LSPedia held its last two public events of 2022 last week: the industry meeting for our Exceptions Pilot, and the year’s final Customer Advisory Board meeting. Both events pointed to the critical changes on the way for the pharmaceutical supply chain as it prepares for full DSCSA enforcement to go into effect in 2023. Every trading partner must succeed in implementing DSCSA, or risk persistent operational issues that can block prescription drugs from reaching patients.
On November 27, 2023, the remaining measures for DSCSA will go into enforcement, including the need for one-to-one interoperable connections between every pair of trading partners, traceability of products at the individual item level, and the need for transaction data to accompany pharmaceutical product — and to match that product — every time it changes hands. The last of these means that if the data is missing, or if it doesn’t reflect the product, the trading partners involved must report and investigate the issue, and cannot receive or sell it until they find out what went wrong.
Over the last few years, we’ve heard numerous pharma trading partners ask whether regulators will extend the deadline or enforce it in full, given the transformational nature of the changes. After all, DSCSA doesn’t just add new requirements to companies’ supply chain operations, but outlines systemic changes to support the interoperability requirement, the capability to manage a massive increase in the amount of data transacted for receiving and shipping, and the ability to correctly identify problems with that data when they occur. Though it’s a tall order, the answer is yes: the FDA has phased in measures of DSCSA over the last decade, and the FDA signaled in its draft guidance last July that its updates were at the stage of clarification rather than broader shifts in compliance, indicating that the final rules will indeed go into enforcement on schedule.
Pharma trading partners have less than a year to complete this transition, whether they started early or are just examining the issue now. Yet, as the Healthcare Distribution Alliance noted in its recent annual survey on DSCSA serialization preparedness, much of the industry is still only in the early phases of compliance. Distributors polled by HDA called particular attention to dispensers, highlighting the possibility that, at the essential patient-facing end of the industry, pharmacies lack the bandwidth to implement the new rules, despite the potential for the change to directly stall their business.
With vital portions of the industry facing information overload — a hundredfold increase in EPCIS data, and an accompanying leap in potential data errors — we’re pushing forward with a new program that will ease this pressure by providing new tools for exceptions management. Our aim is to first remove guesswork by outlining distinct error scenarios, so that companies can categorize and understand a problem when it surfaces; to prove which communications and resolution options are optimal for continued smooth supply chain operation; and to illustrate the practices and policies that fix the issue, or, better, keep it from happening in the first place.
In short: DSCSA is fundamentally changing the pharma industry, and, powered by our industry-leading Investigator solution, LSPedia is finding the fastest, easiest way for companies to adapt. The Exceptions Pilot is front and center in this effort, extending our values of trusted partnership, expertise, and smart use of technology.
We’re bringing a number of partners with us. More than 15 participant and observer organizations registered to join the project, and, at last week’s CAB meeting, 60% of attendees showed interest in following suit. And we expect the effort to grow: the Exceptions Pilot will have an impact beyond LSPedia and its partners, marking the industry’s path forward in the “new normal” of DSCSA.
Whatever you do, don’t wait too long to adapt. For more information: