LANARKSHIRE AREA DRUG & THERAPEUTICS COMMITTEE. PRESENT: Dr Stephanie Dundas Mr George Lindsay

Transcription

1 LANARKSHIRE AREA DRUG & THERAPEUTICS COMMITTEE Minute of the meeting held on Wednesday 20 th April 2011 at 10.00am in the Board Room, 14 Beckford Street, Hamilton. PRESENT: Dr Stephanie Dundas Mr George Lindsay Ms Dawn Farmer Mrs Gail Richardson Ms Linda Johnstone Dr Vijay Sonthalia Ms Frances Leckie Mr Alastair Thorburn [Chair] 2011/46 Apologies Dr Philip McMenemy, Ms Fiona Graham, Mrs Christine Gilmour, Dr Kolin Ooi, Dr Alwaly Majumdar, Dr Lewis Vickers, Ms Karen Patterson (rep by Dawn Farmer), Dr Harpreet Kohli, Mr John Milne, Ms Susan Stewart, Dr Robert Brogan Action 2011/47 Minute of previous meeting The minute of the previous meeting held on 16 th March 2011 was accepted as a true record. 2011/48 Matters arising from the previous meeting (a) Lithium monitoring update GL reported that Memo Langa is leading on this and guidance across all aspects of the service is expected soon. (b) Dabigatran - update There was a wide ranging discussion about the importance of this issue and general agreement with s suggestion that there should be a specific working party established for the management introduction of this medicine, with leadership coming from a senior medical person. (c) Diabetes MCN Management of Painful diabetic Neuropathy reported that he had had communication with Dr S Arnott who had promised to take on board the committees comments about this issue. It was agreed that the ADTC would review the final copy of the guideline before it was issued. (d) Diabetes MCN Guidelines for the administration of insulin by nursing staff GR reported that she had had discussion with Helen Alexander about this issue. also reported that he had received an update from Helen but since this had been received only late last night it was too late to discuss at this meeting. It will be circulated with the next agenda. (e) ALERT Antibiotic document SD indicated that she had asked Medical Illustration to modify the formatting of the wording of the antibiotic policy and there had been a change in the wording due to the withdrawal of a particular antibiotic. It is expected to be implemented in May with a formal launch meeting in each hospital. (f) Care Homes Epilepsy Care Plan VS reported that he had found the feedback very helpful and had amended the document accordingly. He sought agreement that it can now be published on FirstPort and this was agreed. (g) ADTC Membership reported that Mr James Smith will join the committee as a Lay member from May It was also reported that had followed up committee members with a low or zero attendance over the past year and established that an improvement in attendance is expected. Additionally, a community pharmacy representative will be discussed at the Area Pharmaceutical Committee on the 4 th May /49 Electronic Prescribing This item was deferred to the May meeting. It was noted that there is a current project ongoing in Care of the Elderly at MDGH with regard to electronic immediate discharge letters. GL CG 1

2 2011/50 Scottish Medicines Consortium Advice (a) Full submissions: 1. Tocofersolan (Vedrop ) Orphan Europe UK (No 6961/11) Not Recommended tocofersolan oral solution (Vedrop ) is not recommended for use within NHS Scotland. Indication under review: vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region. In an open-label, single-arm study, 96% of patients had an improved or stable neurological score after 2.5 years of treatment with tocofersolan. The manufacturer did not supply any economic analysis therefore the cost-effectiveness could not be assessed. 2. Iron Isomaltoside (Monofer ) Pharmacosmos UK (No 697/11) Accepted: Restricted iron isomaltoside 1000 (Monofer ) is accepted for restricted use within NHS Scotland. Indication under review: Treatment of iron deficiency anaemia in the following conditions: When oral iron preparations are ineffective or cannot be used; Where there is a clinical need to deliver iron rapidly. SMC restriction: use is restricted to administration by high dose infusion within the licensed indication but excluding use in patients receiving haemodialysis. The manufacturer s economic case did not consider the cost-effectiveness of iv bolus administration or use in haemodialysis patients. Efficacy data are limited to two small open-label non comparative studies in patients with chronic kidney disease and chronic heart failure. Haemoglobin levels significantly increased from baseline in one study only. 3. Sunitinib (Sutent ) Pfizer Limited (No 698/11) Accepted sunitinib (Sutent ) is accepted for use within NHS Scotland. Indication under review: Treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. Treatment with sunitinib improved progression free survival compared with placebo in patients with well-differentiated neuroendocrine carcinoma of the pancreas who were receiving best supportive care, including somatostatin analogues if required for symptomatic control. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of sunitinib. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland. 4. Ticagrelor (Brilique ) AstraZeneca (No 699/11) Accepted ticagrelor film-coated tablets (Brilique ) are accepted for use within NHS Scotland. Indication under review: co-administered with aspirin, for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non ST elevation myocardial infarction [NSTEMI] or ST elevation myocardial 2

3 infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG). As dual therapy with aspirin, ticagrelor demonstrated a significant reduction in ischaemic events compared with another antiplatelet drug without significantly increasing the incidence of study-defined major bleeding. Alternative treatments are available at a lower drug acquisition cost. (b) Resubmissions 1. Quetiapine (Seroquel) AstraZeneca (No 549/09) Not Recommended quetiapine (Seroquel/Seroquel XL) is not recommended for use within NHS Scotland. Indication under review: Treatment of major depressive episodes in bipolar disorder. In monotherapy studies quetiapine was superior to placebo and compared favourably with two active comparators. Efficacy relative to current practice for the management of depression in the framework of bipolar disorder in NHS Scotland involving combination therapy with a mood stabiliser or an atypical antipsychotic plus an antidepressant was not demonstrated. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Quetiapine (Seroquel/Seroquel XL) is also licensed for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment. The manufacturer s submission related only to use in the treatment of major depressive episodes in bipolar disorder. Therefore, SMC cannot recommend its use for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment. reported that Dr El-Nujumi will now be an NHS Lanarkshire representative on the SMC and Dr Guthrie Blackhurst and Alastair Thorburn will be NHS Lanarkshire representatives on the NDC. (c) Non submissions 1. Tadalafil (Adcirca ) Eli Lilly and Company Limited (No 710/11) Not Receommended tadalafil (Adcirca ) is not recommended for use within NHS Scotland. Indication under review: for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. 3

4 2011/51 NICE Technology Appraisals / NHSQIS Comments on Guidance MTA no 217 Alzheimer s drugs It was agreed that will write to Dr Alastair Cook (and copy to Rob Brogan and Francesca Aaen) seeking Alastair s advice on the implications of this MTA for Mental Health Services in NHS Lanarkshire. In particular, Alastair will be asked to comment if there is likely to be any change in criteria for establishing patients on cognitive enhancing medicines consider what implications this may have for the drug budget consider what implications this may have for workforce in terms of ongoing follow up care 2011/52 Drug & Therapeutics Bulletin (BMJ Group) Vol 49 No 4 April 2011 Circulated for info. 2011/53 ADTC Bulletin No 44 March 2011 and No 45 April 2011 Circulated for info. 2011/54 Clinical Protocols for the Introduction of New Drugs (a) Policy for the Availability of Unlicensed Medicines There was a debate about the draft paper and members are requested to put their individual comments back directly to CG. (b) Primary Care & Hospital Policy on the Unlicensed use of Fosfomycin There was a useful discussion where it was agreed that the fosfomycin information sheet could be enhanced by including adverse drug reaction information and alternative supply information for community pharmacists e.g. the fact that it may be possible to get this from the hospital pharmacy if there is an urgency e.g. over the weekend etc. SD will work with Steve McCormick to amend these documents. 2011/55 Lanarkshire Formulary Update (a) Appeals - Nil (b) Deletions Nil (c) Additions Nil (d) Formulary section review updates Wound Management Formulary reported that the WMF had been updated and is expected to be launched in May 2011 with a series of Road Shows and targeting community nurses and care home staff. A mechanism to audit compliance with the formulary is also being established. (e) Formulary amendment request Nil (f) SMC submission feedback from specialist sub groups - Nil ALL SD 2011/56 Medication and Clinical Risk in Lanarkshire 1. Medication incident reporting Nil 2. NPSA reports Preventing fatalities from medication loading doses No feedback as yet from the Clinical Quality department about who will lead on this work. GR reported that the issue had been discussed with Dr Malekian and Susan Stewart within the Acute Clinical Governance Group. 3. MHRA Update April SD reported that following this update a review of all patients on stavudine is under way. It is expected that there will be less than 10 patients on stavudine and each will be reviewed individually to see if they can be switched to an alternative treatment. 2011/57 Regional Cancer Prescribing Advisory Group Nil 2011/58 Correspondence (a) A new value-based approach to the pricing of branded medicines: a consultation The SMC response to this consultation had been circulated with the minutes and was noted. (b) Ticagrelor in PLATO The information from this study has been circulated with the minutes and was noted. (c) Nitrofurantoin and Renal Impairment SD spoke to this issue which gave confidence that the local guidance indicating that it s reasonable to use nitrofurantoin in patients whose CrCl is greater than 20ml/min is useful. 4

5 It was also considered that it would be useful if a hyperlink to the evidence supporting this judgement could be made available via the Antibiotic Policy. (d) Linezolid use in primary care A small amount of linezolid is used in primary care but with this being an ALERT antibiotic there is a concern that the appropriate procedures will not always be followed. The cast iron way of ensuring that ALERT antibiotic procedures are followed is to make sure that the medicine is only dispensed in hospital pharmacies and given the low level of prescribing of this medicine this was thought to be the most likely option. Before that decision is finally ratified, will do a PRISMS audit on the use of linezolid and share that with the Antibiotic Management Team. (e) Quality of hospital immediate discharge letters and prescriptions Concerns of a number of GPs were noted. However it is clear that a considerable amount of work is being undertaken at a senior level in the acute division to improve the quality of discharge information sent to GPs. 2011/59 AOCB 1) Publication of Clinical Protocols There was a debate about the value of publishing approved clinical protocols on a website. This was agreed in principle but there is uncertainty about how to put this into practice in a sustainable way, especially considering that Medical Education, which currently hosts drugs and prescribing information on their website, is unlikely to be sustained in the long term. Further consideration needs to be given as to how best to do this. 2) Communicating the Urgency of Outpatient Prescribing VJ raised the issue of the potential value of having the statement about non urgency put on the prescription forms rather than on the envelopes. GR indicated that she will keep an eye on the run down of the stationery with a view to putting this statement on when the next print run is due. 3.) Prescribing of Tacrolimus by Brand indicated that there will be a communication to primary care prescribers to emphasise the importance of brand prescribing of tacrolimus following receipt of advice from the transplant unit at the Western Infirmary in Glasgow. New formulations of tacrolimus are now available and they are not interchangeable therefore prescribing by brand name is recommended. 4.) I Phone App for NHSL Joint Formulary indicated it may be possible to develop an app for the local formulary and asked if the committee would be interested in receiving a presentation on this issue. This was welcomed. 2011/60 Date of next meeting The next meeting will take place on Wednesday 18 th May 2011 at 10.00am in the Board Room, Ground Floor, Kirklands Hospital GR 5