Community-Based Cluster-Randomized Trial to Reduce Opioid Overdose Deaths

Nataraj N., Rikard S.M., Zhang K., Jiang X., Guy G.P., Rice K., Mattson C.L., Gladden R.M., Mustaquim D.M., Illg Z.N., Seth P., Noonan R.K., Losby J.L.

ImportanceGiven the high number of opioid overdose deaths in the US and the complex epidemiology of opioid use disorder (OUD), systems models can serve as a tool to identify opportunities for public health interventions.ObjectiveTo estimate the projected 3-year association between public health interventions and opioid overdose-related outcomes among persons with OUD.Design, Setting, and ParticipantsThis decision analytical model used a simulation model of the estimated US population aged 12 years and older with OUD that was developed and analyzed between January 2019 and December 2023. The model was parameterized and calibrated using 2019 to 2020 data and used to estimate the relative change in outcomes associated with simulated public health interventions implemented between 2021 and 2023.Main Outcomes and MeasuresProjected OUD and medications for OUD (MOUD) prevalence in 2023 and number of nonfatal and fatal opioid-involved overdoses among persons with OUD between 2021 and 2023.ResultsIn a baseline scenario assuming parameters calibrated using 2019 to 2020 data remained constant, the model projected more than 16 million persons with OUD not receiving MOUD treatment and nearly 1.7 million persons receiving MOUD treatment in 2023. Additionally, the model projected over 5 million nonfatal and over 145 000 fatal opioid-involved overdoses among persons with OUD between 2021 and 2023. When simulating combinations of interventions that involved reducing overdose rates by 50%, the model projected decreases of up to 35.2% in nonfatal and 36.6% in fatal opioid-involved overdoses among persons with OUD. Interventions specific to persons with OUD not currently receiving MOUD treatment demonstrated the greatest reduction in numbers of nonfatal and fatal overdoses. Combinations of interventions that increased MOUD initiation and decreased OUD recurrence were projected to reduce OUD prevalence by up to 23.4%, increase MOUD prevalence by up to 137.1%, and reduce nonfatal and fatal opioid-involved overdoses among persons with OUD by 6.7% and 3.5%, respectively.Conclusions and RelevanceIn this decision analytical model study of persons with OUD, findings suggested that expansion of evidence-based interventions that directly reduce the risk of overdose fatality among persons with OUD, such as through harm reduction efforts, could engender the highest reductions in fatal overdoses in the short-term. Interventions aimed at increasing MOUD initiation and retention of persons in treatment projected considerable improvement in MOUD and OUD prevalence but could require a longer time horizon for substantial reductions in opioid-involved overdoses.

Wagner K.D., Fiuty P., Page K., Tracy E.C., Nocerd M., Miller C.W., Tarhuni L.J., Dasgupta N.

Overdose deaths involving stimulants and opioids simultaneously have raised the specter of widespread contamination of the stimulant supply with fentanyl. We quantified prevalence of fentanyl in street methamphetamine and cocaine, stratified by crystalline texture, analyzing samples sent voluntarily to a public mail-in drug checking service (May 2021-June 2023). Samples from 77 harm reduction programs and clinics originated in 25 US states. Sample donors reported expected drug and physical descriptions. Substances were identified by gas chromatography-mass spectrometry. Negative binomial models were used to calculate fentanyl prevalence, adjusting for potential confounders related to sample selection. We also examined if xylazine changed donors’ accuracy of detecting fentanyl. We analyzed 718 lab-confirmed samples of methamphetamine (64%) and cocaine (36%). The adjusted prevalence of fentanyl was 12.5% (95% CI: 2.2%, 22.9%) in powder methamphetamine and 14.8% (2.3%, 27.2%) in powder cocaine. Crystalline forms of both methamphetamine (Chisq=57, p

O’Donnell J., Tanz L.J., Miller K.D., Dinwiddie A.T., Wolff J., Mital S., Obiekwe R., Mattson C.L.

Using data from CDC's State Unintentional Drug Overdose Reporting System, this report describes trends in overdose deaths with evidence of counterfeit pill use during July 2019-December 2021 in 29 states and the District of Columbia (DC) and characteristics of deaths with and without evidence of counterfeit pill use during 2021 in 34 states and DC. The quarterly percentage of deaths with evidence of counterfeit pill use more than doubled from 2.0% during July-September 2019 to 4.7% during October-December 2021, and more than tripled in western jurisdictions (from 4.7% to 14.7%). Illicitly manufactured fentanyls were the only drugs involved (i.e., caused death) in 41.4% of deaths with evidence of counterfeit pill use and 19.5% of deaths without evidence. Decedents with evidence of counterfeit pill use, compared with those without evidence, were younger (57.1% versus 28.1% were aged

Barnett M.L., Meara E., Lewinson T., Hardy B., Chyn D., Onsando M., Huskamp H.A., Mehrotra A., Morden N.E.

Dowell D., Ragan K.R., Jones C.M., Baldwin G.T., Chou R.

This guideline provides recommendations for clinicians providing pain care, including those prescribing opioids, for outpatients aged ≥18 years.It updates the CDC Guideline for Prescribing Opioids for Chronic Pain -United States, 2016 (MMWR Recomm Rep 2016;65[No.RR-1]:1-49) and includes recommendations for managing acute (duration of 3 months) pain.The recommendations do not apply to pain related to sickle cell disease or cancer or to patients receiving palliative or end-of-life care.The guideline addresses the following four areas: 1) determining whether or not to initiate opioids for pain, 2) selecting opioids and determining opioid dosages, 3) deciding duration of initial opioid prescription and conducting follow-up, and 4) assessing risk and addressing potential harms of opioid use.CDC developed the guideline using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework.Recommendations are based on systematic reviews of the scientific evidence and reflect considerations of benefits and harms, patient and clinician values and preferences, and resource allocation.CDC obtained input from the Board of Scientific Counselors of the National Center for Injury Prevention and Control (a federally chartered advisory committee), the public, and peer reviewers.CDC recommends that persons with pain receive appropriate pain treatment, with careful consideration of the benefits and risks of all treatment options in the context of the patient's circumstances.Recommendations should not be applied as inflexible standards of care across patient populations.This clinical practice guideline is intended to improve communication between clinicians and patients about the benefits and risks of pain treatments, including opioid therapy; improve the effectiveness and safety of pain treatment; mitigate pain; improve function and quality of life for patients with pain; and reduce risks associated with opioid pain therapy, including opioid use disorder, overdose, and death.

Han B., Einstein E.B., Jones C.M., Cotto J., Compton W.M., Volkow N.D.

This cross-sectional study describes the nationwide trends in drug overdose mortality during the COVID-19 pandemic by age, sex, and race and ethnicity.

Young A.M., Brown J.L., Hunt T., Sprague Martinez L.S., Chandler R., Oga E., Winhusen T.J., Baker T., Battaglia T., Bowers-Sword R., Button A., Fallin-Bennett A., Fanucchi L., Freeman P., Glasgow L.M., et. al.

IntroductionOpioid-involved overdose deaths continue to surge in many communities, despite numerous evidence-based practices (EBPs) that exist to prevent them. The HEALing Communities Study (HCS) was launched to develop and test an intervention (ie, Communities That HEAL (CTH)) that supports communities in expanding uptake of EBPs to reduce opioid-involved overdose deaths. This paper describes a protocol for a process foundational to the CTH intervention through which community coalitions select strategies to implement EBPs locally.Methods and analysisThe CTH is being implemented in 67 communities (randomised to receive the intervention) in four states in partnership with coalitions (one per community). Coalitions must select at least five strategies, including one to implement each of the following EBPs: (a) overdose education and naloxone distribution; expanded (b) access to medications for opioid use disorder (MOUD), (c) linkage to MOUD, (d) retention in MOUD and (e) safer opioid prescribing/dispensing. Facilitated by decision aid tools, the community action planning process includes (1) data-driven goal setting, (2) discussion and prioritisation of EBP strategies, (3) selection of EBP strategies and (4) identification of next steps. Following review of epidemiologic data and information on existing local services, coalitions set goals and discuss, score and/or rank EBP strategies based on feasibility, appropriateness within the community context and potential impact on reducing opioid-involved overdose deaths with a focus on three key sectors (healthcare, behavioural health and criminal justice) and high-risk/vulnerable populations. Coalitions then select EBP strategies through consensus or majority vote and, subsequently, suggest or choose agencies with which to partner for implementation.Ethics and disseminationThe HCS protocol was approved by a central Institutional Review Board (Advarra). Results of the action planning process will be disseminated in academic conferences and peer-reviewed journals, online and print media, and in meetings with community stakeholders.Trial registration numberNCT04111939.

Peet E.D., Powell D., Pacula R.L.

ImportanceImproving access to naloxone is a critical component of the nation’s strategy to curb fatal overdoses in the opioid crisis. Standing or protocol orders, prescriptive authority laws, and immunity provisions have been passed by states to expand access, but less attention has been given to potential financial barriers to naloxone access.ObjectiveTo assess trends in out-of-pocket (OOP) costs for naloxone and examine variation in OOP costs by drug brand and payer.Design, Setting, and ParticipantsThis observational study analyzed US naloxone claims data from Symphony Health and associated OOP costs for individuals filling naloxone prescriptions by drug brand and payer between January 1, 2010, to December 31, 2018. The data were analyzed from March 31, 2021, to April 12, 2022.Main Outcomes and MeasuresThe main measures were trends in annual number of naloxone claims (overall, by payer, and by drug brand) and mean annual OOP costs per claim (overall, by payer, and by drug brand).ResultsOf 719 612 naloxone claims (172 894 generic naloxone, 501 568 Narcan, and 45 150 Evzio) for 2010 through 2018, the number of naloxone claims among insured patients began rapidly increasing after 2014; at the same time, the mean OOP cost of naloxone increased dramatically among the uninsured population. Comparing 2014 with 2018, the mean OOP cost of naloxone decreased by 26% among those with insurance but increased by 606% among uninsured patients. For the uninsured population, the impediment of cost was even larger for certain brands of the drug. In 2016, the mean OOP cost for Evzio among uninsured patients rose to $2136.37 (a 2429% increase relative to 2015) compared with the mean cost of generic naloxone, $72.88, and the cost of Narcan in its first year, $87.95. Throughout the period, the mean OOP costs paid by uninsured patients were higher for Evzio at $1089.17 (95% CI, $884.17-$1294.17) compared with $73.62 (95% CI, $69.24-$78.00) for Narcan and $67.99 (95% CI, $61.42-$74.56) for generic naloxone.Conclusions and RelevanceIn this observational study, the findings indicated that the OOP cost of naloxone had been an increasingly substantial barrier to naloxone access for uninsured patients, potentially limiting use among this population, which constituted approximately 20% of adults with opioid use disorder.

Friedman J., Montero F., Bourgois P., Wahbi R., Dye D., Goodman-Meza D., Shover C.

Sharp exacerbations of the US overdose crisis are linked to polysubstance use of synthetic compounds. Xylazine is a veterinary tranquilizer, long noted in the street opioid supply of Puerto Rico, and more recently Philadelphia. Yet its national trends, geographic distribution, and health risks are poorly characterized.In this sequential mixed-methods study, xylazine was increasingly observed by ethnographers in Philadelphia among drug-sellers and people who inject drugs (PWID). Subsequently, we systematically searched for records describing xylazine-present overdose mortality across the US and assessed time trends and overlap with other drugs.In 10 jurisdictions - representing all four US Census Regions - xylazine was increasingly present in overdose deaths, rising from 0.36% of deaths in 015m 6.7% in 2020. The highest xylazine prevalence data was observed in Philadelphia, (25.8% of deaths), followed by Maryland (19.3%) and Connecticut (10.2%). Illicitly-manufactured-fentanyls were present in 98.4% of xylazine-present-overdose-deaths - suggesting a strong ecological link - as well as cocaine (45.4%), benzodiazepines (28.4%), heroin (23.3%), and alcohol (19.7%). PWID in Philadelphia described xylazine as a sought-after adulterant that lengthens the short duration of fentanyl injections. They also linked it to increased risk of soft tissue infection and naloxone-resistant overdose.Xylazine is increasingly present in overdose deaths, linked to the proliferation of illicitly-manufactured-fentanyls. Ethnographic accounts associate it with profound risks for PWID. Nevertheless, many jurisdictions do not routinely test for xylazine, and it is not comprehensively tracked nationally. Further efforts are needed to provide PWID with services that can help minimize additional risks associated with a shifting drug supply.

Friedman J.R., Hansen H.

Westgate P.M., Cheng D.M., Feaster D.J., Fernández S., Shoben A.B., Vandergrift N.

Background/aims This work is motivated by the HEALing Communities Study, which is a post-test only cluster randomized trial in which communities are randomized to two different trial arms. The primary interest is in reducing opioid overdose fatalities, which will be collected as a count outcome at the community level. Communities range in size from thousands to over one million residents, and fatalities are expected to be rare. Traditional marginal modeling approaches in the cluster randomized trial literature include the use of generalized estimating equations with an exchangeable correlation structure when utilizing subject-level data, or analogously quasi-likelihood based on an over-dispersed binomial variance when utilizing community-level data. These approaches account for and estimate the intra-cluster correlation coefficient, which should be provided in the results from a cluster randomized trial. Alternatively, the coefficient of variation or R coefficient could be reported. In this article, we show that negative binomial regression can also be utilized when communities are large and events are rare. The objectives of this article are (1) to show that the negative binomial regression approach targets the same marginal regression parameter(s) as an over-dispersed binomial model and to explain why the estimates may differ; (2) to derive formulas relating the negative binomial overdispersion parameter k with the intra-cluster correlation coefficient, coefficient of variation, and R coefficient; and (3) analyze pre-intervention data from the HEALing Communities Study to demonstrate and contrast models and to show how to report the intra-cluster correlation coefficient, coefficient of variation, and R coefficient when utilizing negative binomial regression. Methods Negative binomial and over-dispersed binomial regression modeling are contrasted in terms of model setup, regression parameter estimation, and formulation of the overdispersion parameter. Three specific models are used to illustrate concepts and address the third objective. Results The negative binomial regression approach targets the same marginal regression parameter(s) as an over-dispersed binomial model, although estimates may differ. Practical differences arise in regard to how overdispersion, and hence the intra-cluster correlation coefficient is modeled. The negative binomial overdispersion parameter is approximately equal to the ratio of the intra-cluster correlation coefficient and marginal probability, the square of the coefficient of variation, and the R coefficient minus 1. As a result, estimates corresponding to all four of these different types of overdispersion parameterizations can be reported when utilizing negative binomial regression. Conclusion Negative binomial regression provides a valid, practical, alternative approach to the analysis of count data, and corresponding reporting of overdispersion parameters, from community randomized trials in which communities are large and events are rare.

Rao I.J., Humphreys K., Brandeau M.L.

The U.S. opioid crisis has been exacerbated by COVID-19 and the spread of synthetic opioids (e.g., fentanyl).We model the effectiveness of reduced prescribing, drug rescheduling, prescription monitoring programs (PMPs), tamper-resistant drug reformulation, excess opioid disposal, naloxone availability, syringe exchange, pharmacotherapy, and psychosocial treatment. We measure life years, quality-adjusted life years (QALYs), and opioid-related deaths over five and ten years.Under the status quo, our model predicts that approximately 547,000 opioid-related deaths will occur from 2020 to 2024 (range 441,000 - 613,000), rising to 1,220,000 (range 996,000 - 1,383,000) by 2029. Expanding naloxone availability by 30% had the largest effect, averting 25% of opioid deaths. Pharmacotherapy, syringe exchange, psychosocial treatment, and PMPs are uniformly beneficial, reducing opioid-related deaths while leading to gains in life years and QALYs. Reduced prescribing and increasing excess opioid disposal programs would reduce total deaths, but would lead to more heroin deaths in the short term. Drug rescheduling would increase total deaths over five years as some opioid users escalate to heroin, but decrease deaths over ten years. Combined interventions would lead to greater increases in life years, QALYs, and deaths averted, although in many cases the results are subadditive.Expanded health services for individuals with opioid use disorder combined with PMPs and reduced opioid prescribing would moderately lessen the severity of the opioid crisis over the next decade. Tragically, even with improved public policies, significant morbidity and mortality is inevitable.

Sprague Martinez L., Rapkin B.D., Young A., Freisthler B., Glasgow L., Hunt T., Salsberry P.J., Oga E.A., Bennet-Fallin A., Plouck T.J., Drainoni M., Freeman P.R., Surratt H., Gulley J., Hamilton G.A., et. al.

The implementation of evidence-based practices to reduce opioid overdose deaths within communities remains suboptimal. Community engagement can improve the uptake and sustainability of evidence-based practices. The HEALing Communities Study (HCS) aims to reduce opioid overdose deaths through the Communities That HEAL (CTH) intervention, a community-engaged, data-driven planning process that will be implemented in 67 communities across four states.An iterative process was used in the development of the community engagement component of the CTH. The resulting community engagement process uses phased planning steeped in the principles of community based participatory research. Phases include: 0) Preparation, 1) Getting Started, 2) Getting Organized, 3) Community Profiles and Data Dashboards, 4) Community Action Planning, 5) Implementation and Monitoring, and 6) Sustainability Planning.The CTH protocol provides a common structure across the four states for the community-engaged intervention and allows for tailored approaches that meet the unique needs or sociocultural context of each community. Challenges inherent to community engagement work emerged early in the process are discussed.HCS will show how community engagement can support the implementation of evidence-based practices for addressing the opioid crisis in highly impacted communities. Findings from this study have the potential to provide communities across the country with an evidence-based approach to address their local opioid crisis; advance community engaged research; and contribute to the implementation, sustainability, and adoption of evidence-based practices.ClinicalTrials.gov (NCT04111939).

Winhusen T., Walley A., Fanucchi L.C., Hunt T., Lyons M., Lofwall M., Brown J.L., Freeman P.R., Nunes E., Beers D., Saitz R., Stambaugh L., Oga E.A., Herron N., Baker T., et. al.

The number of opioid-involved overdose deaths in the United States remains a national crisis. The HEALing Communities Study (HCS) will test whether Communities That HEAL (CTH), a community-engaged intervention, can decrease opioid-involved deaths in intervention communities (n = 33), relative to wait-list communities (n = 34), from four states. The CTH intervention seeks to facilitate widespread implementation of three evidence-based practices (EBPs) with the potential to reduce opioid-involved overdose fatalities: overdose education and naloxone distribution (OEND), effective delivery of medication for opioid use disorder (MOUD), and safer opioid analgesic prescribing. A key challenge was delineating an EBP implementation approach useful for all HCS communities.A workgroup composed of EBP experts from HCS research sites used literature reviews and expert consensus to: 1) compile strategies and associated resources for implementing EBPs primarily targeting individuals 18 and older; and 2) determine allowable community flexibility in EBP implementation. The workgroup developed the Opioid-overdose Reduction Continuum of Care Approach (ORCCA) to organize EBP strategies and resources to facilitate EBP implementation.The ORCCA includes required and recommended EBP strategies, priority populations, and community settings. Each EBP has a "menu" of strategies from which communities can select and implement with a minimum of five strategies required: one for OEND, three for MOUD, and one for prescription opioid safety. Identification and engagement of high-risk populations in OEND and MOUD is an ORCCArequirement. To ensure CTH has community-wide impact, implementation of at least one EBP strategy is required in healthcare, behavioral health, and criminal justice settings, with communities identifying particular organizations to engage in HCS-facilitated EBP implementation.

Walsh S.L., El-Bassel N., Jackson R.D., Samet J.H., Aggarwal M., Aldridge A.P., Baker T., Barbosa C., Barocas J.A., Battaglia T.A., Beers D., Bernson D., Bowers-Sword R., Bridden C., Brown J.L., et. al.

Opioid overdose deaths remain high in the U.S. Despite having effective interventions to prevent overdose deaths, there are numerous barriers that impede their adoption. The primary aim of the HEALing Communities Study (HCS) is to determine the impact of an intervention consisting of community-engaged, data-driven selection, and implementation of an integrated set of evidence-based practices (EBPs) on reducing opioid overdose deaths.The HCS is a four year multi-site, parallel-group, cluster randomized wait-list controlled trial. Communities (n = 67) in Kentucky, Massachusetts, New York and Ohio are randomized to active intervention (Wave 1), which starts the intervention in Year 1 or the wait-list control (Wave 2), which starts the intervention in Year 3. The HCS will test a conceptually driven framework to assist communities in selecting and adopting EBPs with three components: 1) a community engagement strategy with local coalitions to guide and implement the intervention; 2) a compendium of EBPs coupled with technical assistance; and 3) a series of communication campaigns to increase awareness and demand for EBPs and reduce stigma. An implementation science framework guides the intervention and allows for examination of the multilevel contexts that promote or impede adoption and expansion of EBPs. The primary outcome, number of opioid overdose deaths, will be compared between Wave 1 and Wave 2 communities during Year 2 of the intervention for Wave 1. Numerous secondary outcomes will be examined.The HCS is the largest community-based implementation study in the field of addiction with an ambitious goal of significantly reducing fatal opioid overdoses.

McGladrey M., Booty M., Stitzer S., Knudsen H.K., Walsh S.L., Goetz M., Mattingly H., Lofwall M., Fanucchi L., Oller D., Fallin-Bennett A., Oser C.B.

Englander H., Rolland B., Jauffret-Roustide M.

Background: Opioid agonist therapies (OAT), including methadone and buprenorphine, are first-line care in national and international guidelines, yet many countries, including the United States, frequently fail to effectively engage and retain people in OAT. How OAT is delivered—including the goals and culture of care—matters to patient engagement, treatment retention, and health outcomes. France has among the highest OAT receipt and lowest opioid-related morbidity and mortality worldwide. This study explored French interprofessional health care clinicians’ approach to OAT, drawing lessons to improve OAT implementation in the United States and elsewhere. Methods: We recruited interprofessional participants (eg, physicians, pharmacists, nurses, administrators) from diverse health care settings (eg, specialty addiction care, hospitals, public health) and regions and conducted in-depth semi-structured qualitative interviews. We conducted a reflexive thematic analysis using an inductive approach at a semantic level, identifying themes that held meaning to study participants and had implications for the United States and other contexts. Results: Twenty-one people participated. Participants described patient engagement as the primary goal of OAT, which has potential to draw people to care. They felt imposing or expecting abstinence was harmful and might obligate patients to lie or “lead a double life,” resulting in mistrust, missed care opportunities, and “losing patients” who disengaged from care. Participants described balancing flexibility and structure. They felt that flexibility promotes OAT access and engagement and that clinicians should contextualize decisions within patients’ risk environments, including those of an illicit drug supply and the black market. Participants described that structure should be offered as support, not punishment or control. Finally, they described that practices prioritizing engagement are sustained by policies and professional norms. Conclusions: Our findings challenge OAT practices and policies centered on abstinence and control. They suggest that approaches that prioritize patient engagement and balance flexibility and structure may be central to achieving high rates of OAT across a population.

Knudsen H.K., Back-Haddix S., Andrews-Higgins S., Goetz M., Davis O.A., Oyler D.R., Walsh S.L., Freeman P.R.

Abstract Background Efforts to scale up overdose education and naloxone distribution (OEND), an evidence-based practice for reducing opioid overdose mortality, was a major focus of the HEALing Communities Study (HCS). The aim of this analysis is to describe the qualitative perspectives of partner organizations regarding the impacts of implementing OEND in a state that used a naloxone “hub with many spokes” model for scaling up this strategy. Methods Small group (n = 20) and individual (n = 24) qualitative interviews were conducted with staff from 44 agencies in eight Kentucky counties that implemented OEND from April 2020 to June 2022. Interviews were conducted between 6 and 8 months after the end of the intervention. Initial deductive coding used the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework, and then additional inductive sub-coding focused on passages within the OEND Effectiveness code. Thematic analysis was then utilized to identify themes regarding the impacts of implementing OEND. Results Participants identified multi-level impacts of implementing OEND. At the individual-level, participants described lives being saved, greater access to naloxone for individuals served by the agency, reduced stigma toward OEND by clients, and greater client-level self-efficacy to respond to overdoses. Organizational impacts included improved staff readiness for overdose response, enhanced clinical relationships between staff and clients, and reduced staff stigma. Participants described positive impacts on their organizational networks and clients’ social networks. Community-level impacts included greater overall access and reduced stigma toward OEND. Conclusions These qualitative data revealed that staff from agencies involved in a community-wide effort to scale up OEND perceived multi-level benefits, including saving lives, reducing stigma, improving naloxone access, and enhancing staff and client readiness, while strengthening organizational and community networks. Trial registration ClinicalTrials.gov, NCT04111939. Registered 30 September 2019, https://clinicaltrials.gov/ct2/show/NCT04111939

McMullan J., Mueller W., Brown J.L., Ewing I., Lyons M.S., Sprunger J., Winhusen J., Collins T.

Marshall B.D.

Freeman P.R., Walley A.Y., Winhusen T.J., Oga E.A., Villani J., Hunt T., Chandler R.K., Oyler D.R., Reilly B., Gelberg K., Douglas C., Lyons M.S., Holloway J., Vandergrift N.A., Adams J.W., et. al.

Objectives. To determine whether the Communities That HEAL (CTH) intervention is effective in increasing naloxone distribution compared with usual care. Methods. The HEALing (Helping to End Addiction Long-Term) Communities Study (HCS) is a cluster-randomized, parallel-arm, wait-list controlled implementation science trial testing the impact of the CTH intervention on increasing the use of evidence-based practices to lower opioid-related overdose deaths. Communities (n = 67) highly impacted by opioid overdose in Kentucky, Massachusetts, New York, and Ohio were allocated to CTH intervention (n = 34) or wait-list comparison (usual care; n = 33) arms. The primary outcome for this study was the number of naloxone units distributed in HCS communities during the comparison period (July 1, 2021‒June 30, 2022), examined using an intent-to-treat negative binomial regression model. Results. Naloxone distribution was 79% higher in the CTH intervention versus usual care arm (adjusted relative rate = 1.79; 95% confidence interval = 1.28, 2.51; P = .001; adjusted rates of naloxone distribution 3378 vs 1884 naloxone units per 100 000 residents), when controlling for urban‒rural status, state, baseline opioid-related overdose death rate, and baseline naloxone distribution rate. Conclusions. The CTH intervention increased naloxone distribution compared with usual care in communities highly impacted by the opioid crisis. Trial Registration. ClinicalTrials.gov identifier: NCT04111939. ( Am J Public Health. Published online ahead of print October 10, 2024:e1–e12. https://doi.org/10.2105/AJPH.2024.307845 )

Sprunger J., Brown J., Rubi S., Papp J., Lyons M., Winhusen T.J.

Abstract Background Opioid-related overdose is a leading cause of death for criminal legal-involved individuals and, although naloxone distribution and medications for opioid use disorder (MOUD) are effective means for reducing post-release overdose death risk, jail-based availability is limited. This case report describes the challenges faced by three Ohio communities as they implemented evidence-based practices (EBPs) in jails to combat post-release opioid overdose deaths. Method We present case examples of how barriers were overcome to implement jail-based EBPs in three Ohio communities (two urban and one rural) as part of the HEALing Communities Study (UM1DA049417; ClinicalTrials.gov Identifier: NCT04111939). Of the 18 participating Ohio HEALing Communities Study counties, we highlight 3 communities for the novelty of their EBPs implemented, the challenges that they faced, and their rural/urban status. We present descriptive data regarding the EBPs that they implemented and discuss the challenges identified by HEALing Communities Study staff with first-hand experience facilitating their implementation. Results Newly implemented interventions included overdose education and direct provision of naloxone to incarcerated individuals upon release (2 of 3 communities), initiating MOUD prior to release (3 of 3), linkage to ongoing MOUD treatment in the community (2 of 3), peer support-facilitated treatment retention efforts (2 of 3) and emergency housing (1 of 3) in the immediate post-incarceration period. Common challenges that emerged included skepticism about the need and feasibility of implementing EBPs to reduce overdose and death, lack of knowledge about the options available and whether external agencies may assist, and difficulty engaging stakeholders to overcome inertia. Conclusions Creative flexibility, calm persistence, technical facilitation, and collaboration with community service providers were assets that helped these Ohio jails implement evidence-based strategies that combat the opioid epidemic and reduce the likelihood of post-incarceration overdose and death in a high risk, formerly incarcerated population.

Walters S.T., Drainoni M., Oga E., Byard J., Chandler R.K.

The concept of the "last mile," crucial in logistics for its complexity and cost, has a parallel in public health services. The last mile in public health is fraught with issues such as fragmented services, regulatory barriers, and resistance to evidence-based interventions. This commentary draws parallels between the challenges in delivering goods to consumers' doorsteps and the difficulties in delivering interventions to reduce overdoses in the community. The HEALing Communities Study (HCS), a large implementation science research study, provides an example of how to navigate some of these last-mile challenges. HCS used a community-driven process that considered local characteristics and preferences, and engaged people with lived experience to create effective and sustainable solutions. However, the study also encountered significant challenges in building a delivery infrastructure, working with delayed and incomplete data, and overcoming stigma around substance use interventions. Lessons from the logistics sector can help improve the efficiency and equity of overdose prevention efforts, ensuring that people receive the life-saving interventions they need.

Mclaughlan D., Barrett L., Hindley J., Digby H., Alves T., McLoughlin T.

This month’s update is by the Liverpool Emergency Department Research Unit Strategy Team. We used a multimodal search strategy, drawing on free open-access medical education resources and literature searches. We identified the five most interesting and relevant papers (decided by consensus) and highlight the main findings, key limitations and clinical bottom line for each paper. There were no competing interests from any of the authors. The papers are ranked as: Topic: Toxicology Outcome rating: Worth a peek Samet et al aimed to address the opioid crisis in the USA through community-level interventions using a cluster-randomised trial design.1 Thirty-four communities were assigned to the intervention group, implementing evidence-based practices such as naloxone distribution, and 33 communities were assigned to no intervention. The primary outcome was opioid-related overdose deaths among community adults between June 2021 and June 2022. By the comparison year, there was no significant difference in opioid-related deaths between the intervention and control group (47.2 deaths per 100 000 population vs 51.7 per 100 000 population, p=0.30). Of 615 proposed strategies, only 235 strategies had been initiated by the comparison year, largely due to the workforce depletion and logistical challenges exacerbated by the COVID-19 pandemic. In addition, the large number of strategies made effective implementation difficult and prevented the determination of which strategies were effective. Generalisability of the findings may be limited as it was conducted during the pandemic. Nevertheless, the study suggests a new model for implementation of strategies, going beyond individual clinics or hospitals. Bottom line: implementation of multiple evidence-based strategies at the community level did not reduce opioid overdose deaths in this study. Topic: End of life Care Outcome rating: Head Turner Patients who …

Ciccarone D.

Sacco M.A., Gualtieri S., Tarallo A.P., Tarda L., Verrina M.C., Costa A., Aquila I.

Fentanyl is an opioid with powerful analgesic effects and a high speed of action. Due to its pharmacological properties, this molecule has therapeutic application as an anesthetic in surgery or as palliative therapy for cancer patients. Unfortunately, in recent years, the easy availability of this substance, the low cost and the illegal online market have favored the large-scale diffusion of fentanyl. Fentanyl is available in different forms, including nasal spray, oral patches, soluble capsules, aerosol or the new version of fentanyl mixed with other drugs, making its use very widespread. Subjects of various ages are involved in fentanyl consumption, including minors that have not yet reached adolescence. In this work, we performed a literature review using the search engines PubMed NCBI and SCOPUS regarding episodes of acute fentanyl intoxication occurring in those of a pediatric age using the Mesh Terms “fentanyl” AND “overdose” AND “children”. The inclusion criteria were English papers published in the last 10 years regarding the cases of children under the age of 10. We evaluated the most frequent methods of intake and the circumstances of such episodes. In cases of death, we analyzed the autopsy, the toxicological findings and the investigations carried out. The review results show that in this age group (under < 10 y.o. s), it is possible to identify the risk factors for fentanyl intake, such as the presence of this molecule within the family unit due to drug addiction or medical therapy. The results also demonstrate a significant risk of underestimation of this phenomenon, since the molecule is often not investigated through adequate toxicological analysis. These results, therefore, suggest always carrying out toxicological investigations in the case of suspected fentanyl intoxication, both on patients or cadavers. The investigations must always include a urinary screening for opiates, and the request for a second level analysis with molecule dosage in cases of positivity or in cases of strong suspicion for assumption. In cases of intoxication in a family context of drug addiction, it is necessary to investigate the chronicity of the intake through hair analysis and evaluate the possible co-administration of other drugs. In conclusion, we suggest a protocol, applicable both on patients or cadavers, which can be useful for physicians and forensic pathologists in order to promptly identify these cases and allow for the reporting of them to the judicial authorities with the adoption of strict prevention and control measures.