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.
Highlights
Medicines are an important health technology in child health (Kimland, Odlind, 2012)
Among the drugs registered as exclusive adult use, we identified those with potential interest for pediatric indication considering, besides the occurrence of the disease in this age group, the possibility of applying the action mechanism of the drug’s therapeutic class in clinical conditions of pediatric interest, such as, for example, drugs classified in groups B01A, C10A, GO4B, N03A, N06A, R03A; to validate this classification, the availability of clinical trials involving children with drugs of these groups in Anvisa’s and Clinical Trials’ databases was investigated (ANVISA, 2016c, NIH, 2016)
From January 2003 to December 2013, 159 new drugs were registered in Brazil
Summary
Medicines are an important health technology in child health (Kimland, Odlind, 2012). The ethical and methodological challenges related to the development of pediatric drugs, together with the pharmaceutical industry’s considerations of Health professionals committed to providing safe and quality childcare recognize the need for scientifically validated medications. In this context, there is a growing concern to encourage the development of research in the different fields of pediatric clinical pharmacology and the training of human resources for research and teaching in this area (MacLeod, 2017; MacLeod, 2015).
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