Off-label and unlicensed medicine use — branching viva

Opening (warm-up)

Examiner: "You are the general paediatric registrar. I am handing you two scenarios. In the first, a 3-month-old is being started on propranolol oral for an infantile haemangioma; the propranolol is licensed for adult hypertension. In the second, our neonatal pharmacy has made up a caffeine citrate solution because no licensed preparation exists at the strength we need for a preterm infant. Classify each prescription for me." ^[1]

Model answer: The propranolol is off-label — a licensed product (it carries a marketing authorisation, for adult hypertension) used outside one or more of its licensed terms (here the age, indication and dose for the infant). The caffeine solution is unlicensed — there is no valid marketing authorisation for that product or formulation in the jurisdiction; it is compounded because no licensed paediatric preparation exists at the required strength. Both are legal, common and often evidence-based; neither is an error. ^{[1] [6]}