When supply chain folks think about anti-counterfeiting in the pharmaceutical supply chain, we naturally think about bar codes and RFID. Those technologies have a role to play, but the requirements go far beyond the simple tracking that occurs in many other supply chains.
My colleagues Janice Abel and John Blanchard have written an ARC Insight (available to ARC clients only) on preventing counterfeiting in the pharmaceutical industry that documents the breadth of this problem, outlines global anti-counterfeiting regulatory initiatives, and delineates the various anti-counterfeiting technologies and the primary vendors who supply them.
What I found interesting was the role of non-scan-based technologies. As my colleagues wrote:
The FDA also issued draft guidance on July 13, 2009 covering the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to counterfeit and to make it easier to identify the genuine version of the drug. PCIDs, inactive ingredients that can be detected and authenticated to deter counterfeiting, are added to coatings, capsule shells, encapsulated particles, or tablet layers of solid oral dosage forms (SODFs) for on-dose protection. PCIDs for SODFs include inks, molecular taggants, pigments, and flavors. The guidance recommends using PCIDs listed in the FDA’s Inactive Ingredient Guide, adding the smallest amount possible and placing them on SODFs so that they do not interact with the API or interfere with the drug release.
Inert substances that are combined with active ingredients in a drug are known as excipients. The kinds of excipients described above are used for covert identification, as opposed to bar codes and RFID tags that are typically not covert. Because of the complexity of the excipient industry, the FDA determined that a paper trail would provide the fastest and least-disruptive approach to tracking chain of custody through the supply chain.
Ideally, however, the excipient approach should be combined with technologies that aid in tracking drugs through a multi-tiered supply chain, from the factory all the way to a drug store’s shelves. Here RFID and bar coding are used to support serialization, ePedigrees, and track and trace. ePedigrees are an electronic record that contains information about each transaction that results in a change of ownership of a given dangerous drug, from sale by a manufacturer through acquisition and sale by one or more wholesalers or retailers. The pedigree needs to be created and maintained in an interoperable electronic system, ensuring genealogy throughout all stages of distribution.
End-to-end tracking and tracing goes even further than ePedigrees. In addition to tracking the changes in ownership, tracking involves knowing the physical location of a product throughout the supply chain at all times, as well as the time spent at each location, environmental storage conditions, and packaging hierarchies that answer questions such as: How many bottles in a case? How many cases on a pallet? What are the dimensions of each of those units? And how does the packaging hierarchy change at each step of the supply chain.
Creating ePedigrees and performing detailed track and trace requires serialization—i.e., a unique serial number for every unit or item produced that can be used to track and trace the product across the supply chain.
ARC is conducting a multi-industry anti-counterfeiting web survey. If you are interested in this topic, please take a few minutes to fill out the survey.