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

Analysis of Necessity and Feasibility in Studies of Post-marketing Drug Safety Active Surveillance Based on Big Data

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。

Drug safety had increasingly became a serious problem of public health. It related to health and life right of public; related to healthy development of economy; related to social harmony and stability; related to the great goal of building a well-off society. However,passive surveillance systems were mainly used currently and had many shortcomings. The conventional epidemiological investigations were time-consuming,high-cost,and could not be real-time surveillance. Development countries as US had built a post-marketing drug safety surveillance systems based on big data,and gained remarkable effects. Following the promulgation and implementation of relevant policies and regulations,and improvement of size and quality of health data,we had already had conditions to carry out related studies. Based on the largescale electronic medical data mode of adverse drug reactions monitoring actively study,this would provide the new thinking and method of active surveillance to realize drug safety more timely and effective.