Page 26 - 《中国药房》2022年9期

我国医疗机构制剂调剂使用制度研究

吴曼妮 ，田 侃 ，王圣鸣（南京中医药大学卫生经济管理学院，南京 210023）
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中图分类号 R95 文献标志码 A 文章编号 1001-0408（2022）09-1044-05
DOI 10.6039/j.issn.1001-0408.2022.09.04

摘 要 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。
关键词 医疗机构制剂；调剂使用；制度

Research on the institutions of dispensing and use for preparations of medical institutions of China
WU Manni，TIAN Kan，WANG Shengming（School of Health Economics Management，Nanjing University of
Chinese Medicine，Nanjing 210023，China）

ABSTRACT 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.
KEYWORDS preparations of medical institutions；dispensing and use；institutions

近年来，“简政放权、放管结合、优化服务”（以下简 机构制剂调剂使用制度的不同之处，并与同我国医疗机
称“放管服”）政策深入人心。为使医疗机构制剂贯彻落 构制剂定义存在相似之处的日本“院内制剂”的调剂制
实“放管服”政策发展要求，加强医疗机构制剂调剂使用 度进行对比分析，总结出我国医疗机构制剂调剂使用的
监管，促进医疗机构制剂更好地在省内或跨省调剂使 发展趋势并提出应对措施，以期为促进我国医疗机构制
用，大范围推广医疗机构制剂应用，为患者提供高质量
剂调剂使用及推广应用提供借鉴。
医疗机构制剂服务，本研究将梳理我国医疗机构制剂调 1 我国医疗机构制剂调剂使用的发展历程
剂使用的发展历程，从不同角度比较国内历年关于医疗
医疗机构制剂是指医疗机构根据本单位临床需要，
＊硕士研究生。研究方向：药事管理。电话：025-85811760。
经批准而配制的自用的固定处方制剂 。医疗机构制剂
[1]
E-mail：745712557@qq.com
应当是市场上没有供应的品种，具有疗效确切、使用方
# 通信作者：教授，博士生导师，硕士。研究方向：卫生法、药事管
理。电话：025-85811760。E-mail：tiankane@aliyun.com 便以及价格实惠等优点，可在指定的医疗机构之间调剂

·1044 · China Pharmacy 2022 Vol. 33 No. 9 中国药房 2022年第33卷第9期