# Optimizing OTC labels for older adults: Empirical evaluation of labels designed to provide older users the information they need to minimize adverse drug events

> **NIH AHRQ R01** · MICHIGAN STATE UNIVERSITY · 2021 · $338,332

## Abstract

Project Summary/Abstract
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.

## Key facts

- **NIH application ID:** 10140313
- **Project number:** 5R01HS025386-04
- **Recipient organization:** MICHIGAN STATE UNIVERSITY
- **Principal Investigator:** Mark W. Becker
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** AHRQ
- **Fiscal year:** 2021
- **Award amount:** $338,332
- **Award type:** 5
- **Project period:** 2018-07-06 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10140313

## Citation

> US National Institutes of Health, RePORTER application 10140313, Optimizing OTC labels for older adults: Empirical evaluation of labels designed to provide older users the information they need to minimize adverse drug events (5R01HS025386-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10140313. Licensed CC0.

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