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.

The Group Decision-Making Using Pythagorean Fuzzy Entropy and the Complex Proportional Assessment.

The Pythagorean fuzzy sets conveniently capture unreliable, ambiguous, and uncertain information, especially in problems involving multiple and opposing criteria. Pythagorean fuzzy sets are one of the popular generalizations of the intuitionistic fuzzy sets. They are instrumental in expressing and managing hesitant under uncertain environments, so they have been involved extensively in a diversity of scientific fields. This paper proposes a new Pythagorean entropy for Multi-Criteria Decision-Analysis (MCDA) problems. The entropy measures the fuzziness of two fuzzy sets and has an influential position in fuzzy functions. The more comprehensive the entropy, the more inadequate the ambiguity, so the decision-making established on entropy is beneficial. The COmplex PRoportional ASsessment (COPRAS) method is used to tackle uncertainty issues in MCDA and considers the singularity of one alternative over the rest of them. This can be enforced to maximize and minimize relevant criteria in an assessment where multiple opposing criteria are considered. Using the Pythagorean sets, we represent a decisional problem solution by using the COPRAS approach and the new Entropy measure.

New Pythagorean Entropy Measure with Application in Multi-Criteria Decision Analysis.

The purpose of this paper is to propose a new Pythagorean fuzzy entropy for Pythagorean fuzzy sets, which is a continuation of the Pythagorean fuzzy entropy of intuitionistic sets. The Pythagorean fuzzy set continues the intuitionistic fuzzy set with the additional advantage that it is well equipped to overcome its imperfections. Its entropy determines the quantity of information in the Pythagorean fuzzy set. Thus, the proposed entropy provides a new flexible tool that is particularly useful in complex multi-criteria problems where uncertain data and inaccurate information are considered. The performance of the introduced method is illustrated in a real-life case study, including a multi-criteria company selection problem. In this example, we provide a numerical illustration to distinguish the entropy measure proposed from some existing entropies used for Pythagorean fuzzy sets and intuitionistic fuzzy sets. Statistical illustrations show that the proposed entropy measures are reliable for demonstrating the degree of fuzziness of both Pythagorean fuzzy set (PFS) and intuitionistic fuzzy sets (IFS). In addition, a multi-criteria decision-making method complex proportional assessment (COPRAS) was also proposed with weights calculated based on the proposed new entropy measure. Finally, to validate the reliability of the results obtained using the proposed entropy, a comparative analysis was performed with a set of carefully selected reference methods containing other generally used entropy measurement methods. The illustrated numerical example proves that the calculation results of the proposed new method are similar to those of several other up-to-date methods.

Maternal buprenorphine treatment and infant outcome.

BACKGROUND AND OBJECTIVES: Maternal buprenorphine maintenance predisposes the infant to exhibit neonatal abstinence syndrome (NAS), but there is insufficient published information regarding the nature of NAS and factors that contribute to its severity in buprenorphine-exposed infants. METHODS: The present study evaluated forty-one infants of buprenorphine-maintained women in comprehensive substance use disorder treatment who participated in an open-label study examining the effects of maternal buprenorphine maintenance on infant outcomes. Modifiers of the infant outcomes, including maternal treatment and substance use disorder parameters, were also evaluated. RESULTS: Fifty-nine percent of offspring exhibited NAS that required pharmacologic management. Both maternal buprenorphine dose as well as prenatal polysubstance exposure to illicit substance use/licit substance misuse were independently associated with NAS expression. Polysubstance exposure was associated with more severe NAS expression after controlling for the effects of buprenorphine dose. Other exposures, including cigarette smoking and SRI use, were not related to outcomes. Maternal buprenorphine dose was positively associated with lower birth weight and length. CONCLUSIONS: Polysubstance exposure was the most potent predictor of NAS severity in this sample of buprenorphine-exposed neonates. This finding suggests the need for interventions that reduce maternal polysubstance use during medication assisted treatment for opioid use disorder, and highlights the necessity of a comprehensive approach, beyond buprenorphine treatment alone, for the optimal care for pregnant women with opioid use disorders.

Maternal buprenorphine treatment and fetal neurobehavioral development.

BACKGROUND: Gestational opioid use/misuse is escalating in the United States; however, little is understood about the fetal effects of medications used to treat maternal opioid use disorders. OBJECTIVE: The purpose of this study was to determine the effect of maternal buprenorphine administration on longitudinal fetal neurobehavioral development. STUDY DESIGN: Forty-nine buprenorphine-maintained women who attended a substance use disorder treatment facility with generally uncomplicated pregnancies underwent fetal monitoring for 60 minutes at times of trough and peak maternal buprenorphine levels. Data were collected at 24, 28, 32, and 36 weeks gestation. Fetal neurobehavioral indicators (ie, heart rate, motor activity, and their integration [fetal movement-fetal heart rate coupling]) were collected via an actocardiograph, digitized and quantified. Longitudinal data analysis relied on hierarchic linear modeling. RESULTS: Fetal heart rate, heart rate variability, and heart rate accelerations were significantly reduced at peak vs trough maternal buprenorphine levels. Effects were significant either by or after 28 weeks gestation and tended to intensify with advancing gestation. Fetal motor activity and fetal movement-fetal heart rate coupling were depressed from peak to trough at 36 weeks gestation. Polysubstance exposure did not significantly affect fetal neurobehavioral parameters, with the exception that fetuses of heavier smokers moved significantly less than those of lighter smokers at 36 weeks gestation. By the end of gestation, higher maternal buprenorphine dose was related to depression of baseline fetal cardiac measures at trough. CONCLUSION: Maternal buprenorphine administration has acute suppressive effects on fetal heart rate and movement, and the magnitude of these effects increases as gestation progresses. Higher dose (≥13 mg) appears to exert greater depressive effects on measures of fetal heart rate and variability. These findings should be balanced against comparisons to gestational methadone effects, relatively good outcomes of buprenorphine-exposed infants, and recognition of the benefits of medication-assisted treatment for pregnant women with opioid use disorders in optimizing pregnancy outcomes.

Substance use and response to psychiatric treatment in methadone-treated outpatients with comorbid psychiatric disorder.

The psychiatric care of opioid users receiving agonist therapies is often complicated by high rates of illicit drug use (Brooner et al., 2013). The present study evaluates if illicit drug use (i.e., opioids, cocaine, sedatives) detected at the start of psychiatric care affects treatment response. Methadone maintenance patients (n = 125) with at least one current psychiatric disorder completed a 3-month randomized clinical trial evaluating the efficacy of financial incentives on attendance to on-site integrated substance abuse and psychiatric services (Kidorf et al., 2013). The present study re-analyzes the data set by grouping participants into one of two conditions based on the 4-week baseline observation: (1) no illicit drug use (baseline negative; n = 50), or (2) any illicit drug use (baseline positive; n = 75). All participants received a similar schedule of psychiatric services, and had good access to prescribed psychiatric medications. The Global Severity Index (GSI) of the Hopkins Symptom Checklist-Revised was administered monthly to evaluate changes in psychiatric distress. Results showed that while both conditions evidenced similar utilization of on-site psychiatric services, baseline negative participants remained in treatment somewhat longer (80.7 vs. 74.8 days, p = .04) and demonstrated greater reductions in GSI scores than baseline positive participants at month 3 (p = .004). These results have implications for interpreting previous studies that have shown inconsistent efficacy of pharmacotherapy and other psychiatric treatments, and for providing clinical care for patients with co-occurring substance use and psychiatric disorders.

Reinforcing integrated psychiatric service attendance in an opioid-agonist program: a randomized and controlled trial.

BACKGROUND: The benefits of integrating substance abuse and psychiatric care may be limited by poor service utilization. This randomized clinical trial evaluated the efficacy of using contingency management to improve utilization of psychiatric services co-located and integrated within a community-based methadone maintenance treatment program. METHODS: Opioid-dependent outpatients (n=125) with any current psychiatric disorder were randomly assigned to: (1) reinforced on-site integrated care (ROIC), with vouchers (worth $25.00) contingent on full adherence to each week of scheduled psychiatric services; or (2) standard on-site integrated care (SOIC). All participants received access to the same schedule of psychiatrist and mental health counseling sessions for 12-weeks. RESULTS: ROIC participants attended more overall psychiatric sessions at month 1 (M=7.53 vs. 3.97, p<.001), month 2 (M=6.31 vs. 2.81, p<.001), and month 3 (M=5.71 vs. 2.44, p<.001). Both conditions evidenced reductions in psychiatric distress (p<.001) and similar rates of drug-positive urine samples. No differences in study retention were observed. CONCLUSIONS: These findings suggest that contingency management can improve utilization of psychiatric services scheduled within an on-site and integrated treatment model. Delivering evidenced-based mental health counseling, or modifying the contingency plan to include illicit drug use, may be required to facilitate greater changes in psychiatric and substance abuse outcomes.

Improving treatment enrollment and re-enrollment rates of syringe exchangers: 12-month outcomes.

BACKGROUND: Developing bridges between community syringe exchange programs (SEPs) and substance abuse treatment could benefit syringe exchangers and the public health. Kidorf et al. (2009) showed that motivational approaches employed at an SEP site improved rates of treatment enrollment and reduced drug use over a 4-month observation window. The present study extends this report by evaluating rates of treatment enrollment and re-enrollment over a 12-month period. METHODS: Opioid dependent individuals (n = 281) newly registered at an SEP were randomly assigned to one of three referral interventions: (1) 8 individual motivational enhancement sessions and 16 treatment readiness group sessions designed to improve treatment interest and readiness (motivated referral condition; MRC-only); (2) MRC-only with monetary incentives for attending sessions and enrolling in treatment (MRC+I); or (3) standard referral (SRC). MRC-only and MRC+I participants discharged from treatment could attend a treatment re-engagement group designed to facilitate return to treatment (MRC+I participants received incentives for attending sessions and re-enrolling in treatment). RESULTS: The 4-month outcomes generally extended over 12 months. MRC+I participants were more likely to enroll in methadone maintenance than MRC-only or SRC participants, and to re-enroll in treatment following discharge. MRC+I participants also reported more days of treatment and less heroin and injection use. CONCLUSIONS: The good harm reduction outcomes for many SEP participants can be enhanced through strategies designed to facilitate treatment enrollment and re-enrollment.