| Registro completo |
| Provedor de dados: |
60
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| País: |
Brazil
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| Título: |
Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital
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| Autores: |
Gonçalves,Adriana Cristina de Souza
Reis,Adriano Max Moreira
Marçal,Ana Carolina Gusmão
Bouzada,Maria Cândida Ferrarez
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| Data: |
2017-01-01
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| Ano: |
2017
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| Palavras-chave: |
Drugs/use/University Hospital/Brazil
Drug/use/off-label/unlicensed
Drug therapy
Neonatology
University Hospital/Brazil.
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| Resumo: |
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.
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| Tipo: |
Info:eu-repo/semantics/article
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| Idioma: |
Inglês
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| Identificador: |
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502017000300622
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| Editor: |
Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
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| Relação: |
10.1590/s2175-97902017000300252
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| Formato: |
text/html
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| Fonte: |
Brazilian Journal of Pharmaceutical Sciences v.53 n.3 2017
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| Direitos: |
info:eu-repo/semantics/openAccess
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