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- Title
Use of off-label and unlicensed medicines in neonatal intensive care.
- Authors
Costa, Haline Tereza Matias de Lima; Costa, Tatiana Xavier; Martins, Rand Randall; Oliveira, Antônio Gouveia
- 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 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. Conclusions: Although 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.
- Subjects
NEONATAL intensive care; HIGH-risk pregnancy; WOMEN'S hospitals; INVESTMENTS; HOSPITAL care
- Publication
PLoS ONE, 2018, Vol 13, Issue 9, p1
- ISSN
1932-6203
- Publication type
Article
- DOI
10.1371/journal.pone.0204427