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
thalidomide
Thalidomide, sold under the brand names Contergan and Thalomid among others, is a medication used to treat a number of cancers (including multiple myeloma), graft-versus-host disease, and a number of skin conditions including complications of ...
disaster, and was developed by
Bill Inman
William Howard Wallace Inman, MRCP, FRCP, FFPHM (1 August 1929 – 20 October 2005), also known as WHW Inman, was a British doctor and pioneer of methods and systems to detect risks of treatment with drugs. As well as holding positions in health i ...
. 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 Medi ...
. 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
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 medicine ...
with a ▼
black triangle Black triangle may refer to one of the following:
* Black triangle (badge), a Nazi concentration camp badge worn by inmates deemed "asocial"
** LGBT symbols#Triangle badges of Nazi Germany, Lesbian or feminist symbol reclaimed from the Nazi use
* 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 portable computer device that combines mobile telephone and computing functions into one unit. They are distinguished from feature phones by their stronger hardware capabilities and extensive mobile operating systems, whic ...
app which is available for
iOS
iOS (formerly iPhone OS) is a mobile operating system created and developed by Apple Inc. exclusively for its hardware. It is the operating system that powers many of the company's mobile devices, including the iPhone; the term also includes ...
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
NHS Digital is the trading name of the Health and Social Care Information Centre, which is the national provider of information, data and IT systems for commissioners, analysts and clinicians in health and social care in England, particularly th ...
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.
See also
*
EudraVigilance
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or bein ...
(European Medicines Agency)
*
Pharmacovigilance
Term Given By Tushar Sharma (UPES Batch 2025)
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharma ...
*
Uppsala Monitoring Centre
Uppsala Monitoring Centre (UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. UMC works by collecting, assessing and communicating information from member c ...
(WHO)
*
Vaccine Adverse Event Reporting System
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveil ...
(USA)
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