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.