SafeRx: A Canonical Pharmaceutical Knowledge Integration Framework for Multimodal Medication Safety

Medication-related harm remains a major patient-safety challenge, substantially driven by fragmented pharmacovigilance ecosystems, inconsistent drug nomenclature, heterogeneous interaction knowledge bases, and the absence of unified multimodal medication-safety infrastructures. Existing clinical decision-support systems frequently remain interaction-centered, with limited integration of complementary safety domains such as lactation risk assessment, intravenous compatibility evaluation, and regulatory toxicity overlays. This study aimed to develop and evaluate SafeRx, a provenance-aware pharmaceutical knowledge integration platform designed to harmonize heterogeneous medication-safety data within a unified canonical framework. SafeRx integrated Romanian regulatory product summaries, Danish drug–drug interaction repositories, OpenFDA boxed warning datasets, LactMed lactation safety records, and Stabilis intravenous compatibility data through automated extraction pipelines, ontology-aware canonical substance normalization, AI-assisted semantic enrichment, and pharmacist-supervised governance workflows. The platform consolidated 2190 canonical substances linked to 9463 validated identifier mappings, 9932 canonical interaction pairs enriched with tier-based prioritization and mechanism-aware annotations, 514 regulatory boxed warning records, 1895 lactation safety entries, and 9088 intravenous compatibility records. SafeRx demonstrates the feasibility of constructing an interoperable, explainable, and pharmacist-supervised medication-safety infrastructure capable of integrating heterogeneous regulatory, pharmacologic, reproductive, and physicochemical safety domains within a unified clinically navigable framework for research, pharmacovigilance, and clinical decision-support applications. Future studies should evaluate prospective clinical implementation, electronic health record interoperability, and the real-world impact of tier-based prioritization on prescribing workflows, alert fatigue, and medication-safety outcomes.