Radio Frequency Tags for Identifying Legitimate Drug Products Discussed by Tech Industry
When FDA reported in February that it would be feasible in 2007 for the pharmaceutical supply chain to use a reliable system for tracking and tracing products, the agency cited radio frequency identification (RFID) as "the most promising approach."
Coupling RFID with something known as the electronic product code (EPC) creates an electronic pedigree, said Shabbir Dahod, president of Cambridge, Massachusetts-based SupplyScape Corporation, a firm working on electronic documentation to keep counterfeit drugs out of the pharmaceutical supply chain.
Dahod and representatives of other companies using the 60-year-old technology discussed RFID applications in health care at Smart Healthcare USA, a conference held on June 10 and 11 in San Francisco, California.
Electronic pedigree. The electronic pedigree envisioned by Dahod's company starts at the manufacturing plant, where each finished pharmaceutical container would receive an RFID tag, essentially a portable memory device, with the product's unique EPC and the drug company's identity. A wholesaler that receives a shipment of the product would add the firm's identity to each tag, a process that does not require the tag to be in the line of sight of the "read writer." This step would be repeated by the second wholesaler that handles the product. Thus, each pharmacy that receives a container of the pharmaceutical would have a complete electronic record of the product's handlers since release from the manufacturing plant.
As yet, FDA has not formally proposed requiring that electronic pedigrees replace paper pedigrees, which can be incomplete and subject to forgery, as was the case in 2002 with a large supply of 2000-unit epoetin alfa vials whose labels were forged, too.
FDA instead expects the private sector to be the driving force behind the adoption of RFID tags.
According to Combating Counterfeit Drugs, a report issued February 18 by FDA, the agency foresees companies this year studying the feasibility of mass serialization, that is, assignment of the EPC to each pallet, case, and package of a pharmaceutical. In 2005, according to FDA's timeline, there will be mass serialization of some pallets, cases, and individual packages of pharmaceuticals likely to be counterfeited. Also, some manufacturers, large wholesalers, large chain drugstores, and hospitals will use RFID technology to track and trace pharmaceuticals. Use of the technology will spread throughout the supply chain in 2006. In 2007, there will be mass serialization of all pallets and cases and most packages of pharmaceuticals and use of RFID technology by all manufacturers, wholesalers, chain drugstores, hospitals, and most "small retailers."
"The FDA is very serious about this," Dahod said, referring to the agency's expectation that nearly the entire pharmaceutical supply chain will use RFID technology by the end of 2007.
A technology gaining momentum. RFID of items, animals, and people did not gain momentum until recently because it's a challenge "getting the physics right under the right economic conditions," said Shahram Moradpour, senior director of market development at Sun Microsystems Inc., based in Santa Clara, California. Specifically, certain radio frequencies do not transmit well through liquids and metals, he said.
Radio frequencies, by definition, are in the range of 300 Hz to 300 MHz, although the field of RFID typically uses tags and labels that respond to frequencies in the range of 125 kHz (dog identification tags) to 2.45 GHz (automatic toll-road billing), said Peter Harrop, chairman of conference host IDTechEx Ltd., based in England. "There will never be an ideal frequency" for all RFID tags, he predicted.
He also predicted that mandates from Wal-Mart Stores Inc., Target Stores, other retailers, and the U.S. military for suppliers to place RFID tags or labels on pallets and cases for inventory purposes will drive supply chains from third in worldwide use of the technology to first in 10 years.
Wal-Mart, for example, gave its top 100 suppliers a January 2005 deadline for placing RFID tags on cases and pallets destined for stores in the Dallas–Fort Worth, Texas, metropolitan area. As of April 30, the company touted receiving RFID-tagged pallets and cases from eight suppliers.
But the New York Times reported March 29 that a similar Wal-Mart initiative for manufacturers of Schedule II controlled substances had fallen short of the initial goal. Whereas the company had set a March 31 deadline for manufacturers to place RFID tags on bulk containers of C-II drugs destined for a Wal-Mart distribution center near corporate headquarters in Arkansas, a spokesman acknowledged to a Times reporter that few of the manufacturers had complied and that the target date had been moved back to June 30.
RF trend for individual items. When discussing tags and labels on individual items, conference attendees most often mentioned a radio frequency of 13.56 MHz.
Tags and labels operating at 13.56 MHz are designed to communicate only their unique identifier and other information required for obtaining that identifier, according to the initial set of standards from EPCglobal Inc., a joint venture of the Uniform Code Council and EAN International (formerly known as the European Article Numbering Association). These standards also include information on "anticollision," meaning that communications can occur nearly simultaneously with multiple tags and labels.
The read range for 13.56-MHz RFID tags and labels is reported by various sources to be less than 1 in up to 4 ft, depending on the antenna.