FDA, Accenture look at RFID for prescriptions

The Food and Drug Administration is eyeing radio frequency identification technology as a means of tracking prescription drugs and preventing the spread of counterfeit drugs, according to a report issued yesterday.

The FDA said it expected RFID technology to be widespread in the prescription drug supply chain within three years.

According to the report, Hamilton, Bermuda-based Accenture Ltd. will lead "a study of RFID involving manufacturers, wholesalers, and retailers that will explore the use of RFID for tracking, tracing, recalls and theft of selected pharmaceuticals." Feasibility tests are set for this year.

"These technologies are becoming widely recognized as a powerful tool," said Jamie Hintlian, a partner in Accenture's Health & Life Sciences practice. "The RFID initiative is groundbreaking in that it brings together leading companies across the pharmaceutical industry to not only design and evaluate ways to improve supply chain integrity and accuracy but, also to help consumers receive authentic medicines."

Under the FDA's plan, pallets, cases or individual packages of prescription drugs would be assigned an electronic product code that would be stored in RFID tags. Those codes would act as an "electronic pedigree" that would follow the products from manufacturer to pharmacist. Consumers would then be able to read the product's pedigree to ensure it was legitimate and safe.

Accenture will explore ways that RFID tags can improve expiration date management, lot and batch tracking, returns management processing, shipping and receiving accuracy and other areas of the prescription drug supply chain.

"We plan to help participating companies accelerate the technology learning curve and to share our findings with the industry," said Lyle Ginsburg, a partner in Accenture's Products Operating Group.

The FDA report details several obstacles to the adoption of RFID. Among them:

* All stakeholders must embrace the technology in similar timeframes in order to realize the full potential of RFID technology.

* There needs to be standards and business rules for RFID adoption.

* Technology providers must address database issues such as structure, ownership, access and security.

* There must be clarification of regulatory requirements pertaining to the use of RFID.

* There needs to be a flexible RFID migration path that meets the needs of different stakeholders.

The FDA report describes various phased approaches to implementing RFID technology, including starting with products identified as "high risk," and combining RFID tags with two-dimensional bar codes.

"This report shows how to achieve modern, comprehensive security protections for our drug supply that can keep pace with the increasingly sophisticated threats we face," said FDA Commissioner Mark McClellan. "FDA will not rest until we have strong protections in each link in the drug supply chain."