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目的:认清药品不良反应中各博弈主体间的利益关系,探讨药品不良反应监测政策的优化问题。方法:建立监管部门与药品生产、经营企业和医疗机构间的博弈模型,并分析药品不良反应监测政策的现有缺陷。结果与结论:建议从进一步完善法律法规建设、建立有效的监管措施、明确药品不良反应损害救济制度的法律地位等方面优化药品不良反应监测政策。
OBJECTIVE: To understand the relationship between the main players in the adverse drug reactions and to explore the optimization of adverse drug reaction monitoring policies. Methods: To establish a game model between the regulatory authorities and the pharmaceutical production, operation enterprises and medical institutions, and to analyze the existing defects of the adverse drug reaction monitoring policy. RESULT AND CONCLUSION: It is suggested to optimize the drug adverse reaction monitoring policy in terms of further improving the construction of laws and regulations, establishing effective regulatory measures, and clarifying the legal status of the adverse effects of adverse drug reactions.