Leveraging Social Media to Enhance the FDA Adverse Event Reporting System (FAERS) Database for Pharmacovigilance: Applications and Limitations

Abstract

This study examines the potential use of social media data to enhance the FDA Adverse Event Reporting System (FAERS) database for pharmacovigilance purposes. The findings suggest that social media data can be valuable in several ways, including early detection of adverse events, identifying patient perspectives, monitoring drug misuse and abuse, identifying off-label use, and enhancing signal detection in the FAERS database. However, the study also highlights several challenges and limitations associated with using social media data for pharmacovigilance purposes. These include issues related to data quality and reliability, privacy concerns, bias and selection effects, difficulty in data extraction and processing, legal and regulatory considerations, and lack of standardization. Despite these challenges, using social media data for pharmacovigilance purposes has potential benefits, such as providing real-time insights into drug safety issues and allowing for the identification of ADRs that may not be reported to the FAERS system. Nevertheless, further research is needed to address the limitations of social media data and develop best practices for using it in pharmacovigilance. This study contributes to the growing body of literature on the use of social media data for pharmacovigilance purposes and highlights the need for a standardized methodology and regulatory framework for collecting and analyzing social media data in this context.