[The incidence of prescriptions without marketing product license in a neonatal intensive care unit]

Arch Pediatr. 2000 Feb;7(2):143-7. doi: 10.1016/s0929-693x(00)88083-5.
[Article in French]


Most of the drugs prescribed in pediatric units have no product licence. The lack of clinical studies in children and appropriate drug formulations decrease their safety. The lack of a legal framework makes the prescriber insecure. Even if the debate is not recent, few studies have been carried out in this field. The aim of the present study was to evaluate the rate of prescriptions of unlicensed and off-label drugs in a neonatal intensive care unit.

Patients and methods: The present study was carried out in our neonatal intensive care unit, from January 12 to February 12, 1998. Forty babies aged 0 to 128 days were included (90% newborns), with a gestational age between 25 to 40 weeks (88% were premature, with a birth weight lower than 1000 g).

Results: Two hundred and fifty-seven prescriptions were administered with 55 different types of drugs during this period. Ten percent of the prescribed drugs had no product licence. Sixty-two percent were off-label for premature infants and 64% for newborns: 90% due to age, 9.3% due to dose and 0.7% to method of administration. No therapeutic alternatives to these prescriptions were found among the few available licensed drugs.

Conclusion: The prescriptions of unlicensed and off-label drugs in neonatal intensive care units are daily and repeated events. The prescribers are usually not aware of the exact status of the drug and do not realize neither he importance of the problem nor the legal and potential consequences. The lack of pediatric clinical studies is to a large extent responsible for the absence of drug registration in pediatrics. The pharmaceutical industry has few incentives to develop the pediatric product licences.

Publication types

  • English Abstract

MeSH terms

  • Age Factors
  • Chemistry, Pharmaceutical / legislation & jurisprudence
  • Drug Industry / legislation & jurisprudence
  • Drug Labeling / legislation & jurisprudence
  • Drug Prescriptions / classification*
  • France
  • Gestational Age
  • Humans
  • Incidence
  • Infant, Newborn
  • Infant, Premature
  • Infant, Very Low Birth Weight
  • Intensive Care, Neonatal / legislation & jurisprudence*
  • Legislation, Drug*
  • Pharmaceutical Preparations / administration & dosage
  • Safety


  • Pharmaceutical Preparations