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Am J Perinatol 2002; 19(2): 067-072
DOI: 10.1055/s-2002-23557
ORIGINAL ARTICLES

Copyright © 2002 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel.: +1(212) 584-4662

Unlicensed and Off-Label Medication Use in a Neonatal Intensive Care Unit: A Prospective Study

Joseph Barr1 , Galit Brenner-Zada1 , Eli Heiman2 , Gideon Pareth1 , Mordechai Bulkowstein1 , Revital Greenberg1 , Matitiahu Berkovitch1
  • 1Clinical Pharmacology Unit, Assaf-Harofeh Medical Center, Zerifin, Israel (affiliate of Sackler School of Medicine, Tel-Aviv University, Israel and
  • 2Neonatal Intensive Care Unit, Assaf-Harofeh Medical Center, Zerifin, Israel (affiliate of Sackler School of Medicine, Tel-Aviv University, Israel)
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Publication Date:
02 April 2002 (online)

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ABSTRACT

The aim of this study is to determine the extent of use of medications that have not been specifically licensed for use in children (unlicensed), or medications whose use is not in accordance with the conditions of their license (off-label), in neonates in a neonatal intensive care unit (NICU). Medications given to 105 neonates were prospectively reviewed every 2 weeks during a 4-month period. The assessment as to whether every medication prescribed was unlicensed or off-label for use in children was based on a number of reference sources. Five hundred and twenty-five series of medications were used, of which 310 (59%) were off-label and 87 (16%) were unlicensed. Ninety-eight neonates (93%) received at least one off-label medication. The major reason for prescribing off-label medications was a deviation from the recommended dosage or age of the patient. The reason for giving unlicensed medications was changes in the formulation of the medication. The use of off-label and unlicensed medications is common in neonates. In view of the gravity and problematic nature of the issue, international consensus is evolving to conduct clinical trials in neonates and infants, with regard to medications already on the market, and new medications.

KEYWORD

Off-label medications - unlicensed medications - neonate - orphan drugs

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