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 o ...
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 acceptabl ...
(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
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 medicines ...
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
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 and
Android
Android may refer to:
Science and technology
* Android (robot), a humanoid robot or synthetic organism designed to imitate a human
* Android (operating system), Google's mobile operating system
** Bugdroid, a Google mascot sometimes referred to ...
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
Ich may refer to:
* Ich, a German pronoun meaning ''I'', also a Middle English form of ''I''
* The ego, one of the psychic apparatus defined in Sigmund Freud's structural model of the psyche
* ''Ich'' (album), an album by German rapper Sido
* I ...
E2B (R2) international standard format.
See also
*
EudraVigilance (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 phar ...
*
Uppsala Monitoring Centre (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