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Isotretinoin Pregnancy Prevention Programme — GPhC CRA MCQ

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HardAdverse Drug Reactions and SafetyIsotretinoin Pregnancy Prevention ProgrammeGPhC CRA

A pharmacist receives a prescription for isotretinoin 30mg daily for a 24-year-old woman. It is dated 10 days ago and the negative pregnancy test was documented 12 days ago. What is the legal classification/requirement?

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Correct answer: CDo not dispense until Pregnancy Prevention Programme timing requirements are satisfied

Isotretinoin is highly teratogenic and dispensing for patients who can become pregnant must comply with Pregnancy Prevention Programme requirements, including strict timing around pregnancy testing and prescription validity. A general 28-day prescription validity approach is not enough for this medicine. Verbal reassurance does not replace documented programme requirements. Folic acid does not mitigate isotretinoin teratogenicity.

Reference: BNF; MHRA Drug Safety Update