New Warning Labels Needed on Prescription Drug Vials

Researchers at Michigan State University (MSU) are urging across-the-board changes to warning labels on vials of medication to make them more effective and attention-grabbing – especially for the elderly. A small study found that only about half of older patients even make eye contact with prescription drug warning labels, a contributing factor in the 15 million medication errors that occur annually among outpatients.

The MSU study divided volunteers into two age groups: 15 participants were in the 20 to 29 age group and 17 participants were in the 51 to 77 age group.

Using eye-tracking technology to conduct their research, the researchers found that when the volunteers were given a new prescription, many did not read critical warning labels such as “do not consume alcohol while taking this medication.” Only 54 percent of the older group made direct eye contact with the warning labels, compared to nearly 92 percent of a younger group.

Surprisingly, red and yellow warning labels failed at being attention grabbers. The color of the label had no effect on the probability that participants would notice it, the researchers reported.

“Given our results, we are recommending a complete overhaul of the design and labeling of the ubiquitous amber bottles, which have seen little change since their introduction some 50 years ago,” said Laura Bix, associate professor in MSU’s School of Packaging. “Our initial recommendations would be to move all of the warnings from the colored stickers to the main, white label, which 100 percent of the participants read, or to reposition the warnings so that they can be seen from this vantage point.”

Warning Labels Not Regulated

The study findings revealed that older patients were less likely to notice a pill warning label (PWL), let alone remember them. With nearly a third of Americans 65 and older taking 10 different daily medications, the odds of adverse drug reactions are increased.

Lack of attention was common when participants were handed five vials in succession. Only half of the volunteers fixated on all five warning labels and 22% did not fixate on any.

“It is surprising that the federal government does not regulate PWLs. To date, there are no universal, federal standards regarding the method of presentation or the information conveyed by PWLs,” the researchers wrote, noting that theU.S.government recently began investigating approaches to standardizing the format and content of prescription drug labeling.

The research is published online in PLoS One.  The study was supported by the Center for Food and Pharmaceutical Packaging Research.

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