Suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups

Abstract

Objective To analyze suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups.Methods A descriptive study of drugs with pediatric indication included in a retrospective cohort of new drugs registered in Brazil. The evaluation of drug suitability for the pediatric age group was performed using the following criteria: suitability of dosage form and capacity to deliver the recommended dose. The drugs were considered adequate for the pediatric age groups when they met both criteria. The statistical analysis included calculation of frequencies and proportions.Results Suitability due to the drug capacity to deliver the recommended dose was greater than 80% across all age groups. Regarding suitability of the dosage form, we identified that the older the age group, the greater suitability for pediatric use. Concerning the drugs presented in solid dosage form, we showed that half were classified as inadequate for one or more pediatric age groups to whom they were indicated. The adequacy of drugs to the pediatric age group was 64.3% for preschool children, 66.7% for full-term newborns, 66.7% for premature newborns, and over 70% for other age groups.Conclusion Drugs for children aged under 6 years were less often adequate, considering the dosage form and capacity to provide the recommended dose. The availability and proportional suitability of medicines for pediatric use are greater for older age groups, according to age groups the drug is registered for.

Compounded medications for cardiovascular use in neonatology: an integrative review

“…This approach takes into account the adaptability of oral liquid dosage forms with regard to their cost-effectiveness and the suitability of this form concerning the anatomical and physiological immaturity of the neonate. This approach has already been used by Castro et al, 33 and the authors highlighted the need to also evaluate data on toxicity of excipients to ensure that the formulation is suitable for this age group.…”

Does EU and US paediatric legislation improve the authorization availability of medicines for children in other countries?

“…Several publications suggest only limited benefit from conducted research for other countries and call for a more active position of local regulators. [34][35][36][37][38][39][40][41][42] Among the six countries selected for this study, Canada is currently in the forefront of paediatric regulatory initiatives (Table 1).…”

“…At the same time, more than 90% of the world's children reside outside of these four high‐income regions. Several publications suggest only limited benefit from conducted research for other countries and call for a more active position of local regulators 34–42 . Among the six countries selected for this study, Canada is currently in the forefront of paediatric regulatory initiatives (Table 1).…”