The Yellow Card Scheme is vital in helping the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users. In addition to collecting suspected adverse drug reactions the Scheme now supports the reporting of medical device incidents, counterfeits and defective healthcare products. For medicines, the Scheme acts as the early warning system to identify new and strengthen existing safety information. Reports can help MHRA to take action, if necessary, to make changes to the warnings given to people taking a medicine or review the way it is used to maximise benefit and minimise the risk to the patient.
You should report all suspected adverse drug reactions that are:
- serious, medically significant or result in harm. Serious events are fatal, life-threatening, a congenital abnormality, disabling or incapacitating, or resulting in hospitalization;
- associated with newer drugs and vaccines; the most up to date list of black triangle medicines is available at: www.mhra.gov.uk/blacktriangle
If in doubt whether to report a suspected adverse drug reaction, please complete a Yellow Card online or via the mobile App, available from Google play and iTunes.
Further info for healthcare professionals including CPD modules can be found on the MHRA website