Pharmacovigilance in Russia: current state of affairs, challenges, and prospects
Gil`deeva G. N., Belostotskij A. V.
Current Medical Research and Opinion
Vol.33, Issue12, P. 2161-2166
Опубликовано: 2017
Тип ресурса: Обзор
DOI:10.1080/03007995.2017.1336082
Аннотация:
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. © 2017 Informa UK Limited, trading as Taylor & Francis Group.
Ключевые слова:
adverse reactions; drugs’ safety monitoring; Eurasian Economic Union; Federal Service for Surveillance in Healthcare; Pharmacovigilance
attention; drug monitoring; drug safety; drug surveillance program; human; medical staff; Review; Russian Federation; adverse drug reaction; Adverse Drug Reaction Reporting Systems; Drug Monitoring; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Russia
Язык текста: Английский
ISSN: 1473-4877
Gil`deeva G. N. Ge`liya Nyazy'fovna 1967-
Belostotskij A. V. Andrej Viktorovich 1967-
Гильдеева Г. Н. Гэлия Нязыфовна 1967-
Белостоцкий А. В. Андрей Викторович 1967-
Pharmacovigilance in Russia: current state of affairs, challenges, and prospects
Текст визуальный непосредственный
Current Medical Research and Opinion
Librapharm Ltd.
Vol.33, Issue12 P. 2161-2166
2017
Обзор
adverse reactions drugs’ safety monitoring Eurasian Economic Union Federal Service for Surveillance in Healthcare Pharmacovigilance
attention drug monitoring drug safety drug surveillance program human medical staff Review Russian Federation adverse drug reaction Adverse Drug Reaction Reporting Systems Drug Monitoring Drug-Related Side Effects and Adverse Reactions Humans Pharmacovigilance Russia
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. © 2017 Informa UK Limited, trading as Taylor & Francis Group.