Impacts of the New York State COVID-19 Disaster Emergency Orders on prescription dispensing for opioids and medication for opioid use disorder.

AIMS: To examine whether the March 2020 New York State (NYS) SARS-CoV-2 Emergency Orders were associated with an initial surge in opioid dispensing and a longer-term reduction in access to medications for opioid use disorder (MOUD). DESIGN: Time-series analyses of the dispensing of non-MOUD opioid and MOUD prescriptions using IQVIA's Longitudinal Prescription Claims Database (n=16,087,429) in NYS by week, from 1/1/2018, to 7/31/2020. IQVIA is a multinational company that provides biopharmaceutical development and commercial outsourcing services. SETTING AND PARTICIPANTS: NYS Zone Improvement Plan (ZIP) Codes (n=1,218) in which prescriptions were dispensed. MEASUREMENT: For each ZIP Code, for each week, the following dispensing measures were calculated: total weekly morphine milligram equivalents/day (MME/day); total weekly MME/day dispensed via prescriptions for ≤7 days; and the count of MOUD prescriptions dispensed. Differences in dispensing metrics, comparing each week in 2020 with corresponding weeks in 2019, were calculated for each ZIP Code. RESULTS: During the study period, weekly MME/day per ZIP Code of dispensed non-MOUD opioids steadily declined. Compared with the difference in dispensing between 2019 and 2020 during the first week in 2020, there was a significantly larger drop in dispensed weekly total MME/day beginning March 21 2020 and lasting until the week of April 17 (p<0.05 for each week). Mean weekly total MME/day dispensed from March 21 to April 17, 2020 was 17.07% lower (95% confidence interval [CI] 13.97%, 20.17%) than in the 4 weeks before March 21, almost entirely due to a drop in MME/day dispensed for prescriptions of ≤7 days. There was not a discernable drop in MOUD dispensing associated with the period of the Emergency Orders. CONCLUSIONS AND RELEVANCE: New York State Emergency Orders in March 2020 to reduce SARS-CoV-2 transmission and preserve hospital capacity appeared to be associated with a decline in dispensing of opioids not used as MOUD. Access to MOUD appeared to be unaffected by the Orders, likely because of policy initiatives by the Substance Abuse and Mental Health Services Administration.

Support for COVID-19-Related Substance Use Services Policy Changes: a New York State-Wide Survey.

This study aims to describe which substance use service (SUS) organizations and who within these organizations support the maintenance of policies targeted at improving substance use treatment services. An online survey assessing respondent, organizational and program demographics, and knowledge and support regarding policy changes was distributed to all certified SUS and harm reduction programs in NYS. Bivariate and latent class analyses were used to identify patterns and associations to policy choices. Across the 227 respondents, there was a support for maintaining expansion of insurance coverage, virtual behavioral health/counseling and medication initiation/maintenance visits, reductions in prior authorizations, and access to prevention/harm reduction services. Three classes of support for policies were derived: (1) high-supporters (n = 49; 21%), (2) low-supporters (n = 66; 29%), and (3) selective-supporters. Having knowledge of policy changes was associated with membership in the high-supporters class. Implications regarding the role of knowledge in behavioral health policies dissemination structures, decision-making, and long-term expansion of SUS are discussed.

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.

COVID-19 related substance use services policy changes: Policymaker perspectives on policy development & implementation.

INTRODUCTION: Due to the COVID-19 pandemic, regulations for substance use services changed to accommodate stay-at-home orders and physical distancing guidelines. METHODS: Using in-depth interviews (N = 14) and framework analysis, we describe how policymakers developed, adopted, and implemented regulations governing services for substance use disorders during COVID-19, and how policymakers' perceived the impacts of these regulations in New York State. RESULTS: During the COVID-19 pandemic, policymakers shifted to more inclusive approaches of knowledge generation and co-production of recommendations. Barriers to adoption and implementation of new regulations included medication/services supply, lack of integration, stigma, and overcriminalization. CONCLUSION: Findings from this study highlight the potential feasibility and benefits of co-produced policies for substance use services and the need for consistent service supply, better integration with health care services, reduced stigma, improved funding structures, best practice guidelines, criminal justice reform, and harm reduction support. These considerations should inform future policy maintenance and modifications to substance use services related to COVID-19.

Medication treatment for opioid use disorder in the age of COVID-19: Can new regulations modify the opioid cascade?

The temporary loosening of regulations governing methadone and buprenorphine treatment for opioid use disorder (OUD) in the U.S., instituted to prevent the spread of COVID-19, has created an opportunity to explore the effectiveness of new models of care for people with OUD. The opioid cascade describes the current status of the treatment system, where only a fraction of people with OUD initiate effective medication treatment for OUD (MOUD), and of those only a fraction is retained in treatment. Regulatory changes-such as availability of larger take-home supplies of methadone and buprenorphine initiated via telemedicine (e.g., no initial in person visit; telemedicine buprenorphine permitted across state lines)-could modify the cascade, by reducing the burden and increasing the attractiveness, availability, and feasibility of MOUD both for people with OUD and for providers. We review examples of more liberal MOUD regimens, including the implementation of buprenorphine in France in the 1990s, primary care-based methadone in Canada, and low-threshold buprenorphine models. Research is needed to document whether new models implemented in the U.S. in the wake of COVID-19 are successful, and whether safety concerns, such as diversion and misuse, emerge. We discuss barriers to implementation, including racial and ethnic health disparities, and lack of knowledge and reluctance among potential providers of MOUD. We suggest that the urgency and public spiritedness of the response to COVID-19 be harnessed to make gains on the opioid cascade, inspiring prescribers, health systems, and communities to embrace the delivery of MOUD to meet the needs of an increasingly vulnerable population.

COVID-19, mental health, and opioid use disorder: Old and new public health crises intertwine.

The United States is facing both the coronavirus disease 2019 (COVID-19) pandemic and an ongoing epidemic of opioid overdose. Opioid use disorder is associated with other mental health problems, trauma, and social and health disparities. While the United States has acted to improve access to treatment for mental health and opioid use, research will be needed to understand the effectiveness of new policies in the context of COVID-19. (PsycInfo Database Record (c) 2020 APA, all rights reserved).