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

Award Number: R01HS025386
ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY
OPDIV: AHRQ
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	5/19/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $331,927 )
2022	2022	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	4/21/2022	NON-COMPETING CONTINUATION	$331,927
														Subtotal = $331,927

Issue Date FY: 2021 ( Subtotal = $338,332 )
2021	2021	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Research on Healthcare Costs, Quality and Outcomes	000	4	3/31/2021	NON-COMPETING CONTINUATION	$338,332
														Subtotal = $338,332

Issue Date FY: 2020 ( Subtotal = $330,300 )
2020	2020	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Research on Healthcare Costs, Quality and Outcomes	000	3	4/7/2020	NON-COMPETING CONTINUATION	$330,300
														Subtotal = $330,300

Issue Date FY: 2019 ( Subtotal = $318,115 )
2019	2019	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Research on Healthcare Costs, Quality and Outcomes	000	2	4/10/2019	NON-COMPETING CONTINUATION	$318,115
														Subtotal = $318,115

Issue Date FY: 2018 ( Subtotal = $313,907 )
2018	2018	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	7/4/2018	NEW	$313,907
														Subtotal = $313,907

Grand Total All Awards = $1,632,581

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

Award Number: R01HS025386

ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY

OPDIV: AHRQ

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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