This study examines effectiveness of an innovative pharmacy design change on over-the-counter (OTC) medication misuse in adults older than 65. A structural pharmacy redesign (the Senior Section™) was conceptualized to increase awareness of higher-risk OTC medications. The Senior Section contains a curated selection of OTC medications and is close to the prescription department to facilitate pharmacy staff/patient engagement to reduce misuse. This study will culminate in the implementation of the Senior Section™ in all Advocate Aurora Health pharmacies in eastern Wisconsin.
Adverse drug events (ADEs) associated with over-the-counter (OTC) medications cause 178,000 hospitalizations each year, representing a major patient safety concern. Older adults aged 65+, one of AHRQ’s priority populations, are particularly vulnerable to ADEs. Of the 2.2 million older adults who are at risk for a major ADE, more than 50% of older adults are because of concurrent use of an OTC and prescription medication. Most older adults do not know OTC safety risks and are susceptible to improper dosing or interactions from polypharmacy. Access to pharmacists at the point of OTC sales can lower older adult OTC medication misuse, but community pharmacies’ design and lack of standardized engagement processes impede such access. This situation demands a pharmacy-based intervention to prevent OTC medication misuse.
Our intervention, the Senior SectionTM, was the first and only physical redesign intervention to demonstrate effectiveness in reducing OTC medication misuse in older adults. The Senior Section is a physical redesign of the community pharmacy’s OTC aisles, informed by human factors engineering and a stakeholder engaged participatory design. The Senior Section is comprised of the following features: a dedicated section of well-lit shelving with a curated list of OTC medications that are safe for older adults, proximity and sightline to the prescription department, tools (e.g., lighted magnifying glass), strategically-placed signage, and shelving height to assist visually and physically impaired older adults.
The Senior Section (R18HS24490) led to significant reductions in OTC misuse types: selecting an OTC that was contraindicated with the participant’s health condition (z=-2.09,p=0.037), and participant’s reported use that differed from the product labeling (z=-2.42,p=0.016 & z=-5.82,p=0.001). Importantly, the intervention fit with pharmacists’ workflow, did not add to pharmacist workload, and facilitated patient communication.
Although successful at reducing misuse, the initial intervention implementation was limited to three pharmacies with homogenous layouts and patient populations. Scaling intervention implementation across heterogeneous community pharmacies and demonstrating effectiveness with diverse patient populations is the clear next step to advance the development of sustainable medication safety strategies.
Our long-term goal is to prevent OTC medication misuse in older adults and subsequent harm. A hybrid effectiveness-implementation study, utilizing the EPIS implementation framework, will scale our Senior Section to Advocate Aurora Health (AAH) community pharmacies serving a demographically diverse catchment area. Our central hypothesis is that a Senior Section tailored and culturally adapted to specific settings and patient populations will lead to greater adoption by pharmacists and older adults and reduce OTC medication misuse. The rationale for this study is to confirm effectiveness across different pharmacy settings to facilitate broad professional acceptance of the Senior Section as a valuable tool for community pharmacies for preventing OTC medication misuse.
Aim 1. To adapt the Senior Section based on the characteristics of pharmacies and their patient population.
Aim 2. To evaluate the effectiveness of the Senior Section in preventing OTC medication misuse in older adults.
Aim 3. To evaluate the implementation of the finalized Senior Section.
Advocate Aurora Health (AAH) is the 10th largest not-for-profit, integrated health system in the U.S. AAH serves nearly 3 million patients annually across more than 500 sites of care. This study will take place in the 63AAH community pharmacies that are geographically dispersed throughout eastern Wisconsin. Both urban and rural catchment areas are represented, with significant populations of older adults with diverse socioeconomic status. AAH also has telepharmacy sites. Telepharmacies are sites in which pharmacists and patients are not in the same place and interact using a real-time video link. AAH telepharmacists, working at a central office, connect with technicians and patients at the telepharmacy sites to verify accuracy and appropriateness of prescriptions and to counsel patients. Telepharmacies have the same physical layout as traditional pharmacies with a prescription department and a front-end OTC medication area.
Our guiding premise for this study is that interventions benefit from ongoing optimization as they are applied in different contexts. As such, the Exploration, Preparation, Implementation, Sustainment (EPIS) framework was selected as the optimal conceptual implementation framework because it allows for examination of a change process at multiple levels (organization and pharmacy staff), across time, and through successive stages that build deliberately toward implementation and sustainment (Figure 1). Consistent with the human factors engineering and systems approach used for our previous research, EPIS takes into account the outer context and the inner organizational contextual factors. The outer context comprises the needs and preferences of diverse patient populations. The inner context includes organizational culture, pharmacy staff characteristics, staffing policies, fidelity, and quality assurance support. These contextual factors are instrumental to the success of the intervention across the EPIS stages. Finally, EPIS promotes a cyclical approach that includes rapid-cycle testing principles and permits us to track the progressive movement through EPIS Preparation and Implementation.
Aim 1 (preparation) will be evaluated with a pilot phase post-test only randomized control trial, matching test, and control site pharmacies. The pilot phase will include a smaller sample of 4 pharmacies, based on pharmacy and patient characteristics, to optimize internal validity.
Aim 2 (effectiveness) will be evaluated with a post-test-only randomized controlled trial, matching test and control site pharmacies, based on pharmacy and patient characteristics, to optimize internal validity.
For Aim 3, AAH will implement the Senior Section in all of their pharmacies, without research team support. To demonstrate the implementation of the Senior Section, we will evaluate the fidelity of delivery, the long-term effectiveness of the Senior Section intervention, and pharmacy staff perceptions of sustainability. This analysis will be a pre (control)/post (intervention) test to determine the long-term effectiveness of the finalized Senior Section to decrease OTC medication misuse in older adults. This sample size will provide 80% power to detect a reduction of OTC medication misuse from 74% to 60%, using the score test for the intervention effect from a mixed-effects logistic regression using a two-sided 5% level test.
Co-Investigators and Collaborators
Gupta, Arushi. Pharmacy Redesign with Older Adults in Mind. Accessed March 18, 2021.
Moon, J., Bove, M. E., Morris, A. O., Gilson, A. M., Stone, J. A., Watterson, T. L., & Chui, M. A. (2022). Eye-tracking for macroergonomics in the wild: Exploring its use for understanding older adults’ over-the-counter medication selection behavior in community pharmacies and its implications for other health care settings International Symposium on Human Factors and Ergonomics in Health Care, New Orleans, LA. March 20-23, 2022.
Morris, A. O., Bove, M. E., Moon, J., Stone, J. A., Gilson, A. M., Watterson, T. L., & Chui, M. A. (2022). Senior Section 2.0: Intersecting Implementation Science and Human Factors to Adapt Our Community Pharmacy Intervention to Improve Over-the-Counter Medication Safety Among Older Adults International Symposium on Human Factors and Ergonomics in Health Care, New Orleans, LA. March 20-23, 2022.
Chui, M. A., Berbakov, M. E., Stone, J. A., Moon, J., Hoffins, E. L., Chladek, J., Gilson, A. M., Watterson, T. L., & Lehnbom, E. C. (2023). Developing Solutions for Challenges Faced When Collecting Healthcare Professional and Patient Data in the Field Nordic Social Pharmacy Conference 2023 – Pharmacist services of tomorrow, Tromsø , Norway. June 7-9, 2023.