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Keeping Drugs Legit With RFID

Sun Microsystems released an RFID package focused on helping pharmaceutical companies track and authenticate drugs.

Sun's RFID Industry Solution for Drug Authentication is custom-tailored software, hardware and services to combat counterfeiting.

Manufacturers need to make sure that counterfeits don't get introduced into their system and that legitimate goods don't fall off the back of the truck.

In December 2004, the U.S. Food and Drug Administration set guidelines for drug companies to use in setting up systems to keep an eye on pharmaceuticals as they move from the supply chain. In its most recent report on the problem, released in May 2005, the FDA said it initiated 58 criminal investigations in 2004, up from 30 cases in 2003. But the increase was attributed to greater awareness and increased cooperation among various local and national law-enforcement agencies.

"While there were not a great number of instances, one of the recalls was for tens of millions of doses," said Liz From, Sun's Pharma RFID practice lead. "We don't know how big the problem really is."

Like Sun's other RFID offerings, the drug authentication package takes a now-and-later approach, providing a relatively inexpensive installation, as well as a full-blown RFID tracking system, in a way that makes it easy for customers to upgrade.

Sun is working its way through industry verticals, launching similar kits for consumer packaged goods and retail. In February 2004, Sun and SupplyScape released an earlier version of a drug-tracking bundle, the Pharmaceutical Anti-Counterfeit RFID Package; at the time, the Sun Java System RFID Software hadn't been fully developed.

"There are two approaches. The first is a lightweight approach, the [electronic product code] authentication approach," said Vivek Khandelwal, principal RFID solutions manager for Sun's RFID business unit. "At the point of sale, you look at the RFID information on the tag and do a simple lookup in a manufacturer's database. That’s something that the industry can start evaluating right now, without the rest of the supply chain buying into it. Second is the pedigree authentication approach that leads to authentication of data that goes across the supply chain."

Companies may want to start with a system that simply reads the tag information and compares it to the manufacturer's database. Later, they may be ready to install a system that can verify and authenticate each drug item at every stage in the drug supply chain, substantiating what's known as a "drug pedigree." Included in the package are design documents describing different how different deployments could be mapped out.

The system is built on the Sun Solaris 10 Operating System, Sun Java Enterprise System and Sun Java System RFID software. Sun Java System Identity Management Suite provides identity management and access controls, while the Sun Java Integration Suite provides a services-oriented platform for real-time access to data, as well as a development environment.

The package includes an electronic pedigree application from SupplyScape, Raining Data Corporation's ePharma Application Suite, TigerLogic XML Data Management Server and VeriSign's Object Naming Services. The software has been qualified for compatibility with TAGSYS' item-level RFID tag and reader technology; it can work with many other third-party RFID readers and RFID printers.

Sun said the same components could help health care providers track patients, medical information and records, as well as monitor instruments and medical waste.

In addition to reducing counterfeits, the system could benefit drug companies and pharmacies by increasing operational efficiencies.

"The pharmaceutical supply chain is very complicated and fragmented, even though there are only three major distributors," From said. "It's not a straight line from the manufacturer to the pharmacy or hospital. Someone may be producing 55 million doses, but how it gets to individual clinics and pharmacies is a hard thing to manage."

Khandelwal noted that enterprise benefits from RFID tracking of drugs would be a by-product of fighting counterfeiting.

"Once a manufacturer has tagged every item, it might as well use RFID for efficiency gains," he said. "This is not the driving force for the industry right now, but it is a by-product. Eventually, they can extract ROI."