Volume 5 Issue 6 CONTENTS September 2015

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1 BERKSHIRE EAST CCGs Medicines Optimisation Prescribing Update General Newsletter East Berkshire Clinical Commissioning Groups Volume 5 Issue 6 CONTENTS September 2015 SAVINGS IDEAS 2 Orthostatic hypotension drug midodrine launched 2 FORMULARY UPDATE DECISIONS THIS MONTH 2 Fortisip is not on East Berkshire Formulary 2 Dicycloverine price increases 2 GUIDANCE UPDATE 3 NICE guidance August Meningococcal B (Men B) vaccination programme, 3 What to say to parents who ask about Men B immunisation for children born before 1st May NHS England updated PGDs for Repavax and Infanrix 4 SUPPLY ISSUES 5 Antepsin(Sucralfate) availability suspended - update 5 Voltarol products discontinued 5 SAFETY UPDATE 5 Medical device alert Accu-Chek mobile meter and Acc-Chek mobile test cassette 5 manufactured by Roche diabetes care Hydroxyzine (Atarax, Ucerax): risk of Qt interval prolongation and Torsade De Pointes 6 High strength, fixed combination and biosimilar insulin products: minimising the risk of 6 medication error MHRA drug safety update Sept 15 Proton Pump Inhibitors (PPIs): Subacute Cutaneous 8 Lupus Erythematosus APP OF THE MONTH 9 Moodkit 9 LOCAL CASE STUDIES SIGNIFICANT EVENT 9 AKI secondary to dehydration 9 CONTACT DETAILS FOR THE MEDICINES OPTIMISATION TEAM 10

2 SAVINGS IDEAS ORTHOSTATIC HYPOTENSION DRUG MIDODRINE LAUNCHED Midodrine hydrochloride (Bramox) has been launched in the UK after obtaining marketing authorisation from MHRA. This will be the first licensed product in the UK available specifically for the treatment of severe orthostatic hypotension caused by autonomic dysfunction when corrective factors have been ruled out and alternative treatments prove inadequate. The product had previously only been available as an unlicensed special. The company says it has priced Bramox at 60% cheaper than the current unlicensed midodrine so the branded product has the potential to reduce the NHS drugs bill. The tablet formulation (2.5mg and 5mg) is due to be launched imminently. In February 2013, NICE looked at the evidence for use. The longer-term efficacy and safety of midodrine has not been assessed, nor has its effect on activities of daily living. The main limitation of the trials was the main focus on surrogate outcomes (changes in standing blood pressure), as opposed to clinical outcomes such as falls or ability to carry out daily activities and longer-term safety data for midodrine are limited. FORMULARY UPDATE DECISIONS THIS MONTH FORTISIP IS NOT ON EAST BERKSHIRE FORMULARY Fortisip ( 2.06 per bottle) is more expensive than both Ensure Shake ( 0.78 per sachet) and Ensure Plus ( 1.40 per bottle). Changing prescriptions from Fortisip to Ensure Shake (or if a powdered product cannot be used to Ensure Plus) will make significant savings. DICYCLOVERINE PRICE INCREASES The price of Dicycloverine (the gastro-intestinal antispasmodic) has increased significantly (84 x 20mg tablets = ). Formulary options that represent better value: Hyoscine butylbromide 10mg tabs 6.00 per 28 days Peppermint oil 0.2ml capsules (not MR version) 7.04 per 28 days Mebeverine 135mg tabs 9.85 per 28 days Propantheline 15mg tabs per 28 days 2

3 GUIDANCE UPDATE NICE GUIDANCE - AUGUST 2015 NICE have published new guidance for the month of August This month there are four clinical guidelines that impact upon primary care. The Type 1 diabetes in adult s guideline covers the care and treatment of adults (aged 18 and over) with type 1 diabetes. This guideline updates and replaces the sections for adults in NICE guideline CG15. The Diabetes (type 1 and type 2) in children and young people guideline covers the diagnosis and management of type 1 and type 2 diabetes in children and young people aged under 18. The guideline recommends strict targets for blood glucose control to reduce the long-term risks associated with diabetes. The Diabetic foot problems guideline covers prevention and management of foot problems in children, young people and adults with diabetes. The guideline aims to reduce variation in practice. The Antimicrobial stewardship guideline covers the effective use of antimicrobials (including antibiotics) in children, young people and adults. It aims to change prescribing practice to help slow the emergence of antimicrobial resistance and ensure that antimicrobials remain an effective treatment for infection. MENINGICOCCAL B (MEN B) VACCINATION PROGRAMME To support the delivery of Public Health England and NHS England s Meningococcal B (Men B) vaccination programme, NHS England South have sent a PGD and protocol for GP practices to use: PGD for Men B - valid for use from 1 September 2015 to 31 August 2017 Public Health England s protocol for the provision of paracetamol to support the delivery of the national Men B immunisation programme - valid for use from 1 September 2015 to 31 August 2017 NHS England South s PGD webpages available at - will be updated as soon as possible with the new PGD and supporting protocol. Many practice nurses will have undertaken training in support of this immunisation programme. For those who were unable to attend the training events, a sheet of FAQs can be seen from the link is attached which may answer any queries they have. For any other concerns or queries, please would you ask practice staff to the following address: england.southcentral-cd@nhs.net rather than individuals, as use of their central address enables queries to be dealt with more quickly and efficiently 3

4 WHAT TO SAY TO PARENTS WHO ASK ABOUT MEN B IMMUNISATION FOR CHILDREN BORN BEFORE 1ST MAY 2015 ARTICLE WRITTEN BY DR MARILYN LANSLEY Men B vaccine is now part of the routine schedule for babies born from 1st July They will be offered a dose at 2, 4 and 12 months. There is a catch-up programme for babies born from 1st May While it is pleasing that there has been interest and enthusiasm amongst parents for this new vaccine, the publicity has caused anxiety in those parents whose children will not be getting the vaccine. Locally some private clinics have been cashing in on this and offering the vaccine to older children. Parents may ask you for your opinion on this. First it is important to remember that Men B disease is rare and is getting rarer for reasons that are not entirely clear (see graph.) Second, the risk to a child peaks at 5 months and then declines. The risk after the age of 2 years is extremely small; even children eligible for the vaccine will not get it after that age if they had missed it as a baby. To those parents who ask you about getting the vaccine privately you can say that, while it is clearly their choice, it is a lot of money and the risk of their child catching the disease after the age of 5 months is very small and is getting smaller as they get older. Healthcare professionals with queries about any aspect of the childhood immunisation programme, are welcome to get in touch by calling me on or ing marilyn.lansley@berkshire.nhs.uk. Dr Marilyn Lansley. NHS ENGLAND UPDATED PGDS FOR REPAVAX AND INFANRIX NHS England has produced updated PGDs for Repavax and Infanrix to support the delivery of Public Health England s and NHS England s childhood immunisation programme: PGD for low dose diphtheria, tetanus, acellular pertussis, and inactivated polio vaccine (dtap/ipv) - Repevax PGD for adsorbed diphtheria, tetanus, acellular pertussis and inactivated polio virus vaccine (DTaP/IPV) - Infanrix-IPV 4

5 NHS England South s PGD webpages available at - will be updated as soon as possible with the new PGDs. These PGDs have been authorised by NHS England South (South Central) for the use of GP practices in Berkshire East CCGs and replace the PGDs for these vaccines that expired on 1 September We d be grateful for your help in ensuring that these PGDs are disseminated as soon as possible to the relevant staff in your practice. If you or practice colleagues have concerns or queries about the flu PGDs, please the following address: england.southcentral-cd@nhs.net rather than individuals, as use of our central address enables queries to be dealt with more quickly and efficiently. Thank you for your practice s co-operation with this request from NHS England. SUPPLY ISSUES ANTEPSIN (SUCRALFATE) AVAILABILITY SUSPENDED UPDATE In the August 2015 Prescribing newsletter we brought to your attention that sucralfate availability has been suspended in primary care. It has been brought to our attention that GPs are being asked to sign and add the initials SP. Prescribers have been advised not to do this. Alternative medications should be used instead e.g. PPIs or H2 antagonists. A recent example of the cost differences occurred recently with trospium 60mg XL capsules which should be supplied as the brand Regurin at a cost of 26 for 28 capsules. The pharmacy ordered through a specials wholesaler called Sigma and the practice prescribing budget was charged 336 for 84 capsules. We cannot get this money back so please be aware when you are asked to initial SP. VOLTAROL PRODUCTS DISCONTINUED Novartis is discontinuing several different Voltarol products, which will become unavailable once stock is exhausted. Products that are already out of stock are: Voltarol dispersible tablets 50mg, Voltarol Retard 100mg and Voltarol SR 75mg. It is estimated that Voltarol tablets 50mg will go out of stock in October 2016, Voltarol SR 75mg in February 2016 and Voltarol rapid tablets 25mg in September These discontinuations have become necessary primarily because of the closure of the manufacturing site in the UK where the products were previously made. SAFETY UPDATE MEDICAL DEVICE ALERT - ACCU-CHEK MOBILE METER AND ACCU-CHEK MOBILE TEST CASSETTE MANUFACTURED BY ROCHE DIABETES CARE This device may give falsely high readings if the specific testing procedure is not followed and, as a consequence, patients may take insulin when they don t need it. 5

6 MHRA continue to receive reports of false high readings relating to this device. The system uses strip-free technology, so users need to follow a specific testing procedure that is different to standard meter and strip systems. Practices are asked to: Identify patients who use this system. Ensure that patients or their carers are able to use this device and that they are aware of what to do if a result is out of their normal range. To avoid false high readings, advise them to follow the manufacturer s specific testing procedure, which includes making sure that, they: > clean and dry their hands before testing > apply the blood droplet immediately in a steady motion within the testing area, without pressing on it. Ensure you are familiar with the technology of this device and can show the patient how to use it correctly Ensure the patient can continue to monitor their blood glucose effectively. Ensure this guidance is incorporated into local protocols. For further details: Tel: Accu-Chek Careline: HYDROXYZINE (ATARAX, UCERAX): RISK OF QT INTERVAL PROLONGATION AND TORSADE DE POINTES A review of the safety and efficacy of hydroxyzine has been undertaken following concerns of heart rhythm abnormalities associated with this medicine. When using hydroxyzine: do not prescribe hydroxyzine to people with a prolonged QT interval or who have risk factors for QT interval prolongation (see below) avoid use in the elderly - they are more susceptible than younger patients to the side effects of hydroxyzine consider the risks of QT interval prolongation and Torsade de Pointes before prescribing to patients taking medicines that lower heart rate or potassium levels the maximum daily dose is now o 100 mg for adults o 50 mg for the elderly (if use cannot be avoided) o 2 mg per kg body weight for children up to 40 kg in weight prescribe the lowest effective dose for as short a time as possible continue to report any suspected side effects to hydroxyzine or any other medicine on a Yellow Card Patients who already have risk factors for QT prolongation include: concomitant use of medicines that prolong the QT interval cardiovascular disease family history of sudden cardiac death significant electrolyte imbalance (low potassium or magnesium levels) significant bradycardia HIGH STRENGTH, FIXED COMBINATION AND BIOSIMILAR INSULIN PRODUCTS: MINIMISING THE RISK OF MEDICATION ERROR Several new high strength insulin products are now on the market. The European Medicines Agency is consulting on guidance to minimise the risk of medication error. 6

7 It is likely that further products will come to market over the next few years. This draft guidance summarises ways to minimise the risk of medication errors with high strength, fixed combination and biosimilar insulin products already on the market. Healthcare professionals and patients need to understand the insulin strength of these products and how to use them correctly to minimise the risk of medication errors such as the wrong insulin dose being administered. Advice for healthcare professionals: Before starting treatment with a high strength, fixed combination or biosimilar insulin product: consult the summary of product characteristics and any educational material ensure that patients read and understand the patient leaflet and any patient education material ensure that patients receive appropriate training on the correct use of the product give patients a patient booklet and Insulin Passport (or safety card) warn patients only to use insulin as they have been trained because using it any other way may result in a dangerous overdose or underdose Monitor glucose levels closely after starting a new treatment and in the following weeks. You may need to adjust doses and timing of concurrent rapid acting or short acting insulin products and other antidiabetic treatments. Overview of products on the market: Several new insulin products have come to market recently; three high strength insulins which have concentrations greater than 100 units/ml (Tresiba, Humalog, Toujeo), a fixed combination of insulin degludec and liraglutide (Xultophy ) and a biosimilar of insulin glargine (Abasaglar ). 7

8 MHRA DRUG SAFETY UPDATE SEPTEMBER 2015 PROTON PUMP INHIBITORS (PPIs): SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS PPIs are associated very infrequently with cases of subacute cutaneous lupus erythematosus (SCLE), a non-scarring dermatosis that can develop in sun-exposed areas. If a patient treated with a PPI develops lesions especially in sun-exposed areas of the skin and it is possibly accompanied by arthralgia, they should be advised to avoid exposure of the skin to sunlight. The PPI should be stopped unless it is imperative for a serious acidrelated condition. A patient who develops SCLE with a particular PPI may be at risk of the same reaction with another. Download the Yellow Card mobile app to report suspected adverse drug reactions. Use it to report suspected reactions and receive up to date information on medicines of interest. 8

9 APP OF THE MONTH: MOODKIT MoodKit helps users engage in mood-enhancing activities, identify and change unhealthy thinking, rate and chart mood across time, and create journal entries using custom templates designed to promote well-being. Developed by two clinical psychologists, MoodKit draws upon the principles and techniques of Cognitive Behaviour Therapy (CBT) Available via apps.nhs.uk LOCAL CASE STUDIES - SIGNIFICANT EVENT CORNER AKI SECONDARY TO DEHYDRATION A 74 year old had episodes of diarrhoea following food poisoning. Initially he contacted the surgery after a 4 day history of this; he was taking plenty of fluids plus loperamide and symptoms were beginning to improve. He was unable to get a stool culture to the surgery. Three days later he was still suffering, with up to 10 episodes of diarrhoea a day. Significant comorbidities included: Hypertension T2DM Previous TIA & CVA Hypercholesterolaemia IHD CABG His medications at this stage were: Furosemide 40mg mane and 20mg lunchtime Lisinopril 20mg mane Bisoprolol 10mg daily Lacidipine 2mg mane Isosorbide mononitrate M/R 120mg mane Atorvastatin 40mg daily Metformin 500mg mane Gliclazide M/R 90mg mane Allopurinol 300mg mane Omeprazole 20mg mane Fenbid 5% gel topically tds He was well hydrated at this stage, and was issued with a 5-day course of Ciprofloxacin 250mg bd. Ten days later he attended A&E with a history of diarrhoea of 3 weeks duration; he was then admitted to hospital and was discharged 19 days later. 9

10 CONTACT DETAILS FOR THE MEDICINES OPTIMISATION TEAM King Edward VII Hospital, St Leonards Rd, Windsor SL4 3DP Main office phone number Fax: Generic in box Catriona Khetyar Head of Medicines Optimisation Tim Langran Slough CCG Lead Support Pharmacist Melody Chapman Bracknell & Ascot CCG CCG Lead Support Pharmacist Dawn Best Maidenhead/Windsor/Ascot CCG Lead Support Pharmacist Caroline Pote CCG Prescribing Support Pharmacist Sundus Bilal Care Home & Practice Support Pharmacist Sally Clarke Care Home & Practice Support Pharmacist Ammar Kazouini Care Home & Practice Support Pharmacist Yan-Yee Sung, Prescribing Support Dietitian Maureen Maul PA to Catriona Khetyar and team Mobile E: mail

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