Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps the Medicines and Healthcare products Regulatory Agency is taking to improve clinician reporting of myocarditis and pericarditis in the Yellow Card system; and whether the Department has assessed under‑reporting rates for these conditions.

The Medicines and Healthcare products Regulatory Agency (MHRA) is committed to continually strengthening the Yellow Card scheme to support patient safety. The MHRA regularly promotes awareness through public health campaigns, conferences, established networks, and new educational resources available on the Yellow Card website. Further information is available on the MHRA website at the following link:

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

Reporting rates through spontaneous reporting systems, such as the Yellow Card Scheme, are highly variable, and dependent not just on the condition, but other factors such as the product, public interest, and media attention. As such, the MHRA does not hold estimates of under reporting rates for these conditions.

The MHRA is expanding and improving digital reporting routes. Every National Health Service webpage relating to a medicine or vaccine now links to the Yellow Card scheme, and the MHRA is working with NHS colleagues to enhance integration with the NHS App to increase visibility and reporting by the public. Yellow Card reporting is now embedded in almost all general practice clinical IT systems, enabling healthcare professionals to submit reports directly on behalf of patients.

Over recent years, the MHRA has delivered a major upgrade programme to modernise the Yellow Card scheme’s technology and infrastructure. This includes improving the quality and timeliness of submitted information, making it easier to report, adding conditional questions to reduce follow up, and support real time signal detection of safety issues.

The Yellow Card app has also been modernised to mirror the website, broaden reporting options, including defective and counterfeit medicines, and improve access to safety data. Multifactor authentication has been introduced to enhance account security and enable future integration with the NHS login. The app has also been upgraded to a progressive web application, providing a seamless and engaging user experience across devices.

Together, these improvements increase public awareness, make reporting, including of myocarditis and pericarditis, easier, and enhance the MHRA’s ability to identify and assess emerging safety concerns across healthcare products.