Dr Alison Cave, MHRA Chief Safety Officer
Established in 1964 to protect and improve patient safety, the Yellow Card scheme is the Medicines and Healthcare products Regulatory Agency’s (MHRA) system for collecting suspected side effects or adverse incidents involving medicines, vaccines, and medical devices. In an average year the scheme will receive and process around 60,000 reports, helping provide an early warning that the safety of a medicine or a medical device may require investigation. This helps us to identify potentially serious issues and patterns, known as ‘safety signalshat were previously unknown before being reported.
Patient and public reporting was first introduced in 2005 and has grown year on year: in 2022, this represented 23% of total (non-Covid vaccine) reports. The faster a report is submitted and the more reports we receive, the likelier it is that we can intervene and prevent others from experiencing serious, life-altering, and occasionally life-threatening issues in future. Thanks to individual reports from medicines users across the nation, the Yellow Card scheme continues to identify numerous safety issues to the benefit of many.
Once a Yellow Card report has been submitted by a patient or healthcare provider, it is carefully analysed by our safety experts, who include doctors, pharmacists, scientists, and medical device specialists. Their analysis involves an assessment of the data to determine if the reported event may be a safety signal associated with a medicine or medical device or if it would have occurred anyway, without medical treatment. This is because the nature of Yellow Card reporting means that reported events may not be side effects or adverse incidents. It is important that everyone continues to report, even if they are unsure if their reaction is associated with the medicine or medical device in question.
Yellow Card reporting has directly led to a reduced risk of harm and strengthened public health. As one example, we received a small number of reports from patients experiencing calciphylaxis as a result of using the medication warfarin, which is prescribed to prevent blood clots. Calciphylaxis is a rare disease that results in wounds that do not heal, and the seriousness of these reports led to an extensive search and resulted in the strengthening of the product information for warfarin to include a new warning about this rare side effect. This was a vital outcome for patient safety and wellbeing – up-to-date product information enables patients and their doctors to have a better understanding about the suitability of treatment and allows them to properly weigh the pros and cons of use.
Medication Safety Officers (MSOs) and Medical Device Safety Officers (MDSOs) form a major part of the Yellow Card scheme and its safety networks. Nationwide, there are 450 MSOs and 300 MDSOs, who are embedded as in-house experts across all hospital trusts. We jointly established the MSO and MDSO networks with NHS England to plug gaps in reporting and to provide a greater volume of local safety data – so that we can better protect patients. As trained safety experts, these networks address gaps by actively reporting suspected side effects and adverse incidents in their trusts, and by encouraging those in their trust to report. They are our eyes and ears on the ground.
We have a two-way system of communication between our agency and these networks, which means we get a more accurate and up-to-speed picture of potential safety issues and can respond to issues as they arise. Significantly, we also use these channels of communication to alert them to act when we know of national safety issues. This protects a greater number of patients from harm, at the earliest possible time.
The value of submitting a Yellow Card report cannot be overstated. By reporting, members of the public continue to help us improve public health for all.
We want to thank everyone that has reported suspected side effects or adverse incidents from a medicine or medical device. Every report you make is important to us and supports us in our aim to protect vulnerable, at-risk groups from potential harm.