Drug Safety Update - November 2017
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2017 (PDF).
This issue reminds clinicians that quinine has a dose-dependent QT-interval-prolonging effect and should be used with caution in patients with risk factors, including taking other medicines that could prolong the QT interval, for QT prolongation or in those with atrioventricular block. Readers are also reminded that serum levels of phenobarbital or carbamazepine could become raised during concomitant use with quinine.
Clinicians are also reminded that oral tacrolimus products need to be prescribed and dispensed by brand name only in order to reduce the risk of toxicity and graft rejection. If brand switching is necessary then the patient should receive careful supervision and therapeutic monitoring by an appropriate specialist.
This issue also requests support for support for a second social media campaign to promote the reporting of suspected adverse drug reactions (ADRs) to the Yellow Card Scheme in support of the ADR awareness week taking place 20-24 November 2017. This year there is a focus on over-the-counter medicines.
Updated advice, that adds to the 3 risk-based categories, for the prescribing of anti-epileptic drugs recommends consideration of patient-related factors when deciding whether it is necessary to maintain continuity of supply for a specific product. For example, patient perception of differences in supply, for example differences in product presentations and also co-morbid conditions such as autism, mental health issues, or learning disability may make it more appropriate to prescribe either by specifying brand name or by using the generic drug name and name of the manufacturer.
This issue also notes that Public Health England has updated their guidance about live vaccination of infants born to a mother who received immunosuppressive biological therapy during pregnancy. It is recommended that children born of mothers who were on immunosuppressive biological therapy during pregnancy will not be eligible to receive rotavirus vaccine and will need to defer BCG, if indicated, for 6 months.
Lastly, the summary of letters sent to healthcare professionals in October includes a letter regarding Solu-Medrone 40 mg containing lactose derived from cows' milk and potentially milk proteins as reported in the update last month.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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