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

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1 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) Perindopril Rivaroxaban for all indications other than AF Decision BROWN RED Unclassified RED Clinical Guidelines Pregnant Women and neonates in contact with chicken pox and shingles Shared Care Guidelines Management of ADHD in childhood Paediatric Buccal Midazolam Patient Group Directions PGD for Human Papillomavirus (HPV) vaccine (Cervarix) PGD for Human Papillomavirus (HPV) vaccine (Gardasil) PGD for Trivalent Seasonal Influenza vaccine 1

2 Present: NHS Derbyshire County Dr J Bell Dr C Emslie Dr D Harris 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 Antimicrobial Pharmacist 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 Specialist Commissioning Pharmacist Derby Hospitals NHS Foundation Trust Mr D Anderton Dr F Game Dr J Leung Senior Pharmacist Chair Elect Drugs and Therapeutic Committee Chair Drugs and Therapeutic Committee Derbyshire Healthcare Foundation Trust Dr S Taylor Consultant Psychologist, Chair Drugs and Therapeutic Committee Chesterfield Royal Hospital NHS Foundation Trust Ms C Lawson Pharmacist In Attendance: Dr B Gray Mr A Thorpe F2 Doctor (Public Health) NHS Derby City (minutes) 2

3 Item 1. APOLOGIES Dr D Fitzsimons, Mr T Gray, Mr S Hulme, Mrs L Hunter and Mr M Shepherd. Action 2. DECLARATIONS OF CONFLICT OF INTEREST No declarations of interest were made. 3. DECLARATIONS OF ANY OTHER BUSINESS Bowel Cleansing Products Rebates/Rebate Values in JAPC Minutes CCG Reporting to the Board Co-enzyme Q10 ECGs Insufficient Lactation 4. MINUTES OF JAPC MEETING HELD ON 10 JULY 2012 The minutes of the meeting held on 10 July 2012 were agreed as a true and accurate record after the following amendments: item number 5a to read Dr Taylor advised that measurement of increased QTc intervals in the use of ECGs would be discussed with the cardiologists and it was confirmed that a measurement of an increased QTc interval greater than 499 milliseconds was an appropriate value for GPs to review. item number 5b to read 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 clinic at CRH. Cyanocobalamin should be classified as BROWN (for B12 deficiency). item number 7 to read Mr Shepherd would follow this up with Medicines Information and report back to JAPC. Dr Bell highlighted the use of the term exceptional in the minutes. Following discussion the use of the word exceptional in the brown drug traffic light list was agreed by JAPC to be the standard dictionary use of the word exceptional which differed from the legally defined use of the word exceptional in Individual Funding Requests. 5. MATTERS ARISING a. New Oral Anticoagulants (NOACs) Mr Dhadli reported that a response from Dr McKiernan had been received in response to a query about whether acenocoumarol could be tried for patients who were intolerant to warfarin. Dr Mckiernan had indicated that this would be done in secondary care in Derby with an appropriate change to the protocol. Dr Justin Cook, Chesterfield Royal Hospital Consultant Cardiologist, had advised that in primary care it was more likely in reality that patients would be tried with dabigatran or rivaroxaban straight away rather than sending patients back to secondary care for acenocoumarol. Ms Needham reported that GPs had queried the reference in the guideline whether they refer patients for phenindione and acenocoumarol to secondary care as they were 3

4 unfamiliar with these drugs. Mr Dhadli stated that it would be necessary to look at the RDH protocol to establish the feasibility for acenocoumarol or phenindione to be initiated in primary care. Mr Anderton commented that the management would be the same as for warfarin regarding the adjustment of dose according to INR but GPs may wish to have some standard guidance and there may not be a necessity for patients to go to hospital. Action: Mr Dhadli would discuss this issue further with Dr McKiernan and report back to the October JAPC meeting. Mr Dhadli referred to the query raised at the last meeting about supporting information about the new NOACs and whether this needed to be looked at by a patient group. This was not necessary as the information was aimed at GPs not patients. Liothyronine Mr Dhadli reported that the shared care guideline for Liothyronine is still waiting to be updated. Royal Derby Hospital and Chesterfield Royal Hospital had been contacted about its use for endocrinology. Mr Dhadli stated that practice pharmacists had been contacted and they had indicated that liothyronine was predominantly used for endocrine use in combination with levothyroxine. Mr Dhadli went on to state that the evidence supporting such use is lacking. CKS and UKMI were cited as references and where cognitive performance only showed statistical significance, however not a clinical significant difference Mr Anderton stated that Dr Rustam Rea, RDH Consultant Endocrinologist, had been contacted about liothyronine for endocrine use. Dr Rea had stated that, apart from the need to get a patient under clinical control, GPs may be involved in the longer term prescribing for the very few patients who had been replaced with T4, but if their quality of life was still poor this may be improved by the addition of T3. A clinical trial may be worthwhile in order to ascertain whether this was the case. Short duration clinical trials had concluded that there was no significant difference between levothyroxine alone and combined treatment. Dr Game referred to the very small numbers of patients involved and that combination therapy would only be given if a patient s T3 was measurably low. c. d. Action: Dr Game agreed to produce a form of words to be included in the traffic light classification. Clinical Trials Dr Bell referred to the policy of the PCTs not to fund drug costs when trials were completed. The PCT research governance team had been contacted to confirm that this was checked when local research studies were being reviewed. Dr Bell would update JAPC when a response had been received. ProD3 Mr Dhadli stated that JAPC needed to be satisfied that Pro D3 was still FG JB 4

5 e. able to meet local demand, was a cost effective choice and whether the use of a food supplement was considered to be a clinically effective and safe choice. Dr Stanworth, RDH Consultant Rheumatologist, and Mark Dasgupta, Head of Medicines Management at Birmingham East and North, had been contacted for their views. Dr Stanworth had indicated that patients would have no difficulty in obtaining ProD3 and supported the use of Fultium D3but queried the pharmalogical dosing and costs. The Head of Medicines Management at Birmingham East and North supported the use of Pro D3 alongside other healthcare products and had no local problems of supply or therapeutic response. Mr Dhadli added that Pro D3 had been recommended as the most cost effective product at the time of guidance production and was available in a wide range of strengths, but it was recognised that reimbursement prices may vary by pharmacy. Dr Tooley queried whether the guidelines should contain a reference to the use of a food supplement ProD3 and also the need for a large daily dosage if the licensed product Fultium D3 was used. Mr Dhadli would include this in the guideline. Agreed: The guidelines to be reviewed in six months in the light of comments received from clinicians at CRH who are currently using ProD3 and RDH. DVLA and blood glucose monitoring for people with diabetes Mr Dhadli stated that JAPC had agreed in June 2012 for a summary relating to BGT to be added to the diabetes guidance. This summary was now presented to JAPC for approval as an appendix to the guidance. Dr Mott commented that there was likely to be an increase in glucose monitoring as a result of the guidance and that it was important to be aware of conflicting messages between the diabetes guidance and that from the DVLA. It was useful to have a reference to the memory function and a link to the DVLA website in the appendix. Agreed: guidance. JAPC ratified the appendix to be added to the diabetes 6. NEW DRUG ASSESSMENT/FORMULARY ADDITION a. Azilsartan medoximil for Hypertension Mr Dhadli stated that azilsartan was a new angiotensin-ii receptor blocker for the treatment of essential hypertension in adults. Mr Dhadli referred to cost comparisons. A review of the current trials predominantly versus olmesartan and valsartan and as combinations. showed azilsartan to be efficacious in the reduction of blood pressure. JAPC decided that ARBs will be acting with a class effect and considered this to be a low priority to fund. JAPC was requested to assign a traffic light classification for azilsartan and also for the other angiotensin-ii receptor blockers. 5

6 Agreed: Azilsartan classified as a BROWN drug and the remaining angiotensin-ii receptors to be left unclassified. Ulipristal acetate (ESMYA) Mr Dhadli stated that ulipristal acetate (ESYMA) was a new oral drug for pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age and duration of treatment was limited to three months. Ulipristal was the first orally administered option for reducing excessive bleeding in uterine fibroid volume prior to surgery compared with GnRH agonists which had to be administered by injection. It was supported by two PEARL studies of which PEARL I compared the efficacy and safety of ulipristal 5mg, 10mg and placebo on uterine bleeding and fibroid volume. PEARL II assessed the efficacy and safety of ulipristal vs leuprorelin acetate for treating symptomatic fibroids prior to surgery. The studies showed that ulipristal was an effective treatment for controlling excessive bleeding and fibroid size in women with uterine fibroids prior to surgery. For patients not undergoing surgery there was a more sustained effect on fibroid volume up to six months after stopping. PEARL did not assess surgical outcomes following ulipristal therapy and its long term safety and efficacy was questioned as it was a new drug for this condition. There were also low incidence of side effects such as hot flushes. Mr Dhadli commented that there could be a case for initiating the drug in secondary care and undertaking follow ups in primary care, but without a clear pathway to reduce outpatients appointments should remain within the hospitals. During discussion it was highlighted that the drug was licensed for three months pre-surgery and that a decision to undertake surgery had to be made first in secondary care. Agreed: Ulipristal acetate classified as a RED drug. c. Perindopril JAPC noted that this was a request by RDH to include indapamide (IR) and perindopril to the traffic light formulary. Mr Anderton stated that the request had been made by a group of stroke physicians who wanted to have access to generic perindopril rather than coversyl arginine as one of their treatments for secondary prevention of stroke and other cardiovascular events. Mr Anderton added that this was based on strong clinical evidence as to its effectiveness compared with other ACE-inhibitors. It was slightly more expensive than the existing standard ACE inhibitors and studies had indicated that it was useful for blood pressure reduction in elderly hypertensive patients 80 years or older. During discussion Mr Dhadli advised that the NICE guidance on hypertension did not specify any brand of ACE inhibitor and referred to the PROGRESS trial which had been a five year randomised study with or without indapamide. Perindopril had been compared against placebo and another ACE inhibitor. A pre-specified sub-group analysis had demonstrated that only combination therapy and not single therapy was effective and the benefit could be largely attributable to the diuretic. Mr Dhadli commented on the cost if the wrong perindopril salt 6

7 was selected and the additional costs of combination products as a risk to prescribing budgets. Dr Bell pointed out that a lot of patients who had strokes were managed in primary care and the number was significant. Dr Mott commented that perindopril had not received a traffic light classification and NICE had not recommended a particular ACE inhibitor. Perindopril was currently available but was not preferentially chosen as an ACE inhibitor. However it had proved to be useful for a particular cohort of patients. Agreed: Perindopril would not be given a traffic light classification and Royal Derby Hospital would place it on its formulary. 7. CLINICAL GUIDELINES a. Antipsychotics Recommended Physical Monitoring Mr Dhadli presented the changes which had been made to the document: QTc interval not to be greater than 499 milliseconds had been added. What should be done about abnormal results following K, Mg and Ca blood tests. Lipids amended to three months and yearly thereafter. During discussion Dr Parkin referred to the concern previously expressed as to whether it was appropriate for GPs to take responsibility for the interpretation of ECG results. Dr Parkin stated that this issue had been taken back to the Hardwick CCG commissioners and a response had now been received from the Hardwick CCG Clinical Reference Group. The Clinical Reference Group had met on 10 August 2012 and a unanimous opinion had been expressed that GPs were not in a position to give an opinion on the subtle ECG changes caused by the psychotropic medications. It was recommended that if it was NICE recommendations that these examinations were conducted regularly on all patients on these medications a separate cardiology service should be commissioned by the provider initiating the treatment to interpret the ECGs. Individual GPs may wish to provide ECGs but this should not be part of any shared care agreement as all GPs do not offer ECGs in practice. Dr Parkin highlighted that this was a safety issue as GPs did not feel confident to interpret the ECG results. Mr Dhadli informed JAPC that every practice in Derby City had been issued with an ECG machine, training provided and funding made available. Mr Anderton referred to the increasing number of drugs which required QTc intervals to be measured. Dr Mott commented that different contracts in primary care made this a particularly challenging issue. Agreed: Dr Bell would draft a letter about the cardiology monitoring to be sent to the Chairs and Accountable Officers of the four CCGS in 7

8 Derbyshire. This would be sent to Dr Mott for comment before dispatch. Agreed: The existing guideline would continue to be used until the cardiology monitoring had been resolved. The guideline would then come back to JAPC for further consideration. JB Pregnant Women and Neonates in Contact with Chicken Pox and Shingles Dr Harris stated the guidance had been reviewed and updated in June 2012 mainly using the relevant chapter in the Green Book. It had also been reviewed in the light of the comments made at the June JAPC meeting in order to provide greater clarity for GPs. Dr Harris outlined the new changes which had been made: Details regarding supplies, practical issues and contacts for expert advice had been updated and placed at the end of the guidelines. Details added on types and severity of risks of varicella to the fetus, neonate and pregnant women. Included dose of VZIG (Human varicella zoster immunoglobulin) for neonates (as 2010 guidance only includes the dose for pregnant women). Added that, if a second exposure occurs after three weeks, a further dose is required. Added some detail on the Definition of a significant exposure to VZ virus. Added the latest details on Determination of VZ immune status. Added the correct details on recommendations of VZIG for neonates. Added details on the Effectiveness of VZIG Prophylaxis for neonates and pregnant women. Two algorithms have been included: VZIG for neonates and VZIG for pregnant women. Telephone numbers given for Health Protection Agency Colindale, virology laboratory at Northern General Hospital, Sheffield and the on call microbiologists at Chesterfield Royal Hospital and Royal Derby Hospital. Dr Harris explained that the GP or midwife should contact microbiology to discuss cases of contact with chicken pox or shingles and look at the first page of the guidance to ascertain who was at risk. RDH and CRH would undertake a blood test to test for antibodies and then liaise with the GP regarding the results. If the patient required VZIG preparations then she or a relative would go to main hospital pharmacy to collect this. At CRH the blood samples for varicella zoster IgG testing would be sent to Sheffield for confirmation and if the sample was still negative would liaise with the microbiologists at CRH who would contact the GP to inform of the results. The CRH microbiologists would then need to arrange with the patients to collect the VZIG from the Northern General Hospital in Sheffield. 8

9 Dr Harris commented that the relevant chapter in the The Green Book had been consulted but this had been found to be complicated. It was therefore more advantageous to provide a weblink to the chapter when this was updated together with an indication to phone for advice. Agreed: JAPC ratified the guideline for the management of pregnant women and neonates in contact with chickenpox and shingles. 8. PATIENT GROUP DIRECTIONS (PGDs) a. PGD for Human Papillomavirus (HPV) vaccine (Cervarix) PGD for Human Papillomavirus (HPV) vaccine (Gardasil) Dr Bell reminded members that it had been agreed that the Patient Group Directions (PGDs) should be signed off by JAPC. Mr Dhadli advised that the Influenza PGD now had a statement regarding Fluenz not included due to its black traffic light classification and the references had been updated. The HPV PGD now included Gardasil as well as Cervarix with updated dosage/frequency and the references had also been updated. Ms Needham highlighted a duplicated statement on page two and that the wording for the duration for doses of Gardasil should be amended. Agreed: JAPC ratified the PGD for Human Papillomavirus with the agreed amendments. PGD for Trivalent Seasonal Influenza Vaccine Mr Dhadli presented the amended PGD for Trivalent Seasonal Influenza Vaccine. Agreed: JAPC ratified the amended PGD for Trivalent Seasonal Influenza Vaccine. 9. SHARED CARE GUIDELINES a. ADHD in Childhood Mr Dhadli stated that the shared care guideline had been updated due to the recent MHRA Drug Safety Update regarding Atomoxetine. Dr Taylor commented that the age group should be under 18 rather than under 16. Agreed: JAPC ratified the Shared Care Guideline for Drugs used in the management of ADHD in childhood (under 18). Paediatric Buccal Midazolam Mr Dhadli stated this was a shared care agreement for paediatric use of the licensed buccal Midazolam preparation (Buccolam). The buccal Midazolam product used in adults was Epistatus and now for paediatrics was Buccolam. Previously there had been a joint paediatric and adult shared care agreement for buccal Midazolam. The Mental Health Trust had developed a separate guideline for adults in January 2012 and an updated agreement for paediatrics on the recommendations of the Children s Epilepsy Workstream in Trent (CEWT). Mr Dhadli highlighted the risks associated with the use of the 9

10 licensed buccal Midazolam preparation which concerned differences in strengths of the preparations and the transition from paediatric care to adult care. During discussion Mrs Needham highlighted that patients who had been prescribed Epistatus may receive any product whereas Buccolam was easy to prescribe and a specified licensed product would be dispensed. It would be necessary to determine how to transfer paediatric patients across and how to move up the doses as they got older. Dr Mott highlighted a challenge concerning the implementation of any significant change for the adult group if a switch from Epistatus to Buccolam was recommended. Dr Taylor referred to the implications of a switch for people living in social care settings and Dr Parkin agreed to raise this at a forthcoming meeting of the Learning Disabilities Clinical Reference Group. Agreed: JAPC approved the shared care agreement for Buccolam Midazolam for Paediatrics. Agreed: The implications of the shared care agreement for adults to be discussed at the September JAPC meeting. 10. FOR INFORMATION The following items were noted for information: BMJ Drugs and Therapeutic Bulletin Exenatide for onceweekly administration. British Hypertension Society statement on efficacy of RESPeRATE device for lowering blood pressure. Clinical trials summary. 11. NICE GUIDANCE Mr Dhadli informed JAPC of the comments for the CCGs which had been made for the following NICE guidance: a. TA 261 Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism The estimated cost implication for Derbyshire was 105,000 but the costing summary referred to cancer patients being switched to rivaroxaban although the guidance did not anticipate the use of rivaroxaban for cancer patients. Agreed: Rivaroxoban as an option for the treatment of deep vein thrombosis (DVT) should be classified as RED until a request for its use for this indication was received. TA 262 Adalimumab for the treatment of moderate to severe ulcerative colitis Terminated appraisal. 10

11 c. CG 145 Spasticity in children with non-progressive brain disorders Mr Dhadli highlighted the use of the drugs botulinum and intrathecal baclofen. Dr Bell commented that the national policy for the use of intrathecal baclofen was the same as the one that was being used locally. 12. JAPC Bulletin The following change to the JAPC bulletin was noted: Clinical trials Add For example, the patient may revert back to the locally agreed formulary drug or the patients may continue the trial drug by arrangement with the trial organiser. Rivaroxaban for AF only GREEN. The amended JAPC bulletin was ratified by the JAPC. 13. ACTION TRACKER The Guideline Group action tracker was noted. 14. TRAFFIC LIGHTS ANY CHANGES? Classifications Azilsartan BROWN (remaining angiotensins-ii unchanged) Ulipristal acetate (Esyma) for uterine fibroids RED Perindopril UNCLASSIFIED Rivaroxaban - RED for all indications other than AF 15. ACTION SUMMARY The action summary was noted. 16. MHRA DRUGS SAFETY UPDATE The MHRA Drug Safety Alert for July 2012 was noted. Mr Dhadli referred JAPC to additional guidance for dabigatran and contra-indications for haemorrhaging. The guidance for dabigatran had therefore been updated in light of the Drug Safety Alert. 17. MINUTES OF OTHER PRESCRIBING GROUPS FOR INFORMATION Sheffield APC 15/5/12 South Staffs APC Group 15/6/12 STAMP - 26/6/12 DHCFT Drugs and Therapeutic 28/6/12 Burton Hospitals NHS Foundation Trust Drugs and Therapeutic Committee 9/7/ ANY OTHER BUSINESS a. Dr Bell stated that Dr Marcus Henn from Erewash CCG had been contacted about the CCG governance structures for reporting of JAPC business. Dr Henn had reported that the JAPC minutes were sent to the prescribing lead of each practice and were placed on the agendas of the bi-monthly Prescribing Group meetings. Items of importance were fed into the Quality and Commissioning Board of the CCG. 11

12 c. d. Miss Needham queried whether rebate details should be included in the minutes of JAPC meetings as these were placed on the website and were commercially sensitive. Dr Bell commented that details of the rebates were part of the JAPC decision making process. It was agreed that the rebates should be included in the supporting papers and not in the minutes of JAPC meetings. Mr Dhadli stated that RDH had a revised procedure for the supply of bowel cleansing products for patients prior to tests. The paper listed the contraindications and co-morbidities and these had been checked for any changes. Patients with bowel or abdominal symptoms may be sent straight to test after receipt of the referral and the form would be signed off by the referring GP. Dr Game queried what would happen in the case of patients with diabetes on insulin and Mr Dhadli would query what this with Mr Tom Gray and look at what was originally contained in the NPSA. Mr Dhadli tabled a letter from a Consultant Neurologist at the Royal Hallamshire Hospital in Sheffield who had requested the help of a Derbyshire GP in the prescribing of Co-enzyme Q10 for a shared patient with Friedrich s ataxia. Miss Needham stated that two requests from practices had been received for Co-enzyme-Q10 to be prescribed. Dr Bell commented that formulary decisions should not be tabled at JAPC meetings and more detailed information should be made available in order for this take place. It was noted that Co-enzyme-Q10 was available as an over the counter product as a nutritional supplement. e. f. Action: To be further discussed at the next JAPC meeting. Mr Dhadli reported that the insufficient lactation policy had been taken to the Guideline Group and comments had been fed back to the author who was currently absent from work. Ms Lawson stated that a lot of requests from GPs had been received by the CRH Medicines Information Pharmacist concerning the prescribing of domperidone in this situation. Mr Dhadli to forward last draft guidance to CRH to complete ECGs had been previously discussed in the meeting. 19. DATE OF NEXT MEETING Tuesday, 11 September 2012 at 1.30 pm in the Birchwood Room, The Post Mill Centre, South Normanton. Please note new venue for this meeting only. N.B. Papers for next meeting to submitted to: slakahan.dhadli@derbycitypct.nhs.uk 12