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Volume 4 Journal of Pediatric Care
ISSN: 2471-805X
Page 44
JOINT EVENT
August 06-07, 2018 Madrid, Spain
&
2nd Edition of International Conference on Adolescent Health & Medicine
18th International Conference on Pediatrics Health
Pediatrics Health 2018
&
Adolescent Health 2018
August 06-07, 2018
The extent of off-label and unlicensed drug use in neonatal intensive care units in Iran
Leila Kouti
Ahvaz Jundishapur University of Medical Sciences, Iran
The present study was designed to evaluate the use of unlicensed and off-labeled drugs in neonatal intensive care units
(NICU) of two academic hospitals in Iran. To our knowledge it is the first study done in this area in Iran. In this cross
sectional study, all neonates that had at least 24 hour NICU admission, during the first 3 months of 2016, in two different
hospitals were included in this study after their parental consent. The drugs were categorized as licensed, unlicensed and off-
labeled according to Pediatric and neonatal dosage handbook (Lexicomp® 22nd Edition). 193 patients (52.85% M, 47.15% F),
64.2% of them delivered via C-section, were included in this study. Mean gestational weight was 409±3317 g for term babies
and 1732± 621 g for preterm neonates. A total of 1049 drug orders were made for these patients (including 59 agents and 72
drug formulations). The mean number of drug orders and pharmaceutical agents for each patient were 5.44±4.08 and 4.46±2.98
respectively. Preterm neonates had a higher number of drug orders and medications (p values 0.003 and <0.001). 38.04% of
the drug orders were off-labeled (received by 85% of the neonates) and 1.91% unsilenced (used in 8% of the patients). 45% of
the off-label use was regarding the dose and 36.86%, dose interval. 60.05% of the used drugs were licensed. It seems that due
to the high rate of off-label and unlicensed drug use in NICUs, further studies regarding their safety and efficacy should be
performed.
Biography
Leila Kouti became a board certified clinical pharmacist at the age of 29 years (2009) and completed her PhD three years later, from Tehran University of Medical
Sciences. She is an assistant professor in clinical pharmacy department at Ahvaz Jundishapur University of Medical Sciences. She has published more than 20
papers in different journals.
Leila Kouti, J Pediatr Care 2018, Volume 4
DOI: 10.21767/2471-805X-C3-012