2026 CONVENTION
Shared constraints and divergent priorities emerge across pharmacovigilance stakeholders: a qualitative focus group study
Public pharmacovigilance data support safety monitoring, but usability may vary across stakeholders. This study examined unmet needs and compared academic and industry perspectives on the use, limitations, and future directions of the Korea Adverse Event Reporting System (KAERS). Semi-structured focus groups with purposively sampled academics (n = 5) and industry professionals (n = 6) covered current use, barriers, and future directions. Transcripts were analyzed by group using Braun and Clarke’s thematic analysis. Multiple analysts independently coded an initial subset, resolved discrepancies by consensus, and compared findings using a matrix-based approach. Reporting followed the Consolidated Criteria for Reporting Qualitative Research (COREQ). Four themes were identified: role-dependent KAERS use; information and operational constraints; strategies for obtaining more complete safety information; and expectations of support from public authorities. Both groups recognized KAERS as a valuable pharmacovigilance resource and saw value in complementing it with other safety information. Academics prioritized research usability, new-drug data access, and linkage with complementary healthcare data; industry participants prioritized regulatory use, efficient preprocessing, timely data availability, and regulator-led ingredient-level analysis. These findings reflect shared needs and distinct stakeholder priorities that may inform future data provision and use.