Research Activities January 2013, No. 389
Including FDA hotline in print drug ads has small effect on adverse event reporting by consumers
Patient Safety and Quality
In 2007, the Federal Government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers about how to report to the Food and Drug Administration (FDA) adverse events that they experienced after taking a prescription drug. The researchers studied adverse event reports for about 123 drugs that came from patients before and after the enactment of the print advertising requirement. They then estimated that requirement's impact with model simulations. In the period from July 2006 to May 2009, the FDA received 7,100 adverse drug reports from patients who were taking one of more of the 123 drugs. On average, patients reported more adverse events per month after the enactment of the requirement than before (2.35 events per drug, compared to 1.17 events). However, this difference was not significant.
Using model simulations, the researchers estimated that before enactment of the requirement, if the cumulative spending on print direct-to-consumer advertising increased to $7.7 million per drug, there would be 0.08 more reports each month of adverse drug events per drug. After enactment, the same increase in spending on print advertising would result in 0.24 more monthly reports of adverse events per drug. Of that increase, 64.8 percent was attributable to the requirement that manufacturers include toll-free reporting numbers in print direct-to-consumer advertisements.
The researchers suggest that if the positive relationship between spending on direct-to-consumer advertising and adverse event reporting holds, adding the toll-free number to television advertisements could have a bigger impact than doing so in print advertising. They also point out that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events.
See "Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low," by Dongyi "Tony" Du, PhD, John Goldsmith, PhD, Kathryn J. Aikin, PhD, William E. Encinosa, PhD, and Clark Nardinelli, PhD, in Health Affairs 31(5), pp. 1022-1029, 2012. Reprints (AHRQ Publication No. 12-R085) are available from the AHRQ Publications Clearinghouse.