The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on safety communications to ensure that medicines, medical devices and other healthcare products reach ‘high standards of safety, quality and efficacy.’
The MHRA’s safety communications encompass a range of forms and channels such as:
- National patient safety alerts: For safety critical issues
- Drug safety updates: For general awareness and guidance for healthcare professionals
- Product recalls: To alert pharmacists and healthcare professionals about defective medical products where immediate action may be required
- Safety round-up bulletins: A monthly summary of key information
- Direct Healthcare Professional Communications (DHPC): Communication sent by the manufacturer or the marketing authorisation holder, typically when a medical product needs to be removed from the market
- Field safety notices (FSN): Communication sent by a device manufacturer, which could include important information such as recalls, labelling errors and new warnings
Other types of safety communications include patient safety leaflets and instructions for use.
This guidance is linked to a wider scheme to improve safety communication. In 2024, the MHRA launched a three-year strategy to provide ‘coordinated, targeted and impactful’ safety communications. As a part of this scheme, the MHRA’s main goals by 2027 are to:
- Consistently provide safety communications to healthcare professionals and organisations
- Provide more accessible and timely updates to patients to help improve their experience
- Ensure transparency and engagement while supporting public health across the UK
At the end of the three-year period, the MHRA will review and publish its findings, assess the success of the strategy and decide how to improve safety communications for future planning.
For more information, refer to the guidance documents, ‘MHRA Strategy for Improving Safety Communications’ and ‘Safety communications concerning medicines, medical devices and other healthcare products’.