EPSOM AND ST HELIER UNIVERSITY HOSPITALS NHS TRUST NEW DRUG AND INTERFACE GROUP

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Bertina Wheeler
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1 EPSOM AND ST HELIER UNIVERSITY HOSPITALS NHS TRUST NEW DRUG AND INTERFACE GROUP MINUTES OF THE MEETING HELD ON WEDNESDAY 12 th June 2013 IN SEMINAR ROOM, 2 ND FLOOR, WELLS WING, EPSOM HOSPITAL Present: Dr V De Silva (Acting Chair) VDS Anne Davies (Chief Pharmacist) AD Dr S Moodie (Consultant Gastroenterologist) SM Dr R Scott (GP, Sutton CCG) RS Dr V Gnanapragasm (GP, Merton CCG) VG Sarah Taylor (Acting Chief Pharmacist, Sutton CCG) ST Liz Clark (Pharmaceutical Adviser, Surrey Downs CCG) LC Anne Lowson (Secretary) AL In attendance: Sumbo Adeyemo (Medicines Management Pharmacist) SA Vanya Slavova Boneva (Medicines Management Pharmacist) VSB Christina Bedford (Medicines Management Technician) Susie Fogg (Administration Coordinator) SF Dr A Rodin (Consultant Diabetologist) AR Dr C Harland (Consultant Dermatologist) CH No Item Responsible for Action 1. Apologies for Absence Dr Sanjeev Patel (Chair) SP Dr G Hayman (Consultant Immunologist) GH Dr M Gardner (Consultant Anaesthetist) MG Sharon Kitcatt (Consultant Nurse Acute Pain Service) SK Susie Mallinder (Lead Renal Nurse) SM 2. Declaration of Conflict of Interest None declared at this meeting. 3. Minutes of the Meeting held on the 10 th April 2013 The minutes were agreed with the following amendments: Page 1 4b should read devices. Page 4 under dexmedetomidine should read avoided. The decision for tapentadol will be amended to read: for use in severe chronic pain in patients with or without a neuropathic pain element who have tried and failed morphine or equivalent opioid. The rest of the decision to remain unchanged. The revised minutes will be resent to the committee. 4. Matters Arising a) SWL Shared Care Prescribing Guidelines for Methotrexate in Crohn s disease ST has prepared a shared care prescribing guideline for methotrexate in Crohn s disease and this will be sent to Dr Moodie for comment. b) NICE Clinical Guideline: Anaphylaxis I. Auto-injector device and education The work for the implementation of the decision is ongoing. c) Colesevelam A draft information sheet for GP s has been prepared by Pharmacy. This will be sent to Dr Moodie for agreement and then forwarded for comment to the other gastroenterologists in Surrey acute Trusts. Ratification will then be required by Surrey PCN. Sutton and Merton CCG s would like the information sheet once available but are happy to prescribe in line with the NDAIG decision until it is ready. Page 1 of 7 SF ST AL/ AL/Dr Moodie/LC

2 d) Fluorouracil with salicylic acid (Actikerall ) The CCG s have discussed the prescribing issues around Actikerall with the GP s. GP s in Sutton and Merton generally felt that they would not be happy to diagnose or re-commence treatment once a specialist had made the diagnosis. Sutton CCG does have GP s with a specialist interest in Dermatology and they may be willing to recommend a treatment to the GP who may then be willing to prescribe. Merton CCG do not have GP s with a specialist interest in Dermatology. Surrey CCG s in Epsom and Dorking have GP s with a specialist interest in Dermatology and patients would be referred to them for a diagnosis. Treatment would be prescribed as appropriate. e) Ulipristal (Esmya ) Sutton and Merton CCG s have advised they are currently not issuing prescriptions for Goserelin for this indication and are therefore unwilling to prescribe ulipristal for uterine fibroids. The option put forward by Surrey CCG s to use FP10 (HP) for a patient to take to a retail pharmacy for 2 months treatment after initial 1 month supply from the Trust is not supported by the Trust. This is mainly because the Trust wish to retain control and monitor medicines issued on FP10 (HP). AD will look into other ways of the Trust obtaining reimbursement. f) Dexmedetomidine Revised protocol is being prepared. This will be taken to the next MMG meeting in July for discussion. g) Balanced gelatin The agreement from all intensivists including those working in EOC is still being sought. However once this is done the implementation plan will be devised and a switch date agreed. This will be followed up at the next MMG meeting. h) Hyperphosphataemia management in chronic kidney disease In line with the NICE Clinical Guidelines recommendation, calcium acetate is the preferred first line phosphate binder and therefore this will be used in preference to calcium carbonate. CCG representatives to feed this information back to colleagues. 5. New Drug Requests a) Insulin Degludec This is the third licensed long acting human insulin analogue and the case for addition to the formulary was made by Dr Rodin. It is suitable as a basal insulin replacement as part of a basal (type 2 diabetes) or basal-bolus (type 1 or 2 diabetes) regimen. It has a long half life (longer than 25 hours) and duration of action which is longer than 40 hours. NICE have published evidence summaries and they see a potential place in therapy in type 1 and 2 patients in reducing nocturnal hypoglycaemia, although there are limitations in the trial data which needs serious consideration. Dr Rodin advised current trial data suggests the absolute difference in nocturnal hypoglycaemia events were small. Further evidence may become available. The potential advantage really lies in the long half life which could potentially allow cover of basal insulin for more than one day. It is licensed for use daily however there are patients who don t use their long acting insulin daily and this can lead to problems including A & E and clinic attendances. Some patients do advise when asked that they omit their insulin injections and reasons include busy lives and time-fixed dosing that does not suit their life style. Insulin degludec may also be useful in patients who require their insulin to be given by a nurse or family member if they are unable to get to the patient at a set time each day. Insulin degludec has been shown to be non inferior to insulin detemir and insulin glargine. Insulin degludec is the first insulin to be available as a 200 units/ml formulation. This has raised safety issues including MHRA guidance to ensure the correct use and to minimise medication error. Risk has been reduced as the flextouch pre filled pen displays the dose in units and it is not available as a cartridge. There is a risk in the hospital setting of a nurse drawing up from a pen. AD/ST/LC Sonia Moore Sonia Moore ST/LC Page 2 of 7

3 Education will be required. The higher strength does allow a patient on a dose greater than 80 units who would otherwise need to administer two injections to just administer one injection. Surrey PCN have not supported the use of insulin degludec routinely so GP s may not maintain treatment. Dr Rodin was advised that he may need to attend the Surrey PCN meeting to discuss his suggested place in therapy. Decision: The committee agreed to the use of insulin degludec in: o Patients who require assistance with administration from health carers who are unable to attend at a fixed time each day to administer insulin glargine/detemir. o 3 rd line after NPH insulin and glargine/detemir for patients with frequent A & E attendances/hospital admissions for hyperglycaemia and diabetic ketoacidosis. o Patients on doses greater than 80 units who would otherwise need to administer two injections. Consultant endocrinologists should initiate treatment and monitor to establish the benefits of using this insulin in terms of A & E attendances/carers/nurses administration etc. Education of patient and carer/district nurse is the responsibility of the Trust clinician. Dr Rodin to attend Surrey PCN to discuss the possible role of GP prescribing if benefit is seen and the patient is clinically stable and has received treatment for at least 6 months. b) Picato Dr Harland presented the case for the addition of Picato to the formulary for the management of actinic keratosis (AK) in adults. It has a novel mechanism of action and has the advantage that it is applied once daily to the affected area for 2 consecutive days for the trunk or extremities and for 3 days if the lesion is on the face or scalp. This is shorter than other licensed topical medicines for this indication. The simple dosing regime makes it easier to explain to patients and the side effects often occur after the treatment is completed which is likely to be beneficial in terms of compliance with treatment. There is no clinical data on the use of more than one course or treatment of an area greater than 25cm 2. It will generally be used for treating AK on the face so this area will not be exceeded. Treatment efficacy is reviewed after approximately 8 weeks. It is currently a black triangle drug. 5 fluorouracil cream is an alternative treatment which is used for an affected area of AK but the adverse reactions e.g. redness and soreness of skin are difficult to manage and it is difficult to explain to the patient how to use it to minimise the side effects. NICE will not be reviewing Picato. Dr Harland stressed that GP s with a specialist interest in dermatology will be key to reducing the referrals and rereferrals to hospital for AK. Renal patients will be screened and monitored by the Trust in line with current practice. If GP s require educational support to help manage patients in the community then the Trust dermatologists are happy to work together with the CCG representatives to provide this. An educational session on AK is planned for Surrey Downs CCG in Oct/Nov. GP s with a specialist interest in dermatology are in Epsom, Dorking and Sutton but not in Merton. Picato will not replace any formulary options, 5 fluorouracil cream and Actikeral for specific lesions will remain on formulary. There is no single recommendation on treatment choice and it needs to be individualised according to clinical presentation, efficacy, morbidity, cost and patient choice. Patient numbers are an estimate. Dermatology has 20,000 referrals a year but it is not known what percentage of these are AK patients. The usage of 5% fluorouracil may give an indication but this is also unlikely to give an accurate reflection. Further information may be available from the directorate. Dr Rodin AL/SA AL/VA Decision: Page 3 of 7

4 To agree to add Picato to the formulary for treatment of actinic keratosis. For use by dermatology specialists only. Hospital to supply initial treatment. Prescribing in primary care to be addressed by discussion with CCG representatives and dermatologists. 6. NICE Guidance Technology Appraisals for discussion a) Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism TA261 CCG s expressed a wish to move this TAG forward. At present the hospital are using the one off drug request process to initiate appropriate patients identified mainly by haematologists. Dr Rice has been trying to arrange a meeting with relevant stakeholders to discuss process and implementation strategy. The committee felt that a working group was needed. Further update at the next meeting. b) Omalizumab for treating severe persistent allergic asthma TA278 Omalizumab will be added to the formulary for use in line with this guidance for severe persistent allergic asthma. Funding will be NHS England but the patients will only be initiated by the Royal Brompton Hospital. (nominated centres only) c) Abatacept for treating rheumatoid arthritis after the failure of conventional disease-modifying anti-rheumatic drugs TA280 Abatacept will be added to the formulary for use in rheumatoid arthritis after failure of conventional disease modifying anti-rheumatic drugs. It will be incorporated into the appropriate pathways. It is PbR excluded and a tick box for submission to the CCG s is available. d) Pirfenidone for treating idiopathic pulmonary fibrosis TA282 Pirfenidone will be added to the formulary for treating idiopathic pulmonary fibrosis. Patient numbers are likely to be small at Epsom and patients at St. Helier are currently entering a co-trimoxazole trial. It is PbR excluded and funding will be via NHS England. The Trust will develop a tick box. Acetylcysteine will be given alongside pirfenidone but it may replace azathioprine in certain patients. e) Macular oedema (retinal vein occlusion) ranibizumab TA283 Ranibizumab will be added to the formulary for treating visual impairment caused by macular oedema secondary to retinal vein occlusion. It is PbR excluded and funding will be via a tick box to CCG s. Internally resource issues have been identified. f) Colistimethate sodium and tobramycin dry powders inhalation for treating pseudomonas lung infection in cystic fibrosis TA276 Discussed at last meeting. g) Mirabegron for treating symptoms of overactive bladder (final appraisal determination) This is a final appraisal document (FAD) and as it stands is favourable. NICE are expected to publish June/July The Trust urologists are interested in using this novel agent and request that should the meeting be cancelled in August then NICE TAG be agreed if positive without waiting until the next meeting in October. The committee agreed to this. Technology Appraisals for information h) Canakinumab for treating gouty arthritis attacks and reducing the frequency of subsequent attacks (terminated appraisal) TA281 This terminated appraisal was noted. i) Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer - TA284 This is not recommended by NICE at present. j) Bevacizumab in combination with gemcitabine and carboplatin for treating the first recurrence of platinum-sensitive advanced ovarian cancer TA285 This is not recommended by NICE at present. k) Loxapine inhalation for treating acute agitation and disturbed behaviours associated with schizophrenia and bipolar disorder (terminated appraisal) TA286 This terminated appraisal was noted. Clinical Guidelines for information Page 4 of 7 Dr Harland Dr Rice/AL AL/ AL/ AL/ AL/ AD AD/

5 l) Social anxiety disorder CG159 Clinical guidelines for information. m) Feverish illness in children CG160 Clinical guidelines for information. 7. Protocols/PGDS/Guidelines For discussion a) NHS Surrey PCN - Pathway for Melatonin No update for this meeting. b) NHS Surrey Shared Care Ivabradine for heart failure This information sheet from Surrey CCG s for the use of ivabradine in selected patients with chronic stable heart failure has been agreed by Trust cardiologists. The committee ratified this document. Trust contacts and logo to be added and document returned to the CCG. c) Apixaban Dr Rice is currently working on a summary document on the Trusts place in therapy for apixaban. Stroke clinicians have a clear position but this needs to be linked with other specialities. The Trust need to devise the initiation and transfer of care documents and a bleeding management protocol. 8. Operational issues a) MHRA Guidance For Information Only I. April 2013 This document is presented for information but particular note to the insulin degludec entry was made as discussed in 5a. II. Medical Device Alert Paradigm ambulatory insulin infusion pumps This alert has been circulated to the diabetes teams within the hospital. III. May 2013 This document was noted. Tolvaptan is not currently on the formulary. The information on thalidomide was circulated to the haematologists. b) Medicines Matters Bulletins For Information Only I. Morphine PCA Switch April 2013 For information the Trust has changed its concentration of morphine PCA syringes and now uses pre-filled fentanyl syringes. c) Prescribing information Sheet for Buccal Midazolam The Trust has previously agreed to switch to the licensed brand of buccal midazolam Buccolam and work has been ongoing on an implementation plan. This has now been agreed with the paediatricians and an information sheet agreed. This was based on the work done by Jayesh Shah for Surrey and Sussex Commissioning Support Unit. New patients will be started on Buccolam and patients currently on Epistatus will only be switched following discussion with patient/carer and education provided. Prescribing will be by brand and doses given in mg and mls, with the presentation also defined. The Trust information sheet was agreed and the first line buccal midazolam in the Trust will now be Buccolam. Confirmation requested by Sutton CCG as to whether this is a hospital only medication. d) Medicines Management Treatment and Devices CQUIN Quarter 4 Report January March 2013 The quarter 4 CQUIN report will be signed off by the chair. e) Terms of Reference Not discussed at this meeting. Information will be provided for the next meeting. 9. Feedback from PCTs a) NHS SWL Sutton & Merton Borough Minutes February 2013 Meeting minutes were noted. b) NHS Surrey Prescribing Clinical Network I. Minutes March 2013 Meeting minutes were noted. II. Minutes May 2013 Meeting minutes were noted. III. PCN Terms of Reference Terms of reference were noted. IV. Guidelines for the treatment of vitamin D deficiency and Page 5 of 7 AL/SA/Dr Rice AL/ SP AD

6 insufficiency in adults Kent, Surrey and Sussex health policy support unit have devised a document for the prevention, investigation and treatment of vitamin D deficiency and insufficiency. The Trust and Sutton and Merton PCT also devised guidance for treatment with vitamin D, which supported the use of Lamberts brand vitamin D tablets 1000 unit which are unlicensed. There are now two licensed oral vitamin D products available Fultium and Desunin both contain 800 units per capsule/tablet. Unlicensed preparations have variable bioavailability and the potential to be costly therefore the licensed preparations are preferred. The Desunin brand is suitable for use in patients with peanut oil allergy and therefore is the Trusts preferred option. The Trusts guideline will be revised with Sutton and Merton CCG s as part of a CQUIN for These guidelines cover treatment rather than insufficiency but statements to be added to cover this situation and the arrangements for prescribing in this clinical situation. Patients should also be educated on what to expect in terms of duration of supply and if it will be prescribed or purchased by the patient. Update at next meeting. NHS Surrey s guidelines were supported by the committee. V. Emollients and soap substitutes NHS Surrey has prepared a review comparing the available emollients and soap substitutes in terms of their preferred choice and cost. The Trust has compared their formulary options with these and currently there are only small savings to be made by switching. It was felt that the switch if required would be best made by the GP where ongoing supplies are made. The Trust will maintain its current formulary options and the Prescribing Clinical Network (PCN) informed of the discussion. VI. Mesalazine 400mg MR preparations in Ulcerative Colitis Dr Moodie and fellow gastroenterologists have discussed the proposed switch to Octasa 400mg and 800mg tablets by Surrey PCN. They have reviewed the currently available data and support the initiation of new patients on Octasa. Treatment will be continued for patients currently on Asacol. Pentasa and Mezavant will remain on formulary. VII. Aflibercept for wet age-related macular degeneration This recommendation was noted. A NICE TA is expected August VIII. Febuxostat for gout The Trust rheumatologists support this guidance and the use of febuxostat in line with NICE guidance. IX. Plenadren (hydrocortisone tablets) for adrenal insufficiency The Trust endocrinologists have been made aware of this guidance. It is not currently on the Trust formulary and therefore only available via the one off drug request process. X. Probiotics for clostridium difficile associated diarrhoea The Trust microbiologists support this stance and do not routinely recommend the use of probiotics in prophylaxis or treatment of clostridium difficile. XI. Retigabine for epilepsy Retigabine is already on Trust formulary in line with NICE guidance so support this PCN statement. However, the European Medicines Agency have recently issued guidance to restrict its use to last line therapy in partial epilepsy due to the risk of retinal pigmentation. This guidance has been circulated to the CCG and Trust neurologists. XII. Wound care formulary The Trust tissue viability nurse specialist has seen the Surrey wound care formulary and supports the general principles. The formulary was noted. XIII. Yasmin combined oral contraceptive This guidance was noted as supplies of oral contraceptives are made to the family planning clinics. XIV. Apixaban for stroke prevention in atrial fibrillation See 7c. The Trust are still working on the implementation of apixaban and until this work is complete are unable to ratify this guidance. SP/AD AL/ Page 6 of 7

7 XV. Long acting muscarinic antagonists in COPD The Trust respiratory physicians are aware of this guidance but at present have not requested the addition of glycopyrronium (Seebri Breezhaler ) or aclidinium (Eklira Genuair ) to the formulary. Until these are reviewed formally patients will not be initiated on these treatments. A recent article in the Drug and Therapeutics Bulletin will be considered when the drugs are discussed. 10. Any Other Business LC will be having discussions with AD about key performance indicators. Feedback at a future meeting. 11. Date of Next Meeting: Wednesday 9 th October 2013, pm, Pink Room, Ground Floor, St. Helier Hospital LC/AB Page 7 of 7

EPSOM AND ST HELIER UNIVERSITY HOSPITALS NHS TRUST NEW DRUG AND INTERFACE GROUP

EPSOM AND ST HELIER UNIVERSITY HOSPITALS NHS TRUST NEW DRUG AND INTERFACE GROUP MINUTES OF THE MEETING HELD ON WEDNESDAY 12 TH FEBRUARY 2014 IN THE BOARDROOM, GROUND FLOOR, ROWAN HOUSE, EPSOM HOSPITAL