Paeds Cases · clinical-pharmacology-and-therapeutics
Counselling a family that a medicine is off-label — OSCE
Communication OSCE on explaining to a parent that a medicine is being prescribed outside its product licence for their child, covering informed consent, the evidence base, the formulation choice, monitoring and the pharmacovigilance plan.
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Study tools
Target exams
MRCPCH ClinicalRACP DCERCPSC Pediatrics
Prompt
A 3-month-old infant is to start propranolol oral for a proliferating infantile haemangioma; the propranolol product is licensed for adult hypertension; the parent has read the box and asked why the licensed age range does not include their baby; the candidate must explain the off-label use, obtain consent, and outline the monitoring and reporting plan.
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]
References4ShowHide
- [5]Cuzzolin L Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf, 2006.PMID 16907660
- [6]Kimland E Off-label drug use in pediatric patients. Clin Pharmacol Ther, 2012.PMID 22472984
- [7]Frattarelli DA Off-label use of drugs in children. Pediatrics, 2014.PMID 24567009
- [8]Bellis JR Adverse drug reactions and off-label and unlicensed medicines in children: a nested case-control study of inpatients in a pediatric hospital. BMC Med, 2013.PMID 24229060