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Issue 12

HOSPITAL PHARMACY NEWS IRELAND THE INDEPENDENT VOICE OF HOSPITAL PHARMACY

IN THIS ISSUE:

HELP CONTAIN THE DANGER IN m CRPC

News: Letterkenny General Pharmacy Department get ready to move Page 5

XTANDI is a direct approach to treating metastatic castration – resistant prostate cancer post – docetaxel1-3. XTANDI directly & potently targets AR receptor signalling at three steps of the AR pathway: Blocking androgen binding; preventing nuclear translocation of the AR; impairing DNA binding – preventing modulation of gene expression.1-5

Profile: Celebrating a lifetime of achievement with Professor Ciaran Meegan Page 9

Take hold of mCRPC in a brand new way.

News: Ireland needs to step up for rare diseases Page 14 Clinical News: Focus on positive results for depression Page 20 Xtandi (enzalutamide) 40mg soft capsules. Prescribing Information: Please read the Summary of Product Characteristics (SPC) before prescribing. Presentation: Xtandi 40 mg soft capsules each containing 40 mg of enzalutamide. Indication: Xtandi is indicated for the treatment of adult men with metastatic castration resistant prostate cancer whose disease has progressed on or after docetaxel therapy. Dosage and administration: The recommended dose is 160 mg enzalutamide (four 40 mg capsules) as a single oral daily dose. For further details please refer to the SPC. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Women who are, or who may become, pregnant. Precautions and warnings: Caution should be used in administering Xtandi to patients with a history of seizures or other predisposing factors. The risk of seizure may be increased in patients receiving concomitant medicinal products that lower the seizure threshold. Caution is required in patients with severe renal impairment as enzalutamide has not been studied in this patient population. Caution is required in patients with moderate hepatic impairment. Xtandi contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicinal product. Interactions: Strong inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin) of CYP2C8 are to be avoided or used with caution during enzalutamide treatment. If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily CYP3A4 plays a minor role in the metabolism of enzalutamide. No dose adjustment is necessary when Xtandi is co-administered with inhibitors or inducers of CYP3A4. Enzalutamide is a potent enzyme inducer and increases the synthesis of many enzymes and transporters; therefore, interaction with many common medicinal products that are substrates of enzymes or transporters is expected. Enzymes that may be induced include CYP3A4 in the liver and gut, CYP2C9, CYP2C19, CYP1A2 and uridine 5’-diphospho-glucuronosyltransferase (UGTs - glucuronide conjugating enzymes). The transport protein P-gp may also be induced, and probably other transporters as well, e.g. multidrug resistance-associated protein 2 (MRP2), breast cancer resistant

protein (BCRP) and the organic anion transporting polypeptide 1B1 (OATP1B1). In vivo studies have shown that enzalutamide is a strong inducer of CYP3A4 and a moderate inducer of CYP2C9 and CYP2C19. The full induction potential of enzalutamide may not occur until approximately 1 month after the start of treatment, when steady-state plasma concentrations of enzalutamide are reached, although some induction effects may be apparent earlier. Patients taking medicinal products that are substrates of CYP3A4, CYP2C9, CYP2C19, CYP1A2 or UGT1A1 should be evaluated for possible loss of pharmacological effects (or increase in effects in cases where active metabolites are formed) during the first month of enzalutamide treatment, and dose adjustment should be considered as appropriate. If their therapeutic effect is of large importance to the patient, and dose adjustments are not easily performed based on monitoring of efficacy or plasma concentrations, these medicinal products are to be avoided or used with caution. In consideration of the long halflife of enzalutamide (5.8 days), effects on enzymes may persist for one month or longer after stopping enzalutamide. A gradual dose reduction of the concomitant medicinal product may be necessary when stopping enzalutamide treatment. In vitro data indicate that enzalutamide may be an inhibitor of the efflux transporter P-gp. The effect of enzalutamide on P-gp substrates has not been evaluated in vivo; however, under conditions of clinical use, enzalutamide may be an inducer of P-gp via activation of the nuclear pregnane receptor (PXR). Medicinal products with a narrow therapeutic range that are substrates for P-gp (e.g. colchicine, dabigatran etexilate, digoxin) should be used with caution when administered concomitantly with Xtandi and may require dose adjustment to maintain optimal plasma concentrations. The safety and efficacy of concomitant use of Xtandi with cytotoxic chemotherapy has not been established. Pregnancy and lactation: Enzalutamide is not for use in women. Enzalutamide is contraindicated in women who are, or who may become, pregnant. If the patient engages in sexual intercourse with a woman of childbearing potential, a condom and another form of birth control must be used during and for 3 months after treatment. Undesirable effects: Very Common (≥ 1/10): headache,

hot flush; Common (≥ 1/100 to < 1/10): neutropenia, visual hallucinations, anxiety, cognitive disorders, memory impairment, hypertension, dry skin, pruritus, fractures, falls; Uncommon (≥ 1/1,000 to < 1/100): leucopenia, seizure, amnesia, disturbance in attention. (In the AFFIRM study, six patients (0.8%) experienced a seizure out of 800 patients treated with a daily dose of 160 mg enzalutamide). Please refer to SPC for further details of other side effects. Legal category: POM/S1A. Marketing Authorisation numbers: EU/1/13/846/001. Marketing Authorisation holder: Astellas Pharma Europe B.V. Sylviusweg 62,2333 BE Leiden,The Netherlands. Further information is available from Astellas Pharma Co. Ltd., 5 Waterside, Citywest Business Campus, Dublin 24. Ph:+353 1467 1555. Date of preparation of API: February 2014 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to: Ireland, IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2. Tel: +353 1 676 4971. Fax: +353 1 676 2517. Website: www.imb.ie Email: imbpharmacovigilance@imb.ie Astellas Pharma Co. Ltd. Tel: +353 1467 1555 Email: irishdrugsafety@astellas.com

XTD 14007IE

1010976 Xtandi ad HPN A5 V3.indd 1

27/02/2014 16:41

Report: Lack of dementia care in the hospital setting, says local study Page 21 Safety CPD: IMD Drug Safety Newsletter 56th edition Page 27


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3

Issue 12

Contents

Foreword

NAHPT announce their conference dates for 2014 P4

Editor

Profile with the Mater's Professor Ciaran Meegan P9

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 define and raise standards across all levels is the over arching target within this field.

Kelly Jo Eastwood

Epilepsy Unit in Cork will open this year, says Minister P12

9

To this end, 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 maintaining and improving professional performance and contributing to the effectiveness of Ireland's health care system.

Agreement reached on clinical trial regulation P18 Award profile with the Hospital Pharmacy Team of the Year P22 22

Regulars Safety CPD: IMD Drug Safety Newsletter 56th edition P27 Clinical News - Focus on positive results for depression P20 46

Out and about P48

Appointments P51 48

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.

MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com EDITOR Kelly Jo Eastwood kelly@hospitalpharmacy.ie ACCOUNTS Julie Daly cs.ipn@btconnect.com

This issue carries details of some of the winning projects. From the lifetime achievement of Professor Ciaran Meegan to the display of pivotal skills shared and enhanced by St Vincent's University Hospital Pharmacy Department team, Ireland is fortunate to have countless individuals and teams who work tirelessly to ensure extremely high levels of pharmaceutical care and improve clinical outcomes for patients. Elsewhere in this issue, the first Irish national audit of the quality of dementia care in Ireland’s acute hospitals has shown that Ireland does not yet have standardised care for dementia in acute hospitals. The audit showed differences in the access to dementia-relevant services between hospitals, with poor access to many diagnostic and support services.

Clinical Profiles P50

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

We were very fortunate to have received so many examples of excellence for entry to the inaugural Hospital Pharmacy Awards. Whilst it is unfortunate there can only be one winner, the submissions from everyone showcased the vital role these professionals have within Ireland's health service.

CONTRIBUTORS Aza Abdulla, Margaret Bone, Nicola Adams, Alison M. Elliott, Derek Jones, Roger Knaggs, Denis Martin, Elizabeth L. Sampson, Patricia Schofield, Morgan O'Connell and Caroline Waldron

The report finds a large number of areas where change is necessary to improve the quality of dementia care in Irish hospitals. It is only hoped the recommendations and inspiration drawn from it will result in a necessary positive impact amongst this population. And to finish on another positive note, building work is ongoing in Letterkenny General Hospital to complete the new Pharmacy Department and it is hoped that it will be fully operational within a few weeks. The hospital pharmacy department was devastated by flooding last July and since that time the pharmacy has been operating from temporary premises in the Education Centre in a more remote part of the campus. But they pulled together as a team, winning runner-up at the Hospital Pharmacy Awards 2013 for Hospital Pharmacy Team of th Year and showing just what can be achieved in the face of adversity.

ART DIRECTED BY Smart Page Design www.pharmacynewsireland.com www.facebook.com/ HospitalPharmacyNews

HPN • Issue 12


4 News

Ireland Hospitals come under fire Tánaiste Eamon Gilmore

hospitals have been experiencing pressures in recent weeks due to seasonal flux. As HPN was going to press, Tánaiste Eamon Gilmore rejected the claim that overcrowding is putting patients in Tallaght hospital at risk.

Hospitals across Ireland have come under fire with claims of overcrowding and concerns being ignored. The concerns were rasied in a letter from the Emergency Medicine Trainees Association, signed by 24 of its members and sent to the HIQA health watchdog

and copied to the Health Service Executive. The letter also states that the May 2012 HIQA Tallaght Hospital report recommendations on overcrowding are being ignored by senior hospital management. The HSE has said that Irish

Speaking in the Dáil, he said he had been informed that hospital chief executive David Slevin had stated it was not the case that the health of patients was under threat. “I understand he has provided assurances that the situation is being managed and that the hospital is providing adequate patient care,’’ he added. Mr Slevin said that the hospital was experiencing an “unprecedented surge” in

admissions and that that many of the patients were sicker and had more complex medical requirements than normal. A statement obtained from the hospital stated: “Tallaght Hospital is implementing a response plan to deal with the current pressures on the Emergency Department from seasonally high admittances and attendances. "The situation is being fully managed by the Hospital and under ongoing review – some cancellations of non urgent elective and day case surgery have occurred. "Significant engagement is taking place with the medical and surgical staff in implementing the plan to address the current staff levels and maintain patient safety. "While this is clearly an undesirable situation, it is not untypical at this time of the year. The cancelations are being carried out in planned manner and patients are being notified in advance.”

HPAI signs AllTrials Petition The Hospital Pharmacy Association of Ireland have recently signed up to the AllTrials campaign. The AllTrials campaign is an initiative being led in the US by Dartmouth Geisel School of Medicine and the Darmouth

Institute for Health Policy and Clinical Practice. It was launched in January of last year and calls for all past and present clinical trials to be registered and their results reported.

A spokesperson for HPAI said: "In the interests of patient safety and to facilitate good decision making, hospital pharmacists need access to all relevant information about medicines arising from clinical trials. To deny access to information is to impair provision

of optimum patient care." For further information on the campaign, please see www.AllTrials.net

Research on Faster Construction of Engineered Tissues Macromolecular crowding (MMC) for tissue engineering is an approach proposed by researchers at the Network of Excellence for Functional Biomaterials (NFB) as a means to engineer tissues faster for transplantation. Research describing methods to speed up production of extracellular matrix (ECM) by using polydispersed macromolecules has recently been published in the most recent issue of Advanced Materials. With an impact factor of 14.829, Advanced Materials is top among all materials science journals for 2012. Injecting cells to treat injured or degenerated tissues can be used to create tissuespecific ECM which avoids the Issue 12 • HPN

shortfalls of man-made devices. Scaffolds have been used to help control the retention and distribution of transplanted cells, but their presence hinders tissue remodelling and function. Techniques such as scaffold-free cell-sheet tissue engineering (CSTE) and tissue engineering by self-assembly (TESA) have been developed which do not require the stabilisation of a scaffold. Despite the promising outcomes for various tissue types, considerable time, up to 196 days, is required for the cells to create ECM once they are transplanted and this often results in loss of cell function. Abhigyan Satyam, PhD student

Living human tissue grown

at the NFB at NUI Galway, is investigating MMC to increase

cellular activities to create ECMrich tissue equivalents faster.


5

Letterkenny General Hospital Pharmacy nears completion Building work is ongoing in Letterkenny General Hospital to complete the new Pharmacy Department. It is hoped that it will be fully operational by the end of March this year. The hospital pharmacy department was devastated by flooding last July and since that time the pharmacy has been operating from temporary premises in the Education Centre in a more remote part of the campus. Chief Pharmacist Tom Ferrie told Hospital Pharmacy News that the new facility will enjoy

Tom Ferrie, Chief Pharmacist, Letterkenny General Hospital

an expanded dispensary area, patient consultation area, seminar room, pre pack and preparation room, amongst other enhanced areas. The department had been planned before the flooding and its completion has been delayed by a number of months by factors arising from the flood.

Industry welcomes latest investment BioMarin has announced the next phase of its investment at its manufacturing operations in Shanbally, Ringaskiddy, Cork. The Cork site will manufacture products to treat rare genetic diseases. PharmaChemical Ireland, the

Ibec group that represents the pharmaceutical and chemical sector, has welcomed the launch. In addition to moves already underway to create 100 new jobs, the company plans to create a further 40 positions by 2015.

PharmaChemical Ireland Director Matt Moran said: "This investment is further evidence that the sector here is continuing to transform and grow. We continue to attract quality investment and the prospects for the industry in Ireland look

good. However, other countries are competing aggressively and we need to stay ahead. Ensuring that Ireland remains an attractive investment location must remain a top priority for government."

Patient perceptions of generic medicines The first ever study in Ireland on patients’ attitudes towards generic medicines has been carried out and shows that although patients are supportive of their more widespread use, concerns regarding safety, clinical effectiveness, and manufacturing quality of generic medicines were identified. Conducted in the time period leading up to the implementation of legislation promoting the use of generic medicines, the study highlights variable knowledge about generic medicines among this key stakeholder group.

In an attempt to benefit from the cost-savings associated with use of generic medicines, in June 2013 Ireland introduced generic substitution and reference pricing for the first time. However, perceptions of Irish patients towards generic medicines have not been published previously. Therefore, the objective of this study was to assess how generic medicines were perceived amongst patients in the time leading up to the enactment of the new legislation. A total of 42 patients were recruited from general practices

affiliated with the Graduate Entry Medical School at the University of Limerick and from community pharmacies. Interviews were semi-structured and included quantitative assessments of opinions using 15 structured questions and a five-point Likert scale response system. Interview transcripts were coded and thematically analysed using NVivo (version 9), for qualitative data. Quantitative data were analysed using SPSS (version 20). Nearly one-third (31%) of patients had no knowledge of generic medicines and 39% of those

exhibited confusion between the words ‘generic’ and ‘genetic’. Almost one-quarter (24%) held the view that generics were of poorer quality than originators, while 18% expressed the opinion that generics do not work as well as originator products. Approximately one-third (30%) of patients believed that generics were manufactured to a poorer quality, with 29% holding the view that generics are less expensive due to being of inferior quality. The study was recently published in 'Patient'.

IMB issue new Guide The Irish Medicines Board has published a new guide to additional monitoring requirements and statements encouraging reporting of adverse reactions. The guide is developed to provide guidance to marketing authorisation holders and marketing authorisation applicants on the implementation and introduction of the new requirements into the product information for medicinal products authorised in Ireland. The Guide can be accessed by visiting www.imb.ie HPN • Issue 12


6 News

Bedside scanning to reduce medication errors one, is about to be given to the right patient, has not been given already, and that it is being given at the right time, and by the right route of administration. Nurses at UZ Leuven hospital, where bedside scanning has been introduced, demonstrated to event attendees how the system works in practice, as well as the need to achieve systematic bar coding of medicines to the single unit at the point of manufacture if the patient safety system is to become more widespread in Europe. Currently UZ Leuven must place bar codes on the individual pill package after the medicines are delivered. This resource burden prevents all hospitals in Europe taking up bedside scanning technology, despite its proven impact in reducing medication error. A report of the proceedings and conclusions of a high level meeting at UZ Leuven on the subject of bedside scanning of medicines at the point of administration to the patient has recently been published. The practice of bedside scanning is important in the prevention of medication administration error in hospitals. The meeting focused on the need to improve the way medicines are bar coded in Europe in order to make bedside scanning a more common practice. Implementation is frustrated by the fact that medicines do not regularly contain a bar code on the primary package, meaning hospitals in Europe must currently conduct

relabeling of medicines in order to implement the bedside scan of a medicine. Over 80 representatives from across the healthcare spectrum, including patient groups, sectors of the pharmaceutical industry, and organisations representing doctors, nurses, and payers, met in Leuven in October 2013 to hear presentations and take part in the debate about the future. Presentations illustrated how bedside scanning can make a marked difference in terms of preventing medication administration error, a reduction of over 40% according to some studies. It enables a final check that the medicine to be given to the patient is indeed the right

The final conclusions of the event were: • Efforts towards achieving systematic bar coding of medicines to the single unit package in Europe must be better coordinated. This should bring in not only hospital pharmacy and the pharmaceutical industry, but also representatives of the packaging, software, IT and equipment industries, hospital and health system management, health insurers, and the nursing and medical professions. • This coalition for medication safety should set out one detailed requirement in respect of the requirements of single unit package bar coding, taking into

account the practicalities of the bar code including static data versus variable data. • This coalition should also look at the possibility of a step-by-step timetable for realising single unit package bar coding and give thought to constructing this timetable according to categories of medicine, whereby orphan drugs could be viewed as step 1, followed by high risk medication. • Remaining opportunities to utilise the national implementation of the Falsified Medicines Directive should be explored. Speaking about the Report, Dr Roberto Frontini, President of the European Association of Hospital Pharmacists (EAHP), said: “The Leuven event vividly demonstrated how interested every kind of health stakeholder is in improving patient safety in European hospitals. There is ample evidence of what a difference bedside scanning can make to reducing administration errors. But until systematic bar coding of medicines to the single unit at the point of manufacture takes place there is no easy way to achieve it. The suggestion that each hospital should conduct its own process of bar coding medicines after delivery is not realistic in the current resource environment. This event took us another step forward, with sensible recommendations, positive engagement from the pharmaceutical industry, and new interest shown from other health sector stakeholders.”

World first in breast cancer research New research funded by the Irish Cancer Society at NUI Galway reveals how breast cancer cells survive and become resistant to treatment. The laboratory-based research led by PhD student and Irish Cancer Society Research Scholar Patricia Cleary is the first in the world to test a new drug in Breast Cancer that is hoped to enhance how chemotherapy works.

Issue 12 • HPN

Cancer cells often grow rapidly in the body, especially in tumors, and this kind of environment can often make them become “stressed” due to a shortage of nutrients/oxygen. Cancer cells can also come under pressure and become “stressed” during chemotherapy treatment. However, cancer cells have adapted ways of coping with

theses stresses. One way of adapting and helping the cell to survive is by increasing the amount of a survival factor called XBP1s, which has been shown to help breast cancer cells survive and become resistant to treatment. Ms Clearly said: “I am looking at a new drug that no one in the world is currently working

with in Breast Cancer that stops the survival factor XBP1s from working in breast cancer cells. Initial findings from my study are very positive and show that if I take the survival factor away, the cells grow much slower and that it may aid current chemotherapeutic drugs to kill breast cancer more efficiently.”


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INCIVO® ▼ 375mg film-coated tablets PRESCRIBING INFORMATION ACTIVE 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.

More adherence3†

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. FREEPOST Pharmacovigilance Section Irish Medicines Board Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.imb.ie e-mail: imbpharmacovigilance@imb.ie 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.


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Hospital Pharmacy Awards 2013

9

Keeping an eye on the profession A 'Lifetime' of achievement for Professor Ciaran Meegan Lifetime Achievement Award 2013 The Evolution of Generics

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Noting a paucity of further educational opportunities for hospital pharmacists, and always having an eye on the progression of the profession, Professor Ciara Meegan was a noteable worthy receipient of the An and evolving company Lifetime Achievement Award, at the inaugural Hospital Pharmacy Awards 2013.Visit us during HPAI Conference

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.

Professor Ciaran John Meegan is Head of Pharmacy Services at the Mater Misericordiae University Hospital.

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The Evolution of Generics

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One of the chief instigators of the MSc in Hospital Pharmacy through Trinity College, petitioning the Department of Health for dedicated posts and funding for this novel course, Professor Meegan has tirelessly campaigned on behalf of hospital pharmacists for the promotion of their craft. An active hospital pharmacist on a national level, becoming a Council Member of the Pharmaceutical Society of Ireland (PSI) in 1994, he has also always worked in a dedicated fashion with his own staff in the Mater Hospital, ensuring the Department has kept within the financial constraints imposed, working to incredibly stringent budgets and deadlines. Professor Meegan, originally from Dundalk, Co. Louth, graduated from Trinity College Dublin in 1981 with a first class Honours Bachelor of Science degree and was awarded the ‘Welcome Award’ for Pharmacognosy. He became a member of the Pharmaceutical Society of Ireland in 1982 and went on to complete his Masters in Pharmacognosy through Trinity. Subsequently, Professor Meegan began his hospital pharmacy career in the newly opened

Professor Ciaran Meegan, Head of Pharmacy Services, Mater Misericordiae University Hospital

Noting a paucity of further educational opportunities for hospital pharmacists at the time, Professor Meegan was one of the chief instigators of the MSc in Hospital Pharmacy through Trinity College, petitioning the Department of Health for dedicated posts and funding for this novel course. Beaumont Hospital in 1988, moving to the Mater Misericordiae University Hospital (MMUH) in 1993 to head up the Pharmacy Department there. Within a short space of time Professor Meegan had made his mark in the Mater, becoming the Honorary Secretary of the Drugs and Therapeutics Committee and

a member of the Research Ethics Committee - posts he still holds to this day. From a hospital pharmacy advancement perspective, he introduced ward Clinical Pharmacy to the Mater in 1993, including the specialisation of clinical roles in cardiology, intensive care and oncology.

In 1995 he compiled the Mater’s first annual ‘Prescriber’s Guide’ to provide Mater-specific clinical advice and information on formulary drugs to newly appointed junior doctors. Says one colleague: "His ambition is highly contagious. From the moment he stepped into his hospital pharmacist shoes,

HPN • Issue 12


10

Hospital Pharmacy Awards 2013

and at senior pharmacist level in Oncology Clinical Trials and Infectious Diseases. Professor Meegan tells HPN: "Throughout my career the educational needs of pharmacy students have always been foremost and I have always been keen to instil a strong sense of professionalism in those under my tutelage." To further this ambition in 2003 the Mater Pharmacy Department began participating in six month European cross border intern training programmes, with students coming from France, Finland, Belgium, Spain and Germany – a programme which continues to date. Professor Ciaran Meegan, Head of Pharmacy Services, Mater Misericordiae University Hospital

Professor Meegan has continually strived to better conditions for both colleagues and, ultimately, patients." In 2000 he embarked on an ambitious computerisation project to commence and roll-out electronic requisitioning of drugs to all wards and clinical areas based on PDA technology. This was built on over the years and seamlessly led him in 2008 to embark on an ambitious project to commission and install an automated dispensing system – the first robot to be introduced to hospital pharmacy in Ireland! "His career has been marked with firsts," continues his colleagues. "Whether it be through dispensing, or drawing notable achievement to the grades of pharmacists themselves, Professor Meegan has never been one to sit back on his laurels and allow someone else to make the changes." With the advancement of his profession in mind, Professor Meegan put forward a business case for new specialist grades of pharmacist. These met with approval by the hospital and national funding agencies and he introduced new posts at Chief 2 level in Drug Safety, Antimicrobial Stewardship and Pulmonary Hypertension/Transplantation

Furthermore he established a new summer training programme for 3rd year pharmacy students from Irish universities in 2006. "This led to greater involvement with undergraduate students and the development of a rapport with the newly opened School of Pharmacy in the Royal College of Surgeons in Ireland (RCSI). This culminated in the signing of a unique cross campus, cross hospital, Memorandum of Understanding with RCSI in 2012, leading to the innovative introduction of pharmacy students to the clinical domain at undergraduate level," he continues. Ciaran was initially appointed as an Honorary Lecturer to the College, but was quickly granted an Honorary Professorship. Ciaran’s educational interests go beyond the disciple of pharmacy and over the years he has become a strong advocate for interdisciplinary teaching. This is evidenced by his involvement in the Professional Completion Module for final Year UCD Medical Students on Safe Drug Use and the introduction of bespoke e learning programmes for medical, nursing, pharmacy and dietetic staff in the Mater. Furthermore he has instigated negotiations with the HSE for national access to be provided to these unique programmes. In recent years Ciaran has developed a significant interest in patient safety, and more

While Ciaran has always had an eye to the progression of the profession nationally, he has also always worked tirelessly with his own staff in the Mater Hospital, ensuring the department has kept within the financial constraints imposed, working with reduced staffing when the pinch came. specifically medication safety, driving the establishment of a Drug Safety Committee in the Mater, which he chairs. Not content with local safety improvement Ciaran got involved nationally and became the inaugural Chair of the newly formed Irish Medication Safety Network (IMSN) in 2007. Furthermore he chairs and provides the opening address at the group’s now annual conference at Farmleigh, in the Phoenix Park. His ongoing dedication to patient safety was recognised in 2009 when he won the ‘Patient Safety Initiative’ at the ARAMARK Irish Healthcare Innovation Awards. "I have always been an active hospital pharmacist on a national level," he says. "This is essential." In tandem with his PSI involvement Ciaran worked extensively with the Hospital Pharmacists Association of Ireland (HPAI). He was a National Executive Member between 1994 and 2000 and was President and Vice-President on a number of

occasions between 1994 and 1998. Since 2000 he has been part of the Career Structure Negotiation team, focusing the HSE’s attentions on Hospital Pharmacists’ career structure now and into the future. In 2008 Ciaran was invited to become a member of the national ‘Medication Safety Forum’, a steering group set up by the Department of Health following the Report of the Commission on Patient Safety and Quality Assurance. This led in 2010 to membership of a ‘Never Events’ steering group and in 2011 to membership of the ‘National Medication Safety Advisory Group’, an advisory group set up by the HSE. In 2003 Ciaran became a member of the National Health Technology Advisory Committee (HTAC) and was the Chairman of its Drugs Sub-committee between 2003 and 2005. Prior to this Ciaran was a member of the Dublin Area Teaching Hospital’s (DATHs) Risk Management Advisory Group Chairman of its Abbreviations Sub Committee form 1999 to 2005. Keeping the home fires burning: While Ciaran has always had an eye to the progression of the profession nationally, he has also always worked tirelessly with his own staff in the Mater 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. A keen birdwatcher, a hopeful Everton fan, an aspiring photographer, Ciaran keeps the positive working environment of the Pharmacy Department alive with his legendary jovial table quizzes! "The Lifetime Achievement Award recognises the career and achievements of a hospital pharmacist who has made an indelible impact on the pharmacy industry within Ireland as a whole’ – I cannot think of a hospital pharmacist that deserves it more," his nominator concludes.

Investing in education and the health of the nation The Evolution of Generics Issue 12 • HPN


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12 News

Opening of new Epilepsy Unit in sight, says Minister The new Epilepsy Monitoring Unit situated at Cork University Hospital, will open later this year, the Minister for Health James Reilly has confirmed. Minister Reilly commented following repeated questions from peers on the status of the unit, which was scheduled to open last year. It was refurbished in the Autumn of 2012. Deputy Jonathan O'Brien highlighted that the hospital have diverted funding received for the unit to other services/ projects within the hospital. "This is a most crucial yet basic service for person's with difficultto-control epilepsy and there is only one other functioning unit in the country, at Beaumont, which re-opened this summer having also been closed for over nine months with many people continuing to be referred abroad for essential monitoring as a result," he said. In reponse, the Minister stated: "The Executive Management Board of Cork University Hospital allocated ward 3A as a suitable location for the dedicated Epilepsy

Deputy Jonathan O'Brien TD

Monitoring Unit to be shared with the facility for stroke services. Funding of ¤140,000 was provided for the infrastructural upgrade of ward 3A and a further ¤217,000 was provided for the purchase of the required epilepsy monitoring equipment. "The HSE has advised that in order to commission the unit, the recruitment of additional nursing and allied health professional staff is required. Interviews for the Neurophysiology Technician posts have been completed and the HSE National Recruitment Agency is contacting successful candidates to offer contracts of employment. Recruitment of nursing staff has, I understand, been particularly challenging, but I am assured that the recruitment process is in the final stages, and candidates who were successful at interview are now being offered contracts of employment. "The HSE has advised that the Unit is now equipped and will open on the 31 March 2014."

New shortages catalogue In late November 2013 the European Medicines Agency (EMA) made available a new online catalogue containing information on medicine shortages that affect, or are likely to affect, more than one European Union (EU) Member State, where the European Medicines Agency has assessed

the shortage and provided recommendations to patients and healthcare professionals across the EU. However the catalogue does not give a complete overview of all medicine shortages occurring in the EU as the Agency consider

that most of these are dealt with at a national level. The catalogue is available via the human medicines section of the EMA website at www.ema.europe.eu

BD and CME to extend Irish coverage BD (Becton, Dickinson and Company), a leading global medical technology company, has announced that following the approval of the BD Saf-T-Intima™ Safety Integrated IV Catheter System for use in subcutaneous infusion therapies that it will be collaborating with pain management and palliative care

Issue 12 • HPN

infusion pump specialists, CME Medical, to increase coverage in the UK and Ireland and to provide expanded specialist support to its growing Saf-T-Intima™ customer base. Jonathan Hughes, UK Marketing Manager for BD explains, “BD Saf-T-Intima™, for use in

subcutaneous infusion therapies such as rehydration and palliative care, is growing in popularity due to an increasing number of healthcare professionals who are looking for ways to increase patient comfort and in-dwell times while enabling cost savings and reducing the risk of sharps injuries and infection.

With palliative care being a key therapy area for subcutaneous infusion, it was a logical step for BD to collaborate with CME Medical which already has a large and clinically respected presence within Acute and Community Care following the popularity and wide adoption of CME Medical’s T34TM Ambulatory Syringe Pumps.”


Votrient® (pazopanib) is indicated in adults for the first line treatment of advanced Renal Cell Carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.

VOTRIENT® (pazopanib) 200 mg and 400 mg film-coated tablets, cardiac disease. Base line & periodic monitoring of electrocardiograms and Abridged Prescribing Information (Refer to the full Summary of Product maintenance of electrolytes within normal range is recommended. Arterial Characteristics before prescribing) thrombotic events: Use with caution in patients who are at increased risk for myocardial infarction, ischaemic stroke, & transient ischaemic attack. PRESENTATIONS: Each tablet contains 200 mg & 400 mg pazopanib (as Venous thromboembolic events (VTE): In clinical studies, VTEs have hydrochloride) respectively for 200 mg film-coated tablets & 400 mg film- occurred. Incidence was higher in STS patients than RCC patients. coated tablets in HDPE bottles with polypropylene child resistant closures Thrombotic Microangiopathy: Thrombotic microangiopathy (TMA) has been containing either 30 or 90 tablets. INDICATIONS: First line treatment of reported in clinical trials of pazopanib as monotherapy, in combination with adults with advanced Renal Cell Carcinoma (RCC) & for patients who have bevacizumab, and in combination with topotecan (see SPC section 4.8). received prior cytokine therapy for advanced disease. Adults with selective Haemorrhagic events: Not recommended in patients with history of subtypes of advanced Soft Tissue Sarcoma (STS) who have received prior haemoptysis, cerebral, or clinically significant GI haemorrhage in the past 6 chemotherapy for metastatic disease or who have progressed within 12 months. Use with caution in patients with significant risk of haemorrhage. months after (neo) adjuvant therapy. Efficacy and safety has only been GI perforations and fistula: Use with caution in patients at risk for GI established in certain STS histological tumour subtypes. POSOlOgy & perforation or fistula. Wound healing: Since VEGF inhibitors may impair ADmINISTRATION: Treatment only to be initiated by a physician wound healing, pazopanib treatment should be stopped at least 7 days prior experienced in administration of anti-cancer agents. Adults: Recommended to scheduled surgery. Discontinue pazopanib use in patients with wound dose is 800 mg once daily. Dose modification should be in 200 mg dehiscence. Hypothyroidism: Patients with hypothyroidism should be increments. Max dose is 800 mg. Paediatric: Should not be used in children treated as per standard medical practice prior to start of pazopanib under 2 years of age. The safety & efficacy of pazopanib in children & treatment. Observe closely for signs & symptoms of thyroid dysfunction. adolescents aged below 18 years of age have not been established. Elderly: Perform laboratory monitoring of thyroid function periodically. Proteinuria: Greater sensitivity of some older individuals cannot be ruled out. Renal Monitor patients for proteinuria and discontinue if patient develops Grade 4 impairment: No dose adjustment required if creatinine clearance above 30 proteinuria. Pneumothorax: Monitor patients closely for signs & symptoms ml/min. Caution advised if creatinine clearance below 30 ml/min. Hepatic of pneumothorax. Infections: Cases of serious infections (with or without impairment: Caution if administered to patients with mild or moderate neutropenia), in some cases with fatal outcome, have been reported. hepatic impairment. Patients with mild abnormalities in serum liver tests Combination with other systemic anti-cancer therapies: Clinical trials of should be treated initially with 800 mg once daily while a reduced dose of pazopanib in combination with pemetrexed & lapatinib were terminated 200 mg once daily is recommended for patients with moderate hepatic early due to concerns over increased toxicity and /or mortality. impairment. Pazopanib is not recommended in patients with severe hepatic INTERACTIONS: CYP3A4 inhibitors & inducers may alter the metabolism of impairment (defined as total bilirubin >3 X ULN regardless of any level of pazopanib. Co-administration of pazopanib with strong inhibitors of the ALT). Pazopanib should be taken without food, at least one hour before or CYP3A4 family (e.g. ketoconazole, itraconazole, clarithromycin, atazanavir, two hours after a meal. Tablets should be taken whole with water & not indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, broken or crushed. CONTRAINDICATIONS: Hypersensitivity. SPECIAl voriconazole) may increase pazopanib concentrations & should be avoided WARNINgS & PRECAUTIONS: Hepatic effects: Cases of hepatic failure (see SPC section 4.4). If no medically acceptable alternative to a strong (including fatalities) have been reported during use of pazopanib. Use with CYP34A inhibitor is available, the dose of pazopanib should be reduced to caution & close monitoring in patients with mild/moderate hepatic 400 mg daily during concomitant administration. Grapefruit juice contains impairment. Concomitant use of pazopanib & simvastatin increases the risk an inhibitor of CYP3A4 and may increase plasma concentrations of of ALT elevations (see SPC Section 4.4). Hypertension: Patient should have pazopanib. CYP3A4 inducers such as rifampicin may decrease plasma a well controlled blood pressure prior to initiating pazopanib; monitor for pazopanib concentrations. Pazopanib is also a substrate for P-gp & BCRP hypertension (early after starting treatment & frequently thereafter) & (breast cancer resistance protein). Co-administration of pazopanib with manage as needed with standard anti-hypertensive therapy & dose potent P-gp or BCRP inducers or inhibitors may alter the concentration of adjustment. Pazopanib should be discontinued if there is evidence of pazopanib. In in vitro studies pazopanib inhibited CYP enzymes 1A2, 3A4, persistently elevated values of blood pressure (140/90 mmHg) or if arterial 2B6, 2C8, 2C9, 2C19, & 2E1. Pazopanib increased the mean AUC and Cmax hypertension is severe and persists despite anti-hypertensive therapy & of midazolam & paclitaxel and the ratio of dextrometrophan to dextrophan pazopanib dose reduction. Posterior reversible encephalopathy syndrome concentrations in the urine after oral administration of dextromethorphan (PRES) / Reversible posterior leukoencephalopathy syndrome (RPLS): (CYP2D6 probe substrate). In vitro, pazopanib inhibited human organic PRES/RPLS has been reported in association with pazopanib. PRES/RPLS anion transporting polypeptide (OATP1B1). It cannot be excluded that can present with headache, hypertension, seizure, lethargy, confusion, pazopanib will affect the pharmacokinetics of substrates of OATP1B1 (e.g. blindness and other visual and neurological disturbances, and can be fatal. statins). Concomitant use of pazopanib & simvastatin increases the Patients developing PRES/RPLS should permanently discontinue treatment incidence of ALT elevations. It cannot be excluded that pazopanib will affect with pazopanib. Cardiac Dysfunction/Heart Failure: Use with caution in the pharmacokinetics of other statins (e.g. atorvastatin, fluvastatin, patients who have pre-existing cardiac dysfunction (see SPC Section 4.4). pravastatin, rosuvastatin) & therefore affect ALT levels. Concomitant QT prolongation and Torsade de Pointes: Use with caution if a history of QT administration of pazopanib with esomeprazole decreases the bioavailability interval prolongation exists, if co-administering with antiarrythmics or other of pazopanib by approximately 40% (AUC and Cmax) and co-administration QT interval-prolonging medicines or in patients with relevant pre-existing of pazopanib with medicines that increase gastric pH should be avoided. If ©GlaxoSmithKline, 2013. All rights reserved. Job code: IE/PAZ/0015/13. Date of preparation: December 2013.

the concomitant use of a proton-pump inhibitor (PPI) is medically necessary, it is recommended that the dose of pazopanib be taken without food once daily in the evening concomitantly with the PPI. Concomitant administration of pazopanib with uridine diphosphate glucuronosyl transferase 1A1 (UGT1A1) substrates (e.g. irinotecan) should be undertaken with caution since pazopanib is an inhibitor of UGT1A1. PREgNANCy & lACTATION: Pazopanib should not be used during pregnancy unless the clinical condition of the women requires treatment. Women of childbearing potential should be advised to use adequate contraception and avoid becoming pregnant while receiving treatment with pazopanib. Breast feeding should be discontinued. Animal studies indicate that male & female fertility may be affected. AbIlITy TO DRIVE & USE mAChINES: Patients should avoid driving or using machines if they feel dizzy, tired or weak. UNDESIRAblE EFFECTS: Very Common (≥ 1/10): hyperalbuminemia, decreased appetite, weight decrease, dysgeusia, hypertension, diarrhoea, nausea, vomiting, abdominal pain, stomatitis, hair colour change, palmarplantar erythrodysaesthesia, Alopecia, skin hypopigmentation, rash, exfoliative rash, fatigue, , headache, elevated AST & elevated ALT. Common (≥ 1/100, < 1/10): Gingival infection, hypothyroidism, hypophosphataemia, dehydration, insomnia, peripheral sensory neuropathy, dizziness, lethargy, paraesthesia, vision blurred, cardiac dysfunction, left ventricular dysfunction, bradycardia, venous thrombolytic event, hot flush, flushing, epistaxis, dysphonia, dyspnoea, haemoptysis, cough, pneumothorax, hiccups, pulmonary haemorrhage, dry mouth, dyspepsia, mouth haemorrhage, mouth ulceration, chills, stomatis, flatulence, anal haemorrhage, abdominal distension, hepatic function abnormal, hepatoxicity, hyperbilirubinaemia, alopecia, skin disorder, skin hypopigmentation, erythema, nail disorder,pruritus, skin depigmentation, dry skin, hyperhidrosis, arthralgia, musculoskeletal pain, myalgia, muscle spasms, proteinuria, asthenia, mucosal inflammation, oedema, chest pain. The following undesirable effects are very common for the STS indication and common for the RCC indication; tumour pain, thrombocytopenia, neutropenia, leukopenia. For more details on undesirable effects, please see SmPC. marketing authorisation (mA) Number: EU/1/10/628/001-004 mA holder: Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom. legal category: POM. Date of preparation of API: August 2013 (Copy Approval Code: IE/PTV/0021/13). Further information available on request from GlaxoSmithKline, Stonemasons Way, Rathfarnham, Dublin 16 Tel: 01-4955000. Adverse events should be reported directly to the IMB; Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.imb.ie, e-mail: imbpharmacovigilance@imb.ie Adverse events should also be reported to GlaxoSmithKline on Free phone 1800 244 255, Fax 01 4938839 or e-mail ireland.drugsurveillance@gsk.com References: 1. Motzer RJ, Hutson TE, Cella D, et al. Pazopanib versus sunitinib in metastatic renal cell carcinoma. 2. Votrient SPC July 2013.


14 News

Ireland urged to support rare diseases On the occasion of World Rare Disease Day (28 February), Dr Roberto Frontini, President of the European Association of Hospital Pharmacists (EAHP), has added his voice to calls for all European countries to design and implement national rare disease plans. A 2009 European Council recommendation encouraged all EU Member States to put in place national strategies to improve care for citizens living with a rare disease by the end of 2013. However at the beginning of 2014 only 19 of the EU’s 28 member

countries have published and shared such plans.

together with the information that they need to use them effectively.

Dr Frontini described the situation as “regrettable” and urged the remaining national health systems to make meeting the 2009 Recommendation a greater priority:

"Hospital pharmacy is also central to improving the pan-European knowledge base in rare disease. Rare disease treatment and the conduct of clinical trials are key parts of our professional specialisation.”

“Hospital pharmacy should be a key part of rare disease plans, for example, in ensuring efficient discharge and interface management of medicines, and enabling patients to receive individually prepared medicines -

Speaking more widely, Dr Frontini said: “The theme of this year’s Rare Disease Day, 'join together for better care', is an excellent motif

for the way we need to work together to deliver better care for rare disease patients. It reminds of the need for health professionals to work collaboratively, and for European countries to combine resource and expertise in rare disease treatment. "I hope the spirit of cooperation between national health systems that was at the heart of the 2009 Recommendation can be met via its full realisation, and further progress made from there.”

Dr Gahan presents on BioMedical Applications Dr. Cormac Gahan

international conference on ‘The Synthetic Biology Future’ to be held in Cork this month (March). The conference featured some of the world’s leading scientists and entrepreneurs in the field of Synthetic Biology to discuss the opportunities and challenges that exist within this exciting new field.

Dr. Cormac Gahan, senior lecturer in Microbiology within the School of Pharmacy at University College Cork, has presented his work on ‘BioMedical Applications in Synthetic Microbiology’ at an

Synthetic biology is an emerging field that combines engineering principles with biology to create useful biological systems with biotechnological or therapeutic applications. The field was galvanised by the recent creation of a synthetic microorganism

(Mycoplasma mycoides JCVI-syn1.0) at the J Craig Venter Institute in the US that demonstrated the potential for this field to produce drug and vaccine delivery systems based upon synthetic life. Dr Gahan described work carried out within the School of Pharmacy, School of Microbiology and Alimentary Pharmabiotic Centre that uses controlled engineering of microorganisms to investigate applications in therapeutic drug delivery, vaccine delivery and gastrointestinal metabolism.

IIOP Information Meetings The Irish Institute of Pharmacy (IIOP) will hold a series of information events around the country in April and May. These will address the IIOP’s role and intended programme. Pharmacists are encouraged to attend to meet with Peer Support Pharmacists in their area and to learn of upcoming activities with the IIOP. Dates and locations are available on the IIOP website at www.iiop.ie

Irish scientist to light up Times Square An Irish scientist will light up Times Square New York next month with his striking image of a lung cancer cell surrounded by a green glow. The image was taken by Dr Martin Barr, Clinical Scientist and Adjunct Assistant Professor at the Institute of Molecular Medicine in Trinity College Dublin and St James’s Hospital, who was announced as a winner of an international competition that showcases the Issue 12 • HPN

beauty of cells and the inspiring research conducted by cellular biologists around the world. The three winners of GE Healthcare Life Sciences’ 2013 Cell Imaging Competition will see their images displayed on high resolution screens in New York’s Times Square next month. Dr Barr’s image which was taken

as part of his ongoing research to better understand and fight resistance to lung cancer treatments shows in extraordinary detail a lung cancer cell from one of the most common forms of lung cancer; non-small cell lung cancer (NSCLC). The cell measures just one thousandth of a millimetre, similar in width to a cotton fibre,

and is shown in a low-oxygen environment known as ‘hypoxia’. This environment, commonly seen in many solid tumours, makes cancer cells more resistant to chemotherapy and encourages the cancer to spread in the majority of patients. The aim of Dr Barr’s research is to target cellular processes triggered by hypoxia in order to make tumours more susceptible to chemotherapy.


15

Collaborative care necessary says Commission Responding to a consultation by the European Commission on the future of EU activity in the field of patient safety, the European Association of Hospital Pharmacists (EAHP) gave a clear message: make collaborative care happen, develop health professional roles, and promote better use of technology. The European Commission conducted a public consultation to gauge the views of stakeholders on the best next steps for the EU to help member states coordinate patient safety improvement. The consultation asked the questions: 'Which areas of patient safety are important for increasing safety of patients in the EU?â&#x20AC;&#x2122; and ' What are the barriers to implementation of patient safety improvements?'. The consultation came in the context of the 2009 European Council Recommendation on patient safety, agreed by the governments of EU countries. The recommendation set out desired activities by health systems inf: combatting antimicrobial resistance; better meeting the challenge of healthcare acquired infections; and instilling adverse event reporting systems and cultures of working. Five years on from the Recommendation and the Commission is leading a review of its implementation, including consideration of renewed recommendations. Contributions from external stakeholder organisations were consequently invited.

Reflecting on the contents of the 2009 Recommendation, and where room existed for improvement, EAHP picked out 3 areas that were under-developed in the original recommendations: > collaborative care, > patient-centred health professional role development, and > better use of technology. Speaking about the response made on behalf of the European hospital pharmacy profession, EAHP President Dr Roberto Frontini said: "Any fresh cooperation between EU countries on patient safety must be welcome and I thank the Commission for providing an opportunity to stakeholders to give perspectives. "There are 3 areas of healthcare practice we know can positively impact patient safety: collaborative care, patient-centred health professional role development, and better use of technology. EAHP therefore emphasised these points in our response to the Commission's consultation and we trust they will be positively received and reviewed. "Beyond this, we also called for the Commission to consider some of the barriers that prevent implementation of patient safety improvement initiatives, including finance, policy coordination and political will. "Patient safety involves everyone

in the health sector, and EAHP hopes open dialogue with stakeholders on achieving continual improvement of patient safety right across Europe can

continue. European citizens should not expect any less of their governments."

Prescribing to reduce patient harm Researchers 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 significant reduce potential misuse of 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.

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.

During the first half of the 12-month trial, researchers monitored patients' current duration of antibiotic use. In the second half, patients receiving antibiotics followed the new prescribing strategy.

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.

During both phases of this study,

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."

Dr Matthew Lloyd, lead author from the University of Dundee, HPN â&#x20AC;˘ Issue 12


16 Feature

The evolving field of cannabinoid research Written by Florian Schiebien, Editorial Contributor

In 1837, Limerick-born Sir William Brooke O’Shaughnessy, MD, published the first Western scientific article on cannabisbased medicinal preparations in the Provincial Medical Journal. Last April, approximately 170 years later, Trinity College Dublin (TCD) hosted the Sixth European Workshop on Cannabinoid Research. The conference was organised by the British Pharmacological Society and a number of Irish cannabinoid researchers from Trinity College Dublin (TCD), National University of Ireland (NUI) Galway, University College Dublin (UCD) and University College Cork (UCC). Cannabis-derived cannabinoids At the conference, Prof Roger Pertwee, Professor of Neuropharmacology at the University of Aberdeen, and one of the world’s most-cited pharmacologists, informed attendees of the complexity of the cannabis plant. He explained that cannabisderived phytocannabinoids, such as delta-9-tetrahydracannabinol (THC) and cannabidiol (CBD), occur in varying quantities within herbal cannabis material; dependent on strain, cultivation technique and conditions, parts used, processing, and storage, as well as a host of other factors. “There are over 100 phytocannabinoids and at least 440 other chemical compounds within cannabis, most of which have not been fully studied or have been neglected altogether,” he told IPN. Prof Pertwee has been conducting laboratory based tests on CBD, cannabidiolic acid (CBDA) and cannabigerol (CBG). “Both CBD and CBDA, through their indirect activation of the 5- hydroxytryptamine 1a ( 5 HT1A)  receptor, could well prove be effective for the treatment of L-dopa dyskinesia; extrapyramidal syndrome; anxiety; stroke; Parkinson’s disease symptoms; depression; and neuropathic pain.  CBG - which blocks 5HT1A receptors and activates α2-adrenoceptors with significant potency - may have a role to play in the treatment of schizophrenia;

Issue 12 • HPN

and, intriguingly, also of depression and neuropathic and inflammatory pain,” he said. Meanwhile, Prof Raphael Mechoulam, Professor of Medicinal Chemistry at the Hebrew University of Jerusalem, Israel whose laboratories first isolated both THC and CBD in the early 1960s - informed conference attendees of the relative safety, even long term, of CBD. “Many years ago the National Institute of Health (NIH), in the United States, undertook animal toxicity trials with CBD. No major problems were noted. We gave CBD, 200-300 mg daily, for 4 1/2 months to patients with epilepsy. The drug was very effective and no side effects were noted.” “Recently, Leweke compared high doses (800 mg daily for 4 weeks) of CBD with an approved antischizophrenic drug. Both drugs were efficient but, contrary to the approved drug, CBD did not cause side effects. Today CBD (together with THC) is an approved drug in several countries as a component of Sativex which is marketed as an oromucosal spray by GW Pharmaceuticals,” he said. Sativex is a licensed medication for Multiple Sclerosis-associated spasticity in UK, Spain, Germany, Denmark, the Czech Republic, Sweden, New Zealand and Canada and is likely to be available on prescription in Ireland for this indication in the near future. Sativex is also being investigated for a number of other conditions including neuropathic pain, cancer pain, rheumatoid arthritis, bladder dysfunction and cannabis dependency. According to Edison Investment Research, GW Pharmaceuticals are currently also in the initial stages of developing a number of other cannabinoid-based preparations, including: a tetrahydracannabivarin (THCV) - based preparation for type II diabetes; a 20/1 CBD: THC preparation for ulcerative colis; a CBD-based preparation for schizophrenia; a cannabidivarin (CBDV)-based preparation for epilepsy; and a THC/CBD preparation for gliomas. Cannabinoids: anticancer? Whilst THC is available in many

countries in the sesame oil based preparation Marinol (Drobinol), approved for the treatment of nausea, vomiting and appetite loss associated with chemotherapy, evidence accumulating for approximately 40 years suggests that THC, and other cannabinoids, exert a specific anticancer action that could potentially be utilised in the treatment of cancer, directly. A review published in 2012, in Nature Reviews Cancer, summarized research: “cannabinoids induce tumour cell death and inhibit tumour angiogenesis and invasion in animal models of cancer”; concluding: “clinical trials testing them as single drugs or, ideally, in combination therapies in glioblastoma and other types of cancer are feasible and promptly needed”. There exists a number of recent preclinical studies that suggest synergy between several cannabinoids and a number of common chemotherapeutic drugs: a Japanese study published, in 2009, in Journal of Surgical Research, found synergism  with paclitaxel in gastric cancer; a Swedish study also published, in 2009, in Cancer, Chemotherapy and Pharmacology found synergism with 5fluorouracil in colorectal carcinoma; and an Italian study published, in 2011, in Cell Death Disease, found synergism with gemcitabine in pancreatic cancer. Prof Manuel Guzman, Professor of Biochemistry and Molecular Biology, Madrid Complutense University, Spain, spoke about his research into the potential anticancer activity of cannabinoids both in isolation, and in synergism, with chemotherapeutic drugs: a study published in the British Journal of Cancer, in 2006, found that pure THC administered both intracranially and intratumorally led to some benefits in nine glioblastoma multiforme patients; another study, published in Molecular Cancer Therapeutics in 2011, found that CBD exerted independent anticancer effects when combined with THC and temozolomide, in animal models, in the same condition. “There is preclinical evidence from mouse studies for a synergic action between cannabinoids

and other chemotherapeutic drugs, and this could provide the rationale for future clinical studies in humans with combinational chemotherapies that include cannabinoids as one of their ingredients,“ Prof Guzman told IPN. The Endocannabinoid system Whilst the structures of THC and CBD were first isolated approximately 50 years ago, it wasn’t until 1988 that the first cannabinoid receptor, CB1,was discovered by Dr William Devane, PhD, currently a postdoctoral researcher in NUI Galway- working with Dr David Finn, PhD, Lecturer in Pharmacology at NUI Galway, and Chair of the Conference Organising Committee. This discovery essentially provided a biochemical foundation for how cannabinoids –and, by extension cannabis- exert their effects on the human body. Subsequently, Dr. Devane, Prof. Mechoulam, and a team of other researchers at Hebrew University, Israel isolated and synthesized the first endogenous cannabinoid or endocannabinoid, anandamide, which acted on this receptor. Later, another endocannabinoid, 2-arachidonylycerol (2-AG), was also discovered in Prof Mechoulam’s lab. In 1993, a team of Cambridge researchers discovered the cannabinoid 2 (CB2) receptor; however, anandamide and 2-AG “bind better to CB1 than to cannabinoid 2 (CB2) receptors” Prof Mechoulam, told IPN. Beta caryophlene, a constituent of black pepper, avocados, thyme, rosemary, coriander, hops, and various other plants acts on the CB2 receptor; as do alklyamides, the active constituents of the herb Echinacea. Prof Mechoulam, -who held a keynote lecture on the future of endocannabinoid research informed attendees that the CB2 receptor could play a role in the treatment of a large variety of conditions. “The endocannabinoid system is found in many organs, including the brain. In many diseases its levels are enhanced, especially the CB2 receptor as well as the


17 endocannabinoids themselves. Action on the CB2 receptors usually has a beneficial effect,” Prof Mechoulam, he said. Endocannabinoids, cannabinoid receptors, and various enzymes that assist in the synthesis and degradation of endocannabinoids form what is commonly referred to as the endocannabinoid system. Prof Vincenzo Di Marzo, Director at the Institute of Biomolecular Chemistry of the National Research Council (ICB-CNR), Italy, and Adjunct Associate Professor of Pharmacology and Toxicology at Virginia Commonwealth University (VCU), US - who first proposed the term endocannabinoid systemsummarizes the current research on the far reaching functions of the system as “relax, eat, sleep, forget and protect”. Endocannabinoids, like anandanmide and 2-arachidonylylycerol (2-AG), are degraded naturally in the body by two key enzymes: fatty acid amide hydrolase (FAAH), and monoacylglycerol lipase (MAGL). At the conference, FAAH and MAGL inhibition were presented as potential treatment strategies for pain: Prof DiMarzo’s colleague at VCU, Prof Aron Lichtman,

Professor of Pharmacology and Toxicology, held a keynote lecture, on the use of FAAH and MAGL inhibitors, for the treatment of pain; and Dr Finn presented data on the role of FAAH in pain modulation during anxiety. Concurrently, Prof Andrea Hohmann, Linda and Jack Gill Chair of Neuroscience, Department of Psychological and Brain Sciences, Indiana University, Bloomington, USA, told IPN: “Inhibitors of MAGL, as well as brain permeant and impermeant inhibitors of FAAH, have utility in the treatment of chemotherapyinduced peripheral neuropathy”. At the end of the conference, in a comment on an intellectual speculation, published last January, in Annual Review of Psychology, Prof Mechoulam suggested that fatty acid amino acids (FAAA) - which are related to endocannabinoids - could play a role in the biochemical formation of personality; and suggested this as an avenue for future research. Approximately 70 years after the discovery of the first cannabinoids, 50 years after their isolation, and 25 years after the discovery of the endocannabinoid system, Prof Mechoulam remains excited and optimistic for a promising future of

Professor Roger Pertwee, Professor Raphael Mechoulam and Dr David Finn, NUI Galway and Chairperson of the conference organising committee

cannabinoid research. The conference received support and sponsorship from Science Foundation Ireland, The Irish Research Council, The Royal Academy of Medicine in Ireland,

The British Pharmacological Society, Fáilte Ireland, The International Society for Neurochemistry, Industry sources and NUI Galway’s Centre for Pain Research.

Public hospitals perform best in antimicrobial policy Professor Stephen Byrne, Head, School of Pharmacy, UCC and one of the report co-authors Most AMTs have representation by Consultants and Pharmacists, but audit and feedback of antibiotic prescribing activities is limited, said the reports authors. Significant differences in audit activities were found between public and private hospitals, with private hospitals performing less well. The survey was entitled, 'A crosssectional survey of the profile and activities of Antimicrobial Management Teams in Irish Hospitals.' Around half of Irish hospitals do not have an antimicrobial management team in place but most hospitals have an antimicrobial prescribing policy, according to a new Irish research study.

Background Surveillance of antimicrobial prescribing, in order to control the increase in antimicrobial resistance, is recommended by the Guidelines for Antimicrobial Stewardship in Hospitals in Ireland.

The objective of this study was to determine the profile and activities of Antimicrobial Management Teams (AMTs) in Irish Hospitals by surveying hospital pharmacists. A self-completion postal questionnaire was developed from a recent study conducted by members of the authoring team in the United Kingdom, adapted for the Irish context. It was issued to all hospitals in Ireland (n = 70). Differences in responses, using Pearson's Chi squared tests, were evaluated between public and private hospitals to determine whether the funding category had an effect on activities. Main outcome measures: (1) A profile of AMTs in Ireland. (2) The presence and content of antimicrobial prescribing policies and how adherence to the policies is measured. The response rate was 73 % (n = 51, 71 % public). 57 % (29/51) of hospitals have an antimicrobial management team in place with

93 % (27/29) having a Consultant Medical Microbiologist, 24 % (7/29) having a Consultant in Infectious Diseases and 69 % (20/29) having an Antimicrobial Pharmacist. There is an antimicrobial prescribing policy in place in 88 % (45/51) of hospitals responding. 80 % (36/51) of replies report that the volume of antibiotics prescribed is monitored, 47 % (24/51) conduct audits to measure appropriateness of all antibiotics prescribed and 43 % (22/51) conduct audits of appropriate prescribing of restricted antibiotics. Public hospitals were significantly more likely than private hospitals to review the volume of antibiotics prescribed (p = 0.021) and to audit the appropriateness of restricted antibiotics use (p = 0.003). A lack of resources was reported as the main barrier to antimicrobial surveillance by hospital pharmacists.

HPN • Issue 12


18 News

Agreement on content of new EU trials regulation criticisms that the 2001 Directive created a more burdensome and bureaucratic environment for conducting clinical trials, with evidence of a reduced number of trials taking place in Europe as a result. The new regulation will therefore: • reduce the potential for member states to interpret requirements differently, which has lead in the past to duplication in assessment and authorization procedures for multi-national trials;

At the end of December 2013, the European Commission, Council of Ministers (representing EU Governments), and the European Parliament reached agreement on the terms of a new EU clinical trials regulation.

The new regulation will replace the current, and much criticised, 2001 Directive on the operation of clinical trial authorisation procedures within the EU. The new regulation is aimed primarily at dealing with

• create a single EU portal for trial assessment and authorization, under the authority of the European Medicines Agency; and, • introduce more proportionate forms of regulatory requirement where a trial is considered to be of a lower risk profile (e.g. a trial into the extended use of an already licensed product).

The proposed regulation was originally published in late 2012 and was subject to scrutiny and review by the European Parliament over the course of 2013. The European Parliament had been particularly keen to achieve improvements in the regulation in terms of public transparency of the clinical trials process. It succeeded in gaining amendments in areas such as: • further requirements upon clinical trial sponsors to openly publish clinical study reports; • ensuring that lay summaries of trials will be produced by their sponsors and published openly; and, requirements that trial protocols include a description about how patients were involved in the design of the trial.

EAHP Annual Congress As we were going to press, the 19th Congress of the EAHP in Barcelona was taking place. At the end of last month organisers published the full schedule of keynote speakers, workshops, symposiums and satellite events. The 19th Congress of the EAHP took as its theme: “The innovative hospital pharmacist – imagination, skills and organization” and was held from March 26-28th in Barcelona. The next issue of Hospital Pharmacy News will carry a full conference report with abstracts and imagery.

Sanofi to expand clinical trial access Starting in January, Sanofi have expanded access to information and data from clinical trials, sponsored by companies of the Sanofi group, in support of industry-wide efforts to promote a set of Principles for Responsible Sharing of Clinical Trial Data that the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) jointly released in July 2013.

Issue 12 • HPN

"Sanofi has a history of contributing in this collective effort of sharing clinical trial data and results with researchers and patients with initiatives such as Project Data Sphere, an independent initiative of the Life Sciences Consortium of the CEO Roundtable on Cancer, the Coalition Against Major Diseases, and Prize4Life", said Christopher A. Viehbacher, Sanofi Chief Executive Officer and currently serving as President of EFPIA. "Finding new therapies can be

accelerated by fully sharing the successful and unsuccessful research results with other researchers. Data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers. The private sector has taken a lead on this which I would hope academic researchers will follow." Sanofi will provide access to clinical trial data and related documents, including Clinical Study Reports (CSR), for studies sponsored by Sanofi companies

that conduct clinical studies in humans. These studies must have been submitted to US and EU regulatory agencies and the product must have been approved by both agencies on or after January 1, 2014. For Sanofi Pasteur, requested studies must have been submitted either to the US or EU regulatory agencies and the product must have been approved by either agency on or after January 1, 2014.


Why Mylan? See inside. Whether it’s ensuring a steady supply of high quality products, providing innovative solutions to meet more needs, or partnering with customers to optimize efficiency—at Mylan, we’re relentless about getting it right.

Scan this code or visit SeeInsideMylan.com to see more from Mylan. Copyright 2012 Mylan Inc. MYL53132 1/2012

Seeing is believing


DRUG BULLETIN

20 Drug News

Issue 12 â&#x20AC;˘ HPN

Focus on positive results for depression Results have been announced from FOCUS, a new study showing that Brintellix (vortioxetine) 10 mg and 20 mg, met its primary endpoint in demonstrating superiority versus placebo in a composite score of two tests, the Digit Symbol Substitution Test (DSST) and Rey Auditory Verbal Learning Test (RAVLT), that measure cognitive function in adults with major depression. In this study, Brintellix was shown to improve measures of cognitive domains such as executive function, speed of processing and attention. These data were presented at the 52nd Annual Meeting at the American College of Neuropsychopharmacology (ACNP) in Hollywood, Florida. The results were announced by Lundbeck. FOCUS, a global, eightweek, randomized, double-blind, parallelgroup, placebo-controlled, fixed-dose study evaluated the efficacy of Brintellix on cognitive function and major depression across three arms in around 600 patients aged 18-65 with an acute episode of major depression. Cognitive function was measured in a series of validated tests that assessed changes from baseline to week 8 on specific cognitive domains known to be impaired in major depression, including executive function, speed of processing, attention and memory. On the study's primary endpoint, Brintellix 10 mg and 20 mg demonstrated a statistically significant improvement in cognitive performance versus placebo (0.36 and 0.33 respectively, p<0.0001), as assessed by a composite score of two validated

neuropsychological tests, DSST and RAVLT. The improvement in cognitive performance was shown to include a direct effect of Brintellix and was not solely due to improvement in depressive symptoms (MADRS score). The study also showed significant improvements in cognitive symptoms for both Brintellix 10 mg and 20 mg assessed with a patient-reported outcome questionnaire (PDQ), which supports the clinical relevance of the findings in the neuropsychological tests. The most commonly observed adverse events in patients treated with Brintellix (incidence â&#x2030;Ľ5%) were nausea (4.1%, 16.4%, and 20.8%) and headache (7.1%, 8.2%, and 12.6%) for placebo, Brintellix 10 mg and 20 mg, respectively. Overall, the most frequent primary reason for withdrawal was adverse events (AE) for placebo (4.1%), Brintellix 10 mg (3.6%) and Brintellix 20 mg (5.3%). "Neuropsychological tests are powerful indicators of cognitive function but are not routinely used in everyday, busy clinical practice, so it was equally important to understand how patients reported changes in cognitive

symptoms that they experienced," explained Dr. Roger McIntyre, Professor of Psychiatry and Pharmacology at the University of Toronto. "We are encouraged that Brintellix not only showed benefits in cognitive function in patients with major depression based on the neuropsychological tests, but that patients themselves also reported noticeable improvements in their cognitive symptoms." "In addition to the emotional symptoms of major depression, people with depression may also frequently experience a range of cognitive symptoms, including an impaired ability to think, concentrate or make decisions that can affect work, school and family life," said Dr. McIntyre. "Reducing highly prevalent symptoms beyond mood, including those related to cognition, remains a huge challenge to achieving full disease remission. While further studies are needed to confirm these findings, it is truly encouraging to have a new treatment option that may target a dimension of major depression that not only is a principal mediator of functional impairment (for example,

workforce performance and attendance) but also a domain so highly related to patient reported quality of life and to feeling themselves again." Brintellix was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with Major Depressive Disorder (MDD) and in October 2013 recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for treatment of adult patients with Major Depressive Episodes. FOCUS study further builds upon established efficacy and tolerability profile of Brintellix Brintellix 10 mg and 20 mg significantly improved depressive symptoms as measured by the traditional MADRS scale, with indication of dose response (-4.7 and -6.7 respectively, p<0.0001, MMRM ANCOVA). The study confirmed Brintellix to have a good safety and tolerability profile and well tolerated overall. References available on request.


Report 21

Irish study shows lack of dementia care in hospital KEY FINDINGS OF THE AUDIT: Demographics and Assessment • 35% of people with dementia admitted from home were discharged to nursing homes • The average length of stay for a person with dementia admitted from home and discharged to a nursing home was 59 days, compared to 22 days in a person admitted from home and discharged home. • Only 43% of the people with dementia had a standardised cognitive test recorded in their HCR (dropping to 20% of those admitted from residential care); 30% were assessed for indicators of delirium; 14% were assessed for recent changes in mood; 20% received a social and environmental assessment. Services Available and Ward Practices

Professor Des Corrigan, Professor of Geriatric Medicine, Trinity College Dublin The first Irish national audit of the quality of dementia care in Ireland’s acute hospitals shows that Ireland does not yet have standardised care for dementia in acute hospitals. The audit showed differences in the access to dementia-relevant services between hospitals, with poor access to many diagnostic and support services. Co-principal investigators on the audit were Professor in Geriatric Medicine Professor Des O’Neill and Dr Sean Kennelly, Clinical Senior Lecture in Medial Gerontology from Trinity College Dublin along with Dr Suzanne Timmons and Paul Gallagher from University College Cork. Professor O’Neill and Dr Kennelly are members of both EngAGE Trinity’s Centre for Research in Ageing, and the Trinity College Intsitute of Neuroscience. The audit also showed differences in the access to dementiarelevant services between hospitals, with poor access to many diagnostic and support services. There was inadequate assessment of cognition, delirium, mood, and behavioural and psychological symptoms, in people with dementia during their admission, and where assessed

and discovered, issues were not highlighted on discharge. People with dementia admitted from nursing homes were least likely to have cognitive and social assessments and had the shortest length of stay in hospital. 35% of people with dementia admitted from home were discharged to nursing homes, and these patients had particularly long lengths of stay in hospital. Up to 25% of patients in a typical general hospital may have a dementia at any one time (Cahill, O’Shea & Pierce, 2012), and dementia costs the state up to ¤21 million per annum. Improving the quality of care received by people with dementia in hospital could decrease the overall cost of dementia care, reduce staff and carer burden, and importantly, lead to more positive health outcomes for people with dementia. In 2013, the Irish National Audit of Dementia audited 35 acute hospitals in the Republic of Ireland, interviewing the senior hospital managers and geriatricians; directly observing the environment/ interviewing the clinical nurse manager of 77 wards, and reviewing 660 healthcare records of people with dementia who had been admitted to the hospitals.

• While the majority of wards (96%) reported they had some level of access to liaison psychiatry, 26% had no access to psychiatry of old age services. The results also highlighted a significant lack of psychology services (91% of wards had no access), specialist continence services (66% of wards had no access), and social work services (47% of wards had no access). • 11% of hospitals (16% or wards) reported having no access to geriatric medicine services and 21% of wards had no access to occupational therapy. • 92% of wards reported that staff are encouraged to report patients missing/uneaten meals to ward managers; 92% of wards were able to provide food to patients between mealtimes; 75% of wards could provide adapted utensils to facilitate patients eating independently. Staffing, Training, Challenging Behaviour and Antipsychotic Medication • 92% of wards have agreed minimum staffing levels across all shifts but only 69% of wards meet their agreed minimum staffing levels. • 50% of hospitals have, or are developing, a protocol governing the use of interventions for patients displaying violent or challenging behaviour, aggression

and extreme agitation, which is suitable for use in people with dementia who present with behavioural and psychological issues (BPSD). However, only 18% of these hospitals reported that their protocol has specific evidence-based guidelines for the prescription and administration of antipsychotic drugs. • Just under a quarter of patients were prescribed a new antipsychotic to be given regularly or as needed their admission. A reason for the prescription was recorded in only 50% of cases, most commonly for ‘agitation’. Suitability of the Ward Environment for People with Dementia • No hospitals used colour schemes to help people with dementia find their way around. • The flooring in the majority of hospitals was appropriate for a person with dementia, with 92% of floors plain/subtly patterned, 82% subtly polished and 88% of floors with non-slip surfaces. • Signs to locate the toilet were not visible from the patient’s bed area/door of their room on the majority of wards (74%). • 35% of wards had signs on all their toilet doors. Even fewer wards (29%) had signs on all their bathroom doors. • Hand rails were present in the majority of wards (91%), while large handles (on taps and doors) were present in 75% of wards. A raised toilet seat was present in only 42% of wards.

Just under a quarter of patients were prescribed a new antipsychotic to be given regularly or as needed during their admission. A reason for the prescription was recorded in only 50% of cases, most commonly for ‘agitation’.

HPN • Issue 12


22

Hospital Pharmacy Awards 2013

Joint collaboration leads to key outcomes Hospital Pharmacy Team of the Year Award winner 2013 Left to Right: Emer Hall, Pharmacy Technician, Lisa Hammond, Aseptic Unit Manager, Jacinta Deane, Dispensary Manager, Nadia Campbell, Pharmacy Technician, Fionnuala Kennedy, Clinical Pharmacy Manager, John Crilly, Pharmacy Porter, Wasiu Sanusi, Pharmacy Aide, June O’Shea Chief Pharmacist & Head of Pharmacy, Elaine Leckie, Pharmacy Technician, Anna Connolly, Pharmacist, Fergal O’Shaughnessy Pharmacist, Kate O’Mahony, Pharmacist and Niamh O’Hanlon, Medicines Information Manager

Providing safe and effective care is the ultimate goal for the hospital pharmacy staff within St Vincent's University and this was one of the founding principles behind their win as Hospital Pharmacy Team of the Year, at the inaugural Hospital Pharmacy Awards 2013. Also the only public hospital in Ireland with Joint Commission International accreditation, each member of the pharmacy team has displayed key skills pivotal to the development of research and education. The JCI accreditation process demands an incredible amount of team work from start to finish, and afterwards. This requires enormous multi-disciplinary involvement from all staff in the hospital, from consultants to nurses to the healthcare Issue 12 • HPN

assistants, all working with pharmacy staff to ensure that medicines use is safe and effective for patients. The pharmacy staff played a central role in ensuring that SVUH achieved accreditation and the reputation of the pharmacy department was greatly enhanced as a result. St Vincents University Hospital is a university teaching hospital with a pharmacy staff of 35. Technicians are principally responsible for medication logistics and work closely with their pharmacist colleagues in this regard. Most of the pharmacists are clinical, practicing on the wards. There are several key clinical / managerial pharmacist positions (medication safety, medicines information, education, formulary

management). The hospital also has a very busy aseptic compounding unit. Chief Pharmacist June O'Shea tells us: "In order to provide safe, effective and timely care for our patients, all members of the pharmacy team work together as a team, to ensure safe, effective high-quality care for the patient and value for the organisation." JCI is an international organisation which inspects and accredits healthcare institutions world-wide according to published standards, which strive towards excellence in healthcare. SVUH achieved JCIaccreditation status for the first time in 2010 and again in 2013. JCI publish seven detailed Medicines Management and Usage (MMU) standards, dealing with all aspects of medicines

use in a healthcare organisation. Medication is the single most common clinical intervention made in a patient. Safe and effective medicines management is the cornerstone of JCI’s standards. Furthermore, all aspects of medicines use in the organisation is the responsibility of the pharmacy staff, who must ensure that medication is managed safely and effectively, no matter who is handling the medication. The pharmacy department’s responsibility is therefore to ensure that the hospital meets the MMU standards at all levels and to support all hospital staff in doing so. This is a very onerous and challenging task, given the complexity and diversity of medication use in a university hospital.


23 MMU STANDARDS 1: Organisation and management 2: Selection and procurement 3: Storage 4: Ordering (prescribing) and transcribing 5: Preparing and dispensing 6: Administration (of medication) 7: Monitoring (therapeutic, adverse effects) There are also medicines management issues in 2 of the 5 JCI International Patient Safety Goals: Avoiding Falls and Improve the Safety of High Alert Medications. Pharmacists participated in multidisciplinary working groups for these goals as well as in the Tracer Teams. Pharmacy updated the Medicines Management Policy to assist all stakeholders in assessing their compliance with these Patient Safety Goals. PREPARATION FOR THE JCI SURVEY IN MARCH 2013 In preparation for the March 2013 survey, June initiated planning in mid-2011. A small JCI steering group (pharmacists and pharmacy technicians) was set up in Jan 2012. The members of the group met initially fortnightly, then weekly for the final three months. They analysed and assessed the hospital’s readiness to meet the MMU standards and Patient Safety Goals by performing a gap analysis at the outset using surveys and audits. Issues identified were discussed in detail and quality improvement plans (QIPs) developed with stakeholders. DRUGS AND THERAPEUTICS COMMITTEE JCI was a standing item on the monthly multi-disciplinary Drugs and Therapeutics (D&T)

committee’s agenda. All policies, procedures and guidelines (PPGs) relating to medication were updated by the steering group in conjunction with other stakeholders, principally nurses and doctors. These were brought to D&T for discussion, agreement and implementation in the organisation. PHARMACY JCI TEAMS Medicines use was divided into two discreet areas for the purpose of assessment against the standards. • Pharmacy department All pharmacy staff worked in different teams to address the pharmacy element of the standards and fed results and decisions back to their pharmacy colleagues. In this way, all staff members actively participated in the process. •All other areas In clinical areas, the pharmacy technicians played the leading role in developing and updating PPGs for the safe and effective distribution of medication, working closely with nurses in particular. Clinical pharmacists on the wards played the main role in ensuring that the clinical of use of medications complied with the MMU standards. Other pharmacists worked with anaesthesia / radiology to address the standards in these areas, where pharmacy traditionally does not have a strong presence.

Emer Hall, Pharmacy Technician, Nadia Campbell ,Pharmacy Technician, June O’Shea Chief Pharmacist & Head of Pharmacy with Fionnuala Kennedy, Clinical Pharmacy Manager

Daily, pharmacy staff spread the message, discussing and educating hospital staff about the MMU standards, answering questions and queries with all staff while on the wards doing their routine work. Various media were used to reinforce safe and effective medicines use: SVUH Medicines Guide, posters in reception areas, A3/ A2 posters in clinical areas, updated signage, reminders, printed FAQs, hospital intranet, newsletters. See attached for examples. The Medicines Management Review was also completed during this period and all 5 medication-related Key Performance Indicators were submitted.

EDUCATION AND COMMUNICATION

PREPARATION OF PHARMACY ENVIRONMENT

In the final 3 months, the JCI teams fed back to their pharmacy colleagues via short presentations each week. Throughout the hospital, pharmacy staff held information and teaching sessions with healthcare staff to increase awareness of PPGs, the rationale behind them, and how to implement safe medication practices everyday in their work.

In the month leading up to the survey, all staff from porters to the chief pharmacist spent some time improving the cleanliness and appearance of the pharmacy by replacing old signage, deep-cleaning and sending obsolete paperwork for shredding, so that a neat and organised department was presented to the surveyors. This spring clean had the effect of

boosting morale in the period immediately pre-survey. DURING THE SURVEY During the JCI survey itself, pharmacy staff participated in all medicines-related meetings and interviews, tracer audits, closed records review and visits to clinical areas. They were on hand to assist the surveyors and support hospital staff at all times. June continues: "The pharmacy department, comprising of all staff members from pharmacists to technicians, and assistants to students, have come together over the past year and worked tremendously hard towards one focused goal. "As a direct result of this team work we have taken a look at how we work together, revising existing schedules and agendas to better suit the skill mix within our department. Every single person has a different role to play and each is as important as the next. The atmosphere since winning this award has been electric and is an excellent platform from which I, as the Chief Pharmacist, can shout about the phenomenal team that I have working with me."

Investing in education and the health of the nation HPN • Issue 12


24

Hospital Pharmacy Awards 2013

One stop clinic for patient centred care in Galway Innovation and Service Development Award winner 2013

Mary O'Toole, Administrator; Esther Courtney, Clinical Nurse Specialist; Elaine Callinan, Acting Clinical Nurse Manager; Allison Dunne, Senior Pharmacist; Elaine Burke, Pharmacy Technician; Sinead Flynn, Nurse Prescriber and Elaine Maloney, Nurse Prescriber

Hospital Pharmacist within Galways University Hospital, Allison Dunne explains further: “Clozapine is a medicine used for patients with treatment resistant schizophrenia. It is an effective treatment but has several side effects. “One of the side effects is agranulocytosis – a potentially life threatening blood disorder. All patients who are prescribed clozapine must undergo regular full blood count testing. Clozapine supply is restricted to hospital pharmacies in the Republic of Ireland. The responsible pharmacist must ensure each patient has a valid blood result before supply of clozapine can be made. Patients attend the clinic weekly, fortnightly or monthly, Issue 12 • HPN

depending on the length of time on treatment.” Clozapine is an anti-psychotic medication that works by blocking receptors in the brain for several neurotransmitters (chemicals that nerves use to communicate with each other) including dopamine type 4 receptors, serotonin type 2 receptors, norepinephrine receptors, acetylcholine receptors, and histamine receptors. Unlike traditional anti-psychotic agents, such as chlorpromazine (Thorazine) and haloperidol (Haldol) as well as the newer anti-psychotics, risperidone (Risperdal) and olanzapine (Zyprexa), clozapine only weakly blocks dopamine type 2 receptors.

Clozapine is suitable for:  Patients who have tried at least two other antipsychotics unsuccessfully  Approximately 25% of patients with schizophrenia will not respond to first line antipsychotic treatment.  Patients who suffer badly from the unwanted sideeffects of other medication, for example, development of tardive dyskinesia Clozapine is also licensed for the treatment of psychosis associated with Parkinson’s Disease Traditionally psychiatric nurses and mental health pharmacists

have worked in separate areas of hospitals, with little daily contact. Clozapine services in many other hospitals in the Republic of Ireland have blood testing organised by nursing staff. The pharmacist would then supply clozapine from the hospital dispensary either directly to the patient, or via the nursing team. Due to the time it can take to obtain blood results there can sometimes be a delay of several days between the patient having a blood test taken, and receiving a supply of clozapine. The Clozapine Clinic in Galway City has evolved over the years to bring the multidisciplinary team and the patient together to improve patient care. The Clinic provides care for over 150 psychiatric patients. The majority


25 As the pharmacist and pharmacy technician work directly in the clinic he/she gets to know the patients and follow them on their clozapine journey. This improves job satisfaction as it is much more interesting that dispensing medicines to a “faceless” name on a prescription. “The pharmacy staff have learned many practical ways of managing clozapine treatment in the “real world.”

of these are outpatients. The patients can attend at any time they choose, there are no fixed appointments. The staff is made up of two full time nurse prescribers, a part time specialist mental health pharmacist, a part time pharmacy technician and a part time administrator. Two wardbased nurse prescribers work in the clinic occasionally to cover holidays and sick leave. The Clinic obtained a desktop Point of Care Blood Analyser in 2010. This enables blood test results to be obtained within five minutes of the blood being taken by the nurse. Prior to this the blood samples were couried to Dublin for analysis which meant a delay of up to four days for blood results. Every nurse working in the Clinic has trained as a nurse prescriber. This means that repeat prescriptions for clozapine can be written in the clinic, without the need for a doctor on-site. A pharmacist and pharmacy technician work in the clinic at set times throughout the week. If a patient attends the clinic when the pharmacist is available, the pharmacist can supply clozapine immediately. Every patient receives a physical health check at each visit to the clinic. Blood pressure, BMI, cholesterol, and cardiac side effects (via a regular ECG) are all monitored closely with referral

to the GP where appropriate. Healthy lifestyle advice is given to each patient at regular intervals by the nurse and pharmacist. “This process has improved waiting time for patients from four days to approximately fifteen minutes. This is a huge benefit for patients who have to travel long distances to the clinic, or who are at work or college.

“The pharmacist and nurse prescribers work very closely together to decide on clozapine doses. Doses are often changed due to side effects or lack of efficacy and it is important that this is managed correctly. Before the “One Stop” service, the prescriptions were signed by junior doctors who did not necessarily know the patient, and there was little opportunity for pharmacy input.” As the clinic takes on more clozapine patients, the pharmacist is spending more hours in the clinic each week.

In September 2013 a patient satisfaction survey will take place, to determine if there are any extra services the clinic could provide. There are very few medicines used in hospitals that have the same restrictions of supply as clozapine. However, the model could be applied to any medicine that is supplied only through hospitals, where the patients need regular attendance for monitoring. One example is the use of IV Normal Immunoglobulins such as Kiovig and Intratect. Allison Dunne commented: “Winning the HPN Innovation Award in 2013 gave our clozapine clinic team recognition within the psychiatry department. It gave us a platform to promote the benefits of our clinic to managers at a local and national level. We felt very proud to win the award and it has strengthened the bond between us as a multidisciplinary team.”

“From a safety point of view, the immediate access to the result of the full blood count means that in the rare event of the patient having an abnormal blood result action can be taken straight away. This could mean stopping clozapine treatment or arranging a follow-up blood sample. Patients have direct access to a specialist mental health pharmacist in addition to the nursing team. This allows discussion about side effects of medication and how to get the best from the clozapine treatment,” Allison continues.

Mary O'Toole, Esther Courtney, Elaine Callinan, Allison Dunne, Elaine Burke, Sinead Flynn and Elaine Malone

Novartis are very proud to be associated with the Hospital Pharmacy Awards and this category in particular as it serves to highlight and promote the lengths hospital pharmacists are going to in order to offer a better standard of care for their patients. Mark Donohue, Market Access Key Account Manager with Novartis

Investing in education and the health of the nation HPN • Issue 12


At Novartis, we live innovation At Novartis, we are driven by meeting patient needs. We lead the Pharma Industry in our global investment in R&D with currently over 140 clinical development projects in progress, and over 17 clinical trials ongoing in Ireland alone. Our vision is to be Irelandâ&#x20AC;&#x2122;s most successful healthcare company: its premier innovator focused on improving patient outcomes, the most trusted company to our healthcare partners, and the best place to work for our associates. Our diverse portfolio in innovative prescription medicines, eye care products, affordable generic medicines, preventative vaccines and diagnostic tools, and consumer health therapies, is helping Irish people live better lives every day.

www.ie.novartis.com NO0413216


Safety CPD

Applying learning in Drug Safety IMB Drug Safety Newsletter Update Morgan O'Connell, B.Sc. (Pharm.), M.Sc., M.P.S.I., PG Cert ODE (Open) and Caroline Waldron, B.Sc. (Pharm.), Ph.D., M.P.S.I., PG Cert ODE (Open) CPD OBJECTIVES 1. Keep up to date with new and emerging information on medicines safety 2. Apply learnings from new safety information in your practice to minimise risks to patient safety. 3. Consider the benefits of using online CPD resources.

The IMB Drug Safety Newsletter (DSN) is a valuable source of Safety information and iaCME utilise the content from the IMB’s Drug Safety Update to deliver defined learning objectives. The IMB is in agreement with the use of its DSN for the purpose of CPD and has contributed to review of the individual modules prior to release. The overall focus of each module is on reducing risks to patient safety by applying learnings from new and emerging safety information as highlighted in the Drug Safety Update. iaCME formats the content using multimedia and adapts it to an appropriate template on the iaCME website (free of charge) to make it more engaging and provide additional resources to explore individual topics in a more practice focussed way for those who wish to do so. Online Discussion forums provide an opportunity for peer learning through sharing ideas/experiences or asking questions. Documentation includes a Certificate which can be printed or saved (remains always available on the website) but also templates for reflection as well as personal blog space for reflection, recording or peer interaction. The modules are accredited by the ICGP for doctors; there is, as yet, no accreditation procedure for any CPD for Pharmacists but the modules are structured to equip pharmacists with evidence of engaging with relevant CPD in a manner specifically chosen to match the goals of the new Pharmacy CPD structure. This article will show how you might use the IMB DSN as a CPD resource. Like the actual DSN itself, it is, of course text based and so does not have the impact of the online version

nor does it provide the optimal tools for using the DSN as a CPD activity. It is based on DSN 56 but does not contain all of the content in that edition – the original Newsletter is available at: "http://www.imb.ie/images/ uploaded/documents/Drug%20 Safety%20Newsletter%20 56-Web%20version%20 hyperlinked.pdf" http://www. imb.ie/images/uploaded/ documents/Drug%20Safety%20 Newsletter%2056-Web%20 version%20hyperlinked.pdf (Accessed Nov 07, 2013) NOVEL ORAL ANTICOAGULANTS (NOACS) There are three NOACs licensed for use in Ireland and across the EU:  the direct thrombin inhibitor, dabigatran and  the two direct factor Xa inhibitors, rivaroxaban and apixaban*. Clinical trials and post-marketing experience have shown that risks of major bleeding events, including events leading to death, are not confined to vitamin K antagonists/LMWH but are also possible when using these NOACs. Furthermore, analysis of EU post marketing reports suggests that not all prescribers in the EU are sufficiently aware of the advice

in the product information for the novel agents in terms of managing bleeding risks. Updated advice for all NOACs has been communicated to Healthcare Professionals; most recently through a letter sent by all Marketing Authorisation Holders for NOACs in September 2013:(http:// www.imb.ie/images/uploaded/ documents/FINAL%20 Oral%20Anticoagulants%20 DHCP%20Letter%20Aug%20 2013%20for%20implement ation_IRELAND_FINAL%20 05.09.2013.pdf).

• Active clinically significant bleeding.

In light of the risk of haemorrhage for all anticoagulants, prescribers should consider each individual patient’s risk of bleeding and observe posology recommendations, contraindications and warnings and precautions for use to minimise the risk of bleeding. This includes a careful benefitrisk assessment in patients with lesions, conditions, procedures and/or treatment (e.g. NSAIDs and antiplatelets) which increase the risk of major bleeding. In addition, clinical surveillance for signs and symptoms of bleeding is recommended throughout the treatment period especially in patients at increased risk of bleeding. While differences in contraindications exist between the NOACs, they share the following contraindications:

• Concomitant treatment with any other antico- agulant agent e.g. unfractionated heparin, low molecular weight heparins (enoxaparin, dal- teparin etc), heparin derivatives, oral anticoagulants (warfarin etc) except under the circumstances of switching to or from the medicine, or when unfractionated heparin is given at doses to maintain an open central venous or arterial catheter.

• Significant risk factors for major bleeding such as current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.

Information regarding additional contraindications specific to each NOAC is described in the product information (Summary of Product Characteristics (SmPC) and Package leaflet (PL)) for each individual medicine available at: "http://www.imb.ie" There is currently no specific antidote available for NOACs HPN • Issue 12


Safety CPD and the product information for each product includes advice on treatment in the event of bleeding complications. Attention should also be paid to renal function. Renal impairment may constitute a contraindication or a reason to consider not using the medicines or reducing the dose. Please refer to the product information since recommendations differ between the three medicines. NOACS - NATIONAL MONITORING EXPERIENCE The majority of reports of suspected ADRs associated with the use of NOACS have been consistent with the expected effects mainly involving various types of haemorrhagic effects ranging from contusions, haematoma and wound secretions to gastrointestinal haemorrhage and menorrhagia. There have also been some reports of DVT, pulmonary embolism and cardiac effects, which would not be unexpected in the patient population. For those cases for which information on outcome is available, the majority of patients were reported to have recovered. Healthcare professionals should continue to report any ADRs suspected to be associated with the use of NOACs to the IMB using an Adverse Reaction Report Form (Yellow Card) obtained either from the IMB or electronically via the website at www.imb.ie. Alternatively they may be reported by telephone (01 676 4971) or fax (01 676 2517). KEY MESSAGES  Close clinical surveillance, including monitoring for signs of haemorrhage, to facilitate early intervention and management is recommended for all patients treated with NOACs.  Detailed, product specific information and advice to support safe and appropriate use of NOACs is provided in the individual SmPCs and educational materials for each of the products.  Renal function should be assessed and monitored during treatment in line with the recommendations in the product information. Issue 12 • HPN

 Patients and caregivers should be advised about the risk of bleeding complications associated with NOACs and of the importance of carrying their patient alert cards at all times. METOCLOPRAMIDECONTAINING MEDICINES Metoclopramide* is an antiemetic, which has been authorised for many years for the treatment of a number of gastrointestinal disorders, including nausea and vomiting associated with chemotherapy, radiotherapy and migraine, following surgery and in the management of gastrointestinal motility disorders. An EU review of the benefits and risks associated with use of metoclopramide-containing medicines, initiated following concerns related to the efficacy of metoclopramide, as well as the risks of neurological and cardiovascular toxicity, was recently completed. The review confirmed the well known risks of neurological effects such as acute extrapyramidal disorders, involuntary movement disorders and tardive dyskinesia. The risk of acute neurological effects is higher in children, although tardive dyskinesia was reported more frequently in the elderly. An increased risk of these adverse effects was also associated with high dose or long term treatment. The evidence indicated that these risks outweigh any benefits of using metoclopramide for the treatment of chronic conditions. As a result of this review, a number of changes to restrict the indications, dose and duration of use of metoclopramidecontaining medicines have been recommended. The product information will be updated accordingly in due course. ADVICE TO PHARMACISTS  In order to minimise the risks of neurological and other ADRs, metoclopramide should only be prescribed for short-term use (up to 5 days). It should no longer be used in chronic conditions such as gastroparesis, dyspepsia and gastro-oesophageal reflux disease, nor as an adjunct in surgical and radiological procedures.  In adults, metoclopramide remains indicated for prevention

of post-operative nausea and vomiting (PONV), radiotherapyinduced nausea and vomiting and delayed (but not acute) chemotherapy-induced nausea and vomiting, and for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics).  In children, metoclopramide should only be used as a second-line option for delayed chemotherapy induced nausea and vomiting and treatment of established PONV. Use is contraindicated in children less than 1 years of age.  For adults and children the maximum dose in 24 hours is 0.5 mg per kg body weight; in adults, the usual dose of conventional formulations (all routes) is 10 mg up to three times daily. In children the recommended dose is 0.1 to 0.15 mg per kg body weight, repeated up to three times daily. Intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects, including cardiovascular reactions.  There have been rare reports of serious cardiovascular reactions associated with metoclopramide, particularly via the intravenous route. Therefore special care should be taken in at risk populations including the elderly, patients with cardiac conduction disturbances, uncorrected electrolyte imbalance or bradycardia, and those taking other drugs known to prolong QT interval. Patients currently taking regular metoclopramide should have their treatment reviewed at a routine medical appointment.  Because of the risk of ADRs with high doses, some high-strength formulations of metoclopramide products will be withdrawn. The 56th Edition of the IMB Drug Safety Newsletter contains more detailed information on the above topics together with synopses of recent safety communications sent to HealthCare professionals.

Quiz and Reflection Prompters After the Quiz, some reflection prompters are presented to assist you in embedding any learnings from the article into your practice. QUIZ: NOACs 1. Which of the following should be assessed and monitored during treatment with NOACs in line with the recommendations in the product information? Renal Function Liver function Cardiac output (using noninvasive technique) 2. The direct thrombin inhibitor, dabigatran and the two direct factor Xa inhibitors, rivaroxaban and apixaban, are classed as Novel Oral Anticoagulants (NOACs). Direct Factor Xa inhibitors are associated with significant risk of bleeding events but Direct Thrombin Inhibitors are not. True or False? 3. Match the medicine with it's classification.

Rivaroxaban

Direct Thrombin Inhibitor

Dabigatran

Apixaban

Direct Factor Xa Inhibitor

4. Fill in the Blank in this Contraindication to the use of NOACs: "Recent brain, spinal or surgery." 5. There is currently no specific antidote available for NOACs. True or False? 6. Fill in the blank: In light of the risk of haemorrhage for all anticoagulants, clinical surveillance for signs and symptoms of is recommended throughout the treatment period especially in patients at increased risk of bleeding.


METOCLOPRAMIDE

repeated up to three times daily.

1. The recent EU review of metoclopramide confirmed the well known risks of neurological effects such as acute extrapyramidal disorders, involuntary movement disorders and tardive dyskinesia. However, different age groups may be affected differently. Complete the following phrases with the correct group – “children” or “the elderly”.

5. Patients currently taking regular metoclopramide should:

 The risk of acute neurological effects is higher in  Tardive dyskinesia was reported more frequently in

 have their treatment reviewed at a routine medical appointment

the time spent on reflection as well as engaging with Part 1 of the article) as evidence of your CPD. An online version of the template is available on the iaCME website and would be useful for record keeping.

 be called in immediately to have their treatment stopped.

Topic 1: NOVEL ORAL ANTICOAGULANTS (NOACs):

6. In children, metoclopramide should only be used as a second-line option for delayed chemotherapy induced nausea and vomiting and treatment of established PONV. Use is contraindicated in children less than what age?

RISK OF BLEEDING – REINFORCEMENT OF RISK MINIMISATION ADVICE FOR DABIGATRAN (PRADAXA®), RIVAROXABAN (XARELTO®) AND APIXABAN (ELIQUIS®)

 1 year 2. In order to minimise the risks of neurological and other ADRs, metoclopramide should only be prescribed for short-term use. What is the maximum number of days recommended? 3

 2 years  12 years We are not going to list the answers to the quiz. If you are not absolutely sure of the answers you should review the article one more time.

5 7 3. The well-known risk of neurological effects associated with metoclopramide are doseindependent. True or False? 4. Fill in the blank - For adults and children the maximum dose of metoclopramide in 24 hours is 0.5 mg per kg body weight; in adults, the usual dose of conventional formulations (all routes) is mg up to three times daily. In children the recommended dose is 0.1 to 0.15 mg per kg body weight,

Better still re-read the original newsletter or try the online multimedia module available on the iaCME website free of charge. Even if you are sure you know the answers to all of the questions, quizzes do not of themselves mean that your professional ability and practice has been advanced by the knowledge you have gained. You can assist the assimilation of your learnings into your practice by using the reflection template below. You can keep a record of the completed template (including

 Record any additional learning needs.  Record any other thoughts/ reflections.  Record any discussions held with colleagues. Topic 2: METOCLOPRAMIDECONTAINING MEDICINES UPDATE ON OUTCOME OF REVIEW AND REVISED RECOMMENDATIONS FOR USE

Do you know and understand the different classes of anticoagulants?

Metoclopramide has been in use for a long time and has been a medicine widely used but have you kept up to date with it’s safety profile and with changes in how it should be used?

Do you know what risk-benefit assessment is appropriate in patients prior to starting treatment with a NOAC? Do you know what the important factors are?

Do you know the indications that remain for use of metoclopramide in adults and the contraindications for use in adults?

Are you aware of what to look out for during treatment with NOACs and what monitoring is necessary? DO you ensure patients carry alert cards?

Do you know the indications that remain for use of metoclopramide in children and the contraindications/age limit appropriate formulation for use in children?

Do you know the common Contraindications among the NOACs and are you able to find further product information?

Do you know what the appropriate dosages are for adults and for children and what formulations are available? Do you know the recommendation regarding IV administration?

Are you aware of how to treat bleeding with NOACs given that they have no specific antidote? Have you discussed this issue with your practice colleagues? Actions required to enhance your practice:

Would you recognise the symptoms of neurological effects that might be associated with use of metoclopramide and the possible differences in effects in different age groups? What is the maximum recommended usage of metoclopramide and does this affect it’s use? What other effects have been noted with intravenous use? Have you discussed this issue with your colleagues? Record actions required to enhance your practice.  Record any additional learning needs.  Record any other thoughts/ reflections.  Record any discussions held with colleagues.

Keep up to date with new and emerging information on medicines safety

HPN • Issue 12


30 Report

Tallaght trial cuts drug medication errors CPP are In Ireland, few hospital pharmacy departments are involved in delivering MedRec at admission or discharge. "Involvement of clinical pharmacists in multidisciplinary clinical activities, with the exception of specialist services, for example, haematology, is rare. To date, there has been no comparative study undertaken in Ireland to determine the benefits of integrating the clinical pharmacy service with medical care. Evidence is needed to support wider implementation of this model of collaboration in Ireland and worldwide. Medication errors include mistakes such as missing out on a tablet, adding a medication that should not be given, or giving the wrong dosage.

Dr Tamasine Grimes, Associate Professor, Trinity College

A new patient safety system has dramatically cut the number of harmful drug errors, following a trial which was run in a major hospital. Study authors which included Dr Tamasine Grimes, Associate Professor at Trinity College, investigated the benefits of the Collaborative Pharmaceutical Care in Tallaght Hospital (PACT) service versus standard wardbased clinical pharmacy in adult inpatients receiving acute medical care, particularly on prevalence of medication error and quality of prescribing. PACT, a collaborative model of pharmaceutical care involving medication reconciliation and review, delivered by clinical pharmacists and physicians, at admission, during inpatient care and at discharge was shown to be protective against potentially severe medication errors in acute medical patients and improved the quality of prescribing in older patients. The system, which was tested in Tallaght Hospital in Dublin, eliminated potentially "severely harmful" medication errors Issue 12 â&#x20AC;˘ HPN

compared with an incidence of 6% among patients receiving the standard model of care. "A number of recent controlled trials have investigated the benefits of complex interventions that involve collaborative medical care and clinical pharmacy activity at admission, during inpatient stay and at discharge," say the authors. "The interventions have involved close working between clinical pharmacy and medical staff, facilitating integrated management of medicines across the entire inpatient episode. Such integration has been proven to reduce the prevalence of medication error and (re) hospitalisation and to improve the quality of prescribing. "This accords with statements from the International Pharmaceutical Federation (FIP) that describe a five-level model of Collaborative Pharmacy Practice (CPP) with advancing models involving closer collaboration with the medical team and greater responsibility for the pharmacist. FIP have identified that examples of the most advanced levels of

Under the ordinary system, hospital pharmacists are involved in taking a patient's medication history and reviewing their prescriptions, but are not involved when they are discharged. Under the new system pharmacists are involved in both the patient's admission and discharge. It means they are able to track what medications the patient is taking coming into hospital, which tablets might interact with other medications and which ones they no longer need. It also means hospital pharmacists can make sure the patients are on proper medication when they are discharged and that this information is given to their GP. The findings of the study published in leading international journal, the 'British Medical Journal Quality and Safety', has shown this approach can significantly reduce and eliminate potentially harmful medication errors. The study, which is the first of its kind in Ireland, was led by researchers from the School of Pharmacy and Pharmaceutical Sciences at Trinity College Dublin in collaboration with the Medical Directorate and the Pharmacy Department from Tallaght Hospital.

The main findings of this study are that the PACT intervention is effective at reducing the prevalence per patient of error at admission and discharge from adult medical inpatient care, preventing potentially severe error and facilitating clinical pharmacy input to improve medication use. PACT improved the quality of prescribing in medical patients aged 65 years and older.The main findings of this study are that the PACT intervention is effective at reducing the prevalence per patient of error at admission and discharge from adult medical inpatient care, preventing potentially severe error and facilitating clinical pharmacy input to improve medication use. PACT improved the quality of prescribing in medical patients aged 65 years and older. PACT improved the quality and safety of prescribing for medical patients receiving acute hospital care: it reduced the prevalence of all medication error and potentially severe error; it improved the quality of prescribing in patients aged 65 years or older. The recommendations are to implement collaborative models of medication management between medicine and pharmacy and to facilitate collaborative prescribing by pharmacists within this model. It resulted in a 78% reduction in the number of patients experiencing medication errors at admission to hospital. And there was a 79% drop in errors at discharge. It improved the quality of prescribing in older patients by allowing for better communication about the patients' drugs, a particularly important factor given the increase in people taking five or more medicines at the same time. Dr Tamasine Grimes said: "Admission and discharge from hospital are vulnerable times for patient safety. A lot of complex information needs to be shared between healthcare providers and patients. The chance for miscommunication is high and sometimes this can rult in error which may result in harm."


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PHI/2013/002/1 April 2013


32

Hospital Pharmacy Awards 2013

Dedication in ensuring hospital pharmacy excellence We Innovate Healthcare

Hospital Pharmacist of the Year Award winner 2013 Patricia Ging, Chief Pharmacist, Mater Misericordiae University Hospital with award sponsor Rory Lee, Business Unit Director, Oncology, Roche Products Ireland

The award category of Hospital Pharmacist of the Year, was a hotly contested one with numerous extremely worthwhile nominations and finalists. This aim of this award category is to recognise those who, through their service to patient care, education or research, to the profession and to the society, are worthy of being rewarded. The judges certainly felt that Patricia Ging, Chief Pharmacist at the Mater Misericordiae University Hospital, fit the bill. Patricia was awarded the title of 'Hospital Pharmacist of the Year' Award at the Hospital Pharmacy Awards 2013. Issue 12 â&#x20AC;˘ HPN

Patricia Ging is a Chief II Pharmacist at the Mater Misericordiae University Hospital (MMUH). She has worked there for twelve years and is the pharmacist for Heart and Lung Transplantation and Pulmonary Hypertension services in the hospital. Since assuming this role in 2008 she has worked exceptionally hard to develop and enhance the role of the pharmacist in these diverse services. A typical lung transplant patient journey begins with in-patient assessment and during this admission Patricia conducts meticulous medicines reconciliation and conducts a thorough medication review,

recommending medication changes prior to transplant in collaboration with the medical team. Patricia educates the patient about these changes pre-transplant and encourages concordance with therapy which is essential for success post-transplant. Once transplanted she reviews the patient on a daily basis ensuring their complex medication needs are met and that all essential medications are prescribed and administered in the most appropriate format. Patricia then further educates the patient in order that they can safely adhere to their complex new medication regimen.

Following discharge she continues to provide advice to the patients during their clinic visits, working with the transplant nurse specialists to ameliorate any medication related adverse effects, ensuring continuity of medication supply and managing interactions. She also provides advice for the happier moments for the post-transplant patients such as medication planning for the long awaited holidays abroad or even planning medication alterations for pregnancy. Multidisciplinary team working is extremely important in such a complex area. Since joining the team Patricia has been active in the multidisciplinary team,


33 educating the rotating medical and nursing staff on both a formal basis in the cardiothoracic nursing course and on an informal basis by presenting conference abstracts at the weekly multidisciplinary meeting. She has also written the unit protocols for the perioperative management of the transplant patients so that management is optimised, streamlined and standardised. Patricia has always shown a strong commitment to pharmacy education. Last year she was appointed an Honorary Lecturer of the RCSI School of Pharmacy. This honour was in recognition of her role as Clinical Liaison Officer for the exciting collaboration between the RCSI and the Pharmacy Department MMUH. She is responsible for the co-ordination of the MMUH input to the RCSI pharmacy course and in addition she has delivered several hours of clinically focused lectures and developed and facilitated innovative “dry round” patient scenarios, these have been specifically designed to provide them with the opportunity to integrate their knowledge and apply it to the management of clinical problems in individual patients. Building on the achievements to date, she is enhancing the direct experiential learning element from 2013-2014 with additional supervised patient contact for all final year students. She is developing a robust framework to ensure that this patient contact is of the same high quality as the material previously delivered, and that learning objectives are identified and met. She is an experienced lecturer and tutor, lecturing for the UCD Higher diploma in Risk Management, the TCD MSc in Hospital Pharmacy, as well as for numerous courses for nurses, pharmacists and physiotherapists. Next year she has been asked to speak at the International Society for Heart and Lung Transplant (ISHLT) conference in San Diego on the role of the pharmacist in pulmonary hypertension. At pharmacy undergraduate level, she has acted as a pre-registration/ intern tutor, as well as an assessor and assisted in question setting for the MPharm exams.

One nominee states: "Advancing the role and profile of the specialist clinical pharmacist has always been Patricia’s passion. She has been a member of the United Kingdom Clinical Pharmacist’s Association (UKCPA) for many years. She is one of the contributors to, and indeed an editor of the highly regarded “Critical Care Journal Club”. This monthly bulletin, now in its 55th edition, aims to keep the multidisciplinary critical care community abreast of the latest research in the area and has a wide circulation internationally. "She was awarded the UKCPA Critical Care Pharmacist of the Year 2007 for initiating, developing and evaluating a project to implement a new drug chart which reduced medication omissions and prescribing errors in critical care. (Crit Care 2008 Vol 12 S168)." Subsequently she was one of the pharmacists who created the drug library for the computerised physician order entry system in critical care, and her research method was used to measure the impact of the system in further reducing medication errors. During this time she led the HPAI submission to the Department of Health commissioned “Consultation on Critical Care Services”, highlighting the beneficial impact of the pharmacist in all aspects of medication use in critically ill patients and the benefits of expanding this service to all units. Since taking on a specialised role in transplant and pulmonary hypertension Patricia has continued to develop her leadership roles. She is a member of the International Society of Heart and Lung Transplant (ISHLT) Pharmacy Council and has taken on the role of increasing the participation of European pharmacists in this vibrant organisation. Thoracic transplantation is a young speciality and international collaborations are extremely important in order to ensure that the pharmacist becomes an integral member of the team. To this end, she was part of the Writing Group who have developed the upcoming statement to assess, describe, and advance the role of the Thoracic Transplant Pharmacist. This document, which will be

Patricia Ging, Chief Pharmacist, MMUH receives her award of Hospital Pharmacist of the Year from Rory Lee, Business Unit Director, Oncology, Roche Products Ireland

ISHLT policy, will oblige Thoracic Transplant units worldwide to incorporate pharmacists into their teams and also define the roles and responsibilities of these pharmacists. "Patricia enjoys doing practice research in transplantation. Recent published work has included “Club Orange, it's the Bits Inside that made the Ciclosporin levels High" which was highly commended at the HPAI conference (Eur J of Hosp Pharm Practice. 2011; 6 (17): 18-19) and Osteoporosis after Lung Transplant which was shortlisted for a prize at the Irish Thoracic Society Conference (Ir J Med Science 2011 Vol 180 S12 ) She has also written continuing education articles on Asthma for

the Irish Pharmacy Journal and is collaborating with a colleague in the UK to write two articles for the Clinical Pharmacist on Idiopathic Pulmonary Fibrosis. "Patricia is a Hospital Pharmacist who has always shown her commitment to her profession. In the last year through her daily clinical interactions, her educational endeavours and her commended and internationally published research she has shown huge dedication to ensuring that the pharmaceutical care she provide to her patients is of the highest quality," they concluded.

Investing in education and the health of the nation We Innovate Healthcare HPN • Issue 12


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Hospital Pharmacy Awards 2013

Using smart technology for antimicrobial progress Antimicrobial Project of the Year winner 2013 Back row from left to right, Fegal McDonnell Technicial Director Doctot, Susan Stack Senior Pharmacist (Antimicrobials), Anne Harnett Chief Pharmacist, Paula Cussen Murphy Hospital Manager, Professor Declan Lyons Professor of Medical Science and Consultant Physician. Front Row from left to right, Siobhan Barrett Senior Pharmacist (antimicrobials), Dr. Nuala O'Connell Consultant Microbiologist, Dr. Lorraine Power Consultant Microbiologist

A mobile APP for antimicrobial prescribing guidelines developed and launched in Ireland, led to the hospital team at Galway University Hospital to winning the ‘Antimicrobial Project of the Year’ at the 2013 Hospital Pharmacy Awards. Led by hospital pharmacist Anne Harnett, the team launched the mobile app as part of an ongoing policy to improve antibiotic use. Antimicrobial resistance is recognised as a global threat to health by the World Health Organisation, the European Commission and Centres for Disease Control. This fact has led to significant emphasis being placed on Issue 12 • HPN

appropriate antimicrobial prescribing. Anne Harnett continues: “The Guidelines for Antimicrobial Stewardship in Hospitals in Ireland 2009 recommend that all acute hospitals should distribute to all prescribers, evidence based antimicrobial prescribing guidelines and where possible these guidelines should be available in electronic format. “This app was developed to do just that, allowing prescribers to access antimicrobial prescribing guidelines for adults using their smartphone at the bedside.” Antimicrobial stewardship (optimising antimicrobial selection, dosing, route and

duration of therapy to maximise clinical cure or prevention of infection while limiting the unintended consequences, such as the emergence of resistance, adverse drug events and cost) is critical to combating antimicrobial resistance. Antimicrobial Guidelines are a critical element of Antimicrobial Stewardship. The process of accessing Antimicrobial Guidelines is leaner when the guidelines are available on an easy to use app on the prescriber’s smartphone at the bedside. Using this technology reduces the non-productive time that both prescribers and antimicrobial pharmacists spend searching for paper based and web based guidelines and

frees-them-up to pursue other critical antimicrobial stewardship initiatives. “This is an innovative multidisciplinary project that reduces antimicrobial resistance by promoting rational antimicrobial prescribing by using technology to allow prescribers access to expert antimicrobial prescribing advice at the bedside,” continues Anne. “This iPhone application was developed to promote and support rational prescribing of antimicrobial agents for adults. Information is available for common infections and includes advice on: investigations to carry out; probable pathogens involved and empiric


35 antimicrobial therapy. Notes and practice points are available where applicable. “Other functions include: common resistance patterns, immunoglobulin treatment advice; anaphylaxis management, notifiable diseases and antimicrobial costings. Interactive scales relevant to prescribing (e.g. creatinine clearance and CURB65), Gentamicin and Vancomycin dosing advice as well as renal and hepatic dosing calculators are features of the app.” The initiative was tailored towards all prescribing practitioners as well as healthcare professionals involved in antimicrobial stewardship. The goal of the project was to provide prescribers with expert antimicrobial prescribing advice at point-of-care, in line with the goals of the antimicrobial stewardship programme based on National Guidelines for Antimicrobial Stewardship in Hospitals in Ireland 2009:  To ensure the best clinical outcome, for treatment and prevention of infection.  To minimise unintended consequences of antimicrobial use including adverse drug events, selection of pathogenic organisms.  To minimise healthcare costs without compromising quality of care. The project has been successfully completed. The app is available to anyone to download from the iTunes store and is available to all medical and pharmacy staff across the University Limerick Hospitals Group. Patients benefit from timely and appropriate antimicrobial therapy, reduced antimicrobial resistance and better health outcomes. Staff benefit from leaner and more productive systems of work and better health outcomes for their patients resulting in reducing healthcare costs. With the app, an updated version can be easily

implemented without waiting for a new hardcopy print. This overcomes the inflexibility of books and the issue of using outdated versions. There is also a cost-benefit when compared to print and the app is more ecofriendly. Future plans for the roll out of this initiative continue. The Guidelines for Antimicrobial Stewardship in Hospitals in Ireland 2009 recommend that antimicrobial prescribing guidelines are updated every two years. “It is our intention to develop version 2 of the app,” explains Anne. “This was a multidisciplinary project where doctors and pharmacists worked together to populate the content of the app. The content of the app was largely provided through the generous and considerable contribution of Dr. Nuala O’ Connell Consultant Microbiologist. The antimicrobial app is used in the training of doctors, pharmacists, nurses and other healthcare professionals. “ Dr Pat Nash, Clinical Director for the Hospital Group said: “The antimicrobial stewardship team at the hospital includes microbiologists, infectious diseases physicians and pharmacists. The team monitor antibiotic use and resistance, update the antimicrobial prescribing guidelines and support medical, surgical, nursing and pharmacy colleagues in antimicrobialuse. “The development of the mobile app is the latest innovation to further improve appropriate antibiotic use and I am delighted that we are able to use mobile technology to give our doctors and nurse prescribers easy access to the guidelines at the point of prescribing.” Prof Martin Cormican, Consultant Microbiologist and member of antimicrobial stewardship team adds: “Since their development over 60 years ago, antibiotics have helped to treat millions of patients with bacterial infections. “Many of the advances in

Anne Harnett, Chief Pharmacist, University Hospital Limerick

modern medicine such as cancer, chemotherapy and organ transplants would not be possible without them. However antibiotics have often been misused; antibiotics are often used when they are not needed and sometimes when antibiotics are needed the antibiotic used may not be best antibiotic for that situation. We have to take steps to improve the use of antibiotics otherwise we risk squandering one of the most important medicaladvances of the past 100 years. “Over the past number of years we have made

significant inroads in improving antimicrobial prescribing by developing user friendly guidelines that benefit patient care. The mobile app we are launching here today was developed by a team of people to provide a user friendly version of our antimicrobial guidelines which we give to our staff in print format, with one version for adults and one for children. The app means that staff have information on the best antibiotic to use for each infection at their fingertips, it is extremely easy to use and it also means that we can update the information very quickly.”

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Hospital Pharmacy Awards 2013

A beacon of oncology care at MMUH Aseptic Unit of the Year Award winner 2013

Jennifer Brown, Pharmacy Head of Operations, Mater Misericordiae University Hospital, Caroline Fitzgerald, Hospital Pharmacy Manager, Actavis Ireland, Brid Ryan, Chief Pharmacist and Professor Ciaran Meegan, Head of Pharmacy Services, Mater Misericordiae University Hospital

The team within the Aseptic Compounding Unit at Mater Misericordiae University Hospital celebrated on stage following a year of hard work and dedication in making their team a beacon of oncology services.

for Oncology (CATO) â&#x20AC;&#x201C; Phase 1,' was deemed by the judging panel to be forward thinking enough to scoop the title of Hospital Pharmacy Aseptic Unit of the Year Award at the 2013 Hospital Pharmacy Awards.

Their project submission, which was entitled 'Introduction of Computer Aided Technology

Chief Pharmacist Brid Ryan tells Hospital Pharmacy News: "Cancer treatment

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has placed an increased workload on pharmacy departments over recent years. The advent of improved therapies, advances in cancer diagnosis and management, and the growth in the ageing population will further increase the requirements for cancer treatment. "While advances in the

diagnosis and treatment of cancer are welcome, the increased workload in the current climate of staff shortages requires mindful management to ensure the ongoing high levels of risk management." The Aseptic Compounding Unit (ACU) of the Mater Misericordiae University


37 Hospital (MMUH) has been using electronic manufacturing software (ASCRIBE) for several years in the manufacture of cytotoxic chemotherapy. This has been complemented by publishing version controlled chemotherapy protocols on the hospital intranet to give oncology/haematology staff access to up-to-date clinical protocols and ensure the safe and accurate treatment of patients. It is recognised that the prescribing, preparation and administration of cytotoxic chemotherapy is a high risk process involving many staff disciplines. Solutions to maintain, and if possible, improve staff and patient safety are constantly sought. This is particularly important as the number and range of aseptically manufactured drugs continues to increase year on year. In 2011 the ACU, Pharmacy Department, MMUH, identified CATO as a potential upgrade to the systems that were currently in place. CATO is a software package which, when implemented to its full potential, can support electronic prescribing, manufacture and administration of cytotoxic chemotherapy in a single resource accessible to medical, pharmacy and nursing staff. It has clear workflow advantages for the aseptic unit and has the potential for improved and more efficient workflow for the whole Oncology Haematology multidisciplinary team. Extensive research by the ACU pharmacists was undertaken and a case for the introduction of CATO was developed. In 2012, Phase 1 of CATO implementation was commenced. The workload for the ACU staff in this phase was intense, and had to be undertaken without additional resources. The ACU staff were extremely committed to the project and continued complete functioning of the

Aseptic Compounding service throughout the extensive work to set up CATO. The requirements for CATO implementation included entry of complete chemotherapy regimens. "This now means that chemotherapy regimens can be set up with the appropriate hydration, anti-emetics and other supportive care medications. Additionally, when a regimen is entered against a patient it will enter all subsequent cycles at the appropriate timing interval and cycle number. A further benefit is that rather than entering individual drugs on a patient history a full chemotherapy regimen can be entered with CATO using a small number of keystrokes," says Brid. CATO has now been implemented in the pharmacy department. Upon the system going live, the aseptic unit have adapted their work flow to use CATO to its best within their current facilities. The changeover was smooth and is due to the months of hard work put into accurately setting up chemotherapy protocols and drug files. Brid adds: "It is also a credit to a team who communicate well and work hard together to ensure this software is successfully implemented." Phase 2 of CATO is the move to gravimetric compounding. This requires further investment as isolators must be fitted with scales and internal computer screens. Phase 2 planning has commenced and will take place as part of the upgrade and move of the compounding unit. The MMUH Aseptic Unit has taken the first step in introduced a fully integrated system for the prescribing, manufacture and administration of cytotoxic chemotherapy. This level of innovation is unique to the Irish healthcare system and to English speaking countries, and the

Brid Ryan, Chief Pharmacist, Mater Misericordiae University Hospital

MMUH ACU will be used as a beacon for further roll-out of the system. The ACU team at the MMUH continue to lead the way in Ireland with initiatives such as CATO implementation.

"The team will continue to strive to maintain a safer and more effective ACU despite the increased demands and restraints placed on them," Brid concludes.

Team Members  Ross Emerson Aseptic Compounding Service Manager  Brid Ryan Deputy Aseptic Compounding Service Manager  Ruth McHugh Senior Clinical Pharmacist, Oncology Clinical Trials  Pauline Gavin Senior Pharmacy Technician, Aseptic Compounding  Kate O’Callaghan Pharmacy Technician, Aseptic Compounding

Investing in education and the health of the nation HPN • Issue 12


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Hospital Pharmacy Awards 2013

Fionnuala is King in Oncology Oncology Pharmacist of the Year Winner 2013

ling gs

Fionnuala King, Lead Pharmacist for Oncology/Haematology and Palliative Care, St James's Hospital 1

The field of oncology is a continually challenging one, particularly for hospital pharmacy. Keen to spotlight this area and the benefits brought by skilled pharmacists and their teams is Fionnuala King, Lead Pharmacist for Oncology/ Haematology and Palliative Care at St James's Hospital. The judging panel of the Hospital Pharmacy Awards 2013 were suitably impressed by her forward thinking, leadership skills and dedication in this area and she was recently crowned BD Oncology Pharmacist of the Year 2013 at the event held in September of last year. Issue 12 â&#x20AC;˘ HPN

As cancer care becomes more complex and concerns arise over the cost of care and patient access, the role of oncology pharmacists is emerging as an important solution to some of the issues looming on the horizon. Although the specialty is relatively new and the number of practitioners is still somewhat low, the attributes of oncology pharmacists are increasingly attractive for those addressing the challenge of today's oncology practice. The complexity of therapeutic agents and support drugs is such that having a pharmacist at the ready helps assure patient

safety, and a pharmacist is well positioned to understand the cost-effectiveness of various therapeutic options. Meanwhile, because of their contribution to clinical care, pharmacists can increase the productivity of a medical practice, an important factor if the anticipated shortage of oncologists comes to pass. Oncology pharmacists are actively engaged in all aspects of cancer careâ&#x20AC;&#x201D;from chemotherapy dose preparation and safety checks, to educating patients about side effects, to drug development research. In addition, if a patient or caregiver

has any questions about a cancer medication, the oncology pharmacist is a helpful resource. Oncology pharmacists have a vital role in the health care team. Pharmacists possess specialised knowledge about medications and how they work to fight cancer. They work with the medical and nursing staff to maximise the benefits of drug therapy while trying to minimise toxicities. Pharmacists also help coordinate the complete medication plan, from inpatient chemotherapy infusions to what medications need to be taken at home. Additionally, oncology


39 pharmacists work with the health care team to educate patients about what to expect during treatment and ensure that each medication is given at the right time and dosed correctly. No matter the setting, oncology pharmacists are true experts in the medications used to treat cancer, as well as the medications used to manage complications of cancer and side effects from its treatment. They can explain to patients exactly how their medications should be taken. They can look at a patient’s current list of medications to identify any worrisome drug interactions and then provide guidance on managing these interactions. Oncology pharmacists also explain what side effects may occur and assist in managing these side effects. Finally, oncology pharmacists work closely with a patient’s oncologist in order to achieve the best possible outcome. Fionnuala joined the staff of St James’s Hospital in 2000. Says one nominee: "She is dedicated to her patients, her team and consistently provides comprehensive pharmaceutical care to this patient cohort." Fionnuala focuses on patient safety , and also efficiency and effectiveness of drug therapy and is known for being the “go to” person amongst her colleagues, both within the hospital and external for up to date information on oncology. Many of Fionnuala's team have been trained and have gone on to work in the same field in other jurisdictions, including New Zealand, Scotland and the UK. She has been instrumental in embedding the oncology pharmacy service into the Haematology/Oncology Day ward services whilst Inpatient services are also safety and patient focused. Fionnuala actively promotes a multidisciplinary approach, with pharmacists verifying prescriptions at ward level. As an active member of the Irish

Medication Safety Network, and oncology representative , She has presented at their annual conference on key issue of patient safety e.g Intrathecal Protocols , using the multidisciplinary example implemented in St James’s. "She has a huge interest in the safety of the patients and particularly with regard to the prescribing and dispensing of oral chemotherapy. www.imsn.ie Fionnuala thinks outside the box and will look for simple solutions and trial before fully implementing, so she will tweak to improve further. She has established a strong team culture which has resulted in even better solutions then on individual. She is constantly looking to improve services and the safety of the patient in this high risk area," says one colleague. Fionnuala has recently undertaken significant personal development, including completing a Masters in Leadership, RCSI, 2010, and more recently Postgraduate Certificate in Cancer Studies 2013., thus increasing her knowledge and ability to the benefit of the wider hospital pharmacy team and the profession. In addition, she is a lecturer on MSc Clinical Pharmacy, Cork and has given lectures for CPD, as part of the ICCPE programme over the years including, e,g. oral chemotherapy, skin cancer. She also teaches inhouse both to pharmacy staff, medical staff and nurses. Fionnuala has introduced mandatory training of new registrars in prescribing for Oncology and haematology patients. This has decreased the error rate, inprescribing and improved safety and efficiency. Examples of the overall contribution to pharmacy oncology which has directly or indirectly had an impact on service delivery and standards include, • introduction and implementation of hospital intra thecal policy,

Fionnuala King, Lead Pharmacist for Oncology, Haematology and Palliative Care receives her award from Paul Boland, Managing Director, Medisource

• updating of protocols for oncology and haematology to ensure easier access on the hospital intranet for prescribing doctors and nurses. • Facilitating improvements on clinical trials including improved processes to returns from patients. • Standardising approach for screening and verify oncology prescriptions

Concludes her colleague: "Fionnuala has made a huge contribution to oncology and the bringing of the role of the pharmacist into the spotlight in a positive manner. She is highly regarded by the hospital consultants as well as nursing staff, colleagues and finance. "She manages to instil great confidence in her own team and leads by example in her knowledge and passion for oncology."

• Introducing specific medication safety meeting to directorate staff allowing follow up of incidents so that learning is passed on and systems improved.

Investing in education and the health of the nation HPN • Issue 12


40 Feature

Evidence-based clinical practice guidelines on management of pain in older people Written by: Aza Abdulla, Margaret Bone, Nicola Adams, Alison M. Elliott, Derek Jones, Roger Knaggs, Denis Martin, Elizabeth L. Sampson and Patricia Schofield

Author Affiliations 1South London Healthcare Trust, Kent, UK 2Leicester University Hospital, Leicester, UK 3 Northumbria University, Newcastle upon Tyne, UK 4Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK 5 Nottingham University Hospitals NHS Trust, Nottingham, UK 6Teesside University, Middlesbrough, UK 7 University College Medical School, London, UK 8School of Health and Social Care, Greenwich University, London, UK

Pain in older people is not only under-recognised, but is also under-treated. Many professional bodies have documented that pain in this rapidly growing population ispoorly controlled [1–7]. This may be related to attitudes and beliefs held by older people, which in turn affects their reporting of pain [8] but also due to misconceptions and educational deficits by health professionals [9, 10]. Treatment when prescribed is often limited to basic medication seldom tailored to the individual [11–14]. There is also a general failure by professionals to consider alternative pain relief options [2]. No doubt more needs to done and national guidance on the management of pain in older people is long overdue. Older people are different; the bio-physiological changes that occur with ageing, the accumulation of comorbidities and co-prescription of medication, frailty and psychosocial changes make older people rather unique when considering treatment modalities for pain control. The British Geriatric Society and British Pain Society have collaborated to produce the first UK guideline on the management of pain in older people. The recommendations follow an extensive systematic review of the available literature and will help health professionals

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consider the options available when managing pain in older patients. The guideline has been categorised into sections dealing with pharmacology, interventional therapies, psychological interventions, physical activity and assistive devices and complementary therapies. This article provides a summary of the recommendations. PHARMACOLOGICAL INTERVENTION Few studies investigating the effects analgesic drugs have been performed specifically in older people [15]. For many analgesic medicines, a lower initial dose may be required than prescribed for younger adults and should be titrated to response. The first line pharmacological treatment, particularly in musculoskeletal pain is paracetamol. It has demonstrated efficacy and a good safety profile, but it is important that the maximum daily dose is not exceeded. Although NSAIDs are effective analgesics, their side effect profile requires cautious use. If essential, the lowest dose should be used for the shortest period and reviewedregularly. Opioids are effective in the short term, but evidence for long-term efficacy is much more limited and hence patients prescribed opioids should have


Guidance on the management of pain in older people is reported to be provided in only about one-third of general practice consultations. Summary statements regular review, both for efficacy effective in relieving pain in and tolerability. Side effects, the short term with little risk There isconstipation, a need to conduct researchand/or into issues of •particularly should further of complications joint pain information as Hyaluronic there is aacid paucity becommunicating anticipated and prophylactic damage. is also of treatments Excessive but appears to have researchprescribed. upon which to base effective any recommendations. sedation can be problematic and a slower onset of action and The be level of cognitive impairment should be considered •should monitored carefully. lasts longer than steroids. The in the assessment of pain as patients with severe cognitive Tricyclic antidepressants or antievidence for IA injection of other epileptics may be considered for joints, however, is limited. by selfimpairment are unable to convey pain information neuropathic pain, although side report methods of assessment. effects often limit their use. The evidence for facet joint interventions is mixed, although Pharmacology Topical analgesics have a role there is some support for in localised pain; both lidocaine radiofrequency lesioning for both Results and capsaicin have limited cervical and lumbar facet joint efficacy in localised neuropathic pain in of appropriately Few studies investigating the effects analgesic selected drugs have pain and topical NSAIDs may patients. There is also limited been performed specifically in older people (those over 65 be suitable for non-neuropathic data to support consideration of years). pain. epidural steroid injections and adhesiolysis for spinal stenosis and radicular symptoms. Combination therapy using However, the use of an imagedifferent classes of analgesics Physiological changes in older people that affect guided transforaminal approach may provide greater pain relief drug handling yielded better outcomes than through synergistic action with the blind approach especially fewer side effects compared Older people a inheterogeneous population. patients with sciatica. In with higher doses of represent a single However, as adults grow older, changes occur in bodyandcompainful vertebral fractures medicine. despite the initial favourable position and the ability to handle drugs. These effects are reports, the current data for INTERVENTIONAL THERAPIES summarised in Table 1 below. the use of vertebroplasty and kyphoplasty is conflicting Interventional therapies in [16–19]. Until further larger the management of chronic studies become available, no pain include a variety of General principles of pharmacological firm recommendations could be neural blocks and minimally management of pain in older people [95] made. Similarly, the evidence invasive procedures. The recommendations produced Physiological changes in older people increase the sensi• IS WEAK FOR in this section are limited tivity to some analgesic drugs, resulting in them someSYMPATHECTOMY IN to specific interventions in times requiring lower doses. Analgesics should, however, NEUROPATHIC PAIN. clinical conditions common in always older people. Intra-articular be titrated to response. In acute herpes zoster andtherapy post(IA) corticosteroid injection in of side effects with drug • Although the incidence osteoarthritis of the knee is herpetic neuralgia, nerve block is higher in older people, analgesics can still be safe and

41

effective when comorbidities and other concomitantly prescribed medicines are carefully considered. • Use the least invasive route of administration. As a usinggeneral a combination local oral route from CBT management rule, ofthe is pain preferred due to its anaesthetic and corticosteroid is interventions. Psychological convenience. effective. There is also support interventions may be used as Timing of medication important. Severe, for •the use of botulinum toxin. administration an adjunct to is pharmacological intervention and/or other episodic pain requires treatment with medicines with a Microvascular decompression rapid onset of action andmodalities. short duration. However, if a is the treatment of choice in patient is experiencing continuous pain, regular analgesia healthy patients with trigeminal PHYSICAL ACTIVITY AND is the effective, possibly using modified release neuralgia whilemost percutaneous ASSISTIVE DEVICES procedures should be formulations. considered in patients with initiatedactivity at a and timeassistive using a low • Only one drug should be Physical significant co-morbidity. devices encompass a wide dose, and this should be followed by slow dose titration. range of interventions. The sufficiently long available intervalsevidence between introducing Interventional where • Allow therapies, supports the evidence the use programmes that drugs toexists, allowshould the assessment of of effect. be considered especially in comprise strengthening, therapy drugs with complementary • Combination patients with chronic pain when using flexibility and endurance mechanisms of action may haveto increase synergistic effects to pharmacological treatments are activities physical ineffective or not tolerated. activity, improve function and provide greater pain relief with fewer side effects than pain [22–26]. There are many higher doses of a single drug. different forms of exercise PSYCHOLOGICAL strategies such • Consider the use of non-pharmacological INTERVENTIONS and the choice of exercise typebehavioural can pose a dilemma. as physiotherapy, cognitive approaches and Given themedication. absence of evidence It is well recognised that acupuncture, in combination with to recommend one type of psychological factors often andpatient adjusted if • Treatment should be monitored exercise regularly over another, influence the manner people required improve efficacy and limit adverse events. preference should be a key respond to and to cope with pain, factorfor andan programmes should and• techniques may modify When choosing an analgesic individual, both cobe customised to individual beliefs and attitudes. However, morbidity and other medication must be considered to capacity and need [27]. A large few studies have focused minimise thesample chance of range drug–disease and drug–drug of potential options on older adults and includes progressive resistance sizesinteractions. are small. Nonetheless, exercise, walking, waterpsychological interventions such based exercise/hydrotherapy. as cognitive behavioural therapy Adaptations of Tai-Chi [28, 29] (CBT) or behavioural therapy and Yoga [30] and advances in mayParacetamol be effective in decreasing gaming technology such as Wii chronic pain in adults and The literature search did not studies andidentify Kinect areany alsoprimary opening up improving disability and mood relating to paracetamol use in older people. new possibilities. [20,specifically 21].

However, it is an effective analgesic for the symptoms of back pain, and is recommended as a first choice analgesic in

Persistent pain is alsoand a strong Elderly nursing home residents musculoskeletal pain, including osteoarthritis low with chronic pain may benefit risk factor for falls in older

Table 1. Physiological changes in older people that affect drug handling Physiological

Change with normal ageing

Clinical consequence of change

Absorption and function of the gastrointestinal (GI) tract

Delayed gastric emptying and reduced peristalsis Reduced blood flow to the GI tract

Distribution

Decreased body water Increased body fat that causes lipid soluble drugs to accumulate in reservoirs Lower concentration of plasma proteins and increased free fraction of drugs that are highly bound to proteins Decreased hepatic blood flow Reduced liver mass and functioning liver cells

Alteration of drug absorption has little clinical effect Increased risk of GI-related side effects including opioid-related gut mobility disturbance Reduced distribution of water soluble drugs Lipid soluble drugs have longer effective half-life

....................................................................................

Hepatic metabolism

Renal excretion

Pharmacodynamic changes

i8

Reduced renal blood flow Reduced glomerular filtration Reduced tubular secretion Decreased receptor density Increased receptor affinity

Increased potential for drug–drug interactions Reduced first pass metabolism Oxidative reactions (phase I) may be reduced, resulting in prolonged half-life Conjugation (phase II metabolism) usually preserved Difficult to predict precise effects in an individual Reduced excretion of drugs and metabolites eliminated by kidney leading to accumulation and prolonged effects Increased sensitivity to the therapeutic and side effects

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42 Feature

Issues of communication between older people and health professionals are important factors affecting the assessment of pain and consequent management strategies

people [31]. Incorporation of cognitive behavioural principles into programmes and the provision of supervision is likely to help [32] in enhancing motivation [33]. Although a wide variety of assistive devices are available, research into these assistive devices is mostly descriptive in nature and very few studies have considered pain reduction in older people. These devices are designed to assist in activities of daily living, either personal activitiesâ&#x20AC;&#x201D;i.e. associated with personal hygiene, dressing, and eating or instrumental, such as cooking, shopping, leisure etc. The evidence to date suggests that assistive devices may support community living, reduce functional decline, reduce care costs and reduce pain intensity relative to older people not provided with devices. COMPLEMENTARY THERAPIES Some types of complementary therapy [e.g. acupuncture, transcutaneous electrical nerve stimulation (TENS), massage] have been used for older adults with painful conditions, although the available studies lack methodological rigour. Acupuncture applied singularly

Issue 12 â&#x20AC;˘ HPN

or in combination with other modalities has an impact on pain and quality of life in patients with osteoarthritis. Conventional TENS can be used for relief of musculoskeletal pain. Similarly, percutaneous electrical nerve stimulation combined with physiotherapy reduces pain and self-reported disability for up to 3 months. Other therapies such as massage can be used to treat chronic pain, in particular shoulder or knee pain. Reflexology reduces anxiety in patients with breast or lung cancer. LIMITATIONS The guidelines focus on the management of chronic pain in older people. However the recommendations, especially in the sections on pharmacology and interventional therapy, may be applied for the management of acute pain. The group opted for a general guidance rather than specific types of pain although those common in older people such as sciatica, osteoarthritis of knee, postherpetic neuralgia and trigeminal neuralgia were also explored. Despite the extensive search, the literature was lacking in studies specifically targeting the management of pain in older people necessitating the

inclusion of studies that were not specific to but included people over the age of 65 years. Where evidence was limited we extrapolated from available evidence based studies in younger adults. The guideline has exposed this deficiency and we call for more robust research and quality studies in pain management in older people. Furthermore, issues of communication between older people and health professionals are important factors affecting the assessment of pain and consequent management strategies. This has hitherto received little attention in the scientific literature. In producing these guidelines, the intention was not to construct flow charts or step by step algorithms for pain management in older people. Instead, the aim was to increase the awareness of clinicians to consider alternatives through highlighting the available evidence. Indeed, often more than one treatment modality may be required for satisfactory pain control, for example, combining psychological therapies alongside non-opioid analgesia in patients with long-standing chronic pain, or the combination of interventional therapy to weak opioids especially in localised pain, has

the advantage of minimising side effects from increasing the dose of systemic medication. The intention is to update these guidelines every 3â&#x20AC;&#x201C;5 years. GUIDELINES The intention of this section is not to compare the guidelines. It is aimed to be more of a summary of available evidence that has been graded by other authors. The AGS provided the first clinical practice guideline on the management of chronic pain in older people in 1998, [288] later updated in 2002 [236]. The two versions concentrated on the assessment of pain and pharmacological management. Many of the surgical interventions were not explored in this document, although non-pharmacological strategies, including physical and behavioural therapies, were discussed. More recently, in 2009, the AGS revised their earlier recommendation on pharmacological management of persistent pain to include advice on the use of newer pharmacologic approaches [95]. In their guideline, the panel highlighted the paucity of rigorous, well-controlled studies involving only older people; a problem that became only too obvious to us when searching the pain literature. Like the AGS,


43 we also had little choice but to extrapolate, where appropriate, some of the evidence from studies on younger adults. In 2010, the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine released practice guidelines on the management of chronic pain excluding cancer, degenerative major joint disease, headache and other facial pain syndromes. The guideline graded the evidence and included interventional therapies as well as pharmacological management, physical therapy and psychological treatment. This guideline was not specifically designed for older people, although it may be argued that the recommendations could be on occasions, extrapolated to this population [289]. The American guidelines made recommendations for people with different degrees of problems. They recommended that health professionals should consider an initial period of appropriate professional-led rehabilitation, again focusing on improving strength, flexibility and stamina, for people who had severe physical problems. For people who were not yet capable of more strenuous exercise, they recommended routine consideration of moderate exercise over a period of 8–12 weeks, under the supervision of a professional with knowledge of the needs of older people. They recommended exercise classes for people who were considered otherwise healthy but unfit. Finally, maintenance of moderate levels of productive and/or leisure activity should be advised. We did not find any specific evidence that classified people over 65 years with chronic pain based on levels of disability to add to these recommendations. REFERENCES: 1. A.G.S. Panel on Chronic Pain in Older Persons. The management of chronic pain in older persons. J Am Geriatr Soc 1998; 46: 635–51. 2. Cairncross L, Magee H,

Askham J. A Hidden Problem: Pain in Older People. Oxford: Picker Institute Europe, 2007. 3. Ferrell BA, Ferrell BR, Rivera L. Pain in cognitively impaired nursing home patients. J Pain Symptom Manager 1995; 10: 591–8. 4. Kumar A, Allcock N. Pain in Older People. Reflections and Experiences from an Older Person’s Perspective. London: The University of Nottingham— The British Pain Society, 2008. 5. Magee H, Parsons S, Askham J. Measuring Dignity in Care for Older People. London: The Picker Institute for Help the Aged, 2008. 6. Zwakhalen S, Koopmans R, Geels P, Berger M, Hamers J. The prevalence of pain in nursing home residents with dementia measured using an observational pain scale. Eur J Pain 2009; 13: 89–93. 7. Zyczkowska J, Szczerbinska K, Jantzi M, Hirdes J. Pain among the oldest old in community and institutional settings. Pain 2007; 129: 167–76. 8. Allcock N, McGarry J, Elkan R. Management of pain in older people within the nursing home: a preliminary study. Health Soc Care Community 2002; 10: 464–71. 9. Ferrell BA, Ferrell BR, Osterweil D. Pain in the nursing home. J Am Geriatr Soc 1990; 38: 409–14. 10. José Closs S. Pain in elderly patients: a neglected phenomenon? J Adv Nursing 1994; 19: 1072–81. 11. Cohen-Mansfield J, Lipson S. Pain in cognitively impaired nursing home residents: how well are physicians diagnosing it? J Am Geriatr Soc 2002; 50: 1039–44. 12. McClean WJ, Higginbotham NH. Prevalence of pain among nursing home residents in rural New South Wales. Med J Aust 2002; 177: 17–20. 13. Melding P. Can we improve pain management in nursing homes? Med J Aust 2002; 177: 5–6. 14. Melding PS. Who is losing the language? Persistent pain in home-dwelling elders. Age Ageing 2004; 33: 432–4.

15. Ickowicz E, Ferrell B, Argoff C et al. Pharmacological management of persistent pain in older persons. American Geriatrics Society panel on the pharmacological management of persistent pain in older persons. J Am Geriatr Soc 2009; 57: 1331–46. 16. Ãlvarez L, Alcaraz M, Pérez-Higueras A et al. Percutaneous vertebroplasty: functional improvement in patients with osteoporotic compression fractures. Spine 2006; 31: 1113–8 10.097/01. brs.0000216487.97965.38. 17. Amar AP, Larsen DW, Esnaashari N, Albuquerque FC, Lavine SD, Teitelbaum GP. Percutaneous transpedicular polymethylmethacrylate vertebroplasty for the treatment of spinal compression fractures. Neurosurgery 2001; 49: 1105– 15. 18. Buchbinder R, Osborne RH, Ebeling PR et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med 2009; 361: 557–68. 19. Kallmes DF, Comstock BA, Heagerty PJ et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009; 361: 569–79. 20. Cipher DJ, Clifford PA, Roper KD. The effectiveness of geropsychological treatment in improving pain, depression, behavioral disturbances, functional disability, and health care utilization in long-term care. Clin Gerontol 2007; 30: 23–40. [doi: 10.1300/J018v30n03_02] (2012/07/08). 21. Eccleston C, Williams AC, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2009; 2: CD007407. 22. Corrêa Dias R, Domingues Dias JM, Ramos LR. Impact of an exercise and walking protocol on quality of life for elderly people with OA of the knee. Physiother Res Int 2003; 8: 121–30. 23. Ferrell B, Josephson K, Pollan A, Loy S, Ferrell B. A randomized trial of walking versus physical methods for chronic pain management. Age Aging 1997; 9: 99–105.

24. Hasegawa R, Islam MM, Nasu E et al. Effects of combined balance and resistance exercise on reducing knee pain in community-dwelling older adults. Phys Occupat Ther Geriatr 2010; 28: 44–56. 25. Jamtdvedt G, Dahm K, Christie A et al. Physical therapy interventions for patients with osteoarthritis of the knee: an overview of systematic reviews. Phys Ther 2008; 88: 123–36. 26. Walsh NE, Mitchell HL, Reeves BC, Hurley MV. Integrated exercise and selfmanagement programmes in osteoarthritis of the hip and knee: a systematic review of effectiveness. Phys Ther Rev 2006; 11: 289–97. 27. Airaksinen O, Brox J, Cedraschi C et al. Chapter 4 European guidelines for the management of chronic nonspecific low back pain. Eur Spine J 2006; 15: S192–S300. 28. Li F, Fisher KJ, Harmer P, Irbe D, Tearse RG, Weimer C. Tai Chi and self-rated quality of sleep and daytime sleepiness in older adults: a randomized controlled trial. J Am Geriatr Soc 2004; 52: 892–900. 29. Wolf SL, Barnhart HX, Kutner NG, McNeely E, Coogler C, Xu T. Reducing frailty and falls in older persons: an investigation of Tai Chi and computerized balance training. Atlanta FICSIT Group. Frailty and Injuries: Cooperative Studies of Intervention Techniques. J Am Geriatr Soc 1996; 44: 489–97. 30. Chen K-M, Tseng W-S, Ting L-F, Huang G-F. Development and evaluation of a yoga exercise programme for older adults. J Adv Nurs 2007; 57: 432–41. 31. Leveille S, Jones R, Kiely D et al. Chronic musculoskeletal pain and the occurrence of falls in an older population. JAMA 2009; 302: 2214–21. 32. Liddle SD, Baxter GD, Gracey JH. Exercise and chronic low back pain: what works? Pain 2004; 107: 176–90. 33. Sabin KL. Older adults and motivation for therapy and exercise: issues, influences, and interventions. Top Geriatr Rehabil 2005; 21: 215–20.

HPN • Issue 12


44 Drug News

DRUG BULLETIN

European Commission approval for Tivicay ViiV Healthcare has announced that the European Commission has approved TivicayTM (dolutegravir), an integrase inhibitor, for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age.

Issue 12 • HPN

The Tivicay clinical development programme was comprehensive in its breadth, including people living with HIV who were new to treatment (naive), as well as those who had already been treated with other HIV medicines (experienced) and those who were infected with a virus that had developed resistance to previously available integrase inhibitors. The submission supporting today’s approval included data from four pivotal Phase III clinical trials in which 2,557 adults received treatment with Tivicay or a comparator1-4. The submission also included data from a fifth study in children aged 12 years and older5. “Today’s approval of Tivicay is an important advance, opening the door to new treatment combinations for people living with HIV in Europe. Tivicay’s clinical development programme was only possible through partnerships with the people living with HIV and healthcare professionals who participated in it, and we aim to move References: 1 Walmsley S, Antela A, Clumeck N et al. Dolutegravir plus abacavir/lamivudine for the initial treatment of HIV-1 infection. N Engl J Med 2013;369:1807-18. 2 Cahn P, Pozniak AL, Mingrone H et al. Dolutegravir versus raltegravir in antiretroviralexperienced, integraseinhibitor-naive adults with HIV: week 48 results from the randomised, double-

forward together with them based on an absolute commitment to the HIV/ AIDS global response,” said Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare. The approval of Tivicay is the European regulatory authorisation to market the medicine in each member state of the European Union. Tivicay will become available in each country as pricing and reimbursement processes are completed, with availability in some of the first countries anticipated in the immediate future. The efficacy of Tivicay – as a ‘third agent’ – was statistically superior to its comparator in two pivotal Phase III studies1,2 and non-inferior in a third comparator study3. In clinical trials1-4, Tivicay had low rates of discontinuation due to adverse events (1-3%) in both treatmentnaive and treatmentexperienced patients. “HIV treatment is not a question of ‘one-size fits all’ – especially now that treatment is something that patients will live with blind, non-inferiority SAILING study. Lancet 2013;382(9893):700-708. 3 Raffi F, Rachlis A, Stellbrink H-J et al. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, doubleblind, non-inferiority SPRING-2 study. Lancet 2013;381(9868):735-743. 4 Eron JJ, Clotet B, Durant J et al. Safety and

for many years,” said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. “We continue to find measurable clinical differences among the treatments now available for use in combination therapy to combat HIV. Using the clinical data for Tivicay, doctors and people living with HIV can fully consider the effectiveness against the virus and the side effect profile that Tivicay may bring.” The safety profile is based on pooled data from Phase IIb and Phase III clinical studies in 980 previously efficacy of dolutegravir in treatment-experienced subjects with raltegravirresistant HIV type 1 infection: 24-week results of the VIKING study. J Infect Dis. 2013;207(5):740-748. 5 Hazra R, Viani R, Acosta E et al. Pharmacokinetics, safety and efficacy of dolutegravir (DTG; S/ GSK1349572) in HIV1-positive adolescents: preliminary analysis from IMPAACT P1093.

untreated patients, 357 previously treated patients unexposed to integrase inhibitors and 234 patients with prior treatment failure that included an integrase inhibitor (including integrase class resistance). The most commonly seen treatment emergent adverse reactions were nausea (15%), diarrhoea (16%) and headache (14%). The most severe adverse reaction, seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects.

19th International AIDS Conference (IAC), 2012. Abstract TUAB0203. 6 Tivicay (dolutegravir) Summary of Product Characteristics (SmPC). Available at www. viivhealthcare.com/ourmedicines.aspx *Atripla is a registered trademark of BristolMyers Squibb and Gilead Sciences, LLC.


The first biosimilar monoclonal antibody (mAb) for use in gastroenterology

Gain a fresh perspective INFLECTRA™ is the world’s first biosimilar mAb. Designed with equivalent efficacy, safety and quality to reference infliximab1,2 to increase the treatment options for your gastroenterology patients. Change your perception. Choose INFLECTRA™. Abbreviated indications: Crohn’s disease (CD): adult patients with moderately to severely active CD who have not responded despite a full and adequate course of therapy with a corticosteroid and/or immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Adult patients with fistulising, active CD who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric patients (aged 6 to 17 years) with severe, active CD who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.

Abbreviated Prescribing Information – INFLECTRA▼ (Infliximab) powder for concentrate for solution for infusion Please refer to full Summary of Product Characteristics (SmPC) before prescribing. Presentation: Vial containing 100 mg of infliximab powder for concentrate for solution for infusion. Indications: 1) Rheumatoid arthritis in adult patients with active disease with inadequate response to disease-modifying antirheumatic drugs (DMARDs) or adult patients with severe, active and progressive disease not previously treated with methotrexate (MTX) or other DMARDs 2) Adult Crohn’s disease a) In patients with moderately to severely active Crohn’s disease who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have contraindications for such therapies. b) In patients with fistulising, active Crohn’s disease who have not responded despite conventional treatment (including antibiotics, drainage and immunosuppressive therapy). 3) Paediatric Crohn’s disease Severe, active Crohn’s disease in patients aged 6 to 17 years, who have not responded to conventional therapy including corticosteroid, immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. 4) Ulcerative colitis In both adult patients with moderate to severely active ulcerative colitis, and children and adolescents aged 6 to 17 years with severely active ulcerative colitis and an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine; or who are intolerant to or have contraindications for such therapies. 5) Ankylosing spondylitis In adult patients with severe active ankylosing spondylitis who have responded inadequately to conventional therapy. 6) Psoriatic arthritis In adult patients with active and progressive psoriatic arthritis when response to previous DMARD therapy has been inadequate. 7) Psoriasis In adult patients with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to systemic therapy including cyclosporine, MTX or PUVA. Dosage & Administration 1) Rheumatoid arthritis 3 mg/kg as an intravenous (IV) infusion repeated 2 and 6 weeks after initiation, then every 8 weeks. Inflectra must be given concomitantly with MTX. 2) Moderately to severely active Crohn’s disease 5 mg/kg IV infusion repeated 2 weeks after initiation. If a patient does not respond after 2 doses, no additional dose should be given. 3) Fistulising, active Crohn’s disease 5 mg/kg IV infusion repeated 2 and 6 weeks after initiation. If a patient does not respond after 3 doses, no additional dose should be given. 4) Ulcerative colitis 5 mg/kg IV infusion repeated 2 and 6 weeks after initiation, then every 8 weeks. 5) Ankylosing spondylitis 5 mg/kg IV infusion repeated 2 and 6 weeks after initiation, then every 6 to 8 weeks. If a patient does not respond by 6 weeks, no additional dose should be given. 6) Psoriatic arthritis 5 mg/kg IV infusion repeated at 2 and 6 weeks after initiation, then every 8 weeks. 7) Psoriasis 5 mg/kg IV infusion repeated 2 and 6 weeks after initiation, then every 8 weeks. If a patient shows no response after 14 weeks no additional dose should be

Ulcerative colitis (UC): adult patients with moderately to severely active UC who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Paediatric patients (aged 6 to 17 years) with severely active UC who have had inadequate response to conventional therapy including corticosteroids and 6-MP or AZA or who are intolerant or have medical contraindications to such therapies.

given. Administer IV over 2 hours initially and monitor for infusion-related reactions. Contraindications: Hypersensitivity to infliximab, to other murine proteins, or to any excipients. Tuberculosis (TB) or other severe infections such as sepsis, abscesses, and opportunistic infections. Moderate or severe heart failure (NYHA class III/IV). Warnings and Precautions: Caution in patients with or at risk of infusion reactions and hypersensitivity. Do not administer in patients with infections, and/or invasive fungal infections. Monitor for TB and do not use in patients with TB. Test for latent/ active TB prior to initiation of therapy. Do not use Inflectra in patients with active TB, patients with latent TB must not be initiated on Inflectra therapy until initiation with anti-TB therapy. Monitor closely for infections, including TB before, during and for six months post-treatment. Patients with fistulising Crohn’s disease with acute suppurative fistulas must not initiate therapy until source of infection, specifically abscess, is excluded. Test for HBV infection before initiating treatment. Consult expert in treatment for HBV-positive patients. Closely monitor carriers of HBV during and after therapy. In patients with HBV reactivation, stop Inflectra and initiate appropriate therapy. Pregnancy should be avoided during therapy, and for at least 6 months after last infusion. Adverse effects: Viral infection, bacterial infection, TB, fungal infection, meningitis, opportunistic infection, parasitic infection, hepatitis B reactivation, lymphoma, non-Hodgkin’s lymphoma, Hodgkin’s disease, leukaemia, melanoma, hepatosplenic T-cell lymphoma, Merkel cell carcinoma, allergic respiratory symptom, anaphylactic reaction/shock, lupus like syndrome, serum sicknesslike reaction, vasculitis, sarcoid-like reaction, depression, insomnia, amnesia, agitation, confusion, somnolence, nervousness, apathy, headache, vertigo, dizziness, hypoaesthesia, paraesthesia, seizure, neuropathy, transverse myelitis, demyelinating disorders, conjunctivitis, keratitis, periorbital oedema, hordeolum, endophthalmitis, transient visual loss, tachycardia, palpitation, cardiac failure, arrhythmia, syncope, bradycardia, cyanosis, pericardial effusion, myocardial ischaemia/ infarction, hypotension, hypertension, ecchymosis, hot flush, flushing, peripheral ischaemia, thrombophlebitis, haematoma, circulatory failure, petechia, vasospasm, URTI, sinusitis, lower respiratory tract infection, dyspnoea, epistaxis, pulmonary oedema, bronchospasm, pleurisy, pleural effusion, interstitial lung disease, abdominal pain, nausea, gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation, intestinal perforation/stenosis, diverticulitis, pancreatitis, cheilitis, hepatic function abnormal, transaminases increased, hepatitis, hepatocellular damage, cholecystitis, jaundice, liver failure, psoriasis (new onset or worsening), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia, bullous eruption, onychomycosis, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation, Toxic Epidermal Necrolysis, Stevens-Johnson syndrome, erythema multiforme, furunculosis, arthralgia, myalgia, back pain, urinary tract infection, pyelonephritis, vaginitis, infusion related reaction, pain, chest pain, fatigue, fever, injection site reaction, chills, oedema,

impaired healing, granulomatous lesion, autoantibody positive, complement factor abnormal. The SmPC should be consulted for further details of adverse effects Legal category: POM Marketing Authorisation Number/Pack: EU/1/13/854/001 (1 vial); EU/1/13/854/002 (2 vials); EU/1/13/854/003 (3 vials); EU/1/13/854/004 (4 vials); EU/1/13/854/005 (5 vials) Marketing Authorisation Holder: Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW. Further information is available on request from: Hospira Ireland Ltd, Unit 15, The Park, The Hyde Building, Carrickmines, Dublin 18, Ireland Date of preparation: October 2013 (IE/INF/13/0003)

Adverse events should be reported. Reporting forms and information can be found at www.imb.ie Adverse events should also be reported to Hospira UK Ltd. Telephone Medical Information: +44 (0) 1926 834400 6-MP = 6-mercaptopurine AZA = Azathioprine References: 1. INFLECTRA™. European Public Assessment Report (EPAR). Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/ medicines/002778/human_med_001677.jsp&mid=WC0b01ac058001d124. [Accessed September 2013]. 2. EMA. Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. May 2012. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2012/06/WC500128686.pdf [Accessed September 2013]. IE/INF/13/0020 November 2013


46 News

NPPG re-establishes Irish branch The Irish branch of the Neonatal and Paediatric Pharmacy Group (NPPG) has recently been re-established. The aim of the NPPG is to facilitate the sharing and discussion of medication management to improve pharmaceutical care in these areas. The group also provides an educational forum for pharmacists working in these clinical areas, and a one day conference will be held in March in the Royal College of Surgeons.

Anne Clohessy, RCSI, School of Pharmacy

This group welcomes pharmacists working in the areas of neonatolgy, paediatrics and women's health. Any pharmacist with an interest in these areas is

also welcome to join this group. President Anne Clohessy told HPN: "There is now more than ever, a need for our own local group focusing on these issues. The numbers of hospital pharmacists that have joined the paediatric ranks has increased substantially and we knew that now was the time to have our voice back." Meetings are held every two months in various locations in Dublin, and teleconferencing is available for pharmacists outside Dublin to join the meetings. Anne Clohessy can be contacted for further information at amclohessy@rcsi.ie.

Strategic Advisory Group on Hospital Groups The first meeting of the Strategic Advisory Group on Hospital Groups took place earlier this year (February). The Group's remit is to ensure that international best practice informs the implementation of hospital groups. The establishment for hospital groups arises from the Programme for Government, the Government decision to approve the Higgins Report and the Minister for Health's intention to implement Hospital Groups based on that decision.

Each group of hospitals will work together as single cohesive entities managed as one, to provide acute care for patients in their area. Seven hospital groups have been established as follows: Dublin North East; Dublin Midlands; Dublin East; South/South/West; West/North West; UL Hospitals Group, and the Children's Hospital Goup. Chair, Mr Leo Kearns stated: "There are potentially huge gains to be made for our healthcare system and ultimately for patients through

Chair Mr Leo Kearns, HSE

the establishment of hospitals groups." Health Minister Reilly added: "The group has key role to play in helping us to adddress the many complex challenges involved in this fundamental reform of our hospitals services."

Draft statutory instrument submissions invited Pharmacists in Ireland are being invited to give submissions on a new draft statutory instrument relating to the education and training of pharmacists for public consultation. This draft statutory instrument will replace the current Pharmaceutical Society of Ireland (Education and

Issue 12 â&#x20AC;˘ HPN

Training) Rules 2008 (S.I. No. 493 of 2008) and will allow for the commencement of the new five-year fully integrated Masters degree programmes in pharmacy. The Council of the PSI, in June 2010, decided that a five-year integrated degree in pharmacy should constitute the qualification for practice for all

those qualifying as pharmacists in Ireland.

copy submissions should be returned via post to:

Submissions are now invited. They can be completed online by visiting the PSI website on www.thepsi.ie or hard copy and email submissions can be made which comprises detailed information on the consultation and the questionnaire. Hard

Public Consultation (Integrated Course Rules), Pharmaceutical Society of Ireland, PSI House, Fenian Street, Dublin 2, or the completed consultation document emailed to education@thepsi.ie.


1,2

1,2

BuTrans Patches ®

…effective analgesia helping 2,4 to improve quality of life

Butrans® patches contain an opioid analgesic BuTrans® 5 µg/h, 10 µg/h and 20 µg/h vasodilatation, dyspnoea, constipation, dry Transdermal Patch. Prescribing mouth, nausea, vomiting, abdominal pain, Information. Republic of Ireland. Please diarrhoea, dyspepsia, sweating, tiredness, read the Summary of Product pain, peripheral oedema, application site Characteristics before prescribing. pruritus, application site reaction, application Presentation: BuTrans 5 µg/h, 10 µg/h, 20 site erythema, application site rash, chest pain, µg/h. Transdermal beige patches containing pruritus, erythema, rash, exanthema, asthenia. buprenorphine. Indications: Treatment of Uncommon but potentially serious (≤ 1/100): non-malignant pain of moderate intensity anaphylactic reaction, anaphylactoid reaction, when an opioid is necessary for obtaining restlessness, agitation, depersonalisation, adequate analgesia. BuTrans is not suitable for euphoric mood, affect lability, hallucinations, the treatment of acute pain. Dosage and psychotic disorder, decreased libido, drug Administration: BuTrans should be admin- dependence, mood swings, sedation, istered every 7 days. Elderly and adults over 18 migraine, balance disorder, speech disorder, years only: Use the 5 µg/h patch for at least blurred vision, visual disturbance, eyelid the first 3 days of treatment, before increasing oedema, vertigo, angina pectoris, palpitations, the dose if necessary. Do not use more than tachycardia, hypotension, circulatory collapse, two patches at a time. Contra-indications: hypertension, asthma aggravated, hypoxia, Known buprenorphine or excipient wheezing, hyperventilation, respiratory hypersensitivity, opioid dependent patients, depression, respiratory failure, diverticulitis, use for narcotic withdrawal treatment, dysphagia, ileus, biliary colic, muscular respiratory depression, use of MAO inhibitors weakness, urinary retention, erectile within the past 2 weeks, myasthenia gravis, dysfunction, sexual dysfunction, oedema, delirium tremens. Precautions and drug withdrawal syndrome, alanine aminoWarnings: Convulsive disorders, head injury, transeferase increased, accidental injury, fall. shock, reduced consciousness of uncertain Please consult the SPC for details of other sideorigin, intracranial lesions or increased effects. Legal category: CD (Sch2) POM intracranial pressure, severe hepatic Package quantities: 5 µg/h transdermal impairment, history of drug abuse. Not patch: 2 individually sealed patches 10 µg/h recommended immediately postoperatively or transdermal patch: 4 individually sealed for situations characterised by a narrow patches 20 µg/h transdermal patch: 4 therapeutic index or for rapidly varying individually sealed patches. Marketing analgesic require-ments. May affect ability to Authorisation numbers: PA 913/24/1-3. drive or use machinery. As with all opioids, Marketing Authorisation holder: chronic use may result in the development of Mundipharma Pharmaceuticals Limited, physical dependence. Interactions: Mono- Millbank House, Arkle Road, Sandyford, amine oxidase inhibitors (MAOIs), CNS Dublin 18. Tel: +353 (0)1 2063800. One of depressants (e.g. benzodiazepines, opioid the Mundipharma / Napp independent derivatives, antidepressants, sedatives, associated companies. Date of preparation: alcohol, anxiolytics, neuroleptics, clonidine). August 2011 (UK/BUTR-11033). References: CYP 3A4 inhibitors and inducers, products 1. Butrans® SPC. 2. James IGV, O'Brien CM reducing hepatic blood flow (e.g. halothane). and McDonald CJ. J Pain Sympt Manage Pregnancy and lactation: BuTrans should not 2010; 40(2):266-278. 3. MIMS Ireland. 4. be used during pregnancy or in women of Karlsson M. et al: Efficacy and Safety of Low childbearing potential who are not using dose Transdermal Buprenorphine Patches effective contraception. The use of BuTrans (5,10 & 20ug/h) versus prolonged release during lactation should be avoided. Side tramadol tablets (75, 100, 150 and 200mgs) Effects: Very common (≥ 1/10) or common in patients with chronic osteoarthritis pain: a (≥ 1/100) side-effects: anorexia, confusion, twelve week, randomized open label, depression, insomnia, nervousness, headache, controlled, parallel-group non inferior study. dizziness, somnolence, paraesthesia, Clinical Therapeutics /Vol 31 No3, 2009. Adverse events should be reported to Mundipharma Pharmaceuticals Limited on 1800 991830 ® BuTrans and the Mundipharma device (logo) are Registered Trade Marks. © 2011 Mundipharma Pharmaceuticals Limited. IRE/BU-12001a. Date of Item: April 2012

BuTrans® 5mg: 7 days continuous pain relief 1 The lowest dose opioid analgesic patch 3 available in Ireland Reduces the burden of daily tablet use 2

A joint effort… good news for your patients and good news for you


48 Out & About

Benefits of partnership at IPHA Annual Meeting 1: Philip Hannon and Francis Lynch, IPHA 2: Muireann McAlister, Astra Zeneca, Aoife McAuliffe, Servier Laboratories Ltd and Maura Kinahan, Pfizer 3: Dr Michelle de Brun, Dr Leisha Daly, Natalie Buhl, Brian Tonge, Janssen and Sinead O'Rourke, Roche Products

1

2 3

The importance of partnership in healthcare and of exploring new opportunities of working together, was the theme of the 20 Irish Pharmaceutical Healthcare Association (IPHA) Annual meeting held at the RDS Concert Hall at the end of last year. IPHA President Francis Lynch outlined how the latest supply agreement between the State and IPHA which was just over a year old and will run until 2015, was already expected to deliver direct savings of around ¤130 million in 2013 alone”, he further added. Among the other contributors to the meeting were Secretary General of the Department of Health Dr Ambrose McLoughlin who highlighted the importance of stakeholders from across all aspects of healthcare working more closely together to bring about reform and better outcomes for patients.

11th St Luke's Young Investigators Award Pictured is Irish Cancer Society Fellow Dr Maria Prencipe, Royal Academy of Medicine in Ireland who has scooped the prestigious 11th St Luke's Young Investigators Award. Dr Prencipe scooped the top prize for her research at University College Dublin that investigates building a pipeline for novel therapies in castrateresistant prostate cancer (CRPC), and will receive an education grant and the Royal Academy of Medicine in Ireland Bronze Medal. This year, all four finalists are Irish Cancer Society Research Fellows, who are receiving combined research grants worth over ¤850,000 from the Society to advance research in their respective cancer fields. Dr Anne Marie Byrne, Dr Britta Stordal, Dr Maria Prencipe and Dr Antoinette Perry were the four finalists selected to deliver ten minute presentations of their research before the selection panel decided on the overall winner.

Launch of BRIEFcases toolkit Lundbeck Ireland have launched BRIEFcases, the first comprehensive alcohol management toolkit for GPs in Ireland that covers all aspects of screening and interventioni. The resource tool was launched as new research shows that only a small minority (10%) of adults over thirty have ever spoken to their doctor about the impact of consuming alcohol on their health, suggesting the need for an improved framework in this area. BRIEFcases, which is based on international best practice, is an all-inclusive alcohol management resource designed to provide GPs with all the relevant information to help them engage with patients about alcohol consumption.It provides advice and information on how to carefully guide the conversation around the sensitive issue of alcohol consumption and provides a structured approach to open and close the discussion. Issue 12 • HPN


Out and About 49

Ireland celebrates stroke heroes Esther Hourigan, from Kerry receives the Act F.A.S.T Award at the Irish Heart Foundation’s 4th Annual Life After Stroke Awards for her fast acting in recognising the signs of stroke in her 31 year old husband Stephen. Pictured left to right: Monaghan Rose and stroke physio Eleanor McQuaid, Winner Esther Hourigan, husband Stephen Hourigan, Esther, Dr Colin Edwards from Boehringer Ingelheim and Awards host RTE broadcaster Marty Whelan. www.stroke.ie Pictures taken by Photocall Ireland.

Ireland’s youngest stroke heroes revealed their super powers of bravery and courage to inspire a nation recently at the Irish Heart Foundation’s 4th Annual Life After Stroke Awards at the Gibson Hotel in Dublin. Every year an estimated 10,000 strokes happen in Ireland which is more than one person struck down by stroke every hour. But once a year the Irish Heart Foundation, which is responsible for driving awareness of the lifesaving FAST stroke symptoms in every corner of the country, grants special awards to acknowledge the courage, dedication and resilience of stroke patients and their carers all around Ireland. Eleven awards were presented at the heart-warming event hosted by national broadcaster Marty Whelan with support from RTE children’s Elev8 TV presenter Diana Bunici and Monaghan Rose and stroke physio, Eleanor McQuaid.

Champion role for Patrick at Lundbeck Ireland Lundbeck Ireland have announced the appointment of Mr. Patrick Campion as Country Manager. Mr. Campion has worked for Lundbeck Ireland for six years and has held the positions of Product Specialist and Sales Manager during his tenure. Most recently, he held the position of National Sales Manager where he was responsible for the sales of Lundbeck’s full product portfolio, specialising in brain diseases such as alcohol dependence, bi polar, depression, Parkinson’s disease, and schizophrenia. In his new role, Mr. Campion will continue Lundbeck Ireland’s commitment to improve the quality of life for people suffering from brain diseases. This is achieved by providing new medicines alongside education programmes for healthcare professionals and patients. A large area of focus for Mr. Campion will be preparing for the launch of several new medicines in the areas of alcohol dependence, depression and schizophrenia.

Rapid Access Prostate Clinic launched in Cork The Bon Secours Hospital Cork has launched a Rapid Access Prostate Clinic in accordance with National Cancer Control Programme (NCCP) protocols and guidelines, as part of the continuing development of the prostate cancer service. BSH Cork has a long track record in prostate cancer diagnostics,

having established the first transrectal ultrasound (TRUS) guided prostate biopsy service in Ireland in 1992. Their patients have been provided with an efficient and ready access to prostate biopsy diagnosis since the early nineties, and the Bon Secours Hospital Cork are now pleased to offer a streamlined and cost-effective service for prostate cancer

diagnostics under the umbrella of the RAPC concept. The Bon Secours Rapid Access Prostate Clinic is a private clinic dedicated to the early diagnosis and efficient management of prostate cancer. Harry Canning, Hospital Manager said of the new addition “One of

our main goals is an improved service for the patient in terms of efficiency, and therefore reduction of anxiety and worry. We will achieve considerable reduction in the time from initial consultation to final patient consultation, with all data including full cancer staging previously discussed at thethe multidisciplinary cancer conference.”

What is being measured in pharmacy? Irish hospital pharmacists are being urged to share their views on service measurement with colleagues across Europe. As part of its Summit project to hep define the future of hospital pharmacy, EAHP has launched a new survey of senior pharmacists within hospitals to better understand what aspects of service are currently measured. Dr David Cousins, Senior Head of Patient Safety within NHS England is conducting a stufy of the current status of measurement within hospital pharmacy and will make recommendations for the future. The 15 minute survey closes at midnight on February 28th, 2014. EAHP President Dr Roberto Frontini said: "I urge all colleagues in hospital pharmacy throughout Europe to assist by taking fifteen minutes to share what they are measuring in their hospital. We look forward to professional engagement in the study and sharing the results with the profession later this year."

HPN • Issue 12


50 Clinical Profiles MEMANTINE CLONMEL 10MG FILM-COATED TABLETS

Clonmel Healthcare have announce the launch of Memantine Clonmel 10mg Film-coated Tablets. Memantine Clonmel 10mg Tablets are indicated for:1 • The treatment of patients with moderate to severe Alzheimer’s disease. Memantine Clonmel Film-coated tablets are available in a 28 and a 56 pack. Memantine Clonmel Film-coated Tablets are GMS reimbursable.

NEW PACK SIZE FOR DOVOBET OINTMENT

DATA PRESENTED AT EASD SUPPORT SAFETY PROFILE OF TRAJENTA® (LINAGLIPTIN)

Ref 1. Memantine Clonmel Summary of Product Characteristics

PA 126/225/2 PA Holder: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary Legal Category: Prescription Only Medicine. Date Prepared: January 2014. 2013/ ADV/MEM/103

The introduction of the 30g pack will be from 1st of February 2014. LEO is fully committed to maintaining product supply during this period of transition. Dovobet® Gel (calcipotrio l /betamethasone dipropionate) remains available. Therefore, from February 2014 the

Dovobet® portfolio will comprise:

Boehringer Ingelheim and Eli Lilly and Company announced that results from two different pooled analyses of clinical studies support previous observations that the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin was shown to be well tolerated in a broad range of adults with Type 2 Diabetes (T2D).

data in 22 linagliptin clinical trials with 7,400 people with T2D (4,810 received linagliptin, 2,590 received placebo) included the following:

• The incidence of AEs with linagliptin compared to placebo remained similar irrespective of the age category (≤65 years, 65-74 years, ≥75 years)

Findings from a pooled comprehensive analysis of safety

Daiichi Sankyo, Company Limited (hereafter, Daiichi Sankyo) have announced that the Marketing Authorization Application (MAA) for its investigational, oral, oncedaily direct factor Xa-inhibitor edoxaban has been submitted to the European Medicines Agency (EMA). In Europe, Daiichi Sankyo is seeking approval for edoxaban for the prevention of stroke and systemic embolic events (SEE)

Issue 12 • HPN

Please contact Clonmel Healthcare on 01-6204000 if you require any additional information on Memantine Clonmel

LEO Ireland will be introducing a 30g pack size of Dovobet® Ointment (calcipotriol / betamethasone dipropionate) to replace the 120g pack size to provide patients and prescribers flexibility of dosing.

This data were presented at the 49th European Association of Diabetes (EASD) Annual Meeting.

MAA FOR EDOXABAN SUBMITTED TO EMA

Full prescribing information is available on request or alternatively please go to www.clonmel-health.ie. Product is subject to medical prescription.

• Linagliptin was well tolerated overall and across all age groups studied, with a low incidence of hypoglycemic events • Overall incidence of adverse events (AE) or serious adverse events (SAE) with linagliptin was similar to placebo (AE 56.5 percent versus 61.2 percent, and SAE 4.8 percent versus 6.3 percent, respectively)

in patients with non-valvular atrial fibrillation (NVAF), as well as for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of recurrence of symptomatic venous thromboembolism (VTE). If approved, edoxaban will be authorized for marketing in all European member states. The MAA submission is based on data from an extensive

• 60g Dovobet® Gel • 120g Dovobet® Gel • 30g Dovobet® Ointment

Linagliptin (5 mg) is marketed in Ireland as Trajenta® (linagliptin), as a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D. Linagliptin should not be used in patients with Type 1 Diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).

global clinical trial program that compared treatment with once-daily edoxaban to warfarin, a current standard of care for patients with atrial fibrillation (AF) or VTE. The two clinical trials that formed the basis of the submission, ENGAGE AF-TIMI 48 and Hokusai-VTE, are the largest comparative trials of a novel oral anticoagulant in these patient populations, involving 21,105 and 8,292 patients, respectively.


Appointments 51

Aidan Donnelly Minister for Jobs, Enterprise & Innovation, Richard Bruton TD, and Minister for Research and Innovation, Seán Sherlock, TD have appointed Aidan Donnelly to the Board of Science Foundation Ireland. Minister Sherlock said, “The appointments of Ann Riordan, Geraldine Ruane and Aidan Donnelly will further strengthen the board of SFI and bring fresh industry perspective to the important work performed at Board level in order to enable SFI to meet its ambitious Agenda 2020 objectives.”

Ann Riordan Minister for Jobs, Enterprise & Innovation, Richard Bruton TD, and Minister for Research and Innovation, Seán Sherlock, TD have formally appointed three members to the Board of Science Foundation Ireland (SFI). Ann Riordan has been appointed Chairperson of the Board of SFI. Minister Bruton said, “Ann Riordan will bring considerable strength to this role based on an impressive track record in delivering within the areas of Science, Technology and Innovation combined with her experience and knowledge of Board governance."

Caroline Collins Public relations consultancy, The Reputations Agency, has announced the recent appointment of Caroline Collins, PhD to the position of Lead, Healthcare and Advocacy Division. A strategic communications, public affairs and PR specialist, Caroline brings over 12 years’ experience and a strong track record of delivering a diverse range of campaigns at a national and European level across each of the private, public and NGO sectors. Immediately prior to joining The Reputations Agency, Caroline worked as a senior client contact for multinational and blue-chip clients including Roche, Pfizer, Shire, Lundbeck, Astellas, Takeda, SPMSD, MSD and VHI along with a range of not-for-profit and advocacy organisations.

Mr Feargal Ó Móráin Minister for Research and Innovation Seán Sherlock TD has announced the appointment of Mr Feargal Ó Móráin as the new Irish co-chair to the US-Ireland R&D Partnership Steering Group. The announcement coincides with a visit by the US co-chair to the Steering Group, Dr. Kerri-Ann Jones, Assistant Secretary of State for the United States Bureau of Oceans and International Environmental and Scientific Affairs.

Geraldine Ruane Minister for Jobs, Enterprise & Innovation, Richard Bruton TD, and Minister for Research and Innovation, Seán Sherlock, TD have appointed Geraldine Ruane to the Board of Science Foundation Ireland. Minister Sherlock said, “Geraldine Ruane and Aidan Donnelly will also bring excellent experience and skills to the Board. I would like to thank Professor Patrick Fottrell for his hard work and dedication in the role and wish Ann, Geraldine and Aidan every success in their new positions.”

Susan McGann O’Brien M.P.S.I. Susan McGann O’Brien M.P.S.I. has recently been appointed as Professional Pharmacy Auditor for the McSharry Pharmacy Group. With over 25 years’ experience in community pharmacy and having been Supervising Pharmacist and Pharmacy Manager within the group, Susan brings a wealth of experience to her new role. She will be working with the management team to continuously improve professional services and standards and to implement a Quality Management System. The McSharry Pharmacy Group continuously strives to provide excellent patient care and service.

Send your appointments announcements to Hospital Pharmacy News Have you taken up a new position recently or moved job roles? Get in touch to feature your new appointment on this page. Contact Kelly Jo Eastwood on 0044 7876548989 / E-mail: kjeastwood@hotmail.com

HPN • Issue 12


The Evolution of Generics

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The Evolution of Generics

HOSPITAL PHARMACY NEWS IRELAND - ISSUE 12 - 2014  
HOSPITAL PHARMACY NEWS IRELAND - ISSUE 12 - 2014  

IN THIS ISSUE: News: Letterkenny General Pharmacy Department get ready to move - Profile: Celebrating a lifetime of achievement with Profess...

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