The studies, designed by experts in FDA’s Division of Drug, Marketing, Advertising and Communications (DDMAC) in the Center for Drug Evaluation and Research, examined ways to improve understanding of how consumers use the “brief summary” section of printed prescription drug ads.
The online edition of the journal “Medical Decision Making” published findings from the third study today.
The Federal Food, Drug, and Cosmetic Act specifies that print advertisements for prescription drugs and biological products are required to provide a true statement of information “in brief summary” about 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. “FDA’s research and policy development seeks to improve the presentation of this information so it is easier for consumers to read and understand.”
Print ads for prescription drugs are often two (or more) pages long. The first page of the prescription drug ad may feature a picture, information about what the product is intended to be used for, and important information about the product’s risks. The second page summarizes all the product’s risks and may be presented as densely-packed text information.
In the first study, a serious risk was added to the first and second page of the ad. In the second study, additional information about side effects was included on the second page. The third study tested four different brief summary formats:
Traditional (block text paragraphs), Question and Answer (with headings framed in the form of questions), Highlights (based on the highlights section of the physician labeling), and Prescription Drug Facts Box (resembling the current Over the Counter Drug Facts label).
Key findings of the studies include:
- Adding a serious risk did not hinder people’s understanding of the risk information.
- Including additional information about how often side effects occur and how long they may last did not hinder people’s understanding of the risk information.
- Participants who viewed the Drug Facts format were better able to recall risks than those who saw the traditional format.
FDA researchers Kathryn Aikin, Ph.D., Amie O’Donoghue, Ph.D., and Helen Sullivan, Ph.D., M.P.H., and Jack Swasy, Ph.D., from American University designed and led the three experimental studies.
A copy of “Randomized Trial of Risk Information Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs” will be available in the September/October 2011 issue of “Medical Decision Making.”
For more information:
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