中国药品检查员药品质量安全风险识别影响因素的研究——基于扎根理论的模型构建

A study on the influencing factors of drug quality and safety risk identification by Chinese drug inspectors—a model construction based on grounded theory

关键词:  扎根理论  药品检查员  风险识别  影响因素  模型

Key words:  grounded theory Study  drug inspectors  risk identification  influencing factors  modeling

摘要:

目的 建立药品检查员识别药品质量安全风险影响因素模型的理论体系。方法 通过对药品检查员及药品质量安全风险相关文献、新闻、政策文件等梳理,以及对8名资深检查员深度访谈,运用扎根理论对检查员药品质量安全风险识别影响因素进行了研究,并构建一套影响因素模型。结果 研究发现法律规章制度是检查员风险识别的先决条件,检查前准备、检查实施过程、检查结果的管理、职业化专业化检查员管理、检查员自身能力素质是检查员风险识别的实践路径,其中检查员自身能力素质是风险识别最重要的内部因素；社会影响是检查员风险识别的外部因素。结论 通过扎根理论对检查员药品质量安全风险识别能力的影响因素进行模型建构并提出政策建议,深化了理论体系和内容框架,为提高药品监管效能提供参考和启示。

Abstract:

OBJECTIVE To establish a theoretical system for drug inspectors to identify the influencing factors and models of drug quality and safety risks. METHODS Through combing the literature, news, policy documents and other materials related to inspectors and drug quality and safety risks, as well as in-depth interviews with eight senior inspectors, this study utilized the grounded theory to study the influencing factors of drug quality and safety risk identification by inspectors, and constructed a set of models.. RESULTS The study found that laws and regulations are the prerequisites for risk identification of inspectors, and that pre-inspection preparation, the inspection implementation process, the management of inspection results , the management of professional and specialized inspectors, and the quality of inspectors"" own competence are the practical paths for risk identification of inspectors, in which the quality of inspectors"" own competence is the most important internal factor; social influence is the external factor.. CONCLUSION a In this paper, the influence factors of inspectors"" risk identification ability are modeled and explained through the grounded theory, and policy suggestions are made accordingly, which deepen the theoretical system and provide references and inspirations for improving the effectiveness of drug supervision..