Big pharmaceutical companies are testing new tracking technology they hope will help them spot counterfeit drugs before they reach consumers’ medicine cabinets.
By putting tags that transmit radio waves on medicine bottles sent to drug stores, company officials think they will be able to detect fake drugs that aren’t moving through usual supply chains.
It’s not an idle worry. In recent weeks, regulatory authorities in Britain have recalled two counterfeit batches of Cialis, the erectile dysfunction drug made by Bothell-based ICOS Corp. and Eli Lilly &Co. Counterfeit versions of an obesity drug also have been recalled in that country.
Drug companies’ concerns about counterfeiting, however, have aroused skepticism among some who see the issue as a way to scare Americans away from buying cheaper drugs from foreign countries.
Also, using radio frequency identification technology, or RFID, may not be the most practical way to track prescription drugs, said Dan Bodnar, director of product marketing for Intermec Technologies Inc. That Everett-based company specializes in RFID, bar code equipment and other supply-chain technologies.
“What’s often overlooked is that there are other means to address anti-counterfeiting,” Bodnar said. RFID, he said, “can be one of many solutions.”
A distribution center in Delran, N.J., owned by wholesaler McKesson Corp., is one of a number of centers nationwide involved in a pilot project shipping small quantities of RFID-labeled drug bottles from manufacturing plants to pharmacies.
There, a worker sets a box of tagged drug bottles on a table where a radio-wave scanner and computer run through a list of scenarios involving theft, recalled drugs, outdated drugs or other logistical errors.
“The track record has been pretty good with it,” said Lon Mietka, the operations manager in Delran.
The $3 million project includes drug makers such as New Jersey’s Johnson &Johnson, Barr Pharmaceuticals Inc., Merck &Co. and Wyeth. Distributors such as Cardinal Health Inc. and McKesson Corp., and retailers such as CVS Corp. and Rite-Aid Corp., also are participating.
“We think it could have a variety of purposes, such as tracking products through our distribution network, seeing where products may be diverted or stolen, thereby reducing incidence of theft, and creating a reliable tag that could help identify counterfeit products and prevent their distribution,” said Johnson &Johnson spokesman Marc Monseau.
The RFID tags look like ordinary labels but are really computer chips with antennas wrapped around them. Sensors at distribution centers use radio waves to activate the tags, which are read electronically and stamped with a record of where they have been.
“It’s as though every bottle of tablets has an EZ-Pass on it, so that every time it is going through a portal it is registered,” said Jamie Hintlian, a partner with consulting firm Accenture Ltd., the company leading the RFID study.
Because pharmacies receive drugs through specific distribution centers, alarms would be raised when an incomplete or incorrect set of locations is listed on a tag, Hintlian said.
The U.S. Food and Drug Administration earlier this year urged the industry to adopt RFID, citing an increase in counterfeiting cases from six cases of fake prescription drugs in 2000 to 22 cases in 2003.
In a February report, the agency said drug counterfeiting is widespread outside the country, but its prevalence within the United States is not known.
Some groups wonder if the FDA and drug companies have ulterior motives with the counterfeiting issue, which has grown in prominence as more Americans order less expensive drugs from Canada and other foreign countries.
The Canadian International Pharmacy Association, which represents 48 mail-order pharmacies in the country, estimates that 2 million Americans are buying $1 billion-worth of Canadian medications every year.
David MacKay, the association’s executive director, said he thinks anti-counterfeiting and tracking measures will disprove the pharmaceutical industry’s main argument against drugs from Canada: that the supply chain is unsafe.
“We have nothing to hide. We’ve always been transparent. Bring it on,” MacKay said.
Hintlian believes widespread use of RFID is possible by 2007 to 2008, though the tags may be limited to specific drugs that are in high demand and therefore prone to counterfeiting.
Intermec’s Bodnar said there are other less expensive and less complex solutions, however. These include the use of specially encrypted bar codes or other anti-counterfeiting “markers” to distinguish the real products from the fake.
Using those instead of tags would get around a problem with RFID: It doesn’t work well with the foil “blister packs,” in which some drugs are packaged. The metal packaging can create interference between the tags and RFID reading devices, Bodnar said.
Associated Press
A tracking code is shown on the bottom of a drug container at manufacturer McKesson Corp.’s distribution center in Delran, N.J.
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