MAH制度下构建药品不良反应损害救济体系的影响因素分析——基于陕西省药品生产企业视角-中国药房

MAH制度下构建药品不良反应损害救济体系的影响因素分析——基于陕西省药品生产企业视角

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篇名：	MAH制度下构建药品不良反应损害救济体系的影响因素分析——基于陕西省药品生产企业视角
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摘要：	目的：为构建我国药品不良反应损害救济体系提供参考。方法：采用普查法对陕西省内全部217家药品生产企业进行问卷调查。采用Fisher’s精确检验和Pearson χ2检验及多元Logistic回归分析影响我国在药品上市许可持有人（MAH）制度下构建药品不良反应损害救济体系的因素及各因素间的交互作用。结果：本研究共调查药品生产企业217家（发放调查问卷217份），回收209份，筛去无效问卷，共获有效问卷204份，有效回收率为94.01％。经Fisher’s精确检验和Pearson χ2检验筛选出9个独立影响因素，分别为企业上年度营业额、药学技术人员占比、是否设置研发部门、近3年是否取得新药/仿制药批件、是否主动开展药品上市后安全性评价工作、药品不良反应专员对MAH制度中涉及药品不良反应相关政策的熟悉与否、对MAH制度是否促进医药产业发展的认知、MAH全面实施后企业的发展方向、对药品不良反应损害救济缺少法律依据的认知等。上述因素对生产企业对于MAH制度下构建药品不良反应损害救济体系的态度有显著影响，P值均小于0.05。多元Logistic回归分析显示，药品不良反应专员是否熟悉MAH制度中涉及药品不良反应相关政策是MAH制度下构建药品不良反应损害救济体系的主要影响因素（P＝0.044），并且与企业是否赞同MAH制度下构建药品不良反应损害救济体系的态度呈正相关（B＝1.697）。结论：药品不良反应专员熟悉MAH制度中涉及药品不良反应相关政策的药品生产企业更倾向于赞同构建MAH制度下药品不良反应损害救济体系。
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.
期刊：	2019年第30卷第20期
作者：	贾夏怡，朱岩冰，刘佐仁，侯鸿军，杨世民
AUTHORS：	JIA Xiayi，ZHU Yanbing，LIU Zuoren，HOU Hongjun，YANG Shimin
关键字：	药品上市许可持有人；药品不良反应损害救济体系；影响因素；药品生产企业
KEYWORDS：	Marketing authorization holder； ADR damage relief system； Influential factor； Pharmaceutical manufacturer
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