基于免疫理论的仿制药短缺风险评价与应对策略研究

Research on Risk Assessment and Coping Strategies of Shortage of Generic Drugs Based on Immune Theory

目的:构建基于免疫理论的仿制药短缺风险评价指标体系,为定量评估仿制药短缺风险大小提供支撑,并根据指标权重结果提出相应的风险应对策略。方法:通过文献研究和专家咨询进行仿制药短缺风险因素界定和指标初筛,采用层次分析法构造判断矩阵并计算各级指标权重。结果:构建了基于免疫理论的仿制药短缺风险评价指标体系,共含7个一级指标和26个二级指标。一级指标中,仿制药生产隐患权重系数最高,为0.3543;二级指标中,原辅料市场价格波动率权重系数最高,为0.1523。结论:基于免疫机理所构建的指标体系可为仿制药短缺风险评估和安全预警提供参考,政府部门、医疗机构和生产企业等相关主体应发挥抗体保障作用。

Objective:By constructing a generic drug shortage risk evaluation index system based on immune theory,it aims to provide support for the quantitative assessment of the risk factors of generic drug shortages,and to propose corresponding countermeasures based on the index weight results.Methods:A preliminary selection of generic drug shortage indicators is conducted through literature research and expert consultation,and the analytic hierarchy process is used to construct a judgment matrix and calculate the weights of indicators at all levels.Results:An immune-theory-based generic drug shortage risk evaluation index system is constructed,which includes 7 first-level indicators and 26 second-level indicators.Among the first-level indicators,the weight coefficient of hidden dangers in generic drug production is the highest(0.3543);among the second-level indicators,the weight coefficient of the market price volatility of raw materials and excipients is the highest(0.1523).Conclusion:The index system constructed based on the immune theory can provide references for the risk assessment and safety early warning of the shortage of generic drugs.Relevant entities such as government departments,medical institutions,and manufacturing companies should play the role of antibody protection.