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药品信息化追溯体系建设的影响因素及其优化路径研究
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| 篇名： | 药品信息化追溯体系建设的影响因素及其优化路径研究 |
| TITLE： | Research on the influencing factors of the construction of pharmaceutical information traceability system and its optimization path |
| 摘要： | 目的 探讨我国药品信息化追溯体系建设实效的影响因素和优化路径，为规范药品市场秩序、保障医保基金安全及维护公众健康提供参考。方法以技术-组织-环境（TOE）理论为框架，采用模糊集定性比较分析（fsQCA）法，选择大数据发展水平、跨部门协同机制、监管曝光力度、追溯人员素质、财政资金投入和社会关注度6个条件变量，通过收集31个省（自治区、直辖市）发布的药品信息化追溯体系相关政策，探讨促进药品信息化追溯体系建设的条件组合和优化路径。结果与结论单个条件不会对建设药品信息化追溯体系产生决定性影响，但是大数据发展水平、追溯人员素质、监管曝光力度和社会关注度在组态路径中发挥关键作用。高效推动药品追溯信息化体系建设有4条路径，分别是素质强化型、技术突破型、技术关注型、环境倒逼型，各路径一致性均高于0.750，且解的一致性为0.790、解的覆盖度为0.897；各省份可根据自身所具备的条件选择合适的路径。建议可通过技术创新、强化部门联动和全链条监管、营造建设药品信息化追溯体系的环境，来推进药品信息化追溯体系高质量建设；同时还要关注医疗机构端的落地困境，从而降低医疗机构执行成本。 |
| ABSTRACT： | OBJECTIVE To explore the influencing factors and improvement pathways for the effectiveness of China’s pharmaceutical information traceability system construction， and to provide references for regulating the pharmaceutical market order， ensuring the security of medical insurance funds， and safeguarding public health.METHODS Based on the technology-organization-environment （TOE） theoretical framework， six conditional variables were selected， including the level of big data development， interdepartmental coordination mechanisms， regulatory exposure intensity， quality of traceability personnel， government financial investment， and degree of public attention. The fuzzy set qualitative comparative analysis （fsQCA） method was employed to collect policies related to pharmaceutical information traceability systems issued by 31 provinces（autonomous regions， municipalities） in China， and to explore the condition configurations and optimization pathways for promoting the construction of pharmaceutical information traceability systems. RESULTS &CONCLUSIONS No single condition exerts a decisive influence on the construction of pharmaceutical information traceability systems. However， the level of big data development， quality of traceability personnel， regulatory exposure intensity， and degree of public attention play key roles in the configuration pathways. There are four pathways for efficiently promoting the construction of pharmaceutical information traceability systems， namely the competence enhancement type， the technological breakthrough type， the technology-focused type， and the environment-driven type； the consistencies of all pathways were higher than 0.750, with an solution consistency of 0.790 and an solution coverage of 0.897. Each province can select an appropriate path according to its own conditions. It is recommended to promote the high-quality construction of pharmaceutical information traceability systems through technological innovation， strengthening interdepartmental coordination and full-chain regulation， and optimizing the environment for system construction. Meanwhile， attention should also be paid to the implementation difficulties faced by medical institutions so as to reduce their implementation costs. |
| 期刊： | 2026年第37卷第18期 |
| 作者： | 李志伟；李颖；王海霞；叶耀辉 |
| AUTHORS： | LI Zhiwei，LI Ying，WANG Haixia，YE Yaohui |
| 关键字： | 药品信息化追溯体系;药品追溯码;政策执行;TOE框架;组态效应;模糊集定性比较分析 |
| KEYWORDS： | pharmaceutical information traceability system;pharmaceutical traceability code;policy implementation;TOE framework;configuration effects;fuzzy set qualitative comparative analysis |
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