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

Autor: Castro JCDSXE; Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil., Botelho SF; Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil., Machado TRL; Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil., Martins MAP; Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil., Vieira LB; Faculdade de Ciências Farmacêuticas, Universidade Federal de Alfenas, Alfenas, MG, Brazil., Reis AMM; Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.
Jazyk: English; Portuguese
Zdroj: Einstein (Sao Paulo, Brazil) [Einstein (Sao Paulo)] 2018 Nov 08; Vol. 16 (4), pp. eAO4354. Date of Electronic Publication: 2018 Nov 08.
DOI: 10.31744/einstein_journal/2018AO4354
Abstrakt: 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.
Databáze: MEDLINE
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