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目的:了解药品不良反应在我国的认知情况,建立药品不良反应赔偿制度的必要性、组织形式等。方法:采用问卷调查的方式,对医护人员、药监部门工作人员、药品生产和销售企业、商业保险公司人员和患者进行考察。结果采用SPSS 19.0进行统计分析。结果:发放问卷450份,收回有效问卷437份。药品不良反应总体认知度为90.4%,患者认知度(71.3%)较低。药品不良反应赔偿制度必要性为80.6%,多数的对象选择建立独立的机构作为赔偿的管理部门,由多方专家组成的委员会作为鉴定机构,研究对象认为建立赔偿制度的主要障碍为药品不良反应造成损害的立法缺失。结论:要加强对患者药品不良反应知识宣传,建立药品不良反应赔偿制度在国内有较好的群众基础,需要重视管理机构的独立性与鉴定机构的专业性,对于赔付承担比例应强制设定,加强药品不良反应的立法是赔偿制度建设的关键。
Objective: To understand the cognitive situation of adverse drug reactions in our country, establish the necessity and organizational form of adverse drug reaction compensation system. Methods: By means of questionnaire survey, medical staff, drug regulatory department staff, drug production and marketing enterprises, commercial insurance companies and patients were inspected. Results SPSS 19.0 was used for statistical analysis. Results: 450 questionnaires were distributed and 437 valid questionnaires were returned. Adverse drug reaction overall awareness was 90.4%, patient awareness (71.3%) lower. The necessity of drug adverse reaction compensation system is 80.6%. Most of the respondents choose to establish an independent agency as the compensation administration department. The committee composed of many experts is the appraisal agency. The main obstacle for establishing the compensation system is that the adverse effects caused by adverse drug reactions The lack of legislation. Conclusion: It is necessary to strengthen knowledge of patients’ adverse drug reactions and establish a mass compensation system for adverse drug reactions in the country. We need to attach importance to the independence of regulatory agencies and the professionalism of the accreditation bodies. The legislation to strengthen adverse drug reactions is the key to the compensation system.