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THURSDAY, July 22 (HealthDayNews) -- A basic measure of the quality of prescription drugs is lacking when it comes to many generic medications ordered online, a new study says.

This raises the specter that other measures may also be substandard, or that some of the drugs may be counterfeit, the authors stated.

An estimated 1,000 Internet pharmacies are currently operating, according to the study, which appears in the July 23 issue of Science.

One-third of the countries producing drugs for sale have regulatory controls similar to those in the United States. Another third have regulatory controls but no enforcement, while the remaining third have no regulation. Because of the Internet, any drug, regardless of where it is manufactured, could turn up for use in the United States, the authors said.

The basic quandary for many Americans is that the medications they need often cost more than they can afford. As a result, many people as well as cities are turning to countries such as Canada, where drugs cost up to 50 percent less. On Wednesday, Boston became the latest and largest U.S. city to offer prescription drugs from Canada -- a program expected to save about $1 million in its first year, according to the Boston Globe.

For brand-name drugs purchased anywhere, quality should not be an issue, said Dr. Marc Siegel, clinical associate professor of medicine at New York University School of Medicine.

"The drug industry is floating around an idea that they can't preserve quality outside of these borders, but I don't buy that," he said. "I think that we can certainly preserve quality among brand-name medications. The companies have the obligation to make sure that's the case."

Siegel agreed, however, that the quality of generic drugs ordered over the Internet can be questionable.

To compare quality measures, the study researchers ordered generic versions of the cholesterol-lowering drug simvastatin (Zocor) from Internet sites in Brazil, India, Mexico and Thailand. These tablets were then compared to brand-name pills that had been purchased at a U.S. pharmacy with a regular prescription.

This particular statin was chosen largely because the brand name is relatively expensive in the United States, making it likely that people would look for less-expensive substitutes on the Internet.

"Drug price may be a big factor in seeking out this drug on the Internet, particularly for senior citizens who may be on limited incomes," said study author Michael A. Veronin, an assistant professor in the School of Pharmacy at Texas Tech University Health Sciences Center.

Veronin found that a 30-day supply of Zocor costs about $140 in a U.S. pharmacy, while generic versions of the drug cost only $50 to $60 on the Internet.

He and a colleague then tested for something called "blend uniformity."

"We looked at one major aspect of quality, how well the tablet's active ingredient was blended," Veronin explained. "This could have an impact on how well the tablet dissolves and allows the active ingredient to be available to the body to be effective."

The level of blending was erratic across the samples, with the pills from the United States and Thailand exhibiting the best quality. "It appears that although the tablets are labeled as the same drug and strength, there were differences in manufacturing processes from different countries," Veronin said.

The study authors also imaged the internal structure of the tablets, giving a visual representation of each chemical component. The images revealed pockets or clumps of the active ingredient, somewhat like clumps of cake mix that remain in the batter if you don't mix it well enough, Veronin said.

Although blending is just one aspect of tablet quality, it is one of the more basic ones. "My thinking is if it wasn't well-blended, it makes the other attributes suspect," Veronin said.

These results are in line with a U.S. Food and Drug Administration (FDA) analysis this month of three drugs -- Viagra, Lipitor and Ambien -- obtained from a Web site advertised as Canadian. The FDA described the drugs as "fake, substandard and potentially dangerous."

Although many Americans feel they have no choice because of cost considerations, the message from the FDA and now this study is to exercise caution when purchasing drugs online.

For Siegel, however, there are other options.

"We can work toward consistency among generics overseas. That's something we can look at," he said. Until then, "an ask-your-physician line is good. If you bring back something from another country, please ask your physician if it is the same dose and the same quality."

More information

Visit the U.S. Food and Drug Administration for more on buying drugs online.

(SOURCES: Michael A. Veronin, Ph.D., assistant professor, School of Pharmacy, Texas Tech University Health Sciences Center, Amarillo; Marc Siegel, M.D., clinical associate professor, medicine, New York University School of Medicine, New York City; July 23, 2004, Science; July 13, 2004, U.S. Food and Drug Administration press release)

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