FORMULARY UPDATES ABUHB s Drug Formulary is at:

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Aneurin Bevan University Health Board Medicines & Therapeutics Committee PRESCRIBING enewsletter archive at: http://www.wales.nhs.uk/sites3/page.cfm?

Committee during the course of its last three meetings (12 th March, 30 th April and 18 th June 2015): FORMULARY UPDATES ABUHB s Drug Formulary is at: http://aneurinbevanhb.inform.wales.nhs.

AWMSG advice is that use of linaclotide should be restricted to adults who have not responded adequately to, or cannot tolerate antispasmodics and/or laxatives.

1 Aneurin Bevan University Health Board Medicines & Therapeutics Committee PRESCRIBING enewsletter archive at: September 2015 Dear Gwent Prescriber In the first section of this prescribing newsletter there is a selection of the Formulary decisions made by ABUHB s Medicines & Therapeutics Committee during the course of its last three meetings (12 th March, 30 th April and 18 th June 2015): FORMULARY UPDATES ABUHB s Drug Formulary is at: BNF section LINACLOTIDE ( Constella ) for IBS ADDED as an option in the symptomatic treatment of moderate to severe irritable bowel syndrome (IBS) with constipation. AWMSG advice is that use of linaclotide should be restricted to adults who have not responded adequately to, or cannot tolerate antispasmodics and/or laxatives. The MTC agreed that the advice on linaclotide in NICE guidance on IBS (update to CG61, at: published in February 2015, should be adopted locally. This states that linaclotide may be considered for people with IBS only if: optimal or maximum tolerated doses of previous laxatives from different classes have not helped and they have had constipation for at least 12 months. NICE CG61 also advises to follow up people taking linaclotide after 3 months. Despite these restrictions it was agreed that linaclotide was appropriate for prescribing by all prescribers within Gwent (Green Traffic Light designation this is consistent with the previous Green classification of both prucalopride and lubiprostone). AWMSG Advice No 0314 on linaclotide in IBS can be found at: Full prescribing information on linaclotide is at: BNF section APIXABAN ( Eliquis ) for the treatment & secondary prevention of DVT and/or PE LICENSE EXTENSION APPROVED in accordance with the recommendation in NICE TA341. Consistent with the advice for dabigatran and rivaroxaban in their DVT/PE indications, apixaban has been designated Amber (specialist initiation only) in the Formulary. See table on Page 4 of this newsletter for further information on Traffic Light classification of oral anticoagulants. Full prescribing information on apixaban is at: RIVAROXABAN ( Xarelto ) in the acute management of ACS LICENSE EXTENSION APPROVED as an option (in combination with aspirin plus clopidogrel or aspirin alone) for preventing atherothrombotic events in people who have had an acute coronary syndrome with elevated cardiac biomarkers, in accordance with NICE TA335. Considering the setting for this use it was designated Amber (specialist initiation only) in the Formulary. See table on Page 4 of this newsletter for further information on Traffic Light classification of oral anticoagulants. Full prescribing information on rivaroxaban is at: Page 1 of 7

2 BNF section 2.12 COLESEVELAM (Cholestagel ) for primary hypercholesterolaemia ADDED as an option for adjunctive therapy (to diet) to provide an additive reduction in LDL C levels in primary hypercholesterolaemia, and with the following restrictions: 1. Used in adults with intolerance or contraindications to statins or ezetimibe i.e. in accordance with the recommendation in NICE CG71 on the management of familial hypercholesterolaemia (FH), at: The recommendation for children with FH, who are intolerant of statins, in CG71 is to consider offering bile acid sequestrants (as opposed to offer ), however the BNFc states that bile acid sequestrants are not well tolerated and compliance with treatment was poor, therefore they were rarely used in children. 2. For specialist initiation only (i.e. designated Amber). This concurred with the recommendation on referral to a specialist in CG Colesevelam should only be used in those individuals who have tried colestyramine (Questran /Questran Light ) and who have either developed gastrointestinal adverse effects and/or tolerability problems which are significant enough to be detrimental to their continuing adherence colesevelam has a significantly increased acquisition cost and a narrower administration window (in patients taking other medication) compared to colestyramine. Full prescribing information on colesevelam is at: BNF section Umeclidinium/vilanterol ( ANORO Ellipta ) 55micrograms/22micrograms inhaler for COPD ADDED in accordance with AWMSG Advice No Anoro Ellipta is recommended as an option for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. This fixed dose combination is considered suitable for prescribing by all prescribers in Gwent (i.e. designated Green in the Traffic Light classification). AWMSG Advice No 0215 on Anoro in COPD can be found at: Full prescribing information on Anoro is at: BNF section LURASIDONE ( Latuda ) tablets for schizophrenia ADDED in accordance with AWMSG Advice No Lurasidone is recommended as an option for the treatment of schizophrenia in adults. The MTC agreed that non specialist repeat prescribing, without the need for a shared care protocol, was appropriate following specialist initiation (i.e. Amber in the local Traffic Light system). Local guidance on lurasidone (2 pages) is available on the Mental Health Prescribing Guidelines and Resources page of MTC s website: AWMSG Advice No 0215 on lurasidone can be found at: Full prescribing information on lurasidone is at: Page 2 of 7

3 BNF section RIFAXIMIN 550mg tablets ( Targaxan ) for hepatic encephalopathy ADDED in accordance with NICE TA337. This recommends rifaximin as an option for reducing the recurrence of episodes of overt hepatic encephalopathy in adults. The MTC agreed that non specialist repeat prescribing of the 550mg tablets was appropriate following specialist initiation (i.e. Amber in the local Traffic Light system). This is consistent with the previous Amber designation of rifaximin 200mg ( Xifaxanta) for the treatment of travellers diarrhoea (AWMSG Advice No. 1212). Full prescribing information on rifaximin 550mg is at: BNF section EMPAGLIFLOZIN ( Jardiance ) for type 2 diabetes ADDED in accordance with NICE TA341. This recommends empagliflozin as an option (in combination with metformin, metformin plus a sulfonylurea, metformin plus a thiazolidinedione or in combination with insulin) for treating type 2 diabetes. Consistent with the local advice for dapagliflozin and canagliflozin, empagliflozin is considered suitable for prescribing by all prescribers in Gwent (i.e. designated Green in the traffic light classification). A NICE multiple technology appraisal of all 3 SGLT2 inhibitors (flozins) as monotherapy in type 2 diabetes is in development, with publication due in May Full prescribing information on empagliflozin is at: BNF section 11.6 BIMATOPROST 0.03% (Lumigan ) SINGLE USE eye drops for the reduction of intraocular pressure ADDED in response to the announcement by Allergan that bimatoprost (Lumigan ) 0.03% eye drops in the 3mL multidose bottle would cease to be available from 30 April Local advice on options for the management of patients established on bimatoprost 0.03% multidose drops was developed, in consultation with ABUHB Ophthalmology, and ed to GP practices (and opticians) in May. The guidance advised use of bimatoprost 0.03% SINGL USE (and preservative free [p/f]) eye drops only in cases where Monopost (p/f latanoprost) AND p/f tafluprost (Saflutan ) were not tolerated (or failed to deliver a sufficient reduction in IOP). Full prescribing information on bimatoprost 0.03% eye drops in single dose container is at: Local advice on options for the management of patients established on bimatoprost 0.03% multidose drops (1 page) is available at: DiscontinuationAdvice14May2015.pdf OTHER PRESCRIBING NEWS SHARED CARE PROTOCOLS (SCPs) Prescribers should note the following changes to Gwent Protocols: 1. SUB CUT METHOTREXATE (Metoject ) UPDATED SCP. Now extended to cover the prescribing and monitoring of Metoject in psoriasis. 2. MYCOPHENOLATE MOFETIL (MMF) 500mg tablets in connective tissue diseases NEW SCP covering the off label use as a disease modifying drug in connective tissue disease responding to immunosuppressive therapy when other standard treatments (e.g. azathioprine) have failed or are not tolerated. Connective tissue disease covers; rheumatoid arthritis, systemic lupus erythematosus and lupus nephritis and inflammatory myopathy such as dermatomyositis and polymyositis. MMF is also used in scleroderma, vasculitis and Behçet s disease. Page 3 of 7

4 Primary Care prescribers should note: The monthly monitoring schedule set out in the SCP is now covered by the DMARD monitoring Local Enhanced Service and can be claimed for. The transfer arrangements to GP practice prescribing/monitoring in this new SCP require the rheumatology specialist to fax the Shared Care Agreement Form (included at the end of the SCP document) to the GP only once they have reviewed the result of the 4 th blood test. The initial monitoring at 1, 2, 3 and 4 weeks post initiation is the responsibility of Rheumatology and they will provide the patient with FOUR blood sample request forms for this and six weeks of medication. All other DMARD SCPs will now be updated in line with this agreed arrangement. 3. AChE Inhibitors EXTENDED SCP. Use of acetylcholinesterase inhibitors (donepezil [e.g. Aricept ], galantamine [e.g. Reminyl ] and rivastigmine [e.g. Exelon ]) in Parkinson s disease dementia is now also covered by the SCP. All the Gwent Shared Care Protocols and the Incident Report Form can be found at: TRAFFIC LIGHT CHANGES 1. TOBI Podhaler and Colobreathe dry powder inhalers Now Red (specialist only prescribing) These antibiotic inhalations, both used in the management of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF), are not recommended for prescribing in Primary Care. This clarification follows advice received from the Lead Respiratory Pharmacist at Llandough Hospital. It is understood that the Patient Access Scheme discount (which was a condition of NICE TA276, when it recommended both the Podhaler and Colobreathe ) is only available to Secondary/Tertiary care and to homecare providers. Note that TOBI and Bramitob nebuliser solutions for CF remain designated Amber with Shared Care. 2. RIVAROXABAN for stroke prevention in non valvular AF Now Green (appropriate for initiation by non specialist prescribers in Gwent Primary Care). This decision was communicated to GP practices at the beginning of June: The table below summarises the current Traffic Light Status for the main uses of oral anticoagulants in Gwent: Drug Indication Traffic Light Status* Warfarin Preventing VTE in rheumatic heart disease and AF GREEN Warfarin Prophylaxis after insertion of prosthetic heart valves AMBER Warfarin Treating and preventing DVT/PE AMBER Rivaroxaban ( Xarelto) Preventing stroke and systemic embolism in non valvular AF GREEN Apixaban ( Eliquis) Preventing stroke and systemic embolism in non valvular AF AMBER Dabigatran (Pradaxa) Preventing stroke and systemic embolism in non valvular AF AMBER Apixaban ( Eliquis) Dabigatran (Pradaxa) Rivaroxaban ( Xarelto) Apixaban ( Eliquis) Dabigatran (Pradaxa) Rivaroxaban ( Xarelto) Treating and preventing DVT/PE Preventing VTE in adult patients undergoing elective hip or knee replacement surgery AMBER RED Rivaroxaban ( Xarelto) Preventing adverse outcomes after acute management of ACS AMBER * Definitions of ABUHB s Traffic Light drug classifications can be found at The Traffic Light classifications of all medicines included in the ABUHB Formulary can be found at: Page 4 of 7

5 GOUT newly developed local treatment algorithm This local treatment pathway was ed to GP practices in early July and is available on the MTC s website at: ABUHBguidelinesFINAL%5BJune2015%5D.pdf Two key prescribing points to note are: 1. The importance, in the long term management of gout, of treating to target serum uric acid (sua) levels of < 300µmol/L, for which doses of allopurniol above 300mg daily may be required. 2. febuxostat (Adenuric ) is now designated Green in ABUHB s Traffic Light classification. The MTC agreed that it is suitable for GP initiation provided that it is used where recommended in the algorithm. METFORMIN use in renal disease Following discussion of the views in a BMJ editorial ( on using metformin in the presence of renal disease the MTC agreed to highlight the following points to prescribers: Guidelines from NICE on type 2 diabetes (CG ) suggest that metformin dose should be reviewed at an egfr of 45 and stopped at an egfr of 30. The draft update of this guideline (due October 2015) states: review the dose of metformin if the egfr is below 45 ml/minute/1.73m 2 : Stop metformin if the egfr is below 30 ml/minute/1.73m 2. Prescribe metformin with caution for those at risk of a sudden deterioration in kidney function and those at risk of egfr falling below 45 ml/minute/1.73m 2. ABUHB s 2013 document Acute Kidney Injury (AKI): Advice to Primary Care (1page) is available at: The NHS campaign THINK KIDNEYS issued an Interim Position Statement in July 2015 on Sick day rules in patients at risk of AKI. This states that a systematic review of the published evidence on this topic is under way and that the position statement is provided as a temporary measure until that review is completed. In terms of medicines management, advice from the THINK KIDNEYS Programme Board is that it is reasonable for clinicians to provide sick day rules guidance on temporary cessation of medicines to patients deemed at high risk of AKI based on an individual risk assessment. However, they consider that investment in a systematic approach to increase uptake of sick day rules by patients should only be undertaken in the context of a formal evaluation. content/uploads/2015/07/think Kidneys Sick Day Rules pdf Prescribing Dilemmas: A Guide for Prescribers guidance on prescribing situations not covered by NHS Wales This all Wales guidance (first produced in 2011) has recently been reviewed and updated. It provides useful advice on a range of prescribing situations including private care and private prescriptions, travel, foodstuffs, infertility treatment, common ailments, complementary medicines and alternative therapies, erectile dysfunction, prescribing for self and family, visitors from overseas, unlicensed medicines, and prescribing outside national guidance. The updated document can be accessed on the link below: %20A%20Guide%20for%20Prescribers.pdf Page 5 of 7

6 Local Antibiotic Guidelines Updated The local antibiotic guidelines were updated in July to include new indications and revised recommendations. The changes are as follows: NEW guidance: Sepsis (non shock) unknown origin (as part of Sepsis Six) to be used for patients without severe sepsis Herpes simplex encephalitis Leg ulcers (Secondary Care) PEG/PEJ insertion prophylaxis Endoscopic ultrasound aspiration prophylaxis Revised guidance: Threadworm in age <6/12 (in Primary Care section) Penicillin allergy Sensitivity rates Gwent Primary Care Bronchiectasis (H. influenzae) ERCP prophylaxis Breast surgery prophylaxis C section prophylaxis Teicoplanin levels C. diff intracolonic vancomycin The guidelines can be accessed online at: guidelines.com/view/abuhb/abx, via the link on the CWS homepage or via the ABUHB applications page, and using the Apple & Android App (search RxGuidelines if using the App, ensure you download the new guidelines when prompted). Prescribing for Care Home residents The MTC strongly endorses two requests from the ABHB Pharmacist with a role dedicated to managing medicines in Care Homes. These requests (to all prescribers, and where it is know that the individual is a Care Home resident) are that you please consider: 1. Reducing the use of take/use as directed on prescriptions (e.g. adding durations for topical steroids and specifying which eye/eyes require the drops) whenever possible. NICE s Social Care Guidance on Managing medicines in care homes (SC1 at: states: GP practices should ensure that there is a clear written process for prescribing and issuing prescriptions for their patients who live in care homes. The process should cover: recording clear instructions on how a medicine should be used, including how long the resident is expected to need the medicine and, if important, how long the medicine will take to work and what it has been prescribed for (use of the term 'as directed' should be avoided). 2. Adding clinical indications to when required medicines (e.g. haloperidol for hiccups or psychosis?). The 2013 GMC guidance on prescribing (at: uk.org/guidance/ethical_guidance/14317.asp) advises you should consider including clinical indications* on your prescriptions. * See clinicalindications.com Chronic Cough This MTC endorsed local guidance on the investigation, management and referral of this common condition was ed to GP practices at the beginning of July. It has been developed by ABUHB s Department of Respiratory Medicine and it included (on page 3) a diagnostic and therapeutic algorithm covering the 3 commonest causes of chronic cough: 1. Gastro oesophageal reflux related cough [37%] 2. Asthma and asthma like syndromes [33%] 3. Rhinitis, sinusitis, post nasal drip [10%] The algorithm also includes detail on ACE inhibitor associated cough. The 6 page document can be accessed via the link below: Page 6 of 7

7 PATIENT INFORMATION on medication for mental health REMINDER In the MTC s last enewsletter this source of simple and accurate patient information on medication for mental health was highlighted (in the item on valproate medicines in pregnancy). The link to this website is: The website is structured into two main strands: 1. Medicines at least 30 questions and answers on over 150 medicines used in mental health Under most medicines there is a link to "download a handy PILL". 2. Conditions at least 14 questions and answers on 21 or so conditions The link to the printable leaflets webpage (medicines listed in alphabetical order) is: DuoResp Spiromax and Symbicort Turbohaler reminder to prescribe as brands Further to the item in the MTC s last enewsletter on addition of the DuoResp Spiromax breathactuated Dry Powder Inhaler device (for COPD and asthma) to ABUHB s Formulary, advice was issued to GP practices at the end of July to prescribe DuoResp and Symbicort devices by BRAND (rather than as generic budesonide/formoterol strengths). This should avoid confusion as, although the two doses of DuoResp are bioequivalent to two of the three Symbicort Turbohaler devices, the doses are differently stated: DuoResp dose is the delivered dose (the dose that leaves the mouthpiece) Symbicort dose is the metered dose (the dose held within the chamber after priming). 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 7 of 7

FORMULARY UPDATES ABUHB s Drug Formulary is at:

FORMULARY UPDATES ABUHB s Drug Formulary is at: Aneurin Bevan University Health Board Medicines & Therapeutics Committee PRESCRIBING enewsletter archive at: http://www.wales.nhs.uk/sites3/page.cfm?orgid=814&pid=48407 Dear Gwent Prescriber At its last