Unlicensed and off-label drug use in an Australian neonatal intensive care unit

Objectives. To determine the extent of unlicensed and off-label drugs prescribed in the level 3 neonatal intensive care unit (NICU) at the Royal Women's Hospital, Melbourne, Australia. Methods. A prospective cohort study was conducted of all infants who were admitted to the NICU during a 10-week period. Each drug prescribed was evaluated in relation to the licensed approved uses to determine whether the drug was administered in a licensed manner or was unlicensed or used in an off-label manner. Results. There were a total of 101 admissions involving 97 infants. A total of 1442 prescriptions were administered; 42% were licensed, 11% were unlicensed, and 47% were off-label. Twenty-one percent were off-label for 2 or more reasons. Eighty percent of infants received either an unlicensed or an off-label prescription or both; this proportion rose to 93% of extremely low birth weight infants. Conclusions. This is the largest study performed of unlicensed and off-label drug use in the NICU. This practice remains widespread despite clear recommendations to improve this undesirable situation. The attendant risks to infants and prescribers remain. It is time for legislation to be introduced to govern this area.