Page 7 - 《中国药房》2021年22期

·药事管理·

药品上市许可持有人药物警戒外包的风险因素分析 Δ

吴其聪 ，刘 颖 ，许 燕 ，熊慧瑜 ，刘佐仁 （1.广东药科大学药学院，广州 510006；2.广东省药品不良反
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应监测中心，广州 510080；3.国家药品监督管理局药物警戒技术研究与评价重点实验室，广州 510006）
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2021）22-2689-06
DOI 10.6039/j.issn.1001-0408.2021.22.01

摘 要 目的：分析药品上市许可持有人（MAH）药物警戒外包的风险因素并提出风险管控策略，为MAH顺利实施药物警戒外包
和监管部门制定相应监管策略提供参考。方法：基于委托-代理理论和头脑风暴法初步确定风险因素，并设计调查问卷，采用随机
抽样的方式对广东省内200家MAH的药物警戒工作人员进行问卷调查。采用因子分析法对问卷数据进行统计分析，归纳得出综
合性风险因素并计算其评分。结果与结论：共发放调查问卷200份，回收有效问卷154份，问卷有效回收率为77.00％。因子分析
结果显示，MAH药物警戒外包活动涉及的综合性风险因素主要有4个，按其影响程度由高到低分别为服务提供商与外包管理因
素（3.792分）、MAH因素（3.766分）、法规因素（3.626分）和市场因素（3.610分）。针对上述影响因素，建议MAH在开展药物警戒外
包时，应重视完善外包合同、与服务提供商建立信息沟通机制、加强审计与管理工作、强化自身药物警戒能力及人才建设、明确适
宜的药物警戒外包业务内容、充分做好对服务提供商的事前调查工作；建议相关部门应尽快制定药物警戒委托质量管理规范或指
南，并加强对服务提供商的监管；建议尝试成立药物警戒外包行业协会，并通过充分发挥协会的影响力来规范行业行为，进而避免
外包风险的发生。
关键词 药品上市许可持有人；药物警戒外包；风险因素；因子分析

Analysis of Risk Factors of MAH Pharmacovigilance Outsourcing
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WU Qicong ，LIU Ying ，XU Yan ，XIONG Huiyu ，LIU Zuoren 1，3 （1. College of Pharmacy，Guangdong
Pharmaceutical University，Guangzhou 510006，China；2. Center for ADR Monitoring of Guangdong，Guangzhou
510080，China；3. NMPA Key Laboratory for Technology Research and Evaluation of Pharmacovigilance，
Guangzhou 510006，China）
ABSTRACT OBJECTIVE：To analyze the risk factors of marketing authorization holder（MAH）pharmacovigilance outsourcing
and propose risk management and control strategies， and to provide reference for MAH to successfully implement
pharmacovigilance outsourcing and regulatory authorities to formulate corresponding regulatory strategies. METHODS：Based on
the principal-agent theory and brainstorming method，the risk factors were preliminarily determined，and a questionnaire was
designed. The questionnaire survey was carried out among pharmacovigilance staff of 200 MAH in Guangdong province by random
sampling. The factor analysis method was used to statistically analyze the questionnaire data，and the comprehensive risk factors
and their respective factor scores were summarized. RESULTS & CONCLUSIONS：A total of 200 questionnaires were distributed，
and 154 valid questionnaires were returned，with effective recovery rate of 77.00％. The results of factor analysis method showed
that there were 4 comprehensive risk factors involved in MAH pharmacovigilance outsourcing activities，which were service
providers and outsourcing management factor（3.792 score），MAH factor（3.766 score），regulations factor（3.626 score）and
market factor（3.610 score）from high to low. In view of the above factors，it is suggested that MAH should focus on improving
outsourcing contract， establishing information communication mechanism with service providers， strengthening auditing and
management，strengthening pharmacovigilance ability and personnel building，defining appropriate pharmacovigilance outsourcing
business contents， and fully doing pre-service investigation of service providers， when MAH conducts outsourcing of
pharmacovigilance. It is suggested that relevant departments should formulate pharmacovigilance entrusted quality management
specifications or guidelines as soon as possible and strengthen the supervision of service providers. It is suggested to try to establish
a pharmacovigilance outsourcing industry association， and
Δ 基金项目：广东省普通高校人文社会科学研究重点项目
standardize the industry behavior by giving full play to the
（No.2018WZDXM029）；广 东 省 药 品 监 督 管 理 局 科 技 创 新 项 目
influence of the association，so as to avoid the outsourcing
（No.2019YDZ22）
risk.
＊ 硕 士 研 究 生 。 研 究 方 向 ：药 事 管 理 与 法 规 。 电 话 ：020-
39352118。E-mail：wuqicongtongxue@163.com KEYWORDS Marketing authorization holder；Pharmacovi-
# 通信作者：教授，硕士生导师，硕士。研究方向：药事管理与法 gilance outsourcing；Risk factors；Factor analysis
规、药物警戒管理。电话：020-39352118。E-mail：gdpc1223@163.com

中国药房 2021年第32卷第22期 China Pharmacy 2021 Vol. 32 No. 22 ·2689 ·