Drug 'fingerprints' may halt counterfeits, say Md. researchers

Drug Store News,  Jan 19, 2004  by Michelle L. Kirsche

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BALTIMORE -- Researchers at the University of Maryland have developed a technology they believe can be used not only to detect counterfeit drugs, but one that makes it so difficult to reproduce the drugs that no one will bother trying.

"It uses near-infrared light, not unlike the type of thing you may recall from organic chemistry lab," said James Polli, R.Ph., associate professor of pharmaceutical sciences at the University of Maryland School of Pharmacy.

"We shine light on a tablet," Polli said. "Some gets absorbed by the tablet, and the remaining light gets reflected off. Depending on the light absorbed, it essentially constitutes a fingerprint because different drugs absorb light differently."

Polli and fellow researcher Stephen Hoag anticipate every drug or drug product will have a unique fingerprint as identified through near-infrared spectroscopy. Counterfeiters would have to reproduce virtually every component of the authentic product for it to pass the fingerprint test.

The technology is about one year away from implementation, said Polli.

According to Andrea Doering, manager of technology commercialization at the University of Maryland, special hardware is needed to implement the technology. The goal is to take a near-infrared spectrometer (about the size of a large toaster oven) and make it work like a pill-counting machine, reading fingerprints, however, instead of counting pills.

Doering said she envisions licensing the technology to a company that combines the hardware component with the infrared software technology, then contracts out to pharmaceutical manufacturers. In turn, pharmaceutical manufacturers would share the data with retail pharmacy.

"Drug stores would buy the [near-infrared spectrometer] and would b-e able to measure the fingerprints of the drugs and compare it with the data provided by pharmaceutical manufacturers," Doering said.

The initial cost to implement the technology could come at a hefty price to manufacturers--anywhere from $500,000 to $1 million per plant, according to Doering. Polli noted that the cost of a near-infrared spectrometer to read the fingerprints is about $20,000.

In October, the U.S. Food and Drug Administration's Counterfeit Drug Task Force issued an interim report recommending a multipronged approach to combat counterfeit drugs. The report said there is no single magic bullet to stop the growing number of sophisticated counterfeiters and that a multipronged strategy to secure the drug supply would be much more difficult for counterfeiters to overcome versus any one single approach.

An option outlined in the task force's report was the use of technology, including authentication technologies defined as overt, covert and forensic.

"Overt features are readily obvious to any observer," Doering said. "Covert features require special instrumentation [such as infrared spectroscopy] to detect, and forensic features cannot be identified unless the observer has special information from the manufacturer. Our [method] would be covert, requiring near-infrared spectroscopy, and forensic, since the fingerprint of the genuine drug would be information the manufacturer would make available to the drug store."

Also as part of the counterfeit prevention initiative, FDA Commissioner Mark McClellan asked National Association of Chain Drug Stores president and chief executive officer Craig Fuller to assist in the effort by providing the insight and perspective of NACDS members.

In December, NACDS issued that information, recommending that the FDA and members of the pharmaceutical industry collaborate to define a uniform prescription drug classification that categorizes drugs according to their counterfeiting risk.

Other NACDS recommendations included implementing a technology-enabled track and trace system, the creation of a market-based model for best practices for purchasing and channel sales policies, the launch of a comprehensive anti-counterfeiting education and awareness campaign and a centralized counterfeiting alert and communication system.

The Counterfeit Drug Task Force's final report is due early this year.

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