Patient Stability for Methadone in Opioid Treatment Programs during a Global Pandemic: Provider Perspectives

COVID-19 has revealed weaknesses in the gold standard for opioid use disorder (OUD) treatment. The methadone dispensing arm of opioid treatment programs (OTPs) delivers life-saving treatment to large volumes of people with OUD, but the COVID era quickly revealed dispensing protocols to be out of date, inefficient, and hazardous for virus transmission risk. The pandemic incited rapid changes in standard, OTP, methadone take-home privileges in order to continue providing life-saving medication while observing physical distancing directives (Peavy et al., 2020). These exceptions to established practices, while COVID specific, dismantle decades of rules for take-home medications set forth through the Code of Federal Regulations (CFR; National Archives and Records Administration, 2022).

Unlike other areas of medicine, OTP services are codified by the CFR, which also establishes standardized decision making. For example, decisions regarding eligibility for take-home privileges have depended in part on patient “stability,” defined as abstinence from drugs including alcohol. In the COVID era, OTP providers must now reconsider how stability is defined and weigh that against the risk of COVID-19 infection and spread. Treatment decisions can now be more individualized, but they are also inevitably more complicated. Researchers and treatment providers are appropriately starting to explore the impact of these changes on treatment operations (Joseph, Torres-Lockhart, Stein, Mund, & Nahvi, 2020; Peavy et al., 2020), but provider perspectives have received less attention. We comment on the immediate effects of these changes on OTP counselors, providers, and patients, anticipating that what we are learning now has implications for redefining patient stability, permanently shaping policies, and rethinking the way OTP services are delivered.

Redefining patient stability in an OTP setting is momentous and has far-reaching implications for providers across multiple domains. Counselor, medical provider, and clinical leadership perspectives were collected at one OTP—Evergreen Treatment Services (ETS), a methadone maintenance program in the Pacific Northwest region of the United States—and are described here in an effort to recognize the scope and multidimensionality of the pandemic-induced overhaul of OTP services that occurred so rapidly and unexpectedly.

COVID-19 Impact on Counseling Practices

Due to COVID-19 and physical distancing precautions, patients now come to the OTP to dose less often. Interestingly, instead of this resulting in greater patient engagement when given the opportunity to come in less frequently, staff have observed the opposite: some patients come to the OTP even less, often resulting in missed doses, and overall engagement appears tenuous. Most concerning is the increased rate of treatment dropout. In other words, making treatment more convenient for patients has not improved retention. Counselors and patients alike have reportedly voiced their dissatisfaction over fewer contact hours with patients and group treatment that has been canceled due to pandemic concerns. As such, counselors indicate feeling disconnected from their work, their patients, and their colleagues.

As with other areas of behavioral health, OTP counselors attempted to quickly convert their services to a telehealth platform. While telemedicine has been shown to have quick uptake among buprenorphine prescribers providing medication treatment (Uscher-Pines et al., 2020), counselors at ETS report that telehealth counseling has been less uniformly successful—counselors describe it as “hit and miss.” One reality in this OTP is that although telehealth via video platform is available, the most reliable medium for reaching patients has been by telephone. Some clear advantages to telehealth availability, via phone or video, are that patients with health issues, parenting responsibilities, and other barriers to in-person contact have benefitted from remote access to counseling. Counselors note that, for a subset of patients, regular telephone contact has resulted in more self-disclosure than occurred during face-to-face encounters, suggesting that the telephone may facilitate more meaningful clinical interactions.

These anecdotal reports are consistent with literature suggesting no differences between telephone and in-person clinical encounters in terms of alliance, disclosure, empathy, attentiveness, or participation (Irvine et al., 2020). In fact, experiments indicate that voice-only communication actually enhances empathic accuracy, the ability to judge others’ thoughts and feelings (Kraus, 2017). These empirical results give credence to counselors’ observations that some of their patients are opening up more via telephone than they were in-person pre-COVID. Whether this has to do with the mode of communication or other factors (e.g., patients feeling more socially isolated and vulnerable because of the pandemic and thus more willing to connect with counselors) is unclear.

Counselors note that telephone contact encourages openness and disclosure only among a select group of patients. Other patients have much reduced or even an absence of counseling encounters due to barriers inherent with this mode of counseling. Specifically, lack of working technology, no access to a private space, new patients who may not know or trust their counselors, and psychiatric symptoms such as anxiety and paranoia have been cited as reasons that patients may not engage in telephone counseling.

Despite the challenges COVID has introduced to the counseling staff and their patients, clinical leadership views the pandemic as an opportunity to examine counseling practices with an eye towards improvement as well as have meaningful conversations about how counselors view treatment “success” in the absence of regular drug testing. The pandemic context highlights diversity in patients’ counseling needs that historically have been met with a “one size fits all” counseling model. Local counseling protocols, state administrative codes, and federal mandates outline the frequency, and to some degree the content, of counseling. In contrast, the pandemic has further reinforced ETS’s commitment to a differentiated and patient-centered approach to counseling.

Diversity in counseling needs is now clearly evident in that some people appear to benefit from regular contact, their tether to the OTP more important now than ever. Such patients appear to thrive within a supportive counseling relationship, while others may need more transactional services (e.g., routing to primary care, housing case management). Finally, some patients may need something else en vtirely. Because counselors are limited in their patient interactions, they now accommodate patient needs wherever possible to maximize engagement. This boots-on-the-ground practical approach also has scientific merit. When tested empirically, patient-centered methadone data indicate patients will voluntarily attend counseling about as often as those for whom counseling is required (Schwartz et al., 2017), demonstrating that patients value counseling perhaps especially when empowered to choose it themselves. COVID emphasized the pitfalls in overstandardizing counseling across the patient population. Future counseling policies at ETS and other similar organizations may reflect the need to be flexible, individualized, and even more patient centered.

Another area of OTP clinical operations that was disrupted by the pandemic was urine and oral swab drug screening, hereafter referred to simply as drug screening. Routine drug screening at ETS was stopped at the outset of the pandemic, and some question its relevance as a mainstay in opioid treatment postpandemic (Pytell & Rastegar, 2021). Historically, OTP clinical staff came to depend on drug screening results for assessing how their patients are doing, targeting interventions, and weighing clinical decisions that may have health and safety implications.

Counselors are among the clinical staff who regularly checked drug screening results and used such results as a platform for counseling discussions. Without these data and accompanying policies and procedures, counseling staff have had to examine other measures of success. For those counselors who relied heavily on the structure provided by drug screens, their absence has been disorienting. However, this sudden and unforeseen treatment modification has brought the opportunity for conversations about the definition of “treatment success” in the OTP environment. Counselors have been forced to examine alternative measures of success that do not include drug screens, allowing them to think more broadly about treatment progress and to work creatively with the individuals in front of them. This coincides with parallel conversations underway throughout the research community and federal agencies such as the National Institute on Drug Abuse (NIDA) and the Federal Drug Administration (FDA) regarding the use of abstinence, confirmed via drug screen, as the only standard definition of “treatment success” for alcohol and other drug use disorders (Volkow, 2020). As Dr. Volkow, NIDA director, writes, other medications such as antidepressants and analgesics have long been approved by the FDA based on symptom reduction, rather than symptom remission (2020). Similarly, COVID-19 has forced OTP treatment staff to consider patient stability and success through other means besides drug screen evidence of abstinence.

COVID-19 Impact on Dosing and Medical Practices

Whereas counselors have had less contact with patients and therefore less involvement in enforcing treatment policies and procedures, burdens on medical providers have increased as they bear the brunt of decision making around medication dosing and take-home privileges in the new COVID-19 climate. Pre-COVID-19 rules were clear cut, enabling consistency and predictability in take-home medication decisions. Information that fed into decision making (e.g., length of time in treatment, attendance, drug testing) was largely counselor driven and obtained via frequent counseling visits. During the pandemic, patient stability is now more independently determined by medical providers, relying more on patient presentation and history without the benefit of routine drug screening, which was suspended with the exception of “for cause” testing (e.g., impairment or questions about prescribed medication use) to increase physical distancing. Consequently, current OTP care is more like general medical care: more patient driven, but also marked by greater uncertainty and more individual judgment calls. As such, it may move closer to models of care utilized in other countries like Canada (Priest et al., 2019).

Equity in patient care may not be assured in the same way as pre-COVID-19 because there is greater latitude for provider-patient determination of stability. Providers may have implicit biases and previous experiences with patients (e.g., patient drug poisonings; deaths) that influence decisions around take-home medication. Patient comorbidities—for example, co-occurring benzodiazepine use or opioids for chronic pain)—may also confer unique risk profiles. Some general guidelines were created early in the pandemic to adapt OTP practices to COVID-19 safety needs such as three-times weekly observed dosing for patients with no take-homes prior to the pandemic, once-weekly observed dosing for those with some take-homes, and twice-monthly observed dosing for those coming in once weekly. Notably, even with certain codified guidelines, medical providers are now spending significantly more time making decisions and in interdisciplinary consultation around responses to patient behaviors like missed doses or coming to clinic on the wrong day. In a busy clinic, such conversations are both an unexpected boon to teamwork and a significant draw on precious time.

Medical providers are experiencing greater anxiety over decision making and its effect on patients. One example is that although ETS has developed its own internal guidance, a key unknown is the point in treatment at which changing from daily to less-frequent dosing supports adherence and retention, versus increases the risk of treatment disengagement or methadone poisoning and diversion into the community. In addition, COVID-19 brought about school closures and stay-home orders, meaning children are at home for more hours of the day, with possible access to methadone in the home. The implications and extent of this increased drug-poisoning risk are yet unknown.

Several other changes in practice have been implemented to further reduce the risk of COVID-19 transmission at the clinic. All patients are queried at the door for symptoms and recent exposure, and if either are present patients are diverted for assessment outside the clinic. The mobile dosing unit was repurposed for nursing assessment and equipped with telehealth capability to allow assessment by medical providers. If appropriate, patients are given take-homes for one to two weeks; patients too unstable for this much medication continue to receive their via the mobile unit outside the clinic. Currently, naloxone distribution has not been increased. Nursing staff deliver methadone for patients in isolation and quarantine facilities. High-risk patients have been provided with curbside dose administration, and dose pick-up by a trusted third party has been allowed for patients quarantining at home. The clinic also piloted the use of a mobile application that allowed remote observation of dose ingestion. Random monthly drug screening was suspended and limited to “for cause.” Random monthly screening was reinstituted approximately five months into the pandemic at the clinic located in the county with a lower incidence of COVID-19.

COVID-19 and Medical Ethics

The exceptions to decades-old rules regarding methadone take-home medication have placed a greater emphasis on medical ethical principles (Gillon, 1994) in treatment decision-making. Pre-COVID, OTP rules placed some emphasis on nonmalfeasance toward patients in limiting the number of doses patients had available to take at one time. However, the application of the take-home limitations appeared primarily driven by the desire to keep methadone out of the community. Patient autonomy was thus deemphasized. Medical providers had limited discretion to determine whether patients’ level of stability would allow safe management of more take-home medication, decreasing the constraints placed on patients by daily attendance. Rather, patients could only slowly progress take-home privileges under rules requiring a full nine months in treatment before being permitted to attend the clinic once weekly.

Under the exceptions granted in response to the COVID-19 pandemic, patient autonomy now has greater weight. In addition, the application of nonmalfeasance has become more complicated in that the potential harm to patients from having too many take-home doses must be balanced against the harm of exposure to viral contagion in a crowded clinic setting. The complication is expanded further in that the potential harm to the community of increased take-home medication must be balanced by the harm of spreading contagion within the clinic and hence increasing the risk of viral spread to the community at large.

Unlike in most areas of medicine where practice evolves faster, OTP take-home standards set in 1971 to address concerns of methadone poisoning and drug diversion have remained largely untouched until 2020. Until that time, this has meant little room for providers to tailor treatment. COVID-19 has disrupted these standard practices immediately and perceptibly. We will be measuring the pandemic’s effect on OTP patients and treatment for years to come, examining variables such as patient mortality, methadone-implicated drug poisonings among patients and in their communities, treatment retention, patient satisfaction with treatment, and relationship of physical distancing policies on substance use. However, these analyses will be complicated due to many confounding factors and no fair comparison groups for analyses.

Before we fully understand these effects empirically, a decision will need to be made whether to reverse the changes set into motion. This process will also benefit from inquiry among patients and staff: What is the potential benefit of entrusting patients with take-home medication? What is the patient experience if the privilege is revoked? What does it mean to be “stable” enough to “earn” the privilege of take-home medication? Whereas abstinence has been a standard criterion for take-home medication eligibility, the field may benefit from a broader view or “a dimensional, personalized, and dynamic approach to treating substance use disorders” (Volkow, 2020).

Increasingly, addiction research and treatment communities—as well as governing bodies such as the Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA), and National Institute on Alcohol Abuse and Alcoholism (NIAAA)—are recognizing the limitations and inherent biases in using abstinence as the sole standard of treatment success (Volkow, 2020). The current, unexpected opportunity afforded by COVID-19 to examine other endpoints for treatment success besides abstinence (e.g., quality of life, management of methadone batch doses, and treatment retention) provides an opportunity to question not only certain OTP standards, but also how tightly we cling to all-or-nothing definitions of patient outcomes and stability. A period of several years to sustain and evaluate these policy changes seems warranted to fully evaluate potential benefits and harms.

Conclusion

OTP idiosyncrasies have been examined in the past, such as daily dosing at a fixed site, mandatory counseling (Schwartz et al., 2017), and methadone maintenance in primary care settings (Fiellin et al., 2001; Merrill et al., 2005). Despite these efforts, OTP rules and regulations have remained largely unchanged until the current pandemic. As of this article’s writing, whether SAMHSA will adopt current policy reversals postpandemic remains unknown. At the end of the COVID-19 natural experiment, we may finally be able and willing to revise long-standing regulations to support what is truly important for OTPs: keeping people retained in treatment (Fugelstad, Stenbacka, Leifman, Nylander, & Thibin, 2007; Pierce et al., 2016; Sordo et al., 2017).

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Editor’s Note: This article was adapted from an article by the same authors previously published in the Journal of Substance Abuse Treatment (JSAT). This article has been adapted as part of Counselor’s memorandum of agreement with JSAT. The following citation provides the original source of the article:

Hatch-Maillette, M. A., Peavy, K. M., Tsui, J. I., Banta-Green, C. J., Woolworth, S., & Grekin, P. (2021). Rethinking patient stability for methadone in opioid treatment programs during a global pandemic: Provider perspectives. Journal of Substance Abuse Treatment, 124, 108223.

Mary A. Hatch-Maillette, PhD

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Mary A. Hatch-Maillette, PhD, is a licensed clinical psychologist, senior research scientist at the University of Washington (UW) Addictions, Drug, and Alcohol Institute (ADAI), and clinical instructor in the UW Department of Psychiatry and Behavioral Sciences. Her NIDA-funded research focuses on improving SUD treatment, access, and engagement; reducing sexual- and drug-related risks for HIV; and understanding provider perspectives in treatment organizations. Dr. Hatch-Maillette also maintains a general private practice in the community specializing in SUDs.

K. Michelle Peavy, PhD

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K. Michelle Peavy, PhD, is a licensed clinical psychologist with clinical and research expertise in SUD treatment. She currently serves as a research scientist at UW’s ADAI and as a consultant at Evergreen Treatment Services, an opioid treatment program in Seattle, Washington. In addition to this work, Dr. Peavy works in the community as a private practitioner, trainer, and consultant focusing on opioid use disorders.

Judith Tsui

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Judith I. Tsui, MD, is an associate professor of medicine at UW, based at Harborview Medical Center and Evergreen Treatment Services. Her NIH-funded research is focused on improving care delivery and health outcomes for persons with SUDs.

Caleb J. Banta-Green, PhD, MPH, MSW

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Caleb J. Banta-Green, PhD, MPH, MSW, is a principal research scientist at the UW’s ADAI and an affiliate associate professor at the UW School of Public Health. His main area of research is SUDs involving illicit drugs and interventions to support recovery and reduce substance-related harms.

Stephen Woolworth, PhD

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Stephen Woolworth, PhD, is the chief executive officer of Evergreen Treatment Services, a forty-eight-year, nonprofit, behavioral health and social service organization based in Western Washington. He has published on topics ranging from community health and safety to education and homelessness.

Sean Soth, BA, SUDP

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Sean Soth, BA, SUDP, is director of clinical services at Evergreen Treatment Services. He has been instrumental in the development of ETS’ transition to integrated care, the development of case management services, and enhancing data driven care. Soth recently coauthored a COVID-related paper titled “Rapid Implementation of Service Delivery Changes to Mitigate COVID-19 and Maintain Access to Methadone Among Persons with and at High-Risk for HIV in an Opioid Treatment Program,” published in the April 2020 issue of AIDS and Behavior.

Carol Davidson, MSW, SUDP

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Carol Davidson, MSW, SUDP, is a clinical supervisor at Evergreen Treatment Services. She has been a treatment provider and clinical supervisor at opioid substance use disorder treatment programs in the Seattle, Washington area since 1980. Davidson has also served as the counseling staff supervisor for several past NIDA- and CSAT-funded chemical dependency and behavioral research studies conducted at ETS that included a focus upon utilizing motivational interviewing and cognitive behavioral clinical skills.

Paul Grekin, MD

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Paul Grekin, MD, is the medical director of Evergreen Treatment Services, a large, nonprofit opioid treatment program with clinics in three Puget-Sound-area cities. He is also a clinical professor in the Department of Psychiatry and Behavioral Medicine at the UW School of Medicine. Dr. Grekin has participated as a study physician on several NIDA Clinical Trials Network protocols.