Page 15 - 2019年10月第30卷第20期

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 Δ

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贾夏怡 ，朱岩冰 ，刘佐仁 ，侯鸿军 ，杨世民（1.广东药科大学药学院，广州 510006；2.陕西省药品监督管理
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局，西安 710065；3.西安交通大学药学院，西安 710061）
中图分类号 R951 文献标志码 A 文章编号 1001-0408（2019）20-2746-06
DOI 10.6039/j.issn.1001-0408.2019.20.03

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
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卷调查。采用Fisher’s精确检验和Pearson χ 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 χ 检验筛选出9个独立影响因
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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。
关键词 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

Analysis of Influential Factors for the Construction of ADR Damage Relief System under MAH System：
Based on the Perspective of Pharmaceutical Manufacturers in Shaanxi Province
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JIA Xiayi ，ZHU Yanbing ，LIU Zuoren ，HOU Hongjun ，YANG Shimin（1. College of Pharmacy，Guangdong
Pharmaceutical University，Guangzhou 510006，China；2. Shaanxi Drug Administration，Xi’an 710065，China；
3. College of Pharmacy，Xi’an Jiaotong University，Xi’an 710061，China）
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
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exact test，Pearson χ 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
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influential factors screened by Fisher’s exact test and Pearson χ 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.
KEYWORDS Marketing authorization holder；ADR damage relief system；Influential factor；Pharmaceutical manufacturer

Δ 基金项目：广东省药品监督管理局科技创新项目（No.2019YDZ22）
＊硕士研究生。研究方向：药品流通与管理。电话：020-39352118。
E-mail：jiaxiayi@163.com
全国药品不良反应监测网络统计数据显示，近年来
# 通信作者：教授，硕士生导师，硕士。研究方向：药事管理、药物
政策法规。电话：020-39352118。E-mail：gdpc1223@163.com 我国累计收到《药品不良反应/事件报告表》的数量逐年

·2746 · China Pharmacy 2019 Vol. 30 No. 20 中国药房 2019年第30卷第20期