Arch Dis Child Fetal Neonatal Ed 1999;80:F142-F145 ( March )

Unlicensed and off label drug use in neonates

Sharon Conroy, John McIntyre, Imti Choonara

Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby DE22 3NE

Correspondence to: Mrs Sharon Conroy.

Accepted 19 October 1998

AIMTo 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.
METHODSA prospective study was conducted over 13 weeks.
RESULTS455 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.
CONCLUSIONThe 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.

Keywords: unlicensed/off label drug use; intensive care

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© 1999 by Archives of Disease in Childhood
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