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Norfolk & Waveney Prescriber The Norfolk & Waveney Prescriber Issue 119 April 2017 For Primary and Secondary Care Health Professionals in Norfolk & Waveney In this issue: Prescribing Safety News: MHRA Drug Safety Updates 2 TAG and Commissioning News 3-4 Drugs – discontinued, shortages and prices 5-6 Drugs – supply issues 7-8 Guidance and Policy News: - National: “NICE Bites” & NICE guidance 9-10 Guidance and Policy News: - Local: Key Message Bulletins 11-12 Cost-effective Prescribing Tips: 13 Ophthalmic Special Order products Atorvastatin Hot Topic: Multimorbidity and Polypharmacy 14 Prescribing Safety: Medicines and Serotonin Syndrome 15-16 Prescribing Advice: Metformin, Finasteride, and Inhalers 17-18 New Medicines & Indications News 19 Feedback and comments on this edition to [email protected] / 01603 257035 Prescribing & Medicines Management Team – 1 NEL CSU Anglia Prescribing Safety News Main points from MHRA Drug Safety Updates February - March 2017 Articles relevant to Primary Care and Secondary Care: SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation (mainly toes) Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes. Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect. Preventive foot care is important for all patients with diabetes. Advice for healthcare professionals: o carefully monitor patients receiving canagliflozin who have risk factors for amputation, such as poor control of diabetes and problems with the heart and blood vessels o consider stopping canagliflozin if patients develop foot complications such as infection, skin ulcers, osteomyelitis, or gangrene o advise patients receiving any sodium-glucose co-transporter 2 (SGLT2) inhibitor about the importance of routine preventive foot care and adequate hydration o continue to follow standard treatment guidelines for routine preventive foot care for people with diabetes o report any suspected side effect with SGLT2 inhibitors or any other medicine on a Yellow Card Articles relevant to Secondary Care: Hyoscine butylbromide (Buscopan) injection: risk of serious adverse effects in patients with underlying cardiac disease o hyoscine butylbromide injection can cause serious adverse effects including tachycardia, hypotension, and anaphylaxis o these adverse effects can result in a fatal outcome in patients with underlying cardiac disease, such as those with heart failure, coronary heart disease, cardiac arrhythmia, or hypertension o hyoscine butylbromide injection should be used with caution in patients with cardiac disease o monitor these patients, and ensure that resuscitation equipment, and personnel who are trained how to use this equipment, are readily available o hyoscine butylbromide injection remains contraindicated in patients with tachycardia The MHRA launch a pilot reporting scheme for harms associated with illicit drugs, particularly new psychoactive substances (“legal highs”) Many new psychoactive substances have been identified in recent years which are readily available over the internet. Hospital admissions for poisoning by psychostimulants with abuse potential have increased by 44% in England and Wales from the period 2009-15. At present, there is a lack of evidence about the long-term harms to health associated with their use, and more monitoring in this area is needed. A pilot reporting website, the Report Illicit Drug Reaction form, will be available for 1 year for UK healthcare professionals (aimed at those who work in emergency departments, general practice, drug treatment services, sexual health services, mental health services, etc) who come into contact with patients experiencing harm associated with use of illicit drugs, particularly new psychoactive substances. The pilot aims to improve data collection on harms from illicit drug use, to support provision of clinical guidance to professionals. The reporting site is modelled on the MHRA Yellow Card website. Registered Yellow Card scheme users can log in and access all their incident reports in the same place. You can subscribe to MHRA updates via https://service.govdelivery.com/accounts/UKMHRA/subscriber/new?topic_id=UKMHRA_0044 Back to top Prescribing & Medicines Management Team – 2 NEL CSU Anglia Therapeutic Advisory Group (TAG) and D&TCG Clinical and Commissioning Recommendations – March 2017 The TAG and the Drugs & Therapeutics Commissioning Group (D&TCG)’s most recent recommendations on prescribing responsibility and funding decisions for medicines include: Classified as Green (GP prescribable following specialist recommendation): Insulin degludec (Tresiba®) for restricted use in adults and children with Type 1 Diabetes Mellitus. Prescriber’s Rating 4. Possibly helpful - The product offers small additional value, and should not change prescribing habits except in rare circumstances Recommended for restricted use only, as follows in certain patients with Type 1 diabetes who fulfil the following criteria: Patients with significant nocturnal hypoglycaemia, despite optimal adjustments of lifestyle (eliminating any contributory factors) and diet (undertaken structured education e.g. DAFNE) and optimising basal insulin/multiple daily injections who fulfil the criteria for insulin pump therapy. “Chaotic patients” who may be at significant risk of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic state (HHS) (previously known as hyperosmolar non – ketotic diabetic state or hyper HONK) if daily basal insulin is missed, despite optimal adjustments of lifestyle, and diet and optimising basal insulin/multiple daily injections. Patients with psychological problems (e.g. eating disorders or patients with intermittent compliance issues with insulin injections), who are not supervised by a daily carer and do not qualify to receive district nurse injections of daily insulin glargine, and who may be at significant risk of DKA or HHS if daily basal insulin is missed. Patients with a diagnosed allergy to either insulin glargine or insulin detemir. Insulin degludec should be initiated by a consultant-led specialist team and is NOT suitable for initiation by GPs or other prescribers in primary care unless under the supervision of a specialist. Initial dose titration and monitoring should be closely supervised by a specialist team. Ongoing provision of the insulin may be undertaken in Primary care by agreement between the Specialist and the Patient’s GP. All patients should be reviewed by the initiating specialist team at 6 months and returned to previous treatment if no improvement in overall disease control from baseline is demonstrated. Confirmed as Amber (Option for GP prescribing under an approved Shared Care Agreement): Atomoxetine for ADHD and related disorders in Stimulants for ADHD and related disorders in Children Children & Adolescents – see revised Shared aged at least 6 years old & Adolescents – see revised Care Agreement Shared Care Agreement. Circadin® (Melatonin) for Sleep Disorders in Tacrolimus for use in ulcerative colitis – see revised Children – see revised Shared Care Agreement. Shared Care Agreement. Secondary Care-led treatments and indications classified as Red (Hospital/Specialist only): Pomalidomide (Imnovid®) (in combination with Pembrolizumab (Keytruda®) for treating locally low-dose dexamethasone) multiple myeloma in advanced or metastatic PD-L1-positive NSCLC after adults at third or subsequent relapse – as per chemotherapy – as per NICE TA 428 NICE TA 427 Ibrutinib (Imbruvica®) for previously treated Everolimus (Afinitor®) advanced renal cell carcinoma adults with CLL and untreated CLL with 17p that has progressed during or after treatment with deletion or TP53 mutation – as per NICE TA 429 vascular endothelial growth factor targeted therapy – as per NICE TA 432 Mepolizumab (Nucala®) for treating severe Sofosbuvir–velpatasvir (Epclusa®) for treating chronic refractory eosinophilic asthma in adults – as per hepatitis C in adults – as per NICE TA 430 NICE TA 431 Ulipristal (Esmya®) for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age: as a second line treatment option, prior to surgery or radiology as first line option for treatment of symptoms of fibroids ≥ 3cm and with Hb ≤102g/L (refn NICE CG 44) – pending the development of a locally approved shared care agreement Continued…../ 3 The following treatments and devices are classified as Double Red (Not recommended for routine use) / Not Commissioned: Insulin degludec (Tresiba®) for all patients with type 2 diabetes mellitus Apremilast (Otezla®), alone or in combination Migalastat (Galafold®) for treating Fabry disease in with disease-modifying anti-rheumatic drugs people over 16 years of age with an amenable mutation, (DMARDs) treating locally active psoriatic and only if enzyme replacement therapy (ERT) (with arthritis in adults - as per NICE TA 433 - agalsidase alfa or agalsidase beta) would otherwise be pending agreement on a locally agreed offered – as per HST 4 Highly specialist use only treatment pathway Smartinhaler for asthma - a technology that Smart One for measuring lung function - a portable monitors the activation of a person's asthma spirometer used for measuring lung function which inhaler and uploads data to a mobile or cloud- transmits measurements wirelessly to a smartphone (or based application tablet) and records results in a diary app which can be shared electronically with a healthcare professional. 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