`Fingerprinting' drugs could stop fakes

Technology: Infrared light beams can identify medication by chemical composition.

Medicine & Science

November 24, 2003|By Dennis O'Brien | Dennis O'Brien,SUN STAFF

Two University of Maryland pharmacy professors say they have found a way to use beams of light and chemical "fingerprints" to help stop the flow of counterfeit drugs.

James Polli and Stephen Hoag say their technology could confirm the authenticity of every medication sold in the United States by measuring the light reflected by chemicals in the drugs.

"There is no one single solution to the problem of dealing with counterfeit drugs, but what we have may be part of the solution," Polli said.

The researchers used near infrared spectroscopy to create light-based fingerprints of various drugs. When developed, devices based on the technology will scan medication bottles with an infrared light beam. The amount of light reflected back - based on the drug's chemical composition - creates a unique "fingerprint" for each drug. The readings from any medication can be matched to a database containing each known drug's infrared fingerprint, Polli said.

Hoag, who spent four years refining the system, said similar technology also is used by agricultural suppliers to measure the moisture, oils and proteins in sunflower seeds and other material shipped to farm supply warehouses.

With additional research, the scientists expect to develop devices that can be connected to computer systems used by pharmacies and drug wholesalers.

The Food and Drug Administration will be looking at several technologies, including the system developed at Maryland's School of Pharmacy, to combat the flow of counterfeit drugs. "Right now we're trying to gather as much information as we can," said Jason Brodsky, an FDA spokesman.

Critics say the present tracking system - based on paper records that connect each bottle with its supplier - is inadequate because the records can be altered, lost or stolen.

The FDA and outside experts are particularly worried now because of an increase in the quantity of drugs sold over the Internet and shipped from overseas to U.S. consumers. Those sales pose the greatest risk of counterfeiting, they say. "The safest way for someone to buy drugs ... is to use a pharmacy in their community where they have a relationship with their physician," said Dennis Lyons, a professor at the University of Massachusetts College of Pharmacy and Health Sciences.

While it is rare for counterfeit drugs to make their way to neighborhood pharmacies, the FDA says it is a growing problem. The agency has investigated about 20 cases per year since 2000, compared with an average of five in the 1990s.

About 200,000 90-tablet bottles of the cholesterol medication Lipitor were recalled this spring in Missouri after complaints that overseas knockoffs were mixed in with U.S. supplies. Thousands of counterfeit bottles of Procrit, a drug used to combat anemia, were recalled last year after Medicaid investigators found bottles without proper paperwork in a Texas warehouse.

The problem, FDA officials say, is that some counterfeits are less potent than the original drug, some contain no active ingredients at all and others may be mislabeled.

The agency established a counterfeit drug task force in July and is seeking suggestions from the public for a January report that will show ways to stem the flow.

Brodsky said the FDA is reviewing a number of technologies That may be used to identify counterfeits, including tiny bar codes painted on pills and packaging embedded with holograms or Radio Frequency Identification tags, similar to speed passes motorists use to go through tollbooths.

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