Yellow Card Scheme

What is it?
The Yellow Card Scheme is run by the MHRA and CHM. It collects, collates and investigates reports of suspected adverse drug reactions.  The scheme was set up in response to the thalidomide tragedy, which highlighted the urgent need for routine monitoring of the safety of medicines by a central body independent of the pharmaceutical industry.  It was the world’s first spontaneous reporting scheme for the reporting of suspected adverse drug reactions and is the cornerstone of post marketing drug safety surveillance in the UK. The scheme is voluntary and relies on the identification and reporting of adverse drug reactions by health professionals and patients.

What to report
Adverse reactions resulting from the following can all be reported, even if there is any doubt about whether or not an adverse reaction has occurred.

  • All reactions to drugs which are under ‘additional monitoring’ (i.e. drugs marked with inverted black triangle black triangle )
  • Any serious reaction to all other drugs
    • Prescription medicines (including off-label use or unlicensed drugs)
    • OTC medications
    • Herbal medicines
    • Vaccines
    • X-ray contrast media
    • Blood products
    • Dental and surgical materials

Click here for further information on adverse drug reactions

  1. Causality
  2. Black triangle drugs black triangle
  3. Serious reactions
  4. Reporting in Children
  5. Adverse reactions in the elderly
  6. Delayed drug effects
  7. Congenital abnormalities
  8. Herbal medicines
    MHRA
    GOV.UK
     

Who can report
Basically anybody!!!

  • Doctors
  • Dentists
  • Coroners
  • Pharmacists
  • Nurses, midwives and health visitors
  • Radiographers
  • Optometrists
  • Patients, carers and parents can find out more information on our patient page

How to report

Healthcare Professionals
Report online at www.mhra.gov.uk/yellowcard
Download a healthcare professional Yellow Card form

Alternatively paper copies of the Yellow Card are available in the BNF, Mims and ABPI Medicines compendium.
 
Guidance regarding completion of a Yellow Card report

Patients, carers and parents
Report online at www.mhra.gov.uk/yellowcard
Patients, carers and parents can report using the online form

Further information can be found on the MHRA site