New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health
Braz. J. Pharm. Sci. (Online)
; 57: e19087, 2021. tab, graf
Article
in English
| LILACS
| ID: biblio-1345459
Responsible library:
BR40.1
Localization: BR40.1
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.
Full text:
Available
Collection:
International databases
Health context:
SDG3 - Target 3.8 Achieve universal access to health
/
SDG3 - Health and Well-Being
Health problem:
Delivery Arrangements
/
Target 3.8 Achieve universal access to health
Database:
LILACS
Main subject:
Brazil
/
Pharmaceutical Preparations
/
Drug Approval
Type of study:
Etiology study
/
Incidence study
/
Observational study
/
Prognostic study
/
Risk factors
Aspects:
Patient-preference
Country/Region as subject:
South America
/
Brazil
Language:
English
Journal:
Braz. J. Pharm. Sci. (Online)
Journal subject:
Farmacologia
/
Teraputica
/
Toxicologia
Year:
2021
Document type:
Article
Affiliation country:
Brazil
Institution/Affiliation country:
Secretaria de Estado da Saúde de Minas Gerais/BR
/
Universidade Federal de Alfenas/BR
/
Universidade Federal de Minas Gerais/BR