REGULATORY FOCUS
Working Toward a Consensus on RFID
FDA brings dozens of experts together to discuss RFID’s role in anticounterfeiting.
By Daphne Allen
Supply chain integrity and patient safety are the leading benefits of using electronic product codes (EPC) and radio-frequency identification (RFID), and these benefits increase as more products are tagged at the item level. John Gray, president and CEO of the Healthcare Distribution Management Association (HDMA), stressed these points to FDA at the agency’s Counterfeit Drug Task Force Public Workshop and Vendor Display. Held February 8–9, the event hosted a diverse group of participants. Industry stakeholders such as Pfizer and Johnson & Johnson spoke, as did technology providers and supply chain participants, including HDMA’s Gray, who cited an RFID study conducted by A.T. Kearney. More than two dozen vendors manned tabletop displays.
FDA held the workshop “to identify current barriers to adoption to find ways these barriers can be overcome,” said Andy von Eschenbach, FDA’s acting commissioner. “We want to gather new information and glean fresh ideas as we come together to decide this important issue.”
Industry’s task is a formidable one. “All package units of targeted prescription medicines should contain a machine-readable serial number that includes the company identifier,” argued Alan Goldhammer from the Pharmaceutical Research and Manufacturers Association. “The machine-readable code can be either a two-dimensional bar code or an RFID tag. The chosen code should be robust and reliable in terms of readability and cost-effective.”
Von Eschenbach said that FDA “is firmly behind the implementation of electronic track-and-trace technology as one leading weapon we can use to combat the counterfeit drug problem. We must use information and technology such as RFID as new opportunities that are essential for our ability to track, trace, and authenticate these new products and our drug products in the marketplace. An electronic pedigree to minimize fraud and mischief is vital in protecting American consumers.”
There is some concern, however, about adoption. Doug Scheckelhoff, director of pharmacy practice sections with the American Society of Health-System Pharmacists, pointed out that “we do not want to send a signal to hospitals that they should hold off on the implementation of bar code technology at the bedside because point-of-care RFID is just around the corner. In fact, a great deal of work and study will need to be done before that might become a reality. Bar code technology is here now, and at the point of care it saves lives every day.”
And industry support of unit-dose bar coding has been an issue, adds Scheckelhoff. “Despite the clear benefit that unit dose brings to patient safety, many manufacturers have chosen to stop producing unit-dose packages, leaving hospitals no choice but to expand their own repackaging operations. In fact, reports have shown a 30% drop in unit-dose packaging over the last five years. This has resulted in inefficiency in the U.S. healthcare system and an increased opportunity for error.” Could such a withdrawal spell similarly weak support for item-level EPC/RFID?
RFID will help hospitals “manage inventory and prevent diversion,” Scheckelhoff continues. “There have been several reports of large-scale drug diversion, diversion of high-cost drugs, primarily injectables, from hospitals. The largely manual systems in place in most hospitals do little to prevent this from happening. ASHP supports the use of this type of technology, RFID, to track products.”
Developing standards is another task. Mike Rose, vice president of Johnson & Johnson Corporate, RFID/EPC Global Value Chain, asked FDA and attendees a series of detailed questions. “What frequency will we use, and will it be compatible with the various packaging types? What information will be on the tag? Will the National Drug Code be included in the EPC? How will the information be stored, secured, and accessed?”
Serialization has been widely discussed in industry, and Dan Engels of MIT advised attendees to pursue it, but with care. “Serialization should be used to uniquely identify every item, whether it’s at the case, pallet, or item level, the sellable unit or usable unit of dose. And we should make sure that when we use a serialized number, it’s a one-time-use number. We assign it once. We use it once. We never, ever use it again.”
Engels cautioned against using the NDC as the serial number. “The NDC is a very U.S.-centric number. We are talking about pharmaceuticals. This is a global industry. When we have identifiers, we need to make sure that whatever we use for unique serialization is able to encompass, at least in its representation form, numbering schemes from around the world.”
FDA also solicited written comments. As of March 1, the agency shared docket replies from Amgen Inc., Pfizer, Mayne Pharma (USA) Inc., Baxter Healthcare Corp., Bayer HealthCare LLC , and others, including technology providers and retail pharmacies.
After reviewing all comments, FDA plans to issue a report in May. Workshop participants urged FDA to provide guidance on “electronic pedigree information content, digital signature use to sign the pedigree, inclusion of the NDC in the electronic product code, and the compatibility of bar code information with the information on the RFID tag.”
For workshop transcripts and presentations, visit www.fda.gov/rfidmeeting.html.
