Report Calls for Better U.S. Efforts to Fight Counterfeit Drugs

By Amanda Gardner HealthDay Reporter

WEDNESDAY, Feb. 13 (HealthDay News) -- Aiming to reduce the global threat of counterfeit drugs, a new Institute of Medicine report also recommends changes in the United States that include a mandatory drug-tracking system and tighter licensing rules for drug wholesalers.

The potential dangers of counterfeit drugs are many, the expert panel noted.

In 2012, the U.S. Food and Drug Administration issued warnings more than once about fake doses of the injectable cancer drug Avastin (bevacizumab).

The scope of the problem is even bigger in developing parts of the world. One 2011 investigation revealed that falsified or substandard drugs have been sold in at least 124 countries.

"We have a rampant problem with malaria medications, tuberculosis medications and others, particularly in low- and middle-income countries, and we know it's increasing," said Lawrence Gostin, chair of the committee that prepared the report, which was released Wednesday. The Institute of Medicine (IOM) is a nonprofit organization that gives expert, evidence-based advice on public health issues to policy makers and health professionals.

Experts say the health consequences of counterfeit drugs depend to a great degree on the disease a particular medication is used to treat.

In a worst-case scenario, a "bad" cancer drug could rob a small child with curable leukemia of the chance to be cured, said Dr. Otis Brawley, chief medical officer of the American Cancer Society, who stressed that the chances of getting substandard cancer drugs, especially in a physician's office or hospital, is quite small.

Meanwhile, antibiotics that have been diluted could actually foster antibiotic-resistant bacteria and push a malaria or tuberculosis outbreak far beyond the borders of a particular country in Africa or Asia, he added.

The problem is that this hugely profitable business is vastly splintered and there is essentially no global regulatory system to combat it; there are not even consistent definitions among countries for terms such as "substandard" and "falsified."

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Report Calls for Better U.S. Efforts to Fight Counterfeit Drugs