Counselling a family that a medicine is off-label — OSCE

Station overview

A communication station testing whether the candidate can honestly and clearly explain off-label prescribing to a parent, obtain informed consent, and outline the governance, monitoring and pharmacovigilance plan. The station is not about the pharmacology of propranolol per se; it is about the licence, the evidence, the consent and the documentation. [7]

Candidate instructions

You are the general paediatric registrar. You have eight minutes. The infantile haemangioma has been assessed and propranolol oral is the agreed treatment; your task is to explain to the parent that the medicine will be used outside its product licence, obtain consent, and outline the plan. The parent (played by an examiner or actor) has read the medicine box and is worried because the licensed age range starts in adulthood. [6]

Encounter structure

1. Establish the parent's understanding and concern first. Ask what they have read and what worries them most. Do not assume. [7]
2. Name the off-label status in plain language. Explain that the propranolol product is licensed for a different condition (high blood pressure) in adults, and that using it for a baby's haemangioma means using it outside that licence — this is called off-label use, and it is legal and common in children. [6]
3. Explain why it is the best choice. Describe the evidence base — propranolol is an established, guideline-supported treatment for proliferating infantile haemangioma — and why no licensed-for-children alternative meets the need as well. [7]
4. Describe the practical plan. The dose is worked out by the baby's weight in kilograms; the baby will be monitored (heart rate, blood pressure, blood glucose, and the haemangioma's response); and any side effect will be assessed and reported. [8]
5. Invite questions and obtain consent. Check the parent's understanding, answer questions, and obtain consent. Where appropriate, obtain the child's assent as well. [7]
6. Document. Tell the parent you will record the indication, the evidence base, the weight-based dose, and this discussion in the notes, and that you will follow the unit's off-label-medicine policy. [7]

Marking domains

• Communication and rapport — plain language, checks understanding, invites and answers questions, acknowledges the worry without dismissing it. (High-weight domain.) [7]
• Accuracy of the off-label explanation — correctly distinguishes off-label from licensed and from unlicensed; does not claim the medicine is licensed; does not conflate off-label with error. [6]
• Evidence and rationale — names the guideline-supported basis for propranolol in infantile haemangioma; explains why it is the best choice. [7]
• Safety and monitoring plan — weight-based dosing, specific monitoring (heart rate, blood pressure, glucose), escalation pathway, and reporting of adverse drug reactions. [8]
• Consent and documentation — obtains informed consent, considers assent, and commits to documenting the off-label status and the discussion. [7]

Common pitfalls (what loses marks)

• Pretending the medicine is licensed, or changing the subject when the parent points out the box. [7]
• Conflating off-label with a prescribing error or with an unlicensed product. [6]
• Giving a dose without referencing the child's weight in kilograms, or without naming a paediatric reference. [5]
• Failing to mention monitoring or adverse drug reaction reporting. [8]
• Forgetting to document the discussion and the off-label status. [7]

Actor notes (for the examiner)

• If the candidate avoids naming the off-label status, ask directly: "The box says it's for adults with blood pressure — is this medicine actually licensed for babies?" [6]
• If the candidate over-reassures without explaining the governance, ask: "So who is responsible if something goes wrong?" [7]
• If the candidate gives a dose without a weight, ask: "How did you work out how much to give?" [5]