The MHRA and the Commission on Human Medicines (CHM) run the UK's spontaneous adverse drug reaction (ADR) reporting scheme - called the Yellow Card Scheme. This receives reports of suspected adverse drug reactions (ADRs) or side effects from healthcare professionals and patients for medicines and vaccines.
The Yellow Card Scheme is the main ADR reporting scheme in the UK and was introduced in 1964 after the thalidomide tragedy highlighted the urgent need for routine monitoring of medicines. It receives more than 20,000 reports of possible side effects each year.
How does the Yellow Card Scheme work?
The Yellow Card Scheme relies on reports of possible or suspected adverse reactions from patients and health professionals made on a voluntary basis. Pharmaceutical companies also have a legal obligation to pass on reports that they receive about suspected side effects of their products that are defined as serious. The scheme acts as an early warning system for the identification of previously unrecognised reactions and enables us to identify risk factors, outcomes of the ADR and other factors that may affect clinical management. .
The value of the scheme has been demonstrated many times and it has helped to identify many safety issues. For example Yellow Cards reports on liver toxicity with black cohosh have resulted in improved safety warnings.
The Yellow Card scheme is administered by the MHRA with the support of five Yellow Card Centres:
- Yellow Card Centre Northern and Yorkshire (external link), Wolfson Unit, Claremont Place, Newcastle upon Tyne, NE2 4HH. Telephone 0191 260 6181. Email YCCNorthernandYorkshire@nuth.nhs.uk
- Yellow Card Centre North West, 2nd Floor, 70 Pembroke Place, Liverpool, L69 3GF, Telephone 0151 794 8122. Email yccnorthwest@lrippu.nhs.uk
- Yellow Card Centre Scotland (external link), 51 Little France Crescent, Old Dalkeith Road, Edinburgh, EH16 4SA. Telephone 0131 242 2919. Email YCCScotland@luht.scot.nhs.uk
- Yellow Card Centre Wales (external link), Cardiff University, Department of Pharmacology, Therapeutics and Toxicology, Heath Park, Cardiff, CF14 4XN. Telephone 029 2074 4181. Email YCCWales@wales.nhs.uk
- Yellow Card Centre West Midlands (external link), City Hospital, Dudley Road, Birmingham, B18 7QH. Telephone 0121 507 5672. Email help@yccwm.org.uk
These centres help to raising awareness of the Yellow Card Scheme and provide education and training in their region (including advice on what to report and help in completing the form). They also help provide information on drug safety matters at a regional level.
