我国医疗机构制剂调剂使用制度研究

Research on the institutions of dispensing and use for preparations of medical institutions of China

目的了解我国医疗机构制剂调剂使用的未来发展趋势,为推广医疗机构制剂应用与调剂使用的高质量发展提供对策建议。方法整体梳理我国医疗机构制剂调剂使用发展历程,从不同角度比较国内历年关于医疗机构制剂调剂使用制度之间的差异,并对比我国该制度与日本院内制剂调剂及使用制度的不同之处。归纳我国医疗机构制剂调剂使用发展趋势并提出对策建议。结果与结论我国医疗机构制剂调剂使用发展历程可大致分为起步阶段(2001-2004年)、成形阶段(2005-2018年)与发展阶段(2019年至今)。历年来,我国医疗机构制剂调剂使用制度的变化呈现出调剂使用范围扩大、审批流程加快及各方责任明晰的趋势;但与日本相比,我国对医疗机构制剂的监管模式仍较为单一。在未来,我国医疗机构制剂的大范围推广应用将常态化发展,调剂审批时限将进一步缩短,审批流程将进一步简化,调剂使用的准入门槛将逐渐降低,调剂使用的事中和事后监管将进一步加强。建议严格把控医疗机构制剂质量安全,对调剂使用的医疗机构制剂实行分类管理,并进一步完善事中和事后的监管机制。

OBJECTIVE To understand the future development trend of dispensing and use for preparations of medical institutions,and to provide countermeasures and suggestions for promoting the high-quality development of application and dispensing use for preparations of medical institutions.METHODS The development history of dispensing and use for preparations of medical institutions of China was reviewed as a whole,and then the differences of domestic dispensing and use institutions for preparations of medical institutions over the years were compared from different perspectives;and the differences between domestic institutions and Japan’s hospital preparation dispensing and use institutions were compared.The development trend of dispensing and use for preparations of medical institutions of China was summarized to put forward countermeasures and suggestions.RESULTS&CONCLUSIONS The development process of dispensing and use for preparations of medical institutions of China could be roughly divided into the initial stage(2001-2004),the forming stage(2005-2018)and the development stage(2019-present).Year by year,the dispensing and use institutions of preparations of medical institutions had shown that the scope of dispensing and use had been expanded;the approval process had been accelerated,and the responsibilities of all parties had been clearly defined.Compared with Japan,regulatory model for preparations of medical institutions was relatively simple in China.In the future,the large-scale promotion and application of preparations of medical institutions will be normalized,the time limit for dispensing approval will be shortened,the approval process will be simplified,the access threshold for dispensing and use will be gradually lowered,and the supervision of dispensing and use will be strengthened during and after the event.It is recommended to strictly control the quality and safety of preparations of medical institutions,implement classified management of use for preparations of medical institutions,and further improve the supervision mechanism during and after the event.