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.
The National Institute of Health and Care Excellence (NICE) have published new or updated guidance for the month of November 2017. This month there are three guidelines that impact upon primary care.
The Bipolar disorder clinical guideline has been updated. It covers recognising, assessing and treating bipolar disorder (formerly known as manic depression) in children, young people and adults. The recommendations apply to bipolar I, bipolar II, mixed affective and rapid cycling disorders. It aims to improve access to treatment and quality of life in people with bipolar disorder. The guideline has been updated with footnotes containing current medication advice and some research recommendations have been stood down.
The Familial hypercholesterolaemia clinical guideline has been updated. It covers identifying and managing familial hypercholesterolaemia (FH), a specific type of high cholesterol that runs in the family, in children, young people and adults. It aims to help identify people at increased risk of coronary heart disease as a result of having FH. The evidence for case finding and diagnosis, identification using cascade testing, and management using statins has been reviewed and some recommendations have been amended.
The Glaucoma guideline has been published. It covers diagnosing and managing glaucoma in people aged 18 and over. It includes recommendations on testing and referral (case-finding) for chronic open angle glaucoma and ocular hypertension, and on effective diagnosis, treatment and reassessment to stop these conditions progressing.
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.
Midazolam (Epistatus®) has been accepted for use in the treatment of prolonged, acute, convulsive seizures in children and adolescents aged 10 to less than 18 years. This product provides a licensed alternative to unlicensed preparations.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During October 2017 Clinical Knowledge Summaries were updated in the following areas.
The following topics were all reviewed:
The majority of topics have undergone reviews and minor restructures.
The most significant changes are in the Crohn's disease topic where recommendations on the diagnosis and management of confirmed Crohn's disease have been amended in line with current evidence, the sections on specialist investigations and management has been updated and expanded and the Prescribing information section has been deleted and links made to other relevant CKS topics. The Knee pain - assessment topic has been updated with new sections on risk factors and prognosis and the assessment and management recommendations have been amended in line with current evidence. Lastly, the Prostate cancer topic has been updated with recommendations on prostate-specific antigen (PSA) testing and treatments for prostate cancer amended in line with the latest guidance.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
