As states get serious about fighting counterfeit drugs, manufacturers and distributors seek help in integrating supply chain, automatic identification, and information technology systems
Although January 2009 may sound like the distant future, it'S right around the corner for drug makers preparing to meet the California electronic pedigree (e-pedigree) law. Given the number of steps and stops between drug manufacturers and consumers, the law'S enactment in January 2009 means wholesalers can expect to begin receiving serialized products in July 2008. With this goal in mind, manufacturers must retool operations to provide for automated serialization and chain-of-custody tracking for their products now.
Serialization may pose the biggest challenge-especially for smaller manufacturers. "The challenge is at the packaging line," says Jack Tarkoff, vice president for sales at e-pedigree software vendor rfXcel Corp. (San Ramon, Calif.)
Tagging individual items with bar codes or radio-frequency identification (RFID) chips on the packaging line and then reading those tags can be tricky, because various factors affect tag-read rates. For serialization tracking, ID tags must be read twice: once as the product goes into the case and again as the cases are placed onto pallets. Tarkoff says these processes are new for some manufacturers and are (given the timeframe established by the California law) a "big challenge."
The impending law joins others on the books or under consideration (Figure 1, p. 19). The concepts of product serialization and electronic pedigree are complicated enough by themselves, but other factors come into play as well. The fact is such systems must coexist with other automated enerprise and operations systems of various vintages and levels of sophistication and integration-each of which is the natural result of growth and efficiency efforts in any manufacturing operation. Add in the information technology (IT) tools in place for regulatory purposes, and the complexity of e-pedigree system integration comes into sharp relief.
SOURCE: CALIFORNIA EXPRESS SOLUTION PRESENTATION
PEDIGREE IMPLEMENTATION A CHALLENGE
Implementation will not be easy. The law requires pharmaceutical manufacturers to create unique identifiers for products, track each product'S pedigree, and maintain electronic supply chain records.
Because every drug product and its manufacturing operation are unique, no single source exists to guide drug makers in implementing an e-pedigree system. Some have conducted vendor searches while getting up to speed on enterprise software integration, e-pedigree software, and packaging line integration. They have also explored the possibility of integrating two-dimensional data matrix and RFID options-the leading automatic identification technologies for chain-of-custody tracking-into printed packaging components.
Fortunately, the task is beginning to assume some structure. The California Board of Pharmacy has affirmed that the drug pedigree standard from standards organization GS1 EPCglobal (Brussels, Belgium) meets the California pedigree requirements. It was ratified as an open standard by companies across the pharmaceutical supply chain in early 2007 and details the pedigree format, including the data fields and certification processes necessary to comply with existing drug pedigree laws in the United States (Figure 2, p. 22). These include the California law and Florida electronic pedigree rules, as well as others in the works.
SOURCE: GS1 EPCGLOBAL.
The EPCglobal standard accommodates a variety of approaches used for drug distribution. Electronic pedigrees are encouraged, but the standard also specifies how paper pedigrees can be scanned and embedded into the electronic record, ensuring a complete pedigree of the drug'S chain of custody. Various product serialization approaches can be used, including RFID, many types of bar codes, or no product serialization at all.
EPCglobal has also certified three e-pedigree software products: Synchrony ePedigree from Axway (Scottsdale, Ariz.), Active ePedigree Management from rfXcel, and ePedigree from SupplyScape (Woburn, Mass.). These products are used to document the chain of custody for pharmaceuticals moving through distribution channels. EPCglobal certification ensures the software'S compliance with EPCglobal'S drug pedigree specification.
The standard gives drug makers a common format for supply chain partners, including distributors and pharmacies, to use in collecting pedigree information. It'S all about inter-operability within manufacturer information technology systems and among manufacturer trading partners. So, even though the software is standards based, implementation can sometimes be challenging due to the details involved in integrating disparate systems.
E-pedigree software vendors sometimes provide what amounts to a custom integration service during such product implementations, though clearly their goal is to avoid doing so whenever possible.
For drug makers, the California e-pedigree law is like the Federal Sarbanes-Oxley accounting act-"a compliance issue," says Tarkoff. "We try to make it as easy and inexpensive as possible for our customers."
Tarkoff says that for many drug makers (already accustomed to the rigors of compliance reporting) the e-pedigree requirements are less daunting than those entailed for serialization by California law. "Pedigree is easy for them because they have the data. It'S the serialization piece for California that will be the big challenge," Tarkoff says.
The rfXcel approach to e-pedigree system implementation is to keep it simple. "When we look at an implementation, the first step is determining where the [pedigree and serialization] data exist," Tarkoff says. "Do they have to bring it in from multiple systems? What takes the longest is the customer having to figure out where the data exists."
Then the implementation process can begin, but customers face a choice. Do they prefer a simple file transfer of existing data, such as electronic data interchange (EDI), integration with third-party enterprise resource planning (ERP), or warehouse management system (WMS) software?
"We recommend the simple file transfer, but some clients want the actual integration," says Tarkoff. Most companies-80% to 90%-choose the former, he says. "We have a specialist if integration is required." The simple file transfer is in line with customers' objectives of keeping compliance as easy and inexpensive as possible. Active ePedigree Management, from rfXcel Corp., has some 30 customers who have integrated the product into their operations.
Like rfXcel, Axway maintains standby technical support for sticky integration issues. The Synchrony Supply Chain Integrity Suite stores supply chain events and demand details both from within and outside the enterprise in a common repository. Components of the Synchrony suite sit atop third-party ERP or WMS software. "We have standard hooks into Oracle and SAP [applications] already," says Kim Loughead, director for healthcare business development at Axway. "We'll continue to enhance them as we move forward."
Axway also has a professional services organization that assists in integration issues. Its approach in such cases is to try to limit scope of work and break it into phases. "We try to keep it very focused, especially in the beginning," says Loug-head. "What are the foundation requirements that we need to meet that make the product useful right out of the box?"
A high-profile Synchrony implementation provides a case in point. Axway announced in late August that AstraZeneca had selected the Synchrony product to enable track-and-trace as part of a global product safety data management initiative. The implementation will cross multiple packaging lines and production sites, with 25 lines and 12 sites identified initially.
"We're implementing in three phases with AstraZeneca," says Loughead. "The first is foundational, building out initial interfaces for analytics. Subsequent phases will involve authentication and then integration with back-office applications."
Synchrony includes modular e-pedigree, track and trace, data integrity, transaction monitoring, and trade activity manager components. AstraZeneca'S purchase of the track-and-trace component will be used to monitor events coming from up the line.
For the implementation, Axway is partnered with Systech International (Cranbury, N.J.), which is responsible for enabling serialization on the AstraZeneca product lines. Loug-head says AstraZeneca is taking a risk-based approach to deciding which lines and manufacturing sites go first. Its mission is to drive patient safety globally, and that mission helps set the priorities.
Because every drug product and its manufacturing operation are unique, no single source exists to guide drug makers in implementing an e-pedigree system.
Loughead says the AstraZeneca implementation is unique in size and scope, the largest serialization implementation that she is aware of. Many implementations today, she says, are pilot implementations restricted to just two or three products and one or two production lines.
"[AstraZeneca] is taking a production view, rather than a pilot view," she says. The company is "putting a stake in the ground saying this technology will solve these problems. They're taking a very practical view, recognizing that the rest of the supply chain will come along eventually."
STRENGTH IN NUMBERS
Among other effects, the California e-pedigree law has driven collaboration among software suppliers, packaging and printing suppliers, and systems integrators. In addition to Axway'S collaboration with Systech for the AstraZeneca implementation, Systech has also joined forces with e-pedigree provider SupplyScape, pharmaceutical printed packaging producer Nosco, and Hewlett Packard (HP) to provide a "solution framework" for California e-pedigree compliance. They call it the California Express Solution.
Each of the partners, according to an October announcement, provides pharmaceutical and biotech companies with industry-standard components needed to build a complete strategy for serialization and e-pedigrees.
The collaboration combines pre-selected two-dimensional- and RFID-enabled packaging components and systems technology with e-pedigree serialization and tracking solutions from the collaborators. These components are then integrated into a customer'S existing enterprise software applications.
HP guides the architecture, ERP, and WMS systems integration and project services for the solution and also manufactures the digital press technology used to print the serialized label and packaging;
Nosco, a packaging provider to more than 325 pharmaceutical manufacturers, creates pre-serialized packaging;
SupplyScape delivers the e-pedigree data management system and serialization strategy; and
Systech provides packaging line serialization expertise.
The goals of the solution are to provide the EPCglobal industry-standard components needed to:
Create a strategy and implementation plan for serialization and e-pedigree;
Define serial number management and carrier plans;
Integrate two-dimensional data matrix bar code or RFID technologies into labels and folding cartons, produced under a manufacturing process based on current good management practices/quality system regulations;
Identify and address changes to manufacturing, packaging lines, and printed packaging components (labels, folding cartons, RFID, two-dimensional, and line control);
Implement electronic pedigree data management systems; and
Integrate with ERP and WMS systems, including SAP.
Various product serialization approaches can be used, including RFID, many types of bar codes, or no product serialization at all.
In addition to its California Express Solution collaborations, SupplyScape has other partnerships with systems integrators geared toward helping customers with implementation issues. Services include implementation, training, technical support, and project management.
Technical consultants are proficient with SupplyScape software solutions, says Stacy Humphrey, marketing director, as well as various application and database server software. "We work with our customers to conduct unit, system, and integration testing to ensure smooth integration between SupplyScape applications and your in-house WMS and ERP solutions," she says.
A CASE STUDY
In early October, national drug distributor Jace Pharmaceuticals (Paramus, N.J.) implemented SupplyScape'S e-pedigree data management system. This was done to comply with state and federal pedigree regulatory requirements, including California'S e-pedigree regulations, according to a SupplyScape announcement.
Jace, a wholesale distributor, specializes in delivering essential time-critical specialty pharmaceuticals to hospitals, clinics, and home infusion providers. The company had been using a paper pedigree-based system it developed, but the pedigrees were not EPCglobal compliant and Jace could not keep up with continually changing pedigree regulations.
Jace is now using the e-pedigree system to demonstrate product security best practices as part of its accreditation from the National Association of Boards of Pharmacy'S Verified-Accredited Wholesale Distributors (VAWD) program. The VAWD program accredits wholesale distributors and certifies that they are legitimate, hold valid licenses in good standing, and employ security and best practices for safely distributing prescription drugs from manufacturers to pharmacies or healthcare facilities.
In a separate announcement, SupplyScape said in late September that Pfizer had licensed its e-pedigree software to expand the drug maker'S channel security initiative, which also includes SupplyScape'S RxAuthentication product authentication system. RxAuthentication enables pharmacies and wholesalers to verify the authenticity and status of the serial number on packages of Viagra at any time prior to final dispensation to a patient. �