The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2014 (PDF).
This issue reports an update to the Yellow Card form used for collecting suspected adverse reactions with the aim of improving our understanding of a medicine’s effect during pregnancy. The forms will be update to collect data about a current pregnancy including the date of last menstrual period and expected date of delivery. The "additional information" field can also be used to include any information on previous pregnancies, dates and findings of ultrasonography and the dates when a woman started or stopped taking any other medicines and supplements during pregnancy (including folic acid).
This issue also contains a reminder about drug-name confusions at the point of dispensing. A previous Drug Safety Update highlighted this issue but this issue notes that there have been recent errors relating to bumetanide and buspirone. It is also noted that the packaging of some morphine sulfate products is being updated to better highlight the strength of the medicine on the pack.
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.
Macitentan (Opsumit®) has been accepted for restricted use in the treatment of pulmonary arterial hypertension in adult patients. The restriction limits initiation and prescribing to a specialist.
Rilpivirine/emtricitabine/tenofovir (Eviplera®) has been accepted for use in the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1). This treatment is already approved for treatment-naive patients; this advice extends use to treatment-experienced patients.
Fluticasone/vilanterol (Relvar®) has been accepted for restricted use in the treatment of adults with chronic obstructive pulmonary disease (COPD). The restriction limits use to patients with an FEV1 less than 50% their predicted normal.
Adapalene and benzoyl peroxide gel has been accepted for restricted use in the treatment of cutaneous treatment of acne vulgaris when comedones, papules and pustules are present. The restriction limits use to patients with mild to moderate facial acne when monotherapy with benzoyl peroxide or adapalene is not considered appropriate.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The manufacturer of ACWY Vax (meningococcal polysaccharide groups ACW135Y vaccine) has written to healthcare professionals advising that this product is being discontinued in the UK. It is expected that stocks will be exhausted by June 2014.
The letter notes that two alternative conjugate vaccines that contain the same A, C, W135 and Y strains are available but also notes that the licensed indications may differ. The brand names for these products are Menveo® and Nimenrix®.
Action: Clinicians who currently use ACWY Vax should be aware of this product being discontinued and make themselves familiar with the alternatives.
The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of March 2014. This month there is one public health guideline that impacts upon primary care.
The Contraceptive services with a focus on young people public health guideline recommends that young men and women should be given advice and information on all types of contraception to help them choose the best method for their needs and lifestyle. This makes it more likely that contraception will be used effectively. The recommendations apply to commissioners, managers and practitioners who have a direct or indirect role in, and responsibility for, contraceptive services.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
MTRAC issued an additional Commissioning Support review in March 2014. This review covers fluticasoe/vilanterol dry powder inhaler.
The fluticasoe/vilanterol (Relvar®) summary advises that this inhaler cannot be recommended for prescribing for the treatment of chronic obstructive pulmonary disease (COPD). It is noted that the evidence for efficacy was considered relatively weak although strong enough to gain regulatory approval. The main reason for this recommendation is a potential safety concern regarding the similarity of this inhaler to reliever inhalers in terms of colour that could result in accidental overuse of the inhaled steroid. The SPC describes the inhaler as having a "light grey body, a pale blue mouthpiece cover and a dose counter". Until now, blue coloured inhalers have generally contained short-acting beta-adrenoceptor agonists (SABA), not inhaled corticosteroids and long-acting beta-adrenoceptor agonists.
Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.