Castro Jaqueline Cristina da Silveira Xavier E, Botelho Stephanie Ferreira, Machado Taisa Roberta Lopes, Martins Maria Auxiliadora Parreiras, Vieira Liliana Batista, Reis Adriano Max Moreira
Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.
Faculdade de Ciências Farmacêuticas, Universidade Federal de Alfenas, Alfenas, MG, Brazil.
Einstein (Sao Paulo). 2018 Nov 8;16(4):eAO4354. doi: 10.31744/einstein_journal/2018AO4354.
To analyze suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups.
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.
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.
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.
分析2003年至2013年在巴西注册的新药对各儿科年龄组的适用性。
对巴西新药回顾性队列中包含的有儿科适应症的药物进行描述性研究。使用以下标准评估药物对儿科年龄组的适用性：剂型的适用性和提供推荐剂量的能力。当药物符合这两个标准时，被认为适用于儿科年龄组。统计分析包括频率和比例的计算。
在所有年龄组中，由于药物提供推荐剂量的能力而具有的适用性均大于80%。关于剂型的适用性，我们发现年龄组越大，儿科使用的适用性越高。对于以固体剂型呈现的药物，我们表明其中一半被归类为对其适用的一个或多个儿科年龄组不适用。药物对儿科年龄组的适用性在学龄前儿童中为64.3%，足月儿为66.7%，早产儿为66.7%，其他年龄组超过70%。
考虑到剂型和提供推荐剂量的能力，6岁以下儿童用药的适用性较低。根据药物注册适用的年龄组，老年组儿科用药的可获得性和比例适用性更高。
