It is mid-2005—have you mass serialized your drug products yet? If you are following FDA’s final report on anticounterfeiting issued in early 2004, you should be in the thick of it. According to the report, by December 2005 you should have mass serialized some pallets, cases, and packages for drugs likely to be counterfeited.
If you aren’t quite there yet, don’t worry. Your wait may give you the time to consider a serialization method a bit different from FDA’s 2004 suggestion: random mass serialization that is not tied to a product’s code.
FDA defines mass serialization as the assignment of unique numbers, “such as the electronic product code (EPC), to each pallet, case, and package of drugs.” That EPC can then be used to track the product’s path through the supply chain. It can provide “an electronic pedigree from the point of manufacture to the point of dispensing.” FDA says “this unique number would allow each drug purchaser to immediately determine a drug’s authenticity, where it was intended for sale, and whether it was previously dispensed.”
Roger G. Johnston, PhD, CPP, suggests an alternative to the EPC for such serialization. Johnston is a member of the Vulnerability Assessment Team at Los Alamos National Laboratory (Los Alamos, NM). In “An Anti-Counterfeiting Strategy Using Numeric Tokens,” he writes about unique identification numbers, or “tokens.” These are random, nonsequential, and unpredictable numeric or alphanumeric codes that can be used to mark individual pharmaceutical containers. These codes “do not contain information about the product that can be used to help guess valid numbers,” he writes.
Customers, such as pharmacists and even patients, can “call” these numbers in to hotlines or check Web sites to verify authenticity. If the number of customers calling in a particular code exceeds the threshold, which is variable based on the particular supply chain, then the drug manufacturer knows in real or near-real time that counterfeiting has occurred.
Verify Brand Inc. (Minneapolis) cited Johnston’s paper during last month’s Interphex show in New York City. Web-based software from Verify Brand enables label printers or manufacturing facilities to securely request codes, input authorized product specific data, automate and inspect printing, and activate codes recorded in a customer-dedicated Web server in a secure data center. Codes can be printed either as human readable codes or 1-D or 2-D bar codes or RFID tags. On an ASP model, Verify Brand maintains the database of assigned codes, facilitates Web or call center authentication and invalid code detection, and tracks, analyzes, and reports data. “Manufacturers can now be assured that products moving through the supply chain are authentic,” says Kevin Erdman, president of Verify Brand. “If products are not authentic, manufacturers can identify and remove them proactively.” Erdman reports that his firm’s first life sciences customer also intends on integrating the solution into its enterprise resource planning system to integrate product authentication data with all other supply chain information.
Printing or encoding another code along with the encoded National Drug Code will require additional effort, both in package production as well as in postmarket tracking. But you may be able to justify it. Duplication of these random codes could provide clear evidence of a crime.
Whatever approach you take to mass serialization, providing a unique identifier for each package has distinct benefit. Each unit of use will have its own mark that can be easily verified with confidence. With counterfeiting increasing, such confidence is priceless.
Daphne Allen