2026 80th Anniversary
International Convention of PSK

D+12
October 21-23, 2026

Abstracts

P10-4

An evidence-guided AI agent for adverse drug reaction causality assessment using the naranjo algorithm

  • Heeyeon Kwon1, Ha Young Jang*2, Sang Pyo Lee*4, Hyeonseo Park2, Changhoon Park2, Soyeung Mo3, Namkug Kim1, Sung-Yoon Kang4
  • 1Department of Convergence Medicine, University of Ulsan College of Medicine, Asan Medical Center
  • 2College of Pharmacy, Gachon University
  • 3Department of Biologics, College of Pharmacy, Gachon University
  • 4Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University College of Medicine, Gachon University Gil Medical Center

Manual assessment of adverse drug reaction (ADR) causality can require reviewing hundreds of medical records per case, creating a workload that can contribute to underreporting and inconsistent assessments. We present an evidence-guided AI agent for automated Naranjo assessment using real-world electronic medical records (EMRs) generated during routine clinical care. A large language model extracts candidate evidence from clinical notes, medication records, and test results. Predefined rules verify its source, relevance, and timing before guiding item-level answers and calculating scores. This separation is designed to reduce hallucinations, or unsupported AI-generated claims, by requiring evidence verification before causality judgments. The agent searches additional records for unresolved questions and returns answers, scores, causality categories, and supporting evidence. In a preliminary evaluation using EMRs from 19 development cases reported at Gachon University Gil Medical Center (2020-2023), item-level agreement under the evaluation criteria was 94.1% across eight Naranjo questions (152 responses), and causality category agreement was 89.5% (17/19). All 309 checked quotations matched source records. By integrating evidence retrieval, verification, and scoring, this framework provides a traceable foundation for automating pharmacovigilance review.


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