The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2023 (PDF).
This issue contains the latest COVID-19 vaccine and medicine information including the latest summary of Yellow Card reports that would include the Autumn 2022 booster campaign. Given the stable safety profile of these vaccines this will be the last special analysis of COVID-19 vaccines. In the future the established routine data publication and communication methods for reporting safety concerns will be used.
Lastly in this issue is a summary of letters to healthcare professionals in February. These generally related to supply issues and recalls.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of March 2023. This month is one technology appraisal that impacts upon primary care.
The Semaglutide for managing overweight and obesity technology appraisal has been published. Semaglutide is recommended as an option for weight management, including weight loss and weight maintenance, alongside a reduced-calorie diet and increased physical activity in adults, only if:
- it is used for a maximum of 2 years, and within a specialist weight management service providing multidisciplinary management of overweight or obesity (including but not limited to tiers 3 and 4), and
- they have at least 1 weight-related comorbidity and:
- a body mass index (BMI) of at least 35.0 kg/m2, or
- a BMI of 30.0 kg/m2 to 34.9 kg/m2 and meet the criteria for referral to specialist weight management services in NICE's guideline on obesity: identification, assessment and management.
It is noted that the Wegovy® brand of semaglutide, which is licensed for this indication, is not commercially available yet. Ozempic®, which is licensed for use in diabetes remains in short supply and use of this brand for weight management would be off-label use. It should also be noted that the licensed doses and dose escalation schedule are different for these two products and therefore they should not be considered as equivalents.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The MHRA has issued advice for healthcare professionals regarding the withdrawal of pholcodine-containing medicines from the market.
These medicines are being withdrawn from sale as a precaution and will no longer be available from pharmacies. A recent a review found that their benefits do not outweigh the increased risk of the very rare event of anaphylaxis to neuromuscular blocking agents (NMBAs) used in general anaesthesia.
Pharmacists are advised not to dispense or sell pholcodine-containing medicines, but to recommend alternatives and quarantine stock for return to wholesalers.
Action: Clinicians should be aware of this withdrawal and cease issuing prescriptions for pholcodine. Patients should be directed to pharmacies for advice and recommendation for alternatives.
During February 2023 Clinical Knowledge Summaries were published or updated in the following areas.
All of the topics have been reviewed and updated with minor structural and layout changes. The Sore throat - acute topic has been updated to align with the NICE Sore throat (acute): antimicrobial prescribing guideline.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
