Drugs in four countries meet U.S. standards

Antiretroviral drugs from four developing countries have been found to meet United States Pharmacopoeia (USP) standards for the active drug amount listed on the label, according to a study in the May 1 Clinical Infectious Diseases.

Six different types of brand-name and generic drugs used to treat HIV were sent to the National Institutes of Health (NIH), and they were assessed by NIH and University of Alabama researchers using the Uniformity of Dosage Units test.

The test stipulates that the active ingredient of a drug must be within 15% of the amount listed on the label.

All of the tested drugs, which were obtained from doctors in Lithuania, South Africa, Jamaica, and Zambia, fell within the range required when stored according to manufacturer specifications.

Brand-name antiretroviral drugs, because of their expense and high demand in developing countries, may be subject to counterfeiting.

Testing for active drug content can help identify imitation medications that do not provide the expected health benefit. Such testing also allows comparison of branded and generic medications, giving physicians confidence that they are not sacrificing efficacy in prescribing the cheaper generic drugs.

The fact that a drug made in a developing country contains a sufficient amount of its active ingredient is reassuring, but it’s only a start, according to Scott Penzak, MD, lead author of the study. "It’s also important that bioequivalency studies be done," he says.

"Bioequivalency" refers to how much drug actually gets absorbed into the bloodstream, which could be affected by the inert ingredients in the medication. So drugs from developing countries that meet active ingredient standards still have to prove their worth when introduced into a human body.

"It’s important to ensure that they achieve the same blood levels as other drugs," Penzak says.

Establishing the integrity of antiretroviral drugs from developing countries through content and bioequivalency testing should continue, he explains.

"By ensuring that the drugs meet stringent manufacturing standards, we have a greater degree of confidence that they’ll work well."