The National Institute of Health and Care Excellence (NICE) has published two new Evidence Summaries for New Medicines in December 2013.
These resources aid budget holders in making informed decisions and aid local planning on the introduction of key new medicines but are not formal NICE guidance. Each summary reviews efficacy, safety, user factors and resource implications.
The reviews this month are for:
Action: These summaries provide a good overview of the current evidence for these new medicines. This information will help to guide commissioning and prescribing decisions.
The National Institute of Health and Care Excellence (NICE) has announced changes to the distribution of the printed version of the BNF.
The BNF and BNFC apps and BNF and BNFC content on NICE Evidence are updated monthly. More clinicians are using these digital formats so the print version of the BNF will now be distributed once each year in September instead of twice yearly. The BNFC will continue to be distributed annually.
Action: Clinicians should be aware of this change. The digital formats will be the most appropriate way to access up to date information.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2013 (PDF).
This issue contains drug safety advice informing clinicians that there have been reports of acquired haemophilia occurring in association with clopidogrel. Clinicians should be aware of this very rare but serious condition; it may easily be missed due to the established risk of bleeding associated with clopidogrel treatment. There have been 12 reported cases of acquired haemophilia worldwide in users of clopidogrel. It is estimated that more than 153 million patient worldwide use clopidogrel.
The stop press section informs reader that there have been 69 complaints about dorzolomide / timolol (Cosopt®) preservative-free single-dose eye drops. A new design of dropper was introduced in July 2013 but it seems to be difficult to use and increases the risk of eye injury. A revised design will be introduced early in 2014. In the meantime patients using this product may need assistance or additional education in the safe self-administration of eye drops.
As is expected at this time of year, this issue also contains the annual drug safety quiz that tests drug safety knowledge based on the updates published this year. Completion of the quiz may be a useful way to demonstrate continuing professional development.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Azelastine and fluticasone nasal spray (Dymista®) has been rejected for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis. It is noted that the combination product is significantly more expensive than the components administered separately.
Imiquimod (Zyclara®) has been rejected for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis. The manufacturer failed to make a submission.
Mannitol (Bronchitol®) has been accepted for restricted use in the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care. The restriction recommends use in patients who are not currently using dornase alfa due to lack of response, intolerance or ineligibility and have rapidly declining lung function and in whom other osmotic agents are considered unsuitable.
Saxagliptin (Onglyza®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus in adults as triple oral therapy in addition to a sulphonylurea and metformin to improve glycaemic control when dual therapy, with diet and exercise, does not provide adequate glycaemic control. The restriction places this treatment as an option among other dipeptidyl peptidase-4 inhibitors because indirect comparisons have demonstrated similar efficacy.
Vildagliptin (Galvus®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus in adults as triple oral therapy in addition to a sulphonylurea and metformin to improve glycaemic control when dual therapy, with diet and exercise, does not provide adequate glycaemic control. The restriction places this treatment as an option among other dipeptidyl peptidase-4 inhibitors because a meta-analysis has suggested similar efficacy.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
MTRAC issued two new Commissioning Support reviews in November 2013. The reviews cover melatonin and nalmefene.
The melatonin (Circadin®) summary advises that this drug is suitable for prescribing in primary care for the treatment of primary insomnia. The review notes that this medication reduces sleep latency but had no effect on total sleep time. It was also noted that there are no studies against active treatments for insomnia so this treatment is given a lower place in therapy.
The nalmefene (Selincro®) summary advises that this drug is suitable for restricted prescribing in primary care for the treatment of alcohol dependence in conjunction with continuous psychosocial support. The review notes that this treatment is most effective in a subgroup of patients with a high drinking risk level who fail to reduce their intake before commencing treatment. It is therefore assessed as having a lower place in therapy with relatively weak evidence.
Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.