上市后大数据药品安全主动监测模式研究的必要性和可行性

发布时间：2018-04-14 19:31

本文选题：大数据 + 药品安全　；参考：《药物流行病学杂志》2016年07期

【摘要】：药品安全性日趋成为威胁人类生命和健康的严重公共卫生问题,关系到公众生命健康权益的维护和保障,关系到经济健康发展和社会和谐稳定,关系到全面建设小康社会宏伟目标的实现,预防和控制药源性损害刻不容缓。现行国内外药品不良反应监测是以自发报告的被动监测为主,容易发生漏报,且由于缺少用药基础人群数量,无法计算不良反应发生率;而流行病学专题调查为主的主动监测花费通常较高,而且费时、费力,时效性较差。欧美等发达国家已建立基于大数据的药品上市后安全性主动监测系统并取得显著的效果。随着相关政策法规的颁布和实施,以及医疗数据的不断积累和质量提升,我国已逐渐具备开展药品安全大数据主动监测研究的条件。基于大规模电子医疗数据开展药品不良反应主动监测模式研究将为实现对药品安全更及时、有效地监测开辟新的途径和方法。
[Abstract]:Drug safety has increasingly become a serious public health problem threatening human life and health, related to the protection and protection of the public's rights and interests of life and health, and related to the healthy development of economy and social harmony and stability.Related to the realization of the grand goal of building a well-off society in an all-round way, it is urgent to prevent and control the drug source damage.The current monitoring of adverse drug reactions at home and abroad is mainly passive monitoring, which is easy to fail to report, and it is impossible to calculate the incidence of adverse reactions because of the lack of the number of people on the basis of drug use.The active surveillance based on epidemiological survey is usually expensive, time-consuming, laborious and inefficient.Developed countries, such as Europe and America, have established the active monitoring system of drug safety after marketing based on big data and achieved remarkable results.With the promulgation and implementation of relevant policies and regulations, as well as the continuous accumulation of medical data and the improvement of quality, China has gradually possessed the conditions for active monitoring and research of drug safety big data.The research on active monitoring mode of adverse drug reactions based on large scale electronic medical data will open up a new way and method for the timely and effective monitoring of drug safety.
【作者单位】：北京大学公共卫生学院流行病与卫生统计学系;
【基金】：国家自然科学基金项目(编号:81473067) 中国博士后科学基金项目(编号:2015M570905)
【分类号】：R954

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