IT infrastructure issues that surround the ePedigree initiative are just as formidable as the procedural decisions. How will
industry track drugs? Will RFID or two-dimensional barcodes prevail as the tagging method of choice?
RFID offers an effective and relatively easy method of collecting and tracking information at the bottle level. It also enables
organizations to "mass scan" serial information for all drugs. In the absence of inference, RFID becomes a necessity for operational
efficiency. RFID, however, is expensive, and some questions remain as to whether RFID tags can affect the stability of certain
Many pharmaceutical organizations are leaning toward leveraging two-dimensional barcodes as a means to attain serialization
of pharmaceutical products. Unlike traditional one-dimensional barcodes that use the bar's width to encode a product or account
number, two-dimensional barcodes are scanned horizontally and vertically, are more secure, and hold considerably more data.
Two-dimensional barcodes offer an affordable alternative to more expensive RFID tags and allow stakeholders to develop an
IT infrastructure for authenticating product and passing an ePedigree. Because barcoding systems work on line of sight, they
are not effective with pallets—and hence inference would be essential when dealing with two-dimensional barcodes.
There is also the issue of how to integrate serial number information with ePedigrees, and how to manage this integration
in high-volume environments. Many participants in the pharmaceutical supply chain are discovering that integration costs and
complexities are the most significant part of their ePedigree initiatives.
It is becoming apparent that the success of an ePedigree solution is tied to the infrastructure software and applications
that will help organizations store and manage ePedigree data and ultimately analyze it. End-to-end ePedigree solutions, which
include business intelligence components, must be able to work with several third-party products across organizations; a service-oriented
architecture and open standards will be important considerations. In addition to facilitating ePedigree compliance, these
systems have the potential to yield commercial benefits such as improving a manufacturer's ability to manage recalls and returns,
ultimately enabling a demand-driven supply chain.
The California ePedigree initiative has the opportunity to significantly curtail the incidence of drug counterfeiting nationally,
and serve as a model for other countries and economies. That said, its success comes with risk and complexity, and will require
further consideration and collaboration among stakeholders, including the IT community.
Arvindh Balakrishnan is senior director of the Life Sciences Industry Business Unit at Oracle, email@example.com
See reader comments on this article.
Also, see the results of our reader poll on the delay of the California ePedigree implementation to 2011.