A novel strategy to optimize critical information on over the counter labels for older adults

Abstract

Background and aims: Labels designed to communicate critical information are paramount for the safe and effective use of over-the-counter medications; in recognition of this, the content and formatting of over the counter (OTC) labels sold in interstate commerce has been regulated for decades. Yet, available studies suggest that consumers frequently rely on limited information during decision making, failing to access the information required in the Drug Facts Label. This is particularly important for older consumers, who are at greater risk for adverse reactions to medicines. In two experiments we objectively evaluate how novel label designs that employ highlighting and a warning label placed on the package's front impact older consumers' attention to, and use of, critical information.

Methods: In Experiment 1, 68 OTC patients (65+) engaged with a computer-based task answering yes/no scenario-based questions about a drug's appropriateness. In Experiment 2, 63 OTC patients (65+) conducted a forced-choice task where one of two drugs presented on a computer screen was appropriate for a provided scenario while the other was not. Both tasks required participants to access and use critical label information (i.e., warnings or active ingredients) to respond correctly. Dependent variables analyzed were the proportion of correct responses and time to correct response.

Results: Highlighting or placing critical information on the front of the package significantly improved response accuracy and time to correct response in Experiment 1 as compared to responses utilizing the standard label. For Experiment 2, participants were faster and more accurate when critical information was highlighted.

Conclusions: Results provide direct measures of the efficacy of novel labeling strategies. This information is relevant for regulations which dictate label design in ways that enhance ease and safety of use of medications for older adults.

Keywords: improved adherence; medication error; patient safety; patient‐centered design.

Conflict of interest statement

Laura Bix has served as a consultant to Vertex Pharmaceuticals, Inc., a biotech firm focused on drugs to treat cystic fibrosis, providing expertise on the development of protocols to evaluate packaging ease of use. Laura Bix has received an honorarium and travel reimbursement to speak at Baxter and Johnson & Johnson Companies and travel reimbursement to share work from her group at the International Quality and Productivity Center's conference on Pharmaceutical Labeling. Travel reimbursement has also been provided by the US Food and Drug Administration and the US Centers for Disease Control and Prevention in support of her participation for ongoing efforts medication safety. Laura Bix and Mark Becker have served as CoPIs on work supported by the Consumer Healthcare Products Association; this funding did not support work presented herein. None of these entities played any role in the design or conduct of the study; collection, management, analysis or interpretation of the date; preparation, review or approval of the manuscript or the decision to submit or publish the study.

© 2023 The Authors. Health Science Reports published by Wiley Periodicals LLC.

Figures

Figure 1

Four experimental treatments with basic terminology.

Figure 2

Experiment 1—absolute judgment warning results. Mean accuracy (left panels) and reaction times to make correct responses (right panels) are presented for trials where the medication was contraindicated (a “yes” response was correct) top panels) and where the medication was not contraindicated (a “no” response was correct lower panels). Error bars are the standard error of the mean.

Figure 3

Experiment 1—absolute judgment active ingredient results. Mean accuracy (left panels) and reaction times to make correct responses (right panels) are presented for trials where the medication was contraindicated (top panels) and where the medication was not contraindicated (lower panels). Error bars are the standard error of the mean.

Figure 4

Experiment 2—forced choice selection results. Mean accuracy (left panels) and reaction times to make correct responses (right panels) are presented for trials where the critical infomration was Warning information (top panels) and where the critical informaiton was Active Ingredient information (lower panels). Error bars are the standard error of the mean.