NEWS: E-Pedigree Delay the Talk of Interphex


Interphex conferences gave packagers the opportunity to learn from serialization experts at an ideal time. The California State Board of Pharmacy (BoP) decided to delay mandatory electronic pedigrees on March 25; the next day, two back-to-back talks concerning electronic tracking and tracing kicked off this year’s event.

Bill McBeath of ChainLink Re­search discussed anticounterfeiting strategies, the need for which he laid out in a general overview and history discussion. When mentioning the California State BoP’s decision to extend the e-pedigree deadline, McBeath said “not to take your foot off the gas.”

In his talk, “Anti-Counterfeiting: A Multi-Layered Approach to Detection and Prevention,” McBeath urged packagers to get up to speed because of the infrastructure overhaul that’s likely needed. He said the looming date was actually deceptive because wholesalers need product much sooner.

Vulnerabilities universally invade the supply chain, McBeath said. The percentage of drugs that are counterfeited is 10% worldwide, according to World Health Organization (Geneva) reports. In the United States, the percentage has been growing at a significantly faster rate.

“This byzantine distribution network allows for it,” McBeath said, of prescription drugs’ complex supply chain. Gray markets have had an opportunity to emerge out of such a complicated system, he said.

To fight this, three main types of anticounterfeiting measures exist: overt, covert, and forensic. A multi­layered approach is best, but the speed of application and space accommodation are vitally important.

“There has to be some critical mass for covert technology,” McBeath said. Once this critical mass is reached, technology will take hold. He sees a future in nanotechnology encryption, offered by companies such as Alcan, Cardinal, JDSU, Nosco, and CCL.

Representatives from Catalent Pharma Solutions and Secure Symbology discussed the same issue of electronic pedigree and serialization. They offered real-world examples of how to initiate a track-and-trace solution for a medication line.

The session titled, “Results of Serialized 2-D Bar Coding Pilot to Support Item-Level Track & Trace,” was led by John Vignola, Catalent Pharma Solutions, and Richard Smith, director of engineering, Secure Symbology. Both speakers shared information on pilot program serialization of the drug Avonex. They touched on the issue of the BoP’s delay. (For more details on Biogen Idec’s serialization program for Avonex, see PMP’s Spring 2008 issue of Tracking & Tracing Pharmaceutical Products.)

“Now you can go from 80 mph to 50 mph, and you can slow down and do everything right—but don’t stop,” said Vignola. Key things discussed include the multiple elements of the Avonex package, and solutions to tagging it.

The speakers presented floor plans of Catalent’s production line, which the audience eagerly discussed. Smith talked about the tight tolerance of the carton capturing and printing machines, and how a new code allows for more movement of the cartons on the line.

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