Last month saw actions by both the US and European Union (EU) that demonstrated concern about the security of the pharmaceutical supply chain and a serious intent to stem the growing number of counterfeit drugs entering the supply chain. The US Senate passed legislation with product authentication provisions and the EU heard from the European Federation of Pharmaceutical Industries and Associations on proposed means to halt counterfeiting. Neither action, however, favors RFID and only the EU seems pre-disposed to using any form of automatic identification technology.
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.
The European pharmaceutical industry plans a pilot program next year to test the effectiveness of its proposed anti-counterfeiting scheme. It will feature a two-dimensional barcode printed on packaging during manufacture rather than RFID
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.
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, producing bar codes on simple self-adhesive labels is not a great challenge.