Opioid treatment program safety measures during the COVID-19 pandemic: a statewide survey

The novel coronavirus 2019 (COVID-19) pandemic fundamentally shifted life, including placing enormous strain on health care systems and services. Because COVID-19 is highly contagious and transmitted via exposure to infectious respiratory aerosols, states, localities and health care systems undertook several policies to reduce the spread of disease, including masking mandates, stay-at-home orders and altering the ways in which health care services are provided to enhance physical distancing [1‐3].

Important questions remain on how specialized behavioral health services, such as those targeting people with substance use disorders, adapted to the pandemic circumstances. This is especially important as the COVID-19 emergency is occurring in the context of an overdose crisis in the United States (US) [4, 5]. Provisional data from the U.S. Centers for Disease Control and Prevention estimate that in 2020, over 93,000 individuals died from drug overdose, a staggering increase from the already elevated 2019 data of over 72,000 deaths [6]. Almost 70,000 overdose deaths in 2020 were opioid-related [6]. Non-fatal overdoes rates also rose in 2020 [7, 8]. During this time, individuals with opioid use disorder were also at increased risk for COVID-19-related health complications [4]. Because these two public health crises are intertwined, it is necessary to understand how the pandemic impacted the provision of opioid use disorder treatment and what COVID-19 risk mitigation efforts these treatment providers adopted.

Opioid agonist treatments, like buprenorphine and methadone, are the gold-standard treatments for opioid use disorder, with extensive evidence showing they reduce mortality and improve treatment outcomes [9‐13]. However, people with opioid use disorder must take these medications daily and accessing these medications in the U.S. is difficult and highly regulated [10]. This in part contributes to low uptake of opioid agonist treatment and disparities in treatment use by race and socioeconomic status [10]. Under U.S. federal law, methadone to treat opioid use disorder must be dispensed in licensed specialty clinics, called opioid treatment programs (OTPs), that have a license from the U.S. Drug Enforcement Administration. In addition to methadone, physicians working at OTPs can also prescribe or dispense buprenorphine treatment [10]. In the U.S., many OTPs operate via private for-profit or non-profit organizations outside of mainstream health services and larger health care systems. Federal and state regulations require patients make near-daily visits to OTPs in the first 90 days and at least weekly visits in the first year of treatment, and often require participation in adjunct services, such as psychosocial counseling and drug screening [14, 15]. Because most patients are required to visit what are often crowded OTPs daily or near daily to receive services under direct observation, these programs are uniquely susceptible to safety issues related to the COVID-19 pandemic. In an attempt to alleviate some of these COVID-19 transmission concerns, federal and state agencies issued several guidance documents allowing for enhanced use of telehealth services and increased the maximum number of days of take-home methadone for patients to self-administer at home (14 days for less stable patients and 28 days for highly stable patients, based on risk criteria established over a decade ago) [16].

A small but growing body of research has documented changes to OTP practices regarding opioid agonist treatment, particularly in response to these regulatory changes. These studies find increased use of take-home medications, increased provision of psychosocial services via tele-health and mixed results on urine drug screening practices [17‐23]. However, less is known about how the pandemic altered OTP operations and what program-level safety protocols were made to mitigate COVID-19 risk. A case study of three OTPs by Quiñones et al. found increased use of telemedicine to separate staff and clients within the clinic, changes in the number of days that services were provided and adoption of some safety measures to encourage physical distancing [19]. A national survey of 142 OTPs conducted by the U.S. Department of Health and Human Services early in the pandemic reported changes to OTP service levels, the adoption of various personal safety measures, physical alterations to facilities and challenges related to maintaining supplies of personal protective equipment and medical supplies [23]. To further understand these issues, we fielded a statewide survey of OTPs in Pennsylvania, a state with one of the highest overdose mortality rates [24], and identified safety and operational changes made by OTPs in the state during the COVID-19 pandemic.

Prior to COVID-19, 93% (n = 41) of respondents offered methadone maintenance, 52% (n = 23) offered buprenorphine maintenance, 39% (n = 17) offered extended-release naltrexone maintenance, 11% (n = 5) offered methadone detoxification/tapering and 9% (n = 4) offered buprenorphine detoxification/tapering. Of OTPs that offered buprenorphine treatment, 71% prescribed buprenorphine by a waivered provider to be filled at a community pharmacy and 58% dispensed buprenorphine on site.

Our study seeks to understand modifications to operations and adoptions of safety measures at Pennsylvania OTPS during the COVID-19 pandemic. Consistent with prior research [17‐23], we find that the vast majority of OTPs made at least one modification to services or operations during the pandemic, but service modifications varied by type of services. However, we find that over half of respondents reported not changing the volume of services or moving to virtual services for medications for opioid use disorder, same-day initiation, case management services, drug screening, infectious disease management services, and naloxone distribution. Patients may be reluctant or unable to attend clinical care schedules and meet requirements that were set pre-pandemic, which may cause disruptions to care [25]. Service and operation adaptations should take into account the preferences and needs of patients, which are still being characterized in the literature [21, 25‐27].

Our study elucidates that OTPs readily adopted safety protocols. However, OTPs were understandably more likely to adopt safety protocols that did not require significant funding, such as limiting the number of people entering the site, enforcing social distancing, posting information and increasing sanitation. Programs were less likely to make physical alterations to space, refer patients to other providers, or stagger visits. In addition, only one-third of respondents were able to provide most of their staff with N95 masks and 68% reported challenges related to insufficient access to personal protective equipment. While emergency funding was made available to increase access to substance use disorder treatment during the pandemic, [28] these findings speak to the need for emergency funding to ensure that OTP providers in Pennsylvania can adopt protocols to deliver these services safely. OTPs limited ability to quickly adopt safety measures that require additional funding during this initial phase of the pandemic may also inform future emergency planning in subsequent phases of the COVID-19 pandemic and future public health disasters that lead to major disruption in health services, which are predicted to increase in the coming decades due to climate change [29, 30].

Research on OTP operations during prior emergency situations may inform the interpretation of these findings. Studies on OTP operations during Hurricane Sandy and the immediate aftermath of the September 11^th attack in New York City found disruptions to care and increased relapse among patients [31, 32]. The rapid rise in overdose deaths in 2020 and the reduced number of clients served by OTPs in our survey allude to similar disruptions in care during the COVID-19 pandemic. Qualitative studies on OTP operations during hurricanes find that providers report that having robust emergency planning prior to a public health disaster, with a focus on communication, transportation, and policies to enhance guest dosing and take-home provisions would reduce burden on OTPs [33‐35]. These findings in the context of the inconsistent application of safety protocols found in this study speak to the need for OTPs to have a distinct resource and regulatory body from whom they can receive clearly-communicated safety protocols and procedure updates. It also highlights the difficulty in communicating rapidly changing safety information and providing safety equipment at a mass scale, particularly for OTPs, which are siloed from the broader U.S. health care system [36, 37]. This separation is a barrier to maintaining and enhancing access to opioid treatment during such disasters, in particular because of the critical emergency preparedness and response that occurs at the health system level [38, 39]. Lessons learned from prior emergency situations are particularly applicable to the results presented in this study which are from earlier phases of the pandemic, but may be less applicable as the pandemic has prolonged and continued to affect long-term operations.

Several studies have documented that during the pandemic there was an increase in negative mental health outcomes in the general population, in part associated with concerns about contracting COVID-19, financial stability, and caregiving challenges [40‐44]. Similar psychological, social and material stressors observed during other emergency and disaster events have been associated with drug use and relapse among individuals in substance use disorder treatment [45‐48]. These stressors may also explain why almost half of OTPs in this survey reported reductions in the number of clients served, indicating disruptions to care. These challenges experienced in the population more broadly are also reflected by our finding that over 80% of respondents reported that OTPs experienced challenges related to staff’s caregiving responsibilities, stress, and negative mental health. Identifying mechanisms to improve mental health and flexible funding mechanisms to support caregiving and other staff and patient needs is another key future intervention point, to ensure that OTPs in the state can adapt during crises and minimize disruptions to care. Bolstering OTPs’ ability to provide services during the pandemic is particularly important given the link between rapidly rising overdose rates associated with synthetic opioids, against which opioid agonist treatments are powerful protective tools [10].

Overall, this survey finds that the vast majority of OTPs in Pennsylvania responded to the COVID-19 pandemic by making services and safety modifications. OTPs reported reductions in the number of clients served, difficulties providing staff with personal protective equipment, and challenges related to staff mental health. As the pandemic is still ongoing, addressing these challenges will be key to ensuring that OTP provision of medication treatment is not further disrupted during this unprecedented overdose crisis.