Patients trust medical systems to protect their safety, particularly when they are being administered medications. However, medication errors are some of the most common health care errors, affecting at least 1.5 million people every year.1 Even before they reach the patient, health systems are also battling a slew of supply chain and management concerns, including shortages, contamination, counterfeiting, and diversion (the illegal distribution of prescription drugs).2,3
The Drug Supply Chain Security Act (DSCSA) was passed to counteract these systemic challenges and enhance patient safety. As of November 2024, the pharmaceutical industry will be required to electronically track and trace drugs throughout their journey from manufacturer to pharmacy.4 To address the critical changes introduced by the DSCSA, there is a clear need for improved drug tracking infrastructure — a need that radio-frequency identification (RFID)-enabled medications and RFID-based medication management systems can help fill to support compliance, enhance data integrity, and improve patient safety.
The Medication Tracking Problem
The DSCSA has been in the works for quite some time, with the ultimate goal of enhancing the FDA’s efforts to protect consumers from harmful prescription drugs that have been counterfeited, stolen, or contaminated. Specifically, it outlines steps and requirements to enable electronic tracing of pharmaceuticals, increasing visibility and creating a more secure and efficient drug distribution system.4
To do this, the DSCSA requires companies and hospitals to improve their medication tracking systems, and it sets requirements for standardized identification and product information that must be represented on the lowest saleable unit. A product identifier is required in a standardized graphic that includes the standardized numerical identifier, lot number, and expiration date of the product in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization. Pharmaceutical manufacturers initially chose the data carrier as a 2-dimensional (2D) data matrix barcode, though room exists within DSCSA for other technologies to be used. This is where an opportunity exists to support DSCSA-driven safety improvements with RFID technology.
Raising the Bar for Medication Tracking
If you’ve shopped in a big retail store like Walmart or Target, you’ve likely encountered RFID-driven systems and their unique RFID tags before. RFID tags can store critical product information and provide many key benefits. Namely, they are recognized automatically by radiofrequency readers, even if they aren’t in the direct line of sight of the reader, and some RFID systems are capable of scanning thousands of tags at once. This enables immense flexibility, visibility, and optimization of medication tracking workflows.5
RFID-based systems can facilitate medication safety and compliance with the DSCSA, while also addressing many of the inefficiencies associated with current medication inventory management. RFID tags that meet GS1 standards (a not-for-profit information standards organization) are readable anywhere, creating consistency and interoperability across the medication supply chain and meeting one of the fundamental goals of DSCSA. RFID tags can also hold a large amount of data, including tag IDs and the information required by DSCSA: the global trade item number, serial number, lot number, and expiration date. This identifying information is embedded in the label, further reducing the risk of counterfeiting and tampering. In the event of a recall, these serialized RFID tags and their embedded data can help staff track down medications within a larger hospital system and trace which patients might have received a recalled product.
