The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected

adverse drug reaction An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term ...

s (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.

History

The scheme was founded in 1964 after the

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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 The Commission on Human Medicines (CHM) is a committee of the UK's Medicines and Healthcare products Regulatory Agency. It was formed in October 2005, and assumed the responsibilities of the Medicines Commission and the Committee on Safety of Med ...

. It was extended to hospital pharmacists in 1997, and to community pharmacists in 1999. The Yellow Card Centre Scotland is a joint venture between MHRA and the Scottish Government.

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

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app which is available for

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and Android devices. The app can also provide news and alerts to users. 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. The scheme provides forms that allow members of the public to report suspected side effects, as well as health professionals. NHS Digital publishes an information standard DCB1582 for electronic submission of adverse reactions by IT systems (until 2014, this was ISB 1582 from the Information Standards Board). The specification is based on the ICH E2B (R2) international standard format.

References

External links

*{{Official website
Commission on Human Medicines (CHM)
Pharmaceuticals policy Pharmacy in the United Kingdom Medical regulation in the United Kingdom Drug safety

History

Scope

Usage

See also

References

External links