Adverse drug reactions in children - the contribution of off-label and unlicensed prescribing

Adverse drug reactions (ADRs) in children are common but their predictors are not fully characterised. It is known that both increasing age and number of concomitant medicines increase ADR risk in children, and there is also some evidence that off-label and unlicensed medicine use may contribute. The purpose of the thesis was to characterise ADRs in children, focusing on known risk factors, which have not been adequately evaluated in the literature. The contribution of off-label and unlicensed prescribing to ADR risk in children was assessed in two large prospective studies. In the first study, which evaluated ADR-related hospital admissions, off-label or unlicensed medicines were more likely to be implicated in an ADR than authorised medicines (relative risk 1.67, 95% CI 1.38, 2.02,