At the just-held Global Track & Trace meeting (Ringoes, NJ; Oct. 25), representatives from AmerisourceBergen presented a radically new approach to serialization and e-pedigree, the long-sought measures to secure pharma distribution against counterfeiting and diversion. The proposal: serialize only to the lot level, rather than put a unique ID code on each unit package of products shipped. While this is a lower level of security than item-level serialization, “it gets us part of the way there, and makes a foundation for later development of item-level serialization,” according to one source at the meeting.
Advantages: lot serialization would eliminate most, if not all, “aggregation” and “inference” problems—the difficulty of matching each coded package of a shipment to the case or carton in which it is shipped. Lot numbers are only occasionally identified and their data stored, in current distribution practices; specifying a lot code would allow for more workflow coordination. Lot-level serialization would be easier and less expensive to implement, and the process of recoding numbers and passing pedigree from, say, a distribution center to a retail pharmacy, would be easier to carry out.
Disadvantages: if a lot has, say, 1000 packages all with the same number, then it becomes easier to duplicate that number on a counterfeit package and have the counterfeit flow into the supply chain. Recalls, should they occur, would require the entire lot to be recovered, as opposed to individual packages. And the chance to link patients with manufacturers for such activities as medication adherence programs becomes more problematic. Finally, the change would require a rethinking of both the California e-pedigree program, for which companies are already anticipating a 2015 deadline, as well as federal actions like the re-introduction of the Safeguarding America’s Pharmaceutical Act (HR 3026), sponsored by Rep. Jim Matheson (D-UT), which occurred on Sept. 22.
According to sources at the meeting, another element of the program would be a strict and thorough nationwide distributor licensing program, which is done currently state-by-state, with varying standards. The two measures would tighten security for the national distribution supply chain, and provide some degree of transparency to the distribution process. Although individual companies are progressing on various pilot or commercial-scale serialization efforts, the overall cost—more than $1 million per packaging line, and totaling several billion dollars overall, is still a daunting hurdle. The proposal is circulating among an informal group of industry serialization project developers, and might become the official stance of industry trade associations as the Matheson bills and others get considerations in the current Congress.