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

Leila Kouti,Kaveh Eslami,Seyyed Mohammad Hassan Aletayeb,Amir Kamal Hardani,Maryam Aletayeb

doi:10.1186/s12887-018-1370-x

Leila Kouti, Kaveh Eslami + Show 3 more

Open Access

https://doi.org/10.1186/s12887-018-1370-x

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Abstract

BackgroundMany 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.MethodsThis 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).ResultsIn 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.ConclusionsThe 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.

Highlights

Many newborns may need to be hospitalized and receive drugs during the first days of their lives
Given the need to reduce the prescription of off-label and unlicensed drugs in Neonatal Intensive Care Unit (NICU) revealed by previous studies, and the available information indicating a lack of such studies in Iran, we aimed to evaluate the extent of off-label and unlicensed drugs prescribed to neonates admitted to the NICUs of two Teaching Hospitals in Ahvaz, Iran and to compare the results between preterm and term neonates
Regarding the type of delivery, 64.2% of neonates were born via cesarean section (C/S)

Summary

Introduction

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. In the newborn period, which is generally defined as the first 28 days of life, hospitalized newborns need to receive multiple medications to survive. Many of these medications can be used in older children and adults, but due to the unique physiology of neonates, the pharmacokinetic findings of drugs in older patients cannot be generalized to this group. One of the concerns associated with this issue is the use of off-label and unlicensed drugs in this age group [4]

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