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Yellow Card reporting — GPhC CRA MCQ

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EasyAdverse Drug Reactions and SafetyYellow Card reportingGPhC CRA

A patient reports a severe rash and facial swelling after starting a newly marketed medicine marked with an inverted black triangle in the BNF. They are now recovering after hospital treatment. What is the legal classification/requirement?

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Correct answer: A — Submit a Yellow Card report for the suspected adverse reaction

Serious suspected adverse drug reactions should be reported through the Yellow Card scheme. Black triangle medicines are subject to additional monitoring, so reporting suspected reactions is particularly important. Causality does not need to be proven before reporting a suspicion.

Reference: MHRA Yellow Card; BNF