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 may result from the combination of two or more drugs. The meaning of this ...

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

thalidomide Thalidomide, sold under the brand names Contergan and Thalomid among others, is an oral administered medication used to treat a number of cancers (e.g., multiple myeloma), graft-versus-host disease, and many skin disorders (e.g., complication ...

disaster, and was developed by Bill Inman. It is run by the

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are accepta ...

(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 The Scottish Government (, ) is the executive arm of the devolved government of Scotland. It was formed in 1999 as the Scottish Executive following the 1997 referendum on Scottish devolution, and is headquartered at St Andrew's House in ...

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 The ''British National Formulary'' (BNF) is a United Kingdom (UK) pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about many medicin ...

with a ▼

black triangle Black triangle may refer to: Places * Black Triangle (region), across Germany, Poland and the Czech Republic, long characterized by extremely high levels of pollution * Black triangle, the nickname given to the area south of Montreal affected by a ...

) * 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 A smartphone is a mobile phone with advanced computing capabilities. It typically has a touchscreen interface, allowing users to access a wide range of applications and services, such as web browsing, email, and social media, as well as multi ...

app which is available for

iOS Ios, Io or Nio (, ; ; locally Nios, Νιός) is a Greek island in the Cyclades group in the Aegean Sea. Ios is a hilly island with cliffs down to the sea on most sides. It is situated halfway between Naxos and Santorini. It is about long an ...

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. Children and Young People can also report suspected Adverse Drug Reactions to the Yellow Card scheme, and specific information for them has been developed and tested.

NHS Digital NHS Digital was the trading name from 2016 of the Health and Social Care Information Centre, which was the national provider of information, data and IT systems for commissioners, analysts and clinicians in health and social care in England, p ...

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