Off-label prescription : practice and problems
Autor(a) principal: | |
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Data de Publicação: | 2013 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10451/32134 |
Resumo: | Approval of a drug for clinical use requires production of data on efficacy and safety through submission of results from randomized controlled trials (RCTs), in which the new molecule is usually compared with placebo (or an active comparator) for a set of outcomes that will serve as the basis for the drug's indications. These indications are crucial, because drugs are approved on the basis of their net clinical benefit for specific and well-defined diseases and--importantly--only for these. Once the drug is available for use in tens or hundreds of thousands of patients, physicians may realize that some medications can be effective in diseases for which they were not approved, i.e., no studies have been presented to the regulatory authorities, and therefore they are not formally approved for those indications. Convinced of the benefits for their patients, some physicians prescribe them for unapproved indications--off-label prescription. In this paper we discuss the prevalence of off-label prescription, and its advantages and problems. |
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Off-label prescription : practice and problemsOff-label prescriptionDrug efficacy and safetyDrug indicationsDrug regulatory approval processesApproval of a drug for clinical use requires production of data on efficacy and safety through submission of results from randomized controlled trials (RCTs), in which the new molecule is usually compared with placebo (or an active comparator) for a set of outcomes that will serve as the basis for the drug's indications. These indications are crucial, because drugs are approved on the basis of their net clinical benefit for specific and well-defined diseases and--importantly--only for these. Once the drug is available for use in tens or hundreds of thousands of patients, physicians may realize that some medications can be effective in diseases for which they were not approved, i.e., no studies have been presented to the regulatory authorities, and therefore they are not formally approved for those indications. Convinced of the benefits for their patients, some physicians prescribe them for unapproved indications--off-label prescription. In this paper we discuss the prevalence of off-label prescription, and its advantages and problems.ElsevierRepositório da Universidade de LisboaCarneiro, António VazCosta, João2018-03-05T15:55:19Z20132013-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/32134engRev Port Cardiol. 2013;32(9):681-6860870-255110.1016/j.repc.2013.01.006info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-08T16:26:10Zoai:repositorio.ul.pt:10451/32134Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:47:27.324105Repositório 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 prescription : practice and problems |
title |
Off-label prescription : practice and problems |
spellingShingle |
Off-label prescription : practice and problems Carneiro, António Vaz Off-label prescription Drug efficacy and safety Drug indications Drug regulatory approval processes |
title_short |
Off-label prescription : practice and problems |
title_full |
Off-label prescription : practice and problems |
title_fullStr |
Off-label prescription : practice and problems |
title_full_unstemmed |
Off-label prescription : practice and problems |
title_sort |
Off-label prescription : practice and problems |
author |
Carneiro, António Vaz |
author_facet |
Carneiro, António Vaz Costa, João |
author_role |
author |
author2 |
Costa, João |
author2_role |
author |
dc.contributor.none.fl_str_mv |
Repositório da Universidade de Lisboa |
dc.contributor.author.fl_str_mv |
Carneiro, António Vaz Costa, João |
dc.subject.por.fl_str_mv |
Off-label prescription Drug efficacy and safety Drug indications Drug regulatory approval processes |
topic |
Off-label prescription Drug efficacy and safety Drug indications Drug regulatory approval processes |
description |
Approval of a drug for clinical use requires production of data on efficacy and safety through submission of results from randomized controlled trials (RCTs), in which the new molecule is usually compared with placebo (or an active comparator) for a set of outcomes that will serve as the basis for the drug's indications. These indications are crucial, because drugs are approved on the basis of their net clinical benefit for specific and well-defined diseases and--importantly--only for these. Once the drug is available for use in tens or hundreds of thousands of patients, physicians may realize that some medications can be effective in diseases for which they were not approved, i.e., no studies have been presented to the regulatory authorities, and therefore they are not formally approved for those indications. Convinced of the benefits for their patients, some physicians prescribe them for unapproved indications--off-label prescription. In this paper we discuss the prevalence of off-label prescription, and its advantages and problems. |
publishDate |
2013 |
dc.date.none.fl_str_mv |
2013 2013-01-01T00:00:00Z 2018-03-05T15:55:19Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10451/32134 |
url |
http://hdl.handle.net/10451/32134 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Rev Port Cardiol. 2013;32(9):681-686 0870-2551 10.1016/j.repc.2013.01.006 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Elsevier |
publisher.none.fl_str_mv |
Elsevier |
dc.source.none.fl_str_mv |
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
instname_str |
Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
instacron_str |
RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository.name.fl_str_mv |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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