Safe and Secure - Pharmaceutical Executive

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Safe and Secure
In the fight against counterfeits, pharma's best hopes are electronic product codes and RFID.But before they can work...


Pharmaceutical Executive


HDMA appears to be driving as hard as possible to build consensus in the industry; EPCglobal Healthcare Action Group and MIT Auto ID Labs Health- care Research Initiative are ready to respond. Their coordinated efforts with users and technology vendors should rapidly create the required technology standards.

There are two other areas in which cooperation should be enhanced: FDA and state pharmacy boards. FDA should work closely with leading states and NABP to develop a national electronic pedigree regulatory framework. A safe and secure supply chain requires both mass serialization and electronic pedigrees. To date, serialization has been an FDA-driven initiative and pedigrees a state-driven initiative. A common regulatory framework for both serialization and pedigrees that starts with manufacturers is needed to achieve a national solution. The industry should help drive this and stimulate state adoption.

HDMA, PhRMA, and NACDS. These organizations need to establish the common business practices to handle exceptions and set consistent best practices. The intercompany processes for resolving damaged tags and data errors need to be efficient and result in fair business practices.

Although many advocates of EPC/RFID do not want to consider investments in implementation projects without a full definition of the standards and complete industry adoption, they must recognize that the gradual integration of the technology does create a progressively safer supply chain. Unless the industry acts, its runs the risk of having deadlines come and go without substantially improving security. Some immediate benefits can be gained by serialization and basic pedigree verification:

EPC serialization. FDA's "Combating Counterfeit Drugs" called mass serialization "the single most powerful tool for securing the supply chain." Even before a full electronic pedigree system is developed, EPC numbers encoded on RFID tags attached to medicines could be verified by pharmacies against manufacturer lists to authenticate product to a high degree of certainty. And this approach would be completely compatible with later full-scale implementation.

Basic pedigree verification. A perfect implementation may require that all items in a case and all cases are read upon each movement of the product. But again, the industry will benefit and patient safety will improve with even a partial implementation. For example, if pedigrees are recorded at a case level and members of the supply chain are provided with information about the serial numbers inside the case, there would be significant improvement in the ability to trace individual products—perhaps enough of an improvement to cut the time required to triangulate on counterfeiters from months to weeks.

As FDA said so clearly in the "Combating Counterfeit Drugs" report, "There is no 'magic bullet.'" The rapidly emerging EPC/RFID system holds extraordinary promise for making electronic pedigree a reality—bringing transparency, security, and efficiency to the pharmaceutical distribution system. It will take the focused efforts of the entire industry to move to the point of full adoption, and it will require honest flexibility to take some of the steps along the path. But it will be worth it in the long run.


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