On Dec. 1 the Federal Drug Administration is expected to lift its stay on its Prescription Drug Marketing Act, which mandates that wholesale pharmaceutical distributors show a paper or electronic “pedigree,” or trail, for every drug that touches their company by 2007.
The upcoming mandate comes as no surprise to the manufacturers, distributors and retailers in the pharmaceutical supply chain, they say—most are already complying with an e-pedigree mandate in Florida with bar-code systems that can be applied on a national basis. But those systems are often considered a stopgap at best.
Whats being looked at in pilot projects—and recommended by the FDA—is the use of RFID technology to not only comply with e-pedigree, but for so-called track and trace efficiencies as well.
But before that can happen, there remain issues to overcome with RFID.
Cardinal Health, one of the worlds “big three” wholesale pharmaceutical distributors (Cardinal also manufacturers drugs and medical supplies) announced Nov. 14 the long-awaited results from an RFID pilot that tests the technologys capabilities in an end-to-end supply chain scenario from the manufacturer to the retailer.
The study concludes that while RFID technology using UHF (ultra-high frequency) at the unit, case and pallet levels is feasible for track and trace, challenges remain before it can be adopted industry-wide.
“While our pilot demonstrated that using UHF RFID technology at the unit, case and pallet level is feasible for track and trace purposes, a great deal of additional work needs to be undertaken by stakeholders across the industry to address significant challenges including global standards, privacy concerns and the safe handling of biologics,” said Renard Jackson, vice president and general manager of global packaging services for Cardinal Health, in Dublin, Ohio.
“Until those challenges are addressed, direct distribution of medicine continues to be the best near-term approach to maintain the highest levels of security and efficiency in the pharmaceutical supply chain.”
There are both technology and process challenges to overcome, according to a statement released by the company.
Those include getting to case and unit level read rates that exceed 99 percent at all reading stations—an issue thats been marked by other industries piloting RFID—and allowing unit level “inference” where read rates are unreliable.
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.
Obstacles to Overcome
The FDA in its 2004 report “Combating Counterfeit Drugs” stated that the expiration of PDMAs stay should coincide with the widespread adoption of RFID for track and trace in the pharmaceutical supply chain.
That prediction was overstated: Most pharmaceutical wholesalers and distributors are already moving ahead with bar-code technology to satisfy the immediate mandate, according to ABI analyst Sara Shaw, who released a July 11 research note titled “RFID Industry Implications of the FDA Update.”
“In the short term, the industry will most likely use bar-code technology to comply with state and federal pedigree regulations,” said Shaw.
“Most companies in the industry agree with the FDAs vision of using RFID to satisfy pedigree requirements in the long term, so the PDMA will spur adoption of RFID.
“Now that the law requires companies to provide pedigrees, they will have more incentive to begin implementing RFID.”
However, as the Cardinal Health pilot pointed out, there are still issues to overcome with RFID.
Shaw points to a laundry list of them, the biggest of which is agreeing on standards.
There is still some major confusion in the industry as to whether UHF promoted by the Gen 2 standard is better than HF (high frequency) for use on pharmaceuticals.
The question is whether the higher frequency radio waves would negatively impact sensitive bio-chemicals.
While most manufacturers had seemed to be leaning toward UF as the standard, Cardinal tested UHF in its pilot—a big vote in that standards direction.
Shaw said the ongoing frequency debate will only serve to slow down the adoption of RFID technology.
“As a result, a mixed environment is likely to develop in the pharmaceutical industry,” she said.
However the frequency debate pans out, AmerisourceBergen sees its current PDMA strategy as a temporary fix—one that can likely be improved with the use of RFID.
“Weve been working on PDMA for more than a year, to implement systems,” said Brungess.
“But we feel thats a stopgap measure and not something we want to see rolled out on a grand scale.”
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