Yellow Card Scheme

The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.[1]

This article is about adverse reactions in human medicine. For veterinary medicine, see Veterinary pharmacovigilance in the United Kingdom.

The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Bill Inman. It is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines. It was extended to hospital pharmacists in 1997, and to community pharmacists in 1999.[2] Suspected adverse reactions are collected on all licensed medicines and vaccines, from those issued on prescription to medicines bought over the counter from a pharmacist or supermarket. The Scheme also includes all herbal preparations and unlicensed medicines. Adverse reactions can be reported by anyone; this is usually done by healthcare professionals – including doctors, pharmacists and nurses – but patients and carers can also make reports.

The sort of adverse reactions that should be reported are:

  • those that have caused death or a serious illness
  • Any adverse reaction, however minor, if associated with a new medicine or one that is under continued monitoring (highlighted in the British National Formulary with a ▼ black triangle)
  • Any adverse reaction, however minor, if associated with a child (under 18 years of age) or in pregnancy

Yellow Cards are available from pharmacies and a few are presented near the back of the BNF as tear-off pages, copies may also be obtained by telephoning +44 (0) 808 100 3352.[3] The scheme provides forms that allow members of the public to report suspected side effects, as well as health professionals.[4]

The NHS Information Standards Board for Health and Social Care has issued an information standard for electronic submission of adverse reactions by IT systems.[5] This is based upon the ICS E2B (R2) international standard.[6] In July 2015 a Yellow Card smartphone app was launched for iOS and Android, allowing patients, carers and healthcare workers to report adverse reactions to medications, as well as enabling them to set up alerts for news on particular drugs and find out how many Yellow Cards a medicine has received.[7]

The Yellow Card Centre Scotland is a joint venture between MHRA and the Scottish Government.[8]

See also

References
  1. "The Yellow Card Scheme". Medicines and Healthcare products Regulatory Agency. Retrieved 8 September 2014.
  2. "NHS70: major moments in pharmacy 1948–2018". Pharmaceutical Journal. 22 June 2018. Retrieved 4 September 2018.
  3. A side effect of your medicine? Report it using Yellow Card leaflet (2008)
  4. "Downloadable information: Reporting forms". Medicines and Healthcare products Regulatory Agency. Retrieved 8 September 2014.
  5. Standard ISB 1582
  6. Maintenance of the ICH Guideline On Clinical Safety Data Management : Data Elements for Transmission of Individual Case Safety Reports E2b(R2)
  7. "Digital evolution for ground-breaking Yellow Card Scheme" (Press release). gov.uk. 2015-07-14. Retrieved 2015-10-11.
  8. "Yellow Card Centre Scotland". Yellow Card Centre Scotland. Retrieved 8 September 2014.
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