PT  - JOURNAL ARTICLE
AU  - Sharon Conroy
AU  - John McIntyre
AU  - Imti Choonara
TI  - Unlicensed and off label drug use in neonates
AID  - 10.1136/fn.80.2.F142
DP  - 1999 Mar 01
TA  - Archives of Disease in Childhood - Fetal and Neonatal Edition
PG  - F142--F145
VI  - 80
IP  - 2
4099  - http://fn.bmj.com/content/80/2/F142.short
4100  - http://fn.bmj.com/content/80/2/F142.full
SO  - Arch Dis Child Fetal Neonatal Ed1999 Mar 01; 80
AB  - AIM 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. CONCLUSION 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.