Problem of insufficient involvement of population into pharmacovigilance system

A. E. Krasheninnikov , B. K. Romanov , R. S. Safiullin

Perm Medical Journal ›› 2018, Vol. 35 ›› Issue (4) : 50 -55.

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Perm Medical Journal ›› 2018, Vol. 35 ›› Issue (4) :50 -55. DOI: 10.17816/pmj35450-55
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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.

Keywords

Pharmacovigilance / unfavourable response / spontaneous messages / population reporting

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A. E. Krasheninnikov, B. K. Romanov, R. S. Safiullin. Problem of insufficient involvement of population into pharmacovigilance system. Perm Medical Journal, 2018, 35(4): 50-55 DOI:10.17816/pmj35450-55

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References

[1]

Загородникова К.А. Организация мониторинга безопасности лекарственных средств в мире - методологические подходы. Тихоокеанский медицинский журнал 2015; 1: 11-15.

[2]

Затолочина К.Э., Снегирева И.И., Казаков А.С., Колесникова Е.Ю. и др. Современные подходы к сбору и репортированию информации о побочном действии лекарственных средств. Безопасность и риск фармакотерапии 2017; 1: 32-38.

[3]

Мурашко М.А. О мониторинге безопасности лекарственных препаратов. Рациональная фармакотерапия в кардиологии 2014; 10 (6): 688-691.

[4]

Петров В.И., Смусева О.Н., Соловкина Ю.В. Совершенствование мониторинга безопасности лекарственных средств в регионах на примере Волгоградской области (фармакоэпидемиологическое исследование). Профилактическая и клиническая медицина 2011; 3 (40): 73-75.

[5]

Федеральный закон от 12.04.2010 № 61-ФЗ «Об обращении лекарственных средств». Российская газета 2010; 78, available at: https://rg.ru/2010/04/14/lekarstva-dok.html

[6]

Хосева Е.Н. Оптимизация системы контроля эффективности и безопасности воспроизведенных лекарственных средств отечественного производства: автореф. дис.. д-ра мед. наук. М. 2014; 49.

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Krasheninnikov A.E., Romanov B.K., Safiullin R.S.

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