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

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Project Summary/Abstract Older adults are susceptible to over-the-counter (OTC) medication safety issues and harms related to misuse. Not only do older adults use OTC medications more than other age groups, but their medication selection often is not appropriate for their age, health conditions, or concomitant medications. They also are frequently non-compliant with labeling instructions. Over 1 million older adults are at risk for a major adverse drug event that involves an OTC medication. Although older adults represent an AHRQ priority population, no effective interventions have broadly attempted to decrease OTC medication misuse harms in this population. The transdisciplinary team, with experts in pharmacy, public health, geriatrics, human factors engineering, biostatistics, mixed-methods analysis, and dissemination and implementation, will collaborate with Advocate Aurora Health (AAH), a large health system with community retail pharmacies. This collaboration will lead to the adaptation, adoption, and long-term evaluation of a system redesign intervention (the Senior Section) to decrease OTC medication misuse for patients in 63 AAH pharmacies. Senior Section features include a curated supply of safer OTC medications, cautionary signage, and tools to support OTC selection, which are designed to facilitate older adult/pharmacy staff encounters about OTC issues. The EPIS (Exploration, Preparation, Implementation, Sustainment) model will be the conceptual framework used to ensure continual optimization of the Senior Section when applied to varied pharmacy settings. A Type 2 effectiveness-implementation hybrid design will: (1) adapt the Senior Section based on characteristics of pharmacies and their patient population, (2) evaluate Senior Section effectiveness for reducing older adult OTC medication misuse, and (3) evaluate implementation of the finalized Senior Section. Using insights gained from pharmacy staff, older adult, and AAH stakeholders, the Senior Section will be adapted using eye-tracking technology and pharmacist/technician interviews to identify features that patients use when selecting OTC medications. These outcomes will be used to inform the development of an Implementation Package. For effectiveness, a post-test randomized controlled trial (comparing test and control pharmacies) will be conducted to evaluate the rate of OTC misuse and characteristics of pharmacy staff/patient encounters. Final implementation by AAH without research team support will be assessed by fidelity of delivery, long-term effectiveness, and perceptions about sustainability, which provide a signal of sustainment. AAH leadership and front-line pharmacy staff are committed to adopting and evaluating this innovative intervention in their pharmacies. This study responds to AHRQ patient safety priorities for system-level change to improve medication use. Outcomes will address an unmet critical need, identified by AHRQ PA-20-028, to “spread existing tools that have previously been used in limited settings, and thus enabling improvement on a larger scale” for older adults, an AHRQ targeted population at high risk for OTC medication misuse.