Page 25 - 《中国药房》2022年4期

湖南省570家药品批发企业风险情况分析及建议

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海 乐 ，黄 丹 ，王 丹 ，于 勇 ，林新文 （1.湖南省药品审核查验中心，长沙 410006；2.湖南省药品监督
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管理局检查分局，长沙 410013；3.湖南省食品药品职业学院药学院，长沙 410208）
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2022）04-0403-05
DOI 10.6039/j.issn.1001-0408.2022.04.04

摘 要 目的 为规范药品批发企业经销行为、提升药品监管部门的监管水平提供参考。方法 对2020年湖南省570家药品批发企
业现场检查中发现的缺陷项目进行汇总，对其主要风险情况进行分析，并提出对策与建议。结果与结论 湖南省省级药品监管部
门对192家药品批发企业进行了日常监督检查，其中有168家企业（87.50％）被责令改正；共发现缺陷项目1 804项，涉及严重缺陷
11项、主要缺陷806项、一般缺陷987项。省级药品监管部门对20家麻醉药品、精神药品批发企业进行了专项检查，其中18家企
业（90.00％）被责令改正；共发现缺陷项目48项，涉及主要缺陷33项、一般缺陷15项，未发现严重缺陷项目。各市（自治州）药品监
管部门对 358 家药品批发企业进行了日常巡查，其中 290 家企业（81.00％）被责令改正；共发现缺陷项目 1 499 项，涉及主要缺陷
665项，一般缺陷834项，未发现严重缺陷项目。按照出现频次统计，湖南省药品批发企业的缺陷项目主要集中在储存与养护（687
项，20.50％）、设施与设备（608项，18.14％）、人员与培训（579项，17.28％）、收货与验收（272项，8.12％）和质量管理体系文件（260
项，7.76％），上述项目合计占缺陷总数的71.80％。药品批发企业存在的主要风险包括企业风险意识淡薄、药品营销环节质量风
险多发、企业质量管理体系文件不健全、企业经营行为存在弄虚作假等情况。建议药品批发企业应建立质量风险管理机构、评价
标准和管理制度，完善经营质量管理体系，加强药品储存管理，规范企业经营管理，加强人员培训，规范采购行为等，从而保障药品
的安全有效和质量可控。
关键词 湖南省；药品批发企业；药品监管；现场检查；缺陷项目；风险；建议

Risk analysis and suggestions of 570 drug wholesale enterprises in Hunan province
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HAI Le ，HUANG Dan ，WANG Dan ，YU Yong ，LIN Xinwen（1. Hunan Drug Inspection Center，Changsha
410006，China；2. Inspection Branch of Hunan Medical Products Administration，Changsha 410013，China；
3. College of Pharmacy，Hunan Food and Drug Vocational College，Changsha 410208，China）
ABSTRACT OBJECTIVE To provide reference for standardizing the distribution behavior of drug wholesale enterprises and
improving the supervision level of drug supervision departments. METHODS The defective items found in the on-site inspection of
570 drug wholesale enterprises in Hunan province in 2020 were summarized，the main risks were analyzed to put forward
countermeasures and suggestions. RESULTS & CONCLUSIONS The provincial drug regulatory departments conducted daily
supervision and inspection among 192 drug wholesale enterprises，of which 168 enterprises （87.50％） were ordered to make
corrections；a total of 1 804 defective items were found，involving 11 serious defects，806 major defects and 987 general defects.
The provincial drug regulatory departments conducted special inspections among 20 wholesale enterprises of narcotic drugs and
psychotropic drugs，of which 18 enterprises（90.00％）were ordered to make corrections；a total of 48 defective items were found，
involving 33 major defects and 15 general defects，and no serious defective items were found. The drug regulatory departments of
all cities（autonomous prefectures）inspected 358 drug wholesale enterprises，of which 290 enterprises（81.00％）were ordered to
make corrections；a total of 1 499 defective items were found，including 665 main defects and 834 general defects，and no serious
defective items were found. According to the statistics of occurrence frequency，defective items of drug wholesale enterprises in
Hunan province were mainly concentrated in storage and maintenance（687 items，20.50％），facilities and equipments（608 items，
18.14％），personnel and training（579 items，17.28％），receipt and acceptance（272 items，8.12％）and quality management
system documents （260 items，7.76％），which together accounted for 71.80％ of the total defects. The main risks of drug
wholesale enterprises included weak enterprise risk awareness，high frequency of quality risks in drug marketing，imperfect
enterprise quality management system documents，and fraud in enterprise business behavior. It is recommended that drug wholesale
enterprises should establish quality risk management institutions，evaluation standards and management systems，improve the
operation quality management system，strengthen the management of drug storage，standardize the operation and management of
enterprises，strengthen personnel training and standardize procurement behavior，so as to jointly maintain the safety and efficacy of
drugs and controllable quality.
＊主管药师，硕士。研究方向：药品审核查验。电话：0731-
KEYWORDS Hunan province；drug wholesale enterprises；
88633352。E-mail：875012357@qq.com
# 通信作者：副主任药师，硕士。研究方向：药品审核查验。电 drug supervision； on-site inspection； deficient items； risk；
话：0731-85680151。E-mail：1705755074@qq.com suggestions

中国药房 2022年第33卷第4期 China Pharmacy 2022 Vol. 33 No. 4 ·403 ·