Problem of insufficient involvement of population into pharmacovigilance system

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Abstract

Aim. To ground the necessity of taking into account the double-component nature of the phenomenon of poor activity of the population in the system of pharmacovigilance so as to work out the measures, aimed at development of UR reporting. The process of formation of a modern system of pharmacovigilance in Russia with appropriate level of reporting on the cases of unfavorable response (UR) to application of drugs is difficult because of the absence of involvement of the population into the system of spontaneous messages.

Materials and methods. The methods of content-analysis of messages and surveys were used; the measures, promoting development of the level of reporting on unfavorable responses to drugs were worked out. The object of the analysis included randomized sampling of 100 tests of messages for the period of 2009–2017, the selection criterion of which was the category “side effects of drugs”. The survey was conducted in direct form among the inhabitants of Kazan in 2018.

Results. Pharmacovigilance of the population in Russia is insufficiently developed and concentrated mainly in metropolitan region (Moscow, Moscow region) and neighboring regions (Republic of Tatarstan, St. Petersburg). Pharmacovigilant culture of the population in Russia has an insufficient level of development and is expressed by lack of correct notions of pharmacovigilance system in this country (responsible state institutions, reporting channels) among the citizens that, probably, makes their participation in active reporting difficult.

Conclusions. When influencing both factors, we can form the basis for working out the measures of efficient development of the proper level of UR reporting among the population of the Russian Federation.

About the authors

A. E. Krasheninnikov

National Research Center of Pharmacovigilance

Author for correspondence.
Email: anatoly.krasheninnikov@drugsafety.ru

кандидат фармацевтических наук, генеральный директор

Russian Federation, 2-2, Malaya Sukharevskaya sq., Moscow, 127051

B. K. Romanov

Pirogov Russian National Research Medical University; Center of Science of Examination of Means of Medical Application

Email: anatoly.krasheninnikov@drugsafety.ru

доктор медицинских наук, исполняющий обязанности заведующего кафедрой фармакологии педиатрического факультета, заместитель генерального директора по научной работе

Russian Federation, 1, Ostrovityanova str., Moscow, 117997; 8-2, Petrovskyi b-d, Moscow, 127051

R. S. Safiullin

Kazan State Medical University

Email: anatoly.krasheninnikov@drugsafety.ru

доктор фармацевтических наук, профессор, заведующий кафедрой управления и экономики фармации

Russian Federation, 49, Butlerova str., Kazan, 420012

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Supplementary files

Supplementary Files
Action
1. JATS XML
2. Fig. Ranking of constituent entities of the Russian Federation by the volume of shares in the general array of reports on the side effects of medicines from citizens (%)

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Copyright (c) 2018 Krasheninnikov A.E., Romanov B.K., Safiullin R.S.

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This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
 


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