我国儿童急需但缺乏的基本药物剂型和规格的遴选

The Selection of Dosage Forms and Specifications of Essential Medicines in Urgent Need and Deficient for Chinese Children

目的遴选儿童用基本药物国外已上市但国内缺乏、儿童适宜且临床急需的剂型、规格。方法依据国内外现存的权威文件,结合专家咨询法,自拟儿童用基本药物品种、适宜剂型、适宜规格遴选标准,临床需求类型分类、需求程度分级标准,分类分级遴选。结果遴选出儿童用基本药物国外上市但国内缺乏、儿童适宜且临床急需的剂型、规格清单,含药物品种61个、剂型20个、规格112个,112个品规包括Ⅰ级需求(即十分急需)0个,Ⅱ级需求(即急需)27个,Ⅲ级需求(即一般急需)85个。结论可将27个Ⅱ级需求药物品规纳入我国儿童药物申报审评专门通道。

Objective To build the list of appropriate dosage forms and specifications of essential medicines for children which is subsistent abroad and absent in China. Methods Based on the authoritative data and expert consultation, we established the selection methodology which included the standard of essential medicine for children, the standard of appropriate dosage for children, the standard of appropriate specifications for children, the standard of urgent classification, the standard of urgent level. Results The list of appropriate dosage forms and specifications included 61 medicines which included 20 dosage forms and 112 specifications. 112 specifications included 27 specifications which belong to level II, and 85 specifications which belong to level III. Conclusion The established list can be included by the green channel.