There was a time—perhaps in the 2005-2007 period, when radio-frequency (RFID) tags for item-level serialization were running hot and heavy—that the US bio/pharma industry and its trading partners could have coalesced around an acceptable standard for identifying product packages uniquely, and tracking their pedigree through supply chains. For many reasons (notably reservations about RFID itself, which has mostly been superseded by 2D barcode as the serialization technology of choice), that didn’t happen. Industry as well as FDA are still struggling with how to manage the e-pedigree process, as evidenced by FDA’s recent workshop on the subject.

But overall e-commerce and supply chain collaboration hasn’t been at a standstill during the intervening years. National efforts outside the US—in Turkey, Brazil, France and even China—are moving ahead. In the medical-device arena, FDA is forging ahead with plans for a unique device identification (UDI) program, and will announce a proposed regulation in June of 2011. US hospital group-purchasing organizations (GPOs) are now in the midst of a “sunrise” program to standardize the location of trading partners, and the identification of product types, according to, respectively, the GLN and GTIN standards of the GS1 organization. According to GS1 US Healthcare, as of March 1, 566 healthcare trading partners (hospitals, suppliers, distributors) have registered over 300,000 global location numbers (GLNs); an increase of 250% over the past two years. By the end of this year, the global trade identification number (GTIN) program will begin in earnest. Add a serialization code to the GTIN, and you get an sGTIN, which is one of the ways to meet FDA’s guidance on serialized pharmaceutical packages, announced a year ago.

Location and product codes are simply the “words” that trading partners use to conduct transactions; it leaves the “grammar” of how the codes are understood, communicated and acted on undefined. The general scheme for collecting, storing and communicating transaction data involves “data pools” or hubs where these transactions could be effected. GS1 has its own horse in this race—the service it calls 1Sync—but now others are cropping up. Prime among these is GHX, Inc. (Louisville, CO), which offers the Health ConneXion data pool in addition to a trading platform that already handles a large portion of med-surg supplies for hospitals. The company has also begun a Track & Trace Project, and will build a prototype this year to be tested by trading partners.

“Our goal is to leverage the expertise we have in handling e-commerce that’s been demonstrated already, and to potentially save the entire industry—manufacturers, wholesalers and providers alike—some of the cost of implementing a track-and-trace solution partially or individually,” says Margot Drees, director, corporate strategy at GHX. “Regulators are still grappling with identifying what is possible and acceptable to the industry, and this could be a model for how we can all move forward.”

Healthcare e-commerce
GHX traces its roots back to the early days of “Internet 1.0,” when businesses were scrambling to set up online exchanges to do e-commerce during the late 1990s. A handful of medical surgical manufacturers formed the Global Healthcare Exchange in 2000. In 2001, it acquired HealthNexus, a distributor-supported exchange; in 2002, Medibuy, a GPO-led exchange; and in 2005, Neoforma, a publicly traded health exchange. Many of the backers of the acquired businesses signed on as equity owners of GHX, which now has 20 investor-members.*

[*Abbott Exchange, Inc.; AmerisourceBergen Corp.; Baxter Healthcare Corp.; B. Braun Medical Inc.; BD; Boston Scientific Corp.; Cardinal Health, Inc.; Covidien; C.R. Bard, Inc.; Thermo Fisher Scientific Inc.; GE Healthcare; HCA; Johnson & Johnson Health Care Systems Inc.; McKesson Corp.; Medtronic USA, Inc.; Owens & Minor; Premier, Inc.; Siemens; University HealthSystem Consortium; and VHA Inc.]

GHX has both a detailed governance policy, to pass muster with antitrust concerns and guide equity owner influence, and a vendor-neutral transaction process, according to the company. Vendors or buyers needn’t be equity owners to participate (there are some 8,400 healthcare providers trading through GHX, representing 80% of the hospital beds in the US, and 4,800 med-surg suppliers, with additional members in Canada and Europe). The company uses a third-party to validate its claim that it has saved over $1.3 billion in healthcare transaction costs in the past four years, including $734 million in the past year alone, and is on target to take more than $5 billion in costs out of healthcare over the next five years.

“Savings occur because our e-commerce tools automate many processes that are usually done manually,” says Drees. “This ranges from automated conversion of fax orders into EDI, to managing item master files, identifying and reconciling order discrepancies during the transaction process, validating GPO memberships and pricing, and handling rebates and discounts,” she says. “The overall idea is ‘touchless’ ordering for buyers and sellers.”
GHX currently manages some $38 billion in healthcare purchasing, according to the company. Trading partners (both buyers and sellers) pay a one-time integration fee to GHX based on complexity of the integration and the size of the organization, and a basic subscription fee that provides trading partner connectivity and transaction services. GHX also offers an additional group of tools and product offerings that members can subscribe to on an a la carte basis. These include:

• contract management, to keep contractual terms between buyers and suppliers current
• item master file data, to keep specifications of vendor products available and up to date
• on-demand accounts payable, to streamline invoice processing
• trading partner collaboration, through a Collaboration Portal, that allows all four
parties to a hospital transaction (manufacturer, wholesaler/distributor, GPO and
hospital purchaser) to jointly set contract and transaction terms
• business performance solutions, which enable suppliers to actively manage sales trends, while optimizing order delivery processes.

Building out track-and-trace
How does all this translate into an effective track-and-trace system for pharma? GHX concedes that the exact mechanisms remain to be determined, but that’s the rationale for developing a prototype this year. “Phase 1 of this undertaking was to survey pharma trading partners—manufacturers, distributors, chain and independent pharmacies—to collect requirements,” says Drees. That process has been completed over the past year. Phase 2 will be to build the prototype, and Phase 3—if it happens—is a full-blown implementation.

Phase 1 has provided some detail on what master file data need to be collected, how data are to be secured, and the data governance policies. GHX has considerable experience in this area, attributing much of the success in gaining industry adoption for the exchange to its strict data privacy rules. Specifications on how track-and-trace events (initiating an order; receipt of a delivery; adjudication of a payment, and so forth), and exception handling—missing data, errant deliveries and the like—are to be addressed.

As Phase 2 gets underway, GHX will be grappling with the requirements for real-time data handling, to validate deliveries (thus providing a pedigree) while maintaining security to the overall data compilation of a transaction. In an eventual commercial-scale deployment, GHX envisions the enablement of a discovery service, so that shipments that are received by a purchaser can be validated even when the originating supplier is not known. Along the way, business processes can be developed to monitor inventory levels, manage product recalls and returns, and—not to be overlooked, since it is the motivator for the whole track-and-trace program—authenticating product deliveries by checking their serial identification data against a repository. Attention will also need to be paid to situations where some transaction data resides in other data pools, to be accessed by GHX but not stored there.

Drees concedes that GHX itself needs to work out some new corporate governance policies, and what aspects of the service will be productized and then offered to the market. But the prototype could demonstrate the necessary capability to guide regulatory policymaking, and could also expedite manufacturer, distributor and purchaser compliance with the 2015 deadline that the California Board of Pharmacy is holding to for a working e-pedigree system. Drees says that the needed ingredient is participation from manufacturers—something GHX has had success with on the medical-surgical side. Stay tuned! PC