我国呼吸系统儿童专用药可及性研究

Research on Accessibility of Child-Specific Drugs for Respiratory System Disease in China

关键词:  呼吸系统疾病  儿童用药  儿童专用药  可及性  定量分析

Key words:  respiratory system disease  pediatric medicine  child-specific drug  accessibility  quantitative analysis

摘要:

目的 分析我国呼吸系统儿童专用药的可及性现状与问题，为政策制定提供参考依据。方法 基于国家药品编码本位码，通过说明书摸排，系统梳理我国已上市呼吸系统儿童专用药批文、品种、剂型现状，对比考察EMLc-8th推荐的呼吸系统用药在国内的上市情况，分析可获得性；基于米内网-药品招标信息相关价格数据，利用WHO/HAI可负担性测算方法，分析可负担性。从上述两个维度综合评估可及性。结果 可获得性方面，我国呼吸系统儿童专用药上市批文及品种数量较为丰富，但相较于成人儿童共用药仍有较大差距；具备一定的剂型丰富度，但在低龄儿童的适宜剂型与创新剂型方面存在缺失；同治疗领域EMLc-8th推荐药品在我国的上市情况良好，但相关药品均未以儿童专用药形式上市。可负担性方面，纳入研究的多数治疗用呼吸系统儿童专用药可负担性良好，但仍有约45%的药品存在不同程度的可负担性问题，预防用呼吸系统儿童专用疫苗可负担性结果则较差。结论 我国呼吸系统儿童专用药可及性整体尚可，但仍存在一定问题。为实现可及性优化目标，国家应完善儿童用药全生命周期激励政策体系，积极探索基于流通使用环节的儿童用药上市后激励。

Abstract:

OBJECTIVE The paper analyzed the current situation and problems of the accessibility of child-specific drugs for respiratory system disease in China, so as to provide reference for making policy on this respect. METHODS Based on the standard code of NDC (national drug code), the approval documents, varieties and dosage forms of the marketed child-specific drugs for respiratory system disease in China were systematically reviewed by means of the user manuals. The marketing situation of respiratory drugs recommended by EMLc-8th in China was compared and analyzed to obtain their availability. Based on the price data of drug bidding information in Menet, WHO/HAI affordability measurement method was used to analyze the affordability. The accessibility was comprehensively assessed from the above two dimensions. RESULTS In terms of availability, the number of marketing approvals and varieties of child-special drugs for respiratory system disease in China is relatively rich, but there is still a big gap compared with the drugs shared by adults and children. It has a certain abundance of dosage forms, but there are deficiencies in the appropriate and innovative dosage forms for young children. The drugs recommended by EMLc-8th in the same treatment field are well marketed in China, but the related drugs are not marketed in the form of child-specific drugs. In terms of affordability, most of therapeutic use child-specific drugs for respiratory system disease have good affordability, but about 45% of the drugs still have affordability problems in different degrees, and the affordability statistics of children"s specialized vaccines for respiratory system prevention are poor. CONCLUSION The accessibility of child-specific drugs with respiratory system disease in China is generally acceptable, but there are still some problems. In order to achieve the goal of accessibility optimization, the State should improve the whole life cycle incentive policy system for child-specific drug using, and actively explore the post marketing incentive for it based on the circulation and use.