GWENT FORMULARY DECISIONS

Transcription

1 Dear Gwent Prescriber At its last three meetings (3rd March, 26th May and 14th July 2011) ABHB s Medicines & Therapeutics Committee (formerly GPMTC) made the following decisions in relation to the ABHB Joint Formulary: GWENT FORMULARY DECISIONS BNF section Emollients Revision of range included in Formulary In consideration of the current poor level of evidence for emollients the MTC agreed to adopt the Dermatology Directorate s proposal to set a price threshold as the criteria for ABHB Formulary inclusion thereby increase patient choice whilst giving due consideration to NHS expenditure. The agreed price thresholds are 6.99/500g for standard emollients/bath additives and 21.85/500g for emollients containing urea. The current definitive list of Formulary section is: EMOLLIENTS Non proprietary emollient preperations Aqueous cream BP Emulsifing ointment BP Hydrous ointment BP (oily cream) Liquid + white soft paraffin ointment NPF Paraffin white soft BP Paraffin yellow soft BP Proprietary emollient preperations Aquamol cream Cetraben emollient cream Diprobase cream Doublebase gel E45 cream E45 lotion Epaderm cream Epaderm ointment Hydromol ointment Oilatum cream QV cream & lotion Zerobase cream Zerocream cream Zeroguent cream (alternative to Unguentum M cream) Kamillosan ointment Preperations containing urea Aquadrate cream (a.k.a. Hydromol Intensive) Balneum cream Balneum Plus cream E45 Itch Relief Cream Eucerin Intensive lotion (Eucerin Intensive Cream is Non Formulary) Hydromol Intensive cream Nutraplus cream With antimicrobials Dermol cream Dermol 500 lotion EMOLLIENT BATH ADDITIVES Balneum bath oil Balneum plus bath oil Cetraben emollient bath additive Dermalo bath emollient Diprobath bath additive Doublebase emollient bath additive E45 emollient bath oil E45 wash cream Hydromol bath + shower emollient Oilatum emollient bath additive Oilatum junior emollient bath additive QV bath oil QV wash Zerolatum emollient medicinal bath additive Zeroneum bath ointment Zerozole bath oil With antimicrobials Dermol 600 bath emollient Emulsiderm liquid emulsion Oilatum plus bath additive Zerolatum Plus bath additive BNF for Children section TRIPTORELIN for precocious puberty ADDED the MTC approved the formulary inclusion of both the monthly 3.75mg Gonapeptyl Depot and 3 monthly 11.25mg Decapeptyl SR preparations for the treatment of confirmed central precocious puberty. Triptorelin s traffic Light designation is Amber WITH Shared Care. A local Shared Care Protocol has now been developed to provide GPs with the relevant details to take on the repeat prescribing and administration. Consistent with the other GnRH analogues the MTC agreed that ABHB s Enhanced Services Group give consideration Page 1 of 7

2 to adding triptorelin to the existing Local Enhanced Service for GPs to administer GnRH analogues Full prescribing information on triptorelin at: cksearch BNF section ULIPRISTAL ACETATE 30mg ( ellaone ) for emergency contraception ADDED Considering the current comparative evidence (non inferiority only), costs (see table) and accessibility of ulipristal versus levonorgestrel (Levonelle ) the MTC agreed that the latter should still be the first option for emergency hormonal contraception in the ABHB Joint Formulary but that ulipristal would be a useful addition where a licensed preparation was required for women presenting between 72 to 120 hours after unprotected sexual intercourse or contraceptive failure. Preparation Qty BNF(60) price Levonorgestrel (Levonelle 1500) 1 x1.5mg 5.20 Ulipristal acetate (ellaone) 1 x 30mg Full prescribing information at: BNF section Combined Oral Contraceptives 5 changes In line with the changes to the All Wales contract and its affect on what is issued by ABHB s Family Planning Service the MTC agreed the following changes to the Formulary: New Contract Replaces 30mcg/gestodene 75mcg Katya 30/75 3x21 = 5.03 Femodene 3x21 or 28 = mcg/Levonor 150mcg 30mcg/Desogestrel 150mcg 20mcg/Desogestrel 150mcg Norethisterone 350mcg Levest 3x21 = 2.55 Gedarel 30/150 3x21 = 4.93 Gedarel 20/150 3x 21 = 5.98 Micronor 3x28 = 1.66 Ovranette 3x21 = 2.20 (Microgynon 30 3x21 = 2.82) Marvelon 3x21= 6.45 Mercilon 3x21 = 7.97 Noriday 3x28 = 2.10 When initiating these combinations in new patients, prescribers should adhere to the Formulary choices (i.e. from the middle column above). BNF section 4.11 MEMANTINE (Ebixa) for moderate and severe Alzheimer s disease ADDED In accordance with national guidance (NICE Technology Appraisal Guidance 217 [March 2011]: ) TA217 recommends memantine as an option for managing Alzheimer s disease for people with: 1. moderate Alzheimer s disease who are intolerant of or have a contraindication to AChE inhibitors or 2. severe Alzheimer s disease. Memantine treatment should be under the following conditions: Page 2 of 7

3 Only specialists in the care of patients with dementia (that is, psychiatrists including those specialising in learning disability, neurologists, and physicians specialising in the care of older people) should initiate treatment. Carers views on the patient s condition at baseline should be sought. Treatment should be continued only when it is considered to be having a worthwhile effect on cognitive, global, functional or behavioural symptoms. Patients who continue on treatment should be reviewed regularly using cognitive, global, functional and behavioural assessment. Treatment should be reviewed by an appropriate specialist team, unless there are locally agreed protocols for shared care. Carers views on the patient s condition at follow up should be sought. The development of Gwent Shared Care protocols for the antidementia drugs is being explored however in the mean time the RED Traffic Light designation for memantine (and the AChE inhibitors) still applies. Full prescribing information at: uicksearch BNF section RANOLAZINE ( Ranexa ) for stable angina pectoris ADDED In accordance with national guidance. Following a resubmission, the AWMSG recommendation (No 1710) is now that ranolazine is an option as an add on therapy for restricted use within NHS Wales for the symptomatic treatment of patients with stable angina pectoris. AWMSG additionally advise that treatment should be initiated by a Cardiologist. Ranolazine has accordingly been designated AMBER Without Shared Care in Gwent. Ranolazine should be restricted for use in patients who remain symptomatic despite treatment with all other pharmacological anti anginal therapies and where revascularisation has been considered and undertaken or is not considered appropriate. AWMSG s recommendation on ranolazine is at: %20website.pdf NICE s Clinical guideline (CG126 July on the management of stable angina also includes guidance on the use of ranolazine. BNF section INDACATEROL ( Onbrez Breezhaler ) for maintenance treatment for COPD NOT ADDED After careful consideration of the current level of patient orientated evidence and the balance of additional cost versus benefit (over existing Formulary LABAs) the MTC decided it was unable to give formulary approval to indacaterol for maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD. Noting the perception that combination LABA + ICS therapy may be being initiated earlier in the COPD treatment pathway than necessary the MTC agreed to remind prescribers that the weight of evidence (clinical and health economic) is superior to LABA alone only in those with FEV 1 <50% predicted. In terms of choosing between a LAMA or LABA + ICS in these more severe patients NICE were unable to recommend one over the other. In less severe disease (FEV 1 > 50%) the option of changing from a LAMA to a LABA or viceversa may be considered before moving to a LABA + ICS combination (see algorithm and comparative costs below). Prescribers should also be aware of the small risk of pneumonia with ICS in COPD patients. Page 3 of 7

4 30 Day Cost of LABAs (+/ ICS) & LAMAs for COPD in Primary Care (BNF 61 & Drug Tariff Jul 2010) OFF LABEL Formoterol + beclometasone Fostair (12/200mcg BD) Salmeterol + fluticasione Seretide Accuhaler (50/500mcg BD) Formoterol + budesonide Symbicort Turbohaler (12/400mcg BD) Formoterol Easyhaler (12mcg BD) Formoterol Atimos Modulite (12mcg BD) Formoterol Oxis Turbohaler (12mcg BD) Salmeterol Accuhaler (50mcg BD) Salmeterol Evohaler (50mcg BD) Indacaterol Breezehaler (150 or 300mcg OD) Tiotropium HandiHaler refil pack (18mcg OD) Tiotropium HandiHaler (18mcg OD) Tiotropium Respimat (50mcg OD) OTHER PRESCRIBING NEWS New Shared Care Protocols The following Gwent protocols have recently been developed or updated: 1. TRIPTORELIN NEW protocol for use of both the monthly 3.75mg Gonapeptyl Depot and 3 monthly 11.25mg Decapeptyl SR preparations covering their licensed use in central precocious puberty. 2. DALTEPARIN ( Fragmin ) REMINDER. This protocol (finalised in Aug 2010) only sets out the shared care arrangements for patients with solid tumours receiving dalteparin for the extended treatment and prophylaxis of venous thromboembolism. There are no shared care arrangements in Gwent for other uses of dalteparin or other low molecular weight heparins e.g. Clexane. All Gwent Shared Care Protocols can be found at: Page 4 of 7

5 DRONEDARONE ( Multaq ) for the treatment of non permanent AF FURTHER SAFETY ADVICE In addition to the two reports of severe liver injury with dronedarone preliminary data from a clinical study (PALLAS) have shown an increased risk of cardiovascular side effects such as cardiovascular death, stroke and cardiovascular hospitalisation in patients with permanent AF. This new data could have an impact on the use of dronedarone in its approved indication in non permanent AF. Until the finalisation of the EMA s review in September 2011, prescribers are reminded to follow the recommendations in the product information with respect to the indication, contraindications and warnings. Specifically, prescribers are additionally advised to monitor patients regularly in order to ensure that they remain within the authorised indication and do not progress to permanent AF. The EMA s July Press release on dronedarone is available at: pdf At its May meeting the MTC agreed that the current AMBER Without Shared Care Traffic Light designation would continue for a further 3 months with Cardiology utilising a robust monitoring and communication system (led by a nominated specialist nurse) but with Primary Care continuing to prescribe dronedarone. The MTC will be reviewing the Traffic Light designation of dronedarone again at its October meeting. DENOSUMAB New all Wales prescribing guidance All Wales guidance (endorsed by the All Wales Medicines Strategy Group {AWMSG]) has now been issued on the prescribing of denosumab ( Prolia ) for the prevention of osteoporotic fractures in postmenopausal women. The guidance includes two recommendations: 1. The first simply states that denosumab should only be prescribed in accordance with the guidelines NICE TA Denosumab should be initiated by a specialist within Secondary Care for the first two doses (one year) and thereafter prescribing and administration responsibility may be transferred to primary care. Denosumab has accordingly been designated AMBER Without Shared Care in Gwent. The full guidance (3 pages) can be found at: TEICOPLANIN Minor amendment to Traffic Light Status The MTC has agreed an exception to the RED Traffic Light deignation of teicoplanin This remains RED for all uses (i.e. longer term use for infected prostheses and osteomyelitis) apart from the initial 72 hours in adults with Class II cellulitis (as defined by CREST 2005 guidelines ni.org/library/guidelines/cellulitis guide.pdf) where it would be designated GREEN (suitable for non specialist initiation). Class II cellulitis patients are either systemically ill or systemically well but with comorbidities such as peripheral vascular disease, chronic venous insufficiency or morbid obesity which may complicate or delay resolution of their infection. The aim is that for those GPs prescribing ceftriaxone (on behalf of the Rapid Response Team) to be encouraged to shift to prescribe teicoplanin, with its superior Gram positive activity and its reduced tendency to cause Clostridium difficile overgrowth. Diabetic peripheral neuropathic pain Updated local prescribing guidance The 2009 pathway for the pharmacological treatment of DPNP has been revised in accordance with NICE Clinical Guideline 96. The significant changes to the ABHB pathway are: Page 5 of 7

6 1. Duloxetine replacing amitriptyline as the first line pharmacological option 2. Pregabalin although still a fourth line option is no longer recommended for initiation only by Secondary Care. 3. Gabapentin is now 3rd line but remains as the option to try before resorting to pregabalin. The full guidance (1 page) can be found at: IMMEDIATE RELEASE (I/R) FENTANYL for breakthrough pain New local prescribing guidance This guideline has been produced in consultation with Gwent Palliative Care; it provides clear guidance on the appropriate use of the 2 ABHB Formulary preparations of I/R fentanyl (Abstral sublingual tablets and Instanyl spray). The full guidance (2 pages) can be found at: FENTANYL TRANSDERMAL PATCHES Updated local prescribing guidance The 2008 ABHB guidelines on the Use of Transdermal Fentanyl Patches have been revised. The significant changes are: 1. Inclusion of the 2008 MHRA safety advice and advice to not use doses greater than 50micrograms/hour for chronic non malignant pain without advice from the Pain Clinic. 2. Inclusion of contact details for the specialist palliative care teams across Gwent (including Out of Hours contact details). The full guidance (3 pages) can be found at: OXYCODONE in cancer pain New local prescribing guidance This ABHB guideline (based on Fife s 2009 version) provides clear guidance on when the use of oral and parenteral oxycodone (OxyContin and OxyNorm ) is appropriate. It includes doses and dose equivalences for oxycodone as well as contact details for specialist Palliative Care Services. The full guidance (2 pages) can be found at: DABIGATRAN License extension to cover stroke prevention in AF There is an imminent extension of dabigatran s UK marketing authorisation to include the prevention of stroke and systemic embolism in adult patients with nonvalvular AF (with specified risk factors). NICE guidance on the use dabigatran in AF is expected but not until the end of December ABHB MTC is therefore planning to issue interim guidance (covering up to January 2012) for both specialist and non specialist prescribers, on which particular patient should be prescribed dabigatran for stroke prevention. Drug Safety Updates from MHRA The MTC felt it was important to highlight the following item in July s edition of the MHRA s Drug Safety Update: Page 6 of 7

7 Paracetamol: updated dosing for children to be introduced The new dosing instructions for paediatric paracetamol will be on products entering the market by the end of In the meantime, parents and carers should follow the advice on the current packaging. The BNF will be updated accordingly. Prescribers may use the new dosing immediately for prescribed paracetamol products. New dosing tables: For paracetamol infant suspension (120mg/5 ml): Age: 2 3 months Dose 1. Post vaccination fever 2.5 ml 2. Other causes of pain and fever if your If necessary, after 4 6 hours, give a baby weighs over 4 kg and was born second 2.5 ml dose after 37 weeks Do not give to babies less than 2 months of age Do not give more than 2 doses Leave at least 4 hours between doses If further doses are needed, talk to your doctor or pharmacist Child's age How much How often (in 24 hours) 3 6 months 2.5 ml 4 times 6 24 months 5 ml 4 times 2 4 years 7.5 ml 4 times 4 6 years 10 ml 4 times Do not give more than 4 doses in any 24 hour period Leave at least 4 hours between doses Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist For paracetamol six plus suspension (240mg/5 ml or 250mg/5 ml): Child s age How much How often (in 24 hours) 6 8 years 5 ml 4 times 8 10 years 7.5 ml 4 times years 10 ml 4 times Do not give more than 4 doses in any 24 hour period Leave at least 4 hours between doses Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist Do not give to children under the age of 6 years Dose for children age years: ml up to 4 times a day. Dose for adults and children over 16 years: ml up to 4 times a day. Prescribing medicines for adults who are unable to swallow oral solid dosage forms The MTC recently considered AWMSG endorsed template guidance developed by Betsi Cadwaladr UHB (in response to the increased demand, complexity and cost of some specials ) and it was agreed to circulate the three Key Priorities for Prescribers: 1. Review the need for the medicine. 2. If a liquid preparation is required, use the BNF to check that it is licensed as most clinical systems do not differentiate between licensed and unlicensed products. If in doubt, check with the dispensing pharmacy before prescribing. 3. If no licensed product is suitable, get advice from your medicines management team or medicines information on alternative strategies like dosage manipulation. The full guidance (20 pages) can be found at: Page 7 of 7