Over-the-Counter Drug Label Warnings Get Overlooked

Consumers overlook warnings about potential tampering on over-the-counter (OTC) or nonprescription medicines at least 80 percent of the time, suggesting packages and labels need to be redesigned to attract attention and improve safety, according to the research today in the Proceedings of the National Academy of Sciences. Participants spent the most time focused on the brand names and product claims of nonprescription drugs. More than half of those surveyed also missed alerts about child safety on medicines that did not have child-resistant packaging, The findings raise doubts about whether the warnings meet U.S. Food and Drug Administration requirements that they be “prominent” and “conspicuous,” the researchers said. Future studies need to look at whether changing package designs may help people’s eyes move more quickly to the notices or convey the information faster, said lead author Laura Bix. “Something is going on with conspicuousness and prominence,” said Bix, an assistant professor in the School of Packaging at Michigan State University in East Lansing, Michigan, in a March 27 telephone interview. “It’s definitely a chance to step back and look at the design of these labels and look at potentially educating consumers on the importance of the information.” Researchers asked 61 participants to wear eye tracker devices to determine how long they looked at five areas of an over-the-counter product’s package. The areas were the tamper- evident notice, the child-safety warning, statements about whether the product was “extra strength” or “aspirin free,” the brand name and the drug facts box, which is similar to nutrition information on food packaging. The participants had 10 seconds to look at each of 10 packages, five of which were over-the-counter medicines, which are drugs sold without a prescription. The other products were dummy packages, including batteries and laundry soap. Those in the study weren’t told of the trial’s emphasis on over-the- counter drug alerts. Participants also were interviewed about their recollections of what they had seen. The researchers found that 80.3 percent to 96.7 percent of people in the study failed to look at the tamper-evident warning area on the label, depending on the product, while 47.5 percent to 57.4 percent didn’t look at the child-safety warning area. At least three-quarters of the participants noticed the brand name on all the medicines. The researchers noted the study’s limitations included the narrow demographics of the participants, most of whom were college students without children, and the failure to collect information about their previous knowledge of the products.
http://www.pnas.org/content/early/2009/03/27/0810665106.abstract?