UNLICENSED AND OFF LABEL DRUG-USE IN PEDIATRIC WARDS - PROSPECTIVE-STUDY

Objective: To determine the extent of use in children in hospital of d rugs that are not specifically licensed for use in children (unlicense d) and of drugs that are used outside the terms of their product licen ce that apply to indication, age, dose, or route of administration (of f label). Design: Prospective study of drugs administered on paediatri c medical and surgical wards for 13 weeks. Setting: Regional children' s hospital. Subjects: Paediatric inpatients in medical and surgical wa rds. Main outcome measures: Comparison of the use of each drug with it s product licence to determine whether the drug was used in an unlicen sed or off label manner. Results: 2013 courses of drugs were administe red to 609 paediatric patients in 707 admissions. 506 (25%) of the dru g courses (prescriptions) were either unlicensed (139) or off label (3 67) uses. In 256 (36%) of the 707 admissions patients received one or more courses of an unlicensed or off label treatment in hospital. Conc lusions: Use of drugs in an off label or unlicensed manner to treat ch ildren is widespread. Drugs are more likely to be used in an off label manner than in an unlicensed manner.