Off-Label Prescribing: Scientific Analysis Taking the Use of Bevacizumab in Ophthalmology as an Example
Autor(a) principal: | |
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Data de Publicação: | 2013 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3946 |
Resumo: | Off-label prescribing poses specific technical/scientific, professional and ethical problems. In this study we carry out a technical and scientific analysis of the off-label prescribing using a current, clinical and economically relevant example: the paradigmatic case of the use of bevacizumab in ophthalmologic pathologies for which it has no formal indication. We conducted a systematic review of the literature on the efficacy and safety of this drug, as well as ranibizumab - which has approved ophthalmologic indications, in order to qualitatively analyze the available evidence on the two interventions. This is a typical case for technical and scientific analysis of the off-label prescribing problems. According to the results of the systematic review, the use of bevacizumab in this context has in fact scientific evidence of appreciable size, including clinical trials head-to-head with ranibizumab. However, the identified safety issues raise the question of the use of this drug in ophthalmologic pathologies. The different players involved in the treatment decisions (physicians, patients and institutional decision makers) should be adequately informed about the existing evidence that supports off-label prescribing which, by definition, must always be on an exceptional basis and properly justified. |
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Off-Label Prescribing: Scientific Analysis Taking the Use of Bevacizumab in Ophthalmology as an ExamplePrescrição Off-Label: Análise Científica tendo como Exemplo a Utilização de Bevacizumab em OftalmologiaOff-label prescribing poses specific technical/scientific, professional and ethical problems. In this study we carry out a technical and scientific analysis of the off-label prescribing using a current, clinical and economically relevant example: the paradigmatic case of the use of bevacizumab in ophthalmologic pathologies for which it has no formal indication. We conducted a systematic review of the literature on the efficacy and safety of this drug, as well as ranibizumab - which has approved ophthalmologic indications, in order to qualitatively analyze the available evidence on the two interventions. This is a typical case for technical and scientific analysis of the off-label prescribing problems. According to the results of the systematic review, the use of bevacizumab in this context has in fact scientific evidence of appreciable size, including clinical trials head-to-head with ranibizumab. However, the identified safety issues raise the question of the use of this drug in ophthalmologic pathologies. The different players involved in the treatment decisions (physicians, patients and institutional decision makers) should be adequately informed about the existing evidence that supports off-label prescribing which, by definition, must always be on an exceptional basis and properly justified.A prescrição off-label levanta problemas técnicos/científicos, profissionais e éticos específicos. No presente trabalho, procurámos realizar uma análise técnico-científica da prescrição off-label recorrendo a um exemplo atual, clinica e economicamente relevante: o caso paradigmático da utilização de bevacizumab em patologias do foro oftalmológico para as quais não tem indicação formal aprovada. Para tal realizámos uma revisão sistemática da literatura sobre a eficácia e segurança deste medicamento, assim como de ranibizumab– o qual tem indicações oftalmológicas aprovadas, no sentido de analisar qualitativamente a evidência científica disponível sobreas duas intervenções. Este caso é exemplar para análise técnico-científica dos problemas da prescrição off-label, já que, de acordo com os resultados da revisão sistemática realizada, o uso do bevacizumab neste contexto possui, de facto, evidência científica de dimensão apreciável, incluindo ensaios clínicos head-to-head com ranibizumab. No entanto, os problemas de segurança identificados levantam a questão da utilização deste fármaco nas patologias oftalmológicas. Os diferentes agentes que participam no processo de decisão terapêutica (médicos, doentes e decisores institucionais) devem estar adequadamente informados sobre a evidência existente que suporta a prescrição off-label, a qual, por definição, deve ser sempre de caracter excecional e devidamente justificada.Ordem dos Médicos2013-08-30info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfapplication/vnd.openxmlformats-officedocument.wordprocessingml.documenthttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3946oai:ojs.www.actamedicaportuguesa.com:article/3946Acta Médica Portuguesa; Vol. 26 No. 4 (2013): July-August; 409-419Acta Médica Portuguesa; Vol. 26 N.º 4 (2013): Julho-Agosto; 409-4191646-07580870-399Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPporhttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3946https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3946/3715https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3946/6885Alarcão, JoanaCosta, JoãoFareleira, FilipaBorges, MargaridaCarneiro, António Vazinfo:eu-repo/semantics/openAccess2022-12-20T11:03:09Zoai:ojs.www.actamedicaportuguesa.com:article/3946Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T16:18:39.734109Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Off-Label Prescribing: Scientific Analysis Taking the Use of Bevacizumab in Ophthalmology as an Example Prescrição Off-Label: Análise Científica tendo como Exemplo a Utilização de Bevacizumab em Oftalmologia |
title |
Off-Label Prescribing: Scientific Analysis Taking the Use of Bevacizumab in Ophthalmology as an Example |
spellingShingle |
Off-Label Prescribing: Scientific Analysis Taking the Use of Bevacizumab in Ophthalmology as an Example Alarcão, Joana |
title_short |
Off-Label Prescribing: Scientific Analysis Taking the Use of Bevacizumab in Ophthalmology as an Example |
title_full |
Off-Label Prescribing: Scientific Analysis Taking the Use of Bevacizumab in Ophthalmology as an Example |
title_fullStr |
Off-Label Prescribing: Scientific Analysis Taking the Use of Bevacizumab in Ophthalmology as an Example |
title_full_unstemmed |
Off-Label Prescribing: Scientific Analysis Taking the Use of Bevacizumab in Ophthalmology as an Example |
title_sort |
Off-Label Prescribing: Scientific Analysis Taking the Use of Bevacizumab in Ophthalmology as an Example |
author |
Alarcão, Joana |
author_facet |
Alarcão, Joana Costa, João Fareleira, Filipa Borges, Margarida Carneiro, António Vaz |
author_role |
author |
author2 |
Costa, João Fareleira, Filipa Borges, Margarida Carneiro, António Vaz |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Alarcão, Joana Costa, João Fareleira, Filipa Borges, Margarida Carneiro, António Vaz |
description |
Off-label prescribing poses specific technical/scientific, professional and ethical problems. In this study we carry out a technical and scientific analysis of the off-label prescribing using a current, clinical and economically relevant example: the paradigmatic case of the use of bevacizumab in ophthalmologic pathologies for which it has no formal indication. We conducted a systematic review of the literature on the efficacy and safety of this drug, as well as ranibizumab - which has approved ophthalmologic indications, in order to qualitatively analyze the available evidence on the two interventions. This is a typical case for technical and scientific analysis of the off-label prescribing problems. According to the results of the systematic review, the use of bevacizumab in this context has in fact scientific evidence of appreciable size, including clinical trials head-to-head with ranibizumab. However, the identified safety issues raise the question of the use of this drug in ophthalmologic pathologies. The different players involved in the treatment decisions (physicians, patients and institutional decision makers) should be adequately informed about the existing evidence that supports off-label prescribing which, by definition, must always be on an exceptional basis and properly justified. |
publishDate |
2013 |
dc.date.none.fl_str_mv |
2013-08-30 |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3946 oai:ojs.www.actamedicaportuguesa.com:article/3946 |
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https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3946 |
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oai:ojs.www.actamedicaportuguesa.com:article/3946 |
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por |
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https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3946 https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3946/3715 https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3946/6885 |
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info:eu-repo/semantics/openAccess |
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openAccess |
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application/pdf application/vnd.openxmlformats-officedocument.wordprocessingml.document |
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Ordem dos Médicos |
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Ordem dos Médicos |
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Acta Médica Portuguesa; Vol. 26 No. 4 (2013): July-August; 409-419 Acta Médica Portuguesa; Vol. 26 N.º 4 (2013): Julho-Agosto; 409-419 1646-0758 0870-399X reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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