Nottinghamshire Joint Formulary Group Meeting Minutes 9 th October 2014, 2-5pm Room 1, Hawthorne House NG18 4LE

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Leslie McKenzie
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1 Nottinghamshire Joint Formulary Group Meeting Minutes 9 th October 2014, 2-5pm Room 1, Hawthorne House NG18 4LE Present: Steve May (SM) Chief Pharmacist, SFHT (chair); Amanda Rawlings (AR) Prescribing Interface Advisor M&A CCG; Steve Haigh (SH) Pharmacist, SFHT; David Kellock (DK) Consultant (left at 4.30pm), SFHT; James Sutton (JS) and Lynne Kennell (LK) Interface/formulary pharmacists, APC; Tanya Behrendt (TB) Pharmacist, Nottingham City CCG; Esther Gladman (EG) GP, Nottingham City CCG; Debbie Storer (DS), Pharmacist, NUH; Julie Curwood (JC) Community Matron, County Health Partnerships, John Lawton (JL) Pharmacist, Notts HC In attendance: Val Yeung, Consultant Psychiatrist, Notts Healthcare for item 5a; David Lang, preregistration pharmacist, NUH, Mohammed-wasim Gul pre-registration pharmacist, SFH Apologies: Khalid Butt (KB) GP, M&A CCG; Meeta Mallik (MM) Consultant Physician, NUH; Judith Gregory (JG) Pharmacist, NUH; Sachin Jadhav (SJ), Consultant, NUH; Felicity Armitage (FA) GP, Notts City CCG; Jill Theobald (JT) Interface/formulary pharmacist, APC. Agenda item Apologies Declarations of Interest Minutes of previous meeting Matters arising and Action Log Notes Noted (see above). None declared. Were accepted as an accurate record It was noted that completed actions had been removed from the action log and APC actions had been added to the APC action log. Rifaximin NICE TA for hepatic encephalopathy had been suspended following information received from the manufacturer. SH reported that there was increasing usage of rifaximin at SFHT Action: TB to investigate reasons for suspension of NICE TA. SH to investigate reasons for increased usage at SFHT. 5. New applications a) Lisdexamfetamine (Elvanse, Shire) for attention deficit/hyperactivity disorder ADHD. Dr Yeung, the requesting consultant, was in attendance Lisdexamfetamine is a pro-drug of dexamfetamine licensed for children and adolescents aged 6 years and over when response to methylphenidate treatment is considered clinically inadequate. The Elvanse SPC states in adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood. A submission has been received from consultant psychiatrists at Notts Healthcare Trust, supported by community paediatricians at SFHT and NUH, for lisdexamfetamine to be available as a second line option (i.e. methylphenidate first line, atomoxetine or lisdexamfetamine second line) in line with its license. Methylphenidate and atomoxetine are currently Amber 1 in Nottinghamshire, whereas dexamfetamine is classified Red. 1 Dr Yeung answered the group s questions related to the product and to shared care arrangements. She highlighted that limited experience had been gained in a small number of patients at NottsHC. The group discussed the potential advantages of this product over dexamfetamine (decreased frequency of administration, associated compliance improvements and lack of school administration issues in children, decreased potential for abuse) and over atomoxetine (decreased time to first response which is potentially

2 linked to its shorter titration regimen). Evidence for lisdexamfetamine is limited to short duration studies, only some of which relate to the licensed place in therapy. It is similar in price to atomoxetine whereas dexamfetamine may be cheaper depending on the dose used. Monitoring requirements and side-effects appear similar to alternative stimulants. Current NICE guidance predates the availability of lisdexamfetamine. EG highlighted reservations in primary care about prescribing medicines for ADHD, in particular with amfetamine based products. Concerns were also raised regarding consistency of monitoring these medicines in general practice, the prescribing of ADHD medications into adulthood, and limited experience with lisdexamfetamine in specialist practice. Based on possible advantages to patients and possible safety advantages the group were minded to recommend lisdexamfetamine for addition to the formulary with an Amber 1 classification. Based on concerns regarding the overall service and shared care agreement currently being discussed, the group felt that further discussions were necessary before this recommendation could be taken to APC. As a result the group recommended a RED classification for lisdexamfetamine for Notts HC trust as an interim, and GREY in other organisations subject to application and funding approvals through other committees. Action: JS/LK to take to APC for ratification Primary care members to canvas opinion from their organisations TB/AR/JL to discuss with commissioners b) Liothyronine for depression Liothyronine is currently classified as Amber 2 for treatment of hypothyroidism only, but is not recommended for this condition by the Royal College of Physicians guidance, and this was discussed under separate agenda item 10. Liothyronine is recommended as an option in treatment resistant depression in the Maudsley and British Association of Psychopharmacology guidelines, and is used by psychiatrists at NottsHC in a small number of patients for this indication. GPs are requested to continue this treatment and monitor those patients who are on it. A request for formal traffic lighting and inclusion in the formulary for this use has been received. A review of the evidence was discussed, although it was acknowledged that there were historical studies that hadn t been included in the review. It was noted that the price of liothyronine had increased significantly since the guidance had been written despite being available generically. Maudsley guidelines recommend thyroid function test monitoring, and when used for hypothyroidism the patient should have a baseline ECG. This indication is not listed in the BNF. Despite there being multiple treatment options for depression, there is some usage in other areas with a shared care agreement in place in one region. Concerns were raised about the appropriateness of prescribing of this drug in general, including indication, who has recommended it and monitoring being undertaken irrespective of indication. Based on the information presented the group we not minded to add liothyronine to the joint formulary, due to limited evidence and lack of proven 2

3 cost-effectiveness. There was the concern that approving liothyronine as specialist use for this indication may legitimise some of the inappropriate prescribing. Action: LK/JL to revise evidence review to include historical studies and bring back to December JFG AR/TB to discuss auditing current patients in primary care c) Beclometasone dipropionate MR tablets (Clipper, Chiesi) for ulcerative colitis Clipper tablets are currently classified as GREY. A recent update to NICE Clinical Guideline for ulcerative colitis recommends this preparation is considered in addition to a high dose oral aminosalicylate to induce remission for adults and children with mild to moderate first presentation of, or inflammatory exacerbation of, left-sided or extensive ulcerative colitis. Prescribing for this recommendation would be off-label. Topical aminosalicylates may also be considered at this step. A submission has been received from a consultant at the Nottingham NHS Treatment Centre supported by specialists at both acute Trusts to add Clipper to the formulary to induce remission as per NICE guidance but only as add on therapy for non-responders to aminosalicylates, in line with the product license. Clipper is not licensed for use in children and young people and therapy cycles of more than four weeks are not recommended. NICE does not recommend use of Clipper as a maintenance therapy. The group discussed that the evidence base for this indication is limited to one small randomised placebo controlled trial and that NICE has recommended further research be undertaken to compare Clipper to oral prednisolone. Low systemic availability of the active metabolite from Clipper is thought to limit the systemic steroid side-effects that would be expected with oral prednisolone. NICE and SMC differ in their assessment of this preparations cost-effectiveness. The group recommended Clipper tablets be added to the formulary for the indication requested in the submission with an Amber 2 (specialist recommendation) classification, based on it being recommended as an option in NICE guidance, and possible benefits to patients in terms of steroid induced side-effects. Action: JS to take to APC for ratification. d) Nadolol (Corgard, Sanofi-Aventis) for Long QT syndrome Nadolol is non-cardioselective beta-blocker with a long half-life licensed for multiple indications including arrhythmias. A submission has been received from consultant cardiologists at NUH for addition of nadolol to the formulary for long QT syndrome. Long acting beta blockers such as propranolol MR or nadolol are recommended as treatments of choice for this condition in European Guidance, but recent evidence has indicated that propranolol may be less effective in a subset of patients with this rare condition. It was discussed that most patients with this rare condition will be under a specialist centre and that there is specialist consensus that nadolol should be available as a first line option. Propranolol MR and nadolol have similar acquisition costs although nadolol is less lipophilic and therefore would be expected to cause fewer CNS side effects such as nightmares. 3

4 The group recommended adding nadolol to the formulary with an Amber 2 (specialist recommendation) classification for treatment of Long QT syndrome only, based on clinical effectiveness compared to existing therapies. 6. Formulary amendments Action: LK to take to APC for ratification. a) Formulary amendments for information were noted. b) Formulary amendments for discussion: The group agreed with the recommendations from the Specialist Formulary Pharmacist with the exception of: Clonazepam liquid Only the 2mg/5ml to be added to reduce the risk of mis-selection errors. Added with caveats regarding alcohol content making the licensed product not suitable for children and care should be taken when switching brands for epilepsy patients. JS/LK to liaise with paediatricians and neurology re clonazepam liquid Levomepromazine 6mg tablets DS requested that it was clarified whether community pharmacists will quarter the 25mg tablets for patients, and whether there are patients on ongoing treatment in primary care as this medicine is anticipated to be used for palliative care. AR/TB to liaise with community pharmacy. AR/TB to liaise with community pharmacy re levomepromazine. AR/TB to obtain epact data re levomepromazine Ceftriaxone and teicoplanin for cellulitis JS to investigate primary care cellulitis pathway and bring to future meeting. JS to investigate primary care cellulitis pathway Glycopyronium tablets Include the 2mg tablets or liquid where necessary (1mg tablets non-formulary not cost-effective) in the formulary. LK to discuss with paediatricians Action: LK to take amendments to APC 7. Horizon scanning c) MHRA and other safety warnings. These were noted with no further action recommended. a) New publications for review The August and September New Drugs Online newsletter and the August and September RDTC newsletters were reviewed. The group agreed with the recommendations made by the SIFP. Action: JS to discuss tiotropium for asthma with specialists and encourage submission if necessary b) NICE new medicines summaries ESMN45, 47 and 48 were reviewed by the SIFP. The group agreed with the recommendations made by the SIFPs. c) NICE unlicensed medicines summaries ESUOM33 was reviewed by the SIFPs. The group agreed with the recommendations made by the SIFPs. d) Miscellaneous publications The group agreed with the recommendations made by the SIFPs with the exception of Fostair NEXThaler which is to be classified as GREY non-formulary no formal assessment. It was felt that the data regarding lung deposition was not sufficient to warrant inclusion in the formulary. Action: LK to take horizon scanning to APC. 8. Safety needles The group agreed that the implementation of European Guidance in this area and risk assessments required were beyond the scope of the JFG. 4

5 This issue has been highlighted to relevant medicines management colleagues in individual organisations for their information and discussion. 9. Asthma Care plan Action: Remove item from agenda AR introduced an asthma self-management plan developed by Mansfield and Ashfield CCG. This document had been developed in response to the nationally recommended document being out of date. However since the development of the local plan, the BTS guidance and the asthma UK asthma management plan have been recently updated. There are versions of this plan on the asthma UK website for adults, children and carers/parents. The group discussed the asthma UK versions and felt that the national document was a recognised standard and promoted within the BTS guidance and therefore was the most appropriate to promote. It was noted that the asthma UK document does not include clear guidance regarding which patients should be issued with steroid cards. The group felt this section to be particularly useful and thus wished to retain this and add it to the formulary / link to the asthma guidelines. 10. Liothyronine for hypothyroidism Action: JS to update link in local asthma guidelines to the latest adult management plan JS to discuss with specialists the table of when to issue a steroid alert card AR to feedback to Mansfield and Ashfield CCG See item 5b also. Concerns were raised about the use of this medicine for nebulous indications possibly including subclinical hypothyroidism. It was requested that liothyronine be made grey (non-formulary). 11. Information sheet on misuse potential of pregabablin & gabapentin meeting dates Action: JS/LK to discuss with specialists the proposal to make liothyronine grey. JS/LK to take to APC TB introduced the document produced by the Nottinghamshire Prescription and Over-the-Counter Medicines Misuse and Dependence Working Group. The document was well received and thought to highlight an important issue locally. Only minor amendments were suggested. Action: AR/TB to take to APC Noted for information Action: JS/LK to arrange venues and send members dates 13. Any other None business 14. Date and time Thursday 11 th December 2014 Duncan Macmillan House. 2pm -5pm. of next meeting The meeting ended at 4:45 pm 5

Nottinghamshire Joint Formulary Group Meeting Minutes Thursday 9th June 2016, 2-5pm A01, Duncan Macmillan House

Nottinghamshire Joint Formulary Group Meeting Minutes Thursday 9th June 2016, 2-5pm A01, Duncan Macmillan House Present: Esther Gladman (EG) GP Prescribing Lead, Nottingham City CCG (chair); Daniel Shipley