Off-label and unlicenced medicine administration to paediatric emergency department patients

Abstract

OBJECTIVE: To determine the prevalence and nature of off-label and unlicenced (off-label/unlicenced) medicine administration to paediatric ED patients. METHODS: We undertook a retrospective, observational study in six EDs (July 2011 to June 2012, inclusive). Patients, aged 0-17 years, who were administered a medicine in the ED were included. At each site, 50 eligible patients were randomly selected each month of the study period. An explicit review of each patient's records was undertaken. Medicines were classified as on or off-label/unlicenced according to categories of use approved by the Therapeutic Goods Administration. RESULTS: There were 3343 patients enrolled (56.5% men, mean ± SD age..