Arch Dis Child Fetal Neonatal Ed 80:F142-F145 doi:10.1136/fn.80.2.F142
  • Original article

Unlicensed and off label drug use in neonates

  1. Sharon Conroy,
  2. John McIntyre,
  3. Imti Choonara
  1. Academic Division of Child Health, University of Nottingham, Derbyshire Children’s Hospital, Derby DE22 3NE
  1. Mrs Sharon Conroy.
  • Accepted 19 October 1998


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.


    Latest from Education & Practice

    Latest from Education & Practice

    Register for free content

    Free sample
    This recent issue is free to all users to allow everyone the opportunity to see the full scope and typical content of ADC Fetal & Neonatal.
    View free sample issue >>

    Don't forget to sign up for content alerts so you keep up to date with all the articles as they are published.

    Navigate This Article