High-risk drug ADR report — GPhC CRA MCQ

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ModerateAdverse Drug Reactions and SafetyHigh-risk drug ADR reportGPhC CRA

A patient has suspected anaphylaxis after a newly marketed medicine and is now stable after hospital treatment. What monitoring is required?

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Correct answer: D — Submit a Yellow Card report

Serious suspected adverse reactions, especially with newer medicines, should be reported via the Yellow Card scheme. In this vignette, "Submit a Yellow Card report" is the safest single best answer. The other options are less appropriate because they miss the key clinical risk, conflict with UK medicines guidance, or delay needed review.

Reference: BNF; MHRA Drug Safety Update