Aneurin Bevan Health Board Medicines & Therapeutics Committee August 2013 enewsletter Dear Gwent Prescriber At its last two meetings (23 rd May and 11 th July) ABHB s Medicines & Therapeutics Committee made the following decisions in relation to the ABHB Formulary: ABHB FORMULARY UPDATES ABHB s Drug Formulary is at: http://aneurinbevanhb.inform.wales.nhs.uk/ BNF section 4.8.1 ZONISAMIDE (Zonegran ) for adjunctive use in epilepsy ADDED in accordance with the recommendations in NICE CG137 for adjunctive use in a variety of seizures, and extending to off label use in children. The MTC designated zonisamide Amber without Shared Care in the ABHB Traffic Light system. Use of zonisamide as monotherapy for seizures/epilepsy is NOT recommended: http://www.awmsg.org/awmsgonline/app/appraisalinfo/997 Full prescribing information on zonisamide at: http://www.medicines.org.uk/emc/medicine/16240/spc/ BNF section 6.1.2.3 LINAGLIPTIN (Trajenta ) as mono & combination therapy in T2D ADDED as a Green drug (non specialist initiation appropriate) in accordance with the recommendations in AWMSG 0513: http://www.awmsg.org/awmsgonline/app/appraisalinfo/1667 Full prescribing information on linagliptin at: http://www.medicines.org.uk/emc/medicine/25000/spc/ BNF section 6.1.2.3 DAPAGLIFLOZIN ( Forxiga ) as combination therapy in T2D ADDED in accordance with recommendation in NICE TA288 (Type 2 diabetes combination therapy) agreed that for an initial period dapagliflozin should be designated Amber without Shared Care (specialist only initiation) It was agreed that such a designation would allow specialists to get first hand experience prescribing it, prior to the anticipated wider use by non specialists across ABHB Primary Care. Full prescribing information on dapagliflozin at: http://www.medicines.org.uk/emc/medicine/27188/spc/ Link to NICE TA288: http://guidance.nice.org.uk/ta288 BNF section 6.1.1.2 INSULIN DEGLUDEC ( Tresiba ) for diabetes mellitus NOT CONSIDERED In the absence of a submission from Novo Nordisk, Tresiba cannot be endorsed by AWMSG for use in accordance with its licensed indication, as a technology appraisal by AWMSG (or NICE) has not been undertaken. Tresiba should NOT be prescribed routinely within NHS Wales for this indication. http://www.awmsg.org/awmsgonline/app/appraisalinfo/840 1
BNF section 3.1.2 Glycopyrronium bromide ( SEEBRI Breezhaler ) for COPD ADDED as a Green drug (non specialist initiation appropriate) in accordance with AWMSG recommendation 0713: http://www.awmsg.org/awmsgonline/app/appraisalinfo/1455 Full prescribing information on this new LAMA is at: http://www.medicines.org.uk/emc/medicine/27138/spc/ BNF section 9.6.4 DESUNIN VITAMIN D TABLETS (COLECALCIFEROL 20 microgram) ADDED as a Green drug (non specialist initiation appropriate). Desunin TABLETS are the same strength (800 units) and cost as Fultium D3 CAPSULES but do NOT contain soya, arachis oil or gelatine. Full prescribing information on Desunin tablets at: http://www.medicines.org.uk/emc/medicine/27007/spc/ Link to ABHB guidance on Management of Vit D Deficiency in Adults: http://www.wales.nhs.uk/sites3/documents/814/vitd ABHBprescribingGuidanceFINAL%5BJuly2013%5D.pdf BNF section 7.4.2 MIRABEGRON ( Betmiga) for urinary frequency, urgency, & urge incontinence ADDED in accordance with the recommendation in NICE TA290 (Overactive bladder). As clinical experience with beta 3 agonist in OAB was currently limited, and the update to CG40 was due for publication in September 2013, the MTC agreed that for an initial period mirabegron should be designated Amber without Shared Care (specialist only initiation). It was agreed that such a designation would allow specialists to get first hand experience prescribing it, prior to wider use by non specialists across Primary Care. Full prescribing information on mirabegron at: http://www.medicines.org.uk/emc/medicine/27188/spc/ ABHB Formulary options in section 7.4.2 Urinary incontinence Duloxetine (Yentreve) [AMBER Traffic Light*] For moderate to severe stress urinary incontinence in women Duloxetine 20mg gastro resistant capsules Duloxetine 40mg gastro resistant capsules *Note non specialist initiation of duloxetine is appropriate for diabetic peripheral neuropathy Oxybutynin [GREEN Traffic Light] Note Immediate Release oxybutynin tablets are recommended as first line antimuscarinic agents for urinary incontinence in ABHB Modified Release and transdermal oxybutynin preparations (Lyrinel XL tablets & Kentera patches) are non Formulary Oxybutynin 2.5mg tablets Oxybutynin 3mg tablets Oxybutynin 5mg tablets Solifenacin (Vesicare) [GREEN Traffic Light] Note solifenacin is a second line antimuscarinic for urinary incontinence (after Immediate Release oxybutynin). Solifenacin 5mg tablets Solifenacin 10mg tablets Tolterodine [GREEN Traffic Light] Note M/R tolterodine 4mg capsules (Detrusitol XL) are non Formulary Tolterodine 1mg tablets Tolterodine 2mg tablets Trospium [GREEN Traffic Light] Note Modified Release trospium capsules (Regurin XL) are non Formulary Trospium chloride 20mg tablets 2
BNF section 9.5.2.2 Calcium acetate 1000mg tablets (PHOSEX ) a phosphate binding agent ADDED as a Green drug and in accordance with NICE CG157 (Hyperphosphataemia in chronic kidney disease) which recommends calcium acetate as the first line phosphate binder. Phosex is the calcium acetate preparation used by the Cardiff renal unit and the one currently most prescribed in ABHB Primary Care. Calcium carbonate 1.25g tablets should be reserved for those unable to tolerate calcium acetate. Full prescribing information on Phosex at: http://www.medicines.org.uk/emc/medicine/14132/spc/ OTHER PRESCRIBING NEWS 2013 14 Clinical Effectiveness & Prescribing Programme (CEPP) Details of the current GP scheme are now on the MTC s website at: http://www.wales.nhs.uk/sites3/page.cfm?orgid=814&pid=68606 BNF section 5.1.5 AZITHROMYCIN in pulmonary disease New local guidance This prescribing/monitoring guidance has been produced in response to increasing requests to GPs to prescribe long term azithromycin to prevent exacerbations in COPD and bronchiectasis patients, which are both OFF LABEL uses. The 2 page guidance is available at: http://www.wales.nhs.uk/sites3/documents/814/azithromycin COPD%26BronchiectasisABHBguidanceFINALJuly2013.pdf GMC s 2013 Good practice in prescribing and managing medicines and devices A brief reminder that this ethical guidance came into effect back in February 2013 and it replaces Good practice in prescribing medicines (2008). Specialists should note that if you recommend that a colleague, for example a junior doctor or GP, prescribes a particular medicine for a patient, you must consider their competence to do so. You must satisfy yourself that they have sufficient knowledge of the patient and the medicine, experience (especially in the case of junior doctors) and information to prescribe. You should be willing to answer their questions and otherwise assist them in caring for the patient, as required. Web version of the GMC guidance is at http://www.gmc uk.org/guidance/ethical_guidance/14316.asp And a.pdf version at: http://www.gmc uk.org/static/documents/content/prescribing_guidance.pdf BNF section 14.4 VARICELLA ZOSTER VACCINE The shingles vaccination programme will begin on 1 September 2013, with eligibility based on a person s age on that date (see Table): 3
The programme will offer routine vaccination to all those aged 70 years on 1 September 2013, and a catch up programme for older cohorts each year (1 September to 31 August), starting with those aged 79 years on 1 September 2013. As the vaccine s effectiveness diminishes with age it is not recommended for people 80 years. To ensure adequate supplies of vaccine for each year of the programme, and given the short shelf life of the product, the vaccine ( Zostavax ) has been procured centrally for the UK. Link to CMO s letter: http://wales.gov.uk/topics/health/cmo/publications/cmo/2013/shinglesvaccination/?lang=en BNF section A2 Prescribing SIP FEEDS Further to the item in the MTC s spring enewsletter, the 2010 comprehensive local guidelines for the Treatment of Under Nutrition in the Community (25 pages) has now been updated. The advice it includes on prescribing sip feeds is also available as a separate 2 page guide titled Which Oral Nutritional Supplement (ONS) to prescribe? This short guide sets out a pathway for prescribers initiating sip feeds as well as suggested products for a 7 day trial on an acute prescription (with costs), and a ready reckoner for 28 day supplies (again with costs). All the patient advice leaflets (e.g. on how to fortify food and make nourishing drinks and snacks) have now been brought together into a single 8 page booklet titled FOOD FIRST AD VICE All these resources are all available at: http://www.wales.nhs.uk/sites3/page.cfm?orgid=814&pid=41750 Should ALL clinical trial results be reported? If you believe that drugs companies publish only a fraction of their results and keep much of the information to themselves then you should be interested in signing the petition at: http://www.alltrials.net/supporters/ This petition is part of the campaign to get all clinical trials registered and all results publically reported. The campaign has the support of a number of eminent organisations including the MRC. 4
BNF section 6.6.2 STRONTIUM ranelate (Protelos ): risk of serious cardiac disorders restricted indications, new contraindications, and warnings Following the recent advice on strontium from the MHRA (DSU April 2013 vol 6, issue 9: S1) the guidance below has been obtained from the relevant ABHB clinicians: 1. Strontium should be withdrawn in Primary Care from patients with the following underlying conditions: Uncontrolled high blood pressure; ischaemic heart disease (such as angina or MI); peripheral arterial disease; cerebrovascular disease. 2. The MHRA advice states that Healthcare professionals should review patients at a routine appointment and consider whether or not to continue treatment. This assessment should be informed by a review of the length of therapy, supported by the use of a fracture risk assessment tool (FRAX/Qfracture) and/or consideration of a repeat DEXA scan. 3. If strontium is withdrawn from a patient and alternative treatment is required, then oral bisphosphonate should be considered and initiated in Primary Care. If the patient has tried bisphosphonate and either been intolerant (worth trying 2 different bisphosphonates as some patients tolerate one bisphosphonate better than another) of it or failed it, then realistically the following options are available: Calcium / vitamin D alone only indicated as monotherapy in the elderly infirm institutionalized patients; Raloxifene only really a good option in younger postmenopausal patients with spinal osteoporosis/ fractures without a history of peripheral or hip fracture (no evidence to support its use in hip fracture patients). Denosumab (Prolia) / IV bisphosphonate / PTH therapy all of which will be assessed for and initiated by Secondary Care. 4. Once oral bisphosphonate have tried without success (point 3 above), then it may be appropriate for these patients to be referred to the osteoporosis clinic for either written advice or out patient consultation. If this is felt necessary please fax the query to Rheumatology (fax number 01873 732297) marked with the heading STRONTIUM QUERY to ensure it is passed to the appropriate clinician for an early decision. The full version of the ABHB guidance can be found at: http://www.wales.nhs.uk/sites3/docmetadata.cfm?orgid=814&id=215454 Full updated prescribing information on strontium at: http://www.medicines.org.uk/emc/medicine/15410/spc/ BNF section 5.2.2 Oral KETOCONAZOLE don t use for fungal infections In July 2013 the EMA s Committee for Medicinal Products for Human Use has said that oral medicines containing ketoconazole (Nizoral ) should no longer be used for the treatment of fungal infections. The decision was reached because of the high level of liver injury associated with oral ketoconazole and in view of the currently available alternative antifungals. The decision is only on oral products. Shampoos and creams containing ketoconazole are not affected by the decision. The MHRA s Press Release is at: http://www.mhra.gov.uk/newscentre/pressreleases/con297530 New From AWMSG Proton Pump Inhibitor & Dyspepsia Educational Pack This pack, endorsed by AWMSG, aims to support the appropriate prescribing of PPIs by providing a practical approach for the initiation and review of PPI prescribing. It includes examples of support material which can be used or adapted for this purpose. http://www.awmsg.org/medman_library.html?jqprselect=button1# 5
Feedback on any item in this enewsletter is welcome. Suggested agenda items for the MTC are also welcome. Follow us @ABHB_Rx Trevor Batt Pharmacist & Professional Secretary to: Aneurin Bevan HB Medicines & Therapeutics Committee Aneurin Bevan Health Board Based at Victoria House, Corporation Rd, Newport NP19 0BH Email: trevor.batt@wales.nhs.uk Tel: 01633 261394 (DIRECT LINE) 6