PVLens: Enhancing Pharmacovigilance Through Automated Label Extraction

Reliable drug safety reference databases are essential for pharmacovigilance, yet existing resources like SIDER are outdated and static. We introduce PVLens, an automated system that extracts labeled safety information from FDA Structured Product Labels (SPLs) and maps terms to MedDRA. PVLens integrates automation with expert oversight through a web-based review tool. In validation against 97 drug labels, PVLens achieved an F1 score of 0.882, with high recall (0.983) and moderate precision (0.799). By offering a scalable, more accurate and continuously updated alternative to SIDER, PVLens enhances real-time pharamcovigilance with improved accuracy and contemporaneous insights.

Ontology-based Semantic Similarity Measures for Clustering Medical Concepts in Drug Safety

Semantic similarity measures (SSMs) are widely used in biomedical research but remain underutilized in pharmacovigilance. This study evaluates six ontology-based SSMs for clustering MedDRA Preferred Terms (PTs) in drug safety data. Using the Unified Medical Language System (UMLS), we assess each method's ability to group PTs around medically meaningful centroids. A high-throughput framework was developed with a Java API and Python and R interfaces support large-scale similarity computations. Results show that while path-based methods perform moderately with F1 scores of 0.36 for WUPALMER and 0.28 for LCH, intrinsic information content (IC)-based measures, especially INTRINSIC-LIN and SOKAL, consistently yield better clustering accuracy (F1 score of 0.403). Validated against expert review and standard MedDRA queries (SMQs), our findings highlight the promise of IC-based SSMs in enhancing pharmacovigilance workflows by improving early signal detection and reducing manual review.

Bridging the Gap in Drug Safety Data Analysis: Large Language Models for SQL Query Generation

Pharmacovigilance (PV) is essential for drug safety, primarily focusing on adverse event monitoring. Traditionally, accessing safety data required database expertise, limiting broader use. This paper introduces a novel application of Large Language Models (LLMs) to democratize database access for non-technical users. Utilizing OpenAI's GPT-4, we developed a chatbot that generates structured query language (SQL) queries from natural language, bridging the gap between domain knowledge and technical requirements. The proposed application aims for more inclusive and efficient data access, enhancing decision making in drug safety. By providing LLMs with plain language summaries of expert knowledge, our approach significantly improves query accuracy over methods relying solely on database schemas. The application of LLMs in this context not only optimizes PV data analysis, ensuring timely and precise drug safety reporting -- a crucial component in adverse drug reaction monitoring -- but also promotes safer pharmacological practices and informed decision making across various data intensive fields.

Extending Consequence-Based Reasoning to SRIQ

Consequence-based calculi are a family of reasoning algorithms for description logics (DLs), and they combine hypertableau and resolution in a way that often achieves excellent performance in practice. Up to now, however, they were proposed for either Horn DLs (which do not support disjunction), or for DLs without counting quantifiers. In this paper we present a novel consequence-based calculus for SRIQ---a rich DL that supports both features. This extension is non-trivial since the intermediate consequences that need to be derived during reasoning cannot be captured using DLs themselves. The results of our preliminary performance evaluation suggest the feasibility of our approach in practice.