Opioid Coprescription Through Risk Mitigation Guidance and Opioid Agonist Treatment Receipt.

Importance: At the onset of the COVID-19 pandemic, the government of British Columbia, Canada, released clinical guidance to support physicians and nurse practitioners in prescribing pharmaceutical alternatives to the toxic drug supply. These alternatives included opioids and other medications under the risk mitigation guidance (RMG), a limited form of prescribed safer supply, designed to reduce the risk of SARS-CoV-2 infection and harms associated with illicit drug use. Many clinicians chose to coprescribe opioid medications under RMG alongside opioid agonist treatment (OAT). Objective: To examine whether prescription of hydromorphone tablets or sustained-release oral morphine (opioid RMG) and OAT coprescription compared with OAT alone is associated with subsequent OAT receipt. Design, Setting, and Participants: This population-based, retrospective cohort study was conducted from March 27, 2020, to August 31, 2021, included individuals from 10 linked health administrative databases from British Columbia, Canada. Individuals who were receiving OAT at opioid RMG initiation and individuals who were receiving OAT and eligible but unexposed to opioid RMG were propensity score matched at opioid RMG initiation on sociodemographic and clinical variables. Data were analyzed between January 2023 and February 2024. Exposure: Opioid RMG receipt (≥4 days, 1-3 days, or 0 days of opioid RMG dispensed) in a given week. Main Outcome and Measures: The main outcome was OAT receipt, defined as at least 1 dispensed dose of OAT in the subsequent week. A marginal structural modeling approach was used to control for potential time-varying confounding. Results: A total of 4636 individuals (2955 [64%] male; median age, 38 [31-47] years after matching) were receiving OAT at the time of first opioid RMG dispensation (2281 receiving ongoing OAT and 2352 initiating RMG and OAT concurrently). Opioid RMG receipt of 1 to 3 days in a given week increased the probability of OAT receipt by 27% in the subsequent week (adjusted risk ratio, 1.27; 95% CI, 1.25-1.30), whereas receipt of opioid RMG for 4 days or more resulted in a 46% increase in the probability of OAT receipt in the subsequent week (adjusted risk ratio, 1.46; 95% CI, 1.43-1.49) compared with those not receiving opioid RMG. The biological gradient was robust to different exposure classifications, and the association was stronger among those initiating opioid RMG and OAT concurrently. Conclusions and Relevance: This cohort study, which acknowledged the intermittent use of both medications, demonstrated that individuals who were coprescribed opioid RMG had higher adjusted probability of continued OAT receipt or reengagement compared with those not receiving opioid RMG.

Buprenorphine Prescribing and Challenges Faced Among National Health Service Corps Clinicians.

Importance: The National Health Service Corps (NHSC) Loan Repayment Program (LRP) expansion in fiscal year (FY) 2019 intended to improve access to medication for opioid use disorder (MOUD) by adding more clinicians who could prescribe buprenorphine. However, some clinicians still face barriers to prescribing, which may vary between rural and nonrural areas. Objective: To examine the growth in buprenorphine prescribing by NHSC clinicians for Medicaid beneficiaries during the NHSC LRP expansion and describe the challenges to prescribing that persist in rural and nonrural areas. Design, Setting, and Participants: This cross-sectional study analyzed preexpansion and postexpansion Medicaid claims data to evaluate the percentage of prescriptions of buprenorphine filled during FY 2017 through 2021. This study also analyzed challenges and barriers to prescribing MOUD between rural and urban areas, using results from annual surveys conducted with NHSC clinicians and sites from FY 2019 through FY 2021. Exposure: Prescribing of buprenorphine by NHSC clinicians. Main Outcomes and Measures: The main outcomes were the percentage and number of Medicaid beneficiaries with opioid use disorder (OUD) who filled a prescription for buprenorphine before and after the LRP expansion and the challenges NHSC clinicians and sites faced in providing substance use disorder and OUD services. Survey results were analyzed using descriptive statistics. Results: During FYs 2017 through 2021, 7828 NHSC clinicians prescribed buprenorphine (standard LRP: mean [SD] age, 38.1 [8.4] years and 4807 females [78.9%]; expansion LRPs: mean [SD] age, 39.4 [8.1] years and 1307 females [75.0%]). A total of 3297 NHSC clinicians and 4732 NHSC sites responded to at least 1 survey question to the 3 surveys. The overall percentage of Medicaid beneficiaries with OUD who filled a prescription for buprenorphine during the first 2.5 years post expansion increased significantly from 18.9% before to 43.7% after expansion (an increase of 123 422 beneficiaries; P < .001). The percentage more than doubled among beneficiaries living in areas with a high Social Vulnerability Index score (from 17.0% to 36.7%; an increase of 31 964) and among beneficiaries living in rural areas (from 20.8% to 55.7%; an increase of 45 523). However, 773 of 2140 clinicians (36.1%; 95% CI, 33.6%-38.6%) reported a lack of mental health services to complement medication for OUD treatment, and 290 of 1032 clinicians (28.1%; 95% CI, 24.7%-31.7%) reported that they did not prescribe buprenorphine due to a lack of supervision, mentorship, or peer consultation. Conclusions and Relevance: These findings suggest that although the X-waiver requirement has been removed and Substance Abuse and Mental Health Services Administration guidelines encourage all eligible clinicians to screen and offer patients with OUD buprenorphine, as permissible by state law, more trained health care workers and improved care coordination for counseling and referral services are needed to support comprehensive OUD treatment.

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.

Exploring dual diagnosis in opioid agonist treatment patients: a registry-linkage study in Czechia and Norway.

BACKGROUND: Knowledge of co-occurring mental disorders (termed 'dual diagnosis') among patients receiving opioid agonist treatment (OAT) is scarce. This study aimed (1) to estimate the prevalence and structure of dual diagnoses in two national cohorts of OAT patients and (2) to compare mental disorders between OAT patients and the general populations stratified on sex and standardized by age. METHODS: A registry-linkage study of OAT patients from Czechia (N = 4,280) and Norway (N = 11,389) during 2010-2019 was conducted. Data on mental disorders (F00-F99; ICD-10) recorded in nationwide health registers were linked to the individuals registered in OAT. Dual diagnoses were defined as any mental disorder excluding substance use disorders (SUDs, F10-F19; ICD-10). Sex-specific age-standardized morbidity ratios (SMR) were calculated for 2019 to compare OAT patients and the general populations. RESULTS: The prevalence of dual diagnosis was 57.3% for Czechia and 78.3% for Norway. In Czechia, anxiety (31.1%) and personality disorders (25.7%) were the most prevalent, whereas anxiety (33.8%) and depression (20.8%) were the most prevalent in Norway. Large country-specific variations were observed, e.g., in ADHD (0.5% in Czechia, 15.8% in Norway), implying differences in screening and diagnostic practices. The SMR estimates for any mental disorders were 3.1 (females) and 5.1 (males) in Czechia and 5.6 (females) and 8.2 (males) in Norway. OAT females had a significantly higher prevalence of co-occurring mental disorders, whereas SMRs were higher in OAT males. In addition to opioid use disorder (OUD), other substance use disorders (SUDs) were frequently recorded in both countries. CONCLUSIONS: Results indicate an excess of mental health problems in OAT patients compared to the general population of the same sex and age in both countries, requiring appropriate clinical attention. Country-specific differences may stem from variations in diagnostics and care, reporting to registers, OAT provision, or substance use patterns.

Buprenorphine dispensing before and after the April 2021 X-Waiver exemptions: An interrupted time series analysis.

BACKGROUND: Until the end of 2022, a special registration, known as the X-waiver, was required to prescribe buprenorphine in the US. Before its removal, US federal regulations trialed an X-waiver exemption, initiated on April 28, 2021, which permitted buprenorphine prescribing for up to 30 patients without additional training. We aimed to understand if these regulatory changes impacted buprenorphine dispensing. METHODS: We conducted an interrupted time series analysis to understand changes in buprenorphine dispensing during the 26 weeks after the X-waiver exemption compared to the expected baseline trend established in the 26 weeks before using the IQVIA Longitudinal Prescription claims database. The primary outcome was number of new buprenorphine prescribers nationwide (defined as no prior buprenorphine prescription dispensed in the last 26 weeks). Segmented regression estimated relative changes in buprenorphine dispensing at 1, 13, and 26 weeks post-X-waiver change. RESULTS: A total of 15,517,525 prescriptions filled for 1,328,172 patients (43.4 % female) ordered by 62,312 providers were included for analysis. At 26 weeks post-X-waiver change, there was no change in the number of new prescribers compared to the expected baseline trend (-2.7 % [95 % CI:-8.3,2.9]). The number of new (15.2 % [4.6,25.8]) and existing (1.7 % [0.9,2.4]) patients and patients per prescriber (4.3 % [3,5.6]) increased. Buprenorphine prescriptions reimbursed by Medicaid increased (7.5 % [6.6,8.4]) while commercial fills decreased (-3.4 % [-5.3,-1.5]). CONCLUSIONS: The number of new prescribers did not increase six months post-X-waiver exemption while new patients continued to enter treatment at higher-than-expected rates. These findings suggest that additional interventions beyond the recent X-waiver removal may be needed to increase access to buprenorphine.

Factors associated with receipt of medication for opioid use disorder among pregnant individuals entering treatment programs in the U.S.

BACKGROUND: Opioid use disorder (OUD) among pregnant individuals in the U.S. has been on the rise, and carries significant health risks if left untreated. Despite the effectiveness of medication for opioid use disorder (MOUD), rates of treatment utilization remain low, and access varies by state. This study seeks to expand on what is known about the utilization of MOUD by estimating annual percentages of MOUD use among treatment admissions among pregnant individuals across all 50 states and U.S. regions. The study also examines how pregnant people experiencing OUD are referred to substance use treatment programs to better understand which referral sources are most effective at linking them to MOUD. METHODS: This study estimated MOUD utilization among pregnant admissions over a 9-year period, identifying trends in the use of this treatment, using national and state level data from the Treatment Episode Dataset-Admissions (TEDS-A). The sample were pregnant females who admitted to treatment with opioids as a primary substance use problem, in all 50 states, from 2010 to 2018. The study examined the referral pathways through which pregnant individuals enter treatment, identifying variations in how they are linked with MOUD. A binary logistic regression was conducted to estimate significant sociodemographic characteristics and referral sources associated with MOUD receipt in treatment. RESULTS: Among admissions who reported both pregnancy and OUD across nine years (n= 84,492), the average percentage of MOUD use was 50.8%. Average annual MOUD use was highest in the Northeast region (63.42%), and lowest in the South (34.01%). Maine had the highest MOUD use, for an average of 81.99% across all years. Pregnant individuals who were self-referred to treatment comprised the largest percentage of admissions leading to MOUD use (62.1%), and those referred by the criminal justice system or other legal entity resulted in the lowest MOUD use across years (23.6%). Binary logistic regression results found that race, education, employment status, and referral source were significantly associated with MOUD receipt in 2018; specifically, individuals with a higher education, those were unemployed, and those who were referred to treatment by another substance use or healthcare provider or from the criminal or legal system, were significantly less likely to receive MOUD. CONCLUSION: This study estimated that an average of approximately half of admissions who were pregnant with OUD received MOUD as part of their treatment plans, and identified regional and state trends which can be further investigated to understand factors contributing to these geographical variations in MOUD access. Also notable were findings pertaining to low MOUD receipt among those referred from criminal or legal entities, warranting further investigation. These findings can lead to a better understanding of which referral sources to treatment can act as effective pathways to MOUD, and best practices to link pregnant individuals with evidence-based care.

Association Between Increased Dispensing of Opioid Agonist Therapy Take-Home Doses and Opioid Overdose and Treatment Interruption and Discontinuation.

Importance: During the COVID-19 pandemic, modified guidance for opioid agonist therapy (OAT) allowed prescribers to increase the number of take-home doses to promote treatment retention. Whether this was associated with an increased risk of overdose is unclear. Objective: To evaluate whether increased take-home doses of OAT early in the COVID-19 pandemic was associated with treatment retention and opioid-related harm. Design, Setting, and Participants: A retrospective propensity-weighted cohort study of 21 297 people actively receiving OAT on March 21, 2020, in Ontario, Canada. Changes in OAT take-home dose frequency were assessed between March 22, 2020, and April 21, 2020, and individuals were observed for up to 180 days to assess outcomes (last date of follow-up, October 18, 2020). Exposures: Exposure was defined as extended take-home doses in the first month of the pandemic within each of 4 cohorts based on OAT type and baseline take-home dose frequency (daily dispensed methadone, 5-6 take-home doses of methadone, daily dispensed buprenorphine/naloxone, and 5-6 take-home doses of buprenorphine/naloxone). Main Outcomes and Measures: Primary outcomes were opioid overdose, interruption in OAT, and OAT discontinuation. Results: Among 16 862 methadone and 4435 buprenorphine/naloxone recipients, the median age ranged between 38 and 42 years, and 29.1% to 38.2% were women. Among individuals receiving daily dispensed methadone (n = 5852), initiation of take-home doses was significantly associated with lower risks of opioid overdose (6.9% vs 9.5%/person-year; weighted hazard ratio [HR], 0.73 [95% CI, 0.56-0.96]), treatment discontinuation (51.0% vs 63.6%/person-year; weighted HR, 0.80 [95% CI, 0.72-0.90]), and treatment interruption (19.0% vs 23.9%/person-year; weighted HR, 0.80 [95% CI, 0.67-0.95]) compared with no change in take-home doses. Among individuals receiving daily dispensed buprenorphine/naloxone (n = 662), there was no significant difference in any outcomes between exposure groups. Among individuals receiving weekly dispensed OAT (n = 11 010 for methadone; n = 3773 for buprenorphine/naloxone), extended take-home methadone doses were significantly associated with lower risks of OAT discontinuation (14.1% vs 19.6%/person-year; weighted HR, 0.72 [95% CI, 0.62-0.84]) and interruption in therapy (5.1% vs 7.4%/person-year; weighted HR, 0.69 [95% CI, 0.53-0.90]), and extended take-home doses of buprenorphine/naloxone were significantly associated with lower risk of interruption in therapy (9.5% vs 12.9%/person-year; weighted HR, 0.74 [95% CI, 0.56-0.99]) compared with no change in take-home doses. Other primary outcomes were not significantly different between groups. Conclusions and Relevance: In Ontario, Canada, during the COVID-19 pandemic, dispensing of increased take-home doses of opioid agonist therapy was significantly associated with lower rates of treatment interruption and discontinuation among some subsets of patients receiving opioid agonist therapy, and there were no statistically significant increases in opioid-related overdoses over 6 months of follow-up. These findings may be susceptible to residual confounding and should be interpreted cautiously.

Individual and Health Policy Factors Associated With Positive Heroin and Opioid Treatment Response: United States, 2018.

Objectives. To identify client- and state-level factors associated with positive treatment response among heroin and opioid treatment episodes in the United States. Methods. We used national data from 46 states using the Treatment Episode Dataset‒Discharges (2018) to identify heroin and opioid treatment episodes (n = 162 846). We defined positive treatment response as a decrease in use between admission and discharge. We used multivariable regression, stratified by race/ethnicity, to identify demographic, pain-related, and state-level factors associated with positive treatment response. Results. Lower community distress was the strongest predictor of better treatment outcomes across all racial/ethnic groups, particularly among White and American Indian/Alaska Native episodes. A primary opioid of heroin was associated with worse outcomes among White and Hispanic episodes. Legislation limiting opioid dispensing was associated with better outcomes among Hispanic episodes. Buprenorphine availability was strongly associated with better outcomes among Black episodes. Conclusions. State-level variables, particularly community distress, had greater associations with positive treatment outcomes than client-level variables. Public Health Implications. Changes in state-level policies and increased resources directed toward areas of high community distress have the potential to improve opioid use disorder treatment and reduce racial/ethnic disparities in treatment outcomes. (Am J Public Health. 2022;112(S1):S66-S76. https://doi.org/10.2105/AJPH.2021.306503).

Availability of Medications for the Treatment of Opioid Use Disorder Among Pregnant and Postpartum Individuals in US Jails.

Importance: Thousands of pregnant people with opioid use disorder (OUD) enter US jails annually, yet their access to medications for OUD (MOUD) that meet the standard of care (methadone and/or buprenorphine) is unknown. Objective: To assess the availability of MOUD for the treatment of pregnant individuals with OUD in US jails. Design, Setting, and Participants: In this cross-sectional study, electronic and paper surveys were sent to all 2885 identifiable US jails verified in the National Jails Compendium between August 19 and November 7, 2019. Respondents were medical and custody leaders within the jails. Main Outcomes and Measures: The primary outcome was the availability of MOUD (methadone and/or buprenorphine) for the treatment of pregnant people with OUD in US jails. Availability of MOUD was assessed based on (1) continuation of MOUD for pregnant incarcerated individuals (if the individual was receiving MOUD before incarceration), with or without initiation of MOUD; (2) both initiation and continuation of MOUD for pregnant individuals; (3) only continuation of MOUD for pregnant individuals; and (4) management of opioid withdrawal for pregnant individuals. Secondary outcomes included MOUD availability during the postpartum period and logistical factors associated with the provision of MOUD. Multivariate logistic regression analysis was used to assess factors associated with MOUD availability during pregnancy. Results: Among 2885 total surveys sent, 1139 (39.5%) were returned; of those, 836 surveys (73.4%; 29.0% of all surveys sent) could be analyzed, with similar proportions from metropolitan (399 jails [47.7%]) and rural (381 jails [45.6%]) settings. Overall, 504 jails (60.3%) reported that MOUD was available for medication continuation, with or without medication initiation, during pregnancy. Of those, 267 jails (53.0%; 31.9% of surveys included in the analysis) both initiated and continued MOUD, and 237 jails (47.0%; 28.3% of surveys included in the analysis) only continued MOUD; 190 of 577 jails (32.9%; 22.7% of surveys included in the analysis) reported opioid withdrawal as the only management for pregnant people with OUD. Among the 504 medication-providing jails, only 120 (23.8%) continued to provide MOUD during the postpartum period. Methadone was more commonly available at jails that only continued MOUD (84 of 123 jails [68.3%]), whereas buprenorphine was more commonly available at jails that both initiated and continued MOUD (73 of 119 jails [61.3%]). In an adjusted model, jails with higher odds of MOUD availability were located in the Northeast (odds ratio [OR], 10.72; 95% CI, 2.43-47.36) or metropolitan areas (OR, 1.92; 95% CI, 1.31-2.83), had private health care contracts (OR, 1.49; 95% CI, 1.03-2.14) and a higher number of women (≥70) reported in the female census (OR, 1.69; 95% CI, 1.02-2.80), and provided pregnancy testing within 2 weeks of arrival at the jail (OR, 2.66; 95% CI, 1.69-4.17). Conclusions and Relevance: In this cross-sectional study, a substantial proportion of US jails did not provide access to MOUD to pregnant people with OUD. Although most jails reported continuing to provide MOUD to individuals who were receiving medication before incarceration, few jails initiated MOUD, and most medication-providing jails discontinued MOUD during the postpartum period. These results suggest that many pregnant and postpartum people with OUD in US jails do not receive medication that is the standard of care and are required to endure opioid withdrawal, signaling an opportunity for intervention to improve care for pregnant people who are incarcerated.

Accessibility to Medication for Opioid Use Disorder After Interventions to Improve Prescribing Among Nonaddiction Clinics in the US Veterans Health Care System.

Importance: With increasing rates of opioid use disorder (OUD) and overdose deaths in the US, increased access to medications for OUD (MOUD) is paramount. Rigorous effectiveness evaluations of large-scale implementation initiatives using quasi-experimental designs are needed to inform expansion efforts. Objective: To evaluate a US Department of Veterans Affairs (VA) initiative to increase MOUD use in nonaddiction clinics. Design, Setting, and Participants: This quality improvement initiative used interrupted time series design to compare trends in MOUD receipt. Primary care, pain, and mental health clinics in the VA health care system (n = 35) located at 18 intervention facilities and nonintervention comparison clinics (n = 35) were matched on preimplementation MOUD prescribing trends, clinic size, and facility complexity. The cohort of patients with OUD who received care in intervention or comparison clinics in the year after September 1, 2018, were evaluated. The preimplementation period extended from September 1, 2017, through August 31, 2018, and the postimplementation period from September 1, 2018, through August 31, 2019. Exposures: The multifaceted implementation intervention included education, external facilitation, and quarterly reports. Main Outcomes and Measures: The main outcomes were the proportion of patients receiving MOUD and the number of patients per clinician prescribing MOUD. Segmented logistic regression evaluated monthly proportions of MOUD receipt 1 year before and after initiative launch, adjusting for demographic and clinical covariates. Poisson regression models examined yearly changes in clinician prescribing over the same time frame. Results: Overall, 7488 patients were seen in intervention clinics (mean [SD] age, 53.3 [14.2] years; 6858 [91.6%] male; 1476 [19.7%] Black, 417 [5.6%] Hispanic; 5162 [68.9%] White; 239 [3.2%] other race [including American Indian or Alaska Native, Asian, Native Hawaiian or other Pacific Islander, and multiple races]; and 194 [2.6%] unknown) and 7558 in comparison clinics (mean [SD] age, 53.4 [14.0] years; 6943 [91.9%] male; 1463 [19.4%] Black; 405 [5.4%] Hispanic; 5196 [68.9%] White; 244 [3.2%] other race; 250 [3.3%] unknown). During the preimplementation year, the proportion of patients receiving MOUD in intervention clinics increased monthly by 5.0% (adjusted odds ratio [AOR], 1.05; 95% CI, 1.03-1.07). Accounting for this preimplementation trend, the proportion of patients receiving MOUD increased monthly by an additional 2.3% (AOR, 1.02; 95% CI, 1.00-1.04) during the implementation year. Comparison clinics increased by 2.6% monthly before implementation (AOR, 1.03; 95% CI, 1.01-1.04), with no changes detected after implementation. Although preimplementation-year trends in monthly MOUD receipt were similar in intervention and comparison clinics, greater increases were seen in intervention clinics after implementation (AOR, 1.04; 95% CI, 1.01-1.08). Patients treated with MOUD per clinician in intervention clinics saw greater increases from before to after implementation compared with comparison clinics (incidence rate ratio, 1.50; 95% CI, 1.28-1.77). Conclusions and Relevance: A multifaceted implementation initiative in nonaddiction clinics was associated with increased MOUD prescribing. Findings suggest that engagement of clinicians in general clinical settings may increase MOUD access.

Improving methadone access for rural communities in the USA: lessons learned from COVID-19 adaptations and international models of care.

CONTEXT: The COVID-19 pandemic led to several changes to methadone treatment protocols at federal opioid treatment programs in the USA. ISSUE: Protocol changes were designed to reduce transmission of COVID-19 while allowing for continuity of care, but those changes also demonstrated that many policies surrounding opioid use disorder care in the USA cause unnecessary burdens to patients. In this commentary, we describe how current policies create and maintain fatal barriers to methadone treatment for people in rural communities who have opioid use disorder, and highlight how COVID-19 adaptations and more flexible methadone models in other countries can better allow for effective and accessible care. Reasons and ways to address these issues to create lasting solutions for rural communities are discussed. LESSONS LEARNED: We focus on three lessons: (1) methadone dispensing and take-home schedules during COVID-19, (2) telehealth services during COVID-19, and (3) international models in use prior to COVID-19. We then outline recommendations for each lesson to improve access to methadone treatment long term for rural communities in the USA. There is an urgent need to implement recommendations that maintain flexible approaches and address methadone treatment barriers in the rural USA. To achieve lasting health policy change and combat stigma about addiction and methadone treatment, there is a need for advocacy efforts that give voice to rural residents impacted by inequitable access to methadone treatment and rural-tailored educational initiatives that promote the evidence base for methadone. We hope opioid treatment program directors, regulatory authorities, and health policymakers consider our recommendations.

Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder.

PURPOSE: To evaluate real-world prescription digital therapeutic (PDT) use and associated clinical outcomes among patients with opioid use disorder (OUD). PATIENTS AND METHODS: A real-world observational evaluation of patients who filled either a 12- or 24-week (refill) prescription for the reSET-O® PDT. The PDT content consists of 67 interactive lessons unlocked in sequence during use as well as the chance to earn rewards for progress and/or negative urine screens. Engagement/retention data (ongoing engagement in weeks 9-12, or 21-24) were collected via the PDT and analyzed with descriptive statistics. Substance use was evaluated as a composite of patient self-reports and urine drug screens (UDS). Missing UDS data were assumed to be positive. A regression analyses of hospital encounters for 12- vs. 24-week prescriptions controlling for covariates was conducted. RESULTS: In a cohort of 3,817 individuals with OUD who completed a 12-week PDT prescription, a cohort of 643 was prescribed a second 12-week 'refill' prescription, for a total treatment time of 24 weeks. Mean age of the 24-week cohort was 39 years, 56.7% female. At 24 weeks of total treatment: abstinence in the last 4 weeks of treatment was 86% in an analysis in which patients with no data are assumed to be positive for illicit opioids. Over 91% of patients were retained in treatment. An analysis of matched insurance claims showed that those treated for 24 weeks had a 27% decrease in unique hospital encounters compared to those who got the first 12-week prescription only. CONCLUSIONS: These data present real-world evidence that a second prescription (24 weeks) of a PDT for OUD is associated with improved outcomes, high levels of retention, and fewer hospital encounters compared to a single prescription for a PDT.PLAIN LANGUAGE SUMMARYPrescription digital therapeutics (PDTs) are software-based treatments that are FDA-authorized to improve clinical outcomes for serious diseases and conditions. The reSET-O PDT consists of 67 interactive lessons unlocked in sequence during use as well as the chance to earn rewards for progress and/or negative urine screens. Multiple studies show that a single 12-week PDT prescription for opioid use disorder (OUD) helps patients engage in treatment, reduces substance use, and helps patients remain in treatment, but to date there has been no evaluation of how patients who receive a 'refill' second prescription engage with the therapeutic and whether the positive effects on substance use and retention are durable across a second 12 weeks (total of 24 weeks) of treatment.This real-world analysis evaluated 643 patients from 12 U.S. states who were prescribed a second PDT prescription. 93% of this cohort completed 8 or more core lesson modules in the second prescription period, 85% completed at least half of core modules, and 64% completed all 32 core modules. Patients used the PDT outside of clinic hours about 40% of the time. 94.4% of patients had 80% or greater negative reports of opioid use across the second 12 weeks of treatment. A 27% decrease in unique hospital encounters was observed in patients who completed a second prescription vs. patients who completed only one prescription.These data show that a second prescription of a PDT for OUD is associated with postive patient outcomes. Patients showed durable and high levels of engagement with the PDT, reduced substance use, and improved treatment retention through 24 weeks of treatment.

A comparison of methods for measuring spatial access to health care.

OBJECTIVE: To compare measures of spatial access to care commonly used by policy makers and researchers with the more comprehensive enhanced two-step floating catchment area (E2SFCA) method. STUDY SETTING: Fourteen southwestern Pennsylvania counties. STUDY DESIGN: We estimated spatial access to buprenorphine-waivered prescribers using three commonly used measures-Euclidean travel distance to the closest prescriber, travel time to the closest provider, and provider-to-population ratios-and the E2SFCA. Unlike other measures, the E2SFCA captures provider capacity, potential patient volume, and travel time to prescribers. DATA COLLECTION/EXTRACTION METHODS: We measured provider capacity as the number of buprenorphine prescribers listed at a given address in the Drug Enforcement Agency's 2020 Controlled Substances Act Registrants Database, and we measured potential patient volume as the number of nonelderly adults in a given census tract as reported by the 2018 American Community Survey. We estimated travel times between potential patients and prescribers with Bing Maps and Mapbox application programming interfaces. We then calculated each spatial access measure using the R programming language. We used each measure of spatial access to identify census tracts in the lowest quintile of spatial access to prescribers. PRINCIPAL FINDINGS: The Euclidean distance, travel time, and provider-to-population ratio measures identified 48.3%, 47.2%, and 69.9% of the census tracts that the E2SFCA measure identified as being in the lowest quintile of spatial access to care, meaning that these measures misclassify 30%-52% of study area census tracts as having sufficient spatial access to buprenorphine prescribers. CONCLUSIONS: Measures of spatial access commonly used by policy makers do not sufficiently accurately identify geographic areas with relatively low access to prescribers of buprenorphine. Using the E2SFCA in addition to the commonly used measures would allow policy makers to precisely target interventions to increase spatial access to opioid use disorder treatment and other types of health care services.

Real-world changes in US health system hospital-based services following treatment with a prescription digital therapeutic for opioid use disorder.

Outcomes associated with buprenorphine therapy for the treatment of opioid use disorder (OUD) are suboptimal. reSET-O is an FDA-authorized prescription digital therapeutic (PDT) delivering neurobehavioral therapy via mobile devices to patients with OUD treated with buprenorphine. This analysis evaluated the net impact of reSET-O on medical costs among actively-engaged reSET-O patients using real-world observations. This real-world retrospective analysis of health care claims between October 2018 and October 2019 evaluated health care resource utilization up to 6 months before and 6 months after the initiation of a reSET-O prescription after accounting for the subset of patients not continuing on therapy after week 1 (non-engaged patients). Repeated-measures negative binomial models compared incidences of hospital-based encounters/procedures adjusted for days in each period as well as associated costs. The number needed to treat (NNT) to avoid an inpatient visit was calculated. Of the 351 patients who were prescribed reSET-O, 321 met the criteria of active engagement. Treatment with reSET-O was associated with a substantial reduction in medical costs of -$765,450 (-$2,385/patient, $235/patient greater than a previous analysis in which non-engaged patients were included) in the 6-month period after initiation. The gross reSET-O prescription cost of $584,415 ($1,665/patient) was substantially offset by $49,950 ($142.31/patient) in refunds to payers. The medical cost reduction in engaged patients offset the cost of the therapeutic resulting in an overall cost reduction of -$230,985 in this cohort (net savings of -$720 per patient). The number needed to treat to avoid an inpatient visit was 4.8. Engagement and continued treatment with reSET-O in patients with OUD treated with buprenorphine is associated with substantial real-world reductions in medical costs in the 6-month period following the initiation of the reSET-O prescription.

Is telemedicine the answer to rural expansion of medication treatment for opioid use disorder? Early experiences in the feasibility study phase of a National Drug Abuse Treatment Clinical Trials Network Trial.

Telemedicine (TM) enabled by digital health technologies to provide medical services has been considered a key solution to increasing health care access in rural communities. With the immediate need for remote care due to the COVID-19 pandemic, many health care systems have rapidly incorporated digital technologies to support the delivery of remote care options, including medication treatment for individuals with opioid use disorder (OUD). In responding to the opioid crisis and the COVID-19 pandemic, public health officials and scientific communities strongly support and advocate for greater use of TM-based medication treatment for opioid use disorder (MOUD) to improve access to care and have suggested that broad use of TM during the pandemic should be sustained. Nevertheless, research on the implementation and effectiveness of TM-based MOUD has been limited. To address this knowledge gap, the National Drug Abuse Treatment Clinical Trials Network (CTN) funded (via the NIH HEAL Initiative) a study on Rural Expansion of Medication Treatment for Opioid Use Disorder (Rural MOUD; CTN-0102) to investigate the implementation and effectiveness of adding TM-based MOUD to rural primary care for expanding access to MOUD. In preparation for this large-scale, randomized controlled trial incorporating TM in rural primary care, a feasibility study is being conducted to develop and pilot test implementation procedures. In this commentary, we share some of our experiences, which include several challenges, during the initial two-month period of the feasibility study phase. While these challenges could be due, at least in part, to adjusting to the COVID-19 pandemic and new workflows to accommodate the study, they are notable and could have a substantial impact on the larger, planned pragmatic trial and on TM-based MOUD more broadly. Challenges include low rates of identification of risk for OUD from screening, low rates of referral to TM, digital device and internet access issues, workflow and capacity barriers, and insurance coverage. These challenges also highlight the lack of empirical guidance for best TM practice and quality remote care models. With TM expanding rapidly, understanding implementation and demonstrating what TM approaches are effective are critical for ensuring the best care for persons with OUD.

Medication Treatment of Active Opioid Use Disorder in Veterans With Cirrhosis.

INTRODUCTION: Although opioid use disorder (OUD) is common in patients with cirrhosis, it is unclear how medication treatment for OUD (MOUD) is used in this population. We aimed to assess the factors associated with MOUD and mortality in a cohort of Veterans with cirrhosis and OUD. METHODS: Within the Veterans Health Administration Corporate Data Warehouse, we developed a cohort of Veterans with cirrhosis and active OUD, using 2 outpatient or 1 inpatient International Classification of Diseases, ninth revision codes from 2011 to 2015 to define each condition. We assessed MOUD initiation with methadone or buprenorphine over the 180 days following the first OUD International Classification of Diseases, ninth revision code in the study period. We fit multivariable regression models to assess the association of sociodemographic and clinical factors with receiving MOUD and the associations between MOUD and subsequent clinical outcomes, including new hepatic decompensation and mortality. RESULTS: Among 5,600 Veterans meeting criteria for active OUD and cirrhosis, 722 (13%) were prescribed MOUD over 180 days of follow-up. In multivariable modeling, MOUD was significantly, positively associated with age (adjusted odds ratio [AOR] per year: 1.04, 95% confidence interval (CI): 1.01-1.07), hepatitis C virus (AOR = 2.15, 95% CI = 1.37-3.35), and other substance use disorders (AOR = 1.47, 95% CI = 1.05-2.04) negatively associated with alcohol use disorder (AOR = 0.70, 95% CI = 0.52-0.95), opioid prescription (AOR = 0.51, 95% CI = 0.38-0.70), and schizophrenia (AOR = 0.59, 95% CI = 0.37-0.95). MOUD was not significantly associated with mortality (adjusted hazards ratio = 1.20, 95% CI = 0.95-1.52) or new hepatic decompensation (OR = 0.57, CI = 0.30-1.09). DISCUSSION: Few Veterans with active OUD and cirrhosis received MOUD, and those with alcohol use disorder, schizophrenia, and previous prescriptions for opioids were least likely to receive these effective therapies.

Chronic Pain Among Patients With an Opioid Use Disorder.

BACKGROUND AND OBJECTIVES: Chronic pain is not well understood in opioid-dependent populations. We report the prevalence of chronic pain and pain characteristics in an opioid-dependent population by treatment type and gender. METHODS: This cross-sectional study opportunistically recruited 569 patients (32% women) receiving treatment for opioid use disorder (DSM-5) in Norway during 2016-2018 (83% received opioid maintenance treatment, 17% received treatment without medication). We asked about chronic pain (≥3 months; ICD-11), pain severity (NRS-11), and other pain characteristics. RESULTS: Overall, 55% reported chronic pain (≥3 months), with a higher prevalence among women (61% vs 52%, P = .041) and patients receiving methadone (66%) compared with buprenorphine or no medication (46% and 45%, P < .001). Chronic pain was associated with higher age (P < .001) and higher doses of methadone (P = .048). The average duration of pain was 11 years. The most frequently reported pain locations were the lower extremities (59%) and the back (54%), and 69% reported more than one pain location. Constant pain and migrating pain were significantly associated with both moderate (adjusted odds ratio [aOR]: 2.04, confidence interval [CI]: 1.12-3.74 and aOR: 2.44, CI: 1.09-5.43) and severe pain intensity (aOR: 2.08, CI: 1.14-3.80 and aOR: 2.46, CI: 1.10-5.47). Reporting no effect of analgesics was associated with severe pain intensity (aOR: 0.54, CI: 0.29-0.99). CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Over half reported chronic pain, and rates were highest among women and patients receiving methadone. New contributions to the field are descriptions of pain characteristics by gender and pain severity, and interactions between medication type and age. (© 2021 The Authors. The American Journal on Addictions published by Wiley Periodicals LLC on behalf of The American Academy of Addiction Psychiatry). (Am J Addict 2021;00:00-00).

Predictors of Initiation of Medication for Opioid Use Disorder and Retention in Treatment Among U.S. Pregnant Women, 2013-2017.

OBJECTIVE: To describe trends and factors associated with medication administration for opioid use disorder (OUD) and retention in treatment among pregnant women with OUD. METHODS: This is a retrospective, nationwide, cross-sectional analysis of treatment episodes for primary OUD among pregnant women from 2013 to 2017. The primary outcome was initiation of methadone, buprenorphine, or naltrexone. Secondary outcomes were retention in treatment defined as length of treatment episode lasting six months or greater, and completion of treatment. Descriptive statistics and logistic regression were applied to describe trends in, and identify factors associated with the outcomes. RESULTS: There were 42,239 treatment episodes for primary OUD among pregnant women who reported using heroin (65.0%, 27,459), synthetic opioid (33.2%, 14,034), or nonprescribed methadone (1.8%, 746) between 2013 and 2017. Medications for OUD were administered in 47.4% (20,013) of episodes. Retention in treatment occurred in 16.6% of episodes without medications for OUD, and 37.8% of episodes with medications for OUD (P=.01). The rate of medication administration for OUD increased from 41.0% in 2013 to 52.0% in 2017; however, retention rates declined from 39.0% to 33.0% among treatment episodes with medication for OUD. History of at least one prior treatment episode was associated with both administration of medications for OUD and retention in treatment. CONCLUSION: In spite of current guidelines, most treatment episodes for OUD during pregnancy did not involve administration of medications for OUD. Although administration of medications for OUD has improved over time, retention in treatment is lagging. These findings highlight gaps in the U.S. addiction care system.

Impacts of the COVID-19 pandemic on healthcare access among patients receiving medication for opioid use disorder.

BACKGROUND: The COVID-19 pandemic significantly altered treatment delivery for opioid treatment programs (OTPs) dispensing medications for opioid use disorder (MOUD). We aimed to identify patterns of substance use among MOUD patients and examine whether COVID-19-related impacts on access to healthcare varied across subgroups. METHODS: This analysis was embedded within a type 3 hybrid trial that enrolled patients across eight OTPs at the start of the pandemic. Enrolled patients reported on past-30 day use of multiple substances during their baseline assessment. Participants re-contacted in May-July 2020 completed a survey about COVID-19-related impacts on various life domains. Using latent class analysis we identified patient subgroups, and then examined group differences on a set of negative and positive COVID-19 impacts related to healthcare access. RESULTS: Of the 188 trial participants, 135 (72 %) completed the survey. Latent class analysis identified three MOUD patient subgroups: minimal use (class probability: 0.25); opioid use (class probability: 0.34); and polysubstance use (class probability: 0.41). Compared to the minimal use group, the polysubstance use group reported increased substance use and difficulty accessing sterile needles, naloxone, and preferred substance. The opioid use group reported increased substance use and difficulty accessing their preferred substance. There were no significant group differences related to accessing routine or specialized healthcare or medication; or paying attention to their health. CONCLUSIONS: During COVID-19, many MOUD patients reported challenges accessing care, particularly harm reduction services for patients with polysubstance use. Additional efforts, like providing wraparound support, may be necessary to serve the needs of MOUD patients.