Unlicensed and off-label drug use in children: implications for safety

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Imti Choonara1, Sharon Conroy

  • 1Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Uttoxeter Road, Derby, DE22 3NE, UK. imti.choonara@nottingham.ac.uk

Drug Safety
|February 1, 2002
PubMed

Insights

Many children in hospitals receive unlicensed or off-label drug prescriptions. This practice is linked to a higher risk of adverse drug reactions in pediatric patients.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety
  • Hospital Pharmacy

Background:

  • A significant proportion of pediatric hospital patients, including neonates, receive medications that are not licensed or are prescribed off-label.
  • Commonly used off-label medications include analgesics, antibiotics, and bronchodilators.

Purpose of the Study:

  • To evaluate the association between the use of unlicensed or off-label drugs and the risk of adverse drug reactions in children.
  • To synthesize existing evidence on the toxicity risks associated with non-standard drug use in pediatric populations.

Main Methods:

  • Review of existing studies examining the incidence and outcomes of unlicensed and off-label drug use in hospitalized children.
  • Analysis of prospective and retrospective data linking drug prescription status to adverse drug event occurrence.

Main Results:

  • One prospective study indicated a significant association between the percentage of unlicensed/off-label drug use and the risk of adverse drug reactions.
  • Two studies suggest an increased risk of severe adverse drug reactions with off-label or unlicensed drug use.
  • Specific findings include 5/8 severe adverse drug reactions linked to off-label use and 14/19 severe adverse drug reactions associated with unlicensed or off-label prescriptions.

Conclusions:

  • Limited data suggest a potential increased risk of adverse drug reactions, particularly severe ones, when children are treated with unlicensed or off-label medications.
  • Further prospective research is needed to clearly define the risks associated with prescribing unlicensed and off-label drugs in pediatric care.

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