The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new monthly safety bulletins, which aim to make medical device and medicine safety information clearer and more accessible for healthcare professionals.
The bulletins are published online each month and sent to MHRA subscribers. They compile safety alert information released by the agency over the past month, covering device safety information (DSI), drug safety updates (DSU), national patient safety alerts, recalls, and medicines notifications.
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Conceived as part of the agency’s broader strategy to improve safety communications between 2024 and 2027, a part of which is to make high-risk alerts surrounding devices and medicines more comprehensible to healthcare professionals, the ‘MHRA Safety Roundup’ was created in response to findings from a consultation the agency ran to gauge sentiment around how it communicates safety information with healthcare professionals and organisations.
A prevailing finding of the research was that healthcare professionals, ranging from GPs to pharmacists, found it useful to receive information at different frequencies, including monthly summaries, to suit their needs.
A separate consultation conducted to further inform the three-year strategy found that healthcare professionals struggled to find the information they needed across the MHRA’s websites, with a low awareness on what the agency published and the range of healthcare product safety information available – a finding the MHRA says has informed a need for ‘optimisation’ in the way information across its websites is presented.
In achieving the goals of the first year of its three-year strategy, the MHRA has now also revamped its drug and device safety alerts, utilising colour and relevant imagery in a move it hopes will “better engage” healthcare professionals.
The MHRA’s overall safety communications strategy reflects similar work being undertaken by the US Food and Drug Administration (FDA).
Last year, the agency launched a communications pilot to enhance its medical device recall programme with the provision of early alerts on potentially high-risk device removals or corrections that have so far led to the release of early alerts on devices including infusion pumps and patient monitoring devices.
The value in a regulatory shakeup at the FDA around early alerts seems especially prescient given a recent study published in the BMJ, which found that almost a third of adverse events (AEs) were reported late – notably, outside of the mandated 30-day reporting window – to the centralised Manufacturer and User Facility Device Experience (MAUDE) database between September 2019 and December 2022.
