With concern about drug counterfeiting and diversion rising, there is no doubt that pharmaceutical products will eventually be identified at the item level by a serialized code and that chain-of-custody, or pedigree, records documenting their travels through the supply chain will be required.
How and when this will be accomplished are far less certain. Although various digital coding systems currently on the market can apply serialized codes to primary packages at line speeds, radio frequency identification (RFID) is favored by the U.S. Food and Drug Administration (FDA) as the enabling technology for collecting the data that will enable product tracking and tracing and the creation of electronic 'e-pedigree' records, which can reveal unauthorized touch points.
Item-level tagging and supply chain visibility also hold the promise of significant cost savings for pharmaceutical companies "through better inventory management at all levels of the supply chain," noted Randall W. Lutter, Ph.D., associate commissioner for Policy and Planning at the Food and Drug Administration (FDA), during a keynote address at RFID World this past March.
However, the industry has been slow to adopt item-level RFID technology largely due to unresolved questions: Which frequency is best? What information should the serialized item-level code contain? What other data should the tag carry? How will data be collected, maintained, and accessed? And where will it reside?
The varying pedigree regulations taking effect and under consideration in multiple states and by the FDA have added another layer of uncertainty.
Nevertheless, for pharmaceutical manufacturers, "Item-level tagging is not a question of if, but when," says Bill Allen, director of strategic alliances and programs at Texas Instruments Inc. (Plano, TX).
And progress has been made. Two working groups recently formed by EPCglobal Inc. (Brussels, Belgium) have been tasked with answering the need for standards. The mission of the UHF (ultra high frequency) Air Interface Working Group is to develop extensions to the current Gen 2 UHF protocol for security features needed for item-level tagging.
The HF (high frequency) Air Interface Working Group's charge is to extend the logic and technology of today's UHF Gen 2 standard into the 13.56 MHz band. "High frequency performs well in certain pharmaceutical applications, so it makes sense to extend the global reach of Gen 2 to HF," says Mike Rose, vice president of RFID/EPC at Johnson & Johnson (New Brunswick, NJ), who co-chairs EPCglobal's Healthcare and Life Sciences Business Action Group and also serves on EPCglobal's Board of Governors.
The FDA also wants to accelerate adoption of RFID technology, which agency officials had expected to be well established by 2007, and has reconvened its Counterfeit Task Force to assess progress, identify obstacles delaying adoption for tracking and tracing product, and recommend ways to overcome these hurdles.
Entering the Fray
Currently, a handful of drug companies, including Pfizer (New York, NY), Purdue Pharma (Stamford, CT), GlaxoSmithKline (London), and Mallinckrodt Pharmaceuticals (St. Louis) are shipping some tagged product. Other firms have item-level tagging pilots underway, and a number of drug makers, including Cephalon, Inc. (Frazer, PA), are running e-pedigree pilots.
Purdue Pharma, maker of the pain killer OxyContin, began looking at item-level tagging late in 2003 to meet a mandate from Wal-Mart Stores (Bentonville, AR) related to controlled substances. "Our initial goal was to verify 100% read rate in the shipper, a 48-count box," recalled Mike Celentano, associate director of supply chain systems at Purdue Pharma, in a presentation at RFID World. "We realized early on we wanted more, and began to investigate data collection options and how we could track and trace within the four walls," he explained.
Initiating events like packaging process orders or sales orders are provided by the company's R/3 ERP system from SAP AG (Walldorf, Germany). Using Auto-ID and Event Manager software, also from SAP, and Class 0 UHF tags and readers from Symbol Technologies Inc. (Holtsville, NY), Purdue established three data collection points. At the outfeed of the case packer, each case is scanned to confirm the readability of each container tag and to collect electronic product code (EPC) and batch/lot number data so that each tag, and the container to which it is attached, can be tied to a batch. Time and event info are also recorded. If any tag doesn't read, the case is rejected.
The second scan point is at the check-in to the vault, where tag data is collected along with a time stamp and event info. The third read point is at vault check-out. This once again verifies tag readability, associates the container with a delivery number, and records the time and event. With this information, the system can identify the EPC, batch/lot number, and delivery destination for each bottle. This not only provides track-and-trace capability, but also, in the case of a recall, allows affected containers to be pinpointed quickly. Device management is provided by Northern Apex Software (Fort Wayne, IN).
Purdue's first cases of tagged products were shipped in November 2004. By mid-2005, the company had decided to leverage the system to provide e-pedigree data as well. A 60-day Electronic Pedigree Pilot using a hosted solution from Unisys Corp. (Blue Bell, PA), pedigree software from SupplyScape (Woburn, MA), and a distribution center located at the headquarters of drug wholesaler H.D. Smith (Springfield, IL) proved successful. "The fundamental building blocks for an RFID-based, serialized, point-to-point e-pedigree model exist today," Celentano notes. "But more testing is needed."
In Cephalon's case, the pilot program uses UHF Class 1 RFID tags; Tyco Sensormatic Agile 2 readers and antennas from ADT Security Services Inc., a unit of Tyco Fire & Security (Boca Raton, FL); and software tools in OAT Foundation Suite 4.5 from OATSystems Inc. (Waltham, MA). Mallinckrodt uses a similar set-up to tag some containers of its generic pain killers.
Pfizer's system, which is installed on a Viagra packaging line in France, uses 13.56 MHz high-frequency tags, readers, and encoders from TAGSYS, Inc. (Doylestown, PA). Label converter West Pharmaceutical Services (Lionville, PA) turns the inlays into smart labels. A TIPS Serialized Product Tracking vision system and software from SYSTECH International (Cranbury, NJ) writes tags and records EPCs, manages rejects, links bar code and RFID data, and stores information in a database. Software from SupplyScape receives the data, creates e-pedigree records, and authenticates product.
Enabling Software
"Track and trace and authenticate activities have to be part of the normal business flow rather than standalone," says Siamak Zadeh, Ph.D., senior director of life sciences at Oracle Corp. (Redwood Shores, CA), which offers an e-pedigree tool composed of various parts of the company's technology stack, including Fusion middleware, Oracle Application Server 10g, and Oracle Database 10g.
Applications should be data-carrier agnostic so that information can be captured from a variety of sources. Some firms, especially in Europe, rely on two-dimensional bar codes to provide serialized item-level information, and a few smaller members of the pharmaceutical supply chain may still rely on fax. Other important features include support for a centralized or distributed data repository, along with data security and privacy.
The good news is that much of the enterprise software commonly used by pharmaceutical companies supports e-pedigree data collection initiatives. For example, an event-level filtering tool in RSLogix software from Rockwell Automation (Milwaukee) moves the data collected from RFID read points to a database where it can be accessed by manufacturing execution systems, ERP systems, and trading partners.
Nutech Systems (Mississauga, ON), which has long offered software to track automotive parts by bar-coded serial number, has updated its product to accept RFID-generated data and transmit it via electronic data interchange -- or via the tag itself, if the tag can write and store information. It's compatible with either HF or UHF systems. To make counterfeiting difficult, the software randomly generates serial numbers.
The need to share data among supply chain partners makes data ownership and access major issues. "Partners need to agree on rules of business engagement," advises Oracle's Zadeh. Such agreements should be formalized, says Daryl Eicher, vice president of health care industry solutions for Cyclone Commerce Inc. (Scottsdale, AZ), "to clarify what the intent is for use and access of the data as well as for the people managing the content." In addition, he notes, successful information sharing "requires common schemas and protocols to allow different software systems to interoperate."
To support business integration, Cyclone Commerce, which recently merged with Axway, provides secure B2B communication over the Internet. Its Healthcare Compliance suite picks up advanced ship notices, which include lot numbers, and creates an XML-based e-pedigree schema that is archived as a legal document by the distributor or manufacturer.
Meanwhile, as RFID or other serialized coding methods evolve, pharmaceutical manufacturers can capture information that is currently available and use it to detect anomalies in the supply chain with tools like channel commerce management software from Edge Dynamics (Redwood City, CA).
"Most companies today take an ad-hoc approach to detecting anomalous flows of product or money in a channel, but this needs to be treated as a mainstream activity," says John McGrory, president and CEO at Edge Dynamics.
Channel commerce management software allows a pharmaceutical manufacturer to define and manage business policies that govern what action is taken under given circumstances and applies these policies to transactions in real time using data from ERP, supply chain management, and business intelligence applications.
All told, it appears industry-wide use of item-level tagging and e-pedigree traceability is a few years away. But, for the manufacturer looking to take advantage of its benefits today, tools are available to protect products now and to begin the implementation process.