GWENT FORMULARY DECISIONS

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1 Dear Gwent Prescriber At its last two meetings (9 th September and 21 st October 2010) the Gwent Partnership Medicines & Therapeutics Committee (GPMTC) made the following decisions in relation to the Aneurin Bevan Health Board (ABHB) Joint Formulary: GWENT FORMULARY DECISIONS Pivmecillinam (Selexid ) for the treatment of UTIs. ADDED the MTC agreed there were no requirements for prescribing guidelines and that pivmecillinam could be initiated by both specialists and non specialists. However, in accordance with the application, the MTC agreed pivmecillinam should be reserved for use on the recommendation of a medical microbiologist only. Empirical use is not recommended. Etonogestrel (Nexplanon ) for contraception ADDED noting that Implanon is due to be discontinued, that the cost of Nexplanon is set to remain the same as Implanon, and that The Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit state they are bioequivalent ( Barium sulphate has been added to make Nexplanon radio opaque. The CEU also state there are no differences in their safety profile and that the UK Medical Eligibility Criteria for Contraceptive Use of progestogen only implants will also apply to Nexplanon. +subdermal+use/ Dronedarone ( Multaq ) for the treatment of non permanent AF ADDED in accordance with the recommendations in NICE TA197 (Atrial fibrillation Dronedarone is recommended as an option for the treatment of non permanent AF only in people: 1. whose AF is not controlled by 1 st line therapy (usually including beta blockers), that is, as a 2 nd line treatment option, and 2. who have at least one of the following cardiovascular risk factors: hypertension requiring drugs of at least 2 different classes diabetes mellitus previous transient ischaemic attack, stroke or systemic embolism left atrial diameter of 50 mm left ventricular ejection fraction < 40% (noting that the SPC does NOT recommend dronedarone for people with left ventricular ejection fraction < 35% because of limited experience of using it in this group) or age 70 years or older, and 3. who do not have unstable NYHA class III or IV heart failure. The MTC agreed that it be designated a specialist only initiated medicine with continued prescribing by non specialists in Primary Care requiring no Shared Care arrangements (i.e. Amber WITHOUT Shared Care in the Gwent Traffic Light system). Compliance with NICE TAG197 through an audit of initiations of dronedarone has been agreed with ABHB Cardiology. Page 1 of 5

2 Fentanyl intranasal spray ( Instanyl ) for breakthrough pain ADDED in accordance with minister endorsed AWMSG s recommendation (0710) as an option in adults already receiving maintenance opioid therapy for chronic cancer pain. Consistent with the decision on Abstral the MTC agreed that Instanyl be designated a specialist only 1 initiated medicine with continued prescribing by non specialists in Primary Care requiring no Shared Care arrangements (i.e. Amber WITHOUT Shared Care in the Gwent Traffic Light system). Gwent Palliative Care have agreed to draw up a position statement of the use of these 2 forms of Immediate Release fentanyl for Gwent. This is awaited. mcg+dose+nasal+spray/ Sildenafil 20mg ( Revatio ) for pulmonary arterial hypertension ADDED BUT minister endorsed AWMSG recommendation (1010) has restricted the use of Revatio to a physician experienced in the treatment of PAH in association with a National Commissioning Group designated expert centre. This concurs with all non erectile dysfunction use of sildenafil being previously designated Red in Gwent by the GPMTC. Pramipexole prolonged release (Mirapexin Prolonged Release) for Parkinson s disease ADDED in accordance with minister endorsed AWMSG recommendation (0810). Consistent with the MTC s previous decision on Immediate Release (IR) pramipexole, it was agreed to designate the Prolonged Release (PR) form as Amber with Shared Care. The existing Gwent Shared Care Protocol for IR pramipexole will be revised to cover the use of the PR pramipexole. Formulary News The ABHB Joint Formulary on the GPMTC website (in Word format at and as linked from CWS Main Menu page) now incorporates the Supplementary List of formulary additions and is currently up to date. Until the web based version of the ABHB Joint Formulary (Inform) is in place this Word version will be updated on a continual basis. OTHER PRESCRIBING NEWS Mixtard 30 Discontinuation Further to the interim guidance in the summer enewsletter ( ed 29/07/2010) joint advice from the ABHB Diabetology Directorate & the GPMTC has now been issued and is available at: df NOTE this has been previously circulated to all Gwent GP Practices (on 19 th August) 1 Appropriate only for initiation by specialists in palliative care and oncology/haematology (within a consultant led team) or by accredited GPs with a special interest in palliative care. Page 2 of 5

3 Rosiglitazone containing medicines Avandia and Avandamet Advice from the ABHB Diabetology Directorate has recently been issued on the options for managing patients on rosiglitazone. This is available at: NOTE this has been previously circulated to all Gwent GP Practices (on 28 th October). Decline to Accept Prescribing Responsibility Form Prescribers are reminded they can use this form if they have concerns about accepting requests from Secondary/Tertiary Care specialist to prescribe unlicensed, off label or non formulary medicines. The form (at: now includes a revised Fax number and should be the version used from now on. ABHB Policy on use of Off label and Unlicensed Medicines A number of recommendations made by GPMTC have been incorporated into this ABHB Policy The Policy has now been endorsed by ABHB Clinical Standards & Policy Group and it is available at: Guidelines for the Treatment of Under Nutrition in the Community In previous discussions on the best way to guide the prescribing of nutritional supplements (both sip and tube feeds) the GPMTC agreed that as tube feeds were initiated predominately in Secondary Care, on the advice of dietitians, that any dietary products formulary would be most effectively applied to Secondary Care only; whereas guidance on the use of sip feeds would be more helpful for Primary Care. The MTC has now endorsed local Guidelines for the Treatment of Under Nutrition in the Community Including Advice on Oral Nutritional Supplement Prescribing and are available at: Gluten free Guidance At the end of 2007 the GPMTC agreed to adopt the 2004 Coeliac Society s (now Coeliac UK) guidance on the prescribing gluten free foods. are_professionalsfull_0.pdf This guidance states: Gluten free foods available on prescription (Table 2 P.8) only includes Bread/rolls Plain biscuits Crackers and crispbreads Flour / flour type mixes Pasta Pizza bases Other gluten free foods, such as cereals, cakes and ready meals, are not prescribable but are available from retail outlets (p.9) ADVICE TO GWENT PRESCRIBERS IS THAT LUXURY ITEMS SUCH AS CHOCOLATE BISCUITS SHOULD NOT BE PRESCRIBED BUT SHOULD BE PURCHASED FROM SUPERMARKETS OR HEALTH FOOD STORES. NOTE: Plain sweet biscuits and cake mixes may be prescribed. Page 3 of 5

4 New Shared Care Protocols The following Gwent protocols have recently been developed or updated: 1. DALTEPARIN (Fragmin ) NEW for extended treatment and prophylaxis of VTE in patients with solid tumours. Note this has been previously circulated (with background information) to all Gwent GP Practices on 26 th August. 2. APOMORPHINE injection (APO go Pen) NEW for the treatment of disabling motor fluctuations in Parkinson s disease. Note this Protocol does NOT currently extend to the pre filled syringes (APO go PFS) used as a continuous subcutaneous infusion by minipump and / or syringe driver. It does cover the ready loaded disposable pens (APO go Pen) for giving self administered intermittent injections: 3. SULFASALAZINE in RA UPDATED in line with the 2008 British Society for Rheumatology / British Health Professionals in Rheumatology guideline for DMARD therapy. The monitoring requirements are now 3 monthly for 1 year and if the results are stable after first year, 6 monthly tests will suffice thereafter. NOTE ALL GWENT SHARED CARE PROTOCOLS CAN BE FOUND AT: Ketamine specialist prescribing only but local guidance for healthcare professionals is now available Gwent Palliative Care have recently developed the following resources for ketamine: 1. Specialist guidelines for using ketamine 2. Ketamine Administration 3. Ketamine Information for community pharmacists 4. Ketamine Patient Information Leaflet They have also developed a Patient Information Leaflet on Strong Pain Killers and Driving All 5 documents can be found at: NOTE these do not affect the recent classification of ketamine (all formulations) as a Red drug in Gwent. Neuropathic Pain Following discussion on the local implementation of NICE Clinical Guideline 96 (Neuropathic pain Pharmacological Management) the GPMTC agreed (in consultation with their representative from the ABHB Chronic Pain Team) to issue interim local guidance on the pharmacological management of neuropathic pain in a non specialist setting. The reasons for this variation from CG96 being: the significant additional funding required to implement NICE s first line recommendation for pregabalin, the ongoing review by NICE of the economic modelling that formed the basis for their recommendation on pregabalin, the current economic challenges facing ABHB and there being no statutory requirement on Health Boards to implement NICE Clinical Guidelines (in contrast to NICE Technology Appraisals). The interim local guidance can be accessed at: tersept10.pdf NOTE this guidance has been previously circulated to all Gwent GP practices (on 28 th September). Page 4 of 5

5 Eplerenone revised guidance Further to the item in the March/April 2010 enewsletter about the reclassification of eplerenone from Red to Amber without shared care the Gwent Trust guidelines of 2007 have now been revised to assist the on going prescribing of eplerenone by GPs. The local guidance now incorporates advice on the use of eplerenone as an alternative to spironolactone (when adverse effects limit its continuation) and clearer recommendations on the monitoring of potassium and renal function in Primary Care (in accordance with the recent NICE CG108 Management of chronic heart failure in adults in primary and secondary care The Gwent guidance on the use of eplerenone are available at: l%5daug10.pdf Feedback on any item in this is welcome. Suggested agenda items for the MTC are also welcome! Regards Trevor Batt Pharmacist & Professional Secretary to: Gwent Partnership Medicines & Therapeutics Committee Aneurin Bevan Health Board Based at Torfaen Locality Office, Mamhilad House. NP4 0YP Tel: (DIRECT LINE) Web: Page 5 of 5

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