The role of pharmaceutical professionals in spontaneous reporting of adverse drug reactions in Russia

Background. Underreporting of adverse drug reactions is a pressing public health concern in the Russian Federation. Addressing this requires evaluating the pharmacovigilance system performance, analyzing stakeholder involvement (patients, healthcare and pharmaceutical professionals, and industry representatives), and refining existing approaches through the enhancement of interagency cooperation and digital solutions.

Objective: To assess the role and level of involvement of pharmaceutical professionals in the spontaneous reporting system of the Russian Federation, identify the primary barriers hindering their participation, and determine areas for improving pharmacovigilance.

Materials and methods. The study analyzes public statistical data from regulatory agencies in the Russian Federation (Roszdravnadzor), the United States (FAERS), and Germany (BfArM) to compare the reporting profiles of key groups. Due to the lack of aggregated national data for the Russian Federation, the authors conducted a survey in 2025 via the Yandex Forms platform, involving 101 respondents (consumers, healthcare professionals, and pharmaceutical professionals).

Results. The study analyzed the causes of underreporting across all target groups, evaluating awareness levels, reporting tool availability, motivation, and other contributing factors. A pronounced imbalance was identified in the Russian reporting system: unlike the multi-channel models of the United States and Germany, the majority of reports in the Russian Federation are submitted by healthcare professionals. The conducted survey revealed that pharmaceutical professionals account for only 8% of reports, which is inconsistent with their legal obligations. Healthcare professionals were found to be the primary contributors (61%), followed by pharmaceutical companies (17%) and patients or their relatives (14%). Notably, despite high pharmacovigilance awareness (88.9%), only 40.7% of pharmaceutical professionals reported encountering consumer complaints. Their preferred method of report submission is direct communication with pharmaceutical companies (51.9%), with online reporting forms being the most convenient format (51.9%). Analysis of comments identified key barriers, including insufficient feedback, procedural uncertainty, and a lack of confidence regarding the effectiveness of reports.

Conclusion. The study identified key problem areas and proposed strategies for improving the pharmacovigilance system in the Russian Federation. Pharmaceutical professionals represent a critical but under-involved category of reporters within the pharmacovigilance system. Improving the completeness and quality of drug safety data requires a comprehensive approach, encompassing educational reform, implementation of digital tools to streamline reporting, and the launch of awareness campaigns. Furthermore, it is essential to foster an environment where reporting adverse reactions is perceived as an integral part of professional responsibility.

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