Present: Deputy Director of Pharmacy, WUTH (Chair) Lead Pharmacist Medicines Management, WUTH (Secretary)

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1 Meeting Notes Meeting Name: Wirral Drug & Therapeutics Panel Date: Wednesday 20 th May 2015 Location: Maternity Conference Room, APH Present: Mrs S Robinson (SRo) Mrs M Charlton (MC) Dr M George (MG) Dr F Newton (FN) Mrs R Pugh (RP) Mrs H Hurley (HH) Mr S Riley (SR) Dr Saket Jalan (SJ) Mrs S Hulse (SH) Lisa Knight (LK) Dianne Atherton (DA) Deputy Director of Pharmacy, WUTH (Chair) Lead Pharmacist Medicines Management, WUTH (Secretary) Consultant Rheumatologist, WUTH GP Partner, Wirral LMC Prescribing Advisor, NHS Wirral Finance Dept, WUTH Senior Prescribing Advisor, NHS Wirral Prescribing Lead, NHS Wirral Team Leader, Pharmacy Clinical Support Services, WUTH Pharmacist, Wirral Community NHS Trust GP NHS Wirral Attending: Mrs Penny Robinson Secretary, WUTH Dr Guy Pritchard (GP) for item 39/15.01 Dr R Dasgupta (RD) for items 39/15.02/03/04 Agenda Item 33/15 Apologies Apologies received: Dr Adrian Hughes, Dr B Hammer, Mrs Pippa Roberts, Dr J Cunniffe, Mrs Naomi Holder, Dr E Sim, Ms Louise Morris, Dr M Van Miert, Ms A Rowlands. Not present no apology sent: Ms M Carroll, Mr S Mwenechanya, Introductions were made around the table and Sue Robinson explained that she was chairing the meeting in the absence of Dr Van Miert due to illness, and as Dr Jalan, the incoming deputy chair, was attending for the first time. Agenda Item 34/15 Conflicts of Interest None Agenda Item 35/15 Minutes of Previous Meeting These were passed as an accurate record. HH noted two people have the same initials; a further initial will be added to differentiate between them. Agenda Item 36/15 Matters arising 36/15.01 WDTP Annual Report The Panel reviewed the WDTP Annual Report for 2014 and was approved. Page 1 of 6

2 It was agreed that the WDTP Gap analysis action plan should be added as an agenda item until all the actions have been completed. 36/15.02 WDTP ToR update ToR were approved but was noted that they may need to be reviewed again once the CCG Governance structure has been reviewed. As the acting chair was absent from the meeting, it was agreed to discuss the re-election of the Chair at the next meeting. On membership, Consultant Anaesthetist, Surgery and Anaesthetics Directorate to be amended to Consultant, WUTH and not include a speciality/directorate or division. Action: remove clinical speciality for Chair of D&T 36/15.03 WDTP appeals process SH presented a short paper outlining the appeals process for Wirral Drug & Therapeutics Panel. The WDTP were asked to approve the process. It was highlighted that it needed to specify who was on the panel and that it should include someone independent from the WDTP. The composition of the appeals panel is to be discussed and agreed at the next meeting. Action: Next meeting of Wirral Drug and Therapeutics to approve appeals process and clarify the appeals panel composition. 36/15.04 WDTP ethical framework The Panel has developed this Ethical Framework to enable it to make fair and consistent decisions which treat patients equally. The purpose of the ethical framework is to support and underpin the decision making processes of the Wirral Drugs and Therapeutics Panel. The WDTP were asked to approve this framework. It was agreed that it was important that confirmation was received from all Panel members that they had read the framework. Action: LM to send out to membership to confirm all not in attendance today have read the Ethical Framework. 36/15.05 WDTP Application form MC has updated the WDTP application form. The guide to completing the form has been moved to the back page and back to top links have been inserted to enable the applicant to move around the document much easier. The WDTP were asked to approve the new template application form. 36/15.06 Management of HIV medicines that are not currently on WUTH formulary Author(s) Marianne Charlton Lead Pharmacist Medicines Mgmt, WUTH There are a number of medicines used to treat HIV that are not currently used at WUTH that have been approved clinically and financially by NHS ENGLAND (NHSE) and are part of the North West HIV Guidelines or as agreed in the HIV Specialist Multi-Disciplinary Team MDT. Any funds spent on these medicines at WUTH are cross charged to NHSE. Options for approving the above HIV medicines onto WUTH formulary: Option 1 Continue with the current D&T application process for HIV medicines that have been evaluated by and are being funded externally through NHSE. Option 2 A report detailing these medicines, their indications and the level of evidence associated with each medicine to be presented to WDTP for consideration and approval. This process would be repeated periodically when new HIV medicines are added to the North West HIV Guidelines. Page 2 of 6

3 Option 3 For these medicines to be placed onto the formulary automatically in a similar way to those medicines that approved by NICE and Cancer Drug Fund medicines. WDTP to be informed of these updates via a report at each meeting. There is a neutral financial impact. There is a neutral governance impact as these medicines are clinically evaluated by NHSE as part of the decision as to whether to fund. The Panel were asked to consider these options. After some discussion, the Panel agreed Option 3. Agenda Item 37/15 Medicines Management Policies & Procedures 37/ Self-Medication Policy (update) Author(s) - Pippa Roberts, Director Medicines Management, Clinical Director Pharmacy Services & Fiona McFarlane, Lead Pharmacist for Education & Training These are the main changes to this policy: Use of patient medicines information card optional Cytotoxics medicines can be self-administered Emphasise that Patients on Parkinson s Disease drugs should self-medicate these medicines if at all possible The Panel were asked to approve these changes. The Panel approved the changes. 37/ Controlled Drugs Policy (update) Author(s) - Amy Janvier, Lead Clinical Dispensary Pharmacist These are the main changes to this policy: Tramadol legally re-classified as a schedule 3 CD Cerner has replaced PCIS as Trust s electronic prescribing system Job title of Accountable Officer has changed 1 References to the Controlled Drugs (supervision of Management and Use ) Regulations 2013 added 5.2 Pharmacy led CD top-up of wards and departments occurs on a Tuesday 5.5 Change to PCA contents 5.6 Addition of information about epidurals 7.6 Addition of PODs should be stored on a separate shelf 8.1 Midazolam buccal liquid to be treated as a full CD 9.10 Removed as laboratory no longer holds a Home Office licence to hold schedule 1 CDs 10 Addition of information about witnessing a continuous CD infusion. Addition of trained CSWs can witness administration of schedule 3 CDs 11.2 Addition of pharmacy technicians can remove CDs for destruction from a ward /department 14.2 Changed requirements for a pharmacist to be involved for the transfer of CDs in a ward move The Panel were asked to approve these changes. The Panel approved these changes Agenda Item 38/15 Reports back None Agenda Item 39/15 New Medicine requests 39/15.01 Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (NICE TA329) Author: Dr Guy Pritchard, Consultant Gastroenterologist, WUTH Dr Guy Pritchard presented his case for infliximab, adalimumab and golimumab, which are recommended, within their marketing authorisations, as options for treating moderately to severely active ulcerative colitis Page 3 of 6

4 in adults whose disease has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for, such therapies as per NICE TA 329. GP was asked how they would choose which agent the patients will receive. He commented that there are no head to head studies between the agents and the individual trial outcomes are comparable. Patients who had already had infliximab for rescue therapy would go on to receive infliximab again. If not they would choose between adalimumab or golimumab as more cost effective than infliximab. GP commented that he favours golimumab as a monthly injection (vs twice monthly with adalimumab) and there is anecdotal evidence that patients find the injection less painful than adalimumab. When asked what they do when patient doesn t respond to one anti-tnf,gp confirmed that they would swap patient on to an alternative anti-tnf. However, this may change when the NICE TA for vedolizumab is published. GP also said that he would consider using biosimilars (if available and licensed for this indication) at a later date if they were to be introduced into the Trust RAG status:red 39/15.02 Dabigatran for the treatment and secondary prevention of VTE (NICE TA327) Author: Dr Dasgupta, Consultant Haematologist, WUTH Dabigatran etexilate is recommended as a possible treatment for adults with deep vein thrombosis or pulmonary embolism as per NICE TA 327. Primary care and WUTH dabigitran checklists have been amended to include this indication. RD commented that he will write some guidance on the advantages and disadvantages of the different NOACS to help clinicians decide which agent to select but is waiting until the NICE TA for apixiban for the treatment and secondary prevention of VTE is published.. Updated checklists approved Rag status: Amber 39/15.03 Rituximab Auto-immune haemolytic anaemia Author: Dr Dasgupta, Consultant Haematologist, WUTH Proposed position in therapy: 1 st Line treatment: Corticosteroids 2 nd Line treatment: Splenectomy or Rituximab (if unsuitable for splenectomy) 3 rd Line treatment: Rituximab if patients refractory to prior splenectomy RD stated that 30-40% of patients don t respond to steroids and some of these patients are not suitable for splenectomy so rituximab would be an option. When asked what other options there are, RD stated that IVIGs don t work for this condition and other immunosuppressants e.g azathioprine take a long time to work and are only effective in 30-40% of patients. RD stated that the response may last for a year and if they relapse then they would consider repeating the course. If a patient has not had a response after 4 doses they would not repeat the course. They have used rituximab in 2 patients so far and have had good responses. Other CCG commissioning bodies include rituximab for this indication.. Rag status: Red 39/15.04 Darbopoetin for treatment of anaemia in patients with cancer having chemotherapy (NICE TA323) Author: Dr Dasgupta. Consultant Haematologist, WUTH Haematology would use in patients with non-myeloid malignancy undergoing chemotherapy as per the NICE TA. RD presented his application to the Panel and stated that historically darbepoetin has been used as it is the easiest option for the patient, requiring one injection per week initially, reducing to once every 2 or 3 weeks and it is used for other indications within haematology. There are cheaper options, however, these are given three times a week so need to consider nursing administration costs on top of drug costs. SR asked Page 4 of 6

5 how patients self-administer vs nurse administration. RD did not have exact figures but speculated that about 50% of patients will self-administer.. The Panel noted that NICE TA 323 states that if different erythropoiesisstimulating agents are equally suitable, the product with the lowest acquisition cost should be used. The panel requested that the haematologists review the suitability of the different erythropoiesis-stimulating agents (including biosimilars) for this indication and the other indications that they use these agents for within haematology to ensure that darbopoetin is currently the most cost-effective preparation available for these indications and report back the review within 6 months. Rag status: Red Agenda Item 40/15 Chairs Actions The Panel noted and approved the list of Chairs actions. MC added one further drug, Cobicistat for HIV for an individual patient, from Dr Gokhale which is not NHSE commissioned but has been recommended by the Liverpool HIV MDT. The panel approved this drug for this patient. Agenda Item 41/15 Health Treatment Panel applications None Agenda Item 42/15 Unlicensed Medicine updates MC explained to the Panel the current supply problems with Ethanolamine used infrequently by gastroenterologists for bleeding oesophageal varices. The stock WUTH holds expired in March 2015, on a 5 year lifespan, and further stock, from a new supplier, is not expected until July. There is an unlicensed version available from America, however the cost is substantially higher and the Trust would be left with unlicensed stock when the licensed stock becomes available again. No other trusts have stock of the licensed or unlicensed version. There are 3 options with how the supply problem can be managed:- Use the out of date stock until new stock arrives Don t stock it until licensed comes back in Use unlicensed product from America The panel discussed the risks of each option but felt that it should be escalated higher up in the Trust for a decision as Panel members felt they didn t have the knowledge on the legal aspects of the different options. Action: SR to escalate Agenda Item 43/15 NICE Guidance New NICE TAs published since last WDTP meeting: TA 335 Rivaroxaban for acute management of ACS TA 336 Empagliflozin for type 2 diabetes TA 337 Rifamixin for hepatic encephalopathy These were approved to be added to the formulary restricted to relevant consultants until application forms have been submitted to WDTP for positioning. MC discussed TA 338 Pomalidomide for multiple myeloma which was a negative TA. However, it is used in the Trust for this indication as is currently funded by CDF and Trust will continue to use unless CDF withdraw funding. Page 5 of 6

6 Agenda Item 45/15 Cancer Drug Fund Medicines A list of all the current Cancer drugs in use at WUTH was distributed with the papers for information. Agenda Item 46/15 Clinical Trials A list of all the current clinical trials was distributed with the papers for information. Agenda Item 47/15 Minutes from other Committees for noting 47/ Medicine Clinical Guidelines Team 5 th December 2014 & 13 th February / Wirral Wide Wound Formulary Group None 47/ Chemotherapy Steering Group 5 th February 2015 & 9 th April / Medical Gas Team 14 th January / Non Medical Prescribing Team 6th November 2014 & 22nd January /15.06 Antimicrobial Stewardship Team - None Agenda Item 48/15 any other business There was no other business. Future Meeting Dates 49/15 Next meeting 15 th July pm in Boardroom Education Centre, APH (papers for submission needed by 12 th June 2015) Page 6 of 6

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