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HPN September 2016

Issue 30

HOSPITAL PROFESSIONAL NEWS IRELAND Ireland’s Dedicated Hospital Professional Publication

Finalists Edition

IN THIS ISSUE: NEWS: Doctor immigration presents serious concerns Page 5 PROFILE: Co-ordinating action against the superbug threat Page 8 REPORT: Stroke largely preventable says study Page 15 For more information please contact your local Lilly Representative

FEATURE: Excellence in Childhood Psychiatry Page 21 CPD: The Management of Psoriasis in Ireland Page 27

TRULICITY® (DULAGLUTIDE) Legal Category POM Marketing Authorisation Numbers and Holder: EU/1/14/956/002, EU/1/14/956/007. Eli Lilly Nederland B.V., Grootslag 1 5, NL 3991 RA Houten, The Netherlands. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Additional information is available on request from Eli Lilly and Co (Ireland) Ltd., Hyde House, 65 Adelaide Road, Dublin 2, Ireland. This medicinal product is subject to additional monitoring. ® TRULICITY and LILLY are registered trade marks of Eli Lilly and Company. © 2015 Eli Lilly and Company. IEDUA00017c - December 2015

MEL3697 MIMS A5.indd 1

AWARDS: The Hospital Professional Awards 2016 Finalists Page 34 08/12/2015 15:27


3

HPN September 2016 Issue 30

Contents

Foreword

Frontline hospital budgets at unrealistic levels P6

Editor

Kelly Jo Eastwood The ability to treat infection with antimicrobial agents represented one of the major technological triumphs of the 20th century. Millions of lives have been saved or improved globally since the discovery of penicillin, and other antimicrobial agents.

Breast cancer trial opens in Ireland P12 6

Calls for special Brexit Committee to deal with the implications for the pharmaceutical industry P16 Ireland gets behind campaign to eliminate Hepatitis C P24 Exclusive look at the 2016 Hospital Professional Award Finalists P34

While progress has been made in larger hospitals in implementing best practice in managing and using antibiotics, the level of progress identified varied across the country, with some smaller hospitals not having safe and sustainable measures in place to protect patients. In addition, more effective national planning and coordination is required to ensure that the entire health system is as prepared as it can be for what is an increasing and serious challenge for healthcare providers.

12

Turn to page 8 for the full story.

Regulars Feature: Childhood Lymphoma P19

34

Event Gallery P52 52

Hospital Professional 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 ¤60 plus vat per year All rights reserved by Hospital Professional News. All material published in Hospital Professional News is copyright and no part of this magazine may be reproduced, stored in a retrieval system of transmitted in any form without written permission. Pharmacy Communication Ireland have taken every care in compiling the magazine to ensure that it is correct at the time of going to press, however the publishers assume no responsibility for any effects from omissions or errors.

PUBLISHER IPN Communications Ireland Ltd Clifton House, Lower Fitzwilliam Street, Dublin 2 (01) 669 0562 MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com EDITOR Kelly Jo Eastwood kjeastwood@hotmail.com 00447876548989 ACCOUNTS Rachel Wilson cs.ipn@btconnect.com

We also report on the news that international recruitment is not an effective long-term strategy for addressing shortages of doctors, with only around one third of foreign doctors planning to remain in Ireland. The latest research from RCSI has shown that there is a consistent pattern of findings. The same problems in how to manage the medical workforce here, whether it is the doctors being trained or those recruited from overseas, are leading to large numbers leaving for more attractive jobs and increasingly to make their long-term careers abroad. The UK, Australia, Canada, US and New Zealand are the most popular destination countries.

CPD: Psoriasis P27

Clinical R&D P54

This month’s issue looks at a new report released by the HIQA on how public acute hospitals are protecting patients from the growing threat of antimicrobial resistance has found that while many hospitals have made significant progress to reduce these risks, more needs to be done in hospitals and the community to better protect patients.

COMMERCIAL MANAGER Ingrid Lyons Ingrid@ipnirishpharmacynews.ie + 353 1 669 0562 + 353 87 777 0480 CONTRIBUTORS B. Eichhorst | T. Robak | P. Ghia E. Montserrat | P. Hillmen | Papp KA M. Hallek | C. Buske | Menter A Gooderham M | Pariser DM Augustin M | Kerdel FA | Goyal K akharzadeh S | Calabro S Langholff W | Chavers S Naessens D | Sermon J | Krueger GG

DESIGN DIRECTOR Ian Stoddart Design www.pharmacynewsireland.com www.facebook.com/ HospitalProfessionalNews

Meanwhile, this issue profiles the 14 finalists for the 2016 Hospital Professional Awards (turn to page 34). These Awards decorate best practice within secondary care, with Award Categories ranging from Consultant-led project and team initiatives to specialised therapeutic area innovations and leading Pharmacy and Pharmacist-driven excellence. Investing in the further development of secondary care within Ireland, the education and clinical learning derived from entries to the Hospital Professional Awards will highlight the quantifiable projects that have been driving benefits to both clinical peers and patients with the objective of greater shared outcomes. The fourth annual Hospital Professional Awards will be held on September 17th, 2016 in the Hilton DoubleTree Hotel, Dublin and will be hosted by TV3 News Anchor Colette Fitzpatrick. We look forward to welcoming you all there!

HOSPITAL PROFESSIONAL NEWS IRELAND Ireland’s Dedicated Hospital Professional Publication HPN • September 2016


4 News

IMO seriously concerned at the lack of action in terms of real change There is serious concern at a number of findings in the Medical Council Report which was published last month (August) and which vindicate many of the concerns expressed by doctors over the past number of years, Hospital Professional News has learned. The Report expresses a concern around systems in the HSE in relation to supporting doctors. A detailed analysis of the complaints and the underlying causes is needed so as to ensure doctors learn from patient complaints and put in place systems to address the core issues. Doctors are working in an increasingly stressful and under resourced environment and they need to see to what extent this is a contributing factor and what changes they can make to ensure communication issues

are not a cause of complaint in the future, says the Irish Medical Organisation. “The Report notes the rapidly changing face of the medical workforce with more and more females taking up medicine. However the Government and HSE continue to fail to acknowledge and work on the changes required in terms of flexible training opportunities and an environment that supports career development so as to ensure we have doctors for the future,” they say. The IMO adds, “The Report confirms that Ireland has one of the highest reliance on international medical graduates. While our overseas colleagues make an invaluable contribution to the running of our service the statistics support the fact that

we are unable to retain or recruit Irish medics who are choosing to work in systems that respect and value their skills. According to OECD statistics, Ireland has the highest reliance on foreign trained doctors in the EU yet produces more medical graduates from its universities than any other EU state, two facts that demonstrate the extent of Ireland’s problem with graduate and doctor retention. Ireland possesses one of the lowest numbers of practising doctors, per population, in the EU. The Report clearly demonstrates the particular problems for the future in certain specialties, most particularly in General Practice. The Report notes that the number of doctors registered with the Medical Council is more than 20,000 however this bears no

relation to the number of doctors working in our public health services, or indeed anywhere in Ireland and is not a reflection of the true problems with medical manpower. Dr John Duddy, President of the IMO told us, “Much of the data contained in the Medical Council Annual Report supports the position of the IMO in relation to the current shortage and predicted future shortage of doctors and the urgent need to create more supportive working environments that will benefit patients and doctors. We hope the Department of Health and the HSE will see this as an opportunity to work with the IMO to improve our structures so as to ensure a better patient experience and a better working environment for doctors.”

Medical Council sees complaints against doctors rise 20% The number of complaints made about doctors to the medical regulator last year rose by 20%, with complaints about poor communication up by some 40%.

Professor Freddie Wood, President, IMO

In its annual report for 2015, the Medical Council revealed it received 369 complaints, compared to 308 the previous year. Medical Council President Professor Freddie Wood says that, in terms of fitness-to-practise, the council was complaint driven. But it needed to look at other avenues of intervention, such as examining the accreditation of medical schools and putting a framework on the intern year and training. “We are actively looking now at the quality of professional competence schemes,” he said. “We are going to have to look at the quality of the schemes and if they are imparting on the doctors of today the knowledge that they need to have.” He noted that the council had only received one complaint from the Health Service Executive last year September 2016 • HPN

about a doctor, which was “a very low” reporting rate compared to the UK and other countries. Professor Wood added the number of complaints about doctors from the major public employers in other countries would probably be about 25% of the total. “This raises a concern; does the HSE, for instance, have systems

in place in particular institutions to recognise doctors in difficulty, and if they are, are they providing them with remediation? We can only draw attention to it for other branches of our society that provides healthcare to address.” He said dealing with complaints was a “very important part” of what the council did. “But it’s not all that we do.”

More than 20,000 doctors were registered with the council last year, bringing the total to its highest ever. Some 2,600 doctors registered for the first time – an increase of 50% in the number of registrations. A total of 1,200 exited the register.


5

Moving from statement to implementation The adoption of the European Statements in 2014 was by itself already a huge success and now the European Association of Hospital Pharmacists and its member associations are working to bring about the full achievement of the Statements in all member countries. EAHP conducted workshops during the 46th General Assembly in Prague to discuss the best ways to start with the Statement Implementation project. Inputs and comments from delegates will be used to prepare the first Plan for the Implementation of the European Statements of Hospital Pharmacy. Even though EAHP has already been working to move towards Statement implementation, additional resources have now been allocated. EAHP has appointed an Implementation team, with Tony West as Project Director, aiming to give a stimulus. During the General Assembly, EAHP's President Joan Peppard and Project Director Tony West presented EAHP's implementation

plan, which was approved. The EAHP Implementation team now has approval to work on the project through 2019 with the goal of showing significant progress by 2020. Although the project is being designed, some main points have already been decided and approved by delegates: • Appointment of national implementation ambassadors. They will work as a link between EAHP, member associations and the work that is done within their countries. • Launch of an awareness campaign. Content will be presented by October 2016 and the full campaing will be launched by March 2017. • Design national strategies to map out and approach relevant stakeholders.

Each country has its own particularities, therefore, EAHP will work together with member associations and ambassadors to understand the needs and priorities of each country/region and to design specific national strategies.

• Develop a self-assesment tool for hospital pharmacists to assess their level of implementation and develop action plans accordingly.

EAHP's President Joan Peppard remarked, "The agreement and publication of the 44 European Statements of Hospital Pharmacy was a significant step, focusing

on the development potential for the role of hospital pharmacists to significantly contribute to continuous improvement of care and outcomes for patients. Building on the consensus achieved in 2014, EAHP is now looking to its members and stakeholder to make the vision described in the Statements a reality for patients in European hospitals.”

40% of medical students plan to stay in Irish Health Service Only 40% of medical students plan to stay and practice in the Irish healthcare system following their intern rotations, a new survey reveals. Over a third polled also say they are “unsure” as to whether they will stay or go. Commenting on the results of the survey IMO President, Dr. John Duddy, Specialist Registrar in Neurosurgery said, “It is obvious from these findings that the reputation of the Irish healthcare system is in shreds amongst our interns. Confidence is at an all-time low, so much so that without even having graduated from medical school they are already packing their bags for foreign shores and are ruling out Ireland as the place where they wish to practice.” Other results from the survey found that over half of interns surveyed are worried or unsure about their intern year. A similar amount say they have a definite idea of the speciality they want to pursue following their intern year. The survey was carried out amongst a sample of medical students who commenced their medical rotation in hospitals across the country.

Minister Challenges eHealth Ireland On the 18th August Minster for Health Simon Harris TD challenged the eHealth Ireland team. He asked, “I am asking that in two weeks they submit answers to a number of questions that I feel could have a significant impact upon the waiting list here in Ireland today.

The questions are: 1. How can we enable a patient to see their referral in real time? 2. How can we enable a patient to make administrative changes to their referral without having to attend a hospital? 3. How can we create a reminder service for patient’s referrals?

4. How can we use information on referrals to better manage capacity and demand across the system? 5. How can we use digital to safely and efficiently manage the discharge process, so the patient is in the right setting at the right time?”

In response, eHealth Ireland's CEO Richard Corbridge issued an open call to ‘all of the partners and vendors that have worked with the HSE in recent times to understand what you think the solution sets should be for this. Our ask to you is 300 words that describe what your solutions would be in this space.’

HPN • September 2016


6 News

Frontline hospital budgets at unrealistic levels The recently elected President of the Irish Hospital Consultants Association (IHCA), Dr Tom Ryan has expressed concern that frontline acute hospital and mental health budgets have consistently been set at completely unrealistic levels in recent years and resulted in a system that is failing the patients who depend on these services. Launching the IHCA’s 2017 prebudget submission, Dr Ryan told Hospital Professional News that since 2008, Ireland’s health budget has consistently failed to cater for patients’ needs. “The unrelenting focus on futile attempts to balance inadequate budgets has resulted in years of failure to invest in essential increases in acute hospital capacity, new technology and equipment. As a result, Ireland’s acute health infrastructure is now crumbling, with many hospitals attempting to treat patients with inadequate capacity and equipment that is increasingly obsolete,” he says. “The Government must address these gaping capacity and equipment problems by ensuring that it substantially increases funding for capital expenditure to reverse the cuts of recent years. “Furthermore the Government must significantly increase funding that targets the frontline in acute hospitals to provide the resources needed to care for the growing number of patients presenting in acute hospital and mental health services. After years of austerity, the Government must now address these overwhelming constraints which are severely restricting and jeopardising the delivery of timely high quality safe care to patients.”

The IHCA, which represents 85% of hospital consultants, strongly recommends that the 2017 acute hospital budget fully addresses the capacity constraints that are preventing the timely provision of care to patients. In particular, it recommends that the acute hospitals budget must include provision for:  An immediate increase in the number of acute, ICU and rehabilitation beds required to treat patients within an acceptable time frame, to relieve emergency department overcrowding, to reduce bed occupancy levels to internationally accepted norms and address the growing waiting lists.  An immediate increase in the availability of step down care and other facilities to support timely discharge of patients from acute hospitals. The delivery of mental health services has been severely restricted by budget and staffing cuts of 21% and 10% respectively, when compared with 2008. The IHCA stresses it is essential that the 2017 mental health budget is significantly increased to enable the provision of improved care and ensure that children and adolescents receive the care they need in age appropriate units. “In its 2017 submission, the Association also highlighted the continuing consultant recruitment and retention crisis which will have lasting effects if not addressed without delay. Dr Ryan said: “In reality Ireland is no longer internationally competitive in attracting highly trained specialists in the numbers needed to treat a growing numbers of patients

Dr Tom Ryan, President, Irish Hospital Consultant's Association

The unrelenting focus on futile attempts to balance inadequate budgets has resulted in years of failure to invest in essential increases in acute hospital capacity, new technology and equipment. As a result, Ireland’s acute health infrastructure is now crumbling and to develop the public health system. There is a continuing failure to fill consultant posts due to the State’s blatant and repeated breaches of contract terms and due to the discrimination against new consultants. Combined with frontline under-resourcing, these fundamental breaches of trust continue to undermine the attractiveness of the Irish health service to highly trained internationally mobile specialists.” The submission outlines the urgent need to address the escalating cost of clinical indemnity, which is now forcing consultants to restrict and cease their practices. In that respect, the IHCA strongly

recommends that proposals to lower the indemnity caps and the provision of indemnity on a commercial basis through the State Claims Agency, for consultants practising in private hospitals, should be brought to Cabinet as a matter of priority. It has also highlighted the pressing need to urgently adopt Regulations and Rules of Court to give effect to the newly enacted Pre-Action Protocols. These changes to Rules of Court must include a requirement for the exchange of information within defined periods, with significant penalties where exceeded, to reduce delays and costs in resolving claims.

Cancer partnership for IEHG The largest cancer treatment centre in Ireland has been launched in a partnership between University College Dublin and the Ireland East Hospital Group (IEHG). The Clinical Academic Directorate for Cancer Care (CaCAD) will be the largest cancer treatment centre in the country and will serve a population of 1.1 million people. The centre will treat more than 45% of all breast cancer cases in Ireland and 25% of all pancreas cancer cases. It will September 2016 • HPN

also account for 50% of all breast cancer screening in Ireland.

underpins new and evolving treatments.

The Ireland East Hospital Group (IEHG) is the largest of the country’s seven hospital groups and encompasses 11 hospitals, including the Mater Misericordiae University Hospital and St Vincent's University Hospital and its formal academic partner UCD.

The Directorate will involve cancer experts at St. Vincent’s University Hospital (SVUH) and the Mater Misericordiae University Hospital (MMUH) working together with research and teaching experts in UCD.

The joint venture will deliver improved cancer care to patients, in terms of the range, depth and complexity of care required and the scientific discovery that

“This new single entity will mean larger departments, more subspecialisation, an expansion in the range of services and more personalised medicine with a clear focus on genetics and translating

research benefits into better patient care,” said Professor Owen Smith CBE, Clinical Director of the CaCAD. Professor Smith is also Professor of Paediatric and Adolescent Medicine at University College Dublin and Consultant Paediatric Haematologist at Our Lady’s Children’s Hospital, Crumlin, Dublin. UCD is also establishing a research imaging centre in partnership with St Vincent’s University Hospital, which will help in rapid diagnosis and monitoring of treatment.


XOFIGO® IS AN ALPHA PARTICLE-EMITTING PHARMACEUTICAL

that is indicated for the treatment of adults with castrationresistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases.1

With Xofigo®

Prolong life. Target bone metastases. The first agent to extend overall survival by targeting bone metastases in CRPC1,2 • Improved Overall Survival2 • Delayed time to first symptomatic skeletal event2 • 1-minute intravenous injection every 4 weeks for 6 injections1

▼ This medicinal product is subject to additional monitoring. Adverse events and product complaints should be reported. To report an adverse event or a product complaint about a Bayer product, please call Bayer on 01 2999 313. Adverse events and product complaints may also be reported to HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie. Xofigo 1100 kBq/mL solution for injection (radium Ra 223 dichloride) Please refer to full Summary of Product Characteristics (SmPC) before prescribing. Composition: Active ingredient: radium Ra 223 dichloride (radium-223 dichloride, 1100 kBq/ml, corresponding to 0.58 ng radium-223 at the reference date). Each vial contains 6 mL of solution (6.6 MBq radium-223 dichloride at the reference date). Contains sodium. Indication: Treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Dosage and Administration: Xofigo should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings and after evaluation of the patient by a qualified physician. Recommended dose is an activity of 55 kBq per kg body weight, given at 4 week intervals for 6 injections. Safety and efficacy beyond 6 injections with Xofigo have not been studied. Xofigo is administered by slow intravenous injection (generally up to 1 minute). The intravenous access line or cannula must be flushed with isotonic sodium chloride 9mg/ml (0.9%) solution for injection before and after injection of Xofigo. No dosage adjustment is considered necessary in elderly patients, patients with hepatic impairment or in patients with renal impairment. Safety and efficacy of Xofigo in children and adolescents below 18 years of age have not been studied. Contraindications: No known contraindications. Warnings and Precautions: Bone marrow suppression, notably thrombocytopenia, neutropenia, leukopenia and pancytopenia, has been reported. Haematological evaluation of patients must be performed at baseline and prior to every dose. In case there is no recovery in values for absolute neutrophil count (ANC) and haemoglobin within 6 weeks after the last administration of Xofigo despite receiving standard of care, further treatment with Xofigo should only be continued after careful benefit/risk evaluation. Patients with evidence of compromised bone marrow reserve e.g. following prior

© 2016 Bayer Pharma AG. February 2016 L.IE.MKT.02.2016.0141

cytotoxic chemotherapy and/or radiation treatment (EBRT) or patients with advanced diffuse infiltration of the bone (EOD4; “superscan”), should be treated with caution as an increased incidence of haematological adverse reactions such as neutropenia and thrombocytopenia has been observed. Limited available data indicates that patients receiving chemotherapy after Xofigo had a similar haematological profile compared to patients receiving chemotherapy after placebo. Crohn’s disease and ulcerative colitis: due to the faecal excretion of Xofigo, radiation may lead to aggravation of acute inflammatory bowel disease, therefore Xofigo should only be administered to these patients after a careful benefit-risk assessment. In patients with untreated imminent or established spinal cord compression, treatment with standard of care, as clinically indicated, should be completed before starting or resuming treatment with Xofigo. In patients with bone fractures, orthopaedic stabilisation of fractures should be performed before starting or resuming treatment with Xofigo. In patients treated with bisphosphonates and Xofigo, an increased risk of development of osteonecrosis of the jaw (ONJ) cannot be excluded. In the phase III study, cases of ONJ have been reported in 0.67% patients (4/600) in the Xofigo arm compared to 0.33% patients (1/301) in the placebo arm. However, all patients with ONJ were also exposed to prior or concomitant bisphosphonates and prior chemotherapy. Xofigo contributes to a patient’s overall long-term cumulative radiation exposure and therefore may be associated with an increased risk of cancer and hereditary defects. No cases of Xofigo-induced cancer have been reported in clinical trials in follow-up of up to three years. Depending on the volume administered, Xofigo can contain up to 2.35 mmol (54 mg) sodium per dose. Undesirable effects: Very common: thrombocytopenia, diarrhoea, vomiting, nausea; Common: neutropenia, pancytopenia, leukopenia, injection site reactions; Uncommon: lymphopenia. Classification for supply: Medicinal product subject to restricted medical prescription. Marketing Authorisation Holder: Bayer Pharma AG. 13342 Berlin. Germany. MA number(s): EU/1/13/873/001. Further information available from: Bayer Ltd., The Atrium, Blackthorn Road, Dublin 18. Tel: 01 2999313. Date of Preparation: October 2015 References: 1. Xofigo® (radium Ra 223 dichloride) solution for injection. Summary of Product Characteristics (SmPC), Bayer Pharma AG, 13342 Berlin, Germany, 2013. 2. Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369(3):213-223.

NEW

radium Ra 223 dichloride SOLUTION FOR INJECTION


8 Profile

Ireland need to co-ordinate to counter growing superbug threat - Says HIQA Regulator Mr Sean Egan

The ability to treat infection with antimicrobial agents represented one of the major technological triumphs of the 20th century. Millions of lives have been saved or improved globally since the discovery of penicillin, and other antimicrobial agents. However, resistance to antimicrobials has begun to outpace the discovery of new antimicrobial medicines, with highly resistant — and indeed untreatable — infection beginning to emerge in some parts of the world. The World Health Organisation has declared this to be a ‘major global threat’ to healthcare. A recent report commissioned by the UK government has estimated that if left unchecked, this problem could conservatively account for in excess of 10 million global deaths annually by 2050, more than cancer and diabetes combined. According to HPN contact Mr Sean Egan in a new report released by the HIQA on how public acute hospitals are protecting patients from the growing threat of antimicrobial resistance has found that while many hospitals have made significant progress to reduce these risks, more needs to be done in hospitals and the community to better protect patients. While progress has been made in larger hospitals in implementing best practice in managing and September 2016 • HPN

using antibiotics, the level of progress identified varied across the country, with some smaller hospitals not having safe and sustainable measures in place to protect patients. In addition, more effective national planning and coordination is required to ensure that the entire health system is as prepared as it can be for what is an increasing and serious challenge for healthcare providers. Mr Sean Egan is the HIQA’s Acting Head of Healthcare Regulation. He told Hospital Professional News, “Resistance to antimicrobials continues to increase in Ireland and internationally. In some instances, the level of antimicrobial resistance now being detected leaves clinical staff with a very limited choice of medicines that they can use to try to treat people. Ensuring prudent antimicrobial usage, through antimicrobial stewardship, should be a priority across all health services to help to address this problem.’’ ‘‘This review examined how well public acute hospitals implement antimicrobial stewardship best practice. We identified that a number of hospitals need urgent support from the national Health Service Executive (HSE) in this area, as they do not have an antimicrobial stewardship programme in place and lack specialised resources. This is a significant patient safety concern and should be reviewed as a matter of urgency by the HSE.”

The Health Information and Quality Authority (HIQA) is an independent authority established to drive highquality and safe care for people using our health and social care services in Ireland. HIQA’s role is to develop standards, inspect and review health and social care services and support informed decisions on how services are delivered. HIQA’s ultimate aim is to safeguard people using services and improve the safety and quality of health and social care services across its full range of functions. HIQA’s mandate to date extends across a specified range of public, private and voluntary sector services. In Ireland, in 2009, the Health Information and Quality Authority (HIQA) published the National Standards for the Prevention and Control of Healthcare Associated Infection (7) (referred to in this report as the Infection Prevention and Control Standards), to promote improved practice in the areas of infection prevention and control, and in the best usage of antimicrobial agents through antimicrobial stewardship. All publically-funded healthcare providers are expected to implement these Standards. In recent years, HIQA has undertaken a rolling programme of inspections against these Standards to promote improvement in infection prevention and control practices across these acute hospitals.

This review of antimicrobial stewardship in public acute hospitals aims to reinforce HIQA’s inspections by examining how these hospitals ensure best practice in antimicrobial stewardship. More broadly, this review explored how the HSE is addressing the wider risks of antimicrobial resistance through antimicrobial stewardship and infection prevention and control. It found that while MRSA and Clostridium difficile rates have fallen in Ireland, the incidence of multi-drug resistance amongst Gram-negative organisms — which can cause a number of different infection types including urinary tract and bloodstream infection, and which may be more difficult to treat — is increasing. Mr Egan continues, “A number of these Gram-negative bacteria are highly resistant, and are associated with serious infections, up to and including life-threatening sepsis. Unlike MRSA, patients who carry these bacteria cannot be treated to eradicate them from their bodies. Antimicrobial prescribing and infection control practices in hospitals, and equally in community health and social care settings, needs to be of a high standard to fully address this emerging problem.” “Therefore, the nature of this change requires a different, nationally co-ordinated response by the HSE and in particular be extended beyond acute hospitals into other non-acute residential and community care settings.” The national plan to deal with these problems in Ireland has not been updated since 2001 and a new one is urgently needed. At an individual hospital level, this review identified that many Irish hospitals have performed very well in implementing antimicrobial stewardship and infection prevention and control best practice. However, there is a need for nationally coordinated mechanisms to be put in place to provide more effective support to those hospitals that perform less well, or indeed find themselves having to deal with specific


IV DRUGS

Adenosine 3 mg/ml solution for injection in pre-filled syringe Very short acting antiarrhythmic Rapid conversion of paroxysmal supraventricular tachycardias to a normal sinus rhythm Suitable for Wolff-Parkinson-White Syndrome Aids diagnosis of broad or narrow complex supraventricular tachycardias Convenient use as pre-filled syringe

Adenosine in PFS 3 mg / 1 ml Pre-filled syringe 10 × 1 ml pre-filled syringes Adenosine in PFS 6 mg / 2 ml Pre-filled syringe 10 × 2 ml pre-filled syringes Adenosine in PFS 12 mg / 4 ml Pre-filled syringe 10 × 4 ml pre-filled syringes Prescribing Information Consult the Summary of Product Characteristics for full information. Additional information is available on request. Adenosine 3 mg/ ml solution for injection in pre-filled syringe. Active ingredients: 1 ml solution contains 3 mg of adenosine. Indications: For adults only: Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory by-pass tracts (Wolff- Parkinson-White Syndrome). Diagnostic Indications: Aid to diagnosis of broad or narrow complex supraventricular tachycardias. Although Adenosine will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity. Sensitisation of intra-cavitary electrophysiological investigations. Posology and administration: For hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use. Adults (including elderly): Initial dose: 3mg given as a rapid intravenous bolus (over 2 seconds). Second dose: If the first dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 6mg should be given also as a rapid intravenous bolus. Third dose: If the second dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes. 12mg should be given also as a rapid intravenous bolus. Additional or higher doses not recommended. Paediatric: Not suitable for paediatric use. Diagnostic dose: The above ascending dosage schedule should be employed until sufficient diagnostic information has been obtained. Method of administration: rapid intravenous (IV) bolus injection into a vein or into an IV line. If given into an IV line inject through as proximally as possible, followed by a rapid saline flush. If administered through a peripheral vein, a large bore cannula should be used. Contraindications: Hypersensitivity to the active substance or to any of the excipients, Sick sinus syndrome, second or third degree Atrio-Ventricular (AV) block (except in patients with a functioning artificial pacemaker). Chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma bronchiale), Long QT syndrome, Severe hypotension, Decompensated states of heart failure. Warnings and precautions (See SPC for full details): Administration should be carried out in a hospital setting with monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary. During administration, continuous ECG monitoring is necessary as life-threatening arrhythmia might occur. Caution in patients with left main coronary stenosis, uncorrected hypovolemia, stenotic valvular heart disease, left to right shunt, pericarditis or pericardial effusion, autonomic dysfunction or stenotic carotid artery disease with cerebrovascular insufficiency. Caution in patients with recent myocardial infarction, severe heart failure, or in patients with minor conduction defects. Caution in patients with atrial fibrillation or flutter and especially in those with an accessory by-pass tract. Rare cases of severe bradycardia reported. Increased sensitivity of the heart to adenosine observed in recent heart transplant patients. Adenosine should not be administered to patients receiving dipyridamole; if use of adenosine is essential, dipyridamole should be stopped 24 hours before hand, or the dose of Adenosine should be greatly reduced. Occurrence of angina, severe bradycardia, severe hypotension, respiratory failure or asystole/cardiac arrest should lead to immediate discontinuation of administration. May trigger convulsions in patients who are susceptible to convulsions. In patients with history of convulsions/seizures, administration should be carefully monitored. Possible risk of torsades de pointes - use with caution in patients with a prolonged QT interval. May precipitate or aggravate bronchospasm. Efficacy of intraosseus administration has not been established. Interactions: Consult SPC for detailed information on interactions. Adenosine should not be administered to patients receiving dipyridamole; if use of adenosine is essential, dipyridamole should be stopped 24 hours before hand, or the dose of adenosine should be greatly reduced. Aminophylline, theophylline and other xanthines should be avoided for 24 hours prior to use. Food and drinks containing xanthines should be avoided for at least 12 hours prior to use. Fertility, pregnancy, lactation: Not recommended, consult SPC. Undesirable effects: Very common: Bradycardia, Sinus pause, skipped beats, Atrial extrasystoles, Atrio-Ventricular block, Ventricular excitability disorders such as ventricular extrasystoles, non-sustained ventricular tachycardia, Dyspnea, Chest pressure/pain, feeling of thoracic constriction/oppression. Common: Headache, Dizziness, light-headedness, Nausea, Burning sensation, Apprehension. Consult SPC for additional adverse reactions. Legal classification: POM. Plastic pre-filled syringe. €80 per pack of 10 PA number: PA 566/68/1. Marketing Authorisation Holder: Fresenius Kabi Limited, Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT UK. Date of preparation: June 2016. Adverse events should be reported via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. Flyer_Adenosine_17.12.14_GB.indd 1

17.12.14 09:55


10 Profile resistance problems which are beyond their individual capacity to deal with in isolation. Allied to this, the review found that there is a need to improve structures to manage the risk of antimicrobial resistance across care settings. Existing structures and resources have been predominately directed towards public acute hospitals, whereas antimicrobial resistance issues increasingly span across acute hospital, residential care and community settings. Mr Egan concludes, “This review found much commendable progress by highly committed front-line staff in advancing antimicrobial stewardship, but this has been hampered by the lack of an up-to-date national plan in this area. There are pockets of excellence in some hospitals, yet others lag behind, and progress in non-acute settings such as nursing homes has been very limited. More needs to be done to ensure that good practice in this area becomes the routine norm.”

This review examined how well public acute hospitals implement antimicrobial stewardship best practice. We identified that a number of hospitals need urgent support from the national Health Service Executive (HSE) in this area, as they do not have an antimicrobial stewardship programme in place and lack specialised resources

September 2016 • HPN

Summary of key findings  Progress has been made, particularly in the major academic teaching hospitals in implementing antimicrobial stewardship programmes, in response to investment. However, at the time of this review, several general hospitals, defined as Model 3 hospitals, require further investment and or the sharing of resources across their respective hospital groups to effectively implement these programmes.  A number of smaller local hospitals, defined as Model 2 hospitals, had no antimicrobial stewardship programme in place. These hospitals had not received specialised resources to support setting up such programmes.  At the start of this review, the national structures to support antimicrobial stewardship and infection prevention and control within the Health Services Executive (HSE) lacked coordination. However, in early 2016, the HSE identified a named person responsible for coordinating and managing its national antimicrobial stewardship programme.  The Irish Government has commenced planning a new national action plan in relation to the threat of antimicrobial resistance, in line with Council of the EU requirements.(8) This action plan is to be ready by mid-2017.  Provision for antimicrobial stewardship and infection prevention and control in non-acute settings needs to be both significantly enhanced and integrated within existing services. The HSE organisational structure includes seven hospital groups, nine HSE community health organisations, and eight public health departments in the country. Not all of their catchment areas are geographically aligned. Therefore, the potential for seamless coordination across each area of responsibility for infection prevention and control and antimicrobial stewardship may be additionally complicated.  HIQA found a progressive approach to monitoring antimicrobial consumption in Irish hospitals. The HSE has established good systems for recording and benchmarking antimicrobial prescribing, and for recording and comparing antimicrobial resistance rates for serious infections with other European countries.  The review found most hospital information and communication technology (ICT) systems dealing with infection operated independently of each other. There is greater potential for ICT to further support antimicrobial stewardship and infection prevention and control.


BE THE

ONE WHO CAN CHANGE WHAT’S POSSIBLE FOR HCV GT1 ADULT PATIENTS1

HARVONI® – Make cure a reality for the majority of your GT1 patients1–4 In clinical trials of compensated hepatitis C (HCV) patients: • Upto 99% Cure 1-4 •

94–97% of treatment-naïve, non-cirrhotic patients cured with 8 wks*1,4

99% of treatment-naïve patients cured with 12 wks2

94–99% of treatment-experienced patients cured with 12–24 wks 3

• 8 weeks may be considered for treatment-naïve, non-cirrhotic patients1 •

One pill once a day1

• Small number of clinically relevant DDIs1** Compensated cirrhosis, decompensated cirrhosis and post-transplant patients may require the addition of RBV 1

Albert Einstein used with permission of the HUJ/GreenLight.

*97% relates to the SVR for patients with a viral load of less than 6 million IU/ml

HARVONI is indicated for the treatment of chronic hepatitis C infection in adults1 ®

PRESCRIBING INFORMATION Consult the Summary of Product Characteristics before prescribing.

90mg ledipasvir/400mg sofosbuvir film coated tablets. HARVONI® Indications: For the treatment of chronic hepatitis C (CHC) in adults. Dosage & Administration: Adults: One tablet, taken orally, once daily with or without food. Genotype 1, 4, 5 or 6; without cirrhosis: 12 weeks of treatment with Harvoni is recommended. 8 weeks may be considered in previously untreated genotype 1-infected patients. Harvoni + ribavirin for 12 weeks or Harvoni (without ribavirin) for 24 weeks should be considered for previously treated patients with uncertain subsequent retreatment options. Genotype 1, 4, 5 or 6; with compensated cirrhosis: Harvoni + ribavirin for 12 weeks or Harvoni (without ribavirin) for 24 weeks of treatment with is recommended. Harvoni (without ribavirin) for 12 weeks may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options. Genotype 1, 4, 5 or 6; post liver transplant without cirrhosis or with compensated cirrhosis: Harvoni + ribavirin for 12 weeks. Harvoni (without ribavirin) for 12 weeks (in patients without cirrhosis) or 24 weeks (in patients with cirrhosis) may be considered for patients who are ineligible for or intolerant to ribavirin. Genotype 1, 4, 5 or 6; with decompensated cirrhosis: Harvoni + ribavirin for 12 weeks. Harvoni (without ribavirin) for 24 weeks may be considered in patients who are ineligible for or intolerant to ribavirin. Genotype 3 with compensated cirrhosis and/or prior treatment failure: 24 weeks treatment with Harvoni in combination with ribavirin is recommended. Please refer to the SmPC for recommended dose & treatment duration for combination therapy. When used in combination with ribavirin, refer also to the SmPC of ribavirin. Refer to the individual SmPCs for additional information regarding dose modifications & discontinuations. Renal impairment: Mild or moderate renal impairment: no dose adjustment required. Severe renal impairment or end stage renal disease (ESRD) requiring haemodialysis: not recommended. Refer to the SmPC for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min. Hepatic impairment: Mild, moderate or severe hepatic impairment: no dose adjustment required. Safety and efficacy of Harvoni have been established in patients with decompensated cirrhosis. Children and adolescents: The safety and efficacy of Harvoni in children & adolescents aged <18 years have not yet been established. Elderly: No dose adjustment is warranted for elderly patients. Contraindications: Hypersensitivity to the active substance or to any excipients. Use with potent P-gp inducers (in the intestine; rifampicin, rifabutin, St. John’s wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin) will significantly decrease ledipasvir & sofosbuvir plasma concentrations and could result in loss of efficacy of Harvoni. When Harvoni is used in combination with ribavirin, contraindications applicable to that agent is applicable to combination therapies. Refer to the ribavirin SmPC for a list of contraindications. Warnings and Precautions: Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir. The clinical data to support the use of Harvoni in HCV genotype 2, 3 and 6 patients are limited. A conservative 24 weeks of therapy is advised in all treatment-experienced genotype 3 patients and those treatment-naïve genotype 3 patients with cirrhosis. Severe bradycardia and heart block: Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone with or without other drugs that lower heart rate. The  mechanism is not established. Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating Harvoni. All  patients receiving Harvoni in combination with amiodarone with or without other drugs that lower heart rate should be warned of the symptoms

**Drug-drug interaction

Cure defined as SVR12

1. HARVONI® SmPC available at https://www.medicines.org.uk/emc/medicine/29471 (Accessed June 2016) 2. Afdhal N et al. N Engl J Med 2014;370:1889–1898. 3. Afdhal N et al. N Engl J Med 2014;370:1483–1493. 4. Kowdley KV et al. N Engl J Med 2014;370:1879–1888. 5. Gilead Data On File – SOFUK1601 (February 2016)

of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them. Patients who are identified as being high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting. Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated with Harvoni. Treatment of patients with prior exposure to HCV directacting antivirals: There are no data to support the effectiveness of retreatment of patients who have failed Harvoni with a subsequent regimen that contains an NS5A inhibitor. Consideration should be given to longer treatment for patients with uncertain subsequent retreatment options. Patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant: The efficacy of Harvoni in genotype 5 and 6 with decompensated cirrhosis and/ or who are awaiting liver transplant or post-liver transplant has not been investigated. Treatment with Harvoni should be guided by an assessment of the potential benefits and risks for the individual patient. Use with moderate P-gp inducers: Medicinal products that are moderate P-glycoprotein (P-gp) inducers in the intestine (e.g. oxcarbazepin) decrease ledipasvir and sofosbuvir plasma concentration leading to reduced therapeutic effect of Harvoni. Co-administration is not recommended. Use with certain HIV antiretroviral regimens: Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat). The safety of tenofovir disoproxil fumarate in this setting has not been established. The potential risks and benefits associated with co-administration of Harvoni with the fixed-dose combination tablet containing elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction. Patients receiving Harvoni concomitantly with elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovir-associated adverse reactions. Refer to the SmPCs of the aforementioned agents for recommendations on renal monitoring. Use with HMG-CoA reductase inhibitors: Co-administration of Harvoni and HMG-CoA reductase inhibitors (statins) can significantly increase the concentration of the statin, which increases the risk of myopathy and rhabdomyolysis. HCV/HBV co-infection: There are no data available. Excipients: Harvoni contains sunset yellow FCF aluminium lake (E110), which may cause allergic reactions. It also contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take Harvoni. Interactions: Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir. Ledipasvir is an in vitro inhibitor of drug transporter P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of co-administered substrates for these transporters. Ledipasvir may be a weak inducer of metabolising enzymes such as CYP3A4, CYP2C and UGT1A1. Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with Harvoni. In vitro ledipasvir inhibits intestinal CYP3A4 and UGT1A1. Medicinal products that have a narrow therapeutic range and which are metabolised by these isoenzymes should be used with caution and carefully monitored. Ledipasvir and sofosbuvir are substrates of drug transporter P-gp and BCRP while GS-331007 is not. Refer to the Contraindication & Warnings & Precautions for P-gp inducers (in the intestine). Co-administration with medicinal products that inhibit P-gp and/or BCRP may increase ledipasvir and sofosbuvir plasma

concentrations without increasing GS-331007 plasma concentration; Harvoni may be co-administered with P-gp and/or BCRP inhibitors. Refer to SPC for full information regarding interactions. Pregnancy & lactation: When Harvoni is used in combination with ribavirin; extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded as recommended in the SmPC for ribavirin. Refer to the SmPC for ribavirin for additional information. There are no or limited amount of data (<300 pregnancy outcomes) from the use of ledipasvir, sofosbuvir or Harvoni in pregnant women. As a precautionary measure, it is preferable to avoid the use of Harvoni during pregnancy. Harvoni should not be used during breast-feeding. See also the SmPC for ribavirin for pregnancy and breast-feeding. Side effects: When Harvoni was studied with ribavirin, the most frequent adverse drug reactions to Harvoni in combination with ribavirin were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions. The following adverse drug reactions have been identified with Harvoni. Frequencies are defined as follows: Very commonly reported adverse events (≥1/10): headache and fatigue. Description of selected adverse reactions; Cardiac arrhythmias: Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone and/or other drugs that lower heart rate. Legal Category: POM. Package Quantities: Bottle of 28 film-coated tablets. Price: UK NHS Price - £12,993.33; Eire Price - €TBA Marketing Authorisation Number: EU/1/14/958/001 Further information is available from the local representative of the marketing authorisation holder: Gilead Sciences Ltd, 280 High Holborn, London, WC1V 7EE, UK. Telephone: +44 (0) 8000 113700, For Ireland: +353 214 825 999. E-mail: ukmedinfo@gilead.com. Harvoni is a trademark. Date of PI preparation: April 2016: HAR/UK/15-11/MM/1992(2)

▼ This medicinal product is currently subject to additional monitoring. Reporting suspected adverse reactions after

authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse reactions to Harvoni should be reported to Gilead via email to safety_FC@gilead.com or by telephone +44 (0) 1223 897500. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Suspected adverse reactions should be reported to the HPRA Pharmacovigilance using a Yellow Card obtained either from the HPRA, or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling +353 1 6764971.

© 2016 Gilead Sciences, Inc. All rights reserved. Date of preparation: June 2016 HAR/UK/14-11/MI/1033(7)


12 News

ICORG open Irish arm of breast cancer trial Cancer Trials Ireland (formerly ICORG) has opened the Irish arm of a European breast cancer trial to test the effectiveness of a new combination of drugs as a first line treatment for advanced breast cancer. Known as The FLIPPER Study, the trial is sponsored by GEICAM, the Spanish Breast Cancer Group, and will involve 190 patients across Europe, with 40 from Ireland. The trial will investigate the added benefit of combining the new drug palbociclib with an existing drug fulvestrant. Fulvestrant is currently used to treat postmenopausal women with hormone receptor (HR)-positive[1] advanced breast cancer. Palbociclib is approved in the USA by the US Food and Drug Administration (FDA) but is not yet approved in Europe for treating HR-positive, HER2-negative advanced breast cancer. As a result Irish patients who receive this new drug combination during the trial will be the first in Ireland to do so as a first line treatment for their advanced breast cancer. As with all Cancer Trials Ireland trials, participants will have free access to the drugs used during the trial and the trial has been

Dr Miriam O’Connor, Consultant Medical Oncologist, University Hospital Waterford

approved by Ireland’s Health Products Regulatory Authority. The new drug combination will be tested among postmenopausal women with advanced breast cancer, who have had at least five years of standard hormonal treatment and have remained disease free for more than 12 months, but have subsequently suffered a relapse or are diagnosed with new cancer which has spread to other parts of their body. The trial is a randomised double blind study, which means that half of the participants will receive the new drug combination (fulvestrant and palbociclib) and half will receive the existing standard of

care i.e. fulvestrant on its own. Patients, their doctors and the study’s research team (including nurses) will not know which patients receive which combination. The trial is expected to continue over the next four years with eight hospitals in Ireland participating. These include St. James’s Hospital, Dublin; St Vincent’s University Hospital, Dublin; Mater Hospital, Dublin; Beaumont Hospital, Dublin; Bon Secours Hospital, Cork; University Hospital Galway, University Hospital Waterford and University Hospital Limerick.

Consultant Medical Oncologist, at University Hospital Waterford. Dr O’Connor said that the growing data about the clinical activity of fulvestrant, together with the efficacy data for palbociclib, support their combined use in women with HR-positive, HER2negative advanced breast cancer. “There is an unmet need for effective, non-toxic therapy for women with this type of breast cancer. We hope the study will provide new data to assist physicians in their management of patients with advanced breast cancer and help us find more answers,” she said.

The study’s Principal Investigator in Ireland is Dr Miriam O’Connor,

EAHP 22nd Annual Congress The 22nd Congress of the EAHP will be held from 22-24 March 2017, in Cannes, with the theme of "Hospital pharmacists – catalysts for change". The scientific programme is relevant for all hospital pharmacists dealing with the challenge of rapid change in healthcare. The hospital pharmacist's role in facilitating change will be addressed. EAHP's annual congress is the largest congress for hospital pharmacy in Europe and attracts pharmacists from all over the world. The EAHP Congress continues to provide professionals with an exceptional opportunity to meet, network and share expertise and best practice with colleagues while keeping up to date with the latest developments in hospital pharmacy and learning about the latest products and innovations. Visit www.eahp.eu for more information.

Superior data for HIV presented ViiV Healthcare have presented 48-week data from the phase IIIb, open-label, international, multicentre ARIA study which showed superior efficacy for Triumeq® (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 495 treatment-naïve women living with HIV. Results show statistically superior viral suppression (HIV-1 RNA <50 c/mL) rates at week 48: 82% versus 71% (adjusted difference September 2016 • HPN

10.5%, 95% CI: 3.1%-17.8%, p=0.005) respectively. ARIA was a non-inferiority study with a prespecified analysis for superiority. Both non-inferiority and superiority endpoints were met, with superiority being driven by lower rates of both virological failures and discontinuations due to adverse events (AEs) in the dolutegravir/ abacavir/lamivudine group. “Women account for over half of the almost 35 million adults living with HIV worldwide, yet

unfortunately they are consistently under-represented in HIV clinical trials.” said John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare. “For this reason, we are committed to ensuring that the specific treatment needs of women are investigated. This trial not only provides physicians with important additional information about Triumeq, it also builds on the strong body of evidence supporting the efficacy of dolutegravir-based regimens

in a broad range of patient populations.” The safety profile of dolutegravir/ abacavir/lamivudine was favourable compared to ATV/r plus TDF/FTC, with fewer drug-related adverse events (AEs) reported on the dolutegravir/abacavir/ lamivudine arm (33% vs 49%); there were also fewer AEs leading to discontinuation compared to those in the ATV/r plus TDF/FTC arm (4% vs 7%).


Extending what’s possible VARGATEF®, the only triple angiokinase inhibitor for advanced adenocarcinoma of the lung after first-line chemotherapy1 VARGATEF® is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer of adenocarcinoma tumour histology after first-line chemotherapy1 Prescribing Information (Ireland) ▼Vargatef® 100 mg and 150 mg soft capsules Soft capsules containing 100 mg or 150 mg nintedanib (as esilate). Indication: Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy. Dose and Administration: Treatment with Vargatef should be initiated and supervised by a physician experienced in the use of anticancer therapies. The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle. Vargatef must not be taken on the same day of docetaxel chemotherapy administration (= day 1). If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose. The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses. The recommended maximum daily dose of 400 mg should not be exceeded. Patients may continue therapy with nintedanib after discontinuation of docetaxel for as long as clinical benefit is observed or until unacceptable toxicity occurs. For posology, methods of administration, and dose modifications of docetaxel, please refer to the corresponding product information for docetaxel. Dose adjustments should be considered in case of adverse events of pre-specified severity: diarrhoea, vomiting, nausea and other non-haematological or haematological adverse reactions, and aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and bilirubin elevations – as initial measure for the management of adverse reactions treatment with nintedanib should be temporarily interrupted. Please refer to the Summary of Product Characteristics (SPC) for further information including when to discontinue treatment. Paediatric population: Safety and efficacy in children aged 0-18 years have not been established. Elderly patients (≥ 65 years): No overall differences in safety and efficacy were observed for elderly patients. No adjustment of initial dosing required on the basis of a patient’s age. Race and body weight: Based on population pharmacokinetic analyses, no a priori dose adjustments necessary. Safety data for Black and African American patients are limited. Renal impairment: Less than 1 % of a single dose of nintedanib is excreted via the kidney. Adjustment of the starting dose in patients with mild to moderate renal impairment is not required. The safety, efficacy and pharmacokinetics have not been studied in patients with severe renal impairment (< 30 ml/min creatinine clearance). Hepatic impairment: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90%). Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B). No adjustment of the starting dose is needed for patients with mild hepatic impairment based on clinical data (Child Pugh A). The safety and efficacy have not been investigated in patients with hepatic impairment classified as moderate (Child Pugh B) and severe (Child Pugh C). Treatment of patients with moderate to severe hepatic impairment is not recommended. The capsules must be taken orally, preferably with food, swallowed whole with water, and must not be chewed or crushed. Contraindications: Hypersensitivity to nintedanib, peanut or soya, or to any of the excipients. Warnings and Precautions: Patients with gastrointestinal disorders including diarrhoea, nausea and vomiting may require interruption, dose reduction or discontinuation of therapy. Diarrhoea should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, e.g. loperamide. Supportive care for nausea and vomiting may include medicinal products with anti-emetic properties, e.g. glucocorticoids, anti-histamines or 5-HT3 receptor antagonists and adequate hydration. In the event of dehydration, administration of electrolytes and fluids is required. Plasma levels of electrolytes should be monitored, if relevant gastrointestinal adverse events occur. Combination treatment with docetaxel is associated with a higher frequency of neutropenia of CTCAE grade ≥ 3 as compared to treatment with docetaxel alone. Subsequent complications such as sepsis or febrile neutropenia have

been observed. Blood counts should be monitored during therapy, please refer to SPC. Hepatic function: treatment is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A). Nintedanib was associated with an elevation of liver enzymes (ALT, AST, ALKP) or bilirubin, with a potentially higher risk for female patients. These increases were reversible in the majority of cases. Transaminase, ALKP and bilirubin levels should be investigated before initiation of combination treatment and monitoring continued as required. If relevant liver enzyme elevations are measured, interruption, dose reduction or discontinuation of the therapy with Vargatef may be required, please refer to the SPC. VEGFR inhibition might be associated with an increased risk of bleeding. Vargatef is not recommended in patients with recent pulmonary bleeding (> 2.5 ml of red blood) as well as patients with centrally located tumours with radiographic evidence of local invasion of major blood vessels or radiographic evidence of cavitary or necrotic tumours. Patients taking concomitant anticoagulation, such as warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, international normalized ratio (INR), and clinical bleeding episodes. Patients with stable brain metastasis should be closely monitored for signs and symptoms of cerebral bleeding. Treatment not recommended for patients with active brain metastasis. Patients should be closely monitored for thromboembolic events and Vargatef should be discontinued in patients with life threatening venous thromboembolic reactions. Caution should be used when treating patients with a higher cardiovascular risk including known coronary artery disease. Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischaemia. Based on the mechanism of action patients treated with Vargatef may have an increased risk of gastrointestinal perforations. Particular caution should be exercised when treating patients with previous abdominal surgery or a recent history of a hollow organ perforation. Treatment should only be initiated at least 4 weeks after major surgery. Therapy should be permanently discontinued in patients who develop gastrointestinal perforation. Nintedanib may impair wound healing. Treatment should therefore only be initiated or, in case of perioperative interruption, resumed based on clinical judgement of adequate wound healing. Caution should be exercised in patients who may develop QTc prolongation. Dietary soya products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy. Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations. Nintedanib exposure increased linearly with patient age, was inversely correlated to weight, and was generally higher in patients of Asian race which may result in a higher risk of developing liver enzyme elevations; close monitoring is recommended in patients with several of these risk factors. Close monitoring is recommended in patients weighing < 50 kg. Interactions: Interaction studies have only been performed in adults. P-glycoprotein (P-gp): Nintedanib is a substrate of P-gp. If co-administered, potent P-gp inhibitors e.g. ketoconazole or erythromycin may increase exposure to nintedanib. Patients should be monitored closely for tolerability of nintedanib. Potent P-gp inducers e.g. rifampicin, carbamazepine, phenytoin and St. John’s Wort may decrease exposure to nintedanib. Co-administration should be carefully considered. Cytochrome (CYP)- enzymes: Likelihood of drug-drug interactions with nintedanib based on CYP metabolism considered to be low. Other medicinal products: The potential for interactions with hormonal contraceptives was not explored. Fertility, Pregnancy and Lactation: Nintedanib may cause foetal harm in humans; women should avoid becoming pregnant while receiving this treatment and use adequate contraception during and for at least 3 months after the last dose of Vargatef. Since the effect of nintedanib on the metabolism

and efficacy of contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy. There is no information on the use of Vargatef in pregnant women, but pre-clinical studies have shown reproductive toxicity and therefore nintedanib should not be used during pregnancy unless the clinical condition requires treatment. Pregnancy testing should be conducted at least prior to treatment. Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy. If the patient becomes pregnant while receiving Vargatef, she should be apprised of the potential hazard to the foetus. Termination of the treatment with Vargatef should be considered. There is no information on the excretion of nintedanib and its metabolites in human milk. Pre-clinical studies showed that small amounts of nintedanib and its metabolites (≤ 0.5 % of the administered dose) were secreted into milk of lactating rats. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with Vargatef. Based on preclinical investigations there is no evidence for impairment of male fertility. There are no human or animal data on potential effects of nintedanib on female fertility available. Undesirable effects: The most frequently reported adverse reactions specific for nintedanib were diarrhoea, increased liver enzymes (ALT and AST) and vomiting. Very common (≥ 1/10): Neutropenia (includes febrile neutropenia), decreased appetite, electrolyte imbalance, peripheral neuropathy, bleeding, diarrhoea, vomiting, nausea, abdominal pain, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, mucositis (including stomatitis), rash. Common (≥ 1/100 < 1/10): Febrile neutropenia, abscesses, sepsis, dehydration, venous thromboembolism, hypertension, hyperbilirubinaemia. Prescribers should consult the Summary of Product Characteristics for further information on side effects and recommended measures. Pack sizes: 100 mg 120 capsules; 150mg 60 capsules. Legal category: POM. MA numbers: 100 mg: EU/1/14/954/002; 150 mg: EU/1/14/954/004. Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Hyde Building, The Park, Carrickmines, Dublin 18. Prepared in February 2016 This medicinal product is subject to additional monitoring.

Adverse events should be reported to the Health Products Regulatory Authority at www.hpra.ie or by email to medsafety@hpra.ie. Adverse events should also be reported to Boehringer Ingelheim Pharmacovigilance on 01 291 3960 or by email to PV_local_uk_ireland@boehringer-ingelheim.com References: 1. VARGATEF® 100/150mg Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/29790 Accessed September 2016. IRE/VAR-161124 Date of preparation: September 2016


14 News

Psychiatrists concerned about superficiality Dr John Hillery, Director of Communication, Faculty of Child and Adolescent Psychiatry

and community supports to help them deal with this, not psychiatric intervention.” Dr Keeley pointed out that children with mental illness need access to fully resourced mental health teams led by specialist psychiatrists as delineated in national policy, A Vision for Change. “Lack of appropriate support means that children are not getting the early intervention they may need and are ending up on waiting lists for mental health services they don’t need or are developing more severe mental health issues, thus increasing waiting times for all.”

The College of Psychiatrists of Ireland fears that uninformed reactions to ISPCC statistics on childhood distress will further delay the development of appropriate interventions for children at risk of mental distress and illness.

to do, only removes pressure for the development of appropriate early intervention services in the community, psychological and education systems. This increases the pressure on already underresourced mental health services.

Media coverage of the ISPCC’s figures from their Childline service rightly focus on the slow pace of access to appropriate help for children in distress. Classifying all children in distress as needing mental health services, as some reports and political reaction seem

“Children exhibiting distress may do so for many reasons” according to Dr Helen Keeley, Consultant Child and Adolescent Psychiatrist and Chair of the Child and Adolescent Faculty of the College of Psychiatrist of Ireland, “Many need educational, psychological

Dr John Hillery, Director of Communication at the College says, “The College has previously indicated to government and other, the factors that are causing delay in access to services. These include the systemic problems outlined by Dr Keeley and the lack of appropriate psychiatrists and allied health professionals to take up already funded posts.” On the issue of the lack of professionals nationally to fill mental health teams, Dr Hillery replied “Recruitment problems need robust examination of the factors that cause them but the College has regularly emphasised

the unattractiveness of working conditions for trained psychiatrists in a situation where A Vision for Change remains short of full implementation.” Dr Hillery said that the College welcomes the recently stated intent of the Minister of State for Mental Health, Deputy Helen McEntee, to set up a commission to plan for the future needs of the mental health of the youth of the country. The College would question remarks made in interviews with the Minister for Children, Deputy Katherine Zappone, proposing that mental health services for children might be best placed in a new agency aligned in some way to Tusla. “Mental Health Services for all age groups must be part of the planning of the nation’s health services and not passed off to a body outside the health services which can only suggest that the health needs of this group are less valued than those of the rest of the population”. Dr Hillery went on to say that the Minister of State has promised to meet with the College soon and the mental health needs of children will be high on the agenda for that meeting.

The ¤12m Distraction; Thoughts on Child and Adolescent Mental Health Services A Trainee’s thoughts on the real issues Affecting Mental Health Services Dr Helen Keeley, Chair, Faculty of Child and Adolescent Psychiatry talks about concern surrounding the recent focus and much talked about ‘¤12million’ which she says, ‘might distract us and all stakeholders from the main issue which is a chronic under-funding of Mental Health Services in Ireland.’ “The Faculty of Child and Adolescent Psychiatry in line with the College of Psychiatrists feel strongly that mental health funding should be increased to a minimum of 12% of the overall health budget, which would be an additional ¤800 million, as is the case in the UK. We feel that 25% of this should be allocated to children’s services, given their proportion of the population and the potential for preventative work which would benefit the whole community. “In general, we all have many individual areas where the September 2016 • HPN

supposedly un-allocated, unspent ring fenced money (¤12m) would be invaluable i.e. supplementing multidisciplinary teams with psychologists, social workers, occupational therapists and so on and in particular front line administrative staff. So it was with dismay we learnt that ¤12 of ¤35 was being siphoned off to another area of health care. How can the money be immediately spent in 2016? “The most recent intake of additional staff for community Child and Adolescent Mental Health (CAMHS) team was of basic grade staff with no provision for upskilling in mental health specialist competencies. This ‘¤12m’ would go a long way towards providing training, for example, in assessment and treatment of sensory processing disorders, which is a major concern for differential diagnosis

of Attention Deficit/ Hyperkinetic Disorders. The recent reduction in senior grade specialists in CAMHS teams is also of concern and this money could be used to help us to retain our staff by allowing senior upgrades where merited, thus enhancing team cohesion and morale. “The lack of basic, appropriate working conditions i.e. safe, adequate premises with reasonable IT and administrative access is an issue for many teams and this money could assist in resolving this issue. “The need to develop / enhance child and adolescent mental health liaison in our paediatric services is self-evident. The money could be used to improve access to emergency services that treat patients in the right place, at the right time by the right person in line with patient preferences. This is also important when considering

the needs of young people and their families coping with chronic and terminal conditions. It has long been recognised that children with medical illnesses experience significant psychological and psychiatric co-morbidity. Psychiatric illness has an impact on adherence to treatment, and thus outcomes, in chronic illnesses and liaison teams are important assets in managing these issues and providing essential psychological insights for paediatric teams. “There are other obvious gaps in the network of services for at risk children including the lack of primary care and community psychology services as well as the severely restricted “after care” programmes for children leaving state care. “The list could go on.”


Report 15

Global study shows stroke largely preventable Ten risk factors, that can be modified, are responsible for nine of 10 strokes worldwide, but the ranking of those factors vary regionally, says a study led by researchers from NUI Galway and McMaster University, Canada.

Dr Martin O'Donnell of HRB-Clinical Research Facility, NUI Galway and formerly McMaster University

Prevention of stroke is a major public health priority, but the variation by region should influence the development of strategies for reducing stroke risk, say the authors. Stroke is a leading cause of death and disability, particularly in low-income and middleincome countries. The two major types of stroke include ischaemic stroke caused by blood clots, which accounts for 85% of strokes, and haemorrhagic stroke or bleeding into the brain, which accounts for 15% of strokes. The study led by Dr Martin O'Donnell of HRB-Clinical Research Facility, NUI Galway and formerly McMaster University and Dr Salim Yusuf of the Population Health Research Institute at McMaster University, Hamilton, ON, Canada, and collaborators from 32 countries, builds on findings from the first phase of the INTERSTROKE study which identified ten modifiable risk factors for stroke in 6,000 participants from 22 countries. This fullscale INTERSTROKE study added 20,000 individuals from 32 countries in Europe, Asia, America, Africa and Australia, and sought to identify the main causes of stroke in diverse populations, young and old, men and women and within subtypes of stroke. “This study has the size and scope to explore stroke risk factors in all major regions of the world and within key populations,” said O’Donnell, a stroke physician at Saolta University Healthcare Group. “We have confirmed that ten modifiable risk factors are associated with 90% of stroke risk in all parts of the world, in both men and women, and in younger and older people.

The study also confirms that hypertension is the most important modifiable risk factor in all regions, and the key target in reducing the burden of stroke globally.” The investigators looked at the different risk factors, and determined the proportion of strokes which would be cut if the risk factor disappeared. The number of strokes would be practically cut in half (48%) if hypertension was eliminated; trimmed by more than a third (36%) if people were physically active; and shaved by almost one fifth (19%) if they had better diets. In addition, this proportion was cut back by 12% if smoking was eliminated; 9% for cardiac (heart) causes, 4% for diabetes, 6% for alcohol intake, 6% for stress, and 27% for lipids (the study used apolipoproteins, which was found to be a better predictor of stroke than total cholesterol). Many of these risk factors are known to also be associated with each other (such as obesity and diabetes), and when were combined together, the total for all 10 risk factors was 91%, which was similar in all regions, age groups and in men and women.

However, the importance of some risk factors appeared to vary by region. For example, the importance of hypertension ranged from 38.8% in western Europe, North America, and Australia to 59.6% in Southeast Asia. The risk of alcohol was lowest in Western Europe, North America and Australia but highest in Africa and south Asia, while the potential impact of physical inactivity was highest in China. An irregular heart rhythm, or atrial fibrillation, was significantly associated with ischaemic stroke in all regions, but was of greater importance in Western Europe, North America and Australia, than in China or South Asia. However, when all 10 risk factors were included together, their collective importance was similar in all regions. “Our findings will inform the development of global population-level interventions to reduce stroke, and how such programs may be tailored to individual regions,” said Yusuf, a professor of medicine of McMaster’s Michael G. DeGroote School of Medicine and director of the PHRI. “This includes better health education, more affordable healthy food, avoidance of

tobacco and more affordable medication for hypertension and dyslipidaemia.” Along with the study, The Lancet published a related comment from New Zealand researchers Valery L. Feigin and Rita Krishnamurthi from the National Institute for Stroke and Applied Neurosciences, of Auckland’s University of Technology. They said the key messages from the study were that stroke is a highly preventable disease globally, regardless of age and sex; that the relative importance of modifiable risk factors means there should be development of regional or ethnic-specific primary prevention programmes, and that additional research on stroke risk factors is needed for countries and ethnic groups not included in INTERSTROKE. “Now is the time for governments, health organisations, and individuals to proactively reduce the global burden of stroke. Governments of all countries should develop and implement an emergency action plan for the primary prevention of stroke,” they wrote.

HPN • September 2016


16 News

Support for EMA re-location to Ireland Former Taoiseach John Bruton has called for the creation of special Brexit Committee to deal with the implications of Brexit for the pharmaceutical industry in Ireland. Mr Bruton was speaking at a seminar organised by the Irish Pharmaceutical Healthcare Association (IPHA). Key leaders of Ireland’s pharmaceutical industry were meeting to discuss how to mitigate the risk of Brexit to pharmaceutical companies in Ireland, and to consider how the pharmaceutical industry should support Ireland in dealing with uncertainties caused by Brexit.

Mr Ian Sutton, Country Director Mundipharma Ireland; Dr Leisha Daly, President of IPHA and Country Director, Janssen; Mr John Bruton, former Taoiseach; Ms Mary Dickens, Vice President of IPHA and Country Director of Sanofi Ireland; Mr Michael O’Connell, Country Director, Biogen Idec Ireland

In his keynote address Mr Bruton called for the creation of Brexit committees for strategic sectors of the Irish economy, including the pharmaceutical sector.

sectoral committees worked very well in those early years. It would be appropriate now, given the seriousness and the complexity of Brexit, to create similarly structured sectoral committees, including for our very important pharmaceutical industry, to manage the Brexit fall-out for Ireland,” said Mr Bruton.

“Forty-three years ago, when Ireland first joined the European Union, the Irish Government established sectoral committees of employers, trade unions and public agencies to handle Ireland’s integration into the EU. Those

At the seminar, the leaders of Ireland’s international researchbased pharmaceutical industry and Mr John Bruton expressed strong support for the re-location of the European Medicines Agency (EMA) to Ireland.

Caernarfon, UK

Dr Leisha Daly, President of the IPHA, said, “The EMA, which is the agency responsible for the protection across the EU of public and animal health through its scientific evaluation and supervision of medicines,

is currently located in Canary Wharf, London. Now that the UK has resolved to leave the EU, Ireland is ideally placed as a hub of pharmaceutical innovation and research to be the new location for the EMA.”

Biosimilars Research The HPRA and UCC's School of Pharmacy are conducting research on the public health impact of increased use of biosimilar medicines. The research highlights the need for pharmacists to be aware of specific pharmacovigilance considerations, and how to report a suspected adverse reaction. The output from this research is intended to inform and drive both the development of national guidelines from HPRA on biosimilars and to assist in identifying and implementing mechanisms to achieve increased understanding of health care professionals, patients, healthcare providers and policy makers involved in the use of these medicinal products.

e-Referral Programme completion GPs across the country can now refer patients into every acute hospital electronically following the completion of phase one of the HSE National e-Referral Programme. Over 10,550 e-referrals were received in hospitals in May, up significantly from the 2,289 received in August 2015 when the new process was initiated. Using the e-referral solution, a GP can submit a referral electronically, directly from their practice management system to the hospital in question using the HIQA approved referral form and immediately receive an acknowledgement confirming receipt. The system also enables the hospital to send a response message to the GP once the patient has been triaged. September 2016 • HPN

David Slevin, CEO Tallaght Hospital, Dr Ciara Martin, Emergency Paediatric Consultant and Clinical Director of Paediatric Services Tallaght Hospital, Orla O’Shea, Clinical Nurse Manager Paediatrics OPD Tallaght Hospital, Dr Catherine Wall, Consultant Nephrologist and Lead Clinical Director Tallaght Hospital and Tony O’ Brien, Chief Executive HSE


18 Clinical Synopsis

Transitional Pain Research Scientific Meeting The University College Dublin Centre for Translational Pain Research recently held their inaugural Scientific Meeting at the Health Science Centre Dr Catherine Blake, CTPR with University College Dublin gave the welcome address before introducing the programme. Keynote speaker was Professor Harriët Wittink, Professor of Lifestyle and Health , Faculty of Healthcare, HU University of Applied Sciences, Utrecht who spoke on “Relapse in rehabilitation; why it happens and strategies to prevent it”. Professor Wittink has been professor in Lifestyle and Health at HU University of Applied Sciences Utrecht since 2007. She began her career as a physiotherapist and gained her PhD in 1998 at Boston University with a thesis on the relationship between physical activity, physical fitness and chronic lower back pain. She is Assistant Professor of anaesthesia / pain management at Tufts University. Within the Lifestyle and Health research group, Wittink looks mainly at the relationship between exercise and health. Her focus is on people with medical conditions that prevent them from exercising. Working with physiotherapists and remedial therapists, she aims to improve care so that patients can benefit from improved treatments. Below we give an overview of some of the oral presentations that were viewed at the event. Oral Presentations Pain profiles following spinal cord injury in Ireland: A national survey Burke D1, Lennon O1, Fullen B.M.1,2. UCD School of Public Health, Physiotherapy and Sports Science, UCD CTPR Background: Neuropathic pain (NP) is a common post spinal cord injury (SCI) [1], presenting at or below the level of injury and described as the most severe pain post SCI [1]. In qualitative research by Spinal Injuries Ireland (n=385), pain was highlighted as a dominant issue for respondents [2]. Aims: To obtain by national survey, data relating to the prevalence of pain and NP and a comparison between NP and general pain presentations with respect to severity of symptoms, health related quality of life and health service utilisation in SCI in Ireland. Methods: Members registered to the SII database (n=1,574) were surveyed. Ethical exemption was granted. September 2016 • HPN

The Questionnaire pack included demographic and SCI characteristics, the ISCIP Basic Pain Dataset [3], the Douleur Neuropathique 4 (DN4) (interview) [4], the WHO QoL Bref [5] and questions on health care utilisation and pain management. Data were entered into SPSS statistical software. Independent t-tests, Mann Whitney U tests and Chi2 tests compared variables between respondents presenting with general pain and NP. Significance was set p<0.05. Results: In total 661 (43%) surveys were completed, 458 (69%) respondents experienced pain and 236 (36%) scores from the DN4 indicated NP. Respondents with NP had higher pain intensities and reported more days with pain (P= <0.001), LOWER health related quality of life scores (P<0.05) and had increased healthcare service utilisation (P= <0.001) when compared to those with generalised pain presentations. Conclusion: The problem of pain post SCI is evident and warrants further investigation and improved management strategies. Investigating the impact of health literacy in individuals with chronic pain Laura M. Mackey BSc1; Dr. Catherine Blake1; Dr. Camillus Power2; Dr. Ray Victory3; Dr. Conor Hearty4; Máire-Bríd Casey MSc4; Dr. Brona Fullen1, 5. 1. University College Dublin, Belfield, Dublin 4, Ireland. 2. Adelaide and Meath Hospital, Tallaght, Dublin 24, Ireland.3. St. Vincent’s University Hospital, Elm Park, Dublin 4, Ireland.4. Mater Misericordiae University Hospital, Eccles Street, Dublin 7, Ireland. 5. UCD Centre for Translational Pain Research, University College Dublin, Ireland. Background: Inadequate health literacy (HL) - a person’s ability to find, understand and utilise information effectively to make informed decisions about their health, has been linked to poorer health outcomes in many chronic diseases. However, the impact of HL in those with chronic pain is unknown, therefore, this study aims to establish if HL is linked to poorer outcomes and behaviours in patients with chronic pain. Methods: A cross-sectional questionnaire was distributed in three pain clinics, in university hospitals in Dublin, Ireland. Those eligible for inclusion had pain

lasting longer than three months. The questionnaire comprised the following assessments: demographics, chronic pain status, quality of life, beliefs about pain control, and a validated HL tool (Newest Vital Sign1). Results: Of the 131 participants that were recruited, 54.2% had inadequate HL. The group was subsequently stratified according to HL level (i.e. inadequate or adequate). In bivariate analysis, inadequate HL was associated with older age (p<0.001), being unemployed or retired (p=0.005), poorer educational attainment (P<0.001), lower income, increased comorbidities (p=0.038), being less likely to use an allied health services (p=0.001), poorer diseaserelated knowledge (p=0.002), and poorer beliefs about pain (p<0.05). In multivariate analysis, HL remained an independent predictor of disease-related knowledge (OR 2.5, 95%CI 1.0—6.3) and beliefs about pain (B=-2.317, 95%CI -4.2—-0.5), signifying that the odds of having greater disease-related knowledge and more appropriate beliefs about pain control were over two times higher in those with adequate HL. Conclusion: Inadequate HL is prevalent in chronic pain patients, and may impact on the development of health behaviours necessary for effective management. Healthcare professionals should consider including HL-sensitive strategies, such as Plain English or ‘Teach-Back Methods’ in their practice. Poster Presentations Examining psychosocial reports and cognitive functioning, whilst controlling for pain, in both fibromyalgia and hepatitis-C patient groups Damien Lowry1,2, Teresa Burke2,3, Stephen Stewart4, Declan O’Keeffe5 , & Geraldine McCarthy6 1Psychology Department, Mater Misericordiae University Hospital; 2 School of Psychology, University College Dublin; 3 School of Nursing and Human Sciences, Dublin City University; 4Liver Centre, Mater Misericordiae University Hospital; 5Dept Pain Medicine, St. Vincent’s University Hospital; 6Rheumatology Department, Mater Misericordiae University Hospital. Background: Fibromyalgia-syndrome (FMS) and hepatitis-C are clinical


19 Conclusion: These findings suggest that HCPs need further support to incorporate HL-sensitive interventions into their practice. Neuropathic pain prevalence following spinal cord injury: A systematic review and meta-analysis

conditions where patients frequently report symptoms across physical, psychological and cognitive domains. It is suggested that pain symptoms might underpin some of these difficulties. To our knowledge, the psychosocial and cognitive functioning of FMS and hepatitis-C patients has never been compared whilst controlling for the effects of pain. Aims: Compare psychosocial wellbeing and neuropsychological functioning among Irish females with FMS and iatrogenic-hepatitis-C-exposure, whilst controlling for pain. Methods: Subsets of existing data comprising a PhD were used. The PhD was investigating the impact of iatrogenic hepatitis-C infection and the potentially confounding role of pain on Mater Misericordiae University and St. Vincent’s University Hospitals were recruited into the larger project. Individuals satisfying inclusion and exclusion criteria completed a psychosocial survey before considering extensive cognitive testing. For the purpose of this study, select subgroups of these larger samples were obtained by removing participants reporting ‘average pain- severity’ below 3/10 on the BPI, yielding two samples of painmatched FMS (N=22) and hepatitis-C (n=20) patients. Results: In controlling for average-pain, these select subgroups were also strongly matched on age, education, health-related-quality-of-life (HRQoL), fatigue and mood, with a series of independent sample t-tests failing to reveal any significant betweengroup differentiation. Of interest, both subgroups reported impaired levels of physical and mental HRQoL, fatigue and mood-distress. On cognitive testing, mean subgroup performances all fell within the normal range, suggestive of relatively healthy cognition, though the FMS subgroup displayed some isolated dual-task difficulties compared to the hepatitis-C group. Conclusions: Poor psychosocial functioning in these cohorts may be explained somewhat by somatic pain. FMS also appears to be a condition more characterised by cognitive dysfunction than hepatitis-C.

An exploration of healthcare professionals’ attitudes towards health literacy, and the clinical encounter with chronic pain patients Laura M. Mackey BSc1, 2; Dr. Camillus Power3; Dr. Brona Fullen1, 2. 1. University College Dublin, Belfield, Dublin 4, Ireland. 2. UCD Centre for Translational Pain Research, University College Dublin, Ireland. 3. Adelaide and Meath Hospital, Tallaght, Dublin 24, Ireland. Background: A recent review of long-term outcomes for patients who attended a pain management programme revealed only moderate improvements1. The authors hypothesised that health literacy (HL) may be a factor, as low HL can result in poorer uptake of self-management behaviours. However, little data exists regarding the use of HL interventions in healthcare settings. This study aimed to explore healthcare professionals (HCPs) attitudes regarding the role of HL in clinical practice. Methods: Semi-structured interviews were utilised to capture HCPs’ (nurses, consultants, physiotherapists, psychologists) perspectives on HL. Interview questions were derived from HL research, focussing on interviewees’ knowledge of HL, recognising those at risk of low HL, the skills required to identify and manage those with low HL, and the economic burden of low HL. The interviews were transcribed verbatim, coded, and inter and intra-reliability was determined by two reviewers. Common themes were identified. Results: Sixteen HCPs (four per discipline) were interviewed, with four main themes emerging: 1) Lack of formal HL awareness in healthcare settings, 2) HL vital for engaging in treatments, 3) varying interventions for low HL, and 4) barriers to addressing low HL in patients. The majority of HCPs were not familiar with HL, Also, HCPs’ knowledge of HL-sensitive interventions varied, and was based on subjective experience as opposed to evidence-based practice. Furthermore, most cited time-restraints as a barrier to facilitating HL development in their patients, despite acknowledging it as their responsibility.

Burke D1, Lennon O1, Stokes D2, Fullen BM1,3. UCD School of Public Health, Physiotherapy and Sports Science, UCD College of Health and Agricultural Sciences, UCD CTPR Background: Following spinal cord injury (SCI) chronic pain is a common secondary complication, with neuropathic pain (NP) cited as one of the most distressing and debilitating conditions leading to poor quality of life, depression and sleep disturbances. Neuropathic pain presenting at or below the level of injury, is largely refractory to current pharmacological and physical treatments. No consensus on the prevalence of NP post SCI currently exsists, hence this systematic review was undertaken. Aims: To systematically review the literature addressing NP from studies which include an adequate definition and assessment of NP post SCI. Where possible meta-analysis will be undertaken to estimate pooled point prevalence rates of NP in the total population, in subgroups of the population defined by SCI and demographic characteristics and at specific time points post injury. Methods: The review comprised three phases: a methodological assessment of databases (Pubmed, EMBASE, Web of Knowledge, CINAHL, Cochrane Library and PEDro) identifying potential papers and screening for inclusion criteria by two independent reviewers; data extraction; and finally rating of internal validity and strength of the evidence, using a published valid and reliable scale. Meta-analysis estimated pooled point prevalence rates using a random effects model. Results: In total 17 studies involving 2,529 patients were included in the review. Overall point prevalence rates for NP were established at 53% (38.58-67.47); 19% (13.26-26.39) for at-level NP and 27% (19.89-34.61) for below level NP, with high heterogeneity noted (I2 =84.2-93%). Conclusions: Prevalence rates for NP following SCI are high. Future studies should include established definitions, classifications systems and assessment tools for NP at defined time points post SCI to follow the trajectory of this problem across the lifespan and include indices of sleep, mood and interference to allow for appropriate, optimal and timely NP management for each patient. HPN • September 2016


20 Feature Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up Authors: B. Eichhorst, T. Robak, E. Montserrat, P. Ghia, P. Hillmen, M. Hallek, C. Buske

Chronic lymphocytic leukaemia is the most common leukaemia in the Western world and generally affects older populations. These updated ESMO Clinical Practice Guidelines present the latest information on CLL including the diagnosis and molecular biology of CLL and treatment strategies for early and advanced disease. Chronic lymphocytic leukaemia (CLL) is the most common leukaemia in the Western world with an incidence of 4.2:100 000/ year. The incidence increases to >30:100 000/year at an age of >80 years. The median age at diagnosis is 72 years. About 10% of the CLL patients are reported to be younger than 55 years. There is an inherited genetic susceptibility for CLL, with a 6- to 9-fold increased risk for family members of CLL patients. Diagnosis and molecular biology

Table 1: Diagnostic and staging work-up Pretreatment Response evaluation evaluation

History, physical examination and performance status

+

+

Complete blood count and differential

+

+

+

+

for TP53 mutation

+

-

Marrow aspirate and biopsy

+a

+b

Hepatitis B and C, CMV and HIV serology

+ ­-

Serum chemistry including serum immunoglobulin and direct antiglobulin test Cytogenetics (FISH) for del (17p)/molecular genetics

Only if clinically indicated.

a

Only for confirmation of CR within clinical studies.

b

The diagnosis of CLL is established by the following criteria [1]: •–  Presence in the peripheral blood of ≥5000 monoclonal B lymphocytes/µl. The clonality of the circulating B lymphocytes needs to be confirmed by flow cytometry. •–  The leukaemia cells found in the blood smear are characteristically small, matureappearing lymphocytes with a narrow border of cytoplasm and a dense nucleus lacking discernible nucleoli, and having partially aggregated chromatin. Larger, atypical lymphocytes or prolymphocytes may be seen but must not exceed 55%. CLL cells co-express the CD5 antigen and B-cell surface antigens CD19, CD20 and CD23. The levels of surface immunoglobulin, CD20 and CD79b are characteristically low compared with those found on normal B cells. Each clone of leukaemia cells is restricted to expression of either kappa or lambda immunoglobulin light chains. Other lymphoma entities to be separated from CLL are leukaemic marginal zone lymphoma, lymphoplasmacytic lymphoma and mantle cell lymphoma (MCL). These tumour cells express B-cell

September 2016 • HPN

surface antigens and MCL also expresses CD5, but usually not CD23. For cases that express CD23, staining for cyclin D1 or SOX11 and fluorescence in situ hybridisation (FISH) for detecting a translocation (11;14) are useful for establishing the diagnosis of MCL. FMC7 may also help differentiating CLL from MCL, but there are also FMC7 positive (atypical) CLL cases. Marginal zone lymphoma or lymphoplasmacytic lymphoma may also be differentiated by a negative or lower CD43 expression in comparison to CLL. In the World Health Organisation classification, small lymphocytic lymphoma (SLL) and CLL are considered to be a single entity. The diagnosis of SLL requires the presence of lymphadenopathy and/or splenomegaly with a number of B lymphocytes in the peripheral blood not exceeding 5 x 109/l. SLL cells show the same immunophenotype as CLL. The diagnosis of SLL should be confirmed by histopathological evaluation of a lymph node biopsy, whenever possible. In absence of lymphadenopathy, organomegaly, cytopaenia and

clinical symptoms, the presence of fewer than 5000 monoclonal B lymphocytes/µl defines ‘monoclonal B-lymphocytosis’ (MBL) [1], which can be detected in 5% of subjects with normal blood count [2]. Progression to CLL occurs in 1%–2% of MBL cases per year [2]. Staging and risk assessment The following examinations are recommended before any treatment (Table 1) [III, B] [1]: •–  History and physical examination including a careful palpation of all lymph node areas, spleen and liver •–  Complete blood cell count and differential count •–  Serum chemistry including lactate dehydrogenase, bilirubin, serum immunoglobulins, direct antiglobulin test •–  The history and status of relevant infections [i.e. hepatitis B and C, cytomegalovirus, human immunodeficiency virus] should be evaluated before chemoimmunotherapy or allogeneic stem-cell

transplantation (alloSCT), to avoid virus reactivation •–  FISH for detection of deletion of the chromosome 17 [del(17p)] affecting the tumour protein p53 expression and in the absence of del(17p) molecular genetics for detection of TP53 gene mutation (at least exons 4–10, eventually exons 2–11) [III, A] [3]. FISH, fluorescence in situ hybridisation; CMV, cytomegalovirus; HIV, human immunodeficiency virus; CR, complete remission. The following additional examinations before treatment are desirable [III, B] [1]: •–  Although a bone marrow biopsy is not required for diagnosis, it is recommended for the diagnostic evaluation of unclear cytopaenias, or FISH or molecular genetics if peripheral blood cell lymphocytosis does not allow adequate immunophenotyping •–  An extended FISH analysis is recommended before the start of therapy because the


21 detection of additional cytogenetic abnormalities [del(11q) or trisomy 12] may have therapeutic consequences

FIGURE 1

Front-line treatment.

•–  Molecular analysis for detecting immunoglobulin heavy chain variable (IGHV) mutation status and better estimation of duration of response •–  Imaging studies by computed tomography (CT) scans may be helpful to assess the tumour load or to determine the cause of unclear symptoms in individual patients, but they should not generally be used in asymptomatic patients or for clinical staging. In addition, CT scans may be useful for baseline and final assessment in clinical trials [III, C]. In elderly patients, abdominal ultrasound might be considered instead. Two clinical staging systems are used to predict median survival. In Europe, the Binet staging system is more widely used, whereas in the United States, the Rai system is more commonly applied. Both Binet and Rai staging systems separate three groups of patients with different prognoses [4, 5]. With the new treatment options available, the overall survival (OS) of patients with advanced disease stages has improved [6]. Additional markers are available to predict the prognosis of patients with CLL, in particular at early stages [7, 8]. Patients with a detectable del(17p) or a mutation of TP53 (∼5% at diagnosis and up to 10% at treatment initiation) have the poorest prognosis, with a median OS of 2–5 years. The formerly poor prognosis of patients with a del(11q) (∼20%) has been improved by chemoimmunotherapy with FCR (fludarabine, cyclophosphamide and rituximab) [9]. More recently described gene mutations such as NOTCH1, SF3B1, MYD88 or BIRC3 [10] may also predict an unfavourable prognosis in the absence of TP53 deletion/mutation [11, 12], but their clinical impact needs further investigation [III, C]. Because leukaemic clones may evolve, FISH and TP53 mutation analyses should be repeated before relapse treatment is administered [III, B] [13]. About 50% of CLL patients present with an unmutated IGHV status [14, 15]. CLL cells with unmutated IGVH status have a higher genetic instability with a higher risk of gaining unfavourable genetic mutations. OS and time to treatment intervention are significantly shorter in this patient group. The expression of CD38 and ZAP70 correlates to some extent with the IGHV mutational status, but has no therapeutic impact and is therefore not required [III, C].

B. Eichhorst et al. Ann Oncol 2015;26:v78-v84 © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Management of early disease stage Binet stage A and B without active disease; Rai 0, I and II without active disease Previous studies have shown that early treatment with chemotherapeutic agents does not translate into a survival advantage in patients with early-stage CLL [16]. The standard treatment of patients with early disease is a watch-and-wait strategy [I, A]. Blood cell counts and clinical examinations should be carried out every 3–12 months. Due to the lack of clinical trials, no evidence-based treatment recommendation can be given for localised, early-stage SLL [I, A]. Treatment of advanced disease stage Binet stage A and B with active disease or Binet stage C; Rai 0–II with active disease or Rai III–IV Treatment indication Treatment should only be initiated in patients with symptomatic, active disease. The following conditions define active disease: significant B symptoms, cytopaenias not caused by autoimmune phenomena and symptoms or complications from lymphadenopathy, splenomegaly or hepatomegaly, lymphocyte doubling time of <6 months (only in patients with more than 30G lymphocytes/l), as well

as autoimmune anaemia and/ or thrombocytopaenia poorly responsive to conventional therapy [I, A]. The presence of del(17p) or TP53 mutation without the abovementioned conditions is not an indication for treatment. Front-line treatment In physically fit patients (physically active, with no major health problems, normal renal function) without TP53 deletion/mutation, FCR is the standard first-line therapy: improvement of OS has been demonstrated with this firstline chemoimmunotherapy (Figure 1) [I, A] [9]. Combinations based on other purine analogues such as cladribine [17] or pentostatin [18] have shown similar activity, but it is uncertain whether they can replace fludarabine in the FCR regimen [II, B]. In fit but elderly patients, FCR was shown to be associated with a higher rate of severe infections when compared with bendamustine plus rituximab (BR) [19]. Therefore, in this group of patients, therapy with BR may be considered, although it produces fewer complete remissions than FCR [I, B]. Further studies evaluating BR as front-line therapy in fit but elderly patients are therefore required. In patients with relevant comorbidity, who are usually older, but without TP53 deletion/ mutation, the combination of chlorambucil plus an anti-CD20 antibody (rituximab, ofatumumab or obinutuzumab) prolongs progression-free survival (PFS)

when compared with monotherapy and is therefore the standard approach [I, A] [20, 21]. In a head-to-head comparison of chlorambucil-based combinations, the type II antibody obinutuzumab was superior to the type I antibody rituximab with regard to PFS, complete remission (CR) and minimal residual disease (MRD)negative remissions. Patients with TP53 deletion/ mutation have a poor prognosis even after FCR therapy [9]. Therefore, it is recommended that patients with TP53 deletion/ mutation are treated with novel inhibitors (ibrutinib; idelalisib and rituximab) in front-line and relapse settings [V, A]. For fit patients responding to inhibitor treatment, an allogeneic haematopoietic stem-cell transplantation (HSCT) may be discussed, using individual and transplant-related risk factors [III, B] [22]. Maintenance therapy in CLL patients with higher risk of relapse may have some benefit, but cannot be generally recommended. Treatment of relapse and refractory disease As for the first-line therapy, treatment at relapse should only be started in symptomatic patients. Many patients with relapsed but asymptomatic CLL can be followed with no therapy for a long period of time. First-line treatment may be repeated if the relapse

HPN • September 2016


22 Feature or progression occurs at least 24–36 months after chemoimmunotherapy and if TP53 deletion/mutation was excluded [III, B].

FIGURE 2

Relapse treatment.

If relapse occurs within 24–36 months after chemoimmunotherapy, or if the disease does not respond to any first-line therapy, the therapeutic regimen should be changed. Treatment options include [III, B]: •–  BCL2 antagonists alone or in combination within a clinical study •–  Bruton's tyrosine kinase inhibitor ibrutinib [23] •–  PI3K inhibitor idelalisib in combination with rituximab [24] •–  Other chemoimmunotherapy combinations should only be administered if TP53 deletion/ mutation was excluded (Figure 2). Patients not responding nor progressing upon therapy with kinase inhibitors might be switched to a different kinase inhibitor or to BCL2 antagonists when available (according to clinical trials). Fit patients achieving second remission following the second application of an inhibitor should proceed to allogeneic HSCT [V, B] [22]. Role of haematopoietic stemcell transplantation

B. Eichhorst et al. Ann Oncol 2015;26:v78-v84 © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

be a reasonable treatment option before splenectomy [III, B]. In patients with resistant autoimmune cytopaenia, treatment of the underlying CLL is recommended.

Autologous stem-cell transplantation is not useful in CLL [I, A] [25]. An alloSCT should be considered in patients achieving remission with kinase inhibitors or BCL2 antagonists after early relapse from chemoimmunotherapy and/or with del(17p) or TP53 mutation. In this situation, long-term treatment with inhibitors is an alternative option. The decision should be based on transplant- and disease-risk (e.g. availability of matched donor, patient age and comorbidities and response to treatment) and the patient's preferences, following a careful discussion of the risks and benefits of an allogeneic transplant [22]. In patients failing to several lines of therapy, allogeneic bone marrow transplantation should be considered [III, B].

Infections are a common complication in CLL patients; therefore, use of immunosuppressive agents, as for example corticosteroids, should be restricted to a possible minimum. The use of prophylactic systemic immunoglobulin does not have an impact on OS [27, 28], and is only recommended in patients with severe hypogammaglobulinaemia and repeated infections [I, A]. Antibiotic and antiviral prophylaxis should be used in patients with recurrent infections and/or very high risk of developing infections (e.g. pneumocystis prophylaxis with cotrimoxazole during treatment with chemoimmunotherapies based on purine analogues or bendamustine) [IV, B]. Pneumococcal vaccination as well as seasonal influenza vaccination is recommended in early-stage CLL [IV, B].

Treatment of CLL complications

Response evaluation

Treatment of patients with autoimmune cytopaenia should be carried out according to the statement from the ‘ESMO guidelines consensus conference on malignant lymphoma: CLL’ [26]. Most patients with autoimmune cytopaenia respond to corticosteroids [III, B]. For patients not responding to corticosteroids, rituximab administration might

Response evaluation includes a careful physical examination and a blood cell count. A bone marrow biopsy may be carried out to define CR [III, B] [1]. Chest X-ray and an abdominal ultrasound or CT for response evaluation may be carried out, if abnormal before therapy [IV, C] [1].

September 2016 • HPN

Detection of MRD by four-colour

flow cytometry has a strong prognostic impact [29, 30]. Patients who are MRD-negative after therapy show a longer response duration and survival. Additional clinical consequences of MRD positivity post-therapy remain unclear except for patients after an allogeneic transplantation, where a positive MRD signal may trigger the reduction of immunosuppressive therapies or the start of anti-leukaemic maintenance therapy. Therefore, MRD assessment is not generally recommended for monitoring posttherapy outside clinical studies. Follow-up and long-term implications CLL is an incurable disease. Therefore, life-long observation and follow-up is recommended for all patients. Follow-up of asymptomatic patients should include a blood cell count and the palpation of lymph nodes, liver and spleen every 3–12 months depending on the dynamics of the leukaemic development. Special attention should be paid to the appearance of autoimmune cytopaenias. Moreover, CLL patients have a two- to sevenfold increased risk of developing secondary malignancies (mostly solid cancers, but also secondary myelodysplastic syndromes or acute myeloblastic leukaemia). The transformation into a diffuse large B-cell lymphoma (DLBCL) or Hodgkin's lymphoma (HL) occurs in 2%–15% of CLL patients during

the course of their disease. The diagnosis has to be confirmed by histopathology exam of a lymph node (biopsy or excision). A positron emission tomography–CT might be useful to guide biopsy [IV, C]. The transformation of CLL into Hodgkin's disease represents a separate entity, where conventional chemotherapy against HL often achieves long-lasting remissions. The transformation into DLBCL is called Richter's transformation (RT) and usually has a very poor prognosis, with the exception of clonally-unrelated de novo DLBCL. Treatment regimens for RT include therapies used in DLBCL such as rituximab plus CHOP (cyclophosphamide, vincristine, doxorubicin and dexamethasone). More intense treatment regimens such as rituximab plus hyper CVAD (cyclophosphamide, vincristine, doxorubicin and dexamethasone alternating with methotrexate and cytarabine) or OFAR (oxaliplatin, fludarabine, cytarabine and rituximab) have not been proven to induce better outcomes than R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone) [IV, B]. Response duration of RT is typically short, and an allogeneic HSCT should be recommended to all patients with clonally related DLBCL with an available donor and sufficient fitness [IV, B].

References available on Request.


NOhep Our Next Greatest Achievement

Join the NOhep campaign to help make the elimination of Hepatitis C our next greatest achievement

#NOhep

NOhep is an independent initiative led by the World Hepatitis Alliance. All content and design has been developed solely by NOhep with no influence or support from MSD or any other commercial organisation.

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24 News

Eliminating the Hepatitis C virus epidemic World Hepatitis Day was held at the end of July, and locally it was supported by the HSE, who welcomed the many initiatives that were organised by the voluntary and advocacy sectors to mark the day in Ireland. In 2010 the World Health Organisation made World Hepatitis Day one of only four official disease-specific worldwide health days, celebrated each year on the 28th July. Millions of people across the world now take part in World Hepatitis Day, to raise awareness about viral hepatitis, including hepatitis C and to call for access to treatment, better prevention programmes, improved surveillance and testing, and government action. The theme of World Hepatitis Day 2016 was ‘Elimination’ and in 2015 the HSE established a National Hepatitis C Treatment Programme whose ultimate goal is the elimination of Hepatitis C in Ireland by 2026. This will be done through the implementation of a multi annual public health plan – this fully supports the hepatitis elimination strategy as adopted by WHO member states at its World Health Assembly meeting in May 2016. Professor Suzanne Norris, Consultant Hepatologist and Clinical Lead for the National Hepatitis C Treatment Programme says, “Hepatitis C is curable and the National Hepatitis C Treatment Programme aims to provide everyone in Ireland infected with Hepatitis C access to treatment over the coming years with a view to making Hepatitis C a rare disease in Ireland by 2026. Our goal is to meet or exceed the WHO target of elimination by 2030. “One of our objectives in taking part in the World Hepatitis Day

is to raise awareness about the virus and to encourage people to recognise if they are at risk or have previously been at risk for Hepatitis C and get tested. Many people infected with hepatitis do not know they are infected with Hepatitis C (see list of symptoms below). Currently there are an estimated 20,000 to 50,000 people in Ireland chronically infected with hepatitis C, more than half of whom are not aware of their infection, the stage of their disease and, in some cases, are not linked to care.” Michele Tait, Project Manager for the HSE Treatment Programme added, “Taking part in World Hepatitis Day is important for everyone affected by Hepatitis C and for everyone working to support people who are infected. The day helps us to raise awareness as there are thousands of people who are infected but unaware. The HSE is taking part in the World Hepatitis Alliance (WHA) NOhep campaign; WHA is a global patient led group made up of 230 organisations across 81 countries working in the field of viral hepatitis. The HSE has signed up to the WHA to show our commitment to the elimination of Hepatitis C in Ireland by 2026. As part of World Hepatitis Day the WHA will launch a new international movement called NOhep. The HSE is asking all of its staff and partner agencies to partake in the NOhep worldwide Twitter Thunderclap at 12.00 on Thursday 28th July to raise awareness across the world (#NOhep: Eliminate hepatitis). “By working with agencies, the HSE National Treatment Programme, the HSE Hepatitis C Strategy Implementation group and our staff who deliver services; we can raise awareness of hepatitis and improve access to treatments.”

Professor Suzanne Norris

Signs and symptoms of Hepatitis C (four stages) are listed below:

Others with chronic hepatitis C will develop symptoms, including:

 The acute stage

extreme tiredness

 The chronic stage

depression

 Compensated cirrhosis, and

short-term memory problems or difficulty concentrating

 Decompensated cirrhosis The acute (initial) stage The acute stage is the first six months of infection. Most people do not experience any symptoms during this phase. Other people will have vague flulike symptoms, including: fever tiredness loss of appetite stomach pains nausea vomiting These occur a few weeks after being infected. A few people also develop jaundice. Approximately one in five people will fight off the hepatitis C virus and clear it from their body during this period. The chronic stage Hepatitis C is said to be chronic when you have been infected for longer than six months. In people with a chronic infection, the virus remains active but may not cause any symptoms throughout their life or for many years. They may remain well and develop no liver problems. However, they are carriers, which means that they can pass the virus on to others, for example, by sharing needles.

September 2016 • HPN

mood swings digestive problems joint and muscle aches and pains headaches flu-like symptoms pain or discomfort in the liver area stomach pains itching Compensated cirrhosis About one in five people with chronic hepatitis C will develop cirrhosis over a period of about 20 to 30 years (it can be sooner in people who drink alcohol). Cirrhosis is scarring of the liver as a result of long-term, continuous damage to the liver. It is a serious condition where healthy tissue in the liver is destroyed and replaced by scar tissue, which starts to block the flow of blood through your liver. Compensated cirrhosis means that the liver can still carry out its normal functions (the liver can compensate for the damage). Decompensated cirrhosis A few people with compensated cirrhosis will deteriorate further and develop decompensated cirrhosis. This means the liver stops functioning (liver failure).


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Proven efficacy comparable to well-controlled warfarin1,2 Superior reduction in clinically relevant bleeding vs. well-controlled warfarin1,2 Once-daily dosing across both NVAF and VTE indications3 Indicated for: 3 Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA) Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults LIXIANA▼ (edoxaban) 60 mg/30 mg/15 mg film coated tablets ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. See summary of product characteristics prior to prescribing for full list of adverse events. Presentation: 60 mg (yellow) / 30 mg (pink) / 15 mg (orange) edoxaban film coated tablets (as tosilate). Indications: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA) and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Posology and method of administration: NVAF - The recommended dose is 60 mg edoxaban once daily with or without food. Therapy with edoxaban in NVAF patients should be continued long term. VTE - The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5 days with or without food. Duration of therapy (at least 3 months) should be based on risk profile of the patient. For NVAF and VTE the recommended dose is 30 mg edoxaban once daily in patients with one or more of the following clinical factors: moderate or severe renal impairment (creatinine clearance (CrCl) 15–50 ml/min), low body weight ≤60 kg and/or concomitant use of the following P-glycoprotein (P-gp) inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole. The 15 mg dose of edoxaban is not indicated as monotherapy, and should only be used during a switch from edoxaban to VKA (see SmPC for full details). If a dose of edoxaban is missed, the dose should be taken immediately and then continued once daily on the following day. Contraindications: Hypersensitivity to the active substance or to any of the excipients; clinically significant active bleeding. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk. Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal (GI) ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Uncontrolled severe hypertension. Concomitant treatment with any other anticoagulants e.g. UFH, low molecular weight heparins, heparin derivatives (fondaparinux, etc.), VKA or NOACs except under specific circumstances of switching oral anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter. Pregnancy and breastfeeding. Special warnings and precautions for use: Haemorrhagic risk: Use with caution in patients with increased risk of bleeding such as elderly on ASA and should be discontinued if severe haemorrhage occurs. The anticoagulant effect of edoxaban cannot be reliably monitored with standard laboratory testing. A specific anticoagulant reversal agent for edoxaban is not available. Haemodialysis does not significantly clear edoxaban. Renal impairment: Renal function should be assessed prior to initiation of edoxaban and afterwards when clinically indicated. Not recommended in patients with end stage renal disease or on dialysis. Renal function and NVAF: A trend towards decreasing efficacy with increasing creatinine clearance was observed for edoxaban compared to well-managed warfarin. Edoxaban should only be used in patients with NVAF and high creatinine clearance after a careful benefit risk evaluation. Hepatic impairment: Not recommended in patients with severe hepatic impairment and should be used with caution in patients with mild or

www.lixiana.ie

moderate hepatic impairment. Edoxaban should be used with caution in patients with elevated liver enzymes (ALT/ AST > 2 x ULN) or total bilirubin ≥1.5 x ULN. Surgery or other interventions: discontinue edoxaban at least 24 hours before the procedure. If the procedure cannot be delayed, the increased risk of bleeding should be weighed against the urgency of the procedure. Edoxaban should be restarted as soon as haemostasis is achieved. Prosthetic heart valves and moderate to severe mitral stenosis: Not recommended. Haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy: Not recommended. Patients with active cancer: Not recommended. Drug interactions: The P-gp inhibitors ciclosporin, dronedarone, erythromycin, or ketoconazole result in increased concentration of edoxaban and a dose reduction of 30 mg is required. Edoxaban should be used with caution with concomitant P-gp inducers (e.g. phenytoin, carbamazepine, phenobarbitol or St John’s Wort). Concomitant high dose ASA (325 mg) or chronic NSAIDs is not recommended. There is very limited experience with dual antiplatelet therapy or fibrinolytic agents. Pregnancy: Not recommended. Breastfeeding: discontinue breastfeeding or edoxaban therapy. Undesirable effects: Common: anaemia, epistaxis, lower GI haemorrhage, upper GI haemorrhage, oral/pharyngeal haemorrhage, nausea, blood bilirubin increased, gamma GT increased, cutaneous soft tissue haemorrhage, rash, pruritus, macroscopic haematuria/urethral haemorrhage, vaginal haemorrhage, puncture site haemorrhage, liver function test abnormal. Uncommon: hypersensitivity, intracranial haemorrhage (ICH), intraocular haemorrhage, other haemorrhage, haemoptysis, surgical site haemorrhage. Rare: anaphylactic reaction, allergic oedema, subarachnoid haemorrhage, pericardial haemorrhage, retroperitoneal haemorrhage, intramuscular haemorrhage (no compartment syndrome), intra-articular haemorrhage, subdural haemorrhage, procedural haemorrhage. Legal category: POM. Package quantities: 60 mg/30 mg – 28 tablets. 15 mg – 10 tablets. Marketing Authorisation (MA) number: EU/1/15/993/001-16. MA holder: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany. Additional Information: Available on request from Daiichi Sankyo Ireland Ltd. Telephone: (01) 489 3000. Fax: (01) 489 3033. Email: medinfo@daiichi-sankyo.ie. Date of preparation: July 2015. ▼ This medicine is subject to additional monitoring. Adverse events and product complaints should be reported. To report an adverse event or a product complaint about a Daiichi Sankyo medicine, please call Daiichi Sankyo Ireland Ltd. on (01) 489 3000. Healthcare professionals are also asked to report any suspected adverse reactions to Daiichi Sankyo medicines to HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: (01) 676 4971; Fax: (01) 676 2517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

References: 1. Giugliano RP et al. NEJM 2013;369(22):2093–2104. 2. The Hokusai-VTE Investigators. NEJM 2013;369(15):1406–1415. 3. LIXIANA®, Summary of Product Characteristics, www.medicines.ie, September 2015. Date of item: July 2015. EDX/15/0169


26 News

Continuous Professional Development for NCHDs The 2016/2017 Continuous Professional Development Support Scheme (CPDSS) for non-consultant hospital doctors (NCHDs) working in the fields of surgery and emergency medicine, taking place at RCSI (Royal College of Surgeons in Ireland), has been announced with this year's programme offering a newly expanded choice of modules. The programme, which is now in its sixth year, is commissioned and funded by the Health Service Executive (HSE) to facilitate NCHDs within the public health

service, who are not on training schemes, to maintain their professional competence in line with Medical Council requirements and provides a structured means of achieving 20 external CPD credits. For 2016/17 RCSI will offer participants an expanded range of classes in surgical skills; emergency medicine; human factors in patient safety; clinical audit; quality improvement processes; research and ethics; computers for doctors; and a range of e-learning activities.

The Continuous Professional Development Support Scheme is open to NCHDs who are registered on the General Division or Supervised Division of the Register of Medical Practitioners maintained by the Medical Council. NCHDs must hold the 2010 NCHD contract and be working within the public health service. To successfully enrol on the Continuous Professional Development Support Scheme applicants must have paid the annual Professional Competence Scheme Fee for 2016/2017.

Since 1st of May 2011, it has been mandatory for all doctors to register with a Professional Competence Scheme (PCS) run by one of the postgraduate training bodies. RCSI has been designated by the Irish Medical Council to run PCS for Surgery and Emergency Medicine. For further information on the scheme delivered by RCSI visit rcsi.ie/cpd-support-scheme. The CPD Scheme runs until May 2017 and details of classes are available on schoolforsurgeons.com.

Orphan medicine regulation consultation The European Commission has opened a public consultation to gain views from stakeholders on proposed revisions to EU regulation on orphan medicines, especially in respect to how the concept of 'similar medicinal product' is understood. The consultation closes on 4th November 2016.

A short four-page document explains the rationale for the proposed changes. Fifteen years after EU regulations on orphan medicines were put in place, changes in science, technology and the pharmaceutical market has caused a rethink in how the concept of 'similar medicinal product" is understood when

it comes to applying the various incentives provided by designation of a product as 'orphan' (i.e. intended for treatment for rare conditions). Developments in respect to biological medicines and Advanced Therapy Medicinal Products (ATMPs) are particularly cited as giving rise to

reconsideration of the term's meaning. New texts for understanding the meaning of terms within EU orphan medicine regulation, such as 'similar active substance", are proposed.

Clodagh More than Just Medicine Pharmacist and trainee doctor Clodagh Murray has made a solo crossing of the English Channel — in an impressive 10 hours, 51 minutes. This confirms her as the second-fastest Irish woman to ever swim the channel — and means she holds one of the top five times of any Irish person to swim the 21-mile course. But Clodagh, who is a qualified pharmacist and entering her final year of medical school in Trinity College, Dublin, almost missed her chance to take on one of the world’s toughest sporting challenges because of bad weather. She spent a full week waiting in Dover for the right weather conditions and was finally told at 8pm on the evening before that she would be starting the swim at 5.50am the next morning, August 14. “I had to meet the pilot and crew at 5am, which meant getting up at 3.30am. I hardly slept as I was so nervous —and excited. The waiting was one of the most gruelling aspects of the entire September 2016 • HPN

endeavour,” says Clodagh, who is a Trinity Scholar. “It’s what also makes it so different to other sporting challenges as there is no start time or date. It is all down to Mother Nature so you need to be ready to peak when the weather gods decide to play ball. If I didn’t get a break in the weather, I would have been told to come back next year.” Conditions were rough for Clodagh’s swim, with winds reaching force three and four at different stages. “The choppiness felt relentless, like there was no let-up in the wind,” she says. “The one thing I wasn’t prepared for was the number of jellyfish and I got my first sting after about three hours. Because I was so cold and a bit numb, the stings were almost a distraction from the weather conditions. You are swimming into them telling yourself to put your head down and get on with it.” The preparation for swimming the English Channel is tough and Clodagh trained throughout the

winter under the watchful eye of Coach David Warby of Connect to Perform. Clodagh has started writing a health and lifestyle blog,

drawing on her own personal experiences as a pharmacist, trainee doctor and sportswoman. You can read her posts at iammorethanmedicine.com.


CPD 24: Psoriasis Continuing Professional Development

CPD

27

Menter A1, Papp KA2, Gooderham M3, Pariser DM4, Augustin M5, Kerdel FA6, Fakharzadeh S7, Goyal K7, Calabro S7, Langholff W8, Chavers S9, Naessens D10, Sermon J10, Krueger GG11

1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice?

3. PLAN - If I have identified a knowledge gap - will this article satisfy those needs or will more reading be required?

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.

4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result? Have I identified further learning needs?

60 Second Summary The introduction of biologic agents over the past decade has led to a significant shift in the treatment paradigm for both psoriasis and psoriatic arthritis (PsA), chronic disorders that invariably require long-term therapy to maintain clinical response. The trend towards long-term use of biologics for maintenance treatment underscores the need to understand drug survival (i.e. how long a patient stays on a given therapy). PSOLAR (PSOriasis Longitudinal Assessment and Registry) is a large international registry initially undertaken to address a postmarketing commitment to capture safety outcomes for infliximab and ustekinumab. The majority of patients were enrolled at North American sites (79.2% for first-line therapy, 91.0% for second-line therapy and 92.8% for third-line therapy). During first-line therapy, the most common dose and dosing interval was 45 mg every 12 weeks for ustekinumab (57.5%), 5 mg/kg every 8 weeks for infliximab (44.4%), 40 mg every other week for adalimumab (80.9%), and 50 mg weekly (57.9%). For first-line therapy, Kaplan–Meier survival curves showed the time to discontinuation was longer for ustekinumab compared with each TNF-α inhibitor. Similar results were observed among second- and third-line therapies. While 119 of the 1115 psoriasis patients (10.6%) starting first-line therapy reported a concurrent diagnosis of PsA confirmed by a rheumatologist, corresponding proportions for second- and third-line therapies were 192/1436 (13.4%) and 141/922 (15.3%). A total of 539 new biologic starts (first- through seventh-line) were identified in the PsA subgroup. Lack of response was the most common reason observed for discontinuation of treatment in PSOLAR, which is in keeping with prior reports. In conclusion, our results indicate that drug survival of ustekinumab is better than that of TNF-α inhibitors for both biologic-naive and biologic-experienced patients with psoriasis.

5. WHAT NEXT - At this time you may like to record your learning for future use or

assessment. Follow the 4 previous steps, log and record your findings. Published by HPN, sponsored by MSD. 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. MSD has no editorial oversight of the CPD programmes included in these modules.

Drug survival of biologic therapy in a large, disease-based registry of patients with psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) The introduction of biologic agents over the past decade has led to a significant shift in the treatment paradigm for both psoriasis and psoriatic arthritis (PsA), chronic disorders that invariably require long-term therapy to maintain clinical response. The trend towards long-term use of biologics for maintenance treatment underscores the need to understand drug survival (i.e. how long a patient stays on a given therapy). Drug survival can be influenced by a range of factors,[1] including safety, treatment effectiveness (possibly relating to the development of antibodies to individual drugs),[2] side-effects, cost, convenience, quality-of-life, access and other patient-oriented factors. Biologics have been shown to be highly effective for the initial treatment of psoriasis; however, response may wane over time and lead to stopping/switching of treatment.[3] In fact, the most common reason for discontinuing biologics is lack of effectiveness.[3-6] Recent observational studies of treatment persistence have reported variable results for tumour necrosis factor-alpha (TNF-α) inhibitors, (infliximab, adalimumab and etanercept), ranging from 40% to 80% after at least 1 year of treatment.[7-9] Drug survival rates as high as 80% have been reported for etanercept and ustekinumab through up to 5 years of treatment, and small observational studies indicate that treatment with ustekinumab has significantly longer survival compared with TNF-α inhibitors.[10-12] However, there are few evaluations of drug survival in large populations within real-world settings.[4, 5, 13] PSOLAR (PSOriasis Longitudinal Assessment and Registry) is a large international registry

initially undertaken to address a postmarketing commitment to capture safety outcomes for infliximab and ustekinumab (Janssen Scientific Affairs, LLC, Horsham, PA, USA). The disease-based design of the registry also allows the capture of safety and clinical outcomes across a spectrum of agents used to treat psoriasis (ustekinumab, infliximab, adalimumab and etanercept). The purpose of this report was to present results of analyses based solely on the longevity of biologic therapies received in PSOLAR. Analyses of comparative effectiveness for these treatments, a key element of drug survival, is presented separately.[14] Materials and methods Details of the eligibility criteria and study design of PSOLAR have been reported.[15, 16] Briefly, this multicentre, prospective, observational registry was developed to monitor safety outcomes in approximately 12,000 patients receiving, or eligible to receive, treatment with systemic therapies (including phototherapy) for psoriasis. Registry data reported herein are based on data collected from 20 June 2007 to 23 August 2013. Physicians prescribed treatments as they would in their usual clinical routine; the use of concomitant medications was not restricted. Data were collected at enrolment and approximately every 6 months after the initial visit. Most demographic and disease characteristics were collected at enrolment and, again, at the time of any biologic start on registry. Patients were asked at enrolment if they had a concomitant diagnosis of PsA and if it had been confirmed by a rheumatologist. Adverse events, disease assessments and

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28

CPD 24: Psoriasis

psoriasis medications were documented at interval visits. Per the study design, start and stop dates were recorded and analysed uniformly for biologic agents administered during the registry. The current analyses are based on a subset of PSOLAR patients who initiated ustekinumab, infliximab, adalimumab, and/ or etanercept as first-, secondor third-line therapy during the registry. While the patient cohorts within each line of therapy were mutually exclusive, the same patients could be included in more than one line of therapy, if they started more than one biologic treatment over the course of their participation in the registry. Therapy was considered ‘firstline’ for biologic-naive patients who initiated their first biologic ever after enrolment in PSOLAR. Second- and third-line therapies included patients who initiated their second and third biologic, respectively, after enrolment; they could have initiated/discontinued their previous biologic either before or after enrolment. Patients initiating treatment on registry with a biologic to which they were previously exposed were not included in these analyses. For the first-, second- and thirdline biologic cohorts, duration of exposure was defined as the time (days) between the date of administration of the first dose of the cohort-defining therapy and the earlier date of the following: (i) discontinuation of biologic therapy, (ii) initiation of new biologic therapy, (iii) withdrawal from the registry or death or (iv) annual database cutoff (23 August 2013). The reasons for discontinuation were summarized for each biologic agent. Kaplan–Meier time-to-event analyses were conducted to estimate time to treatment discontinuation. ‘Event’ was defined as stopping or switching a biologic therapy. The ‘event date’ was defined as the date of treatment discontinuation. A patient was censored if that patient had not discontinued treatment at the time of withdrawal from the registry, loss to follow-up, or the date of annual data cut. In addition, Cox proportional hazard regression analyses with adjustment for covariates collected either at entry into the registry or prior to initiation of new therapy (Table 1) were performed to compare time to discontinuation of ustekinumab treatment with that of each anti-TNF inhibitor. Adjusted hazard ratios (HRs), 95% confidence intervals (95% CIs)

Table 1: Covariates in the multivariate analyses of predictors of time to discontinuation Collected at entry into the registry

Collected prior to initiation of new therapy

• Gender

• Agea

• Ethnicity

• Types of insurance

• Body mass indexb

• Prior biologic therapies used

• Familial psoriasis history prior biologicc

• Reasons for discontinuation of

• Smoking status

• Physician's Global Assessment

• Alcohol use status

• Concomitant methotrexate use

• Duration of psoriasisa • Age at psoriasis diagnosis • Diagnosis of psoriatic arthritis • Study site/geographic region • History of immunomodulator use

and corresponding P-values (Wald Chi-square test) were calculated for each clinical characteristic for comparison between given treatment groups and a defined reference group. Missing values for covariates in the Cox model were imputed (i.e. mean for continuous factors and median for categorical factors). a Divided by 10 for age and by 5 for duration of psoriasis. b Based upon National Heart, Lung and Blood Institute Obesity Education Initiative criteria: Underweight/normal = body mass index (BMI) <25, Overweight/obesity class I BMI ≥25 and <35 and Obesity class II–III = BMI ≥ 35. c For second- and third-line therapies only. Subgroup analyses for the three lines of therapy were also performed for the PsA subpopulation (i.e. patients with PsA confirmed by a rheumatologist) at registry entry. These analyses did not include patients who developed PsA during registry follow-up, as these data were not systematically captured. The methodology for the PsA subgroup analyses mirrored that for all psoriasis patients. Results Overall psoriasis population Baseline characteristics of the overall PSOLAR population have been described previously.[16]

Among the subset of psoriasis patients who initiated any new biologic agent on registry, a total of 4000 new treatment starts/switches occurred (1833 for ustekinumab, 1303 for adalimumab, 537 for etanercept and 327 for infliximab); these totals include all new starts (i.e. firstline through seventh-line starts/ switches; Table 2). Only the 1115 first-line, 1436 second-line and 922 third-line starts reported during PSOLAR are studied here. New starts among bio-naïve patients were highest for adalimumab, followed by ustekinumab, etanercept and infliximab; etanercept was initiated most often as first-line therapy, ustekinumab and adalimumab as second-line therapy and infliximab as third-line therapy (Table 2). Data are presented as number of patients (%). a For lines of therapy beyond firstline, the prior biologic may have been any of the four biologics included in these analyses or other biologics not approved for psoriasis (golimumab), those no longer available for treating psoriasis (efalizumab and alefacept) or those received via participation in a clinical study but not available for treatment of psoriasis (briakinumab). The majority of patients were enrolled at North American sites (79.2% for first-line therapy, 91.0% for second-line therapy and 92.8% for third-line therapy). The proportion of patients

initiating first-line therapy from European sites (20.1%) was higher compared with the proportions of second- and third-line therapies (8.4% and 6.6% respectively); the remaining patients were enrolled in Latin America (0.7%, 0.6% and 0.5%). Just over half of all biologic starters were male (56.7%); mean age was 46.9 years and mean body mass index (BMI) was 30.4. Demographic, disease and treatment characteristics prior to first-line therapy were comparable across treatment groups. The duration of psoriasis ranged from 11.8 to 16.6 years, and the percent body surface area (BSA) affected with psoriasis ranged from 18.2 to 27.9. Although Physician's Global Assessment (PGA) scores were generally similar across biologic groups, (mean score, 2.8), the proportion of patients with marked/severe psoriasis (PGA 4/5) varied from 17.0% for etanercept to 26.6% for ustekinumab. Patient and disease characteristics collected before initiating second- and third-line use of biologic therapies (data not shown) were generally consistent with those reported for first-line treatment, although the proportions of patients receiving methotrexate (MTX) prior to firstand second-line therapies (30.5% and 37.6% respectively) were lower compared with third-line therapy (50.3%). During first-line therapy, concomitant MTX use was reported in higher proportions of patients receiving etanercept (46.6%) and adalimumab (25.1%) compared with infliximab (13.8%) and ustekinumab (10.5%); proportions varied during second-line [adalimumab (49.2%), etanercept (29.3%), infliximab (25.2%) and ustekinumab (20.0%)] and third-line [infliximab (36.6%), ustekinumab (34.5%), etanercept (19.5%) and adalimumab (6%)] treatment. During first-line therapy, the most common dose and dosing interval was 45 mg every 12 weeks for ustekinumab (57.5%), 5 mg/ kg every 8 weeks for infliximab (44.4%), 40 mg every other week for adalimumab (80.9%), and 50 mg weekly (57.9%). In addition, notable proportions of doses were given as 90 mg every 12 weeks for ustekinumab, 5 mg/kg every 6 weeks for infliximab and 50 mg twice weekly for etanercept, whereas smaller proportions were recorded at other doses and intervals. Ustekinumab and infliximab were typically administered at a physician's office or hospital location (83.1% and 73.3% of doses respectively), while adalimumab and etanercept were

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29 overall psoriasis group; higher proportions of patients had received phototherapy and immunomodulators as well.

Table 2: Summary of new starts for first- through seventh-lines of therapy included in the current analyses; patients with psoriasis initiating new therapy during the registry

Ustekinumab

Infliximab

Adalimumab

Etanercept

Total

New therapy starts, N

1833

327

1303

537

4000

First-line therapya

361 (19.7)

63 (19.3)

402 (30.9)

289 (53.8)

1115

Second-line therapy

566 (30.9)

93 (28.4)

622 (47.7)

155 (28.9)

1436

Third-line therapy

551 (30.1)

103 (31.5)

197 (15.1)

71 (13.2)

922

Fourth-line therapy

248 (13.5)

49 (15.0)

71 (5.4)

16 (3.0)

384

Fifth-line therapy

84 (4.6)

14 (4.3)

9 (0.7)

6 (1.1)

113

Sixth-line therapy

21 (1.1)

5 (1.5)

2 (0.2)

0

28

Seventh-line therapy

2 (0.1)

0

0

0

2

administered in such settings in a small minority of administrations (7.1% and 3.0% of doses, respectively). Generally similar dosing patterns were observed for each biologic agent when prescribed as second- or thirdline therapy. The median duration of registry follow-up varied among biologics, possibly due to differences in approval dates, regional market availability and prescribing tendencies. For first-line users who discontinued biologic therapy, median duration of treatment was 676 days for infliximab, 613 days for ustekinumab, 569 days for adalimumab and 565 days for etanercept. In addition, ustekinumab was received for 621 days and 510, 446 and 317 days for adalimumab, infliximab and etanercept, respectively, for second-line therapy; corresponding days for third-line therapy were 592, 457, 416 and 337 days. Across all three lines of therapy, numerically lower proportions of patients discontinued ustekinumab compared with each anti-TNF agent. For first-line use, 8.6% of patients discontinued ustekinumab compared with 25.4% (infliximab), 37.6% (adalimumab) and 43.9% (etanercept). Trends were generally similar for second-line and third-line therapies, although the proportions of patients who discontinued treatment were numerically higher than those for first-line therapy. The most common reason for discontinuing

treatment was lack of effectiveness for each treatment cohort and for each line of therapy. For first-line therapy, Kaplan–Meier survival curves showed the time to discontinuation was longer for ustekinumab compared with each TNF-α inhibitor (Fig. 1a) on page 30. Similar results were observed among second- and third-line therapies. Also, the survival curves for the TNF-α inhibitor groups initiating second- and third-line therapies declined more rapidly compared with ustekinumab and were overlapping. Multivariate analysis revealed significantly shorter times to discontinuation of first-line use of infliximab, adalimumab and etanercept compared with ustekinumab (reference treatment); the same was true for secondand third-line biologic therapy. Factors significantly affecting time to treatment discontinuation varied across first-, second- and third-line lines of therapy. For first-line therapy only, concomitant MTX use was independently associated with a shorter time to discontinuation of biologic therapy compared with no use of MTX. Additional factors associated with time to discontinuation of biologic therapy included gender (i.e. lower likelihood of stopping/switching for males for first- and third-line biologic therapy) and geographical differences (e.g. lower likelihood of discontinuing treatment in Europe vs. North America) for first-line therapy and higher likelihood in

Latin America vs. North America for second-line therapy). The remaining covariates evaluated were not found to be significantly associated with drug survival. Of note, the presence of PsA did not significantly affect time to discontinuation for first-line (HR: 0.886, CI: 0.90, 1.138, P = 0.3445), second-line (HR: 0.878, CI: 0.722, 1.068, P = 0.1928) or third-line (HR: 1.064, CI: 0.832, 1.360, P = 0.6234) therapies. Results presented here represent the imputed model, in which there were very few patients with missing data (except for age at diagnosis of psoriasis;. Psoriatic arthritis subgroup While 119 of the 1115 psoriasis patients (10.6%) starting first-line therapy reported a concurrent diagnosis of PsA confirmed by a rheumatologist, corresponding proportions for second- and third-line therapies were 192/1436 (13.4%) and 141/922 (15.3%). A total of 539 new biologic starts (first- through seventhline) were identified in the PsA subgroup. Demographic and disease characteristics of the PsA subgroup were comparable across first-, second- and thirdline therapies and varied from those of the overall psoriasis population. Specifically, patients in the PsA subgroup were older, had been diagnosed with psoriasis for a longer period of time, and had more severe psoriasis (i.e. higher %BSA and higher mean PGA score) compared with the

The patterns for most common dose and dosing interval for each biologic agent in the PsA subgroup were generally comparable to those in the overall psoriasis population. As in the overall psoriasis population, the median duration of registry follow-up in the PsA subgroup varied across treatment groups and median days on therapy for each line of therapy were generally higher in the ustekinumab group compared with the other treatment groups. As in the overall psoriasis population, the proportion of patients in the PsA subgroup who discontinued therapy was lower for patients treated with ustekinumab compared with each anti-TNF agent across the first-, secondand third-line cohorts. Multivariate analyses showed that comparisons of drug survival did not reach statistical significance for infliximab, adalimumab or etanercept for first-line therapy; however, the comparison between ustekinumab and all three biologics for second-line therapy and between ustekinumab and etanercept for third-line therapy showed significantly better survival in the PsA subgroup. Again, other significant predictors affecting time to treatment discontinuation varied across first-, second- and thirdline lines of therapy in the PsA subgroup, and the evaluation was limited by cohort sizes. In this analysis of PSOLAR, the drug survival of biologics for the treatment of psoriasis was evaluated, while considering whether patients initiated treatment as first-, second- or third-line therapy. Based on multiple measures, including proportion of patients who discontinued therapy and time to discontinuation, ustekinumab had better drug survival compared with TNF-α inhibitors among patients with psoriasis across all three lines of therapy and generally among those with concurrent PsA across second- and third-line therapies. This is in keeping with the recently published results from another registry of 3523 bionaive patients (BADBIR), which also found that ustekinumab had the highest drug survival compared with infliximab, adalimumab and etanercept[17] Importantly, our evaluation included a large number of patients who initiated a new biologic therapy at, or after, enrolment in PSOLAR. While each biologic

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30

CPD 24: Psoriasis

Fig. 1a

of patients who adapted to initial challenges and were less likely to discontinue therapy later. Declining drug survival may also, in part, be related to treatment effectiveness, which was slightly diminished in patients receiving biologics as later-line therapy compared with those receiving their first biologic. Multivariate analyses validated the finding of better treatment survival with ustekinumab based on significant differences in time to discontinuation between ustekinumab and each TNF-α inhibitor during first-, secondand third-line therapy. Also, male gender was favourably associated with drug survival, as documented in other studies.[9, 12, 25, 26] Of note, patients receiving MTX were significantly more likely to discontinue biologic treatment compared with those without concomitant MTX use in bionaive (i.e. first-line therapy), but not in biologic-experienced, patients; the reason for these findings is unclear. Also, MTX usage increased with each subsequent line of therapy. As antibody formation has been shown to diminish response to some biologic therapies,[2] it is possible that MTX was used more often with subsequent therapies to prevent antibody formation and potentially increase effectiveness. Finally, it is noteworthy that the presence of PsA was not significantly associated with treatment discontinuation in our analyses.

was most frequently administered at a dosage consistent with the product labels,[18-21] dosing was maximized in some patients. We believe the findings presented here represent patterns of treatment and drug survival in real-world dermatologic practice. The Kaplan–Meier survival curves generated from these analyses showed ustekinumab had the longest time to discontinuation compared with the other biologics; results were generally comparable to those from other studies that included ustekinumab and TNF-α inhibitors.[4, 5, 10, 12, 22] The overall decline in drug survival observed within each treatment cohort among patients receiving second- or third-line therapies relative to first-line therapy suggests that discontinuation of prior biologic therapies may be predictive of lower drug survival with subsequent biologics, as reported elsewhere.[3, 4, 12, 23, 24] This suggests that patients who discontinued one or more biologic may have more refractory disease or perhaps alterations in their immune system related to prior therapy. The common trend towards initially steeper curves followed by a flattening over time may reflect a well-motivated group

Lack of response was the most common reason observed for discontinuation of treatment in PSOLAR, which is in keeping with prior reports.[3-6] The proportions of patients who discontinued treatment due to lack of effectiveness in PSOLAR tended to be somewhat higher with second- and third-line biologic use, although the numbers are not large enough to draw definitive conclusions. Other factors that could lead to discontinuation of treatment include lack of tolerability, development of an adverse event requiring cessation of treatment, or lack of access (e.g. change or loss of health insurance). Moreover, factors related to dosing interval or convenience of administration may influence drug survival. For example, both infliximab and ustekinumab are generally administered by a health care provider, which could, in turn, promote better adherence to the prescribed treatment regimen; however, infliximab was not associated with better drug survival on a consistent basis. In the current analyses, the proportion of first-line users of biologics with concomitant PsA was somewhat lower compared with second- and third-line therapy (10.6%, 13.4% and 15.3%, respectively), suggesting that patients with PsA may be more likely to be treated with sequential biologics. This is in keeping with other reports that indicated response to treatment may be reduced in bioexperienced patients with PsA and rheumatoid arthritis, often leading to a switch in treatment to achieve a better response.[27-30] Consistent

with overall psoriasis patients, the proportion of confirmed PsA patients who discontinued treatment was lower and the time to discontinuation was longer for the ustekinumab cohort compared with the infliximab, adalimumab and etanercept groups. While the power of the analysis was limited by smaller cohort sizes in the confirmed PsA subgroup, the hazard ratios for drug survival for ustekinumab compared with the TNF-α inhibitors were notably favourable for all comparisons (except for first-line use) among PsA patients. Therefore, taking into account the limitations of the analysis, the overall findings suggest that drug survival for ustekinumab in patients with concurrent PsA reflect observations among the overall psoriasis population. Our analyses were designed to reduce the impact of prior exposure to other biologic treatments on the evaluation of drug survival. Specifically, the cohorts were defined by whether newly initiated treatments represented first-, second- or third-line biologic use, which may have prevented potential biases and confounding factors associated with an analysis of all new users. However, the results reported herein may be subject to limitations inherent to observational studies, such as lack of randomization of patients to different biologic agents as well as various factors that affect patient access to therapy. Limitations with regard to data capture include that dose escalation data were not consistently available for all biologic cohorts preventing stratification based on this factor, the number of patients with Psoriasis Area and Severity Index data was too small to allow meaningful interpretation, and specific details with regard to dose and duration of MTX usage were not available. Also, the numbers of patients initiating ustekinumab and adalimumab in our analyses were higher than those for etanercept and infliximab. The large majority of patients received ustekinumab and infliximab in a medical setting while adalimumab and etanercept were self-administered in most cases. Finally, the subset of PsA patients was limited to only those who were diagnosed before entering the registry. In conclusion, our results indicate that drug survival of ustekinumab is better than that of TNF-α inhibitors for both biologic-naive and biologic-experienced patients with psoriasis. Findings among patients with a concurrent diagnosis of PsA were limited by population size, but they suggest no difference from those reported for all psoriasis patients, which supports the sustainability of chronic therapy with ustekinumab for both conditions. Additional studies of comparative effectiveness and quality of life among biologics in PSOLAR will help evaluate the reasons for differences in drug survival reported here. References available on Request.

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Feature 31

Cancer survival rates for men continue to improve Survival rates across men’s cancers continue to improve according to recent figures. Latest figures from the National Cancer Registry of Ireland show that five year survival rates for prostate cancer were at 90.6% from 2008 to 2012, up from 68.9% between 1994 to 1999. Five year survival for testicular cancer is now at 95.7% up from 90.3% between 1994 to 1999. The Irish Cancer Society, the Marie Keating Foundation, Cancer Focus Northern Ireland and the Men’s Health Forum joined forces during Men’s Health Week recently to highlight cancer incidence and survival among men. Men are urged to remain vigilant when it comes to their health and to get informed on how to reduce the risk

of cancer and detect it early. The European Code Against Cancer, a 12 point code, is a useful tool to help men and women reduce the risk of cancer by up to 50%. The Code emphasises the importance of avoiding tobacco, alcohol and excessive sun exposure as well as the benefits of maintaining a healthy body weight and being physically active. It is also relevant for people who have had cancer and want to reduce their risk of recurrence. Men who maintain a normal body weight, eat a healthy diet, limit the consumption of alcoholic drinks and are moderately active for at least 30 minutes per day will have an estimated 18% lower risk of cancer compared to people whose lifestyle and body weight do not

meet the recommendations. It is also advised that men who are eligible should attend for bowel screening and protect their skin from harmful UV rays as skin cancer can be prevented in 9 out of 10 cases. Kevin O’Hagan, Cancer Prevention Manager at the Irish Cancer Society said, “We know that you are more likely to survive cancer if you spot it at an early stage. We want to see survival rates increase even further in the coming years as we move towards a future without cancer. The message for older and younger men alike is get informed about the risk factors of cancer and what you can do to protect your health. Know your body, look out for any unusual changes and take action.”

The Irish Cancer Society and the National Adult Literacy Agency (NALA) has recently commissioned research to identify the barriers preventing men accessing and understanding information about cancer and reducing their cancer risk. The Society and NALA have awarded a research grant to Dr Frances Drummond, who is based at the Department of Epidemiology and Public Health in University College Cork, to explore health literacy issues around men and cancer. In particular, the research hopes to identify barriers that may prevent men over the age of 40 from lower socioeconomic groups accessing or understanding cancer information. Once completed, the Society hopes to use the findings of this study to inform the future development of cancer prevention programmes for men.

Study finds marker of aggressive prostate cancer The level of a specific molecule present in prostate tumours is an indicator of whether the cancer is aggressive and likely to spread, according to new research. The study, available online in the journal European Urology, may inform future clinical tests that help doctors decide how best to treat prostate tumours. Many men with prostate cancer have slow-growing tumours that do not require surgery, radiation or other treatments that can leave patients impotent, incontinent or both. But doctors often have difficulty telling the difference between these indolent tumours and those that will prove to be more aggressive. "Distinguishing patients who have indolent versus aggressive prostate cancer is probably one of the biggest challenges in the field," said senior author Christopher A. Maher, an Assistant Professor of Medicine. "Our study suggests that levels of a molecule called PCAT-14 may be a marker of whether the tumour is likely to be aggressive, helping doctors decide whether to intensify a patient's treatment." The scientists measured levels of PCAT-14 from prostate tumours after their surgical removal. Maher said one of his group's goals is to design a non-invasive method, such as a urine test, to make the same measurement.

The scientists found that levels of PCAT-14—an RNA molecule— were elevated across 180 prostate cancer patients treated at three different institutions. Analysing another 910 tumour samples from patients with known treatment outcomes, the researchers also showed that the patients with more aggressive tumours, perhaps surprisingly, had lower levels of PCAT-14. Patients with slowgrowing tumours had higher levels of the molecule. That may seem counterintuitive, but according to Maher, the data suggest that high levels of this RNA molecule suppress tumour spreading. So when levels decrease, that suppression is lost and the cancer cells are free to metastasize. Past work by Maher and his colleagues has identified PCAT14 as one of 121 similar RNA molecules strongly associated with prostate cancer. Many of the other PCAT molecules they found associated with a variety of cancers, including prostate, but PCAT-14 was specifically found only in prostate cancer. RNA is similar in structure to DNA and serves various functions in cells, especially in turning genes on and off. "We looked at all similar RNA molecules in these prostate tumours," Maher said. "Only PCAT-14 was consistently altered in all prostate cancer patients and

able to distinguish indolent and aggressive disease." Working with aggressive prostate cancer cells in the lab, the researchers showed that dialing up levels of PCAT-14 appeared to build up barriers to cancer spreading, slowing the growth and mobility of these normally aggressive cells. Likewise, dialing down levels of PCAT-14 appeared to remove barriers to spreading, making these cells even more aggressive, increasing the number of cells and their ability to move. Maher and his colleagues also showed that low levels of PCAT14 were associated with poor response to androgen deprivation

therapy, a hormone-based treatment for prostate cancer that is less toxic than chemotherapy and radiation therapy. Prostate tumour growth often is driven by male hormones, such as testosterone. Depriving prostate tumours of hormonal fuel can slow or stop growth, but some tumours grow even in a state of hormone deprivation. "We suspect that PCAT-14 may be a good predictor of whether patients will respond well to androgen deprivation therapy," Maher said. "Low PCAT-14 means the cells are likely to grow and spread even when deprived of androgens."

HPN • September 2016


32 Feature

John Fitzpatrick Research Fellow to investigate role of cholesterol Dr Emma Allott, John Fitzpatrick Research Fellow, has been awarded a three-year research grant to investigate the role of cholesterol in prostate cancer. The Dublin native, who is based in the University of North Carolina at Chapel Hill, has been awarded the John Fitzpatrick Research Fellowship â&#x20AC;&#x201C; a three-year grant award established by the Irish Cancer Society, the Dana-Farber Cancer Institute and Harvard TH Chan School of Public Health to fund an Irish scientist or clinician to undertake high quality research into prostate cancer. The Fellowship is named in memory of the late Professor John Fitzpatrick, the former Head of Research at the Irish Cancer Society, who made a significant contribution internationally to research, particularly in the field of prostate cancer.

September 2016 â&#x20AC;˘ HPN

Over the next three years, Dr Allott will investigate if high cholesterol levels impact survival rates in men with advanced prostate cancer. More specifically the Research Assistant Professor of Nutrition at the University of North Carolina will investigate if reducing cholesterol levels has the potential to improve survival rates when combined with hormonal treatment. Current treatment options for men with advanced prostate cancer involve blocking hormones called androgens, which drive the development of the cancer. Cholesterol is a building block for these hormones, however, and there is now evidence to suggest that high cholesterol levels may help the tumour override this hormone-blocking action, allowing the cancer to grow and progress. Through this research, however, Dr Allott is hoping to identify

Dr Emma Allott, John Fitzpatrick Research Fellow

prostate cancer survival rates by reducing cholesterol levels through lifestyle changes, such as diet and exercise, or through cholesterollowering medication.

tumour biomarkers linked with high cholesterol levels that may indicate how well prostate cancer patients will respond to hormonal treatment. The study will also investigate the potential to improve

In collaboration with experts from the world-renowned Dana-Farber Cancer Institute and Harvard TH Chan School of Public Health, this study will involve analysing the lifestyle and tumour characteristics of more than 1,000 Irish and American prostate cancer patients.


STILL EXPLORING

34.7 median OS1

MO N T H S

94.9%

of patients treated with ZYTIGA® plus low-dose prednisolone did not experience grade 3 or 4 corticosteroidassociated adverse event2

reduction in the risk of

48% radiographic progression3 WITH

of median follow up

YEARS

ZYTIGA maintains a favourable safety profile and is generally well-tolerated1

4+

ZYTIGA® 250 mg Tablets PRESCRIBING INFORMATION ACTIVE INGREDIENT(S): Abiraterone acetate. Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATION(S): Taken with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. The treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. DOSAGE & ADMINISTRATION: Adults: 1000 mg (4 tablets) single daily dose. Not with food as this increases the systemic exposure (take dose at least two hours after eating; no food for at least one hour post-dose). Swallow whole with water. Take with recommended dose of prednisone or prednisolone of 10 mg daily. Medical castration with LHRH analogue should be continued during treatment in patients not surgically castrated. Children: No relevant use. Hypokalaemia: In patients with pre-existing, or who develop hypokalaemia during treatment with Zytiga, consider maintaining potassium level at ≥4.0 mM. Patients who develop Grade ≥ 3 toxicities (hypertension, hypokalaemia, oedema and other nonmineralocorticoid toxicities) stop treatment and start appropriate medical management. Do not restart Zytiga until symptoms of the toxicity have resolved to Grade 1 or baseline. Renal impairment: No dose adjustment, however no experience in patients with prostate cancer and severe renal impairment; caution advised. Hepatotoxicity: If hepatotoxicity develops (ALT or AST >5x upper limit of normal - ULN), stop treatment immediately until liver function returns to baseline; restart Zytiga at 500 mg (2 tablets) once daily and monitor serum transaminases at least every 2 weeks for 3 months and monthly thereafter (see Special warnings & precautions). If hepatotoxicity recurs on reduced dose, stop treatment. If severe hepatotoxicity develops (ALT or AST 20xULN), discontinue Zytiga and do not restart. Hepatic impairment: Mild (Child-Pugh class A) - no dose adjustment required. Moderate (Child-Pugh class B) approximately 4x increased systemic exposure after single oral doses of 1,000 mg. Moderate/Severe (Child-Pugh class B or C) – no clinical data for multiple doses. Use with caution in moderate impairment, benefit should clearly outweigh risk. CONTRAINDICATIONS: Pregnancy or potential to be pregnant. Hypersensitivity to active substance or any excipients. Severe hepatic impairment (Child-Pugh Class C). SPECIAL WARNINGS & PRECAUTIONS: Zytiga may cause hypertension, hypokalaemia and fluid retention due to increased mineralocorticoid levels. Cardiovascular: Caution in patients with history of cardiovascular disease. In patients with a significant risk for congestive heart failure (history of cardiac failure, uncontrolled hypertension, ischaemic heart disease) consider an assessment of cardiac function before treating (echocardiogram). Safety not established in patients with left ventricular ejection fraction < 50% or NYHA Class II to IV (pre-chemotherapy) and III or IV (post-chemotherapy) heart failure. Before treatment cardiac failure should be treated and cardiac function optimised. Correct and control Hypertension, hypokalaemia and fluid retention pre-treatment. Caution in patients whose medical conditions might be compromised by hypertension, hypokalaemia or fluid retention e.g. heart failure, severe or unstable angina pectoris, recent myocardial infarction or ventricular arrhythmia, severe renal impairment. Monitor blood pressure, serum potassium and fluid retention and other signs and symptoms of congestive heart failure before treatment, then every two weeks for 3 months, and monthly thereafter. QT prolongation observed in patients experiencing hypokalaemia with Zytiga treatment. Consider discontinuation if there is a clinically significant decrease in cardiac function. Hepatotoxicity & hepatic impairment: Measure serum transaminases pre-treatment and every two weeks for first three months, then monthly. If symptoms/signs suggest hepatotoxicity, immediately measure serum transaminases. If ALT or AST > 5x ULN, stop treatment and monitor liver function. Restart treatment after liver function returns to baseline; use reduced dose (see dosage and administration). No clinical data in patients with active or symptomatic viral hepatitis. Rare reports of acute liver failure and hepatitis fulminant, some fatal. Corticosteroid withdrawal: Monitor for adrenocortical insufficiency if prednisone or prednisolone is withdrawn. Monitor for mineralocorticoid excess if Zytiga continued after corticosteroids withdrawn. Bone density: Decreased bone density may be accentuated by Zytiga plus glucocorticoid. Prior use of ketoconazole: Lower response rates may occur in patients previously treated with ketoconazole for prostate cancer. Hyperglycaemia: Use of glucocorticoids could increase hyperglycaemia, measure blood sugar frequently in patients with diabetes. Use with chemotherapy: Safety and efficacy of concomitant use of Zytiga with cytotoxic chemotherapy not established. Intolerance to excipients: Not to be taken by patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Take sodium content into account for those on controlled sodium diet. Potential risks: Anaemia and sexual dysfunction may occur in men with metastatic castration resistant prostate cancer including those taking Zytiga. Skeletal muscle effects: Cases of

myopathy reported. Some patients had rhabdomyolysis with renal failure. Caution is recommended in patients concomitantly treated with drugs known to be associated with myopathy/rhabdomyolysis. SIDE EFFECTS: Very common: urinary tract infection, hypokalaemia, hypertension, diarrhoea, peripheral oedema. Common: sepsis, hypertriglyceridaemia, cardiac failure (including congestive heart failure, left ventricular dysfunction and decreased ejection fraction), angina pectoris, arrhythmia, atrial fibrillation, tachycardia, dyspepsia, increased alanine aminotransferase, increased aspartate aminotransferase, rash, haematuria, fractures (includes all fractures with the exception of pathological fracture). Other side effects: adrenal insufficiency, myocardial infarction, QT prolongation, hepatitis fulminant, acute hepatic failure, myopathy, rhabdomyolysis. Refer to SmPC for other side effects. FERTILITY/ PREGNANCY/ LACTATION: Not for use in women. Not known whether abiraterone or its metabolites are present in semen. A condom is required if the patient is engaged in sexual activity with a pregnant woman. If the patient is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method. Studies have shown that abiraterone affected fertility in male and female rats, but these effects were fully reversible. INTERACTIONS: Caution with drugs activated by or metabolised by CYP2D6 particularly when there is a narrow therapeutic index e.g. metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecanide, codeine, oxycodone and tramadol. Avoid strong inducers of CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John’s wort). Zytiga is a CYP2C8 inhibitor (in vitro data). Examples of medicinal products metabolised by CYP2C8 incl paclitaxel, repaglinide. No clinical data are available on the use of Zytiga with CYP2C8 substrates. May increase concentrations of drugs eliminated by OATP1B1. Food (see Dosage & Administration). Caution with medicines known to prolong QT interval or induce Torsade de pointes e.g. quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, antiarrhythmic medicinal products, methadone, moxifloxacin and antipsychotics. Use of Zytiga with spironolactone is not recommended. Refer to SmPC for full details of interactions. LEGAL CATEGORY: Prescription only medicine. PRESENTATIONS, PACK SIZES & MARKETING AUTHORISATION NUMBERS: Bottle, 120 tablets, EU/1/11/714/001. MARKETING AUTHORISATION HOLDER: JANSSENCILAG INTERNATIONAL NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK. Prescribing information last revised: May 2016 Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse events via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, E-mail: medsafety@hpra.ie. Adverse events should also be reported to Janssen-Cilag Limited on +44 1494 567447 or at dsafety@its.jnj.com. © Janssen-Cilag Limited 2016 References: 1. Ryan CJ, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo controlled phase 3 study. Lancet Oncol 2015; 16: 152–60. 2. Fizazi, K., et al (2015). ASCO GU 2015 (abstract 169). 3. Rathkopf, DE et al. Updated Interim Efficacy Analysis and Long-term Safety of Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer Patients Without Prior Chemotherapy (COU-AA-302). Eur Urol (2014), http://dx.doi.org/10.1016/j. eururo.2014.02.056. Date of Preparation: June 2016 | PHIR/ZYT/1014/0004(4)


Awards 34 Awards

Hospital Professional

2016

The Hospital Professional Awards 2016 – The Finalists

The Hospital Professional Awards are now in their fourth consecutive year and their success has driven further growth as we open our entry process to encompass the greater hospital team, to now include Consultants, Specialists and clinical teams in addition to our leading base of hospital Pharmacists. The Hospital Professional Awards offer a unique programme to bring these leading professionals together to showcase the ongoing projects currently being undertaken throughout Ireland's hospitals to disseminate results, promote learning and best practice so that the excellence in specialist work is shared in every hospital setting in Ireland. Winners of a Hospital Professional Award will be chosen by an esteemed judging panel for their evidence-based research and/or work in the enhancement of a field and/or therapeutic area for the ultimate benefit of Ireland's hospital patients or the growth of the profession as a whole. The applications for this year’s awards surpassed the previous two years with

September 2016 • HPN

just under 100 submissions representing Ireland’s leading hospital specialists and departments and teams.

Whilst the short listing process was extremely difficult – with some strong entries failing to make it to the shortlist – it is important to highlight that it is not just about winners and losers. Everyone who entered this year’s awards deserves commendation. Over the following pages we feature the finalists in each of our 14 Award Categories. These awards celebrate best practice within secondary care, with Award Categories ranging from Consultant-led project and team initiatives to specialised therapeutic area innovations and leading Pharmacy and Pharmacist-driven excellence. Investing in the further development of secondary care within Ireland, the education and clinical learning derived from entries to the Hospital Professional Awards will highlight the quantifiable projects that have been driving benefits to

both clinical peers and patients with the objective of greater shared outcomes. The fourth annual Hospital Professional Awards will be held on September 17th, 2016 in the Hilton DoubleTree Hotel, Dublin and will be hosted by TV3 News Anchor Colette Fitzpatrick. These awards have been met with great enthusiasm from suppliers, healthcare professionals including Consultants and Pharmacists. They have raised the profile of the industry within Ireland. Our sponsors are amongst the elite of the industry, all of whom see the awards as the perfect vehicle to show their support in this arena. There are a limited number of tickets still available so to book your place at Ireland’s leading hospital healthcare event contact Kelly Jo Eastwood on 0044 7876548989 or email kelly@ipnirishpharmacynews.ie Make sure you catch the next issue of Hospital Professional News which will have exclusive coverage of all the winners and of the night itself.


Awards Hospital Professional

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2016

Hospital Specialist of the Year 2016

Sarah Molony Hospital: Mater Misericordiae University Hospital Nomination Overview: Sarah Molony is the Deputy Clinical Pharmacy Services Manager in the pharmacy department in the Mater Misericordiae University Hospital. The pharmacy department there is a large, dynamic one which embraces technology. Sarah is an innovative clinical pharmacist who has the ability to identify where service development can be achieved and determines how best to achieve this. Sarah’s work as an Opthalmology Specialist has greatly enhanced the provision of patient care within the MMUH for inpatients and importantly for patients upon discharge. Her work within the specialty of ophthalmology has aided the provision of a useful educational tool. She develops a good rapport with patients and with community pharmacy colleagues and acknowledges the strength of her colleagues and has learned to develop the ophthalmology service in conjunction with her pharmacy and pharmacy technician colleagues.

Carol O’Brady Hospital: Tallaght Hospital Pharmacy Nomination Overview: Carol O’Brady works in Tallaght Hospital, a 500 bed teaching hospital. The pharmacy department has over 60 employees. Carol is the Medicines Information Manager and has worked in this position since 2004. She is responsible for answering and documenting medicines information queries from all pharmacists, pharmaceutical technicians, consultants, non-consultant hospital doctors, nurses, other departments and community pharmacies. Specialities include intensive care, oncology services, cardiology, antimicrobials, psychiatry, nephrology, paediatrics and surgical specialities. These are answered to the highest standard to ensure the best patient care. Carol is constantly striving to improve the information available to hospital staff. This has been achieved by ensuring the maximum number of references are available to all. To this end she has been included in a 6 month hospital library review project as her insight and ideas are greatly valued.

Professor Donal O’Shea Hospital: University College Dublin Nomination Overview: Donal O’Shea qualified in Medicine from University College Dublin in 1989. He moved to Hammersmith Hospital in London and was awarded a Wellcome Trust Training Fellowship to study how the brain controls appetite. In 1999, he moved to his current position in Dublin where he runs a hospital based multi-disciplinary treatment unit for the management of adult obesity. He is a member of the Department of Health special action group on obesity, established in 2011, and chaired the Health Impact Assessment Group on the potential benefits and harms of a tax on sugar sweetened drinks. He is also a member of the Healthy Ireland Council. Research interests include immune effects of obesity, diabetes, steroid metabolism, gender identity disorder and thyroid disorders.

HPN • September 2016


Awards 36 Awards

Hospital Professional

2016

Idis Hospital Pharmacist of the Year 2016

Part of the Clinigen Group

Evelyn Deasy Hospital: Tallaght Hospital

Nomination Overview: Evelyn Deasy is the Pharmacy Education and Research Manager in Tallaght Hospital. Evelyn co-ordinates in-house CPD and research; PhD, MSc, Pharmacy Intern and Undergraduate student programmes; is a committed Pharmacy Management Team member; Cardiology Pharmacist and Adjunct Assistant Professor with TCD. She has a passion for educating the pharmacists of the future and is a committed driver of advanced practitioner roles in pharmacy practice delivering best patient care. Her enthusiasm and strengths in teaching and organisation and strong belief in educating the pharmacists of the future have brought innovative and advanced pharmacy practice to very many pharmacy undergraduates and pharmacy colleagues, almost 40 Pharmacy interns and over 20 MSc pharmacists.

Michael Fitzpatrick

Hospital: Our Lady’s Children’s Hospital, Crumlin Nomination Overview: Michael Fitzpatrick is currently Head of Pharmacy Services at OLCHC and Pharmacy Lead for the new National Children’s Hospital. He joined the pharmacy team in Crumlin ten years ago and in that time he has accomplished a vast amount both within and outside of the hospital setting. He has been the leading figure on a number of major changes in the department and within the paediatric hospital circuit. Michael is a diverse character; having previously worked as a pharmacy technician; followed by some time in the private hospital sector and then eventually evolving to his role as the Head of pharmacy services in OLCHC. Managing people is a massive component of the role of chief pharmacist. He has exceptional communication and people skills and this is evident from the respect and hard work that is seen from his staff.

Maria Creed

Hospital: Mater Misericordiae University Hospital Nomination Overview: Maria Creed is the Dispensary Services Manager in the Mater Misericordiae University Hospital with responsibility for co-ordinating and supervising the distribution and storage of medicines for the hospital. Maria has a track record of using innovation to enhance pharmacy care to patients and colleagues. In all of her roles, Maria has consistently strived to improve patient care. At the core of all decisions and process reviews, the impact of patient welfare is paramount. This has been demonstrated from her role in negotiating the national supply process for essential drugs used in the management of pulmonary hypertension, through to her focused patient safety initiatives as the MMUH Drug Safety Facilitator. More recently this has been evident through her development of dispensary services as a crucial specialism in hospital pharmacy.

September 2016 • HPN


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Awards 38 Awards

Hospital Professional

2016

Roche Oncology Pharmacist of the Year 2016

Joanne Nally

Hospital: University Hospital Limerick Nomination Overview: Joanne has worked as a Senior Pharmacist in the Aseptic Compounding Unit in the University Hospital Limerick for the past five years and prior to that she worked as a Senior Clinical Pharmacist for the hospital since 2006. She has excelled in her role, undertaking roles and responsibilities associated with Oncology Pharmacy and is seen by her colleagues as a true role model in her attitude, energy and enthusiasm to her work. She plays a pivotal role in pharmacy operations in the A.C.U ensuring the clinical pharmacy service adequately meets the needs of staff and patients, managing dispensary operations, clinically checking and verifying Chemotherapy prescriptions and developing chemotherapy protocols on the hospitals e-prescribing system.

Grant Carroll Hospital: Beaumont Hospital

Nomination Overview: Grant Carroll joined Beaumont Hospital Pharmacy Department in September 2012, taking up the post of Chief II Pharmacist as Aseptic Services Manager. He had already worked for 5 years as a Senior Pharmacist in this same specialist area in St. Vincentâ&#x20AC;&#x2122;s Hospital, giving him a sound basis on which to build on in this post. Grant is always focused on improving patient care, and the patientâ&#x20AC;&#x2122;s experience while in Beaumont Hospital. As such, he has suggested, and helped to implement efficiencies on the Day Ward, such as rapid infusions of both rituximab and bevacizumab decreasing the length of patient time on the ward. Currently he is heavily involved in an interdepartmental LEAN review of all the processes used to deliver services to oncology and haematology patients in Beaumont Hospital.

Li Wah Kyaw Tun Hospital: Tallaght Hospital

Nomination Overview: Li Wah Kyaw Tun is the Adelaide and Meath Hospital senior clinical pharmacist with responsibility for clinical trials and has been at the forefront of the oncology and haematology cancer clinical trials service in Tallaght Hospital since 2012. She works closely with the oncology day ward, the pharmacy aseptic unit and dispensary. Li Wah has provided all the pharmaceutical supports required in the continued development of a centre of expertise for clinical trials. Her organizational skills have allowed her to work efficiently and effectively with consultants and the clinical trials services based on day ward. She is a valued member of their multidisciplinary team and is a key contributor to management of all cancer clinical trials. She participates in the induction training of all pharmacy staff and staff in the oncology service and ensuring they have the skills required to run an efficient trials service.

September 2016 â&#x20AC;˘ HPN


Awards Hospital Professional

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2016

Innovation & Service Development Award 2016 National Rehabilitation Hospital Project Lead: Claire Meaney Nomination Overview: This submission project is entitled – ‘Documentation of the administration of opioid transdermal patches: A Safety and Best practice initiative’. This project was initiated by the Pharmacy Department at the National Rehabilitation Hospital (NRH). By introducing this safety initiative clear documentation and education should decrease errors and risk for both the patient and staff. This new safety initiative has highlighted that opioid patches are a useful therapeutic option but can be dangerous if not managed appropriately. The team at NRH strive to continue looking at different methods and ideas in the medication process to improve patient care in the hospital.

Blackrock Clinic Project Lead: Niamh Bonar Nomination Overview: All pharmacy staff were involved in developing a service with the objective to maximise the number of drug charts reviewed by a pharmacist prior to first dose administration, by implementing a system to conduct First Dose Appropriateness Review (FDAR). The service change was commenced to meet JCI standards and remains in place today. The team will continue to develop the service, collecting feedback and looking for ways to improve the service. This project has also helped identify areas for improvement in the usability, layout and transparency of the drug kardex and it has been revised to reflect this. This innovation directly impacts patient care, along with improving and expanding the pharmacist’s role in patient care. It is a reproducible model, and can serve as an example for other establishments to follow.

Pharmacist, Rosemary King, Lisa Foley and Niamh Bonar, Chief Pharmacist

St Patrick’s University Hospital Pharmacy Department Project Lead: Clare Butler

Senior Pharmacists Ciara Ni Dhubhlaing and Clare Butler

Nomination Overview: This submission detailed their project entitled – ‘Optimisation of Lithium Therapy - Exploring innovative ways to provide Medicines Education.’ Incorporating the NHS England guidance on medicines optimisation, the team explored a cost effective intervention to optimise medicines use and ensure it is deliverable and affordable on the scale required for their target demographic, a large number of service users in rural/urban areas throughout the country. The objective was to develop an on-line resource package that is accessible to all service users, carers and family relatives providing information on lithium therapy. Results suggest that providing lithium education through a multimedia format with a combination of visual and verbal methods increased knowledge and understanding of lithium treatment for over 86% of participants and 80% agree that they find it a better information resource than leaflets.

St John of God Hospital Project Lead: Dolores Keating Nomination Overview: Their project is titled – ‘Embracing Technology to Facilitate Engagement.’ - The purpose of this project was to engage with the development of our own EHR so that the team could explore and implement new ways of working to improve the service patients receive. The Mental Health Information System (MHIS) is an electronic health record for people using Saint John of God Hospital in-patient services and the outpatient community services of Cluain Mhuire. Pharmacy was the first clinical service in the hospital to engage with the new system when, in 2005, a connection between the MHIS and the in-patient dispensing system was developed which allowed information regarding admission and discharge to the hospital to be transferred between the systems. Since then, pharmacy staff have been represented on specific MHIS project development groups, the MHIS user groups and contributed to the strategic planning process.

Dolores Keating, Zoe Duncan, Audrey Purcell, Melissa Curley, Aoife Carolan, Sheenagh McCarthy HPN • September 2016


Awards 40 Awards

Hospital Professional

2016

Actavis Innovation in Aseptic Compounding Award 2016 St Vincentâ&#x20AC;&#x2122;s Private Hospital Pharmacy Department Project Lead: Emma O'Grady

Aseptic Compounding Team, St Vincent's Private Hospital led by Emma O'Grady

Nomination Overview: The Aseptic Unit in SVPH is extremely busy compounding approximately 1200 products a month. The team of pharmacists and technicians work closely to promote a culture of GMP and to ensure that aseptic manufacture of all these products are of high quality, and are safe and effective. One of the main achievements of the unit in 2016 was a project to assess compliance to the H-PIC/S guidelines and to identify key areas for improvement in their current practice in aseptic compounding. All interventions were performed with the aim to improve work practices in the ACU and ultimately the quality of sterile preparation of injectable medicines for patients. This audit has raised awareness of the areas for improvement within the ACU. This work will form the basis for CAPA over the coming months.

Department of Pharmacy, Aseptic Compounding Unit, University Hospital Limerick Project Lead: Olivia Flynn Nomination Overview: The Aseptic Compounding Unit (ACU) at UHL manufactures individually tailored chemotherapy and biological preparations for patients attending UHL for cancer treatment and is fully equipped with modern isolator technology in a clean room environment. The team try to ensure work is done as quickly and as efficiently as possible, with an emphasis on the importance of continually providing the highest of standards in safety and quality control. They decided to embrace the principles of lean management in the A.C.U. With this system they reviewed every step in their processes to determine if/where any time savings could be made to ensure they provide the most efficient pharmacy service possible. Utilising the lean process system has been a new innovation and has resulted in significant time saving to work in the A.C.U. This project demonstrates a new innovation that the whole team embraced, fostering good team spirit resulting in a more efficient service to patients and other service users which is always the primary aim.

Back: Bernadette Quinn, Pharmacy Technician, Rita Sweeney, Senior Pharmacy Technician, Joanne Nally, Snr Pharmacist, Marie O'Grady, Senior Pharmacy Technician. Front: Anne O'Flynn, Pharmacy Technician, Olivia Flynn, Chief II Pharmacist, Marie Godley, Senior Pharmacist. Missing from photo Michelle English, Senior Pharmacy, Clinical Trials, Nora McSweeney, Senior Pharmacy Technician, Sheila Walsh, Pharmacy Technician

Pharmacy Department, Cork University Hospital Project Lead: Elaine Murphy

Dr Derek Power, Team Member, Cork University Hospital Aseptic Compounding Unit September 2016 â&#x20AC;˘ HPN

Nomination Overview: The initial objective here was to draw up a poster to make urgent and relevant information required for the treatment of extravasations easily available at ward/clinic level, as a result of recent policy changes to the document entitled "Management of Infiltration of Non-Vesciant and Vesicant Cytotoxic Intravenous Medication in Cork University Hospital". Once the team commenced the project, they found that there was an inconsistency of knowledge surrounding extravasation, its prevention, recognition and treatment. It was decided to roll out training for all staff involved in the manufacture and administration of cytotoxic drugs to inform them of and standardise all aspects of extravasation management. This poster presentation was an entry in the NAHPT (National Association of Hospital Pharmacy Technicians) conference poster competition in April 2016. It was also presented at the first annual Nursing Research Conference in Cork University Hospital in May 2016.


Date of Preparation: May 2016. NA-059-03

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Awards 42 Awards

Hospital Professional

2016

Medisource Hospital Pharmacy Technician of the Year Award 2016

Rebekah Corrigan

Hospital: Mater Misericordiae University Hospital Nomination Overview: Rebekah Corrigan is a Senior Pharmacy Technician in the Pharmacy Department, Mater Misericordiae University Hospital. Rebekah’s role is as the Dispensary Workflow Manager. In her 12 years of experience, Rebekah has demonstrated a true passion for her work and her profession. She is the type of Pharmacy Technician that loves a challenge and is willing to engage in any role that will enrich her experience as. She is always looking for ways to improve her skills and encourages others to do so. The role of the hospital pharmacy technician is evolving and Rebekah’s career and current position symbolise the transition. She is described as an excellent colleague who demonstrates compassion, empathy and friendship to fellow staff.

Leonor O’Connor Hospital: St James’s Hospital

Nomination Overview: Leonor O Connor has been working in the pharmacy in St James's Hospital for the last 14 years. She constantly motivates her colleagues and is continuously working to improve the role of the pharmacy technician within SJH and also through her volunteer work with the NAHPT. Leonor has been working at St James’s Hospital for the last 14 years. During this time she has aided in the enhancement of the role of a pharmacy technician within the hospital. She is described as someone who has always been welcoming, helpful and a hard working person. She is continuously coming up with fresh ideas on how to change pharmacy procedures to help improve efficiencies within the department. Her enthusiasm and positive attitude is infective and encourages everyone to think in the same positive way.

Marie O’Grady

Hospital: University Hospital Limerick Nomination Overview: Marie O’Grady is a highly motivated and dedicated hospital pharmacy technician who has worked in the pharmacy department at University Hospital Limerick since 2000. Marie has continually challenged herself and modified her role within the department to respond to the diversifying nature of the department and also to extend the capacity of her work and her role over the years. High quality patient care is always at the forefront of her work whether it in her role of drug distribution and procurement, roll out of patients own drugs scheme or the high standards she maintains in the running of the aseptic unit. She has continually challenged herself and diversified her role to the ever expanding demands of the hospital. She excels in team motivation and has always acted a as a leader encouraging fellow technicians to evolve and expand their roles and to publicise their work to a wider forum.

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43

Tracey Burke

Hospital: Beaumont Hospital Nomination Overview: Tracey Burke has been a pharmacy technician for 15 years and was promoted to senior pharmacy technician in 2015. She recognised the need for training new staff members in the dispensary some years ago and made it her role to take new recruits under her wing to guide them through the many procedures within the dispensary. She ensured they had a mentor and took the time to listen to queries or concerns until they were confident enough to undertake the role on their own. Her leadership, sense of responsibility, ability to train and deep commitment to the profession has made her an invaluable member of staff.

Deirdre Whelan Hospital: Tallaght Hospital

Nomination Overview: Deirdre Whelan is the team leader in the pharmacy Aseptic Unit (AU) in Tallaght Hospital. She manages the daily running of a safe, efficient and quality assured compounding service producing over 1000 items per month for haematology, oncology, rheumatology and gastroenterology patients. This requires close co-ordination with her multi-disciplinary team of pharmacists, technicians, porters, healthcare assistants, cleaners, and nursing staff from clinical areas. Deirdre is dedicated, dynamic, hardworking, reliable and enthusiastic, and always strives for excellence in both her own role and that of her colleagues. She has excellent leadership and organisational skills, combined with a positive attitude and an outstanding work ethos and is an inspiration to her colleagues. She is always approachable and handles the stress of a busy work environment competently. Deirdre is motivated which is highlighted by her extensive postgraduate training.

Elizabeth Devlin

Hospital: Our Lady’s Children’s Hospital Crumlin Nomination Overview: Elizabeth Devlin is a pharmacy technician who has been based at Our Lady’s Children’s Hospital for the last two years. Previous to this she worked in the Pharmacy Department in Mount Carmel. She is described as someone who will do anything that is asked of her and helps everyone with whatever job need to be done. She currently takes care of all the dispensing of medicines for the "HIV clinic" and liaises with the Pharmacist and the CNS's in a very professional and courteous manner. She also provides a ward based technician service to an award winning ward. Elizabeth has a great range of skills that she has brought to the pharmacy department since she joined the team in 2014. She is very dedicated and hard-working member of staff who never shies away from any job whether it is big or small that is thrown at her and always does so with a smile on her face. She runs the out-patient dispensary service for the HIV Clinic and makes sure that their supply is always consistent and up to date.

HPN • September 2016


Awards 44 Awards

Hospital Professional

2016

HPN Young Hospital Professional of the Year 2016

Anne Marie Garvin Hospital: Beaumont Hospital Pharmacy Department Nomination Overview: Anne Marie Garvin has worked in Beaumont Hospital Pharmacy Department since September 2015. She joined during a difficult time where the department was experiencing a severe shortage of staff. She very quickly adapted to her surroundings and transferred her Diploma studies from her previous hospital liaising well with her newly assigned Diploma Tutor and intends to convert this to a Masters by undertaking a thesis later this year. Her interest and drive to delve into the reasons why has brought developments in policy and procedure, raising the profile of the pharmacy department, inviting other input by other healthcare professionals and having the positive knock on effect of providing patient medication safety and saving the hospital in funds by rationalising the use of medication and providing guidelines to ensure the continuation of a logical sequential use of medication.

Dearbhla Murphy Hospital: Mater Misericordiae University Hospital Pharmacy Department Nomination Overview: Dearbhla works in the Pharmacy Department at the Mater Misericordiae University Hospital (MMUH). Upon qualification as a pharmacist in 2013, Dearbhla has been working in the speciality of Oncology for the past two years. Dearbhla works half time as a Clinical Pharmacist alongside her role in the Aseptic Compounding Unit. Dearbhla is described as an ambitious, driven and hard-working individual. She is enthusiastic and dedicated to her role in oncology, always striving to improve the Oncology Pharmacy service for the better of her patients. Most people aren’t typically thought of as leaders in the workplace early in their careers, and it is often difficult for young professionals to assume a leadership role. In Dearbhla’s case, the right attitude, hard work and a desire to learn have demonstrated her leadership capabilities and there is no doubt that Dearbhla will continue to develop pharmacy services, both within her speciality and beyond throughout her career.

Sean Collins Hospital: University Hospital Galway Nomination Overview: Sean has been described as a young pharmacist who is highly professional, competent and someone who is an ideal role model for younger pharmacists. In the last few years has proved himself an exceptional member of the team in two key areas. These include work within CPD as he has sought out learning opportunities to enhance his value as a professional contributing to patient care and to apply such new learning in a MDT context. Recently he sought out and successfully completed a Clinical Cardiology module in Trinity, and set about applying that learning in the cardiology setting, most clearly seen in a series of lectures on cardiology drugs that he now provides to cardiology nursing, as well as in the pharmaceutical care of cardiology patients.

September 2016 • HPN


Awards Hospital Professional

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2016

Shire Excellence in Child Psychiatry Award 2016

Dr David McNamara Hospital: St John of God Hospital Nomination Overview: Dr David McNamara was appointed to St John of God Hospital in May 2005 as a Consultant Child & Adolescent Psychiatrist to provide the clinical lead for the Adolescent Inpatient Unit. A graduate of University College Dublin, he completed his basic clinical training on the Eastern Health Board Rotational Scheme in Psychiatry. His specialist training was completed at the Maudsley Hospital London, where he took up his first consultant post. His research and special interests include disorders of adolescence, with a particular focus on early onset psychosis, tic disorders and obsessive compulsive disorders.

Dr Blánaid Gavin Hospital: The Children’s Mental Health Clinic Nomination Overview: Dr Blánaid Gavin, Consultant Child and Adolescent Psychiatrist, has worked for over 10 years with children who have experienced mental health difficulties. She has extensive training in a number of therapeutic interventions including: Cognitive Behavioural Therapy (CBT), Behavioural Therapy, Family Therapy, Interpersonal Therapy, Supportive Therapy, Parenting, Motivational Interviewing, Dynamic Psychotherapy and Brief Solution Focused Therapy. As a Clinical Lecturer in University College Dublin (UCD) School of Medicine, she is responsible for running CBT courses which train clinicians in this very effective therapy. Dr Gavin has instigated a number of very successful service innovations and has chaired/been a member of a range of national committees designed to improve mental health services for children in Ireland.

Paediatric Eating Disorder Working Group; Cross Hospital (OLCH, TSCUH, NCH) Hospital: Our Lady’s Children’s Hospital Crumlin Nomination Overview: Roisin Gowan recognised the lack of direction for all staff in the acute admission for Paediatric patients with an eating disorder (ED) and in late 2015 contacted multiple disciplines to gather a multidisciplinary approach to developing guidance to the treatment of the acutely unwell patient with an eating disorder. The aim of the project is to develop a cross-hospital (OLCHC-Temple street- National Children’s Hospital Tallaght) multidisciplinary guideline or consensus for the treatment of the acute admission for eating disorders. It is a multidisciplinary approach with cross hospital involvement.

Back: Carole Boylan, Dr Elizabeth Barrett, Vice-Chair, Bridget Conway, Caroline McGrath, Sara McMahon and Edel McCarra. Front: Anna Delahunt, Marianne O'Reilly, Roisin Gowan, Chair and Lani Smith

HPN • September 2016


Awards 46 Awards

2016

Hospital Professional

Excellence in Patient Safety Award 2016 Ciara Ni Dhubhlaing Hospital: St Patrick’s University Hospital Pharmacy Department

Adele Ward, Ciara Ni Dhubhlaing, Emma Walsh and Clare Butler

Nomination Overview: This entry looked at ‘The impact of pharmacist counselling on patient knowledge of clozapine with reference to health literacy.’ The objectives included assessing baseline health literacy in outpatients attending a clozapine clinic using the Rapid Estimate of Adult Literacy in Medicine (Revised) (REALM-R), devising a checklist of key information points about clozapine to assess patient knowledge and assessing if there is an association between a change in patient knowledge and health literacy. Aims included development of the role of the dispensarybased pharmacist to include on-going education and adverse effect monitoring of clozapine clinic attendees. All participants in this study gained knowledge of clozapine as a result of pharmacist counselling, which adds to the evidence that pharmacist counselling can improve patient knowledge of medication in a broad range of patient groups, including those with schizophrenia.

Anne Marie Cushen Hospital: Beaumont Hospital Pharmacy Department Nomination Overview: There are three projects used as examples of Anne Marie Cushen’s input into the Pharmacy Department including the review for the first time since the 1990’s of the existing drug Kardex to the now implemented MPAR; the co-ordination and implantation of the care of the elderly initiative and liaising with the HSE Clinical Lead Medication Safety Programme and allowing Beaumont Hospital Pharmacy Department to be the pilot site for the national guidelines for VTE prophylaxis (ongoing). Since taking up post as the first Medication Safety Pharmacist in Beaumont Hospital in 2010 Anne Marie has raised the profile of medication safety in the hospital and made a significant contribution to changing the safety culture within the hospital.

Sarah Molony & Deirdre Lenehan Hospital: Mater Misericordiae University Hospital Nomination Overview: ‘The treatment of hypoglycaemic events in the MMUH – improving the safety of diabetic patients.’ The Pharmacy Department and the Endocrinology / Diabetes Department in the MMUH recognised that the treatment of hypoglycaemia in the hospital was inconsistent and required review. Of note, the hypoglycaemia protocol in use also recommended glucose 50% for patients who were fasting or required prolonged treatment but expert opinion suggests that glucose 10% or 20% is preferred to minimise the risk of extravasation and high post treatment BG levels. A comprehensive, patient-centred initiative was undertaken by the two departments in order to enhance the care provided to the vulnerable and significantly sized diabetes patient population within this large Dublin academic teaching hospital. Sarah Molony, Professor Ciaran Meegan and Deirdre Lenehan

Moninne Howlett Hospital: Our Lady’s Children’s Hospital, Crumlin Nomination Overview: In 2012, Our Lady’s Children’s Hospital Crumlin (OLCHC) developed and implemented a smart-pump drug library of paediatric SCIs into their paediatric intensive care unit (PICU), operating theatres and cardiac ward. A few months later, a clinical management content system (CIMS) was introduced into the PICU. A further safety initiative was to integrate the smart-pumps with the CIMS. In late 2014, the Irish Paediatric Acute Transport Services (IPATS) was commissioned and was to be run out of the PICUs in both OLCHC and Temple Street Children’s University Hospital (TSCUH). With the current resource restraints in the Irish health service, and critically ill children’s safety being paramount, a decision was made to standardise practices and align all sites with best practice recommendations.

September 2016 • HPN


Awards

47

2016

Hospital Professional

MSD Antimicrobial Pharmacist of the Year 2016

Marie Tierney Hospital: University Hospital, Galway Nomination Overview: Marie works with the Antimicrobial Stewardship Team at University Hospital Galway. In 2014, the team developed The GAPP (Galway Antimicrobial Prescribing Policy/Guidelines) App, an 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.

Bernie Love Hospital: Connolly Hospital, Blanchardstown Nomination Overview: Bernie Love is the Antimicrobial Pharmacist at Connolly Hospital, Blanchardstown. In 2014 she was instrumental in helping to establish new smartphone app with the RCSI (Royal College of Surgeons in Ireland) Hospitals Group, in association with the Dublin North East Healthcare-Associated Infection (HCAI) Committee, which provide healthcare professionals in hospitals within the RCSI Hospitals Group with immediate access to guidelines for antimicrobial prescribing. These guidelines, which vary by individual hospital, will help to ensure appropriate antibiotic prescribing and improved patient outcomes as well as helping to combat the ongoing threat of antibiotic resistance.

Marie Philbin Hospital: Midland Regional Hospital, Tullamore Nomination Overview: Marie Philbin has been the Antimicrobial Pharmacist in Midland Regional Hospital Tullamore (MRHT) since 2004 and is the longest serving in this role in Ireland. Marie’s initial work in MRHT demonstrated significant cost savings, a trend from broad spectrum to narrow spectrum agents and an accompanying reduction in Clostridium difficile infection. This work was the stimulus for the HSE creation of 20 Antimicrobial Pharmacist positions in hospitals around the country. This initial work also won Marie the Servier award bursary of ¤3,500 at the HPAI annual conference in 2005. Marie’s work in MRHT initially involved audit and feedback, education and bedside patient review. Over the years her work has also encompassed guideline development, expenditure and consumption monitoring, quality improvement projects on surgical prophylaxis, implementation of restriction policies, creation of a designated antimicrobial section in the medication chart.

HPN • September 2016


Awards 48 Awards

Hospital Professional

2016

Daiichi Sankyo Hospital Pharmacy Team of the Year Award 2016 National Rehabilitation Hospital Project Lead: Sheena Cheyne Nomination Overview: The team at NRH endeavour to ensure that their practice is optimal by regular review and change to their systems. Improving patient care is always the core priority. Being a small team it is important that all members are included and motivated to engage and participate in change. An example of an area in which all pharmacy staff play an essential role is that of antimicrobial stewardship. As NRH hospital does not have a specific antimicrobial pharmacist post, all members of the team work together to ensure that practice is optimal in this area.

Brian Battles, Senior Technician, Nessa Walsh, Pharmacy Intern, Mary Maguire, Pharmacist, Claire Meaney, Senior Technician, Mairead Murrihy, Senior Pharmacist, Sheena Cheyne, Pharmacy Manager, Sadhbh O’Leary, Senior Pharmacist, Dr Sinead McNicholas, Consultant Microbiologist and Eimear McManus, Pharmacist

Cavan General Hospital Project Lead: Roisin Daly Nomination Overview: Cavan General Hospital Pharmacy Department has significantly developed in the last year. Expansion of the workforce included recruitment of experienced Senior Pharmacy Technicians from different backgrounds each bringing their own expertise and knowledge to enable the department to advocate the future development of pharmacy in the hospital setting. Collectively the whole pharmacy team has brought a modern approach to compare and compete with other hospitals in the country. The department now offers a more patient focused service while still maintaining the duties of a very busy professional pharmacy department in an ever growing healthcare system.

Jude Silao, Technician, Linda Clarke, Senior Technician, Martina Sherry, Technician, Donna Martin, Pharmacist, Caroline Lambe, Pharmacist, Miriam Concannon, Senior Technician, Roisin Daly, Chief II Pharmacist, Sarah O'Reilly, Technician, Aine Duffy, Senior Technician, Patrick McGovern, Pharmacist. Missing from picture: Pharmacists Mary Shiels & Susan Reilly, Technicians Austin O'Reilly & Leona Brady, Mary Mangan, Senior Technician and Eimhear McGovern, Pharmacist

St James’s Hospital Pharmacy Department Project Lead: Eimear Ni Bheachain Nomination Overview: This entry is for the Medicines Management Team. St James’s hospital (SJH) is an acute academic teaching hospital. It has approximately 900 beds and a wide range of specialities including the National Burns Unit, the Bone Marrow Transplant Centre and a large HIV service. The Medicines Management team consists of 22 dispensary & distribution senior technicians, basic grade technicians, a business manager, a purchasing officer, clerical and stores staff. They work closely together to purchase, supply, dispense and distribute medicines, dressings, feeds and fluids (and maggots and leeches!) for both St. James’s and St. Luke’s Hospitals. The team continuously strives to provide a high quality pharmacy service while always looking to the future in developing new ideas which will maximise the use of staff skills and improve our efficiency and effectiveness. Back: Ciara Floody, Laura Hudson, Bernie Reynolds, Eimear Ni Bheachain, Stephen Dunne, Carol Purcell, Paul Redmond, Jonathan Murray, Samuel Yessudoss. Front: Lynn Power, Frances Jordan, Leonor O'Connor, Shimona Poon, Gail Melanophy September 2016 • HPN


49 Tallaght Hospital Pharmacy Department Project Lead: Niamh Kilcullen Nomination Overview: The team nominated are all who have been involved in the introduction of a Medicines Management Technician (MMT) Service in Tallaght Hospital. This service has reduced the burden of medication ordering for nursing staff who now have more time for direct patient care. It makes better use of the skill set of both Pharmaceutical technicians and nurses and has led to improvements in communication between nursing and pharmacy staff, advanced roles for pharmaceutical technician’s, generated efficiencies within the system and reduced the risk of missed doses for our patients. The team are motivated to ensure that the patients in Tallaght Hospital receive the best possible pharmaceutical care in a timely manner.

Back: Bernadette Connaughton, Imelda Corcoran, Linda Maher, Cormac Cullen, John O'Byrne, Niamh Kilcullen, Jennifer O'Meara, Oliver Fitzgerald, Temitope Agebele, Aidan Nolan, Mick Gregg, Raj Sasidharan. Front: Aline Chirtullescu, Caroline Monaghan, Sarah Fay, Lorraine Cooper, Sharon Curran-Rae, Trish Dalton

Blackrock Clinic Pharmacy Department Project Lead: Niamh Bonar Nomination Overview: Motivation for this project was established by developing a mind-set that the project could be achieved, ensuring there was a clear goal and outlining the steps to achieve the goal. A hospital wide desire to meet the standard was evident and multidisciplinary team meetings were held to develop the process. Throughout the process, the types of errors identified and interventions were highlighted at these meetings showing that the project was of confirmed benefit, which helped keep people motivated to make the project work. Working as a team and recognising the clear professional abilities of each group ensures a seamless and efficient supply of medicines to the patient while optimising patient safety. Aoife McManus, Rosemary King, Lisa Foley, Christine Doyle, Sarah Agius,Nuala Kenny, Eddie Mills and Niamh Bonar

Beaumont Hospital Pharmacy Department Project Lead: Nuala Doyle Nomination Overview: The pharmacy team at Beaumont Hospital have accepted the need to modernise, trust their manager, and are genuinely interested in achieving an efficient, lean, effective, cost saving and cost rationalisation department that they can be proud of. They are well on the way and deserve the recognition of the difficult task they have whole heartedly undertaken and the motivation, inspiration and pride an award like this gives is worth considerably more to them than the savings already made for the hospital. The team have, together, entered into a journey of evolution throughout the department which has moved significantly forward since September 2014.

Back: Martin McArdle, Grant Carroll, Patrick McGee, Paul Hollywood, Nuala Doyle, Brigid Lynam, Anne Marie Garvin, Leah Gaughan; Middle: Bronwyn Cummings, Brona Staunton, Denise Killalee, Emma Flemming, Mairead McCabe, Marina Rosca, Aisling Kerr, Linda O’Neill, Tracey Burke, Anne Marie Cushen, Nadia Campbell; Front: Jane Gibbons, Margaret Triggs, Ciara Reddy, Elizabeth Florencio, Mairi Donald, Cait Skeffington

St John of God Hospital Pharmacy Department Project Lead: Dolores Keating Nomination Overview: Medication plays an important part in recovery for many people who experience mental health difficulties. It is vital to that person’s health and wellbeing to support them to optimise the use of medicines, ensuring that medicines are actively used to support recovery. At Saint John of God Hospital the pharmacist plays a key role in medicines optimisation as part of an interdisciplinary, holistic approach to care. For this team, being person centred not only requires them to focus on the systems and process of medicines management but also to engage with people, understand their experience of using medicines, support shared decision making and have an in-depth understanding of the other treatment options and supports that enhance a personal recovery journey. Zoe Duncan, Audrey Purcell, Melissa Curley, Aoife Carolan, Sheenagh McCarthy, Dolores Keating

Our Lady’s Children’s Hospital Crumlin Project Lead: Lani Smith Nomination Overview: Medication plays an important part in recovery for many people who experience mental health difficulties. It is vital to that person’s health and wellbeing to support them to optimise the use of medicines, ensuring that medicines are actively used to support recovery. At Saint John of God Hospital the pharmacist plays a key role in medicines optimisation as part of an interdisciplinary, holistic approach to care. For this team, being person centred not only requires them to focus on the systems and process of medicines management but also to engage with people, understand their experience of using medicines, support shared decision making and have an in-depth understanding of the other treatment options and supports that enhance a personal recovery journey.

Back: Carole Boylan, Dr Elizabeth Barrett, Vice-Chair, Bridget Conway, Caroline McGrath, Sara McMahon and Edel McCarra. Front: Anna Delahunt, Marianne O'Reilly, Roisin Gowan, Chair and Lani Smith HPN • September 2016


Awards 50 Awards

Hospital Professional

2016

Consultant-Led Team of the Year Award 2016 Dr Oisin O Connell/Professor Jim Egan Hospital: Mater Misericordiae University Hospital Nomination Overview: The Lung transplant team in the MMUH celebrated a record year in 2015 by conducting a record number of lung transplants, and a number of other “firsts” including the first heart-lung transplant and the first Irish EVLP transplant. The EVLP technique allows more time for the team to assess and manage donated lungs using a machine and therefore gives more patients the chance of receiving the “gift of life”. These advances in the complexity and volume of transplant surgery are only possible with the concerted teamwork of a highly skilled group of professionals. We were very proud to be featured on the Late Late show recently along-side three patients who benefited from unique lifesaving surgery made possible by the multidisciplinary team.

Dr Oisin O Connell, Professor Jim Egan, Consultant medical leads, Mr Iain Lawrie, Ms Sara Winward and Ms Fiona Dargan, Post lung transplant clinical nurse specialists, Ms Karen Redmond, Ms Donna Eaton, Mr David Healy, Mr Seyed Hossain Javadpour, Mr Jim McCarthy, Mr Lars Nolke: Consultant Transplant Surgeons, Ms Patricia Ging, Transplant Pharmacist Chief II, Ms Irene Byrne and Ms Petra Grehan, Senior transplant Physiotherapists, Ms Yvonne Sayles and Ms Katie Newton, Senior Clinical Dieticians, Ms Maria Love, Senior Medical Social Worker, Ms Ciara Murphy, Speech and Language Therapist, Dr Katie O Brien, Clinical Psychologist Transplant Coordinators, Ms Vivian Vize, Ms Elaine Burke, Ms Mary Connolly, Ms Zita Lawlor Ms Brid O Connor, Ward Clerk Nursing teams in Heart Lung Transplant Ward, Cardiothoracic wards (St Cecelia’s and CTHDU) and ICU

Dr Maria Donnelly Hospital: Tallaght Hospital ICU Nomination Overview: Professor Owen Corrigan and Dr Maria Donnelly, Consultant in Intensive Care Medicine together with the pharmacy department set up a joint ICU-Pharmacy Pharmacokinetic research group in 2000, a group which continues to work collaboratively together today. Professor Deirdre Darcy from the TCD School of Pharmacy is now a key member of that group together with ICU and Renal colleagues, Dr Maria Donnelly and Dr Peter Lavin and pharmacy department, Mary Coyle and Evelyn Deasy. The mission of the ICU-Pharmacy Clinical Pharmacokinetic Research Group (CPRG) is to design and conduct high quality research into the pharmacokinetic and pharmacodynamic handing of pharmaceuticals in critically ill patients and to answer clinically important relevant questions. Dr Maria Donnelly, Evelyn Deasy, Maria Coyle, Cairtiona Gowling, Dr Deidre D'Arcy and Lisa Dunne

Dr Elizabeth Barrett Hospital: Our Lady’s Children’s Hospital Crumlin Nomination Overview: This project is the first of its kind in the field of eating disorders in child psychiatry. With limited services allocated for child psychiatry as well as a lack of guidance for both community and hospital services, we felt that it was imperative that we endeavour to develop clearcut and a consistent approach to the treatment of vulnerable adolescents with eating disorders. This project is innovative in its cross-hospital need for patients to be treated in acute setting. The aim is not to initiate a new service, but use the limited resources we have in our current service to help deliver the best possible approach to patient care and patient safety. Ultimately the project and working group is about developing the service to help healthcare professionals in the community and in the tertiary centres, and ultimately help the vulnerable patients. The project although in its infancy is enthusiastically received and ongoing work is to continue throughout the next few months.


Awards Hospital Professional

51

2016

Multidisciplinary Award 2016 National Rehabilitation Hospital Entry Overview: In 2015, the pharmacy department at NRH worked in conjunction with other health care professionals, both inside and outside the hospital to improve the care of asthma and COPD patients. Due to the success of this project, the team has linked up with various other disciplines in the hospital to highlight and work together on important issues. Pictured: Nessa Walsh, Pharmacy Intern, Eimear McManus,Pharmacist and Sheena Cheyne, Pharmacy Manager

Multidisciplinary Atrial Fibrillation Clinic Team, Tallaght Hospital Entry Overview: A multidisciplinary Atrial Fibrillation (AFib) Clinic was developed which brings together all of the key specialities required for this improved model of care. It is the first of its kind multidisciplinary clinic in Ireland for AFib which implements best practice in treatment and monitoring of patients with this condition. The clinic has developed a comprehensive clinical programme for the detection, treatment, safe anticoagulation and education of patients with AFib. Pictured: Marguerite Vaughan, Ciara McManamly, Christine McAuliffe, Dr Ronan Collins, Dr Tara Coughlan, Dr Rebabonye Pharithi and Cathy Burke

Blackrock Clinic Pharmacy Department Entry Overview: At Blackrock Clinic, clinical pharmacists review drug charts to ensure the safe and appropriate use of medicines whilst aiming to minimise medication error. Admissions outside of pharmacy hours were not applicable to pharmacist review. In 2011, this standard was ‘unmet’, prompting pharmacy to devise and implement a service to ensure review of medication charts is maximised and patient safety optimised. A hospital wide desire to meet the standard was evident and multidisciplinary team meetings were held to develop the process. Successful implementation of FDAR is the result of all clinical team members working together to achieve the end goal. Pictured: Rosemary King, Lisa Foley and Niamh Bonar

Beaumont Hospital Pharmacy Department Entry Overview: Beaumont Hospital embarked on a hospital improvement project in 2015. The focus was on the elderly, the highest numbers of patient admissions and provision of care. The initiative and challenge was to innovate, initially with the staff the team had, change their service for the elderly, improving the quality of care provided, in particular, to the FRAIL elderly in the Emergency Department (ED). Pictured: The team from Beaumont Hospital

Catherine Boyle, Infectious Diseases Pharmacy Lead-Chief II, Mater Misericordiae University Hospital Entry Overview: The Infectious Diseases Pharmacy Service and in particular, Mairead O Connor, play an invaluable role in the successful treatment of patients with HCV in the MMUH. This is achieved by working effectively with many teams and departments within the hospital. This multidisciplinary collaborative approach to managing HCV has led to improved patient engagement and subsequently hugely successful cure rates. Pictured: Catherine Boyle, Conor Moran and Mairead O'Connor HPN • September 2016


52 Event Gallery Hybrid Cardiac Catheterisation Laboratory opens doors Minister for Health, Mr Simon Harris TD and Minister for Health Ms. Michelle O’Neill MLA officially opened the new Hybrid Cardiac Catheterisation Laboratory (HCCL) at Our Lady’s Children’s Hospital Crumlin recently. The Hybrid Cardiac Catheterisation Laboratory is the only paediatric interventional cardiology service on the island of Ireland. OLCHC as the National Centre for Paediatric Cardiology and Cardio-Thoracic Surgery is the Republic of Ireland’s (ROI) partner in the Congenital Heart Disease (CHD) All Island Network, treating approximately 600 patients per year. The project was funded in totality by the Health Service Executive at a cost of ¤5.6million.

Minister for Health Simon Harris TD & Minister for Health Michelle O’Neill MLA open New Hybrid Cardiac Catheterisation Laboratory

This new Hybrid Cardiac Catheterisation Laboratory at Our Lady’s Children’s Hospital Crumlin has the most advanced paediatric interventional cardiology equipment in Europe. This Unit has been designed to create the infrastructure and technology to deliver cardiac catheterisation procedures to the Children of Ireland, to international standards. In addition, the design enables a group of children to proceed directly from cardiac catheterisation to cardiac surgery without having to change facilities. This was not available to OLCHC previously.

Multi-million Euro Diagnostic Imaging Facility launched 2016 RTÉ presenter, Dáithí Ó Sé took a well-earned break from his Rose of Tralee duties to officially open the new multi-million euro diagnostic imaging facility at Bon Secours Hospital, Tralee. Operated by Alliance Medical, the facility offers timely access to radiology for almost 30,000 patients in the Kerry region and surrounding areas. The partnership between the Bon Secours and Alliance Medical is part of the Bon Secours Health System’s ¤150m investment strategy across its hospital network in Ireland. The upgraded MRI and CT technology at the Bon Secours hospital offers faster and more comfortable scans for patients with the capability to perform a wider range of CT examinations and an unrivalled MRI image quality. Together with Bon Secours in Tralee, Alliance Medical provides access to MRI and CT scans for people in the Kerry region and surrounding areas. CEO of Bon Secours Hospital Tralee, T. J. O’Connor, said, "As the largest private healthcare provider in Ireland, the delivery of world-class medical treatment is vital to us. It is important therefore when choosing our partners that we work with like-minded organisations.” Pictured are: Head Radiographer and Unit Manager at Alliance Medical, Doireann Ní Sheaghdh; Managing Director, Alliance Medical, Malcolm Banks; Television Presenter, Daithí Ó Sé and Regional Manager, Alliance Medical, Yvonne Davidson.

Leading Cancer Surgeon delivers Memorial Lecture NUI Galway recently hosted the 41st Sir Peter Freyer Memorial Lecture and Surgical Symposium, the largest Surgical Conference in Ireland, from 2-3 September. The annual event provides a platform for healthcare professionals to present their research and clinical work, and allows for the merging of both scientific and clinical information. It is named in memory of the Galway-born surgeon, Sir Peter Freyer, who performed the first successful surgical operation to remove an enlarged prostate in 1900. Professor Michael Solomon, Consultant Surgeon and Director of Colorectal Research at the Royal Prince Alfred Hospital in Sydney, delivered the Memorial Lecture entitled ‘20 Years of Evolving Pelvic Exenteration’. Professor Martin Corbally delivered the State of the Art Lecture entitled ‘The Surgeon in the Modern World’ on Saturday, 3 September.

September 2016 • HPN


53

ESTRO Lifetime Achievement Award Mary Coffey, Adjunct Professor in the Discipline of Radiation Therapy at Trinity College Dublin was recently honoured with a Lifetime Achievement Award by the European Society for Radiotherapy and Oncology. Mary received this award in recognition of a lifetime dedicated to improving the quality of radiotherapy patient care through raising safety awareness and promoting educational standards for Radiation Therapists (RT) throughout the world. Mary led the development of the International

Atomic Energy Agency (IAEA) Handbook for RT Education and the ESTRO European core curriculum for RTs. She was a member of the expert group who published the ‘Hollywood Report: The Development of Radiation Oncology Services in Ireland’ which shaped Radiation Oncology (RO) services in Ireland as we now know them. Mary also sits on the IAEA group in staffing for RO and the ESTRO Health Economics group.

ESTRO and the European Organisation for Research and Treatment of Cancer (EORTC). She also promotes RT education and improved standards of patient care through her chairship of the ESTRO Best Practice in RO programme: a Project to Train RT Trainers. Another of Mary’s passions is risk management and safety in radiotherapy, where she is a founder member of the Radiation Oncology Safety Information System (ROSIS) and is the current chair of the ESTRO Radiation Oncology Safety Committee.

Mary forged the way for RTs in Europe through the establishment of the RT committees within

Pictured from left to right: Mary Coffey, Ben Mijheer (The Netherlands), Yolande Lievens (ESTRO), Philip Poortmans (ESTRO) , Michael Brada (UK), Vincenzo Valentini (ESTRO) and Jean-Pierre Geard (France) at the Lifetime Achievement Award Ceremony

Driving Patient Care through Innovation Lorna Ross, Director of Design at the Centre for Innovation in the Mayo Clinic recently gave a Trinity lecture at Tallaht Hospital on, “Driving Improved Patient Care Through Innovation.”

Pictured left is Dr Barry McMahon Head of Department of Medical Physics & Clinical Engineering Tallaght Hospital and Associate Professor Medical Physics & Bioengineering, TAGG Research Centre, Department of Clinical Medicine, Trinity College Dublin; Lorna Ross Director of Design at the Centre for Innovation, Mayo Clinic; David Slevin, CEO Tallaght Hospital; Lucy Nugent Deputy CEO Tallaght Hospital.

HPN • September 2016


54 Clinical R&D NEW PHASE III STUDY FOR STIVARGA® (REGORAFENIB) Bayer and the U.S. National Surgical Adjuvant Breast and Bowel Project (NSABP), a leading clinical trials cooperative group, are collaborating on a new Phase III study to investigate Stivarga® (regorafenib) as an additional adjuvant therapy in colon cancer. The ARGO trial will investigate regorafenib as a single agent for the adjuvant treatment of Stage IIIB and IIIC colon cancer following completion of standard adjuvant chemotherapy. In this stage, the tumor has started to invade the wall of the colon, but not yet spread to other distant organs. “In 2016, more than 134,000 adults in the United States will be diagnosed with colorectal cancer. Two-thirds of these cases, or more than 95,000, will be cancers of the colon,” said Norman Wolmark, MD, Chairman of the Foundation. “Despite receiving adjuvant chemotherapy, patients with stage IIIB and IIIC colon cancer have about a 40% risk of developing metastatic disease, meaning that the disease has spread from the colon to distant organs. Given the antimetastatic effects of regorafenib demonstrated pre-clinically and the treatment benefits in the metastatic setting of colorectal cancer, we are keen to explore if it could also help patients at earlier stages of the disease.” The Phase III study ARGO, a randomised, double-blind, placebo-controlled study, will be conducted by NSABP, with Bayer offering consultation as well as financial support. If positive, Bayer may use the results for submission of marketing authorization of Stivarga in this earlier stage of the disease. “We are excited to be collaborating with NSABP to further explore the potential of regorafenib in an earlier line of treatment for patients with colon cancer, one of the most common forms of cancer worldwide,” said Dr. Joerg Moeller, member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Development. “We believe that by partnering with those on the front line of patient care, we will be in a position to September 2016 • HPN

deliver additional therapeutic options to treating physicians and their patients.” Regorafenib is approved under the trade name Stivarga® in 90 countries worldwide, including the United States, Europe, and Japan for the treatment of metastatic CRC. The approval of regorafenib was based on data from the pivotal Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. Full results from the CORRECT study were published in January 2013 in The Lancet.

BAYER NOTICE OF DISCONTINUATION OF GLUCOBAY 100MG X 90 TABS FROM THE IRISH MARKET Bayer Ltd. wishes to announce the planned discontinuation of Glucobay 100mg x 90 tabs from the Irish market. Glucobay 50mg x 90 tabs tablets will continue to be available. The discontinuation is from October 1st 2016. Stock remaining in circulation is expected to last until 31st October 2016 however it is difficult to predict with certainty when stocks will be depleted as abnormal buying patterns may arise following the announcement of this planned discontinuation. For queries regarding availability of stock please contact customer service at 01 2999313 or ordersireland@bayer.com For other queries regarding this product please contact Bayer Ltd., The Atrium, Blackthorn Road, Dublin 18; Tel: +353 1 2999313; Fax: +353 1 2061456; E-mail: info.ireland@ bayerhealthcare.com

ROCHE RECEIVES EU APPROVAL OF AVASTIN® (BEVACIZUMAB) IN COMBINATION WITH TARCEVA® Roche Products (Ireland) Limited has announced that the European Commission has approved the use of Avastin® (bevacizumab) in combination with Tarceva® (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-

small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR)-activating mutations. The approval follows the results of the pivotal phase II JO25567 study, which showed a statistically significant 46 per cent relative reduction in the risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015) for people treated with the combination of Avastin plus Tarceva compared to Tarceva alone. The recent decision marks the first time Avastin has been approved in combination with another targeted therapy. Avastin and Tarceva each target pathways known to be key drivers in the development and growth of tumours, and the beneficial effect of Avastin plus Tarceva is supported by results of other clinical studies, which have shown the combination to be effective and tolerable. “Cancer treatment is becoming more targeted and more specific. This cohort of patients with this specific form of lung cancer will benefit hugely from the synergies of the combination of Avastin and Tarceva, meaning that Irish oncologists have another powerful weapon in their treatment armamentarium,” said Dr Mike Starnawski, Medical Director, Roche in Ireland. Lung cancer is the leading cause of cancer death in both sexes in Ireland, comprising 18% of cancer deaths in women and 23% of cancer deaths in men during the period 2011-2012. NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world.

FASLODEX MET PRIMARY ENDPOINT IN FIRST LINE TREATMENT OF ADVANCED BREAST CANCER AstraZeneca recently announced positive results from the Phase III FALCON trial comparing Faslodex 500mg (fulvestrant) to Arimidex 1mg (anastrozole) for the treatment of locally advanced or metastatic breast cancer, in post-menopausal women who have not had prior hormonal treatment for

hormone-receptor-positive (HR+) breast cancer. Faslodex 500mg demonstrated superiority compared with Arimidex 1mg in FALCON, and met its primary endpoint of extended progression-free survival. The trial showed an adverse event profile generally consistent with current knowledge of the safety profile of the medicines. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The FALCON results bring us closer to offering more and earlier treatment options to postmenopausal women with HR+ locally-advanced or metastatic breast cancer; the potential to delay disease progression is important for these patients as there is currently no cure. Faslodex has over 10 years of clinical evidence and we are committed to exploring its potential along with the rest of our outstanding oncology portfolio.” A full evaluation of the data is ongoing and the results are expected to be presented at a medical meeting in 2016. Aromatase inhibitors (such as Arimidex) are the current standard of care in first-line treatment for postmenopausal women with advanced HR+ breast cancer. Faslodex 500mg is approved for the treatment of postmenopausal women with oestrogenreceptor (ER)-positive locally-advanced or metastatic breast cancer whose cancer has progressed following anti-oestrogen therapy. Most recently, on 2 March 2016, the US Food and Drug Administration approved Faslodex 500mg, in combination with palbociclib, for the treatment of women with hormone-receptor-positive, human-epidermal-growth-factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC), whose cancer has progressed after endocrine therapy.


55 MSD RECEIVES POSITIVE CHMP OPINION FOR ELBASVIR/GRAZOPREVIR

REAL WORLD DATA FROM PREFER IN AF PATIENT REGISTRY

MSD recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of elbasvir/grazoprevir (50mg/100mg), an investigational once-daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus (HCV) in adult patients.

Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) have announced new sub-analysis data from the PREvention oF thromboembolic events— European Registry in Atrial Fibrillation (PREFER in AF) patient registry which reveal at-risk patient groups, current treatment gaps in the management of atrial fibrillation (AF) and trends associated with specific patient characteristics. The registry provides unique insights on recent developments in AF management across Europe and the current treatment challenges, helping to bolster the body of evidence of AF patient outcomes in a clinical setting. These data are being presented at the European Society of Cardiology (ESC) Congress 2016, August 2731, in Rome, Italy.

The CHMP positive opinion will be reviewed by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralised marketing authorisation with unified labelling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. MSD anticipates that the European Commission decision will be made in mid2016. The U.S. Food and Drug Administration and Health Canada approved elbasvir/ grazoprevir (50mg/100mg) tablets (marketed under the brand name of ZEPATIER™) in January 2016. “We are pleased with the CHMP’s positive opinion recommending the marketing authorisation of elbasvir/grazoprevir in the European Union, which marks an important step forward in the regulatory process,” said Dr Colm Galligan, Medical Director, MSD in Ireland. “The application was based on the findings from a broad clinical development program evaluating the efficacy and safety of elbasvir/grazoprevir across diverse populations of patients with chronic hepatitis C, including patients with compensated cirrhosis and those with stage 4 or 5 chronic kidney disease.” Elbasvir/grazoprevir is an investigational, once-daily, fixed-dose combination therapy containing elbasvir and grazoprevir. The combination was granted breakthrough therapy designation by the FDA, for the treatment of patients with chronic HCV GT1 infection with end stage renal disease on haemodialysis, and breakthrough therapy designation for elbasvir/ grazoprevir for the treatment of patients with chronic HCV GT4 infection.

The registry, sponsored by Daiichi Sankyo, informs on AF patient profiles in a real-world clinical context, helping to identify specific at-risk patient groups, including those with co-morbidities that predispose them to thrombotic events. Data from the registry reveals that AF patients with diabetes, on insulin treatment are at a significantly increased risk of stroke/systemic embolism at one year follow-up compared to AF patients without diabetes (5.2% versus 1.9% respectively; Hazard Ratio [HR] 2.89, 95% Confidence Interval [CI] 1.675.02; P=0.0002) and compared to those with diabetes not on insulin treatment (5.2% versus 1.8% respectively; HR 2.96, 1.49-5.87; P=0.0019). Interestingly, diabetic patients not receiving insulin therapy had similar incidence of thromboembolic events than patients without diabetes (HR 0.97, 0.58-1.61; P=0.9). Through comprehensive data capture, the registry has also enabled a comparison of specific patient characteristics such as gender alongside clinical aspects including therapy choice and clinical outcomes. The registry has revealed that women experience a greater burden of symptoms compared to men and that treatment with oral anticoagulation was similar in both genders.

FIRST PIVOTAL NIVOLUMAB IMMUNOTHERAPY DATA IN BLOOD CANCER SHOW 66% TUMOUR REDUCTION IN HODGKIN LYMPHOMA The Lancet Oncology has published data1 from CheckMate -205, a single-arm, Phase II trial evaluating nivolumab in patients with the blood cancer, classical Hodgkin lymphoma (cHL) which showed considerable tumour reduction. The data focused on heavily pre-treated patients who had relapsed or progressed after stem cell transplantation* and post-transplantation brentuximab vedotin (n=80).1 Data on the primary endpoint showed that the number of patients with considerable tumour reduction (objective response rate (ORR)) was 66.3% (95% CI: 54.8-76.4). Median duration of remission was 7.8 months (95% CI: 6.6-NE). The authors of the paper recommend ongoing follow-up to assess the durability of the response. “Hodgkin lymphoma is a disease which is commonly diagnosed in people under 30 years old. The majority of patients are cured with first line therapy. For those patients who relapse early or fail to respond to first line treatment, options are limited,” said Dr Larry Bacon, Consultant Haematologist, St James’s Hospital, Dublin. “These data are very encouraging and highlight the potential of immunotherapy in reducing cancer burden. Nivolumab is offering real hope for the future of this disease. The hope is that this will translate into longer survival in more patients than has been possible to date. It is important that all patients affected by Hodgkin lymphoma receive the best possible treatment and care, and the more options there are to improve outcomes and quality of life for patients, the better.” Nivolumab has an innovative mode of action that works by harnessing the ability of the immune system to fight cancer. In this study, as well as ORR and duration of response, median time to response was 2.1 months and the majority of responses (62.3%) were ongoing at the time of analysis. In an exploratory analysis, the authors also observed that 72.1% of patients who did not respond to most recent prior brentuximab vedotin treatment did respond to nivolumab. The safety profile of nivolumab in CheckMate -205 was consistent with previously reported data in this tumour

type. Grade 3/4 adverse events occurred in 32 patients (40%), and one Grade 5 event occurred (1%; multi-organ failure). Hodgkin lymphoma (HL) is a relatively aggressive cancer that develops in the lymphatic system - a network of vessels and glands throughout the body that forms a key part of the immune system. It affects cells called B-lymphocytes, causing them to multiply in an abnormal way. HL incidence rates have increased in Ireland, with 133 people diagnosed with the cancer in Ireland in 2013. Approximately half of all patients with HL are under 35 years old when diagnosed, only 16% of all patients with HL are 65 years old or over. The disease is the fourth most common cancer in patients aged 15-34 (after testicular cancer, melanoma and breast cancer). These data are very positive and demonstrate real potential for nivolumab to improve outcomes in patients with blood cancer like Hodgkin lymphoma” said Siobhan Mitchell, Medical Director, BristolMyers Squibb Ireland. “BristolMyers Squibb is pioneering the area of immunotherapy and we are wholeheartedly committed to progressing this research with the aim of improving survival for more cancer patients in the future.” Nivolumab is currently investigational and under regulatory review for cHL in Europe. It is currently licensed in Europe as monotherapy under the brand name Opdivo®† for the treatment of adult patients with: • Advanced (unresectable or metastatic) melanoma • Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy • Advanced renal cell carcinoma after prior therapy. Ipilimumab is licensed in Europe as a monotherapy for adult patients with advanced (unresectable or metastatic) melanoma.6 Nivolumab is licensed in combination with ipilimumab for the treatment of adult patients with advanced (unresectable or metastatic) melanoma.2

HPN • September 2016


IV DRUGS

Voriconazole Used to treat serious, invasive fungal infections, generally seen in patients who are immunocompromised, and include invasive candidiasis, invasive aspergillosis and certain emerging fungal infections

Triazole antifungal medication Used to treat serious, invasive fungal infections. It works by disrupting the formation of ergosterol, which is an important component of fungal cell membranes. Without a functional cell membrane, the fungus is killed or prevented from spreading. Not for bolus injection, reconstitute and dilute before use. Voriconazole 200 mg Powder for solution for infusion 1 and 20 × 25 ml glass vials

Prescribing Information Consult the Summary of Product Characteristics for full information. Additional information is available on request. Voriconazole 200 mg powder for solution for infusion. Active ingredients: After reconstitution, each ml contains 10 mg of voriconazole. Indications: Broad-spectrum, triazole antifungal agent in adults and children 2 yrs+ in the treatment of invasive aspergillosis, candidaemia in non-neutropenic patients, fluconazole-resistant serious invasive Candida infections (including C. krusei), serious fungal infections caused by Scedosporium spp. and Fusarium spp. Primarily for patients with progressive, possibly life-threatening infections. Consult SPC for additional indications for use. Dosage and administration: Max. rate of 3 mg/kg per hour over 1-3 hrs. Adults: Initiate therapy with specified loading dose regimen, either IV or oral, to achieve plasma concentrations on Day 1 that are close to steady state. Dosage recommendations: Loading dose regimen (first 24 hrs) – IV: 6 mg/kg every 12 hrs. Oral: Patients (aged 15 yrs +) 40kg and above; 400 mg every 12 hrs. Patients (aged 15 yrs +) less than 40kg; 200 mg every 12 hrs. Maintenance dose (after first 24 hrs) – IV: 4 mg/kg twice daily. Oral: Patients (aged 15 yrs +) 40kg and above; 200 mg twice daily. Patients (aged 15 yrs +) less than 40kg; 100 mg twice daily. Treatment duration should be short as possible depending on patient’s clinical and mycological response. Consult SPC for information on dosage adjustments. Children (2 to <12 yrs) and young adolescents with low body weight (12-14 yrs and <50 kg): Dose as children. Dosage recommendations: Loading dose regimen (first 24 hrs) – IV: 9 mg/kg every 12 hrs. Oral: Not recommended. Maintenance dose (after first 24 hrs) – IV: 8 mg/kg twice daily. Oral: 9 mg/kg twice daily (max. dose of 350 mg twice daily). All other adolescents (12-14 yrs and > 50 kg; 15 – 17 yrs regardless of body weight): Dose as adults. Consult SPC for information on dosage adjustments and prophylaxis. Method of administration: Reconstitution and dilution required prior to administration as IV infusion. Not for bolus injection. Not for oral use. Contraindications: Hypersensitivity to active substance or excipients. Coadministration with the following; CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine, rifampicin, carbamazepine and Phenobarbital, efavirenz doses of 400 mg once daily or higher, high-dose ritonavir (400 mg + twice daily), ergot alkaloids (ergotamine, dihydroergotamine) which are CYP3A4 substrates, sirolimus, St. John’s Wort. Warnings and precautions (See SPC for full details): Caution in patients with hypersensitivity to other azoles. IV treatment should not exceed 6 months. Voriconazole is associated with QTc interval prolongation. Rare cases of torsades de pointes reported. Caution in patients with potentially proarrhythmic conditions. Electrolyte disturbances should be monitored and corrected. Infusion-related reactions observed during IV administration. Depending on severity of symptoms, consider stopping treatment. Monitor patients for hepatic toxicity. Reports of visual adverse reactions. Acute renal failure observed in severely ill patients – monitor patients for development of abnormal renal function. Patients with risk factors for acute pancreatitis should be monitored closely. Dermatological adverse reactions also reported – monitor closely if rash develops. If lesions progress discontinue use. Voriconazole is associated with phototoxicity – avoid exposure to direct sunlight. Treatment >180 days requires careful assessment of benefit-risk balance. Severe adverse events reported in relation to long-term treatment. Paediatric population: Safety and effectiveness in patients <2yrs not established. Frequency of phototoxicity reactions higher in paediatrics. Interactions: Voriconazole is metabolised by, and inhibits activity of, cytochrome P450 isoenzymes, CYP2C19, CYP2C9, and CYP3A4. Consult SPC for detailed information on interactions with other medicinal products. Fertility, pregnancy, lactation: Not recommended. See SPC. Undesirable effects: Very common: Oedema peripheral, headache, visual impairment, respiratory distress, diarrhoea, vomiting, abdominal pain, nausea, liver function test abnormal, rash, pyrexia. Common: Sinusitis, agranulocytosis, pancytopenia, thrombocytopenia, leukopenia, anaemia, hypoglycaemia, hypokalaemia, hyponatraemia, depression, hallucination, anxiety, insomnia, agitation, confusional state, convulsion, syncope, tremor, hypertonia, paraesthesia, somnolence, dizziness, retinal haemorrhage, arrhythmia supraventricular, tachycardia, bradycardia, hypotension, phlebitis, acute respiratory distress syndrome, pulmonary oedema, cheilitis, dyspepsia, constipation, gingivitis, jaundice, jaundice cholestatic, hepatitis, dermatitis exfoliative, alopecia, rash maculo-papular, pruritus, erythema, back pain, renal failure acute, haematuria, chest pain, face oedema, asthenia, chills, blood creatinine increased. Consult SPC for additional adverse reactions. Legal classification: POM. Pack size: 1 x 25 ml clear, colourless glass vial type I, packaged into a single box. €90 per Vial. PA Number: PA566/72/1. Marketing Authorisation Holder: Fresenius Kabi Ltd., Cestrian Court, Eastgate way Manor Park, Runcorn Cheshire WA7 1NT, United Kingdom. Date of preparation: June 2016. Adverse events should be reported via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

HPN September 2016  
HPN September 2016  
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