Reports to Yellow Card scheme increase in Northern Ireland, annual report shows

The first annual report of Northern Ireland's Yellow Card Centre shows that more people are reporting suspected safety concerns associated with healthcare products.

The Northern Ireland Yellow Card Centre, based in the Belfast Health and Social Care Trust, was first launched in 2023. Its aim is to increase awareness of reporting suspected adverse events to the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme.

The scheme provides a mechanism for patients, care givers and healthcare staff to report suspected safety concerns associated with healthcare products.

The first annual report shows that in Northern Ireland in 2023/24, 797 reports to the Yellow Card scheme were made, which is an increase of 32%* compared to 2022.

Northern Ireland Chief Pharmaceutical Officer Professor Cathy Harrison said: “I am really encouraged to see that more people are reporting to the Yellow Card scheme in Northern Ireland.

“Reporting suspected side effects and adverse incidents, including defective or fake healthcare products, to the scheme helps to improve the safety of medicines and medical devices for all patients.”

Paula King, Regional Lead Pharmacist Yellow Card centre and Medicines and Poisons Advice Service, said: “The Yellow Card Centre team is here to help those who report, raise awareness, and provide education and training sessions. Your Yellow Card report plays a key part in keeping others safe. Anyone can report a suspected adverse reaction.

“You should report all suspected adverse reactions, even if the effect is well recognised or minor.”

Dr Alison Cave, MHRA Chief Safety Officer, said: “Patient safety is our top priority. The Yellow Card scheme plays a crucial role in our ongoing safety monitoring of medicines and medical devices, helping us identify potential issues early so we can take the necessary action to protect public health.

“We welcome Northern Ireland's first Yellow Card Centre annual report, which highlights a 32% rise in reporting. Regional Yellow Card Centres are critical to supporting timely, high-quality reporting and we would like to thank the Northern Ireland team at the Department of Health and the Yellow Card Centre for their work in raising awareness.

“As always, we encourage patients, healthcare professionals and carers to report any suspected side effects to the Yellow Card scheme – every report counts.”

Reports to the Yellow Card scheme can help to identify new and serious adverse effects and can help make medicines safer. You can report  at https://yellowcard.mhra.gov.uk/ or via the Yellow Card app, available from Apple App or Google Play Store.

Notes to editors:

1. * Yellow Card reports increased significantly during the COVID-19 pandemic both in Northern Ireland and across the UK.  Comparing this year's data with previous years in Northern Ireland is challenging due to the impact of pandemic reporting levels and that past data is available in calendar years, rather than financial/business years, or includes COVID-19 reports. To offer a more precise indication of reporting trends the general non-COVID-19 Yellow Card reports have been used as a benchmark, as they likely reflect pre-pandemic reporting levels more accurately.  This method aligns with the approach adopted by other Yellow Card centres across the UK.
2. You can view the Annual Report here: Yellow Card Centre Northern Ireland | Belfast Health & Social Care Trust website
3. For more information on the MHRA Yellow Card scheme visit the Yellow card website(external link opens in a new window / tab). The Yellow Card app is available from the Apple App Store, or Google Play Store. Key features of the app include the ability to create a ‘watch list' of medications for which you can receive news and alerts from the MHRA.
4. You can read more about the Yellow Card Centre in Northern Ireland here: Yellow Card Centre Northern Ireland | Belfast Health & Social Care Trust website
5. A report  to the Yellow Card scheme does not necessarily mean that it was caused by the medicine, only that the reporter has a suspicion it may have been. Underlying or previously undiagnosed illness unrelated to the medicine can also be factors in such reports. 
6. The number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile of different medicines or medical devices.