Characteristics and Prescribing Patterns of Clinicians Waivered to Prescribe Buprenorphine for Opioid Use Disorder Before and After Release of New Practice Guidelines.

Importance: In April 2021, the US Department of Health and Human Services (HHS) released practice guidelines exempting educational requirements to obtain a Drug Addiction Treatment Act (DATA) waiver to treat up to 30 patients with opioid use disorder with buprenorphine. Objective: To compare demographic and practice characteristics of clinicians who received traditional DATA waivers before and after release of the education-exempted HHS practice guidelines and those who were approved under the guidelines. Design, Setting, and Participants: This survey study was conducted electronically from February 1 to March 1, 2022. Eligible survey recipients were US clinicians who obtained an initial DATA waiver between April 2020 and November 2021. Exposure: DATA waiver approval pathway. Main Outcome and Measures: The outcomes were clinician demographic and practice characteristics, buprenorphine prescribing barriers, and strategies to treat patients with opioid use disorder, measured using χ2 tests and z tests to assess for differences among the waivered groups. Results: Of 23 218 eligible clinicians, 4519 (19.5%) responded to the survey. This analysis was limited to 2736 respondents with a 30-patient limit at the time of survey administration who identified their DATA waiver approval pathway. Among these respondents, 1365 (49.9%; female, 831 [61.9%]; male, 512 [38.1%]) received their DATA waiver prior to the education-exempted practice guidelines (prior DATA waiver), 550 (20.1%; female, 343 [63.4%]; male, 198 [36.6%]) received their waiver after guidelines were released but met education requirements (concurrent DATA waiver), and 821 (30.0%; female, 396 [49.2%]; male, 409 [50.8%]) received the waiver under the education-exempted guidelines (practice guidelines). Among practice guidelines clinicians, 500 (60.9%) reported that traditional DATA waiver educational requirements were a reason for not previously obtaining a waiver. Demographic and practice characteristics differed by waiver approval type. Across all groups, a large minority had not prescribed buprenorphine since obtaining a waiver (prior DATA waiver, 483 [35.7%]; concurrent DATA waiver, 226 [41.2%]; practice guidelines, 359 [44.3%]; P < .001). Clinicians who prescribed buprenorphine in the past 6 months reported treating few patients in an average month: 27 practice guidelines clinicians (6.0%) prescribed to 0 patients and 338 (75.1%) to 1 to 4 patients compared with 16 (2.2%) and 435 (59.9%) for prior and 11 (3.6%) and 166 (55.0%) for concurrent DATA waiver clinicians, respectively (P < .001). Across waiver types, clinicians reported multiple challenges to buprenorphine prescribing. Conclusions and Relevance: In this survey of DATA-waivered clinicians, clinician- and systems-level challenges that limit buprenorphine prescribing were observed, even among clinicians approved under the education-exempted guidelines pathway. The findings suggest that as implementation of legislation removing the DATA waiver begins, addressing these barriers could be essential to increasing buprenorphine access.

Infective endocarditis in people who inject drugs: A scoping review of clinical guidelines.

BACKGROUND: The incidence of infective endocarditis (IE) among people who inject drugs (PWID) is rising worldwide. Multiple clinical guidelines differ on the management of this condition, and few guidelines comment on treatment for primary substance use disorder (SUD). A comprehensive comparison of these guidelines is lacking. OBJECTIVES: To perform a critical review identifying key differences in clinical guideline recommendations for treating IE among PWID, focusing on the inclusion of recommendations for SUD treatment and the presence of stigmatizing language. ELIGIBILITY CRITERIA: Recently published, English-language, society-developed clinical guidelines for the treatment of IE among PWID. SOURCES OF EVIDENCE: PubMed, Google Scholar, and CINAHL Plus databases. CHARTING METHODS: In line with Arksey and O'Malley's framework, a scoping review was adapted using Joanna Briggs Institute and PRISMA-ScR guidelines. Two reviewers independently performed database searches for clinical guidelines published between 2007 and 2020 that commented on the management of IE among PWID. RESULTS: Ten clinical guidelines were included in the final analysis. Treatment recommendations varied with some societies proposing nonstandard care due to concern for return to drug use. Three guidelines include reference to addiction treatment. Only one guideline specifies the use of opioid agonist therapy for treating opioid use disorder and identifies the benefits of an addiction specialist consultation. Acute withdrawal management is not mentioned in any guideline. All guidelines utilized stigmatizing language to describe PWID. CONCLUSIONS: Most guidelines do not address SUD treatment, despite its effectiveness in reducing adverse health outcomes. Future guidelines should address SUD treatment using patient-first language.

What Is Addiction? History, Terminology, and Core Concepts.

Medicine's acceptance of addiction as a medical concept has waxed and waned over time. Addiction, as a disease, fits with modern disease definitions and scientific advances in elucidating the interactions between neurobiology and environment. Definitions of addiction need to acknowledge the complex interactions of brain circuits, genetics, environmental factors, and individual life experiences. Addiction aligns with diagnostic categories of substance use disorders that do not rely on tolerance and withdrawal as defining characteristics. Shifts in social and political views of addiction continue to propel and mirror changes in addiction treatment approaches and terminology within the medical community.

The Role of Evidence in the US Response to the Opioid Crisis.

The National Institutes of Health is investing hundreds of millions of dollars into new research on opioids. As these studies yield insights and results, their results will have to change policy and practice before they can bend the curve of the epidemic. However, the United States does not have a strong track record of translating evidence on drug policy into action. Three reasons for the translation gap are the historical legacy of drugs in the United States, vested interests, and politics. Researchers can become engaged in policy and political processes to strengthen the US response.

Help Is on the Way: Medicare Coverage of Opioid Treatment Programs.

Opioid use disorder (OUD) among older adults has been increasing, yet evidence still remains scarce for age-specific treatment. We discuss the three US Food and Drug Administration-approved medications used to treat OUD (methadone, buprenorphine, and naltrexone) and consider evidence gaps in OUD treatment in older adults. Legislation passed in 2018 (the Substance Use Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act [also known as the SUPPORT Act]) expanded Medicare coverage to include bundled payment for OUD treatment through opioid treatment programs, permitting coverage of methadone treatment for the first time. Since the policy change will take effect in January 2020, healthcare providers need to be aware of new opportunities for treatment when caring for older adult patients with OUD. J Am Geriatr Soc 68:637-640, 2020.

Barriers and facilitators of hepatitis C treatment uptake among people who inject drugs enrolled in opioid treatment programs in Baltimore.

BACKGROUND: Hepatitis C virus (HCV) infection is a major public health issue among people who inject drugs (PWID) with prevalence of 50-80% in the United States. Effective, simple, oral direct acting agents (DAA) of short duration with minimal side effects have been associated with cure rates > 95%. However, HCV treatment uptake among PWID remains low. We characterized the HCV care continuum, HCV treatment knowledge, as well as barriers and facilitators to HCV treatment uptake among PWID enrolled in two opioid treatment programs (OTPs) in Baltimore, Maryland, USA. METHODS: Between July and November 2016, 124 HCV infected PWID were recruited from two opioid treatment programs in Baltimore through convenience sampling. Participants completed a 50-item questionnaire to assess HCV treatment knowledge, attitudes, and practices. Progress through the HCV care continuum was assessed based on a series of questions assessing evaluation for HCV treatment, recommendation for HCV treatment by a provider, and HCV treatment initiation. HCV status was assessed based on participant self-report. RESULTS: The median age was 52 years (IQR 44-58), 56% were male, the majority were African American (69%), and 19% reported HIV coinfection. Participants had been tested for HCV at their primary care provider's (PCP's) office (34%), drug treatment center (20%), emergency room (11%), or prison (9%), and most (60%) had been diagnosed with HCV over 5 years prior. The majority reported that HCV was a major health concern for them (91%), were aware there were new treatments for HCV (89%), and that the new treatments cure most people (69%). More than half (60%) had seen a health professional who could treat HCV, 40% had HCV therapy recommended by their HCV specialist, and 20% had started or completed treatment. In univariable analysis, PWID were significantly more likely to have been treated if they were HIV co-infected (OR 3.4 (95% CI 1.3-9.2)) or had a partner or friend concerned about their HCV (OR 3.4 (95% CI 1.2-9.7)), and were significantly less likely to have been treated if they had used any illicit drugs in the preceding 6 months (OR 0.4 (95% CI 0.2-0.99). In multivariable analysis, having a friend or partner concerned about their HCV remained significantly associated with HCV treatment (OR 5.0 (95% CI 1.4-17.7)). When questioned about what would facilitate HCV treatment, the majority (85%) reported that a friend telling them that HCV treatment had helped them and having HCV treatment provided at their opioid treatment program would make them more likely to engage in HCV treatment. CONCLUSION: Despite a high prevalence of HCV among opioid treatment program patients and the availability of effective treatments, uptake remains low. We identified several key barriers and facilitators that can affect HCV treatment uptake.

Patient-centered methadone treatment: a randomized clinical trial.

BACKGROUND AND AIMS: Methadone patients who discontinue treatment are at high risk of relapse, yet a substantial proportion discontinue treatment within the first year. We investigated whether a patient-centered approach to methadone treatment improved participant outcomes at 12 months following admission, compared with methadone treatment-as-usual. DESIGN: Two-arm open-label randomized trial. SETTING: Two methadone treatment programs (MTPs) in Baltimore, MD, USA. PARTICIPANTS: Three hundred newly admitted MTP patients were enrolled between 13 September 2011 and 26 March 2014. Their mean age was 42.7 years [standard deviation (SD) = 10.1] and 59% were males. INTERVENTION: Newly admitted MTP patients were assigned randomly to either patient-centered methadone treatment (PCM; n = 149), which modified the MTP's rules (e.g. counseling attendance was optional), and counselor roles (e.g. counselors were not responsible for enforcing clinic rules) or treatment-as-usual (TAU; n = 151). MEASUREMENTS: The primary outcome was opioid-positive urine test at 12-month follow-up. Other 12-month outcomes included days of heroin and cocaine use, cocaine-positive urine tests, meeting DSM-IV opioid and cocaine dependence diagnostic criteria, HIV risk behavior and quality of life and retention in treatment. FINDINGS: There was no significant difference between PCM and TAU conditions in opioid-positive urine screens at 12 months [adjusted odds ratio = 0.98; 95% confidence interval (CI) = 0.61, 1.56]. There were also no significant differences in any of the secondary outcome measures (all Ps > 0.05) except Quality of Life Global Score (P = 0.04; 95% CI = 0.01, 0.45). There were no significant differences between conditions in the number of individual or group counseling sessions attended. (Ps > 0.05). CONCLUSIONS: Patient-centered methadone treatment (with optional counseling and the counselor not serving as the treatment program disciplinarian) does not appear to be more effective than methadone treatment-as-usual.

Incorporation of poison center services in a state-wide overdose education and naloxone distribution program.

BACKGROUND: To help curb the opioid overdose epidemic, many states are implementing overdose education and naloxone distribution (OEND) programs. Few evaluations of these programs exist. Maryland's OEND program incorporated the services of the poison center. It asked bystanders to call the poison center within 2 hours of administration of naloxone. Bystanders included law enforcement (LE). OBJECTIVE: Description of the initial experience with this unique OEND program component. METHODS: Retrospective case series of all cases of bystander-administered naloxone reported to the Maryland Poison Center over 16 months. Cases were followed to final outcome, for example, hospital discharge or death. Indications for naloxone included suspected opioid exposure and unresponsiveness, respiratory depression, or cyanosis. Naloxone response was defined as person's ability to breathe, talk, or walk within minutes of administration. RESULTS: Seventy-eight cases of bystander-administered naloxone were reported. Positive response to naloxone was observed in 75.6% of overall cases. Response rates were 86.1% and 70.9% for suspected exposures to heroin and prescription opioids, respectively. Two individuals failed to respond to naloxone and died. DISCUSSION: Naloxone response rates were higher and admission to the intensive care unit rates were lower in heroin overdoses than prescription opioid overdoses. CONCLUSIONS: This retrospective case series of 78 cases of bystander-administered naloxone reports a 75.6% overall rate of reversal. SCIENTIFIC SIGNIFICANCE: The findings of this study may be more generalizable. Incorporation of poison center services facilitated the capture of more timely data not usually available to OEND programs. (Am J Addict 2016;25:301-306).

Prior Experience with Non-Prescribed Buprenorphine: Role in Treatment Entry and Retention.

Buprenorphine availability continues to expand as an effective treatment for opioid dependence, but increases in availability have also been accompanied by increases in non-prescribed use of the medication. Utilizing data from a randomized clinical trial, this mixed-method study examines associations between use of non-prescribed buprenorphine and subsequent treatment entry and retention. Quantitative analyses (N = 300 African American buprenorphine patients) found that patients with prior use of non-prescribed buprenorphine had significantly higher odds of remaining in treatment through 6 months than patients who were naïve to the medication upon treatment entry. Qualitative data, collected from a subsample of participants (n = 20), identified three thematic explanations for this phenomenon: 1) perceived effectiveness of the medication; 2) cost of obtaining prescription buprenorphine compared to purchasing non-prescribed medication; and 3) convenience of obtaining the medication via daily-dosing or by prescription compared to non-prescribed buprenorphine. These findings suggest a dynamic relationship between non-prescribed buprenorphine use and treatment that indicates potential directions for future research into positive and negative consequences of buprenorphine diversion.

Changes in Quality of Life following Buprenorphine Treatment: Relationship with Treatment Retention and Illicit Opioid Use.

Studies of substance abuse treatment outcomes that give priority to cessation of all drug use may obscure other tangible benefits of treatment that are important to patients. The aim of this study was to examine the association between changes in quality of life (QoL) and: (1) retention in treatment; and (2) opioid use as measured by self-report and urine testing. Participants were 300 African American men and women starting outpatient buprenorphine treatment. Participants completed assessments at baseline, three and six months consisting of the World Health Organization's Quality of Life brief scale, Addiction Severity Index, and urine testing for opioids. There were statistically significant increases over time across all four QoL domains: physical, psychological, environmental, and social. Self-reported frequency of opioid use was negatively associated with psychological QoL, but opioid urine test results were not significantly associated with any QoL domains. Continued treatment enrollment was significantly associated with higher psychological QoL and environmental QoL. Patients entering buprenorphine treatment experience improvements in QoL, which are amplified for patients who remain in treatment. Point-prevalence opiate urine test results obtained at each assessment were not associated with any of the QoL domains and may not accurately reflect improvements perceived by patients receiving buprenorphine treatment.

Treatment Outcomes of African American Buprenorphine Patients by Parole and Probation Status.

This secondary analysis compared outcomes of African-American adults newly-admitted to buprenorphine treatment who were on parole and probation to patients who were not under criminal justice supervision. Buprenorphine patients (N=300) were randomly assigned to receive either Intensive Outpatient Treatment (IOP) or Standard Outpatient Treatment (OP) treatment and were assessed at baseline, 3- and 6-months. There were no differences between groups in treatment retention. Among probationers/parolees, IOP was associated with lower 3-month treatment retention compared to OP, but among participants not on probation/parole the relationship was reversed (p=.004). Both conditions showed significant declines in heroin and cocaine use, illegal activity, and in meeting DSM-IV criteria for opioid and cocaine dependence. Probationers/parolees reported lower frequency of illegal activities at 3-months compared to non-probationers/parolees (p=.007). Buprenorphine treatment should be made more widely available to individuals on parole/probation as they respond as well to treatment as patients not supervised by the criminal justice system.