The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2023 (PDF).
This issue advises clinicians about differences in bioavailability and therefore biological effect seen with metolazone 5mg tablets. Preferential use of the licensed formulation (Xaqua®) is recommended for all new patients. Caution is recommended if switching patients between different preparations.
This issue also warns of the risk of harm following accidental exposure to topical testosterone. Patients using topical testosterone should be warned of the risks of accidental exposure and advised to wash their hands after application, cover the application site with clothing once the product has dried, and wash the application site before physical contact with another adult or child.
This issue also encourages Yellow Card reporting of adverse incidents involving technology-based solutions such as software, apps, and artificial intelligence (AI) when used as a medical device, for example Electronic Prescribing and Medicines Administration Systems (ePMAS). It is noted that these products are considered an effective way to reduce medication errors but they may cause new technology-related errors as was the case recently when a child received an overdose of an anticoagulant while in hospital.
This issue contains the latest COVID-19 vaccine and medicine information including continued Yellow Card summaries and an update to the SmPC and PIL for the Pfizer/BioNTech vaccines.
Lastly in this issue is a summary of letters to healthcare professionals in December. 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 January 2023. This month there are three Guidelines that impact upon primary care.
The Tobacco: preventing uptake, promoting quitting and treating dependence guideline has been updated. It covers support to stop smoking for everyone aged 12 and over, and help to reduce people's harm from smoking if they are not ready to stop in one go. It also covers ways to prevent children, young people and young adults aged 24 and under from taking up smoking. This update amended recommendations for carbon monoxide testing at antenatal appointments.
The Diabetic foot problems: prevention and management guideline has been updated. It covers preventing and managing foot problems in children, young people and adults with diabetes. This update reviewed the evidence on risk assessment tools for diabetic foot problems and frequency of diabetic foot reviews.
The Delirium: prevention, diagnosis and management in hospital and long-term care guideline has been updated. It covers diagnosing and treating delirium in people aged 18 and over in hospital and in long-term residential care or a nursing home. It also covers identifying people at risk of developing delirium in these settings and preventing onset. This update contains new recommendations on assessing and diagnosing delirium.
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.
Estetrol / drospirenone (Drovelis®) has been rejected for use as an oral contraceptive. The manufacture failed to make a submission for this indication.
Ferric maltol (Feraccru®) has been rejected for use in adults for the treatment of iron deficiency. The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
