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.
Expectations for DSCSA Compliance
When examining the medication tracking requirements set out by the DSCSA, RFID technology can be a powerful element. RFID not only meets the requirements of the DSCSA, but it can also ensure high degrees of consistency and accuracy with medication tracking — in some cases, more than 99% accuracy.6 It can also enable the tracking of medications throughout hospital systems, all the way to administration. While this level of tracking is not within the scope of DSCSA, it dramatically increases visibility into medication decisions while permitting health care professionals, pharmacy staff, and others within the hospital system to select, move, or immediately put a product to use. RFID-tagged medications can also reduce errors in medication data entry across the supply chain, reduce labor for distribution and inventory management, help streamline and automate inventory management, and ensure that drugs are replenished when needed.
About the Author
Jay Williams is the vice president of business development for Intelliguard, a medication management solutions company that provides real-time data, analytics, and insights to help strengthen the supply chain and create an environment of patient safety. With more than 30 years of industry experience, he works closely with health systems, distributors, and manufacturers to help them leverage the power of end-to-end connectivity to increase efficiencies, reduce waste, and cut costs.
The deadline to be compliant with the DSCSA is set for November 2024, and some in the industry are shifting toward RFID and its associated management systems. Additionally, some manufacturers and distributors are tagging medications with RFID tags as well.7,8 Meanwhile, hospitals have begun tagging their medication inventories with RFID tags and installing RFID tracking systems, advancements that improve end-to-end visibility for medications.9 This represents a growing trend shaping the industry toward broader adoption of RFID and serves as a new standard of health care that aids adherence to DSCSA compliance.
The Next Evolution of Medication Tracking
RFID technology can help address the same challenges that DSCSA has set out to solve while further evolving prescription drug tracking. The future of medication management is synchronized and interoperable, from the manufacturer to the point of use. As with other supply chains, such as in the retail goods sector, each package will be traced from manufacturer to point of care. Enabled by seamless tracking of RFID-based systems, care providers can ensure patients receive the right medications, freeing health care providers to focus on treatment rather than navigating medication dispensing systems. At the same time, systems like these can increase visibility and improve hospital workflows, inventory management system-wide, and challenges like product recalls. Together, this will enhance patient safety and improve efficiency within the supply chain.
REFERENCES
Medication Errors. Academy of Manage Care Pharmacy. Accessed August 7, 2024. https://www.amcp.org/concepts-managed-care-pharmacy/medication-errors
Knight T. Three Health Care Drug Diversion Trends Are Shaping 2023. Pharmacy Times. 2023. Accessed August 7, 2024. https://www.pharmacytimes.com/view/three-health-care-drug-diversion-trends-are-shaping-2023
Fleck A. Counterfeit Drugs on the Rise Globally. Statista. Accessed August 7, 2024. https://www.statista.com/chart/30067/worldwide-counterfeit-pharmaceuticals-incidents/
Drug Supply Chain Security Act (DSCSA). FDA. July 2024. Accessed August 7, 2024. https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
Pilot Study: Drug Security Supply Chain Act (DSCSA) and the Pharmaceutical Chain. Axia Institute. Accessed August 27, 2024. https://axia.msu.edu/wp-content/uploads/2023/11/Axia_Report_RFID_Feasability_Pilot_10252023_FINAL.pdf
The Risk of Relying on Human Perfection. Intelliguard. 2015. Accessed August 8, 2024. https://intelliguardhealth.com/wp-content/uploads/2024/06/Risk-of-Relying-on-Human-Perfection.pdf
Case Study: Fresenius Kabi. GS, Healthcare US. Accessed August 12, 2024. https://intelliguardhealth.com/wp-content/uploads/2024/06/GS1US-Fresenius-Kabi-CaseStudy-111820-hi-res.pdf
AmerisourceBergen Debuts RFID Tagging Service, Allowing Customers Nationwide to Purchase Pre-Tagged Product that is also Technology Agnostic. Cencora. 2021. Accessed August 12, 2024. https://www.cencora.com/newsroom/amerisourcebergen-debuts-rfid-tagging-service
Rady Children’s Hospital Tracks Controlled Substances with RAIN RFID. IMPINJ Insights. Accessed August 12, 2024. https://www.impinj.com/library/customer-stories/rady-childrens-hospital-tracks-controlled-substances-with-rain-rfid
