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Unlicensed specials — GPhC CRA MCQ

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HardPharmacy Law and EthicsUnlicensed specialsGPhC CRA

A prescriber orders an unlicensed strawberry-flavoured omeprazole liquid for a child who can swallow a licensed dispersible formulation and has no excipient intolerance. The special is preferred only because the family likes the flavour. What should the pharmacist do?

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

Reveal the answer and explanation

Correct answer: E — Query the special and recommend the licensed formulation that meets the clinical need

Explanation lettering: C = shown as A · E = shown as B · A = shown as C · B = shown as D · D = shown as E

A is wrong because a prescription does not remove the pharmacist’s need to establish a genuine special clinical need. B is wrong because price alone does not justify an unlicensed product where a suitable licensed medicine meets the patient’s need. C is wrong because consent does not reverse the hierarchy. D is correct: flavour preference alone is insufficient, so the pharmacist should clarify with the prescriber and use the suitable licensed option. E is wrong because extemporaneous preparation is not thereby licensed and does not avoid the same governance question.

Reference: MHRA: supply unlicensed medicinal products (specials). https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials GPhC: standards for pharmacy professionals. https://assets.pharmacyregulation.org/files/standards_for_pharmacy_professionals_may_2017_0.pdf