Suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups.
Einstein (Sao Paulo)
; 16(4): eAO4354, 2018 Nov 08.
Article
em En, Pt
| MEDLINE
| ID: mdl-30427486
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Prescrições de Medicamentos
/
Preparações Farmacêuticas
/
Cálculos da Dosagem de Medicamento
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Uso Off-Label
Tipo de estudo:
Observational_studies
/
Prognostic_studies
Limite:
Child
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Child, preschool
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Humans
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Infant
/
Newborn
País/Região como assunto:
America do sul
/
Brasil
Idioma:
En
/
Pt
Revista:
Einstein (Sao Paulo)
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Brasil
País de publicação:
Brasil