关键词: 药品不良反应, 死亡病例, 调查, 报告, 实施要点

Abstract: Objective To guide the drug marketing authorization holder (MAH) to standardize the investigation and report of death cases, so as to provide a basis for in-depth evaluation of drug safety. Methods This paper refers to the requirements of domestic and foreign regulatory guidelines, elaborated the key points of field investigation and internal investigation of suspected death cases of adverse drug reactions known to MAH, as well as the comprehensive analysis of death cases. Results Field investigation includes basic information of cases, drug use, adverse reactions, diagnosis and treatment of patients, and medical institutions. Internal investigation and evaluation can be carried out from the whole process of production and quality control. In addition to the investigation and disposal, the investigation report can provide comprehensive analysis and evaluation combined with the previous safety analysis of the variety. Within the prescribed time limit, the investigation content should be summarized and analyzed to form the investigation report, and submitted as required. Conclusion To standardize the investigation and report of death cases, MAH needs to improve the pharmacovigilance system, and multi-department interaction and efficient disposal, so as to provide reliable basis for risk assessment and risk control, and better guide clinical safe drug use.

Key words: adverse drug reaction, deaths case, investigation, report, key points