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Kimberly A. Kaphingst and William DeJong The Educational Potential Of Direct-To-Consumer Prescription Drug Advertising Health Affairs, July/August 2004; 23(4): 143-150. [Abstract] [Full Text] [PDF] [Reprints & Permissions]

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Brief Summaries Formats for Direct-to-Consumer Prescription Drug Advertising

Sujit S. Sansgiry, Aniket A. Kawatkar   ( 25 August 2004 )

Brief Summaries Formats for Direct-to-Consumer Prescription Drug Advertising 25 August 2004
Sujit S. Sansgiry, Assistant Professor and Director University of Houston, Houston, Texas, Aniket A. Kawatkar Send comment to journal: Re: Brief Summaries Formats for Direct-to-Consumer Prescription Drug Advertising ssansgiry{at}uh.edu Sujit S. Sansgiry, et al.	Kaphingst and DeJong provide an excellent overview of the educational potential of direct-to-consumer advertising (DTCA) of prescription drugs. We concur with the results of the study and would like to provide two additional sources of data that may enhance the decision making process by the FDA to develop policy guidelines. First, we would like to point out a study that was conducted to evaluate the inconsistencies in DTCA practices by manufacturers.[1] A content analysis of all print DTCA published in the National Geographic from January 2000 to October 2003 was performed; it identified 128 advertisements. We noticed two formats used for brief summaries. The older, more cluttered version was predominantly used (56.25%). A few manufacturers had voluntarily adopted a new version sometime during the year 2000, which appears slightly better based on visual judgment, due to the increased font size and print formatting. Although a few companies had adopted the new version, they did not do so for all their products. In addition, the trend analysis indicated that the use of the new format fluctuated over the years, with a drop of 14% in 2001 and a respective drop of 18% in 2002. The question that seems to arise is, Do these new print DTCA summaries by being user-friendly induce positive attitudes toward the product, thus leading consumers to request more information regarding such drugs from manufacturers, physicians, or pharmacists? To answer this question, pharmacy students (N = 147) in an experimental, randomized study evaluated four formats of DTCA brief summaries.[2] These formats included the two existing formats, those reported as old (format A) and the new version (format B) in the above mentioned study, and two new formats developed based on previous research and FDA proposed guidelines for nonprescription drug labels (format C) as well as brief summaries (format D).[3] It was found that format C, developed based on similar formatting design principles as those seen on the nonprescription drug labels (Drug Facts panel), was perceived to be more easy to use, had the most favorable attitude towards the product, and received the highest score for satisfaction with the information provided. The overall rank received for superiority was format C, followed by format D (which was based on FDA guidance on brief summary format), format B (new version currently in use), and format A. Formats currently in existences received very low scores, with the worst scores predominantly seen for format A. We hope that this new information provides the FDA with the needed direction toward developing guidelines for DTCA print summaries that would enhance the educational potential of DTCA. NOTES 1. S.S. Sansgiry and A.A. Kawatkar, “Inconsistency in DTCA Practices by Manufacturers: Is It Time to Standardize Print Summaries?” Value in Health 7, no. 2 (2004): 216-217. 2. A.A. Kawatkar, “Modified Brief Summary Format to Improve Consumer Comprehension Regarding Advertised Prescription Drugs” Thesis, University of Houston, 2004. 3. FDA HHS Final Rule, “Over-the-Counter Human Drugs: Labeling Requirements,” Federal Register 64 no. 51 (1999): 13254-13303; and FDA Guidance for Industry, “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements,” January 2004, www.fda.gov/cder/guidance/5669dft.doc (4 February 2004).