Reporting of drug adverse reactions during treatment of COVID-19 in the Russian Federation and the United States

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There are various approaches to the organization and implementation of the pharmacovigilance system. It includes databases of spontaneous reports and electronic monitoring systems involving various parts of the healthcare system in the process of reporting information.


To compare systems for reporting events associated with drug safety issues in the Russian Federation and the United States during COVID-19 pandemics.

Material and methods

We conducted a retrospective analysis of the national databases of the Russian Federation and the United States. Adverse drug reactions associated with the use of drugs for the treatment of COVID-19 were collected from April 28th, 2020, to July 11th, 2021.


Spontaneous reporting system has been shown to be ineffective during the pandemic of COVID-19. The development and regular updating of a direct online reporting system and open access to information on adverse drug reactions to all participants of the pharmacovigilance system could contribute to an increase in the submission of reports.

Key words

COVID-19, drugs, pharmacovigilance, pharmacotherapy, adverse drug reaction