiveness in a particular patient and may also be very important in the management

Prof Lorraine O'Driscoll

of resistance to these drugs. The findings have just been published in leading international, peer reviewed journal: Cancer Research, the most frequently cited cancer journal in the world.

Speaking about the challenges some patients face with these newer anti-cancer drugs, Professor O'Driscoll said, "Many patients with HER2 positive tumours gain huge benefit from these drugs. Unfortunately, however, some

who seem suitable candidates based on a HER2 test, don't gain the maximum intended benefit from these treatments. They may have a natural level of resistance to the treatment which is not detectable with currently available tests, while some other patients respond at first but may then become unresponsive or develop resistance to the treatments."

Professor O'Driscoll continued: "Clinicians urgently need ways of predicting which patients with 'HER2 tumours' are likely to gain real benefit, both to ensure patients are given the optimal treatments and to ensure these very costly drugs are used where they will have the most benefit. Our discovery may offer a new way to predict or identify both innate and acquired resistance, overcome it and potentially block or prevent resistance. This would allow patients to get the full benefit from these particular anti-cancer treatments and help other patients to be more quickly identified and receive the treatment options which are more appropriate for them."

(RR: 66.3% vs. 38.6%, respectively; odds ratio: 3.11; 95% confidence interval [CI]: 2.03–4.78; p<0.0001; PFS: median 11.4 months vs. 8.4 months, respectively; hazard ratio [HR]: 0.56; 95% CI: 0.41–0.76; p=0.0002; OS: median 28.4 months vs. 20.2 months, respectively; HR: 0.69; 95% CI: 0.54–0.88; p=0.0024).1

Dr Ray McDermott, Consultant Medical Oncologist, St. Vincent’s University Hospital, Dublin, said “Biomarker testing in colorectal cancer is important to inform our treatment options so that we can ensure that patients in Ireland can get the best treatment. The updated RAS wild type data being

presented at ASCO reinforces the importance of personalised testing for colorectal cancer patients in Ireland.”

Following an update to the Erbitux label that was approved by the European Commission in December 2013, Erbitux is now indicated for the treatment of patients with epidermal growth factor receptor-expressing RAS wild-type mCRC in combination with irinotecan-based chemotherapy, in 1st line in combination with FOLFOX, or as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

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HPN • Issue 14

Clinical Profiles

Bristol Myers Squibb and Pfizer Healthcare Ireland announced Eliquis as the first Factor Xa inhibitor to include information on cardioversion in its product information

The Summary of Product Characteristics (SmPC) for Eliquis® has been updated to include the statement that “patients can stay on Eliquis® while being cardioverted.” The SmPC update

FIRST INHIBITOR TO INCLUDE INFORMATION ON CARDIOVERSION

was based on a post-hoc sub-analysis of the outcomes of the landmark ARISTOTLE study.

The ARISTOTLE study was designed to evaluate the efficacy and safety of Eliquis® compared to warfarin for reduction of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). In ARISTOTLE, 540 patients underwent 743 cardioversions for NVAF. The outcomes of patients

treated with Eliquis® compared to those treated with warfarin were assessed in the 30 days following cardioversion attempts. Adverse clinical events occurring after cardioversion were found to be comparable between the warfarin and Eliquis® groups with no reported stroke or systemic emboli in either group and low observed rates of myocardial infarction and major bleeding.

Pfizer receives European approval for Vfend® in prophylaxis of invasive fungal infections in high-risk allogeneic hematopoietic stem cell transplant (alloHSCT) recipients

The European Commission’s decision to approve Vfend® for prophylaxis of IFIs in high-risk alloHSCT recipients is based on phase III clinical trials (IMPROVIT and VOSIFI studies) showing the effectiveness of Vfend® for primary and secondary prophylaxis of IFIs in alloHSCT recipients.2,3

Vfend® is available in both oral and IV formulations, making

PFIZER HEALTHCARE RECEIVES EUROPEAN APPROVAL FOR VFEND®

it convenient for patients and clinicians, and the recommended dosing for prophylaxis is the same as the well-established regimen for Vfend® in the treatment of IFIs.

“Vfend® is already the standard first line therapy for the treatment of invasive aspergillosis and the new indication is supported by extensive clinical evidence clearly demonstrating the efficacy of Vfend® in both primary and secondary prophylaxis of IFIs in the alloHSCT setting,” said Dr Declan O’Callaghan, Medical Director, Pfizer Healthcare Ireland.

In the prospective, randomized,

open-label, multicentre IMPROVIT study of primary antifungal prophylaxis in alloHSCT recipients, success of prophylaxis in patients receiving Vfend® was superior to itraconazole (48.7% vs 33.2%, p<0.01).2 Success of prophylaxis (primary composite endpoint) was defined as the ability to tolerate study drug for at least 100days, with ≤14 days interruption with survival with no proven or probable IFI to Day 180.2 In the study, Vfend® was better tolerated than itraconazole for longer durations. In addition, there was less need for other systemic antifungals compared with itraconazole.

Astellas Pharma Inc. and Medivation, Inc. announced the online publication in the New England Journal of Medicine of the results from the Phase 3 PREVAIL trial. The PREVAIL trial is an international, randomised, double-blind, placebo-controlled clinical study of enzalutamide (XTANDITM) in men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of

RESULTS FROM PROSTATE CANCER TRIAL

androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

About XTANDI™

XTANDI is a novel, oral, once-daily androgen receptor signalling inhibitor. XTANDI directly targets the androgen receptors (AR) and exerts its effects on all three steps of AR signalling pathway:

• Blocks androgen binding o Androgen binding induces a conformational change that triggers activation of the receptor

• Prevents nuclear translocation o Transit of the AR to the nucleus is an essential step in AR-mediated gene regulation

• Impairs DNA binding

KRKA bring Valsartan HCTZ KRKA 320/25mg, 320/12.5mg to market.

KRKA Pharmaceuticals are happy to announce the launch of another exclusive molecule to the generic market. Valsartan HCTZ KRKA 320/12.5mg and 320.25mg are the only generic options for Valsartan HCTZ 320mg available on the Irish market. This addition to our portfolio allows us to offer unique options to our customers with an exclusive and unique Valsartan and

KRKA LAUNCH TWO ADDITIONS TO PORTFOLIO

Valsartan HCTZ portfolio.

KRKA launch Azithromycin KRKA 250mg

KRKA Pharmaceuticals are happy to announce the launch of their Azithromycin KRKA 250mg. Azithromycin is one of the most recent additions to our rapidly growing portfolio. KRKA joined the Irish market just over three years ago. We have rapidly increased our portfolio and now offer over 40 molecules ranging over 100 SKU’s. We believe that

our success and strong growth in this marked is down to our transparent way of dealing with our customers and partners alike. We believe that in a market that is changing to the degree that the healthcare market is, it is crucial to make things as simple and easy as possible. We strive to provide quality products to our customers through a consistent and reliable supply chain. Azithromycin KRKA is our most recent addition to our commitment of achieving and maintaining that goal.

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Issue 14 • HPN

Data from the international, multicenter Phase 3 PCYC-1112 (RESONATETM) trial in 391 patients suggest monotherapy ibrutinib administered once-daily signifi cantly lengthened progression-free survival (PFS) (median not reached vs. 8.1 months; HR 0.215, 95% CI, 0.146 to 0.317; P<0.0001) and overall survival (OS) (HR 0.434; 95 CI, 0.238 to 0.789; P=0.0049) versus ofatumumab administered intravenously in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Ibrutinib is an investigational compound in the EU within a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors*.

RESONATE TRIAL DATA RELEASED

Janssen announced that this data has been published in a special edition of The New England Journal of Medicine. In 2011, Janssen and Pharmacyclics Inc. entered into an agreement to jointly develop and commercialise ibrutinib.

PFS is the primary endpoint of the RESONATE study, with OS, overall response rate (ORR) and safety as key secondary endpoints. The results from the RESONATE study showed ibrutinib monotherapy signifi cantly improved PFS, OS and ORR in the diffi cult-to-treat patient population, regardless of baseline characteristics. The median PFS in the ibrutinib arm was not reached because progression events occurred more

slowly than in the ofatumumab arm. The PFS results represent a 79% reduction in the risk of progression or death in patients treated with ibrutinib compared to ofatumumab. The OS median was also not reached in either arm because progression events occurred slowly. The OS results represent a 57% reduction in the risk of death in patients receiving ibrutinib versus those in the ofatumumab arm.

Additionally, the ORR was signifi cantly higher in patients taking ibrutinib monotherapy versus ofatumumab monotherapy, regardless of response criteria or baseline characteristics.

Aspirin fi lm-coated tablets are indicated for:

• Secondary prevention of myocardial infarction

• Prevention of cardiovascular morbidity in patients suffering from stable angina pectoris

• History of unstable angina pectoris, except during the acute phase

CLONMEL HEALTHCARE ARE LAUNCHING ASPIRIN 75MG GASTRO-RESISTANT TABLETS.

• Prevention of graft occlusion after Coronary Artery Bypass Grafting (CABG)

• Coronary angioplasty, except during the acute phase

• Secondary prevention of transient ischaemic attacks (TIA) and ischaemic cerebrovascular accidents (CVA) provided intracerebral haemorrhages have

been ruled out

Aspirin gastro-resistant tablets are available in a 28 pack size. Aspirin gastro-resistant tablets are GMS reimbursable. Full prescribing information is available on request or alternatively please go to www.clonmel-health.ie. Product is subject to medical prescription.

Sucampo has announced that the UK’s National Institute of Health and Care Excellence (NICE) has published the technology appraisal guidance recommending the use of AMITIZA® (lubiprostone).

The drug is used in the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults who have failed laxatives.

The NICE guidance recommends AMITIZA as an option for treating CIC for adults in whom treatment

NICE GUIDANCE ON AMITIZA

with at least two laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and for whom invasive treatment for constipation is being considered.

"We are pleased that NICE has published its recommendation for AMITIZA today, as this will make AMITIZA more widely accessible to patients in the U.K. who may benefi t from it,” stated Peter Greenleaf, Chief Executive Offi cer

of Sucampo. “Through more than eight years of experience and eight million prescriptions dispensed globally, AMITIZA has been demonstrated to be an effective treatment option with a well-tolerated safety profi le. Today’s NICE recommendation for AMITIZA is an important step in allowing us to fulfi l Sucampo’s mission of meeting unmet patient needs in the U.K., and on a global basis."

Save money on your drug budget and continue to use the most effective dry mouth products on the market!

BioXtra Gel Mini Pack and BioXtra Mouth Rinse Mini Pack are now available to order from Allphar Services.

The BioXtra Gel Mini Pack contains 20 x 15ml tubes. This allows you the following

• Greater Flexibility which saves you money! (20 patients per pack at ¤12.99 versus 4 patients on standard stock tube)

SAVE MONEY ON DENTAL PRODUCTS

• Smaller tubes which mean Less Wastage

• No risk of Cross Infection (one tube per patient, no sharing)

The BioXtra Mouth Rinse Mini Pack offers you the same convenience at a cost of just ¤11.99 for 12 x 30ml mini bottles.

These products are now available to you directly from Allphar Services.

To order please ring 01 4688456.

Clinical Profi les

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51

HPN • Issue 14

Appointments

Leo Varadkar TD was appointed Minister for Health on July 11, 2014. He previously served as Minister for Transport, Tourism and Sport from March 9, 2011 to July 11, 2014. He represents the constituency of Dublin West and was first elected to Dáil Éireann in 2007. Leo first ran for election in the 1999 Local Election for Mulhuddart at the age of 20, and received 380 votes. He is a qualified GP, having studied Medicine at Trinity College Dublin.

L�eo Varadkar TD

The Pharmaceutical Group of the European Union has elected Mr Darragh O'Loughlin from the Irish Pharmacy Union (IPU) as PGEU President for 2015. Ireland, which became a full member of PGEU in 1964, will take over the PGEU Presidency for the third time since its creation. Secretary General of the Irish Pharmacy Union since 2013 and previously its President (2010 - 2012), Mr O'Loughlin has been Treasurer and IPU representative for European Affairs in PGEU since 2013.

Mr Darragh O'L�oughlin

The Pharmaceutical Society of Ireland has elected a new Vice-President, Dr Ann Frankish. Ann Frankish has also previously been on the PSI Council and has served as Vice-President and President prior to the introduction of the Pharmacy Act of 2007, which established the current regulatory system. She graduated from the UK and first registered with the PSI in 1982. For the past 26 years she has served as Chief Pharmacist in the Rotunda Hospital, Dublin, a post from which she has recently retired. Ann has had a long career in pharmacy, in a variety of settings including community, hospital, and academia and has recently taken up a role in industry. Ann follows Noel Stenson as Vice-President.

Dr Ann Frankish

Professor Frank KeeA Queen’s University Professor had been appointed Chair of the National Institute for Health Research (NIHR) Public Health Research Programme.

Professor Frank Kee, Director of the Centre of Excellence for Public Health NI and Deputy Director of the Centre for Public Health at Queen’s University, joins Professor Martin White from Newcastle University who is the newly appointed Director of the programme.

Professor Frank Kee and Professor Martin White succeed Professor Catherine Law, whose term of office is due to come to an end in 2014.

Joan Peppard has been elected as the next President of the European Association of Hospital Pharmacists (EAHP), commencing a 3 year term of office from June 2015. She will now serve one year as President Elect during the final 12 months of Dr Roberto Frontini’s Presidency of the Association. Joan, a chief pharmacist in a hospital in the Irish midlands, currently serves on the EAHP Board as Director of Professional Development and has twice been the head of the Hospital Pharmacists Association of Ireland in the position of President.

Joan Peppard

Ms. L�eonie ClarkeThe Council of the Pharmaceutical Society of Ireland (PSI), the pharmacy regulator, has elected a new President, Ms. Leonie Clarke. Leonie Clarke has served on the PSI Council since 2010, studied pharmacy in Trinity College Dublin and holds an MSc by research and diplomas in legal studies and accounting and finance. She runs her own pharmaceutical consultancy, focusing primarily on compliance with medicines legislation, corporate governance and quality management.

Martina McCabe Martina McCabe has recently taken up position as Hospital Pharmacy Technician with Kevin General Hospital. Martina joins the team here having formerly been with the Tallaght Hospital.

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MEDICINES MANAGEMENT PROGRAMME

Visit www.hse.ie/yourmedicines for more information.

So remember:

Thinking PPI? Think LANSOPRAZOLE.

Thinking Statin? Think SIMVASTATIN.

Thinking ACE Inhibitor? Think RAMIPRIL.

Prescribing preferred drugs can save a massive €19.5 million a year.Creating savings without affecting frontline services while maintaining health outcomes.

Thinking ARB? Think CANDESARTAN.

Thinking SSRIs? Think CITALOPRAM.

Thinking SNRIs? Think VENLAFAXINE.