DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday 10 th May 2011 Summary Points Shared care updates Acetylcholinesterase inhibitors Modafanil for narcolepsy Riluzole Rivastigmine for PD dementia complex Traffic lights NuvaRing GREEN [after specialist initiation] Romiplostim - RED Insulin analogues The RDTC Drug Update no. 66 to be proactively promoted to health professionals involved in the management of people with type 2 diabetes 1
Present: Derbyshire County PCT Mr P Barrett Assistant Director of Finance [Chair] Mr P Burrill Specialist Pharmaceutical Adviser for Public Health Mr S Hulme Assistant Director of Medicines Management [arrived 1.40] Dr A Morkane Associate Director of Public Health Dr A Mott GP Amber Valley Dr D Fitzsimons GP Darley Dale Mrs S Qureshi NICE Liaison and Audit Pharmacist Derbyshire Community Health Services Trust Mr M Steward Head of Medicines Management Derby City PCT Mr S Dhadli Assistant Director of Medicines Management Mrs S Sims Assistant Director of acute commissioning Dr N Qureshi GP Derby Dr R Elkheir Consultant in Public Health Medicine [arrived 1.55] Derby Hospitals NHS Foundation Trust Mr D McLean Dr J Leung Principal Pharmacist Chair D & T C Derbyshire Healthcare NHS Foundation Trust Dr P Brownsett Consultant Chesterfield Royal Hospital NHS Foundation Trust In Attendance: Mr M Bond for item 5 Ms R Walsh Research Manager DCHS/PCT Senior Pharmacist DHCFT 1. APOLOGIES Dr J Bell, Mr I Gibbard, Dr C Emslie, Dr I Tooley The Chair reported that Mr Shepherd, representative from CRH, would be 30 minutes late but he had indicated that he had no issues with the early part of the agenda and supported the draft minutes of the last meeting. The meeting was therefore declared as quorate. 2. DECLARATIONS OF INTEREST No declarations of interest were made. 3. MINUTES OF JAPC MEETING 12 th April 2011 The minutes of the meeting held on 12 th April 2011 were agreed as a true and accurate record. 2
4. MATTERS ARISING a SCA for acetylcholinesterase inhibitors Dr Brownsett presented the changes to the SCA that had been requested at the last meeting. Agreed: the updated SCA for acetylcholinesterase inhibitors was ratified. Mr Dhadli reported that based on the NICE costing template, the additional expenditure on these drugs would be 112k for City and 318k for County per year. b c CG 115 alcohol-use disorders Dr Brownsett reported that she had consulted with the substance misuse specialist and as medication was rarely used in alcohol-use disorders this guidance would not increase prescribing costs. Dronedarone prescribing Mr Burrill presented data for dronedarone prescribing that he had received from the relevant trusts. RDH had commenced in 6 patients in the last 12 months and CRH in 6 patients since October 2010. Fifteen GP practices in Derbyshire County and three in Derby City were prescribing dronedarone. Agreed: this data to be considered at the prescribing sub-groups and medicines management to discuss with the individual practices involved. Meds man 5. RESEARCH GOVERNANCE AND EXCESS TREATMENT COSTS Mr Bond attended to give an update on research governance and excess treatment costs, which had been stimulated by the SCOT trial. The purpose was to inform JAPC of national and local policy on research governance approval and excess treatment costs and the related issues of the circumstances where a project can be declined through the research governance process. The payment of excess treatment costs is national policy and the circumstances where a trial can be turned down through the research governance process are clear. The requirements for Research Governance approval are set out by the Department of Health (Research Governance in Health & Social Care second edition 26/11/2008). If the following are in place approval should be a formality provided the sponsor can confirm who is authorised to act on behalf of the sponsor provide evidence of its MHRA clinical trial authorisation provide evidence of a favourable ethics committee opinion and provide details of indemnity and/or insurance. There is also a list of circumstances where approval can be withheld: no suitable sponsor is identified; or no evidence of an application for ethical approval has been supplied; or there are no agreements for the allocation of responsibilities, or for indemnity and/or insurance (or those provided are clearly unacceptable to the NHS); or the NHS has evidence of local issues that could make it unsafe to conduct the study at the proposed sites within its area, which the ethics committee needs to consider; or the study would harm service delivery, because of local issues the ethics committee or the sponsor did not take into account. NHS excess treatment costs are the patient care costs provided as part of research, that is either an experimental treatment or a service provided in a different location from where it would normally be given and it differs from the normal, standard treatment for that condition. This includes all types of patient care services including diagnostic, preventive, continuing-care, rehabilitation and health promotion. 3
In April 2009 DH issued clarification guidance in relation to funding excess treatment costs for non commercial research studies. NHS excess treatment costs are the responsibility of the NHS and are funded through normal arrangements for commissioning patient care. Researchers should discuss excess treatment costs with the provider trust where the costs will be incurred. The provider trust should be able to cover these costs through existing commissioning arrangements and are expected to do so as part of the NHS tariff. Exceptionally, where the provider trust feels they are not able to cover the costs, it is the trust (not the researcher) who should present a business case to the commissioners for additional funding. Local policy is that any research studies that are being conducted in primary care will not be granted NHS permission to commence by the PCTs until any negotiations about primary care excess treatment costs have been successfully concluded. Mr Bond added that it is difficult to judge the amount of excess treatment costs that will be needed each year. Researchers should not bypass trusts and come direct to PCTs for funding. Mr Dhadli commented that medicines management are not aware when these trials are taking place in primary care. Mr Bond responded that links need to be made with Falu Bharmal. The Chair thanked Mr Bond for attending. 6. FROM RDH NHS FT a] SCA for modafanil Agreed: ratified with a 2-year review date. b] SCA for riluzole Agreed: ratified with a 2-year review date and the amendment Originally prepared by Dr A Wills. Reviewed by The Shared Care Guidelines Group, RDH. c] SCA for rivastigmine Agreed: ratified with a 2-year review date. 7. TYPE 2 DIABETES UPDATE Mr Dhadli presented the guideline updated by Dr Tan. All the additions and changes were highlighted in red font. After discussion it was agreed: 1] to put back the insulin cost chart 2] add the dosage regime for metformin used in UKPDS 3] check NICE recommendations on use of liraglutide and confirm that lack of efficacy with exenatide is an appropriate indication 4] put the new HbA1c figures in the algorithm 5] check the reference to a separate flowchart in the algorithm 6] add a reference to the insulin passport. Agreed: Mr Dhadli to make these changes and bring back to the next meeting. Dr Leung asked whether the position of gliptins should now be reconsidered in the traffic lights. It was agreed that as use should still be exceptional they should remain BROWN. Dr Qureshi asked what progress had been made in providing training for GPs in the use of GLP-1 agonists. Mr Hulme responded that two training events had been organised so far and the first was that evening. He would feed back at the next meeting. 8. NPSA SAFETY ALERT NPSA/2011/PSA003 Mr Hulme reported that GPs would be best placed initially to deliver the insulin passports to patients and community pharmacists would have a role checking that patients on insulin had received one. It was noted that the final implementation date was 31 August 2012. Agreed: to be discussed at the prescribing sub-groups SD SH Meds man 4
Agreed: to reference in the type 2 diabetes guideline Agreed: to highlight in the PACE Newsletter SD PB 9. NICE GUIDANCE a] CG 117 - tuberculosis Mr Burrill reported that Diane Harris, Specialist Antimicrobial Pharmacist, had reviewed this document and was preparing an article for the PACE Newsletter in conjunction with the TB specialist nurses. b] CG 118 colonoscopic surveillance for prevention of colorectal cancer No implications noted c] CG 119 diabetic foot problems No implications noted d] CG 120 psychosis with co-existing substance misuse Dr Brownsett reported that it was not anticipated that this guideline would have any impact. e] TAG 219 everolimus for renal cell carcinoma Specialist use received for information f] TAG 220 golimumab for psoriatic arthritis Specialist use received for information g] TAG 221 romiplostim for chronic immune thrombocytopenic purpura The bizarre situation of the discount agreed as part of the PAS being commercial in confidence and how this could be managed in practice was discussed. Requests for this drug would need prior approval. Agreed: romiplostim was classified as RED h] TAG 222 trabectedin for relapsed ovarian cancer Specialist use received for information 10. INSULIN ANALOGUES for information Mr Burrill presented this useful synopsis of the evidence for insulin analogues and recommended that it be proactively promoted to all health professionals involved in the management of people with type 2 diabetes. Agreed: medicines management to promote 11. JAPC BULLETIN APRIL 2011 Ratified with corrections to spelling errors. Mr Hulme to prepare the May bulletin. Meds man SH 12. TRAFFIC LIGHTS ANY CHANGES? Mr Steward presented a request from Dr Searle for NuvaRing to be moved from RED to Green [after specialist initiation]. Currently 7 patients were being supplied by the DCHS sexual health service. Dr Mott highlighted that Dr Searle should have completed the conflicts of interest declaration and not Mr Steward. Agreed: NuvaRing reclassified as Green [after specialist initiation]. 13. ACTION SUMMARY The action summary was discussed and updated accordingly. 5
Mr Dhadli reported that he expected the COPD guideline to be ready for the July meeting. 14. MINUTES OF OTHER PRESCRIBING GROUPS FOR INFORMATION Sheffield Area Prescribing Committee 22/2/11 Sheffield Hospitals MMTC 18/3/11 Derbyshire Healthcare DTC 24/3/11 15. ANY OTHER BUSINESS Mr Burrill noted that Mr Shepherd had in fact not arrived for the meeting at all and hence CRH was not represented. He asked if we could therefore ratify the decisions made today. The Chair recommended informing Mr Shepherd of the decisions made to see if he had any concerns. If he agreed with them then the meeting could be regarded as quorate. : Mr Burrill Post-meeting note: response from Mr Shepherd Decisions all look fine PB 16. DATE AND TIME OF NEXT MEETING Tuesday 14 th June 2011, at 1.30pm in the Parkhouse Room, Coney Green, Clay Cross NB. Papers to Peter Burrill by 27 th May 2011 please 6