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MAH制度下我国药品不良反应损害赔偿保险模型初探
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篇名: MAH制度下我国药品不良反应损害赔偿保险模型初探
TITLE: Preliminary Study on China ’s Insurance Model for ADR Injury Compensation under MAH System
摘要: 目的:构建药品上市许可持有人(MAH)制度下我国药品不良反应(ADR)损害赔偿保险模型,为减少我国因ADR损害导致的医疗纠纷问题、保障患者权益提供参考。方法:采用推荐法和“滚雪球”法邀请访谈专家进行半结构化访谈获得定性数据,并用主题分析法对访谈结果进行分析;根据主题分析结果从保险类型设置、投保等级划分和强制保险保障对象等3方面设计ADR损害赔偿模型,并使用基于层次分析的模糊综合评价法对模型进行评估;通过问卷调查并结合多因素Logistic回归分析对药品相关机构是否愿意建立ADR损害赔偿体系的影响因素进行分析。结果:共邀请专家40位,其中有34位完成了访谈,回应率为85.0%。目前我国ADR损害赔偿面临的问题主要包括第三方鉴定和ADR损害举证困难,ADR损害导致的医疗纠纷难以得到及时、公平的解决,ADR损害纠纷处理成本高、耗时长以及赔偿模式不确定等。半数以上的受访专家赞同保险这一赔偿模式。所建强制保险与商业保险联合的ADR损害赔偿模型的整体得分为89.50。共发放调查问卷640份,回收有效问卷559份(药品生产企业204家、药品经营企业172家、医疗机构183家),问卷有效率87.3%。多因素Logistic回归分析结果显示,与赞同我国在MAH制度施行后建立ADR损害赔偿体系成正相关的因素包括药品生产企业ADR专员对ADR相关政策的熟悉程度(β=1.697,P<0.05)、药品经营企业经营品种(β=2.987,P<0.05)和医疗机构人员对ADR的认知水平(β=2.800,P<0.05);与赞同我国在MAH制度施行后建立ADR损害赔偿体系成负相关的因素是医疗机构人员工作年限(β=-2.544,P<0.05)。结论:本研究建立的ADR损害赔偿模型具有可行性,对于减轻ADR损害患者的经济负担,及时解决ADR损害引发的患者健康问题,促进我国药品保险发展可能具有一定的参考价值。药品生产企业ADR专员对ADR相关政策的熟悉程度、医疗机构人员对ADR的认知水平、药品经营企业经营的药品品种和医疗机构人员工作年限是MAH制度下构建ADR损害赔偿模型的主要影响因素。
ABSTRACT: OBJECTIVE:To construct China ’s Insurance Mode for ADR injury compensation model under marketing authorization holder (MAH)system,and to provide reference for reducing the medical disputes caused by ADR damage and protecting the rights and interests of patients. METHODS :Using the methods of recommendation and “snowball”,the interviewers were invited to conduct semi-structured interviews to obtain qualitative data ,and the results were analyzed by thematic analysis. According to the results of subject analysis ,the ADR injury compensation model was designed from three aspects of insurance type setting,insurance level division and compulsory insurance protection objects ,and the Fuzzy comprehensive evaluation method based on AHP was used to evaluate the model ;questionnaire and multiple factor Logistic regression analysis was adopted to analyze the influential factors of whether drug related institutions were willing to establish ADR injury compensation system. RESULTS:A total of 40 experts were invited and 34 of them completed the interview ,with a response rate of 85.0%. At present , the problems of ADR injury compensation in China mainly included the difficulties of third-party identification and adducing evidence of ADR injury ,the difficulty of timely and fair settlement of medical disputes caused by ADR injury ,the high cost and long time of handling ADR injury disputes ,and the uncertainty of compensation mode. More than half of the experts interviewed agreed with the compensation mode of insurance . The overall score of established model was 89.50. A total of 640 questionnaires were distributed and 559 valid questionnaires were recovered (204 drug manufacturers ,172 drug distributors and 183 medical institutions). The effective rate of the questionnaire was 87.3%. Multiple Logistic regression analysis showed that the factors positively correlated with the approval of establishing ADR injury compensation system after the implementation of MAH system in China included the familiarity of ADR staff in drug manufacturing enterprises with ADR related policies (β=1.697,P<0.05),the types of drugs operated by pharmaceutical companies (β=2.987, P<0.05),the cognitionlevel of medical staff on ADR (β= 2.800,P<0.05). The working years of medical staff were negatively correlated with the approval of establishing ADR injury compensation system after the implementation of MAH system ( β =- 2.544,P<0.05). CONCLUSIONS :ADR injury compensation model designed in this study is feasible. It has reference value for reducing the economic burden of ADR patients , treating patients ’health problems caused by ADR injury in time ,and promoting the development of China ’s drug insurance. Main influential factors for the establishment of ADR injury compensation model under MAH system contain the familiarity of ADR staff in drug manufacturing enterprises with ADR related policies ,the types of drugs operated by pharmaceutical companies ,the cognitionlevel of medical staff on ADR ,the types of drugs operated by pharmaceutical companies ,the cognitionlevel of medical staff on ADR.
期刊: 2021年第32卷第02期
编辑: 贾夏怡,朱岩冰,方宇,侯鸿军,刘佐仁,常捷
AUTHORS: JIA Xiayi,ZHU Yanbing ,FANG Yu,HOU Hongjun ,LIU Zuoren ,CHANG Jie
关键字: 药品上市许可持有人;药品不良反应;损害赔偿模型;影响因素
KEYWORDS: Marketing author ization holder ;ADR;Injury compensation model;Influential factors
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