Using RFID for Pharma End-to-End Traceability Pilot Phases 1 and 2

Describe the Axia Institute’s Pharma End-to-End Traceability Pilot:  What was the impetus, the study goal, who is involved, and how does RFID play a role? 

Bahar:

We, at the Axia Institute at Michigan State University, initiated this project to help the healthcare and pharmaceutical industries track medications, making them safer for patients and the supply chain more efficient. The goal was to test whether Radio Frequency Identification (RFID) technology could provide a more effective way to track drugs from start to finish – from the point of manufacture to the patient – while meeting government regulations, such as the Drug Supply Chain Security Act (DSCSA),and industry standards like GS1.

Currently, most medications use a barcode system, the same system that consumers use when using self-checkout scanners. This has some limitations, mainly the barcode needing a clear view for the scanner to scan. If there is not a clear line of sight, it can lead to extra work and items being missed.

Unlike barcodes, RFID scans use radio waves and capture individual and/or bulk items. Passive UHF RFID tags encoded with GS1 standards can contain all the critical information about medication, including Global Trade Item Number (GTIN), serial number, lot number, and expiry date. This helps track products in real-time and integrates with current inventory systems, reducing errors. RFID was originally identified as a technology capable of delivering Electronic Pedigree Information (a digital record of a pharmaceutical product) and is a key tool for making medications safer for patients. The digital record authenticates that the product is genuine and untampered, preventing counterfeit drugs from entering the supply chain.

So, the main goal of this study was to see if RFID technology could track pharmaceuticals from the very beginning to the very end. We wanted to show that this technology, when following standard rules (like those from GS1 and the FDA’s DSCSA), could actually solve these supply chain problems and ultimately enhance patient safety. Phase 1 of the End-to-End Pilot was completed in 2023 and simulated using RFID in a lab-based setting. Phase 2 of the project specifically aimed to prove this works in a real-world setting and to develop an online platform (a cloud-based system) to help manage the tracking data.

The pilot project is a collaborative effort led by us, conducted in close collaboration with key industry partners, which we refer to as our “Pilot Advisory Group.” Phase 2 was funded by a number of our partners representing the key nodes of the pharma supply chain: Fresenius Kabi (manufacturer), Cencora (wholesaler), CCL eAgile (tags and software provider), Barcoding Inc., Antares Vision Group, IntelliGuard, and GS1 US. Their participation in providing pharmaceutic products, RFID tags, reading equipment, and totes as well as their insights were crucial to the successful planning and execution of the pilot.

You just completed Phase 2, what were the most impactful results?

Bahar:

The project was planned in phases. Phase 1, completed in 2023, successfully showed that RFID was technically feasible for tracking individual drug units in a lab . Phase 2 then took it a step further, testing the system in a real operational setting, like a wholesaler’s warehouse. A significant win in Phase 2 resulted in 100% traceability for 6,920 tagged items, allowing for the automatic detection and resolution of any issues immediately. This demonstrated that using RFID can create a highly secure medication supply chain. All exceptions, such as missing or extra products, were automatically identified and corrected in real-time, preventing the errors from moving further in the supply chain. The integration of RFID with IoT improved process efficiency and enabled real-time decision-making and error correction. Significantly, the pilot validated a chain of custody, showing that a highly secure medication supply chain is achievable with RFID. The system required minimal training, improving “people ROI” by reducing manual labor. The findings have important implications for controlled substance handling, potentially preventing diversion and supporting the U.S. Drug Enforcement Administration’s (DEA) requirements, such as Automation of Reports and Consolidated Ordering System (ARCOS) reporting through real-time tracking and automation.

How are Phases 1 and 2 of the pilot connected?

Bahar:

Phase 2 was built upon the success of Phase 1. Phase 1, completed in 2023, focused on the technical feasibility of RFID technology in a laboratory setting. It tested RFID performance for aggregation from sellable unit to the tote level using an RFID tunnel. Phase 1 also involved preliminary tests to determine optimal tag placement and tested different RFID tags and their readability on various drug formulations, including liquids and solids, within totes. The most efficient tag from Phase 1 was selected for Phase 2. Phase 2 expanded the testing to evaluate the robustness and interoperability in operational environments, including a real wholesaler distribution center (Cencora in Williamston, Michigan). It also extended the aggregation testing from tote level to pallet level using an RFID transition portal and pallet wrapper. In Phase 2, four full pallets of pharmaceuticals—comprising various drug formulations and packaging configurations provided by FK—were utilized. Each product at its lowest saleable unit was affixed with an RFID tag encoded in accordance with GS1 Tag Data Standard (TDS) version 2.X. These tags contained essential traceability data, including the GTIN, serial number, lot or batch number, and expiration date. Products at the lowest saleable unit were aggregated into cases, each assigned a unique Serial Shipping Container Code (SSCC). These cases were then stacked onto pallets. All Serialized Global Trade Item Numbers (SGTINs) and SSCCs were scanned and consolidated to generate an Electronic Product Code Information Services (EPCIS) event file using the CCL eAgile software platform. These EPCIS files enabled precise tracking of product movement across different locations using Axia Observer Platform, an IoT-based software solution designed to track materials across the supply chain.

The results from both phases of the pilot clearly demonstrated the effectiveness of RFID technology in enabling end-to-end traceability of pharmaceutical products. This approach not only ensured full compliance with regulatory requirements but also significantly enhanced supply chain visibility, operational efficiency, and data accuracy.

What will Phase 3 entail, and what are you hoping to learn? 

Bahar:

Phase 3 will be around “Pharmacy Workflow Integration,” which Axia plans to see how RFID technology works in actual pharmacies and hospitals, aiming to track drugs from the manufacturer tagged medications using GS1 standards, all the way to the patient. It will involve introducing real pharmacy systems and staff. The phase aims to simulate dispensing, returns, and reorders. The overarching goal is to close the loop on item-level tracking from Manufacturer -> Wholesaler -> Pharmacy -> Patient. The goal is to learn how RFID integrates into actual pharmacy and hospital workflows and to validate its effectiveness in completing the traceability journey to the patient level.

How can we learn more about the pilot and each of its phases?

Bahar:

To learn more about the pilot, go to https://bit.ly/AxiaPilot.