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August 21, 2012

New Tests Rapidly Identify Counterfeit Medications

by Rebecca Widiss

Counterfeit medications are a serious and sometimes deadly problem in developing countries. But two teams of U.S.-based scientists have developed quick tests that can identify counterfeit drugs before they can cause harm.

The researchers presented the new testing methods this week at the annual meeting of the American Chemical Society in Philadelphia. Scientists hope their efforts can help prevent the thousands of deaths caused by fake medicines every year.

Counterfeiting medications is a lucrative and popular enterprise. The World Health Organization estimates that 10 to 30 percent of drugs sold in developing countries are fake.

“It appears that a lot of counterfeit drugs are coming out of Southeast Asia and Northern Africa,” said Toni Barstis, a chemist at Saint Mary’s College in the Midwestern state of Indiana. “This is much more of a problem in developing countries because of a lack of a strong regulatory system. This could vary from people in the backyard making counterfeit drugs to a more organized ring.”

To begin tackling this problem, Barstis and a team of undergraduate students focused on creating a test to identify the pain and fever medication Panadol, also known by its brand name Tylenol. The medication’s active ingredient, Acetaminophen, is absent or insufficient in the fake pills. And it is commonly used in fake antimalarial drugs and antibiotics, where it is ineffective.

Barstis’s test, which she developed with colleagues at nearby Notre Dame University, consists of chemically treated paper the size of a business card. A person simply rubs a pill on the paper and dips it in water. She says color changes on the paper indicate suspicious ingredients.

"The whole thing takes less than five minutes. We had children from 5 [years old] through adults of 90-plus conduct this test. And those darn kids - they performed some races. The record for speed with these tests stands at 1 minute 38 seconds," Barstis said.

Barstis’s team also checked their paper test for accuracy. They analyzed 570 Panadol pills, many with fake ingredients added by the researchers.

"Now we’re working with pharmacists in Kenya. They have a vested interest in the quality of their products. We want to make sure that this is a viable product in the field," Barstis said.

Barstis says the team is close to developing similar paper tests for several other popular medicines. And she is considering how to make the tests widely available.

"We’ve talked about starting a nonprofit [organization]. We’ve talked about working with non-governmental organizations. We purposely want an inexpensive, low technology device. We’re looking for something really cheap -- under a quarter [i.e., 25 cents] for sure -- so that people can use them," Barstis said.

At the Georgia Institute of Technology, chemist Facundo Fernández has spent 10 years working on a different testing method. Fernández uses standard laboratory technology to inventory the components in suspicious medicines, based in large part on the amount of matter they contain. The inventory is called a mass spectrum.

"The mass spectrum of a genuine molecule looks very different from the mass spectrum of a fake, in most cases," Fernandez said.

As part of a study, Fernández’s team collaborated with 11 African countries to detect fake antimalarial drugs. It also recently tested 900 samples from Cambodia in only two weeks, a task the team says would have taken months using traditional approaches.

Fernández says his method can detect even the best fakes.

"It depends on the type of mass spectrometer that you use. The higher the resolution of your equipment, the better you can resolve between two molecules that look almost identical," Fernández said.

Although his approach requires a laboratory, Fernández is working on a similar tool that researchers can use in the field.

The new techniques should help combat what the World Health Organization calls a serious threat to health care systems around the world.