论药品不良反应信息通报制度的目的与作用

目的:利用《药品不良反应(ADR)信息通报》,进一步发挥药物警戒与干预的作用,有效避免或减少ADR。方法:收集国家ADR监测中心自2001年11月～2009年5月发布的共22期《ADR信息通报》,运用Excel软件进行数据分类统计,探讨《ADR信息通报》制度的目的与作用。结果:《ADR信息通报》的定期公布,使ADR病例报告数量显著提高,但同时也存在政府监管部门与临床用药单位信息反馈滞缓,部分药品反复通报但ADR仍重复发生与蔓延等现象。被通报药品中,中药ADR居多,占25%以上;重复通报的14个药品中,中药高达50%。结论:需进一步采取多种形式加强ADR的宣传与培训,使医务人员有效利用《ADR信息通报》,确保公众用药安全。

Purpose and Effect of the Information Notification System of Adverse Drug Reactions

OBJECTIVE： To bring the effect of the pharmacovigilance and intervention into full play through ＂ADR （adverse drug reactions） Notifications＂ in order to effectively avoid or reduce the incidence of ADR. METHODS： The data collected from a total of 22＂ADR Notifications＂ （periodical No. 22） issued from Nov. 2001 to May 2009 by national ADR Monitoring Center were analyzed statistically by using Excel software, and the purpose and effect of the ADR notification system were discussed. RESULTS： Through periodic publication of ＂ADR Notifications＂, the number of the informed ADR cases increased markedly. The delayed information feedback of government supervision department and clinical medication department were also noted, and some drugs were notified repeatedly yet the ADR induced by these drugs occurred repeatedly and extensively. Most of reported ADR cases were induced by traditional Chinese medicines, by which more than 25% of the ADRs were induced, and more than half of the 14 kinds of repeatedly notified drugs were traditional Chinese medicines. CONCLUSION： Numerous methods should be taken to strengthen ADR monitoring and training of medical staff to effectively utilize ADR notifications to ensure medication safety of the public.