Consumer Comprehension of Efficacy Data in Four Experimental Over-The-Counter Label Conditions
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
CONSUMER COMPREHENSION OF EFFICACY DATA IN FOUR EXPERIMENTAL OVER-THE-COUNTER LABEL CONDITIONS* DOUGLAS B. GRISAFFE,PHD Vice President, Research Sciences, Product Development and Management
SUSANSHELLABARGER, MS Mce President, Business Development, Healthcare Product Research Walker Information, Indianapolis, Indiana
Recently marketed over-the-counter (OTC)drugs include efficacy data in their labeling/ packaging. A mall intercept methodology was used with a hypothetical antacid product to investigate consumer comprehension of such efficacy data under four experimental label conditions. Consumers who were given no efficacy data were inaccurate in predicting the drug’s effectiveness. People who were given efficacy data were much more accurate, but their accuracy depended upon which experimental label they received. A textpresentation showed some advantage over graphical presentations. Other analyses point to a logical chain of effects from demographic and label characteristics, to cornprehension and anticipation of eficacy, to purchase intentions. A model is presented which summarizes this chain of effects. This study has practical implicationsfor consumers, the Food and Drug Administration (FDA), and manufacturers of OTC drug products. In fairness to the consumer, the ultimate link to purchase intention dictates label conditions that maximize comprehension and foster accurate anticipation of personal efficacy. Key Work: OTC drug labeling; Efficacy data; Label comprehension;Demographic differences; Purchase intention
INTRODUCTION
being offered for over-the-counter purchase. For pharmaceutical companies to obtain apIN AN ERA OF INCREASING health care proval by the FDA for such an ‘‘Rx-to-oTC costs, more responsibility for health mainte- switch,” however, an approval process must nance is being shifted to individuals. Concur- be followed. Several steps in this process rently, powerful medications that once were are likely to incorporate empirical dam availab1eOnly by prescription are now carefullyconducted scientific research (1). One place where it is critical to collect empirical data is in the area of label compre*Resented in part at the Institute for Intemtional Re- hension. Beyond just being able to read a search Drug Market Conference,” October ’3label (legibility), consumers must be able to 25, 1995, Philadelphia Pennsylvania. understand, interpret, and apply label inforReprint address: Doug Grisaffe, Walker Infonnamation if they me to use an OTC product tion, 3939 ~iorityWay south Drive, Indianapolis, IN safely and correctly (1). In other words, com46240-0972. 937 Downloaded from dij.sagepub.com at Oakland University on June 4, 2016
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Douglas B. Grisaffe and Susan Shellabarger
pliance logically traces back to comprehension. Thus, for a switch to be approved, the FDA requires scientific research evidence that substantiates consumer comprehension of label information. Understanding the elements of labeling that lead to high levels of compr
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