COVENTRY & WARWICKSHIRE AREA PRESCRIBING COMMITTEE

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COVENTRY & WARWICKSHIRE AREA PRESCRIBING COMMITTEE MINUTES OF THE COVENTRY AND WARWICKSHIRE AREA PRESCRIBING COMMITTEE HELD ON FRIDAY 17 th MARCH 2017 AT 12.30 PM IN THE CLINICAL SCIENCES BUILDING (CSB) AT UHC&W NHS TRUST PRESENT: - Richard Lambert South Warwickshire GP (RL) Vice-chair Altaz Dhanani Coventry & Rugby CCG (AD) Interim secretary Joe Booker Coventry LMC (JB) Jane Smith Coventry GP (JS) Claire Keane Coventry GP (CK) Rita Sanghera Arden & GEM CSU representing Warwickshire North and South Warwickshire CCG (RS) Ruth David Arden & GEM CSU representing Warwickshire North CCG (RD) Nigel Johnson Warwickshire North CCG (NJ) Kim Panting South Warwickshire GP (KP) Bernhard Usselmann South Warwickshire NHS Trust (BU) Ashwin Hindocha Coventry LPC (Ahi) Satyan Kotecha Warwickshire LPC (SK) Franco Cappuccio University Hospitals Coventry & Warwickshire NHS Trust (FC) Mark Easter - University Hospitals Coventry & Warwickshire NHS Trust (ME) Cath Sansby - University Hospitals Coventry & Warwickshire NHS Trust (CS) Paul Mills George Eliot Hospital NHS Trust (PM) Loay David George Eliot Hospital NHS Trust (LD) David Tait Coventry & Warwickshire Partnership Trust (DT) Ian Bayman Lay Member (IB) Terry Spicer Lay Member (TS) IN ATTENDANCE: Anita Hunjan (AH), Susan Dhesi (SD) 1. APOLOGIES Simon Fletcher, Priti Ved, Bev Bazant-Hegemark, Genette Edmunds, Martin Phillips, Paula Harris, Portia Chikwanha 2. MINUTES OF THE LAST MEETING The minutes of the last meeting held on 27th January 2017 were agreed with the exception of some grammatical changes on pages 2/3 matters arising 7.4 items and paragraphs 5.1.2, 8.1.1, 8.1.2 which were to be amended prior to the publication of the minutes. 1

2.2 - Action log RL went through the list of outstanding actions that still required the committee s response. He suggested adding a date completion by to the action log. 3. MATTERS ARISING DT briefly updated the committee about the ADHD commissioning model that Coventry and Warwickshire Partnership Trust were implementing to increase the capacity and to have all ADHD patients as shared care (SC). He confirmed that it looks as if the CCGs will not provide the extra funds and subsequently this will impact on transition patients, as there are no provisions available to continue treatment in primary care unless they have a severe mental health condition. NJ advised that the LMC are keen to withdraw from the shared care protocol, they feel there is not appropriate funding available for services in primary care. RL felt that this discussion was more of a commission matter rather than an Area Prescribing Committee (APC) issue. DT insisted that it was an APC issue as it impacts on safety and quality. He felt that it would be beneficial if the committee were to agree on a consensus on the reclassification of the shared care agreement (SCA) to classify all ADHD age groups as shared care. Section 3 Decisions 3A Email completed declaration interest form RH/SDh/PH/PC 3B Email David Weston ( LMC Lead letter) to RL & SF NJ 4. APC Development 4.1 RMOC update AD updated the committee on his attendance at last month's development workshop. Key plan outcomes were:- RMOC inauguration first meeting will be held at the end of April 2017 Subsequent meetings will be held on a monthly basis One RMOC split into 4 regional areas: The North, The South, The Midlands& The East and London all acting as one whole body No recruitment of members has taken place yet, delegates were asked various questions regarding who should be represented No confirmed decisions on how it will all pan out Above the RMOCs will sit a Medicines Optimisation Priority panel (MOPs) this group will devise and prioritise what the RMOCs should be discussing 4.1.1 - AD stated that he will send the committee a link to the RMOC proposal and the feedback/discussion taken place at the workshops. His view was that APCs will still be crucial to the local health economy. The APCs will not be forced to abide by the RMOCs decision locally which defeats the purpose of the new remit 2

4.1.2 - NJ asked if there were any discussions around the of Drug and Therapeutic Committees (DTCs), AD said that DTCs were not mentioned, he added that the RMOC fundamental principle is to reduce the workload of APCs and DTCs 4.1.3 - AD pointed out that there were lots of reservations from delegates about Pharmaceutical Industry representations 4.2 APC Website AD notified the committee that SD is currently working with ArdenGem GP fusion IT to reformat the current website layout to make navigation to documents more accessible and user friendly. The launch date is 1 st April 2017 and he asked the committee to provide feedback. Section 4 Decisions 4A Send RMOC workshop link to the committee AD 5. Drug Positioning Statements 5.1 - Opicapone A DPS was brought to the committee for consideration as adjunctive therapy to preparations of levodopa/dopa decarboxylase inhibitors (DDCI) in adult patients with Parkinson s disease (PD) and end-of-dose motor fluctuations who cannot be stabilised on those combinations; 5.1.1 - AH summarised the contents of the draft DPS; stating that this was a once a day preparation, EMA review evidence was shown to be non-inferior to entacapone. The safety intolerability appeared to be good Committee viewed item 7.5 Parkinson disease algorithm at this point. 5.1.2 - CS described the draft Parkinson disease algorithm which was devised by consultants at University Hospital Coventry and Warwickshire NHS Trust (UHCW), placing opicapone as second-line to entacapone and noting that consultants do not use tolcapone 5.1.3 - JB commented that tolcapone is always an issue in primary care 5.1.4 - RL asked if there is a plan to have a combined preparation 5.1.5 - IB commented on the contra-indication paragraph and suggested naming the MAO-A and MAO-B class of inhibitors The committee agreed that the verdict status should read as specialist initiated (SI). 5.2 - Safinaminde A DPS was brought to the committee for consideration for the treatment of adult patients with idiopathic Parkinson s disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients. 5.2.1 - AH briefly summarised the contents of the draft DPS; a once daily dosage that can be increased, it is more expensive compared with other drugs. There is no data on the long- 3

term use and no dietary restrictions; it is also placed in the algorithm as an option where other drugs are not tolerated 5.2.2 - BU questioned the contraindication with pethidine, he said they use it often in their trust 5.2.3 - RD thought the algorithm was excellent guidance; she suggested that these drugs should be added to the netformulary, her recommendation were 3, 4, 5 drugs to be placed as preferred line, 7, 8, 9 drugs to be placed as second line and the bottom line drugs can be placed as third line 5.2.4 - RL thought that duodopa was a funding request drug 5.2.5 - RD questioned whether further drug clarification was needed especially around the COMT inhibitor The committee agreed that the verdict status should read as SI and the revised algorithm should be brought back to the next meeting after seeking approval from the neurologists. 5.3 - Relvar Ellipta A decision review request discussed at the last meeting was brought back to the committee for reconsideration along with a revised DPS; 5.3.1 - AH briefly summarised that there is no significant change from the previous DPS, the main addition is changing the BTS guideline where it positions relvar 92/22 as low to medium dose and the 184/22 strength positioned as high dose. The BTS guidelines suggest that high dose patients should be referred to secondary care. Ellipta device is a once daily dose which may be more beneficial to some patients 5.3.2 - JB recalled that the committee previously had two reasons for rejection; the colour of the device and concerns around vilanterol 5.3.3 - IB read out a summary of the observation study 5.3.4 - PM pointed out that the LABA/LAMA had already been approved The committee agreed the verdict status should read as recommended use in primary care, to amend the asthma guidelines and update the net formulary. 5.4 - Paliperidone - A DPS along with a draft SIDC from CWPT was brought to the committee for consideration for the treatment of schizophrenia in adult patients who are clinically stable on 1- monthly paliperidone palmitate injectable product. 5.4.1 DT summarised the contents of the draft DPS; introduction of a 3-monthly depot injection. CWPT propose that their patients should be stabilised for at least 12 months, specialists should complete the back page (internal use only) and approve those steps. The advantage of this product is that patients are only injected 4 times a year and receive a more sustained cover. He added that the verdict statement reflects what happens in primary care for GP prescribing. 4

5.4.2 NJ queried ECG assessments and thought that CWPT should be carrying out these assessments The committee agreed for verdict status to read as SI and also approved the SIDC. The four DPSs would be reformatted into the correct template and then published. Section 5 Decisions 5A Write opicapone DPS verdict & send out for virtual ratification, format document and then publish on both websites ALL 5B Write safinamide DPS verdict & send out for virtual ratification, format document and then publish on both websites ALL 5C Re-write relvar (asthma) DPS verdict, format document and then republish on both websites AH/SD 5D Amend Asthma guidelines and republish AH/SD 5E Write to specialist regarding relvar decision review outcome AD 5F Format paliperidone 3-monthly depot injection DPS and publish to both websites AD/SD 5G Publish paliperidone 3-monthly checklist to both websites AD/SD 6. Specialist Drugs List 6.1 - SDL Amendments Five proposed amendments from CRCCG were brought to the committee for consideration to change the renal immunosuppressant drugs SC classification; 6.1.1 - AD recommended to the committee that Azathioprine, Tacrolimus (oral), Ciclosporin (oral), Sirolimus, and Mycophenolate be changed to specialist only (SO). National guidance recommends that all transplant drugs be repatriated to secondary care and that UHCW homecare system will supply and prescribe from the trust 6.1.2 - JB requested that this be highlighted on the APC website; he said that these drugs are used currently for different indications and classifications and that junior doctors find this confusing. RD confirmed that this will be highlighted on the netformulary website 6.1.3 - BU asked about the renal drugs process in South Warwickshire; RL informed that there is a mix of out of area patients needing prescribing The committee agreed to publish the proposed amendments. 6.2 - SDL Amendment An amendment request from UHCW Breast Surgeons was brought to the committee for consideration to change aromatase inhibitors to SI; 6.2.1 - CS briefly informed that the breast surgeons do not feel that this should be SC 5

6.2.2 - RD and JS both stressed that the monitoring of discharge patients is crucial and specialists need to alert GPs 6.2.3 - CS said that she will feedback the committee comments The committee agreed to this amendment. Section 6 Decisions 6A Publish the agreed SDL amendments RD/SD 7. Guidelines/Resource Documents 7.1 - Local Blacklist amendment One proposed amendment from ArdenGEM CSU was brought to the committee for consideration; 7.2.1 - RD asked the committee to consider the inclusion of coconut oil, an OTC product which is not listed in the BNF The committee agreed to this proposal. 7.2- Local Blacklist amendment One proposed amendment clarification from CWPT Podiatry was brought to the committee for consideration; 7.1.1 - DT highlighted that the request is to make an exception to dermatonics once heel balm (25% urea ointment) as it can be prescribed for the management of foot problems in high risk patients when recommended by a specialist from podiatry and dermatology services 7.1.2 - IB said there is no evidence of support for 25%; however evidence is available for 10% product. He thought that 25% flexitol is much cheaper 7.1.3 - JB asked if the product was available over the counter (OTC) The committee rejected this proposal, but agreed to a blacklist amendment for 10% urea product being submitted to the next meeting. 7.3 - Infant Formula A revised guidance along with a draft quick reference guide from SWFT and UHCW dietitians was brought to the committee for consideration; 7.3.1 - AD read out a summary of the changes to the revised guidance; Similac Alimentum added as a first line treatment; Althera added as a second line treatment options for CMPA and Alfamino added for completeness as a third line option from dietitians 7.3.2 - CK thought the document was very useful; however the overall guidance seemed bit lengthy 6

7.3.3 - SK commented on the following:- 1. Page 2 do not table pre-thickened formula should stipulate names and say they are OTC products. 2. Queried the quantities supplied and suggested prescribers should add these as repeat dispensing on a quarterly basis which will reduce waste in community pharmacies 3. Suggested that the cost should be included for all the products The committee agreed that the revised guidance be amended with the committee comments, sent out for virtual ratification and then republished along with the quick reference guide. 7.5 - Parkinson s disease algorithm this item was discussed along with items 5.1 and 5.2 7.6 - Antimuscarincs A revised guidance discussed at the December 2016 meeting was brought back to the committee for reconsideration; 7.6.1 - CS mentioned that the Urologists wanted to simplify the pathway; remove the extended release preparations, remove solifenacin which is too expensive and move mirabegron to third line 7.6.2 - RD noted that tolterodine MR is a once a day formulation and suggested that it remained on the algorithm 7.6.3 - PM asked if the APC should focus on a more effective treatment pathway rather than having a separate pathway for women. CS confirmed that NICE have already separated their guidance for men and women 7.6.4 - IB stated that solifenacin should remain as an add-on therapy to mirabegron for some patients 7.6.5 - Committee briefly debated the solifenacin and mirabegron treatment therapy The committee agreed to amend guidelines and republish. 7.7 - Chronic Constipation A UHCW pathway that had been discussed at previous meetings with disagreement around some of the newer agents that did not follow the NICE guidance, was brought to the committee for reconsideration; 7.7.1 - CS briefed the background to previous meeting discussions; the consultant view is that GPs are in an ideal position to prescribe chronic constipation drugs as they see patients frequently. Consultants request that all these drugs are reclassified for primary care prescribing 7.7.2 - JB felt that most GPs do not have the experience in using the new agents and that the existing drugs are well tolerated by the majority of patients 7.7.3 BU added that the consultants would often do further investigations first before prescribing these drugs to patients, he questioned how this would work in primary care 7.7.4 - RL queried what the definition of adequate responsibility was 7

7.7.5 - GP members preferred the secondary care referral to be done before the switch to newer agents The committee agreed for this pathway to be amended with the committee's comments and then published as guidance. 7.8 - Fast-acting insulin - A joint formulary application submitted by Diabetologists and Endocrinologists from all 3 trusts was considered requesting inclusion of the new generation injection; 7.8.1 - AD reported that the new formulation has a therapeutic advantage over existing treatment 7.8.2 - IB commented that the reason for the Fiasp request is pure speculation, he stated that the key trials have not been published but there is a full EMA report. There is no data on important outcomes. IB read out the evidence report and noted with respect to safety, there was a difference in the pattern of hypoglycaemic episodes with a significantly higher rate of hypoglycaemia within the first 2 hours after the meal for Fiasp compared to Novorapid. However, the overall rate and severity of events was comparable between treatments 7.8.3 - RD queried the no excess cost compared to standard therapy 7.8.4 - SK thought the benefit is that the device is much better and the advantage is that the insulin can be give during the mealtime The committee agreed for this application to be brought back with more evidence to support its use and give better cost comparison against existing insulins. Section 7 Decisions 7A Publish the agreed local blacklist amendments RD/SD 7B Feedback dermatonics once heel balm 25% decision outcome to CWPT Podiatry Clinical Lead DT 7C Bring blacklist addition form for Dermatonics once heel balm 10% DT 7D Amend infant formula guidance and republish AD/SD 7E Publish infant formula quick reference guide on APC website AD/SD 7F Bring back revised Parkinson disease algorithm to the next meeting, add item to May agenda CS/SD 7G Amend antimuscarinic pathway and republish to APC website, amend drugs on netformulary CS/RD/SD 7H Amend chronic constipation pathway with committee comments publish on APC website CS/RD/SD 7I Write to specialist requesting some more evidence on fast acting insulin, bring application back item to the next meeting AD/SD 8

8. Shared Care Agreements 8.1 - Metolazone - A UHCW proposed SCA was brought to the committee for consideration for the treatment of fluid overload in patients with heart failure; 8.1.1 CS briefly stated that metolazone is now an unlicensed drug, and she had a request to devise a share care agreement 8.1.2 - RD confirmed that the drug is expensive and is a special item. She said that she had concerns around the patient safety aspect in primary care 8.1.3 - Committee members did not recall a previous meeting discussion, a brief debate took place around the prescribing concerns in primary care 8.1.4 - AD asked who had requested the SCA; he thought that a drug classification needed to be defined as GPs are quite often asked to prescribe metolazone The committee agreed for the specialist classification to be placed as specialist only (SO) until the cost price decreases. Section 8 Decisions 8A Change metolazone status on netformulary RD/SD 9. AOB 9.1 - Hypertension guidance - FC mentioned that the current guidance on the APC website dated January 2013 is out of date. He suggested that it required an overall update of the therapies and to have a simplified pathway. FC noted that the issue is that NICE have already started to review the national guidance alongside the British Hypertension Society (BHS) and this will be published in 2018. FC confirmed that in his hypertension clinic a number of concerns have arisen relating to secondary and primary care. At present they are inundated with referrals which breach the 18 weeks rule. FS felt strongly that he was unable to provide an efficient service. 9.1.1 - FC asked for the committee's view on whether they thought it was better to redraft the existing document now or to wait for the national guidance to be published 9.1.2 - AD commented that it would make sense to reformat the document now and any national guidance amendment could then be added at a later date The committee agreed to the proposal of reformatting the guidance and to bring the revised document to the meeting for approval. 9

9.2 - NJ reported on the new secondary care contract effective from 1 st April 2017, in which secondary care are to issue the first prescription and send a letter of advice to GP practices if they wish them to take over the prescribing. He acknowledged that the LMC will take action if the process is not adhered too. 9.2.1 - ME answered that he understood that there might be a contractual issue, however, there is an existing agreement between the hospital trusts and CCGs. It is a national decision and is outside the remit of this committee 9.2.2 - RL suggested confirming clarification of the local agreement under matters arising at the next meeting 9.3 - SK informed that there is a National Urgent Medicine Service (NUMS) for community pharmacies that has been commissioned nationally. It is for those patients who have run out of their medicines; patients can contact NHS 111 who will contact a community pharmacy direct to supply emergency medication. SK wondered what the local medication supply guidance was for Coventry and Warwickshire. Community pharmacies have discretion of up to 30 days of supply. He stated that this system is not a repeat dispensing service, currently the default is 28 days supply unless otherwise stated in the local guidance. 9.3.1 - AD asked how this service fits in with the emergency supply that community pharmacies can already provide 9.3.2 - SK replied that it is part of the contractual change for community pharmacies, the figures state that 200,000 patient telephone calls a year are made to NHS 111 service 9.4 - AD urged those members who submit meeting attendance invoices, that they should be completed and sent to the office within 2 weeks after each meeting otherwise invoices may not be processed. Section 9 Decisions 9A Devise revised hypertension guidance and bring back to meeting FC/SD 10. Date of next meeting The date and time of the next meeting is Friday 19 th May 2017 at 12.30 pm until 3pm. 10