Buprenorphine Treatment Episodes During the First Year of COVID: a Retrospective Examination of Treatment Initiation and Retention.

BACKGROUND: During the COVID pandemic, overall buprenorphine treatment appeared to remain relatively stable, despite some studies suggesting a decrease in patients starting buprenorphine. There is a paucity of empirical information regarding patterns of buprenorphine treatment during the pandemic. OBJECTIVE: To better understand the patterns of buprenorphine episodes during the pandemic and how those patterns compared to pre-pandemic patterns. DESIGN: Pharmacy claims representing approximately 92% of all prescriptions filled at retail pharmacies in all 50 US states and the District of Columbia. PARTICIPANTS: Individuals filling buprenorphine prescriptions indicated for treatment of opioid use disorder. MAIN MEASURES: The number of active, starting, and ending buprenorphine treatment episodes March 13 to December 1, 2020, and the expected number of such episodes in 2020 based on the growth in treatment episodes from March 13 to December 1, 2019. KEY RESULTS: The observed number of active buprenorphine episodes in December 2020 was comparable to the expected number, but new treatment episodes starting between March 13 and December 1, 2020, were 17.2% fewer than expected based on the 2019 experience. Similarly, the number of episodes that ended between March 13 and December 1, 2020, was 16.0% fewer than expected. Decreases from expected episode starts and ends occurred throughout the period but were greatest in the 2 months after the declaration of the public health emergency. CONCLUSIONS AND RELEVANCE: Beneath the apparent stability of buprenorphine patient numbers during the pandemic, the flow of individuals receiving buprenorphine treatment changed substantially. Our findings shed light on how policy changes meant to support buprenorphine prescribing influenced prescribing dynamics during that period, suggesting that while policy efforts may have been successful in maintaining existing patients in treatment, that success did not extend to individuals not yet in treatment.

Clinician Perspectives on Delivering Medication Treatment for Opioid Use Disorder during the COVID-19 Pandemic: A Qualitative Evaluation.

OBJECTIVE: The coronavirus disease 2019 (COVID-19) pandemic necessitated changes in opioid use disorder care. Little is known about COVID-19's impact on general healthcare clinicians' experiences providing medication treatment for opioid use disorder (MOUD). This qualitative evaluation assessed clinicians' beliefs about and experiences delivering MOUD in general healthcare clinics during COVID-19. METHODS: Individual semistructured interviews were conducted May through December 2020 with clinicians participating in a Department of Veterans Affairs initiative to implement MOUD in general healthcare clinics. Participants included 30 clinicians from 21 clinics (9 primary care, 10 pain, and 2 mental health). Interviews were analyzed using thematic analysis. RESULTS: The following 4 themes were identified: overall impact of the pandemic on MOUD care and patient well-being, features of MOUD care impacted, MOUD care delivery, and continuance of telehealth for MOUD care. Clinicians reported a rapid shift to telehealth care, resulting in few changes to patient assessments, MOUD initiations, and access to and quality of care. Although technological challenges were noted, clinicians highlighted positive experiences, including treatment destigmatization, more timely visits, and insight into patients' environments. Such changes resulted in more relaxed clinical interactions and improved clinic efficiency. Clinicians reported a preference for in-person and telehealth hybrid care models. CONCLUSIONS: After the quick shift to telehealth-based MOUD delivery, general healthcare clinicians reported few impacts on quality of care and highlighted several benefits that may address common barriers to MOUD care. Evaluations of in-person and telehealth hybrid care models, clinical outcomes, equity, and patient perspectives are needed to inform MOUD services moving forward.

Design, Implementation, and Evolution of the Medicaid Outcomes Distributed Research Network (MODRN).

BACKGROUND: In the US, Medicaid covers over 80 million Americans. Comparing access, quality, and costs across Medicaid programs can provide policymakers with much-needed information. As each Medicaid agency collects its member data, multiple barriers prevent sharing Medicaid data between states. To address this gap, the Medicaid Outcomes Distributed Research Network (MODRN) developed a research network of states to conduct rapid multi-state analyses without sharing individual-level data across states. OBJECTIVE: To describe goals, design, implementation, and evolution of MODRN to inform other research networks. METHODS: MODRN implemented a distributed research network using a common data model, with each state analyzing its own data; developed standardized measure specifications and statistical software code to conduct analyses; and disseminated findings to state and federal Medicaid policymakers. Based on feedback on Medicaid agency priorities, MODRN first sought to inform Medicaid policy to improve opioid use disorder treatment, particularly medication treatment. RESULTS: Since its 2017 inception, MODRN created 21 opioid use disorder quality measures in 13 states. MODRN modified its common data model over time to include additional elements. Initial barriers included harmonizing utilization data from Medicaid billing codes across states and adapting statistical methods to combine state-level results. The network demonstrated its utility and addressed barriers to conducting multi-state analyses of Medicaid administrative data. CONCLUSIONS: MODRN created a new, scalable, successful model for conducting policy research while complying with federal and state regulations to protect beneficiary health information. Platforms like MODRN may prove useful for emerging health challenges to facilitate evidence-based policymaking in Medicaid programs.

Subsequent Buprenorphine Treatment Following Emergency Physician Buprenorphine Prescription Fills: A National Assessment 2019 to 2020.

STUDY OBJECTIVE: Buprenorphine treatment for opioid use disorder provided in the emergency department with subsequent buprenorphine treatment by community prescribers is associated with improved outcomes, but the frequency with which this occurs is unknown. We examined the rates of subsequent buprenorphine treatment for buprenorphine-naïve individuals filling buprenorphine prescriptions from emergency physicians and initiated buprenorphine treatment and how such rates varied before and during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: Using pharmacy claims capturing an estimated 92% of prescriptions filled at US retail pharmacies, we identified buprenorphine prescriptions filled between February 1, 2019, and November 30, 2020, written by emergency physicians. In this observational study, we calculated the rate at which patients subsequently filled buprenorphine prescriptions from other nonemergency clinicians, the frequency with which subsequent filled prescriptions were from different types of prescribers, and the changes in the rates of subsequent prescriptions following the declaration of the COVID-19 public health emergency. RESULTS: We identified 22,846 prescriptions written by emergency physicians and filled by buprenorphine-naïve patients. They were most commonly paid for by Medicaid and were in metropolitan counties; 28.5% of patients subsequently filled buprenorphine prescriptions written by other clinicians. Adult primary care physicians and advanced practice providers (eg, physician assistants and nurse practitioners) were responsible for most of the subsequent prescriptions. The rates of subsequent prescriptions were 3.5% lower after the COVID-19 public health emergency declaration. CONCLUSION: The majority of patients filling buprenorphine prescriptions written by emergency physicians do not subsequently fill prescriptions written by other clinicians, and the rates of subsequent prescriptions were lower after the declaration of the COVID-19 public health emergency. These findings highlight the need for a system of care that improves buprenorphine treatment continuity of care for patients with opioid use disorder from emergency settings to community treatment providers.

Rationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans.

BACKGROUND: To address the US opioid epidemic, there is an urgent clinical need to provide persons with opioid use disorder (OUD) with effective medication treatments for OUD (MOUD). Formulations of sublingual buprenorphine/naloxone (SL-BUP/NLX) are considered the standard of care for OUD including within the Veterans Healthcare Administration (VHA). However, poor retention on MOUD undermines its effectiveness. Long-acting injectable monthly buprenorphine (INJ-BUP) (e.g., Sublocade®) has the potential to improve retention and therefore reduce opioid use and overdose. Designing and conducting studies for OUD pose unique challenges. The strategies and solutions to some of these considerations in designing Cooperative Studies Program (CSP) 2014, Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE), a randomized, 20-site, clinical effectiveness trial comparing INJ-BUP to SL-BUP/NLX conducted within the VHA may provide valuable guidance for others confronted with similar investigation challenges. METHODS: This 52-week, parallel group, open-label, randomized controlled trial (RCT) evaluates the comparative effectiveness of two current FDA-approved formulations of buprenorphine: (1) daily SL-BUP/NLX vs. (2) monthly (28-day) INJ-BUP for Veterans with moderate to severe OUD (n = 952). The primary outcomes are (1) retention in MOUD and (2) opioid abstinence. Secondary outcomes include measures of other drug use, psychiatric symptoms, medical outcomes including prevalence rates of HIV, hepatitis B and C as well as social outcomes (housing instability, criminal justice involvement), service utilization and cost-effectiveness. Special considerations in conducting a comparative effectiveness trial with this population and during COVID-19 pandemic were also included. DISCUSSION: The evaluation of the extended-release formulation of buprenorphine compared to the standard sublingual formulation in real-world VHA settings is of paramount importance in addressing the opioid epidemic. The extent to which this new treatment facilitates retention, decreases opioid use, and prevents severe sequelae of OUD has not been studied in any long-term trial to date. Positive findings in this trial could lead to widespread adoption of MOUD, and, if proven superior INJ-BUP, by clinicians throughout the VHA and beyond. This treatment has the potential to reduce opioid use among Veterans, improve medical, psychological, and social outcomes, and save lives at justifiable cost. Trial registration Registered at Clinicaltrials.gov NCT04375033.

Medication treatment for opioid use disorder and community pharmacy: Expanding care during a national epidemic and global pandemic

Medications for opioid use disorder (MOUD), such as methadone and buprenorphine, are effective strategies for treatment of opioid use disorder (OUD) and reducing overdose risk. MOUD treatment rates continue to be low across the US, and currently, some evidence suggests access to evidence-based treatment is becoming increasingly difficult for those with OUD as a result of the 2019 novel corona virus (COVID-19). A major underutilized source to address these serious challenges in the US is community pharmacy given the specialized training of pharmacists, high levels of consumer trust, and general availability for accessing these service settings. Canadian, Australian, and European pharmacists have made important contributions to the treatment and care of those with OUD over the past decades. Unfortunately, US pharmacists are not permitted to prescribe MOUD and are only currently allowed to dispense methadone for the treatment of pain, not OUD. US policymakers, regulators, and practitioners must work to facilitate this advancement of community pharmacy-based through research, education, practice, and industry. Advancing community pharmacy-based MOUD for leading clinical management of OUD and dispensation of treatment medications will afford the US a critical innovation for addressing the opioid epidemic, fallout from COVID-19, and getting individuals the care they need.

Clinical leaders and providers' perspectives on delivering medications for the treatment of opioid use disorder in Veteran Affairs' facilities.

BACKGROUND: Improving access to medication treatment of opioid use disorder (MOUD) is a national priority, yet common modifiable barriers (e.g., limited provider knowledge, negative beliefs about MOUD) often challenge implementation of MOUD delivery. To address these barriers, the VA launched a multifaceted implementation intervention focused on planning and educational strategies to increase MOUD delivery in 18 medical facilities. The purpose of this investigation was to determine if a multifaceted intervention approach to increase MOUD delivery changed providers' perceptions about MOUD over the first year of implementation. METHODS: Cross-disciplinary teams of clinic providers and leadership from primary care, pain, and mental health clinics at 18 VA medical facilities received invitations to complete an anonymous, electronic survey prior to intervention launch (baseline) and at 12- month follow-up. Responses were summarized using descriptive statistics, and changes over time were compared using regression models adjusted for gender and prescriber status, and clustered on facility. Responses to open-ended questions were thematically analyzed using a template analysis approach. RESULTS: Survey response rates at baseline and follow-up were 57.1% (56/98) and 50.4% (61/121), respectively. At both time points, most respondents agreed that MOUD delivery is important (94.7 vs. 86.9%), lifesaving (92.8 vs. 88.5%) and evidence-based (85.2 vs. 89.5%). Over one-third (37.5%) viewed MOUD delivery as time-consuming, and only 53.7% affirmed that clinic providers wanted to prescribe MOUD at baseline; similar responses were seen at follow-up (34.5 and 52.4%, respectively). Respondents rated their knowledge about OUD, comfort discussing opioid use with patients, job satisfaction, ability to help patients with OUD, and support from colleagues favorably at both time points. Respondents' ratings of MOUD delivery filling a gap in care were high but declined significantly from baseline to follow-up (85.7 vs. 73.7%, p < 0.04). Open-ended responses identified implementation barriers including lack of support to diagnose and treat OUD and lack of time. CONCLUSIONS: Although perceptions about MOUD generally were positive, targeted education and planning strategies did not improve providers' and clinical leaders' perceptions of MOUD over time. Strategies that improve leaders' prioritization and support of MOUD and address time constraints related to delivering MOUD may increase access to MOUD in non-substance use treatment clinics.

Pregnancy and the Opioid Crisis: Heightened Effects of COVID-19.

The opioid epidemic continues to affect pregnant women with opioid use disorder adversely in unique and enduring ways. The onset of the coronavirus disease 2019 (COVID-19) pandemic and the necessary public health measures implemented to slow the transmission have increased barriers to care for these same women. This commentary explores the implications of these measures and discusses strategies we have developed to manage these challenges based on our work in a clinical trial providing patient navigation to pregnant mothers with OUD. We believe these solutions can be applied in medical, behavioral health, and research settings through the pandemic and beyond to increase the quality of care and resources to this vulnerable population.

Common themes in early state policy responses to substance use disorder treatment during COVID-19.

Background: Limited research has examined how states have changed policies for treatment of substance use disorder (SUD) during the COVID-19 pandemic.Objectives: We aimed to identify themes in state policy responses to the pandemic in the context of SUD treatment. Identifying themes in policy responses provides a framework for subsequent evaluations of the relationship between state policies and health service utilization.Methods: Between May and June 2020, we searched all Single State Agencies for Substance Abuse Services (SSA) websites for statements of SUD treatment policy responses to the pandemic. We conducted Iterative Categorization of policies for outpatient programs, opioid treatment programs, and other treatment settings to identify themes in policy responses.Results: We collected 220 documents from SSA websites from 45 states and Washington D.C. Eight specific themes emerged from our content analysis: delivery of pharmacological and non-pharmacological services, obtaining informed consent and documentation for remote services, conducting health assessments, facility operating procedures and staffing requirements, and permissible telehealth technology and billing protocols. Policy changes often mirrored federal guidance, for instance, by expanding methadone take-home options for opioid treatment programs. The extent and nature of policy changes varied across jurisdictions, including telehealth technology requirements and staffing flexibility.Conclusion: States have made significant policy changes to SUD treatment policies during COVID-19, particularly regarding telehealth and facilitation of remote care. Understanding these changes could help policymakers prioritize guidance during the pandemic and for future health crises. Impacts of policies on disparate treatment populations, including those with limited technological access, should be considered.

Response to coronavirus 2019 in Veterans Health Administration facilities participating in an implementation initiative to enhance access to medication for opioid use disorder.

The actions needed to mitigate the spread of the coronavirus 2019 (COVID-19) have forged rapid paradigm shifts across healthcare delivery. In a time of crisis, continued access to and delivery of medication for opioid use disorder (M-OUD) is essential to save lives. However, prior to COVID-19, large variability in M-OUD adoption existed across the Veteran Health Administration (VHA) and it is unknown whether the COVID-19 pandemic exacerbated this divide. For the past two years, our team worked with eight VHA facilities to enhance adoption of M-OUD through a multi-component implementation intervention. This commentary explores these providers' responses to COVID-19 and the subsequent impact on their progress toward increasing adoption of M-OUD. Briefly, the loosening of regulatory restrictions fostered accelerated adoption of M-OUD, rapid support for telehealth offered a mechanism to increase M-OUD access, and reevaluation of current practices surrounding M-OUD strengthened adoption. Overall, during the COVID-19 crisis, facilities and providers responded positively to the call for increased access to M-OUD and appropriate care of patients with OUD. The VHA providers' responses and continued progress in enhancing M-OUD amidst a crisis may, in part, be attributable to their participation in an implementation effort prior to COVID-19 that established resources, expert support, and a community of practice. We anticipate the themes presented are generalizable to other healthcare systems grappling to deliver care to patients with OUD during a crisis. We propose areas of future research and quality improvement to continue to provide access and high quality, life-saving care to patients with OUD.

Medication treatment for opioid use disorder and community pharmacy: Expanding care during a national epidemic and global pandemic.

Medications for opioid use disorder (MOUD), such as methadone and buprenorphine, are effective strategies for treatment of opioid use disorder (OUD) and reducing overdose risk. MOUD treatment rates continue to be low across the US, and currently, some evidence suggests access to evidence-based treatment is becoming increasingly difficult for those with OUD as a result of the 2019 novel corona virus (COVID-19). A major underutilized source to address these serious challenges in the US is community pharmacy given the specialized training of pharmacists, high levels of consumer trust, and general availability for accessing these service settings. Canadian, Australian, and European pharmacists have made important contributions to the treatment and care of those with OUD over the past decades. Unfortunately, US pharmacists are not permitted to prescribe MOUD and are only currently allowed to dispense methadone for the treatment of pain, not OUD. US policymakers, regulators, and practitioners must work to facilitate this advancement of community pharmacy-based through research, education, practice, and industry. Advancing community pharmacy-based MOUD for leading clinical management of OUD and dispensation of treatment medications will afford the US a critical innovation for addressing the opioid epidemic, fallout from COVID-19, and getting individuals the care they need.