The use of radio-frequency identification (RFID) to monitor drug movement is a relatively recent phenomenon, but one that is long overdue. With the increases in drug counterfeiting and diversion across the world, pharmaceutical companies are striving to maintain top safety standards to keep their products in safe hands.
In 2004, the FDA initiated 58 counterfeit- drug investigations, up from 30 in 2003 and only 6 in 2000. In February 2004, the agency issued a report confirming that RFID was vital to the efforts of combating pharmaceutical diversion and counterfeiting.
Through technology, companies are endeavoring to keep one step ahead of those who would intercept legitimate pharmaceuticals on their way to waiting patients. To this end, they are working to develop state-of-the-art equipment that will aid drug makers in getting their products to the proper destinations.
H. D. Smith (Springfield, Ill), the fourth largest pharmaceutical wholesaler in the country, has long been a partner with health care in maintaining safety standards. Founded in 1954, the company in 2004 became the first wholesaler to install an Electronic Product Code (EPC)?compliant RFID system in its distribution centers to track controlled- substance pharmaceuticals. The medicines are tagged as they move into the vault and are placed in a tote that passes through an RFID portal. If a product is not already tagged by its manufacturer, H. D. Smith tags it. Each item is identified by its tag - the first step in the enabling of an electronic pedigree (e-pedigree). Once created, an e-pedigree is mandatory for every transaction involving that product in the supply chain, from manufacturer to pharmacy.
Between 2004 and 2005, H. D. Smith piloted an innovative supply chain anticounterfeiting and security system, using e-pedigree software from SupplyScape Corp (Woburn, Mass). It employed this system to track Purdue Pharma's oxycodone (OxyContin), a prime target for diversion. Together, the companies used the software to track and authenticate the e-pedigree for each high-profile drug that came through H. D. Smith's warehouses. The pilot became a fully operational program a year later, as H. D. Smith's Pompano Beach, Fla, center installed SupplyScape's then-latest version of RFID software well in advance of the state's deadline for e-pedigree compliance.
Robert Kashmer, vice president of information technology at H. D. Smith, explained how the e-pedigree works. "We did the major integration work, interfacing the software with our proprietary enterprise system. We've also interfaced it to our [warehouse management] system for lot tracking and to the RFID system." The necessary information about the drugs - manufacturer, product identification number, lot, date of manufacture, National Drug Code number, and expiration date - is transmitted to H. D. Smith by the drug maker. SupplyScape E-Pedigree software at H. D. Smith originates the epedigree, certifies it with the digital signature, and provides it to customers down the supply chain.
H. D. Smith ships its products directly to retailers from its warehouses. Its customers can use a Web browser to view e-pedigrees and track a product's movements from door to door.
Brenda Kelly, vice president of marketing at SupplyScape, talked about how the software works. "[It] contains a self-authenticating mechanism. If the software can open and read the pedigrees, users know all the nested digital signatures inside those pedigrees are intact. It's proof that the pedigree documents were not adjusted, forged, or tampered with," she said.
SupplyScape's E-Pedigree software helps companies comply with regulations in all states that have pedigree laws and with the Federal Prescription Drug Marketing Act. Since its successful trial with H. D. Smith, more than 50 companies have come on board with the E-Pedigree program, including pharmaceutical companies, retail pharmacy chains, specialty wholesalers, and repackagers throughout the United States.
Pfizer is another pharmaceutical company that uses RFID to protect a primary product - sildenafil citrate (Viagra), a main target for counterfeiting. In 2006, Pfizer worked with SupplyScape to deploy SupplyScape's RxAuthentication Service, an online service provided by SupplyScape to which pharmacists and wholesalers must subscribe. After receiving Pfizer's product, a pharmacist or wholesaler will use an RFID interrogator, linked to the RxAuthentication Service over a secure Internet connection, to read the tag's EPC and chip identification. The RxAuthentication Service checks to see that Pfizer initiated the EPC. By October 2006, H. D. Smith and other wholesalers had completed more than 200,000 authentications of both item- and caselevel tags of Pfizer's sildenafil.
In June, SupplyScape awarded its first Value Chain Leadership Award to H. D. Smith, recognizing it as a "forward- thinking company that solves the challenges of the pharmaceutical supply chain in breakthrough ways." H. D. Smith was honored for being the first pharmaceutical wholesaler to adopt a safe, secure pharmaceutical supply chain by providing e-pedigrees and receiving and distributing serialized products with RFID tags.
A messaging format that allows different e-pedigree systems to interact was developed by the Pedigree Messaging Work Group, part of EPCglobal, the standards body for RFID technology. EPCglobal recently awarded its first software certification mark to Supply- Scape for its E-Pedigree software. The mark is awarded by the EPCglobal Software Certification program, a standards- based compliance testing program that provides a neutral and official source for testing EPC/RFID software. The certification mark ensures that all software programs in the system have been tested and will work within the overall structure of the EPC Network.
Chris Adcock, president of EPCglobal, said, "By choosing software with an EPCglobal ? Certification Mark, the end user can be confident that the software will perform according to defined EPCglobal standards." Shabbir Dahod, president and chief executive officer of SupplyScape, said, "The widespread adoption of the EPCglobal Drug Pedigree Messaging Standard creates a foundation of precise and timely information that will transform the pharmaceutical value chain."
H.D. Smith's Kashmer said, "Our main goal is patient safety, which is why we're leading the industry on epedigree. We're also working with [the Healthcare Distribution Management Association] to help the industry move forward on RFID."
Kashmer hopes that in the future more manufacturers will realize the potential of RFID technology to initiate the e-pedigrees on their ends, making the process more efficient and convenient. He said that H. D. Smith is out "to prove [the efficiency of] the technology to ensure the safety of the supply chain," and that his company is ready to "offer any help we can" to make this happen.
Progressively, companies are coming to realize the value of containing data in an e-pedigree that can help them improve the reconciliation processes, such as returns and recalls. Dahod shares H. D. Smith's vision of a time when more companies will benefit from RFID technologies. "Innovative companies, such as H. D. Smith, are leveraging SupplyScape's product security solutions ? to increase patient safety, enhance collaboration within the supply chain, and improve business performance," he said.