吴莹 夏金根 金德庄

摘 要 目的：按照对第二类精神药品经营环节的基本管理要求，分析近2年在上海市第二类精神药品经营环节专项检查中所发现的缺陷项目，并提出相应建议，为今后加强特殊药品监管提供参考。方法：以上海市具有第二类精神药品经营范围的药品批发企业和药品零售连锁企业总部为研究对象，对2019年和2020年第二类精神药品专项检查的结果进行统计分析，总结发现的缺陷和发生的原因，提出防范措施。结果与结论：第二类精神药品经营环节专项检查发现的缺陷主要集中在人员培训、仓库储存、系统管理、药品运输和信息报告等方面。建议特殊药品经营企业强化日常风险防控意识，在采用科学、合理、务实的方式实施质量管理的同时，注重构建质量文化并加强人员和技术的投入，确保特殊药品的质量安全，消除流通环节的安全隐患。

关键词 第二类精神药品 药品经营 药品监管

中图分类号：R951 文献标志码：C 文章编号：1006-1533（2021）13-0017-04

Analysis of defects in special inspections and supervision thoughts of the second-class psychotropic drugs in Shanghai

WU Ying， XIA Jingen， JIN Dezhuang

（Shanghai Center for Drug Evaluation and Inspection， Shanghai 201203， China）

ABSTRACT Objective： To analyze the defects in the special inspection of the second-class psychotropic drugs in Shanghai in the past two years according to the basic management requirements of the second-class psychotropic drugs and put forward corresponding suggestions so as to provide references for strengthening the supervision of special drugs in the later period. Methods： Taking the drug wholesale companies and drug retail chain headquarters with the business scope of the secondclass psychotropic drugs in Shanghai as the research objects， the results obtained from the special inspection of the second-class psychotropic drugs in 2019 and 2020 were statistically analyzed， the defects found and the reasons for their occurrence were summarized and the preventive measures were proposed. Results & Conclusion： The defects were mainly in personnel training， warehouse storage， system management， drug transportation， information reporting and so on. It is recommended that special drug companies should strengthen their awareness of daily risk prevention and control and should also focus on building a quality culture and strengthening personnel and technology investment to ensure the quality and safety of special drugs and eliminate potential safety hazards in circulation while implementing quality management in a scientific， reasonable and pragmatic manner.

KEy WORDS second-class psychotropic drugs； drug supply； drug regulation

第二類精神药品在临床上主要用于镇静、催眠和抗焦虑。随着社会竞争压力增大，焦虑症、失眠和抑郁症等精神系统疾病发病率持续增高，第二类精神药品的使用相应增加。但长期使用第二类精神药品会产生依赖性和耐受性，故如使用不合理，就可能造成成瘾或非医疗目的的滥用，进而给社会带来危害。

为有效保障公众用药安全，切实规范第二类精神药品经营行为，严防第二类精神药品流……