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Valproate pack warnings — GPhC CRA MCQ

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HardDispensing and SupplyValproate pack warningsGPhC CRA

A woman of childbearing potential collects sodium valproate tablets. The dispenser notices the tablets have been repacked into a plain bottle without the manufacturer's warning card or leaflet. What is the legal classification/requirement?

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

Reveal the answer and explanation

Correct answer: A — Supply should preserve required pregnancy warning information and patient materials

Valproate has strict pregnancy prevention and warning requirements because of serious fetal risk. Dispensing should maintain prominent warnings and provide patient materials unless there is a justified reason and equivalent information is supplied. Counselling and referral for specialist review may be needed if pregnancy prevention requirements are unclear.

Reference: MHRA Drug Safety Update; BNF