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Peterborough Hospitals Formulary and Medicines Management Committee Minutes of the meeting held on Thursday 17th September 2015 Room 4 Learning Centre, 4th floor, PCH There were no declarations of interest with regard to items discussed. In Attendance: Dr C Gardner Mrs C McIntyre Mrs A Ritchie Mrs S Mavani Deputy Medical Director – Chair Chief Pharmacist – Deputy Chair Pharmacist Team Manager Procurement and Formulary - Joint Secretary Pharmacist Team Manager Medicines Governance – Joint Secretary Ms K Broad Specialist Pharmacist – C&PJPG/HCD, Cambridgeshire and Peterborough CCG Consultant Paediatrician Consultant Oncologist (from 12.55 onwards) Pharmacy Technician-Higher Level Consultant Microbiologist Interface Lead Pharmacist, Greater East Midlands Commissioning Support Unit. Lead Pharmacist, Peterborough and Borderline LCG Dr D Woolf Dr C Jephcott Mrs S Milne Dr D Mlangeni Ms C Johnson Mr K Claire Minute Taker: ML Denton, PA to Chief Pharmacist 15/39 Apologies for Absence: Dr R Mittra Mr A Massraf 15/40 Consultant in General Medicine Consultant Orthopaedic Surgeon Minutes of the Formulary and Medicines Management Meeting held on Thursday 16th July 2015. The following changes were requested: 15/17 2nd sentence - “Medicines” to be changed to “Medicine” 15/31 1st sentence – “urticarial” should be “urticaria” 15/37.5 “Dexamehasone” should be spelt “Dexamethasone”. Once these amendments are made, the minutes are agreed as a true record of the meeting. 15/41 Matters arising from the minutes: 15.16.13 Guidance for Post-operative Analgesia after Day-case Arthroscopic Shoulder procedure. Still awaiting confirmation that the leaflet has been approved. If Lesley Crosby confirms approval the policy is approved. 15/27.4: Protocol for the Prescribing and Administration of Tecfidera (Dimethyl Minutes of Formulary and Medicines Management Committee September 2015 Page 1 of 8 Fumarate) This is still being looked at by C Semple and the specialist pharmacist. ACTION: To be deferred to the next agenda. 15/27.8 Peripheral Venous Cannulation in Babies, Children and Young People Guideline: this needs to be chased as it has not been sent back to SMavani. There were only minor changes to be made. 15/31: Discussion took place about concerns over NICE Technology Appraisals that cannot be fully implemented in the Trust. It is likely that it will be agreed that rifaximin can be prescribed by GPs in Cambridgeshire and Peterborough CCG following specialist initiation. 15/36 Reports from Groups and Subcommittees: information will need to be pulled together from these groups to inform the Committee. Some may be removed if no longer active; to be discussed later in the agenda. 15/37.3 Antibiotic Prescribing: if this is new prescribing it must be shared. No feedback has been received from N. Phillimore (pharmacist). 15/37.5 Dexamethasone: a poster is being worked on to explain the confusion in different strengths and to be taken to the Medication Safety Committee for approval 15/42 15/26 Chair’s Approval given from cancelled meeting from March 2015. There is a need for the outstanding decisions to be agreed and documented. New Drug Requests: Colesevalm and Linaclotide; the quality of the submissions and evidence provided was poor. Dr Das had not responded to Mrs Ritchie’s email explaining concerns over the submissions in the format presented or asking who would be coming to the original meeting to present the case. Mrs Ritchie to email again. . Outcome: Not approved. Glaucoma eye drops and glaucoma protocol: only to be used if problems with compliance or true allergy. Will be added to formulary where appropriate. Outcome: Approved Clinical Guideline given Chair’s Approval Clinical Guidelines Pre-conceptual care for women with Diabetes. Outcome: Approved Guidelines and Policies Disease Modifying Therapy Care Pathway Multiple Sclerosis Service. Policy not approved, issues addressed with the author and the Policy is with her now. Outcome: Referred back to author. Not approved. Guidance for Post-operative Analgesia after Day-case Arthroscopic Shoulder Procedures: this is still on-going and will need to be chased. Outcome: not approved Guideline for the Management of Sedation, Analgesia and Delirium in the intubated Adult Patient within the Critical Care Unit: On agenda Guidelines for the Management of patients on Warfarin or Clopidogrel undergoing all endoscopic procedures: this had been withdrawn and the author has now left. To be taken to Sunny Nair. Minutes of Formulary and Medicines Management Committee September 2015 Page 2 of 8 Guidelines for the use of Variable Rate Intravenous Insulin Infusion (VR 111) in Adult Inpatients: Chair’s Action was given. Outcome: Approved Guidelines for the Management of Carotid Artery Rupture in Patients with Advanced Head and Neck Cancer: Chair’s Action was given. Outcome: Approved Policy for the Management Deep Vein Thrombosis (DVT) Nurse Led DVT Clinic: Outcome: not approved - on the agenda. Guidelines for the Therapy of Fungal Infections in Adults: Guideline approved at July 2015 meeting, sent to the Chair for QA to be signed and forwarded to Caroline Sykes. Outcome: Approved Guideline for the Use of Granulocyte Colony Stimulating Factors (G-CSF: Guideline approved at July 2015 meeting. Outcome: Approved NICE Technology Appraisals: confirmed addition to Formulary for appropriate products. NICE technology appraisal guidance TA 329 - Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy. NICE technology appraisal guidance TA 330 - Sofosbuvir for treating chronic hepatitis C. NICE technology appraisal guidance TA 331 - Simprevir in combination with peginterferon alfa and ribavirin for treating genotypes 1 and 4 chronic hepatitis C. NICE technology appraisal guidance TA 332 - Sipuleucel-T for treating asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer. Not recommended. NICE technology appraisal guidance TA 333 - Axitinib for treating advanced renal cell carcinoma after failure of prior systemic treatment. NICE technology appraisal guidance TA 334 - TA 334 - Regorafenib for metastatic colorectal cancer after treatment for metastatic disease (terminated appraisal). 15/43 Moviprep v Citramag/Senna: Discussion took place regarding why Citramag and Senna was stopped as it is more effective than the Moviprep and there is less risk. Naveen Kumar presented the data around the effectiveness of Moviprep vs Citramag and Senna. Other hospitals have not had an issue with Moviprep as they were previously using Picolax which is not very good anyway. Citramag and Senna PGDs will need to be unarchived. Any Moviprep stock is to be used up. Checks will be made as one hospital is supplying without an overlabel. Outcome: Citramag and Senna to replace Moviprep. Peppermint water – the Chair decided that this could be added to the formulary to prevent spasms during colonoscopy. The product is an unlicensed medicine and therefore the processes in the Policy for Unlicensed Medicines will need to be followed. Minutes of Formulary and Medicines Management Committee September 2015 Page 3 of 8 Special solution for lifting polyps: Naveen Kumar also discussed the issue around preparing methylene blue and adrenaline in a special solution for lifting polyps. C.McIntyre raised concerns that this is not a stable product and will look into this. Action: CMc 15/44 Formulary Items given Chair’s Approval, New Drug Requests and Updates 15/44.1 Levofloxacin eye drops: Miss Ramirez Florez explained the reasons for wanting this product to be available. There were concerns regarding infections and it was agreed that a little ciprofloxacin should be kept in stock as a 3rd line treatment. Outcome: Levofloxacin eye drops were approved. Ciclosporin eye ointment/drops: this product has been in use for 12 years for severe dry eyes, allergic conjunctivitis and similar problems. The product used has not been licensed for human use. There is now a licensed eye drop on the market and NICE is producing a TA, the consultation papers suggest that it will not be recommended. Outcome: Ciclosporin eye drops have been approved. 15/44.2 Proposal to remove Tripotassium dicitratobismuthate (De-noltab) from the formulary with immediate effect: this will be discontinued at the end of year, none has been used for two years. Outcome: Tripotassium dicitratobismuthate (De-noltab) can be removed from the formulary. 15/45 Horizon Scanning: New Drugs Online newsletter July 015 and NICE Technology Appraisals in Development expected publication September 2015 to February 2016. Each year the Trust is expected to predict the amount of spend on tariff excluded drugs for the following year. This will tie up with the data from Guy Sabbagh. Specialists and directorate pharmacists plus more information which can be obtained from coding. The Senior Clinical Leadership Team in Pharmacy will liaise with consultants. It was agreed that it would be useful to receive these documents on a regular basis. 15/46 Trust policies and guidelines for approval 15/46.1 Policies given Chair’s Approval 15/46.1.1 Hepatitis Policy: this policy has been amended but unfortunately the changes are tracked. This policy to be given Chair’s approval when the final version is available. Final version has been made available via S Mavani and has been approved by Callum Gardner Outcome:Policy approved 15/46.2 Guidelines for the safe withdrawal of Corticosteroids after long-term use: this item was discussed. Prolonged use is 3 months or more. Make sure main specialisms know about the guidelines. It was suggested it should contain a one liner to explain what a Synacthen test is. Outcome: approved 15/46.3 Guidelines for Glycaemic Control during Contrast Angiography: these are old guidelines which now require reviewing. A number of changes were requested such as referring to combination preparations with metformin also. Approval committee should be changed to FMMC. Outcome: approved with changes . Minutes of Formulary and Medicines Management Committee September 2015 Page 4 of 8 15/46.4 Nutritional Guidelines for adults in Critical Care: this document is again for reviewing. There are no major changes or changes in drugs but this must be recorded as being for over 18s only. The amended document must come back to the Committee. Outcome: approved with changes 15/46.5 Guideline for the Use and Administration of Intravenous Iloprost for Raynaud’s, Severe Peripheral Arterial Occlusive Disease and Buerger’s Disease: this document is approved with changes. Outcome: approved with changes – not seen yet. Needs to be chased 15/46.6 Guideline for the management of Sedation, Analgesia and Delirium in the intubated adult patient within the CCU: a number of amendments are needed. Outcome: approved subject to changes – need to be chased. 15/46.7 Guideline for the Management of Children and Young People with Diabetic Ketoacidosis: Dr McDevitt explained that NICE has changed the fluid rates and these would need changing. The committee raised concerns that that the guideline suggested making products titled 0.45% sodium chloride/ 10% glucose and 0.9% sodium chloride / 10% glucose with solutions containing potassium. This needs to be changed. Mrs Ritchie explained that 0.45% sodium chloride with 10% glucose is already bought in for paediatric use and that it could be possible to buy in the 0.9% sodium chloride with 10% glucose; she will confirm this is still available and inform Dr McDevitt. Outcome: approved 15/46.8 Seizures in Neonates-Guideline for Management: Outcome: approved 15/46.9 Percutaneous Endoscopic Gastroscopy (PEG) Feeding Tube Placement Pre and Post Insertion Care and Management Procedure: this is a procedural document regarding administration of medication through tube. There are 2 other policies on SharePoint, could these all be combined? A section needs to be added regarding seeking the opinion of a member of the microbiology team. Outcome: Not approved. 15/46.10 Pain relief advice document: there was discussion regarding this document and concerns regarding nursing staff translating the doses into mls rather than this being done by the doctors. Discussion took place as to whether this would be classed as transcribing It was finally agreed that the doctors would write the dose in mgs in the drug chart and fill in the information sheet in mls; the calculation of which will be checked by the nurses and countersigned. The prescribers name must be added for the audit trial. Outcome: the document was approved as long the procedure was carried out as described. 15/46.11 Citrate Haemofiltration Prescription & Monitoring Chart: discussion took place and it was agreed that all the drugs need to be on one chart. Saline should be changed to sodium chloride. The chart is to be sent back for amendment. Outcome: not approved 15/46.12 Guidelines for the Management of Anticoagulant reversal in Adults: a number of changes were requested and the advice given is currently different to that on the anticoagulation drug chart. Not to be used until pink chart is revised and updated. Callum Gardner to email Sateesh Nagumantry regarding this action Action: CG Outcome: To be put on hold Minutes of Formulary and Medicines Management Committee September 2015 Page 5 of 8 15/46.13 Policy for the Management of Deep Vein Thrombosis (DVT) Nurse Led Clinic: a number of minor changes were requested. Outcome: approved with changes 15/46.14 Misoprostol-General Risk Assessment: 15/47 Outcome: approved NICE Technology Appraisals published July and August 2015: TA345 Naloxegol for treating opioid‑induced constipation: not yet is use; added to formulary for this indication. TA346 Aflibercept for treating diabetic macular oedema: a different drug used for this condition, added to formulary for this indication. TA347 Nintedanib for previously treated locally advanced, metastatic, or locally recurrent non‑small‑cell lung cancer: added to formulary for this indication. TA348 Everolimus for preventing organ rejection in liver transplantation: Not needed in this Trust as transplants not done here. TA349 Dexamethasone intravitreal implant for treating diabetic macular oedema: a different drug used for this condition. Added to formulary for this indication. TA350 Secukinumab for treating moderate to severe plaque psoriasis added to formulary for this indication. TA351 Cangrelor for reducing atherothrombotic events in people undergoing percutaneous coronary intervention or awaiting surgery requiring interruption of anti‑platelet therapy (terminated appraisal). TA352 Vedolizumab for treating moderately to severely active Crohn's disease after prior therapy: added to formulary for this indication. TA353 Bevacizumab for treating relapsed, platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal cancer (terminated appraisal). TA354 Edoxaban for treating and for preventing deep vein thrombosis and pulmonary embolism: added to formulary for this indication. Information is needed from Clinical Audit team who ask the directorates about their adherence to NICE. Without information from clinicians it is not possible to predict the amount used; the commissioners require this information. There needs to be a robust system/process in place. The Chair suggested that Dr Sabbagh attends future meetings. (C Jephcott left at 3.05) 15/48 NICE-Medicines Management Guidance There are problems with getting guidance as baseline assessments are not being returned to Guy Sabbagh and his team. There are 3 recent medicines management NICE guidelines: Medicines Optimisation Medicines Adherence Drug Allergies Minutes of Formulary and Medicines Management Committee September 2015 Page 6 of 8 There needs to be a medicines adherence discussion between clinicians and patient. Discussion took place as to whether this should be a pharmacy issue or use pharmacy as a safety net? It was agreed that there should be further discussion on how to take this forward; possibly with individual team governance meetings. However it is the responsibility of clinicians to ask patients if they are taking their medications. C.McIntyre will put something together to go out to Governance Meetings. Action: CMc 15/49 QIPP / CIP initiatives This will be picked by the new Pharmacy Clinical Leadership Group. 15/50 Unlicensed Medicines Update N.Phillimore asked that Chlorapep be discussed as we currently use an unlicensed product. However, Dr Gardner requested this not be discussed because of a Datix he had received. 15/51 Reports from Groups and Subcommittees: 15/51.1 Antibiotic Prescribing Group: This group continues to meet and is planning an Awareness Day in November with activities, teaching and education sessions for junior doctors. The minutes of meetings to be sent for information (S Oyibo left at 3.15). 15/51.2 Medication Safety Committee (Safer Prescribing Group): Prescribing errors need to feed back to actual prescriber. With regard to having a “duty of candor”, if patients are given wrong the drug then we should be telling them even if it does them no harm. Datix need to be actioned in regard to patients. 15/51.3 IVIG demand management panel: Although needed a meeting has not been held for some time. A.Ritchie to check if there is a requirement for this group to report to the Committee. Action: AR 15/51.4 Thrombosis Committee: there have been a lot of discussions on VTE assessments. Paper risk assessment done by the doctors would be best. The Trust is currently failing on VTE assessments because they are not being done on-line and this results in fines. An electronic tick box to inform then national return would be helpful. Also the new Maternity system that does not talk to current system. 15/51.5 Oxygen Committee: no meeting to report on, next due in October. 15/51.6 C&PJPG : takes place next week. 15/51.7 NMAG: S.Mavani is working on Cquin for omitted medicines. The Chair suggested that the highlights of each meeting should be presented as a summary to this meeting. It needs to be agreed who should do this and also resolve the difficulty of obtaining the minutes from each meeting. 15/52 Future format of the Formulary and Medicines Management Committee Meetings: CMcIntyre went through the proposed future agenda. NPSAs should be on the agenda. Also MHRA safety alerts and pharmacy audits. Any policies to go through a named pharmacist first to ensure policies are ready Minutes of Formulary and Medicines Management Committee September 2015 Page 7 of 8 to go to the Committee. It is not the Committee’s role to make these changes. Pharmacists will liaise with policy writers etc and sign off policies as appropriate. It was proposed that a new front page with signatures, similar to that on PGDs should be put on the front page of the policies. A checklist to go in the policy for policies. Pharmacists will then present any new policies etc; not the consultants. Formulary applications: there should be joint responsibility with the pharmacist and clinicians to produce applications and the pharmacist will present the applications at the meetings. However this process must be clinician led with support by pharmacists. Senior Pharmacy Clinical Team will have training to enable them to assist. Medicine optimisation (cost of drugs, review of formulary is important; cost effective use of drug budget) should be looked at. Speak to Guy Sabbagh regarding representation. Any other ideas regarding the formula of the future meetings please pass on to CMcIntyre. 15/53 Drugs added to infusion labels. It was agreed that the colour of the infusion labels could be changed. 15/54 Any Other Business Internal auditors: will be looking at Medicines Management and Controlled Drugs. The committee was asked to approve a minor change to the policy. This states that TTO CDs if not going to be taken home straight away by patients should be locked away and this information recorded in the “appropriate register”. Outcome: Above minor change to the Controlled Drugs policy agreed. 15/55 Date of Next Meeting: Thursday,12th November 2015, 12.45pm Pharmacy Seminar Room, First Floor, PCH Minutes of Formulary and Medicines Management Committee September 2015 Page 8 of 8