Purdue Pharma Blazes a Trail for Drug Security
Purdue Pharma is RFID-tagging bottles of OxyContin and Palladone, taking product safety and supply chain oversight to new levels.
By Paul Thomas, Managing Editor
[Editor’s Note: On July 13, FDA asked Purdue to withdraw Palladone from the market for safety reasons. See sidebar below.]
This has allowed Purdue to monitor the products as they move through production at Wilson and Totowa, and to coordinate with H.D. Smith and Wal-Mart to track and trace individual bottles throughout the supply chain — all the while gaining more robust information than would be possible with bar codes or other technologies.
Other manufacturers have dabbled in item-level RFID — Pfizer is tagging some bottles of Viagra — but none to the degree that Purdue has. Purdue is driven by the desire for state-of-the-art product and brand protection. As narcotics, OxyContin and Palladone are highly attractive targets to drug diverters and counterfeiters, and drug abusers.
The company is responding to a number of other factors as well:
- Wal-Mart’s mandate that, by scheduled dates, all products being shipped through its key distribution centers must have RFID verification, at least at the case level;
- FDA’s backing of RFID as a preferred means for drug manufacturers, especially those producing high-risk medications, to better control their products and supply chains;
- Pending legislation by states such as Florida requiring that drugs being shipped across their borders have valid “pedigrees.”
Purdue initially invested some $2 million to make its plants RFID-ready — installing equipment such as RFID reader systems by Northern Apex (Huntertown, Ind.) at various stages in production, then making sure they would read tagged bottles properly and with minimal interference from the surrounding environment. It also committed to spending 30 to 50 cents for every RFID device affixed to a bottle — in this case, basic read-only (i.e., non-programmable) Class O tags made by pilot partner Symbol Technologies (Holtsville, N.Y.). To date, more than 200,000 tagged bottles have been shipped.
“We didn’t really prepare an ROI from a dollar perspective,” says Chuck Nardi, the company’s information officer. “Item-level tagging is great technology that we wanted to use and understand and feel like it will be beneficial in the industry going forward.”Tracking success
Is it working? Yes, says Aaron Graham, chief security officer. The company has met its goals of performing 100% on-line verification of individual bottles in the plant and of those bottles once packaged in 48-count cartons, says Graham. It is also successfully using RFID capabilities to monitor product flow throughout the supply chain. And it is associating the electronic product code (EPC) data with other business transaction data to gain better oversight of shipments and leverage existing processes. “We have proved that we can use RFID to monitor and authenticate a product and protect the patient from counterfeit, adulterated, mislabeled drugs,” Graham says. “We now know it can work.”
No one, least of all Purdue, views RFID as the cure-all for supply chain security. It is only one facet of the company’s comprehensive, multi-layered security approach for drugs like OxyContin and Palladone. In its facilities, Graham notes, Purdue employs closed-circuit TVs and “Vegas-style” surveillance cameras, puts color-coded, pocketless uniforms on workers, and uses advanced biometrics and the latest access controls, all in an effort to reduce the potential of internal product theft.
When drugs leave the plant, the company’s transportation security protocol kicks in. Drug shipments are delivered by armored vehicles with armed drivers, tracked by GPS systems, and watched by independent countersurveillance experts.
“This is what everybody should be doing now,” says Graham, a former undercover investigator for FDA. The biggest surprise for Graham is that organizations along the pharmaceutical supply chain have not yet grasped the impact that RFID will have. “Ten years ago when I was working for FDA we knew this technology was needed,” he says.Designing an RFID landscape
Symbol Technologies and Northern Apex have been the major equipment providers for the pilot. Symbol manufactures the RFID chips and inlays that are affixed to the OxyContin and Palladone labels.
Northern Apex has supplied reading systems — including Symbol RFID scanners, an industrial PC and software, and an operator interface—used in manufacturing and shipping. Integrating the readers into production was the greatest manufacturing challenge Purdue faced. Handheld scanners were incorporated into receiving operations to monitor incoming raw tags for effectiveness. In addition, Purdue placed mounted, stationary reader systems:
- On the packaging line, after the label applicator
- At the case pack station
- At both inbound and outbound vault locations.
Once the equipment is in place and functioning, Northern Apex software relays data to SAP asset management and ERP applications. The key to hardware and software integration was getting representatives from packaging, IT, internet security, engineering and supply chain groups all involved in the process and meeting on a regular basis, says Nardi.
A concern going into the project was the effectiveness of the RFID tags themselves. Tag technology, while improving, is still somewhat immature. Nardi says that 20% to 30% of the labels supplied for the pilot have experienced read failures, whether due to the design of the silicon chips, problems in equipping the chips with RFID antennae, or in applying the tag inlays to product labels.
Last fall, Purdue Pharma (Stamford, Conn.) took drug product security where no other company had ever gone before — putting radio frequency identification (RFID) tags on commercial pill bottles. At its Wilson, N.C. plant, Purdue began applying labels with one-inch tag inlays to every 100-count bottle of the painkiller OxyContin headed to distributor H.D. Smith and retailer Wal-Mart, two willing partners in the pilot project. A few months later, the same was done for bottles of its new painkiller, Palladone, at the company’s Totowa, N.J. facility.