The Devil in the Details
April 30th, 2009 | Sources: BurrillReport, PNASSubjects: Pharmaceuticals, Quality and safety
Michigan State University scientists have found that brand name information and marketing claims overshadow fine print safety warnings on OTC medications, despite Federal regulations requiring that display of the latter should be “prominent” and “conspicuous.”
Laura Bix and colleagues used an eye-tracking device to quantify the visual inspection patterns of subjects as they scanned package labels on OTC pain killers and subsequently assessed the extent to which subjects could recall the information.
The scientists focused on five elements of the package label: brand name, the statement of claims such as “extra strength,” drug facts information, the child-resistant warning and the tamper-evident warning.
They observed that subjects focused primarily on the brand name and much less on the 2 warnings. For example, 67% of the subjects were able to remember one or more brands they had observed during the study, but only 18% recalled alcohol-related warnings.
A dismal 8% remembered the warning that the product shouldn’t be used in homes where young children were around and not one single participant recalled the warning about tamper-evident features.
Part of the explanation, according to Bix and Co., is that the brand and product claims were more legible than the warning statements.
Their write-up appears in Proceedings of the National Academies of Science.
“To be effective, warnings about the lack of a child-resistant feature, or those that alert consumers to potential tampering of the product, need to be read and comprehended at the time of purchase,” Bix told BurrillReport.
“Little guidance exists from the federal government regarding what it means to be ‘prominent’ or ‘conspicuous,’ yet, this term is used quite frequently in the regulations that dictate labeling for a variety of product,” Bix added.








