摘要
药物警戒是保障药品安全的重要手段。随着我国医药卫生事业的迅速发展,药品安全监管体系正逐步完善,涉及药物警戒的相关法规制度亦在逐步建设。为加速建立完善统一的药品安全监管体系,推动我国药物警戒工作与国际接轨,该文系统介绍2015年颁布的世界卫生组织(WHO)药物警戒指标的定义、功能、特点、分类以及该指标在建设药品安全监管体系中的重要意义。强调WHO药物警戒系列指标对我国建设高效规范的药品安全监管体系具有重要的参考价值。
Pharmacovigilance is an important means to ensure drug safety. With the rapid development of the pharmaceutical and healthcare fields, the drug safety monitoring system is continuously improving and the laws and regulations related to pharmacovigilance are gradually building in China. To establish a perfect unity of drug safety monitoring system and implement pharmacovigilance activities to be in line with international standards, this article introduces the definition, functions, characteristics and classification of WHO pharmacovigilance indicators （issue date： 2015） and its important values for the drug safety monitoring system in details. It is emphasized that the series of pharmacovigilanee indicators in WHO are especially significant values for constructing the efficient and normative drug safety monitoring system in China.
作者
曾繁典
ZENG Fandian(Tongfi Medical College, Huazhong University of Science and Technology, Wuhan 430030, Chin)
出处
《医药导报》
CAS
2016年第11期1159-1163,共5页
Herald of Medicine
关键词
药物警戒
药物警戒指标
药品监管
Pharmacovigilance
Pharmacovigilance indicators
Drug safety monitdring
