According to its press release, DoseID is “the first member-driven industry consortium for the use of radio-frequency identification (RFID) technology in the healthcare space.” That statement is debatable on several levels, in that RFID is being used for, among other things, asset management for hospital equipment—but let’s not quibble. The announcement appears to bring together several trends that collectively, could make RFID a preferred vehicle for serializing pharma products, at the item level, and providing not only compliance with the Drug Supply Chain Security Act (DSCSA) but also operational benefits in hospital pharmacies and elsewhere.
DoseID lives at Auburn University, where Dr. Bill Hardgrave, SVP for Academic Affairs, founded the RFID Lab, within which a function called the ARC Lab has provided certification for RFID applications in retail and aerospace over the past 15 years. Fifteen years ago happens to be around the time when pharma manufacturers and distributors began experimenting with RFID item-level tagging, but over the next 3-5 years the technology was mostly abandoned in favor of 2D barcoding. Today, nearly all newly manufactured pharma packages have those barcodes, and under DSCSA mandates, pharma products will be tracked from the factory to the pharmacy by 2023.
Founding members of DoseID include Omnicell Inc., Sandoz, Baxter, Hikma, Nephron Pharmaceuticals, Avery Dennison, Kit Check, MPI Label System and CCL Healthcare. Kit Check, notably, has been deploying RFID tagging for drugs used in hospital pharmacies, and participated in the recently concluded FDA Pilot Program for DSCSA advances. According to the company, more than 75 million dosages have been tracked within 500 hospital customers using its technology.
“Sandoz is committed to driving innovation that improves access to medicines, and we encourage the industry towards RFID technology. We believe this will be game-changing in the hospital setting, and we are proud to be at the forefront as one of the founding members of DoseID,” said Carol Lynch, president, Sandoz, in a statement. “This collaboration uniquely fits with our goal of creating strategic alliances to ensure patient access to critical, high-quality, affordable medicines when they need them.”
Significantly, DoseID participants see operational values that go beyond DSCSA compliance, at least in the hospital setting. These include reducing medication errors, ensuring expired product is not dispensed, and further automating pharmacy practices. Kit Check touts the fact that when its tagged product is included in the med-surg trays used in operating rooms, unused (but unexpired) dosages can be safely re-kitted, cutting pharmacy waste.
A foundational aspect of DoseID is to create standards for performance and interoperability among RFID device makers, label converters, and IT solution providers that would generate or store serial data. Within the ARC Lab, a set of standards on how RFID devices can be analyzed for quality and performance have been developed (and the ARC Lab can perform this testing). The consortium’s website makes reference to GS1 EPC standards (a basic step followed by most organizations involved in DSCSA compliance today), but also indicates a desire to go beyond them in order to accommodate other types of product information. A somewhat startling element of the DoseID standards effort is to have a master data repository as “the central database that all members can access to create new serialized items, log events and view an item’s history.” Such a one-off, centralized repository for the entire industry has been the bane of many, many DSCSA discussions over the years: a significant part of the pharma industry will resist enabling all its traceability data to be stored in this manner.
Another key question (and we’re surely getting ahead of ourselves here) is how the consortium forming up around DoseID will interact with the Partnership for DSCSA Governance (PDG), a less-than-one-year-old group whose mission is to help establish interoperability among pharma supply-chain participants. Two industry groups with the same general goal, but non-overlapping members, usually spells trouble for both.