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 companys Totowa, N.J. facility.[Editors 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-Marts mandate that, by scheduled dates, all products being shipped through its key distribution centers must have RFID verification, at least at the case level;
- FDAs 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.
- On the packaging line, after the label applicator
- At the case pack station
- At both inbound and outbound vault locations.
Purdue Ceases Palladone ManufacturingCiting safety concerns, FDA has forced the drug off the market
By Gregg Carlstrom
Purdue Pharma L.P. is halting production of its prescription painkiller Palladone, amidst new FDA concerns about the drugs side effects. July 13, FDA asked Purdue to voluntarily remove the drug from the market, citing concerns that the drug could have potentially fatal side effects if mixed with alcohol.
Purdue had disclosed information regarding alcohol-related dangers that alcohol could accelerate the rate of release of the drugs active ingredient, hydromorphone when seeking regulatory approval for Palladone last winter. The drugs label carries a warning advising doctors and patients of the risk.
A recently completed study by Purdue suggested that the combination of Palladone and alcohol could be deadly. To date, there have been no documented cases of patients experiencing life-threatening side effects. But in light of the new study, the Agency said it had no choice but to recall the drug.
When FDA approved Palladone, the Agency had evidence from laboratory studies that alcohol could accelerate the release of hydromorphone from Palladone capsules, the Agency said in a press release. Neither the Agency nor Purdue Pharma anticipated that this would be life-threatening to patients themselves.
Purdue has begun work to reformulate the drug and reduce the risk of a deadly alcohol interaction. Purdues CEO and president, Michael Friedman, says his company has always made a policy of complete disclosure to FDA. We acted responsibly and worked closely with the FDA in launching Palladone on a limited basis with a rigorous risk management program, said Friedman. We will continue to work collaboratively with the Agency to resolve all open issues and to reintroduce the reformulated product as soon as possible.