ePedigree: Using the Gift of Time Wisely - Pharmaceutical Technology

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ePedigree: Using the Gift of Time Wisely
The year 2011 may seem far off, but there is much to do to prepare for electronic pedigrees.

Pharmaceutical Technology

Technology decisions

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 drugs.

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,

See reader comments on this article.

Also, see the results of our reader poll on the delay of the California ePedigree implementation to 2011.


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