Paths Forward for Clinicians Amidst the Rise of Unregulated Clinical Decision Support Software: Our Perspective on NarxCare.

Amidst the US overdose epidemic, policymakers, law enforcement agencies, and healthcare institutions have contributed to a decrease in opioid prescribing, assuming reduced mortality would result-an assumption we now understand was oversimplified. At this intersection between public health and public safety domains as they relate to opioid prescribing, unregulated and proprietary clinical decision support tools have emerged without rigorous external validation or public data sharing. In the following piece, we discuss challenges facing clinicians practicing medicine amidst unregulated clinical decision support tools, using the case of Bamboo Health's NarxCare-a prescription drug monitoring program-based analytics platform marketed as a clinical decision support tool-that is already positioned to impact over 1 billion patient encounters annually. We argue that sufficient evidence does not yet exist to support NarxCare's wide implementation, and that clinical decision support tools like NarxCare have flourished in recent years due to a lack of federal regulatory oversight and shielding by their proprietary formulas, which have facilitated their unchecked and outsized influence on patient care. Finally, we suggest specific actions by federal regulatory agencies, healthcare institutions, individual clinicians, and researchers, as well as academic journals, to mitigate potential harms associated with unregulated clinical decision support tools.

Opioid Taper Is Associated with Subsequent Termination of Care: a Retrospective Cohort Study.

BACKGROUND: Opioid tapering is increasingly utilized by providers to decrease risks of chronic opioid therapy, but it is unknown whether tapering is associated with termination of care. OBJECTIVE: To determine whether patients taking chronic opioid therapy who experienced opioid tapers were at greater risk of subsequently terminating their care compared with those who were continued on their doses. DESIGN: Retrospective cohort study of patients in a large, urban health system between 2008 and 2012 with 2 years of follow-up. PARTICIPANTS: Adult patients prescribed a stable baseline dose of chronic opioid therapy of at least 25 morphine milligram equivalents per day during a baseline year. MAIN MEASURES: An opioid taper during an exposure year, defined as a reduction in the average daily dose of at least 30% from the baseline dose in both of the two 6-month periods in the year following the baseline year. Opioid dose continuation was defined as any increase in dose, no change in dose, or any decrease up to 30% compared with baseline dose in the exposure year. The primary outcome was termination of care, defined as no outpatient encounters in the health system, in the year following the exposure year. KEY RESULTS: Of 1624 patients on chronic opioid therapy, 207 (15.5%) experienced an opioid taper and 78 (4.8%) experienced termination of care. Compared with opioid dose continuation, opioid taper was significantly associated with termination of care (AOR 4.3 [95% CI 2.2-8.5]). CONCLUSIONS: Opioid taper is associated with subsequent termination of care. These findings invite caution and demonstrate the need to fully understand the risks and benefits of opioid tapers.

Medical Record Documentation About Opioid Tapering: Examining Benefit-to-Harm Framework and Patient Engagement.

OBJECTIVE: Guidelines recommend that clinicians make decisions about opioid tapering for patients with chronic pain using a benefit-to-harm framework and engaging patients. Studies have not examined clinician documentation about opioid tapering using this framework. DESIGN AND SETTING: Thematic and content analysis of clinician documentation about opioid tapering in patients' medical records in a large academic health system. METHODS: Medical records were reviewed for patients aged 18 or older, without cancer, who were prescribed stable doses of long-term opioid therapy between 10/2015 and 10/2016 then experienced an opioid taper (dose reduction ≥30%) between 10/2016 and 10/2017. Inductive thematic analysis of clinician documentation within six months of taper initiation was conducted to understand rationale for taper, and deductive content analysis was conducted to determine the frequencies of a priori elements of a benefit-to-harm framework. RESULTS: Thematic analysis of 39 patients' records revealed 1) documented rationale for tapering prominently cited potential harms of continuing opioids, rather than observed harms or lack of benefits; 2) patient engagement was variable and disagreement with tapering was prominent. Content analysis found no patients' records with explicit mention of benefit-to-harm assessments. Benefits of continuing opioids were mentioned in 56% of patients' records, observed harms were mentioned in 28%, and potential harms were mentioned in 90%. CONCLUSIONS: In this study, documentation of opioid tapering focused on potential harms of continuing opioids, indicated variable patient engagement, and lacked a complete benefit-to-harm framework. Future initiatives should develop standardized ways of incorporating a benefit-to-harm framework and patient engagement into clinician decisions and documentation about opioid tapering.

Race and Gender Are Associated with Opioid Dose Reduction Among Patients on Chronic Opioid Therapy.

OBJECTIVE: Among patients with chronic pain, risk of opioid use is elevated with high opioid dose or concurrent benzodiazepine use. This study examined whether these clinical factors, or sociodemographic factors of race and gender, are associated with opioid dose reduction. DESIGN AND SETTING: A retrospective cohort study of outpatients prescribed chronic opioid therapy between 2007 and 2012 within a large, academic health care system in Bronx, New York, using electronic medical record data. Included patients were prescribed a stable dose of chronic opioid therapy over a one-year "baseline period" and did not have cancer. METHODS: The primary outcome was opioid dose reduction (≥30% reduction from baseline) within two years. Multivariable logistic regression tested the associations of two clinical variables (baseline daily opioid dose and concurrent benzodiazepine prescription) and two sociodemographic variables (race/ethnicity and gender) with opioid dose reduction. RESULTS: Of 1,097 patients, 463 (42.2%) had opioid dose reduction. High opioid dose (≥100 morphine-milligram equivalents [MME]) was associated with lower odds of opioid dose reduction compared with an opioid dose <100 MME (adjusted odds ratio [AOR] = 0.69, 95% confidence interval [CI] = 0.54-0.89). Concurrent benzodiazepine prescription was not associated with opioid dose reduction. Black (vs white) race and female (vs male) gender were associated with greater odds of opioid dose reduction (AOR = 1.82, 95% CI = 1.22-2.70; and AOR = 1.43, 95% CI = 1.11-1.83, respectively). CONCLUSIONS: Black race and female gender were associated with greater odds of opioid dose reduction, whereas clinical factors of high opioid dose and concurrent benzodiazepine prescription were not. Efforts to reduce opioid dose should target patients based on clinical factors and address potential biases in clinical decision-making.

Adoption of methadone take home policy by U.S. state opioid treatment authorities during COVID-19.

BACKGROUND: Patients face well documented problems accessing methadone from opioid treatment programs (OTPs) in the U.S., yet addressing these barriers has proven difficult due in part to the sheer number of actors governing treatment, including state authorities. Changes in federal methadone regulations during COVID-19 offer an opportunity to study the timing and extent of U.S. state opioid treatment authority (SOTA) adoption of policies expanding take home dosing for methadone treatment since March 2020. METHODS: We completed a policy scan between February 23 and May 2, 2023 on state adoption and subsequent rescinding of federal regulatory exemptions for expanded take-home dosing. This scan involved three components: a policy survey of SOTAs, a freedom of information act (FOIA) request of SAMHSA, and outreach to members of National Survivors Union (NSU)'s methadone work group. RESULTS: Of the 39 of 50 (78 %) SOTAs that responded, only 2 states (HI and MT) indicated that they never adopted federal exemptions for expanded take-home dosing. Of the 37 adopting states, all adopted the exemptions within the first month after the agency's announcement. Additionally, four SOTAs (OH, IN, FL, MS) indicated that their state subsequently rescinded expanded take-home dosing for methadone. CONCLUSIONS: Among responding states, regulations expanding take-home dosing appear to have been adopted by U.S. SOTAs in a widespread and rapid manner at the start of the COVID-19 pandemic, but some states have begun to rescind such policies. Our findings suggest that state regulators can rapidly modify OTP regulations in response to federal policy changes. SOTA policies are likely to become critical factors in the adoption of methadone treatment innovations if new federal regulatory flexibilities become permanent.

U.S. state policies on opioid prescribing during the peak of the prescription opioid crisis: Associations with opioid overdose mortality.

BACKGROUND: In response to the opioid overdose crisis in the United States, many states implemented policies to guide opioid prescribing, but their impact on overdose mortality (prescription and non-prescription) remains poorly understood. We examined the impact of U.S. state opioid-prescribing policies on opioid overdose mortality following implementation. METHODS: We calculated opioid overdose mortality rates from 1999-2016 by U.S. state using the CDC WONDER database, overall and separately for overdose deaths from prescription and non-prescription opioids. For each state, policies active on 1/1/2014 were reviewed for the presence and strength of six provisions recommending judicious opioid prescribing practices; "strong" provisions used the words "should," "shall," or "must". Interrupted time series (ITS) tested the association of each strong provision with overdose mortality, overall and separately for prescription and non-prescription opioids, in the two years following implementation. Sensitivity analyses compared between states, used time-lagged analyses, and excluded synthetic opioids from non-prescription opioid deaths. RESULTS: All six provisions had consistent direction of effect in ITS and sensitivity analyses. Strong provisions for prescriber training and limits on opioid dose reduced the slope of overall and prescription opioid overdose mortality in both ITS and sensitivity analyses. Reduced non-prescription opioid overdose mortality was only associated with strong provision for prescriber training. Some provisions had a negative impact. In ITS, strong provision for prescriber response to misuse increased the slope of non-prescription opioid overdose mortality. Strong provision for mandatory prescription drug monitoring program use had no relationship with overdose mortality in ITS and was associated with increased overall, prescription and non-prescription opioid overdose mortality in between-state sensitivity analysis. CONCLUSION: Opioid prescribing policies in U.S. states at the peak of the prescription opioid epidemic had modest mortality benefit, and did not reduce non-prescription opioid overdose mortality. A strong provision for prescriber training was the only provision associated with reduced prescription and non-prescription opioid overdose mortality. These findings can inform future efforts addressing prescription drug epidemics.

"It's Better in a Group Anyway": Patient Experiences of Group and Individual Acupuncture.

OBJECTIVES: Chronic pain is prevalent, burdensome, and costly, and there are ethnic and racial disparities in treatment. Acupuncture is effective and safe, but access is limited. Group acupuncture can decrease cost and increase capacity by decreasing clinic space needs and increasing patient volume per acupuncturist; however, the effectiveness and patient acceptability of group and individual session acupuncture have never been directly compared. DESIGN: The Acupuncture Approaches to Decrease Disparities in Pain Treatment (AADDOPT-2) study is a randomized comparative effectiveness trial of acupuncture for chronic pain. Semistructured in-depth interviews were conducted with a subset of patients enrolled in the trial. SETTINGS/LOCATION: Outpatient clinics in an urban, low income area serving a primarily black and Hispanic population. SUBJECTS: Qualitative interviews were conducted with 46 patients; 23 in each arm of the AADDOPT-2 study. INTERVENTIONS: Patients were randomized to receive either individual acupuncture or acupuncture delivered in a small group. OUTCOME MEASURES: Transcripts of the interviews were analyzed using an inductive thematic framework to explore and compare the patient experience in group and individual settings. RESULTS: Patients in both study arms valued the pain relief, improved quality of life, and relaxation experienced during acupuncture. Privacy and mixed-sex groups were cited as a concern by a minority of patients; however, most of those randomized to the group setting noted that these concerns abated after initiating treatment. Differences between arms included the depth of the relationship with the acupuncturist and misgivings related to the treatment space. Group dynamics varied; some groups fostered a supportive, therapeutic interaction, while others were more reserved. CONCLUSIONS: Patients in both arms valued their acupuncture experience. Participants described both positive and negative aspects of the group setting.

Self-reported Use of Prescribed Buprenorphine Among US Adults With Nonmedical Use of Prescription Opioids Motivated by Pain.

This cross-sectional study of US adults examines the prevalence of and characteristics associated with prescribed buprenorphine use among US adults with pain-motivated nonmedical use of prescription opioids.

"I Felt Like It Was God's Hands Putting the Needles In": A Qualitative Analysis of the Experience of Acupuncture for Chronic Pain in a Low-Income, Ethnically Diverse, and Medically Underserved Patient Population.

OBJECTIVES: To examine the experience of patients from a low-income, ethnically diverse medically underserved population receiving acupuncture for chronic pain. DESIGN: Qualitative analysis using inductive thematic analysis of interviews with participants from an acupuncture trial. SETTINGS/LOCATION: Four community health centers in the Bronx, New York. PARTICIPANTS: Thirty-seven adults with chronic neck or back pain or osteoarthritis who participated in a previous acupuncture trial. INTERVENTIONS: Up to 14 weekly acupuncture treatments. OUTCOME MEASURES: Pain and quality of life were examined in the original trial; this study examines qualitative outcomes. RESULTS: The themes grouped naturally into three domains of the acupuncture experience: the decision-making process, the treatment experience, and the effect of acupuncture on health. Regarding decision-making, important factors were a willingness to try something new even if you do not necessarily "believe" in it or have specifically positive expectations; a sense that medications were not working for their pain, that they also caused significant adverse effects, and that natural strategies might be preferable; and a feeling of desperation. Cost and access were significant barriers to acupuncture treatment. Regarding the process of acupuncture, the open and personal communication with the acupuncturist was an important factor, as were the sense that the process of acupuncture related to a natural process of healing or correction within the body and that part of making acupuncture successful required being open to the power of the mind to generate a positive outcome. Regarding the effect of treatment, notable aspects were the deep sense of rest and relaxation participants reported during treatment as well as the benefit they experienced for conditions other than pain. CONCLUSIONS: The themes that emerged in this ethnically diverse, low-income population were very similar to those that have emerged over the past decade of qualitative research on the acupuncture experience in other patient populations.

Varying perceived social threat modulates pain behavior in male mice.

UNLABELLED: We previously demonstrated that male mice display significantly reduced pain behavior on the acetic acid abdominal constriction test when confined in close proximity to a stranger male mouse. We show here the testosterone-dependence (via castration and testosterone propionate replacement) of this phenomenon, likely a form of (social) stress-induced analgesia. However, when similar male dyads are separated by vertical metal bars, allowing only partial physical contact, we find that the mice exhibit hyperalgesia, not analgesia, in response to both acetic acid injection and noxious radiant heat, relative to testing in isolation. This finding is specific to same-sex male dyads, and no change in nociceptive sensitivity is observed when males are tested in the presence of a female conspecific. We propose that pain sensitivity varies with respect to the severity of the social threat: mild social threat produces hyperalgesia and more severe social threat produces analgesia. PERSPECTIVE: This work highlights the importance of social threat in modulating pain behavior in a sex-specific manner. The findings add to a growing body of evidence that social factors affect pain behavior in mice, thus allowing the study of the mechanistic underpinnings of social modulation of pain in humans.