FORMULARY UPDATES ABUHB s Drug Formulary is at:

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1 Aneurin Bevan University Health Board Medicines & Therapeutics Committee July 2014 PRESCRIBING enewsletter archive at: Dear Gwent Prescriber At its last two meetings (10 th April 2014 and 22 nd May 2014) ABUHB s Medicines & Therapeutics Committee made the following decisions in relation to the ABUHB Formulary: FORMULARY UPDATES ABUHB s Drug Formulary is at: and access to the BNF and the BNF for Children is easy via NHS evidence at: BNF section INDACATEROL/GLYCOPYRRONIUM ( Ultibro Breezhaler ) for COPD ADDED to section as a Green drug (appropriate for initiation and repeat prescribing by all prescribers) in accordance with AWMSG advice No AWMSG s recommendation on Ultibro Breezhaler in COPD (Advice No 0814) can be found at: Full prescribing information on Ultibro is at: _Product_Information/human/002679/WC pdf BNF section EXENATIDE (Byetta ) twice daily REMOVED in accordance with the consensus view of ABUHB s Diabetes Directorate the standardrelease injection (Byetta) has been removed from the Formulary. The MTC noted that NICE s advice on this TWICE DAILY formulation of exenatide was from a non statutory guideline (CG87). Byetta s non Formulary status does NOT require patients established on Byetta to be changed to an alternative GLP 1 agonist. New patients should not be started on Byetta. The ONCE WEEKLY formulation of exenatide (Bydureon ) injection remains in the ABUHB Formulary. Bydureon may be a suitable option in patients with Type 2 diabetes and more severe hyperglycaemia, particularly if third party administration is required (by a district nurse for example). The GLP 1 agonists 1 st & 2 nd line choices 1. Lixisenatide (once daily, less expensive that Liraglutide and Bydureon) will be used as 1 st line GLP 1 injection in suitable patients with Type 2 diabetes and milder degrees of hyperglycaemia (e.g. HbA 1C < 70 mmol/mol) 2. Liraglutide 1.2 mg once daily may be used as 1 st line GLP 1 injection in suitable patients with Type 2 diabetes and more severe hyperglycaemia (e.g. HbA 1C 70 mmol/mol). All GLP 1 agonists are designated Amber in the local Traffic Light system (specialist initiation only and without the need for any formal shared care arrangement). Specialist initiation covers initiation by GPs based in practices that have a relevant accreditation to provide an advanced diabetic service. Comparative acquisition costs (from BNF March 2014) of GLP 1 agonists: Drug Dose Regimen Cost / yr Lixisenatide 20microgram once daily 706 Liraglutide 1.2 once daily Note NICE do NOT recommend 1.8mg once daily 955 Exenatide m/r (Bydureon ) 2mg once weekly 954 Exenatide (Byetta ) 5 to 10microgram twice daily 830 Doses are for general comparison and do not imply therapeutic equivalence. All GLP 1s are administered via subcutaneous injection. Page 1 of 6

2 BNF section COLESEVELAM (Cholestigel ) 625mg tablets ADDED for the OFF LABEL treatment of diarrhoea and other gastrointestinal symptoms in patients with bile acid malabsorption. Prescribers receiving requests to repeat prescribe should note the following restrictions: Colesevelam should only be initiated by specialists in gastroenterology (i.e. it is designated Amber in ABUHB s Traffic Light classification NO shared care arrangements are required). Colesevelam should only be used in individuals with a clinical diagnosis of bile acid malabsorption who have shown an improvement in diarrhoea and gastrointestinal symptoms on colestyramine (following an unsuccessful trial of antimotility drugs) but have not been able to tolerate continued treatment. Current evidence did not support the use of colesevelam for the symptomatic treatment of diarrhoeapredominant IBS. Colesevelam remains non formulary for its licensed indications of primary hypercholesterolaemia (either alone or with a statin) and primary/familial hypercholesterolaemia with ezetimibe (+/ a statin). Patients should be stabilised on colesevelam before GPs are requested to repeat prescribe. Full prescribing information on colesevelam is at: BNF section NALMEFENE ( Selincro ) 18mg tablets ADDED in accordance with AWMSG s advice for it to be used as an option for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL) without physical withdrawal symptoms and who do not require immediate detoxification. Nalmefene should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Nalmefene should be initiated only in patients who continue to have a high DRL two weeks after initial assessment. The MTC has requested the Gwent Substance Misuse Area Planning Board to consider delivering a psychological support programme. The Board will be responding to the MTC once they had scoped existing provision in primary mental health care teams. Until a continuous psychological support programme is widely available in Gwent, nalmefene s Traffic Light is designation is Red (suitable for prescribing only by specialists). This will enable services that are currently able to provide regular ongoing psychosocial support (such as GSSMS) to have access to nalmefene. AWMSG s recommendation on nalmefene (Advice No 0414) can be found at: Full prescribing information on nalmefene at: BNF section VITAMIN B COMPOUND STRONG REMOVED because NICE CG100 Alcohol use disorders: Diagnosis and clinical management of alcoholrelated physical complications (June does not include Vitamin B Compound Strong (or Vitamin B Compound) in its recommendations for preventing Wernicke's encephalopathy: Offer thiamine to people at high risk of developing, or with suspected, Wernicke's encephalopathy in doses toward the upper end of the BNF range Offer prophylactic oral thiamine to harmful or dependent drinkers: if they are malnourished or at risk of malnourishment or if they have decompensated liver disease or if they are in acute withdrawal or before and during a planned medically assisted alcohol withdrawal And Vitamin B Compound Strong and Vitamin B Compound are also both preparations that are considered by the BNF s Joint Formulary Committee to be less suitable for prescribing and both bear this symbol: in the BNF and BNFc. Page 2 of 6

3 If your practice has not yet reviewed and stopped the prescribing of Vitamin B Compound preparations, please contact a member of the medicines management team: Blaenau Gwent Newport Caerphilly Torfaen Monmouthshire BNF section FULTIUM D unit Capsules ADDED these higher strength capsules are now included as an option in the local guidance on Vitamin D insufficiency and deficiency This guidance is available at: ABHBprescribingGuidanceFINAL[June2014].pdf Fultium D 3 capsules (both 400unit and 3200unit) are contra indicated in those with peanut or soya allergy. Full prescribing information on Fultium D unit caps is at: OTHER PRESCRIBING NEWS SHARED CARE PROTOCOLS Prescribers should note the following changes to Gwent Protocols: NALTREXONE NEW Protocol covering use of naltrexone in the maintenance of abstinence from alcohol (now a licensed indication). NICE CG115 (February 2011) Alcohol use disorders: diagnosis, assessment and management of harmful drinking and alcohol dependence advises that naltrexone should be considered (in combination with an individual psychological intervention) for: 1. harmful drinkers and people with mild alcohol dependence who have not responded to psychological interventions alone, or who have specifically requested a pharmacological intervention. 2. people with moderate and severe alcohol dependence after a successful withdrawal. The monitoring (at month 2 and monthly up to month 6 and then 3 monthly thereafter) is an evaluation of treatment adherence and does not involve blood tests. Although there is no standard duration of treatment in maintaining abstinence from alcohol with naltrexone, an initial period of 3 months should be considered, although prolonged administration for up to 12 months may be necessary. All the Gwent Shared Care Protocols can be found at: STRONTIUM now an Amber drug Following the revised MHRA advice (of March 2014) that strontium should only be used by people (postmenopausal women with severe osteoporosis and adult men at high risk of fracture) for whom there are no other treatments for osteoporosis (i.e. for reasons such as contraindications or intolerance), the local Traffic Light classification of strontium ranelate (Proteolos ) has been changed from Green (appropriate for initiation by all prescribers) to Amber without Shared Care (suitable for specialist initiation only). Further practical advice from Gwent Rheumatology specialists on options for managing patients inappropriately on strontium has again gone out to GP practices. This local advice is available (in a 2 page letter) at: ABHBletterUpdateJune2014.pdf The MHRA s advice on strontium is available at: Page 3 of 6

4 FUNGAL NAIL INFECTIONS new local guidance on treatment This guidance is a local adaptation of the wider HPA s 2011 Quick Reference Guide (on fungal nail and skin infections). It covers fungal nail infections only and prescribers should note the key prescribing message in the box below (agreed by the MTC in consultation with ABUHB Dermatology, Podiatry and Microbiology): Topical amorolfine (Loceryl or Curanail ) and topical tioconazole (Trosyl ) are NOT RECOMMENDED as there are no clinically important results from RCTs about their effects in fungal toenail infection. This advice NOT to use topical antifungals also includes: Any treatment of superficial white infection of the top surface of the nail plate or localised distal nail disease Situations where there are contraindications or significant adverse reactions to oral terbinafine or oral itraconazole. Further advice Patients currently mid way through a course of topical treatment should have their treatment reviewed at their next routine appointment. Consideration should be given to switching to more effective oral treatment if required (in line with the detail in the guidance on oral treatments in the table below) and stopping ineffective topical antifungals. Considering the evidence, advising patients to purchase over the counter topical antifungals (e.g. 3mls of amorolfine 5% lacquer), as an alternative to prescribing, is not recommended. CONDITION COMMENTS DRUG DOSE LENGTH OF TREATMENT Dermatophyte and candidal infection of the fingernail or toenail Treat only if infection confirmed by lab. For infections with dermatophytes use oral terbinafine or itraconazole. For infections with candida or non dermatophyte moulds use oral itraconazole. Idiosyncratic liver and other severe reactions occur very rarely with terbinafine and itraconazole. For children seek expert advice Terbinafine Itraconazole 250mg OD 200mg BD fingers toes fingers toes 6 12 weeks 3 6 months 2 courses of 7 days/month 3 courses of 7 days/month The full local guidance (3 pages) is available at: ABUHBquickreferenceGuideFINAL[April2014].pdf NITROFURANTOIN Pulmonary toxicity As UTI causing coliforms are declining in sensitivity to trimethoprim and amoxicillin, local guidance on the treatment of UTIs currently advises In the elderly, or patients who have received antibiotics within the last 3 months consider nitrofurantoin OR co amoxiclav Respiratory physicians in Gwent wish to alert prescribers in Primary Care to nitrofurantoin s potential to cause serious pulmonary reactions. Key prescribing points for all adults on long term nitrofurantoin: To include checks at each issue of a repeat prescription for nitrofurantoin (i.e. when used long term) to ensure there are no new respiratory symptoms (especially breathlessness and/or cough), and/ or three monthly practice spirometry for these patients On finding any evidence of new respiratory symptoms an urgent chest x ray should be performed with consideration of discontinuation of nitrofurantoin and referral to the respiratory physicians. The nitrofurantoin SmPC (at: states: Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin should be discontinued immediately. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis) can develop insidiously, and may occur commonly in elderly patients. Close monitoring of the pulmonary conditions of patients receiving long term therapy is warranted (especially in the elderly). Page 4 of 6

5 The SmPC also states that if any of the following respiratory reactions occur the drug should be discontinued: Acute pulmonary reactions usually occur within the first week of treatment and are reversible on cessation of therapy. Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnoea, pulmonary infiltration with consolidation or pleural effusion on chest x ray, and eosinophilia. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form Chronic pulmonary reactions occur rarely in patients who have received continuous therapy for six months or longer and are more common in elderly patients. Changes in ECG have occurred, associated with pulmonary reactions. Minor symptoms such as fever, chills, cough and dyspnoea may be significant. Collapse and cyanosis have been reported rarely. The severity of chronic pulmonary reactions and their degree of resolution appear to be related to the duration of therapy after the first clinical signs appear. It is important to recognise symptoms as early as possible. Pulmonary function may be impaired permanently, even after cessation of therapy. NITROFURANTOIN High cost of 25mg/5ml oral suspension The cost of nitrofurantoin 25mg/5ml oral suspension sugar free is disproportionately high compared to capsules or tablets (300ml is ). Although nitrofurantoin is still a recommended treatment option for UTIs in children in ABUHB s antibiotic guidance for Primary Care, prescribers wishing to use a less costly oral liquid for a UTI should note that the risk of beta lactams causing C. diff overgrowth rises exponentially with age. Therefore cefalexin may be a more appropriate alternative to trimethoprim in children (than adults, in terms of a reduced risk of C. diff developing). DOMPERIDONE risk of cardiac side effects and review of long term use The MHRA has recently recommended changes to the use of domperidone, including restricting the dose, duration of use and its licensed indication (it is now only indicated for the relief of nausea and vomiting), to minimise the known risks of potentially serious cardiac adverse effects. The MTC considered the MHRA s advice and offers the following further practical implementation advice: For gastrostomy tube fed patients on long term domperidone (where domperidone is used to reduce the risk of aspiration pneumonia, to which delayed gastric emptying of feed can contribute) prescribers should seek specialist advice from ABUHB gastroenterology. For those on domperidone for the symptomatic relief of GORD, dyspepsia or gastroparesis refer to the suggested action plan at: Link to MHRA advice (May 2014): ANTIBIOTICS FOR ACUTE EXACERBATIONS OF COPD Revised local guidelines The recommendation to use amoxicillin 500mg for acute exacerbations of COPD has been revised in view of the increasing level of local resistance to amoxicillin. DOXYCYCLINE is now the first choice for treating acute exacerbations of COPD. This change will be reflected in what is supplied in the COPD Rescue Packs. All local guidelines on antibiotics/anti infectives can be found at: Page 5 of 6

6 HAY FEVER local guidance Updated local guidance on the pharmacological management of hay fever can be found on the Prescribing Guidelines / Resources page on the MTC website (in row 3.4 of the table): page.cfm?orgid=814&pid=48819 Prescribing Guidelines / Resources webpage The layout of the Prescribing Guidelines / Resources page on the MTC s website had been changed so that items are now presented in BNF Chapter order so gastro drug related guidance will come in the first section and cardiology drug related guidance in the second. All the pain management guidelines/resources have now been placed on a separate webpage (with a link from section 4): It is hoped that these changes will make local prescribing guidance easier to find. DECLINE FORMS a reminder These Forms provide an easy to use template for GPs to communicate to a hospital specialist their wish to decline an inappropriate request to repeat prescribe. The Forms have been highlighted in previous editions of this newsletter (November 2010 and May 2013). Please note that these Forms are scrutinised by the MTC and can enable ABUHB s Medicines Management team to act to improve prescribing practice in Secondary/Tertiary Care. Recent examples of this are: GP requested to prescribe dronedarone by a consultant cardiologist in Cwm Taf. The cardiology team were alerted to the fact that all Wales advice is that dronedarone should be prescribed and monitored by specialist teams only GP requested to prescribe ulipristal 5mg (Esmya) for uterine fibroids. The consultant gynaecologist was not aware of Esmya s Red status and was happy to prescribe it for the patient. GP requested to prescribe rasagiline. The non Formulary status of rasagiline was clarified with the specialist and a Formulary application is currently being considered. The Decline Forms are available at: The Cost of SPECIALS is there a list of prices somewhere? Part VIIIB of the Drug Tariff covers specials and imported unlicensed medicines and the prices shown will be used for reimbursement regardless of the cost charged to the dispenser by the supplier. The June 2014 list includes over 200 preparations mostly oral solutions and suspensions. Feedback on any item in this enewsletter is welcome. Suggested agenda items for the MTC are also welcome. Trevor Batt Pharmacist & Professional Secretary to: Aneurin Bevan HB Medicines & Therapeutics Committee Aneurin Bevan Health Board Based at Victoria House, Corporation Rd, Newport NP19 0BH trevor.batt@wales.nhs.uk Tel: (DIRECT LINE) Web: Page 6 of 6