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Background: Opioid utilization and related harm have increased in recent decades, notably in Australia, the United States, Canada, and some European countries. For people who are prescribed opioids, pharmacies offer an accessible, regular point-of-contact, providing a unique opportunity to address opioid prescription drugs risks., Objective: This project aimed to develop consensus-based, best practice statements for improving the safer use of prescription opioids through community pharmacy settings., Methods: The e-Delphi technique is used to obtain consensus from experts about issues where conclusive evidence is lacking, using multiple rounds of online participation. The investigator group identified an international group of potential participants with relevant expertise who were invited to the study, and asked to identify other experts for invitation. The e-Delphi process comprised three online rounds, involving (1) statement idea generation, (2) developing statement consensus, and (3) confirming and ranking statements., Results: A diverse group of 42 experts (76 % female, 6 countries) participated, comprising pharmacists (n = 24, 57 %), medical doctors of differing specialties (n = 12, 29 %), and/or researchers (n = 28, 67 %), with a mean of 15 years' professional experience (SD = 8.08). Eighty-five statements were initially developed in Round 1, and 78 were supported with amendments, with suggestions to merge and remove items in Round 2, resulting in 72 final statements which were all endorsed in Round 3. Items spanned seven themes: education, monitoring outcomes and risk, deprescribing and pain management, overdose education and naloxone, opioid agonist treatment, staff education, and overarching practices. Preferred terminology was determined in Round 2 and confirmed in Round 3., Conclusions: Community pharmacies offer a unique opportunity to support the safer use of prescription opioids. These 72 best practice statements provide practical guidance on specific practices that pharmacists can undertake to support patients' safer use of prescription opioids and prevent or reduce harms from prescribed opioid use., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: In response to the opioid crisis in the United States, population-level prescribing of opioids has been decreasing; there are concerns, however, that dose reductions are related to potential adverse events., Objective: Examine associations between opioid dose reductions and risk of 1-month potential adverse events (emergency department (ED) visits, opioid overdose, benzodiazepine prescription fill, all-cause mortality)., Design: This observational cohort study used electronic health record and claims data from eight United States health systems in a prescription opioid registry (Clinical Trials Network-0084). All opioid fills (excluding buprenorphine) between 1/1/2012 and 12/31/2018 were used to identify baseline periods with mean morphine milligram equivalents daily dose of  ≥ 50 during six consecutive months., Patients: We identified 60,040 non-cancer patients with  ≥ one 2-month dose reduction period (600,234 unique dose reduction periods)., Main Measures: Analyses examined associations between dose reduction levels (1- < 15%, 15- < 30%, 30- < 100%, 100% over 2 months) and potential adverse events in the month following a dose reduction using logistic regression analysis, adjusting for patient characteristics., Key Results: Overall, dose reduction periods involved mean reductions of 18.7%. Compared to reductions of 1- < 15%, dose reductions of 30- < 100% were associated with higher odds of ED visits (OR 1.14, 95% CI 1.10, 1.17), opioid overdose (OR 1.41, 95% CI 1.09-1.81), and all-cause mortality (OR 1.39, 95% CI 1.16-1.67), but lower odds of a benzodiazepine fill (OR 0.83, 95% CI 0.81-0.85). Dose reductions of 15- < 30%, compared to 1- < 15%, were associated with higher odds of ED visits (OR 1.08, 95% CI 1.05-1.11) and lower odds of a benzodiazepine fill (OR 0.93, 95% CI 0.92-0.95), but were not associated with opioid overdose and all-cause mortality., Conclusions: Larger reductions for patients on opioid therapy may raise risk of potential adverse events in the month after reduction and should be carefully monitored., (© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Objective: Develop and implement a prescription opioid registry in 10 diverse health systems across the US and describe trends in prescribed opioids between 2012 and 2018., Materials and Methods: Using electronic health record and claims data, we identified patients who had an outpatient fill for any prescription opioid, and/or an opioid use disorder diagnosis, between January 1, 2012 and December 31, 2018. The registry contains distributed files of prescription opioids, benzodiazepines and other select medications, opioid antagonists, clinical diagnoses, procedures, health services utilization, and health plan membership. Rates of outpatient opioid fills over the study period, standardized to health system demographic distributions, are described by age, gender, and race/ethnicity among members without cancer., Results: The registry includes 6 249 710 patients and over 40 million outpatient opioid fills. For the combined registry population, opioid fills declined from a high of 0.718 per member-year in 2013 to 0.478 in 2018, and morphine milligram equivalents (MMEs) per fill declined from 985 MMEs per fill in 2012 to 758 MMEs in 2018. MMEs per member declined from 692 MMEs per member in 2012 to 362 MMEs per member in 2018., Conclusion: This study established a population-based opioid registry across 10 diverse health systems that can be used to address questions related to opioid use. Initial analyses showed large reductions in overall opioid use per member among the combined health systems. The registry will be used in future studies to answer a broad range of other critical public health issues relating to prescription opioid use., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Medical Informatics Association.)

Background Studies have consistently found high rates of unintended pregnancy among women with opioid use disorder (OUD). Few interventions have been developed to specifically engage and address the family planning (FP) needs of women in substance use disorder treatment. Objectives : Our goal was to collect formative qualitative data to identify the FP experiences, needs and service preferences of women receiving medications for OUD and to use these data to develop a FP education and navigation intervention that could be tested in diverse, resource-limited treatment settings. Methods : From August 2016 to April 2017, we conducted 21 guided qualitative interviews with women from two outpatient treatment clinics in Denver, Colorado. We recorded, transcribed, and coded all interviews. We then facilitated three focus groups ( n  = 16) from May to July 2017 to verify or challenge interview themes and to further inform the development of the FP intervention. Results : Most participants expressed ambivalence or low perceived risk regarding unintended pregnancy and desired more information about contraceptive methods. Many participants described mistrust or lack of engagement in the medical system and histories of trauma were a common barrier to seeking services. Focus group participants endorsed a peer-led FP navigation intervention and provided feedback to tailor existing FP educational materials to fit the specific needs of women in recovery. Conclusions/Importance : Results from this qualitative study suggest that women in recovery from OUD have unique, unmet FP education and service needs. These findings provide important information for the development of feasible and acceptable FP service delivery within diverse, resource-limited treatment settings and informed the development of a trauma-informed, peer-led FP education and navigation intervention that would be implemented in a subsequent phase of the study.

Drug overdose is the leading cause of death among formerly incarcerated people. Distribution of the opioid overdose medication naloxone to people who use drugs reduces overdose mortality, and officials in many jurisdictions are now considering or implementing programs to offer naloxone to people exiting jails and prisons. The principles and practices of harm reduction programs such as naloxone distribution conflict with those of penal institutions, raising the question of how organizations based on opposing institutional logics can collaborate on lifesaving programs. Using in-depth interviews and observations conducted over four years with 34 penal, medical, public health, and harm reduction practitioners, we introduce and conceptualize two organizational features to explain why this therapeutic intervention was implemented in local jails in two of three California counties. First, interorganizational bridges between harm reduction, medical, and penal organizations facilitated mutual understanding and ongoing collaboration among administrators and frontline workers in different agencies. Second, respected and influential champions within public health and penal organizations put jail-based naloxone distribution on the local agenda and cultivated support among key officials. Our findings offer guidance for future studies of institutional logics and policy responses to the overdose crisis., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Objective: High rates of unintended pregnancy occur among women with opioid use disorder (OUD). OUD treatment settings may provide an ideal opportunity to address the family planning needs of patients. However, few studies have rigorously evaluated interventions designed to address family planning needs in the OUD treatment setting. This study assessed the feasibility, acceptability, and preliminary efficacy of a peer-led navigation intervention designed to educate and link women receiving medications for OUD to family planning services., Methods: The study recruited women from four OUD treatment programs in Denver, Colorado, to participate in a pilot randomized controlled trial from March 2018 to February 2019. Eligible participants were English-speaking adult females who were neither pregnant nor desiring a pregnancy and who were not using a long-acting reversible contraceptive (LARC) method. Participants completed a baseline survey, and the study randomized them to receive a two-session, peer-led family planning navigation intervention or usual care. The study assessed feasibility by participant engagement in the intervention. The study used follow-up self-report surveys and electronic health record data to assess intervention acceptability and intervention efficacy for the primary outcomes of a family planning visit and use of a LARC method., Results: The study enrolled 119 women who were randomized to the Sexual Health Initiative for Navigation and Empowerment (SHINE) peer-led navigation intervention (n = 56) or usual care (n = 63). The average age was 32 (SD = 6.4); 76% were receiving methadone, 24% were receiving buprenorphine and 19% reported a treatment provider had ever discussed family planning with them. Most had a previous pregnancy (82%) and of these, 93% reported an unplanned pregnancy. Among intervention participants, 93% completed the first navigation session, 90% felt that intervention topics were important, 76% indicated that the information was new, and 82% found working with a peer helpful. At six months postbaseline, significantly more (p = 0.01) intervention participants (36%) received a family planning visit compared to control participants (14%). There was no between-group difference on use of LARC methods., Conclusions: A peer-led family planning navigation intervention was feasible to implement, acceptable to participants, and showed evidence of preliminary efficacy. This model may be an effective and potentially sustainable approach to support the family planning needs of women in treatment for OUD., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Certain medications may increase the risk of death or death from specific causes (eg, sudden cardiac death), but these risks may not be identified in premarket randomized trials. Having the capacity to examine death in postmarket safety surveillance activities is important to the US Food and Drug Administration's (FDA) mission to protect public health. Distributed networks of electronic health plan databases used by the FDA to conduct multicenter research or medical product safety surveillance studies often do not systematically include death or cause-of-death information., Objective: This study aims to develop reusable, generalizable methods for linking multiple health plan databases with the Centers for Disease Control and Prevention's National Death Index Plus (NDI+) data., Methods: We will develop efficient administrative workflows to facilitate multicenter institutional review board (IRB) review and approval within a distributed network of 6 health plans. The study will create a distributed NDI+ linkage process that avoids sharing of identifiable patient information between health plans or with a central coordinating center. We will develop standardized criteria for selecting and retaining NDI+ matches and methods for harmonizing linked information across multiple health plans. We will test our processes within a use case comprising users and nonusers of antiarrhythmic medications., Results: We will use the linked health plan and NDI+ data sets to estimate the incidences and incidence rates of mortality and specific causes of death within the study use case and compare the results with reported estimates. These comparisons provide an opportunity to assess the performance of the developed NDI+ linkage approach and lessons for future studies requiring NDI+ linkage in distributed database settings. This study is approved by the IRB at Harvard Pilgrim Health Care in Boston, MA. Results will be presented to the FDA at academic conferences and published in peer-reviewed journals., Conclusions: This study will develop and test a reusable distributed NDI+ linkage approach with the goal of providing tested NDI+ linkage methods for use in future studies within distributed data networks. Having standardized and reusable methods for systematically obtaining death and cause-of-death information from NDI+ would enhance the FDA's ability to assess mortality-related safety questions in the postmarket, real-world setting., International Registered Report Identifier (irrid): DERR1-10.2196/21811., (©Candace C Fuller, Wei Hua, Charles E Leonard, Andrew Mosholder, Ryan Carnahan, Sarah Dutcher, Katelyn King, Andrew B Petrone, Robert Rosofsky, Laura A Shockro, Jessica Young, Jea Young Min, Ingrid Binswanger, Denise Boudreau, Marie R Griffin, Margaret A Adgent, Jennifer Kuntz, Cheryl McMahill-Walraven, Pamala A Pawloski, Robert Ball, Sengwee Toh. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.11.2020.)

This special issue of Addiction Science & Clinical Practice, "Addiction treatment access and utilization among criminal justice involved populations", presents a series of articles on substance use disorder treatment access and utilization by people who have contact with the criminal justice system (e.g., jails, prisons, and courts). Despite the high prevalence of substance use disorders among people who experience these settings, evidence-based treatment for substance use disorders may be unavailable and/or care may be fragmented during transitions between settings. Articles in this special issue address several gaps in the literature and present a conceptual model of opioid overdose risk, the results of a randomized controlled trial to increase treatment uptake and retention during and after incarceration, descriptions of barriers to treatment after release from incarceration, and data from nationally representative surveys of substance use disorders and treatment use among people who have been involved in the criminal justice system. Importantly, the voices of people with lived experience in the criminal justice system were incorporated in two manuscripts. Together these articles advance our understanding of how to improve care coordination and expansion of services across systems and organizations to prevent overdose, improve treatment utilization, and ultimately, improve health outcomes among criminal justice involved populations in the United States who have substance use disorders or use substances.

Introduction: More than 30 million adults are released from incarceration globally each year. Many experience complex physical and mental health problems, and are at markedly increased risk of preventable mortality. Despite this, evidence regarding the global epidemiology of mortality following release from incarceration is insufficient to inform the development of targeted, evidence-based responses. Many previous studies have suffered from inadequate power and poor precision, and even large studies have limited capacity to disaggregate data by specific causes of death, sub-populations or time since release to answer questions of clinical and public health relevance., Objectives: To comprehensively document the incidence, timing, causes and risk factors for mortality in adults released from prison., Methods: We created the Mortality After Release from Incarceration Consortium (MARIC), a multi-disciplinary collaboration representing 29 cohorts of adults who have experienced incarceration from 11 countries. Findings across cohorts will be analysed using a two-step, individual participant data meta-analysis methodology., Results: The combined sample includes 1,337,993 individuals (89% male), with 75,795 deaths recorded over 9,191,393 person-years of follow-up., Conclusions: The consortium represents an important advancement in the field, bringing international attention to this problem. It will provide internationally relevant evidence to guide policymakers and clinicians in reducing preventable deaths in this marginalized population., Key Words: Mortality; incarceration; prison; release; individual participant data meta-analysis; consortium; cohort., Competing Interests: Statement of Conflicts of Interest: SF is on the UK’s Independent Advisory Board on Deaths in Custody. PC has received grants from Abbvie and Echosens to conduct research relating to prison health. IB has received royalties from Uptodate for educational content on health care for incarcerated persons. All other authors report no conflicts of interest.

This study examined whether, among Veterans Health Administration (VHA) patients, veterans with recent or current justice involvement have equal receipt of pharmacotherapy for alcohol use disorder compared to veterans with no justice involvement. Using national VHA records, we calculated the overall and facility rates of receipt as the number of patients who received pharmacotherapy for alcohol use disorder divided by the number of patients diagnosed with an alcohol use disorder. Using a mixed-effects logistic regression model, we tested whether justice involvement was associated with pharmacotherapy receipt. Male veterans with jail/court involvement had significantly higher odds of receiving pharmacotherapy for alcohol use disorder compared to other male veterans. Justice-involved veterans had equal or better receipt of pharmacotherapy for alcohol use disorder compared to veterans with no justice involvement. Pharmacotherapy rates are low overall, suggesting that more work can be done to connect veterans to these medications.

The Veterans Health Administration (VA) Health Care for Reentry Veterans (HCRV) program links veterans exiting prison with treatment. Among veterans served by HCRV, national VA clinical data were used to describe contact with VA health care, and mental health and substance use disorder diagnoses and treatment use. Of veterans seen for an HCRV outreach visit, 56 % had contact with VA health care. Prevalence of mental health disorders was 57 %; of whom 77 % entered mental health treatment within a month of diagnosis. Prevalence of substance use disorders was 49 %; of whom 37 % entered substance use disorder treatment within a month of diagnosis. For veterans exiting prison, increasing access to VA health care, especially for rural veterans, and for substance use disorder treatment, are important quality improvement targets.

The opioid overdose epidemic claims the lives of tens of thousands of Americans every year. Opioid overdose is reversible by the administration of naloxone, a pure antagonist now available in formulations specifically designed and labeled for layperson use. Despite broad support for layperson access to naloxone from professional organizations, health officials, and clinical experts, qualitative studies suggest that some providers have concerns about legal risks associated with naloxone prescribing, particularly co-prescribing naloxone to pain patients. Such concerns are unfounded. The legal risk associated with prescribing naloxone is no higher than that associated with any other medication and is lower than many. Additionally, laws in a majority of states provide explicit legal protections for providers who prescribe or dispense naloxone, in many cases extending this protection to prescriptions issued to friends, family members, and others. In this large and increasing number of states, the liability risk of prescribing or dispensing naloxone in good faith to a patient at risk of overdose (or, in states where such prescribing is permitted, to an associate of such a patient) is either extremely low or absent entirely. Where a prescriber determines, in his or her clinical judgment, that a patient is at risk of overdose, co-prescribing naloxone is a reasonable and prudent clinical and legal decision. No clinician should fail or refuse to issue such a prescription based on liability concerns.

Background: Pharmacotherapy - methadone, buprenorphine, or naltrexone - is an evidence-based treatment for opioid use disorder, but little is known about receipt of these medications among veterans involved in the justice system. The current study examines receipt of pharmacotherapy for opioid use disorder among veterans with a history of justice involvement at U.S. Veterans Health Administration (VHA) facilities compared to veterans with no justice involvement., Methods: Using national VHA clinical and pharmacy records, we conducted a retrospective cohort study of veterans with an opioid use disorder diagnosis in fiscal year 2012. Using a mixed-effects logistic regression model, we examined receipt of pharmacotherapy in the 1-year period following diagnosis as a function of justice involvement, adjusting for patient and facility characteristics., Results: The 1-year rate of receipt for pharmacotherapy for opioid use disorder was 27% for prison-involved veterans, 34% for jail/court-involved veterans, and 33% for veterans not justice-involved. Compared to veterans not justice-involved, those prison-involved had 0.75 lower adjusted odds (95% confidence interval [CI]: 0.65-0.87) of receiving pharmacotherapy whereas jail/court-involved veterans did not have significantly different adjusted odds., Conclusions: Targeted efforts to improve receipt of pharmacotherapy for opioid use disorder among veterans exiting prison is needed as they have lower odds of receiving these medications., (Published by Elsevier Ireland Ltd.)

The Veterans Justice Outreach (VJO) program of the U.S. Veterans Health Administration has a primary mission of linking military veterans in jails, courts, or in contact with law enforcement to mental health and substance use disorder treatment. National data of veterans with VJO contact were used to describe demographic characteristics, and mental health and substance use disorder diagnoses and treatment use and test correlates of treatment entry and engagement using multi-level logistic regression models. Of the 37,542 VJO veterans, treatment entry was associated with being homeless and having a mental health disorder or both a mental health and a substance use disorder versus a substance use disorder only. Being American Indian/Alaskan Native was associated with lower odds of treatment entry. Engagement was associated with female gender, older age, Asian race, urban residence, and homeless status. Increased utilization of substance use disorder treatment, especially pharmacotherapy, is an important quality improvement target.

Background: Risk interpretation affects decision making. Yet, there is no valid assessment of how clinicians interpret the risk data that they commonly encounter., Objective: To establish the reliability and validity of a 20-item test of clinicians' risk interpretation., Methods: The Critical Risk Interpretation Test (CRIT) measures clinicians' abilities to 1) modify the interpretation based on meaningful differences in the outcome (e.g., disease specific v. all-cause mortality) and time period (e.g., lifetime v. 10-year mortality), 2) maintain a stable interpretation for different risk framings (e.g., relative v. absolute risk), and 3) correctly interpret how diagnostic testing modifies risk. There were 658 clinicians and medical trainees who participated: 116 nurse practitioners (NPs) at a national conference, 273 medical students at 1 institution, 148 residents in internal medicine at 2 institutions, and 121 internists at 1 institution. Participants completed a self-administered paper test during educational conferences. Seventeen evidence-based medicine experts took the test online and formally assessed content validity. Eighteen second-year medical students were recruited to take the test and a retest 3 weeks later to explore test-retest correlation., Results: Expert review supported test clarity and content validity. Factor analysis supported that the CRIT identifies at least 3 separable areas of clinician knowledge. Test-retest correlation was fair (intraclass correlation coefficient = 0.65; standard error = 0.15). Scores on our test correlated with other tests of related abilities. Mean test scores varied among groups, with differences in prior evidence-based medicine training and experience (93 for NPs, 101 for medical students, 101 for residents, 103 for academic internists, and 110 for physician experts; P < 0.001)., Conclusions: Our results provide supporting evidence for the reliability and validity of the CRIT as an index of critical risk interpretation abilities, which is acceptable and feasible to administer in an educational setting., (© The Author(s) 2014.)

We systematically reviewed randomized controlled trials of interventions to improve the health of people during imprisonment or in the year after release. We searched 14 biomedical and social science databases in 2014, and identified 95 studies. Most studies involved only men or a majority of men (70/83 studies in which gender was specified); only 16 studies focused on adolescents. Most studies were conducted in the United States (n = 57). The risk of bias for outcomes in almost all studies was unclear or high (n = 91). In 59 studies, interventions led to improved mental health, substance use, infectious diseases, or health service utilization outcomes; in 42 of these studies, outcomes were measured in the community after release. Improving the health of people who experience imprisonment requires knowledge generation and knowledge translation, including implementation of effective interventions.

Competing Interests: Dr. Nussbaum reports no financial relationships with commercial interests. Dr. Thurstone has received research funding from a grant from the National Institute on Drug Abuse. Dr. Binswanger receives research funding from the Robert Wood Johnson Physician Faculty Scholars Program, from the National Institute on Drug Abuse (1R03DA029448-01), and from the Agency for Health Care Research and Quality (AHRQ K12 HS019464).

Setting: The correctional system in the United States is large and growing. The Centers for Disease Control and Prevention recommend baseline and annual testing of employees in correctional facilities for latent tuberculosis infection (LTBI)., Objective: To describe the extent of and factors associated with LTBI testing practices for jail correctional officers., Design: A national survey of 1760 randomly selected jails was conducted. We used multivariable logistic regression models to examine factors associated with testing officers in a guideline-concordant manner and having a written policy., Results: A total of 1174 (67%) surveys were returned. Only 52% of jails had a written policy on LTBI testing of officers, and 51% screened officers at least annually (guideline concordance). Large jails (OR 2.41, 95%CI 1.67-3.49) and jails in states with a high tuberculosis incidence (OR 1.67, 95%CI 1.17-2.38) and in the Midwest (OR 1.58, 95%CI 1.07-2.33) were more likely to screen in a guideline-concordant manner., Conclusion: Screening for LTBI among correctional officers in the United States was inconsistent. Strategies to improve LTBI testing among correctional officers are needed.

Background: Soft tissue infections (STIs) from injection drug use are a common cause of Emergency Department visits, hospitalizations, and operating room procedures, yet little is known about factors that may predict the need for these costly medical services., Objective: To describe a cohort of injection drug users seeking Emergency Department care for STIs and to identify risk factors associated with hospitalization. We hypothesized that participants who delayed seeking care would be hospitalized more often than those who did not., Design: Cohort study using in-person structured interviews and medical record review. Logistic regression assessed the association between hospital admission and delay in seeking care as well as other demographic, clinical, and psychosocial factors., Participants: Injection drug users who sought Emergency Department care for STIs from May 2001 to March 2002., Results: Of the 136 participants, 55 (40%) were admitted to the hospital. Delay in seeking care was not associated with hospital admission. Participants admitted for their infection were significantly more likely to be living in a shelter (P = .01) and to report being hospitalized 2 or more times in the past year (P < .01)., Conclusions: We identified a subpopulation of injection drug users, mostly living in shelters, who were hospitalized frequently in the past year and who were more likely to be hospitalized for their current infections compared to others. As members of this subpopulation can be easily identified and located, they may benefit from interventions to reduce the health care utilization resulting from these infections.