East Berkshire Clinical Commissioning Groups BERKSHIRE EAST CCGs Medicines Optimisation Prescribing Update Contact Details for the Medicines Optimisation Team CCG Support Pharmacists: Head of Medicines Optimisation Team Catriona Khetyar 07500 606169 Email: catriona.khetyar@nhs.net -----Bracknell & Ascot Melody Chapman 07826 533736 Email melody.chapman@nhs.net -----Maidenhead/Windsor/Ascot Dawn Best 07793 007976 dawnbest@nhs.net ------Slough Tim Langran 07775 010727 Email tim.langran@nhs.net Volume 2, Issue 3 June 2013 Contents of this issue Page no Cerelle (Desogestrel 75 Microgram) available as a generic version of Cerazette Naproxen once again shown to have safest CV profile compared to other NSAIDS Prescribing Guidelines for Adult ADHD 2 Co-Enzyme Q10 for side-effects ofstatins is notrecommended locally Ticagrelor – an antiplatelet Omega - 3 Fatty acid supplement no longer recommended 3 2 2 3 4 -----Practice Support Pharmacist Sundus Bilal 07909 505658 Email sundusbilal@nhs.net -----Prescribing Support Pharmacist Caroline Pote 01753 636845 Email: caroline.pote@nhs.net 1 CERELLE(DESOGESTREL 75 MICROGRAM) AVAILABLE AS A GENERIC VERSION OF CERAZETTE The Effective Prescribing Group recommends the use of Cerelle in place of Cerazette. Cerelle contains the same active ingredient, at the same strength as Cerazette and costs half the price (3x28: £4.20 versus £8.68). Action: Consider using Cerelle in place of Cerazette for new and existing patients. NAPROXEN ONCE AGAIN SHOWN TO HAVE SAFEST CV PROFILE COMPARED TO OTHER NSAIDS A Lancet meta-analysis this month has once again highlighted the cardiovascular toxicity of NSAIDs and that Naproxen has the safest cardiovascular profile1. This article was widely reported in the media. The review found that for every 1000 patients treated for one year with Diclofenac or a COX2 (Etoricoxib or Celecoxib) there are three additional major vascular events over placebo or Naproxen. All NSAIDs were shown to be associated with upper GI complications. Action: Naproxen (plus Lansoprazole 15mg or Omeprazole 20mg) is recommended as NSAID of choice locally. Reference: 1. Bhala N et al. Vascular and upper gastrointestinal effects of non-steroidalantiinflammatory drugs: meta-analyses of individual participant data from randomised trials. www.thelancet.com Published online May 30, 2013 http://dx.doi.org/10.1016/S01406736(13)60900-9 PRESCRIBING GUIDELINES FOR ADULT ADHD Prescribing Guidelines for Adult ADHD have recently been ratified since our last newsletter. These guidelines have been the product of a joint working group including GP Mental Health Lead and Medicines Optimisation Team input. The intention of these guidelines is to give prescribing information and advice to enable any GP who wishes to prescribe for their patients following an assessment and recommendation for treatment by medication by the Adult ADHD team. The drugs detailed will be listed on the formulary as red for Children with ADHD but acceptable for prescribing by a GP in line with Prescribing Guidelines for Adult ADHD. If you have any questions about these guidelines please contact Catriona Khetyar, Head of Medicines Optimisation. The guidelines will be made available via the CCG websites. 2 CO-ENZYME Q10 FOR SIDE-EFFECTS OF STATINS IS NOT RECOMMENDED LOCALLY Some practices have recently been asked to prescribe Co-enzyme Q10 for reduction of muscle-related side-effects of statins. Co-enzyme Q10 is not a licensed medicine and is not recommended for prescribing on the NHS locally. The evidence for use of Coenzyme Q10 to reduce the risk of myotoxicity was reviewed by UKMI in 20121. It found only 2 RCTs, one with 32 patients and one with 4 patients enrolled. One of these trials found benefit on muscle-related side-effects of statins and one found no benefit. The review concluded that “the evidence does not support the use of coenzyme Q10 supplementation with statin treatment”. A previous systematic review examining articles addressing the relationship between statin treatment and coenzyme Q10 levels found that there was insufficient evidence to recommend the routine use of coenzyme Q10 in statin-treated patients to relieve myopathic symptoms2. Action – Co-enzyme Q10 should not be co-prescribed with statins on the NHS for muscle protection. Note – Co-enzyme Q10 can be prescribed on the NHS for some rare metabolic disorders. References: 1. Should patients on statins take Coenzyme Q10 supplementation to reduce the risk of myotoxicity? UKMI Q&A September 2012, available via www.evidence.nhs.uk . 2. Marcoff L, Thompson PD. The role of coenzyme Q10 in statin-associated myopathy. A systematic review. J Am CollCardiol 2007; 49(23):2231-2237. TICAGRELOR – AN ANTIPLATELET Ticagrelor is now included in the pathway for treating ACS, at Wexham Park Hospital. It is an amber drug which on the initiation of a consultant cardiologist may be continued for up to 12 months. Please be aware that other centres may still be discharging patients on prasugrel, which should also be continued for up to 12 months only. Ticagrelor is given in combination with aspirin for prevention of atherothrombotic events in patients with acute coronary syndrome. Co-administration with aspirin is for 12 months only, followed by aspirin monotherapy. Shortly after initiation a commonly reported side effect is dyspnoea, this resolves after 7 days. The SPC recommends that renal function is checked one month after initiating treatment, as creatinine levels may increase during treatment. Co-administration with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir) is contraindicated, as these drugs increase the levels of ticagrelor. Co-administration with simvastatin 80mg is not recommended. Common side effects include bruising, increased bleeding and shortness of breath. 3 As with clopidogrel, it is recommended that a stop date is entered onto the prescription label directions and as a note on the computer system. RECOMMENDATIONS Please search for patients on ticagrelor to ensure that a stop date has been added to the computer records and entered in the prescription directions. Treatment beyond 12 months has not been studied. 1 Patients on prasugrel, should also have a stop date added into the computer records, prescription directions and treatment stopped at 12 months. 1. SPC Ticagrelor, available at http://www.medicines.org.uk/emc/medicine/23935/spc#PRODUCTINFO OMEGA- 3 FATTY ACID SUPPLEMENT NO LONGER RECOMMENDED Use of omega-3 fatty acids post MI was based on one trial, the GISSI-P Trial. However, GISSI-P was an open-label trial that was not controlled with placebo, and other secondary prevention treatments, in particular statins, had not been optimised. In 2012, two meta-analyses were published, which do not confirm the results seen in GISSIP and do not support the use of fatty acid supplementation in primary nor secondary prevention. The first meta-analysis, published in the Arch Intern Med, of 14 randomised, double-blind, placebo-controlled trials of omega-3 fatty acid supplements in people with a history of CVD found no reduction in the risk of CV events or all-cause mortality.1 The second meta-analysis of 20 randomised controlled trials, found similar results. Omega-3 supplements did not reduce the risk of all-cause mortality, cardiac death, sudden death, MI or stroke. 2 This larger meta-analysis included the ORIGIN study, which looked at people with early type 2 diabetes who also had cardiovascular risk factors (about 60% had previous MI, stroke or revascularisation). ORIGIN found that daily supplementation with 1 g of omega3 fatty acids for 6 years did not reduce the rate of cardiovascular events or mortality compared with placebo. Based on the lack of evidence for reduction in CVD can this spend be justified? Omega-3 preparations are available OTC and a patient information leaflet is available, whereby patients may be advised about incorporating oily fish into their diet. RECOMMENDATION: Review and stop prescribing of omega-3 products for primary and secondary prevention of CVD . References 1. 2. Arch Intern Med. 2012;172(9):686-694 JAMA. 2012;308(10):1024-1033 4