Research Activities, October 2011: Patient Safety and Quality: Simpler drug warning labels are easier to understand

Patient Safety and Quality


Simpler drug warning labels are easier to understand

Many drugs are off limits to pregnant women because they can harm fetuses. But not all drug labels state this warning clearly enough for some women to understand it. When researchers tested the standard drug label that warns pregnant women to avoid a drug against a new text version and a text-and-icon version of the label, most women best understood the combination version.

Researchers interviewed 132 women at outpatient care clinics in Shreveport, LA, and Chicago, IL. Ninety-four percent of the women were able to understand the message of the enhanced text (Do not use if you are pregnant, think you are pregnant, or breast feeding) when it accompanied an icon that was a silhouette of a pregnant woman with a slash through it. In contrast, just 76 percent of women comprehended the standard label and 79 percent understood the enhanced text alone.

Because care providers do not often explain that the medicine they are prescribing may cause birth defects, warning labels may be the best line of defense in providing that information. Standardizing the labels and testing them with consumers may make them easier to understand so they do their job better. This study was funded in part by the Agency for Healthcare Research and Quality (T32 HS00078).

See "Improving pregnancy drug warnings to promote patient comprehension," by Whitney B. You, M.D., William Grobman, M.D., M.B.A., Terry Davis, Ph.D., and others in the April 2011 American Journal of Obstetrics and Gynecology, 204(4), pp. 318.e1-318.e5.


Research Activities, October 2011: Patient Safety and Quality: Simpler drug warning labels are easier to understand