the TABLET Issue1, January 2014 Welcome .................................................................................................................................................................................... 1 Halton CCG ................................................................................................................................................................................. 1 Pan Mersey Area Prescribing Committee ................................................................................................................................... 2 Current issues ............................................................................................................................................................................. 2 Drug Tariff .................................................................................................................................................................................. 3 Drug Safety Issues ...................................................................................................................................................................... 6 National Institute for health and Care Excellence (NICE) ............................................................................................................ 8 NICE Medicines and Prescribing Centre ...................................................................................................................................... 8 European Medicines Agency (EMA) ............................................................................................................................................ 9 Welcome Welcome to the first edition of the Cheshire and Mersey Commissioning Support Unit’s Medicines Management Newsletter - The Tablet - which will be distributed electronically to all GP Practices and local Pharmacies once a month. This newsletter aims to keep you informed of the latest medicine updates, drug alerts/recalls and the work currently being completed in GP Practices by the Medicines Management Team. We hope that you find it interesting and informative. Please send any comments on format or content to your Practice Pharmacist or Technician. Halton CCG NEWS Prescribers are reminded about the recently ratified black statement in relation to Omega-3-Acid Ethyl Esters (Omacor® and Teromeg®) supplements. A link to the information involved can be found at: http://www.panmerseyapc.nhs.uk/recommendations/documents/PS15.pdf The Halton Medicines Management Team are currently doing work around this, please discuss with either your Medicines Management Pharmacist or Technician if this is of interest. In December the Halton CCG Quality Committee ratified the Area Prescribing Committee’s Lipid Guidelines which can be accessed at: http://www.panmerseyapc.nhs.uk/guidelines/documents/G2.pdf Additionally, if approached by pharmaceutical companies or medicines management companies, please remember that your local Medicines Management Team is available to provide support and information. The contact number for the Medicines Management Team Office is 01928 593 452. The Medicines Management team are available between 9:00 AM and 5:00 PM. Back to top 1 Pan Mersey Area Prescribing Committee RECOMMENDATIONS DAPAGLIFLOZIN film coated tablets (Forxiga®▼) as MONOTHERAPY The Pan Mersey Area Prescribing Committee does not recommend the prescribing of DAPAGLIFLOZIN film coated tablets (Forxiga®▼) as monotherapy for the treatment of type 2 diabetes mellitus. Dapagliflozin COMBINATION THERAPY has a GREEN policy statement as per NICE TA288. http://www.panmerseyapc.nhs.uk/recommendations/documents/PS28.pdf ORAL MESALAZINE The Pan Mersey Area Prescribing Committee recommends that oral MESALAZINE should always be prescribed by brand. http://www.panmerseyapc.nhs.uk/recommendations/documents/PS29.pdf NALMEFENE film coated tablets (Selincro®▼) The Pan Mersey Area Prescribing Committee does not recommend the prescribing of NALMEFENE film coated tablets (Selincro®▼) tablets for the reduction of alcohol consumption in adult patients in line with its product licence. http://www.panmerseyapc.nhs.uk/recommendations/documents/PS24.pdf OCRIPLASMIN intravitreal injection (Jetrea®▼) The Pan Mersey Area Prescribing Committee recommends OCRIPLASMIN concentrate for solution for injection (Jetrea®▼) as an option for treating vitreomacular traction in line with the criteria defined in NICE TA297. http://www.panmerseyapc.nhs.uk/recommendations/documents/PS27.pdf Current issues NEWS Atorvastatin 30mg and 60mg strengths – not a cost effective dose titration option Atorvastatin 30mg and 60mg tablets are available from Consilient Health Ltd. They are considerably more expensive than prescribing formulary 20mg, 40mg or 80mg atorvastatin (£23.58 for box of 28 x 30mg, £26.95 for box of 28 x 60mg). Action: When titrating doses up or down, use cost effective 20mg, 40mg or 80mg atorvastatin tablets. Back to top 2 Soluble drug formulations associated with increased CV events The British Medical Journal has published the results of an observational study that aimed to determine whether patients taking formulations of drugs that contain sodium (soluble, effervescent or dispersible formulations) have a higher incidence of cardiovascular events, compared with patients on non-sodium formulations of the same drugs. http://www.bmj.com/content/347/bmj.f6954 The authors conclude that, "Exposure to sodium-containing formulations of dispersible, effervescent and soluble medicines was associated with significantly increased odds of adverse cardiovascular events compared with standard formulations of those same drugs". They recommend that "Sodium-containing formulations should be prescribed with caution only if the perceived benefits outweigh these risks". The authors note several limitations in the study, including accuracy of information in the database, inability to correct for family history, health behaviours and dietary sodium intake, and lack of data on over-the-counter medicine use. Action: Clinicians should be aware of the association between sodium-containing drug formulations and increased cardiovascular events. Use of dispersible, effervescent and soluble medicines should be avoided where possible. QUERY CORNER Risks of tramadol with selective serotonin reuptake inhibitors (SSRIs) Despite the known risks of developing serotonin syndrome with the combination of tramadol and SSRIs, it is not uncommon to see concomitant prescribing. The BNF lists the combination as a potentially serious interaction with increased risk of CNS toxicity. Serotonin syndrome is caused by an excess of the neurotransmitter serotonin. The syndrome manifests itself with the following groups of symptoms: neuromuscular hyperactivity, e.g. tremor, clonus, myoclonus, rigidity autonomic hyperactivity, e.g. fever, tachycardia, tachypnoea, diaphoresis (perspiration) altered mental state, e.g. agitation, confusion, anxiety, hypomania. Signs and symptoms usually resolve within 24 hours of withdrawing the causative medication (unless the drug has a long elimination half-life) but severe manifestations can progress rapidly to death. The reaction can occur with tramadol monotherapy particularly at high dose but the number of reported incidences in combination with antidepressants is rising due to the increased use of SSRIs. UK Medicines Information (UKMI) published a Q&A 'Risk of developing serotonin syndrome following concomitant use of tramadol with selective serotonin reuptake inhibitors (SSRIs)' in 2012. http://goo.gl/GG9scN Summary: Patients and healthcare professionals should be aware of the potential risk of developing serotonin syndrome when combinations of tramadol and SSRIs are prescribed, and monitor for any of the symptoms of the syndrome on initiation and dose increases of either medication. Drug Tariff PRICE CHANGES (JANUARY 2014) Top ten monthly price reductions Levobunolol 0.5% eye drops [1 x 5] £1.85 (-£8.10) Back to top 3 Memantine 10mg tablets [1 x 56] £61.92 (-£7.09) Pramipexole 350microgram tablets [1 x 30] £24.98 (-£4.16) Olanzapine 20mg orodispersible tablets sugar free [1 x 28] £26.88 (-£3.24) Olanzapine 15mg orodispersible tablets sugar free [1 x 28] £19.98 (-£2.44) Diamorphine 500mg powder for solution for injection ampoules [1 x 5] £188.58 (-£2.05) Hyoscine hydrobromide 400micrograms/1ml solution for injection ampoules [1 x 10] £29.83 (-£2.03) Risperidone 1mg/ml oral solution sugar free [1 x 100] £41.59 (-£1.81) Olanzapine 10mg orodispersible tablets sugar free [1 x 28] £13.79 (-£1.59) Rivastigmine 2mg/ml oral solution sugar free [1 x 120] £88.30 (-£1.55) Top ten monthly price increases Isradipine 2.5mg tablets [1 x 56] £37.47 (+£24.24) Primidone 250mg tablets [1 x 100] £35.24 (+£22.64) Primidone 50mg tablets [1 x 100] £29.54 (+£16.94) Hydrocortisone 20mg tablets [1 x 30] £56.18 (+£5.04) Ramipril 2.5mg/5ml oral solution sugar free [1 x 150] £84.80 (+£4.80) Vitamin B compound tablets [1 x 28] £19.84 (+£4.18) Nortriptyline 25mg tablets [1 x 100] £81.85 (+£4.08) Levothyroxine sodium 50micrograms/5ml oral solution sugar free [1 x 100] £57.77 (+£3.75) Carbimazole 20mg tablets [1 x 100] £95.62 (+£3.71) Salbutamol 4mg tablets [1 x 28] £63.05 (+£3.69) Top 100 annual price reductions http://www.panmerseyapc.nhs.uk/home/tariff_watch/partviiia_reductions_201312.pdf Top 100 annual price increases http://www.panmerseyapc.nhs.uk/home/tariff_watch/partviiia_increases_201312.pdf PATENT EXPIRIES Telmisartan (Micardis®) December 2013 DRUG AVAILABILITY The following generic drugs have supply issues and are incurring increased costs; they have been given a NCSO (no cheaper stock obtainable) status for January 2014. Please consider the costs of the following drugs before prescribing. Contact your Medicines Management Team for further advice on suitable alternatives. Note: gabapentin is still considerably less expensive than pregabalin. Amiloride 5mg tablets (28) – £20.61 Co-amoxiclav 250/125 tablets (21) – £3.75 Co-amoxiclav 500/125 tablets (21) – £7.35 Gabapentin 100mg capsules (100) – £5.85 Gabapentin 300mg capsules (100) – £11.00 Mebeverine 135mg tablets (100) – £6.95 Prednisolone 5mg tablets (28) – £2.27 Propranolol 10mg tablets (28) – £5.80 Propranolol 40mg tablets (28) – £6.40 Propranolol 80mg tablets (56) – £6.85 Other drugs with long term supply issues Description Due date Comment Piroxicam Gel 60g, 112g Supplier unable to confirm A raw material issue is causing a delay in supply Back to top 4 Trimovate® Cream Late Spring 2014 Ongoing supply issue Ursofalk® 250mg capsules Supplier unable to confirm Ongoing supply issue Slow K® tablets 600mg Manufacturer unable to confirm A manufacturing issue is causing a delay in supply Kwells®/Kwells Jr® tablets Manufacturer unable to confirm A manufacturing issue is causing a delay in supply Eurax® cream 10% (30g, 100g) Supplier unable to confirm Ongoing supply issue Dermacort® cream Supplier unable to confirm A supplier issue is causing a delay in supply Buccastem M® tablets Manufacturer unable to confirm A manufacturing issue is causing a delay in supply Caverject® Dual Chamber all strengths Early 2016 A manufacturing issue is causing a disruption in supply Back to top 5 Discontinuation of Lid Care® Lid Care® has been discontinued. Action: We would advise that patients’ treatment be reviewed and recommend advising patients on the management of blepharitis as detailed on the Clinical Knowledge Summaries (CKS) website: http://www.nhs.uk/Conditions/Blepharitis/Pages/Treatment.aspx Discontinuation of Otosporin® Ear Drops (5ml and 10ml bottles) Otosporin® Ear Drops 5ml – estimated stock exhaustion January 2014 Otosporin® Ear Drops 10ml – estimated stock exhaustion May 2014 Action: Prescribers are asked to review patients currently receiving this medicine at the earliest opportunity to identify appropriate alternatives. Discontinuation of Mysoline® It is recommended that primodine is prescribed by brand when used for epilepsy. The Mysoline® brand of primidone has been discontinued, but these tablets are now made by Serb under the generic name primidone and are exactly the same formulation as Mysoline®. Action: To ensure that the same formulation as Mysoline® tablets is supplied for patients with epilepsy, prescriptions should be changed to read primidone (Serb). Discontinuation of meprobamate Meprobamate is indicated for the short-term relief of the symptoms of anxiety. In 2012 the European Medicines Agency (EMA) recommended the suspension of all marketing authorisations for meprobamate because of the risks, particularly of serious CNS side effects, outweighing the benefits. The manufacturer, Genus Pharmaceuticals, has advised that the production of meprobamate will cease by Aug 2014, and there could be a shortage of stock nearer the time. Action: The EMA advice is that Doctors should review the treatment of patients currently taking meprobamatecontaining medicines, with a view to switching them to alternative treatments, in line with national recommendations for the condition being treated. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/meprobamate/human_referral_ 000293.jsp&mid=WC0b01ac0580024e99 Drug Safety Issues Insulin passports A recent audit performed at a diabetic outpatient clinic in Whiston hospital revealed that only 50 % of patients had an insulin passport. The remainder were unaware what an insulin passport was or had not received one. The passport is a useful means of providing information as to type and dosage of Insulin and reduces interface issues. Action: Prescribers should ensure that insulin passports are issued to diabetic patients. Community pharmacists should ask insulin patients if they have an insulin passport and if not, direct them to their GP Practice to obtain one. Please see the following links for further information: http://www.northmerseydiabetes.nhs.uk/library/documents/NMDNdiabetespostern.pdf http://www.nrls.npsa.nhs.uk/resources/?EntryId45=130397 Back to top 6 http://www.sthk.nhs.uk/library/documents/STHKinsulinpassportfaqs.pdf Please note the CCG contacts have now changed. MHRA DRUG SAFETY UPDATES (NOVEMBER & DECEMBER 2013) Rituximab: screen for hepatitis B virus before treatment Screening for hepatitis B is now recommended in ALL patients (not only those at risk of infection) before starting treatment with rituximab PATIENTS WITH ACTIVE HEPATITIS SHOULD NOT BE TREATED WITH RITUXIMAB A patient with positive serology for hepatitis B virus should be referred to a specialist in liver disease. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON350669 Clopidogrel: risk of acquired haemophilia Acquired haemophilia is a very rare but serious condition which affects between 1 and 4 per million people per year; generally occurring in the elderly. The condition tends to cause bleeding into the skin and soft tissues. Prompt diagnosis is required to minimise the time the patient is at risk of bleeding and to avoid major bleeding. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON350671 Dorzolamide hydrochloride/timolol maleate (Cosopt®) preservative-free SINGLE DOSE eye drops: reports of eye injury The wings that extend from the eye drop pipette and pieces of plastic that remain on the tip, can cause scratches to the cornea. Patients who are currently using this product may be experiencing problems administering their eye drops and may benefit from additional education. Report any problems via the Yellow Card Scheme www.mhra.gov.uk/yellowcard http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON350696 Mefloquine: strengthened warnings on neuropsychiatric side effects Mefloquine must not be used for chemoprophylaxis in patients with active, or a history of, psychiatric disturbances such as depression, anxiety disorders, schizophrenia, or other psychiatric disorders. Symptoms such as nightmares, acute anxiety, depression, restlessness or confusion should be regarded as potentially prodromal for a serious event. Adverse reactions may occur and may persist up to several months after discontinuation of mefloquine because of its long half-life. In a small number of patients, dizziness or vertigo, and loss of balance have continued for months after discontinuation of the drug. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON336723 Risperidone and paliperidone: risk of intraoperative floppy iris syndrome in patients undergoing cataract surgery Primary-care physicians should document the use of α1- adrenergic antagonists – including risperidone and paliperidone-when making a referral for cataract surgery. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON336724 Back to top 7 National Institute for health and Care Excellence (NICE) TECHNOLOGY APPRAISALS Teriflunomide for treating relapsing–remitting multiple sclerosis Teriflunomide is recommended as a possible treatment for adults with active relapsing-remitting multiple sclerosis that isn’t highly active or rapidly evolving severe relapsing-remitting multiple sclerosis. http://guidance.nice.org.uk/TA303 CLINICAL GUIDELINES Prostate cancer: diagnosis and treatment This clinical guideline updates and replaces Prostate cancer (NICE clinical guideline 58). It offers evidence-based advice on the care of men referred to secondary care with suspected or diagnosed prostate cancer, including followup in primary care for men with diagnosed prostate cancer. http://guidance.nice.org.uk/CG175 Head injury: triage, assessment, investigation and early management of head injury in children, young people and adults This clinical guideline updates and replaces Head injury (NICE clinical guideline 56). It offers evidence-based advice on the care of children, young people and adults with head injury. http://guidance.nice.org.uk/CG176 NICE Medicines and Prescribing Centre NEW MEDICINES Prostate cancer: triptorelin (Decapeptyl® SR) In 2013, the licensed indications for the luteinising hormone-releasing hormone (LHRH) agonist, triptorelin (Decapeptyl® SR), were extended to include 2 new indications for prostate cancer: neoadjuvant treatment before radiotherapy in high-risk localised or locally advanced disease, and adjuvant treatment to radical prostatectomy in locally advanced disease at high risk of progression. http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM30.jsp UNLICENSED / OFF-LABEL MEDICINES Non-cystic fibrosis bronchiectasis: colistimethate sodium Colistimethate sodium (Colobreathe®, Colomycin® injection and Promixin®) is licensed for treating pulmonary infections caused by Pseudomonas aeruginosa in people with cystic fibrosis but not in non-cystic fibrosis bronchiectasis. http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/ESUOM25.jsp Back to top 8 European Medicines Agency (EMA) EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL PRAC recommends suspending use of Protelos®/Osseor® The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos®/Osseor® should no longer be used to treat osteoporosis. Action: Await MHRA guidance before reviewing patients. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/01/WC500159375.pdf Medicines Management Team is available from Monday to Friday between 9:00am and 5:00pm on 01928 593 452 Back to top 9