DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday 11 December 2012 CONFIRMED MINUTES

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1 DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday 11 December 2012 CONFIRMED MINUTES Summary Points Traffic lights Drug Ivabradine for heart failure Denosumab Fluoxetine in children Prucalopride Pyrimethamine with sulfadiazine Mannitol Dry Powder Tiotropium (Spiriva) Respimat Decision GREEN specialist initiation AMBER GREEN specialist initiation (licensed in 8-18 years) BROWN (gastro specialist initiation as monotherapy) RED (dual classification) RED Re-classified BROWN Shared Care Guidelines Denosumab for prevention of osteoporotic fractures in post-menopausal women Phosphate Binders 1

2 Present: NHS Derbyshire County Dr J Bell Mr S Hulme Dr A Mott Mrs K Needham Dr T Parkin Assistant Director of Public Health (Chair) Head of Prescribing Southern Derbyshire CCG GP Southern Derbyshire CCG Head of Medicines Management North North Derbyshire CCG GP Hardwick CCG Derbyshire Community Health Services NHS Trust Mr M Steward Head of Medicines Management NHS Derby City Mr S Dhadli Specialist Commissioning Pharmacist Derby Hospitals NHS Foundation Trust Dr F Game Mr D Anderton Chair Drugs and Therapeutic Committee. Senior Pharmacist Derbyshire Healthcare NHS Foundation Trust Mr D Branford Chief Pharmacist Chesterfield Royal Hospital NHS Foundation Trust Mr M Shepherd Chief Pharmacist In Attendance: Mr A Thorpe Dr D Smith NHS Derby City (minutes) GP VTS2, Jessop Practice 2

3 1. APOLOGIES Dr C Emslie, Mrs L Hunter, Mrs S Qureshi and Dr I Tooley. 2. DECLARATIONS OF CONFLICT OF INTEREST No declarations of interest were made. 3. DECLARATIONS OF ANY OTHER BUSINESS Amendment to October 2012 JAPC minutes Spiriva (tiotropium) Respimat TTR Values for NOACs 4. MINUTES OF JAPC MEETING HELD ON 9 OCTOBER 2012 Mr Dhadli reported that he had been contacted by the manufacturer of Flutiform with a request that a section of the minutes of the October JAPC meeting be clarified. The meeting which had referred to the discussion about Flutiform be amended to read A table was presented comparing inhalers of Flutiform to formulary inhalers and Seretide. The information included dosages, licence and cost. The licensing for Flutiform is 12 years and above and Seretide is for over age of 5. Mrs Hunter queried whether because of the different licensing relating to age, if potential savings could be calculated if used over Seretide. JAPC were informed that epact data does not give breakdown by age groups.' Agreed: JAPC ratified this amendment to the minutes of the meeting held on 9 October MINUTES OF JAPC MEETING HELD ON 13 NOVEMBER 2012 The minutes of the meeting held on 13 November 2012 were agreed as a correct record after an amendment to minute 9 to read Mr Dhadli added that the fundamental difference between NICE and the National Osteoporosis Guideline Group (NOGG) was the use by NICE of 20,000 per QALY. 6. MATTERS ARISING a. Fluorouracil 5% Cream Mr Dhadli reported that the guidance from the north had been sent to Dr Kid Wan-Shum, RDH Consultant Dermatologist, who had agreed to forward this onto the East Midlands Cancer Network to ascertain whether the north guidelines could be adopted for use in the south. Dr Bell commented that if the East Midlands Cancer Network did not approve then this would raise questions with the Trent Cancer Network which served the north. It was important to achieve consistency in the use of the guidelines and a decision from the East Midlands Cancer Network would be awaited. b. Transgender Dr Bell stated that it had been agreed at the last JAPC meeting to ascertain what happened pre-operatively in terms of responsibility for HRT. A check had been made with the Specialised Services Commissioners and the transgender service advised the GP about aspects such as dosing pre and post-operatively and this would need to be included in the shared care guidelines. 3

4 c. Co-dydramol and Co-codamol A traffic light classification for co-dydramol and co-codamol would be discussed at the January JAPC meeting. 7. CLINICAL GUIDELINES a. Heart Failure Guideline Mr Dhadli reported that the heart failure guideline had been updated in November 2012 and there had been no major changes except for the inclusion of ivabradine to reflect the NICE TA publication on ivabradine. Mrs Needham commented that ivabradine should be included in the treating heart failure flowchart on page 7 and that the appropriate NHS logo should be used throughout. Mr Dhadli would amend accordingly. SH Dr Bell referred to the Map of Medicine pathway and advised that JAPC should make a decision on the medicines elements only of the guidelines and that pathway development was mutually beneficial and should take account of the different routes into the system used by different organisations. Dr Bell would send the guideline to Ruth Cooper who was working on a Map of Medicines heart failure pathway. Mr Anderton queried whether the guidelines had been sent to the RDH consultant cardiologists in addition to Dr Cooke at Chesterfield Royal Hospital. Mr Dhadli advised that both guidelines had been sent to Mr McLean and Mr Shepherd to forward to the consultant cardiologists. Mr Steward also queried whether the guideline being developed by Dr Cooper could be considered by JAPC. DCHS had heart failure specialist nurses working in both north and south and knowledge and awareness of different policies and guidelines would be useful. Dr Bell stated that this guidance would come to JAPC for information but it would be useful for DCHS to liaise with Mrs Anne Hayes in the NHS Derbyshire County Public Health Directorate, who was leading on the Map of Medicines work. Agreed: Ivabradine classified as a GREEN specialist initiation drug for heart failure. 8. SHARED CARE GUIDELINES a. Denosumab Mr Dhadli stated that in October 2010 NICE had published guidance on the use of denosumab for the prevention of osteoporotic fractures in postmenopausal women. A traffic light classification of red had subsequently been assigned by JAPC due to long term safety data for exclusive use in secondary care. The new shared cared for denosumab has an appendix requiring the specialist/consultant to complete a form. The completed form is a useful audit tool for GPs to monitor compliance to the NICE TA. Mrs Needham commented that a reference should be included in the patient specialist section to inform their dentist that they were taking denosumab when they attended their next routine appointment because of risk to the jaw. The monitoring requirement for vitamin D levels should be taken out and the requirement to monitor plasma-calcium concentrations if egfr was less than 30mL due to increased risk of hypocalcaemia added. 4

5 b. Mr Anderton highlighted the need to include a reference to the risk of hypocalcaemia in the patient responsibilities and identification of the symptoms. A link to the MHRA drug safety update could also be included. Mr Anderton also referred to the five year specialist review and that this should be included in the consultant responsibilities. It should also be made clear in the summary of monitoring in order to avoid mis-interpretation that both baseline and six months should be administered by secondary care. Dr Mott commented that it would be necessary to discuss at CCG level the implementation of the shared care guideline which would be particularly challenging to primary care. Mr Dhadli advised that an had been received from the manufacturer of denosumab which indicated that 102 primary care organisations had denosumab as amber, 50 as red and 10 as green and that only four had a primary care LES in place. Mr Anderton referred to the possibility of including self-administration in the patient responsibilities and Dr Mott highlighted that a lot of the patients would be elderly and frail and that it may be difficult to determine which patients were being dealt with in primary care. Mr Branford commented generally that in the north a shared care agreement once approved by JAPC used to be implemented by every GP practice but this was no longer the case. Consequently there was a need for agreement that all shared care agreements should be implemented by every practice and it was highly important that a solution to the current inconsistencies be obtained. In connection with the five year review it was agreed that the need for the patient to contact the GP surgery after this time period had elapsed should be included in the list of patient responsibilities. : The implementation of the shared care guideline by primary care would be discussed by the Derbyshire CCGs. Agreed: JAPC ratified the shared care guideline for denosumab with the inclusion of the suggested amendments. Fluoxetine in Children Mr Shepherd stated that a shared care guideline had been developed for use in the north to address the current lack of clarity as to whether children could be discharged back to primary care due to the fact that some GPs were willing to prescribe fluoxetine to children and others were not. During discussion Mr Dhadli queried the age when children would start on fluoxetine as the shared care guideline indicated up to the age of eighteen. The licensing was from 8 years old and the NICE guidance indicated 12 to 18 or cautiously in 5 to 11 year olds. Mr Shepherd stated that it would be used in the over 8 age group. Mr Anderton queried whether any benefit could be obtained from having a shared care guideline as opposed to having a traffic light classification of green specialist with initiation in adolescents by CAMHS. AM 5

6 c. Dr Parkin referred to the need for discussion at CCG level about practice engagement with shared care guidelines. Mrs Needham highlighted the necessity of establishing which practices were having particular issues with these. Mr Anderton commented on the potential impact of a shared care guideline for CAMHS on paediatric prescribing of fluoxetine within other settings such as the Derbyshire Children s Hospital. Dr Mott added that it would be useful to highlight which practices were not implementing the shared care and convey this information to CCGs. Agreed: A wider discussion of concordance by primary care to shared care agreements would be held at the February JAPC meeting. Agreed: It was agreed that fluoxetine for children be classified as a GREEN specialist initiation drug. Agreed: It was agreed not to have a shared care guideline. Phosphate Binders Mr Anderton stated that the shared care guidance for the treatment of hyperphosphataemia in patients on dialysis had been updated with the inclusion of three new products. Mr Dhadli added that the new formulations were cost neutral and that the existing products were not close to patent expiry. Agreed: JAPC ratified the updated Phosphate Binders Shared Care Guideline. 9. MISCELLANEOUS a. QIPP Switching of Dipyridamole to Clopidogrel Following TIA Mr Dhadli explained that currently local guidance reflected advice from NICE TAG 210 which recommended Asasantin Retard following a TIA. This had been highlighted as a QIPP opportunity by PrescQIPP (NHS East Midlands and East) who had identified that TIA patients could be switched to clopidogrel if this was supported in consultation with the local Trust/Stroke Network. There were significantly lower costs for clopidogrel over dipyridamole MR (with or without aspirin) now that clopidogrel was a generic medicine. This approach was supported by both CRH and RDH. Agreed: It was agreed that TIA would be included with ischaemic stroke in local guidance and a reference to this and the use of an unlicensed indication for clopidogrel be included in the JAPC bulletin. Agreed: JAPC approved the QIPP switching of dipyridamole to clopidogrel following TIA. b. Seretide Mr Dhadli stated that it had been agreed at the October JAPC meeting to traffic light Seretide following the traffic light classification of flutiform as a brown drug. Seretide was a combination inhaler with active ingedients of fluticasone and salmeterol licensed for the prophylaxis of asthma and COPD. 6

7 c. A traffic light classification for Seretide had been deferred in the past due to safety concerns and the use of single combination inhalers with beclomethasone, the preferred steroid choice. Mr Dhadli referred to a study which had revealed cases of adrenal suppression in children when fluticasone had been used above the licensed dosage. During discussion Mr Anderton commented that, if a traffic light classification of brown was given, a strategy would be needed to explain the preferred choice of combination inhaler and how to ensure compliance. The emphasis should be placed on the use of current products which had been available for some time and about which information was available. It would be preferable to use fluticasone within licensed dosages and in accordance with guidelines rather than to restrict its use with a brown traffic light classification. Dr Bell queried whether the traffic light classification of fluticasone should be re-considered and whether the use of combination inhalers in the light of rising costs be discussed when the appropriate information was available. Dr Mott suggested that it would also be necessary to consider the treatment of asthma separate from COPD and whether separate paediatric asthma guidance was required in conjunction with the asthma guidance for adults. A traffic light classification of brown for Seretide for use by adults would be acceptable but there were licensing implications for the use in children. Mr Hulme stated that it may be advantageous to focus more on the appropriate use of inhalers in order to avoid the current concerns about the use of seretide and fluticasone and have a robust mechanism in place to ensure that this happened. Agreed: Mrs Qureshi would be requested to develop an asthma guideline for children for discussion at the January JAPC meeting. Agreed: A traffic light classification for Seretide to be deferred pending further discussion of an asthma guideline for children. Prucalopride Mr Anderton referred to NICE TA 211 which had recommended prucalopride as an option for the treatment of chronic constipation only in women for whom treatment with at least two laxatives from different classes and at the highest recommended doses had failed to provide adequate relief. The drug was currently classified as red as it required specialist input in prescribing. RDH proposed that this drug could be continued in primary care and to support primary care they had developed an algorithm with gastro-enterology input. The algorithm included a four week trial to determine efficacy and the appropriateness of further treatment. Mr Anderton added that it was also important to ensure that people with drug induced constipation were excluded as there was no evidence that this drug was useful in the treatment for this group of patients. Mr Dhadli recognised that whilst CCGs must support NICE technologies the evidence for prucalopride and the potential for widespread primary care prescribing was a concern. It was noted that the SMC had rejected /SQ 7

8 d. e. prucalopride in 2010 and again in 2011 and also MTRAC s decision as a lower place in primary care in Details were given of the Drugs and Therapeutics Bulletin review in 2011 which had referred to three randomised double-blind trials of 2mg and 4mg versus placebo for twelve weeks. Mrs Needham stated that a red classification had been given as the NICE TA had stated it should only be prescribed by a specialist clinician with experience of treating chronic constipation. Mrs Needham added that there was a lack of long term safety data arising from its use in primary care and a lack of guidance as to when to review or stop its use. It was agreed that 12 monthly reviews be undertaken by secondary care to assess efficacy. A green classification could indicate that it could be widely used. Mrs Needham stated that the algorithm needed to be changed, the middle box needed to include a 6-month trial of at least two laxatives prior to prucalopride initiation by the specialist. Agreed: Prucalopride classified as a BROWN specialist initiation drug in accordance with agreed algorithm, with an annual review by a gastroenterologist specialist. : A reference to the need for an annual review to be included in the algorithm and adjustment to the algorithm to include 6 month trial of two laxatives in the middle box, prior to prucalopride initiation. Pyrimethamine Mr Dhadli stated that a request had been received by a GP to prescribe pyrimethamine for a patient with an infection caused by Toxoplasma gondii. The drug was currently classified as a black drug and a re-classification to red when co-prescribed with sulfadiazine had been requested. Both CRH and RDH had indicated that they did not object to a red light classification. Agreed: Pyrimethamine re-classified as a RED drug when used in combination with sulfadiazine. Rufinamide Mr Dhadli reported that a Derby GP had been asked to continue prescribing rufinamide following a request from secondary care. The current formulary advised that consultant advice should be followed and that the NICE clinical guideline 137 on the diagnosis and management of the epilepsies in adults and children in primary and secondary care should be followed. Mr Dhadli noted to JAPC a gap in policy whereby newer more expensive antiepileptics could be prescribed without scrutiny of evidence and place in treatment as examples previously classified retigabine and stiripentol, which were two drugs used in the control of epilepsies, had been classified by JAPC as red. Rufinamide is licensed for adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients four years of age and older. Mr Dhadli stated that it was not known how rufinamide compared with 8

9 f. g. currently available treatments lamotrigine and topiramate which were significantly cheaper. Mr Branford commented that it would be useful to obtain agreement as to which drugs to be used as there now was a wide range of anti-epileptic drugs some of which had limited effectiveness and this was particularly important in a learning disabilities setting. Mr Anderton stated that rufinamide would only be used in the most difficult cases and, until more knowledge was obtained as to its safety and efficacy, red was the most appropriate classification. Mr Dhadli added that prescribing data indicated that it was being more widely prescribed in primary care than anticipated. Mr Hulme stated that there was a need to look at the whole range of drugs as these were a group of drugs in a specialist area which were increasing in cost with little added benefit and there was a great deal of clinical variation. Agreed: It was agreed that Medicines Management would An update would be given to the April JAPC meeting. Agreed: It was agreed that a traffic light classification be deferred pending further discussions about the use of anti-epileptic drugs. Carbamazepine Mr Dhadli advised that a Derby GP had queried whether patients should be actively switched from taking immediate release carbamazepine to the modified release formulation according to a recommendation in NICE Clinical Guideline 137 The epilepsies:: the diagnosis and management of the epilepsies in adults and children in primary and secondary care. It had been concluded that it may be worthwhile switching those patients whose seizure control was good but who are experiencing unacceptable adverse effects. Agreed: Patients should not be switched to the controlled-release formulation of carbamazepine if their seizure control was good and not experiencing adverse reactions. Prescribing Specification JAPC was requested to convey comments on the new prescribing specification to Mr Dhadli before the January meeting. SH All 10. NICE Mr Dhadli informed JAPC of the comments for the CCGs which had been made for the following NICE guidance: a. b. TA266 Cystic fibrosis - mannitol dry powder for inhalation for treating cystic fibrosis It was noted that mannitol was specialised commissioning and would not have a big cost impact. TA267 Ivabradine for treating chronic heart failure Ivabradine for treating chronic heart failure had been assigned a traffic light 9

10 c. classification earlier in the meeting. QS23 drug use disorders This was noted for information. 11. JAPC BULLETIN The following changes to the JAPC bulletin were noted: Osteoporosis and screening risk tools JAPC agreed that both tools provide a good screening assessment when patients present opportunistically and before considering referral for a DEXA. 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? Classifications Ivabradine for heart failure GREEN specialist initiation Denosumab AMBER Fluoxetine in children GREEN specialist initiation Prucalopride BROWN specialist initiation Pyrimethamine RED in combination with sulfadiazine Mannitol Dry Powder RED 14. ACTION SUMMARY The action summary was noted and amendments made: Shared care disulfiram/acamprosate To be discussed by JAPC in January Fluorouracil 5% - Awaiting decision from the Cancer Network. 15. MHRA DRUGS SAFETY UPDATE The MHRA Drug Safety Alert for November 2012 was noted. Mr Dhadli highlighted the request to provide the brand name and batch number when reporting adverse drug reactions associated with biological medicines such as biosimilar products or vaccines. 16. MINUTES OF OTHER PRESCRIBING GROUPS FOR INFORMATION RDH Drugs and Therapeutic Committee 15/10/12 Burton Hospital Drugs and Therapeutic Committee 11/9/12 Stockport Area Medicine Panel 9/10/12 Burton Hospital Drugs and Therapeutic Committee 19/11/ ANY OTHER BUSINESS a. Mr Hulme reported that a challenge had been made by a GP on the Erewash Prescribing Group about the JAPC decision on TTR values for the new 10

11 b. NOACs. It would be necessary to clarify why the lower TTR value had been chosen by JAPC to highlight a possible impact on patient care if different TTR values were used in neighbouring Trusts. Mr Dhadli commented that Dr McKernan, RDH Consultant Haematologist, had recommended a lower value in the guidance in order that experience be gained and then reviewed in the new year. Dr Bell suggested that it would be helpful if Erewash CCG were represented at JAPC. Mrs Needham stated that tiotropium Respimat was currently classified as green but, due to recent MHRA safety concerns about potential increased cardiovascular events, it was proposed that tiotropium Respimat be reclassified as brown and made clear that it was for exceptional use only. Agreed: Tiotropium Respimat re-classified as a BROWN drug. 18. DATE OF NEXT MEETING Tuesday, 8 January 2013 in The Birchwood Room, Post Mill Centre, South Normanton. 11

DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC)

DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday 12 March 2013 CONFIRMED MINUTES Summary Points Traffic lights Drug Bromfenac Loteprednol Apixaban Circadin (Metatonin