Regulatory Focus™ > News Articles > Study Calls for Additional Regulation of Package Labeling

Study Calls for Additional Regulation of Package Labeling

Posted 19 June 2012 | By Alexander Gaffney, RAC 

To hear Laura Bix's analysis, it's a wonder more people aren't hurt each year by the medications they take.

In a study published in the online medical journal The Public Library of Science: One, Bix, an associate professor at Michigan State University, and colleagues looked at how consumers analyze information presented on drug labels in the form of additional prescription drug warning labels (PWLs)-the small stickers on drug packaging imploring you to take heed of important risk information.

So how do consumers react to the information? In large part, they don't.

In a small study of 32 subjects exposed to eye-tracking analysis, just half of study participants actually looked directly at the PWLs on their medication, while more than a fifth of study participants failed to look at the warnings at all. Older patients also exhibited a worse probability of viewing the warnings, with 29% failing to view any of the warnings.

The label's failure to capture a patient's attention is more than just a quirk or curiosity, said Bix. "Failure to heed these messages has the potential to result in an adverse event."

Having established the risk to patients, Bix and her colleagues then moved to the next obvious question: what measures can reduce patient inattentiveness to PWLs?

For the researchers, a lack of standardization and regulation represented the most obvious deficiency in need of improvement. "It is surprising that the Federal government does not regulate PWLs," wrote Bix. "To date, there are no universal, federal standards regarding the method of presentation or the information conveyed by PWLs."

The group made a number of recommendations for government regulators, whom Bix noted are currently looking to reevaluate how it regulates the warnings. "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," Bix said. "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."  

Read more:

PLoS One: Quantifying Age-Related Differences in Information Processing Behaviors When Viewing Prescription Drug Labels


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