RFID, Bar Codes and Pharmaceutical Authenticity (Updated)
Tuesday, June 12, 2007 - AIM Connections
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Bert Moore
Editor
Last month saw actions by both the
During the first week of May this year, the US Senate passed the Food and Drug Administration Revitalization Act (S.1082) that included provisions for anti-counterfeiting that specified the use of "overt optically variable counterfeit-resistant technologies" (sec. 514). The intent of this legislation is to ensure that pharmaceutical authenticity can be verified without the use of any type of scanner, microscope or any other specialized reader. Although the Act does not prohibit the additional use of automatic identification technologies, in fact it includes provisions for covert security features as well (and many pharmaceutical manufacturers already employ such technologies), it is clear that neither RFID nor bar codes alone would satisfy the provisions of the Act.
The provisions focus on the growing popularity of non-US Internet-based pharmacies. It includes a provision that, "a standardized numerical identifier (which, to the extent practicable, shall be harmonized with international consensus standards for such an identifier) unique to each package of such drug, applied at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing)." This is intended to prove that the shipment comes from a licensed pharmaceutical supplier and provide a standardized source code for the drugs regardless of whether it comes in the original manufacturer's packaging or has been repackaged.
In a similar vein, the EU Parliament held a high-profile symposium on the problem of counterfeit drugs at the end of May. According to published reports, Bayer AG's Arthur Higgins, who heads the European Federation of Pharmaceutical Industries and Associations, said the introduction of unique coding for each pack of medicine together with authentication, track and trace systems and physical security in the form of tamper-resistant packaging could solve the problem.
However, automatic identification technologies are not being entirely ignored. The sentiment in
While there have been widely publicized pilot projects and implementation of RFID for pharmaceuticals in the US, a lesser known plan is underway on the part of U.K.-based AstraZeneca for its NEXIUM® erosive esophagitis medication. In addition to tamper-evident seals, each carton will contain a unique carton (serial) number encoded in Data Matrix.
Currently, the US FDA requires a bar code identifier of manufacturer and product on "the lowest level of packaging" -- but not necessarily the "unit of use" -- for prescription drugs. Leading pharmaceutical manufacturers, however, have managed to incorporate a composite bar code with the National Drug Code (NDC) within the 14-digit GS1 GTIN as well as lot and expiry information even on individual doses of blister pack medications [see figure 1]. The FDA Bar Code Rule limits the encodation of the NDC in a linear symbology. Additional data can be encoded in a 2D component. In January of this year, GS1 petitioned the U.S. FDA for a change in the Bar Code Rule that would allow the use of Data Matrix in addition to current GS1 linear symbologies. This use of bar codes or matrix symbols, however, is intended for product identification to prevent medication errors and not as an anti-counterfeiting move.
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Figure 1: GS-1 DataBar™ Composite symbol with GTIN (NDC), lot number and expiry date. Courtesy Quint Company |
Still, producing readable bar codes on difficult surfaces, such as the back of blister packs, is no easy task and would require a much higher degree of sophistication on the part of counterfeiters. If drugs are repackaged, however, production of bar codes or matrix symbols on simple self-adhesive labels would pose no great challenge.
However, an anti-counterfeiting, track and trace solution designed to meet today's regulatory e-pedigree requirements has been developed that uses standard bar code symbologies combined with a secure, hashed database in a unique way to serialize individual product units.
Both the
The EU scheme requires pharmacies to have access to a supplier's database (or prior electronic communication) to verify the authenticity of product it receives based on the unique number in the bar code. The
The requirement to mark products or shipments with a unique identifier does little to protect the consumer from fraud if they purchase medications directly from questionable sources. Consumers would have no way of knowing whether the code actually represented a legitimate source or whether it was copied from another supplier.
Thus, from a consumer perspective, the use of overt, optically verifiable anti-counterfeiting technologies -- such as safety seals, holograms, and other easily identified techniques -- makes sense. While these can be counterfeited by high-end operations, it does help cut down on the number of possible sources for counterfeits. The major caveat, however, is that consumers must know what to look for and how to spot fakes. In some parts of the world, authentic drugs are so rare that consumers might reject the real ones in favor of the counterfeits because that's what they're used to seeing. And for individuals purchasing cut-rate drugs from offshore Internet pharmacies, the labeling of repackaged drugs cannot assure authenticity.
Both the
In that regard, Cardinal Health, a major wholesaler, is anticipating the future use of RFID and is already putting RFID in place for e-pedigree to comply with
According to some sources, the US Congress will eventually take action to improve pharmaceutical supply safety but there is no clear indication that it will mandate a strong e-Pedigree program or the use of secure automatic ID technologies.
The FDA has already recommended, but not mandated, that the pharmaceutical industry implement RFID for shipping containers to improve track-and-trace and, possibly, as the beginning of an e-Pedigree program. Even with the use of RFID, some form of overt or covert security seals would be necessary to ensure that the shipping container has not been tampered with.
Securing the pharmaceutical supply chain is no easy task. Tighter controls over the licensing of distributors and repackagers is one step. Maintaining physical security measures is certainly another. Increasing penalties for manufacturing or distributing counterfeit drugs is also necessary. And the development of a secure database of authorized distributors or e-Pedigree data is another necessary step.
Ultimately, however, the use of GPS to track containerized shipments to watch for unscheduled stops or diversions from a pre-determined route, the use of RFID e-Seals on containers to identify tampering, the use of both bar codes and RFID to quickly verify shipping container or product IDs, and the use of both overt and covert means to identify authentic packaging and detect tampering will all be necessary to help secure the pharmaceutical supply chain.
For consumers purchasing drugs directly from Internet pharmacies, however, the best protection will continue to be caveat emptor ("let the buyer beware").
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This column is an expansion of the Viewpoint published in the June 7, 2007 "RFID Connections." Thanks to John Gover of Pepperl-Fuchs for additional material included in this column.
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Comments on this column? E-mail me: b.moore@aimglobal.org
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