Unlicensed and off-label drug use in paediatrics in a mother-child tertiary care hospital

OBJECTIVE: To assess unlicensed and off-label drug use in a tertiary care paediatric hospital in Canada on a single day. METHODS: A cross-sectional study in a tertiary care paediatric hospital was conducted on one randomly selected day. Active prescriptions for children <18 years of age were analyzed. Unlicensed drug use was defined as the use of nonmarketed drugs in Canada or marketed drugs with pharmacy compounding. Off-label drug use was defined as the use of marketed drugs in Canada for an unapproved age group, indication, dosing, frequency and/or route of administration. Off-label drug uses associated with strong scientific support were analyzed using the Pediatric Dosage Handbook, 14th edition and Micromedex (R) Solutions. Number and proportion of unlicensed and off-label drug uses, and off-label drug uses associated with strong scientific support were measured. RESULTS : A total of 2145 drug prescriptions were extracted on March 5, 2014, for inclusion in the present study. The unlicensed drug use rate was 8.3% (57 unlicensed drug products; 75 nonmarketed drug prescriptions and 103 pharmacy compounding prescriptions) and the off-label drug use rate was 38.2% (161 substances; 819 prescriptions). Reasons for off-label drug use included unapproved age group (n = 436 [53.2%]), dosing (n = 226 [27.6%]), frequency (n = 206 [25.2%]), indication (n = 45 [5.5%]) and administration route (n = 46 [5.6%]). Of the off-label drug prescriptions, 39.3% (n = 322) were associated with strong scientific support. CONCLUSIONS: On a randomly selected day, 8.3% of prescriptions were unlicensed and 38.2% were off-label for children hospitalized at the authors' institution. Of off-label prescriptions, only 39.3% were associated with strong scientific support.