Yellow Card Scheme

The Yellow Card Scheme is the British spontaneous reporting system for suspected adverse reactions. It was established in 1964, directly in response to the thalidomide disaster, and is now run by the Medicines and Healthcare products Regulatory Agency together with the Commission on Human Medicines. Reports were originally restricted to doctors and have since been opened to all healthcare professionals and, from 2005, to patients and carers reporting on their own behalf.

Its scope is wider than medicines alone, covering vaccines, medical devices, and defective and falsified products. The reporting threshold is suspicion rather than proof, which is deliberate. Products under intensive monitoring, typically new active substances and new biologicals, carry an inverted black triangle symbol in their labelling and prescribing information, marking them as ones for which every suspected reaction is wanted.

The scheme feeds the regulator's own signal assessment and flows onward into the World Health Organization international collection, and the cumulative counts are published as interactive drug analysis profiles that anyone can inspect. The value of an individual report is not that it proves anything; it is that a rare reaction only becomes visible when several independent clinicians think the same thought and write it down.

Those published counts are the part most often misused. They are report totals with no exposure denominator, so they cannot yield an incidence and cannot be compared between an old and a new product without accounting for how many people took each and how heavily reporting was stimulated by publicity. For unlicensed peptides the position is worse still, since a reaction can be reported but there is no authorisation holder, no denominator and frequently no confirmed product identity.