Gildeeva Geliya, Belostotsky Andrey
a Pharmaceutical Science Department , I.M. Sechenov First Moscow State Medical University , Moscow , Russia.
Curr Med Res Opin. 2017 Dec;33(12):2161-2166. doi: 10.1080/03007995.2017.1336082. Epub 2017 Jun 25.
This review outlines current issues of the pharmacovigilance (PV) system in the Russian Federation, namely the present state of regulatory aspects, regulatory requirements in both Russia and the Eurasian Economic Union, and review of causes of under-reporting of adverse drug reactions. Specific attention will be focused on how the system is designed to monitor drug safety functions, reporting and accountability of pharmaceutical products, their manufacturers and medical staff, the role played by regional centers for drug-safety monitoring, and insufficient understanding of the part taken by patients in the system of PV. The prospects of the Russian PV system and its harmonization with global practice will also be discussed.
本综述概述了俄罗斯联邦药物警戒（PV）系统当前存在的问题，即监管方面的现状、俄罗斯及欧亚经济联盟的监管要求，以及药物不良反应报告不足的原因。将特别关注该系统如何设计以监测药品安全功能、药品及其制造商和医务人员的报告与问责制、地区药品安全监测中心所发挥的作用，以及患者在药物警戒系统中所起作用的认识不足。还将讨论俄罗斯药物警戒系统的前景及其与全球实践的协调。
