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Please use this identifier to cite or link to this item: http://hdl.handle.net/1843/75939
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dc.creatorAdriana Cristina de Souza Gonçalvespt_BR
dc.creatorAdriano Max Moreira Reispt_BR
dc.creatorAna Carolina Gusmão Marçalpt_BR
dc.creatorMaria Cândida Ferrarez Bouzadapt_BR
dc.date.accessioned2024-09-04T15:31:26Z-
dc.date.available2024-09-04T15:31:26Z-
dc.date.issued2017-
dc.citation.volume53pt_BR
dc.citation.issue3pt_BR
dc.citation.spage1pt_BR
dc.citation.epage10pt_BR
dc.identifier.doi10.1590/s2175-97902017000300252pt_BR
dc.identifier.issn21759790pt_BR
dc.identifier.urihttp://hdl.handle.net/1843/75939-
dc.description.resumoThis 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.pt_BR
dc.format.mimetypepdfpt_BR
dc.languageengpt_BR
dc.publisherUniversidade Federal de Minas Geraispt_BR
dc.publisher.countryBrasilpt_BR
dc.publisher.departmentFAR - DEPARTAMENTO DE PRODUTOS FARMACÊUTICOSpt_BR
dc.publisher.initialsUFMGpt_BR
dc.relation.ispartofBrazilian Journal of Pharmaceutical Sciences-
dc.rightsAcesso Abertopt_BR
dc.subjectDrugs-use-University Hospital-Brazilpt_BR
dc.subjectDrug-useoff-label-unlicensedpt_BR
dc.subjectDrug therapypt_BR
dc.subjectNeonatologypt_BR
dc.subjectUniversity Hospital-Brazil.pt_BR
dc.subject.otherMedicamentos - Utilizaçãopt_BR
dc.subject.otherUso Off-Labelpt_BR
dc.subject.otherTerapia medicamentosa - Gerenciamentopt_BR
dc.subject.otherNeonatologiapt_BR
dc.subject.otherHospitais universitários - Brasilpt_BR
dc.titleUse of unlicensed and off-label drugs in neonates in a Brazilian university hospital.pt_BR
dc.typeArtigo de Periódicopt_BR
dc.url.externahttps://www.scielo.br/j/bjps/a/xdLBTgjykmnm47jHFFrDQMf/?lang=en#pt_BR
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