The Yellow Card Scheme is the UK system, run by the MHRA, for collecting reports of suspected adverse drug reactions, medical device adverse incidents, defective or falsified products and safety concerns relating to e-cigarettes. It has operated since 1964, established after the thalidomide tragedy exposed the absence of any systematic way to detect harms emerging after a product reached the market.
Its purpose is signal detection. Clinical trials involve limited numbers of relatively selected participants over limited periods, so rare reactions, delayed effects and problems in groups excluded from trials often only become visible once a product is in widespread use.
Anyone can. Healthcare professionals of all kinds, patients, carers and parents can submit reports through the Yellow Card website, the app, or a link embedded in many electronic prescribing systems. Patient reporting has been shown to add value rather than duplicate professional reports, because patients describe the impact of a reaction on daily life in ways clinical notes often do not.
Certainty is not required. The threshold is suspicion, and reporters are explicitly asked not to wait until causality is proven.
Reports are assessed and combined with other data sources to look for patterns. Where a signal is confirmed, the MHRA can update product information and warnings, restrict indications, issue safety alerts to the NHS, require a Field Safety Corrective Action or, in the most serious cases, suspend or withdraw a product. Under-reporting remains the scheme's main limitation, so making reporting quick and embedding it in clinical software is a practical priority.
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