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

Autor: Antonio Gouveia Oliveira, Haline Tereza Matias de Lima Costa, Tatiana Xavier Costa, Rand Randall Martins
Rok vydání: 2018
Předmět:
Male
Neonatal intensive care unit
Physiology
lcsh:Medicine
Off-label use
Pediatrics
Drug Licensing
Cohort Studies
0302 clinical medicine
Medicine and Health Sciences
Birth Weight
030212 general & internal medicine
lcsh:Science
Prospective cohort study
Routes of Administration
education.field_of_study
Multidisciplinary
Pharmaceutics
Drugs
Physiological Parameters
Female
Cohort study
Research Article
medicine.medical_specialty
Drug Administration
Drug Research and Development
Birth weight
Population
Cardiology
03 medical and health sciences
Drug Therapy
030225 pediatrics
Intensive care
medicine
Humans
Medical prescription
education
Pharmacology
business.industry
lcsh:R
Body Weight
Infant
Newborn
Biology and Life Sciences
Neonates
Off-Label Use
Emergency medicine
Intensive Care
Neonatal
lcsh:Q
business
Developmental Biology
Zdroj: PLoS ONE
PLoS ONE, Vol 13, Iss 9, p e0204427 (2018)
ISSN: 1932-6203
Popis: 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.
Databáze: OpenAIRE
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