By Mary Catherine O'Connor
Mar. 24, 2006—According to
GlaxoSmithKline (GSK), the
National Association of Boards of Pharmacy (NABP) lists Trizivir, an HIV medicine, as one of the 32 drugs most susceptible to counterfeiting and diversion. That's why the drugmaker is now placing
high-frequency passive tags on all bottles of the drug manufactured for U.S. distribution at its plant in Zebulon, N.C., near Raleigh. The tagging is part of a pilot project aimed at determining whether
RFID tags can be attached to bottles of the drug at the GSK packaging facility and later
read by GSK at its Raleigh distribution center. The tags could also be used to authenticate the products and fight counterfeiting and diversion.
In 2004, the
U.S. Food and Drug Administration (FDA) recommended the use of RFID for product
authentication as a means of eliminating counterfeit drugs, which pose health risks to anyone taking them. The FDA has asked the pharmaceutical industry to develop standards and pilot processes for using the technology.
Purdue Pharma is working with distributor
H.D. Smith to test RFID in authenticating and tracking bottles of Purdue's OxyContin painkiller (see
Purdue Pharma to Run Pedigree Pilot).
Pfizer is also testing RFID to authenticate and track shipments of Viagra in the U.S., while distributor
McKesson is also using the tagged Viagra in its own RFID technology pilot (see
Pfizer Using RFID to Fight Fake Viagra and
McKesson Starts RFID Pilot for Viagra).
GSK spokesperson Mary Ann Rhyne says her company's primary goal in the pilot is to authenticate the Trizivir product, sales of which were $302 million in 2005. RFID can also be used to improve efficiencies and visibility into supply chain processes, but the company doesn't believe it likely will find such benefits in the Trizivir pilot. "There aren't many efficiencies [that will result from tracking] one stock-keeping unit," says Rob Coyle, director of warehouse and distribution services in GSK's IT department. "And since we're tagging only one product, we're treating it as an exception," he says, noting that the pilot will add some time and labor to GSK processes. As a result of this pilot, he says, GSK will gain a better understanding of RFID technology, how well and consistently tags attached to bottles and cases of its product can be read, and what business process changes might be required to integrate the technology on a permanent basis.
Coyle explains that GSK conducted in-house testing to determine the best types of tags to use in the pilot. "We did some early testing when we were getting ready to tag consumer goods for retail mandates," says Coyle, "and then we did some additional testing for the pilot, using three different form factors." The tests showed that high-
frequency (13.56 MHz) tags outperformed
ultra-high frequency tags when read at the item level. For cases of products, however,
UHF tags performed best.
GSK designed its pilot with the help of
IBM, which provided the RFID
middleware the drugmaker is using to collect and filter the
RFID tag data and associate it with batch and order information as the units of tagged Trizivir move from the packaging line to a GSK distribution center in Raleigh.
GSK is applying labels embedded with the
ISO 15693-compliant RFID inlays to the bottles of Trizivir as they move down the packaging line. Pre-encoded on the inlay is an
Electronic Product Code (
EPC) containing the product manufacturer ID and a random serialized number. "Nowhere on the EPC does it say that the product is Trizivir," says Coyle. "We're doing this to address consumer privacy, and because standards as to how product data should be encoded on pharmaceuticals are still being developed."