GWENT FORMULARY DECISIONS

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Paula Ball
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1 Dear Gwent Prescriber At its last three meetings (12 th January, 1 st March and 19 th April 2012) ABHB s Medicines & Therapeutics Committee (formerly GPMTC) made the following decisions in relation to the ABHB Joint Formulary: GWENT FORMULARY DECISIONS BNF section TROSPIUM modified release 60mg (Regurin XL ) for urinary frequency, urgency and incontinence NOT ADDED having examined both the efficacy and tolerability evidence for M/R trospium versus active comparators) and in consideration of the balance of additional cost versus benefit for M/R trospium over the existing Formulary option of twice daily I/R trospium 20mg tablets ( for 60 Flotros tablets) the MTC decided it was unable to give formulary approval to Regurin XL. OXYBUTYNIN patches (KENTERA ) for urinary frequency, urgency and incontinence NOT ADDED The MTC felt that any benefits in terms of dry mouth incidents avoided (by using the transdermal route) would be offset by adverse application site reactions. BNF section QUINAGOLIDE (Norprolac ) for hyperprolactinaemia ADDED Second line and used where cabergoline (an ergot derived dopamine agonists) is contraindicated or in circumstances where there are concerns over using cabergoline e.g. in patients with severe cardiovascular disease or in women trying to conceive. Full prescribing information on quinagolide is at: CABERGOLINE 500 microgram tablets (Dostinex ) for hyperprolactinaemia ADDED First line. Note: the SmPC for Dostinex states that following treatment initiation, the first echocardiogram (to monitor for development of fibrotic disorders) should occur within 3 6 months, thereafter, the frequency of echocardiographic monitoring should be determined by appropriate individual clinical assessment with particular emphasis on the above mentioned signs and symptoms, but must occur at least every 6 to 12 months. Full prescribing information on cabergoline (Dostinex) is at: Note: This decision on Dostinex does not affect the Non Formulary status of cabergoline 1mg and 2mg tablets (e.g. Cabaser ) for Parkinson s disease in Gwent. Quinagolide and cabergoline were both designated AMBER Without Shared Care (i.e. specialist only initiation with continued prescribing by GPs) in the Gwent Traffic Light system. Note: Prescribers of both quinagolide and cabergoline should be aware that pathological gambling and increased libido, including hypersexuality, may be rare class effects of dopamine agonists. See Drug Safety Update August 2007; Vol 1, Issue 1: 6 BNF section Page 1 of 7

2 EPIDUO gel (adapalene 0.1%/benzoyl peroxide (BPO) 2.5%) for acne NOT ADDED having considered the clinical trial evidence, as well as the balance of additional cost vs benefit over the existing Formulary option of using the individual components sequentially (e.g. BPO in the morning and adapalene [Differin ] in the evening). Note: it is the view of ABHB s dermatologists that consideration should be given to the early use of the combination of adapalene and BPO in the treatment of mild to moderate acne. CKS/Prodigy* advice is to prescribe a topical retinoid (e.g. adapalene) or benzoyl peroxide (especially if papules and pustules are present) as first line treatment for mild acne and to consider combined treatment in all people with moderate acne. * BNF section BALANCE ACTIV Rx (Lactic acid 4.9%, glycogen 0.1% gel) for bacterial vaginosis NOT ADDED having considered the evidence together with the 2012 guidance on the management of vaginal discharge from the Faculty of Sexual & Reproductive Healthcare. 1 ILLNESS Noting that the current ABHB Joint Formulary (section 7.2.2) did not list any intravaginal antibacterials the MTC moved to rectify this historical anomaly and added both clindamycin 2% cream and metronidazole 0.75% vaginal gel to the ABHB Formulary, as options for women unable to tolerate oral metronidazole. This is consistent with the 2010 MTC endorsed guidance on management of infections in Primary Care, 2 see extract below: GENITAL TRACT INFECTIONS Bacterial vaginosis BASHH HPA, CKS COMMENTS DRUG DOSE DURATION OF TX Oral metronidazole (MTZ) is as effective as topical treatment 1A+ but is cheaper. Less relapse with 7 day than 2g stat at 4 wks 3A+ Pregnant 2A+ 3A+,4B /breastfeeding: avoid 2g stat Treating partners does not reduce relapse 5B+ oral metronidazole 1,3A+ OR metronidazole 0.75% vag gel 1A+ OR clindamycin 2% crm 1A+ 400mg BD or 2g 5g applicatorful at night 5g applicatorful at night 7 days 1A+ stat 3A+ 5 nights 1A+ 7 nights 1A+ BNF section 14.4 Meningococcal quadrivalent (A, C, W135, and Y) conjugate vaccine ( MENVEO ) for immunisation against N. meningitidis ADDED in accordance with the recommendations for Menveo 1. on P. 244 to 247 of the JCVI s Green Book ( Mar12_acc.pdf) and 2. under Asplenia, splenic dysfunction or complement deficiency in Section 14.4 of the BNF: Individuals diagnosed with asplenia, splenic dysfunction, or complement deficiency at: under 2 years of age should be vaccinated according to the Immunisation Schedule (BNF section 14.1). The booster dose of Haemophilus influenzae type b vaccine (combined with meningococcal group C conjugate vaccine), given at months of age, should be followed at least 1 month later by one dose of meningococcal A, C, W135, and Y conjugate vaccine. An additional dose of Haemophilus influenzae type b vaccine (combined with meningococcal group C conjugate vaccine) should be given after the second birthday; Gwent%5BHPA%5DDec10.pdf Page 2 of 7

3 over 2 years of age should receive one dose of haemophilus influenzae type b vaccine (combined with meningococcal group C conjugate vaccine), followed 1 month later by one dose of meningococcal A, C, W135, and Y conjugate vaccine. Note: Menveo is currently licensed for children 2yrs. As there are no arrangements for NHS reimbursement for travel vaccinations within the GMS contract regulations 2004 (other than provision for GPs to be able to charge patients directly Schedule 5, 1[g]) then Menveo should only be prescribed using a private prescription for travel immunisation (e.g. for travel to the Hajj). Full prescribing information on Menveo is at: BNF section TAPENTADOL prolonged release ( PALEXIA SR) for severe chronic pain ADDED in accordance with AWMSG Advice No 1511: 3 AWMSG is of the opinion that tapentadol prolonged release ( Palexia SR) should be initially prescribed by a specialist. Prescribing may be continued in primary care with appropriate communication and specialist input. Noting; that the immediate release form of tapentadol has yet to be appraised by AWMSG and is currently covered by an Advisory Notice and the current lack of specialist (Pain Clinic and Rheumatology) experience with using tapentadol prolonged release, the MTC agreed to consult with Palliate Care specialists in Gwent on the proposal to designate Palexia SR a RED drug (i.e. specialist only initiation AND ongoing repeat prescribing). Current advice is that tapentadol prolonged release ( Palexia SR) should not be initiated by non specialist prescribers. Further advice will follow. BNF section CAPSAICIN PATCH ( QUTENZA ) for peripheral neuropathic pain ADDED as a RED drug (i.e. specialist only initiation AND ongoing repeat prescribing). in accordance with AWMSG Advice No 0412: 4 AWMSG is of the opinion that capsaicin patch ( Qutenza ) is suitable for specialist only prescribing within NHS Wales for the treatment of peripheral neuropathic pain in nondiabetic adults in combination with other medicinal products for pain and in patients who have not received adequate benefit from, or are intolerant to, alternative conventional treatments. Capsaicin patches ( Qutenza ) should be administered by healthcare professionals who have completed the approved training and in a specialist clinic setting. OTHER PRESCRIBING NEWS RESPeRATE requests to prescribe this medical device listed in the Drug Tariff Part IXA Appliances The MTC is aware of several requests for GPs to prescribe this interactive respiratory modulation device for the adjunctive treatment of hypertension. Although the ABHB 3 %20FAR.pdf 4 Page 3 of 7

4 Medicines Formulary does not routinely extend to medical devices (and the MTC do not appraise them), it was agreed to make GPs aware of the recommendations on lifestyle interventions in NICE CG127 (Hypertension) of August 2011: Relaxation therapies can reduce blood pressure and people may wish to pursue these as part of their treatment. However, routine provision by primary care teams is not currently recommended. [2004] GAMOLENIC ACID not for NHS prescribing Added to the local list of Not recommended Medicines In October 2002 the UK marketing authorisations for use of Epogam (in atopic eczema) and Efamast (for mastalgia ) were withdrawn. This followed a review by the MCA/CSM, which concluded, did not support the standard of efficacy required for the authorisation of these products as medicines for the treatment of eczema and mastalgia. Patients currently being prescribed gamolenic acid on the NHS should have their treatment stopped. Unlicensed versions of Evening Primrose Oil continue to be available in health food shops for those who want to take this product as a supplement. A letter (2 sides) sent to all GP practices in December 2011 on NHS prescribing of gamolenic acid can be found at: 1.pdf DOSULEPIN (Prothiaden ) Traffic Light status Now designated AMBER without Shared Care the MTC agreed to designate it a specialist only initiated medicine having noted the National Prescribing Indicators for and and consulted with ABHB Mental Health. The Prescribing Indicator aims to reduce the level of its use as evidence supporting its tolerability relative to other antidepressants is outweighed by the increased cardiac risk and toxicity in overdose. Note: The BNF notes that dosulepin is considered (by the Joint Formulary Committee) to be less suitable for prescribing marked in the BNF by a symbol. Shared Care Protocols The following Gwent protocols have recently been developed or updated: 1. METOJECT carer administration now an option in addition to self administration. This reflects the revised wording in Metoject SmPC, which now allows for it to be administered under the supervision of physicians. licensed indication now covers Severe Psoriatic Arthritis (in addition to RA). 2. TOBI (nebulised tobramycin for CF) Bramitob (300mg/4mL) now included as an additional brand to TOBI (300mg/5mL) The presentations of the two brands is similar and the ABHB Protocol now matches the current Cardiff & Vale UHB protocol. 3. MODAFINIL (Provigil ) NEW PROTCOL covering use of modafinil only for the treatment of excessive daytime sleepiness associated with narcolepsy. All Gwent Shared Care Protocols can be found at: pdf Page 4 of 7

5 DABIGATRAN for stoke prevention in AF ABHB s position following publication of NICE guidance ABHB s interim position statement on the appropriate use of dabigatran for the prevention of stroke and systemic embolism in patients with non valvular AF has been reviewed following publication of NICE TA249 in March ( Having considered NICE s recommendation, in the context of the potential risks (both clinical and financial) vs. benefits and ABHB MTC (in collaboration with ABHB Cardiology, Haematology and Stroke physicians) still feel that the initial recommendations (for use in isolated cases only and with initiation only by specialists with Secondary Care (i.e. AMBER Without Shared Care) should stay in place until June 2102 by which time the NICE TA on rivaroxaban ( Xarelto ) in AF should be published. ABHB s Position Statement on dabigatran is available at: ABHBpositionStatement%5B16March2012%5D.pdf BNF section DENOSUMAB requests to repeat prescribe REMINDER Requests for Primary Care to continue the prescribing (and administration) of denosumab ( Prolia ) are now coming from ABHB Rheumatology. This is in accordance with the MTC supported all Wales advice for specialists to initiate and prescribe the first two doses (covering a treatment period of one year) with subsequent prescribing responsibility transferring to Primary Care at the request of the specialist. Note: There is no ABHB Protocol covering shared care arrangements for denosumab. Full prescribing information on denosumab is at: All Wales Advice on denosumab is at: e%20doc%20for%20awmsg%20website.pdf VITAMIN D deficiency Guidance on Diagnosis and Management In Adults LOCAL GUIDANCE NOW AVAILABLE First line oral vitamin D preparation for insufficiency and deficiency is the UK licensed FULTIUM D3 800 unit capsule. Fultium D3 is considered suitable for initiation by non specialists (i.e. a GREEN drug in the local Traffic Light system). Full prescribing information on Fultium D3 is at: Second line option (where adherence or oral absorption is a concern) is to use DEKRISTOL unit capsules. Dekristol capsules are UNLICENSED in the UK however the MTC endorsed recommendation to use them will support GPs in meeting the GMC s requirements for prescribing unlicensed medicines. The ABHB guidance does require Dekristol capsules to be initiated by a specialist before GPs are requested to take on the responsibility for repeat prescribing i.e. they are designated AMBER Without Shared Care in the local Traffic Light system. Dekristol capsules are prescribable on a WP10 form. Although the guidance includes lifestyle advice it does not include specific recommendation on which vitamin D preparation(s) to recommend/provide/prescribe as supplements (i.e. in individuals not assessed as deficient/insufficient in vitamin D). The full ABHB guidance (8 pages) is at: ABHBprescribingGuidanceFINAL%5BMarch2012%5D.pdf Page 5 of 7

6 ALFACALCIDOL (OneAlfa ) / CALCITRIOL capsules Traffic Light status Now designated AMBER without Shared Care These short acting, potent oral vitamin D analogues have no routine place in the management of primary vitamin D deficiency and should be reserved for use in renal disease, liver disease and primary hypoparathyroidism. For further information see BNF section and an NPSA resource at: OXYCODONE revised guidance Local guidance on Use of Oxycodone in Cancer Pain is now less restrictive. The in Cancer Pain has now gone from the title. The guidance now covers use of oxycodone for other conditions (such as COPD and end stage LVF) where a requirement for palliative strong analgesia (in cases of morphine resistance / intolerance) could be appropriate. TRAMADOL Prescribing Further to the communication from ABHB Medical Director highlighting the high rate of prescribing of tramadol in Gwent, it is worth noting that local guidance on the use of strong opiates in chronic non malignant pain is available at: GwentGuidance%5BFinal%5DJan2010.pdf Guidance from the British Pain Society for patients: There is also a handy A4 summary: GLUTEN FREE products All Wales Guidance on Prescribing (Dec 2011) New national guidance (initially developed within ABMU) has now been adopted by ABHB. It contains prescribing advice on what gluten free items are considered essential, those that are subject to clinical discretion and luxury items considered not essential and therefore not to be prescribed. All the items allowed are approved by the Advisory Committee on Borderline Substances (ACBS) and are listed in the BNF. The guidance is presented in a simple traffic light prescribing format and importantly gives advice on the quantities to be prescribed (advice currently not presented in the BNF). Note: This guidance (together with the Prescribable Product List at: does not represent a significant shift from the previous GPMTC endorsed Coeliac UK guidance/prescribable Product List. Updates to this list are in hand. The all Wales guidance is available on the ABHB MTC website at: FreeProductsOct2011.pdf Page 6 of 7

7 ABHB Wound Healing Products Guidelines & Formulary The new 2012 edition of this booklet is now available It replaces the previous (2009) edition. Many of the changes in the wound healing products recommended in the new edition reflect the new all Wales contract for dressings. Printed copies of the Formulary/Guidelines will be available from 10th May 2012 and distribution to District Nurses, GP practices, Community Pharmacies and to hospital wards etc. will follow. If you are a healthcare professional working in Gwent and have not received a printed copy by the end of May you can a request to gpmtc@wales.nhs.uk. A downloadable.pdf version of the Formulary/Guideline is now available at: ormulary%5b2mayl2012%5d.pdf Feedback on any item in this enewsletter is welcome. Suggested agenda items for the MTC are also welcome! Regards Trevor Batt Pharmacist & Professional Secretary to: Aneurin Bevan HB Medicines & Therapeutics Committee Aneurin Bevan Health Board Based at Torfaen Locality Office, Mamhilad House. NP4 0YP trevor.batt@wales.nhs.uk Tel: (DIRECT LINE) Web: Page 7 of 7

Aneurin Bevan Health Board Medicines & Therapeutics Committee. enewsletter

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