More than 100 million Americans have multiple chronic conditions [1] that contribute to more than 1 million adverse drug events (ADEs) annually, prompting 4 million people to seek medical care, costing the US health care system >US $8 billion per year [2,3]. Health care spending for patients with multiple chronic conditions is up to 20 times higher than for patients with no chronic conditions; that is, Americans with 5 or more chronic conditions comprise 12% of the population but contribute to 41% of the total health care spending, averaging 20 physician visits per year and using up to 50 times more prescription medications [1]. Challenges with managing multiple chronic conditions have a direct impact on health care use, with such patients representing a quarter of all hospital admissions annually, with one-third of all patients having at least 1 emergency department visit every year [1]. Despite these health consequences, efforts to improve medication safety for patients with complex chronic health conditions in outpatient settings have not been allocated appropriate resources to be effective.

Community pharmacists are recognized as the champions of medication safety not only for performing dispensing tasks but also for their expanding role in chronic care management (CCM) [4]. CCM can include managing health problems and goals, medications, other health care providers, and community services that patients have and need. In many states, CCM also encompasses ordering and interpreting tests for chronic conditions, such as diabetes [4], through collaborative practice agreements with health care providers and ensuring patients receive appropriate screenings and immunizations. Such expanded practice was facilitated by the COVID-19 pandemic due to pharmacists being one of the few health care professionals providing face-to-face care and assuming clinical responsibilities when primary care physicians and nurses were managing COVID-19 emergencies [5].

Furthermore, community pharmacists play a vital role in medically underserved communities [6], such as in locations with too few primary care providers, high poverty, or a high older adult population. Patients in these areas face difficulties or delays in getting basic health care because of long travel distances to health care providers, long wait times for appointments, or a lack of health care providers who can serve uninsured or underinsured patients. Therefore, pharmacists are considered accessible primary care practitioners, seeing patients 5 to 8 times more frequently than primary care physicians [7]. Numerous studies have demonstrated the ability of pharmacists to address medication nonadherence [8], support naloxone provision and opioid safety counseling [9], provide pain management and palliative care [10], improve diabetes and cardiovascular outcomes [11], and improve vaccination rates in medically underserved communities [12,13].

However, the abilities of community pharmacists to fill this gap are constrained by a work system that is unsustainable and essentially broken [14]. Pharmacies adhere to product-based reimbursement contracts with pharmacy benefit managers, incentivizing pharmacy staff to fill more prescriptions. Therefore, for more than a decade, pharmacists have reported high workload and burnout, with opaque corporate performance metrics based on prescription volume and customer service [14] rather than on safety or clinical outcomes. The COVID-19 pandemic exacerbated pharmacists’ workload strain by adding testing and vaccinations to a system that is chronically understaffed and stretched beyond capacity. With pharmacist burnout rates at an all-time high, a call for action to improve pharmacist work systems is critical to prevent a complete collapse in the US pharmacy system. Pharmacists across the United States have been executing a series of walkouts since September 2023 to improve harsh working conditions and preventable errors in care [15]. In Walgreens alone, 600 employees across 20 stores have participated in walkouts, resulting in multiday disruptions in workflow and patient care [15]. The purpose of these walkouts is to shed light on the need for a solution to improve the working conditions of pharmacy staff.

In light of pharmacists’ unmanaged workload, there is a push for them to do more. This is evidenced by the introduction and recognition that pharmacists are health care providers (eg “provider status”) [16]. This status will allow pharmacists who provide services such as CCM, comprehensive medication management, and immunizations to receive reimbursement for such clinical services in addition to product-based dispensing services [17]. This provides a timely opportunity for pharmacists to envision innovative designs to improve medication safety for their patients. To reimagine community pharmacies as an accessible destination for CCM, we must recognize the increased complexity of the community pharmacy work system. Similar to the increase in pharmacy staff responsibility related to the COVID-19 pandemic response, adding more clinical services with the addition of reimbursement has potential implications for the quality of pharmacist education, business practices, and safe medication dispensing. Opening up avenues for reimbursement that are not product based allows stronger sustainability of expanded services and greater impact in their patient care practices, which can potentially fill a critical gap in Wisconsin, where two-thirds of its counties are medically underserved [12,13].

This opportunity to adopt new services and create coordinated care models can present a significant medication safety challenge. Community pharmacists’ heroic response to the COVID-19 pandemic demands created work systems that increased stress and negatively impacted their ability to ensure safe use of medications they dispense [18]. Pharmacist provider status can lead to sustainable and collaborative programs that holistically address chronic care conditions of patients with complex chronic health conditions. However, doing so without prospectively considering and testing unintended consequences may negatively transform the community pharmacy work system, threatening the very medication safety strategies on which pharmacists have come to rely. The consequence of this reality is synergistic; high workload demands contribute to medication errors and ADEs, leading to pharmacists experiencing “learned helplessness” and a lack of resiliency (or the ability to adapt to unpredictable work situations) in the face of these ADEs [19-22].

Many medication safety studies strive for “zero harm” [23-25] by focusing on “what went wrong” in the face of undesired outcomes, referred to as a “safety-I” approach [26]. The traditional harm-reduction approach has been to conduct root cause analyses of errors and understand the contributing factors that led to the error to reduce their incidence or mitigate their harm. A number of strategies have been encouraged based on this approach, including those developed and tested in our previous studies [27,28], but in the end, these frequently result in more constraints in a complex system that limit workers’ ability to adapt. Such strategies end up limiting the capacity to adapt to practice demands and make the system more brittle, which can unintentionally lead to other medication safety hazards. Furthermore, stacking isolated interventions does not lead to fundamental changes to the approach to medication safety. It is not surprising that little progress on substantive improvement has been made in medication safety in the outpatient community pharmacy setting [29].

Medication safety must be considered in a new way that encompasses safety-II, the “what went right approach.” Safety-II [30] is based on resilience engineering, which focuses on understanding how resilient performance is achieved, creating a work system that will address unexpected threats while also responding to opportunities [31]. Instead of framing safety as a linear, failure-based model, we need to broaden the scope of inquiry to recognize the complexity and inherent variability in modern systems, such as community pharmacies. Furthermore, we need to shift beyond an exclusive consideration of ADEs and failures to understand and strengthen a work system’s abilities to continuously create safety in everyday practice [32]. This goal is achieved by focusing on the abilities of a work system to absorb significant stress before a disruption impacts safety, return to normal operations as quickly as possible, and, importantly, adapt to undesirable situations. A system with adaptive capacity can anticipate disruptions and reorganize workflows using alternative paths to maintain successful work and minimize disruptions [33]. An example of safety-I and safety-II approaches can be found in Textbox 1.

Despite numerous calls, there has not been a systematic engineering approach toward outpatient medication safety within community pharmacies.

Previous patient safety learning laboratories (PSLLs) have evaluated the physical environment, sociotechnological factors, and clinical workflow within inpatient and clinical settings but not within the outpatient community pharmacy settings [34]. This project, informed by resilience engineering, will address the challenges common in community pharmacies to achieve safe medication use in community-dwelling patients with multiple complex chronic conditions. The goal is to evolve from the safety-I approach to a combined safety-I and safety-II approach. The resulting outcome, the Engineering Resilient Community Pharmacies (ENRICH) PSLL, is expected to gain knowledge of strategies for building resilience capacity in community pharmacy work systems in conducting CCM. PSLLs encompass a systematic engineering approach to allow cross-disciplinary professionals to evaluate clinical processes and approaches toward improvements in patient safety [34].

Our long-term goal is to position the ENRICH PSLL as the premier center for medication and patient safety and CCM in community pharmacies. Despite our previous work, a current gap exists in the systematic application and evaluation of human factors and health systems engineering approaches to improve medication safety and staff work life in community pharmacies. Our PSLL, which is led by experts in human factors and health systems engineering, represents a foundational step toward the creation of a center to promote and normalize a safety-I and safety-II approach in pharmacy systems research. Our PSLL will include a focus on the use of the principles of dissemination and implementation research to enhance the potential for sustainability of improvements resulting from patient safety innovations. In addition, this PSLL is designed to generate ideas for future research projects and examine the implications and outcomes related to pharmacists’ provider status, which can serve to expand CCM to support patients with complex chronic health conditions living in medically underserved areas. The PSLL resulting from this study represents the beginning of a new paradigm, unprecedented in the pharmacy setting, for improving medication safety for community-dwelling patients with complex chronic diseases.

The methods used in this project have demonstrated success with other health care practitioners and in other patient safety studies [27,28]. The concepts for applying resilience engineering (CARE) model guides our data collection, analysis, and interpretation (Figure 1). Resilience is the ability of the community pharmacy work system to adjust its functioning before, during, and following sentinel or unexpected events and thereby sustain operations under both expected and unexpected conditions [35]. It assumes that variability in the environment creates the need for adjustment. Work as imagined (WAI) is conceptualized as the intended or imagined alignment between demands of the system (prescription volume and patient acuity) and the capacity to meet those demands. Demand and capacity can never completely align because of the complex nature of the system; there will always be unforeseen demands that require workers to adjust in situ. In addition, workers do not simply comply with protocol but naturally adapt and innovate as part of taking control over their environment. In the CARE model, work as done (WAD) refers to the adjustments and natural variability in how tasks are conducted. Predicting acceptable (what goes right) and unacceptable (what goes wrong) outcomes depends on an understanding of WAD in different demand and capacity circumstances. In this project, we will be using the concepts of WAI and WAD to identify the gap in how pharmacy staff plan their approaches to patient care and how they are able to actually fulfill their responsibilities (Figure 1).

Because resilience also applies to the organizational level and adaptations in complex systems, it is essential to ensure that characteristics and adaptations of the entire work system are captured. To operationalize the discrete facets of the work system, we have used systems engineering initiative for patient safety (SEIPS) 2.0, a human-factors engineering model to improve patient outcomes (Figure 2 [36]). The SEIPS model has framed the design and analysis of many safety studies, including the research we conducted in community pharmacies [28,37-39]. The CARE and SEIPS models work well in tandem because both models contain feedback loops and account for the interconnectedness of work system components. In Figure 2, professional work references both pharmacists and technicians. Patient work includes the work of the patient and their caregiver, which is essential to CCM (Figure 2).

Ethics approval for human participant research will be obtained from the University of Wisconsin–Madison Institutional Review Board (S-2023-1100, S-2024-1747). Each aim of this study will be individually submitted to the institutional review board (IRB) for review and approval before initiating the research activities concerning each aim.

To ensure a complete understanding of the problems and implementation strategies of varied community pharmacy work systems, we will partner with 3 pharmacy organizations. First, Advocate Health is the 10th largest not-for-profit, integrated health system in the United States, with 70 community pharmacies that are geographically dispersed throughout urban and rural Wisconsin and Illinois. Second, UW Health is the integrated health system of the University of Wisconsin–Madison, with 12 outpatient pharmacies. Third, Boscobel Pharmacy and Center Pharmacy are located in rural southwest Wisconsin and are independently owned.

Within each of these organizations, 2 pharmacies will participate that serve ethnically diverse populations and people in medically underserved areas that have high area deprivation indices based on income, education, employment, and housing quality for 6 pharmacy sites. In addition, all pharmacies will have at least read-only access to the electronic health records of their patients, which may serve as a tool to facilitate CCM.

We will also partner with Fitchburg Family Pharmacy to conduct in situ simulations, in which we will use simulated scenarios of patients with complex chronic health conditions in a pharmacy itself rather than in training facilities for the design and development phases (aim 2) of the project. Fitchburg Family Pharmacy is a medium-sized urban independent pharmacy that provides CCM to a diverse patient population.

Table 1 describes our project structure, starting with problem analysis (aim 1) and continuing with design and development (aim 2), which will lead to implementation and evaluation (aim 3). An expert advisory board, comprising transdisciplinary stakeholders, will be formed to provide us with high-level consultation and content expertise for each of the 3 project aims. This board includes patients, caregivers, a pharmacy technician researcher, a pharmacy owner, primary care physicians, managers of independent, local, and chain pharmacies, and leaders of pharmacy and medical societies in Wisconsin.

We anticipate that MedSafeMap will support pharmacists’ and technicians’ ability to embed CCM and other clinical services into their workflow, which will improve the quality of patient care, ideally, without increasing workload. To assess perceived changes in service provision, pharmacists and technicians will be administered a validated subjective workload survey [61]. Moreover, the number and type of documented medication-related problems during CCM services [62] that are identified and resolved for 6 months before and 12 months following MedSafeMap implementation will be collected. Pre-post comparisons of services provided and medication-related problems that they averted will be conducted.

We also want to gain a more in-depth understanding of how MedSafeMap changed attitudes, behaviors, and performance. It is expected that pharmacists and technicians will feel more resilient after the implementation of MedSafeMap, that is, they will feel more “capable, facilitated, and supported by the organization to utilize resources to continually adapt and flourish at work, even if/when faced with challenging circumstances” [63]. This construct will be represented through the Employee Resilience Scale [63], a measure of behavioral elements, such as learning orientation, proactive posture, positive outlook, network leveraging, and adaptive capacity.

Pharmacists and technicians also are likely to eventually feel a greater sense of shared responsibility and teamwork, which would create an environment that enhances the medication safety of their patients. This construct will be represented through the National Aeronautics and Space Administration (NASA)–developed Cockpit Management Attitudes Questionnaire [64,65], comprising 3 scales, namely communication and coordination, command responsibility, and recognition of stressor effects, which have application for the pharmacy work system.

Because we are working with a small number of pharmacists and technicians and we want to conduct an in-depth exploration of pharmacy staff attitudes and behaviors, we will adapt the Employee Resilience and Cockpit Management Attitudes Questionnaire items into an interview guide that will include semistructured probes. In addition, 8 months following MedSafeMap’s implementation, interviews will be conducted using a retrospective pre- and posttest design approach [66,67] by asking, “Compared to before MedSafeMap was implemented...” This approach is appropriate because it is pragmatic and less time consuming, eliminates the impact of response-shift bias [66], and has been used successfully in pharmacy studies [68,69]. Questions will prompt insights into the impact of MedSafeMap on pharmacist and technician resilience, teamwork, and shared responsibility. Interview data will be subjected to the same rigorous qualitative data analysis techniques described in aim 1.

Study outcomes are targeted to help populations of medication safety researchers and organizational leaders responsible for implementing proven practices. A summary of the anticipated outcomes can be found in Textbox 4.

The anticipated duration of the project is from September 30, 2023, to August 31, 2027. Activities concerning aim 1 were anticipated to end by August 31, 2024, but data collection has extended beyond that date. Activities concerning aim 2 were planned to commence on September 1, 2024, but began in February 2025 and will conclude in December 2025. Activities concerning aim 3 will begin on January 1, 2026, and last till August 31, 2027. Participant recruitment is expected to be completed by the conclusion of aim 3, alongside data collection. Results from varying analyses within the project are anticipated to be disseminated during the project’s duration and following its completion. Aims 1 and 2 have received IRB approval, and aim 3 will be reviewed by the University of Wisconsin-Madison IRB before recruitment begins.

The prevailing safety-I approach for improving medication safety has emphasized retrospective incident analysis, reactive measures targeted at past problems, human error as an explanation, and control of work through procedural compliance and outcome monitoring [70]. This approach has proven to be insufficient and frustratingly slow at achieving zero harm in outpatient settings and specifically the community pharmacy [71]. Such a lack of success stems from investigating medication errors through root cause analysis, which assumes a shortsighted linear cause-and-effect model rather than a complex model [72]. Finally, importantly, these approaches create a negative psychological impact on staff by creating a culture of blame [31,73,74].

This study will be the first to operationalize resilience engineering to include a safety-II approach to medication safety in community pharmacies. Most of the safety studies involving community pharmacies assume a linear work process, which limits understanding of community pharmacies as complex work systems. Our research demonstrates that work is not conducted linearly but rather is composed of interdependent processes [75]. The use of the innovative FRAM model will provide a robust model to map multiple processes and their variability, which can inform co-design of potential solutions [36,76,77].

This project will prioritize and emphasize the role of pharmacy technicians as critical members of the community pharmacy work system. Technicians are increasingly being recognized for their willingness to assume new roles and adapt to changing environments [78] which was expedited during the COVID-19 pandemic. Technicians have proven themselves effective in collecting patient medication histories [79], performing administrative functions associated with vaccinations, and even providing immunizations to patients [80].

Pharmacist provider status, a new legal designation authorizing Medicaid reimbursement for pharmacists’ services, presents a timely opportunity to evaluate how increased or broadened responsibilities can be adopted while improving quality of care and medication safety. Legal endorsement to stretch professional boundaries and envision innovative designs [53] is the perfect circumstance to move the needle on outpatient medication safety through the design of the next generation of community pharmacies. Pharmacists and technicians, depleted by the unrelenting workload and additional responsibilities since the COVID-19 pandemic, find the safety-II approach to be attractive [71]. Safety-II also better represents and supports a culture of safety because it accurately portrays the constant variability of pharmacy work, the need for adjustment, and the importance of flexible adaptation in producing outcomes.

Introducing and using a safety-II approach will provide the test bed, tools, metrics, and frameworks to build the ENRICH PSLL. This new paradigm of approaching CCM with resilience engineering methodologies to improve quality in community pharmacies could then be disseminated to and adopted by medication safety researchers around the country.

Participant bias caused by sensitivity to the researcher’s presence is a recognized risk in qualitative observational studies, but it can be minimized by ensuring that observers have frequent presence in the research setting, which can lead to habituation to their presence and improvement in the researcher’s sensitivity to and respect for pharmacy staff’s concerns, and their ability to build relationships and trust. The risk of measurement bias will be reduced by having 2 researchers collect data only after achieving a satisfactory interrater reliability rate, ensuring that differences in interpretation can be identified, discussed, and resolved before full data collection is accomplished.

We will use 1 simulation site, despite being aware that community pharmacies have very different work systems. We also know that using multiple simulation sites would increase the generalizability of findings and enable comparison between sites. However, using simulations to evaluate prototypes that focus on workflow changes related to CCM is unprecedented in community pharmacies, so we want to begin with a single setting to ensure a robust infrastructure to evaluate such simulations. To expand our understanding beyond the single work system exemplified by the simulation site, we will seek input from advisory board members who will provide feedback on the feasibility of implementing MedSafeMap in their diverse community pharmacy settings.

Community pharmacies have experienced a great deal of change in the last decade alone. With an increase in responsibilities due to the COVID-19 pandemic as well as changes to the health care structure that increase their workload, pharmacy staff are becoming increasingly burnt out. Coupled with high turnover rates and understaffing concerns, there is an unprecedented risk of safety errors and resulting patient harm. To allow the pharmacy staff to take on these responsibilities as CCM health care providers, we must find a way to manage the workload and optimize resources. We are in a unique position to provide support directly to the pharmacies and give them a voice to influence change in the pharmacy work system. Through this PSLL, we can rethink the current safety approaches and develop an improved work system for medication safety, resulting in improved work conditions for pharmacy staff and increased patient care.