Yellow Card Scheme

Yellow Card Scheme

The Yellow Card Scheme is a pharmacovigilance system in the United Kingdom that allows healthcare professionals and patients to report adverse drug reactions (ADRs) to the Medicines and Healthcare products Regulatory Agency (MHRA). The scheme, which was established in 1964, is a crucial component of the UK's system for monitoring the safety of medicines and vaccines after they have been licensed for use.

History

The Yellow Card Scheme was introduced by the Committee on Safety of Medicines (CSM) following the Thalidomide disaster in the early 1960s. The scheme was named after the yellow cards that healthcare professionals were originally asked to send to the CSM if they suspected a medicine had caused an adverse reaction.

Purpose

The primary purpose of the Yellow Card Scheme is to provide an early warning system for the identification of previously unrecognised adverse reactions to medicines. It also provides a mechanism for the ongoing collection of data on the benefits and risks of medicines, which can be used to support decisions about the licensing of new medicines and the continued licensing of existing medicines.

Operation

The Yellow Card Scheme operates through the voluntary reporting of ADRs by healthcare professionals and patients. Reports can be submitted online, by post, or by telephone. The MHRA then analyses the reports and, if necessary, takes action to protect public health. This can include updating the information provided with a medicine, restricting its use, or in rare cases, withdrawing it from the market.

Limitations

While the Yellow Card Scheme plays a vital role in pharmacovigilance, it has some limitations. These include under-reporting of ADRs, lack of information about the number of people taking a medicine (which makes it difficult to calculate the incidence of ADRs), and the fact that it can only identify potential associations between a medicine and an adverse reaction, not prove causality.

See also

• Pharmacovigilance
• Adverse drug reaction
• Medicines and Healthcare products Regulatory Agency
• Committee on Safety of Medicines

External links

• Official Yellow Card Scheme website

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