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

Abstract

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.