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Yellow Card Scheme

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This article is about adverse reactions in human medicine. For veterinary medicine, see Suspected Adverse Reaction Surveillance Scheme.

The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. 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 (CHM). Suspected ADRs 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. ADRs 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 ADRs that should be reported are:

  • ADRs that have caused death or a serious illness
  • Any ADR, however minor, if associated with a new medicine or one that is under continued monitoring (highlighted in the British National Formulary (BNF) with a ▼ black triangle)
  • Any ADR, 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.[1] It is also possible to report suspected side effects online.[2]

The NHS Information Standards Board for Health and Social Care has issued an information standard for electronic submission of ADRs by IT systems.[3] This is based upon the ICS E2B (R2) international standard.[4]

See also

References

  1. ^ A side effect of your medicine? Report it using Yellow Card leaflet (2008) [full citation needed]
  2. ^ http://www.yellowcard.gov.uk
  3. ^ Standard ISB 1582
  4. ^ Maintenance of the ICH Guideline On Clinical Safety Data Management : Data Elements for Transmission of Individual Case Safety Reports E2b(R2)
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