GWENT FORMULARY DECISIONS

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Rosa Copeland
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1 Dear Gwent Prescriber At its last two meetings (13 th October and 24 th November 2011) ABHB s Medicines & Therapeutics Committee (formerly GPMTC) made the following decisions in relation to the ABHB Joint Formulary: GWENT FORMULARY DECISIONS BNF section SAXAGLIPTIN 5mg ( Onglyza ) as add on combination therapy for Type 2 diabetes ADDED in accordance with its licensed indications and the recommendations for use of DPP 4 inhibitors in NICE CG87 1 Type 2 diabetes: the management of type 2 diabetes. In accordance with the GREEN Traffic Light designation of the other DPP 4 inhibitors in the ABHB Formulary the MTC agreed that saxagliptin could be initiated by specialists and non specialists. The use of saxagliptin 2.5mg as an add on treatment for adults with Type 2 diabetes with moderate or severe renal impairment (a license extension) has been appraised at a national level by AWMSG (7 th December 2011) and recommendations will follow. Note: NICE s CG87 recommends that DPP 4 inhibitors should only be continued beyond six months where there is a reduction in HbA 1c of at least 0.5%. Full prescribing information on saxagliptin is at: VILDAGLIPTIN containing medicines ( Galvus and Eucreas ) REMOVED Noting the advice on liver function monitoring with vildagliptin 2 (and the associated costs of this) the MTC agreed with the Diabetes and Endocrinology Directorate s request that saxagliptin should replace vildagliptin on the ABHB Formulary. BNF section 4.4 METHYLPHENIDATE modified release capsules (Equasym XL ) for ADHD ADDED In keeping with other methylphenidate preparations, Equasym XL was designated AMBER with Shared Care (i.e. specialist only initiation with continued prescribing under shared care arrangements). The existing Gwent Shared Care Protocol covering methylphenidate in ADHD has been updated to include Equasym XL: The MTC agreed Equasym XL should be considered second line after immediate release methylphenidate and used only in circumstances where there is clear evidence that administration of a midday dose is problematic or inappropriate. See table below for comparative release properties of MR methylphenidate: liver function should be monitored during treatment with Galvus at 3 month intervals during the first year and periodically thereafter. Page 1 of 9

2 Name Concerta XL Equasym XL Product details Modified release hours duration Modified release Up to 8 hours duration Strengths Formulation Release profiles Administration details 18mg 27mg 36mg 54mg Dose equivalent: 18mg = 5mg IR tds 36mg = 10mg IR tds 54mg = 15mg IR tds 10mg 20mg 30mg Capsule shaped tablet containing two layers of drug separated by semipermeable membrane Outer layer (overcoat) released first followed by gradual release of drug from inner core. Empty tablet shell excreted. Capsule containing two types of pellets/beads which allow immediate release of drug, followed by gradual release over the day. 22% IR: 78% MR Initial peak plasma concentration in 1 2 hours. Second peak at 6 8 hours 30% IR: 70%MR Initial peak plasma concentration in 1 2 hours. Second peak at 4.5 hours Tablet must be swallowed whole, not chewed crushed or broken Capsules may be opened and contents mixed with soft foods. (stability unknown) Contents must be swallowed not chewed crushed or broken Full prescribing information on Equasym XL is at: 30+mg+Capsules/ BNF section ESLICARBAZEPINE ( Zebinix ) and LACOSAMIDE ( Vimpat ) for adjunctive therapy in adults with partial onset seizures ADDED The MTC approved ABHB Formulary inclusion for both eslicarbazepine and lacosamide in accordance with their licensed indications as adjunctive therapy in adults with partial onset seizures (with or without secondary generalisation). The approval was on the understanding that recommendations 89 and 90 in NICE s final draft Clinical Guideline on epilepsy 3 (Update of the 2004 CG20) remain unchanged when they appear in January The MTC agreed that these two AEDs should most appropriately be initiated by specialists (NICE refers to tertiary epilepsy specialists) within ABHB Secondary Care with repeat prescribing continued by GPs. Whilst formal Shared Care arrangements were not considered necessary (i.e. eslicarbazepine and lacosamide are designated AMBER without Shared Care in Gwent s Traffic Light system) it was agreed that brief guidance covering the practicalities of prescribing these would be a useful local supplement to the NICE guidance. RETIGABINE ( Trobalt ) for the adjunctive treatment of partial onset seizures ADDED in accordance with the advice in NICE TAG232 4 ; as an option for the adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years with epilepsy, only when previous treatment with carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, sodium valproate and topiramate has not provided an adequate response, or has not been tolerated. Retigabine is also designated Amber without Shared Care in Gwent s traffic Light system. Full prescribing information on retigabine is at: Page 2 of 9

3 BNF section NAFTIDROFURYL OXALATE (Praxilene ) for peripheral vascular disease (not cerebral vascular disease) ADDED in accordance with recommendation 1.1 in NICE TA223: 1.1 Naftidrofuryl oxalate is recommended as an option for the treatment of intermittent claudication in people with peripheral arterial disease for whom vasodilator therapy is considered appropriate after taking into account other treatment options. Treatment with naftidrofuryl oxalate should be started with the least costly licensed preparation. The MTC agreed: Naftidrofuryl should be designated GREEN in the Gwent Traffic Light system (i.e. suitable for non specialist initiation) Naftidrofuryl s Formulary entry should clearly state its use is for peripheral vascular disease only. To highlight the availability of relevant NICE guidance which recommends that vasodilator therapy is appropriate after taking into account other treatment options (e.g. exercise and treatment to reduce the risk of cardiovascular events) and that drug treatment should not replace referral for consideration of specialist treatment. Link to NICE TA223 (Peripheral arterial disease cilostazol, naftidrofyryl oxalate, pentoxifylline and inositol nicotinate: guidance May 2011): Full prescribing information on naftidrofuryl is at: CILOSTAZOL (Pletel ) for intermittent claudication REMOVED in accordance with recommendation 1.2 in NICE TA223: 1.2 Cilostazol, pentoxifylline and inositol nicotinate are not recommended for the treatment of intermittent claudication in people with peripheral arterial disease. The MTC agreed that leaving cilostazol on the ABHB Formulary when not recommended by NICE would leave it open for further initiations. Existing cilostazol patients are covered by this statement: 1.3 People currently receiving cilostazol, pentoxifylline and inositol nicotinate should have the option to continue treatment until they and their clinicians consider it appropriate to stop. BNF section INDAPAMIDE 2.5mg for hypertension ADDED In accordance with the new recommendations in NICE CG127 5 (August 2011) on the use of thiazide like diuretics. The guidance recommends calcium channel blockers (CCBs) as first line therapy in most people aged over 55 years, and for black people of African or Caribbean family origin of any age. The recommendation for thiazide type diuretics is that chlortalidone mg once daily, and indapamide 2.5mg (or modified release 1.5mg) once daily, are preferred to bendroflumethiazide or hydrochlorothiazide for either initial treatment or as add on therapy: Offer chlortalidone or indapamide in preference to bendroflumethiazide or hydrochlorothiazide if diuretic therapy is to be changed or initiated as an alternative to calcium channel blockers (CCBs) at step 1 or step 2 if CCB is not tolerated or the person has oedema, evidence of heart failure or a high risk of heart failure, or in combination with CCB and an ACE inhibitor or low cost A2RA if necessary to achieve suitable blood pressure reduction (step 3 drug treatment). 5 Page 3 of 9

Chlortalidone (Hygroton ) and indapamide 1.5mg MR tablets (Natrilix SR ) remain non Formulary in ABHB. Full prescribing information on indapamide 2.5mg tablets at: http://www.medicines.org.

4 Chlortalidone (Hygroton ) and indapamide 1.5mg MR tablets (Natrilix SR ) remain non Formulary in ABHB. Full prescribing information on indapamide 2.5mg tablets at: An NPC summary of the other important changes from the previous NICE guidance on hypertension can be found at: BNF section PECFENT fentanyl Nasal Spray for breakthrough pain in patients receiving opioid therapy for chronic cancer pain ADDED In accordance with AWMSG recommendation In keeping with the Traffic Light designation of other IR fentanyl preparations on the ABHB Joint Formulary ( Abstral S/L tablets and Instanyl nasal spray) and the recommendations from AWMSG, the MTC have classed PecFent as Amber without Shared Care. Full prescribing information on PecFent is at The ABHB Guidance on Use of Immediate Release (IR) Fentanyl for the management of Breakthrough Cancer Pain issued in May 2011 has now been updated to cover PecFent. The key advice is that oral morphine (as oral solution or standard formulation tablets) remain the first option for treating breakthrough cancer pain and IR fentanyl should only be initiated by specialists in Palliative Care. The updated ABHB guidance on IR fentanyl can be found at: OTHER PRESCRIBING NEWS BNFc section Buccal midazolam Gwent s former MTC (GPMTC) gave Joint Formulary approval to the UNLICENSED buccal midazolam maleate preparation EPISTATUS (10mg/ml) in March This approval was given with the agreement that it would be initiated and repeat prescribed within Secondary Care only i.e. Epistatus was designated RED in the Gwent Traffic Light system. A licensed preparation of buccal midazolam (as the hydrochloride salt) is now available in 4 volumes of pre filled syringe (as BUCCOLAM ) however at 5mg/ml, this is half the strength of Epistatus (meaning a larger volume of Buccolam needs to be administered). Although there is some suggestion that the maleate salt used in some other products is better absorbed by buccal administration, there are adequate studies to support the licensed doses of Buccolam. The MTC discussed Buccolam at its November meeting and having sought the views of those with expertise in paediatric epilepsy in ABHB (and from the South Wales Paediatric Epilepsy Network), ABHB MTC now advises: 6 Page 4 of 9

5 1. Continued use of the unlicensed Epistatus for the next 6 months pending further information on the likelihood of it receiving a license within a reasonable timeframe. 2. GPs should NOT to switch patients from unlicensed Epistatus to Buccolam and should note the difference in the formulation of these two products to avoid inadvertent under dosing if a switch is made. See MHRA s safety information on Buccolam (Drug Safety Update Oct 2011, vol 5 issue 3: A2.) at: 3. If GPs are unhappy to continue prescribing an unlicensed drug when a licensed alternative is now available they can request that the prescribing reverts back to the responsible paediatrician Epistatus is still classed as a 'RED' drug in Gwent. ABHB MTC will be discussing buccal midazolam further at its next meeting on 12 th January Other Safety Information on buccal midazolam from the MHRA: 1. Buccolam is licensed for the treatment of prolonged, acute convulsive seizures in infants, toddlers, children and adolescents (from 3 months to <18 years of age). Use of Buccolam in adults would be off label. 2. It must only be used by parents/carers where the patient has been diagnosed to have epilepsy and for infants between 3 and 6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. 3. Midazolam should be used with caution in patients with chronic respiratory insufficiency because it may further depress respiration. 4. Midazolam may accumulate in patients with chronic renal failure, or impaired hepatic or cardiac function and should therefore be used with caution in these individuals. 5. The most common adverse reactions in clinical trials of buccal midazolam were sedation, somnolence, depressed levels of consciousness, respiratory depression, and nausea and vomiting. Full prescribing information on Buccolam is at: earch Protocol for Out Patient prescribing Gwent s former MTC (GPMTC) endorsed the use of this protocol by Secondary Care in May The Protocol was developed in response to a recommendation in WHC(2002)71 Medication Supply to Hospital Patients (see 71.pdf). This stated: Hospital outpatients should only receive their initial supply of medication from the hospital when there is an urgent clinical need. The consultant should request that the GP considers initiating or continuing treatment. In order to facilitate a GP s compliance with local prescribing formularies, consultants should, wherever appropriate, recommend a class of drug to be prescribed by the GP, rather than a specific individual drug or brand. GP practices should be aware that they would now be seeing the Form (reproduced below) coming from ABHB Secondary Care. Practices should note that use of the forms is not mandatory and may not be used by all specialities. The Protocol (ABHB 0029 which includes the Form in Appendix 1) can be found at: ines%20for%20outpatients%20protocol%20 %20Issue%201.pdf Page 5 of 9

6 Symptom Control Guidelines for palliative care The MTC and the Gwent Palliative Medicine Consultant Group have endorsed brief general guidelines on symptom control in palliative care these have been adapted from a leaflet compiled by Dr Marlise Poolman, Clinical Lecturer in Palliative Medicine, Betsi Cadwaladr University Health Board. The guidance (2 sides) can be found at For more detailed advice prescribers should access the Palliative Adult Network Guidelines (2011) at: IVABRADINE ( Procoralan ) Traffic Light status MINOR CHANGE Although the MTC agreed that ivabradine should remain a specialist only initiated medicine (AMBER without Shared Care); in recognition of the widening experience with ivabradine and the publication of NICE s guidance on Stable Angina (CG126) it was agreed that GPs could now initiate it on the recommendation of a specialist (i.e. the specialist would not be required to write the first prescription). The check on heart rate and rhythm (between 2 and 6 weeks) would remain the GP s responsibility. Prescribers should note that ivabradine is currently only licensed for the symptomatic treatment of chronic stable angina pectoris in adults with normal sinus rhythm and where: use of beta blockers is not tolerated or contra indicated an optimal dose of beta blockers alone provides inadequate control (heart rate is > 60 bpm). Full prescribing information on ivabradine at: Page 6 of 9

7 MODAFINIL (Provigil ) Traffic Light status CHANGED from RED to AMBER with Shared Care the MTC agreed to change its recommendation to enable GPs to repeat prescribe modafinil for the treatment of excessive sleepiness associated with narcolepsy, on the condition that a local Shared Care arrangement is put in place i.e. Traffic Light designation is now AMBER with Shared Care. Development of the protocol is ongoing and will be circulated to GP practices as soon as it has received final endorsed from the MTC. METOJECT Requests to undertake shared care With the extension of shared care arrangements to cover subcutaneous methotrexate (Metoject ) ABHB Rheumatology initially adopted a request to prescribe approach, rather than assuming acceptance of prescribing for Metoject. As Primary Care monitoring of methotrexate is covered by a funded Enhanced Service, GP acceptance of Metoject prescribing is progressing smoothly and there is less delay, the assumed acceptance approach will be adopted from now on. This is in accordance with the wording in the MTC endorsed Shared Care Protocol for Metoject : AS THE PRACTICE IS ACCREDITED TO UNDERTAKE NEAR PATIENT TESTING, IT WILL BE ASSUMED THAT THE PRACTICE WILL WISH TO ACCEPT REFERRALS FOR SHARED CARE. IF FOR ANY REASON THIS IS NOT THE CASE, PLEASE CONTACT THE CONSULTANT URGENTLY SO THAT ARRANGEMENTS CAN BE MADE TO UNDERTAKE THE NECESSARY MONITORING FOLLOWING INITIATION OF THE DRUG All Gwent Shared Care Protocols can be found at: DRONEDARONE ( Multaq ) Traffic Light status CHANGED from AMBER to RED In view of recommendations from the EMA s Committee for Medicinal Products for Human Use (to reduce the risk of adverse liver, lung and cardiovascular events with dronedarone) the MTC agreed this change in dronedarone s designation. ABHB Cardiology are arranging individual reviews of all patients currently taking dronedarone to go through the risks and benefits in the light of the EMA s Q&A document and to ensure that it remains appropriate treatment. Cardiology will prescribe and monitor dronedarone for any patients opting to remain on it. GPs with patients on dronedarone do not need to take any action, other than continue prescribing it in the short term. Link to EMA Questions and Answers: pdf ABHB s RED designation of dronedarone is supported by AWMSG: DABIGATRAN License extension to cover stroke prevention in AF An interim position statement on the appropriate use of dabigatran (pending the publication of NICE TAG on dabigatran for the prevention of stroke in AF) was agreed and circulated to all Gwent GP Practices on 12 th September Following an appeal against NICE s Final Appraisal Determination by NHS Salford the publication of this TAG is now delayed beyond 7 th February 2012 ABHB s Position Statement will therefore continue to apply beyond the original expected publication date of December ABHB s Position Statement on dabigatran is available at: ABHBpositionStatement%5B12Sept2011%5D.pdf Page 7 of 9

CITALOPRAM and QT interval prolongation A Dear Healthcare Professional letter (24 th October 2011) warning of the association of Cipramil (citalopram hydrobromide) with dose dependant QT interval

8 CITALOPRAM and QT interval prolongation A Dear Healthcare Professional letter (24 th October 2011) warning of the association of Cipramil (citalopram hydrobromide) with dose dependant QT interval prolongation has been issued by Lundbeck. The letter includes the following recommendations: The maximum dose of citalopram is now 40mg daily In the elderly and in patients with reduced hepatic function the maximum dose is lowered to 20mg daily. Citalopram is contraindicated in patients with known QT interval prolongation or congenital long QT syndrome. Use of citalopram with other medicinal products known to prolong QT interval is contraindicated. Caution is advised in patients at higher risk of developing Torsade de Pointes, e.g. congestive heart failure, recent MI, bradyarrhythmias or a predisposition to hypokalaemia or hypomagnesaemia because of concomitant illness or medicines. Lundbeck s letter is at: MHRA s Drug Safety Update on citalopram (and escitalopram [Non Formulary in ABHB]) is at: An algorithm to guide the reductions in high doses of citalopram has been endorsed by the MTC: This pathway may be more easily viewed at ABHBalgorithm%5BFINAL%5DDec2011.pdf Learning Module on the SSRIs The MHRA are currently developing learning materials on minimising the risk of harm from medicines. The materials focus on important hazards of commonly prescribed classes of medicines and discuss specific risks and how to prevent or minimise them when prescribing, dispensing or taking medicines. Questions are included to consolidate the learning. The SSRIs learning module is the first in this series It can be accessed at: es/reducingmedicinerisk/ssrilearningmodule/index.htm Page 8 of 9

9 Drug Safety Updates from MHRA The MTC felt it was useful to highlight the following item in June s edition of the MHRA s Drug Safety Update (Drug Safety Update June 2011, vol 4 issue 11: A2.): YASMIN: risk of venous thromboembolism higher than levonorgestrel containing pills Advice for healthcare professionals: The risk of VTE in association with drospirenone containing pills, including Yasmin, is higher than that for levonorgestrel containing second generation pills and may be similar to the risk for thirdgeneration pills that contain desogestrel or gestodene Levonorgestrel containing pills (e.g. Levest and Ovranette ) have the lowest thrombotic risk and are the safest pill for a woman who wants to start or switch contraception. Prescribers should be aware of the updated information when discussing the most suitable type of contraceptive for a woman who wants to start or switch contraception Any prescribing decision should take into account each woman s personal risk factors and any contraindications, including her experience with other contraceptive formulations All COCs, including Yasmin, should be prescribed with caution to obese women (BMI >30), or those with a higher baseline risk of VTE for other reasons Estimates are not precise, but for women who do not use a contraceptive pill about one case of VTE per is expected each year. By comparison, about six cases of VTE are expected to occur in every pregnancies. In healthy women who take Yasmin, between three and four cases of VTE are expected to occur in every women each year. The previous estimate was between two and four cases in every women each year. All these estimates relate to women who are otherwise in good health There is no reason for women to stop taking drospirenone containing COCs or any other COC on the basis of these findings The Faculty of Sexual & Reproductive Healthcare have recently published clinical guidelines on combined hormonal contraception: Drug Safety Update December 2011 quiz: AWMSG s Prescribing Dilemmas: A Guide for Prescribers Primary Care prescribers should find this AWMSG endorsed 20 page guidance (of August 2011) useful. Topics covered are: CLINICAL RESPONSIBILITY PRIVATE REFERRAL Patients who request to be referred privately Top up payments PRIVATE PRESCRIPTIONS Following a private consultation For NHS patients For a branded product PRESCRIBING OF MEDICINES FOR AN UNLICENSED USE PRESCRIBING OUTSIDE NATIONAL GUIDANCE HPV TRAVEL ABROAD NHS patients travelling for three months or less NHS patients living or travelling abroad for more than three months of the year Immunisation for travel abroad Malaria prophylaxis Controlled drugs: implications for patients PRESCRIBING OF BORDERLINE FOODS AND DIETARY PRODUCTS COMPLEMENTARY MEDICINE AND ALTERNATIVE THERAPIES MINOR AILMENTS FERTILITY TREATMENT Prescribing implications TREATMENT OF ERECTILE DYSFUNCTION DOCTORS PRESCRIBING FOR THEMSELVES OR THEIR FAMILIES VISITORS FROM OVERSEAS VACCINES FOR OCCUPATIONAL HEALTH PURPOSES.. The guide can be found at: Page 9 of 9

GWENT FORMULARY DECISIONS

GWENT FORMULARY DECISIONS 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