Quality assessment of similar, generic and reference drugs sold in Brazil: a literature review

Detalhes bibliográficos
Autor(a) principal: Santos, Talles de Sousa
Data de Publicação: 2020
Outros Autores: Souza, Osmar Galvão Bispo de, Melo Neto, Bernardo, Sousa, Paulo Victor Amorim de
Tipo de documento: Artigo
Idioma: por
Título da fonte: Research, Society and Development
Texto Completo: https://rsdjournal.org/index.php/rsd/article/view/4355
Resumo: Eventually, there are reports of inadequacies in relation to the quality of medicines, and there are still doubts regarding the quality and effectiveness of similar and generic medicines compared to reference medicines. Therefore, this study aimed to investigate in the literature, studies that deal with the quality of similar, generic and reference drugs sold in Brazil. To carry out the present study, a bibliographic survey was carried out in the Medline, Lilacs, Scielo and VHL databases, of articles published in the period from 2015 to 2020, in English and Portuguese that fit the inclusion and exclusion criteria, 10 were selected articles. In all studies, the authors unanimously concluded that most generic and similar drugs sold in Brazil have the same quality profile and can be safely inserted by patients. Therefore, this review demonstrates that generic drugs have the same therapeutic quality and efficacy as reference drugs. However, some authors have shown that similar drugs, despite undergoing quality tests to be released on the market, do not meet the criteria of quality and efficacy when compared to generic or reference drugs.
id UNIFEI_185c1a0f8ea459af25ea8f1b1fc05081
oai_identifier_str oai:ojs.pkp.sfu.ca:article/4355
network_acronym_str UNIFEI
network_name_str Research, Society and Development
repository_id_str
spelling Quality assessment of similar, generic and reference drugs sold in Brazil: a literature reviewEvaluación de calidad de medicamentos similares, genéricos y de referência vendidos en Brasil: una revisión de la literaturaAvaliação da qualidade de medicamentos similar, genérico e referência vendidos no Brasil: Uma revisão de literaturaControl de calidadMedicinasEquivalencia terapéutica.Controle de QualidadeMedicamentosEquivalência Terapêutica.Quality controlMedicinesTherapeutic equivalence.Eventually, there are reports of inadequacies in relation to the quality of medicines, and there are still doubts regarding the quality and effectiveness of similar and generic medicines compared to reference medicines. Therefore, this study aimed to investigate in the literature, studies that deal with the quality of similar, generic and reference drugs sold in Brazil. To carry out the present study, a bibliographic survey was carried out in the Medline, Lilacs, Scielo and VHL databases, of articles published in the period from 2015 to 2020, in English and Portuguese that fit the inclusion and exclusion criteria, 10 were selected articles. In all studies, the authors unanimously concluded that most generic and similar drugs sold in Brazil have the same quality profile and can be safely inserted by patients. Therefore, this review demonstrates that generic drugs have the same therapeutic quality and efficacy as reference drugs. However, some authors have shown that similar drugs, despite undergoing quality tests to be released on the market, do not meet the criteria of quality and efficacy when compared to generic or reference drugs.Finalmente, hay informes de deficiencias en relación con la calidad de los medicamentos, y todavía hay dudas con respecto a la calidad y la eficacia de medicamentos similares y genéricos en comparación con los medicamentos de referencia. Por lo tanto, este estudio tuvo como objetivo investigar en la literatura estudios relacionados con la calidad de medicamentos similares, genéricos y de referencia vendidos en Brasil. Para llevar a cabo el presente estudio, se realizó una encuesta bibliográfica en las bases de datos Medline, Lilacs, Scielo y BVS, de artículos publicados en el período de 2015 a 2020, en inglés y portugués que se ajustaban a los criterios de inclusión y exclusión, se seleccionaron 10 artículos En todos los estudios, los autores concluyeron por unanimidad que la mayoría de los medicamentos genéricos y similares vendidos en Brasil tienen el mismo perfil de calidad y los pacientes pueden insertarlos de manera segura. Por lo tanto, esta revisión demuestra que los medicamentos genéricos tienen la misma calidad terapéutica y eficacia que los medicamentos de referencia. Sin embargo, algunos autores han demostrado que medicamentos similares, a pesar de someterse a pruebas de calidad para ser lanzados al mercado, no cumplen con los criterios de calidad y eficacia en comparación con los medicamentos genéricos o de referencia.Eventualmente existem relatos de inadequações em relação a qualidade de medicamentos, havendo ainda dúvidas em relação a qualidade e a eficácia de medicamentos similares e genéricos em comparação com medicamentos de referência. Diante disso, este estudo teve como objetivo investigar na literatura, estudos que tratem da qualidade de medicamentos similares, genérico e de referência vendidos no Brasil. Para realização do presente estudo foi realizado um levantamento bibliográfico nas bases de dados Medline, Lilacs, Scielo e BVS, de artigos publicados no período de 2015 a 2020, nos idiomas inglês e português que se adequassem aos critérios de inclusão e exclusão, foram selecionados 10 artigos. Em todos os estudos, os autores concluem de forma unanime que a maioria dos medicamentos genéricos e similares vendidos no brasil, possuem o mesmo perfil de qualidade e podem ser intercalados de forma segura pelos pacientes. Portanto, esta revisão demonstra que os medicamentos genéricos possuem a mesma qualidade e eficácia terapêutica que os medicamentos de referência. Entretanto, alguns autores demonstraram que os medicamentos similares, apesar de passarem por testes de qualidade para serem liberados no mercado, não cumprem os critérios de qualidade e eficácia se comparados com medicamentos genéricos ou de referência.Research, Society and Development2020-05-25info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://rsdjournal.org/index.php/rsd/article/view/435510.33448/rsd-v9i7.4355Research, Society and Development; Vol. 9 No. 7; e534974355Research, Society and Development; Vol. 9 Núm. 7; e534974355Research, Society and Development; v. 9 n. 7; e5349743552525-3409reponame:Research, Society and Developmentinstname:Universidade Federal de Itajubá (UNIFEI)instacron:UNIFEIporhttps://rsdjournal.org/index.php/rsd/article/view/4355/3771Copyright (c) 2020 Talles Sousa Santos, Osmar Galvão Bispo de Souza, Bernardo Melo Neto, Paulo Victor Amorim de Sousainfo:eu-repo/semantics/openAccessSantos, Talles de SousaSouza, Osmar Galvão Bispo deMelo Neto, BernardoSousa, Paulo Victor Amorim de2020-08-20T18:05:03Zoai:ojs.pkp.sfu.ca:article/4355Revistahttps://rsdjournal.org/index.php/rsd/indexPUBhttps://rsdjournal.org/index.php/rsd/oairsd.articles@gmail.com2525-34092525-3409opendoar:2024-01-17T09:28:14.444539Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)false
dc.title.none.fl_str_mv Quality assessment of similar, generic and reference drugs sold in Brazil: a literature review
Evaluación de calidad de medicamentos similares, genéricos y de referência vendidos en Brasil: una revisión de la literatura
Avaliação da qualidade de medicamentos similar, genérico e referência vendidos no Brasil: Uma revisão de literatura
title Quality assessment of similar, generic and reference drugs sold in Brazil: a literature review
spellingShingle Quality assessment of similar, generic and reference drugs sold in Brazil: a literature review
Santos, Talles de Sousa
Control de calidad
Medicinas
Equivalencia terapéutica.
Controle de Qualidade
Medicamentos
Equivalência Terapêutica.
Quality control
Medicines
Therapeutic equivalence.
title_short Quality assessment of similar, generic and reference drugs sold in Brazil: a literature review
title_full Quality assessment of similar, generic and reference drugs sold in Brazil: a literature review
title_fullStr Quality assessment of similar, generic and reference drugs sold in Brazil: a literature review
title_full_unstemmed Quality assessment of similar, generic and reference drugs sold in Brazil: a literature review
title_sort Quality assessment of similar, generic and reference drugs sold in Brazil: a literature review
author Santos, Talles de Sousa
author_facet Santos, Talles de Sousa
Souza, Osmar Galvão Bispo de
Melo Neto, Bernardo
Sousa, Paulo Victor Amorim de
author_role author
author2 Souza, Osmar Galvão Bispo de
Melo Neto, Bernardo
Sousa, Paulo Victor Amorim de
author2_role author
author
author
dc.contributor.author.fl_str_mv Santos, Talles de Sousa
Souza, Osmar Galvão Bispo de
Melo Neto, Bernardo
Sousa, Paulo Victor Amorim de
dc.subject.por.fl_str_mv Control de calidad
Medicinas
Equivalencia terapéutica.
Controle de Qualidade
Medicamentos
Equivalência Terapêutica.
Quality control
Medicines
Therapeutic equivalence.
topic Control de calidad
Medicinas
Equivalencia terapéutica.
Controle de Qualidade
Medicamentos
Equivalência Terapêutica.
Quality control
Medicines
Therapeutic equivalence.
description Eventually, there are reports of inadequacies in relation to the quality of medicines, and there are still doubts regarding the quality and effectiveness of similar and generic medicines compared to reference medicines. Therefore, this study aimed to investigate in the literature, studies that deal with the quality of similar, generic and reference drugs sold in Brazil. To carry out the present study, a bibliographic survey was carried out in the Medline, Lilacs, Scielo and VHL databases, of articles published in the period from 2015 to 2020, in English and Portuguese that fit the inclusion and exclusion criteria, 10 were selected articles. In all studies, the authors unanimously concluded that most generic and similar drugs sold in Brazil have the same quality profile and can be safely inserted by patients. Therefore, this review demonstrates that generic drugs have the same therapeutic quality and efficacy as reference drugs. However, some authors have shown that similar drugs, despite undergoing quality tests to be released on the market, do not meet the criteria of quality and efficacy when compared to generic or reference drugs.
publishDate 2020
dc.date.none.fl_str_mv 2020-05-25
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/4355
10.33448/rsd-v9i7.4355
url https://rsdjournal.org/index.php/rsd/article/view/4355
identifier_str_mv 10.33448/rsd-v9i7.4355
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://rsdjournal.org/index.php/rsd/article/view/4355/3771
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 Research, Society and Development
publisher.none.fl_str_mv Research, Society and Development
dc.source.none.fl_str_mv Research, Society and Development; Vol. 9 No. 7; e534974355
Research, Society and Development; Vol. 9 Núm. 7; e534974355
Research, Society and Development; v. 9 n. 7; e534974355
2525-3409
reponame:Research, Society and Development
instname:Universidade Federal de Itajubá (UNIFEI)
instacron:UNIFEI
instname_str Universidade Federal de Itajubá (UNIFEI)
instacron_str UNIFEI
institution UNIFEI
reponame_str Research, Society and Development
collection Research, Society and Development
repository.name.fl_str_mv Research, Society and Development - Universidade Federal de Itajubá (UNIFEI)
repository.mail.fl_str_mv rsd.articles@gmail.com
_version_ 1797052649901654016

Registros relacionados