| 引用本文: | 吴锦,石萍,刘梁,夏克楷,王蝶,王淑玲.药品经营质量信用评价指标体系研究——基于浙江省药品经营企业调研数据[J].中国现代应用药学,2021,38(3):350-357. |
| WU Jin,SHI Ping,LIU Liang,XIA Kekai,WANG Die,WANG Shuling.Study on the Index System of Credit Evaluation of Drug Operation Quality—Based on the Survey Data of Pharmaceutical Trading Enterprises in Zhejiang Province[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(3):350-357. |
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| 摘要: |
| 目的 加强药品经营质量信用评价指标体系建设，为政府推进相关监管政策提供参考。方法 采用问卷调查法，对浙江省11个地市的药品经营企业进行调研，收集药品经营质量信用评价指标体系的相关数据，建立结构方程模型进行验证性因子分析。结果 共回收有效问卷520份。5个一级指标包括企业内部因素、社会环境因素、政府监管策略、政府监管程度和差异化管理，它们的路径系数均>0.6，其中差异化管理和政府监管程度对药品经营质量信用评价的影响非常大，必须考虑。在28个二级指标中，药品经营企业的经营品种风险程度、与政府监管部门配合支持程度、药品经营企业的经营规模、对药品经营企业的差别化监管、政府相关制度的健全程度、企业对缺陷项目整改情况、监管人员综合素质和执法意识这7个指标对药品经营质量信用评价的影响非常大，必须考虑。结论 通过提升监管能力，创新监管方式；积极探索联合监管和“精准监管”，加强宣传与社会监督；加强信用等级应用，规范信用信息采集与处理；落实企业主体责任，强化企业对药品质量的重视等途径，可促进药品经营质量信用评价指标体系的应用，提高政府的监管效率。 |
| 关键词: 药品经营质量 信用评价 指标体系 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.03.018 |
| 分类号:R956 |
| 基金项目:浙江省药品监督管理局项目——药品经营企业药品质量信用评定情况评估（ZPC2018013） |
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| Study on the Index System of Credit Evaluation of Drug Operation Quality—Based on the Survey Data of Pharmaceutical Trading Enterprises in Zhejiang Province |
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WU Jin1, SHI Ping2, LIU Liang2, XIA Kekai1, WANG Die1, WANG Shuling2
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1.Zhejiang Pharmaceutical College, Ningbo 315000, China;2.Shenyang Pharmaceutical University, Shenyang 110015, China
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| Abstract: |
| OBJECTIVE To strengthen the construction of the index system of credit evaluation of drug operation quality and to provide a reference for the government to promote relevant regulatory policies. METHODS The questionnaire method was used to survey pharmaceutical trading enterprises in 11 prefectures and cities in Zhejiang Province, to collect relevant data of the index system of credit evaluation of drug operation quality, and structural equation modeling was established for confirmatory factor analysis. RESULTS There were 520 valid questionnaires collected. The five first-level indexes included internal factors of enterprises, social environmental factors, government supervision strategies, the degree of government supervision, and differentiated management, and their path coefficients were all >0.6. Among them, the differentiated management and the degree of government supervision had a significant impact on the credit evaluation of drug operation quality, so they must be considered. Among the 28 secondary indexes, the risk level of operating variety of pharmaceutical trading enterprises, the degree of cooperation with government regulatory agencies, the scale of operation of pharmaceutical trading enterprises, the differentiated supervision of pharmaceutical trading enterprises, the soundness of government-related systems, the rectification of defective items by enterprises, the comprehensive quality and executive consciousness of supervisory personnel had a great influence on the credit evaluation of drug operation quality, so the above 7 indexes must be considered. CONCLUSION By enhancing supervision capabilities and innovating supervision methods, actively exploring joint supervision and "precision supervision", strengthening publicity and social supervision, strengthening the application of credit rating and regulating the collection and processing of credit information, implementing corporate responsibilities and strengthening the emphasis on drug quality, they can promote the application of the index system of credit evaluation of drug operation quality, improve the efficiency of government supervision. |
| Key words: drug operation quality credit evaluation index system |
