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Background: In the United States, most (~ 70%) annual newly diagnosed HIV infections are among substance-using sexual minority men (SMM) and gender minority transgender women (trans women). Trans women and SMM are more likely to report or be diagnosed with a substance use disorder (SUD) than their cisgender or heterosexual counterparts and the presence of an SUD substantially increases the risk of HIV infection in both groups. Although Pre-Exposure Prophylaxis (PrEP) is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes; thus, the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration., Objective: To determine the optimal (considering efficacy and cost-effectiveness) strategy for advancement along the PrEP Care Continuum among trans women and SMM with an SUD., Methods: This study will implement a randomized controlled trial, evaluating two Stepped Care approaches involving A.S.K.-PrEP vs. standard of care (SOC) to determine optimal intervention strategies for trans women and SMM with an SUD (N = 250; n = 83 trans women; n = 167 SMM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care (n = 187) or SOC (n = 63). Participants in the Stepped Care arm will be assessed at 3-months for intervention response; responders will be maintained in A.S.K.-PrEP, while non-responders will receive added attention to their SUD via Contingency Management (CM). Non-responders will be re-randomized (1:1) to either (a) receive A.S.K.-PrEP + CM, or (b) shift the primary focus to their SUD (CM alone)., Results: Recruitment and enrollment began in May 2023. Recruitment will span approximately 36 months. Data collection, including all follow-up assessments, is expected to be completed in April 2027., Discussion: Trans women and SMM with an SUD have the two highest HIV prevalence rates in the United States, which underscores the urgent need for effective measures to develop scalable behavioral interventions that can encourage advancement along the PrEP Care Continuum. To improve public health, researchers must identify scalable and cost-effective behavioral interventions to promote PrEP initiation, adherence, and persistence among trans women and SMM who use substances., Trial Registration: This trial has been registered at ClinicalTrials.gov under the number NCT05934877., (© 2024. The Author(s).)

Background: Offering medications for opioid use disorder (MOUD) in carceral settings significantly reduces overdose. However, it is unknown to what extent individuals in jails continue MOUD once they leave incarceration. We aimed to assess the relationship between in-jail MOUD and MOUD continuity in the month following release., Methods: We conducted a retrospective cohort study of linked NYC jail-based electronic health records and community Medicaid OUD treatment claims for individuals with OUD discharged from jail between 2011 and 2017. We compared receipt of MOUD within 30 days of release, among those with and without MOUD at release from jail. We tested for effect modification based on MOUD receipt prior to incarceration and assessed factors associated with treatment discontinuation., Results: Of 28,298 eligible incarcerations, 52.8 % received MOUD at release. 30 % of incarcerations with MOUD at release received community-based MOUD within 30 days, compared to 7 % of incarcerations without MOUD (Risk Ratio: 2.62 (2.44-2.82)). Most (69 %) with MOUD claims prior to incarceration who received in-jail MOUD continued treatment in the community, compared to 9 % of those without prior MOUD. Those who received methadone (vs. buprenorphine), were younger, Non-Hispanic Black and with no history of MOUD were less likely to continue MOUD following release., Conclusions: MOUD maintenance in jail is strongly associated with MOUD continuity upon release. Still, findings highlight a gap in treatment continuity upon-reentry, especially among those who initiate MOUD in jail. In the wake of worsening overdose deaths and troubling disparities, improving MOUD continuity among this population remains an urgent priority., Competing Interests: Declaration of Competing Interest Dr. Murphy served on an advisory board panel for Indivior, outside the submitted work. Dr. Krawczyk receives compensation for expert testimony for ongoing opioid litigation. All other authors declare no conflicts of interest., (Copyright © 2024. Published by Elsevier B.V.)

Background: Expanding access to naloxone through pharmacies is an important policy goal. Our objective was to characterize national county-level naloxone dispensing of chain versus independent pharmacies., Methods: The primary exposure in our longitudinal analysis was the proportion of chain pharmacies in a county, identified through the U.S. Department of Homeland Security 2010 Infrastructure Foundation-Level Data. We defined counties as having "higher proportion" of chain pharmacies if at least 50% of pharmacies were large national chains. The primary outcome was quarter-year (2016Q1-2019Q2) rate of pharmacy naloxone claims per 100,000 persons from Symphony Health at the county level. We compared the naloxone dispensing rate between county types using 2-sample t tests. We estimated the association between county-level chain pharmacy proportion and rate of naloxone claims using a linear model with year-quarter fixed effects., Results: Nearly one-third of counties (n = 946) were higher proportion. Higher proportion counties had a significantly higher rate of naloxone claims across the study period, in 4 of 6 urban-rural classifications, and in counties with and without naloxone access laws (NALs). The linear model confirmed that higher proportion counties had a significantly higher rate of naloxone claims, adjusting for urban-rural designation, income, population characteristics, opioid mortality rate, coprescribing laws, and NALs., Conclusion: In this national study, we found an association between naloxone dispensing rates and the county-level proportion of chain (vs. independent) pharmacies. Incentivizing naloxone dispensing through educational, regulatory, or legal efforts may improve naloxone availability and dispensing rates-particularly in counties with proportionately high numbers of independent pharmacies., Competing Interests: Disclosure The authors declare no relevant conflicts of interest or financial relationships., (Copyright © 2024 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: Non-fatal overdose is a leading predictor of subsequent fatal overdose. For individuals who are incarcerated, the risk of experiencing an overdose is highest when transitioning from a correctional setting to the community. We assessed if enrollment in jail-based medications for opioid use disorder (MOUD) is associated with lower risk of non-fatal opioid overdoses after jail release among individuals with opioid use disorder (OUD)., Methods: This was a retrospective, observational cohort study of adults with OUD who were incarcerated in New York City jails and received MOUD or did not receive any MOUD (out-of-treatment) within the last three days before release to the community in 2011-2017. The outcome was the first non-fatal opioid overdose emergency department (ED) visit within 1 year of jail release during 2011-2017. Covariates included demographic, clinical, incarceration-related, and other characteristics. We performed multivariable cause-specific Cox proportional hazards regression analysis to compare the risk of non-fatal opioid overdose ED visits within 1 year after jail release between groups., Results: MOUD group included 8660 individuals with 17,119 incarcerations; out-of-treatment group included 10,163 individuals with 14,263 incarcerations. Controlling for covariates and accounting for competing risks, in-jail MOUD was associated with lower non-fatal opioid overdose risk within 14 days after jail release (adjusted HR=0.49, 95% confidence interval=0.33-0.74). We found no significant differences 15-28, 29-56, or 57-365 days post-release., Conclusion: MOUD group had lower risk of non-fatal opioid overdose immediately after jail release. Wider implementation of MOUD in US jails could potentially reduce post-release overdoses, ED utilization, and associated healthcare costs., Competing Interests: Declaration of Competing Interest None to declare., (Copyright © 2024. Published by Elsevier B.V.)

Background: Treatment with methadone and buprenorphine medications for opioid use disorder (MOUD) during incarceration may lead to better community re-entry, but evidence on these relationships have been mixed. We aimed to identify community re-entry patterns and examine the association between in-jail MOUD and a pattern of successful reentry defined by rare occurrence of reincarceration and preventable healthcare utilization., Methods: Data came from a retrospective, observational cohort study of 6066 adults with opioid use disorder who were incarcerated in New York City jails and released to the community during 2011-14. An outcome was community re-entry patterns identified by sequence analysis of 3-year post-release reincarceration, emergency department visits, and hospitalizations. An exposure was receipt of in-jail MOUD versus out-of-treatment (42 % vs. 58 %) for the last 3 days before discharge. The study accounted for differences in baseline demographic, clinical, behavioral, housing, and criminal legal characteristics between in-jail MOUD and out-of-treatment groups via propensity score matching., Results: This study identified five re-entry patterns: stability (64 %), hospitalization (23 %), delayed reincarceration (7 %), immediate reincarceration (4 %), and continuous incarceration (2 %). After addressing confounding, 64 % and 57 % followed the stability pattern among MOUD and out-of-treatment groups who were released from jail in 2011, respectively. In 2012-14, the prevalence of following the stability pattern increased year-by-year while a consistently higher prevalence was observed among those with in-jail MOUD., Conclusions: Sequence analysis helped define post-release stability based on health and criminal legal system involvement. Receipt of in-jail MOUD was associated with a marker of successful community re-entry., (Published by Elsevier Inc.)

Objective: Accurate naloxone distribution data are critical for planning and prevention purposes, yet sources of naloxone dispensing data vary by location, and completeness of local datasets is unknown. We sought to compare available datasets in Massachusetts, Rhode Island, and New York City (NYC) to a commercially available pharmacy national claims dataset (Symphony Health Solutions)., Data Sources and Study Setting: We utilized retail pharmacy naloxone dispensing data from NYC (2018-2019), Rhode Island (2013-2019), and Massachusetts (2014-2018), and pharmaceutical claims data from Symphony Health Solutions (2013-2019)., Study Design: We conducted a descriptive, retrospective, and secondary analysis comparing naloxone dispensing events (NDEs) captured via Symphony to NDEs captured by local datasets from the three jurisdictions between 2013 and 2019, when data were available from both sources, using descriptive statistics, regressions, and heat maps., Data Collection/extraction Methods: We defined an NDE as a dispensing event documented by the pharmacy and assumed that each dispensing event represented one naloxone kit (i.e., two doses). We extracted NDEs from local datasets and the Symphony claims dataset. The unit of analysis was the ZIP Code annual quarter., Principal Findings: NDEs captured by Symphony exceeded those in local datasets for each time period and location, except in RI following legislation requiring NDEs to be reported to the PDMP. In regression analysis, absolute differences in NDEs between datasets increased substantially over time, except in RI before the PDMP. Heat maps of NDEs by ZIP code quarter showed important variations reflecting where pharmacies may not be reporting NDEs to Symphony or local datasets., Conclusions: Policymakers must be able to monitor the quantity and location of NDEs in order to combat the opioid crisis. In regions where NDEs are not required to be reported to PDMPs, proprietary pharmaceutical claims datasets may be useful alternatives, with a need for local expertise to assess dataset-specific variability., (© 2023 Health Research and Educational Trust.)

BACKGROUND\OBJECTIVES: Concomitant with low rates of pharmacotherapy for incarcerated individuals with OUD, there is a high rate of opioid overdose following re-entry into the community. Our research objective was to develop a better understanding of the factors that influence health-related quality-of-life (HRQoL) among this population during the high-risk transition period from incarceration to community. Few studies have assessed health-related quality-of-life (HRQoL) among individuals with OUD who are involved with the criminal-legal system, let alone over the period directly surrounding release from incarceration., Methods: Secondary longitudinal analysis of data from a clinical trial where participants were randomized 1:1 to pre-release extended-release naltrexone (XR-NTX) + referral to community XR-NTX, vs. referral only. We conducted individual, multivariable regressions of EQ-5D domains (mobility, pain/discomfort, anxiety/depression; usual activities and self-care were excluded due to insufficient variation in scores), and the overall preference/utility score. HRQoL data were subset to timepoints immediately before release (baseline) and 12 weeks post-release; treatment groups were collapsed across condition. Multiple imputation by chained equations was conducted to handle missing 3-month data in the dependent variables and covariates, ad hoc., Results: Greater severity in the psychiatric composite score was associated with substantially lower HRQoL, across all measures, following release from incarceration. Greater severity in the medical composite score was associated with lower pain/discomfort-related HRQoL., Conclusions: Our findings highlight the importance of ensuring individuals with OUD are linked not only to MOUD, but also treatment for their comorbid conditions upon release from incarceration., (© 2023. The Author(s).)

Background: Given the personal and public consequences of untreated/undertreated OUD among persons involved in the justice system, an increasing number of jails and prisons are incorporating medication for opioid use disorder (MOUD) into their system. Estimating the costs of implementing and sustaining a particular MOUD program is vital to detention facilities, which typically face modest, fixed health care budgets. We developed a customizable budget impact tool to estimate the implementation and sustainment costs of numerous MOUD delivery models for detention facilities., Methods: The aim is to describe the tool and present an application of a hypothetical MOUD model. The tool is populated with resources required to implement and sustain various MOUD models in detention facilities. We identified resources via micro-costing techniques alongside randomized clinical trials. The resource-costing method is used to assign values to resources. Resources/costs are categorized as (a) fixed, (b) time-dependent, and (c) variable. Implementation costs include (a), (b), and (c) over a specified timeframe. Sustainment costs include (b) and (c). The MOUD model example entails offering all three FDA-approved medications, with methadone and buprenorphine provided by vendors, and naltrexone by the jail/prison facility., Results: Fixed resources/costs are incurred only once, including accreditation fees and trainings. Time-dependent resources/costs are recurring, but fixed over a given time-period; e.g., medication delivery and staff meetings. Variable resources/costs are those that are a direct function of the number of persons treated, such as the medication provided to each patient. Using nationally representative prices, we estimated fixed/sustainment costs to be $2919/patient, over 1 year. This article estimates annual sustainment costs to be $2885/patient., Conclusion: The tool will serve as a valuable asset to jail/prison leadership, policymakers, and other stakeholders interested in identifying/estimating the resources and costs associated with alternative MOUD delivery models, from the planning stages through sustainment., Competing Interests: Declaration of competing interest No competing interests to declare., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Opioid overdose is a leading cause of death during the immediate time after release from jail or prison. Most jails in the United States do not provide methadone and buprenorphine treatment for opioid use disorder (MOUD), and research in estimating its impact in jail settings is limited. We aimed to test the hypothesis that in-jail MOUD is associated with lower overdose mortality risk post-release., Design, Setting and Participants: Retrospective, observational cohort study of 15 797 adults with opioid use disorder who were released from New York City jails to the community in 2011-2017. They experienced 31 382 incarcerations and were followed up to 1 year., Measurements: The primary outcomes were death caused by accidental drug poisoning and all-cause death. The exposure was receipt of MOUD (17 119 events) versus out-of-treatment (14 263 events) during the last 3 days before community re-entry. Covariates included demographic, clinical, behavioral, housing, health-care utilization and legal characteristics variables. We performed a multivariable, mixed-effect Cox regression analysis to test association between in-jail MOUD and deaths., Findings: The majority were male (82%) and their average age was 42 years. Receiving MOUD was associated with misdemeanor charges, being female, injection drug use and homelessness. During 1 year post-release, 111 overdose deaths occurred and crude death rates were 0.49 and 0.83 per 100 person-years for in-jail MOUD and out-of-treatment groups, respectively. Accounting for confounding and random effects, in-jail MOUD was associated with lower overdose mortality risk [adjusted hazard ratio (aHR) = 0.20, 95% confidence interval (CI) = 0.08-0.46] and all-cause mortality risk (aHR = 0.22, 95% CI = 0.11-0.42) for the first month post-release., Conclusions: Methadone and buprenorphine treatment for opioid use disorder during incarceration was associated with an 80% reduction in overdose mortality risk for the first month post-release., (© 2022 Society for the Study of Addiction.)

Introduction: Opioid use disorder (OUD) is highly prevalent among incarcerated populations, and the risk of fatal overdose following release from prison is substantial. Despite efficacy, few correctional facilities provide evidence-based addiction treatment. Extended-release injectable naltrexone (XR-NTX) administered prior to release from incarceration may improve health and economic outcomes., Methods: We conducted an economic evaluation alongside a randomized controlled trial testing the effectiveness of XR-NTX before release from prison (n = 38) vs. XR-NTX referral after release (n = 48) of incarcerated participants with OUD, both groups continuing treatment at a community addiction treatment center. The incremental cost-effectiveness ratio (ICER) assessed the cost-effectiveness of XR-NTX before release compared to referral after release for three stakeholder perspectives at 12- and 24-week periods: state policymaker, health care sector, and societal. Effectiveness measures included quality-adjusted life-years (QALYs) and abstinent years from opioids. In addition, we categorized resources as OUD-related and non-OUD-related medical care, state transfer payments, and other societal costs (productivity, criminal justice resources, etc.)., Results: Results showed an association between XR-NTX and greater OUD-related costs and total costs from the state policymaker perspective. QALYs gained were positive but statistically insignificant between arms; however, results showed XR-NTX had an estimated 15.5 more days of opioid abstinence over 24 weeks and statistically significant at a 95 % confidence level based on the distribution of bootstrapped samples. We found that estimated ICERs to be > $500,000 per QALY for all stakeholder perspectives. For the abstinent-year effectiveness measure, we found XR-NTX before release to be cost-effective at a 95 % confidence level for willingness-to-pay values >$49,000 per abstinent-year, across all perspectives., Conclusions: XR-NTX administered to persons who are incarcerated with OUD before release may provide value for stakeholders and bridge a well-known treatment gap for this vulnerable population. Lower than expected participant engagement and missing data limit our results, and study outcomes may be sensitive to methods that address missing data if replicated., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Naloxone distributed to people at risk for opioid overdose has been associated with reduced overdose death rates; however, associations of retail pharmacy-distributed naloxone with overdose mortality have not been evaluated., Methods: Our analytic cohort uses retail pharmacy claims data; three health departments' community distribution data; federal opioid overdose data; and American Community Survey data. Data were analyzed by 3-digit ZIP Code and calendar quarter-year (2016Q1-2018Q4), and weighted by population. We regressed opioid-related overdose mortality on retail-pharmacy and community naloxone distribution, and community-level demographics using a linear model, hypothesizing that areas with high overdose rates would have higher current levels of naloxone distribution but that increasing naloxone distribution from one quarter to the next would be associated with lower overdose., Results: From Q1-2016 to Q4-2018, the unadjusted naloxone distribution rate increased from 97 to 257 kits per 100,000 persons, while the unadjusted opioid overdose mortality rate fell from 8.1 to 7.2 per 100,000 persons. The concurrent level of naloxone distribution (both pharmacy and community) was positively and significantly associated with fatal opioid overdose rates. We did not detect associations between change in naloxone distribution rates and overdose mortality., Conclusion: Naloxone distribution volumes were correlated with fatal opioid overdose, suggesting medication was getting to communities where it was needed most. Amid high rates of overdose driven by fentanyl in the drug supply, our findings suggest additional prevention, treatment, and harm reduction interventions are required-and dramatically higher naloxone volumes needed-to reverse the opioid overdose crisis in the US., Competing Interests: Declaration of Competing Interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ✰All authors report no conflict of interest.

Health care providers may play an important role in detection of elder mistreatment, which is common but underrecognized. We used the Health Care Cost Institute insurance claims database to describe elder mistreatment diagnosis among Medicare Advantage (MA) and private insurance patients in the United States from 2011 to 2017. We used International Classification of Diseases (ICD) coding to identify cases, examining the impact of transition from ICD-9 (Ninth Revision) to ICD-10 (Tenth Revision), which occurred in October 2015 and added 14 new codes for "suspected" mistreatment. 8,127 patients (0.051% of all aged ≥ 65), including 6,304 with MA (0.058%) and 1,823 with private insurance (0.026%) received elder mistreatment diagnosis. Transition from ICD-9 to ICD-10 was associated with a small increase in diagnosis rate, with "suspected" codes used in 45.3% of ICD-10 versus 9.7% of ICD-9 cases. Overall rates remained low. Rates, settings, and types of diagnosis differed between MA and private insurance patients.

Background and Aims: In a US randomized-effectiveness trial comparing extended-release naltrexone (XR-NTX) with buprenorphine-naloxone (BUP-NX) for the prevention of opioid relapse among participants recruited during inpatient detoxification (CTN-0051), the requirement to complete opioid detoxification prior to initiating XR-NTX resulted in lower rates of initiation of XR-NTX (72% XR-NTX versus 94% BUP-NX)., Design: This was a retrospective secondary analysis of CTN-0051 trial data, including follow-up data over 24-36 weeks., Setting: Eight community-based, inpatient-detoxification and follow-up outpatient treatment facilities in the United States., Participants: A total of 283 participants randomized to receive XR-NTX., Measurements: Efficiency was estimated using a multivariable generalized structural equation model to explore simultaneous determinants of XR-NTX induction and induction duration (detoxification + residential days). Cost-effectiveness was estimated from the health-care sector perspective and included expected costs and quality-adjusted life-years (QALYs)., Findings: Treatment site was the only modifiable factor that simultaneously increased the likelihood of XR-NTX induction and decreased induction duration. Incorporating the higher predicted probability of XR-NTX induction, and fewer predicted days of detoxification and subsequent residential treatment into the cost-effectiveness framework, reduced the incremental average 24-week total cost of XR-NTX treatment from $5317 more than that of BUP-NX (P = 0.01) to a non-statistically-significant difference of $1016 (P = 0.63). QALYs gained remained similar across arms., Conclusion: Adopting an efficient model of extended-release naltrexone initiation could result in extended-release naltrexone and buprenorphine-naloxone being of comparable economic value from the health-care sector perspective over 24-36 weeks for patients seeking treatment for opioid use disorder at an inpatient detoxification facility., (© 2021 Society for the Study of Addiction.)

Introduction: This study assesses the associations between the recent implementation of robust features of state Prescription Drug Monitoring Programs and the abrupt discontinuation of long-term opioid therapies., Methods: Data were from a national commercial insurance database and included privately insured adults aged 18-64 years and Medicare Advantage enrollees aged ≥65 years who initiated a long-term opioid therapy episode between Quarter 2 of 2011 and Quarter 2 of 2017. State Prescription Drug Monitoring Programs were characterized as nonrobust, robust, and strongly robust. Abrupt discontinuation was measured on the basis of high daily morphine milligram equivalents over the last 30 days of a long-term opioid therapy episode or no sign of tapering before discontinuation. Difference-in-differences models were estimated in 2019‒2020 to assess the association between robust Prescription Drug Monitoring Programs and abrupt discontinuation., Results: Among nonelderly privately insured adults, robust Prescription Drug Monitoring Programs were associated with an increase from 14.8% to 15.4% (4% relative increase, p=0.02) in the rate of ending long-term opioid therapy with ≥60 daily morphine milligram equivalents. For older Medicare Advantage enrollees, strongly robust Prescription Drug Monitoring Programs were associated with a reduction from 4.8% to 4.3% (10.4%, p=0.01) and from 3.0% to 2.4% (17.3%, p=0.001) in the rate of ending long-term opioid therapy with ≥90 and 120 daily morphine milligram equivalents, respectively. Prescription Drug Monitoring Programs robustness was not associated with clinically meaningful changes in the rate of discontinuing long-term opioid therapy without tapering., Conclusions: Discontinuation without tapering was the norm for long-term opioid therapies in the samples throughout the study years. Findings do not support the notion that policies aimed at enhancing Prescription Drug Monitoring Program use were associated with substantial increases in abrupt long-term opioid therapy discontinuation., (Copyright © 2021 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

A strengthened evidence base and earmarked federal funding have spurred the implementation of coordinated specialty care (CSC) for people experiencing early psychosis. However, existing funding mechanisms are insufficient and unsustainable to support population-wide deployment of CSC. This article describes the design framework of an innovative payment model for CSC that includes a bundled case rate payment and an optional outcome-based payment. To assist CSC payer and provider organizations in designing payment systems tailored to local preferences and circumstances, the research team is developing a decision-support tool that allows users to define design choices and provide input. The authors document the analytical algorithms underlying the tool and discuss how it could be further developed or expanded for CSC and other behavioral health interventions that feature an interdisciplinary team of clinicians and nonclinical professionals, public education and outreach, patient centeredness, and a recovery orientation.

Background: Since early 2016, an increasing number of states passed legislations that limit the duration and/or dosage of initial opioid prescriptions or opioids for acute pain., Objective: The objective of this study was to assess changes in the number of opioid prescriptions covered by Medicaid and received by Medicaid patients associated with state implementation of legislative limits on initial opioid prescriptions., Research Design: We explored the natural experiment resulting from the staggered implementation of state legislative limits. The analysis adopted a Difference-in-Differences framework and controlled for other major state policies bearing implications for prescription opioid use. The main analysis included 26 states that implemented limits from early 2016 to late 2018. A secondary analysis included all 50 states and the District of Columbia., Measures: Population-adjusted state-quarter level counts of Schedule II and III opioid prescriptions received by Medicaid patients, based on data from the Medicaid State Drug Utilization Data and state Medicaid enrollment reports for 2013-2018., Results: Implementation of legislative limits on initial opioid prescriptions was associated with a 7% reduction in the number of opioid prescriptions per 100 Medicaid enrollees. Such reduction was largely attributable to a reduction in Schedule II opioid prescriptions. Secondary analysis by including all jurisdictions and sensitivity checks supported the robustness of results., Conclusion: The recent implementation of state legislative limits on initial opioid prescriptions was associated with meaningful reductions in the volume of Schedule II opioid prescriptions received by Medicaid patients.

Objective: To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients., Methods: We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes., Results: We identified two subpopulations: HRQoL "pharmacotherapy responsive" (82.3 %) and HRQoL "characteristic sensitive" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics., Conclusion: Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: State policies to optimize prescriber use of Prescription Drug Monitoring Programs (PDMPs) have proliferated in recent years. Prominent policies include comprehensive mandates for prescriber use of PDMP, laws allowing delegation of PDMP access to office staff, and interstate PDMP data sharing. Evidence is limited regarding the effects of these policies on adverse opioid-related hospital events., Objective: The objective of this study was to assess the effects of 3 PDMP policies on adverse opioid-related hospital events among patients with prescription opioid use., Research Design: We examined 2011-2015 data from a large national commercial insurance database of privately insured and Medicare Advantage patients from 28 states with fully operating PDMPs by the end of 2010. We used a difference-in-differences framework to assess the probabilities of opioid-related hospital events and association with the implementation of PDMP policies. The analysis was conducted for adult patients with any prescription opioid use, a subsample of patients with long-term prescription opioid use, and stratified by older (65+) versus younger patients., Results: Comprehensive use mandates were associated with a relative reduction in the probability of opioid-related hospital events by 28% among patients with any opioid and 21% among patients with long-term opioid use. Such reduction was greater (in relative terms) among older patients despite the lower rate of these events among older than younger patients. Delegate laws and interstate data sharing were associated with limited change in the outcome., Conclusion: Comprehensive PDMP use mandates were associated with meaningful reductions in opioid-related hospital events among privately insured and Medicare Advantage adults with prescription opioid use.

Objective: Vallecular cyst coexisting with laryngomalacia (VC-LM) can cause significant pharyngolaryngeal obstruction. Traditionally, it is diagnosed with flexible endoscopy (FE) and treated by rigid endoscopy. This study evaluates the effectiveness of solely using FE with novel noninvasive ventilation (NIV) of sustained pharyngeal inflation (SPI) support for both diagnosis and treatment in such infants., Methods: A retrospective review of consecutive infants who were diagnosed and treated for VC-LM in the 12-year period, 2007 to 2018, was conducted. Clinical variables, techniques, and outcomes were analyzed and reported., Results: Eighteen infants (10 males) were included. The mean age was 3.0 ± 0.6 months and the mean body weight was 4.6 ± 1.3 kg. Before FE, 14 infants were supported with bi-nasal prongs NIV (BN-NIV) and four infants with tracheal intubation. During diagnostic and therapeutic FE, all infants supported with a nasopharyngeal NIV (NP-NIV) only. All diagnoses were made in the first FE inspection of 3.5 ± 1.2 minutes. Thirteen lesions were immediately treated with FE laser therapy in 18.1 ± 1.7 minutes in the same FE course. Total FE time was 24.6 ± 2.8 minutes. Three infants needed revision laser therapy 4 days later. There was no desaturation (<90%), bradycardia (<100/min), or pneumothorax. After FE therapy, all infants were supported with BN-NIV only with significantly (<0.01) lower pressure and completely weaned off before being discharged 8.4 ± 1.5 days later. All infants, followed up for a 6-month period, showed many clinical improvements., Conclusions: FE, with this NP-NIV and SPI supports, could offer accurate diagnosis and successful laser therapy of the VC-LM with procedural sedation in the same session in infants., (© 2020 Wiley Periodicals, Inc.)

Background: Persons with an opioid use disorder (OUD) who were incarcerated face many challenges to remaining abstinent; concomitantly, opioid-overdose is the leading cause of death among this population, with the initial weeks following release proving especially fatal. Extended-release naltrexone (XR-NTX) is the most widely-accepted, evidence-based OUD pharmacotherapy in criminal justice settings, and ensures approximately 30 days of protection from opioid overdose. The high cost of XR-NTX serves as a barrier to uptake by many prison/jail systems; however, the cost of the medication should not be viewed in isolation. Prison/jail healthcare budgets are ultimately determined by policymakers, and the benefits/cost-offsets associated with effective OUD treatment will directly and indirectly affect their overall budgets, and society as a whole., Methods: This protocol describes a study funded by the National Institute of Drug Abuse (NIDA) to: evaluate changes in healthcare utilization, health-related quality-of-life, and other resources associated with different strategies of XR-NTX delivery to persons with OUD being released from incarceration; and estimate the relative "value" of each strategy. Data from two ongoing, publicly-funded, randomized-controlled trials will be used to evaluate these questions. In Study A, (XR-NTX Before vs. After Reentry), participants are randomized to receive their first XR-NTX dose before release, or at a nearby program post-release. In Study B, (enhanced XR-NTX vs. XR-NTX), both arms receive XR-NTX prior to release; the enhanced arm receives mobile medical (place of residence) XR-NTX treatment post-release, and the XR-NTX arm receives referral to a community treatment program post-release. The economic data collection instruments required to evaluate outcomes of interest were incorporated into both studies from baseline. Moreover, because the same instruments are being used in both trials on comparable populations, we have the opportunity to not only assess differences in outcomes between study arms within each trial, but also to merge the data sets and test for differences across trials., Discussion: Initiating XR-NTX for OUD prior to release from incarceration may improve patient health and well-being, while also producing downstream cost-offsets. This study offers the unique opportunity to assess the effectiveness and cost-effectiveness of multiple strategies, according to different stakeholder perspectives.

Background: The Los Angeles County (LAC) Division of HIV and STD Programs implemented a medical care coordination (MCC) program to address the medical and psychosocial service needs of people with HIV (PWH) at risk for poor health outcomes., Methods: Our objective was to evaluate the impact and cost-effectiveness of the MCC program. Using the CEPAC-US model populated with clinical characteristics and costs observed from the MCC program, we projected lifetime clinical and economic outcomes for a cohort of high-risk PWH under 2 strategies: (1) No MCC and (2) a 2-year MCC program. The cohort was stratified by acuity using social and clinical characteristics. Baseline viral suppression was 33% in both strategies; 2-year suppression was 33% with No MCC and 57% with MCC. The program cost $2700/person/year. Model outcomes included quality-adjusted life expectancy, lifetime medical costs, and cost-effectiveness. The cost-effectiveness threshold for the incremental cost-effectiveness ratio (ICER) was $100 000/quality-adjusted life-year (QALY)., Results: With MCC, life expectancy increased from 10.07 to 10.94 QALYs, and costs increased from $311 300 to $335 100 compared with No MCC (ICER, $27 400/QALY). ICERs for high/severe, moderate, and low acuity were $30 500/QALY, $25 200/QALY, and $77 400/QALY. In sensitivity analysis, MCC remained cost-effective if 2-year viral suppression was ≥39% even if MCC costs increased 3-fold., Conclusions: The LAC MCC program improved survival and was cost-effective. Similar programs should be considered in other settings to improve outcomes for high-risk PWH., (© The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: The opioid epidemic in the United States has resulted in over 42,000 U.S. opioid overdose fatalities in 2016 alone. In New York City (NYC) opioid overdoses have reached a record high, increasing from 13.6 overdose deaths/100,000 to 19.9/100,000 from 2015 to 2016. Supervised injection facilities (SIFs) provide a hygienic, safe environment in which pre-obtained drugs can be consumed under clinical supervision to quickly reverse opioid overdoses. While SIFs have been implemented worldwide, none have been implemented to date in the United States. This study estimates the potential impact on opioid overdose fatalities and healthcare system costs of implementing SIFs in NYC., Methods: A deterministic model was used to project the number of fatal opioid overdoses avoided by implementing SIFs in NYC. Model inputs were from 2015 to 2016 NYC provisional overdose data (N = 1852) and the literature. Healthcare utilization and costs were estimated for fatal overdoses that would have been avoided from implementing one or more SIFs., Results: One optimally placed SIF is estimated to prevent 19-37 opioid overdose fatalities annually, representing a 6-12% decrease in opioid overdose mortality for that neighborhood; four optimally placed SIFs are estimated to prevent 68-131 opioid overdose fatalities. Opioid overdoses cost the NYC healthcare system an estimated $41 million per year for emergency medical services, emergency department visits, and hospitalizations. Implementing one SIF is estimated to save $0.8-$1.6 million, and four SIFs saves $2.9-$5.7 million in annual healthcare costs from opioid overdoses., Conclusions: Implementing SIFs in NYC would save lives and healthcare system costs, although their overall impact may be limited depending on the geographic characteristic of the local opioid epidemic. In cities with geographically dispersed opioid epidemics such as NYC, multiple SIFs will be required to have a sizeable impact on the total number of opioid overdose fatalities occurring each year., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Comprehensive mandates for prescription drug monitoring programs (PDMPs) require state-licensed prescribers and dispensers both to register with and to use the programs in most clinical circumstances. Such mandates have the potential to improve providers' participation and reduce opioid-related adverse events. Using Medicaid prescription data and hospital utilization data across the US in the period 2011-16, we found that state implementation of comprehensive PDMP mandates was associated with a reduction in the opioid prescription rate from 161.47 to 147.07 per 1,000 enrollees per quarter, a reduction in the opioid-related inpatient stay rate from 97.50 to 93.34 per 100,000 enrollees per quarter, and a reduction in the opioid-related emergency department (ED) visit rate from 74.60 to 61.36 per 100,000 enrollees per quarter. Our estimated annual reductions of approximately 12,000 inpatient stays and 39,000 ED visits could save over $155 million in Medicaid spending, a fact that deserves policy attention when states attempt to strengthen and refine PDMPs to better tackle the opioid crisis.

Objective: To estimate the own-price elasticity of demand for naloxone, a prescription medication that can counter the effects of an opioid overdose, and predict the change in pharmacy sales following a conversion to over-the-counter status., Data Sources/study Setting: The primary data source was a nationwide prescription claims dataset for 2010-2017. The data cover 80 percent of US retail pharmacies and account for roughly 90 percent of prescriptions filled. Additional covariates were obtained from various secondary data sources., Study Design: We estimated a longitudinal, simultaneous equation model of naloxone supply and demand. Our primary variables of interest were the quantity of naloxone sold, measured as total milligrams sold at pharmacies, and the out-of-pocket price paid per milligram, both measured per ZIP Code and quarter-year., Data Collection/extraction Methods: Primary data came directly from payers and processors of prescription drug claims., Principal Findings: We found that, on average, a 1 percent increase in the out-of-pocket price paid for naloxone would result in a 0.27 percent decrease in pharmacy sales. We predict that the total quantity of naloxone sold in pharmacies would increase 15 percent to 179 percent following conversion to over-the-counter status., Conclusions: Naloxone is own-price inelastic, and conversion to over-the-counter status is likely to lead to a substantial increase in total pharmacy sales., (© 2019 The Authors. Health Services Research published by Wiley Periodicals, Inc. on behalf of Health Research and Educational Trust.)

Objective: This study examined organizational variability of process-of-care and depression outcomes at eight community health centers (CHCs) in the years following implementation of collaborative care (CC) for depression., Methods: The authors used 8 years of observational data for 13,362 unique patients at eight CHCs that participated in Washington State's Mental Health Integration Program. Organization-level changes in depression and process-of-care outcomes over time were studied., Results: On average, depression outcomes improved for the first 2 years before improvement slowed, peaking at year 5. Significant organization-level variation was noted in outcomes. Improvements in depression outcomes tended to follow process-of-care measures., Conclusions: Findings suggest that it may take 2 years after implementation of CC to fully observe depression outcome improvement at an organization level. Substantial variation between organizations in depression outcomes over time suggests that sustained attention to processes of care may be necessary to maintain initially achieved gains.

Background: Not enough evidence exists to compare buprenorphine-naloxone with extended-release naltrexone for treating opioid use disorder., Objective: To evaluate the cost-effectiveness of buprenorphine-naloxone versus extended-release naltrexone., Design: Cost-effectiveness analysis alongside a previously reported randomized clinical trial of 570 adults in 8 U.S. inpatient or residential treatment programs., Data Sources: Study instruments., Target Population: Adults with opioid use disorder., Time Horizon: 24-week intervention with an additional 12 weeks of observation., Perspective: Health care sector and societal., Interventions: Buprenorphine-naloxone and extended-release naltrexone., Outcome Measures: Incremental costs combined with incremental quality-adjusted life-years (QALYs) and incremental time abstinent from opioids., Results of Base-Case Analysis: Use of the health care sector perspective and a willingness-to-pay threshold of $100 000 per QALY showed buprenorphine-naloxone to be preferable to extended-release naltrexone in 97% of bootstrap replications at 24 weeks and in 85% at 36 weeks. Similar results were obtained with incremental time abstinent from opioids as an outcome and with use of the societal perspective., Results of Sensitivity Analysis: The base-case results were sensitive to the cost of the 2 treatments and the success of randomized treatment initiation., Limitation: Relatively short follow-up for a chronic condition, substantial missing data, no information on patient out-of-pocket and social service costs., Conclusion: Buprenorphine-naloxone is preferred to extended-release naltrexone as first-line treatment when both options are clinically appropriate and patients require detoxification before initiating extended-release naltrexone., Primary Funding Source: National Institute on Drug Abuse, National Institutes of Health.

Background: National guidelines make recommendations regarding the initial opioid prescriptions, but most of the supporting evidence is from the initial episode of care, not the first prescription., Objective: To examine associations between features of the first opioid prescription and high-risk opioid use in the 18 months following the first prescription., Design: Retrospective cohort study using data from a large commercial insurance claims database for 2011-2014 to identify individuals with no recent use of opioids and follow them for 18 months after the first opioid prescription., Participants: Privately insured patients aged 18-64 and Medicare Advantage patients aged 65 or older who filled a first opioid prescription between 07/01/2011 and 06/30/2013., Main Outcomes and Measures: High-risk opioid use was measured by having (1) opioid prescriptions overlapping for 7 days or more, (2) opioid and benzodiazepine prescriptions overlapping for 7 days or more, (3) three or more prescribers of opioids, and (4) a daily dosage exceeding 120 morphine milligram equivalents, in each of the six quarters following the first prescription., Key Results: All three features of the first prescription were strongly associated with high-risk use. For example, among privately insured patients, receiving a long- (vs. short-) acting first opioid was associated with a 16.9-percentage-point increase (95% CI, 14.3-19.5), a daily MME of 50 or more (vs. less than 30) was associated with a 12.5-percentage-point increase (95% CI, 12.1-12.9), and a supply exceeding 7 days (vs. 3 or fewer days) was associated with a 4.8-percentage-point increase (95% CI, 4.5-5.2), in the probability of having a daily dosage of 120 MMEs or more in the long term, compared to a sample mean of 4.2%. Results for the Medicare Advantage patients were similar., Conclusions: Long-acting formulation, high daily dosage, and longer duration of the first opioid prescription were each associated with increased high-risk use of opioids in the long term.

Policies and practices have proliferated to optimize prescribers' use of their states' prescription drug monitoring programs, which are statewide databases of controlled substances dispensed at retail pharmacies. Our study assessed the effectiveness of three such policies: comprehensive legislative mandates to use the program, laws that allow prescribers to delegate its use to office staff, and state participation in interstate data sharing. Our analysis of information from a large commercial insurance database indicated that comprehensive use mandates implemented during 2011-15 were associated with a 6-9 percent reduction in opioid prescriptions with high risk for misuse and overdose. We also found delegate laws to be associated with reductions of a similar magnitude for selected outcomes. In general, the effects of all three policies strengthened over time, especially beginning in the second year after implementation. Our findings support comprehensive use mandates and delegate laws to optimize prescribers' use of drug monitoring programs, but the results will need updates in the context of evolving state opioid policies-including the increasing integration of drug monitoring data with electronic health records.

Medicaid program criteria for accessing hepatitis C treatment are changing. Medicaid drug utilization data from 2014 to 2016 show that programs that have relaxed their criteria have seen significant increases in treatment utilization, as have states with Medicaid expansions.

Calcium phosphates are used widely as orthopaedic implants and in nanocrystalline form to enable the transfer of genetic material into cells. Despite widespread use, little is known about their fate after they have crossed the cell membrane. Here we present a method of surface modification of silicon-substituted hydroxyapatite (SiHA) through a silane group, which enables the engraftment of a fluorescent dye to facilitate real-time biological tracking. Surface modification of the nanocrystal surface was undertaken using (3-mercaptopropyl)trimethoxysilane (MPTS), which presented a thiol for the further attachment of a fluorophore. Successful modification of the surface was demonstrated using zeta potential measurements and fluorescence microscopy and the number of thiol groups at the surface was quantified using Ellman's reagent. In vitro experiments using the fluorescently modified particles enabled the discrimination of the calcium phosphate particulate from other biological debris following internalisation by a population of MC3T3 (pre-osteoblast) cells and the particles were shown to maintain fluorescence for 24 hours without quenching. The successful modification of the surface of SiHA with thiol groups offers the tantalising possibility of the intracellular growth factor delivery.

A number of calcium phosphate materials have been investigated as drug release matrices for the prophylactic treatment of implant-related osteomyelitis. However, some studies have shown the influence of processing on the efficacy of the delivered drug. The objective of this study was to evaluate the influence of pH during processing on the efficacy of vancomycin hydrochloride (VH) against Staphylococcus aureus. VH was loaded into a brushite cement (CaHPO(4).2H(2)O; pH 2.4); a hydroxyapatite cement (Ca(10)(PO(4))(6)OH(2); pH 9.4); and an apatite xerogel (pH 7.4). The pH of the material during processing had a significant influence on the mechanism of release from the cement. VH released from the apatite cement (pH 9.4) was not released in accordance with the Higuchi model. In addition to affecting release, the basic pH was shown to diminish the antibacterial potency of the released VH. Despite exceeding the minimum inhibitory concentration, the eluent from the apatite cement was ineffective against a culture of S. aureus. The findings of this study reinforce the importance of evaluating not only the release of the drug from the material matrix but also the antibacterial potency of the released drug.