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The year 2011 may seem far off, but there is much to do to prepare for electronic pedigrees.
Electronic pedigree (ePedigree) is still coming to California, just not as soon as expected. Many in the industry breathed a sigh of relief earlier this spring when the California Board of Pharmacy voted to delay for another two years (until Jan. 1, 2011) implementation of ePedigree requirements for tracking drugs from the manufacturer to the pharmacy. Although many in the industry view this extra time as a gift, the delay should not signal a halt to planning. Instead, the industry should view it as a new opportunity for regulators, distributors, manufacturers, and information technology (IT) vendors to get it right.
The California ePedigree initiative, which will require all prescription drugs to be electronically tagged and tracked from the manufacturer to the pharmacy, holds the potential to significantly reduce the possibility of counterfeit prescription drugs. As all stakeholders in the process agree, success in this complex initiative will require creative and committed cooperation on the part of all involved parties.
IT is at the core of the initiative. Even though most pharmaceutical manufacturers are well into their ePedigree planning process, nearly all have been reluctant or unable to execute their programs because of unanswered questions related to policy, procedures, and technology. The way in which these significant remaining issues are resolved will shape the types of solutions needed to ensure ePedigree compliance.
How will the California board and industry address what to do with prescription drugs in the distribution pipeline as of Jan. 1, 2011? Hospitals and retailers risk spending millions of dollars replacing drugs on the shelf shipped to California before the 2011 deadline. As such, the board is considering grandfathering as a viable solution. Grandfathering would permit transfers without pedigree documentation for drugs transferred or acquired before the effective date of the law. The board is also reviewing comments from industry regarding the possibility of a phased approach, which would allow manufacturers to rate their drugs based on the risk for counterfeiting; those drugs at the highest risk would be integrated into the process first.
The California law requires that drugs be tracked at the bottle/package level. However, managing the serial number for every individual bottle and the ePedigree associated with that bottle could be unwieldy. To improve efficiency, several pharmaceutical organizations have suggested incorporating inference (a managed-risk business process) into the drug serialization and ePedigree process. For example, if a manufacturer places 63 bottles of serialized bottles in a box and ships them to a distributor, the recipient will "infer" the serial numbers being received into the system without manually scanning each individual bottle (they would only scan the barcode on the box, or use a single radio frequency identifcation [RFID] scan at the box level). To support this approach, the California board is considering the possibility of license-plating packages and pallets, allowing ePedigree information, instead of individual bottles, to move with the licensed-plated shipments through the distribution channel.
Hand-in-hand with inference, the board must also define an audit strategy to determine which pharmacies, manufacturing and packaging organizations, distributors, and suppliers it should audit and how often. The board also must decide whether there should be a standard audit procedure or whether organizations with previous infractions should face more frequent audits. The California board and other likeminded bodies must develop an efficient, manageable process that helps organizations comply with audit procedures and ensure safety, without inflicting cumbersome tasks that could potentially interfere with productivity.
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, firstname.lastname@example.org
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