On Track with RFID?
RFID may help drug manufacturers and distributors navigate the road to electronic pedigrees.
By Daphne Allen
With a major radio-frequency identification (RFID) pilot entitled OnTrack, it is easy to borrow analogies from the automotive industry. RFID could be like a vehicle identification number (VIN) for your drug or medical device. Better yet, RFID could be like LoJack for tracking cargo shipments (but not individual drugs or devices, especially those dispensed to patients). The first analogy shows that RFID can provide you with the manufacturer, product, current owner, and lot code, while the second can give you all of that plus pinpoint the cargo location.
When discussing the safety of the drug supply chain, such features seem particularly useful. But are they absolutely needed? Affordable? Realistic?
FDA stands behind RFID, although not as vehemently as it did a couple of years ago. Originally urging RFID use at the unit level by the end of 2007, the agency now promotes a multilayered approach. In February 2007 at the Industry Advisory Council, FDA's Ilisa Bernstein explained FDA's revised plan: "Implement track/trace technologies [that rely] on a unique serial number on each drug package [using] RFID [and/or] bar codes." Authentication technologies also are suggested. Further, the Counterfeit Drug Task Force recommends that "stakeholders continue moving forward in implementing RFID across the drug supply chain. Stakeholders [should also] consider a phased-in approach, placing RFID tags on products most vulnerable to counterfeiting and diversion as a first step." FDA also "continues to believe that RFID is the most promising technology."
In addition, as drug manufacturers and distributors start grappling with drug pedigree requirements from states as well as from the federal government, many are weighing the costs and benefits of RFID and other solutions, such as 2-D bar codes. The question remains: Is RFID a viable platform for serialization to meet the strictest of pedigree rules?
Many along the drug supply chain are trying to answer that question. For instance, one industry expert observes that "the big three wholesalers are doing pretty significant piloting. There is more pilot activity than you were seeing a year or two ago. Many people have identified pedigree requirements as a fundamental driver for RFID adoption."
Thus, the number of RFID pilots is growing. "The good news is that people are evaluating RFID and moving forward and finding value in it," says Daniel Engels, a professor at the University of Texas, Arlington. Engels is former director of research for MIT's Auto-ID Center and one of the center's original members. "The really good news is that RFID is forcing the industry to reevaluate its supply chain, creating visibility."
McKesson believes that RFID can be used to satisfy California pedigree laws. Under them, set to take effect in 2009, manufacturers will be required to attach a unique identifier to each drug at the smallest packaging level or container distributed to the wholesaler. "Our preferred tracking technology for all levels of packaging is RFID, using approved standards from EPCglobal," reads a letter from McKesson to manufacturers. "McKesson will need product packaging marked by manufacturers on or before July 1, 2008, to ensure compliance with the California pedigree law."
McKesson has participated in a number of pilots, beginning with JumpStart and EPCglobal's Health and Life Science Industry Action Group in 2003. The company also has participated in OnTrack 1 in 2005–2006, which studied Florida's pedigree laws as well as product authentication and RFID tag frequencies. It is now participating in OnTrack 2, which is looking at serialization and Gen2 ultrahigh frequency (UHF) RFID.
"California's pedigree requirement is driving our RFID program," says Ted Ng, director, risk management, of McKesson's Business Technology Solutions. "California law dictates the use of an interoperable electronic track-and-trace system that records the movement of each product, starting with the manufacturer, using a nonproprietary data structure. The most-efficient solution is RFID."
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Distributors have a practical reason for backing RFID, and for encouraging manufacturers to do so, too: volume. "We have 400 manufacturers/suppliers," reports Ng. "The big companies—Purdue Pharma, Pfizer, and GlaxoSmithKline—they are on top of the pending requirements. Small or specialty manufacturers are less able to comply—but if they don't send us serialized product, we can't sell it in California." California law says after January 1, 2009, a wholesaler or pharmacy may not acquire a drug without receiving a pedigree. Additionally, a wholesaler or pharmacy may not sell, trade, or transfer a drug at wholesale without providing a pedigree.
Cardinal Health is working to integrate RFID technology into its Sacramento, CA, pharmaceutical distribution center by the fall of 2007. Company representatives report that such work is to prepare for California's pedigree legislation. "While the Sacramento project is designed to support the pedigree legislation in California, it's also an extension of the end-to-end RFID pilot that we completed last year," says Steve Inacker, executive vice president of global supplier services for Cardinal Health. "We look forward to leveraging this work to further validate the effectiveness and viability of RFID technology in real-world settings, should it be adopted as an industry standard."
In late 2006, Cardinal Health shared the results of its RFID pilot program, which showed that "UHF as a single frequency is a feasible solution to track and trace the possession of pharmaceuticals at the unit, case, and pallet levels," the company reports. "The pilot also confirmed that RFID technology offers significant promise to provide an added layer of safety within the pharmaceutical supply chain, by enabling item-level pedigrees to be tracked and traced as they pass from manufacturer to wholesaler to pharmacy." (For more details, see the news story, "Test Shows Value of Gen2 Tags at Unit, Case, and Pallet Levels," in the December 2006 issue of PMP News.)
In May, AmerisourceBergen's Sacramento distribution center went live with its Track and Trace pilot program using an Electronic Product Code Information Services (EPCIS) system based on EPCglobal standards. (For more on that system, see the Data Exchange section below as well as the June 2007 Regulatory Focus column, "Sharing Supply-Chain Data.") AmerisourceBergen's solution includes IBM's Websphere RFIDIC EPCIS and Premises middleware package to read RFID tags and store tag data information. "The advantage of using the RFID and EPCIS system is that the information regarding the product's journey through the supply chain is stored in a manner that is useful for a number of different applications," says Shay Reid, AmerisourceBergen vice president for integrated solutions. "Once the RFID tags have been read and the data has entered the EPCIS, the system can be queried to build a product pedigree for customers on demand, to provide realtime receiving and shipping information to manufacturers as well as to more closely track both inventory and product demand."
Two manufacturers with one product line each are sending RFID-tagged cases and units to AmerisourceBergen. "We are hoping to see more manufacturers engaged in pilots," Reid says. "We are getting indications that more are coming in the fall."
Pending California laws state that drug manufacturers must initiate product serialization at the unit level. This differs from current Florida state laws, which only require nonauthorized distributors of record to generate pedigrees, paper or otherwise. For the industry to comply with the stricter California laws, AmerisourceBergen, Cardinal Health, and McKesson advocate a standards-based approach. Cardinal Health and McKesson seek a single RFID protocol and technology, whereas AmerisourceBergen feels that it is premature for industry to select a single frequency. "Industry acceptance is also needed for standard practices like accepting bar code technology as a complementary and redundant technology to RFID," Cardinal Health adds.
But pedigrees, even those communicated by RFID, can be counterfeited, says Engels. "Wholesalers could have two streams of product—one with pedigrees, one without," he says. "If the wholesaler is authenticating product, and if they are the ones starting the pedigrees, as Florida requires, how will anyone ever know?"
The key for California is serialization. "Serialization gives you synchronization of product information with physical product flow," says Engels. "Pedigrees themselves must be authenticated. There are proposals to use public and private keys to digitally secure documents at each stage. End users get visibility in pedigrees—where the drug came from and its history—so the pedigree becomes an authentication tool. And by allowing people to authenticate with manufacturers, manufacturers could potentially get accurate supply-chain data back to them. It's more difficult for counterfeiters to enter the supply chain."
Pedigrees could be even more thorough, says Engels: "Proper pedigrees begin at the point of manufacture with unique serialization of every pill. Pedigrees should even start with raw materials."
Ng agrees that "any system can be defeated and reverse-engineered. But what California law is requesting is raising the bar for entry." In addition, he says, "Most of the major players do not see value using PKI infrastructure. Pedigree is not about a single document or transaction, but a coordinated effort using technology and business practices."
FREQUENCY DEBATES LINGER
During RFID World's Rapid-Fire Roundtable in Dallas, the point was made that when drug companies are stuck debating frequency, then very little progress will be made as companies won't make the investment. They will not start testing in their own environment with their own packages to come to their own conclusions. Some companies may be waiting for EPCglobal to identify the standard frequency or at least explain the business cases for high frequency and ultrahigh frequency.
McKesson and Cardinal have had successful UHF tests. Confident in UHF, McKesson is recommending that for item marking, manufacturers use Gen2 UHF RFID tags with the SGTIN-96 data format. Two-dimensional Data Matrix is advised as a backup for item-level packages and very small cases.
Gen2 standards have improved UHF, and other innovations may drive adoption. But others who have tested and used HF successfully may have invested in the frequency and therefore may encourage its use. But can two frequencies operate side by side in an e-pedigree environment?
Ng says that using two coexisting frequencies is inefficient. "The downstream supply chain is concerned with the duplication of technology and costs," he says. However, "a single frequency (UHF or HF) may not have the technology maturity to be able to be used in all use-cases defined by the pharma industry. Show me the data that meet use cases."
So far, AmerisourceBergen is achieving 100% reads on inbound UHF RFID tags in the pilot, which was designed to handle more than 1500 serialized items from manufacturers and can be scaled up on short notice. "Read rates on HF RFID–tagged items are better than expected, especially when we ship loose pieces in a mixed tote," says Reid. Totes are read by tunnel readers or manually at individual workstations.
Using technology debates as reasons to wait is "just a good excuse," says Kevin Ashton, vice president of marketing for ThingMagic. Ashton is a founder of MIT's Auto-ID Center and was formerly executive director. "If you want to do it, jump in and take a chance," he says. "HF and UHF can both work. It has nothing to do with physics—it's all about innovation."
EPCglobal has been active in helping companies follow pedigree rules. In January, the group issued its Pedigree Messaging Standard, a document-based model using XML schemas that move chain-of-custody data forward to recipients and are secured with certified digital signatures. It is written to help users meet rules from a number of states, including California.
In April, the group ratified EPCIS, Version 1. EPCIS standardizes event-related data sharing, such as the "what, where, when, and why of events," writes EPCglobal. "[It] supports a detailed representation of the location and state of material as it moves between organizational boundaries and provides for sharing this in a technology supplier-independent way between entities or partners."
"The Pedigree Messaging Standard and any future pedigree based on EPCIS will coexist for quite a while," says Robert Celeste, director, healthcare, EPCglobal North America. "The industry is busy implementing the Pedigree Messaging Standard while exploring the structure and features of an EPCIS-based pedigree."
There are other incentives to employing RFID besides pedigree rules. "The easy answer to the question, 'What will motivate the pharma industry to adopt RFID widely?' is e-pedigrees and FDA," says Ashton. "But the pharma industry often resists FDA pressure. The reality is that in this market-driven economy, companies need a business case for wholehearted adoption. The business driver is that brand protection is a good and sensible business reason."
Even though there is much to be decided and standardized about pedigrees and RFID, the pharmaceutical industry is definitely progressing. "With RFID, all we are trying to do is raise the bar," says Ng. "But an RFID system is not just technology. It involves companies exchanging data back and forth."