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O-102 Analyses Of Current Unlicensed And Off-label For Age Drug Prescriptions At A Neonatal Intensive Care Unit
  1. RB Flint1,
  2. SHP Simons1,
  3. DM Burger2,
  4. R de Groot3,
  5. IKM Reiss4,
  6. D Tibboel5
  1. 1Neonatology, Erasmus University Medical Center – Sophia Children’s Hospital, Rotterdam, Netherlands
  2. 2Pharmacy, RadboutUMC, Nijmegen, Netherlands
  3. 3Pediatrics, Radbout University Medical Center, Nijmegen, Netherlands
  4. 4Neonatology, ErasmusMC Sophia Children’s Hospital, Rotterdam, Netherlands
  5. 5Intensive Care and Pediatric Surgery, ErasmusMC Sophia Children’s Hospital, Rotterdam, Netherlands


Background and aims Treatment of critically ill and preterm neonates includes the use of multiple drugs. Many drugs are unlicensed for children or used off-label. Recent changes of drug legislation by FDA and EMA should encourage more drug research in children. We aimed to study the current drugs used in a neonatal intensive care unit.

Methods All drug prescriptions at the level III NICU of Erasmus MC from January 2007 till June 2013 were retrieved from the patient data management system. The product license of each drug was used to judge the label for use in neonatal age.

Results A total of 4,054 neonates (2,240 males) with a median gestational age of 32+0 (range 23+6–42+2) weeks and a bodyweight at admission of median 1.8 (range 0.36–5.4) kg, were included. Most frequently administered drugs were benzyl-penicillin, gentamycin, caffeine, morphine and surfactant. Of the 24,903 prescriptions, 7,948 (32%) were off-label for neonatal age, and 1,932 (8%) were unlicensed for children.

Conclusion The availability of adequately licensed drugs still shows important shortcomings. Almost all CNS drugs were off-label for neonatal age (93%) although few unlicensed for use in children (7%). On the other hand most antimicrobial drugs were on label (7%). We believe that drug research in neonates should have high priority to access safe and appropriate medicines.

Abstract O-102 Table 1

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