Tracking and Tracing and Authenticating Pharmaceutical Products

We clarify our intentions with industry challenges in mind.

When we first sensed the need for a separate publication on pharmaceutical security that would branch off from Pharmaceutical & Medical Packaging News, Tracking & Tracing Pharmaceutical Products seemed like the perfect name. After all, tracking pharmaceutical items through the supply chain gives manufacturers and other trading partners product visibility and history; tracing seems to suggest a deeper level of identification, almost authentication. (It could’ve been that a few years ago when the name came to me I had the company Microtrace in mind, with its taggant technology for authenticating material identity. Or maybe I was fondly remembering my childhood affinity of igneous rocks and their “trace elements.”)

But some of you have suggested we should have just mentioned authentication all along. It would’ve denoted a difference between track and trace and authentication. (It just would have been a really long name!)

Whatever the case may be, we were thinking about pharmaceutical authentication, too, when we conceived this magazine. (For absolute proof, please see our January 2006 Security Packaging Supplement, “When Track and Trace Meets Authentication.”)

Our own magazine-naming challenge represents the exact challenge you are facing today as you set out to battle counterfeiters and diverters. Tracking your products seems to come to mind first—perhaps spurred by California’s aggressive electronic pedigree rule endeavor as well as FDA’s initial support of RFID. And there are true benefits of an open system for automatic drug identification, as Ulrike Kreysa and Jan Denecker of GS1 Healthcare convey so well in this issue on page 8. Further, Kreysa helps us see how practical and far-reaching such an approach is when she reminds us that pharmacists need a common, accessible, global system, not proprietary tools for each product.

But what about authentication? As we ask in our article beginning on page 14, is tracking a numbered package enough? Is that process itself a means of identifying—or authenticating—a product? Or is further analysis—say examination of a covert or forensic feature—essential to truly ensure that the packages you are tracking contain legitimate products? If so, who performs authentication, and how often?

You may have already asked and answered these questions and may have a covert system for identifying products. Now you may just be figuring out the details of electronic pedigrees (which could clearly be a more burdensome project given the need to work with supply-chain partners). But the pharmaceutical industry and FDA need to distinguish whether there is a difference between track and trace and authentication, and, if so, what needs to be standardized and what shouldn’t be standardized.

Why do I bring up standards? The lack of official standards is probably the biggest hurdle cited when it comes to addressing counterfeiting and diversion. Companies are waiting for mandates and for their supply-chain partner commitments. As Mark Davison from SICPA said at the Global Forum on Anticounterfeiting in Washington, DC, in June, “Until someone says what should be done, the money stays in the pocket.” (Plus, Congress has compelled FDA to develop such standards.)

So, don’t take the same course (I hesitate to call it a mistake) we did when we named this magazine and speak just about drug tracking. Consider what you may do to authenticate products and how that could complement your tracking strategy.

Daphne Allen

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