Barriers to Buprenorphine Dispensing by Medicaid-Participating Community Retail Pharmacies.

Importance: Controlled substances have regulatory requirements under the US Federal Controlled Substance Act that must be met before pharmacies can stock and dispense them. However, emerging evidence suggests there are pharmacy-level barriers in access to buprenorphine for treatment for opioid use disorder even among pharmacies that dispense other opioids. Objective: To estimate the proportion of Medicaid-participating community retail pharmacies that dispense buprenorphine, out of Medicaid-participating community retail pharmacies that dispense other opioids and assess if the proportion dispensing buprenorphine varies by Medicaid patient volume or rural-urban location. Design, Setting, and Participants: This serial cross-sectional study included Medicaid pharmacy claims (2016-2019) data from 6 states (Kentucky, Maine, North Carolina, Pennsylvania, Virginia, West Virginia) participating in the Medicaid Outcomes Distributed Research Network (MODRN). Community retail pharmacies serving Medicaid-enrolled patients were included, mail-order pharmacies were excluded. Analyses were conducted from September 2022 to August 2023. Main Outcomes and Measures: The proportion of pharmacies dispensing buprenorphine approved for opioid use disorder among pharmacies dispensing an opioid analgesic or buprenorphine prescription to at least 1 Medicaid enrollee in each state. Pharmacies were categorized by median Medicaid patient volume (by state and year) and rurality (urban vs rural location according to zip code). Results: In 2016, 72.0% (95% CI, 70.9%-73.0%) of the 7038 pharmacies that dispensed opioids also dispensed buprenorphine to Medicaid enrollees, increasing to 80.4% (95% CI, 79.5%-81.3%) of 7437 pharmacies in 2019. States varied in the percent of pharmacies dispensing buprenorphine in Medicaid (range, 73.8%-96.4%), with significant differences between several states found in 2019 (χ2 P < .05), when states were most similar in the percent of pharmacies dispensing buprenorphine. A lower percent of pharmacies with Medicaid patient volume below the median dispensed buprenorphine (69.1% vs 91.7% in 2019), compared with pharmacies with above-median patient volume (χ2 P < .001). Conclusions and Relevance: In this serial cross-sectional study of Medicaid-participating pharmacies, buprenorphine was not accessible in up to 20% of community retail pharmacies, presenting pharmacy-level barriers to patients with Medicaid seeking buprenorphine treatment. That some pharmacies dispensed opioid analgesics but not buprenorphine suggests that factors other than compliance with the Controlled Substance Act influence pharmacy dispensing decisions.

Mapping Buprenorphine Access at Philadelphia Pharmacies.

OBJECTIVES: Buprenorphine is not reliably stocked in many pharmacies, and pharmacy-level barriers may deter patients from opioid use disorder care. We surveyed all outpatient pharmacies in Philadelphia to describe variation in buprenorphine access and developed a map application to aid in identifying pharmacies that stock the medication. METHODS: Using a dataset from the Bureau of Professional and Occupational Affairs, we conducted a telephone survey of operating outpatient pharmacies (N = 422) about their buprenorphine stocking and dispensing practices. We used ArcGIS Pro 3.0.3 to join US Census Bureau ZIP code-level race and ethnicity data, conduct descriptive analyses, and create a map application. RESULTS: We collected data from 351 pharmacies (83% response rate). Two hundred thirty-eight pharmacies (68%) indicated that they regularly stock buprenorphine; 6 (2%) would order it when a prescription is sent. Ninety-one (26%) said that they do not stock or order buprenorphine, and 16 (5%) were unsure. We identified 137 "easier access" pharmacies (39%), meaning they regularly stock buprenorphine, dispense to new patients, and have no dosage maximums. Zip codes with predominantly White residents had a median (interquartile range) of 3 (2-4) "easier access" pharmacies, and those with predominantly Black residents a median (interquartile range) of 2 (1-4.5). Nine zip codes had no "easier access" pharmacies, and 3 had only one; these 3 zip codes are areas with predominantly Black residents. CONCLUSIONS: Buprenorphine access is not equitable across Philadelphia and a quarter of pharmacies choose not to carry the medication. Our map application may be used to identify pharmacies in Philadelphia that stock buprenorphine.

Availability of Long-Acting Injectable Buprenorphine at Substance Use Treatment Facilities in 2021.

This study assesses the proportion of US substance use and mental health care facilities that offered any medications for opioid use disorder and, specifically, long-acting injectable buprenorphine in 2021.

Availability of medications for opioid use disorder in outpatient and inpatient pharmacies in South Florida: a secret shopper survey.

BACKGROUND: Despite the proven efficacy of medications for opioid use disorder (MOUD) and recent reduction in barriers to prescribers, numerous obstacles exist for patients seeking MOUD. Prior studies have used telephone surveys to investigate pharmacy-related barriers to MOUD. We applied this methodology to evaluate inpatient and outpatient pharmacy barriers to MOUD in South Florida. METHODS: Randomly selected pharmacies in South Florida (Miami-Dade, Broward, and Palm Beach Counties) were called using a standardized script with a "secret shopper" approach until 200 successful surveys had been completed. The primary outcome was the availability of any buprenorphine products. Second, a list of all 48 acute care hospitals within the aforementioned counties was compiled, and hospitals were contacted by telephone using a second structured script. RESULTS: A total of 1374 outpatient pharmacies and 48 inpatient pharmacies were identified. 378 randomly selected outpatient pharmacies were contacted to accrue 200 successful calls (53% success rate). All 48 inpatient pharmacies were contacted to successfully complete 25 inpatient surveys (52%). Of the 200 outpatient pharmacies contacted, 38% had any buprenorphine available. There was a significant difference in buprenorphine availability by county, with Miami-Dade having the least availability and Palm Beach having the most availability (27% vs. 47%, respectively; p = 0.04). Of the 38% with buprenorphine available, 82% had a sufficient supply for a two-week prescription of buprenorphine 8 mg twice daily. Of the pharmacies that did not have buprenorphine, 55% would be willing to order with a median estimated time to receive an order of 2 days (IQR 1.25-3 days). Of the 25 surveyed inpatient pharmacies, 88% reported having buprenorphine on inpatient formulary, and 55% of hospitals had at least one restriction on ordering of buprenorphine beyond federal regulations. CONCLUSIONS: The results of this study highlight significant pharmacy-related barriers to comprehensive OUD treatment across the healthcare system including both acute care hospital pharmacies and outpatient community pharmacies. Despite efforts to increase the number of MOUD providers, there still remain downstream obstacles to MOUD access.

Using telehealth to improve buprenorphine access during and after COVID-19: A rapid response initiative in Rhode Island.

Despite its proven efficacy, buprenorphine remains dramatically underutilized for management of opioid use disorder largely due to onerous barriers to treatment initiation. During the COVID-19 pandemic, many substance use disorder treatment facilities have reduced their hours and services, exacerbating existing barriers. To this end, the U.S. Drug Enforcement Administration and Substance Abuse Mental Health Services Administration adjusted their guidelines to allow for new buprenorphine prescriptions following audio-only telehealth encounters, no longer requiring an in-person evaluation prior to treatment initiation. Under this new guidance, we established a 24/7 telephone hotline to function as a "tele-bridge" clinic where people with opioid use disorder can be linked with a buprenorphine prescriber in real-time for OUD assessment and unobserved buprenorphine initiation with connection to follow-up if appropriate. Additionally, we developed an ED callback protocol to reach patients recently seen for opioid overdose and facilitate their entry into care if interested. In this commentary we describe our hotline and ED callback protocols, discuss theoretical and anecdotal benefits to this approach, and advocate for continuation of current regulatory changes post-COVID-19 to maintain expanded access to novel treatment approaches.

Depot buprenorphine during COVID-19 in Australia: Opportunities and challenges.

The COVID-19 pandemic has presented challenges for traditional models of opioid use disorder treatment worldwide. Depot buprenorphine became available in Australia shortly before the height of the COVID-19 pandemic. This timing provided us an opportunity to examine the utilization and uptake of depot buprenorphine, and to understand the particular benefits and implementation challenges associated with this new formulation of opioid agonist treatment.

Rise and regional disparities in buprenorphine utilization in the United States.

PURPOSE: Buprenorphine is an opioid partial agonist used to treat opioid use disorder. While several policy changes have attempted to increase buprenorphine availability, access remains well below optimal levels. This study characterized how buprenorphine utilization in the United States has changed over time and whether there are regional disparities in distribution of the medication. METHODS: The amount of buprenorphine distributed from 2007 to 2017 was obtained from the Drug Enforcement Administration's Automated Reports and Consolidated Ordering System. Data were expressed as the percent change and milligrams per person in each state. The formulations and cost for prescriptions covered by Medicaid (2008 to 2018) were also examined. RESULTS: Buprenorphine distributed to pharmacies increased about 7-fold (476.8 to 3179.9 kg) while the quantities distributed to hospitals grew 5-fold (18.6 to 97.6 kg) nationally from 2007 to 2017. Buprenorphine distribution per person was almost 20-fold higher in Vermont (40.4 mg/person) relative to South Dakota (2.1 mg/person). There was a strong association between the number of physicians authorized to prescribe buprenorphine and distribution per state (r[49] = +0.94, P < .0005). The buprenorphine/naloxone sublingual film (Suboxone) was the predominant formulation (92.6% of 0.31 million Medicaid prescriptions) in 2008 but accounted for less than three-fifth (57.3% of 6.56 million prescriptions) in 2018. CONCLUSIONS: Although buprenorphine availability has substantially increased over the last decade, distribution was very nonhomogeneous across the United States.

Differences in Availability and Use of Medications for Opioid Use Disorder in Residential Treatment Settings in the United States.

Importance: While many individuals with opioid use disorder seek treatment at residential facilities to initiate long-term recovery, the availability and use of medications for opioid use disorder (MOUDs) in these facilities is unclear. Objective: To examine differences in MOUD availability and use in residential facilities as a function of Medicaid policy, facility-level factors associated with MOUD availability, and admissions-level factors associated with MOUD use. Design, Setting, and Participants: This cross-sectional study used deidentified facility-level and admissions-level data from 2863 residential treatment facilities and 232 414 admissions in the United States in 2017. Facility-level data were extracted from the 2017 National Survey of Substance Abuse Treatment Services, and admissions-level data were extracted from the 2017 Treatment Episode Data Set-Admissions. Statistical analyses were conducted from June to November 2019. Exposures: Admissions for opioid use disorder at residential treatment facilities in the United States that identified opioids as the patient's primary drug of choice. Main Outcomes and Measures: Availability and use of 3 MOUDs (ie, extended-release naltrexone, buprenorphine, and methadone). Results: Of 232 414 admissions, 205 612 (88.5%) contained complete demographic data (166 213 [80.8%] aged 25-54 years; 136 854 [66.6%] men; 151 867 [73.9%] white). Among all admissions, MOUDs were used in only 34 058 of 192 336 (17.7%) in states that expanded Medicaid and 775 of 40 078 (1.9%) in states that did not expand Medicaid (P < .001). A relatively low percentage of the 2863 residential treatment facilities in this study offered extended-release naltrexone (854 [29.8%]), buprenorphine (953 [33.3%]), or methadone (60 [2.1%]). Compared with residential facilities that offered at least 1 MOUD, those that offered no MOUDs had lower odds of also offering psychiatric medications (odds ratio [OR], 0.06; 95% CI, 0.05-0.08; Wald χ21 = 542.09; P < .001), being licensed by a state or hospital authority (OR, 0.39; 95% CI, 0.27-0.57; Wald χ21 = 24.28; P < .001), or being accredited by a health organization (OR, 0.28; 95% CI, 0.23-0.33; Wald χ21 = 180.91; P < .001). Residential facilities that did not offer any MOUDs had higher odds of accepting cash-only payments than those that offered at least 1 MOUD (OR, 4.80; 95% CI, 3.47-6.64; Wald χ21 = 89.65; P < .001). Conclusions and Relevance: In this cross-sectional study of residential addiction treatment facilities in the United States, MOUD availability and use were sparse. Public health and policy efforts to improve access to and use of MOUDs in residential treatment facilities could improve treatment outcomes for individuals with opioid use disorder who are initiating recovery.

"They're making it so hard for people to get help:" Motivations for non-prescribed buprenorphine use in a time of treatment expansion.

BACKGROUND: Buprenorphine maintenance therapy (BMT) has been widely recognized as one of the most effective treatments for opioid use disorders (OUD). In the midst of the U.S. opioid overdose crisis, local, state, and federal authorities have attempted to increase the availability of BMT, yet few individuals meeting the criteria for OUD utilize BMT. Moreover, recent research suggests that a significant proportion of individuals who use opioids seek out buprenorphine on the illicit market to self-govern and manage withdrawal sickness. METHODS: This paper presents data from a geographic sub-sample within a multi-site study of buprenorphine diversion in Pennsylvania. We endeavor to bolster a slim qualitative literature on the use of non-prescribed buprenorphine through in-depth interviews with 20 individuals who reported buying or receiving buprenorphine outside of medically-sanctioned contexts. Interviews characterized participants' reasons for both using non-prescribed buprenorphine and eschewing formal treatment, in a state (Pennsylvania) afflicted with high rates of heroin use and overdose deaths. Transcripts were initially coded for broad interview topics, while latent themes relating to buprenorphine diversion and extra-medical use also emerged. RESULTS: Analyses revealed complex motivations underlying participants' extra-medical use of buprenorphine. Where some expressed a desire for treatment autonomy and treatment medications that could not be achieved or obtained within BMT, individuals also indicated a persistent lack of treatment availability and access due to diverse barriers. CONCLUSION: This study shows how issues related to availability, accessibility, and acceptability many explain low rates of BMT utilization, even within a place and time defined by medication-assisted treatment expansion. Beyond offering broad rhetorical and financial support for MAT, our findings suggest that governmental actors should continue to pursue policies that expand the spatial distribution of BMT. It also underscores the need to look beyond current models of buprenorphine maintenance and to consider modes of buprenorphine delivery beyond long-term maintenance.

Legal and policy changes urgently needed to increase access to opioid agonist therapy in the United States.

The United States continues to face a public health crisis of opioid-related harm, the effects of which could be dramatically reduced through increased access to opioid agonist therapy with the medications methadone and buprenorphine. Despite overwhelming evidence of their efficacy, unduly restrictive federal, state, and local regulation significantly impedes access to these life-saving medications. We outline immediate, concrete steps that federal, state, and local governments can take to change law from barrier to facilitator of evidence-based treatment for opioid use disorder. These include removing onerous restrictions on the prescription and dispensing of buprenorphine and methadone for opioid agonist therapy, requiring insurance coverage of these medications, and mandating that they be provided in correctional settings and promoted by drug courts. Finally, we argue that jurisdictions should proactively offer opioid agonist therapy to individuals at high risk of overdose, remove barriers to establishing methadone treatment facilities, and address underlying social determinants and barriers to treatment. These changes have the ability to save thousands of lives annually.

Impact of Medicaid Restrictions on Availability of Buprenorphine in Addiction Treatment Programs.

OBJECTIVES: To examine how utilization restrictions on state Medicaid benefits for buprenorphine are related to addiction treatment programs' decision to offer the drug. METHODS: We used data from 2 waves of the National Drug Abuse Treatment System Survey conducted in 2014 and 2017 in the United States to assess the relationship of utilization restrictions to buprenorphine availability. RESULTS: The proportion of programs offering buprenorphine was 43.2% in states that did not impose any utilization restrictions, 25.5% in states that imposed only annual limits, 17.3% in states that imposed only prior authorization, and 12.8% in states that imposed both. Programs in states requiring prior authorization from Medicaid had substantially lower odds of offering buprenorphine (odds ratio = 0.50; 95% confidence interval = 0.29, 0.87). CONCLUSIONS: Medicaid prior authorization was linked to lower odds of buprenorphine provision among addiction treatment programs. Public Health Implications. State Medicaid prior authorization requirements are linked to reduced odds of buprenorphine provision among addiction treatment programs and may discourage prescribing.

Comparison between buprenorphine provider availability and opioid deaths among US counties.

BACKGROUND: Buprenorphine is an effective medication for the treatment of opioid addiction, but current barriers to buprenorphine access limit treatment availability for many patients. We identify and characterize regions within the United States (US) with poor buprenorphine access relative to the observed burden of overdose deaths. METHODS: This cross sectional study includes US county-level data on the number of available buprenorphine providers (Substance Abuse and Mental Health Services Administration Buprenorphine Treatment Practitioner Locator) and the number of opioid-related overdose deaths between 2013 and 2015 (Centers for Disease Control and Prevention WONDER Database). Counties with fewer than 10 deaths during this time period were excluded to maintain patient privacy. Population-adjusted county death rates and provider availability were compared to identify locations with high disease burdens and limited buprenorphine access. The presence of significant clustering across the dataset was evaluated using Global Moran's I and zones of significant spatial clusters and anomalies were identified using Local Indicator of Spatial Autocorrelation. RESULTS: County data were available for 846 counties from 49 states and the District of Columbia, comprising 83% of the US population. The median number of opioid overdose deaths per county was 20.0 deaths per 100,000 residents (interquartile range 13.4-29.9, range 2.9 to 108.8). The number of buprenorphine providers per 100,000 county residents ranged from 0 to 45, with a median of 5.9 (interquartile range 3.2 to 9.5). Global Moran's I analysis yielded significant clustering in the distribution of both providers and deaths, with notable significant clusters of higher than average providers and deaths in the Northeast, and scattered mismatched regions of lower-than-average providers and higher-than-average deaths across the Southern, Midwestern, and Western US. Graphical analysis of buprenorphine provider availability and overdose burden reveals limited treatment access relative to overdose deaths throughout much of the Midwestern and Southern US. CONCLUSIONS: Substantial county-level imbalances between the availability of buprenorphine providers and the burden of opioid overdose deaths are present within the US.

Improving Rural Access to Opioid Treatment Programs.

This article explores challenges to accessing opioid treatment programs in rural areas, and offers solutions that would ease these problems.

Buprenorphine Supply, Access, and Quality: Where We Have Come and the Path Forward.

Buprenorphine is a form of opioid agonist treatment that has been demonstrated to be an effective medication for opioid addiction. It is available in different formulations and marketed under various trade names, including commonly as a buprenorphine/naloxone combination. This paper provides an overview of existing literature on the supply of buprenorphine treatment, the ability of people to access treatment with buprenorphine, and the quality of treatment received. We argue that better data for each of these aspects of treatment could inform policy to expand effective treatment with buprenorphine, and we suggest steps to obtain and act on such data.

Barriers Rural Physicians Face Prescribing Buprenorphine for Opioid Use Disorder.

Opioid use disorder is a serious public health problem. Management with buprenorphine is an effective, office-based, medication-assisted treatment, but 60.1% of rural counties in the United States lack a physician with a Drug Enforcement Agency waiver to prescribe buprenorphine. This national study surveyed all rural physicians who have received a waiver in the United States and found that those who were not actively prescribing buprenorphine reported significantly more barriers than those who were, regardless of whether they were treating the maximum number of patients their waiver allowed. These findings suggest the need for tailored strategies to address barriers to providing buprenorphine for opioid use disorder and to support physicians who are adding or maintaining this service.

Buprenorphine physician supply: Relationship with state-level prescription opioid mortality.

BACKGROUND: Buprenorphine is an effective treatment for opioid use disorder but the supply of buprenorphine physicians is currently inadequate to address the nation's prescription opioid crisis. Perception of need due to rising opioid overdose rates is one possible reason for physicians to adopt buprenorphine. This study examined associations between rates of growth in buprenorphine physicians and prescription opioid overdose mortality rates in US states. METHODS: The total buprenorphine physician supply and number of physicians approved to treat 100 patients (per 100,000 population) were measured from June 2013 to January 2016. States were divided into two groups: those with rates of prescription opioid overdose mortality in 2013 at or above the median (>5.5 deaths per 100,000 population) and those with rates below the median. State-level growth curves were estimated using mixed-effects regression to compare rates of growth between high and low overdose states. RESULTS: The total supply and the supply of 100-patient buprenorphine physicians grew significantly (total supply from 7.7 to 9.9 per 100,000 population, p<0.001; 100-patient supply from 2.2 to 3.4 per 100,000 population, p<0.001). Rates of growth were significantly greater in high overdose states when compared to low overdose states (total supply b=0.033, p<0.01; 100-patient b=0.022, p<0.01). CONCLUSIONS: The magnitude of the US prescription opioid crisis, as measured by the rate of prescription opioid overdose mortality, is associated with growth in the number of buprenorphine physicians. Because this observational design cannot establish causality, further research is needed to elucidate the factors influencing physicians' decisions to begin prescribing buprenorphine.

Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements. Final rule.

This final rule outlines annual reporting requirements for practitioners who are authorized to treat up to 275 patients with covered medications in an office-based setting. This final rule will require practitioners to provide information on their annual caseload of patients by month, the number of patients provided behavioral health services and referred to behavioral health services, and the features of the practitioner's diversion control plan. These reporting requirements will help the Department of Health and Human Services (HHS) ensure compliance with the requirements of the final rule, "Medication Assisted Treatment for Opioid Use Disorders," published in the Federal Register on July 8, 2016.

Diffusion and diversion of suboxone: an exploration of illicit street opioid selling.

Interviews with fourteen opioid retail pill sellers provides an exploration into the diversion and diffusion of Suboxone to recreational ("week-end warriors") drug users. The use of social media and electronic devices enables the diffusion of Suboxone to dependent and non-dependent opiate/opioid drug abusers. Overprescribing by physicians and prescribing in drug treatment settings fuels the diversion of Suboxone. The diversion and the diffusion of Suboxone have the potential to delay entrance into drug treatment and promote the misuse of the drug by both dependent opiate/opioid drug abusers and recreational users. The dilemma posed by Suboxone maintenance treatment will not be easily addressed or mitigated in the near future.