湖南省570家药品批发企业风险情况分析及建议
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篇名: 湖南省570家药品批发企业风险情况分析及建议
TITLE: Risk analysis and suggestions of 570 drug wholesale enterprises in Hunan province
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1804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1499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。
ABSTRACT: OBJECTIVE To provi de 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 j ointly maintain the safety and efficacy of drugs and controllable quality.
期刊: 2022年第33卷第04期
作者: 海乐,黄丹,王丹,于勇,林新文
AUTHORS: HAI Le,HUANG Dan,WANG Dan,YU Yong,LIN Xinwen
关键字: 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
KEYWORDS: Hunan province ;drug wholesale enterprises ;
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