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.
ABSTRACT
OBJECTIVE： To provide reference for constructing ADR damage relief system in China. METHODS： Questionnaire survey was conducted among 217 pharmaceutical manufacturers in Shaanxi province by census method. Fisher’s exact test， Pearson χ2 test and multivariate Logistic regression analysis were used to analyze the factors effecting construction of ADR damage relief systerm unter marketing authorization holder （MAH） system， and the interaction among various factors. RESULTS： A total of 217 drug manufacturers were investigated in this study （217 questionnaires were sent out）. 209 questionnaires were collected and 204 valid questionnaires were screened out with recovery rate of 94.01％. Totally 9 independent influential factors screened by Fisher’s exact test and Pearson χ2 test had a significant impact on the attitude of building ADR damage relief system under MAH system， i.e. the last year’s earnings of enterprises， the proportion of pharmaceutical technicians， whether to set up R&D departments， whether to obtain new drugs/generic drugs in recent 3 years， whether to actively carry out post-marketing safety evaluation of drugs， whether ADR commissioners are familiar with ADR-related policies in MAH system， cognition about whether MAH system promotes the development of pharmaceutical industry， the development direction of enterprises after the full implementation of MAH， cognition about the lack of legal basis for ADR damage relief （P＜0.05）. Multivariate Logistic regression analysis showed that whether the ADR specialist was familiar with the ADR-related policies in MAH system was the main influential factor for constructing ADR damage relief system under the MAH system （P＝0.044）. It was positively correlated with the attitude of approving the construction of ADR damage relief system under MAH system （B＝1.697）. CONCLUSIONS： The pharmaceutical manufacturers， in which ADR specialists who are familiar with the ADR-related policies in the MAH system， are more inclined to agree to constructing ADR damage relief system under MAH system.