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


Another visible initiative is the Accenture Jump Start program. In the summer of 2004, 11 industry participants (five pharma companies, two distributors, two chain pharmacies, and two industry associations) began moving a set of EPC/RFID tagged, commercially packaged medicines from manufacturer to pharmacy, using the tags to track their movement. This test program will be "challenged" with simulated counterfeits, recalls, and other incidents requiring intercompany exchange of information. Accenture plans to present the results in the fall, and several more pharma manufacturers and other companies are in line to join the next phase of the project.

On July 27, 2004, Cap Gemini and SupplyScape announced the opening of the first pharma RFID center of excellence focused on anticounterfeiting. The center was established to allow pharma companies to pilot their own drug pedigree authentication programs.

In addition to HDMA and the other groups mentioned, two organizations are central to efforts to implement EPC/RFID in the pharma industry. On July 1, 2004, EPCglobal held an organizational meeting of its Health Care Action Group, which will work on business structures and practices, including the implementation of electronic pedigree. And MIT Auto-ID Labs has created the Healthcare Research Initiative (HRI), to research various technical aspects of EPC/RFID in healthcare—for example, the effect of RF energy on product stability and RF collision in the hospital environment. Both organizations are open to industry membership.

The Practicalities of Progress So the stage is set. Now, the primary questions are: How quickly can a full prescription medicine supply chain system be implemented? What barriers stand in the way? How can they realistically be overcome? And, what interim steps are available if the full implementation schedule slips? Unfortunately the answers to these tough questions are not entirely clear.

On July 13, 2004, PSTF released "The Healthcare Indus- try's Business Requirements for Electronic Track and Trace (An Anticounterfeiting Strategy)." The paper was intended to summarize the business issues to be resolved in implementing electronic track-and-trace and identify the next steps industry needs to take. The list includes at least 26 major issues and more than 60 sub-issues grouped into four main categories: technology, implementation, business processes, and governance. The following sections outline just a few of the critical issues that must be resolved.

Mass serialization: the naming of products. The core of the EPC system is the serialization/naming of products. The PSTF paper calls it "the most critical component of the track-and-trace system." "

Although existing EPC standards provide a basic protocol (a 96-bit code that identifies the company, product, and serial number), there is no agreement within the industry on exactly what information should be used in the "product" field.

Many argue for using FDA National Drug Code (NDC) numbers, which already play various roles in prescribing and administering drugs and would thus be easy to integrate with current practices. Privacy advocates, however, point out that if NDCs are used, third parties might be able to determine what drugs an individual was taking by reading data from bottles carried by the patient. Privacy concerns of this sort have led some to propose labeling products with a random number that does not directly reveal identity of the product but can be looked up in an associated secure database. That approach would be compatible with the overall conceptual design of EPC/RFID, but it could put greater demands on the system's information architecture and lead to a more complex and expensive data management system. Other suggestions —such as securing the information on the chip—would necessitate new security standards for EPC devices and would significantly increase the cost of both chips and readers.

It is not clear exactly how and when the naming standard will be developed. If the industry can agree quickly, the issue may not present much of a hurdle. On the other hand, if FDA has to step in and adopt a standard by regulation, with the required notice and comment periods and possible litigation, the process could take years.

Database architecture: pedigree representation. Another basic issue concerns how the track-and-trace database will be constructed. Four approaches are under consideration:


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