VKontakte Social Network as a Data Source for Pharmacovigilance: Applicability for Marketing Authorization Holders

INTRODUCTION. Social media (social networks, forums, review websites, etc.) contain a lot of essential information about adverse drug reactions (ADRs). So far, no previous studies of social media were conducted in the Russian Federation.

AIM. This study aimed to evaluate the possibility of using VKontakte social network as an additional source of ADR reports exemplified by users mentioning the use of metformin, azithromycin, metronidazole, and clotrimazole.

MATERIALS AND METHODS. VKontakte social network was monitored for the period of 09.01.2023 to 03.31.2024 using LITVISOR^® software to collect entries mentioning the use of metformin, azithromycin, metronidazole, and clotrimazole (International Non-proprietary Names). We analyzed the completeness of information about the reporters and the patients, as well as ADRs and special safety situations. The identified safety information was encoded using MedDRA terminology; their seriousness and listedness were assessed.

RESULTS. A monitoring of VKontakte social network resulted in 4,969 entries on the use of azithromycin, metformin, metronidazole, and clotrimazole. We identified 195 ADRs related to 15 systemic organ classes; of them, 93.3% were classified as non-serious and 6.7% as serious. 85.56% of ADRs were expected, while 14.4% were unexpected. Cases of off-label use, overdose, and use in pregnant women were identified. In 35.5% of spontaneous reports, the reporter was identified, in 89.5%, the patient’s sex was known, and in 36.3%, the patient’s age was known.

CONCLUSIONS. The findings show that the monitoring of VKontakte social network is a promising source of data on drug safety approved in the Russian Federation. The study confirms the fundamental possibility of validating the entries from the social network users as spontaneous reports.

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