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Yellow card scheme

Created: 23/11/2004

The Yellow Card Scheme for spontaneous reporting of suspected adverse drug reactions (ADRs) was introduced in 1964, after the thalidomide tragedy highlighted the urgent need for routine post-marketing surveillance of medicines. Since then, more than 400,000 reports of suspected ADRs have been submitted to the Committee on Safety of Medicines (CSM)/Medicines and Healthcare products Regulatory Agency (MHRA) on a voluntary basis by doctors, dentists, pharmacists, coroners, radiographers, optometrists and nurses and by pharmaceutical companies under statutory obligations.

Click here to view the guidance notes for reporting.

Adverse reactions

An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs and is suspected to be related to the drug. The reaction may be a known side-effect of the drug or it may be a new, previously unrecognised ADR.

What is the difference between an adverse drug reaction and an adverse event?

Very often, the terms "adverse reaction" and "adverse event" are used synonymously. This is not always correct. An adverse event is any undesirable experience that has happened to the patient while taking a drug but may or may not be related to the drug. An adverse event is not always the same as an adverse drug reaction, as adverse events encompass ADRs but may also include cases where no association has been or can be made between drug administration and the adverse event experienced. An example of an adverse event is a patient being hit by a car while on a specific medication, while an ADR could be a patient experiencing anaphylaxis shortly after taking the drug.

Click here to submit a Yellow card.

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