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Off-label and unlicensed drug use in neonatal intensive care units in Turkey: the old-inn study

S Suna Oguz1, H Gozde Kanmaz, Ugur Dilmen

  • 1Neonatal Intensive Care Unit, Zekai Tahir Burak Maternity Teaching Hospital, 06230, Cebeci, Ankara, Turkey.

International Journal of Clinical Pharmacy
|January 12, 2012
PubMed

Insights

Unlicensed and off-label drug use is common in Turkish neonatal intensive care units (NICUs), affecting over 60% of prescriptions for infants. This highlights an urgent need for safer medication practices for neonates.

Area of Science:

  • Neonatal pharmacology
  • Pediatric drug safety
  • Clinical pharmacy

Background:

  • Developed countries have improved drug safety for infants and pediatric patients.
  • Many drugs used in children are unlicensed or prescribed off-label.
  • Licensed drug approvals for adults specify indications, doses, and administration routes.

Purpose of the Study:

  • To assess the extent and nature of unregistered and off-label drug use in Turkish neonatal intensive care units (NICUs).
  • To explore public awareness and views on unlicensed medicine use in preterm and term infants in developing countries.

Main Methods:

  • Prospective observational study of 464 neonates across 17 NICUs in Turkey.
  • Recording all medications administered to neonates over a 24-hour period.
  • Analyzing prescriptions for licensed versus unlicensed or off-label use.

Main Results:

  • A total of 1,315 prescriptions for 93 different medicines were analyzed.
  • 62.3% of all prescribed drugs were used in an unlicensed or off-label manner.
  • High prevalence of off-label and unlicensed medication use in neonates.

Conclusions:

  • Unlicensed and off-label medicines are frequently administered to preterm and term infants in Turkish NICUs.
  • This finding is consistent with reports from other countries.
  • Urgent attention is required to prioritize the needs of the neonatal population and ensure access to safe, appropriate medicines.
Abstract

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