Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil

Detalhes bibliográficos
Autor(a) principal: Santos, Djanilson Barbosa
Data de Publicação: 2008
Outros Autores: Clavenna, Antonio, Bonati, Maurizio, Coelho, Helena Lutescia Luna
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFBA
Texto Completo: http://www.repositorio.ufba.br/ri/handle/ri/6003
Resumo: Acesso restrito: Texto completo. p. 1111-1118.
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spelling Santos, Djanilson BarbosaClavenna, AntonioBonati, MaurizioCoelho, Helena Lutescia LunaSantos, Djanilson BarbosaClavenna, AntonioBonati, MaurizioCoelho, Helena Lutescia Luna2012-05-30T19:51:52Z20080031-6970http://www.repositorio.ufba.br/ri/handle/ri/6003v. 64, n. 11Acesso restrito: Texto completo. p. 1111-1118.Objectives To investigate the use of drugs, the extent and pattern of unlicensed and off-label use, and the potential relationship between off-label drug use and adverse drug reactions in northeastern Brazil. Methods A follow-up study of drug utilization in a general ward of a pediatric reference hospital, involving patients hospitalized for more than 24 h. Prescriptions and medical records were reviewed daily from August to December 2001. Drug licensing status of all prescriptions given to these patients was determined. Results A total of 272 patients were admitted during the study, 265 (97.4%) of whom received one or more drugs. The median number of drugs/patient was 6 (1–18), and the most frequent diagnosis was pneumonia (29.4% of patients). The therapeutic class most prescribed was antiinfectives for systemic use (68.8% of all children). In all, 82.6% of children received at least one unlicensed or offlabel drug, and 17% received both an unlicensed and an off-label drug. Dose/frequency was the most common form of off-label drug use. Off-label drug use was significantly associated with adverse drug reactions (relative risk 2.44; 95% CI 2.12, 2.89). Conclusions Although off-label drug use is a complex issue and is not synonymous with inappropriate drug use, a high rate of unlicensed/off-label drug use was found and was also associated with an increased risk of adverse drug reactions. More efforts are needed to increase rational drug use in children.Submitted by JURANDI DE SOUZA SILVA (jssufba@hotmail.com) on 2012-05-30T19:51:52Z No. of bitstreams: 1 __www.springerlink.com_c...yxv135w602750g63_fulltext.pdf: 146167 bytes, checksum: 84bbfdcb1ad4e3e5130792812e689964 (MD5)Made available in DSpace on 2012-05-30T19:51:52Z (GMT). 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dc.title.pt_BR.fl_str_mv Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil
dc.title.alternative.pt_BR.fl_str_mv EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
title Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil
spellingShingle Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil
Santos, Djanilson Barbosa
Pharmacoepidemiology
Drug utilization
Hospitalized children
Off-label
Unlicensed
Pediatrics
title_short Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil
title_full Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil
title_fullStr Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil
title_full_unstemmed Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil
title_sort Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil
author Santos, Djanilson Barbosa
author_facet Santos, Djanilson Barbosa
Clavenna, Antonio
Bonati, Maurizio
Coelho, Helena Lutescia Luna
author_role author
author2 Clavenna, Antonio
Bonati, Maurizio
Coelho, Helena Lutescia Luna
author2_role author
author
author
dc.contributor.author.fl_str_mv Santos, Djanilson Barbosa
Clavenna, Antonio
Bonati, Maurizio
Coelho, Helena Lutescia Luna
Santos, Djanilson Barbosa
Clavenna, Antonio
Bonati, Maurizio
Coelho, Helena Lutescia Luna
dc.subject.por.fl_str_mv Pharmacoepidemiology
Drug utilization
Hospitalized children
Off-label
Unlicensed
Pediatrics
topic Pharmacoepidemiology
Drug utilization
Hospitalized children
Off-label
Unlicensed
Pediatrics
description Acesso restrito: Texto completo. p. 1111-1118.
publishDate 2008
dc.date.issued.fl_str_mv 2008
dc.date.accessioned.fl_str_mv 2012-05-30T19:51:52Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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status_str publishedVersion
dc.identifier.uri.fl_str_mv http://www.repositorio.ufba.br/ri/handle/ri/6003
dc.identifier.issn.none.fl_str_mv 0031-6970
dc.identifier.number.pt_BR.fl_str_mv v. 64, n. 11
identifier_str_mv 0031-6970
v. 64, n. 11
url http://www.repositorio.ufba.br/ri/handle/ri/6003
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
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