Track-and-trace tags to tackle counterfeiters

NEW YORK —The brazenness of the burglary of some $75 million in drugs from an Eli Lilly warehouse in Enfield, Conn., in March was shocking enough, but its effects will likely linger for a long time as those stolen drugs creep back into the pharmaceutical supply chain, probably via such illegitimate means as illegal online pharmacies.

Many of the stolen drugs may be detected before they enter the bodies of unsuspecting patients, but many won’t, and they could cause serious harm to patients if they’re adulterated. But one company has developed a means of thwarting counterfeiters, making counterfeited drugs—as well as other products—easier to detect before they get to patients and consumers.

Honolulu-based TruTag Technologies, a spinoff of Cellular Bioengineering, has developed tiny tags that create a unique identification for drugs. Made from edible silica, the tags look like a white powder to the naked eye but can have any of more than 1 trillion combinations of custom-made spectral signatures, allowing products to be identified individually or by lot number using a hand-held optical reader.

“Manufacturers can change signatures on the product over time, or the lot number or batch number can have a different spectral signature,” TruTag Technologies chief technology officer Mike O’Neill told Drug Store News. This, O’Neill said, creates a “moving target that is another level of puzzle that the counterfeiters have to solve.”

Counterfeiters throughout history have found ways to get around technologies designed to thwart them. But O’Neill said getting around TruTags would be a little more complicated for counterfeiters, particularly because they would have no knowledge of when, if or how the pattern on a tag had been changed. “They would have to have much deeper insider knowledge,” he said.

In March, research and consulting firm Frost & Sullivan named TruTags the 2010 North American Pharmaceutical and Biotechnology Innovation of the Year, but so far, the tags have yet to reach the market. The company is testing them under a pilot program with an undisclosed neutraceutical company. O’Neill predicted it would be a couple of years before pharmaceutical companies began using the tags, though he said TruTag Technologies has been in talks with large drug makers.

One possible use for the tags would be as part of a track-and-trace system. For now, the chain drug industry has opposed mandatory use of track-and-trace systems. “[Track-and-trace] technology simply has not developed to the point that it is ready for across-the-board deployment, and thus a mandate would not be effective in protecting patients,” National Association of Chain Drug Stores president and CEO Steve Anderson wrote in an April 5 letter to The New York Times in response to an op-ed that had called for track-and-trace mandates in light of the Lilly theft.

For its part, TruTag Technologies doesn’t have an official stance on track-and-trace mandates but sees it as part of the solution. “We don’t believe track and trace is an end-all and be-all solution,” O’Neill said. “Any barrier can be helpful.”

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