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
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
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.
NCPIE encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, NCPIE does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not NCPIE.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.