精神类药品集中带量采购的执行现状与政策优化

Implementation Status and Policy Optimization of Centralized Volume-based Procurement of Psychotropic Drugs

目的:分析精神类药品集中带量采购执行情况和存在问题,为政策完善提供参考建议。方法:采用文献分析法综述精神类药品的特殊性以及采购、使用风险,描述性分析草酸艾司西酞普兰片、帕罗西汀片在医院端和零售端的销售量和销售结构。结果:前八批国家集中带量采购共纳入25种精神类药品,基本覆盖常用药品,中选产品销售量上升,未中选仿制药市场份额逐渐被替代,未中选原研药份额变化不大;仿制药替换管理尚不完善,国家层面尚未出台针对精神类药品集中带量采购的特殊管理政策。结论:国家药品集中带量采购在政策设计层面要慎重纳入高风险精神类药品,采购量约定实行特殊药品特殊设置,并建立全链条质量管理闭环;在政策执行层面要设置过渡期,鼓励地方探索并完善配套政策;在临床使用层面要遵循患者个体化用药原则,谨慎使用替换,加强药物浓度和不良反应监测,并强化医患沟通。

Objective To analyze the implementation status and problems of centralized volume-based procurement of psychotropic drugs,and to provide reference suggestions for policy improvement.Methods Literature analysis was used to review the special characteristics of psychotropic drugs and the risks of procurement and use,and descriptive analysis was used to analyze the sales volume and sales structure of escitalopram oxalate tablets and paroxetine tablets in hospitals and retailers.Results A total of 25 psychotropic drugs were included in the first eight batches of national centralized volume-based procurement,basically covering commonly used drugs.The sales volume of the selected products increased,the market share of unsuccessful generic drugs was gradually replaced,and the share of unsuccessful originator drugs did not change much.The management of generic drug substitution was still imperfect,and the state has not yet issued a special management policy for centralized volume-based procurement of psychotropic drugs.Conclusion In national volume-based procurement of medicines,at the policy design level,high-risk psychotropic drugs should be carefully included,and special drug settings should be implemented in the procurement volume agreement,and a closed-loop quality management system should be established throughout the entire chain.At the policy implementation level,a transition period should be set up to encourage local governments to explore and improve supporting policies.At the clinical use level,it is necessary to follow the principle of individualized medication for patients,use replacement with caution,strengthen drug concentration and adverse reaction monitoring,and strengthen doctor-patient communication.