Unlicensed and off label drug use in neonates.
OBJECTIVE
To determine the extent of use of drugs that are either not licensed (unlicensed), or are outside the terms of their product licence (off label) in a neonatal intensive care unit.


METHODS
A prospective study was conducted over 13 weeks.


RESULTS
455 prescription episodes were administered to 70 babies. 63 (90%) patients were given a drug that was either unlicensed or used in an off label way. 54.7% prescription episodes were off label, many for more than one reason, and 9.9% (45) were unlicensed; 35.4% (161) prescription episodes were licensed.


CONCLUSIONS
The use of unlicensed and off label drugs in neonatal intensive care seems to be far greater than other paediatric settings. This highlights the difficulties faced by those trying to ensure safe and effective prescribing for neonates. Urgent action is required to resolve this situation.
D017277:Drug Approval; D004363:Drug Utilization; D004739:England; D006801:Humans; D007231:Infant, Newborn; D015931:Intensive Care, Neonatal / Q000379:methods*; D011446:Prospective Studies