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

Autor: Costa HTML; Integrated Multiprofessional Health Residency Program-Neonatal Intensive Care Unit, Pharmacy Department, Health Sciences Centre, Universidade Federal do Rio Grande do Norte, Natal, RN, Brazil., Costa TX; School Maternity Januário Cicco, Health Sciences Centre, Universidade Federal do Rio Grande Norte, Natal, RN, Brazil., Martins RR; Pharmacy Department, Health Sciences Centre, Universidade Federal do Rio Grande do Norte, Natal, RN, Brazil., Oliveira AG; Pharmacy Department, Health Sciences Centre, Universidade Federal do Rio Grande do Norte, Natal, RN, Brazil.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2018 Sep 25; Vol. 13 (9), pp. e0204427. Date of Electronic Publication: 2018 Sep 25 (Print Publication: 2018).
DOI: 10.1371/journal.pone.0204427
Abstrakt: 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.
Competing Interests: The authors have declared that no competing interests exist.
Databáze: MEDLINE
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