Ensuring Patient Safety and Regulatory Compliance with Advanced Pharmaceutical Supply Chain Systems

Abstract

The Drug Supply Chain Security Act (DSCSA) aims to enhance the integrity of the pharmaceutical supply chain within the United States by incorporating serialization, traceability, and electronic data exchange for prescription drugs. The capacity to securely and efficiently provide real-time monitoring and tracking of a product throughout the supply chain using edge IoT devices, data pipelines, serialization technologies, and cloud-based compliance methods are a unified, component-focused method. Compliance with the GS1 EPCIS standards, exception/recall management, and unique identification of a product using 2D Data Matrix barcodes are important components of adherence to the DSCSA. The ecosystem we have described is built on RFXCEL's technology (for example: Traceability System, Integrated Monitoring, Accurate Immunization Management), which provides a response to complex needs, such as the tracking of temperature-sensitive medications, whilst also enabling direct connectivity to electronic health records. A pilot study conducted at five high-volume retail pharmacies exhibited a large reduction in the response time to a recall, improved inventory accuracy, and adherence to compliance with DSCSA standards, while supporting patient safety. This technology is a compelling alternative to blockchain solutions in the pharmaceutical industry as it supports real-time data capture and alerts while improving the operational capabilities and security of the pharmaceutical supply chain in compliance with FDA and DEA traceability standards.