Some Rxs ordered on-line may lack quality control

Generic and name-brand prescriptions bought over the Internet may be cheaper, but the quality may be severely compromised, according to researchers who published their findings in Science (July 2004). "Reports have been in the news about "battle lines" being drawn between those in favor of drug importation and those opposed," said principal investigator Michael A. Veronin, R.Ph., Ph.D., in an interview. Veronin is an assistant professor of pharmacy practice in the school of pharmacy at the Texas Tech University Health Sciences Center in Amarillo.

"The Food & Drug Administration and drug manufacturers have issued repeated warnings to consumers about the health risks involved with purchasing drugs on-line," Veronin said. "They assert that medications brought in from foreign sources may be unsafe and even deadly."

Veronin and his colleagues confirmed that generic formulations of a drug ordered from several on-line pharmacies varied widely by certain quality control measures. Because approximately 1,000 Internet pharmacies are now in operation, the risk of a consumer obtaining an inferior or harmful product is a real concern, the researchers stated.

Therefore, in order to test whether quality control might be an issue for drug products purchased on-line, the researchers focused on one particular lipid-lowering agent in the statin class. A generic form of the statin is not yet available in the United States, but it can be bought in other countries.

The researchers compared the blend uniformity of this statin tablet ordered from Internet sites in four different countries: Brazil, India, Mexico, and Thailand. They identified the Internet pharmacy Web sites selling this particular statin by using the search engine Google and entering the generic name of the drug. Using a prescription,they also obtained a sample of the brand-name drug at a U.S. pharmacy.

The blend uniformity for the tablets varied widely. In the samples from Mexico, India, and Brazil, several areas were apparent where the active ingredient and the inactive components were clustered, or clumped. Samples from the United States and Thailand showed a more even distribution of the components. These findings suggest that the latter two countries may have better manufacturing conditions.

Obviously, the reason that people order generic drugs on-line, particularly those used to treat chronic conditions, is to save money. Veronin and his team found that a 30-day supply of the brand-name statin they investigated cost $140 when purchased from a pharmacy in the United States. Generic versions available abroad were purchased on-line for $50 to $60.

One of the real concerns with prescriptions filled on-line is that they will be approved by a physician who has no contact with the patient seeking the prescription, said Marc Siegel, M.D., who was not involved in the study. "I prefer that patients get their prescriptions from doctors who actually see them," said Siegel, an associate professor of medicine and internist at New York University School of Medicine. In contrast, some Internet-based pharmacies will fill prescriptions after, at most, a telephone consult with a physician on the pharmacy's staff. That practice is Siegel's deepest concern about on-line prescriptions, regardless whether they are generic or brand-name formulations.

However, Siegel thought there might be an overreaction to the concern about the quality of the drugs themselves that are bought through such outlets. "We should not assume that the medications obtained through Internet pharmacies are of [lesser] quality," he said. "Regardless of the country where they're manufactured, they're often sold under the auspices of U.S. pharmaceutical companies and are therefore subject to U.S. regulations."