A bundle of software, hardware and services unveiled this week is getting the once-over by companies in the pharmaceutical supply chain to keep drugs moving through legal sales channels -- and help them to do it more efficiently.
Sun Microsystems and SupplyScape Corp. on Thursday announced their joint Pharmaceutical Anti-Counterfeit RFID Package. The announcement comes at a time when federal agencies are cracking down on illegal sales.
"The FDA is looking to have an actual record of the chain of custody," said SupplyScape vice president of marketing Brenda Kelly.
SupplyScape makes "digital pedigree software" that lets every party in the supply chain track individual containers of drugs via RFID (define) tags. While manufacturers, distributors and retailers now maintain information on how many pallets or cases of a product were shipped, they can't be sure that an individual case or bottle of meds in the warehouse is the same one that was shipped from the factory.
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"By tracking the exact bottles and having the pedigree document showing the bottle went from one party to the other, the FDA can be sure that all the custodians of the product are legitimate suppliers of the drug and have treated the drug properly, all the way through to the consumer," she said.
The announcement followed the Monday release of a report from the Federal Food and Drug Administration's Counterfeit Drug Task Force that recommended using
RFID technology to track pharmaceuticals in order to combat counterfeiting and diversion of drugs out of legal sales channels.
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The FDA said that, while it doesn't believe counterfeiting is widespread in the U.S.
pharmaceutical industry, it's seen an increase in sophisticated counterfeiting, with investigations increasing from an average of five a year to more than
20 a year since 2000.
The FDA said criminal operations introduce finished drug products that may closely resemble legitimate drugs; but they may contain inactive ingredients, incorrect ingredients, improper dosages, sub-potent or super-potent ingredients, or be contaminated. The report recommended "mass serialization," a process of
supplying a unique ID number for each item of a product. It recommended the use of RFID technology, coupled with electronic product codes, or EPCs, at the individual product level.
Cambridge, Mass.-based SupplyScape was one of the companies that advised the FDA task force on the report.
SupplyScape worked with Santa Clara, Calif.-based Sun to integrate its Electronic Pedigree application into the pharmaceutical product package, which is based on Sun Java Enterprise System Software and Sun's RFID infrastructure software. Sun says its RFID infrastructure interoperates with EPC-compliant RFID readers and tags. The complete package, which includes SupplyScape Electronic Pedigree, incorporates business rules to comply with the Federal Prescription Drug Marketing Act and state pedigree regulations for Nevada and Florida. Customers can also enable the
specific business rules they require for their business operations.
Liz From, Sun's life sciences marketing manager, said that the automation supplied by RFID technology removes human error from the shipping process.
"You can use RFID to make sure that it actually came in the door. You can physically and automatically know upon receipt of the pallet or case or tote that those are the actual physical items that were shipped." Sun's RFID infrastructure product provides those functions. It also translates information from the pedigree application to corporate business systems. "Just reading something off the bottle doesn't help unless you can connect it with corporate data," From said.
The partners are selling the package as a business enabler as well as a compliance tool.
"Aside from making sure there aren't counterfeits in the supply chain, this delivers real business value to the company," Kelly said. "This solves a business problem, and, by the way, it also helps you in terms of shipping and receiving, it helps in the event of a
recall because you can pinpoint exactly which bottles need to be recalled. It helps with returns process and many other supply chain processes."
The SupplyScape on Sun solution is expected to be available in the second quarter of calendar year 2004. Sun has spent more than three years working on its RFID infrastructure tools and services. It's also opening RFID test centers where companies can test their RFID implementations.
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