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Re-thinking patient stability for methadone in opioid treatment programs during a global pandemic: Provider perspectives

  • Mary A. Hatch-Maillette
    Correspondence
    Corresponding author at: Alcohol & Drug Abuse Institute, 1107 NE 45th Street, Suite 120, Seattle, WA 98105, United States of America.
    Affiliations
    Alcohol and Drug Abuse Institute, University of Washington, Seattle, WA 98105, United States of America

    Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine, Seattle, WA 98195, United States of America
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  • K. Michelle Peavy
    Affiliations
    Evergreen Treatment Services, 1700 Airport Way S., Seattle, WA 98134, United States of America
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  • Judith I. Tsui
    Affiliations
    Evergreen Treatment Services, 1700 Airport Way S., Seattle, WA 98134, United States of America

    Division of Internal Medicine, University of Washington School of Medicine, Seattle, WA 98195, United States of America
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  • Caleb J. Banta-Green
    Affiliations
    Alcohol and Drug Abuse Institute, University of Washington, Seattle, WA 98105, United States of America

    Department of Health Services, University of Washington School of Public Health, Seattle, WA 98195, United States of America
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  • Stephen Woolworth
    Affiliations
    Evergreen Treatment Services, 1700 Airport Way S., Seattle, WA 98134, United States of America
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  • Paul Grekin
    Affiliations
    Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine, Seattle, WA 98195, United States of America

    Evergreen Treatment Services, 1700 Airport Way S., Seattle, WA 98134, United States of America
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Published:December 04, 2020DOI:https://doi.org/10.1016/j.jsat.2020.108223

      Highlights

      • COVID-19 has changed methadone provider medication decision-making.
      • Clinical decisions regarding take-home doses are less clear and potentially more prone to bias.
      • Complications necessitate more provider time and may challenge provider confidence.
      • Some patients have more autonomy but the benefit and harms are as-yet unclear.

      Abstract

      COVID-19 necessitated rapid changes in methadone take-home policies in opioid treatment programs (OTPs); these changes markedly contrast with existing, long-standing federal mandates on OTP rules about take-home methadone. OTP providers describe how these changes have affected clinical decision-making, equity in patient care, and workflow. We also discuss implications for medical ethics and patient autonomy. We provide suggestions for future research that will examine the impact of COVID-19 on OTP treatment and its patients, as well as the effect of making methadone take-home polices patient centered, all of which may foreshadow larger changes in the ways OTPs deliver their services.

      Keywords

      COVID-19 has revealed weaknesses in the gold standard for opioid use disorder treatment. The methadone dispensing arm of opioid treatment programs (OTPs) delivers life-saving treatment to a large number 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 so practitioners could continue providing life-saving medication while observing physical distancing directives (
      • Peavy K.M.
      • Darnton J.
      • Grekin P.
      • Russo M.
      • Green C.J.B.
      • Merrill J.O.
      • Tsui J.I.
      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.
      ). 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;

      Office of the Federal Register and the Government Publishing Office. (2020, April 8). Electronic code of federal regulations. Retrieved from https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=3&SID=7282616ac574225f795d5849935efc45&ty=HTML&h=L&n=pt42.1.8&r=PART.

      ).
      Unlike other areas of medicine, the CFR codifies OTP services and 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, practitioners can now make treatment decisions that are more individualized, but inevitably are more complicated. OTP providers must now reconsider notions of stability and weigh them against the risk of COVID-19 infection and spread. We comment on the immediate impact of these changes on OTP 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 has far-reaching implications for providers across multiple domains. We collected medical providers' perspectives between March and May 2020 at one OTP, Evergreen Treatment Services (ETS), in the Pacific Northwest region of the United States. Because our discussion centers on methadone dosing issues, we focus on medical providers' perspectives, without voices from counseling or other nonmedical staff. While future inquiries should examine the impact of the pandemic on psychosocial services in OTP treatment, medical providers reveal several illuminating points about how they are reconsidering OTP patient stability. First, medical providers' decision-making has changed. Pre-COVID-19, rules were clear-cut, enabling consistency and predictability in take-home medication decisions. Information that fed into decision making, such as patients' length of time in treatment, attendance, and drug testing, was largely counselor-driven and they obtained this information via frequent counseling visits with patients. During the pandemic, medical providers now more independently determine patient stability, relying more on patient presentation and history without the benefit of routine drug testing, which was suspended with the exception of “for cause” testing (e.g., impairment; questions about prescribed medication use) to increase physical distancing. We resumed drug testing organization-wide on October 1, 2020. 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 used in other countries such as Canada (
      • Priest K.
      • Gorfinkel L.
      • Klimas J.
      • Jones A.A.
      • Fairbairn N.
      • McCarty D.
      Comparing Canadian and United States opioid agonist therapy policies.
      ). Second, equity in patient care may not be assured in the same way as it was pre-COVID-19, since there is greater latitude for provider-patient determination of stability. Providers may bring implicit biases and previous experiences with patients (e.g., patient drug poisonings; deaths) that influence decisions around take-home medication. Patient co-morbidities (e.g., co-occurring benzodiazepine use, opioids for chronic pain) may also confer unique risk profiles. We created some general guidelines; for example, 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. Even with certain codified guidelines, medical providers are spending significantly more time making decisions and in interdisciplinary consultation around responses to patients' behaviors (e.g., missed doses, coming to clinic on the wrong day). In a busy clinic, such conversations are both a boon to teamwork and also a significant draw on precious time. Third, medical providers are experiencing greater anxiety over decision-making and its impact on patients. 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 increasing 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 these increased drug poisoning risks are yet unknown. Fourth, the clinic has implemented several other changes in practice 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 the patient is diverted for assessment outside of the clinic. The clinic repurposed the mobile dosing unit for nursing assessment and equipped with telehealth capability to allow a medical provider to assess in this capacity. If appropriate, patients are given take-homes for one to two weeks; patients too unstable for this much medication continue to receive medication on the mobile unit outside of the clinic. Currently, the clinic has not increased naloxone distribution. Nursing staff deliver methadone for patients in isolation and quarantine facilities. A trusted third party provides high risk patients with curbside dose administration and dose pick-up for patients isolating at home. Counseling staff are divided into cohorts, alternating weeks in the office. Clinicians use telehealth (usually telephone) visits whenever possible. The clinic also piloted the use of a mobile application that allowed remote observation of dose ingestion. The clinic suspended random, monthly drug testing, with testing limited to “for cause.” Random monthly testing was reinstituted about 5 months into the pandemic at the clinic in the county with a lower incidence of COVID-19.
      The exceptions to decades-old rules regarding methadone take-home medication have placed a greater emphasis on medical ethical principles (

      Gillon, R. (1994). Medical ethics: Four principles plus attention to scope. British Medical Journal, 309 (6948), 184–188. doi: 10.1136/bmj.309.6948.184.

      ) in treatment decision-making. Pre-COVID, OTP rules placed some emphasis on nonmalfeasance toward the patient in limiting the number of doses a patient had available to take at one time; however, a desire to keep methadone out of the community largely drove the application of the take-home limitations. This approach de-emphasized patient autonomy. Medical providers had limited discretion to determine whether a patient's level of stability would allow safe management of more take-home medication, decreasing the constraints placed on the patient by daily attendance. Rather, patients could only slowly progress toward 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 has greater weight. In addition, the application of nonmalfeasance has become more complicated in that the potential harm to the patient 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. Operationally, this has meant little room for providers to tailor treatment, but the impact of 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 the impact 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 impacts empirically, we will need to make a decision 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 N.D.
      Personalizing the treatment of substance use disorders.
      , p. 113). Increasingly, addiction research and treatment communities and governing bodies such as the Food and Drug Administration, National Institute on Drug Abuse and National Institute on Alcohol Abuse and Alcoholism are recognizing the limitations and inherent biases in using abstinence as the sole standard of treatment success (
      • Volkow N.D.
      Personalizing the treatment of substance use disorders.
      ). The current, unexpected opportunities that COVID-19 has afforded us to examine other endpoints for treatment success besides abstinence, such as 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 patients' outcomes and stability. We will need a period of several years to sustain and evaluate these policy changes to fully evaluate potential benefits and harms.
      Some studies have challenged OTP idiosyncrasies in the past (daily dosing at a fixed site; (
      • Samet H, Jeffrey
      • Botticelli Michael
      • Bharel Monica
      Methadone in Primary Care — One Small Step for Congress, One Giant Leap for Addiction Treatment.
      ), other idiosyncrasies have been empirically tested (mandatory counseling;

      Schwartz, R. P., Kelly, S. M., Mitchell, S. G., Gryczynski, J., O'Grady, K. E., Gandhi, D., … & Jaffe, J. H. (2017). Patient-centered methadone treatment: a randomized clinical trial. Addiction, 112(3), 454–464. doi:https://doi.org/10.1111/add.13622.

      ), and research has successfully tested and implemented OTP alternatives (methadone maintenance in primary care settings;
      • Fiellin D.A.
      • O’Connor P.G.
      • Chawarski M.
      • Pakes J.P.
      • Pantalon M.V.
      • Schottenfeld R.S.
      Methadone maintenance in primary care: A randomized controlled trial.
      ;
      • Merrill J.O.
      • Jackson T.R.
      • Schulman B.A.
      • Saxon A.J.
      • Awan A.
      • Kapitan S.
      • Donovan D.
      Methadone medical maintenance in primary care: An implementation evaluation.
      ). Despite these efforts, OTP rules and regulations have remained largely unchanged until the current pandemic. As of this commentary's writing, we do not know whether the Substance Abuse and Mental Health Services Administration will adopt current policy reversals post-pandemic. At the end of the COVID-19 natural experiment, we may be able to see through long-standing regulations to what is truly important for OTPs, which is keeping people retained in treatment (
      • Fugelstad A.N.N.A.
      • Stenbacka M.
      • Leifman A.
      • Nylander M.
      • Thiblin I.
      Methadone maintenance treatment: The balance between life-saving treatment and fatal poisonings.
      ;
      • Pierce M.
      • Bird S.M.
      • Hickman M.
      • Marsden J.
      • Dunn G.
      • Jones A.
      • Millar T.
      Impact of treatment for opioid dependence on fatal drug-related poisoning: A national cohort study in England.
      ;

      Sordo, L., Barrio, G., Bravo, M. J., Indave, B. I., Degenhardt, L., Wiessing, L., Ferri, M., Pastor-Barriuso, R. P. (2017). Mortality risk during and after opioid substitution treatment: Systematic review and meta-analysis of cohort studies. British Medical Journal (Clinical research ed.), 357, j1550. doi:https://doi.org/10.1136/bmj.j1550.

      ).

      CRediT authorship contribution statement

      Mary Hatch-Maillette: Conceptualization, Methodology, Investigation, Project administration, Roles/Writing-original draft, Writing-review and editing, Supervision, Funding Acquisition; Michelle Peavy: Conceptualization, Methodology, Investigation, Roles/writing-original draft, Writing-review and editing; Judith Tsui: Conceptualization, Methodology, Writing-review and editing; Caleb Banta-Green: Methodology, Writing-review and editing; Stephen Woolworth: Resources, Writing-review and editing; Paul Grekin: Conceptualization, Investigation, Data Curation, Resources, Roles/Writing-original draft, Writing-review and editing.

      Declaration of competing interest

      None.

      Funding

      This work was supported by the National Institute on Drug Abuse (5UG1DA013714, Clinical Trials Network: Pacific Northwest Node, Hatch-Maillette & Roll, MPI). The funding source had no role in the design, implementation, analysis, or description of this project.

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