Naloxone Availability and Cost After Transition to an Over-the-Counter Product.

Importance: The US Food and Drug Administration approved Narcan, a nasal spray formulation of naloxone, for sale as an over-the-counter (OTC) medication in March 2023. The purpose of OTC approval was to improve naloxone accessibility to reduce opioid overdoses; however, research has not yet evaluated whether naloxone's availability and cost changed since this policy was implemented. Objective: To evaluate whether the accessibility and cost of naloxone at North Carolina community pharmacies changed after OTC naloxone became available and whether cost and availability varied by pharmacy type and urbanicity. Design, Setting, and Participants: This longitudinal telephone-based secret shopper survey study included a stratified sample of 202 North Carolina community pharmacies, including health department, independent, and chain pharmacies. There were 2 separate data collection efforts from March to April 2023 (before OTC naloxone could be sold at pharmacies) and November 2023 to January 2024 (after OTC naloxone was sold at pharmacies). Exposure: OTC naloxone first became available for sale at community pharmacies in September 2023. Main Outcomes and Measures: The main outcomes were same-day availability of naloxone without a clinician-issued prescription and the quoted out-of-pocket cost for cash-paying patients. Results: Data were collected from 192 pharmacies. Same-day naloxone availability increased from 42.2% (81 of 192) before OTC naloxone availability to 57.8% (111 of 192) after (P < .001). The mean (SD) quoted out-of-pocket cost decreased from $90.93 ($42.6) pre-OTC availability to $62.67 ($41.0) post-OTC availability (P < .001). Independent pharmacies had higher mean (SD) costs than chain pharmacies in both the pre-OTC phase ($109.47 [$37.90] vs $86.40 [$35.70]; P < .001) and post-OTC phase ($77.59 [$38.90] vs $57.74 [$35.90]; P = .004). Out-of-pocket costs did not differ by urbanicity in the pre-OTC phase; however, mean (SD) costs were higher at suburban ($88.67 [$66.80]) and rural ($65.43 [$35.00]) pharmacies compared with urban pharmacies ($53.58 [$29.00]) in the post-OTC phase (P = .003). Conclusions and Relevance: The Food and Drug Administration's approval of OTC naloxone nasal spray contributed to an increase in pharmacy-based availability of naloxone and a reduction of its cost for cash-paying patients. Cost was higher at independent pharmacies compared with chain pharmacies and lower in urban pharmacies compared with suburban and rural pharmacies.

Accessibility of Naloxone in Pharmacies Registered Under the Illinois Standing Order.

Introduction: To expand access to naloxone, the state of Illinois implemented a standing order allowing registered pharmacies to dispense the drug without an individual prescription. To participate under the standing order, pharmacies were required to opt in through a formal registration process. In our study we aimed to evaluate the availability and price of naloxone at registered pharmacies. Methods: This was a prospective, de-identified, cross-sectional telephone survey. Trained interviewers posed as potential customers and used a standardized script to determine the availability of naloxone between February-December, 2019. The primary outcome was defined as a pharmacy indicating it carried naloxone, currently had naloxone in stock, and was able to dispense it without an individual prescription. Results: Of 948 registered pharmacies, 886 (93.5%) were successfully contacted. Of those, 792 (83.4%) carried naloxone, 659 (74.4%) had naloxone in stock, and 472 (53.3%) allowed purchase without a prescription. Naloxone nasal spray (86.4%) was the formulation most commonly stocked. Chain pharmacies were more likely to carry naloxone (adjusted odds ratio [aOR] 3.16, 95% confidence interval [CI] 1.97-5.01, P < 0.01) and have naloxone in stock (aOR 2.72, 95% CI 1.76-4.20, P < 0.01), but no more likely to dispense it without a prescription. Pharmacies in higher population areas (aOR 0.99, 95% CI 0.99-0.99, P < 0.05) and rural areas adjacent to metropolitan areas (aOR 0.5, 95% CI 025-0.98, P < 0.05) were less likely to have naloxone available without a prescription. Associations of naloxone availability based on other urbanicity designations, overdose count, and overdose rate were not significant. Conclusion: Among pharmacies in Illinois that formally registered to dispense naloxone without a prescription, the availability of naloxone remains limited. Additional interventions may be needed to maximize the potential impact of a statewide standing order.

Trends in Naloxone Dispensing From Retail Pharmacies in the US.

This cross-sectional study examines trends in naloxone dispensing by US retail pharmacies from 2019 to 2023, including prescriber specialty and product brand.

ASAP: A pharmacy-level intervention to increase nonprescription syringe sales to reduce bloodborne illnesses.

BACKGROUND: Pharmacy syringe sales are effective structural interventions to reduce bloodborne illnesses in populations, and are legal in all but two states. Yet evidence indicates reduced syringe sales in recent years. This study was designed as a feasibility test of an intervention to promote syringe sales by pharmacies in Arizona. METHODS: A four-month pilot among three Arizona pharmacies measured feasibility and acceptability through monthly surveys to 18 enrolled pharmacy staff members. RESULTS: Pharmacy staff reported increased ease of dispensing syringes across the study. Rankings of syringe dispensing as 'easiest' among 6 measured pharmacy practices increased from 38.9 % at baseline to 50.1 % post intervention module training, and to 83.3 % at pilot conclusion. The majority (72.2 %) of pharmacy staff agreed that intervention materials were easy to use. Over 70 % indicated that the intervention was influential in their "being more open to selling syringes without a prescription to someone who might use them for illicit drug use," and 61.1 % reported that in the future, they were highly likely to dispense syringes to customers who would use them to inject drugs. A vast majority (92 %) reported being likely to dispense subsidized naloxone if available to their pharmacy at no cost. CONCLUSIONS: An education-based intervention was found to be feasible and acceptable to pharmacy staff and had an observed impact on perceptions of ease and likelihood of dispensing syringes without a prescription to people who may use them to inject drugs.

Evaluation of Strategies to Enhance Community-Based Naloxone Distribution Supported by an Opioid Settlement.

Importance: Many US states are substantially increasing community-based naloxone distribution, supported in part through settlements from opioid manufacturers and distributors. Objectives: To evaluate the potential impact of increased naloxone availability on opioid overdose deaths (OODs) and explore strategies to enhance this impact by integrating interventions to address solitary drug use. Design, Setting, and Participants: This decision analytical modeling study used PROFOUND (Prevention and Rescue of Fentanyl and Other Opioid Overdoses Using Optimized Naloxone Distribution Strategies), a previously published simulation model, to forecast annual OODs between January 2023 and December 2025. The simulated study population included individuals from Rhode Island who misused opioids and stimulants and were at risk for opioid overdose. Exposures: The study modeled expanded naloxone distribution supported by the state's opioid settlement (50 000 naloxone nasal spray kits each year). Two approaches to expanding naloxone distribution were evaluated: one based on historical spatial patterns of naloxone distribution (supply-based approach) and one based on the spatial distribution of individuals at risk (demand-based approach). In addition, hypothetical interventions to enhance the likelihood of witnessed overdoses in private or semiprivate settings were considered. Main Outcomes and Measures: Annual number of OODs and ratio of fatal to nonfatal opioid overdoses. Results: Modeling results indicated that distributing more naloxone supported by the state's opioid settlement could reduce OODs by 6.3% (95% simulation interval [SI], 0.3%-13.7%) and 8.8% (95% SI, 1.8%-17.5%) in 2025 with the supply-based and demand-based approaches, respectively. However, increasing witnessed overdoses by 20% to 60% demonstrated greater potential for reducing OODs, ranging from 8.5% (95% SI, 0.0%-20.3%) to 24.1% (95% SI, 8.6%-39.3%). Notably, synergistic associations were observed when combining both interventions: increased naloxone distribution with the 2 approaches and a 60% increase in witnessed overdoses could reduce OODs in 2025 by 33.5% (95% SI, 17.1%-50.4%) and 37.4% (95% SI, 19.6%-56.3%), respectively. Conclusions and Relevance: These findings suggest that interventions to address solitary drug use are needed to maximize the impact of continued efforts to increase community-based naloxone distribution, which may be particularly important for jurisdictions that have strong community-based naloxone distribution programs.

Stocking and supplying naloxone: Findings from a representative sample of community pharmacies in Victoria, Australia.

INTRODUCTION: Naloxone is an opioid receptor antagonist, which can rapidly reverse the effects of an opioid overdose. Community pharmacists may experience several barriers to stocking and supplying naloxone including a lack of confidence or knowledge and time constraints. The current study aimed to examine the extent to which Victorian community pharmacies stock and supply naloxone and determine specific characteristics associated with stocking naloxone. METHODS: A representative sample of community pharmacists (n = 558) in Victoria, Australia, were contacted between October and November 2020 and invited to participate in an online survey. Data related to pharmacy- and pharmacist-related characteristics, including stocking and frequency of supplying naloxone in the past year. Multivariate logistic regression analysis was performed to examine the effect of various covariates on stocking naloxone. RESULTS: The sample comprised 265 pharmacists (response rate 47%). Most pharmacies were located in Melbourne (the capital city of Victoria, 59.6%) and were part of a pharmacy chain (61.5%). In total, 100 (38%) pharmacies stocked naloxone, a third of whom did not supply it in the past year. Pharmacies that provided opioid agonist treatment had 2.4 times higher odds of stocking naloxone (95% confidence interval 1.425-4.136; p = 0.001). DISCUSSION AND CONCLUSION: Less than half of Victorian community pharmacies stock naloxone, with even fewer actually supplying it in the past year. Future efforts are needed to increase the number of pharmacies that stock naloxone and the frequency in which it is supplied, while also addressing possible barriers to stocking and supplying naloxone among community pharmacists.

Naloxone Accessibility by Standing Order in North Carolina Community Pharmacies.

BACKGROUND: According to a standing order in North Carolina (NC), naloxone can be purchased without a provider prescription. OBJECTIVE: The objective of this study is to examine whether same-day naloxone accessibility and cost vary by pharmacy type and rurality in NC. METHODS: A cross-sectional telephone audit of 202 NC community pharmacies stratified by pharmacy type and county of origin was conducted in March and April 2023. Trained "secret shoppers" enacted a standardized script and recorded whether naloxone was available and its cost. We examined the relationship between out-of-pocket naloxone cost, pharmacy type, and rurality. RESULTS: Naloxone could be purchased in 53% of the pharmacies contacted; 26% incorrectly noting that naloxone could be filled only with a provider prescription and 21% did not sell naloxone. Naloxone availability by standing order was statistically different by pharmacy type (chain/independent) (χ2 = 20.58, df = 4, P value < 0.001), with a higher frequency of willingness to dispense according to the standing order by chain pharmacies in comparison to independent pharmacies. The average quoted cost for naloxone nasal spray at chain pharmacies was $84.69; the cost was significantly more ($113.54; P < 0.001) at independent pharmacies. Naloxone cost did not significantly differ by pharmacy rurality (F2,136 = 2.38, P = 0.10). CONCLUSION: Approximately half of NC community pharmacies audited dispense naloxone according to the statewide standing order, limiting same-day access to this life-saving medication. Costs were higher at independent pharmacies, which could be due to store-level policies. Future studies should further investigate these cost differences, especially as intranasal naloxone transitions from a prescription only to over-the-counter product.

Statewide efforts to address the opioid epidemic: Results from a national survey of single state agencies.

BACKGROUND: Single State Agencies (SSAs) are at the forefront of efforts to address the nation's opioid epidemic, responsible for allocating billions of dollars in federal, state, and local funds to ensure service quality, promote best practices, and expand access to care. Federal expenditures to SSAs have more than tripled since the early years of the epidemic, yet, it is unclear what initiatives SSAs have undertaken to address the crisis and how they are financing these efforts. METHODS: This study used data from an internet-based survey of SSAs, conducted by the University of Chicago Survey Lab from January to December 2021 (response rate of 94 %). The survey included a set of 14 items identifying statewide efforts to address the opioid epidemic and six funding sources. We calculated the percentage of SSAs that supported each statewide effort and the percentage of SSAs reporting use of each source of funding across the 14 statewide efforts. RESULTS: Treatment of opioid-related overdose figured most prominently among statewide efforts, with all SSAs providing funding for naloxone distribution and all but one SSA supporting naloxone training. Recovery support services, Project ECHO, and Hub and Spoke models were supported by the vast majority of SSAs. Statewide efforts related to expanding access to medications for opioid use disorder (MOUD) received somewhat less support, with 45 % of SSAs supporting mobile methadone/MOUD clinics/programs and 70 % supporting buprenorphine in emergency departments. A relatively low proportion of SSAs (54 %) provided support for syringe services programs. State Opioid Response (SOR) funds were the most common funding source reported by SSAs (57 % of SSAs), followed by block grant funds (19 %) and other state funding (15 %). CONCLUSION: Results highlight a range of SSA efforts to address the nation's opioid epidemic. Limited adoption of efforts to expand access to MOUD and harm reduction services may represent missed opportunities. The uncertainty over reauthorization of the SOR grant post-2025 also raises concerns over sustainability of funding for many of these statewide initiatives.

Racial/ethnic differences in receipt of naloxone distributed by opioid overdose prevention programs in New York City.

INTRODUCTION: We evaluated racial/ethnic differences in the receipt of naloxone distributed by opioid overdose prevention programs (OOPPs) in New York City (NYC). METHODS: We used naloxone recipient racial/ethnic data collected by OOPPs from April 2018 to March 2019. We aggregated quarterly neighborhood-specific rates of naloxone receipt and other covariates to 42 NYC neighborhoods. We used a multilevel negative binomial regression model to assess the relationship between neighborhood-specific naloxone receipt rates and race/ethnicity. Race/ethnicity was stratified into four mutually exclusive groups: Latino, non-Latino Black, non-Latino White, and non-Latino Other. We also conducted racial/ethnic-specific geospatial analyses to assess whether there was within-group geographic variation in naloxone receipt rates for each racial/ethnic group. RESULTS: Non-Latino Black residents had the highest median quarterly naloxone receipt rate of 41.8 per 100,000 residents, followed by Latino residents (22.0 per 100,000), non-Latino White (13.6 per 100,000) and non-Latino Other residents (13.3 per 100,000). In our multivariable analysis, compared with non-Latino White residents, non-Latino Black residents had a significantly higher receipt rate, and non-Latino Other residents had a significantly lower receipt rate. In the geospatial analyses, both Latino and non-Latino Black residents had the most within-group geographic variation in naloxone receipt rates compared to non-Latino White and Other residents. CONCLUSIONS: This study found significant racial/ethnic differences in naloxone receipt from NYC OOPPs. We observed substantial variation in naloxone receipt for non-Latino Black and Latino residents across neighborhoods, indicating relatively poorer access in some neighborhoods and opportunities for new approaches to address geographic and structural barriers in these locations.

Saving lives in our homes: Qualitative evaluation of a tenant overdose response program in supportive, single-room occupancy (SRO) housing.

BACKGROUND: People using opioids alone in private settings are at elevated risk of dying in the event of an overdose. In San Francisco, single room occupancy (SRO) tenants are 19 times more likely to die of overdose than non-SRO residents. The "SRO Project" pilot aimed to reduce fatal overdoses in SROs by recruiting and training tenants to distribute naloxone and provide overdose education in their buildings. We explore the implementation and program impacts of the SRO Project pilot in two permanent supportive housing SROs. METHODS: We conducted eight months of ethnographic fieldwork (May 2021 - Feb 2022), including 35 days observing SRO Project pilot activities, and semi-structured interviews with 11 housing staff and 8 tenant overdose prevention specialists ('specialists'). Data were analyzed using a grounded theory approach to characterize program impacts, implementation strengths, and implementation challenges from the perspective of specialists and housing staff. FINDINGS: We found that the SRO project increased awareness, access to, and understanding of naloxone; facilitated other mutual-aid practices; supported privacy and autonomy of tenants regarding their drug use; and improved rapport, communication and trust between tenants and housing staff. Strengths of the implementation process included involvement of tenants with diverse social locations and skill sets and, at one site, a team-based approach that fostered program innovation, tenant solidarity and a sense of collective ownership over the project. Program implementation was challenged by frequent turnover and capacity constraints of housing staff, particularly during overnight shifts when overdose risks were greatest. Additional challenges arose due to the psychosocial burden of overdose response work, gendered violence, issues with compensation methods, and scope creep in specialists' roles. CONCLUSION: This evaluation contributes further evidence regarding the effectiveness of tenant-led naloxone distribution and overdose education in permanent supportive and SRO housing environments. Findings indicate program implementation and sustainability can be improved by expanding tenant specialist training, compensating specialists in cash, and building stronger psychosocial support for tenants responding to overdoses in their homes.

Projected Estimates of Opioid Mortality After Community-Level Interventions.

Importance: The United States is experiencing a crisis of opioid overdose. In response, the US Department of Health and Human Services has defined a goal to reduce overdose mortality by 40% by 2022. Objective: To identify specific combinations of 3 interventions (initiating more people to medications for opioid use disorder [MOUD], increasing 6-month retention with MOUD, and increasing naloxone distribution) associated with at least a 40% reduction in opioid overdose in simulated populations. Design, Setting, and Participants: This decision analytical model used a dynamic population-level state-transition model to project outcomes over a 2-year horizon. Each intervention scenario was compared with the counterfactual of no intervention in simulated urban and rural communities in Massachusetts. Simulation modeling was used to determine the associations of community-level interventions with opioid overdose rates. The 3 examined interventions were initiation of more people to MOUD, increasing individuals' retention with MOUD, and increasing distribution of naloxone. Data were analyzed from July to November 2020. Main Outcomes and Measures: Reduction in overdose mortality, medication treatment capacity needs, and naloxone needs. Results: No single intervention was associated with a 40% reduction in overdose mortality in the simulated communities. Reaching this goal required use of MOUD and naloxone. Achieving a 40% reduction required that 10% to 15% of the estimated OUD population not already receiving MOUD initiate MOUD every month, with 45% to 60%% retention for at least 6 months, and increased naloxone distribution. In all feasible settings and scenarios, attaining a 40% reduction in overdose mortality required that in every month, at least 10% of the population with OUD who were not currently receiving treatment initiate an MOUD. Conclusions and Relevance: In this modeling study, only communities with increased capacity for treating with MOUD and increased MOUD retention experienced a 40% decrease in overdose mortality. These findings could provide a framework for developing community-level interventions to reduce opioid overdose death.

A Healthcare System-Level Intervention to Increase Naloxone Availability for Patients With Opioid Prescriptions.

BACKGROUND AND OBJECTIVES: National guidelines recommend prescribing naloxone to patients receiving chronic opioids. However, provider adherence to naloxone co-prescribing best practices is poor and knowledge gaps for improvement efforts are large. As part of a system-wide quality improvement intervention to improve opioid safety, we sought to improve access to naloxone for patients with opioid prescriptions. METHODS: A prompt for naloxone co-prescribing was implemented in the electronic health record. Baseline data and data after implementation were collected for naloxone co-prescribing and fill rates on naloxone prescriptions s (n = 9122 pre, 8368 post). RESULTS: In the 9 months following the implementation of the electronic prompt, the total number of naloxone prescriptions increased more than 15-fold. Patients prescribed naloxone filled their naloxone prescriptions similarly (42%) before and after the prompt implementation, resulting in a marked increase in the absolute number of patients with access to naloxone. Patient fill rates varied by clinical area (33% emergency medicine to 47% general medicine). CONCLUSION AND SCIENTIFIC SIGNIFICANCE: An electronic prompt, encouraging providers to prescribe naloxone to at-risk patients led to a marked increase in the percentage of patients with an active naloxone prescription. The availability of naloxone in communities saves lives and this study is the first to demonstrate an intervention, which led to increased naloxone prescribing and reported on actual pharmacy fills of naloxone when co-prescribed with opioids. (Am J Addict 2020;00:00-00).

The University of Miami Infectious Disease Elimination Act Syringe Services Program: A Blueprint for Student Advocacy, Education, and Innovation.

After the closure of pill mills and implementation of Florida's Prescription Drug Monitoring Program in 2010, high demand for opioids was met with counterfeit pills, heroin, and fentanyl. In response, medical students at the University of Miami Miller School of Medicine embarked on a journey to bring syringe services programs (SSPs) to Florida through an innovative grassroots approach. Working with the Florida Medical Association, students learned patient advocacy, legislation writing, and negotiation within a complex political climate. Advocacy over 4 legislative sessions (2013-2016) included committee testimony and legislative visit days, resulting in the authorization of a 5-year SSP pilot. The University of Miami's Infectious Disease Elimination Act (IDEA) SSP opened on December 1, 2016. Students identified an urgent need for expanded health care for program participants and founded a weekly free clinic at the SSP. Students who rotate through the clinic learn medicine and harm reduction through the lens of social justice, with exposure to people who use drugs, sex workers, individuals experiencing homelessness, and other vulnerable populations. The earliest success of the IDEA SSP was the distribution of over 2,000 boxes of nasal naloxone, which the authors believe positively contributed to a decrease in the number of opioid-related deaths in Miami-Dade County for the first time since 2013. The second was the early identification of a cluster of acute human immunodeficiency virus infections among program participants. Inspired by these successes, students from across the state joined University of Miami students and met with legislators in their home districts, wrote op-eds, participated in media interviews, and traveled to the State Capitol to advocate for decisive action to mitigate the opioid crisis. The 2019 legislature passed legislation authorizing SSPs statewide. In states late to adopt SSPs, medical schools have a unique opportunity to address the opioid crisis using this evidence-based approach.

Point-of-sale Naloxone: Novel Community-based Research to Identify Naloxone Availability.

INTRODUCTION: Expanding naloxone availability is important to reduce opioid-related deaths. Recent data suggest low, variable urban naloxone availability. No reports describe naloxone availability at the point of sale (POSN). We characterize POSN without prescription across a Midwestern metropolitan area, via a unique poison center-based study. METHODS: Pharmacies were randomly sampled within a seven-county metropolitan area, geospatially mapped, and distributed among seven investigators, who visited pharmacies and asked, "May I purchase naloxone here without a prescription from my doctor?" Following "No," investigators asked, "Are you aware of the state statute that allows you to dispense naloxone to the public under a standing order?" Materials describing statutory support for POSN were provided. Responses were uploaded to REDCap in real time. We excluded specialty (veterinary, mail order, or infusion) pharmacies a priori. POSN availability is presented as descriptive statistics; characteristics of individual sites associated with POSN availability are reported. RESULTS: In total, 150 pharmacies were prospectively randomized, with 52 subsequently excluded or unavailable for survey. Thus, 98 were included in the final analysis. POSN was available at 71 (72.5%) of 98 pharmacies. POSN availability was more likely at chain than independent pharmacies (84.7% vs 38.5%, p<0.001); rural areas were more commonly served by independent than chain pharmacies (47.4% vs 21.5%, p = 0.022). Five chain and five independent pharmacies (18.5% each) were unaware of state statutory support for collaborative POSN agreements. Statutory awareness was similar between independent and chain pharmacies (68.8% vs 54.6%, p = 0.453). Rationale for no POSN varied. CONCLUSION: POSN is widely available in this metropolitan area. Variability exists between chain and independent pharmacies, and among pharmacies of the same chain; awareness of statutory guidance does not. Poison centers can act to define local POSN availability via direct inquiry in their communities.

Overdose Education and Naloxone Distribution Within Syringe Service Programs - United States, 2019.

Syringe service programs (SSPs), which provide access to sterile syringes and other injection equipment and their safe disposal after use,* represent a highly successful human immunodeficiency virus (HIV) prevention intervention. SSPs are associated with a 58% reduction in the incidence of HIV infection among persons who inject drugs (1). In addition, SSPs have led efforts to prevent opioid overdose deaths by integrating evidence-based opioid overdose education and naloxone distribution (OEND) programs (2-4). OEND programs train laypersons to respond during overdose events and provide access to naloxone and directions for drug delivery (2-4). SSPs are ideal places for OEND because they provide culturally relevant services designed to reach persons at high risk for experiencing or observing an opioid overdose. A 2013 survey found that only 55% of SSPs in the United States had implemented OEND (5). To characterize current implementation of OEND among SSPs, and to describe the current reach (i.e., the ratio of persons who received naloxone per opioid overdose death and the ratio of naloxone doses distributed per opioid overdose death) of SSP-based OEND programs by U.S. Census division,† a survey of known U.S. SSPs was conducted in 2019, which found that 94% of SSPs had implemented OEND. In addition, the reach of SSP-based OEND programs varied by U.S. Census division. Scaling up of SSP-based OEND delivery programs could be a critical component for areas of the country with high opioid overdose death rates and low reach.

Economic Evaluation of Interventions to Address Opioid Misuse: A Systematic Review of Methods Used in Simulation Modeling Studies.

OBJECTIVES: Several evidence-based interventions exist for people who misuse opioids, but there is limited guidance on optimal intervention selection. Economic evaluations using simulation modeling can guide the allocation of resources and help tackle the opioid crisis. This study reviews methods employed by economic evaluations using computer simulations to investigate the health and economic effects of interventions meant to address opioid misuse. METHODS: We conducted a systematic mapping review of studies that used simulation modeling to support the economic evaluation of interventions targeting prevention, treatment, or management of opioid misuse or its direct consequences (ie, overdose). We searched 6 databases and extracted information on study population, interventions, costs, outcomes, and economic analysis and modeling approaches. RESULTS: Eighteen studies met the inclusion criteria. All of the studies considered only one segment of the continuum of care. Of the studies, 13 evaluated medications for opioid use disorder, and 5 evaluated naloxone distribution programs to reduce overdose deaths. Most studies estimated incremental cost per quality-adjusted life-years and used health system and/or societal perspectives. Models were decision trees (n = 4), Markov (n = 10) or semi-Markov models (n = 3), and microsimulations (n = 1). All of the studies assessed parameter uncertainty though deterministic and/or probabilistic sensitivity analysis, 4 conducted formal calibration, only 2 assessed structural uncertainty, and only 1 conducted expected value of information analyses. Only 10 studies conducted validation. CONCLUSIONS: Future economic evaluations should consider synergies between interventions and examine combinations of interventions to inform optimal policy response. They should also more consistently conduct model validation and assess the value of further research.

Regional variation in states' naloxone accessibility laws in association with opioid overdose death rates-Observational study (STROBE compliant).

Though overall death from opioid overdose are increasing in the United States, the death rate in some states and population groups is stabilizing or even decreasing. Several states have enacted a Naloxone Accessibility Laws to increase naloxone availability as an opioid antidote. The extent to which these laws permit layperson distribution and possession varies. The aim of this study is to investigate differences in provisions of Naloxone Accessibility Laws by states mainly in the Northeast and West regions, and the impact of naloxone availability on the rates of drug overdose deaths.This cross-sectional study was based on the National Vital Statistics System multiple cause-of-death mortality files. The average changes in drug overdose death rates between 2013 and 2017 in relevant states of the Northeast and West regions were compared according to availability of naloxone to laypersons.Seven states in the Northeast region and 10 states in the Western region allowed layperson distribution of naloxone. Layperson possession of naloxone was allowed in 3 states each in the Northeast and the Western regions. The average drug overdose death rates increased in many states in the both regions regardless of legalization of layperson naloxone distribution. The average death rates of 3 states that legalized layperson possession in the West region decreased (-0.33 per 100,000 person); however, in states in the West region that did not allow layperson possession and states in the Northeast region regardless of layperson possession increased between 2013 and 2017.The provision to legalize layperson possession of naloxone was associated with decreased average opioid overdose death rates in 3 states of the West region.

Laws Mandating Coprescription of Naloxone and Their Impact on Naloxone Prescription in Five US States, 2014-2018.

Objectives. To examine early impacts of laws that require naloxone to be prescribed to patients at increased overdose risk.Methods. Using data from 2014 to 2018 from a large pharmacy chain, CVS Pharmacy, we examined the effects of naloxone-prescribing mandates 90 days before and after they took effect in Arizona, Florida, Rhode Island, Vermont, and Virginia. We compared the number of naloxone doses initiated directly by prescribers and by pharmacy standing order, prescriber specialty, pharmacies dispensing, and payor type by applying linear models and the χ2 test.Results. Naloxone-prescribing mandates increased pharmacy naloxone provision 255% from 90 days before to after implementation. This approach appeared to engage more prescribers (1028 before to 4285 after), complement ongoing naloxone provision under pharmacy standing orders, expand geographic reach (from 40% to 80% of pharmacies dispensing), and broaden the naloxone payor mix in 4 (P < .05) of 5 states.Conclusions. Mandating the prescribing of naloxone quickly expands access to this life-saving medication for more people in more places. Other states should consider mandating the coprescription of naloxone to individuals at increased risk of overdose.