RFID to Combat Drug Counterfeiting
Unisys and SupplyScape announced a joint pilot project today designed to electronically certify the authenticity of commercial drugs and track them through the supply chain, using radio frequency identification (RFID) technology. Unisys will serve as the implementation service provider for the pilot, which involves an eight-week implementation stage, followed by 60 to 90 days of monitoring the supply chain. The system is designed to help reduce the risk of counterfeit medicines being introduced into the supply chain. The companies say the move will be the first step to help secure the flow of prescription medicines, from factory to pharmacy counter.
The project will serve as an electronic drug pedigree, a certificate of authenticity and tracking, for one of Purdue Pharma's pain-reducing medications. It will follow the drug from the privately held company's manufacturing facility to pharmaceutical distributor H.D. Smith.
The open system uses technology designed to certify medicines as legitimate throughout the supply chain. It uses RFID or barcodes to match each medication container with its corresponding pedigree, helping to determine where a drug has been and whether it's authentic. "If there's an adverse event and the patient gets an affected drug that doesn't give them the therapeutic value--or it was a fake drug, or it was a placebo--the inspector wants to be able to chase down the person responsible and find out where the compromise occurred," says Brenda Kelly, vice president of marketing for SupplyScape.
Evolving state regulations will drive part of the adoption pattern over the next 12 to 18 months, according to Todd Skrinar, partner at Unisys Healthcare and Life Sciences. Subsequent phases could include additional products, distribution centers, and extension to pharmacies.
Next year Florida and Indiana will require all drugs to carry pedigrees, California will do so in 2007, and other states are following suit. The laws don't require these certifications to be electronic, but most companies prefer it, according to Peter Spellman, senior vice president of products for SupplyScape. Keeping track of a drug's movement through the supply chain on paper is impossible to do on a large scale. But Ron Buzzeo, chief regulatory officer at Dendrite International, says paper is a good start. "Some people say, let's wait for electronic--that doesn't make sense," he says. "We have to start someplace. Where there's no capacity, paper pedigrees should be the start. When they have the wherewithal, they'll move to electronic."
H.D. Smith will receive the pedigree through the program, receive the product, and then certify its authenticity. The same process will occur when it sells the item to a pharmacy. The law requires pharmacies to provide pedigrees within 48 hours of an inspector's request, but the electronic version can be captured immediately, because the system integrates with a company's ERP or warehouse system.
"The whole point is to protect patients from counterfeit drugs," Kelly says. "Most people assume the pharmacy knows exactly where that drug came from and that's not the case most of the time. It's not the three hops from manufacture to wholesaler to pharmacy. This is an opportunity for a number of companies doing warehousing management, ERP, or pharmaceutical systems inside their system to start looking at this requirement."
"Anything that tracks products in the distribution systems is going to have an impact on counterfeiting," Buzzeo says. "We need education, stronger law enforcement, better inspection programs, tighter controls, penalties and RFID technologies. I'm glad to see this. I think it's a positive first step. We have the safest healthcare system in the world, but all these things working together will make it even better."
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