The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2016 (PDF).
Nicorandil is now placed a second-line treatment, after beta-blockers or calcium channel blockers, for stable angina due to the risk of ulceration. It can cause serious skin, mucosal and eye ulceration, including gastrointestinal ulcers which may progress to perforation, haemorrhage, fistula, or abscess and treatment must be stopped if ulceration occurs.
Clinicians are advised that levonorgestrel-releasing intrauterine systems should always be prescribed by brand name because there are license differences. Mirena has been available for several years but recently a new product called Levosert was licensed. For contraception or heavy menstrual bleeding Mirena is licensed for 5 years of use while Levosert is licensed for 3 years. In addition Mirena is licensed for endometrial protection while Levosert is not. Additionally, there are differences in the insertion techniques between the two products. Prescribing by brand name will ensure the correct and expected product is supplied.
This issue also contains a summary of letters sent to healthcare professionals in December 2015. Galantamine has been associated with serious skin reactions including Stevens Johnson Syndrome (SJS), acute generalised exanthematous pustulosis (AGEP) and erythema multiforme. It is recommended that patients and carers are advised to monitor for skin reactions. In the advent of an apparent skin reaction patients should be advised to stop treatment and seek medical advice.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The National Institute of Health and Care Excellence (NICE) have published new guidance for the month of January 2016. This month there is one clinical guideline that impacts upon primary care.
The Tuberculosis guideline covers prevention, identification and management of latent and active tuberculosis (TB) in children, young people and adults. It aims to improve ways of finding people who have TB in the community and recommends that everyone under 65 with latent TB should be treated.
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.
Albiglutide (Eperzan®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus in adults to improve glycaemic control in combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. The restriction notes that this product is an alternative once weekly glucagon-like peptide-1 (GLP-1) agonist for use in combination with oral anti-diabetic agents as a third-line pre-insulin treatment option. It is also recognised that this advice is contingent upon the continuing availability of a Patient Access Scheme.
Dulaglutide (Trulicity®) has been accepted for restricted use in adults with type 2 diabetes mellitus to improve glycaemic control as add-on therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. The restriction limits use to triple therapy in patients with inadequate glycaemic control on two oral anti-diabetic drugs, as an alternative glucagon-like peptide 1 (GLP-1) agonist option.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Department of Health has written to healthcare professionals via the Central Alerting System (PDF) to advise that antiviral medicines may now be prescribed at NHS expense due to rising levels in reporting of influenza-like illness.
Antiviral medicines can be prescribed for the prophylaxis and treatment of influenza, in accordance with National Institute for Health and Care Excellence (NICE) guidance and Schedule 2 to the National Health Service, commonly known as the Grey List or Selected List Scheme (SLS). Prescribing these medicines should be considered if patients are at risk of severe illness and/or complications from influenza if not treated, whether or not they are in a 'clinical at risk group'. The NICE guidance on the use of antiviral medicines covers treatment and prophylaxis.
Clinicians are reminded to endorse the prescription with 'SLS' to ensure that it can be dispensed in community pharmacies without undue delay. The letter also contains prescribing advice for children.
Action: Clinicians should be aware of this letter and familiarise themselves with the current NICE guidance.
