The Yellow Card Scheme is the United Kingdom’s system for collecting information on suspected adverse reactions (ADRs) to medicines. The scheme allows monitoring the safety of drugs and vaccines available on the market.
History Yellow Card Scheme
The Yellow Card scheme was founded in 1964 after the thalidomide disaster and was designed by Bill Inman. It is administered by the Medicines and Health Products Regulatory Agency (MHRA) and the Human Medicines Commission. It was extended to hospital pharmacists in 1997 and community pharmacists in 1999.
The Yellow Card Center in Scotland is a joint venture between the MHRA and the Scottish Government.
Sphere of Yellow Card Scheme
Information about suspected adverse reactions is collected for all licensed medicines and vaccines that are prescribed or purchased from a pharmacy or supermarket. The Yellow Card Scheme also includes all herbal preparations and unlicensed medicines. Anyone can report adverse reactions; This is usually done by healthcare professionals, including doctors, pharmacists, and nurses, but patients and caregivers can also make reports.
The following types of adverse reactions should be reported:
- Those that caused death or serious illness
- Any adverse reaction, even a minor one, if it is related to a new drug or a drug under constant surveillance (highlighted in the British National Formulary with a black triangle ▼ )
- Any adverse reaction, even if it is minor, if it is associated with a child (under 18 years old) or pregnancy.
Usage of Yellow Card Scheme
Reports can be entered through the MHRA website or a smartphone app available for iOS and Android devices. The app can also provide users with news and alerts.
Yellow cards can be purchased from pharmacies and some are featured at the back of the BNF as tear-off pages; copies are also available on +44 (0) 808 100 3352. The scheme provides forms that allow members of the public to report suspected side effects, as well as healthcare professionals.
NHS Digital publishes the information standard DCB1582 for the electronic reporting of adverse reactions by IT systems (until 2014 it was ISB 1582 of the Information Standards Board). The specification is based on the international standard ICH E2B (R2) format.
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