DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday 8 May 2012

Transcription

1 DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday 8 May 2012 Summary Points Traffic lights Drug Pro D3 Fultium Rifaxamin for traveller s diarrhoea Rifaxamin for hepatic encephalopathy Eribulin Telaprevir Boceprevir Fingolimod Decision GREEN GREEN BLACK RED BLACK RED RED RED Clinical Guidelines Use of Suppressive Aciclovir in Patients with Recurrent Genital Herpes Cost Effective Prescribing of Oral Vitamin D Antipsychotics Physical Monitoring 1

2 Present: NHS Derbyshire County Dr A Mott Dr D Fitzsimons Mr S Hulme Ms K Needham Dr T Parkin Mrs S Qureshi Dr A Tooley GP Southern Derbyshire CCG (Deputy Chair) GP North Derbyshire CCG Head of Prescribing, 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 Ms L Hunter Specialist Commissioning Pharmacist Assistant Head of Finance Southern Derbyshire CCG Derby Hospitals NHS Foundation Trust Mr D Anderton Dr J Leung Senior Pharmacist Chair Drugs and Therapeutic Committee Derbyshire Healthcare Foundation Trust Ms B Thompson Pharmacist Chesterfield Royal Hospital NHS Foundation Trust Mr M Shepherd Chief Pharmacist In Attendance: Dr A McKiernan Dr R Stanworth Mr A Thorpe Dr P Trifunovic Consultant Haematologist, RDH (for item 6a) Consultant Endocrinologist, RDH (for item 7a) NHS Derby City (minutes) F2 Doctor in Public Health 2

3 Item 1. APOLOGIES Dr J Bell, Dr C Emslie and Mr I Gibbard. Action 2. DECLARATIONS OF CONFLICT OF INTEREST No declarations of interest were made. 3. DECLARATIONS OF ANY OTHER BUSINESS Keppra Irbesartan 4. MINUTES OF JAPC MEETING HELD ON 10 APRIL 2012 The minutes of the meeting held on 10 April 2012 were agreed as a true and accurate record after the following amendments: Item 5a Ticagrelor to read Royal Derby Hospital proposed to change the duration of prasugrel treatment to 12 months in patients with STEMI and to limit the use of ticagrelor so that it would not be used for patients with unstable angina but in NSTEMI patients with strict criteria and STEMI patients with contra-indications to prasugrel. Item 5a reference to TIMI Score to be amended to read TIMI trial. Item 16 noted that Dr Markus Henn is the Prescribing Lead not Chair of Erewash CCG. 5. MATTERS ARISING a. Drugs of Limited Clinical Value Mr Dhadli reported that it had taken longer than expected to collect the responses from JAPC members and consequently the final version of the table would be considered at the next JAPC meeting. b. Ticagrelor Dr Leung advised that the NSTEMI algorithm was awaited from the Royal Derby Hospital. This would need to be discussed by both the JAPC and the Drugs and Therapeutic Committee. Mr Dhadli referred JAPC to the costings for antiplatelet (ticagrelor) ACS for South and North Derbyshire based on figures supplied by Royal Derby Hospital and the NICE costing template respectively as follows: South Derbyshire estimated cost avoidance figure of 151,232 by the one month switch from prasugrel to clopidogrel and incremental cost of 532,656 at a cost per head of population revised to 81p. North Derbyshire - estimated cost avoidance figure of 41,000 by the one month switch from prasugrel to copidogrel and incremental cost of 377,914 at a cost per head of population of Mr Dhadli advised that the cost per head figure is a guide to show the difference of policy between North and South. If RDH predicted figures are correct NICE may have overestimated those requiring treatment in which case the cost for the North may also be an overestimate. 3

4 In connection with these costs Mr Anderton commented that it would be useful to ascertain the number of outcomes prevented based on these figures. Dr Mott stated that ticagrelor had now been classified as green cardiologist initiation and it is helpful to obtain indications of likely expenditure as a baseline to compare with the actual costs involved in due course. Mr Dhadli queried whether the duration of treatment for STEMI patients with non PCI for ticagrelor was 28 days only and then stop. Dr Leung stated that this would be extremely rare and these patients would need to be treated on an exceptional basis. Mr Dhadli would query this with the cardiologists. 6. CLINICAL GUIDELINES a. Vitamin D Deficiency Dr Stanworth explained that vitamin D had featured extensively in the media and an estimated 60-70% of the UK population, particularly in the ethnic minority communities and the immigrant population, had been estimated to be deficient in vitamin D. However, no national guidance was currently available and there was a lack of evidence in this area. Dr Stanworth stated that the focus in the development of the guideline had been placed on those patients who really had symptoms that suggest a low level of vitamin D and split these away from the others without symptoms who could be managed by lifestyle modification and perhaps supplementation. There were huge costs associated with oral vitamin D preparations due to the lack of available licensed products in the UK and the necessity to obtain unlicensed specials. Dr Stanworth referred to a nutritional supplement ProD3 which was now available and was the preferred formulary choice for treatment. There was also a licensed daily dose product Fultium D3 available for prescription which did not contain calcium due to concerns about long term effects of this. Discussion followed and Mr Shepherd stated that the guideline would be discussed by the CRH Drugs and Therapeutic Committee next week. Dr Leung queried whether the vitamin D products were vegan, vegetarian and Halal suitable as it was important that there were different options available. It was confirmed that ProD3 was vegetarian and Halal and that the ProD3 liquid preparation would conform to vegan requirements. Mr Anderton highlighted the importance of awareness about the range of vitamin D products which were available and the importance of flexibility with these. Ms Needham requested that Pro D3 be added to the dose section of the management of vitamin D deficiency on page four of the guideline and also queried the reference to the length of course for adults of 15 to 30 days according to vitamin D level and children of 3 to 6 months. Dr Stanworth stated that the reference in the adult section referred to the vitamin D level at the start but the children s section was based on the work being undertaken by Dr Tinklin, Consultant Paediatrician, with 4

5 the rickets patients. Dr Stanworth would discuss with Dr Tinklin whether there was any other way of determining the length of dose for children other than the measurement of calcium and creatine ratios. Ms Needham also requested that a reference be added that children over the age of 12 years for maintenance could use Fultium D3. The reference to calcium in the children s section would be removed. RS Dr Tooley commented that the inclusion of the product information in the guidelines as opposed to a separate document would be useful for GPs together with details of where Healthy Start Vitamins could be obtained in the County. Mr Dhadli stated that arrangements in the County were under review although information could be found on the Healthy Start website. Mr Hulme requested that a statement be placed in the front of the guideline about the cost effectiveness of vitamin D products and these should be approved by JAPC when available. A date for review of the guidelines should be inserted and Dr Stanworth would discuss this with Sarah Fitton from Medicines Management. The second bullet point on the front of the guideline would be amended to read recommended for supplementation rather than prevention. It was also pointed out that Pro D3 was an unlicensed product and that this should be highlighted in the bulletin. Agreed: Dr Stanworth would incorporate the amendments which had been suggested and send the updated guideline to Mr Dhadli for circulation to JAPC members. RS/ b. Antipsychotics Recommended Physical Monitoring Ms Thompson informed JAPC that changes had been made to the recommended physical monitoring document: Lipids added to monitoring at three and six months and annually Recommendation for U & Es, LFTs and FBC at three and six months removed Check cholesterol in annual monitoring amended to cv risk assessment ECG baseline for all patients Mr Anderton queried the need to have lipid monitoring at the stated intervals. Ms Thompson explained that lipid monitoring had been included according to the paper by the Royal College of Psychiatrists and there was some evidence that disruption to blood glucose was more likely at the earlier stage of treatment rather than later. It was agreed to remove the reference to lipid monitoring at three months. Dr Mott referred to ECGs and that it is unclear whether or not these would be undertaken in primary care, apart from the baseline which would be done by the Trust. Ms Thompson stated that the DHFT Medical Director had been requested to take this issue including ECG 5

6 interpretation up with Hardwick CCG as lead commissioners. Dr Tooley highlighted the need for specific guidance to enable GPs to understand what they should be looking for such as the measurement of QT intervals and this would assist with any decisions to stop a drug. c. Action: Ms Thompson would send the amended version of the guideline to Mr Dhadli for circulation to JAPC members. Use of Suppressive Aciclovir in Patients with Recurrent Genital Herpes Mr Dhadli stated that this was an update prepared by Dr Ade Apoola, Consultant in Genito-Urinary Medicine, to an existing guidance which expired in May Dr Parkin commented that parts i and ii in the section on indications were the same and that part i could be taken out. Mr Anderton highlighted that following a period of antiviral suppression and in the event of a breakthrough patients would be provided with 200mg of acyclovir five times a day. Mr Anderton suggested that instead the dose should be increased to 400mg three times a day. Mr Dhadli would feed this back to Dr Apoola. Agreed: JAPC approved the updated guidance for the use of suppressive aciclovir in patients with recurrent genital herpes. BT/ 7. NEW DRUG ASSESSMENTS a. Dabigatran/Rivaroxaban Mr Dhadli stated that Dabigatran and Rivaroxaban were two New Oral Anticoagulant drugs (NOAC) and it would be necessary to choose a preferred product or products, devise bleeding protocols, agree affordable TTR values, decide on patient decision aids and agree clinical guidelines with inclusion/exclusion criteria, exceptionality and referral criteria for GPs and a protocol for switching to and from warfarin. In addition the uptake of the guidance would need to be monitored together with activity and disinvestment. An audit plan would need to be developed and a holding position agreed for the current traffic light status of red for dabigatran. The rivaroxaban NICE technology appraisal is expected in May Dr McKiernan stated that the two drugs each had one randomised control trial which showed that both were non-inferior to warfarin at preventing embolic stroke. Both drugs had a major bleeding risk and overall mortality rates were similar to warfarin. Dabigatran and rivaroxaban are not reversible unlike warfarin and no new clinical trials have yet been published about reversibility. Warfarin remains a good drug which is reversible and easily testable. NICE have recommended dabigatran as an option and if the patient is already on warfarin the time in treatment range should be borne in mind. There were a variety of documents about which groups of patients could be put on dabigatran or rivaroxaban. It would be advisable to start with a small group of patients with clear cut guidelines as to who would meet the criteria until there is more experience in using these drugs and longer 6

7 term safety in the wider population is established. JAPC was informed that the TTR values from RDH (72%+) and from a random selection of practices in Derbyshire (80%+) operating a warfarin monitoring LES indicated that current control was very good. During discussion Dr McKiernan commented that it was difficult to compare the two drugs due to a lack of evidence by direct comparison. Mr Anderton highlighted that NICE had recommended a higher dose of dabigatran and that the lower dose would only be given if the patients were elderly. Dr McKiernan added that it would be desirable to commence with a small group of patients with very tight criteria in order to ascertain whether they were compliant and who were most likely to benefit. Mr Shepherd commented that Chesterfield Royal Hospital was looking at rivaroxaban for treatment in IV drug users as an alternative to heparin. There was no great pressure from the physicians. Dr Mott outlined the action which would now need to be taken. It was agreed that warfarin would remain the first line drug of choice but the choice of agent after this is not yet clear. This would need to be determined in view of the fact that the two new drugs would need to be handled differently if there was a significant bleeding event. The patient cohort would have to be identified and implementation agreed. It would be advantageous to understand the position to be adopted in surrounding areas such as Nottingham and Leicester. Dr McKiernan requested that some patient publicity be produced to give a realistic view of the agents and to emphasise the good points of warfarin. It was noted that the NPC will shortly be issuing patient decision aids to support prescribers during consultation. Mr Anderton queried whether greater emphasis should be placed on the lower dose of dabigatran which in the RE-LY study had shown to be as effective as warfarin but with fewer major bleeds and fewer haemorrhagic strokes compared to the higher dose recommended by NICE. Dr Leung stated that NICE had based their cost effectiveness on 150mg which would be affected if the dose was changed. Mr Anderton added that there were other options to warfarin such as coumarins and phenindione which needed to be highlighted. Dr McKiernan pointed out that there were some drug interactions associated with rivaroxaban such as with St John s Wort. Action: The cohort of patients would be agreed and a statement on bleeding risks developed for the next JAPC meeting when a decision would be made to adopt dabigatran or rivaroxaban. Dr McKiernan would send this to Mr Dhadli together with the document from Teeside. Action: Dr McKiernan would discuss with colleagues about the desirability of developing a Derby and Nottingham joint approach. AMcK AMcK 7

8 Action: An interim statement of the points made by Dr McKiernan concerning equal bleeding risk, equal stroke reduction, clinical trials only two years and non reversibility would be produced for use by GPs and prescribing leads. 8. MISCELLANEOUS a. Duac Mr Hulme advised that Duac was not currently classifed under the traffic light system but is commonly used and a request had been made for it to be classified by a GP. JAPC was requested to consider the position on the usage of antibacterials and combination products in acne. Mr Anderton stated that Duac was a combined proprietary product of benzoyl peroxide combined with clindamycin and is a once daily product. A Drugs and Therapeutic Bulletin (December 2010) concluded that combination products had not proved to be more effective than the individual components but were more expensive. Dr Fitzsimons commented that from a compliance point of view patients preferred to use the once a day product. Discussion followed and it was suggested that there was a need for the use of combination products to be discussed with the dermatologists and to establish whether there were any existing guidelines. Agreed: The traffic light classification would be delayed until more information was available. b. Piogltazone Generic Prescribing and Licensing Mr Dhadli stated that several pioglitazone products were available and had been granted a licence based on their ability to demonstrate bioequivalence with the original brand Actos. Community pharmacists had requested clarity about this as the generic pioglitazone does not have the full licensed indications that Actos has. Agreed: JAPC approved the prescribing and dispensing of generic pioglitazone products and that this should be used within the local guidance. c. Rifaxamin for Hepatic Encephalopathy Mr Dhadli advised JAPC that hepatic encephalopathy (HE) was a disturbance in the central nervous system function because of hepatic insufficiency. The cause of HE is accumulation in the blood of toxic substances that are usually removed by the liver. This is reversed with treatment which relies on suppressing the production of the toxic substances in the intestine with the laxative lactulose or with nonabsorbable antibiotics. There is evidence for the efficacy of rifaxamin in the treatment, but evidence for prevention was not well established. NICE guidance is to be published in June 2013, however two GPs had been requested to prescribe rifaxamin for HE, hence a traffic light classification is needed. 8

9 Mr Anderton informed JAPC that the DHFT Drugs and Therapeutic Committee had discussed this in 2011 and there was good evidence to support in terms of treatment and recurrent episodes. A licence had been given to an American product for the treatment of HE which is a 550mg tablet which is much more expensive than the 200mg tablet Mr Anderton referred to studies which had revealed an improvement in the breakthrough events of HE. The Drugs and Therapeutic Committee had proposed that the liver specialists would use this drug in selected patients with a review every three months if patients were on long term maintenance. Agreed: Rifaxamin for Hepatic Encephalopathy classified as a RED drug. Rifaxamin for Traveller s Diarrhoea Dr Parkin highlighted the following statement from the DTB What to do about traveller s diarrhoea which stated that The NHS does not cover prescription of antibacterials in case of illness while travelling abroad so travellers will need to buy them with a private prescription. Agreed: Rifaxamin for Traveller s Diarrhoea classified as a BLACK drug. 9. NICE a. TA250 Eribulin for the treatment of locally advanced or metastatic breast cancer Eribulin classified as a BLACK drug. b. c. d. e. TA 251 Dasatinib, Nilotinib and Standard-dose Imatinib for the first-line treatment of chronic myeloid leukaemia Dasatinib, Nilotinib and Standard-dose Imatinib classified as RED drugs TA 252 Telaprevir for the treatment of genotype 1 chronic hepatitis Telaprevir classified as a RED drug TA 253 Boceprevir for the treatment of genotype 1 chronic hepatitis C Boceprevir classified as a RED drug. TA 254 Fingolimod for the treatment of highly active relapsingremitting multiple sclerosis Mr Dhadli highlighted a cost implication of 122,000 for the whole of Derbyshire. Fingolimod re-classified from black to a RED drug in view of the positive NICE TA. 10. JAPC Bulletin Mr Dhadli stated that a saving of approximately 380,000 would be 9

10 added to the luteinising hormone releasing hormone (LHRH) analogues. A statement to be added to the glucosamine section that it is line with NICE, BNF and SMC recommendations. The amended JAPC bulletin was ratified by the JAPC. 11. GUIDELINE GROUP The Guideline Group action tracker was noted. 12. TRAFFIC LIGHTS ANY CHANGES? Classifications Pro D3- GREEN Fultium GREEN Duac No classification Rifaxamin for traveller s diarrhoea BLACK Rifaxamin for hepatic encephalopathy RED Eribulin BLACK Dasatinib, Nilotinib and standard-dose Imatinib RED Telaprevir RED Boceprevir RED Fingolimod - RED 13. ACTION SUMMARY The action summary was discussed. Vitamin D To be taken off. Buccal Midazolam Still waiting for response from Royal Derby Hospital. Ticagrelor To be taken off. PGD for emergency hormonal contraception To be discussed at June JAPC meeting. Dabigatran/Rivaroxaban Formulary choice of NOAC and cohort to be discussed at June JAPC meeting. 14. MHRA DRUGS SAFETY UPDATE The MHRA Drug Safety Alert for April 2012 was noted. Dr Mott highlighted the advice for healthcare professionals in the Drug Safety Update concerning prolonged use of proton pump inhibitors (PPIs) being associated with hypomagnesaemia and the desirability of having a position on this. Mr Dhadli informed JAPC that 825,000 items had been dispensed last year and if the message of testing is not clear could impact on pathology costs. For each test at RDH it would be 48p per magnesium testing and the cost in Chesterfield was 3.95p per head. The difference being due to RDH operating under a block plus activity contract. Following discussion it was agreed that attention 10

11 should be drawn in the JAPC bulletin to awareness of the symptoms of hypomagnesaemia and the patients who may be at risk of this. It was suggested that GPs may consider testing in symptomatic patients. Ms Needham also highlighted the risk of bone fracture with the use of PPIs and this would also be included in the bulletin. Action: Mr Dhadli to highlight the risks identified concerning hypomagnesaemia and the use of PPIs in the JAPC bulletin. 15. MINUTES OF OTHER PRESCRIBING GROUPS FOR INFORMATION DCHFT Drugs and Therapeutic Meeting 22/3/ ANY OTHER BUSINESS a. Ms Needham requested that an amendment be made to section 13 of the minutes of the JAPC meeting held on 10 January 2012 concerning Keppra and Generic Prescribing. This should say that JAPC supports the generic prescribing of Keppra and only supports brand prescribing by exception. b. Dr Leung reported that a request had been received from a GP to prescribe irbesartan for a diabetic patient. Irbesartan was on the hospital formulary but had not been given a traffic light classification. It would be necessary to ascertain why this drug had been chosen in preference to losartan and this would be discussed by the RDH Drugs and Therapeutic Committee at its next meeting. 17. DATE OF NEXT MEETING Tuesday, 10 June 2012 in Meeting Room 3, The Hub, South Normanton. 11