Use of off-label and unlicensed medicines in neonatal intensive care.

Haline Tereza Matias De Lima Costa,Rand Randall Martins,Antônio Gouveia Oliveira,Tatiana Xavier Costa,Ricardo Queiroz Gurgel

doi:10.1371/journal.pone.0204427

Haline Tereza Matias De Lima Costa, Rand Randall Martins + Show 3 more

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https://doi.org/10.1371/journal.pone.0204427

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Journal: PloS one	Publication Date: Sep 25, 2018
Citations: 53	License type: CC BY 4.0

Affiliation: Universidade Federal do Rio Grande do Norte

Abstract

PurposeTo evaluate the use of off-label and unlicensed medicines in a neonatal intensive care unit (NICU) of a teaching maternity hospital specialized in high risk pregnancy.MethodsA prospective cohort study was conducted between August 2015 and July 2016. All newborns admitted to the NICU who had at least one medication prescribed and a hospital stay longer than 24 hours were included. The classification of off-label and unlicensed drugs for the neonatal population was done according to the information of Food and Drug Administration.ResultsA total of 17421 medication items were analyzed in 3935 prescriptions of 220 newborns. The proportion of newborns exposed to off-label drugs was 96.4%, and to unlicensed medicines was 66.8%. About one-half (49.3%) of the medication items were off-label and 24.6% were unlicensed. The main reason for off-label and unlicensed classification was, respectively, frequency of administration and the administration of adaptations of pharmaceutical forms.ConclusionsAlthough there are actions to encourage the development of pharmacological studies with neonates, this study observed a high rate of prescription and exposure of newborns to off-label and unlicensed drugs in NICUs and pointed out areas of neonatal therapy that require scientific investment.

Highlights

The proportion of newborns exposed to off-label drugs was 96.4%, and to unlicensed medicines was 66.8%
There are actions to encourage the development of pharmacological studies with neonates, this study observed a high rate of prescription and exposure of newborns to offlabel and unlicensed drugs in neonatal intensive care unit (NICU) and pointed out areas of neonatal therapy that require scientific investment
Newborns represent a patient population with special concerns regarding drug therapy, because prematurity and low birth weight may have a significant effect on the pharmacokinetics and pharmacodynamics of many drugs, making the administration of medicines rather delicate [1,2]

Summary

Introduction

Newborns represent a patient population with special concerns regarding drug therapy, because prematurity and low birth weight may have a significant effect on the pharmacokinetics and pharmacodynamics of many drugs, making the administration of medicines rather delicate [1,2]. The European started the encouragement through the European (EU) Pediatric Regulation by EU Medicines Agency (EMA) and a document released in October 2017 shows a growth of medicines for children [10]. Despite this effort, the use off-label and unlicensed drugs in neonatology has been repeatedly reported in the literature [4, 5, 11,12,13,14]. Unlicensed drugs are imported medicines, contraindicated for neonatal use, as well as those that are adapted or manipulated by health care professionals to make the drug appropriated for neonates [16,17]

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