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http://hdl.handle.net/1843/75939| Type: | Artigo de Periódico |
| Title: | Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital. |
| Authors: | Adriana Cristina de Souza Gonçalves Adriano Max Moreira Reis Ana Carolina Gusmão Marçal Maria Cândida Ferrarez Bouzada |
| Abstract: | This study was designed to investigate the use of off-label and unlicensed drugs in a Neonatal Care Unit (NCU) and to compare the frequency of use of off-label drugs according to the drug regulatory agencies in Brazil (Agência Nacional de Vigilância Sanitária-ANVISA) and the United States Food and Drug Administration (FDA). A prospective observational study was carried out in the NCU. Prescriptions were classified as off-label and unlicensed using both ANVISA and FDA criteria. A total of 157 newborns and 1187 prescriptions were analyzed. The most prescribed drug was fentanyl (9.3%), followed by multivitamin (8.4%) and gentamicin (7.9%). According to ANVISA criteria, there were 665 (56.0%) off-label prescriptions and 86 (7.2%) unlicensed prescriptions and 95.5% of newborns received at least one drug off-label. By contrast, according to FDA criteria, there were 592 (49.9%) off-label prescriptions and 84 (7.1%) unlicensed prescriptions, and 72.0% of newborns received at least one drug off-label. The off-label use of drugs registered by ANVISA differed significantly from that of drugs registered by the FDA. There was a high frequency of off-label and unlicensed drug use in the investigated NCU, and there was an inverse relationship between off-label and unlicensed usage and the gestational age of the newborns. |
| Subject: | Medicamentos - Utilização Uso Off-Label Terapia medicamentosa - Gerenciamento Neonatologia Hospitais universitários - Brasil |
| language: | eng |
| metadata.dc.publisher.country: | Brasil |
| Publisher: | Universidade Federal de Minas Gerais |
| Publisher Initials: | UFMG |
| metadata.dc.publisher.department: | FAR - DEPARTAMENTO DE PRODUTOS FARMACÊUTICOS |
| Rights: | Acesso Aberto |
| metadata.dc.identifier.doi: | 10.1590/s2175-97902017000300252 |
| URI: | http://hdl.handle.net/1843/75939 |
| Issue Date: | 2017 |
| metadata.dc.url.externa: | https://www.scielo.br/j/bjps/a/xdLBTgjykmnm47jHFFrDQMf/?lang=en# |
| metadata.dc.relation.ispartof: | Brazilian Journal of Pharmaceutical Sciences |
| Appears in Collections: | Artigo de Periódico |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital.pdf | 291.93 kB | Adobe PDF | View/Open |
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