Over-the-counter medicines (OTCs) provide many benefits, including increased access, independence, flexibility and affordability. Despite their advantages, OTCs carry risks of having an Adverse Drug Reaction (ADR) such as those caused by drug-drug interactions or drug- diagnosis interactions. The risk of ADRs due to OTC uses is particularly pronounced in older consumers, who tend to consume more OTCs and have higher rates of polypharmacy than other age groups. While OTC labels are required to contain critical information (e.g., active ingredients and warnings) designed to minimize ADRs, evidence suggests that a lack of engagement with key information on OTC labels is endemic and problematic, particularly among older consumers. This proposal leverages research on nutrition, medical device and prescription labels and applies basic research in visual cognition to develop and objectively evaluate the ability of varied OTC label designs to attract attention to critical information, thereby promoting appropriate decision making in older adults. Specifically, it addresses whether adopting a warning label that places information that is critical for avoiding ADRs on the front panel of the packaging increases attention to these warnings and supports better decision making. It also evaluates whether color highlighting of this critical information improves attention and decision making. Finally, investigate the possibility that adopting these techniques could have the potential negative consequence of making people less likely to attend to the more comprehensive warning information that appears in the traditional drugs fact panel. To evaluate these issues the proposal applies empirical methods from basic research on attention and visual cognition (e.g., eye-tracking, change detection, and visual search tasks) to investigate how well different OTC label designs attract attention to critical information, promote decision making, and facilitate rapid, cross-product comparisons. Using this information to optimize delivery format should produce a label that successfully communicates critical drug information to at-risk older consumers, thereby empowering them to make healthful medication decisions, ultimately reducing ADR rates. Finally, this research has implications for regulatory policy related to label design.

Public Health Relevance

The proposal applies basic research from the field of visual cognition and attention to the design and evaluation of over-the-counter drug labels. An optimal label will attract attention and effectively communicate information critical to the reduction of Adverse Drug Reactions, thereby empowering people to make healthier medication decisions, improving health. It targets older consumers who are at increased risk for adverse drug reactions associated with over-the- counter medication use.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Project (R01)
Project #
5R01HS025386-03
Application #
9912730
Study Section
Healthcare Effectiveness and Outcomes Research (HEOR)
Program Officer
Perfetto, Deborah
Project Start
2018-07-06
Project End
2023-04-30
Budget Start
2020-05-01
Budget End
2021-04-30
Support Year
3
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Michigan State University
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
193247145
City
East Lansing
State
MI
Country
United States
Zip Code
48824