ARCHITECTING DSCSA-COMPLIANT SYSTEMS FOR REAL-TIME INVENTORY MANAGEMENT IN HIGH-VOLUME RETAIL PHARMACY NETWORKS

Abstract

The U.S. Drug Supply Chain Security Act (DSCSA) requires stakeholders in the pharmaceutical supply chain to provide a means for unit traceability, type verification, and serialization of prescription medications. Considering the number of prescriptions dispensed by high-volume retail pharmacy operations, those very systems also encounter significant challenges with real-time compliance, such as managing inventory and keeping patients safe. This paper introduces an integrated architecture that marries DSCSA-compliant serialization standards with state-of-the-art supply chain visibility tools available from RFXCEL. The system utilizes the capabilities of the end-to-end traceability provided by the Traceability System of rFXCEL (rTS), the Integrated Monitoring (rIM) and the Accurate Immunization Management (rAIM) systems, including handling of temperature-sensitive drugs and integration with the electronic health records (EHRs) and public health records. A pilot implementation was performed in five high-volume retail pharmacies, where RFXCEL was interfaced to enterprise inventory systems. Inventory accuracy, recall response time, patient safety indicators, and regulatory compliance rate were major metrics analysed. The ability to rapidly read, parse, and retain Track and Trace data meant 35% better inventory accuracy, 45% faster recall response, and almost-full DSCSA compliance. Patient safety was enhanced by reducing the potential for counterfeit drug dispensing. The architecture of the system allows the data capturing, monitoring and alert generation to be done in real time, which enables agility in pharmaceutical logistics. Unlike blockchain-focused strategies, the model is pragmatic, compatible with standards, and already used in national hubs (e.g., Bahrain). Combining RFXCEL’s suite with DSCSA-compliant workflow, the solution provides a scalable answer for pharmaceutical traceability. This paper presents a validated, non-blockchain system to meet the DEA and FDA traceability requirements that still have the potential to improve operational capability and protect public health.