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ePedigree requirement and RFID debate in California

A New York federal court's invalidation of some aspects of the U. S. Food and Drug Administration's drug pedigree requirement has not dampened the push being made by many pharmaceutical manufacturers to quickly get a handle on the complexities of item-level RFID tagging. Both manufacturers and wholesalers are motivated as much by California's January, 2009, ePedigree requirement as the FDA Pedigree dictate, which would have required many smaller wholesalers without formal, manufacturer contracts to get detailed product information from manufacturers and pass it down the supply chain, step-by-step.



Paul Fowler, Axway's vice president of healthcare strategy and a McKesson expatriate, says, "California is pushing very, very hard, and it will be the test case for whether RFID gets launched in the U.S." Axway, a leading global provider of business solutions, is a wholly owned subsidiary of Sopra Group.

Paul Chang, RFID/Pharma executive, IBM Software Group, says every drug company that is mid-sized or larger will be working to put RFID tags on at least one stockkeeping unit (SKU) by mid-2008. In addition, a federal court has shot holes in the FDA pedigree requirement by axing some of the package information the FDA said needed to be included. The FDA is considering opening up a new front in its drive to convince drug manufacturers to implement item-level RFID tagging as an anti-counterfeiting measure.

Linear bar codes

The FDA is well aware of the pressure California is putting on drug manufacturers, and it now may be ready to help out by easing its requirements for bar-coding of drugs going to hospitals. An upcoming Federal Register notice will ask for the drug industry's thoughts on how the agency might update the technology requirements in the final rule mandating linear bar codes on pharmaceuticals going to hospitals, a rule which went into effect in April 2006.

The rule says that manufacturers must encode the National Drug Code number in a linear bar code on the package. When the agency issued a compliance guide for that rule, it admitted that some companies had asked the agency for permission to use RFID to encode the NDC number on the item package.

The agency said that its thinking at that moment was that companies could put an RFID inlay on the package, but it could only include the lot number and expiration date. The NDC number had to be in a linear bar code. But, significantly, the FDA added, "that we will consider revising the rule to accommodate new technologies and may begin examining other automatic identification technologies by April 2006."

More than a year after that date, and undoubtedly prompted by California's looming ePedigree requirement, the FDA is apparently gearing up to update the hospital drug bar-code rule, according to FDA spokeswoman Crystal Rice. The impetus for this reconsideration is the fact that the earlier compliance guide expires on December 1, 2007, and the FDA has to get the lead out if it intends to have a revised compliance guide in place.

California-'inspired' serials

Barbara Brungess, director, corporate & investor relations at Amerisource Bergen, says that the 96-bit serialization number which will be required by California in all pedigrees in January, 2009, could theoretically be linked to the NDC number, allowing the FDA to revise its hospital drugs bar-code requirement to allow the NDC to be indirectly "encoded" on an RFID inlay.

In fact, drug manufacturers may be pressuring the agency to do just that, and because of California. The companies may be especially aggressive on that score because the drug wholesalers do not want manufacturers to send product to California with the serialization number in a bar code. That would mean Amerisource Bergen, Cardinal, and others would have to open every carton and read every bar code, a process that would be prohibitively expensive.

California's approaching 2009 ePedigree requirement (Florida does not require serialization, so it's a horse of a different breed) underlies Amerisource Bergen's upcoming pilot program at its Sacramento distribution center. As opposed to Cardinal's pilot completed last November, which had both pluses and minuses, Amerisource Bergen will read item-level tags already applied to labels on product sent to its distribution center by 10 to 20 manufacturers.

The identity of those manufacturers, Shay Reid, vice president of integrated solutions at Amerisource Bergen, declines to disclose. In its test, Cardinal applied UHF Gen2 tags on its own packaging line on products supplied by an unidentified manufacturer, and encoded them with EPC data. Read rates were good in some places, not so good with regard to item-level reads when product was inside cases placed on pallets.

Modifying packaging lines

However, in what is very good news for packagers, Julie Kuhn, vice president of operation technologies for Cardinal Health, says the packaging line does not have to be modified very muchthere is a hardware investment, of courseto accommodate tagging and encoding of product. Nor does the packaging line speed have to decrease.

Amerisource Bergen will be testing both 13.56 MHz high-frequency (HF) item-level tags and 915 UHF Gen2 UHF tags. Reid says the debate over whether HF or Gen2 UHF tags are best for item-level tagging still rages on, despite what were high 90% read rates found by Cardinal when it applied the Gen2 tags on its packaging line. "Cardinal is pretty adamant that UHF is the technology," Reid says. "We don't have the same view necessarily."

Another UHF-doubter is John Jordon, president of worldwide field operations for Tagsys RFID , which has assembled a supplier team that is advertising it can provide Six-Sigma read rates on the packaging line via use of HF tags. Jordon notes that Cardinal, using the UHF Gen2 item-level tags, got read rates on the packaging line of 97.7% or 94.8% for two products, which Cardinal called "highly reliable."

What's reliable?

But the "War of Words" goes on. "We are guaranteeing 99.5 percent, or five or fewer failures in 1,000 packages tagged at the first quality-control point. We then guarantee no more than five in 10,000 failures on the case consolidation and Six Sigma coming off the manufacturing line and into the client's own distribution center," Jordon explains. He's alluding to the Six-Sigma guarantee Tagsys announced it would be making in March in conjunction with suppliers such as Odin Technologies, Systech Intl. , West Pharmaceutical Services , NXP , and Alcan Pharmaceutical Plastics . "That is dramatically better than anyone has seen." To achieve Six Sigma, a process must not produce more than 3.4 defects per 1,000,000 opportunities.

The pro-UHF forces contest the alleged superiority of HF item-level read rates. Vince Moretti, vice president of RFID systems, Impinj, Inc. , argues that its UHF item-level tags will show higher read rates than Cardinal's for a variety of reasons. One of those is that Impinj is using near-field reader antennas, which maximize power delivery to tags at short range.

Brian Chisholm, new product development engineer at O-I , points out that because its container is supplied to drug manufacturers with the RFID inlay already embedded in the bottle and encoded, the tags are more secure and have a more consistent orientation.

This technique is different from the manufacturer having to put the inlay behind the label and write on it as the bottle moves through the packaging line.

Packaging line speeds

Of course the knock on HF has been its effect on packaging line speed. Companies encoding HF item-level tags on packaging lines cannot run the packaging line at speeds greater than 120 bottles per minute, says Moretti. The HF protocol simply cannot accommodate a higher speed, Moretti argues.

A company could split the line, but that is expensive and invasive. In contrast, UHF has been demonstrated at 250 bottles a minute in formal testing. In addition, UHF inlays are about two-thirds cheaper than HF inlays. That is because the HF tags require a multi-layer antenna that is more complex than a UHF tag design.

Moretti's claims about the enhanced read rates from Impinj's near-field readers have credibility because Purdue Pharma added Impinj to its OxyContin tagging team. During its pilot program, the company used Symbol Technologies alone. But Purdue is in the process of expanding its pilot to the entire OxyContin run, and moving from Class 0 Gen1 UHF item tags to Class 1 Gen 2 tags, which both Symbol and Omron will supply, both using Impinj chips.

Harry Ramsey, senior package development engineer, Purdue Pharma, confirms the pilot program expansion is to be completed by the second quarter of 2007. Purdue will be installing new readers, antennas on those readers, and software on the packaging line. Ramsey declines to divulge the cost of shifting to Gen2 tags.
--By Stephen Barlas, Contributing Editor

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