Yellow Card Scheme

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.

For information on reporting to the Yellow Card Scheme, please see the ‘reporting adverse drug reactions’ page of the website.

Campaign to encourage reporting of side effects to medicines… ‘Help make medicines safer for everyone’
We have launched a new, targeted campaign to increase public awareness of the Yellow Card Scheme. Yellow Card leaflets have been distributed to GP surgeries and pharmacies across the UK. This is supported by poster displays and the information video below, which encourages reporting to the scheme and is being shown in a number of GP surgery waiting rooms.

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 Mersey, Freepost, Liverpool. L3 3AB
• Yellow Card Centre Wales, Freepost, Cardiff. CF4 1ZZ
• Yellow Card Centre Scotland, 51 Little France Crescent, Old Dalkeith Road, Edinburgh. EH16 4SA
• Yellow Card Centre Northern and Yorkshire, Freepost, Newcastle-upon-Tyne. NE1 1BR
• Yellow Card Centre West Midlands, Freepost, Birmingham. B18 7BR

These centres promote and assist in the administration of the Yellow Card scheme and provide education and training in their areas. They also undertake any follow-up required on Yellow Card reports from their respective areas on behalf of the MHRA.