Investigating the complexity of naloxone distribution: Which policies matter for pharmacies and potential recipients.

Despite efforts to expand naloxone access, opioid-related overdoses remain a significant contributor to mortality. We study state efforts to expand naloxone distribution through pharmacies by reducing the non-monetary costs to prescribers, dispensers, and/or potential recipients of naloxone. We find that laws that only address liability costs have small and insignificant effects on the volume of naloxone dispensed through pharmacies. In contrast, we estimate large effects of laws removing the need for patients to obtain prescriptions from traditional prescribers (e.g., primary care physicians): laws authorizing non-patient-specific prescription distribution and laws granting pharmacists prescriptive authority. We test whether areas designated as primary care shortage areas-where it would be costlier to obtain a prescription-were disproportionately impacted. Shortage areas experienced sharper growth in pharmacy naloxone dispensing in states adopting prescriptive authority policies. These gains were primarily due to those facing low out-of-pocket costs, suggesting that price barriers also must be addressed to increase naloxone purchases.

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.

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.

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.

Racial and Ethnic Disparities in Geographic Availability of Buprenorphine.

OBJECTIVES: Overdose mortality has risen most rapidly among racial and ethnic minority groups while buprenorphine prescribing has increased disproportionately in predominantly non-Hispanic White urban areas. To identify whether buprenorphine availability equitably meets the needs of diverse populations, we examined the differential geographic availability of buprenorphine in areas with greater concentrations of racial and ethnic minority groups. METHODS: Using IQVIA longitudinal prescription data, IQVIA OneKey data, and Microsoft Bing Maps, we calculated 2 outcome measures across the continental United States: the number of buprenorphine prescribers per 1000 residents within a 30-minute drive of a ZIP code, and the number of buprenorphine prescriptions dispensed per capita at retail pharmacies among nearby buprenorphine prescribers. We then estimated differences in these outcomes by ZIP codes' racial and ethnic minority composition and rurality with t tests. RESULTS: Buprenorphine prescribers per 1000 residents within a 30-minute drive decreased by 3.8 prescribers per 1000 residents in urban ZIP codes (95% confidence interval = -4.9 to -2.7) and 2.6 in rural ZIP codes (95% confidence interval = -3.0 to -2.2) whose populations consisted of ≥5% racial and ethnic minority groups. There were 45% to 55% fewer prescribers in urban areas and 62% to 79% fewer prescribers in rural areas as minority composition increased. Differences in dispensed buprenorphine per capita were similar but larger in magnitude. CONCLUSIONS: Achieving more equitable buprenorphine access requires not only increasing the number of buprenorphine-prescribing clinicians; in urban areas with higher racial and ethnic minority group populations, it also requires efforts to promote greater buprenorphine prescribing among already prescribing clinicians.

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.

Barriers to Buprenorphine Dispensing by Medicaid-Participating Community Retail Pharmacies.

Importance: Controlled substances have regulatory requirements under the US Federal Controlled Substance Act that must be met before pharmacies can stock and dispense them. However, emerging evidence suggests there are pharmacy-level barriers in access to buprenorphine for treatment for opioid use disorder even among pharmacies that dispense other opioids. Objective: To estimate the proportion of Medicaid-participating community retail pharmacies that dispense buprenorphine, out of Medicaid-participating community retail pharmacies that dispense other opioids and assess if the proportion dispensing buprenorphine varies by Medicaid patient volume or rural-urban location. Design, Setting, and Participants: This serial cross-sectional study included Medicaid pharmacy claims (2016-2019) data from 6 states (Kentucky, Maine, North Carolina, Pennsylvania, Virginia, West Virginia) participating in the Medicaid Outcomes Distributed Research Network (MODRN). Community retail pharmacies serving Medicaid-enrolled patients were included, mail-order pharmacies were excluded. Analyses were conducted from September 2022 to August 2023. Main Outcomes and Measures: The proportion of pharmacies dispensing buprenorphine approved for opioid use disorder among pharmacies dispensing an opioid analgesic or buprenorphine prescription to at least 1 Medicaid enrollee in each state. Pharmacies were categorized by median Medicaid patient volume (by state and year) and rurality (urban vs rural location according to zip code). Results: In 2016, 72.0% (95% CI, 70.9%-73.0%) of the 7038 pharmacies that dispensed opioids also dispensed buprenorphine to Medicaid enrollees, increasing to 80.4% (95% CI, 79.5%-81.3%) of 7437 pharmacies in 2019. States varied in the percent of pharmacies dispensing buprenorphine in Medicaid (range, 73.8%-96.4%), with significant differences between several states found in 2019 (χ2 P < .05), when states were most similar in the percent of pharmacies dispensing buprenorphine. A lower percent of pharmacies with Medicaid patient volume below the median dispensed buprenorphine (69.1% vs 91.7% in 2019), compared with pharmacies with above-median patient volume (χ2 P < .001). Conclusions and Relevance: In this serial cross-sectional study of Medicaid-participating pharmacies, buprenorphine was not accessible in up to 20% of community retail pharmacies, presenting pharmacy-level barriers to patients with Medicaid seeking buprenorphine treatment. That some pharmacies dispensed opioid analgesics but not buprenorphine suggests that factors other than compliance with the Controlled Substance Act influence pharmacy dispensing decisions.

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.

The association between naloxone claims and proportion of independent versus chain pharmacies: A longitudinal analysis of naloxone claims in the United States.

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.

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.

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.

Availability of Long-Acting Injectable Buprenorphine at Substance Use Treatment Facilities in 2021.

This study assesses the proportion of US substance use and mental health care facilities that offered any medications for opioid use disorder and, specifically, long-acting injectable buprenorphine in 2021.

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.

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.

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.

Community pharmacy naloxone supply, before and after rescheduling as an over-the-counter drug: sales and prescriptions data, 2014-2018.

OBJECTIVES: To characterise the community pharmacy supply of naloxone by supply type - individual prescription, prescriber bag, and non-dispensed (supplied over the counter or expired) - during 2014-2018; to examine whether the 2016 rescheduling of naloxone as an over-the-counter drug influenced non-dispensed naloxone supply volume. DESIGN, SETTING: Analysis of monthly naloxone prescriptions (Pharmaceutical Benefits Scheme) and sales data (IQVIA), 2014-2018, for Australia and by state and territory; time series analysis of non-dispensed naloxone supply to assess effect of rescheduling on naloxone supply. MAJOR OUTCOMES: Total naloxone supply to community pharmacies; prescribed and non-dispensed naloxone supply. RESULTS: During 2014-2018, 372 351 400 µg units of naloxone were sold to community pharmacies: non-dispensed naloxone accounted for 205 866.5 units (55.3%), prescriber bags for 155 841 units (41.8%), and individual prescriptions for 10 643.5 units (2.9%). Population-adjusted national naloxone sales to community pharmacies increased between 2014 and 2018 (per year: incidence rate ratio [IRR], 1.15; 95% CI, 1.09-2.22). This increase was primarily attributable to increased volumes of prescriber bag naloxone (IRR, 1.63; 95% CI, 1.50-1.78) and, to a lesser extent, increased individual prescription supply (IRR, 2.04; 95% CI, 1.85-2.26). Non-dispensed naloxone supply volume was unchanged at the national level (IRR, 0.93; 95% CI, 0.85-1.01); changes in non-dispensed supply immediately following rescheduling and subsequently were not statistically significant in time series analyses for most jurisdictions. CONCLUSIONS: Total naloxone supply to community pharmacies in Australia increased between 2014 and 2018, but rescheduling that enabled over-the-counter access did not significantly influence the volume of non-dispensed naloxone.