| On March 17, 1999 the Food and Drug Administration (FDA) issued a regulation mandating the design and font size of over-the-counter (OTC) drug labels. The FDA used a prescriptive approach in an attempt to ensure label legibility. Research presented here proposes that this not the best way to ensure the legibility of labels. A performance standard, one that incorporated the Lockhart Legibility Instrument (LLI) for instance, would be a better approach.; This research tests two hypotheses using the LLI: (1) noncompliant labels can be created that have equal or greater legibility than labels that comply with FDA's regulation; and (2) labels that contain a familiar drug message will be easier for subjects to read than those that are not familiar (a nonsense message).; Hypothesis 1, noncompliant labels can be created that have equal or greater legibility than compliant labels, was found to be true at a statistical level of α = 0.01. This result is especially pertinent because one of the two compliant designs tested did not just meet FDA's 6 point minimum, it exceeded it. Noncompliant messages created using a typeface that was 5.5 points were found to be more legible than the compliant designs, which were created using a typeface that was 9.0 points in size. This difference was highly significant, p = 5.0*10−7, vividly illustrating the flaws of the prescriptive approach.; Hypothesis 2, labels that contain a familiar drug message will be easier for subjects to read than those that are not familiar, was not found to be true at a statistical level of α = 0.05. There are two possibilities with regard to this result. The first is that subjects arrive at the same measurement on the instrument, regardless of their level of familiarity with message; a desirable outcome for the LLI.; The second possibility is that subjects were no more familiar with this common drug message (a decongestant) than the message that was created using random words. This conclusion would support the idea that, despite potential dangers of OTC misuse, consumers are not highly involved with OTC products (Reisenwitz and Wimbish, 1997; Sansgiry and Cady, 1995; Robinson and Stewart, 1981); uninvolved consumers are less likely to seek information, use complex rules when evaluating alternatives, and devote focal attention and controlled comprehension to the product (Rifon, 2000). In other words, the finding supports the idea that consumers are not reading OTC labels.; This is consistent with the findings of a survey conducted by Dr. Janet Engle, Professor of Pharmacy at the University of Illinois, Chicago. At a news conference in December 1998 she indicated, “47% failed to always read the product label before starting a pain medication, and one-third were unaware that over-the-counter (OTC) drugs carry risk” (Norton, 1999). Given the significant ramifications of improper OTC use, and the difficulty in changing consumer/product involvement, this second possibility is a frightening, but real, risk. |
