中国儿童药品短缺原因分类体系的系统评价

Classification system of the causes of pediatric drug shortages in China:a systematic review

目的系统评价中国儿童药品短缺原因分类体系,对儿童药品短缺原因做准确分类,为制定针对性的解决策略提供参考。方法计算机检索Embase、PubMed、CBM、CNKI数据库,检索时间均为建库至2023年11月,纳入中国不同地区儿童药品短缺原因的量化研究、质性研究、混合方法研究等。两名研究者独立进行文献筛选及数据提取后,采用主题分析法,基于有效市场和有为政府理论,按药品供应链的全流程,整理归纳药品短缺的根本原因。结果最终纳入14篇文献,按照药品供应链的4个阶段(研发、生产、流通和使用),归纳总结19类儿童药品短缺原因,其中研发阶段5类、生产阶段4类、流通阶段6类、使用阶段4类。运用有效市场和有为政府理论进一步分析发现,目前梳理的短缺原因最终可归因于市场失灵、政府失灵和其他原因三大根本原因,其中6类原因涉及市场失灵、7类涉及政府失灵、6类归为其他原因。结论本研究基于有效市场和有为政府结合理论,建立了儿童药品短缺根本原因分类体系,并提出了相应的政策建议。后续可尝试运用该根本原因分类体系,从政府和市场两个角度、药品供应链各环节,制定针对性的解决策略,解决儿童药品短缺问题。

Objective To systematically review the classification system for the causes of pediatric drug shortages in China,and classify the causes of pediatric drug shortages accurately,so as to provide references for the formulation of targeted strategies.Methods Four databases including Embase,PubMed,CBM and CNKI were searched from inception to November 2023.Quantitative research,qualitative research and mixed-method research on the causes of pediatric drug shortages in China were included.Two researchers independently screened the literature and extracted data.Based on the theory of efficient market and effective government,and according to the life cycle of the drug supply chain,the fundamental causes of drug shortages were classified and summarized by thematic synthesis.Results Fourteen articles were included.According to the four stages of the drug supply chain(research and development,production,circulation and use),a total of 19 categories of causes of the pediatric drug shortages were summarized,including 5 categories in the research and development stage,4 categories in the production stage,6 categories in the circulation stage,and 4 categories in the use stage.Based on the theory of efficient market and effective government,further analysis of the causes revealed that the identified reasons could be attributed to three major fundamental causes:market failure,government failure,and other causes.Among them,6 categories were related to market failure,7 categories were related to government failure,and 6 categories were classified as other causes.Conclusion Based on the theory of efficient market and effective government,this study established a classification system of fundamental causes of the pediatric drug shortages,and made policy suggestions accordingly.Subsequently,the classification system established in this study can be used as references to develop targeted strategies to solve the problem of pediatric drug shortages in the life cycle of drug supply chain from government and market perspectives.