Access to treatment for opioid use disorder (OUD) remains a challenge in rural settings and communities of color (Steihaug et al., 2016; Substance Abuse and Mental Health Services Administration [SAMHSA], 2023; Wyse et al., 2022). One contributing factor is the limited availability of healthcare providers equipped and willing to provide medications for opioid use disorder (MOUD) in those regions (Joudrey et al., 2022). Recent discussion has explored the role of pharmacies in enhancing access to MOUD within underserved areas as a result of broader pharmacy availability compared with other healthcare entities (Bach & Hartung, 2019; Kosobuski et al., 2022). Although three MOUDs are approved by the U.S. Food and Drug Administration (FDA; methadone, buprenorphine, and long-acting injectable naltrexone), methadone, which is dispensed in pharmacies for chronic pain, cannot be dispensed by pharmacies for OUD, and availability of buprenorphine and naltrexone in pharmacies may be limited (Hill et al., 2022; Kazerouni et al., 2021; Skelton et al., 2017). Nevertheless, research suggests that adequately prepared pharmacies could take on a larger role in supplying all FDA-approved MOUD and other resources to those with OUD (Wu et al., 2021, 2022, 2023). A key question, however, is the practicality of this proposition. Pharmacies face multiple obstacles, including legal actions stemming from national chains' involvement in the opioid crisis, along with resource constraints, labor shortages, service reimbursement limitations, and training demands related to expanded responsibilities in dispensing MOUD, especially in rural and other communities.
Method
To address this issue, the National Drug Abuse Treatment Clinical Trials Network (CTN) funded a study (CTN-0124) (Gustafson et al., 2023) to examine the practicality of expanding pharmacy roles in treating OUD in underserved communities. This was not a research study to test a hypothesis but a 9-month engineering systems analysis, a problem solving discipline that breaks an existing system into its component pieces, analyzes how well those parts interact to accomplish their purpose, and creates an aspirational design for the future. Systems analysis differs from qualitative research in that qualitative research is typically conducted to understand a phenomenon, whereas systems analysis is intended to improve a system or process. As an engineering approach, systems analysis has a natural bias toward using data and technology to solve problems. These differences lead to differences in the types of questions asked and even the focus of analyses conducted.
The study team's local human subjects review board determined this to be a quality improvement project exempt from review. Our approach addressed nine key issues: (1) clarifying our goal (to efficiently provide MOUD to those in need through pharmacies); (2) understanding pharmacist needs; (3) defining structural, process, and outcome indicators for tracking progress; (4) documenting workflows involved in achieving the goal; (5) identifying external factors affecting the system's success; (6) determining necessary staffing for system goals; (7) outlining data and information requirements; (8) specifying equipment and physical resources for efficient operation; and (9) documenting ongoing processes for system improvement.
To do this, we, a group of five systems analysts (three from the healthcare field and two from the industrial risk management and compliance field) as well as experts in pharmacy systems and law:
collaborated with a regional chain of more than 70 independent pharmacies serving rural and underserved communities in Wisconsin and Michigan (national chains were invited but elected not to participate);
involved subject matter experts (SMEs) representing addiction treatment, tertiary prevention, and policy fields;
assessed MOUD distribution processes, regulation, staffing, data systems, training, and reimbursement; and
identified opportunities for process improvement and potential elements for a next-phase project with resource analysis, process flows, technology development, testing, and refinement.
Our systems analysts interviewed 43 experts (Guest et al., 2006): 15 community pharmacists, primarily in Wisconsin; 13 staff from pharmacy associations; and 15 addiction experts (SMEs) nationwide. We used semi-structured interviews (typically taking approximately 1 hour to complete) with pharmacists and small groups from pharmacy associations. We conducted one-on-one interviews with SMEs and held these discussions using an audiovisual digital communication platform. We did not interview patients or families. The interviews were typically conducted by a group of three to five analysts. The interviews were not recorded or coded in the traditional qualitative research sense. Rather, the interviewers met after each interview to discuss what was learned and identify the key points and implications (Gustafson et al., 2011). A number of follow-up interviews were conducted.
Results
When our project began, we believed that pharmacy roles related to MOUD distribution could significantly expand (Steihaug et al., 2016). We have concluded that although there are possibilities in large population centers, dramatic expansion seems impractical in rural and underserved areas without significant systemic change. Pharmacy profit margins are thin, and staff are stressed and feel unprepared to address mental health issues that are central to OUDs. We now conclude that pharmacies can take on a much greater role in providing MOUD access, but only if they take advantage of technological innovations. Our specific recommendations are based on the following nine themes that arose in the analysis: (1) mindset and stigma, (2) simplified and powerful prescription drug monitoring programs (PDMPs), (3) innovations in technology, (4) work simplification, (5) family education and support, (6) integration with other health providers, (7) regulatory reform, (8) reimbursement, and (9) integrated demonstration.
Mindset and stigma
Some pharmacists (and the public more generally) believe that addiction is a curable, self-inflicted condition. Addiction treatment leaders stressed the need to shift mindsets about patients with OUD to recognize addiction as a chronic and treatable disease like diabetes, with almost inevitable relapses. We manage, rather than cure, these conditions. Addressing this mindset requires short-term systemic and long-term educational solutions. We believe that catalyst films (short-form online videos) about people with OUD should be developed to shift mindsets and build empathy (Caplan et al., 2014). Furthermore, OUD patients and their families can face stigma when interacting in public with pharmacists and other healthcare providers. The impact of stigma can and should be reduced by delivering MOUD in nonstigmatizing locations (such as churches or the home) monitored from a distance.
Simplified and powerful PDMPs
We must develop and test fast, simple, easy-to-use PDMPs. PDMPs can prevent misuse by making it difficult to obtain narcotics from multiple providers in a short time (Rhodes et al., 2019). However, prescribers and pharmacists often find that existing PDMPs (1) have incomplete coverage (one of the key MOUDs, methadone, is not in the PDMP system); (2) are infrequently used by emergency departments and other providers; (3) have cumbersome and time-consuming designs that limit their potential by not taking full advantage of the information contained therein (for instance, predictive analytics—addressed in the following theme—could more accurately identify high-risk patients); and (4) have multiple rules and interfaces, despite control by one dominant vendor. Having multiple PDMPs can be catastrophic when the systems are not integrated. Recent legislation (42 U.S. Code 1396-w3a; SAMHSA, 2020) mandated PDMPs for Medicaid populations but not for others. A userfriendly, simple but technologically sophisticated, nationally adopted PDMP model should be created and tested.
Technologies to reduce workloads
Community pharmacists and association representatives wanted easy ways to obtain MOUD knowledge, e.g., about dosing and injecting MOUD and detecting and countering side effects. They felt that with effective PDMPs and other technological supports, they could flag prescriptions associated with opioid misuse, educate consumers on the dangers and signs of opioid use or misuse, offer pain management alternatives, and distribute naloxone. However, without technological support, pharmacists in underserved areas will not have the time or the resources to provide meaningful support. The technologies (available onsite or at home) could include virtual reality programs, predictive analytics (decision analysis and artificial intelligence models created to forecast high-risk events such as relapse; Chih et al., 2014), serious games, chatbots and checklists, reminders, recommender systems, coach marks, training management systems, and virtual support groups that deliver personalized guidance and mutual support (Thaler & Sunstein, 2021). COVID-19 taught us that we can speed the implementation of innovations with the creative use of technology. As technologies become more powerful and simple, their adoption becomes easier. Our project developed a model assessment tool (see the online-only supplemental material) to assess a pharmacy's capability and maturity to provide evidence-based, promising practices related to OUD, assisting those with pain management issues and OUD, and using quality improvement practices to reduce the impact of the opioid epidemic through pharmacy-based medication dispensing functions. These tools can assess gaps in the use of promising practices, set improvement benchmarks, and guide progress for those advancing their services in the opioid crisis.
Workflow simplification
Many opportunities exist for pharmacies to be more responsive to the opioid epidemic. However, the intense pressures faced by retail pharmacists—including long hours, understaffing, and a heavy workload—are concerns that permeated our discussions. It was clear that pharmacists cannot add work without taking something off the table.
Pharmacy innovations must reduce workloads, inefficiencies, paperwork, rework, and waste and require very little training. Systems analysis tools are designed to simplify inefficient processes and could be applied to distributing and being reimbursed for medication and other pharmacy roles. The lessons learned from these analyses would be relevant to all pharmacies, not just those in rural and underserved areas.
Pharmacy support for families
Families (including close friends and peer support specialists) have the potential to help address addiction. Families can help compensate for staff shortages while helping themselves. For MOUDs, family members can assist with navigating health insurance, acquiring medications, providing emotional support, and promoting medication adherence. At the same time, families suffer enormously from their loved ones' addiction. Families need to understand what it is like to have a substance use disorder (the benefits and costs). They need to know how to have constructive conversations with their loved ones to help them deal with cravings and triggers and understand potential medication risks and strategies for self-care as caregivers. They don't know where to go for help. For many, the only place they can go may be a pharmacy. Questions about medication and side effects can lead to further questions about OUD as families search for answers. Pharmacy staff may lack the credentials required to address these issues. These consultations (which can be replaced by a QR code on the receipt for the medication) take pharmacist time. Families can use the code to connect to technological platforms that provide high-quality education and support without burdening pharmacy personnel with questions that take them beyond their skill set.
Integration with other health providers
Pharmacists often pointed out that if they were more integrated with the healthcare team, they could improve patient safety and enhance the effectiveness of the addiction treatment processes. Collaborative practice agreements offer a mechanism for collecting, storing, and working with data stored in electronic health records and other information systems that can improve working relationships between physicians, pharmacists, PDMPs, and opioid treatment programs (OTPs). These agreements will also provide ways to collaboratively manage patients to avoid harmful medication interactions, provide reports on medication adherence, and assist with patient clinical management, making pharmacists a more integral part of the healthcare team. Computer-based inter-professional training can enhance collaboration among pharmacists, families, physicians, and others.
Information and communication technology (e.g., artificial intelligence systems, augmented reality, digital therapeutics, computer-based communication systems) could greatly enhance a pharmacy's ability to be a key player in an integrated system of care for hard-to-reach rural and urban populations. If regulatory approval is achieved, technology can, for instance, facilitate methadone stabilization and delivery by local pharmacies under collaborative practice agreements with OTP providers.
Regulatory reform
Regulations are vital for safe, effective treatment but can hinder access and innovation. First, pharmacies should be classified as OTPs or be given another appropriate designation so they can distribute methadone for OUD. Fortunately, other changes are under way. Naloxone is now available over the counter. Congress recently reduced constraints on who can prescribe buprenorphine. More changes need to occur, such as the recently relaxed requirements on take-home methadone and reducing the frequency of required appearances after individuals are stabilized. Hopefully, telehealth waivers established during COVID-19 will continue for OUD (and substance use disorders more generally). The COVID-19 pandemic also saw waivers allowing pharmacists to be more engaged in direct testing and vaccination. Expanding and harmonizing across states' pharmacist scope of practice to allow more direct care for those with OUD and the administration of MOUD (including methadone and long-acting injectable MOUD) would further improve access to care. An additional area of potential improvement is adaptive regulation. Currently, most regulations are one size fits all. With predictive analytics and other artificial intelligence tools, it may be possible to know when relapses are likely and be more selective in when and how regulations are applied. For instance, the scope of practice regulations in some states interferes with a pharmacist's ability to do what they are trained to do. Training management systems could be developed to monitor and flag potential problem areas to reduce fears of inadequate preparation leading to questionable restrictions.
Reimbursement
Reimbursement arose as a barrier because of inadequate compensation that hinders pharmacy willingness to take on expanded roles, such as naloxone distribution, MOUD deliverance, and adherence support. There are no billing codes or other reimbursement mechanisms that can allow pharmacies to build and sustain interventions for OUD. System engineers should conduct time studies that examine pharmacy reimbursement systems to determine appropriate reimbursement levels. Adequate reimbursement is not just about the amount but also the delivery method. For example, contingency management (Petry, 2010) can be used to incentivize pharmacists by paying them to complete and maintain training (mentioned above) that would expand their capacity and ability to adopt innovative practices.
Integrated demonstration
The above recommendations should be combined into a single system because the whole can be greater than the sum of its parts. This will require regulatory waivers. Technology would be developed. Pharmacies would acquire, fill, and deliver all MOUD in stigma-free ways. After induction, MOUD (monitored through video conferencing) could be dispensed at home. Families and other loved ones would become partners in getting their loved ones into treatment and ongoing management. The demonstration would, for instance, need to (a) enable audits of MOUD taken by the patient to facilitate medication adherence; (b) recognize pharmacies as OTP-monitored dosing locations; (c) allow pharmacists to give MOUD injections, (d) create an easy-to-use cross-state PDMP covering all MOUD (e.g., methadone and even naltrexone), (e) automate PDMP analytics for rapid detection of suspicious prescriptions, and (f) monitor system performance.
Summary of where to use technologies to expand pharmacy roles in supporting addiction treatment and relapse prevention
Address negative mindsets pharmacy personnel have toward those with OUDs.
Provide pharmacy personnel with up-to-date information, training, and support systems for evidence-based addiction treatment and relapse prevention through methods that accommodate their work routine.
Have OUD relapse prevention resources that do not require lengthy education by pharmacy staff be easily available to patients and families.
Have a tool to assess model evidence-based and promising pharmacy-based OUD prevention and MOUD practices and to guide best practice adoption and implementation.
Conduct workflow design activities that can simplify, streamline, and re-engineer how prescriptions are filled, administered (as appropriate), and documented.
Offer technological resources that can improve a family's understanding of what it is like to be addicted and that enhance their ability to get loved ones into and remain in treatment, acquire medications, and promote medication adherence and OUD relapse prevention.
Enhance pharmacy integration with other health systems.
Promote access to MOUD for those living in rural areas.
Improve regulations that prevent pharmacies from providing MOUD and complicate pharmacy work routines.
Create a simple, nationwide PDMP.
Conduct a workflow cost analysis to ensure that pharmacies are adequately reimbursed, including any new services required to support MOUD delivery.
Conduct a national demonstration project to test these changes to pharmaceutical practice.
Discussion
The findings of this systems analysis shed light on the potential for pharmacies to play a significant role in improving access to resources for addiction treatment and relapse prevention, such as MOUD in underserved regions. Initially, there was optimism regarding the expansion of pharmacy roles in distributing MOUD, especially in rural areas. However, it became apparent that significant systemic changes are necessary to make this and other expansions practical. Challenges such as thin profit margins, staff shortages and burnout, and the stigma surrounding addiction present substantial barriers to the widespread adoption of expanded pharmacy services related to MOUD distribution. In light of these findings, the discussion has shifted toward the crucial role of regulatory, reimbursement, workflow, and technological innovations in overcoming these challenges. Recommendations include leveraging technology to address mindset and stigma issues, simplifying PDMPs, supporting families, reducing the workload for pharmacists, and enhancing pharmacy integration with other healthcare providers.
Moving forward, a balanced approach that integrates technological innovations with regulatory reforms and workforce development initiatives will be crucial in realizing the full potential of pharmacies in addressing the opioid crisis and improving access to MOUD in underserved areas.
Conclusion
This systems analysis involved community pharmacists, pharmacy associations, and addiction treatment experts to investigate pharmacy roles in enhancing MOUD access in underserved regions. We assessed the existing system, envisioned an ideal future state, identified gaps, and highlighted improvement opportunities. The outcomes offer actionable strategies and research and development to expand MOUD availability, potentially warranting additional process improvement and systems change.
Acknowledgments
The authors acknowledge the contributions made by the people we interviewed in this study, including community pharmacists, pharmacy association staff, and SMEs who participated in our expert meetings. They provided important insights without which we never would have been able to carry out this study. We also wish to acknowledge the valuable contributions of Maureen Fitzgerald and Stacey Pisani (editors).
This research is supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UG1DA040316. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr. Ghitza was involved in UG1DA040316, consistent with his role as Scientific Officer on a cooperative agreement.
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