Scientific Publications by FDA Staff

Drug Saf 2016 Feb;39(2):171-84

Consumer understanding, preferences, and responses to different versions of drug safety messages in the United States: a randomized controlled trial.

McCormack L, Craig Lefebvre R, Bann C, Taylor O, Rausch P

INTRODUCTION: As part of its mission, the US Food and Drug Administration (FDA) communicates with the public regularly about the benefits and risks of prescription and over-the-counter (OTC) drugs. Effectively communicating risk, however, is a significant public health challenge. OBJECTIVE: To better understand how different populations understand information communicated by the FDA about drug safety, we conducted a randomized experiment to examine comprehension and other measures of effectiveness of drug safety messages that occurred in a post-market surveillance phase. METHODS: We used an Internet panel survey of 1244 consumers, of whom 58 % used prescription drugs in the past year. Half of the sample panel was randomized to read a previous FDA Drug Safety Communication (DSC) with the drug name changed, and the other half was randomized to read a revised version of the same DSC. We examined how making certain modifications to the way drug risk information is communicated has an impact on comprehension and behavioral intentions, including the user's likelihood of discontinuing the drug. We also studied how comprehension varied by respondent characteristics, health literacy skills, risk perceptions, and trust in the message. RESULTS: Based on a five-item comprehension index, the revised version of the message was associated with significantly greater comprehension of the information relative to the standard version (63 vs 52 % correct, p < 0.001). Significantly more respondents found the revised version to be clear (82 vs 73 %, p < 0.000), while fewer in that group reported learning something new (78 % vs 84 %, p = 0.015). No significant differences emerged between the two groups in terms of the message being informative, convincing, or helpful. We found no significant differences between the two groups in terms of behavioral intentions, risk perception, and trust. CONCLUSIONS: We found that making plain language changes to the DSC significantly increased consumers' level of comprehension of its content, providing support for ongoing use and further exploration of these strategies in pharmacovigilance communication research. The study findings have important implications for future drug safety and other communication messages related to prescription drugs.