'Red Flags' and 'Red Tape': Telehealth and pharmacy-level barriers to buprenorphine in the United States.

Structural vulnerabilities for people who use drugs (PWUD) were exacerbated by the COVID-19 pandemic. In this context, federal lawmakers in the United States (U.S.) invoked an exemption to the 2008 Ryan Haight Act requiring in-person evaluation to prescribe buprenorphine for treatment of opioid use disorder (OUD), which allowed for the initiation and maintenance of buprenorphine via telehealth. Despite the potential for telehealth to address some of the geographic disparities in OUD treatment access, recent research has suggested that significant barriers to buprenorphine also exist at the pharmacy level. The purpose of this study was to qualitatively assess how efforts to increase access to buprenorphine via telehealth are implemented by prescribers and pharmacists and experienced by patients. Participant observation and semi-structured interviews focused on telehealth for OUD treatment and buprenorphine prescribing and dispensing were conducted with patients (n = 19), prescribers and clinic staff (n = 24), and pharmacists (n = 10) in Pennsylvania and California between May 2020 - May 2021. While participants stated that telehealth for OUD treatment was a welcome option, pharmacy-level barriers to buprenorphine persisted. Geographical distance from patient to provider or pharmacist continued to serve as "red flags" for pharmacists, leading to pharmacy-level "red tape:" gatekeeping measures including geographic restrictions, telephone prescription "confirmations," prescription cancellations and refusals. Patients' unmet expectations of buprenorphine access in some cases led to unanticipated risks including a return to injection drug use. Challenges to increasing buprenorphine access persist in the U.S. even in settings where telehealth is implemented, and telehealth may inadvertently produce new barriers for some patients. Despite national support for policies aimed at increasing access to treatment for substance use disorders rather than punishment, policy shifts from punishment to treatment have not permeated evenly across all geographic areas and populations. Perceived threats of Drug Enforcement Administration (DEA) enforcement, and self-defensive institutional practices in pharmacies, reinforce ideologies of drug law enforcement, leading to poor patient outcomes including lack of buprenorphine access.

Textor L ，Ventricelli D ，Aronowitz SV 《-》

Addressing buprenorphine bottlenecks in the context of MAT Act implementation: A shared responsibility.

Medications for opioid use disorder (OUD) such as buprenorphine reduce overdose mortality and other opioid related acute health events but have historically been highly regulated. The recent Mainstreaming Addiction Treatment (MAT) Act ended the requirement clinicians complete a specified training and apply for a DATA 2000 ("X") waiver on their Drug Enforcement Administration (DEA) number, to prescribe buprenorphine. With the MAT Act, any practitioner with Schedule III prescribing authority (a regular DEA number) can now prescribe buprenorphine for OUD. While this has potential to improve OUD treatment access, the impact will depend on implementation. Though the MAT Act may facilitate increased buprenorphine prescribing, ensuring adequate buprenorphine dispensing is also critical to improving Medications for opioid use disorder. Recognized buprenorphine bottlenecks arise from a complex convergence of factors in community pharmacies, threatening to undercut the benefits of the MAT Act. If prescribing increases but is not matched by increased dispensing, bottlenecks may worsen. Any worsening of buprenorphine bottlenecks could have a disproportionate impact in rural areas where residents may rely on fewer pharmacies to fill prescriptions for people in larger geographic area and where larger prescribing-dispensing gaps already exist such as in Southern states. Rigorous research will be needed to document the overall impact of the MAT Act on community pharmacists and their patients. At the federal level, pharmacists and their professional organizations should lobby the DEA to de-schedule or re-schedule buprenorphine. The DEA should announce a moratorium on enforcement actions against wholesalers and pharmacies related to buprenorphine distribution and dispensing. More supports should be offered to community pharmacies by state pharmacy boards and associations including continuing pharmacy education and technical assistance for advocating with wholesalers to increase buprenorphine order sizes, and to more effectively communicate with prescribers. Pharmacies should not have to face these challenges alone. Regulators, wholesalers, and researchers must join together with community pharmacies to further reduce regulatory barriers to dispensing, provide evidence-based interventions where needed to support pharmacy dispensing efforts, conduct rigorous implementation research, and be constantly vigilant in identifying and addressing multi-level buprenorphine bottlenecks in the wake of the MAT Act.

Ostrach B ，Hill L ，Carpenter D ，Pollini R ... -  《-》

Telehealth for opioid use disorder treatment in low-barrier clinic settings: an exploration of clinician and staff perspectives.

The majority of individuals with opioid use disorder (OUD) face access barriers to evidence-based treatment, and the COVID-19 pandemic has exacerbated the United States (US) opioid overdose crisis. However, the pandemic has also ushered in rapid transitions to telehealth in the USA, including for substance use disorder treatment with buprenorphine. These changes have the potential to mitigate barriers to care or to exacerbate pre-existing treatment inequities. The objective of this study was to qualitatively explore Philadelphia-based low-barrier, harm-reduction oriented, opioid use disorder (OUD) treatment provider perspectives about and experiences with telehealth during the COVID-19 pandemic, and to assess their desire to offer telehealth to patients at their programs in the future. We interviewed 22 OUD treatment prescribers and staff working outpatient programs offering OUD treatment with buprenorphine in Philadelphia during July and August 2020. All participants worked at low-barrier treatment programs that provide buprenorphine using a harm reduction-oriented approach and without mandating counseling or other requirements as a condition of treatment. We analyzed the data using thematic content analysis. Our analysis yielded three themes: 1/ Easier access for some: telehealth facilitates care for many patients who have difficulty attending in-person appointments due to logistical and psychological barriers; 2/ A layered digital divide: engagement with telehealth can be seriously limited by patients' access to and comfort with technology; and 3/ Clinician control: despite some clinic staff beliefs that patients should have the freedom to choose their treatment modality, patients' access to treatment via telehealth may hinge on clinician perceptions of patient "stability" rather than patient preferences. Telehealth may address many access issues, however, barriers to implementation remain, including patient ability and desire to attend healthcare appointments virtually. In addition, the potential for telehealth models to extend OUD care to patients currently underserved by in-person models may partially depend on clinician comfort treating patients deemed "unstable" via this modality. The ability of telehealth to expand access to OUD care for individuals who have previously struggled to engage with in-person care will likely be limited if these patients are not given the opportunity to receive treatment via telehealth.

Aronowitz SV ，Engel-Rebitzer E ，Dolan A ，Oyekanmi K ，Mandell D ，Meisel Z ，South E ，Lowenstein M ... -  《Harm Reduction Journal》

Buprenorphine implementation at syringe service programs following waiver of the Ryan Haight Act in the United States.

Among people with an opioid use disorder in the United States, only 10% receive buprenorphine treatment. The Ryan Haight Act is a federal law that has regulated buprenorphine delivery, requiring an in-person examination between a patient and provider before initiating treatment. At the beginning of the COVID-19 pandemic, federal agencies waived in-person examination requirements for buprenorphine treatment initiation. We examined whether Ryan Haight Act waiver improved implementation of telehealth buprenorphine within syringe service programs (SSPs) - organizations that serve people with historically low access to treatment. We surveyed all known SSPs operating in the US in 2021 (N = 421) of which 77% responded (n = 325). We calculated the prevalence and accompanying 95% confidence intervals (CI) for implementation of telehealth buprenorphine inductions at SSPs in 2020. Multivariable logistic regression was used to assess differences in implementing telehealth buprenorphine inductions by organizational characteristics. In 2020, the prevalence of implementing buprenorphine inductions via telehealth was 24% (95% CI:19-30%). Non-governmental SSPs had a higher odds of telehealth buprenorphine inductions (adjusted odds ratio (aOR)= 2.92; 95% CI:1.22-7.00; p = 0.016), compared to governmental SSPs. Furthermore, the larger the organization's annual budget, the higher the odds of telehealth buprenorphine implementation (aOR=2.00 per quartile (95% CI:1.33-2.99; p = 0.001). SSPs located in states with higher opioid overdose mortality rates did not have significantly higher likelihood of telehealth buprenorphine implementation. A substantial number of SSPs implemented telehealth buprenorphine after waiver of the Ryan Haight Act. Permanent adoption of this waiver will be critical and providing financial resources to SSPs is vital to support implementation of new innovations.

Lambdin BH ，Bluthenthal RN ，Tookes HE ，Wenger L ，Morris T ，LaKosky P ，Kral AH ... -  《-》

The impact of the mainstreaming addiction treatment act and associated legislative action on pharmacy practice.

The recent passage of the Mainstreaming Addiction Treatment (MAT) Act will expand access to treatment for opioid use disorder (OUD) by eliminating prescriber registration requirements introduced as part of the Drug Abuse Treatment Act (DATA) of 2000. Without the X-Waiver, and Drug Enforcement Administration (DEA) registered prescriber can now prescribe buprenorphine. Eliminating DATA-2000 registration is the first step in improving access to buprenorphine, but additional barriers, including unclear restrictions on wholesale buprenorphine supply and insurance coverage, remain. Recently, the DEA formally clarified that suspicious order monitoring programs were managed entirely by wholesalers and manufacturers and that DEA does not set suspicious order monitoring limits. In this commentary, we address the somewhat conflicting implications of the MAT Act and recent DEA guidance on buprenorphine dispensing in community pharmacies. We also discuss innovative practice models that leverage pharmacists' cognitive skills to manage pharmacotherapy for persons with OUD. Recent policy changes and emerging evidence suggest that pharmacists are better positioned than ever to provide low-barrier access to treatment for OUD and to show their value in this practice area by actively engaging patients with prescribed buprenorphine.

Varisco TJ ，Wanat M ，Hill LG ，Thornton D ... -  《-》