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

ABSTRACT:

Purpose

To 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.

Methods

A 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.

Results

A 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 medi

SUBMITTER: Costa HTML 

PROVIDER: S-EPMC6155521 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature