The traditional method of conveying information in the brief summary of a printed prescription-drug advertisement is neither the most comprehensible nor the most preferred by consumers, according to an FDA study published online this week in Medical Decision Making. The study is the third in a series designed by experts in FDA’s Division of Drug, Marketing, Advertising, and Communications (DDMAC) in the Center for Drug Evaluation and Research to better understand how consumers use the brief summary section of these ads.

Print ads for prescription drugs are often at least two pages long. The first page may include a picture, information about the product’s intended use, and important information about the product’s risks. The second page generally summarizes all of the product’s risks. The summary may be presented as densely packed text information.

The study published this week tested participants’ understanding of four brief summary formats. Information was provided in the traditional format (i.e., a plain-language version of the risk sections from professional labeling), question and answer form (i.e., with headings framed in the form of questions), highlights (i.e., a format based on the highlights section of physician labeling), and a prescription-drug facts box (i.e., a format similar to that of the current Over-the-Counter Drug Facts label).

Participants who viewed the drug-facts format were better able to recall risks than those who saw the traditional format, according to the study results. The researchers also noted differences in participants’ preference of format. Participants ranked the drug-facts format highest, followed by the question-and-answer format, the traditional format, and the highlights format.

Findings from all three FDA studies confirmed that the way that information is conveyed and displayed in printed drug advertising affects consumers’ understanding of prescription medications. In the first study, researchers added a serious risk to the first and second page of an ad, which did not hinder people’s understanding of the risk information. In the second study, researchers added information about the frequency and duration of side effects to the second page, which also did not hinder people’s understanding of the risk information.

The Federal Food, Drug, and Cosmetic Act requires print advertisements for prescription drugs and biological products to provide a true and brief summary of the advertised product’s side effects, contraindications, and effectiveness. “Some of the current approaches to fulfilling the brief-summary requirement, while adequate from a regulatory perspective, are not optimal in communicating this important information to consumers,” said Thomas Abrams, director of DDMAC, in an FDA press release. “FDA’s research and policy development seeks to improve the presentation of this information so it is easier for consumers to read and understand.”

FDA researchers Kathryn Aikin, Amie O’Donoghue, and Helen Sullivan designed and led the three experimental studies with Jack Swasy of American University. Their article, “Randomized Trial of Risk Information Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs,” will appear in the September­–October 2011 issue of Medical Decision Making.

See related Pharm Tech article:

FDA Reviews First Year of Bad Ad Program (ePT)