Purdue Pharmaceuticals is in discussions with several major wholesalers about expanding its ongoing program to attach radiofrequency identification (RFID) tags to individual bottles of its popular painkiller OxyContin, Michael Celentano, associate director of supply chain systems, told PIR.
The tags are currently attached to bottles of OxyContin sold through H.D. Smith, the nation’s largest privately held pharmaceutical distributor, and those sold at Wal-Mart, which is requiring the use of RFID tags by all suppliers, not just pharmaceutical manufacturers.
OxyContin (oxycodone HCl controlled-release) is a narcotic drug produced in tablet form to treat moderate to severe pain. The Center for Drug Evaluation and Research (CDER) strengthened the warnings and precautions sections for the drug on Jan. 22, 2004 following “numerous reports of OxyContin diversion and abuse in several states,” some associated with “serious consequences including death.” Probably the most notorious case involved talk-show radio host Rush Limbaugh, who became addicted to the drug after spinal surgery and recently signed a plea agreement to settle charges of “doctor shopping.”
Purdue Pharma’s initial pilot program to tag bottles of the drug began around the same time CDER issued its statement, in late 2003 or early 2004, according to Celentano.
“We were the first company in the country, or even the world, to put RFID tags on individual items,” as opposed to cases or pallets, said Purdue Pharma Vice President Aaron Graham.
Establishing Electronic Pedigree
Many pharmaceutical companies are now using RFID tags to combat drug diversion and counterfeiting, thereby improving patient safety. For Purdue Pharma, the “bigger threat” has been diversion, not counterfeiting, said Graham. For other popular drugs, like Viagra and Lipitor, the reverse is true, he said. “But we want to be proactive as the threat of counterfeiting grows so that we don’t have to play catch-up.”
Graham, who is a former FDA official, said that Purdue Pharma’s use of RFID “helped bring the FDA along,” but he praised the agency’s activism in this area, including its Feb. 18, 2004 guidance on counterfeiting that said that RFID tagging “appears to be the most promising approach to reliable product tracking and tracing.”
RFID tags “help law enforcement if the product is stolen,” Graham said. For example, if a pharmacy that carries OxyContin is burglarized and three bottles are later found in a suspect’s possession, the RFID tag enables the authorities to ascertain that the bottles were from the targeted pharmacy. The tags can also help fight counterfeiters who might try to retrieve empty bottles from pharmacy trash and fill them with fake OxyContin, he said. This in turn helps establish electronic pedigree (epedigree), a requirement under the Prescription Drug Marketing Act for pharma companies to be able to trace drugs throughout the supply chain. Implementation has been stayed until December 2006.
RFID is a highly efficient technology, Graham added. It is not necessary with RFID to have a direct line of sight from the scanner to the tag, which would make it necessary to scan bottles one at a time. Instead, Graham said, “you can scan a case of 48 bottles in three to five seconds.”
Purdue Pharma introduced RFID into OxyContin packaging in two phases, Graham said. “First, we established the capability to satisfy Wal-Mart. Then, we saw the FDA guidance and decided we wanted to do more working with EPCglobal [a consortium seeking to develop industry-wide standards for RFID]. We identified epedigree as a priority early on. In phase two of the pilot program, we developed RFID beyond just tagging. We do not just tag and collect data; we send the data on to the wholesaler in advance, in accordance with epedigree.” The company is also looking to introduce RFID tags onto cases and pallets in addition to the individual bottles, a progression that Graham said accords with what other pharma companies are doing.
Gen 2 Developments
Privacy advocates have expressed concern that RFID tags could be used to track individual patients’ prescription information, but the way the tags are used on OxyContin would seem to obviate these fears. “There is no other information for us other than the unique serial number, which just identifies the product. There is nothing else on the tag,” Celentano said.
He added that the company’s internal discussions of the subject have focused on attaching the tags to a typical 100-count bottle, which is not dispensed to the consumer. “[The drug] is not dispensed to the consumer in that [100-count] bottle, and we are not putting other information into the tag. It is not a mini-database,” Celentano said. Pharmacists typically count out a given number of pills into the familiar amber-colored plastic pillboxes, which do not have RFID tags, Graham added. EPCglobal specifications for second-generation RFID tags call for the ability to “decommission” them (partially or completely erase the information encoded on them), but it is not clear whether that will become a requirement, Celentano said.
Another issue is the use of high frequency (HF) as opposed to ultra-high frequency (UHF) tags. At present, “we use UHF Class Zero tags to be in compliance with Wal-Mart, but some of the pharmaceutical community has started doing HF for item-level tagging,” Celentano said. UHF is universally used at the case and pallet levels, he noted. “At Purdue, we are evaluating our options,” he said. “We’re using an old technology for the UHF tags, but Gen 2 is now generating a lot of interest with a technology that is equivalent to or better than HF for item-level tagging. We are working toward a standard, but we’re not married to any one technology.”
When asked how he would advise other pharma companies considering adopting RFID, Graham said they should go ahead with it. “As you see the price of tags going down and the technology evolving, you don’t have to reinvent the wheel every time. It’s not a billion-dollar technology — we did it for less than $2 million, plus the individual bottle cost. It’s a couple of pennies per bottle.” As organized crime targets high-profile drugs for HIV/AIDS, blood pressure medication, and drugs like Cipra and Tamaflu, drug companies should adopt RFID because “we want to ensure the integrity of the nation’s drug supply,” he added. — Martin Gidron