Over-the-counter (OTC) medications are nonprescription drug products approved by the U.S. Food and Drug Administration as safe and effective for use by the general public without seeking treatment by a healthcare professional.

As Figure 1 shows, US consumers spent $32.2 billion on OTCs in 2019. It is estimated that the US healthcare system saves $7 for every $1 spent on OTCs, which roughly translates to $225.4 billion saved by the US healthcare system in 2019 alone.

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Figure 1: US Consumer Perception and Use of Over-the-Counter (OTC) Medications

Studies have shown that consumers perceive OTCs to be normal, simple, and easy. In fact, 8 in 10 US adults use OTCs as a first response to minor ailments, and 9 in 10 believe OTCs are an important part of their overall family healthcare. Unfortunately, the rising usage rates of OTC medications is causing concern among public health officials.

Research shows this perception that OTC use is common and simple may lead consumers to overestimate the safety of these products. As new medications are made available for purchase without a prescription, it is becoming more and more difficult for healthcare providers to ensure patient safety. The scope of concern with respect to OTC medication use is underscored by 178,000 hospitalizations each year due to adverse drug events (ADEs) associated with OTC medications.

Older adults (65+), who represent 13% of the population, account for a full third of the OTC medication use in the United States as well as 61.5% of ADE-associated emergency department visits. As life expectancy lengthens and the proportion of older adults in the population increases, so does the need for interventions that help older adults use OTC medications safely and effectively.

Current Research on OTC Medication Misuse

Many of our projects have focused on preventing OTC medication misuse by community-dwelling older adults, a critical issue that had been left largely unaddressed.

Active grant

Effectiveness and Sustainment of a Tailored Over-the-Counter Medication Safety Intervention in Community Pharmacies

Past grant

Improving Over-the-Counter Medication Safety for Older Adults

Preliminary Studies

Our preliminary studies helped us to identify both pharmacist barriers (Figure 2) and older adult barriers (Figure 3) to safe over-the-counter medication selection in the community pharmacy.

Barriers graphics Fig 2, Fig 3

Grant information

2020: $1,491,590 “Effectiveness and Sustainment of a Tailored Over-the-Counter Medication Safety Intervention in Community Pharmacies”, AHRQ R18

2016: $1,500,000 “Improving Over-the-Counter Medication Safety for Older Adults” Award by the Agency for Healthcare Quality and Research, AHRQ R18

2014: $75,000 “Exploring Over the Counter Medication Safety in Older Adults” Award by the UW Institute for Clinical and Translational Research

2010: $12,500 “Appropriate Over-the-counter Medication Use in the Older Adult: Pharmacists’ Role in Reducing Harm” Award by the UW School of Pharmacy Research Innovations Award

2010: $311,250 “Applying a Human Factors Approach to Community Pharmacies: The First Step in Improving Medication Safety in Pharmacies” Award by the KL2 Scholars Career Development Program and UW ICTR (funded through an NIH CTSA)