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Cold-chain deviation — GPhC CRA MCQ

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ModerateDispensing and SupplyCold-chain deviationGPhC CRA

A pharmacy delivery driver returns insulin pens that were accidentally left in a hot car for five hours during summer. The packaging is warm and the temperature record is outside the validated range. What is the most appropriate action?

Educational content. Not a substitute for clinical judgement or local policy.

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Correct answer: D — Quarantine the stock and follow cold-chain deviation procedures before deciding on supply

Cold-chain medicines must be stored within validated temperature limits. A temperature excursion should trigger quarantine and local procedures, including assessment of stability data or manufacturer advice. Returning stock to the fridge does not undo a deviation. Supplying before assessment risks ineffective or unsafe treatment and poor traceability.

Reference: BNF; GDP guidance; MEP