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.