Date of Next Meeting: Wednesday 10Th April 2013 9Am-12Noon Room 4, QEH Education Centre

Gateshead Medicines Management Committee

13th February 2013 0900-1200 Room 6, Education Centre QEH

Attendees: Consultant Anaesthetist, Gateshead Health NHS Foundation Trust (Chair) Consultant Microbiologist, Gateshead Health NHS Foundation Trust Prescribing Lead, Gateshead Clinical Commissioning Group (Vice-Chair) GP (Primary care prescriber) Chief Pharmacist, Gateshead Health NHS Foundation Trust Senior Pharmacist NECS Medicines Governance Pharmacist, Gateshead Health NHS Foundation Trust (Secretary) Community Pharmacist Prescribing Representative, Gateshead Community Services Regional Drug & Therapeutics Centre (Newcastle) Advisor Primary Care Medicines Management Provider

Apologies: (item 1) Head of Commissioning Medicines Management, NHS SoTW

Item 2 Declaration of Conflict of Interest With Any Agenda Items Discussion: No-one present had any interest to declare with today’s agenda items. Item 3 Notes of meeting on 28th November 2012 Enc 1 Discussion: Minutes agreed as a true record. Item 4 Ongoing Action Points Enc 2 Discussion: Circulated for information. SC Methotrexate – agreed business case not really required as no different to use of drug for rheumatology provided patients are taught to self-administer. Need an indication of patient numbers. Item 5 Matters Arising Enc 3-5 Discussion: a) Dekristol to ProD3 switch – updated version Vit D supplementation guideline was approved with suggested comments made by those present being included. b) SoTW Dermatology Specials Guidance – guideline was approved. General policy of not prescribed products that do not appear on BAD list in Gateshead also agreed. c) Gluten Free Product Supply – update of current progress circulated for information. Work still ongoing. d) Pramipexole MR New Drug Request – no further progress to report. e) Shared Care Prescribing Policy in SoTW – final policy & A-Z list of drugs approved. Noted that implementation pack is being developed to roll this out to each individual GP practice. Some concerns about new system for amber drugs still remain in secondary care and a group is being formed to address these. Memantine & Acetylcholinesterase leaflets were approved to support their transition from amber to Green+ status. f) Needles for Insulin Pens – RDTC have now done an evidence to search to support drive to use shorter needles. AMB will now discuss with Diabetes Nurses and develop a recommendation as to which needles should be used with which pen. Noted there is also a drive now to introduce needle safety devices to prevent needle stick injuries which may have cost implications, as such will need a formal request to GMMC before their use can be endorsed/approved. g) GMMC Revised New Drug Approval Process – still waiting for final decision to approve interim GMMC New Drug Approval Process by CCG, as new committee structure in Gateshead CCG not yet in place. The CCG wishes to keep the status quo with regard to new drug approvals but where possible undertake joint working regionally to do some things once e.g. implementation of specific drug safety alerts. An operational sub- group of GMMC to meet in the alternate months to GMMC is also being considered. Item 6 New Drug Requests for February 2013 Meeting Discussion: Tigecycline injection Requested by Dr Horne (Note Dr Horne took no part in discussion or decision for this agenda item) Requested for use in complicated skin & soft tissue infections, excluding diabetic foot infections, and complicated intra-abdominal infections in adults on advice of microbiologist only. Evidence presented as per application form. Reviews:  NICE – not considered  SMC – not considered  AWMSG – not consider  RDTC – not considered  LNDG – not considered  MTRAC – not considered  NETAG – not considered  NoT APC – approved.

DNase / Alteplase – Dr Curtis in attendance

Requested by Dr Curtis for use together for intra-pleural use in empyema and complicated parapneumonic pleural effusion (pH <7.2). Evidence presented as per application form. Reviews:  NICE – not considered  SMC – not considered  AWMSG – not consider  RDTC – not considered  LNDG – not considered  MTRAC – not considered  NETAG – not considered  NoT APC – not considered This drug combination is also use by Northumbria Hospitals for this indication. Noted that this combination & indication would be an unlicensed use of these two drugs. Would particularly like to use as an alternative to streptokinase in ITU patients to avoid surgery.

Inadine – Mr Patterson in attendance

Requested by Mr Patterson for use in ankle/foot surgery. Evidence presented as per application form. Reviews:  NICE – not considered  SMC – not considered  AWMSG – not consider  RDTC – not considered  LNDG – not considered  MTRAC – not considered  NETAG – not considered  NoT APC – not considered Would like to use in wounds with potential for sepsis after surgery, to prevent wound deteriorating and therefore requiring further surgery. Currently using mepitel or soaking gauze in betadine which is more expensive than inadine. Meptiel does not have any anti-infective properties. Generally applies inadine for 1 week under plaster cast and would not be applying more than 2 dressings. To date as not seen an adverse reactions to inadine in his practice. Use of inadine for this indication is common practice amongst orthopaedic surgeons in the UK. All dressing changes for foot/ankle surgery are managed in secondary care so this request would have no impact on primary care. Noted that inadine is currently used in community by the podiatry service.

Jelonet – Mr Patterson in attendance

Requested by Mr Patterson for use in ankle/foot surgery. Evidence presented as per application form. Reviews:  NICE – not considered  SMC – not considered  AWMSG – not consider  RDTC – not considered  LNDG – not considered  MTRAC – not considered  NETAG – not considered  NoT APC – not considered This request is purely to replace the use of mepitel on cost grounds. Decision around evidence presented took place and also views of Tissue Viability Service. He has some concerns that Meptiel is difficult to use in practice. It is understanding of GMMC that Jelonet was removed from formulary because dressing technology had moved on in recent years. Atrauman has been suggested as another alternative to mepitel and it is already on the formulary. Atrauman is a similar price to jelonet, and is available from NHS supplies. Conclusion:  Tigecycline – approved as red drug on advice of microbiology only.  DNase / Alteplase – approved as red drug for use on ITU only on advice of respiratory intensivist consultant only.  Inadine – approved as red drug for use in ankle/foot surgery only.

 Jelonet - the Committee debated this request and the alternatives available on the South of Tyne & Wear wound formulary. The Committee were receptive to the concerns regarding the use of Mepitel in particular the handling characteristics and the poor availability of sizes. The GMMC would ask that the foot and ankle team trial Atrauman. This is currently on the South of Tyne & Wear wound formulary, is available in multiple sizes which should meet the requirements of the orthopaedic team.

Item 7 New Drug Requests for April 2013 Discussion:  Ranolazine – requested for use by Dr Kearney

Item 8 Gateshead CCG Antimicrobial Update Discussion: Nothing to report. Item 9 NICE Guidance and Formulary Status of NICE Enc 12 & 13 Technology Appraised Drugs Discussion: NICE have now issued their Good Practice Guidance on the maintenance and development of formularies. Work is underway in both the CCG and GHFNT to ensure compliance with the recommendations. Intrahealth are putting together a spreadsheet of all TAGS and compliance with them across South of Tyne. An enclosure of GHFNT compliance with TAGs as of Jan 2013 was circulated for information. The following documents will appear on publically accessible websites in the CCG and GHFNT by 1st April 2013:  Minutes of GMMC (names of attendees replaced by job titles)  Copy of formulary – interim version until final format agreed.  TOR of GMMC  Decision Summary of New Drug Requests following each meeting – to adapt North of Tyne document as of Feb 2013  Spreadsheet of TAGs and compliance within organisation The following actions require further work:  New Drug Approvals Policy – section on appeals will require revision  CCG still reviewing the resources required to maintain the formulary within Gateshead & what IT software can be used to help maintain formulary.  Confirmation of wording to use in formulary for those drugs with a positive TAG from NICE but which are currently not part of the preferred commissioned treatment pathway locally. Wording suggested: “not currently used locally as preferred options of choice in the current treatment pathway but is available on individual patient basis as per NICE Technology Appraisal”. The following guidance have been identified as applicable to GHFNT but are not currently on the formulary, so hence in the spreadsheet attached they do not have a date of local decision:

2012/13

Venous thromboembolism (treatment and Rivaroxaban – a recommended option for treating long term secondary prevention) - DVT, and to help prevent a pulmonary embolism or rivaroxaban ( TA261 ) another DVT. 23/07/12 Atrial fibrillation (stroke prevention) - Rivaroxaban – a recommended option for atrial rivaroxaban (TA256 ) 24/05/12fibrillation patients with risk factors.

2011/12

Venous thromboembolism (hip and knee 31/01/12Apixaban – a recommended option to reduce surgery) - apixaban ( TA245 ) thromboembolism after knee/hip replacement. Ankylosing spondylitis - golimumab 31/08/11Golimumab – a recommended option for severe, (TA233) active ankylosing spondylitis in the same circumstances as TA143 when NSAIDs unsuccessful. Rheumatoid arthritis (after failure of 30/06/11Golimumab – a recommended option (in the same previous anti-rheumatic drugs) - golimumab circumstances as TA130) after other specified (TA225) treatments have failed or not been tolerated. Psoriatic arthritis - golimumab (TA220) 30/04/11Golimumab – recommended as a possible treatment after trying other DMARDs in the same circumstances as TA199.

2009/10

Rheumatoid arthritis - certolizumab pegol 28/02/10Certolizumab pegol – a recommended option for ( TA186 ) severe 'active' disease if methotrexate and another DMARD unsuccessful. Usually given with methotrexate, but monotherapy if methotrexate not tolerated. Use as per TA130.

Venous thromboembolism - rivaroxaban 30/04/09Rivaroxaban – a recommended option for (TA170) thromboembolism prophylaxis arising from elective total hip or knee replacement surgery. With regard to the above Technology appraisals the following actions were agreed: TA261 – highlight to commissioners that CCG & GHNFT remain non-compliant with this guidance as requires significant redesign of local treatment pathway hence not appropriate to add Rivaroxaban to formulary list at this stage for this indication. TA256 – add to formulary list with the following wording “not currently used locally as preferred options of choice in the current treatment pathway but is available on individual patient basis as per NICE Technology Appraisal”. To note on formulary that may suitable instead of dabigatran or warfarin for those patients with compliance aids, as unlike dabigatran it can go in compliance aids. TA245 - add to formulary list with the following wording “not currently used locally as preferred options of choice in the current treatment pathway but is available on individual patient basis as per NICE Technology Appraisal”. Should also be flagged to commissioners for them to review local treatment pathway for this indication. TA233 - add to formulary list with the following wording “not currently used locally as preferred options of choice in the current treatment pathway but is available on individual patient basis as per NICE Technology Appraisal”. Should also be flagged to commissioners for them to review local treatment pathway for this indication. TA225 - add to formulary list with the following wording “not currently used locally as preferred options of choice in the current treatment pathway but is available on individual patient basis as per NICE Technology Appraisal”. Should also be flagged to commissioners for them to review local treatment pathway for this indication. TA220 - add to formulary list with the following wording “not currently used locally as preferred options of choice in the current treatment pathway but is available on individual patient basis as per NICE Technology Appraisal”. Should also be flagged to commissioners for them to review local treatment pathway for this indication. TA186- add to formulary list with the following wording “not currently used locally as preferred options of choice in the current treatment pathway but is available on individual patient basis as per NICE Technology Appraisal”. Should also be flagged to commissioners for them to review local treatment pathway for this indication. Item 10 Adrenaline Auto Injector Contract Discussion: The regional contract for adrenaline auto-injectors has now changed from Epipen® to ALK Jext®. GM meeting with rep from ALK next week to discuss change over in Gateshead. Rep is also meeting with JS to discuss switchover in primary care. Conclusion: GMMC agreed to support changeover to Jext® Item 11 Gateshead Chronic Pain Guidelines Enc 14 Discussion: Chronic Pain Guidelines have been updated as now due for review. No major changes required. Conclusion: Guideline approved subject to adding new statement from GMC about the prescribing of unlicensed drugs. Item 12 Buccolam Switch Enc 15 -17 Discussion: A regional switch to using Buccolam instead of Epistatus as buccal midazolam formulation of choice has been proposed. This is because Buccolam is now licensed for use in both children and adults whereas Epistatus is not. Noted that may still need to have Epistatus available on formulary because some patients may have difficulty with the increased volume for administration required with the Buccolam product. A regional group is to be put together to take this forward. Conclusion: Switch to Buccolam supported in principle. Item 13 SoTW BPH Guidance Enc 18-19 Discussion: Guideline was been slightly amended. Conclusion: Updated version of guideline approved.

Item 14 Heart Failure Guidance Enc to follow Discussion: Guideline has been updated in collaboration with GHFNT cardiology service to reflect all current NICE guidance in this area. Conclusion: Guideline approved.

Item 15 Medicines Management Behaviour Change Project Enc 20-22 Discussion: Circulated for information.

Item 16 Shared Care Guidelines for Approval Discussion: None received this month.

Item 17 NHS SoTW PGDs For Approval Conclusion:  MMR Vaccine – approved

Item 18 Exceptional Case Requests Discussion: Patient IC – Ruxolitinib for pulmonary idiopathic myelofibrosis – gone forward to IFR panel with chair’s endorsement.

Item 19 NICE Guidance November 2012, December 2012 & Enc 23-28 January 2013 Discussion:  CG154 – Ectopic pregnancy & miscarriage – all relevant drugs on formulary.  CG155 – Psychosis & Schizophrenia in young people – n/a to GHNFT. No specific drug recommendations.  TA266 – Cystic Fibrosis – mannitol dry powder for inhalation – n/a to GHFNT as pts treated in Newcastle  TA267 – Chronic heart failure – ivabradine – already on formulary for his indication & heart failure guidelines have been updated to include this TAG.  TA268 – Melanoma – Ipilimumab – n/a to GNFT as patients treated at NCCT.  TA269 – Melanoma – Vemurafenib - n/a to GNFT as patients treated at NCCT.  TA270 – AML – Decitabine – appraisal terminated. n/a to GNFT as patients treated at NCCT.  TA271 – diabetic macular oedema – fluocinolone implant – not approved by NICE. n/a to GHFNT as pts treated in Newcastle.  TA272 – urothelial tract carcinoma – vinflunine – not approved by NICE. n/a to GNFT as patients treated at NCCT.  TA273 – Hyperplasia – tadalafil – appraisal terminated. Drug not on formulary for this indication.

NICE guidance published in November, December and January can be found on the NICE website. The committee is asked to note any implications for prescribing guidance across Gateshead and any additional prescribing costs resulting from implementation of the guidance.

Item 20 Drug Safety Updates Nov 2012 – Jan 2013 Enc 29-30 Following MHRA Drug Safety Updates issued since last meeting:  Nov 2012 Drug Safety Update  Dec 2012 Drug Safety Update  Jan 2013 Drug Safety Update  Following other Safety Updates of note:  Tredaptive The committee is asked not note any implications for prescribing across Gateshead and recommend any actions required.

Item 21 Items from NETAG Enc 31-33

Discussion:  NETAG Decision Summary – Afibercept for AMD – approved with licensed indication. n/a to GHNFT  NETAG Decision Summary – Horse ATG for AAA – approved as alternative to rabbit ATG. n/a to GHNFT  NETAG Decision Summary – Ulipristal for PCC – no change in previous approval

Item 22 Items from NECDAG Discussion: See NECDAG minutes

Item 23 Items for Information Only Enc 34 & 35 Discussion: Items circulated were:-  NETAG Minutes 13.11.12  NECDAG Minutes 28.11.12

Item 24 AOB

Discussion: Alfentanil to replace fentanyl in palliative care patients with renal failure Agreed to approve request to add alfentanil to the formulary to replace fentanyl in palliative care patients with renal failure as per NECN Palliative Care Guidelines. Noted that Out of Hours team are currently applying to change their Home Office License so they can keep supplies of alfentanil. FATS6 Guideline Updated version was approved. Rifaximin – now licensed for hepatic encephalopathy A licensed rifaximin product for use in hepatic encephalopathy has now been launched. As licensed product cost- neutral to current unlicensed product on the formulary for this indication, agreed to switch to the licensed product from 1st April 2013, and no formal new drug request application form is required for the licensed product. Rifaximin will be a Green+ drug for this indication. Isosorbide Mononitrate Noted there is a national supply problem with all strengths of immediate release isosorbide mononitrate until June/July 2013. In the short-term MR preparations may be a suitable alternative. AMB will also speak with Dr Barker/Scott as to other alternatives in the longer term, and about maintaining stocks of MR preparations. Temazepam Noted there is supply problem with temazepam in primary care which is increasing the cost of temazepam in primary care significantly. Alternatives are diazepam and zopiclone, but this is also an opportunity to review the use of these agents in the majority patients.

Date of Next Meeting: Wednesday 10th April 2013 9am-12noon Room 4, QEH Education Centre