CHICAGO, Nov. 19 (UPI) -- Radio tracking technology is poised to remake the prescription drug distribution business -- and maybe even save lives -- after the U.S. Food and Drug Administration this week cleared the regulatory pathway.
The FDA issued a special guidance to the pharmaceutical industry that said companies using this new technology will not violate regulations governing product labeling -- a fear that had kept the industry from placing the tiny computer chips -- Radio Frequency Identification tags -- on product packaging, even though the technology has been available for this task for some time, experts told United Press International.
The government's initial motivation in making this policy decision, policymakers told reporters earlier this week during a teleconference briefing, was to stop the flow of counterfeit drugs into the United States -- fake bottles of Viagra, some AIDS medications and other drugs that had been making their way from overseas.
"Bogus medications have become a growing public health threat," acting FDA Commissioner Dr. Lester Crawford, said during the phone briefing.
The technology will tell pharmacists which shipments of drugs are legitimate and which are not. Druggists can use hand-held identification and capture devices that will scan boxes of drug bottles. The RFID chips contain data on the shipment, indicating the date of manufacture, the shipper, and other quality data.
Companies such as Unisys have undertaken an array of RFID pilot projects, creating what is called a "truly visible supply chain," spokeswoman Jennifer Kuhl told UPI's Wireless World.
The technology also will act as additional "agents" to help keep the supply chain safe, she added. The benefits, however, could be even broader.
"Surveillance technology enabled by RFID prevents medicine mix-ups by ensuring that the right patients receive the medicine they need at the right time," Michelle Rudolph, spokeswoman for EDS in Plano, Texas, told UPI.
Leading drug distributors reckon that in the long-run this application may prove to be the most powerful for wireless RFID technology in the drug industry.
"The three largest pharmaceutical distributors, McKesson being the largest, share a unique vantage point, carefully monitoring the movement of about 90 percent of the nation's drugs from manufacturers to pharmacies," Ed Lang, a spokesman for McKesson in San Francisco, told UPI's Wireless World. "Distributors like McKesson understand the complexity of getting each individual customer the exact drug they need, in the right place, at the right time."
Nearly a year ago, McKesson began shipping a limited amount of drug products tagged with the wireless RFID chips from a distribution center in Delran, N.J., and other sites, Lang said.
The company has been "continually increasing the use of RFID in its distribution centers across the country" and developing new business processes that can take advantage of the emerging technology, he added.
RFID tags are actually transponders, made of an antennae that both receives and transmits data, and a microchip for data storage. The tags become activated when a radio frequency signal moves along the path of the tagged item. The devices work with readers that receive data from the tags, decode it and authenticate it before it is transmitted to a local host computer.
Twenty years ago, General Motors Co. achieved the first major RFID deployment in U.S. industry when it attached RFID tags to the chassis carriers of its just-in-time manufacturing process, according to research by Esynch, a consulting firm, located in Watsonville, Calif.
For drug applications, a firm called Tekmark Solutions is hosting a record called the Global Trade Item Number database, which contains information describing drugs and related products in RFID tags.
In many ways, technologists told UPI, the RFID tags are similar to barcodes, devices embedded on many consumer packaged goods to track inventory.
"RFID tags have the advantage that they can be read at a distance," Wilson Pearson, director of the Center for Wireless Communications at Clemson University, told UPI. "The reader sees a flood of different IDs, and sorts them out in the computer."
The cost of RFID tags used 20 years ago by GM was about $100 each, but experts told UPI the price is now about 5 cents each for the devices. Leading chip manufacturers like Texas Instruments have been making the chips since the early 1990s, and TI is now "in the process of working with major pharmaceutical companies," Kim Novino, a spokeswoman for TI, told UPI.
In addition to the tracking of drugs, there are other healthcare applications emerging. Hospitals can track newborns with RFID tag bracelets, and can outfit Alzheimer's patients with the technology to "prevent them from wandering off," Rudolph told UPI.
Hospitals can also track inventory -- surgical instruments and other equipment -- with RFID. Drug store chains like CVS, Tesco and others have shelf-tested RFID systems.
There still are drawbacks to the technology, however, despite the lower price. They include concerns about invasion of privacy should the tags are used on individual bottles of the medicine given directly to patients.
"RFID use is rapidly expanding but companies adopting this technology need to understand the legal risks inherent in such an implementation, particularly those in the healthcare field," said Kenneth A. Adler, a partner at the law firm of Brown Raysman Millstein Felder & Steiner in New York City. "While much attention has been given to privacy issues related to RFID, there are significant legal issues, such as IP (intellectual property) and IT (information technology) risks, which need to be carefully reviewed in order to formulate a strategy to mitigate unnecessary risk."
Experts also cautioned there are practical limitations to what the technology can accomplish, including the amount of data that can be stored on the chips and the kind of information that can be extracted from those chips.
The tags also can be inadvertently destroyed if used too early in the distribution process.
"One of our customers was frying tags when they went through the shrink wrap machine -- and they were cooked at 400 degrees," Jeff Richards, chief executive officer of R4 Global Solutions, a San Francisco RFID technology firm, told UPI.
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Wireless World is a weekly series by UPI examining emerging wireless telecommunications technologies. E-mail [email protected].
