New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health

Jaqueline Cristina da Silveira Xavier e Castro; Stephanie Ferreira Botelho; Maria Auxiliadora Parreiras Martins; Liliana Batista Vieira; Adriano Max Moreira Reis

doi:10.1590/s2175-97902020000419087

Authors

Jaqueline Cristina da Silveira Xavier e Castro Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
Stephanie Ferreira Botelho Diretoria de Medicamentos Estratégicos, Secretaria de Estado da Saúde de Minas Gerais, Belo Horizonte, Brazil
Maria Auxiliadora Parreiras Martins Departamento de Produtos Farmacêuticos, Faculdade de Farmácia da Universidade Federal de M
Liliana Batista Vieira Departamento de Alimentos e Medicamentos, Faculdade de Ciências Farmacêuticas da Universidade Federal de Alfenas, Alfenas, Brazil https://orcid.org/0000-0003-2273-5326
Adriano Max Moreira Reis Departamento de Produtos Farmacêuticos, Faculdade de Farmácia da Universidade Federal de Minas Gerais, Belo Horizonte, Brazil https://orcid.org/0000-0002-0017-7338

DOI:

https://doi.org/10.1590/s2175-97902020000419087

Keywords:

New drugs. Approval of medications. Pediatric. Safety alert. Disease burden.

Abstract

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 WHO
Drug 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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