FDA to Lift Mandate on Prescription Drug Pedigrees - Page 2

The study conclusions recommend that bar-code technology—the current gold standard for tracking items in the supply chain—be used as "complementary and redundant" technology to RFID.

The study showed that costs need to come down to enable companies to implement and sustain RFID technology.

At the same time, there needs to be improved collaboration across the industry to identify opportunities to "significantly improve efficiency," officials said.

AmerisourceBergen—the second in the "big three" triumvirate; McKesson International is the third—announced Nov. 13 that its implementing an RFID pilot that will not only be the next technology step for PDMA, but potentially the answer to electronic track and trace.

"The driver behind the pilot is simple. The pedigree serves one purpose—to create an e-pedigree—but we see an opportunity to track and trace products throughout the supply chain for business benefits," said Barbara Brungess, a spokesperson for AmerisourceBergen, in Valley Forge, Pa.

"Being able to track products on a per-unit basis will allow us to feed data back to manufacturers with respect to when we receive their product in our warehouse, how long it stays there, when it leaves."

All the data generated from the pilot will be fed into EPCIS to, eventually, enable AmerisourceBergen to figure out, at any time, where a product is—a measure that would be "very beneficial" to streamlining the supply chain, tracking returns and being more efficient with drug recalls, according to Brungess.

As part of the pilot AmerisourceBergen is working with five major pharmaceutical manufacturers—it declined to name which five—so that medications are tagged at the item level.

"The key is the manufacturer really needs to put an RFID tag on the product—thats the only way to be certain that a product is authentic and came directly from a manufacturer," said Brungess.

"Other pilots have involved a wholesaler putting tags on [products], but in order to really create a closed-loop system, manufacturers need to put RFID tag [on items] and initiate the data."

AmerisourceBergen expects to be able to start tracking data from tagged pharmaceuticals by March, 2007.

Cardinals study, which used software and hardware from IBM and Alien Technology, respectively, put RFID tags on the labels of solid-dose prescription drugs, and then encoded the electronic product code standard data at the unit, case and pallet levels during the packaging process.

The products were then shipped to a Cardinal Health distribution center in Findlay, Ohio, where the data was read and authenticated as products were handled under typical operating conditions.

From Findlay, the tagged products were sent to a pharmacy to further test read rates and data flow, officials said. (The RFID tags were removed before the drugs found their way into consumer hands, avoiding yet another issue with RFID: consumer privacy).

Cardinal did not say whether it will move forward with a full-scale RFID implementation.

Next Page: Obstacles to overcome.