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. 2019 Jan 4;19(1):3.
doi: 10.1186/s12887-018-1370-x.

Pattern and extent of off-label and unlicensed drug use in neonatal intensive care units in Iran

Leila Kouti  1 , Maryam Aletayeb  2 , Seyyed Mohammad Hassan Aletayeb  3 , Amir Kamal Hardani  4 , Kaveh Eslami  1
Affiliations

Pattern and extent of off-label and unlicensed drug use in neonatal intensive care units in Iran

Leila Kouti et al. BMC Pediatr. .

Abstract

Background: Many newborns may need to be hospitalized and receive drugs during the first days of their lives. These drugs are fundamentally prescribed as off-label and unlicensed. This study aimed to investigate the amount of these kinds of drugs administered in the Neonatal Intensive Care Units (NICUs) of Abuzar and Imam Khomeini Teaching Hospitals in Ahvaz, Iran.

Methods: This was a 3-month descriptive, cross-sectional study with retrospective nature in which 193 hospitalized newborns were studied. Demographic data were extracted from the patients' files. The drugs were classified as off-label, unlicensed or licensed according to the Pediatric & Neonatal Dosage Handbook (Lexicomp®, 22nd Edition).

Results: In total, 1049 prescriptions were registered for the 193 hospitalized newborns (term and preterm). For each newborn, the mean numbers of prescriptions and drugs received were 5.4 and 4.5, respectively. The mean numbers of prescriptions and drugs were greater for preterm newborns. Of the total 1049 prescriptions, 38.1% were off-label and 1.9% were unlicensed. Of the 193 newborns, 85% received at least one off-label or unlicensed prescription. Off-label prescriptions were mostly related to dose (44.8%) and dosing interval (36.5%). Most off-label drugs were antibiotics (mainly Gentamicin). Albuterol was used off-label in 100% of the cases.

Conclusions: The results of the present study show that the prescription of off-label and unlicensed drugs in NICUs is as high in Iran as in other countries. This suggests that it is necessary to provide information to neonatologists to decrease the prescription of off-label and unlicensed drugs.

Keywords: Drug use; NICU; Newborn; Off-label; Unlicensed.

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Conflict of interest statement

Ethics approval and consent to participate

The study was reviewed and approved by the local ethics committee of the Ahvaz University of Medical sciences (IR.AJUMS.REC.13494.531). All participants were personally informed beforehand about the measurement procedure and parental written consent was obtained.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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