As the November 27, 2023 enforcement deadline for the Drug Supply Chain Security Act approaches, companies across the prescription drug supply chain are onboarding EPCIS, causing a massive wave of new file exchanges.
It's a good thing. As outlined by DSCSA, prescription drugs are becoming fully traceable, down to the level of the individual item; this makes it possible to safeguard the U.S. pharmaceutical supply chain at a level never seen before.
However, it's also creating a surge in data that can cause headaches for trading partners -- and migraines for those who haven't paid any attention to EPCIS onboarding or exceptions management. These problems can become negligible if you're using a comprehensive DSCSA solution like OneScan Suite (or OneScan Pharmacy Pro for dispensers), but even so, it's important to have a thorough view of what EPCIS is and how it works.
Last July, the FDA revised its guidance with new standards for the information exchange necessary for product tracing. In addition to phasing out paper transaction records, the FDA made the recommendation that trading partners adopt GS1's Electronic Product Code Information Services standard. The authors wrote that EPCIS was the standard that could best ensure DSCSA compliance, citing its compatibility “with a range of technological approaches” and its broad existing uptake.
The guidance released recommended that trading partners “make a collaborative effort” to follow the shared standard, employing additional systems and practices as needed to make this possible. The move supported the pharma supply chain's transition to a secure, accessible, efficient, and uniform electronic method to confirm that any products exchanged are safe and genuine.
This also made clear that pharma businesses who ignore EPCIS are risking their businesses and their essential partner relationships. As LSPedia CEO Riya Cao said a few months after the release, “There’s no looking back. The FDA has confirmed it, and the industry has conformed.”
It's easiest to explain an EPCIS file as a simple yet thorough event history for a single entity. EPCIS captures and shares supply chain events in a common, interoperable way, providing visibility into a product from its creation to final end-user sale. It enables trading partners to share detailed product data between organizations, supporting accurate track-and-trace operations. Its data consists of events, records of changes that affect a physical item's status.
Basically, EPCIS data details what happened, where and when it happened, and other changes, such as:
EPCIS files record any number of events in exacting detail. Attempting to review a single file manually, depending on its history, can take minutes of scrolling. (Yet another reason to automate as much of the process as you can.) But not only are EPCIS files large and complex, the rate at which they're exchanged is skyrocketing.
In January, LSPedia found that total EPCIS exchange volume in the Test Environment -- where manufacturers test their EPCIS exchange with wholesale customers -- had increased fifteen-fold the previous month. Where volume had been steady at around 1,000 for months, suddenly the volume skyrocketed in December. The increase shows that upstream trading partners are getting on track now.
Item-level traceability, which goes into enforcement on November 27, 2023, means that a file will be generated for each individual saleable unit. Our rough estimate is that, overall, this change will eventually increase overall file exchanges by 100 times.
Trading partners who aren't ready for that volume of EPCIS file exchanges are going to be at risk of expensive slowdowns. (And those who don't comply with DSCSA will be at risk of heavy costs, regulatory consequences, and generally being unable to do business). In fact, some trading partners have even set their own deadlines for partners, to prevent disruptions and ensure that patients continue to receive their medications normally when the DSCSA enforcement deadline arrives. Pharmacies who haven't begun their DSCSA compliance journey yet have a fairly short time left to align with this transformational change.
With massive increases in data complexity and data exchange volume, the industry is bracing for a commensurate increase in the transaction data errors known as exceptions. Every business in the pharma supply chain will need to be ready for these, and they can be unpredictable, particularly as new situations occur across all businesses following the switch to EPCIS.
Without preparation, any pharma trading partner is vulnerable to showstopping problems that take time and money to solve, all while product is quarantined. So, given that there's just seven months left -- which isn't a ton of time, considering the transformational nature of DSCSA -- the best move is to find effective resources quickly.
LSPedia’s mission is to make DSCSA compliance easy and stress-free for any pharma trading partner. Our team can get any business onboarded with EPCIS data -- and improve their operational efficiency -- but we can't extend the deadline or add more time before November 2023. Start early to save yourself some stress.
Here's a few places to start: