New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Brazilian Journal of Pharmaceutical Sciences |
Texto Completo: | https://www.revistas.usp.br/bjps/article/view/204033 |
Resumo: | This study aims to analyze the new drugs registered in Brazil from 2003 to 2013 from the perspective of childcare needs, drug safety and considering the disease burden of the country. This is a retrospective cohort study including new drugs registered in Brazil between 2003 and 2013. Drug indications were related to the Disability-Adjusted Life Year (DALY) of the 2015 Global Burden of Disease Study. Association between the number of new drugs and DALY was determined by Spearman’s coefficient. Post-marketing safety alerts specific to the pediatric population have been identified in the WHODrug Information Bulletin and on websites of drug regulatory agencies. A total of 134 new drugs were included in the cohort and 46 (34.3%) had a pediatric indication. There was no evidence of an association between the disease burden in children in Brazil and the number of pediatric drugs. The safety alert data associated with the pediatric population published after registration of the new drugs were scarce. The number of new drugs launched in Brazil with a pediatric indication was small, reflecting the international challenges of developing effective and safe medicines for children. No association was found between the number of new drugs and the disease burden. |
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Brazilian Journal of Pharmaceutical Sciences |
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New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child healthNew drugs. Approval of medications. Pediatric. Safety alert. Disease burden.This study aims to analyze the new drugs registered in Brazil from 2003 to 2013 from the perspective of childcare needs, drug safety and considering the disease burden of the country. This is a retrospective cohort study including new drugs registered in Brazil between 2003 and 2013. Drug indications were related to the Disability-Adjusted Life Year (DALY) of the 2015 Global Burden of Disease Study. Association between the number of new drugs and DALY was determined by Spearman’s coefficient. Post-marketing safety alerts specific to the pediatric population have been identified in the WHODrug Information Bulletin and on websites of drug regulatory agencies. A total of 134 new drugs were included in the cohort and 46 (34.3%) had a pediatric indication. There was no evidence of an association between the disease burden in children in Brazil and the number of pediatric drugs. The safety alert data associated with the pediatric population published after registration of the new drugs were scarce. The number of new drugs launched in Brazil with a pediatric indication was small, reflecting the international challenges of developing effective and safe medicines for children. No association was found between the number of new drugs and the disease burden.Universidade de São Paulo. Faculdade de Ciências Farmacêuticas2022-11-09info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://www.revistas.usp.br/bjps/article/view/20403310.1590/s2175-97902020000419087Brazilian Journal of Pharmaceutical Sciences; Vol. 57 (2021)Brazilian Journal of Pharmaceutical Sciences; v. 57 (2021)Brazilian Journal of Pharmaceutical Sciences; Vol. 57 (2021)2175-97901984-8250reponame:Brazilian Journal of Pharmaceutical Sciencesinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/bjps/article/view/204033/187676Copyright (c) 2022 Brazilian Journal of Pharmaceutical Scienceshttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessda Silveira Xavier e Castro, Jaqueline CristinaFerreira Botelho, StephanieParreiras Martins, Maria AuxiliadoraBatista Vieira, LilianaMoreira Reis, Adriano Max2022-11-09T19:00:52Zoai:revistas.usp.br:article/204033Revistahttps://www.revistas.usp.br/bjps/indexPUBhttps://old.scielo.br/oai/scielo-oai.phpbjps@usp.br||elizabeth.igne@gmail.com2175-97901984-8250opendoar:2022-11-09T19:00:52Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)false |
dc.title.none.fl_str_mv |
New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health |
title |
New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health |
spellingShingle |
New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health da Silveira Xavier e Castro, Jaqueline Cristina New drugs. Approval of medications. Pediatric. Safety alert. Disease burden. |
title_short |
New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health |
title_full |
New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health |
title_fullStr |
New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health |
title_full_unstemmed |
New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health |
title_sort |
New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health |
author |
da Silveira Xavier e Castro, Jaqueline Cristina |
author_facet |
da Silveira Xavier e Castro, Jaqueline Cristina Ferreira Botelho, Stephanie Parreiras Martins, Maria Auxiliadora Batista Vieira, Liliana Moreira Reis, Adriano Max |
author_role |
author |
author2 |
Ferreira Botelho, Stephanie Parreiras Martins, Maria Auxiliadora Batista Vieira, Liliana Moreira Reis, Adriano Max |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
da Silveira Xavier e Castro, Jaqueline Cristina Ferreira Botelho, Stephanie Parreiras Martins, Maria Auxiliadora Batista Vieira, Liliana Moreira Reis, Adriano Max |
dc.subject.por.fl_str_mv |
New drugs. Approval of medications. Pediatric. Safety alert. Disease burden. |
topic |
New drugs. Approval of medications. Pediatric. Safety alert. Disease burden. |
description |
This study aims to analyze the new drugs registered in Brazil from 2003 to 2013 from the perspective of childcare needs, drug safety and considering the disease burden of the country. This is a retrospective cohort study including new drugs registered in Brazil between 2003 and 2013. Drug indications were related to the Disability-Adjusted Life Year (DALY) of the 2015 Global Burden of Disease Study. Association between the number of new drugs and DALY was determined by Spearman’s coefficient. Post-marketing safety alerts specific to the pediatric population have been identified in the WHODrug Information Bulletin and on websites of drug regulatory agencies. A total of 134 new drugs were included in the cohort and 46 (34.3%) had a pediatric indication. There was no evidence of an association between the disease burden in children in Brazil and the number of pediatric drugs. The safety alert data associated with the pediatric population published after registration of the new drugs were scarce. The number of new drugs launched in Brazil with a pediatric indication was small, reflecting the international challenges of developing effective and safe medicines for children. No association was found between the number of new drugs and the disease burden. |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022-11-09 |
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://www.revistas.usp.br/bjps/article/view/204033 10.1590/s2175-97902020000419087 |
url |
https://www.revistas.usp.br/bjps/article/view/204033 |
identifier_str_mv |
10.1590/s2175-97902020000419087 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://www.revistas.usp.br/bjps/article/view/204033/187676 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2022 Brazilian Journal of Pharmaceutical Sciences https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2022 Brazilian Journal of Pharmaceutical Sciences https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
dc.publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
dc.source.none.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences; Vol. 57 (2021) Brazilian Journal of Pharmaceutical Sciences; v. 57 (2021) Brazilian Journal of Pharmaceutical Sciences; Vol. 57 (2021) 2175-9790 1984-8250 reponame:Brazilian Journal of Pharmaceutical Sciences instname:Universidade de São Paulo (USP) instacron:USP |
instname_str |
Universidade de São Paulo (USP) |
instacron_str |
USP |
institution |
USP |
reponame_str |
Brazilian Journal of Pharmaceutical Sciences |
collection |
Brazilian Journal of Pharmaceutical Sciences |
repository.name.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP) |
repository.mail.fl_str_mv |
bjps@usp.br||elizabeth.igne@gmail.com |
_version_ |
1800222915665330176 |