There's a great debate brewing in the RFID technology sector, and for once it doesn't involve consumer goods manufacturers and their prospects for payback on RFID investments. This time, the debate involves the pharmaceutical industry and the frequency of the RFID tags used to identify, track, and trace drugs (particularly individual bottles of drugs) from manufacture to delivery.
On one side of the divide are those who back high-frequency (HF) tags; on the other, supporters of ultra-high-frequency (UHF) technology. Backers of HF tags claim they offer more accurate read rates than their UHF counterparts and are less susceptible to interference from metal and water. They also like to point out that the HF tags' smaller, tighter read ranges cut down on the risk of unwanted reads from tags on nearby objects.
Proponents of UHF tags counter that interference problems from water and metal have been largely resolved. They also point out that UHF tags, which offer faster reads than their HF counterparts and can operate over longer distances, are already in widespread use in case- and pallet-tagging applications. Companies that have UHF readers and hardware in place might be reluctant to invest in HF readers as well.
All these arguments have merit, which will make it difficult, if not impossible, for the industry to settle on a standard. But that leaves pharmaceutical manufacturers with a difficult choice: wait for the dust to settle or forge ahead on their own.
Complicating matters is growing regulatory pressure on drug makers to provide drug "pedigrees" to help track their products. Considered the most effective weapon against theft and counterfeiting, drug pedigrees document a drug's chain of custody as it moves through the supply chain—something many believe is best done via RFID. Right now, 15 states have drug pedigree requirements, and another 12 have legislation pending or are likely to introduce measures this year. Though some states will accept paper pedigrees, at least one, California, will require electronic documentation, known as an "e-pedigree," beginning in January 2009. The Food and Drug Administration (FDA), too, would like to see the industry move to full-scale adoption of RFID-based e-pedigrees, though it has not mandated the technology's use.
Given the regulatory climate, it's no surprise that several large pharmaceutical companies have decided they can't afford to wait. As the battle over frequencies rages, they're moving forward with their RFID programs in preparation for becoming compliant with impending pedigree requirements. They're expanding their tagging programs to include more product lines. They're rolling out the technology to additional production facilities. And, perhaps most significantly, they're refining their procedures for harvesting tracking data from the tags.
Safe and secure
One drug maker that's pressing ahead with its RFID tagging program is Purdue Pharma, which produces the wellknown— and often counterfeited—pain killer OxyContin. Purdue announced earlier this year that it will integrate Impinj's Gen 2 UHF RFID tags into its high-speed pharmaceutical packaging lines. Purdue recently concluded a low-volume pilot and was scheduled to have the technology ready for productionlevel deployment as early as this month.
Purdue is already something of a veteran where RFID is concerned. The manufacturer has been using UHF RFID tags to track OxyContin and another potent painkiller, Palladone, for more than two years now. However, the company did not achieve the results it had hoped for with the earlier generation of the technology (EPC Class 0 chips). It's making the switch to the new Gen 2 tags with the expectation of boosting throughput rates, read rates, and programming reliability.
Up until now, Purdue's tagging capacity has been limited to small batches. But as it moves forward with its plans, Purdue will expand its tagging operations to include two entire packaging lines for four different types of bottles for OxyContin. It will also expand its program beyond itemlevel tagging to include the case level.
Purdue's latest RFID effort is part of a push to boost supply chain efficiency and security. "We are working to implement innovative solutions that will enhance security within the supply chain," says Aaron Graham, a former law enforcement agent who serves as vice president of corporate security and chief security officer at Purdue Pharma. "The Impinj RFID technology has been selected as an integral part of our packaging line improvements to help the company establish an e-pedigree process that will significantly improve the delivery of products from the factory to the pharmacy counter."
Getting ahead of the game
Another drug manufacturer that's not waiting around for the HF/UHF debate to be resolved is Wyeth Pharmaceuticals. Wyeth is in the midst of retrofitting a high-speed bottling line at a plant in Puerto Rico so it can start applying RFID tags to a strategic product SKU.
Tom Pizzuto, Wyeth's director of RFID technologies, says the company may eventually apply as many as 750,000 HF RFID tags to individual bottles of the new drug. In the meantime, Wyeth will continue to use UHF tags at both the case and the pallet level. Later this year, Wyeth plans to outfit one of its U.S. distribution centers to take inbound and outbound RFID reads.
Like Purdue Pharma, Wyeth is already a seasoned RFID user. A supplier to Wal-Mart,Wyeth got its introduction to RIFD when Wal-Mart handed down its now-famous RFID mandate. It has been shipping tagged cases of painkiller Advil to the mega-retailer's DCs for some time now.
Though its first foray into RFID was driven by a customer's mandate,Wyeth says things are different this time. The current tagging initiative reflects the company's strategic decision to begin preparing for what it sees as the inevitable tightening of drug tracking requirements. "This is a case of Wyeth looking at [drug pedigree laws] in California and Florida, and also the FDA's interest in this, and internalizing all that to realize we need to start down this path," says Pizzuto. "That's why we initiated this pilot."
The more, the merrier
In the meantime, Pfizer is also stepping up its commitment to RFID. The giant pharmaceutical concern, which has been tagging all bottles of Viagra since the end of 2005, has extended RFID to a second product line. It will be tagging over-the-counter pain reliever Celebrex at both the case and pallet levels by the end of 2007. Although the company doesn't have immediate plans to tag individual bottles of Celebrex, it says it may re-evaluate that decision at a later date.
Pfizer uses HF tags on individual bottles of Viagra, but like many manufacturers, it uses UHF tags to identify cases and pallets. It will do the same with Celebrex, using UHF Gen 2 tags to track cases and pallets of the arthritis remedy. But tagging cases of Celebrex will be a much more complicated process than tagging Viagra, which is produced on a single production line in France. Celebrex will be produced on four high-speed lines at Pfizer's manufacturing facility in Puerto Rico. The company expects the first RFIDenabled cases and pallets to roll off the manufacturing line by the fourth quarter. Tagged product could work its way to wholesalers and pharmacies by the end of the year or early in 2008.
"We wanted to roll out the technology being applied to Viagra somewhere else, and Celebrex far outsells Viagra," Byron Bond, director of trade operations and customer service for Pfizer, told attendees at the RFID Healthcare Industry Adoption Summit in November. "Within the next four to six years, we expect to have something close to a universal track and trace [e-pedigree system], so we realize we need to spread our RFID capabilities into other areas."
Bond didn't say how many RFID tags the Celebrex line will consume, but the number will be significantly higher than the number Pfizer uses for Viagra, given Celebrex's extremely high volume. Although Bond says prices for tags have dropped 20 percent since it started tagging Viagra, he says it is still too costly to tag the millions of individual bottles of Celebrex.
Bond also announced that Pfizer is in the midst of initiating an e-pedigree pilot with trade partners using Viagra, and will also change the tag placement on its cases from the top of the case to the side. In addition, Pfizer now plans to rigorously pursue the operational efficiencies to be gained from RFID relative to shipping and receiving, both internally and externally. The company has also had discussions with the U.S. government about using RFID to improve the customs process for Viagra that enters the country from France.
Cardinal's numbers
Like Purdue, Wyeth, and Pfizer, Cardinal Health has decided to get a jump on the e-pedigree development process. But it's taking a slightly different route. While many pharmaceutical companies have taken a hybrid approach to tagging (using HF tags for items and UHF tags for cases and pallets), Cardinal Health is concentrating its efforts solely on UHF technology.
Late last year, Cardinal announced the results of a pilot program to test the feasibility of using UHF RFID technology for tracking and tracing at the unit, case, and pallet levels. As part of the program, it also looked at ways to use the tags to collect data needed for e-pedigrees.
Cardinal placed RFID tags on the labels of brand-name solid-dose prescription drugs, and then encoded the EPC standard data on those tags during the packaging process. The products were shipped to a Cardinal Health DC in Findlay, Ohio, where the data were collected and authenticated as workers handled products under typical operating conditions. From Findlay, the tagged product was sent to a pharmacy, where further tests of read rates and data flow were conducted.
Data from the pilot indicate that it is indeed feasible for RFID tags to be inlaid into existing FDA-approved pharmaceutical label stock, and that tags can be applied and encoded on packaging lines at normal operating speeds. Online encoding yields were 95 percent to 97 percent, and fine tuning of the process is expected to produce yields that approach 100 percent.
Cardinal Health executives note that although the overall test results were positive, there are some hurdles to overcome before the UHF RFID tracking technology can be adopted industry-wide. The challenges include achieving case-level reads in excess of 99 percent at all case-reading stations and achieving unit-level read rates in excess of 99 percent when reading from tote containers at DC and pharmacy locations.
Wreaths Across America