Use este identificador para citar ou linkar para este item: http://bibliotecadigital.anvisa.gov.br/jspui/handle/anvisa/1685
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dc.rights.licenseEscolha o acesso:::ACESSO ABERTO (CC BY-NC-ND 4.0) - A Regulação Autoral da Biblioteca Digital da Anvisa permite o reconhecimento da produção intelectual como sendo de acesso aberto, adotando-se assim, a Creative Commons Attribution-NonCommercial-NonDerivates 4.0 International. Concedendo a outros que realizem o download e compartilhamento da produção intelectual desde que atribuam crédito ao autor, mas sem que possam alterá-los de nenhuma forma ou utilizá-los para fins comerciais.pt_BR
dc.contributor.authorSilva, Ricardo Eccard da-
dc.contributor.authorLima, Elisangela da Costa-
dc.contributor.authorNovaes, Maria Rita C. G.-
dc.contributor.authorOsorio-de-Castro, Claudia G. S.-
dc.date.accessioned2022-09-06T18:32:48Z-
dc.date.available2022-09-06T18:32:48Z-
dc.date.issued2020-05-19-
dc.identifier.issn1663-9812-
dc.identifier.urihttp://bibliotecadigital.anvisa.ibict.br/jspui/handle/anvisa/1685-
dc.description.abstractBackground: Brazilian patients have legal right to access unlicensed medicines undergoing clinical research, if there is evidence of efficacy and safety. This study investigated the occurrence of serious adverse events related to very high-cost medicines from clinical studies, expanded access and compassionate use programs, obtained by patients though health litigation. Methods: A descriptive study using secondary data investigated unlicensed medicines obtained through lawsuits from 2010 to 2017, costing more than 1 million Brazilian reais (BRL), adjusted by the Brazilian Consumer Index to July 2017. Data sources were the Brazilian Health Surveillance Agency Registry (DATAVISA) and Adverse Events in Clinical Studies (NotivisaEC) Databases. Medicines were categorized by the Anatomical Therapeutic Chemical classification to level 03 and events by the WHO Adverse Drug Reaction Terminology. The study received ethical approval by the University of Brasilia Institutional Research Board. Results: In the period, 812 drugs were obtained through litigation, and of these, 78 exceeded cost of 1 million BRL; 44 of them presented reports of 1,248 serious adverse events. Total Brazilian Government expenditure with these drugs was 3.2 billion BRL. Class L04A (n=7) showed greater expenditures (over 1.8 billion BRL). One hundred ninety-six deaths occurred and L01X was the most involved category (49.5%). Most other serious events (n=419) and sequelae (n=10) were related to L01X. Conclusion: Very high-cost drugs paid for by the government and obtained through health litigation presented deaths and serious adverse events in expanded access and compassionate use programs in Brazil.pt_BR
dc.language.isoenpt_BR
dc.titleThe high "cost" of experimental drugs obtained through health litigation in Brazilpt_BR
dc.typeArtigopt_BR
dc.rights.holderRicardo Eccard da Silvapt_BR
dc.rights.holderElisangela da Costa Limapt_BR
dc.rights.holderMaria Rita C. G. Novaespt_BR
dc.rights.holderClaudia G. S. Osorio-de-Castropt_BR
dc.identifier.doihttps://doi.org/10.3389/fphar.2020.00752-
dc.local[Lausanne]pt_BR
dc.description.physical7 p.pt_BR
dc.description.additionalReceived: 28 January 2020 -- Accepted: 06 May 2020 -- Published: 19 May 2020pt_BR
dc.description.additionalComo citar: SILVA, Ricardo Eccard da; LIMA, Elisangela da Costa; NOVAES, Maria Rita C. G.; OSORIO-DE-CASTRO, Claudia G. S. The high "cost" of experimental drugs obtained throught health litigation in Brazil. Frontiers in Pharmacology, [Lausanne], v. 11, article 752, May 2020. DOI 10.3389/fphar.2020.00752. Disponível em: https://www.frontiersin.org/articles/10.3389/fphar.2020.00752/full. Acesso em: 6 set. 2022.pt_BR
dc.subject.keywordLitigationpt_BR
dc.subject.keywordClinical trialspt_BR
dc.subject.keywordCompassionate usept_BR
dc.subject.keywordExpanded accesspt_BR
dc.subject.keywordAdverse drug eventpt_BR
dc.subject.keywordLitígiospt_BR
dc.subject.keywordENSAIOS CLÍNICOSpt_BR
dc.subject.keywordUso compassivopt_BR
dc.subject.keywordAcesso expandidopt_BR
dc.subject.keywordEventos adversos a medicamentospt_BR
dc.rights.accessAcesso Abertopt_BR
dc.itemdestaqueNãopt_BR
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