Overcoming barriers to traditional care delivery and pharmacy challenges: a qualitative study of buprenorphine, telehealth, and a digital therapeutic for opioid use disorder

Abstract

Background

The opioid epidemic contributes to increasing morbidity and mortality due to drug overdoses in the US, but barriers to traditional opioid use disorder (OUD) treatment prevent a vast majority of patients from accessing quality care and medications for opioid use disorder (MOUDs). Public Health Emergency (PHE) provisions during the COVID-19 pandemic relaxed in-person evaluation requirements for buprenorphine inductions, allowing for the expansion of telehealth care to OUD populations. This qualitative study explores patients’ experiences with a novel digital therapeutic telehealth program with buprenorphine for OUD.

Method

Semi-structured qualitative interviews were conducted with a sub-sample (n = 15) of participants from a larger feasibility and acceptability pilot. Interviews explored participants’ opioid use, OUD treatment history, previous MOUD experience, barriers to previous treatment attempts, medication adherence, counseling experience, treatment satisfaction, and comparisons between current and previous treatments.

Results

Barriers to care in previous OUD treatment episodes included logistical and program related inconveniences (program attendance requirements, commute distances, transportation, appointment wait times, and clinic patient volumes), financial strain, unreliable access to prescribers, residential program experiences, and the availability of detox-only based treatments. Participants with previous treatment experiences contrasted these barriers with the virtual delivery study setting and reported that the characteristics of telehealth OUD care facilitated improved engagement and retention by overcoming many of these barriers through: no transportation requirements, open and flexible appointment scheduling, appointment times confined to care team meetings only, absence of provider availability concerns, and the ability to receive buprenorphine maintenance care from home. The primary barrier noted for virtual care delivery was the fulfillment of buprenorphine prescriptions from local pharmacies.

Conclusion

A novel digital therapeutic telehealth program was reported to overcome almost all of the barriers encountered by participants during previous traditional OUD treatment episodes, contributing to a growing body of evidence supporting the permanency of current PHE expansions for OUD telehealth care. Findings also emphasize the importance of coming to workable policy solutions for buprenorphine supply threshold constraints on local pharmacies that unintentionally constrict access for telehealth and other OUD patients.

Background

For the last three decades, the United States has struggled to address its opioid epidemic. Three waves of overdose deaths since the 1990’s have accentuated population adaptations from prescription opioids, to heroin, to fentanyl, and have ultimately contributed to a national decline in life expectancy at birth [1]. Across 2020 and 2021, more than nine million people reported misusing opioids as the opioid epidemic coincided with the onset of the COVID-19 pandemic, with nearly 2.7 million becoming diagnosed with an opioid use disorder (OUD) [2]. In 2020, of the nearly 91,800 recorded overdose deaths, 75% involved some type of opioid [3].

These conditions intensify the need for access to sufficient, evidence-based treatment for OUD. The current standard of care for supporting those with OUDs is a tailored combination of psychotherapy and pharmacotherapy, alongside appropriate referrals to address all biopsychosocial needs [4]. The three Food and Drug Administration (FDA)-approved medications for addressing opioid use disorder (MOUD) - buprenorphine, methadone, and extended-release naltrexone - have all demonstrated effectiveness in reducing incidence of overdose and death as well as improving health outcomes [5]. Buprenorphine in particular has been found to reduce overdose and mortality rates (both in relation to opioid and all-cause), lessen the transmission of infectious diseases, and generally ease other health and social problems [6, 7].

Engaging patients with OUD in this care is critical and lifesaving, but despite efforts to implement these evidence-based approaches many individuals struggle to access medication and necessary treatment services. In 2021, just a third of adults with past-year OUD received any substance use treatment, and only about one in five (22%) received any MOUD [8]. In-person OUD treatment, the traditional care model, offers one avenue for implementing psychotherapy and pharmacotherapy but its static methodology may interfere with a truly person-centered approach and restrict the ability for many to be engaged and retained in care.

One possible solution to expanding access to MOUDs has been telehealth prescribing, but the 2008 Ryan Haight Online Pharmacy Consumer Protection Act has been a primary barrier to these innovations. Initially intended to restrict online pharmacies from supplying controlled substances to patients without a medical evaluation, the Act required providers to meet with a patient in person before issuing MOUD prescriptions. Unintentionally, this requirement created significant barriers to patients obtaining medication for managing their OUD, specifically rural patients with limited access to in-person services [9,10,11,12], people with inadequate transportation or childcare support, and those with confidentiality concerns [13].

In response to the in-person care limitations related to COVID-19 pandemic restrictions, regulations softened and medical providers turned to innovation and technology to reach their patients [14]. During the declared public health emergency (PHE), policymakers waived in-person requirements in March 2020 to address clinician concerns about providing care in person and minimize disruptions to treatment [13]. In addition, covered telehealth services were expanded by various insurance companies, including the Centers for Medicare and Medicaid Services, and the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug Enforcement Administration (DEA) established guidelines for providers to prescribe buprenorphine via non-video modes such as telephone [15]. Through these policy changes, providers could prescribe buprenorphine via video and audio calls without an initial in-person visit, setting up a unique opportunity to study the impact of a complete telehealth experience for treating OUD. The abrupt integration of telehealth in SUD treatment has promoted the importance of understanding its role in supporting those with OUDs, as studies of post-COVID policies are demonstrating comparable or improved OUD patient clinical outcomes via telehealth compared to in-person care, including increased completed MOUD visits and provider availability [16,17,18,19,20].

This qualitative study sought to explore patients’ experiences engaging in a novel digital therapeutic telehealth program with buprenorphine for OUD to understand how this treatment episode compared with previous OUD treatment attempts, barriers participants encountered with traditional OUD modalities, and new challenges encountered with virtual OUD care delivery. Semi-structured qualitative interviews were completed with a sub-sample of participants from a larger feasibility and acceptability pilot study to understand the dynamic context of accessing OUD treatment in the post-COVID era [21].

Methods

The current study reports results from the qualitative component of a feasibility and acceptability study that recruited individuals with OUD to participate in a 12-week intervention combining buprenorphine with psychosocial treatment and a digital therapeutic mobile app experience [21]. Participants in the primary study (n = 27) completed monthly quantitative survey measures targeting continued opioid use, buprenorphine adherence, treatment engagement and retention, treatment satisfaction, healthcare outcomes, and psychological outcomes [21]. Results of the primary study were used to evaluate the feasibility and acceptability of the intervention and supported the preparation of a larger randomized trial. These results, as well as greater detail surrounding the treatment intervention for the primary study, can be reviewed in Monico et al. [21].

Participants

The qualitative component of the study included semi-structured qualitative interviews with a sub-sample of participants (n = 15) from the primary study. Inclusion criteria for participation in the primary study included: (1) ≥ 18 years of age; (2) reside in the United States (US); (3) own a smartphone with video call functionality to utilize the study mobile application; (4) have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of moderate to severe OUD; (5) be able and willing to participate in study procedures, including taking study medication (buprenorphine/naloxone); (6) be in good general health; and (7) have Medicaid, Medicare, or commercial insurance. Exclusion criteria included: (1) had a known sensitivity to buprenorphine/naloxone formulation; (2) received a medication for opioid use disorder (MOUD) including naltrexone, methadone, or buprenorphine for OUD within the past 30 days; (3) had a serious medical condition that would make participation hazardous; (4) required medical detoxification from any substances; (5) lacked English proficiency; or (6) had clinically significant psychiatric symptoms that would make study participation difficult.

Participants were purposively sampled to maximize the diversity of experience represented in qualitative narratives. These considerations included opioid treatment history, previous medication for opioid use disorder (MOUD) experience, age, gender, and primary opioid of choice. Opioid treatment history and previous MOUD experience were considered primarily in the purposive sampling strategy given the focus of the qualitative interviews on participants’ experience in the current episode of care and comparisons to previous treatment episodes. Age, gender, and opioid of choice were considered secondarily in the purposive sampling strategy to ensure representation from the primary study (see Table 1), with additional consideration for the way that these characteristics may impact barriers and challenges to traditional treatment modalities. Opioid of choice was specifically included given the salience of opioid use type and barriers to buprenorphine induction and subsequent engagement. Patients who use fentanyl (knowingly or unknowingly) tend to encounter greater challenges inducting onto buprenorphine and therefore may encounter related difficulties with early engagement in a telehealth program.

Table 1 Participant characteristic comparison of the primary feasibility study sample and qualitative subsample

All participants who were invited to participate in qualitative interviews accepted, and all had completed informed consent as part of participation in the primary study. Oversight for this study was provided by the Ethical and Independent Review Services’ Institutional Review Board (IRB).

Data collection

The purpose of these interviews was to explore participants’ experience receiving buprenorphine and cognitive behavioral therapy in a remote care delivery setting, and contextualize the quantitative findings from the primary study by allowing for expanded, open-ended responses. These responses allow study participants to offer unstructured narratives that provide an inductive understanding of OUD patients’ experiences that is not constrained by predetermined, quantitative response categories. Qualitative interviews targeted participants’: background, opioid use prior to entering treatment, OUD treatment history, previous MOUD experience, barriers to previous treatments, medication adherence, counseling experience, treatment satisfaction, and comparisons between current and previous treatments.

Interviews were conducted by the lead author, an experienced qualitative researcher. Interviews lasted approximately 45–60 min, and participants were compensated with a $50 gift card.

Data analysis

Qualitative interview data were analyzed using an iterative content analysis approach [22]. Three investigators (LM, DM, PP) systematically reviewed and discussed interview transcripts for key concepts highlighted to generate a primary coding scheme. Transcripts were loaded into Atlas.ti software and the primary coding scheme was applied [23]. Subsequent discussions between these investigators revealed additional emergent concepts to generate a secondary coding scheme that was also applied to the transcripts. Thematic summaries across all transcripts were developed to highlight three primary content areas that informed study findings. Participant background descriptions and previous experiences were triangulated with primary study survey data collection to support methodological rigor [24].

Results

Participant characteristics

Of the qualitative participants, 5 identified as female and the average age was approximately 37 years (see Table 1). Six participants had a primary opioid of choice of fentanyl, 5 prescription opioids, 2 heroin and fentanyl, 1 prescription opioids and fentanyl, and 1 heroin only. Six participants were treatment naive at the time of study entry, 4 had previously received buprenorphine treatment, 4 had previously received buprenorphine and methadone treatment, and 1 reported only having received non-medication based treatment prior to the study-based telehealth treatment episode.

Findings

Previous treatment barriers: methadone

Participants who had been previously enrolled in a local methadone program for OUD treatment highlighted well-documented methadone program restrictions as significant inconveniences that made treatment engagement and retention difficult [25,26,27]. As this participant notes, requirements to receive methadone doses daily and in person, and attend regular counseling sessions were burdensome. To qualify for take-home doses that would have eased these logistical burdens this participant was required to submit urine drug screens that were negative for all substances, including cannabis. Taken together, these policies translated to a restrictive patient experience that prevented her from going on vacation or doing “anything.”

First of all, I had to go every day. Second of all, you have to see your counselor once a week for an hour. It’s so much. It takes up so much of your time, you have to plan everything around it… I literally couldn’t go on vacation because I smoked marijuana. So I couldn’t get any take home or anything like that. I couldn’t do anything. (Female, 48)

Rural participants faced additional challenges given the large geographical catchment areas of rural methadone clinics. These participants were forced to drive significant distances at very early hours of the day to receive their methadone doses. Although participants expressed their willingness to overcome these barriers in the short term, maintaining this large commitment over time was often insurmountable and largely resulted in subsequent relapse as in the case of the following participant.

I went to the methadone clinic about probably about eight years ago. And, you know, it kind of works. But the way that they make you do it, you know, you have to drive 60 miles there every day and pick it up at 6:00 in the morning and then drive 60 miles back. It just made it too hard. (Male, 32)

Other participants noted the volume of patients enrolled in local methadone clinics to far exceed the resources available, including the number of providers onsite and the time they had available to spend with patients. When this ratio became disproportionate, it often resulted in significant waiting periods for a medical evaluation and reduced quality of care.

And you spend a lot of time there physically and you don’t get very good treatment because the number of patients to doctors, the ratio of patients to doctors isn’t very good. So you’re not really getting very much personalized health care. So that’s a problem. That, and like spending 3 to 6 h in the waiting room, that’s not exactly pleasant. (Male, 29)

Previous treatment barriers: buprenorphine

Participants reporting previous treatment experience receiving buprenorphine for OUD also noted significant transportation barriers to treatment engagement and retention. Since buprenorphine can be prescribed in an office-based setting (as opposed to methadone dosing in specialty clinics) providers can independently decide whether their practice will accept certain insurance carriers. Many rural buprenorphine providers are often selective about accepting insurance, especially Medicaid, and require patients to otherwise pay out-of-pocket for care visits [28, 29]. For some patients, this coupled with the cost of prescriptions makes regular access to buprenorphine significantly more difficult.

What happened was I ran out of money, you know, and it’s hard to pay for the doctor when you’re broke. I ran out of a ride, and having to drive 200 miles a day. I was having to pay, I think it was $175 every two weeks. And that’s still quite a bit of money, that’s just paying the doctor, not the script. So, about $300 every two weeks. It adds up. (Female, 44)

Participants also mentioned that local buprenorphine providers offered unreliable access to ongoing buprenorphine prescriptions, sometimes ceasing to prescribe to patients “out of the blue.” This was especially salient for participants living in rural areas where there are fewer independent providers willing to prescribe buprenorphine relative to urban and suburban locations. When these participants needed to find an alternative provider, they struggled.

I have done the [buprenorphine] treatment two other times. The reason that they weren’t successful is because the first doctor, he ended up not practicing anymore, like out of the blue. So then trying to find another doctor to prescribe it around here was just not easy. [Buprenorphine] was very scarce. There was only like maybe two or three doctors in the area and he was like the last one that would prescribe it. I don’t know if they don’t believe in it or they don’t have, you know, the proper knowledge or whatever that they need to in order to prescribe it. But it was really serious around here and doctors weren’t prescribing it at all. (Female, 36)

Previous treatment barriers: non-MOUD treatment

One participant reflected on his previous residential treatment experience that included a brief detoxification using buprenorphine without ongoing maintenance. While he found the detox component helpful in managing significant withdrawal symptoms, he found being in residential care confining and “like a jail.” While he successfully completed detox and over 80 days in care, he left against medical advice and subsequently relapsed.

They give you just a taper, a detox period when you’re in there. So some people could be up in the detox section for almost a month. They put you on a taper from the day that you come in, every few days reducing the milligrams and the doses that you’re taking. And a lot of it was the lockdown part, just being inside of a building. I stayed like 80 something days. Like towards the end, they just got to a point where they weren’t giving me a day to leave when I should have been getting a day to leave. And I was like, ‘Yeah, I’m not doing all this anymore.’ You can’t force me to stay here. I’m not extra locked in here like a jail. I don’t think this extra five, six, seven, eight days, whatever it was, is going to actually make or break me on the knowledge that I learned. And like I said, I ended up relapsing or whatever. (Male, 35)

Comparison to virtual care: overcoming traditional modality barriers

One of the primary benefits that participants mentioned to receiving virtual OUD care is the ability to meet with providers and other clinicians for appointments from their home - overcoming logistical, geographical, and transportation barriers to traditional OUD care. Participants also noted that this flexibility reduced the burden of scheduling around work and family obligations.

Well, the huge thing that I like the most is being remote and not having to leave my house to go to so many appointments during the week because that’s a pain. A lot of times, when you have to go see the doctor, and then you have to go to a counseling appointment, and then you have to go here, and go there, and go get your prescription. It’s just a lot of running around. So being at home and being able to do it all remotely is one of the huge things that I really like. (Female, 36)

Rural study participants echoed these sentiments, but also added the unique convenience of virtual care delivery given the relatively few buprenorphine providers available, farther geographical distances between their homes and provider/treatment offices, and the reliance on private automobile transportation in rural and remote areas.

I guess the biggest part of it is you don’t have to leave your house. I mean, you can do it from the comfort of your home. And that’s a huge deal, especially in this area. There’s a lot of people that don’t even have vehicles or whatnot. And so that’s an issue, you know, getting back and forth to the doctor. You can do this from the comfort of your home, on your time, versus going to other programs where they’re like, here’s your appointment this week to see me, here’s your counseling appointment this week, here’s this and that. And then you got to find a way to make all that work around your life or you’re not going to get treatment. I don’t have to do that with you guys. I don’t have to have a car ride everywhere. I don’t have a car. So convenience factor right there. Just being able to do this from home and still being able to go to work and see my kids and get on with my regular day to day life. (Female, 42)

Adding on to the convenience benefits of virtual care, this participant notes that transportation barriers had historically resulted in impacts to their treatment continuity given the stringent policies applied to patients at traditional in-person environments. When transportation barriers resulted in missed appointments or unfulfilled program obligations, patients’ care could be reset to a new patient status.

And plus, a lot of treatments, you miss one time, and that’s it. You know, you have to start completely over. We had to miss one time because our car was messed up in the snow and they still made us start it completely over because we missed the appointment. And so we had to do the intake process, everything completely all over again. And it’s like, well, that’s kind of that’s not right. That’s, you know, punishing you for something you have no control over. (Female, 42)

Other participants reported that coming out of active addiction to opioids was complicated, and involved addressing and rebuilding numerous areas of their lives simultaneously to be consistent with their recovery path. The convenience of virtual care delivery allowed them to devote attention to all of these areas, such as finding a job and meeting criminal justice obligations, while still engaging in OUD treatment. In practical terms, virtual care appointments were isolated to only the blocks of time in a participant’s day that were explicitly devoted to the time with their care team, either a counselor or medical provider. Traditional treatment program appointments were bookended with travel time to and from the office or clinic, as well as waiting room time if the program was running behind schedule.

So going to your traditional doctor’s office is a huge pain, it’s inconvenient, especially trying to get your life together. Most people who are on opioids they’ve hit some kind of a rock bottom and they need all the time that they have to go to work, apply for jobs, do whatever it is they have to do, or go to court, see a parole agent, whatever they’ve got going on and handle it. Handling it with telehealth, it afforded me the opportunity that, instead of me cutting like a 4 h slice out of my day because I have to drive somewhere, I have to go to the waiting room for paperwork, sit there and wait 2–3 h for a doctor, and then meet with the doctor for like 20 min or less. Instead of doing that, it was just like a 30 min quick talk to the doctor, or whatever dealing with your therapist. You know, only the literal amount of time that the appointment takes. Whereas the majority of the time that you spend in treatment in general is actually just waiting for them to become available to you. So telehealth was really good because it took a lot of that out of it, because a lot of people don’t have the time to go and sit in a doctor’s office for 4 h, especially when they’re trying to get their lives together. (Male, 29)

The following participant echoes this perspective, and adds that their previous intensive outpatient setting provided through their local county only offered treatment programming during large blocks of time that overlapped with working hours.

Yeah, I guess just the ease of use and ability to schedule it on your own time like that was the problem a lot of people had in the county program is like they wanted you to be in group like I think it was Monday through Thursday, 8am to 11am every day. And some people were like, “Well, what if I want to get a job?” They’re like, “Well, you should get a night job then, because you have to be here.” And treatment’s your main commitment and your number one thing, which that’s not a bad thing. But most of us have to work and we’re not in control of the hours we get. So if we have to work, if the only job we can get is from 8am to 4pm every day, but County is saying, “No, you can’t do that. You have to be at our programming.” So being able to see the flexibility that the scheduling has with telehealth, that was very helpful. (Male, 41)

Participants also noted that virtual care delivery allowed them a mechanism to stay in consistent contact with their care team through digital communication and messaging. Not only was this tied to treatment convenience, but also an approach that made participants feel supported when they needed it most.

What really got me was having a therapist and a doctor any time that I needed it. Like it could be a Saturday and I could be having the worst time. And all I had to do was text, that helped out a lot. Just knowing that if my boyfriend wasn’t there for me, then I had somebody to lean on or to talk to about it. But, yeah, I think it was just them being there for me. (Female, 45)

Combining virtual care delivery with a digital therapeutic mobile phone application added to the convenience of patients communicating directly with the program and members of their care team. Participants were able to message their care team directly through the application, which was especially helpful if they needed any logistical support with their care, like rescheduling appointments, or if they encountered any issues. This direct messaging also allowed for streamlined coordination between counselors and providers, which facilitated the experience of patient-centered care.

Any time I needed to talk to anybody about anything, I could just message. And that was addressed promptly and made me feel very well taken care of. But I would message any time there was an issue or something. We typically handled it through the app that way. I believe [medical provider] and [counselor] could both see the messages, so they were able to coordinate together. There was multiple times where they had to talk together and [counselor] would schedule me if I had missed the appointment or something. And she was always on top of it, making sure I was taken care of. (Male, 31)

Participants noted that in traditional OUD care modalities their communications with counselors or providers were filtered through program administrative staff, where their options were generally limited to scheduling an additional appointment to speak to their care team about any emergent issues they encountered. The following participant also mentioned that messaging their care team between established appointments allowed them to keep their care team updated about their progress throughout their treatment, rather than waiting for scheduled appointment times because so many events can happen rapidly during periods of early OUD recovery.

Another thing that’s really good is that there’s like a lot more accessibility because generally, you know, if you call a doctor’s office, you’re going to get a secretary. And the secretary might be like, okay, well, I can set you an appointment. Usually they’re not going to let you talk to anybody in your treatment team or whatever unless you have an appointment. And I think it works, a lot of stuff happens in a month, especially if you’re in recovery. You know, you might not necessarily remember something that you wanted to talk to your doctor or therapist about in a month, because 26 things have happened. So, it’s better, like if you’re able to kind of feed in information as it comes, as things happen to you. (Male, 29)

Barrier: pharmacy issues

While participants in this study noted that virtual care delivery for OUD was significantly more convenient than traditional modalities, one area that created problems for participants was filling prescriptions for buprenorphine at their local pharmacies. While the virtual care program utilized a by-mail pharmacy for ongoing prescriptions, initial prescriptions were sent to local pharmacies to allow participants to begin inducting on to the medication as soon as they were deemed eligible for study participation and evaluated by a medical provider on the care team. Follow up prescriptions would then be sent directly to the participants’ homes. However, due to pervasive confusion around prescribing controlled substances under the PHE and allowances granted by these exceptional policies, many major pharmacy chains refused to fill buprenorphine prescriptions from telehealth providers. This was especially problematic for the study participants living in rural communities with few brick-and-mortar pharmacy options around their area.

The first problem that we had was like when I first started, she had to send a prescription into a drugstore close to me here because I guess how you send the medicine or whatever it took a few days to get to me. And we had problems here that the pharmacy, they wouldn’t take it because the doctor was from a different area outside of here. So my first couple of days, I think maybe three days, I didn’t have any medication. She tried every way to get me the [buprenorphine] and stuff, we had several pharmacies all around me and nobody would take it. We finally talked to somebody, and it was just a couple days worth, and I think that’s what made them give it to us. It was a rough ride there for a minute because I got turned away each time. (Female, 44)

In the case of this and other participants, providers often had to leverage 3-day emergency bridge prescriptions to begin patient inductions as soon as possible rather than wait for the buprenorphine to arrive by mail.

So the only thing is, and it’s not the doctor’s fault or the team’s fault, but the medication - no pharmacy around here will fill any telehealth prescriptions. So that was a big thing in the beginning. We went to every pharmacy in town and they just won’t do it. So we had to have them mailed. (Female, 36)

While providers were often able to find a local pharmacy to fill telehealth buprenorphine prescriptions, there were a few instances where patients lived in such remote areas that they were unable to find a willing pharmacy within a geographical radius accessible to the patient. While study participants understood these limitations, such restrictions placed patients at possible risk of harm and overdose due to delays.

Yeah, well, we had some issues with no pharmacies being able to do the telehealth around here, so I had to wait and get a prescription through the mail. That was a little bit difficult, but we managed to work through it. I just had to wait a little bit longer. They tried to call around to all the pharmacies around here, and I did what I could and tried to see. And none of them would do it. (Male, 31)

While participants expressed frustration in waiting for these issues to be resolved, they also recognized that there had been equivalent frustration with in-person care, specifically surrounding wait times and delays. As the following participant notes, although they had to spend some hours navigating these regulatory challenges in their local pharmacy, the time did not compare to the number of hours they had collectively spent in previous treatment episodes waiting to complete care and provider appointments.

There was a time where there was some kind of issue with my prescription. I was a little annoyed about it, but again, you know, it was worth it and it’s less time than I would have spent waiting around at most treatment doctor’s offices. So all in all, I would have spent, you know, like 30 h in doctor’s offices and instead I spent like 6 h at a pharmacy. So it works out to being much better anyways. (Male, 29)

Discussion

This qualitative study leveraged semi-structured interviews to explore participants’ experiences in a novel digital therapeutic telehealth program with buprenorphine for OUD. Many participants in this study had previous treatment experiences with traditional OUD modalities that provide methadone and buprenorphine, and were able to compare and contrast these experiences with receiving buprenorphine in a virtual environment. Barriers to care in previous OUD treatment episodes echoed those in existing literature, including: logistical and program related inconveniences (rigid program attendance requirements, long commute distances, reliance on private vehicle transportation, extended appointment wait times, and high patient volumes), financial strain, unreliable access to prescribing providers, confining residential experiences, and the availability of detox-only based treatments. Participants contrasted these experiences with the virtual delivery study setting and acknowledged that the characteristics of telehealth OUD care facilitated improved engagement and retention by overcoming many of these barriers through: no transportation required for appointments, open and flexible appointment scheduling, appointment times confined to care team meetings only, absence of provider availability concerns, and the ability to receive buprenorphine maintenance care from home. Additionally, participants also emphasized the saliency of direct communication with care team members through the digital therapeutic as facilitating personalized and patient-centered support during the course of their treatment, including allowing for easy appointment rescheduling, bringing issues or concerns to the attention of their care team, or simply feeling supported in a time of need.

Previous studies have established similar findings related to logistical difficulties with engaging in traditional, in-person care - for example, significant travel to limited treatment sites extending both time and financial resources especially when there are co-occurring needs to find child care and adhere to a work schedule [30, 31]. Obstacles such as limited transportation and the need to prioritize treatment among other well-being concerns (including insufficient housing, job insecurity, and food scarcity) have expanded the discrepancies in access to care across various demographic groups [32], especially among socioeconomically disadvantaged populations [33].

Perhaps some of the most notable in-person OUD treatment barriers have been documented in rural settings, due to a reduced number of MOUD providers and OUD treatment options [9, 10, 12, 34]. The number of available providers delivering MOUD care has been found to be limited by institutional and regulatory barriers (regulations attached to buprenorphine prescribing, Drug Enforcement Agency scrutiny and audits, etc.), insufficient training and support (lack of specialized addiction knowledge or background, reduced patient access to counseling and other support services, etc.), and an unwillingness to prescribe MOUD as a result of negative attitudes and stigma toward patients with OUD and MOUD itself [7, 35,36,37].

Participant narratives from this study demonstrate that telehealth treatment for OUD embraces a patient-centered model of care that allows treatment services and life-saving MOUD to be brought to the patient - quite literally meeting the patient where they are. Because virtual delivery of treatment services provides various conveniences compared to traditional in-person care, common barriers to engagement and retention (rigid attendance policies, transportation, wait times, provider availability, patient volumes, etc.) were legitimized and addressed as a foundation of the modality. Ultimately these factors work together to combat the often punitive nature of treatment policies in traditional MOUD environments [27], and instead promote a more empowering experience for the patient. As Schwartz et al. [27]. note, clinical staff in traditional MOUD environments often serve as program disciplinarians, in direct contrast with building, promoting, and maintaining a beneficial therapeutic alliance. By allowing for a more empowering patient-centered experience that is responsive and respectful of individual needs, preferences, and values, virtual MOUD care delivery has demonstrated an early indication of reducing premature treatment discontinuation.

In the current study, participants noted that increased frequency and ease of communication with their care team helped promote satisfaction with care, a factor that was enhanced through messaging capabilities of the digital therapeutic. However, clinicians have reportedly been hesitant to implement telehealth services citing the risk of interrupting rapport building efforts and therapeutic alliance with patients [38]. Previous studies suggest that individuals with OUD enrolled in telehealth programs have expressed appreciation for increased access to their counselor through telehealth services because counselors are often able to meet more frequently or with less notice [39]. Not only have patients acknowledged the convenience of virtual appointments, but they have also benefited from technology-enabled services’ ability to send messages and reminders, increasing their communication potential with their care team and creating more touch points to improve retention [40].

Similarly, patient satisfaction has a significant impact on SUD treatment results: higher levels of satisfaction have been found to correlate with reduced substance use, as well as improved treatment retention, engagement, and compliance [31]. A growing body of literature is pointing to comparable patient satisfaction with telehealth to in-person care [16], as various studies observe significant non-clinical outcomes of providing telehealth treatment, such as the increased ability for patients to attend appointments with reduced wait times and improved outreach [30]. Similar patient narratives also report that telehealth sessions are easier to fit into their schedule, require less time away from work, and reduce the need for childcare and physical transportation [41], all resulting in higher rates of satisfaction given reduced financial burdens (fewer travel obligations, child care needs, time taken off work, etc.), a greater sense of accountability to their recovery plan, and more flexibility in treatment [16].

While all of these conveniences have improved the overall patient experience of OUD treatment through telehealth, the current state of ambiguous PHE policies and the prescribing climate following Multidistrict Litigation (MDL) settlements with opioid manufacturers and distributors have created a disruptive patient experience in accessing buprenorphine [42]. Participants in the current study were able to access ongoing buprenorphine prescriptions through a by-mail pharmacy, but initial prescriptions sent to local brick-and-mortar pharmacies presented numerous fulfillment challenges.

Following MDL settlements, manufacturers and distributors established controlled substance supply thresholds as part of an anti-diversion effort, which include buprenorphine. Pharmacies that exceed these thresholds risk losing access to buprenorphine supply without warning, but pharmacists find it difficult to follow these guidelines due to being unaware of the exact parameters of the thresholds and different threshold levels set by various manufacturers, and when thresholds are exceeded, an expensive and disruptive audit is triggered that can extend for months. Because exceeding a manufacturer threshold can threaten a pharmacy’s ability to fill prescriptions for all controlled substance medications for all patients, pharmacies have become hesitant to accept any new buprenorphine prescriptions, but especially those that may contain ‘red flags’ or trigger alerts that put pharmacists’ licenses at risk for revocation - including those issued from non-local addresses, such as through telehealth.

These red flags and trigger alerts, however, often require context and nuance not accounted for in stringent and predetermined supply thresholds. For example, buprenorphine mono- and combination- products are ordered under the same drug code which artificially inflates supply request amounts. Similarly, macro-dosing induction protocols that are becoming increasingly common in the age of fentanyl, may be determined clinically appropriate by a provider but contain the milligram equivalent of 4–5 average patients, thus also artificially inflating supply request levels. Although supply limit thresholds emerged out of concern for exacerbating the opioid epidemic through diversion of more opioid-based controlled substances, many unanticipated consequences have resulted and patients’ ability to access potentially life-saving medications to treat OUD have been constricted at the top of the funnel. While SAMHSA is currently facilitating consensus-building conversations between pharmacies and manufacturers to relax these policies, patients continue to bear the weight of the consequences.

Limitations

This study recruited a subsample of participants to interview from a small feasibility and acceptability pilot. Although every attempt was made to diversify participants’ age, gender, primary opioid of choice, opioid treatment history, and previous MOUD experience, the larger study also contained a small sample from which the qualitative component could enroll. Also, as a qualitative study, the findings from this analysis are used to generate conceptual conclusions and are not generalizable to the participant experience of all individuals who complete telehealth treatment for OUD with buprenorphine. Along similar lines, the participants in the feasibility and acceptability pilot also had access to a mobile app-based digital therapeutic that provided the messaging component to facilitate communication between patients and their care team. Although this appeared to be a highly utilized component of the main study intervention, not all patients who participate in telehealth treatment for OUD with buprenorphine have access to such technology. Finally, the inclusion and exclusion criteria for the main study limited the overall study sample to include those who had access to a smartphone and some form of state, federal, or commercial insurance coverage, which may exclude those who occupy very low socioeconomic statuses.

Conclusion

Patients with OUD report encountering significant barriers to traditional in-person care with methadone, buprenorphine, and non-MOUD treatment modalities, including logistical and program related inconveniences, financial strain, unreliable access to prescribing providers, confining residential experiences, and the availability of detox-only based treatments. Compared to these experiences, a novel digital therapeutic telehealth program with buprenorphine overcame nearly all of these challenges by providing convenient, patient-centered access to quality, evidence-based treatment. This was especially salient for participants residing in rural communities where these barriers were exacerbated by large geographical areas and reduced access to resources and care. While the expanded guidelines for providing buprenorphine treatment through telehealth has been extended until the DEA revises existing regulations, this study contributes to the growing body of evidence that supports the permanency of the PHE expansions. Moving forward, these findings also suggest that federal regulatory agencies work with pharmaceutical manufacturers and pharmacies to create workable solutions to supply threshold challenges that create unnecessary restrictions on access to buprenorphine for telehealth patients while the US continues to try and scale meaningful solutions to the opioid epidemic.