Yellow Card Scheme
Encyclopedia
The Yellow Card Scheme is the UK system for collecting information on suspected Adverse Drug Reactions (ADRs) to medicines. The Scheme was founded in 1964 after the thalidomide
disaster, and was developed by Dr Bill Inman
.
It is run by the Medicines and Healthcare products Regulatory Agency (MHRA)
and the Commission on Human Medicines
(CHM). Suspected ADRs are collected on all licensed medicines and vaccines, from those issued on prescription to medicines bought over the counter from a pharmacist or supermarket. The Scheme also includes all herbal preparations and unlicensed medicines. ADRs 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 sort of ADRs that should be reported are:
Yellow Cards are available from pharmacies and a few are presented near the back of the BNF
as tear-off pages.
Reports can also be submitted online through the MHRA-run Yellow Card Scheme website. The NHS Information Standards Board for Health and Social Care is currently developing an information standard for electronic submission of ADRs by IT systems. This is based upon the ICS E2B (R2) international standard
Thalidomide
Thalidomide was introduced as a sedative drug in the late 1950s that was typically used to cure morning sickness. In 1961, it was withdrawn due to teratogenicity and neuropathy. There is now a growing clinical interest in thalidomide, and it is introduced as an immunomodulatory agent used...
disaster, and was developed by Dr Bill Inman
Bill Inman
William Howard Wallace "Bill" Inman, MRCP, FRCP, FFPHM , also known as WHW Inman, was a British doctor and pioneer of methods and systems to detect risks of treatment with drugs...
.
It is run by the Medicines and Healthcare products Regulatory Agency (MHRA)
Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....
and the Commission on Human Medicines
Commission on Human Medicines
The Commission on Human Medicines is a committee of the UK's Medicines and Healthcare products Regulatory Agency. It was formed in October 2005 by the amalgamation of the Medicines Commission and the Committee on Safety of Medicines....
(CHM). Suspected ADRs are collected on all licensed medicines and vaccines, from those issued on prescription to medicines bought over the counter from a pharmacist or supermarket. The Scheme also includes all herbal preparations and unlicensed medicines. ADRs 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 sort of ADRs that should be reported are:
- ADRs that have caused death or a serious illness
- Any ADR, however minor, if associated with a new medicine or one that is under continued monitoring (highlighted in the British National Formulary (BNF)British National FormularyThe British National Formulary is a medical and pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about all medicines available on the National Health Service , including indication,...
with a ▼ black triangleBlack triangle (pharmacology)A black triangle appearing after the trade name of a British medicine indicates that the medication is new to the market, or that an existing medicine is being used for a new reason or by a new route of administration....
) - Any ADR, however minor, if associated with a child (under 18 years of age) or in pregnancy
Yellow Cards are available from pharmacies and a few are presented near the back of the BNF
British National Formulary
The British National Formulary is a medical and pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about all medicines available on the National Health Service , including indication,...
as tear-off pages.
Reports can also be submitted online through the MHRA-run Yellow Card Scheme website. The NHS Information Standards Board for Health and Social Care is currently developing an information standard for electronic submission of ADRs by IT systems. This is based upon the ICS E2B (R2) international standard
See also
- Medicines and Healthcare products Regulatory AgencyMedicines and Healthcare products Regulatory AgencyThe Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....
(MHRA) - PharmacovigilancePharmacovigilancePharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
- EudraVigilanceEudraVigilanceEudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...
- Uppsala Monitoring CentreUppsala Monitoring CentreThe Uppsala Monitoring Centre , located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring...
(WHO) - British National FormularyBritish National FormularyThe British National Formulary is a medical and pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about all medicines available on the National Health Service , including indication,...