HOSPITAL PHARMACY NEWS IRELAND - ISSUE 13 - 2014

THE INDEPENDENT VOICE OF HOSPITAL PHARMACY

HOSPITAL PHARMACY

NEWS IRELAND

Issue 13

IN THIS ISSUE:

News: The use of Lean Technology to empower hospital

pharmacists Page 6

Profi le: Lifetime of Achievement for

Dr Andrew Barber, Galway University

Hospital Page 9

Report: HPAI Biosimilars

Seminar Report2

Awards: Time to get prepared for the 2014 Hospital

Pharmacy Awards Page 22

CPD: Metastatic Breast Cancer

Updates Page 25

Feature - COPD: Insights in Breast Cancer research

Page 39

Clinical: Cancer in Ireland overview

Page 42

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HPN • Issue 13

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Issue 13

Contents ForewordEditor Kelly Jo Eastwood

This issue of Hospital Pharmacy News leads with the story that the Hospital Pharmacists Association of Ireland has called for hospital pharmacists to have a greater, enhanced role in the prescription management of novel anticoagulants (NOACs).

Such a move would help tackle patient safety issues with the new drugs, as highlighted by recent reports of poor prescribing practices for NOAC patients, says the Association.

Over 13,000 HSE patients currently receive treatment with NOAC drugs across Ireland, with the number increasing rapidly. In March the HSE wrote to GPs and other community healthcare staff warning of the risks of NOACs in relation to inappropriate dosing and the potential for drug interactions.

HSE auditing found that some patients on NOACs were being prescribed a dose that was too low to be effective while many patients were taking other drugs such as aspirin and NSAIDs that could react badly with the NOAC they were taking or increase the risk of bleeding. A number of patients have been admitted to hospital with NOAC-related issues due to drug-drug interactions and incorrect dosing.

President of the HPAI Deirdre Lynch has said it is vital that hospital pharmacists play a more significant role in the management of NOAC prescribing, as they have the expertise to identify and protect patients from incorrect dosages and drug interactions.

Elsewhere, a robust set of hospital pharmacy practice standards for Europe has been agreed at an international Summit in Brussels. These standards should be met across European health systems to ensure safe, effective and optimal use of medicines in collaboration with multi-disciplinary teams.

The news has been welcomed by hospital pharmacists in Ireland as clear pathways to realise ambitious goals in enhancing and improving patient care.

And in more clinical news, a pioneering early stage study has posted a near five-fold increase in survival rates of skin cancer using immunotherapy.

The results add to the increasing amount of evidence of the role of the immunotherapy in curative cancer treatments and indicates that new drugs and treatments are able to deliver on our understanding that the immune system plays an invaluable role in the bodies fight against cancer.

Researchers pioneering methods of harnessing the body’s own immune system to fight cancer, have uncovered further dramatic results in a worldwide clinical trial involving 7,000 patients, with some in Dublin, Cork and Galway, presented this month at ASCO’s annual meeting.

Hospital Pharmacy News is Circulated to all independent, multiple and hospital pharmacist, pre reg pharmacists, students pharmacy student’s offi cial bodies, government officials and departments, Pharmacy Managers, Manufactures, Wholesalers. Buyers of pharmacy groups and healthcare outlets. Circulation is free to all pharmacists Subscription rate for Hospital Pharmacy News 60euro plus vat per year

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

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

MANAGING DIRECTOR Natalie Maginnis [email protected]

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Benyam Muluneh

David Luter

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Hospital pharmacy summit and the impact for Ireland P5

Mariosa Kieran, Manager of the Year 2013 P20

Launch of the 2014 Hospital Pharmacy Awards - Page P22

Actavis Poster Competition winners and runner-up 2014 P46

Regulars

CPD: Breast Cancer updates P25

Feature: Treatment options in COPD P32

Feature: Management of Crohn's Disease P38

NAHPT Poster Competition P46

Clinical Profiles P48

Appointments P51

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Issue 13 • HPN

Two new preferred drugs announced

News

Key role in poor NOAC prescribing

The Medicines Management Programme (MMP) has identified CITALOPRAM as the preferred Selective Serotonin Re-uptake Inhibitor (SSRI) and VENLAFAXINE as the preferred Serotonin Noradrenaline Re-uptake Inhibitor (SNRI) for the treatment of depression.

This is part of an ongoing programme by the MMP, where preferred drugs are recommended to prescribers. The preferred drugs announced are in addition to the preferred drugs announced in 2013.

The preferred drugs identified by the MMP are:

• Preferred SSRI: CITALOPRAM

• Preferred SNRI: VENLAFAXINE

When initiating SSRI or SNRI therapy, prescribers are asked to consider these preferred drugs as the drugs of first choice.

Prof Michael Barry, Clinical Lead for the Medicines Management Programme, says; “Prescribing the preferred drugs as identified by the Medicines Management Programme makes sense for the patient, prescriber, and for the

Hospital pharmacists have called for an enhanced role in the prescription management of novel anticoagulants (NOACs), blood-thinning agents that prevent stroke.

Such a move would help tackle patient safety issues with the new drugs, as highlighted by recent reports of poor prescribing practices for NOAC patients, the Hospital Pharmacists’ Association of Ireland (HPAI) has said.

More than 13,000 HSE patients in Ireland receive treatment with NOAC drugs and the number is increasing rapidly.

In March the HSE wrote to GPs and other community healthcare staff warning of the risks of NOACs in relation to inappropriate dosing and the potential for drug interactions.

HSE auditing found some patients were being prescribed a dose that was too low to be effective while

Prof Michael Barry

many patients were taking other drugs that could react badly with the NOAC they were taking.

President of the HPAI, Deirdre Lynch, said it was vital that hospital pharmacists played a more active role in the management of NOAC prescribing, as they had the expertise to identify and protect patients from incorrect dosages and drug interactions.

“Hospital pharmacists are the solution to improving the safety around the use of NOACs. We could deliver on this if the appropriate structures were put in place through the implementation of the Hospital Pharmacy Career Structure Review, the recommendations of which were

published almost two and a half years ago.”

Ms Lynch was speaking at the HPAI Annual Educational Conference, which took place in Dublin last weekend.

Prof Michael Barry, HSE National Lead of Medicines Management & Pharmacotherapeutic Interventions Programme and head of the National Centre for Pharmacoeconomics, gave the keynote address. He spoke about the opportunities the HSE’s medicines management programme can afford to hospital pharmacists in facilitating safe, appropriate and cost-effective prescribing in the Irish health system.

Echoing Ms Lynch’s call, Professor Barry said hospital pharmacists could play a key role in helping to tackle the issues caused by poor quality prescribing of NOACs, as highlighted in his letter to GPs last month.

He said more than 70% of patients on NOACs were over 70 years of age, and NOACs cost the HSE ¤15 million a year in direct drug costs. He said warfarin – an older blood thinning agent – when managed well was cheaper and just as effective and safe.

taxpayer.

The Medicines Management Programme is asking prescribers following their decision to prescribe an SSRI or SNRI that they consider CITALOPRAM and VENLAFAXINE as the drugs of first choice. This will also mean savings for patients who pay for their medicines themselves, and will also result in savings for the taxpayer.”

To date, the Medicines Management Programme has identified six preferred drugs:

Statins – SIMVASTATIN PPIs – LANSOPRAZOLE

ACE inhibitor - RAMIPRIL ARB - CANDESARTAN

SSRI - CITALOPRAM SNRI- VENLAFAXINE

Since the initiative started 12 months ago, there has been a significant increase in the prescribing of Simvastatin and Lansoprazole in line with the recommended preferred drug. Early indications in data for the prescribing of Ramipril and Candesartan are encouraging.

Breakthrough in Leukaemia fightPatients in Ireland have been involved in a breakthrough international trial of a new cancer drug which has given researchers renewed hope in the fight against leukaemia. Research published in the New England Journal of Medicine has found Ibrutinib, an inhibitor of Bruton’s Kinase, to have better rates of survival for patients with the commonest form of leukaemia than conventional therapy and is a breakthrough for people with resistance to chemotherapy.

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HPN • Issue 13

Pharmacy standards welcomed in Ireland

A robust set of hospital pharmacy practice standards for Europe has been agreed at an international Summit in Brussels. These standards should be met across European health systems to ensure safe, effective and optimal use of medicines in collaboration with multi-disciplinary teams. The standards, comprising 44 statements of practice, were agreed at the European Hospital Pharmacy Summit which concluded on Thursday 15th May, and was attended by more than 100 persons.

Nuala Doyle, Dispensary Manager, Mater Misericordiae University Hospital and Irish delegate to the Summit commented, "The new European Statements of Hospital Pharmacy, agreed with patients and other healthcare professionals at the European level, have set very clear challenges for hospital pharmacy in Ireland, particularly in respect to delivering optimised and seamless patient care.

"We will continue to work with DOH, HSE and hospital management to progress the implementation of the 2011 Report on the Review of Hospital Pharmacy. It is through the implementation of the structures agreed in the Report that these ambitious goals for better patient

care will be achieved."

The statements were subject to open Delphi consultation with national hospital pharmacy associations, European patient groups, doctors and nursing organisations. The organisations then gave their final joint approval to each statement individually by a weighted voting method at the Summit event. The European Statements of Hospital Pharmacy include:

• All hospitals should have access to a hospital pharmacist who

Bon Secours secure breast cancer firstBon Secours Hospital Cork is the first location in the Republic of Ireland to offer digital breast tomosynthesis (DBT). DBT is the latest advance in breast cancer diagnostics and has been proven to improve breast cancer detection rates by up to 50% and reduce recall rates by up to 30%.

DBT is a new mammographic technology which allows the breast to be examined in 3D as opposed to the current standard

of 2D mammography. DBT allows the breast to be imaged in multiple thin slices rather than in one single image. This technique reduces the effect of overlapping breast tissue in the radiological evaluation of the breast allowing for better visualisation, particularly in dense breast tissue or those with an increased risk of breast cancer. DBT also enables clearer identification of lesions within the breast.

In clinical practice, DBT will be beneficial to women who are referred to the Bon Secours Hospital Cork with breast symptoms and for regular screening. Currently, the Bon Secours Hospital Cork sees approximately 4,500 women on an annual basis divided between screening and symptomatic breast care clinics. This new DBT will be offered as standard to all women who require mammography. DBT is performed in conjunction with

a standard mammography and equates to an additional view of each breast adding only a couple of minutes to the examination time for patients.

Breast cancer is the third most common cancer in Ireland with 2,766 new cases of breast cancer identified every year.

Nuala Doyle - EAHP News

Flooded hospital pharmacy re-opens doorsThe Pharmacy Department at Letterkenny General Hospital has reopened with what’s been described as one of the most up to date and modern facilities in the country.

The unit was opened by Junior Health Minister Alex White, who also toured the hospital and was briefed by management on the progress being made to restore and improve the hospital in the wake of last year’s flooding.

Minister White says Letterkenny General Hospital’s realignment as part of the West and North West Hospitals Group has been a significant factor in recovering from what happened last July. Turn to page 18 for the full story.

has overall responsibility for the safe, effective and optimal use of medicines.

• Hospital pharmacists should be involved in all patient care settings to prospectively influence collaborative, multidisciplinary therapeutic decision-making.

• All prescriptions should be reviewed and validated as soon as possible by a hospital pharmacist.

• Hospital pharmacists should play a full part in decision making including advising, implementing

and monitoring medication changes in full partnership with patients, carers and other health care professionals

• Hospital pharmacists should have access to the patients’ health record. Their clinical interventions should be documented in the patients’ health record and analysed to inform quality improvement interventions.

Clinical pharmacy services should continuously evolve to optimise patients’ outcomes

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Issue 13 • HPN

News

The School of Pharmacy at UCC is embarking on a unique initiative in Ireland using the concept and principles of Lean Management.

The Lean concept was developed by Toyota and supports the identification of wasteful activities in a healthcare process that does not enhance the patient experience, and provides a means to remove or reduce them. The School of Pharmacy are hosting this Lean based educational and consulting programme for all pharmacies across the South/South West Hospital Group to be delivered by the international healthcare improvement organisation, the Leading Edge Group.

The objectives of the programme is to educate and empower pharmacists and pharmaceutical

Prof Stephen Byrne, Head of School of Pharmacy; Prof John Higgins, Head of College of Medicine & Health; Joe Aherne, CEO of the Leading Edge Group; Pat Field, Network Performance Leader, Pfizer; Deirdre Lynch, Chief Pharmacist, Cork University Hospital and President of the Hospital Pharmacists Association of Ireland; Caroline Reidy, Hospital Key Account Manager, Pfizer Healthcare.

technicians in the use of techniques and methodologies that will not only improve their pharmacy processes within their hospitals but deliver better care to their patients.

The Leading Edge Group has successfully worked with the Pharmacy Department at University Hospital Galway and recently embarked on a 6-month pharmacy project with the Northern Health Authority in British Columbia, Canada. Joe Aherne, CEO, of the Leading Edge Group was present at the launch and was excited about the benefits for the Irish Healthcare System “Our results in Canada and Ireland to date have been really impressive. Improvements have incorporated reduced times to fill orders; reductions in cycle times for managing returns of unused medicines; time spent

by pharmacists checking and correcting medication orders and paperwork and standardization of core processes across pharmacies. We have seen a paradigm shift in Pharmacy through the adoption of a culture of continuous improvement”

Prof. Stephen Byrne, Head of School of Pharmacy and Chair of Clinical Pharmacy Practice at University College Cork emphasized the significance and importance of this programme “This is the inaugural partnership between the School of Pharmacy, UCC, the Academic Health Centre and the Leading Edge Group. The deliverables from this programme will be the identification of improvement projects within the pharmacies and their subsequent implementation over a 3 month period. The School of Pharmacy will work with the Leading Edge

Group and project teams in a mentoring capacity, with the aim of publishing case reports on the success of such implementations. We are proud to be the first healthcare group working collaboratively in Pharmacy to improve patient care using an integrated Lean approach”

Prof. John Higgins, Head of College of Medicine & Health at University College Cork spoke at the programme launch and emphasized the importance of collaboration within our healthcare systems with Academia and third party healthcare practitioners. Mr. Pat Field of Pfizer Ireland also spoke at the launch about the impact of LEAN processes within the Pharmaceutical Manufacturing Industry in Ireland. The programme is being kindly sponsored by an Educations grant from Pfizer Ireland.

Herceptin alert to HCPsThe European Medicines Agency (EMA) has issued an alert to healthcare professionals across the European Union after being informed that vials of the cancer medicine Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries.

Further information is available via the EMA website at www.ema.europe.eu

Using lean to empower pharmacists

Over 350 million patients treated with Clexane worldwide2

NOT ACTUAL SIZE

Clear visibility of expiry date

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

Needle completely covered by the protection cap immediately after the injection

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

Clear product identification

Designed to

protect against

needle stick

injuries1

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

CLEXANE® CONFIDENCE AT YOUR FINGERTIPS

New Clexane® and Clexane® Fortesafety lock syringes

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

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

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

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

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

GBIE.ENO.13.06.01 Date of preparation June 2013

8

Issue 13 • HPN

News

Hospital Pharmacists must engage with IIOP, hears conference

The 2014 Hospital Pharmacists’ Association of Ireland’s (HPAI’s)

Annual Education Conference took place in April in the Crowne Plaza Hotel, Santry.

This year’s conference was well attended with a detailed educational and research programme that refl ected the changing face of Irish healthcare.

President Deirdre Lynch said the Association recognised the changing face of healthcare and hospital pharmacy practice with workshops on quality improvement and getting research published. “We have seen some major works by Irish hospital pharmacists reach publication recently and it is something we want to actively encourage within the HPAI. Finally, by popular demand, we welcomed back Prof Neil Maskrey for a second consecutive year, to present a workshop on evidence-based decision-making. We would like to sincerely thank all our presenters for their contribution and commitment,” she said.

As well as a showcase of hospital pharmacy research work, the plenary sessions on Sunday provided an insight into some of the macro issues in healthcare. Guest speakers

this year included a Keynote address from Professor Michael Barry, the National Lead of Medicines Management & Pharmacotherapeutic Interventions Programme and head of the National Centre for Pharmacoeconomics.

Prof Barry spoke about the opportunities the HSE’s Medicines Management Programme (MMP) can afford to hospital phar macists in facilitating safe, appropriate and cost effective prescribing in the Irish health system.

“I don’t think there is anybody in this room who has to tell me about the value of hospital pharmacy and the people who work in it. When we looked at setting up the National Centre for Pharmacoeconomics, where did we go? We went to hospital pharmacists. The vast majority of people working with us are hospital pharmacists, he said, adding that when the MMP was being set up he again turned to hospital pharmacists for their expertise," he said.

The cost of the HSE’s medicines bill must be reduced and medicine use needs to be better monitored and supported and hospital pharmacists can help make this happen, Prof Barry maintained.

Dr Catriona Bradley

Giving an overview of the work of the MMP, Prof Barry said the HSE estimates it spent just under ¤2 billion on medicines in 2013, up slightly from the ¤1.95 billion it spent the year before. In the context of a fi ve fold increase in the cost of medicines over a ten-year period (1999-2009) and ¤4 billion being cut from the health budget over the last six years, which is approximately ¤12 billion for 2014, these costs are simply unsustainable he said, saying if the amount wasn’t cut internally it would be cut by someone else.

Many efforts are being made to reduce the State’s medicine costs to more sustainable levels, such as the new generic prescribing and reference pricing legislation, as well as increased value for money initiatives under the MMP, he confi rmed. These include the preferred medicines initiative, which asks prescribers to prescribe the MMP’s preferred choice in a particular medicine class in order to save money. The MMP started with proton pump inhibitors (PPIs) and statins because they account for 14 per cent of total expenditure under the GMS, Prof Barry explained, and then moved on to ACE inhibitors and ARBs. Using preferred medicines can save the HSE ¤17 million a year, he said.

Some regions are better at applying the preferred drugs initiative than others, with large geographic variations Prof Barry revealed, saying in Munster it is more successful than in the South East for example. In the hospital setting, there are also regional variations, and only 30 per cent of hospitals that provided feedback (n=37) to the MMP indicated that they had a hospital formulary.

Overall, he said Irish doctors are very fond of branded medicines and are more likely to prescribe the most expensive medicine in its class. Up until recently, generic prescribing was at a mere 2.6% in Ireland, Prof Barry noted, but the new legislation is improving rates.

Meanwhile, talking about SSRIs and SNRIs, he said there is a very high discontinuation rate with these drugs due to side effects, with about 50,000 patients discontinuing them every four weeks, with about the same number commencing them. Over 150,000 patients are being treated with an SSRI or an SNRI annually, and total expenditure exceeds ¤55.7 million per annum.

Prof Barry was very critical of the use of oral nutritionals in the Irish health system, claiming that there was no clinical evidence for their use.

Concluding, Prof Barry encouraged hospital pharmacists with useful ideas on safer, better and more cost effective use of medicines to talk to the MMP, “If you have a good idea, we want to hear it. We have the potential to take your idea and apply it on a national level.”

Further coverage in the next issue of Hospital Pharmacy News

HPAI Annual Conference Report by Eileen Butler, HPAI Committee member

9

HPN • Issue 13

The Hospital Pharmacy Awards believe in recognising the outstanding achievements of our readers and the hospital pharmacy profession of Ireland. The annual Hospital Pharmacy Awards bestow a prestigious honour that acknowledges the hard work and dedication of hospital pharmacists and the contributions they make through their leadership, services, and commitment.

These awards are presented annually and honour hospital pharmacy’s heroes, both extraordinary and everyday; those who go above and beyond for their patients, mentor new pharmacists, grow their profession through education and expanded service delivery, or work collaboratively with other healthcare providers.

Dr Andrew Barber of Galway University Hospital serves to represent the embodiment of everything the Hospital Pharmacy Awards stand for. Someone who has served the industry in a professional capacity with leadership.

Having made significant contributions to the hospital pharmacy industry overall that have resulted in meaningful improvements in the quality of patient care and improved delivery models, Dr Barber was an extremely worthy winner of the 2013 Lifetime Achievement Award.

The Lifetime Achievement Award is given to hospital pharmacists for their achievements in promoting and developing pharmacy, innovation, research and development, publication and dissemination of good

Hospital Pharmacy Awards 2013

Pharmacy Representative

of the Year Finalist

Irish Pharmacy Awards 2013EXCELLENCE IN PHARMACY

A 'Lifetime' of achievement for Dr Andrew Barber

practice over a period of time. It rewards excellence and innovation to those setting the highest benchmark standards.

One nominee of Dr Barber commented, 'Throughout his career, Dr Barber has made an outstanding contribution to pharmaceutical knowledge and has shown real dedication to his profession. I am very proud to nominate him for the Lifetime Achievement Award in recognition of his crucial, pioneering research and his admirable commitment to the hospital pharmacy profession.'

Dr Barber was selected as the outstanding recipient of this award by a selection of his peers and colleagues.

He told Hospital Pharmacy News: "This is such a surprise and yet such an honour. I would like to pay tribute to Professor Meegan, my fellow Lifetime Achievement co-winner and also to my entire pharmacy team at Galway University Hospital. Our ethos is, and has always been, very much that of teamwork and thus I salute them."

While he has always had an eye to the progression of the profession nationally, he has also always worked tirelessly with his own staff in Galway University Hospital, ensuring the Department has kept within the financial constraints imposed, working with reduced staffing when the pinch came and incredibly, in these straitened times, managing to convince the hospital that they needed two new pharmacist posts and filling them this year.

Andrew Barber, Galway University Hospital

The Evolution of Generics

An evolving company

Accord Healthcare Ltd.24-26 Bullford Business Campus Kilcoole, County Wicklow - Ireland E-mail: [email protected] Tel. +353 (0)1 2592020

www.accord-healthcare.ie

Part of the Intas Group, Accord Healthcare is a young and dynamic pharmaceutical company, involved in the development, manufacturing and distribution of pharmaceutical products to over 50 markets around the world.

The group’s vision is to be involved in all the aspects of bringing pharmaceuticals to patients. Our activities today encompass the entire pharmaceutical value chain and so create a truly integrated offering.

By being vertically integrated and owning all steps of the process, Accord can bring high quality medicines to patients faster, more economically and with greater efficiency than our rivals.

Visit us during HPAI Conference

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Lifetime Achievement Award 2013

10

Issue 13 • HPN


Within a short space of time since qualifying as a hospital pharmacist Dr Barber has made his mark within the profession. He has been instrumental in establishing the Home Chemotherapy Service at Galway University Hospital, which has made an enormous and significant impact on the quality of life for cancer patients.

University College Hospital Galway (UCHG) is a major academic teaching hospital serving an urban and widely dispersed rural population. The UCHG mission is to provide high quality and equitable care for all patients, in a safe and secure environment and to achieve

excellence in clinical practice, teaching, training and research.

One patient of this particular service is quoted as stating, "I could be gone from half-nine to half-four or more....a trip is a day wasted, a day lost in my life. When you are at the hospital, you hear what the doctors and nurses are saying, but it doesn't

always sink in. At home, you can listen to what you are being told."

Their partner adds, "Sometimes she wouldn't sleep for three or four night thinking about it. She is now more confident. Sometimes the tension grows in the person who is being treated; you don't see that when they are being treated at home."

This demonstrates quite clearly what a tremendous difference this service has made to so many patients lives.

The service was bourne when the question, “How can we improve patient care?” was asked. Multiple myeloma is the second most prevalent blood cancer with a high incidence in the elderly population. Although it is incurable, novel agents have emerged over the last five years leading to a significant improvement in patient outcomes, including survival. Due to strong clinical data there has been an increase in the use of bortezomib (Velcade) in University College Hospital Galway.

The recommended dose of bortezomib is 1.3 mg/m2 body surface area twice weekly for two weeks (days 1, 4, 8

and 11). A 10-day rest period completes the 3-week treatment cycle. Once reconstituted, bortezomib has an 8-hour shelf life. The reconstituted solution is administered as a 3–5 second bolus intravenous injection requiring no special handling precautions.

Patients being treated with bortezomib can spend up to six hours in the hospital, waiting for blood testing, review by an attending doctor, dispensing and administration of the medicine.

Many patients are elderly, travel long distances and need family support. To alleviate these burdens, alternative possibilities for administration of bortezomib were looked at and a unique service piloted. The result was ‘Velcade at Home’, an IV chemotherapy administration service for patients with multiple myeloma. Support and input was needed from all hospital personnel in order to establish a safe, effective and viable home administration service for bortezomib, which included the pharmacy department reconstituting the Velcade prior to its collection by the homecare nurse.

Following the success of the 7-month pilot phase, hospital management and the multidisciplinary team involved in supporting the service felt that it was of benefit both to the patients and the hospital to officially establish the service.

To quote one patient: “I could be gone from half-nine until half-four or more… a trip is a day wasted, a day lost in my life.” The patient’s partner added: “Sometimes she wouldn’t sleep for two or three nights thinking about it”. The patient also commented: “When you’re at the hospital, you hear what the doctors and nurses are saying but it doesn’t always sink in. At home, you can listen to what you’re being told”. She is now more confident and her partner added: “… Sometimes the tension grows in the person

who’s being treated… you don’t see that when she’s being treated at home”.

Home administration of bortezomib enables patients with difficulties in getting to the hospital to receive bortezomib. It helps to optimise workflow in pharmacy and eases the burden on the day ward medical and nursing staff. The collaborative effort was centred on the common goal of improving patients’ quality of life without compromising their care.

Even more recently, Dr Barber has been involved in more research and studies, including an investigation into the health literacy of the population, examining the change in knowledge when patients are administered a questionnaire about warfarin at different time points before and after counselling by a pharmacist.

The objectives of this study were to investigate the effect of pharmacists counselling on the warfarin knowledge of the patient receiving anticoagulation therapy; and to investigate the health literacy of the population and assess whether there were any associations between health literacy and warfarin knowledge.

Warfarin is the most commonly prescribed oral anticoagulant. The newer therapeutic options for anticoagulation e.g. dabigatran and rivaroxaban, were thought to signal the demise of warfarin, and indeed they have been found to be non-inferior to warfarin therapy. Currently however, they are not without their disadvantages having no known antidote; hence warfarin will remain an important therapy for the foreseeable future.

Whatever the study, whatever the innovation, and through whatever medium, Dr Andrew Barber continues to be a beacon of inspiration to both colleagues, peers and patients alike within hospital pharmacy in Ireland.

Investing in education and the health of the nation


An evolving company

Accord Healthcare Ltd.24-26 Bullford Business Campus Kilcoole, County Wicklow - Ireland E-mail: [email protected] Tel. +353 (0)1 2592020

www.accord-healthcare.ie

Part of the Intas Group, Accord Healthcare is a young and dynamic pharmaceutical company, involved in the development, manufacturing and distribution of pharmaceutical products to over 50 markets around the world.

The group’s vision is to be involved in all the aspects of bringing pharmaceuticals to patients. Our activities today encompass the entire pharmaceutical value chain and so create a truly integrated offering.

By being vertically integrated and owning all steps of the process, Accord can bring high quality medicines to patients faster, more economically and with greater efficiency than our rivals.

Visit us during HPAI Conference

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Andrew Barber receives his Lifetime Achievement Award

Less DIsRUPTION More freedoM

NOW, Less Is More

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

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

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

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

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

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

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

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

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

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TWICE DAILY DOSING1

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

12

Issue 13 • HPN

News

HPAI Biosimilars Seminar 2014 report

Hospital pharmacists should trust the regulators at the European Medicines Agency, a seminar on biosimilars was told in Dublin recently.

Dr Martina Weise of the Federal Institute of Drugs and Medical Devices Germany and vice-chair of the EMA working party on similar biological medicinal products explained that biosimilar drugs must comply with the same standards of quality for all biological drugs, so they should not been viewed as substandard in any way. Licensing of biosimilars stipulates an additional requirement –a comparability study between the innovator/original molecule and the biosimilar. However, the EMA does not require the manufacturer of the biosimilar to establish clinical effectiveness or safety de novo.

Opening the event, HPAI president Ms Deirdre Lynch, spoke of the huge advances in biologics in 25 years from the wonder drug that was epoetin to the way biologics revolutionised the quality of life of patients with rheumatoid arthritis and inflammatory bowel disease. With therapeutic advances, however, came significant increased spend. “We have to consider how we can maximise patient benefit within the financial resources available. The issues around biosimilars are occupying hours of debate in our hospitals, from Pharmacy departments to clinicians to Drugs & Therapeutics committees. The issues in question are complex and the consequences of wrong decision-making may be serious”.

FEARS

Some clinicians are somewhat nervous about biosimilars, with concerns of insufficient safety data, differing clinical efficacy profile from the innovator product and a tendency towards more immunogencity. Ms Weise countered these arguments by explaining that the nature of biological agents is that there is inherent variability between batches and variability may also arise as the manufacturing process is modified during the lifecycle of the drug. Prof. Gerry Wilson, consultant rheumatologist Mater Misericordiae and St Vincent’s hospitals, pointed out

that “we have probably been using biosimilars for years!” and wondered about all the fuss.

CHECKLISTS

A comprehensive checklist is key when selecting a biosimilar was Prof. Mike Scott’s message at the seminar. Prof Scott wears many hats including Head of Pharmacy and Medicines Management Northern Ireland HSC trust. Drug product selection for the trust is now a highly evolved process. He described the process for biologics in Northern Ireland and surprised the audience, revealing that price may sometimes account for just 20% of the overall score.

Caution was mentioned when interpreting clinical trial data, as trials designed to examine comparability may use different end points than previous trials designed to examine clinical effectiveness. He also warned that

Continued on page 13

Professor Michael Scott, Head of Pharmacy and Medicines Management, NI HSC Trust

Deirdre Lynch, President, HPAI

Annette Whiriskey, Tallaght Hospital, Annemarie Cushen, Beaumont Hospital and Ciara Kirke, also Tallaght Hospital

Donal Carroll, St Luke's Hospital and Eileen Butler, HPAI

Professor Gerry Wilson, MMUH

13

HPN • Issue 13

News

Pharmacist role must be advanced

Hospital pharmacists must be utilised in providing both counselling about medication use and antimicrobial stewardship services, it has been claimed. The statement was made as recent data published by the European Centre for Disease Control and Prevention shows European health systems are still facing problems in treating multidrug-resistant TB successfully.

President of the European Association of Hospital Pharmacists, Dr Roberto Frontini said, “A major factor in the development of multidrug-resistant

studies on similarity and safety were conducted in pre-defined disease groups and extrapolation may be difficult.

TRACEABILITY

The new EU pharmacovigilence legislation requires that the batch numbers of biological agents be traced all the way to the patient. This will help with post-marketing surveillance and aid retrospective reviews of biosimilars and their adverse drug reaction profile. However, there was concern that the technology to achieve this was not in place to a sufficient level in primary and secondary care.

Everyone seemed to be on the same team, nodding in agreement, until the panel discussion kicked off in earnest. The biggest issue was that of switching patients from innovator product to biosimilar. While Dr Weise told the audience to “trust the science, trust the regulator”, Dr Barbara Ryan,

consultant gastroenterologist and AMNCH admitted that while she agreed in the most part with Dr Weise, she would be very hesitant to switch a patient whose disease was well controlled from one product to another i.e. innovator to biosimilar. This, she explained was partly due to a small range of biologics being licensed in her field, the implications of losing disease control for the patient and somewhat unease in being expected by the EMA to accept extrapolation over randomised controlled trials.

One camp followed the laboratory science line of thinking and argued that if the product had been licensed and been shown to be biosimilar, then there should be no issue in switching. “After all”, exclaimed Prof Gerry Wilson, consultant rheumatologist at the Mater and St Vincent’s Hospitals, “we’ve been using biosimilar for years”, referring to the several

Dr Roberto Frontini

changing in the manufacturing process for infliximab. He did admit that he would be influenced by patient choice when making his decision.

The Q&A session covered questions about the naming of biosimilar molecules, to traceability legislation and the value of batch traceability, pharmacovigilence and disease registries.

Referring to early problems with the quality of biosimilars manufactured in India and later withdrawn from market, the panel were asked if there is likely to be fear among patients if the read about this when they are requested to agree to treatment with a biosimilar. Dr Weise pointed out that the EMA did not stipulate that patient consent was required in order to switch. The clinicians on the panel agreed that dealing with what patients reading the media is part of their everyday practice.

The chairperson for the evening, Ms Joan Peppard, thanked all the speakers, panelists and attendees for their engaging contribution to a fascinating discussion. A huge debt of gratitude was paid to Ms Elaine Conyard, who expertly organised the entire event. Thanks were also extended to the industry sponsors of the seminar –Roche, Teva and Abbvie.

After two hours of presentation, questions and debate, we came away with more knowledge, some questions answered and seeds planted for more. And the overall conclusion? While the theory is compelling, there is cautiousness among healthcare professionals about this growing field. Until science and experience succeeds in convincing them otherwise, many prescribers may choose to reserve a biosimilar for new patients and may prefer to leave well-controlled patients on their existing product.

tuberculosis (TB) has been non-adherence to treatment. Yet with TB being an infectious and contagious disease, adherence takes on that extra importance. Hospital pharmacists have a pivotal role to play both in improving adherence through patient counselling, but also in improving prescribing and treatment through multidisciplinary collaboration. I urge policy makers overseeing national responses to the TB challenge in Europe to grasp the opportunities before them by advancing the pharmacist role in these areas.

"Further to this, many countries have now instituted policy measures to ensure hospital pharmacists have prominent roles in antimicrobial stewardship. This occurs to me as the right policy response given the gravity of the antimicrobial resistance problem and I encourage other countries to give such measures serious consideration.

"Finally, alongside reducing inappropriate use of antibiotics, there is a clear need to scale up the search for new agents. European Governments must accept the urgency of this

Continued from page 12

challenge and work together to create an improved environment for discovery. Whilst this includes the EU’s Horizon 2020 research programme and the Innovative Medicines Initiative, the new Commission scheduled for late 2014 should review what further improvements can be made.”

EAHP have stated that Ireland provides an example of a country that has adopted the importance of pharmacists in taking responsibility for antimicrobial stewardship within hospitals, reflected in 2009 Health Service Executive Guidelines on the topic.

A recent Surveillance Report by the European Centre for Disease Prevention and Control (ECDC) found that whilst there had been a decrease between 2011 and 2012 in respect of the notification rate of the disease, EU/EEA states are still not meeting the set targets for successful treatment of the multidrug-resistant form of tuberculosis, MDR TB. Only one in every three (34%) patients in the reporting EU/EEA countries finishes MDR TB treatment successfully. More than half die, fail treatment or default (stop taking treatment).

14

Issue 13 • HPN

News

Midlands Pharmacist appointed President-elect of EAHP

Midlands hospital pharmacist Joan Peppard has been appointed as President-elect of the the European Association of Hospital Pharmacists. Hospital Pharmacists’ Association of Ireland (HPAI) President, Deirdre Lynch, congratulated Joan on her new role.

“Having an Irish pharmacist at the helm of the EAHP shows that Europe appreciates the patient care provided by Irish Hospital Pharmacists. Our commitment to work for better patient care for all patients is demonstrated in Joan’s record and is typical of the level to

which Irish hospital pharmacists aspire.’’

Joan sees the opportunity to lead European Hospital Pharmacists as coming at a signifi cant time. “A robust set of hospital pharmacy practice standards for Europe has been agreed by the EAHP. These standards should be met across European health systems to ensure safe, effective and optimal use of medicines, in collaboration with multi-disciplinary teams. The standards were agreed at European Hospital Pharmacy Summit in Brussels with national hospital pharmacy associations,

Joan PepperdEuropean patient groups, doctors and nursing organisations,” she says.

Deirdre Lynch added, “The HPAI and EAHP look forward to working together to bring about the full achievement of the European Statements of Hospital Pharmacy in Ireland. Implementing the Report on the Reform of Hospital Pharmacy in Ireland will facilitate the achievement of these standards.”

Joan Peppard is Chief Pharmacist in Midland Regional Hospital Tullamore, Co Offaly and previously held the post of Director of Professional Development for the European Association of Hospital Pharmacists.

With a keen interest in the growth and development of hospital pharmacy and a strong commitment to excellence in patient care, Joan has served in a leadership capacity on a number of key committees in Ireland at local, regional and national level. Joan served as President of the Hospital Pharmacists’ Association Ireland from 2004 - 2006 and 2011 – 2012. She participated in national negotiations on the reform of Hospital Pharmacy, resulting in the Report on the Reform of Hospital Pharmacy in Ireland in 2011.

In 2006, Joan proposed the establishment of a clinical skills

course for Hospital Pharmacists which came to fruition in subsequent years. She also created the post of antimicrobial pharmacist in the hospital in Tullamore and on its evident success, antimicrobial hospital pharmacists were established in many hospitals country-wide.

Joan's professional qualifi cations and memberships include:

• Masters of Administration Degree (M.A. Ethics)

• Bachelor of Science Degree (B.Sc. Pharm)

• Bachelor of Administration (B.A. Public Management)

• Diploma in Healthcare Management

• Member of the Pharmaceutical Society Ireland

• Member of the Hospital Pharmacists’ Association of Ireland (positions held include President, Business Manager, EAHP Delegate)

• Member of the Midland Regional Hospital Tullamore Management Team

Joan will take up the post of President in June 2015

Hospital pharmacy Charter debated

Hospital Pharmacists in Ireland and from 34 European countries have gathered for a unique Summit to tackle current diversities in health provision and set out the future services to be delivered by the profession. Alongside representatives from over 25 European patient organisations and associations representing tother healthcare professionals, the Summit will deliver a long term vision for maximising the contribution pharmacists make to patient care in European hospitals.

Taking place in Brussels across two days (14-15 May), 45 bold and aspirational statements of hospital pharmacy practice across 6 thematic areas were debated and scrutinised by over 100 attendees, before being subject to fi nal voting on the last day of the Summit.

Designed to help address inequalities in health provision across Europe by offering a consensus view on what should be achieved by health systems, the Summit is a unique undertaking to

build the political will and common vision to improve the care of patients.

Commenting on the Summit, EAHP President Dr Roberto Frontini: “Today’s Summit is the culmination of months of preparation, but the start of years of focused improvement efforts. As Seneca reminds us, if one does not know to which port one is sailing, no wind is favourable. By the end of these two days, 34 national hospital pharmacy

platforms, alongside over 25 patient and healthcare professional organisations, will have agreed together what we need to achieve in hospital pharmacy practice development. The onus then shifts to EAHP, our members and national health systems to see the aspirations brought to reality. It’s a challenge we relish, knowing that it is high quality patient care and patient safety that is the benefi ciary.”

Pinewood Healthcare, Ballymacarbry, Clonmel, Co.Tipperary, IrelandT: + 353 52 6186000

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Issue 13 • HPN




Despite cuts in staffing, resourcing and increased demands on all staff within hospital pharmacy, Caroline Monaghan, Hospital Pharmacy Technician at the Tallaght Hospital, has worked constantly with fewer resources to deliver and improve this service.

It was this displayed leadership which led to her being awarded the title of Medisource Hospital Pharmacy Technician of the Year 2013.

"Caroline has a vision for the future of pharmacy and will work constantly to bring about these quality improvements. She understands how important pharmacy’s role is in shifting from pill to patient and that being at ward level helps improve patient care. It is great for other pharmacy staff to see her motivation in these difficult times and it is inspiring to other

pharmacy technicians," says her nominee.

Caroline is a Senior Pharmaceutical Technician in the Pharmacy Department, Tallaght Hospital. She has contributed many years of outstanding service to the Pharmacy Department. In this time there have been a significant number of changes in the healthcare environment, including in the provision of hospital pharmacy services and Caroline has continually challenged herself and modified her role within the department to extend the capacity of her work and her role over the years.

As long as pharmacists have been dispensing medications, pharmacy technicians have been assisting in the medication delivery process, and as the profession of pharmacy evolves, so too have the roles and

Caroline takes home Technician crown

Paul Boland, Medisource, presents Caroline Monaghan with her award

Medisource Hospital Pharmacy Technician of the Year 2013


17

HPN • Issue 13

responsibilities of pharmacy technicians.

To create an environment where pharmacists are consistently able to practice to the top of their license has required the development of technician roles that are capable of supporting pharmacy’s clinical efforts. Technician roles must be driven by standardised education and training along with pharmacy’s commitment to develop effective pharmacy technician programs.

Caroline has clearly demonstrated to her peers, and to the judges, her ability to go above and beyond all of this and to meet what is the necessary requirements.

As well as the responsibility for the Pharmacy Department stock management processes, her job involves placing orders, dealing with invoice queries internally and externally to the hospital, compiling invoices for reimbursement purposes and maintaining contracts and involvement in tender processes. Caroline is also responsible for ensuring that the appropriate documentation is completed, when necessary, to complete the order process, for example for financial or reimbursement reasons, or for unauthorised drugs.

The ideal technician roles enable pharmacists to devote additional time to direct patient care. Thus, it is important for technicians to continually look for opportunities to expand their responsibilities or even create new roles that permit pharmacists to then work to the top of their license.

Caroline has always been an active Hospital Pharmaceutical Technician on a national level, becoming a member of the National Association of Hospital Pharmaceutical Technicians (NAHPT) Committee. The commitment to NAHPT highlights Caroline's dedication to the advancement of the role of hospital pharmacy technicians in Ireland.

For one nominee, the key quality that Caroline possesses, and that strengthens her role within the Pharmacy Department is her relationship with department staff, other hospital staff, patients and representatives from outside the hospital. She has built up good relationships with customer service personnel and hospital representatives in the Pharmaceutical Industry as a result of her role in purchasing and as a member of the NAHPT committee.

Caroline commented on receiving her Award, "I have had such a fantastic night so far and this has topped it all off. I really didn't expect to win this award tonight, I was happy to enjoy the celebration with my colleagues. This award will stand pride of place within our pharmacy department. I would really like to pay tribute to the work being carried out by all hospital pharmacy technicians throughout Ireland."

Caroline has been described as having 'a vision for the future of pharmacy and will work constantly to bring about these quality improvements,' understanding how important pharmacy’s role is in shifting from pill to patient and that being at ward level helps improve patient care.

Paul Boland, Managing Director of Medisource comments: "Medisource are delighted to sponsor the HPN Hospital Pharmacy Technician of the Year award and convey many

congratulations to Caroline for her well deserved win.

"Our mission is to explore all avenues in tracking down unlicensed medicines to assist in continuing patient care, and our emphasis is on personal communication to ensure that medicines are sourced and delivered within

the required timeframe and that such sourcing is done only through verified and legitimate distribution channels within regulations. We offer a global reach and commit to significant local stockholding so that your patient doesn’t have to suffer a break in treatment."


Caroline Monaghan, Tallaght Hospital, holds aloft her trophy

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Issue 13 • HPN




Providing safe and effective care is the ultimate goal for the hospital pharmacy staff within Letterkenny General Hospital's Pharmacy Department along with excellent team work and this was one of the founding principles behind their being crowned with the 'Highly Commended' title in the Pfizer Hospital Pharmacy Team of the Year award category at the inaugural Hospital Pharmacy Awards 2013.

Good communication is vital for the efficient functioning of any team or organisation and the department at LGH suffered the worst kind of event when a catastrophic flood last year demanded an immediate and an ongoing response and the work carried out by all members of pharmacy staff in the weeks since the occurrence was deemed as remarkable.

The Pharmacy Department team recognised that implementation of successful significant changes would require meaningful engagement with all grades of staff. Communication and consistently liaising with the staff who actually deliver the

services and are experts in their field allowed the identification of the value and waste elements of services and what potential improvements could be made. All sections of the Pharmacy Department have contributed to the review process with team members from each discipline playing a role in the re-organisation.

Projects that were undertaken to optimise the services currently provided and to address priority issues included:

A review of the potential for increased utilisation of information technology including:

• Works to upgrade and extend the Pharmacy Department robotic dispensing system in 2012. This required a temporary review of all Pharmacy Department work processes to ensure continuity of service provision, and that the integrity and security of the drug management system was maintained with no impact on other hospital staff and on patients.

• The introduction of tablet computers to improve the

efficiency of the transmission of the selected ward top-up lists to the Pharmacy Department. Priority areas selected included the Intensive Care Unit. This project required implementing the use of the Hospital Information System via wireless technology.

The success of this project in the selected areas has lead to the submission for funding to extend the process across the hospital.

• The introduction of a ‘Pharmacy Porter’ function on the Hospital Information System to allow wards

From out of the Flood - Letterkenny Hospital Pharmacy Department

Joanne English, Rakhee Chandupatla, Edel Bradley, Patricia Donaghey, Patrycja Karczewska, Marguerite Keys, Annalisa Deeney, Daniel Sweeney, Padraig Cahill, Pfizer, Tom Ferrie, Stephen Boucher, Annalisa Mullan, Ciara Bannon, Anne Machniewski, Michael Bouchier-Hayes, Michelle Blake, Julie McGonigle and Keith Durning

Pfizer Hospital Pharmacy Team of the Year 'Highly Commended'


Tom Ferrie, Head Pharmacy Services, Letterkenny General Hospital

19

HPN • Issue 13

and departments to request or query porter collection. The function has been rolled out for Controlled Drugs collections and has allowed rationalisation of the schedule to certain hospital areas on specific days for specific times negating the requirement for the porters to visit each ward/department daily for Controlled Drugs. The efficiencies established have been utilised to distribute other deliveries across the additional hospital site.

• The implementation of an additional property on the pharmacy requisition queuing system screen that identifies the volume of the order and the number of items in the order that will be dispensed from the robot. This allows prioritisation of workflow to meet delivery schedule targets for the different hospital sites, and also allows effective continuation of work if the robot is off-line.

RESEARCH

• Research into the drug delivery process to identify areas of inefficiency in the current requisition delivery schedule from the dispensary to wards. This investigation successfully identified inefficiencies within the schedule of requisition deliveries through the use of a triangulated methodology. The cumulative findings of this investigation identified that improvement in productive efficiency can be achieved without additional resources leading to modifications to delivery schedules that had minimal impact on the hospital service needs

• The use of LEAN Six Sigma processes to review process including requisition picking, the scheduling of top-up services for both pharmaceutical technicians and pharmacy porters and identification of interruptions to work flow. The processes identified waste and methodologies to improve efficiencies.

EDUCATION

• The signing of a memorandum of understanding in 2012 leading to the establishment of a strategic partnership with the School of Pharmacy, RCSI to increase professional and academic excellence in the Pharmacy Department, MMUH and for the RCSI students. Many members of the Pharmacy Department team have contributed to this programme, providing lectures,

taking students for ‘dry rounds’ and mentoring sessions, in addition to their current roles.

• In 2012 the Pharmacy Department, Letterkenny faced additional challenges taking staff out of their comfort zones, but this gave them the impetus to explore alternative methods for service delivery. As the Head Pharmacy Services, the main achievement for me has been the collective effort by the entire Pharmacy Department team and the continued cohesiveness of the department. All staff showed great enthusiasm to participate in the review processes. I feel this is underpinned by a desire to show leadership within their own core areas of work to drive the change required, while ensuring that the available resources were used to the best effect for Pharmacy Department service provision. All disciplines of staff have shown self-motivation in order to successfully change work practices. All research and change activities have been undertaken with the ongoing provision of day to day services.

The underpinning for the Pharmacy Department include building reliable systems, engaging leaders, insisting on a team-based culture, and ensuring that staff have the necessary improvement skills. The Pharmacy Department, MMUH is a work environment where all staff can prosper and contribute. This team has displayed the characteristics to ‘never waste a good crisis’ and the informed understanding of inefficiencies has allowed for the development of evidence based solutions to the management and functional problem of hospital expansion.

Letterkenny Hospital recently had their new pharmacy department officially opened by Minister of State for Primary Care, Mr Alex White TD.

The project to develop a new Pharmacy Department had been designed and planned before the flood last July, but had to be put on hold to allow the re-instatement of patient services at the hospital after the flood. The cost of the new development was ¤550,000.

Sean Murphy, General Manager, Letterkenny General Hospital commented on the significance of the new department. He said, “The Pharmacy project has delivered a modern, purpose built department that is designed to support a busy modern hospital. Previously

the department was based in a small prefab and consisted of a dispensary, small store, goods inwards space and a seminar room."

The new pharmacy facility is modern, spacious, well designed and consists of:

• A state of the art dispensary (double the size of the previous dispensary);

• A waiting room for patients;

• A consultation room for hospital staff and patients to meet with pharmacists (a requirement of the Pharmaceutical Society of Ireland, the regulatory body for pharmacists);

• A general office;

• A cold room (with capacity 3 or 4 times what existed previously);

• A non-sterile preparation room (for preparing ointments, nose drops etc); and

• A seminar room for staff meetings.

“This is another significant step forward in the rebuild of the hospital. The Pharmacy Department here is progressive and innovative and the team of pharmacists and pharmacy technicians under the leadership of Tom Ferrie, Chief Pharmacist are to be commended on developing an

excellent service and for meeting the difficult logistical problems in the aftermath of the flood."

Tom Ferrie added at the official opening, “Many patients and the public may not appreciate the breadth of service provided by our Pharmacy Department. We have pharmacists specialising in various disciplines including Oncology, Palliative Care, Mental Health, Geriatric Medicine, General Medicine, Renal and Anti Microbial Therapy. The pharmacy technicians lead on drug purchasing, price negotiation, information technology, maintaining the automated ward medication system / supplies to the wards and they are also involved in cancer therapy.

“Letterkenny was one of the first hospitals outside Dublin to have a Clean Room for preparing cancer drugs which meant that we could treat many more patients who previously would have had to travel. We were also the first hospital to introduce an automated ward system.

“The new department we are officially opening today is an important step in the further development of this critical service.”


Sharon Moohan, Non-Executive Director, West/North West Hospitals Group; Sean Murphy, General Manager, Letterkenny General Hospital; Minister White; Tom Ferrie, Chief Pharmacist, Letterkenny General Hospital ;and Tony Canavan, Chief Operating Officer, West/North West Hospitals Group.

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Issue 13 • HPN




A successful manager creates a productive environment to work in as well as the drive and impetus to make things happen. They must balance technical and management skills.

Maríosa Kieran, Hospital Pharmacy Manager at the Mater Misericordae University Hospital fi t such a bill as she was crowned the Hospira Hospital Pharmacy Manager of the Year at the 2013 Hospital Pharmacy Awards.

The fi eld of hospital pharmacy is a continually challenging one. Keen to spotlight this area and the benefi ts brought by skilled pharmacists and their teams is Mariosa.

Maríosa has successfully operated in three managerial roles in the Mater Misericordiae University Hospital (MMUH) Pharmacy Department over the last year: Medicines Information Service Manager, Clinical Pharmacy Service Manager and Deputy Head of Pharmacy Services.

Due to recruitment delays that are currently common

place in the public service, a considerable amount of time was spent in all three managerial posts simultaneously and at all times the services was effectively and professionally managed. Mariosa seamlessly transitioned from the detailed work involved in Medicines Information to high level management duties, such as liaison with hospital senior management that is inherent in the Deputy Head of Pharmacy role.

As the Medicines Information (MI) Manager she continuously improved the standards of the service, up-skilling MI capabilities of MMUH pharmacists, introducing self-documentation of enquiries by specialist pharmacists, transitioning the work to an almost completely electronic based service and signifi cantly reducing fi nancial expenditure on reference sources.

As the Deputy Head of Pharmacy she was responsible for the daily operation of the Pharmacy Department and was accountable for departmental purchasing and procurement,

Mariosa scoops Manager of the Year Award

Winner Mariosa Kieran,Mater Misericordiae University Hospital is pictured receiving her award from Dennise Broderick, Country Manager, Hospira.

Hospira Hospital Pharmacy Manager of the Year Award


21

HPN • Issue 13

dealing with l fi nancial queries, managing service delivery and supervising staff.

As the Clinical Pharmacy Manager, Maríosa managed a team of 14 clinical pharmacists and technicians and maintained a patient orientated service that maximises therapeutic benefi ts of drugs to individual patients, whilst minimising associated risks.

"Over the past year, Maríosa has successfully introduced a number of new services, most notably a Clinical Pharmacy Service to two transitional care units, based offsite from the MMUH campus. Establishment of a new clinical pharmacist post was secured from her identifi cation of the importance of having a clinical pharmacist in such a unit. Other new initiatives successfully introduced include a palliative care pharmacist and an outpatient dispensing service to Hepatitis C patients," says a colleague.

She has been involved in a wide variety of multidisciplinary projects that have positively contributed to patient care and improved inter-department relationships. Such projects include;

Development and implementation of a cardiovascular drug chart that addresses the diffi culty of documenting drug administration by the prescribing doctor when they are intra- procedure.

Development and dissemination of endocrine function tests.

Introduction of emergency packs for patients with adrenal insuffi ciency.

Development of a cross reference for drug photosensitivity that has streamlined the screening process for phototherapy patients

Improvement of adult metabolic patient care through

identifi cation and supply of products and protocols for emergency management.

Maríosa has overseen the Pharmacy Department involvement in the relocation of a number of wards and departments from outdated clinical confi gurations to the new, state of the art, Whitty Building. This involved reconfi guration of drug supply to an increased number of storage areas and review of the clinical pharmacy service to single patient rooms for entire wards. Maríosa effortlessly managed this relocation with the wards and Pharmacy Department experiencing minimal disruption.

The transfer of operations to the Whitty Building was viewed by hospital management as an opportunity to reassess hospital processes by Maríosa was the group lead on a ward based project which used lean methodology to look at improving effi ciencies in the oral drug administration round. Following introduction of the improvements, the time taken to complete the drug round was reduced. Roll out of this project hospital wide is calculated to save 17,000 nursing hours per year.

Maríosa has always placed a strong emphasis on establishing the MMUH Pharmacy Department as a leading driver in education. Education projects she was involved with this year include teaching prescribing practicalities to undergraduate medical students, lecturing M.Sc. students and involvement in the RCSI pharmacy undergraduate programme. She successfully submitted a number of posters to national and international conferences. A poster she submitted at the

HPAI conference was highly commended and was also featured in the Irish Times Health Supplement. Maríosa was a Servier award judge at the annual HPAI conference. This work did not take away from the day to day educational duties of organising the Pharmacy Department’s continuing professional development rota and tutoring of M.Sc. students, pharmacy interns and other undergraduate pharmacy students.

Maríosa’s expertise and hard working ethos has been recognised in her appointment to a number of multidisciplinary committees in the MMUH. She

is an active member of the Drug Safety Committee, helping to identify failings in the hospital’s medication use system and implement positive change including the guidelines for the use of transdermal patches - a policy introduced in response to a number of potentially serious medication incidents involving opioid patches.

"In the current rapidly changing health service, Maríosa is thriving on the challenge of maintaining a productive work environment and implementing changes to drive the MMUH Pharmacy Department forward," her colleague concludes.


Mariosa Kieran

AwardsAwardsHospital Pharmacy

2014

The Roche Oncology Hospital Pharmacist of the Year 2014

The MSD Hospital Multidisciplinary Award 2014

The Actavis Aseptic Hospital Unit of the Year 2014 Award

The Pinewood Young Hospital Pharmacist of the Year 2014 Award

The Medisource Hospital Pharmacy Technican of the Year 2014 Award

The Novartis Hospital Pharmacy Innovation & Service Development 2014 Award

The Hospira Hospital Pharmacy Managerof the Year 2014 Award

Hospital Pharmacist of the Year 2014

Hospital Pharmacy Team of the Year 2014

Excellence in Patient Safety Award

The Hospital Specialty Pharmacist of the Year Award 2014

The Hospital Pharmacy Awards take place on Saturday, September 20th 2014 in the Hilton

DoubleTree Hotel - Burlington Road, Dublin and promise to be a fantastic night and

evening of celebration and recognition. The Awards up for grabs this year are:

We Innovate Healthcare

for GenericsFirst

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

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

Quality Choice Value Service

Recognising Excellence inhospital pharmacy -

The Hospital Pharmacy Awards 2014

The ultimate goal of all hospital pharmacists is to optimise patient outcomes through the accurate, safe, competent and cost effective use of medicine. Following guidelines and national efforts to defi ne and raise standards across all levels is the over arching target within this fi eld.

The Hospital Pharmacy Awards support and enable pharmacy professionals to recognise and reward innovation, initiative, drive and dedication. They showcase the many examples of the hospital pharmacy ethos, in maintainig and improving professional performance and contributing to the effectiveness of Ireland's health care system.

Furthermore, they create the opportunity for sharing of ideas and promote learning from colleagues, relaying recent innovations to the wider hospital pharmacy sector.

The Hospital Pharmacy Awards offer tremendous benefi ts to enhance excellence from the pharmacy department to the frontline.

The highlights can reap values beyond the trophy and title. The investment on return for everyone involved can include enhanced networking with colleagues and peers and the boosting of staff morale, amongst others.

These awards offer the opportunity to showcase the transcendence and talent within hospital pharmacy, highlighting hospital pharmacists as vital component of the health service and the role played by pharmaceutical companies in supporting these professionals on their road to excellence.

The 2013 inaugural event was a great success.

"The Hospital Pharmacy Awards 2013 provided a tremendous occasion to celebrate the many achievements in hospital pharmacy. They certainly got me thinking about innovation within our own department. Thank you for bringing to the foreground, such a worthwhile event." - Amanda Fitzpatrick, Chief Pharmacist, St Patrick's University Hospital

Over 300 of Ireland's hospital pharmacy and pharmaceutical industry enjoyed an evening of celebration and recognition never witnessed before in this arena.

Ireland is extremely fortunate to have so many hospital pharmacy individuals and teams who are working tirelessly to ensure exceedingly high levels of pharmaceutical care.

It is the goal of Hospital Pharmacy News to continue to champion hospital pharmacy now, and into the future.

On the forthcoming pages are all the details of this year's event. Application forms can now be requested via our website at www.pharmacynewsireland.com or by contacting us directly at [email protected] - Telephone 0044 7876548989

Full and further details on each category and entry criteria will follow in the next issue.

"The Hospital Pharmacy Awards 2013 has been a fantastic experience. I would like to sincerely congratulate Hospital Pharmacy News for making us within hospital pharmacy feel like we make a difference and for recognising us for it." - Ann Pilkington, Pharmacy Department, Naas General Hospital

"The team at St Vincent's University Hospital have been overwhelmed with winning the Hospital Pharmacy Team of the Year 2013 Award and it has brought such positivity to the whole department. It really is excellent to recognise the contribution made by hospital pharmacy to patient care in Ireland, as historically, we have never been very good at getting our contribution recognised ourselves!" - Fionnuala Kennedy, Chief II Clinical Pharmacy Manager, St Vincent's University Hospital

24

Issue 13 • HPN

AwardsHospital Pharmacy

2014

Date: September 20th 2014 | Venue: DoubleTree by Hilton Dublin - Burlington Road

Issue 13 • HPN

Investing in education and the health of the nationMedisource Hospital Pharmacy Technician of the Year Award 2014

Company Mission Statement

To explore all avenues in tracking down unlicensed medicines to assist in continuing patient care along prescriber’s requirements, and to do so only through verifi ed and legitimate distribution channels within a meaningful timeframe and within regulations.

This Award category serves to recognise and salute those pharmacy technicians whose hard work quite often fl ies under the radar. If you know someone that has enriched the depth and broadened the scope of pharmacy technicians then this award category is for you/them.

Hospital pharmacy technicians have a vital role to play in supporting the team within hospital pharmacy departments. In recognition of this, this award will be given to someone who has provided an outstanding support for the pharmacy profession within their department.

We will be looking for those that have been able to demonstrate exemplary accomplishments which foster the advancement of patient care and/or the profession of pharmacy technicians. Judges will want to see professionalism / leadership, support for and participation in continuous professional development, with a commitment to safe, rational, economic pharmaceutical care within the pharmacy technician role.

Examples:

Evidence of new innovation or new thinking which has enhanced the hospital pharmacy department within which they work

Excellent communication with staff and additional pharmacy team members

Examples of your/their expertise exceptional effort resulting in a milestone being achieved or target exceeded

Examples of collaboration whereby outstanding teamwork and/or leadership skills have ensured a task was completed regardless of challenges faced

Criteria:

You may enter more than one category but each individual entry can only be submitted for a maximum of two categories

You will need to submit a short summary of no more than 500 words with supporting information

Entries should generally cover the twelve month period from January 2013 – December 2013

Judging:

There will be three fi nalists selected from all applications submitted

Each fi nalist submission will be judged by our independent judging panel

Each fi nalist will be invited to attend the gala awards ceremony on September 20, 2014 at the Hilton DoubleTree Hotel, Dublin where the winner will be announced

For further information please visit our website at www.pharmacynewsireland.com

Category Entry




25

HPN • Issue 13

25

HPN • Issue 13

Metastatic Breast Cancer UpdatesBreast cancer continues to be the leading cause of cancer-related mortality in women, with an estimated 1 in 8 (12%) being diagnosed with invasive breast cancer during their lifetime.1 In 2013, it is estimated that 230,000 women will get diagnosed and nearly 40,000 will die from breast cancer. Despite these staggering numbers, the incidence of breast cancer has actually been dropping steadily since the early 2000s after the landmark Women’s Health Initiative study linking hormone replacement therapy (HRT) to the development of breast cancer.2 In addition to HRT, other risk factors for the development of breast cancer are increased biological exposure to estrogen, such as increasing age, early menarche, late menopause,

nulliparity, and fi rst birth after 30 years of age.3

There are also genetic risk factors, such as mutations with the BRCA gene, that have been implicated in the pathogenesis of breast cancer.4 As we continue to better our understanding of the biomolecular markers of breast cancer, treatment has been better individualised in order to achieve maximum therapeutic benefi t with minimal toxicity.

The biological features and extent of the disease guide the treatment options for breast cancer. Tumor specimen is used to determine the molecular markers such as ER (estrogen receptor), PR (progesterone receptor), and HER2 (human epidermal growth factor receptor) status.

ER/PR status is determined by immunohistochemistry (IHC) testing. Hormone receptor– positive patients will likely receive an anti-estrogen therapy with selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs). Although HER2 positivity is considered more aggressive in the natural progression of breast cancer, the availability of targeted therapy has made the prognosis much more favorable over the past several years.

Treatment of breast cancer is generally divided into localised and metastatic disease. In localised disease, the goal of treatment is long-term survival with breast-conserving surgical resection followed by adjuvant chemotherapy to eliminate residual tumor cells. Women

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

2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.

3. PLAN - If I have identified a knowledge gap - will this article

satisfy those needs - or will more reading be required?

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

5. WHAT NEXT - At this time you may like to record your learning for future use or assessment. Follow the 4 previous steps, log and record your findings.

Biography - Benyam Muluneh, PharmD, CPP, is a clinical pharmacist practitioner in the malignant hematology clinic at UNC Health Care and an adjunct assistant professor at UNC Eshelman School of Pharmacy.David N. Luter, PharmD, is a clinical generalist pharmacist at University

of North Carolina Hospitals.Elizabeth Rowe, PharmD, is a clinical generalist pharmacist at

University of North Carolina Hospitals.

60 Second SummaryBreast cancer continues to be the leading cause of cancer-related mortality in women, with an estimated 1 in 8 (12%) being diagnosed with invasive breast cancer during their lifetime.1 In 2013, it is estimated that 230,000 women will get diagnosed and nearly 40,000 will die from breast cancer.

The biological features and extent of the disease guide the treatment options for breast cancer. Tumor specimen is used to determine the molecular markers such as ER (estrogen receptor), PR (progesterone receptor), and HER2 (human epidermal growth factor receptor) status. ER/PR status is determined by immunohistochemistry (IHC) testing.

Treatment of breast cancer is generally divided into localised and metastatic disease. In localised disease, the goal of treatment is long-term survival with breast-conserving surgical resection followed by adjuvant chemotherapy to eliminate residual tumor cells.

Over the past few years, there have been innovative approaches to improving survival in metastatic breast cancer patients. Table 2 outlines newer treatment options categorised by HER2 and hormone receptor positivity. Several targeted agents are currently in the pipeline for the treatment of breast cancer.13 As we have learned more details about tumor biology, we have discovered several potential targets that have been implicated in the pathogenesis of breast cancer.

Published by HPN, sponsored by Pfizer Healthcare Ireland. Copies can be downloaded from www.irishpharmacytraining.ie

Disclaimer: All material published is copyright, no part of this can be used in any other publication without permission of the publishers and author. Pfizer Healthcare Ireland has no editorial oversight of the CPD programmes included in these modules.

CPD 7: BREAST CANCER

CPDContinuing Professional

Development

CPDCPDCPDCPDBenyam Muluneh

26

Issue 13 • HPN

a strong trend toward an improvement in the overall survival (23.6% vs 17.2% in the pertuzumab and placebo arms, respectively), this was not statistically significant.6 The pertuzumab combination is now considered the gold standard for first-line therapy in patients who are diagnosed with metastatic HER2-positive breast cancer.

T-DM1 (ado-trastuzumab emtansine)

T-DM1 is an antibody-drug conjugate which has DM1, a cytotoxic drug, bound to trastuzumab, which allows for targeted delivery of chemotherapy to HER-2 positive breast cancer cells (Online Figure 1). Hurvitz and colleagues conducted a phase II open-label, randomized trial (n = 137) in HER2-positive unresectable, advanced breast cancer without prior chemotherapy or trastuzumab for metastatic disease. Patients were assigned to T-DM1 or trastuzumab and docetaxel and treated until

disease progression. Results showed T-DM1 had significant improvement in progression-free survival over trastuzumab (14.2 months vs 9.2 months). Overall survival was similar between the 2 groups. Based on these data, T-DM1 could be considered a suitable first-line option in advanced or metastatic breast cancer.7

Also, in the phase III EMILIA trial, 991 women with metastatic breast cancer who had failed a taxane and trastuzumab combination were randomized between T-DM1 or lapatinib and capecitabine. This study by Verma and colleagues found median PFS was 9.6 months in the T-DM1 arm versus 6.4 months in the lapatinib and capecitabine arm (P <0.001), which had been a preferred option in metastatic breast cancer as a second-line option.8

Also, in the phase III EMILIA trial, 991 women with metastatic breast cancer who had failed a taxane and trastuzumab combination were randomized between T-DM1 or lapatinib and capecitabine. This study by Verma and colleagues found median PFS was 9.6 months in the T-DM1 arm versus 6.4 months in the lapatinib and capecitabine arm (P <0.001), which had been a preferred option in metastatic breast cancer as a second-line option.8

ER/PR-POSITIVE BREAST CANCER

Patients presenting with metastatic hormone receptor positive breast cancer typically receive anti-estrogen therapy as first line. These include agents such as aromatase inhibitors (anastrozole, letrozole, exemestane),

with localised breast cancer have a favorable prognosis with treatment options that have generally remained the same over the past several years. In metastatic disease, the goal is primarily to delay disease progression and preserve quality of life by using chemotherapy agents with favorable toxicity profiles. The 5-year overall survival for metastatic breast cancer is less than 25%; thus, treatment continues to evolve with the development of unique therapeutic strategies.5 The principles of treatment for localised and metastatic breast cancer are outlined in Tables 1 and 2, respectively.

EVOLUTION IN TREATMENT

Over the past few years, there have been innovative approaches to improving survival in metastatic breast cancer patients. Table 2 outlines newer treatment options categorised by HER2 and hormone receptor positivity.

HER2-POSITIVE BREAST CANCER

Pertuzumab

Pertuzumab is a humanized monoclonal antibody that blocks HER2 receptors at different subdomains, allowing it to be synergistic with trastuzumab. Baselga and colleagues conducted a randomized, double-blind, placebo-controlled trial in HER2-positive metastatic breast cancer patients who had not yet received therapy. Patients were randomized to a placebo, trastuzumab, and docetaxel combination group or to a pertuzumab, trastuzumab, and docetaxel group.

The primary end point, progression-free survival (PFS), was significantly improved in the pertuzumab group compared with the placebo group (18.5 months versus 12.4 months; hazard ratio 0.62; confidence interval 0.51 to 0.75; P <0.0001). Despite


HER2 pathway and targets

27

HPN • Issue 13

estrogen receptor modulators (tamoxifen), and estrogen receptor downregulators (fulvestrant). Over time, the majority of patients will develop resistance to hormonal treatment. Recently there has been development of strategies to improve initial response to therapy in order to overcome or delay resistance. Two of these strategies include dual anti-estrogen therapy and estrogen therapy in combination with mTOR inhibitors.

Dual Anti-Estrogen Therapy

Regimens evaluated for combination endocrine therapy include fulvestrant and anastrozole in women with advanced breast cancer. Fulvestrant binds to estrogen receptors, causing downregulation and degradation, while anastrozole is a non-steroidal aromatase inhibitor that blocks the conversion of androgens to estrogens. Both drugs work to reduce the malignancy’s exposure to estrogen, thereby inducing apoptosis and cell death.

In the FACT study, pre- and post-menopausal women with ER/PR-positive breast cancer who received a gonadotropin releasing hormone agonist with first relapse were randomized to anastrozole alone or anastrozole plus fulvestrant. The combination group failed to show any significant difference in time to progression or overall survival.9 A contradictory second study looked at the combination of anastrozole and fulvestrant in postmenopausal women and found that those in the combination group had a significant longer PFS (15 vs

Mechanism of action of trastuzumab and pertuzumab

13.5 months, P = 0.007) and improved overall survival.10 A meta-analysis of these 2 articles found marginal benefit in response rate, PFS, and overall survival which failed to reach statistical significance. Because of the conflicting data, combining anastrozole and fulvestrant is not a preferred mode of therapy.

mTOR Inhibitors

Upregulation of the phosphatidylinositol 3-kinase pathway and the mammalian target of rapamycin (PI3K/mTOR) pathway has been implicated in the intrinsic and acquired resistance of breast cancer to endocrine therapy and HER2-targeting agents. Recent studies have

looked at the use of mTOR inhibitors, such as everolimus and temsirolimus, to either improve initial outcomes of endocrine therapy or overcome resistance in hormone receptor positive breast cancer. The most promising data come from the BOLERO-2 trial, which randomized women with advanced breast cancer to receive exemestane alone or

Table 1: Treatment of Localised Breast Cancer

Classification Treatment

Non-Invasive Lobular carcinoma In situ Surgery followed by radiation and (LCIS) consideration for tamoxifen in ER/PR-positive DCIS

Ductal carcinoma in situ (DCIS)

Invasive Backbone: doxorubicin and cyclophosphamide

ER/PR-positive + Endocrine Therapy (tamoxifen, aromatase inibitors)

HER2 positive + Trastuzumab

Lymph node involvement + Taxane derivatives (paclitaxel, docetaxal)

ER = estrogen receptor; HER = human epidermal growth factor receptor; PR = progesterone receptor

28

Issue 13 • HPN


exemestane plus everolimus. These patients had progressed through previous therapy with non-steroidal aromatase inhibitors.

Addition of everolimus to exemestane was shown to signifi cantly improve PFS; however, patients in the combination group experienced signifi cantly more side effects, including stomatitis, anemia, dyspnea, hyperglycemia, fatigue, and pneumonitis.11 The addition of everolimus to tamoxifen has also been shown to improve PFS in patients who progressed on AI therapy when compared with tamoxifen alone.12 However, another study of fi rst-line treatment of advanced or metastatic breast cancer in AI-naive patients was stopped early when the addition of temsirolimus to letrozole had no signifi cant difference in progression free survival when compared with letrozole alone. Currently, this strategy is reserved in the second-line setting for women with hormone receptor positive metastatic disease that have failed at least 1 line of therapy.

FUTURE STRATEGIES

Several targeted agents are currently in the pipeline for the treatment of breast cancer.13 As we have learned more details about tumor biology, we have discovered several potential targets that have been implicated in the pathogenesis of breast cancer. Table 3 summarises the current classes of agents in development that will continue to revolutionise the way we manage advanced-stage breast cancer.

The use of these novel agents, as well as the ones discussed here, in earlier stages of breast cancer is currently a question of interest. This strategy would lead to declining rates of relapse and progression into advanced stage disease, which has a much less favorable long-term survival. Despite the challenges of metastatic breast cancer, we are encouraged by the incremental gains in survival over the past several years and eagerly wait for a breakthrough that will hopefully lead to a cure by blocking key steps in the disease development process.

References

1. American Cancer Society. Breast cancer. www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-key-statistics. Accessed May 23, 2013.

2. Chlebowski RT, Hendrix SL, Langer RD, et al. Infl uence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women. JAMA. 2003;289(24):3243-3253.

3. National Comprehensive Cancer Network. NCCN guidelines for patients: breast cancer. Version 3.2012.

4. Pierce LJ, Levin AM, Rebbeck TR, et al. Ten-year multi-institutional results of breast-conserving surgery and radiotherapy in BRCA1/2-associated stage I/II breast cancer. J Clin Oncol. 2006;24(16):2437-2443.

5. Howlader N, Noone AM, Krapcho M, et al, eds. SEER cancer statistics review, 1975-2010. Fast stats. National Cancer Institute. http://seer.cancer.gov/statfacts/html/breast.html. Accessed August 29, 2013.

6. Baselga J, Cortes J, Kim S, et al. Pertuzumab plus trastuzumab plus docetaxel for Metastatic Breast Cancer. N Engl J Med. 2012;366:109-119.

7. Hurvitz SA, Dirix L, Kocsis J, et al. Phase II randomized study of trastuzumab emtansine versus trastuzumab plus docetaxel in patients with human epidermal growth factor

receptor 2–positive metastatic breast cancer. J Clin Oncol. 2013;31:1157-1163.

8. Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367:1783-1791.

9. Bergh J, Jonsson P, Lidbrink EK, et al. FACT: An open-label randomized phase III study of fulvestrant and anastrozole in combination compared with anastrozole alone as fi rst-line therapy for patients with receptor-positive postmenopausal breast cancer. J Clin Oncol. 2012;30:1919-1925.

10. Mehta RS, Barlow WE, Albain KS, et al. Combination anastrozole and fulvestrant in metastatic breast cancer. N Engl J Med. 2012;367:435-444.

11. Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor–positive advanced breast cancer. N Engl J Med. 2012;366:520-529.

12. Bachelot T, Bourgier C, Cropet C, et al. TAMRAD: a GINECO randomized phase II trial of everolimus in combination with tamoxifen versus tamoxifen alone in patients (pts) with hormone-receptor positive, HER2 negative metastatic breast cancer (MBC) with prior exposure to aromatase inhibitors (AI). Presented at: 33rd Annual San Antonio Breast Cancer Symposium; December 8-12, 2010; San Antonio, TX.

13. National Cancer Institute. Targeted therapies for breast cancer.

"Despite the challenges of metastatic breast cancer, we are encouraged by the incremental gains in survival over the past several years and eagerly wait for a breakthrough that will hopefully lead to a cure by blocking key steps in the disease development process"

29

HPN • Issue 13

Investing in education and the health of the nationNovartis Innovation and Service Development Award 2014


Novartis is the only healthcare company globally with leading positions in pharmaceuticals, eye care, generics, biosimilars, vaccines and diagnostics, OTC medicines and animal health. Novartis employs over 123,000 people worldwide.

Approximately 1,200 people are employed in two manufacturing plants in Cork and commercial operations in Dublin. Novartis is committed to R&D in Ireland. In 2012 ¤4m was invested in R&D and over the last three years, 17 clinical trials have been conducted, in areas such as Oncology, Respiratory, Ophthalmology and Neurology.

Located in Model Farm road Cork, Alcon's manufactures the world's leading intraocular lens for various countries around the globe. Alcon's AcrySof lenses are implanted in six of every 10 cataract surgery patients worldwide.

This award will be presented to a practising hospital pharmacist and/or team in recognition of a project which could easily be accomplished regardless of hospital size or staff, which need not be sophisticated, and which serves a useful purpose or has recently been published.

The judges will be looking for signifi cant innovation in practice, method or service directly or indirectly resulting in improved patient care and/or advancement of the profession of hospital pharmacy. We know that many pharmacists have initiated exciting programmes in their hospitals and we would like to recognise them.

This award is ultimately for the forward thinking hospital pharmacists who are sourcing new ways of overcoming challenges faced. Key to this is optimising the health status of the patients under the care of hospital team, targeting areas of need and effective health enhancement and promotion.

Examples:

How and why was the project started and what were the key objectives?

Examples of how this particular innovation is unique and the development process in getting it to fruition

Examples of the fundamental changes made by this innovation and the practicality of its application

Examples of published work directly relevant to the innovation

Impact of the innovation on patient care and for the wider hospital pharmacy industry

Criteria:




Judging:






2014


Category Entry




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Issue 13 • HPN


Hospital Pharmacy Team of the Year Award 2014There are many key elements to building a productive team, including communication and co-operation. Good communication means everyone is aware of their own responsibilities and what the team's goals are whilst co-operation leads to increased productivity.

The judging panel will be looking for the pharmacy that can demonstrate a close working relationship internally and with the doctors, nurses and other members of the multi-disciplinary team to ensure that patients receive optimal pharmaceutical care while attending the hospital. Teams that have adopted a key role in monitoring and reviewing patients and their medications, providing medication counselling where appropriate and liaising with community pharmacy colleagues and GPs to promote seamless pharmaceutical care. This can also include pharmacists and technicians, who are involved in ongoing research projects, in teaching and tutoring undergraduate and postgraduate healthcare personnel and in clinical training that enhances the overall performance of their department.

A team that excels is the one who, together, endlessly work to improve their efforts. They comprehend the importance of on-going improvements and how this helps support the overall objectives of the department.

The Award is open to any hospital pharmacy team with a minimum of three team members

Examples:

Display of how team members are motivated and keep each other in team spirit positively

What is the methodology for this particular team in tackling a particular project?

Describe a project the team worked on recently and how individual team members worked towards a shared goal

How do you identify each other’s strong skills and structure them to the betterment of the team as a whole?

Please give examples of your success from working together as a team

Criteria: You may enter more than one category but each individual entry can only be submitted for a maximum of two categories



Judging: There will be three fi nalists selected from all applications submitted




Hospital Pharmacist of the Year Award 2014This aim of this award category is to recognise those who, through their service to patient care, education or research, to the profession and to the society, are worthy of being rewarded.

The judges will be looking for those individuals whom exhibit promising leadership, dedication and commitment to practice excellence and professional growth. This may be through hospital pharmacy activities or their experiential training in direct patient care, research or education.

The winner will exhibit eagerness, dedication and a positive attitude toward the academic learning, the practice, and the profession of hospital pharmacy.

This Award is open to any pharmacist working within a Hospital Pharmacy unit in Ireland

Examples:

What campaigns have you/they been involved in within the last twelve months worthy of recognition?

What has been the measurable outcomes/success of these?

What benefi ts have others derived as a result of your/their innovation and hard work?

Give examples of their outstanding work and commitment to the betterment of the hospital pharmacy profession

Evidence of an ability to identify opportunities and develop them through initiative and excellent interpersonal skills

What additional groups and bodies do you/they subscribe to in assisting towards the future growth of the profession?


2014


Category Entry




31

HPN • Issue 13

Investing in education and the health of the nationRoche Oncology Pharmacist of the Year Award 2014

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

One of Roche’s Pillars supporting our Vision is People - We achieve more by challenging ourselves to grow and develop. By creating an environment where people can flourish, where achievements are recognised and where we are accountable to one other and to Roche.

We are happy to support the Hospital Pharmacist of the Year , that awards a Pharmacist who demonstrates these values of Integrity Courage and Passion in today’s challenging Hospital environment.

We Innovate Healthcare

Recognising those who provide quality patient care in relation to a patient’s oncologic diagnosis, prescribed treatment, age group and other identifi ed needs and provides comprehensive pharmaceutical care to oncology patients to assure safe and effective drug therapy.

The judging panel will be looking for a high calibre individual who can demonstrate organisation, management and quality of care and services that optimise outcomes in patients with malignant diseases. This person will be able to show how they coordinate the drug therapy process through drug selection, drug information, dosing, monitoring, outcomes management, and patient education/counselling.

Examples: Judges will want to see examples of where knowledge and expertise have been used to both inspire colleagues within the industry and/or enhanced the patient experience within the fi eld of oncology

How have you/they shown inventive thinking and novel application of techniques to solve a problem, improve effi ciency or develop a new concept?

How have you/they undertaken signifi cant personal development and/or increased your/their knowledge and ability to the benefi t of the wider hospital pharmacy team and the profession?

Examples of the overall contribution to pharmacy oncology which has directly or indirectly had an impact on service delivery and standards









2014


Category Entry




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Issue 13 • HPN


"Actavis develops and manufactures pharmaceuticals of the highest quality. We meet current and future customer needs through smart investments in R&D. We deliver best-in-class service and superior value."

Statement from Actavis Representative, Caroline Fitzgerald,

Actavis is delighted to support the hospital pharmacy awards & are proud to sponsor the Aseptic Unit of the year Award.

With 2 EU cytotoxic sites of manufacture we pride ourselves on our robust supply chain & can be a partner you can trust.

Actavis sell an affordable quality oncology range of products to Irish aseptic units.

This award category is open to qualifi ed, trained pharmacists and technicians engaged in the preparation of injectable and other sterile products for individual patient use.

The judges will be looking for the unit that can best demonstrate safety and quality within their department while incorporating initiatives. This could be through SOPs, cost saving projects, clinical trials medication, interaction with other departments, identifi cation and fulfi lment to training needs or other.

An aseptic hospital unit can be made up of pharmacists, technicians, assistants and support staff and this award is open to any number of team members working within this capacity to ensure that the products prepared are sterile and free from contamination.

In addition, the judges will be looking at the team that offers an exceptional level of good clinical practice and puts patient safety and effi cacy at the heart of its objectives.

Examples: Have you/they displayed observation in following strict procedures to ensure accuracy and/or to improve accuracy within the aseptic unit?

Have you/they engaged in training, development and/or further education to ensure continuation in meeting patient needs? Judges will expect to see evidence and results

Can you show examples of reducing wastage by improving effi ciency and effective team working?

Have you recently carried out any internal audits, with documented results completing an accurate assessment checklist to ensure smooth and effective running of the unit?








Investing in education and the health of the nationActavis Hospital Aseptic Unit of the Year Award 2014


2014


Category Entry




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HPN • Issue 13


Hospital Pharmacy Representative of the Year Award 2014This aim of this award category is to recognise the sales representatives who excel in customer service, knowledge of their product base and a commitment to their profession in terms of future growth and development. The winner of this category must stand out in business ethics and integrity.

Judges will be looking for exceptional applicants that show creativity and an inspiring work ethic. Whether it’s interacting with customers, going that extra mile, running new initiatives or training and promotional campaigns, this person will be an integral part of their company’s business.

Nominated individuals may stand out due to their excellent team morale and motivation boosting techniques; their involvement in staff education and training or may be known to hospital pharmacists and the wider pharmacy team as being a beacon of knowledge for the products which form their sales list.

Examples:

How have you/they improved the company’s operation, resulting in positive sales growth and tangible results?

Can you/they demonstrate a commitment to outstanding customer/ client service?

How have you/they shown a commitment to provide innovative and driven services?

How have you/they demonstrated a sales service above and beyond that from which is expected to motivate team members, clients and colleagues?

Criteria:




Judging:





Speciality Hospital Pharmacist of the Year Award 2014This Award will be relevant to those hospital pharmacists working within a specialist fi eld such as, but not limited to, haematology, immunology, infectious diseases and antimicrobial medicines.

We will be seeking applicants that can clearly demonstrate how they have made a difference to their chosen patient group and/or the hospital pharmacy profession of their chosen speciality.

They may have undertaken research, or taken part in a recent initiative to change/improve/enhance services within their chosen area and we will expect to see results.

This Award is open to any hospital pharmacist working within a Hospital setting in Ireland.

Examples:

Judges will want to see examples of how the individual has excelled in providing specialty pharmacy services in a variety of settings within the hospital

Judges will be looking for a winner that has made signifi cant contributions to a specialty hospital pharmacy sector overall that has resulted in meaningful improvements in the quality of patient care, improved delivery models, and pharmacy’s role on the health care team

How have you demonstrated innovation within specialty services in diseases that require specialty pharmacists?

Can you show clear development of cost-effective clinical specialty pharmacy services, or have you shown sustained excellence in providing clinical specialty pharmacy services?

Criteria:

You may enter more than one category but each individual entry can only be submitted for a maximum of two catgeories

You will need to submit a summary of no more than 800 words with supporting information


Judging:



Each fi nalist will be invited to attend the gala awards ceremony on September 20th, 2014 at the Hilton DoubleTree Hotel, Dublin where the winner will be announced



2014


Category Entry




34

Issue 13 • HPN

Investing in education and the health of the nationHospira Hospital Pharmacy Manager of the Year Award 2014

Company Mission Statement Hospira is a global speciality pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in speciality generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care.

Learn more at www.hospira.com

Biosimilars - Biosimilars that are licensed for the UK are high-quality, cost-effective alternatives to proprietary biopharmaceuticals. With patents for these biopharmaceuticals expiring, Hospira is expanding its competencies to develop, manufacture and market Biosimilars in order to meet the growing demand for lower cost alternatives. A 20% price reduction on 5 high-cost drugs resulting from Biosimilar competition could save the EU over ¤1.6 billion per year.

A successful manager creates a productive environment to work in as well as the drive and impetus to make things happen. They must balance technical and management skills.

This Award is aimed at any individual who has made a signifi cant contribution in the past year to their pharmacy department, to those pharmacy managers who have been instrumental in driving the department forward. This could be through improving fi nancial and clinical performance through effective medication management, inter department relations, reviews or clinical trials, developing a new service or development of staff

The judges will be looking for that candidate who has exceeded expectations by an innovative approach, who plans, directs, revises, and modifi es pharmacy procedures.

Pharmacy Manager of the Year award recognises those who provide the most effective demonstration of their pharmacy management competence, no matter the scale of the hospital or department.

Examples:

How have you/they made a personal contribution to the hospital pharmacy team as a whole?

How have you/they managed and handled the team over the last twelve months to improve the working of the pharmacy department?

Please give examples of challenges faced over the last twelve months and how they have been overcome

How does your/their management approach make them special and stand out from any other hospital pharmacy manager?

Demonstrate techniques for motivating staff and detail any major achievements worthy of the Hospital Pharmacy Manager of the Year Award

Criteria:




Judging:






2014


Category Entry




35

HPN • Issue 13

Investing in education and the health of the nationPinewood Young Pharmacist of the Year Award 2014 Hospital pharmacists are vital elements of medicines management within the secondary care setting and those in their infancy years of the profession can hint at leadership excellence that inspires and develops the potential of others.

The Young Hospital Pharmacist of the Year Award recognises rising talent and potential amongst those at the beginning of their careers – those individuals who are already demonstrating that they can make a difference to the pharmacy profession and the patients they serve.

This Award focuses specially on the talent we will all rely on to deliver services for the next 20 years and more: the young pharmacists, currently delivering and planning services at the sharp end - but whose skills will be vitally important over the coming years as pharmacy increasingly comes to be seen as the key part of the primary healthcare service.

This award is open to pharmacists up to age 30 who are working within any hospital pharmacy where their involvement has been greater than six months.

Examples:

Judges will want to see effective communication skills with both staff and patients and a demonstration of a commitment to mentoring or other leadership activities

A dedication and commitment to furthering the profession into the future

Innovation and forward thinking in expanding the role of the pharmacist

Criteria:



Entries should generally cover the twelve month period from January 2013 to December 2013

Judging:





for GenericsFirst

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

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

Quality Choice Value ServiceCompany Mission Statement

Hospira is a global speciality pharmace2


2014


Category Entry




36

Issue 13 • HPN

Investing in education and the health of the nationMSD Innovation in Multidiciplinary Working Award 2014

Company Mission Statement MSD is a leader in healthcare, dedicated to helping the world be well through a wide range of innovative health solutions. This includes the development, production and distribution of prescription medicines, vaccines and biologic therapies as well as consumer care and animal health products. Our extensive operations in Ireland encompass manufacturing, global financial services, and sales & marketing facilities across six sites in five counties where we employ over 2,000 people.

As a healthcare leader, it is important for us to develop strong relationships with our customers, partners, employees and other stakeholders. We place great importance on ensuring that the general public understands us and has well-founded confidence in our commitment to behaving responsibly at all times. We have strong corporate policies and safeguards in place and are extremely proud of our long history of abiding by and promoting high ethical standards.

Known as MSD worldwide, and as Merck in the United States and Canada, we have operations in more than 140 countries.

This is a brand new Award for 2014Treatment of patients is, in most cases, a combined effort of several individuals and it is recognised that the outcome of a procedure is optimal when the professionals do indeed work together as a team.

Obviously, pharmacists are part of treatment teams in healthcare establishments. With expertise of product and processes, they improve the therapeutic outcome and the quality of work fl ow.

Although it seems obvious that a pharmacist form part of a team, this Award will seek to recognise those who can demonstrate added value by their contribution. The judging panel will want to see actual multidisciplinary healthcare working and actual examples of it in practice as well as an outline of what lessons have been learnt from its implementation.

Examples:

How have you helped to improve daily working for hospital pharmacists through multidiciplinary working, for example through education,the introduction of new procedures, strengthening relations with policy makers and other healthcare

professions and social care networks?

How have these measurably improved the delivery of pharmaceutical care?

Describe the key areas of clinical effi ciencies/service improvements as a result of this multidisciplinary working and what their effect has been upon the success of the profession and pharmaceutical care delivery

Criteria:




Judging:






2014


Category Entry




Copyright© 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All Rights Reserved. CARD-1088502-0008

For more than 150 years, a very special passion has driven the people of MSD. A leading global healthcare

company, we have a longstanding presence in and commitment to Ireland and aspire to be the best human

and animal healthcare company in the country. Our goal is to develop medicines, vaccines, consumer care

and animal health innovations that will improve the lives of millions.

We employ over 2,000 people across eight businesses in Carlow, Cork, Dublin, Tipperary and Wicklow, including

manufacturing sites, global financial services and commercial operations. A member of Guaranteed Irish, we

are proud to be one of Ireland’s leading exporters, manufacturing and packaging many of our leading products

in Ireland for the world’s markets.

See all we’re doing at msd.ie

BE WELL. NOT A WISH. A PROMISE.

/MSDinIreland

3918_MSD_CorpAd_A4_v.indd 1 26/02/2014 18:12

38

Issue 13 • HPN


2014


Category Entry




Investing in education and the health of the nationExcellence in Patient Safety Award 2014

This is a brand new Award for 2014

This Award will seek applicants who have shown commitment and dedication to improving patient safety/medication safety amongst patients in the secondary care setting.

This may be through team working with consultants, nurses, pharmacy colleagues but the endpoint result will be to improve this area for patients in terms of medication effi cacy and adherence, as just two examples of many.

This Award will encompass all aspects of patient safety within the hospital pharmacy sector in Ireland and invites applications from those who have recently undertaken patient safety initiatives to the betterment of the profession; those who are or who have offered patient safety expertise to the profession perhaps in the line of lecturing; or even those who have undertaken a recent patient safety innovation or initiative within a fi eld pertinent to hospital pharmacy that will have a positive effect on the whole profession.

Examples:

Can you clearly demonstrate your innovation; the quality and originality of the idea and results

Judges will want to see patient involvement; involvement of patients in the design of the initiative;

Judges will also want to see the potential; the contribution the patient safety work is likely to make to the wider development of patient safety interventions across all care

Demonstration of ongoing professional commitment to patient safety, innovation in patient safety technology, procedures, and processes; implementation of patient safety programs

Criteria:



Entries should generally cover the twelve month period from January 2013 to December 2013

Judging:





39

HPN • Issue 13

COPD - A new approachto treatmentAre patients being correctly diagnosed with COPD, are they on the correct treatment, and are they getting the best outcomes achievable for their condition?

These were among the major questions addressed during a number of dedicated COPD sessions at the recent 2013 ERS Congress in Barcelona. There was a heavy focus on the new GOLD COPD guidelines, concern about the inappropriate and overuse of inhaled corticosteroids (ICS), plus the announcement of positive trial data on a new dual bronchodilator during the meeting, highlighting that there is now a vastly improved treatment landscape for these pa tients.

BURDEN

Despite its growing prevalence, there is an inadequate recognition of the burden of COPD, the ERS Congress heard. COPD affects up to 210 million people worldwide1 and is projected to be the third leading cause of death by 20202, accounting for nearly 6% of all

deaths3. The incidence of COPD is on the rise in Ireland and Europe; total deaths from COPD are projected to increase by more than 30% over the next 10 years unless urgent action is taken to reduce the risk factors4.

GOLD STANDARDS

Earlier this year the Global Initiative for Chronic Obstructive Lung Disease (GOLD) updated their best practice strategy for the diagnosis, management and prevention of COPD5.

According to GOLD, effective COPD management should be based on an individualised assessment of the patient in order to:

• Reduce symptoms (relieve symptoms, improve exercise tolerance, improve health status)

• Reduce risk (prevent disease progression, prevent/treat exacerbations, reduce mortality).

Bronchodilators are central to COPD treatment and are recommended by GOLD for

all types of COPD patients. However, despite this, there is still widespread prescribing of ICS for COPD in the absence of any clear clinical rationale, Prof David Price, Professor of Primary Care Respiratory Medicine, UK, told a Novartis-hosted ERS Congress media briefi ng on COPD.

INAPPROPRIATE TREATMENT

“There are no indications in the GOLD guidelines for COPD patients in category A and B to get ICS. They have some role in C and D [category patients] but is a debatable role,” Prof Price said.

However, UK data shows around 50% of GOLD A patients are receiving therapy they shouldn’t, primarily ICS, while only 7% of B patients, 60% of C patients, and 70% of D patients are being appropriately treated, he told the briefi ng.

“So we have a major problem with inappropriate therapies for COPD patients, particularly overuse of ICS and underuse of bronchodilators,” Prof Price stated.

Incorrect COPD treatment not only means poorer outcomes and more costs to the health service and wider economy in the long run, it also increases co-morbidity risk factors6, he explained. Prof Price quoted Canadian research that shows a signifi cantly increased risk of developing diabetes in COPD patients treated with ICS7. Diabetes is a major risk factor for fl are-ups of cardiovascular issues in COPD patients. COPD patients prescribed ICS are also at increased risk of developing of pneumonia or osteoporosis, he added.

Dr Dermot O’Callaghan, consultant respiratory physician, Mater Hospital, Dublin, said inappropriate prescribing for COPD patients is an issue of growing concern in Ireland, but acknowledged that GPs, as well as some respiratory specialists, can fi nd it diffi cult to differentiate whether a patient has COPD or asthma, especially as some patients overlap. “However, that is why it is so important to try and distinguish between them so we do not inappropriately treat patients with expensive medications that have their own negative risk profi les,” he maintained.

DUAL BRONCHODILATION

The symptoms and exacerbations of COPD are often inadequately controlled by bronchodilator monotherapy8, but dual bronchodilation, using a LABA/LAMA combination, has more effective outcomes for patients, the Congress heard.

New data presented during the Congress on QVA149 (Ultibro® Breezhaler®), a once daily, fi xed dose combination of two bronchodilators, showed it produces superior, rapid and sustained improvements in lung function, and signifi cant improvements in shortness of breath and health-related quality

1514

HPN • Issue 12Issue 12 • HPN

Are patients being correctly diagnosed with COPD, are they on the correct treatment, and are they getting the best outcomes achievable for their condition?

These were among the major questions addressed during a number of dedicated COPD sessions at the recent 2013 ERS Congress in Barcelona. There was a heavy focus on the new GOLD COPD guidelines, concern about the inappropriate and overuse of inhaled corticosteroids (ICS), plus the announcement of positive trial data on a new dual bronchodilator during the meeting, highlighting that there is now a vastly improved treatment landscape for these patients.

BURDEN

Despite its growing prevalence, there is an inadequate recognition of the burden of COPD, the ERS Congress heard. COPD affects up to 210 million people worldwide and is projected to be the third leading cause of death by 2020, accounting for nearly 6% of all deaths. The incidence of COPD is on the rise in Ireland and Europe; total deaths from COPD are

COPD - A new approach to treatment

Professor David Price

projected to increase by more than 30% over the next 10 years unless urgent action is taken to reduce the risk factors.

GOLD STANDARDS

Earlier this year the Global Initiative for Chronic Obstructive Lung Disease (GOLD) updated their best practice strategy for the diagnosis, management and prevention of COPD.


• Reducesymptoms(relievesymptoms, improve exercise tolerance, improve health status)

• Reducerisk(preventdiseaseprogression, prevent/treat exacerbations, reduce mortality).

Bronchodilators are central to COPD treatment and are recommended by GOLD for all types of COPD patients. However, despite this, there is still widespread prescribing of ICS for COPD in the absence of any clear clinical rationale, Prof David

Price, Professor of Primary Care Respiratory Medicine, UK, told a Novartis-hosted ERS Congress mediabriefingonCOPD.



However, UK data shows around 50% of GOLD A patients are receiving therapy they shouldn’t, primarily ICS, while only 7% of B patients, 60% of C patients, and 70% of D patients are being appropriately treated, he told the briefing.


Incorrect COPD treatment not only means poorer outcomes and more costs to the health service and wider economy in the long run, it also increases co-morbidity risk factors, he explained. Prof Price quoted Canadian research that

showsasignificantlyincreasedrisk of developing diabetes in COPD patients treated with ICS. Diabetes is a major risk factor forflare-upsofcardiovascularissues in COPD patients. COPD patients prescribed ICS are also at increased risk of developing of pneumonia or osteoporosis, he added.

Dr Dermot O’Callaghan, consultant respiratory physician, Mater Hospital, Dublin, said inappropriate prescribing for COPD patients is an issue of growing concern in Ireland, but acknowledged that GPs, as well as some respiratory specialists,canfinditdifficulttodifferentiate whether a patient has COPD or asthma, especially as some patients overlap. “However, that is why it is so important to try and distinguish between them so we do not inappropriately treat patients with expensive medications that have their ownnegativeriskprofiles,”hemaintained.


The symptoms and exacerbations of COPD are often inadequately controlled by bronchodilator monotherapy, but dual bronchodilation, using a LABA/LAMA combination, has more effective outcomes for patients, the Congress heard.

New data presented during the Congress on QVA149 (Ultibro® Breezhaler®), a once daily, fixeddosecombinationoftwobronchodilators, showed it produces superior, rapid and sustained improvements in lungfunction,andsignificantimprovements in shortness of breath and health-related quality of life for COPD patients, versus competitor therapies.

QVA149 received a positive opinion for approval from the European Medicines Agency’s CHMP in July as a maintenance bronchodilator treatment to relieve symptoms in adult patients, and it is currently being assessed in the IGNITE clinical trial programme, which involves more than 10,000 patients.

“Some of the new data we’ve heard about the combination of bronchodilators is really intriguing. What I think is fascinating is that all the major pharmaceutical companies have recognised that this is the way to go and I think in the next three to four years we will have a range of choices for patients. We will go from a situation from where there were virtually no licensed treatments for this disease to where we will be spoiled for choice,” Dr O’Callaghan commented.

EXACERBATIONS

Exacerbations can be frequent and occur at all levels of COPD, not just more severe patients, the Congress heard. Exacerbations lead to poor quality of life poorer long-term outcomes and are associatedwithsignificantmortality.

“Long acting bronchodilators prevent exacerbations in all types of COPD patients and should be the basis for initial treatment and only those that persist with exacerbations after proper bronchodilation should go with further treatment according to their individual category,” Dr Marc Miravitlles, respiratory physician, Spain, speaking at a Novartis symposium on dual bronchodilation, contended.

MISDIAGNOSIS

Misdiagnosis and under-diagnosis of COPD were key issues raised by a number of speakers during the Congress.

Many COPD patients are misdiagnosed as having asthma, while others are diagnosed late, or not at all. Concern was raised that GPs are not adequately educated on recognising patients who should be assessed for COPD, or are adequately equipped or

comfortable making a diagnosis of COPD within a primary care setting.

The public, and indeed the medical community, still consider the typical COPD patient to be an overweight, middle-aged, male, heavy smoker and it is a very stigmatised disease, the Congress heard.

However COPD affects a much wider spectrum of patients: “COPD comes in all sizes and shapes, and it affects more women than men now – more women are dying worldwide annually. Over 50% of COPD patients are under 65 years, individuals predominantly in the workforce,“ Mr John Walsh, President of the COPD Foundation, US, told a special mediabriefingonCOPDduringtheCongress, organised by Novartis.

Speakersatthebriefingpointedout that according to the latest GOLD guidelines, a clinical diagnosis of COPD should be considered in any patient who has dyspenia, chronic cough or sputum production, and a history of exposure to COPD risk factors (smoking, occupational dust and chemicals, etc). Spirometry is required to make the diagnosis in this content, and the presence of a post-bronchodilator FEV1/FVC <0.70confirmsCOPD.

Dr O’Callaghan said the guidelines are very useful in indentifying real life impact in the management of the disease, whereas previously the focus was simply on worsening lung function and increased treatment.

“There has been a paradigm shift in how we approach patients, now it is not simply in terms of lung function. We now realise symptoms are an incredibly important component of the

disease. We tend to get bogged down in FEV1 but patients care about whether they can do their shopping, go up and down the stairs by themselves and whether they will have exacerbations and have to go their doctor or hospital,” he noted.

SUMMARY

Itisclearthattherearesignificantunmet needs regarding the earlier and correct diagnosis of COPD and optimal management of the disease and associated risk factors/comorbidities through following the latest GOLD guidelines.

There is now evidence that dual bronchodilation offers effective and safe treatment that improves qualify of life, reduces exacerbations and could improve long-term outcomes for COPD patients. In addition, simplifying treatment through once daily fixeddosecombinationdual

bronchodilators should help improve treatment compliance, a major issue in this cohort.

“From the fairly extensive evaluation to data on these treatments, they appear to be safe and are effective in improving patients lung function, reducing exacerbations and improving quality of life,” Dr O’Callaghan concluded.

Also attending the ERS, respiratory nurse Ms Ann Toher, Mullingar, said she believes the development of combined dual bronchodilators will improve compliance and make treatment easier for patients, especially the elderly, as well as improving quality of life.

Dr John Kiely, consultant in respiratory medicine, Cork, agreed that the data on dual bronchodilation to date looks positive, especially in relation to reducing exacerbations.

The GOLD COPD Classification Index

Chronic Obstructive Pulmonary Disease (COPD)

Prescribing to reduce patient harmResearchers have developed a new strategy for prescribing antibiotics that could reduce patient harm and help combat the rise in antibiotic resistance.

The study, which was presented at the European Respiratory Society (ERS) Annual Congress in Barcelona, found that a new prescribing protocol could significantreducepotentialmisuseof antibiotics.

The research followed over 500 patients with lower respiratory tract infections during the course of one year. The new prescribing

protocol included automatic stop dates, with time limits on prescriptions depending on the severity of an infection, coupled with support from pharmacists to ensure that antibiotics were issued with stop dates that were clearly visible for patients.

Duringthefirsthalfofthe12-month trial, researchers monitored patients' current duration of antibiotic use. In the second half, patients receiving antibiotics followed the new prescribing strategy.

During both phases of this study,

researchers monitored antibiotic side-effects, includeding new symptoms occurring during the period of antibiotic exposure that were potentially caused by the antibiotics. They also monitored patients' length of stay in hospital and death rates.

The study found that when the new protocol was followed, there was a near 20% reduction in antibiotic use and an associated 40% reduction in antibiotic-related side-effects.

Dr Matthew Lloyd, lead author from the University of Dundee,

said: "The threat from growing resistance to antibiotics is increasing, which is in part attributable to inappropriately lengthy courses of antibiotics. Our study aimed to implement a simple system for preventing patients taking antibiotics for longer than they should. The results were promising and found that through prescribing automatic stop dates and working with our multidisciplinary colleagues, we can help prevent this problem and reduce patient harm."

GROUP A [low risk of

exacerbation, less

symptoms]

Post- bronchodilator FEV1

Exacerbations

Symptoms*

LOW RISK HIGH RISK

Moderate Severe Moderate Severe

>50% of predicted

AND

<2 per year

>50% of predicted

AND/OR

≥2peryear

GROUP B [low risk of

exacerbation, more

symptoms]

GROUP C [high risk of

exacerbation, less

symptoms]

GROUP D [high risk of

exacerbation, more

symptoms]Professor David Price


COPD

40

Issue 13 • HPN

of life for COPD patients, versus competitor therapies9.

Ultibro® Breezhaler® is now approved as a maintenance treatment to relieve symptoms in adult patients, and it is currently being assessed in the IGNITE clinical trial programme, which involves more than 10,000 patients.


EXACERBATIONS

Exacerbations can be frequent and occur at all levels of COPD, not just more severe patients, the Congress heard. Exacerbations lead to poor quality of life poorer long-term outcomes and are associated with significant mortality10.


MISDIAGNOSIS


Many COPD patients are misdiagnosed as having asthma, while others are diagnosed late, or not at all.

Concern was raised that GPs are not adequately educated on recognising patients who should be assessed for COPD, or are adequately equipped or comfortable making a diagnosis of COPD within a primary care setting.


However COPD affects a much wider spectrum of patients: “COPD comes in all sizes and shapes, and it affects more women than men now – more women are dying worldwide annually. Over 50% of COPD patients are under 65 years11, individuals predominantly in the workforce,“ Mr John Walsh, President of the COPD Foundation, US, told a special media briefing on COPD during the Congress.

Speakers at the briefing pointed out that according to the latest GOLD guidelines, a clinical diagnosis of COPD should be considered in any patient who has dyspnea, chronic cough or sputum production, and a history of exposure to COPD risk factors (smoking, occupational dust and chemicals, etc)12. Spirometry is required to make the diagnosis in this content, and the presence of a post-bronchodilator FEV1/FVC <0.70 confirms COPD13.


“There has been a paradigm shift in how we approach patients, now it is not simply in terms of lung function. We now realise symptoms are an incredibly important component of the disease. We tend to get bogged down in FEV1 but patients care about whether they can do their shopping, go up and down the stairs by themselves and whether they will have exacerbations and have to go their doctor or hospital,” he noted.

SUMMARY

It is clear that there are significant unmet needs regarding the earlier and correct diagnosis of COPD and optimal management of the disease and associated risk factors/comorbidities through following the latest GOLD guidelines.

There is now evidence that dual bronchodilation offers effective and safe treatment that improves qualify of life, reduces exacerbations and could improve long-term outcomes for COPD patients. In addition, simplifying treatment through once daily fixed dose combination dual bronchodilators should help improve treatment compliance, a major issue in this cohort.

Also attending the ERS, respiratory nurse Ms Ann Toher, Mullingar, said she believes the development of combined dual bronchodilators

will improve compliance and make treatment easier for patients, especially the elderly, as well as improving quality of life.


References:

1. Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD%20Book%202007.pdf.

2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Revised 2013. Available at:

http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html.

3. World Health Organisation. Chronic Obstructive Pulmonary Disease Factsheet No. 310, Available at: http://www.who.int/mediacentre/factsheets/ fs310/en/index.html.

4. World Health Organisation. Chronic Obstructive Pulmonary Disease Factsheet No. 315, Available at: http://www.who.int/mediacentre/factsheets/ fs315/en/.


6. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management..html.

7. Suissa S, Kezouh A, and Ernst P,Inhaled Corticosteroids and the Risks of Diabetes Onset and Progression. The American Journal of Medicine, Volume 123, Issue 11, Pages 1001-1006, November 2010


9. Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes. [ERS abstract 851178; Session 82; Date: September 8, 2013 Time: 12:50-14:40], and Banerji D et al. Dual bronchodilation with once-daily QVA149 improves dyspnea and health status and reduces symptoms and rescue medication use in patients with COPD: the IGNITE trials. [ERS abstract 851388; Session 346; Date: September 10 2013 Time: 8:30-10:30].

10. Vestbo J et al. (2012). Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease, GOLD executive summary [published online ahead of print August 9, 2012]. Am J Respir Crit Care Med. doi: 10.1164/ rccm.201204-0596PP.

11. Fletcher MJ et al. COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011; 11: 612.

12 . Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Revised 2013. Available at: http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html.

13. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Revised 2013. Available at: http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html.

1514

HPN • Issue 12Issue 12 • HPN

Are patients being correctly diagnosed with COPD, are they on the correct treatment, and are they getting the best outcomes achievable for their condition?

These were among the major questions addressed during a number of dedicated COPD sessions at the recent 2013 ERS Congress in Barcelona. There was a heavy focus on the new GOLD COPD guidelines, concern about the inappropriate and overuse of inhaled corticosteroids (ICS), plus the announcement of positive trial data on a new dual bronchodilator during the meeting, highlighting that there is now a vastly improved treatment landscape for these patients.

BURDEN

Despite its growing prevalence, there is an inadequate recognition of the burden of COPD, the ERS Congress heard. COPD affects up to 210 million people worldwide and is projected to be the third leading cause of death by 2020, accounting for nearly 6% of all deaths. The incidence of COPD is on the rise in Ireland and Europe; total deaths from COPD are

COPD - A new approach to treatment

Professor David Price

projected to increase by more than 30% over the next 10 years unless urgent action is taken to reduce the risk factors.

GOLD STANDARDS

Earlier this year the Global Initiative for Chronic Obstructive Lung Disease (GOLD) updated their best practice strategy for the diagnosis, management and prevention of COPD.


• Reducesymptoms(relievesymptoms, improve exercise tolerance, improve health status)

• Reducerisk(preventdiseaseprogression, prevent/treat exacerbations, reduce mortality).

Bronchodilators are central to COPD treatment and are recommended by GOLD for all types of COPD patients. However, despite this, there is still widespread prescribing of ICS for COPD in the absence of any clear clinical rationale, Prof David

Price, Professor of Primary Care Respiratory Medicine, UK, told a Novartis-hosted ERS Congress mediabriefingonCOPD.



However, UK data shows around 50% of GOLD A patients are receiving therapy they shouldn’t, primarily ICS, while only 7% of B patients, 60% of C patients, and 70% of D patients are being appropriately treated, he told the briefing.


Incorrect COPD treatment not only means poorer outcomes and more costs to the health service and wider economy in the long run, it also increases co-morbidity risk factors, he explained. Prof Price quoted Canadian research that

showsasignificantlyincreasedrisk of developing diabetes in COPD patients treated with ICS. Diabetes is a major risk factor forflare-upsofcardiovascularissues in COPD patients. COPD patients prescribed ICS are also at increased risk of developing of pneumonia or osteoporosis, he added.

Dr Dermot O’Callaghan, consultant respiratory physician, Mater Hospital, Dublin, said inappropriate prescribing for COPD patients is an issue of growing concern in Ireland, but acknowledged that GPs, as well as some respiratory specialists,canfinditdifficulttodifferentiate whether a patient has COPD or asthma, especially as some patients overlap. “However, that is why it is so important to try and distinguish between them so we do not inappropriately treat patients with expensive medications that have their ownnegativeriskprofiles,”hemaintained.


The symptoms and exacerbations of COPD are often inadequately controlled by bronchodilator monotherapy, but dual bronchodilation, using a LABA/LAMA combination, has more effective outcomes for patients, the Congress heard.

New data presented during the Congress on QVA149 (Ultibro® Breezhaler®), a once daily, fixeddosecombinationoftwobronchodilators, showed it produces superior, rapid and sustained improvements in lungfunction,andsignificantimprovements in shortness of breath and health-related quality of life for COPD patients, versus competitor therapies.

QVA149 received a positive opinion for approval from the European Medicines Agency’s CHMP in July as a maintenance bronchodilator treatment to relieve symptoms in adult patients, and it is currently being assessed in the IGNITE clinical trial programme, which involves more than 10,000 patients.


EXACERBATIONS

Exacerbations can be frequent and occur at all levels of COPD, not just more severe patients, the Congress heard. Exacerbations lead to poor quality of life poorer long-term outcomes and are associatedwithsignificantmortality.


MISDIAGNOSIS


Many COPD patients are misdiagnosed as having asthma, while others are diagnosed late, or not at all. Concern was raised that GPs are not adequately educated on recognising patients who should be assessed for COPD, or are adequately equipped or

comfortable making a diagnosis of COPD within a primary care setting.


However COPD affects a much wider spectrum of patients: “COPD comes in all sizes and shapes, and it affects more women than men now – more women are dying worldwide annually. Over 50% of COPD patients are under 65 years, individuals predominantly in the workforce,“ Mr John Walsh, President of the COPD Foundation, US, told a special mediabriefingonCOPDduringtheCongress, organised by Novartis.

Speakersatthebriefingpointedout that according to the latest GOLD guidelines, a clinical diagnosis of COPD should be considered in any patient who has dyspenia, chronic cough or sputum production, and a history of exposure to COPD risk factors (smoking, occupational dust and chemicals, etc). Spirometry is required to make the diagnosis in this content, and the presence of a post-bronchodilator FEV1/FVC <0.70confirmsCOPD.


“There has been a paradigm shift in how we approach patients, now it is not simply in terms of lung function. We now realise symptoms are an incredibly important component of the

disease. We tend to get bogged down in FEV1 but patients care about whether they can do their shopping, go up and down the stairs by themselves and whether they will have exacerbations and have to go their doctor or hospital,” he noted.

SUMMARY

Itisclearthattherearesignificantunmet needs regarding the earlier and correct diagnosis of COPD and optimal management of the disease and associated risk factors/comorbidities through following the latest GOLD guidelines.

There is now evidence that dual bronchodilation offers effective and safe treatment that improves qualify of life, reduces exacerbations and could improve long-term outcomes for COPD patients. In addition, simplifying treatment through once daily fixeddosecombinationdual

bronchodilators should help improve treatment compliance, a major issue in this cohort.

“From the fairly extensive evaluation to data on these treatments, they appear to be safe and are effective in improving patients lung function, reducing exacerbations and improving quality of life,” Dr O’Callaghan concluded.

Also attending the ERS, respiratory nurse Ms Ann Toher, Mullingar, said she believes the development of combined dual bronchodilators will improve compliance and make treatment easier for patients, especially the elderly, as well as improving quality of life.




Prescribing to reduce patient harmResearchers have developed a new strategy for prescribing antibiotics that could reduce patient harm and help combat the rise in antibiotic resistance.

The study, which was presented at the European Respiratory Society (ERS) Annual Congress in Barcelona, found that a new prescribing protocol could significantreducepotentialmisuseof antibiotics.

The research followed over 500 patients with lower respiratory tract infections during the course of one year. The new prescribing

protocol included automatic stop dates, with time limits on prescriptions depending on the severity of an infection, coupled with support from pharmacists to ensure that antibiotics were issued with stop dates that were clearly visible for patients.

Duringthefirsthalfofthe12-month trial, researchers monitored patients' current duration of antibiotic use. In the second half, patients receiving antibiotics followed the new prescribing strategy.

During both phases of this study,

researchers monitored antibiotic side-effects, includeding new symptoms occurring during the period of antibiotic exposure that were potentially caused by the antibiotics. They also monitored patients' length of stay in hospital and death rates.

The study found that when the new protocol was followed, there was a near 20% reduction in antibiotic use and an associated 40% reduction in antibiotic-related side-effects.

Dr Matthew Lloyd, lead author from the University of Dundee,

said: "The threat from growing resistance to antibiotics is increasing, which is in part attributable to inappropriately lengthy courses of antibiotics. Our study aimed to implement a simple system for preventing patients taking antibiotics for longer than they should. The results were promising and found that through prescribing automatic stop dates and working with our multidisciplinary colleagues, we can help prevent this problem and reduce patient harm."

GROUP A [low risk of

exacerbation, less

symptoms]

Post- bronchodilator FEV1

Exacerbations

Symptoms*

LOW RISK HIGH RISK

Moderate Severe Moderate Severe

>50% of predicted

AND

<2 per year

>50% of predicted

AND/OR

≥2peryear

GROUP B [low risk of

exacerbation, more

symptoms]

GROUP C [high risk of

exacerbation, less

symptoms]

GROUP D [high risk of

exacerbation, more

symptoms]


COPD

IE02/ULT14-CNF098

Once-daily ULTIBRO BREEZHALER is indicated as maintenance bronchodilator treatment to relievesymptoms in adult patients with chronic obstructive pulmonary disease (COPD).1

Ultibro Breezhaler▼This medicinal product is subject to additional monitoring. This will allow quick identifi cation of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

ABBREVIATED PRESCRIBING INFORMATIONPlease refer to Summary of Product Characteristics (SmPC) before prescribing.

Presentation: Ultibro Breezhaler 85mcg / 43mcg inhalation powder hard capsules containing indacaterol maleate and glycopyronium bromide respectively and separate Ultibro Breezhaler inhaler. Indications: A maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Dosage and administration: Recommended dose is the inhalation of the content of one capsule once daily, administered at the same time of the day each day, using the Ultibro Breezhaler inhaler. Capsules must not be swallowed. No dose adjustment required in elderly patients, for patients with mild and moderate hepatic impairment or for patients with mild to moderate renal impairment. No data available for use in patients with severe hepatic impairment and should only be in patients with severe renal impairment or end-stage renal disease requiring dialysis if the expected benefi t outweighs the potential risk. No relevant use in the paediatric population. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings/Precautions: Not to be administered concomitantly with medicinal products containing other LABA’s or LAMA’s. Asthma: ♦ULTIBRO BREEZHALER SHOULD NOT BE USED FOR TREATMENT OF ASTHMA. Acute use: ♦Not indicated for treatment of acute episodes of bronchospasm. Hypersensitivity related to indacaterol: ♦Immediate hypersensitivity reactions have been reported after administration of indacaterol. If signs suggesting allergic reactions (in particular, diffi culties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, treatment should be discontinued immediately and alternative therapy instituted. Paradoxical bronchospasm: ♦If paradoxical bronchospasm occurs, Ultibro Breezhaler should be discontinued immediately and alternative therapy instituted. Anticholinergic e� ects related to glycopyrronium: ♦To be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Patients with severe renal impairment: ♦Should only be used in patients with severe renal impairment,

including those with end-stage renal disease requiring dialysis, if the expected benefi t outweighs the potential risk. These patients should be monitored closely for potential adverse reactions. Cardiovascular e� ects: ♦To be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with known or suspected prolongation of the QT interval or patients treated with medicinal products affecting the QT interval and in patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fi brillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged. ♦LABA’s may produce a clinically signifi cant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms, ECG changes. In case such effects occur, treatment may need to be discontinued. Hypokalaemia: ♦ LABA’s may produce signifi cant hypokalaemia in some patients, which has the potential to produce cardiovascular effects. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment which may increase the susceptibility to cardiac arrhythmias. Hyperglycaemia: ♦Inhalation of high doses of LABA’s may produce increases in plasma glucose. Upon initiation of treatment with Ultibro Breezhaler plasma glucose should be monitored more closely in diabetic patients. ♦ Ultibro Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled. General disorders: ♦To be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to LABA’s. Excipients: ♦ Patients with rare hereditary problems of galactose intolerance, the Lapp lactase defi ciency or glucose-galactose malabsorption should not take this medicine. Pregnancy and Lactation: ♦Ultibro Breezhaler should only be used during pregnancy if the expected benefi t to the patient justifi es the potential risk to the foetus. ♦Not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk. Use of Ultibro Breezhaler by breast-feeding women should only be considered if the expected benefi t to the woman is greater than any possible risk to the infant. Interactions: ♦Concomitant use is not recommended with beta-adrenergic blockers, anticholinergics or sympathomimetic agents. ♦Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution. ♦Inhibition of the key contributors of indacaterol clearance, CYP3A4 and

P-gp, does not raise any safety concerns given the safety experience of treatment with indacaterol. ♦No clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of the organic cation transport. Adverse reactions: ♦Very common: upper respiratory tract infection. ♦Common: nasopharyngitis, urinary tract infection, sinusitis, rhinitis, dizziness, headache, cough, oropharyngeal pain including throat irritation, dyspepsia, dental caries, gastroenteritis, musculoskeletal pain, pyrexia, chest pain. ♦Uncommon: hypersensitivity, diabetes mellitus and hyperglycaemia, insomnia, paraesthesia, glaucoma, ischaemic heart disease, atrial fi brillation, tachycardia, palpitations, paradoxical bronchospasm, epistaxis, dry mouth, pruritus / rash, muscle spasm, myalgia, pain in extremity, bladder obstruction and urinary retention, peripheral oedema and fatigue. ♦Please refer to SmPC for a full list of adverse events for Ultibro Breezhaler.

Legal Category: POM

Pack sizes: Cartons containing 6 capsules (1x6 capsule blister strips) and one Ultibro Breezhaler inhaler or 30 capsules (5x6 capsule blister strips) and one Ultibro Breezhaler inhaler.

Marketing Authorisation Holder: Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom.

Marketing Authorisation Numbers: EU/1/13/862/001 & 003.

Full prescribing information is available on request from Novartis Ireland Ltd, Beech Hill Offi ce Campus, Clonskeagh, Dublin 4. Tel: 01 2601255 or at www.medicines.ie

Date of Creation of API Text: February 2014

Date of Preparation: March 2014

1. Ultibro Breezhaler SmPC. www.medicines.ie , accessed on Nov 2013.2. Vogelmeier CF, Bateman ED, Pallante J, et al. Effi cacy and safety of once-daily QVA149 compared with twice-daily salmeterol/ fl uticasone in patients with COPD (ILLUMINATE): a randomised, double-blind, prallel group study. Lancet Respir Med. 2013;1:51-60.3. Bateman ED, Ferguson GT, Barnes et al. Dual bronchodilation with QVA149 vs single bronchodilatot therapy: the SHINE study. EUR Respir J. Published online May 2013 as doi: 10.1183/0931936.00200212.4. Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulnmonary disease exacerbations with the dual bronchodilator therapy QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel group study. Lancet Respir Med. 2013;1:199-209.

THE FIRST ONCE-DAILY DUAL BRONCHODILATOR1

START A NEW CHAPTER IN COPD2-4

ULTIBRO® BREEZHALER®THE FIRST ONCE-DAILY DUAL BRONCHODILATOR11

START A NEW CHAPTER IN COPDSTART A NEW CHAPTER IN COPD2-4

BREEZHALER®

NEWNEW

85mcg indacterol maleate/43mcg glycopyrroniumbromide inhalation powder

HPN A4 ADVERT.indd 1 22/05/2014 10:00

42

Issue 13 • HPN

Clinical Research

Research offers insights into breast cancer resistance

Research conducted by the BREAST-PREDICT cancer research team has yielded exciting new insights about the resistance of some breast cancers to a commonly used breast cancer drug. The research has also identified frequent changes in a ‘druggable’ gene in a difficult-to-treat type of breast cancer, and how levels of a certain protein can be used to predict outcome for some breast cancer patients.

These findings come just six months after the founding of BREAST-PREDICT, the Irish Cancer Society’s first Collaborative Cancer Research

Centre (CCRC), which are aimed at improving integration of cancer research and cancer care in Ireland and internationally.

Led by Professor William Gallagher, an Associate Professor of Cancer Biology at University College Dublin, BREAST-PREDICT (www.breastpredict.com) is a country-wide collaboration between experts in the area of breast cancer research. More than 50 researchers are working on this research programme which will run for a period of five years, with an investment of ¤7.5 million from the Irish Cancer Society.

At the heart of the study is the development of a national breast cancer biobank and database which includes tumour tissue, blood samples and patient information collected, with permission, from almost every breast cancer patient in the country. BREAST-PREDICT is using this data to improve its understanding of how breast cancer can spread and become resistant to treatment, with the overall aim of delivering a more personalised approach to breast cancer treatment.

Breast cancer patients who test positive for high levels of the Her2 protein are usually treated with Herceptin, which has vastly improved the outlook for this group of patients. However, BREAST-PREDICT researchers have found that many patients whose tumours were positive for the estrogen receptor in addition to the Her2 protein, were more likely to develop resistance to the commonly used Herceptin therapy. This piece of research may aid clinicians in identifying, in advance, breast cancer patients who are likely to respond poorly to Herceptin. This could then inform the clinical decision to prescribe alternative or additional treatments.

Research of the role of a gene called AKT-3 in triple negative breast cancer (TNBC) has also been undertaken. BREAST-PREDICT found that approximately 10% of TNBCs have high levels of AKT-3, and these tumours were more likely to recur after initial treatment. This finding paves the way for

future studies investigating the benefit of therapies targeting AKT-3 for this difficult-to-treat type of breast cancer.

Estrogen receptor (ER) positive breast cancer, which accounts for 70% of all breast cancers, is generally very treatable and has an excellent prognosis. However, some patients develop resistance to the more common therapies over time, leading to recurrence of the primary tumour, and in some cases, metastasis and eventual death. BREAST-PREDICT researchers have discovered that patients whose primary tumours express a protein called PRDX1 are more likely to develop a recurrence in the future. This finding may have implications for future breast cancer care, where it could be used to help guide treatment decisions in these patients.

Under the leadership of Prof William Gallagher, the BREAST-PREDICT team consists of more than 50 researchers from University College Dublin, Trinity College Dublin, the Royal College of Surgeons in Ireland, Dublin City University, National University of Ireland Galway, University College Cork, and the All-Ireland Co-Operative Oncology Research Group (ICORG).

Prof Gallagher, said, “We have made great strides in the first six months of BREAST-PREDICT with initial findings coming through now that are actually making an impact on the way in which we treat breast cancer. Every cancer is different. Personalised medicine, which takes into account the exact type of tumour, will be what delivers better outcomes for patients in the future. The Irish Cancer Society funding and support is helping to make this a reality and we hope to make further announcements in the near-future as our highly active team builds on the successes of the first six months.”

Professor William Gallagher

43

HPN • Issue 13

Crohn's Feature

The Integral Role of Hospital Pharmacists in Managing Crohn's Disease

Irritable bowel disease is a chronic inflammatory disease of the gastrointestinal (GI) tract which encompasses both Crohn’s disease (CD) and ulcerative colitis (UC). The inflammation in CD can spread through as much as the entire GI wall thickness and can extend anywhere along the GI tract from the mouth to the anus.1 In UC, the inflammation is generally limited to the colon.

Studies have shown that CD tends to be more prevalent in urban areas versus rural areas due to greater exposure to the following environmental risk factors: cigarette smoking,

microbial exposure, sanitation, pollution, and lifestyle.2-4 The highest incidences of CD are found in Westernized countries, and these incidences increase between the second and fourth decades of life.2,3 Currently, there is no cure for CD. The increase in incidence presents an opportunity for pharmacists to understand how best to evaluate and manage this disease through pharmacologic and nonpharmacologic means

CLINICAL MANIFESTATIONS AND CLASSIFICATION

CD is classified into 3 categories: mild to moderate, moderate

to severe, and severe to life-threatening. Patients with CD may present with a variety of symptoms depending on their disease classification or severity.3,4 Some may experience times of continuous symptomatic disease, while others may only experience a single incident and be asymptomatic for years.

The most common CD symptoms are abdominal pain and diarrhea.3,4 Patients may also experience malaise and fever, frequent bowel movements, hematochezia, fistulas, weight loss/malnutrition, and arthritis. Upon further examination, an abdominal mass with tenderness, as well as perianal fissures or fistulas, may be seen.3,4 In mild to moderate CD, patients usually have no signs of dehydration, weight loss, or abdominal tenderness. In moderate to severe CD, however, patients may present with a fever, weight loss, abdominal pain, vomiting, and significant anemia. Patients with severe to life-threatening CD present with persistent abdominal symptoms, intestinal obstruction, abscesses, and cachexia.3,4

Patients with CD commonly present with extraintestinal manifestations affecting the muscles, bones, skin, liver, kidney, and pancreas.5 Most extraintestinal manifestations will resolve when the underlying CD is appropriately managed.5

DIAGNOSIS

Imaging modalities can determine the severity and location of CD in the GI tract.6 These modalities include push enteroscopy, capsule endoscopy, computed tomography (CT) scanning, nuclear medicine imaging, and magnetic resonance imaging (MRI). Both push enteroscopy and CT scanning evaluate the whole colon, while MRI enterography can help identify fistulas and stenosis associated with CD. Although very useful in

identifying disease progression and severity, these modalities also have associated risks and costs.6

Within the past several years, genetic and serologic markers have become useful tools in determining the severity of CD. Genetic factors are constant and present long before the onset of CD, making them valuable in verifying if a patient has the disease.7 Three common mutations of the innate immune gene NOD2 (found in the gastrointestinal tract), have been predictive of a more aggressive disease course. Patients with at least 1 of these mutations have a higher risk of having fibrostenosing CD.7

Patients with CD have been shown to be positive for the presence of anti– Saccharomyces cerevisiae antibodies.4,6 Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels are used to determine CD severity. The CRP and ESR values, however, are only useful in predicting short-term incidence of relapse.The Crohn’s Disease Activity Index (CDAI) has been used repeatedly in clinical practice to assess a patient’s well-being by quantifying symptoms.6 The CDAI includes number of liquid or soft stools each day, abdominal pain, general well-being, presence of complications, taking loperamide or opiates for diarrhea, presence of an abdominal mass, hematocrit of <0.47 in men and <0.42 in women, and percentage deviation from standard weight (in a 7-day period). Although a very subjective tool, the CDAI gives the physician a general idea of how well the patient is doing.6

MANAGEMENT

CD can be managed medically or surgically.8,9 The goals of medical management in a patient with CD are to “approach, initiate, and maintain symptom control, improve quality of life, avoid hospitalizations and surgery, and

Authors: Hana Kim, BS; Peter Kim, BA; Toyin Tofade, MS, PharmD, BCPS, CPCC

44

Issue 13 • HPN

Crohn's Feature

minimize short- and long-term toxicity and complications.”8 Treatment choice depends on the severity, stage, and location of disease, and the extraintestinal complications.8,9 Medications aid in the induction and maintenance of remission.

For mild to moderate disease, the first-line agents are 5-aminosalicylates (5-ASAs), budesonide, and antibiotics. 9 5-ASA compounds consist of sulfasalazine or mesalamine, a delayedrelease 5-ASA. Mesalamine has an enteric coating, allowing slow release of the drug throughout the GI tract. Usual prescribed dosage range for oral mesalamine is 3.2 to 4 g daily and for oral sulfasalazine is 3 to 6 g per day. Although there has not been much clinical evidence to show the effectiveness of mesalamine over placebo, it is still often used in clinical practice.8,9

Budesonide, however, at 9 mg daily has shown positive effects in studies compared with placebo and mesalamine.8 Controlled-release budesonide is the first-line agent for mild to moderate CD affecting the ileum and/or right colon. 8 Antibiotics have not shown efficacy or long-term benefit despite the hypothesis that bacteria may exacerbate CD.8,9

In moderate to severe disease, patients are usually started on prednisone 40 to 60 mg a day for about 7 to 28 days until symptoms subside. Most patients using steroids long term become steroid dependent and may be prone to toxicities and side effects.8 The main role of corticosteroids for moderate to severe CD should be in the induction of remission. 8 Azathioprine 2 to 3 mg/ kg and 6-mercaptopurine (6-MP) 1.0 to 1.5 mg/ kg have shown benefit, when added to steroids, in maintaining a steroidinduced remission.8,10

In refractory cases, anti-tumor necrosis factor (TNF) agents and methotrexate can be helpful.10 Infliximab, an anti-TNF agent, is the most commonly used biologic

in CD. Studies with infliximab have demonstrated positive results with non-responders and as such its use in CD is reserved for patients who have failed or not responded to 5-ASAs, corticosteroids, 6-MP, or azathioprine.8,10 Infliximab is given as a 5 mg/kg IV infusion at weeks 0, 2, and 6 to induce remission and every 8 weeks thereafter for maintenance therapy. Infliximab plus azathioprine was more likely to provide a steroid-free remission than infliximab alone.11-13

Typically, 50% of these patients relapse after 1 year. Factors such as smoking, disease severity, and blood levels of coagulation factors may contribute.13 Adalimumab and cetolizumab pegol, other anti-TNF agents, have shown promising results in active disease.8,14 Induction of remission and maintenance with 160 mg at week 0, 80 mg at week 2, and 40 mg subcutaneously every other week has been effective.15

Surgery is a safe and effective option in select patients with CD limited to the terminal ileum or anus.16 Surgery is often considered when patients fail medical treatment and/or demonstrate serious complications to pharmacologic therapy.8,17 The goal of surgery is to relieve symptoms and improve quality of life.8,17,18 The surgical modality employed could be laparoscopic or conventional. Laparoscopic bowel resection has demonstrated more favorable postoperative outcomes compared with a conventional approach.16 Unfortunately, surgery does not reduce the risk of CD recurrence.6 The timing of the surgery is patient-specific and dependent on several factors. Patients should be involved in this important decision process to maximise quality of life.17,18

TIPS FOR HOSPITAL PHARMACISTS

Pharmacists can play an integral role in optimizing the management of a patient with CD. Obtaining a

medication history and monitoring for signs of long-term side effects or toxicities with corticosteroids, infliximab, and methotrexate is essential. In the patient with a severe allergy, extreme caution is advised in the use of 5-ASA products.18 Risk factors for methotrexate hepatotoxicity include obesity, diabetes, history of alcohol abuse, elevated liver function tests, and a cumulative total dose of methotrexate of 1.5 g.6 If a patient’s transaminase levels exceed 2 to 3 times the upper limit of normal, exercise caution and reevaluate therapy. Infusion-related reactions can occur within 2 hours of infliximab treatment. Premedicating with corticosteroids, acetaminophen, and/or diphenhydramine is effective.9

If patients develop an acute infection in the face of biologic-induced immunosuppression, CD therapy must be stopped until the infection is treated. It is also recommended to screen patients for tuberculosis (TB) before initiation of infliximab to prevent activation of latent TB. The pharmacist can recommend stopping therapies when the risks outweigh the benefits or alert the physician of the patient’s response to prior regimens in the face of surgical consideration. 18 In the future, the pharmacist may be able to provide pharmacogenomics consultation as studies increase.7

REFERENCES

1. Kozuch PL, Hanauer SB. Treatment of inflammatory bowel disease: A review of medical therapy. World Journal of Gastroenterology. 2008 Jan 21; 14(3):354-377.

2. Molodecky NA, Soon IS, Rabi DM, et al. Increasing Incidence and Prevalence of the Inflammatory Bowel Diseases with Time, Based on Systematic Review. Gastroenterology. 2012 Jan;142(1):46-54.

3. Hovde Ø, Moum BA. Epidemiology and clinical course of Crohn’s disease: Results from observational studies. World Journal of Gastroenterology. 2012 April 21;18(15):1723-1731.

4. Hemstreet BA. Chapter 41. Inflammatory Bowel Disease. In:

Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM.eds Pharmacotherapy: A Pathophysiologic Approach. 8th ed. New York: The McGraw-Hill Companies; 2011.

5. Levine JS, Burakoff R. Extraintestinal Manifestations of Irritable Bowel Disease. Gastroenterology & Hepatology. 2011 Apr;7(4):235-241.

6. Lichtenstein GR. Emerging Prognostic Markers to Determine Crohn’s Disease Natural History and Improve Management Strategies: A Review of Recent Literature. Gastroenterology & Hepatology. 2010 Feb;6(2):99-107.

7. Vermeire S, Van Assche G, Rutgeerts P. Role of genetics in prediction of disease course and response to therapy. World Journal of Gastroenterology. 2010 June 7;16(21):2609-2615.

8. Lichtenstein GR, Hanauer SB, Sandborn WJ et al. Management of Crohn’s Disease in Adults. American Journal of Gastroenterology. 2009 Jan 6;104(2):465-483.

9. Feldman PA, Wolfson D, Barkin JS. Medical Management of Crohn’s Disease. Clinics in Colon and Rectal Surgery. 2007 November;20(4):269-281.

10. Cottone M, Criscuoli V. Infliximab to treat Crohn’s disease: An update. Journal of Clinical and Experimental Gastroenteorology. 2011 September 26;4:227-238.

11. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn’s disease. New England Journal of Medicine. 2010 Apr;362(15):1383-95.

12. Siegel CA, Finlayson SR, Sands BE, et al. Adverse events do not outweigh benefits of combination therapy for Crohn’s disease in a decision analytic model. Clinical Gastroenterology and Hepatology 2012 Jan;10(1):46-51.

13. Louis E, Mary JY, Vernier-Massouille G, et al. Maintenance of remission among patients with Crohn’s disease on antimetabolite therapy after infliximab therapy is stopped. Gastroenterology 2012 Jan;142(1):63-70.

14. Sandborn WJ, Hanauer SB, Rutgeerts PJ, et al. Adalimumab for Maintenance Treatment of Crohn’s Disease: Results of the CLASSIC II Trial. Gut 2007 Sept;56(9):1232-1239.

15. Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn’s disease: the CLASSIC-I trial. Gastroenterology. 2006 Feb;130(2):323-33.

16. Kessler H, Mudter J, Hohenberger W. Recent results of laparoscopic surgery in inflammatory bowel disease. World Journal of Gastroenterology. 2011 March 7;17(9):1116-1125.

17. Alos R, Hinojosa J. Timing of surgery in Crohn’s disease: A key issue in the management. World Journal of Gastroenterology. 2008 September 28;14(36):5532-5539.

18. Umanskiy K, Fichera A. Health related quality of life in inflammatory bowel disease: The impact of surgical therapy. World Journal of Gastroenterology. 2010 October 28;16(40):5024-5034.

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Date of preparation February 2013 IE/13/001

46

Issue 13 • HPN

News

NAHPT Poster Competition - bringing work to life

For the fourth consecutive year, Actavis Ireland sponsored the NAHPT Poster Competition. The poster competition provides a great opportunity for Hospital Pharmacy Technicians to share information and really bring their fi eld of work to life.

Eleanor Muir, St. James Hospital Dublin, was the overall winner of the Poster Competition sponsored by Actavis.

Her poster entitled ‘A review of the Reaccreditation Programme in the Aseptic Compounding Unit in St James’s Hospital’ detailed the improvements made to St James’s Hospital (SJH) reaccreditation training programme in the Aseptic Compounding Unit (ACU).

The poster details the methodology of ACU in St James’s Hospital of standard practice in holding a written training programme and documenting all staff member's initial training. In accordance with national guidelines for aseptic compounding this training was

then reassessed on an annual basis. Eleanor and her team saw a number of limitations with the standard programme as it was both time-consuming and diffi cult to determine individual training requirements. A more structured approach has been created to address competency in production areas and an on-going training programme has been developed for non-production tasks. This streamlined programme will reduce the time required to undertake the reaccreditation programme.

The new reaccreditation process is currently being piloted at St James’s Hospital.

Eleanor won the prize of an Apple iPad and was honoured with a plaque. Other winners on the day included Technician runner-up Trish Scully, Student 1st place Winner Aine Casey and Highly commended student Mary Connor-Kilkenny.

Caroline Fitzgerald, Actavis Hospital Business Manager said, “Actavis are delighted to sponsor

this award for the fourth year running. The response has been overwhelming and the standard of posters submitted is just fantastic. Actavis will continue to sponsor this competition for the foreseeable future.

"We are proud to act as a link in this amazing share of information and improvements between hospitals. We are also proud to sponsor the student award as they are our future; we feel it is vital to support and encourage their development from as early in their careers as possible. We congratulate the winners Eleanor, Trish, Aine and Mary and wish to thank everyone who submitted entries this year.”

The National Association of Hospital Pharmacy Technicians held their annual conference on Saturday 12th of April, in the Crowne Plaza Hotel, Santry.

The response has been

this competition for the

we feel it is vital to support and we feel it is vital to support and encourage their development encourage their development

The National Association of Hospital Pharmacy Technicians held their annual

All production tasks are now in the ACU technician reaccreditation programme. The newly developed reaccreditation tools have made the programme more comprehensive and efficient. The observation-based approach and the simulation tests have strengthened the programme by providing information on the technician’s ability to complete a task without error and to detect known errors. Completed annually, the reaccreditation programme now provides a higher level of quality assurance in production tasks. References: 1. Beaney Alison M. Quality Assurance of Aseptic Preparation Services. London: Pharmaceutical Press 2006.

2. HPAI H-PIC\S National Guidelines for Aseptic Compounding in Irish Hospital Pharmacy Practice. Version 1: 2013.

3. Smith Sinead. Development and Evaluation of an Internal Audit Approach for the ACU, SJH. Trinity Masters Dissertation

2011. CONTACT: Eleanor Muir Email: [email protected]

INTRODUCTION Quality assurance of the aseptic process is of paramount importance to ensure the quality of the product as there is no quality control of the product before release and use1. Training and competency assessment are a core part of quality assurance. All staff should receive initial and continued training to ensure the quality of the product2. Regular reassessment of competency should be undertaken with revision or retraining provided where necessary1. In 2009 a reaccreditation programme was introduced in the Aseptic Compounding Unit (ACU), St James’s Hospital. Reaccreditation involves an annual reassessment of competency in production plus attendance at training workshops and sessions for non production tasks in areas such as GMP, isolator technology, quality control and health and safety. Microbiological validation of hand washing, transfer disinfection and aseptic technique are also completed every three months. This poster is focused on the reaccreditation of technicians in the production process. Figure 1 shows the key tasks in the production process.

A Review of the Technician Reaccreditation Programme in the Aseptic Compounding Unit Muir E, Relihan E, Treacy V, Collins A Aseptic Compounding Unit, Pharmacy Department, St James’s Hospital, Dublin

OBJECTIVES To review the current reaccreditation programme in order to identify its limitations and

modify it to develop a more comprehensive, efficient process more sensitive to detection of technician error.

1. In September 2013 a working group was set up to redesign the reaccreditation programme. The working group consisted of two senior technicians and one basic grade technician.

2. To identify gaps in the 2009 reaccreditation programme the production process was mapped. A list of the tasks that technicians are trained on was compiled.

3. For each task a specific reaccreditation tool was developed. In line with best practice1

the following methods of competency assessment were incorporated -Simulation and written questioning -Checklists -Observation -Supported questioning. 4. The new reaccreditation programme was piloted on two basic grade

technicians, observed and assessed by a senior technician, and signed off by the ASM.

METHODOLOGY

To complete the 2009 reaccreditation programme, outlined in figure 2, technicians read standard operating procedures (SOPs) and carried out each task a defined number of times. The completed task was checked by an assessor. Aseptic technique and volume checking were the only tasks observed by an assessor. Each technician had a reaccreditation close out meeting with the Aseptic Services Manager (ASM). It took approximately two weeks for each technician to complete the reaccreditation process.

Over time, a number of limitations in the reaccreditation programme were identified including: • Low likelihood to detect if the end result was achieved by following the SOP • Did not test ability to detect errors • Difficult to identify retraining requirements • Some critical tasks were not covered • Time consuming In addition, a risk based audit initiated in the ACU in 20113 identified further gaps in the

training documentation, competency assessment , on going training and reaccreditation.

RESULTS 1.Gap analysis The review and mapping identified that transfer disinfection, isolator cleaning and

product dispatch were not in the 2009 reaccreditation programme.

2. Reaccreditation Programme The 2013 reaccreditation programme is illustrated in figure 3. Using the new reaccreditation tools, the assessor now accompanied the technician and observed him/her completing all tasks.

Tool 1: Checklist, Observation and Supported Questioning Using our SOPs as a guide, checklists were created for selected production tasks e.g.

gowning, as illustrated in Figure 4. The assessor completed the checklist by observing and questioning the technician completing the task. This observational-based approach enabled the assessor to confirm that the end result had been achieved by the technician following the correct procedure.

Figure 4 Reaccreditation checklist tool for gowning Tool 2: Simulation and written questioning Simulation tests were created for production tasks such as tray assembly checking.

Actual local data on errors and process deviations were reviewed, and a selection of the most relevant errors were deliberately included to assess the technician’s ability to detect and record errors. The technician’s drug knowledge was assessed by a closed book written drug test.

Review and sign off The assessor reviewed the reaccreditation results with the technician and non-compliances/errors were discussed. The assessor categorised the non-compliances/errors as minor or major and determined revision or retraining requirements e.g. read SOP and reassess the task.

3. Impact on duration The pilot demonstrated that the reaccreditation programme could be completed in one day.

4. Error detection sensitivity Checklists, observation and supported questioning detected non-compliance with SOPs e.g. incorrect cleaning of isolator transfer devices. Simulation tests and written questioning demonstrated that technicians detected critical errors e.g. incorrect drug on the tray; drug out of date.

5. General comments from (a) Technicians: programme was simple to follow; quicker; liked that feedback was available on the same day; clearer understanding of re-training needs, for example, more focused reading of SOPs. (b) Assessor: process gave a true indication of each technician’s ability to complete the tasks correctly; assessor confident to complete the reaccreditation review and competency sign-off; reproducible process. (c) ASM: Provides (i) on-going re-validation of technician checking competencies (ii) data on compliance with SOPs for the internal audit process (iii) current training and competency records for the annual risk-based ACU audit.

CONCLUSION

Conor Sadiler, Actavis presents award to Trish

Scully, Runner-Up, Actavis Poster Competition

Conor Sadiler, Actavis, presents award to Eleanor Muir, Winner, Actavis Poster Comptetition 2014

Martina McCabe, Cavan General Hospital; Caroline Fitzgerald, Hospital Business Manager, Actavis; Gail Murray, Mercy Hospital; Conor Sadlier, Key Account Executive, Actavis; Pauline Gavin, Mater Hospital and Evelyn Deasy, Tallaght Hospital

NAHPT Annual Conference 2015. Save the date: Saturday 25th April, Crowne Plaza, Santry.

Actavis, Inc. represents the powerful combination of Watson Pharmaceuticals and the Actavis Group.

Together we share a broader commercial footprint, an expanded product portfolio and enhanced capabilities in Ireland and around the world.

With 2 EU cytotoxic manufacturing sites, we are the partner you can trust.

THE FUSION OF ACTION, VISION AND STRENGTH

www.actavis.ie

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

48

Issue 13 • HPN

Hospital Pharmacy Association Research winners 2014

The 2014 winning entrants were as follows:The winner of the Servier award for research in pharmaceutical care was Dolores Keating from St John of God's hospital, Stillorgan. The title of her entry was "Preparing pharmacists to practice in mental healthcare".

CATEGORY 1 - RESEARCHOverall Comments: Good to see new topics and innovative approaches.

First Prize: Glasgow Antipsychotic Side Effects scale for clozapine

Primary Author: Caroline Hynes

Institution: St. John of God

Second Prize: Inappropriate prescribing in older people.

Primary Author: Ciara McGann

Institution: Connolly Hospital Blanchardstown

Highly Commended 1. Incorporation of the STOPP Criteria into Clinical Pharmacy Practice

Author: Brona Kehoe

Institution: Mater Misericordiae University Hospital

2. Documentation of Adverse Drug Reactions at a Dublin University Teaching Hospital

Author: Annette Whiriskey

Institution: AMNCH

3. Patient self-administration of medication in Tallaght Hospital: a baseline survey

Author: Evelyn Deasy

Institution: AMNCH

CATEGORY 2 - AUDIT

Overall Comments: The panel found the diversity and scope of the topics of interest.

First Prize: Are the appropriate staff group performing serum sampling for TDM of gentamicin and vancomycin?

Primary Author: Emily Ahern

Institution: St. James' Hospital

Second Prize: GP Referal letters: is the medication list accurate?

Primary Author: Mark McCullagh

Institution: Beaumont Hospital

Highly Commended: Are we dosing gentamicin appropriately?

Author: Emily Ahern

Institution: St. James Hospital

CATEGORY 3 - INNOVATION AND DEVELOPMENT

Overall Comments: The standard was very high, very difficult to judge.

Where possible the authors should include more detailed methods and results in the abstracts and on posters.

First Prize: Innovating and Collaborating-Synergy between the hospital and the university

Primary Author: Patricia Ging

Institution: Mater Misericordiae University Hospital

Second Prize: Gentamicin- Reducing harm and optimising use

Primary Author: Carmel McKenna

Institution: Our Lady of Lourdes Hospital, Drogheda

Highly Commended: 1. Pharmacist Verification of Oral anticancer medication prescriptions in Beaumont Hospital

Author: Grant Carroll

Institution: Beaumont Hosptial

2. Antimicrobial Prophylaxis for Interventional Radiological Procedures

Author: Deirdre Lenehan

Institution: MMUH

3. Evaluation of Rapid Rituximab infusion guideline on the oncology day ward in Beaumont hospital

Author: Margaret Triggs

Institution: Beaumont Hospital

CATEGORY 4 - MARY HARTE AWARDOverall Comments: The standard of work was exceptionally high. All work was relevant to hospital practice. They were enjoyable to read.

First Prize: A Clinical Audit of Ranitidine Use in Neonates, Pre-term and very low birth weight infants in the ICUs in Our Lady's Hospital Crumlin

Primary Author: Azeema Moolan

Institution: Our Lady's Children’s Hospital, Crumlin

Highly Commended: A Clinical Audit of Novel Oral Anticoagulant Prescribing in CUH

Author: Kieran Walsh

Institution: Cork University Hospital

CATEGORY 5 - PHARMACEUTICAL TECHNICIAN ANNOUNCEMENTFirst Prize: De-bugging a Bugbear: management of out of stock critical drugs

Primary Author: Eglina Corrigan

Institution: University Hospital Galway

HPAI President Deirdre Lynch thanked the education committee for putting together an excellent education programme for delegates over the two days. Special thanks go to Máire Murray, Shirley Guerin, Geraldine Colohan, David Walsh, Mairead Casserly and Catherine Boyle for bringing together the many elements of the weekend programme.

News

Caroline Hynes, pictured right, who won 1st place in Category 1 of the Pharmacist Poster Competition being presented by Caroline Reidy from Pfizer

Maria Creed, Mater Hospital on behalf of Deirdre Lenehan who received a Highly Commended in the Pharmacist Poster Competition in Category 3 being presented by Joan Peppard

Caroline Reidy, Pfizer presenting Brona Kehoe, Highly Commended in Category 1 for her entry in Pharmacist Poster Competition

Joan Peppard presenting Patrick McGee, on behalf of Mark McCullagh, Pharmacist Poster Competition Award for 2nd place in Category

Caroline Hynes and Dolores Keating, both St

John of God Hospital, Olivia Flynn, Limerick

Mid Western Hospital, Miriam Coghla, St James

Hospital, Diana Hogan- Murphy, Cavan General Hospital, Brona Kehoe,

MMUH and Gillian Oates, Sligo Regional Hospital

49

HPN • Issue 13

Clinical Profi les

GlaxoSmithKline have announced that the US Food and Drug Administration (FDA) has approved Incruse™ Ellipta® (umeclidinium) as an anticholinergic indicated for the long-term, once-daily, maintenance treatment of airfl ow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Umeclidinium is GSK’s fi rst once-daily anticholinergic, a type of bronchodilator also known as a long-acting muscarinic antagonist (LAMA), and is contained in the

FDA APPROVE IN-CRUSE ELLIPTA

Ellipta® inhaler. The FDA-approved strength is 62.5 mcg.

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said: “We believe Incruse Ellipta, our fi rst monotherapy in the anticholinergic class, will be an important once-daily treatment option for appropriate patients with COPD. GSK has a long-standing commitment to the development of respiratory medicines in order to offer physicians a choice of treatment options for their patients. We are delighted by this approval, and are looking forward

to making Incruse Ellipta available for appropriate patients with COPD in the US.”

Following this approval by the FDA, it is anticipated that launch activities in the US will commence during the fourth quarter of 2014.

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

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

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

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

SAVE MONEY ON DENTAL PRODUCTS

• Smaller tubes which mean Less Wastage

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

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

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

To order please ring 01 4688456.

On 1 July 2014, the Irish Medicines Board (IMB) will change its name to the Health Products Regulatory Authority (HPRA).

The IMB wish to give all their stakeholders advance notice so that you are aware of this change when you visit their website from 1 July and start to see documents and other materials displaying the new name and logo from that date forward. It may also be necessary

NEW NAME FOR IRISH MEDICINES BOARD

for some organisations to update internal systems and records.

Over the last 18 years the IMB regulatory remit has expanded to include other health products as well as a number of health related functions. The new name now more clearly refl ects the wider scope of their work, functions and responsibilities across the health products sector. At the same time, it is intended to build on

the IMB’s established reputation as a professional, progressive and science driven public sector organisation.

E-mail Addresses

The email addresses will change from @imb.ie to @hpra.ie on 1 July. However, the IMB versions will continue to work as normal for a transitional period thereafter.

Kora Healthcare announce the launch of its latest addition to its Vitamin D portfolio – Kora LiquiD®. Kora LiquiD® is an oral cholecalciferol solution, containing 3,000 IU per mL, equivalent to 15,000 IU per 5 mL in a 100mL bottle.

Both Vitamin D defi ciency and insuffi ciency remain a public health issue, and are widely discussed in both professional literature and increasingly in the public media. Kora LiquiD® enables personalised dosage with its oral dosing syringe and provides patients with

KORA HEALTHCARE EXTENDS ITS VITAMIN D PORTFOLIO

convenience and value through its availability and longer shelf life than “specials” which it replaces.

Following the launch of Kora LiquiD®, Margaret Larkin, Kora Healthcare’s CEO commented that “Kora listens closely to our customers and today KoraLiquiD® provides them with higher strength liquid vitamin D, manufactured to high quality standards whilst being readily available from United Drug wholesale’’.

For further information about KoraLiquiD®, please contact (01) 8900406

50

Issue 13 • HPN

Clinical Profiles

New data on Merck & Co's recently-filed anti-PD1 drug pembrolizumab (MK-3475) suggest the drug could be a 'paradigm shift' in the treatment of melanoma, according to clinical investigators.

The results of a 411-patient phase 1b study presented this week at the American Society of Clinical Oncology (ASCO) conference in Chicago showed that 69% of

NEW DATA ON PEMBROLIZUMAB (MK-3475)

pembrolizumab-treated individuals were still alive at one year.

The impressive survival rate was achieved even though more than half the patients in the study were in the most advanced stages of melanoma and 77% had been treated with other drugs, including Bristol-Myers Squibb's Yervoy (ipilimumab), which has rapidly emerged as the standard therapy for the skin cancer as it was the

first to extend survival.

Overall, 34 per cent of patients experienced tumour response, including 40 per cent of patients not previously treated with ipilimumab and 28 per cent of those whose disease progressed on prior ipilimumab.

A combination therapy based on two AstraZeneca (AZ) compounds - olaparib and cediranib - has nearly doubled progression-free survival (PFS) compared to olaparib alone in a phase II trial in ovarian cancer.

Moreover, the combination of the two orally-administered drugs could be an alternative to platinum-based chemotherapy if its initial promise is backed up

COMBINATION THERAPY CANCER SUCCESS

in further trials, according to the study investigators.

The trial was carried out by researchers at the National Cancer Institute and included 90 patients with recurrent ovarian cancer that had either initially responded to platinum-based therapy or whose tumours expressed the BRCA gene mutation. Results were presented at the American Society for Clinical Oncology (ASCO) in

Chicago over the weekend.

Patients treated with olaparib alone had an average PFS of around 9 months, but this increased to 17.7 months with the combination. Meanwhile, the objective response rate was 80 per cent for patients on the combination arm compared with 48 per cent for patients on olaparib alone.

Lundbeck (Ireland) Ltd have announced the discontinuation from the Irish market for commercial reasons of:

• Clopixol Acuphase 50 mg/ml Solution for Injection - PA 115/5/9

• Depixol 200 mg/ml Solution for injection - PA 115/1/10

PRODUCT DISCONTINUATIONS FROM THE IRISH MARKET

Please note that all other presentations in the Clopixol and Depixol product ranges will remain on the Irish market: Clopixol 10 mg film-coated tablets, Clopixol 200mg/ml and Clopixol 500mg/ml solution for injection as well as Depixol 20 mg/ml and Depixol 100 mg/ml solution for injection

Lundbeck (Ireland) Ltd apologise for any resulting inconvenience. For further information, please contact the company’s Medical Department: Tel: 01-4689800 or by email: [email protected].

Orion Corporation has entered into a global partnership with Bayer for the development and commercialisation of the compound ODM-201, an investigational novel oral androgen receptor inhibitor. ODM-201 is in clinical development for the treatment of patients with prostate cancer. Bayer and Orion will start jointly a clinical Phase III program to further evaluate the efficacy and safety of ODM-201 in patients with

ORION AND BAYER ENTER GLOBAL AGREEMENT

non-metastatic castration-resistant prostate cancer (nm-CRPC) in 2014. As a result of the agreement Orion Corporation upgrades the full-year outlook estimate for 2014.

Under the terms of the agreement, Orion and Bayer will jointly develop ODM-201, with Bayer contributing a major share of the costs of future development. Bayer will commercialize ODM-201 globally, Orion has the option to co-promote ODM-201 in Europe

and Orion is eligible to receive substantial royalties on the product sales. Orion will be responsible for manufacturing of the product.

As a result of the agreement Orion Corporation upgrades the full-year outlook estimate for 2014 provided on 4 February 2014. The company estimates that the full-year operating profit will be at similar level to 2013 (operating profit in 2013 was EUR 268 million).

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HPN • Issue 13

Novartis has announced changes at the top of two of its key divisions, with new leadership for generics unit Sandoz and eyecare business Alcon. Biogen Idec executive Richard Francis is appointed division head at Sandoz, replacing Jeff George who has moved sideways to become head of Alcon from May 1. Alcon's current division head Kevin Buehler is retiring from his position after a 30-year career at the unit.

Richard Francis

Following the recent recruitment process for the post of Executive Director of the Irish Institute of Pharmacy, the Institute is delighted to announce the appointment of Dr. Catriona Bradley. Dr. Bradley brings a wealth of experience to the Institute from her time with Boots Retail (Ireland) Ltd. where she currently holds the position of Director of Pharmacy.

Dr Catriona Bradley

Real World Retail are pleased to announce the appointment of Adele Curran as Customer Success Manager. Adele brings a wealth of retail experience having previously worked for Dunnes Stores and Heatons Department stores in change management roles in Training, IT implementation, Buying, Merchandising & Distribution. Adele will be responsible for training and benchmarking of customers to bring them to the highest level of operational and financial performance in the shortest possible time this will lead to business industry leaders in pharmacy in Ireland.

Adele Curran

Dr Hugh Brady The contract research organisation (CRO) ICON has appointed Dr Hugh Brady to its board of directors. Dr Brady is former president of University College Dublin (UCD) in Ireland, where he served from 2004 to 2013. In his role at Icon Dr Brady will be able to offer an in-depth knowledge of academia and research networks to Icon's efforts to support the pharma, biotech and medical device industries.

Dr Mary Holohan has been appointed Dean of Examinations at RCPI. She took up the role on May 1, replacing Dr Stephen Patchett who has held the position since 2007. On taking up the role, Dr Holohan will relinquish her current role as Dean of Professional Competence at RCPI. Dr Holohan will lead the strategic management and development of RCPI’s postgraduate examinations, ensuring their delivery to the highest international standards.

Dr Mary Holohan

Prof Patrick Johnston Prof Patrick Johnston has taken over as president and vice-chancellor of Queen’s University Belfast. A leading cancer researcher, Prof Johnston, who is originally from Derry/Londonderry, is the 12th vice chancellor in the university’s 168-year history.

He was appointed chair of the Translational Research Group of the Medical Research Council (MRC) in 2012. He received the 2013 international Bob Pinedo Cancer Care Prize. He also serves on the Cancer Research UK (CR-UK) science executive/advisory board.

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Contact Kelly Jo Eastwood on 0044 7876548989 / E-mail: [email protected]

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HOSPITAL PHARMACY NEWS IRELAND - ISSUE 13 - 2014

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