Yellow Card Scheme

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

The Yellow Card Scheme is the United Kingdom's 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]

History

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]

The Yellow Card Centre Scotland is a joint venture between MHRA and the Scottish Government.[3]

Scope

Suspected adverse reactions are collected on all licensed medicines and vaccines, whether issued on prescription or 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 types 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

Usage

Reports can be entered through the MHRA's website, or a smartphone app which is available for iOS and Android devices. The app can also provide news and alerts to users.[4]

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.[5] The scheme provides forms that allow members of the public to report suspected side effects, as well as health professionals.[6]

NHS Digital publishes an information standard DCB1582 for electronic submission of adverse reactions by IT systems[7] (until 2014, this was ISB 1582 from the Information Standards Board).[8] The specification is based on the ICH E2B (R2) international standard format.[9]

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.[permanent dead link]
  3. ^ "Yellow Card Centre Scotland". Yellow Card Centre Scotland. Retrieved 8 September 2014.
  4. ^ "Digital evolution for ground-breaking Yellow Card Scheme" (Press release). gov.uk. 14 July 2015. Retrieved 11 October 2015.
  5. ^ A side effect of your medicine? Report it using Yellow Card leaflet (2008) [full citation needed]
  6. ^ "Downloadable information: Reporting forms". Medicines and Healthcare products Regulatory Agency. Retrieved 29 November 2020.
  7. ^ "DCB1582: Electronic Yellow Card Reporting". NHS Digital. 26 October 2017. Retrieved 20 February 2021.
  8. ^ "Amd 28/2012 — ISB". webarchive.nationalarchives.gov.uk. Retrieved 20 February 2021.
  9. ^ "ICH E2B (R3) Electronic transmission of individual case safety reports (ICSRs)". European Medicines Agency. 28 July 2013. Retrieved 20 February 2021.