The hard copy of the British National Formulary for Children 2016-2017 has been updated and published. Electronic versions are updated monthly.
Hard copies can be ordered from the publishers however many NHS clinicians should receive a free hard copy through usual channels and can also access the online version.
Significant changes in this revision include:
- New safety information about the risk of abnormal pregnancy outcomes with sodium valproate and valproic acid
- Updated guidance for conditions including asthma and obesity
- Updated pregnancy-prevention advice for patients taking mycophenolate mofetil
- New drug monographs including cholic acid
- New indications for adalimumab including chronic plaque psoriasis
- New safety information about the risk of osteonecrosis of the external auditory canal with bisphosphonates
- Guidance on suspected or confirmed drug allergies
- Evidence grading of BNF recommendations
Action: BNFC is the primary source of prescribing information when prescribing to all children up to the age of 18 years.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2016 (PDF).
This issue contains updated advice introducing a lower recommended dose of etoricoxib (Arcoxia®) at 60 mg daily for patients with rheumatoid arthritis or ankylosing spondylitis. A European review in 2008 requested further clinical trials to compare the safety and efficacy for a 60mg daily dose with the previously recommended daily dose of 90mg. These trials have established that 60mg is an effective dose although some patients may still require the 90mg dose. As such the following recommendations are now made:
- the lowest effective daily dose should be used, and the need for treatment should be regularly reassessed to reduce cardiovascular and other risks
- the recommended dose is 60 mg once daily
- in patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may improve efficacy
- once the patient is clinically stabilised, down-titration to 60 mg once daily may be appropriate
- in the absence of therapeutic benefit, other treatment options should be considered
There is also a summary of letters sent to healthcare professionals in September including the planned withdrawal of retigabine (Trobalt®) and the interaction between levonorgestrel-containing emergency hormonal contraception and hepatic enzyme inducers reported in Drug Safety Update last month.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Budesonide (Cortiment®) is accepted for restricted use in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where aminosalicylate (5-ASA) treatment is not sufficient. The restriction limits use to patients with active left-sided disease and/or proctosigmoiditis who are not suitable for oral prednisolone, as an alternative to budesonide rectal formulations or off-label oral budesonide.
Budesonide / formoterol dry powder and pressurised aerosol inhalers (Symbicort Turbohaler® and pMDI) have been rejected for the treatment of patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) 50% to 70% predicted normal (post bronchodilator) and an exacerbation history despite regular bronchodilator therapy. The manufacturer failed to make a submission. This intervention has previously been accepted for those with an FEV1% predicted of less than 50% and an exacerbation history despite regular bronchodilator therapy. As such this treatment can be used in severe and very severe COPD but is not recommended for moderate COPD.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During September 2016 Clinical Knowledge Summaries were updated for the following topics:
The timing of referral to a breast specialist was reduced from 6 months to 3 months if cyclical pain is unresponsive to first-line treatment. Otherwise there were only minor structural changes.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.