MAH 制度下我国药品不良反应损害赔偿保险模型初探

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.