December 1, 2008 (Vol. 28, No. 21)
Angelo DePalma Ph.D. Writer GEN
Improvements in Technology and Evolving Best Practices Are Winning Over Skeptics
Radiofrequency identification (RFID) has been the darling technology of supply-chain gurus since at least 2003, but industry in general, and pharmaceutical and biotechnology companies in particular, have been slow to adopt it, even for the most basic track and trace applications.
Over the last several years, RFID has improved in ways that make it more attractive than ever for inventory and shipping: chips are smaller and less expensive and possess more functionality and hurdles related to proximity, orientation, and environmental effects, and detection through materials—particularly liquids—are now mostly solved. Difficulties still exist, but far fewer than at the peak of the RFID frenzy four or five years ago.
RFID in biotech is mainly used as a means of controlling inventories of large quantities of product. Few deployments have occurred during R&D, manufacturing, or clinical trials, notes Carla Reed, senior vp at Marsh Risk Consulting. “Supply relationships are transactional during research,” she says.
Some laboratory and bioprocess equipment vendors have taken the plunge. Since 2007, Millipore has tagged its bioprocess filter products with RFID tags for easy tracking and validation. Similarly BioMatrica offers SampleWare® software, which with RFID tags, enables biotech companies to track biological samples and anything else in the lab that is tagable. More such applications are no doubt on the way. But for the most part, labs and biomanufacturing keep track of things the old-fashioned way.
Clinical trials were considered to be a natural place for RFID to gain traction, but experience there illustrates how difficult breaking the mold of established industry practices can be.
The idea of employing RFID during clinical trials is not new. In 2003, consulting firm CapGemini Ernst & Young called for wider use of RFID during clinical trials, claiming potential time savings of 5%, shorter startup costs, and lower attrition and medication errors. Three years later, Simon Hollaway of Microsoft argued in a white paper that automation of data collection and sample identification through RFID during trials would be a significant benefit.
A 2007 report authored by Carla Reed at ChainLink Research makes the case for RFID and other tracking/identification technologies during clinical trials, but its conclusions were prospective: four years after the CapGemini and Microsoft reports, none of the executives interviewed by Reed were actually using RFID in that manner.
According to the Chainlink report, RFID’s benefits would be in amassing and collecting study data, for example, when drugs are taken and by whom, and for creating a “single system of record” for critical data that could be shared with all participants.
“The data captured would create a digital audit trail, less prone to human error than the current process that includes manual data capture and secondary entry into information systems,” Reed wrote, noting training, data-handling systems, and installing tag readers at all study locations as roadblocks.
Research for this article turned up only one large study that has employed RFID. An NIH-sponsored antibiotic drug trial that began in 2005 used the Med-ic® identification system from Information Mediary. which includes RFID. Readers who know of other clinical implementations of RFID are encouraged to submit information on them at: https://www.genengnews.com/articles/chitem.aspx?aid=2694.
Reed cites the healthcare industry’s legacy practice of using paper for most record-keeping for why advanced tracking and identification technologies have been slow on the uptake. Reliance on paper, she notes, is one reason why clinical studies take so long. “A tremendous amount of data needs to be pulled together at this stage, but digitizing it is not a high priority.” The physical distances between headquarters and clinical trial sites—most studies are now outsourced and conducted overseas—compounds pharm’s/biotech’s paper problem. Yet, she notes that “digitizing information has not been a high priority” for biotech companies, and that “they clearly have not cared as much about supply-chain issues as they should have.”
Mandates Not the Answer
Mandates for RFID implementation have barely spurred industry to action. The California e-pedigree law, set to go into effect in 2009, was closely watched by other states and the FDA, which had enthusiastically endorsed RFID but not issued any requirements for it. The regulations required that any company distributing or selling drugs in the state provide a verifiable electronic track on a product’s ownership down to the small-package (but not individual dose) level. But in March, the California State Board of Pharmacy voted to delay implementation of e-pedigree requirements from 2009 until 2011.
California’s failure to meet its deadlines was due to myriad factors that are normal for implementing broadly applicable standards. RFID technology was probably not mature or robust enough for a 2009 mandate, and many companies balked at the added cost in light of what they viewed as minimal benefits over existing technology, particularly 2-D bar codes.
End-users have always balked about costs of RFID chips as well. But tags represent but a fraction of the expense of deploying RFID, particularly at the large multidose level. Chip readers, software, infrastructure, and harmonization across the supply chain represent significant investments for pharmaceutical/biotech manufacturers, shipping and logistics, distribution centers, and for dosage-level tracking for dispensers and caregivers. Very few drug companies can dictate tracking and inventory terms to suppliers and distributors, as does Walmart, particularly given the drug industry’s labarynthine supply chain.
Many potential users still have reservations about RFID’s benefits. Perry DeFazio, an analyst with Nerac Consulting, notes that, optimizing return on investment, requires that everyone be on the same technological page. “Speed, accuracy, and consistency is everything in biotech,” says DeFazio, “and anything less than 100 percent accuracy diminishes the benefit side of the equation.”
RFID has been hailed as the solution for thwarting counterfeiting, diversion, tampering, and other malefactions that compromise pharmaceutical supply chain integrity. But some view these problems as so complex that reliance on any single technology—or even combinations—is futile.
One skeptic, Roger Johnston, Ph.D., who heads the Vulnerability Assessment Team as Los Alamos National Laboratory, acknowledges RFID’s potential for inventory control. Closed distribution environments, for example hospitals, are another potential sweet spot. But Dr. Johnston has demonstrated that any security technology deployed at the package level is easy to circumvent. He and his group have achieved a level of notoriety by their ability to hack RFID tags in less than one hour. Moreover tags are easy to duplicate, and those with no technical expertise whatsoever may simply lift the tags from one package to another.
Security experts therefore believe that no single solution assures supply chain integrity. Reed believes RFID technology must be part of a comprehensive approach to security that includes bar codes, tamper-proof packaging, nano-inks, sensors, and other technologies.
“You have to look at which business problems need to be solved, in what type of physical environment, then evaluate solutions on a case-by-case level. We have to understand not only the supply chain but where the risks are, and the stakeholders. Often a technology must be made to work for the least-sophisticated player.”
It is not unusual for a technology, even one as promising as RFID, to take several years to mature and win over the hearts and minds of users. “There was a lot of hype originally, four or five years ago, that led to unrealistic expectations,” notes Tom Reese, senior manager for RFID business development at Motorola. The earlier GEN1 standard had problems, he says, that took a while to work through. “GEN2 has proved to be quite robust and has matured, based on lessons learned from the GEN1 standard.”
Motorola works with various manufacturers on readers for passive tags. Its product line includes readers that are hand-held, fixed (for example on doors or conveyors), and mobile (located on movable equipment). All readers are based on the UHF EPCglobal GEN2 standard, approved by the International Standards Organization in 2006 and part of the new wave of RFID implementation.
David Gulian, CEO of Infologix, an RFID and wireless firm, sees a significant upswing in RFID in biotechnology as the technology continues to improve and best practices evolve. “Bar coding works well, but the pharmaceutical industry is looking for something more intelligent that has more data in it, and is not driven by ink,” he explains.
He sees RFID eventually deployed down to the dosing level—where a tag is read before withdrawing a pill or filling a syringe—and even, perhaps, to the unit-dose level.