DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday 10 July 2012 CONFIRMED MINUTES

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1 DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday 10 July 2012 CONFIRMED MINUTES Summary Points Traffic lights Drug Rivaroxaban Dabigatran Drugs of Limited Clinical Value Hyaluronic Acid Injections Decision GREEN (see local guidance) for AF GREEN (see local guidance) for AF See full traffic light database BLACK Guidelines Prevention of Stroke and Systemic Embolism in AF with Warfarin and New Oral Anticoagulants Guideline flowchart for anti-platelet therapy in non-st elevation ACS. Oxygen Guidelines. 1

2 Present: NHS Derbyshire County Dr J Bell Dr D Fitzsimons Mr S Hulme Dr A Mott Ms K Needham Dr T Parkin Mrs S Qureshi Dr A Tooley Assistant Director of Public Health (Chair) GP North Derbyshire CCG Head of Prescribing Southern Derbyshire CCG GP Southern Derbyshire CCG Head of Medicines Management North North Derbyshire CCG GP Hardwick CCG NICE Liaison and Audit Pharmacist GP Southern Derbyshire CCG Derbyshire Community Health Services NHS Trust Mr M Steward Head of Medicines Management NHS Derby City Mr S Dhadli Mrs L Hunter Specialist Commissioning Pharmacist Assistant Head of Finance Southern Derbyshire CCG Derby Hospitals NHS Foundation Trust Mr T Gray Chief Pharmacist Derbyshire Healthcare NHS Foundation Trust Dr S Taylor Consultant Psychiatrist, Chair Drugs and Therapeutic Committee Chesterfield Royal Hospital NHS Foundation Trust Mr M Shepherd Chief Pharmacist In Attendance: Dr A McKiernan Consultant Haematologist, RDH (for item 7) Mr A Thorpe NHS Derby City (minutes) 2

3 1. APOLOGIES Dr C Emslie and Dr J Leung. 2. DECLARATIONS OF CONFLICT OF INTEREST No declarations of interest were made. 3. DECLARATIONS OF ANY OTHER BUSINESS Phenindione JAPC September meeting venue 4. MINUTES OF JAPC MEETING HELD ON 12 JUNE 2012 The minutes of the meeting held on 12 June 2012 were agreed as a correct record after the following amendments: Minute number 5e to read Dr Shum, Royal Derby Consultant Dermatologist. Minute number 6a However GPs could administer the vaccine privately at no additional charge to the patient. Minute number 7 to read These could involve the patients with VTE who could not tolerate warfarin and nicoumalone Minute number 8a to read : The two guidelines would be reviewed in the light of the changes proposed and brought back to the JAPC meeting in July. 5. MATTERS ARISING a. Antipsychotics Recommended Physical Monitoring Dr Taylor advised that measurement of increased QT intervals in the use of ECGs would be discussed with the cardiologists and it was confirmed that a measurement of an increased QT interval not to be greater than 499 milliseconds was an appropriate value for GPs to review. Mr Dhadli referred to the query which had raised at the last JAPC meeting about lipid monitoring and stated that some wording had been agreed which would be brought back to JAPC for ratification. b. Drugs of Limited Clinical Value (DLCV) Mr Dhadli explained that all the drugs of limited clinical value in the British National Formulary had been listed and comments sought from the different providers. The DLCV list had subsequently been discussed by the Guideline Group and a two-section table had been produced, one of which classified the black drugs and the other indicated those which were exempted from the black category. Discussion followed and the following points were made: Minocycline should continue to be classified as a BROWN drug. Methadone linctus should be classified as BROWN for exceptional use in palliative care and pain relief. Dr Tooley pointed out that some drugs in the black category such as pseudoephedrine were prescribed by GPs and were items that could be purchased over the counter (OTC). Mr Dhadli would identify black OTC items so patients could be advised to self manage should they want these medicines. Sofradex should be classified as GREEN. 3

4 c. Cyanocobalamin should be classified as BROWN (for B12 deficiency). Hirudoid should be put in the BLACK drugs category. Co-codamol 15/500 had not been included in the list and should be classified as BROWN. Comments would be included on the database as to the reasons why some drugs had been classified as brown. Agreed: JAPC approved the DLCV list with the suggested amendments which would be incorporated. Dual Antiplatelet for ACS A flowchart for guidelines for antiplatelet therapy in non-st elevation ACS to be used alongside the ACS/NSTEMI pathway for use in South Derbyshire was tabled. Agreed: JAPC approved the guideline flowchart for anti-platelet therapy in non-st elevation ACS. 6. NEW DRUG ASSESSMENT a. Hyaluronic Acid Injections Mr Dhadli stated that two new products Renehavis, for painful knee osteoarthritis, and SportVis, for ankle sprain/pain in epicondyle, had been launched in April Mr Dhadli added that in February 2008 JAPC had classified hyaluronic acid as RED as the draft NICE osteoarthritis guideline did not support its use. NICE had subsequently published an osteoarthritis clinical guideline in 2012 which did not recommend intra-articular hyaluran injections and a relevant publication had concluded that in patients with knee osteoarthritis viscosupplementation was associated with a small and clinically irrelevant benefit and an increased risk for serious adverse events. Mr Steward stated that this had recently been requested by a surgical podiatrist in DCHST who had used hyaluronic acid in a previous role. Mr Steward had informed the podiatrist of the BNF guidance which stated that hyaluronic acid and its derivatives were available for osteoarthritis of the knee but are not recommended, but had also contacted other surgical podiatrists for their opinions. Information had subsequently been received that this was used occasionally and was also classified as a medical device and therefore ordered direct from the manufacturers rather than via pharmacy. Mr Dhadli referred to a Cochrane review of SportVis in 2010 concerning its use for treatment for osteo-condyle defects of the ankle bone which had referred to one very small randomised control trial. The trial had no data to check the claim for qualitative evaluation and the conclusion had been made that there was no evidence to determine which interventions were most appropriate for the treatment of osteo-condyle defects of the ankle bone in adults. Agreed: The whole category of hyaluronic acid injections to be classified as BLACK drugs and put on the database. 7. CLINICAL GUIDELINES a. New Oral Anticoagulants (NOACs) 4

5 Dr McKiernan stated that a meeting had been held with Mr Dhadli to discuss the guideline for the prevention of stroke and systemic embolism in atrial fibrillation with warfarin and NOACs. Dr McKiernan outlined the main changes which had been made since the discussion at the last JAPC meeting which included the use of rivaroxaban as the preferred drug although dabigatran had been left in. In the event of dabigatran being used it would be initiated in primary care in the county potentially if rivaroxaban not appropriate/tolerated - the guideline allows initiation of either. Dr McKiernan suggested that the review date should be changed from two years to one year to allow for review and for consideration of the other availability of other agents such as apixaban. In connection with the treatment of drug addicts with DVT Dr McKiernan highlighted the recommendation in the guideline that NOAC could be used for this group of patients where enoxaparin would otherwise be used. Mr Dhadli advised that this guideline was for AF. Any other drugs outside this policy should be the subject of separate discussion. Dr McKiernan also referred to the need for a database of patients who were on the new agents and queried how this could be done in primary care. Dr Mott suggested that this might be difficult due to the varying primary care computing systems in the county. Dr Tooley commented that it would be advantageous to include a reference in the guidance to the usefulness of undertaking a bleeding risk assessment and the HAS-BLED bleeding risk score was a useful way to do this. The reference to a bleeding risk assessment and the option to use the HAS-BLED score would be included in the guidance. Dr Tooley also suggested that, due to the length of the guidance, a quick reference guide for GPs such as a flowchart would be helpful. Dr Fitzsimons referred to difficulties in obtaining phenindione and queried the position regarding an individual patient who had an allergic reaction to warfarin. Guidance from Chesterfield had indicated that in this case a cross reaction to nicoumalone was also likely and the practice was advised by CRHFT that the patient should be initiated on rivaroxaban. Mr Shepherd would follow this up with Medicines Information and report back to JAPC. The supporting information for prescribers and patient FAQs was discussed and it was suggested that the patient section was perhaps too clinically focussed and should therefore go via the PCT Reader s Panel this was agreed. Mr Dhadli would report back to JAPC. Mr Dhadli stated that the criteria for exceptional patients for NOAC section in the Derbyshire Medicines Management update needed to be amended to Poor control with warfarin (TTR<50%) once stabilised on warfarin (usually 6 months) and the drug addicts reference removed. This was agreed by JAPC. Agreed: JAPC ratified the Guideline for the prevention of stroke and systemic embolism in AF with warfarin and NOACs with the agreed amendments. Mr Shepherd queried the process for the agreement on the use for the various groups of patients and the increasing pressure for their use together with the AMcK/ MS 5

6 b. c. potential cost savings for primary care in moving away from the use of low molecular weight heparins. Dr McKiernan suggested that it would be useful to have guidance for the use of rivaroxaban in VTE. In addition there would be limited use for drug addicts and a need to establish the other groups of patients and how many would be involved as there would be a cost implication. Dr McKiernan would liaise with Mr Shepherd about further patients who would benefit from NOACs and it was agreed that should come back as a separate proposal or business case. Oxygen Guidelines Mr Dhadli stated that JAPC had requested clarification on the place of blood gasses as a measure of oxygen saturation and this had now been included on the cover sheet. The most recent Home Oxygen Order Form (HOOF) with the new Home Oxygen Contract had been included as an appendix. A minor amendment had also been made on page 4 to read Only Part A (nonspecialist or temporary order) of the new HOOF and a consent form will be completed by the prescriber. Agreed: JAPC approved the Oxygen Guideline. Chicken Pox in Neonates Mr Dhadli stated that the existing guideline had been updated by Dr Diane Harris, Specialist Antimicrobial Pharmacist, and the amended version was tabled for discussion. Dr Bell highlighted that part of the algorithm did not give definitive alternative answers to the questions raised and Dr Parkin queried the role of GPs in the sourcing of results and the need to ensure that the patient received the vaccination. Agreed: The Guideline to be reviewed in the light of the comments made and brought to the JAPC meeting in August. AMcK/MS DH/ 8. SHARED CARE GUIDELINES a. Liothyronine and Liothyronine Traffic Light Status Dr Taylor presented the minor changes which had been made to the existing shared care guideline for Liothyronine. During discussion a question was raised as to how often liothyronine was used. Dr Taylor commented that very small numbers of patients were involved and that a range of treatments was needed in the treatment of depression. The use of liothyronine as an adjunct to any antidepressant in managing unipolar resistant depression was an unlicensed use of the product. It was noted that a consequence of the use of the drug may be to affect thyroid function. Dr Mott referred to the need for a consistent format for the guideline and Dr Taylor agreed to put this in the new format and include up to date telephone numbers and contact telephone numbers for North Derbyshire. Dr Parkin referred to the ongoing issues as to whether GPs should monitor ECGs for psychiatric drugs and whether the six month reviews should be done in primary or secondary care. These issues were currently being considered by the commissioners and it was agreed that the general ECG issue required further discussion in the light of this. 6

7 Agreed: The shared guideline for Liothyronine to be discussed by JAPC at the August meeting. Mr Dhadli stated that a request had been made for a traffic light classification for the licensed indication for endocrine use following several GP queries regarding its prescribing. The drug was currently classified as amber as an adjunct in the management of unipolar treatment resistant depression (unlicensed) and was also listed in the formulary as not recommended for use outside of specialist initiation for very specific indications. Dr Mott highlighted that hypothyroidism was a GP not specialist condition and it was queried how long should rapid response treatment be needed for. Mr Gray and Mr Shepherd would find out the length of treatment for endocrine use. Agreed: The traffic light classification for the use of liothyronine for endocrine use to be discussed by JAPC at the August meeting. T G/MS 9. MISCELLANEOUS a. Pro D3 Mr Dhadli referred to the compilation of s received from the Managing director of Matrix Medical Consultancy who appeared to be acting on behalf of the manufacturers of a new vitamin D product Fultium-D3 who had raised concerns about the inclusion of Pro D3 in the formulary. Pro D3 did not come under the remit of MHRA as it is not a licensed product or an unlicensed import. JAPC had been requested to review its decision to include Pro D3 in the formulary. During discussion Ms Needham commented that having Fultium-D3 was easier for pharmacies to obtain and practices to prescribe and was licensed, but patients had to take more tablets per day. The use of Fultium-D3 could be included as an option and the advantages and disadvantages of having a licensed product against an unlicensed product discussed. It was noted with concern that the company which produced Pro D3 was currently dormant and that it was indicated in the vitamin D guidance for treatment not supplementation. Mr Dhadli added that that Dr Stanworth, RDH Consultant Rheumatologist who had been involved in the development of the vitamin D guidance, had been contacted for comments. Dr Fitzsimons highlighted the necessity of not including unlicensed products in guidelines until the sourcing had been checked and Mr Hulme advised that any further decision should be made in the light of advice received from Dr Stanworth. : Fultium-D3 to be included as an alternative treatment in the formulary alongside Pro-D3. : Mr Gray would ascertain what was being used in the Royal Derby Hospital. Agreed: JAPC to discuss Pro D3 at the August JAPC meeting when comments from Dr Stanworth had been received. TG 7

8 b. Clinical Trials Mr Dhadli stated that the circulated clinical trial was a 12-week multi-centre, randomised, double-blind, parallel to compare glycopyrronium bromide and indacaterol. Indacaterol had been classified as a brown drug and glycopyrronium bromide was unclassified. Mr Dhadli added that it would be important for the GP practices which signed up to participate in the trial to understand and ascertain that a clear exit strategy was in place once the trial had been completed. Dr Bell commented that it would be necessary to establish what would happen to the patients on the trial who would need to revert back to their original drug. Dr Parkin advised that it would be helpful for JAPC to liaise with the Primary Care Research Network and CLARC, both of which organised trials via primary care, in order to establish agreed exit strategies for any of their trials. Dr Bell suggested that the RDH Governance team could ensure that exit strategies were in place after Ethic Committee approval for the trials had been approved. : Dr Bell would follow up the issues raised about the need for exit strategies to be in place in all clinical trials. JB 10. NICE Mr Dhadli informed JAPC of the comments for the CCGs which had been made for the following NICE guidance: a. b. c. d. TA 257 Breast cancer (metastatic hormone-receptor) lapatinib and trastuzumab (with aromatase inhibitor This was a negative appraisal. The Provider Trust should provide assurance for no new starters as first line treatment as per TA 275. TA 258 Lung cancer (non-small cell, EGFR-TK mutation positive) erlotinib (first line) This was cost neutral as it was offset against its competitor gefitinib and there was a patient access scheme in place and a confidential discount from list price as applied to the original invoice. The CCGs would need to understand the process as to how the discount was applied and also to confirm that the discounted price was the same as gefitinib. TA 259 Prostate cancer (metastatic, castration resistant) arbiraterone (following cytotoxic therapy) The estimated current cost in Derbyshire was 76,000 and the cost of future practice was 930,000. There was a patient access scheme in place and CCGs would need to confirm details of compliance. TA 260 Migraine (chronic) botulinum toxin type A Potential impact on budgets as migraine was a common condition and needed to be carefully managed. The CCGs would need to monitor initiation criteria for eligibility and reviews for stopping. A referral criteria and pathway may need to be agreed for suitable duration and definition of failure. The price for 200 unit vial was 275 and the cost of a twelve week cycle estimated to be 8

9 e. f. g. h The year 1 cost for Derbyshire was 21,000 and for year 5 the cost would be 220,000 so a net resource of 200,000. CG141 Acute upper gastrointestinal bleeding: management This was a potential service change which could result in savings through an increase in early discharge, use of formal risk assessment scoring, reduction in mortality and complications and reduction in daily endoscopy lists if seeing more than 330 cases per year. CG142 Autistic Spectrum in Adults NICE had indicated that there was insufficient data to cost all the variations across health communities and referred to the establishment of a multidisciplinary team to develop a multi-agency strategy to deal with the diagnosis, care intervention and provide support for housing, education, family, employment and training. Dr Taylor commented that most of the prescribing would be for the co-morbidity conditions. CG 143 Sickle Cell Acute Painful Episode NICE had referred to the potential saving and increase in costs associated with the introduction of these guidelines. The CCGs would need to agree from specialist services Trust protocols for pain management. Efficiency savings would result from reduced length of hospital stay to the benefit of providers and commissioners. Venous Thromboembolic Diseases This was unlikely to result in significant change of resource as the recommendations reflected current practice. 11. JAPC BULLETIN The following changes to the JAPC bulletin were noted: Zostavax Clarified that GPs should not charge for the writing of the prescription or the administration of the drug. Metenix (metolazone) Included a reference to the lack of the red EU banned colourant dye which can be found in imported generic metolazone but is not present in Zaroxolyn and an amendment agreed to the last line to read Specialists can continue to recommend metolazone only as second line where appropriate. The amended JAPC bulletin was ratified by the JAPC. 12. GUIDELINE GROUP The Guideline Group action tracker was ratified by the JAPC. 13. TRAFFIC LIGHTS ANY CHANGES? Specific amendments to the DLCV papers: - Sofradex GREEN - Cyanocobalamin BROWN (for dietary purposes) - Hirudoid BLACK - Cocodamol 15/500 BROWN - Minocycline BROWN 9

10 - Methadone linctus BROWN Hyaluronic Acid Injections BLACK Rivaroxaban - GREEN anticoagulant option in AF patients as per local guidance after warfarin, acenocoumarol and phenindione Dabigatran GREEN anticoagulant option in AF patients as per local guidance after warfarin, acenocoumarol/phenindione and rivaroxaban 14. ACTION SUMMARY The action summary was discussed. Buccal Midazolam (Paediatric) Mr Gray stated that there was a preference to use the single licensed product buccalam and that it was unknown when epistatus would obtain its licence. Guidance from the Regional Paediatric Group would be obtained and discussed at the August JAPC meeting. PGDs To be discussed at the August JAPC meeting. TG 15. MHRA DRUGS SAFETY UPDATE The MHRA Drug Safety Alert for June 2012 was noted. 16. ANY OTHER BUSINESS a. Phenindione had been already discussed under agenda item 7 a. b. Mr Thorpe reported that it was necessary to change the venue for the JAPC meeting to be held on 11 September 2012 from The Hub to the Post Mill Centre, South Normanton. An would be sent to all JAPC members to inform them of the change and directions would be included in the September agenda papers. 17. DATE OF NEXT MEETING Tuesday, 14 August 2012 in Meeting Room 3, The Hub, South Normanton. 10

DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday 14 August 2012 CONFIRMED MINUTES RED

DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday 14 August 2012 CONFIRMED MINUTES Summary Points Traffic lights Drug Azilsartan medoximil Ulipristal acetate (ESMYA)