Alison Cave, chief safety officer at the MHRA sets out how the Agency's new strategy will improve safety
As the regulator for medicines, medical devices and blood components for transfusion in the UK, issuing safety advice has been a vital part of the Medicines and Healthcare products Regulatory Agency (MHRA)’s role for many years. We have well-established systems for issuing this advice, but we know how it is received is crucial to it being effective. We are therefore always receptive to exploring alternative strategies to ensure our advice reaches the right people, at the right time.
Our advice is essential in enabling health care professionals (HCPs), NHS providers and all who work in health and care to have the latest information to support them to protect their patients and maintain confidence in the life-changing benefit that medicines and medical devices can provide.
Patients are at the heart of what we all do, and we know effective communication is vital in ensuring patients understand the benefits and risks of the medicines and devices they are using.
That’s why, through our recently launched Strategy for Improving Safety Communications, we aim to transform the way we communicate information about the risk and safety of medicines, medical devices and healthcare products. Our aim is that, through this three-year strategy, we will deliver communications to health professionals in a more coordinated, targeted and impactful way, using the best possible channels.
Incorporating the vital feedback from our consultation
The strategy is underpinned by the findings of a consultation with HCPs and healthcare organisations across the four UK nations. We received clear and consistent feedback on improvements that need to be made.
We gathered insight and recommendations through an online survey, interviews and focus groups, and received written submissions from a number of organisations. The feedback received was vital. It gave us clear direction to improve our communications, websites, awareness and engagement with an audience, where our key focus should be bringing improved patient safety.
That feedback was remarkably consistent across the hundreds of responses. Increasing workload and time pressures were identified by HCPs as directly impacting their capacity to remain up-to-date with communications of relevance to their specific practice.
The basis for our strategy
Our strategy will shape our engagement with HCPs and ensure the MHRA continues to support organisations across the medicines, devices and patient safety landscape.
Today’s public expect the medicines and medical devices they are using to be effective and safe, and to be involved in decisions about the use of these healthcare products. Our new strategy complements and builds on the success of the MHRA’s Patient Involvement Strategy 2021 to 2025, embedding our patient-centric focus into our system of safety communications. We must ensure that we consider potential new areas that the MHRA will need to communicate on, such as new medical technologies including artificial intelligence (AI) and diagnostics.
External safety communications need to be relevant, brief and actionable, so we are launching a new monthly MHRA Safety ‘round up’ bulletin, bringing together safety advice across the medical products we regulate, so HCPs can stay up to date for their patients more easily. We will also continue to issue safety communications throughout the month in a targeted way, to anyone who wishes to receive them.
More information about the MHRA’s role and responsibilities – particularly with regards to safety warnings and how they should be actioned – was also asked for by HCPs. As a result, we will work to raise awareness of our role, as well as the importance of our safety communications.
Closer relationships with healthcare professionals and organisations
We are working to build closer relationships with healthcare organisations and HCPs to ensure our advice is actionable and informed by their needs. We are also working to increase our direct reach to patients. This forms part of our strategic priority in our Corporate Plan for 2023 to 2026: to maintain public trust through transparency and proactive communication.
The MHRA will also continue to work with other organisations representing all parts of the health and care system in the UK, as these partnerships are important in ensuring effective collaborative communications and safety efforts that lead to meaningful change.
Next steps
As modern healthcare evolves alongside society and technology, so must our communications and systems of issuing messages. The way we issue safety communications is always developing. We
must ensure clear and accessible messages are reached by all those who need to see them, at the best time to act.
We will continue to listen to and shape our work in light of feedback from all relevant stakeholders. This includes a further consultation with patients and patient representatives next year, in which we will ask directly for their views on how the MHRA communicates with them about safety. This will inform both our work during the later years of this strategy, as well as our future strategic directions.
We also plan to run a second HCP consultation towards the end of the three-year strategy and will publish our findings so that we can transparently measure its success and impact and set our next direction.
We will always comprehensively evaluate the changes we make to show they have had a positive impact on patient safety and avoided unintended harmful consequences, while continuing to examine our outcomes to identify areas that may require adjustments, as well as areas of success.
The MHRA’s safety communications are an essential part of our safety system in the UK, and our Strategy for Improving Safety Communications sets out how we are ensuring the right information is being provided at the right time, using the best possible communication channels. This ensures HCPs and patients stay informed of the benefits and risks associated with a medicine or device, and that safety concerns are reported and can be acted on quickly.