• E-mail
• Print
• RSS

Physicians are prescribing harmful drugs to pregnant women, AHRQ finds

Patient Safety Monitor Alert, September 15, 2004

Want to receive articles like this one in your inbox? Subscribe to Patient Safety Monitor Alert!

Nearly half of pregnant women who receive medications other than vitamins may be taking drugs that the Food and Drug Administration (FDA) classifies as having no human evidence of safety for use during pregnancy, or which have been shown to cause harm to a developing fetus, according to new research funded by HHS' Agency for Healthcare Research and Quality (AHRQ).

Researchers at AHRQ's HMO Research Network Center for Education and Research on Therapeutics (CERTs), reviewed data from eight health maintenance organizations in diverse geographic areas. They evaluated prescription drug use by 152,531 women who delivered an infant in a hospital from January 1, 1996, through December 31, 2000, based on the FDA's risk classification system of drugs during pregnancy. They did not review the use of over-the-counter medications or drugs prescribed in hospitals.

They found that 64% of women were dispensed a medication other than a vitamin or mineral supplement within the 270 days prior to delivery. Of those, nearly 40% were dispensed a drug for which human safety has not been established (Category C on the FDA's list).

Nearly 5% were dispensed drugs from Category D, which the FDA classifies as having positive evidence of fetal risk, but benefits of use may be acceptable despite the risk. An additional 5% were dispensed a drug from Category X, for which the evidence has found definite fetal risks based on human or animal studies or based on human experience, and risk of using the drugs clearly outweighs any possible benefit.

The other approximately 50% of prescriptions were classified as Category A (risk to the fetus is remote) and Category B (animal studies do not show fetal risk and there are no controlled studies in women; or animal studies show risk, but controlled studies in women fail to show risk). The results appear in the August 2004 issue of the American Journal of Obstetrics and Gynecology.

"The limitations of the letter category system and its application are well established, as is the public health need for better information," says Sandra L. Kweder, MD, deputy director of the FDA's Office of New Drugs. "FDA is revising the system to provide a more informative tool for doctors and patients."

Routine medication audits and physician education as well as new technologies, such as computerized prescription systems with clinical supports, may have the potential to reduce inappropriate prescribing for pregnant women, the researchers conclude.

The study is the largest to date to examine the prescription drug use of women during pregnancy, according to AHRQ.

-- Wendy Johnson
wjohnson@hcpro.com

Want to receive articles like this one in your inbox? Subscribe to Patient Safety Monitor Alert!

• E-mail to a Colleague
• Print
• RSS
• Archive