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Industry Opinion Favors RFID for Drug E-pedigree

Comments received by the FDA show a preference for RFID technology—generally EPC—for a pharmaceutical e-pedigree identification system, with 2-D bar-coding as a backup.
By Claire Swedberg
When it comes to cost of technology infrastructure, Merck reported its engineering studies found that it costs approximately $1.3 million to retrofit one existing packaging line for serialization—either 2-D bar-coding or RFID.

The American Society of Health-System Pharmacists (ASHP) commented that RFID could be adopted in situations where bar codes are currently being employed for tracking and tracing, but encryption would be necessary to guarantee security of product information.

"For automatic tracking, encryption should be used in any portion of the supply chain that could be compromised by an outside source," the ASHP urged. "It would be beneficial to encrypt all prescription drug-related communications." The ASHP also recommended the FDA mandate using the EPCglobal's Electronic Product Code (EPC) RFID standard, as did Healthcare Distribution Management Association (HDMA). HDMA recommends that the FDA include provisions for a single non-line-of-sight technology such as RFID, as the primary data carrier. It also recommends that the FDA provide for a single secondary data carrier—the 2-D bar codes—to back up RFID. HDMA argues that non line-of-sight technologies are harder to duplicate and therefore provide greater security. The organization says it is also more efficient for the high-volume, high-throughput operations of the typical healthcare distributor.

Representing retail chain pharmacies and suppliers, the National Association of Chain Drug Stores NACDS was less enthusiastic about RFID. In its comments, the organization stated that prescription drug tracking and tracing technologies, although promising, are yet to be reliable and acceptable: "Many benchmarks must be met before prescription drug tracking and tracing is ready for use across the drug distribution supply chain."

When it comes to the unique standard numerical identifier, for example, NACDS wrote, adoption of a standard numerical identifier is only the first step toward a tracking and tracing system. "After the standard for the numerical identifier is announced, many steps must follow. The producers of the data carriers will need time to design, develop, test and manufacture the data carriers."

The group stated that from retail pharmacy's perspective, "non-line-of-sight readability would make the identification and track and trace system more efficient and less costly for ongoing operations." The NACDS cited a study conducted by one of its members that found that 2-D bar codes are time-consuming and inefficient due to the manual scanning process. "However, challenges exist for RFID as well, such as the upfront capital expense and the lack of maturity of the technology." NACDS said that because RFID technology is still under development, existing RFID technology could become outdated quickly. "Mandating existing technology could actually frustrate the goal of a stable uniform system. It would be premature for the drug distribution supply chain industry to lock into existing technology that is still under development, evaluation and testing."

USER COMMENTS

Andrew Strauch 2008-05-30 11:56:01 AM
The RFID Tag Physical Security Hole The general benefits of RFID for pharmaceutical e-pedigree applications are well stated in the FDA public comments. However, one major assumption must be addressed. Assuming that typical RFID tags are less likely to be counterfeited or duplicated is extremely dangerous. As it stands, RFID systems track RFID tags – not the asset to which the tag is attached. Counterfeits can simply remove the tags without affecting the RFID function. The tags can then be placed on counterfeit items, or placed back in the empty carton. The reader will be none the wiser. Robust tamper evidence is needed to ensure a unique relationship between the RFID tag and the actual pharmaceutical product. Without this, the pharmaceutical industry cannot be certain that e-pedigrees remain secure. According to the U.S. Chamber of Commerce, the pharmaceutical industry loses $32 billion annually to counterfeiting. With that much revenue on the line, the pharmaceutical industry must stay at least one step ahead of counterfeiters. This means physical security on top of data security. Andrew Strauch MIKOH Corporation

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