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.

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.

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.

Naloxone Availability in Retail Pharmacies and Neighborhood Inequities in Access.

INTRODUCTION: This study examines the implementation of North Carolina's statewide naloxone standing order and identifies community characteristics associated with pharmacy stocking and willingness to sell naloxone under the standing order. METHODS: In April-June 2019, a mystery caller protocol was completed to assess if (1) North Carolina pharmacies had naloxone available and were willing to dispense it without a prescription, (2) pharmacy characteristics associated with availability, and (3) there were neighborhood differences (e.g., Census tract population size, density, racial composition, SES, rates of opioid overdoses, and rates of opioid prescriptions dispensed) in availability. Using random sampling stratified by inclusion on North Carolina's public list of pharmacies participating in the standing order, chain, independent, and health department pharmacies in North Carolina were sampled (n=161 of 2,044). In June 2019, the data were analyzed. Survey weights were utilized to calculate the prevalence of availability, and regression models were conducted to examine associations. RESULTS: An estimated 61.7% (95% CI=54.3, 68.5) of North Carolina retail pharmacies have naloxone available without a prescription. The odds of naloxone availability were lower for independent pharmacies than chains (OR=0.12, 95% CI=0.06, 0.25). Inclusion on North Carolina's public list of pharmacies had greater odds of naloxone availability (OR=2.32, 95% CI=1.22, 4.43). Naloxone availability was lower in communities with higher percentages of residents with public health insurance (OR=0.97, 95% CI=0.95, 0.999). CONCLUSIONS: Though more than half of the pharmacies in North Carolina participate in the standing order for naloxone, efforts to identify the best practices for ensuring widespread implementation of statewide standing orders for naloxone are warranted.

Cost-effectiveness analysis of alternative naloxone distribution strategies: First responder and lay distribution in the United States.

BACKGROUND: The U.S. is facing an unprecedented number of opioid-related overdose deaths, and an array of other countries have experienced increases in opioid-related fatalities. In the U.S., naloxone is increasingly distributed to first responders to improve early administration to overdose victims, but its cost-effectiveness has not been studied. Lay distribution, in contrast, has been found to be cost-effective, but rising naloxone prices and increased mortality due to synthetic opioids may reduce cost-effectiveness. We evaluate the cost-effectiveness of increased naloxone distribution to (a) people likely to witness or experience overdose ("laypeople"); (b) police and firefighters; (c) emergency medical services (EMS) personnel; and (d) combinations of these groups. METHODS: We use a decision-analytic model to analyze the cost-effectiveness of eight naloxone distribution strategies. We use a lifetime horizon and conduct both a societal analysis (accounting for productivity and criminal justice system costs) and a health sector analysis. We calculate: the ranking of strategies by net monetary benefit; incremental cost-effectiveness ratios; and number of fatal overdoses. RESULTS: High distribution to all three groups maximized net monetary benefit and minimized fatal overdoses; it averted 21% of overdose deaths compared to minimum distribution. High distribution to laypeople and one of the other groups comprised the second and third best strategies. The majority of health gains resulted from increased lay distribution. In the societal analysis, every strategy was cost-saving compared to its next-best alternative; cost savings were greatest in the maximum distribution strategy. In the health sector analysis, all undominated strategies were cost-effective. Results were highly robust to deterministic and probabilistic sensitivity analysis. CONCLUSIONS: Increasing naloxone distribution to laypeople and first responder groups would maximize health gains and be cost-effective. If feasible, communities should distribute naloxone to all groups; otherwise, distribution to laypeople and one of the first responder groups should be emphasized.

Availability of Naloxone in Pharmacies and Knowledge of Pharmacy Staff Regarding Dispensing Naloxone to Younger Adolescents.

PURPOSE: This study assessed the immediate availability of naloxone in pharmacies and the knowledge of pharmacy staff regarding naloxone dispensing protocols, especially as it relates to younger adolescents. METHODS: The primary sample included pharmacies in the 10 states with the highest number of opioid-related overdose deaths in 2016; in addition, pharmacies in the 2 states with the highest prevalence of opioid-related overdose deaths in 2016 were also contacted. Researchers simulated a routine conversation between pharmacy staff and a potential customer about the immediate availability of and requirements to purchase naloxone. RESULTS: The primary sample included 120 pharmacies (82.5% chain pharmacies; 50.8% rural). The majority (80.3%) had at least one form of naloxone in stock. Pharmacy staff were knowledgeable about prescription and third-party purchasing requirements. However, almost half incorrectly responded that there was a minimum age requirement to purchase naloxone. CONCLUSION: This study reveals barriers to obtaining naloxone, including a lack of immediate in-store availability and a common misperception that naloxone cannot be dispensed to minors.

"They're making it so hard for people to get help:" Motivations for non-prescribed buprenorphine use in a time of treatment expansion.

BACKGROUND: Buprenorphine maintenance therapy (BMT) has been widely recognized as one of the most effective treatments for opioid use disorders (OUD). In the midst of the U.S. opioid overdose crisis, local, state, and federal authorities have attempted to increase the availability of BMT, yet few individuals meeting the criteria for OUD utilize BMT. Moreover, recent research suggests that a significant proportion of individuals who use opioids seek out buprenorphine on the illicit market to self-govern and manage withdrawal sickness. METHODS: This paper presents data from a geographic sub-sample within a multi-site study of buprenorphine diversion in Pennsylvania. We endeavor to bolster a slim qualitative literature on the use of non-prescribed buprenorphine through in-depth interviews with 20 individuals who reported buying or receiving buprenorphine outside of medically-sanctioned contexts. Interviews characterized participants' reasons for both using non-prescribed buprenorphine and eschewing formal treatment, in a state (Pennsylvania) afflicted with high rates of heroin use and overdose deaths. Transcripts were initially coded for broad interview topics, while latent themes relating to buprenorphine diversion and extra-medical use also emerged. RESULTS: Analyses revealed complex motivations underlying participants' extra-medical use of buprenorphine. Where some expressed a desire for treatment autonomy and treatment medications that could not be achieved or obtained within BMT, individuals also indicated a persistent lack of treatment availability and access due to diverse barriers. CONCLUSION: This study shows how issues related to availability, accessibility, and acceptability many explain low rates of BMT utilization, even within a place and time defined by medication-assisted treatment expansion. Beyond offering broad rhetorical and financial support for MAT, our findings suggest that governmental actors should continue to pursue policies that expand the spatial distribution of BMT. It also underscores the need to look beyond current models of buprenorphine maintenance and to consider modes of buprenorphine delivery beyond long-term maintenance.

Pharmacist dispensed naloxone: Knowledge, availability, participation and cost in selected California counties.

BACKGROUND: In 2014, California signed into law AB1535 permitting pharmacists to dispense naloxone upon request and without physician or midlevel provider prescription. OBJECTIVE: We sought to determine pharmacist knowledge of AB1535, participation, availability of naloxone, future plans for participation, and out-of-pocket charges to consumers amongst outpatient pharmacies in selected California counties. METHODS: All pharmacies in Plumas, Lake, Lassen, Humboldt, Shasta, Fresno, and San Diego Counties were identified. Between January 30 and March 30, 2017, pharmacies meeting inclusion criteria were contacted and the pharmacist-on-duty were queried regarding knowledge, participation, availability, and cost of naloxone. RESULTS: A total of 2296 pharmacies were identified in the 7 counties. Twenty-six were unwilling or unable to participate and an additional 1648 were excluded because of licensing or special pharmacy status. Six-hundred-twenty-two pharmacies completed the survey. There was variation in knowledge of AB1535, participation in, immediate availability of naloxone, charge, and expressed future interest in participation identified. Charge to consumers was similarly variable amongst surveyed pharmacies within counties. CONCLUSIONS: Despite considerable public health and political support, the passage of CA AB1535 has not resulted in broad current, future planned participation, or availability of naloxone in selected counties. Out-of-pocket costs to the consumer remain highly variable.

Availability and Cost of Naloxone Nasal Spray at Pharmacies in Philadelphia, Pennsylvania, 2017.

Importance: Despite the increasingly important role of pharmacies in the implementation of naloxone access laws, there is limited information on the impact of such laws at the local level. Objective: To evaluate the availability (with or without a prescription) and cost of naloxone nasal spray at pharmacies in Philadelphia, Pennsylvania, following a statewide standing order enacted in Pennsylvania in August 2015 to allow pharmacies to dispense naloxone without a prescription. Design, Setting, and Participants: A survey study was conducted by telephone of all pharmacies in Philadelphia between February and August 2017. Pharmacies were geocoded and linked with the American Community Survey (2011-2015) to obtain information on the demographic characteristics of census tracts and the Medical Examiner's Office of the Philadelphia Department of Public Health to derive information on the number of opioid overdose deaths per 100 000 people for each planning district. Data were analyzed from March 2018 to February 2019. Main Outcomes and Measures: Availability and out-of-pocket cost of naloxone nasal spray (with or without a prescription) at Philadelphia pharmacies overall and by pharmacy and neighborhood characteristics. Results: Of 454 eligible pharmacies, 418 were surveyed (92.1% response rate). One in 3 pharmacies (34.2%) had naloxone nasal spray in stock; of these, 61.5% indicated it was available without a prescription. There were significant differences in the availability of naloxone by pharmacy type and neighborhood characteristics. Naloxone was both more likely to be in stock (45.9% vs 27.8%; difference, 18.0%; 95% CI, 8.3%-27.8%; P < .001) and available without a prescription (80.6% vs 42.2%; difference, 38.4%; 95% CI, 23.0%-53.8%; P < .001) in chain stores than in independent stores. Naloxone was also less likely to be available in planning districts with very elevated rates of opioid overdose death (≥50 per 100 000 people) compared with those with lower rates (31.1% vs 38.5%). The median (interquartile range) out-of-pocket cost among pharmacies offering naloxone without a prescription was $145 ($119-$150); costs were greatest in independent pharmacies and planning districts with elevated rates of opioid overdose death. Conclusions and Relevance: Despite the implementation of a statewide standing order in Pennsylvania more than 3 years prior to this study, only one-third of Philadelphia pharmacies carried naloxone nasal spray and many also required a physician's prescription. Efforts to strengthen the implementation of naloxone access laws and better ensure naloxone supply at local pharmacies are warranted, especially in localities with the highest rates of overdose death.

Naloxone Availability and Pharmacy Staff Knowledge of Standing Order for Naloxone in Pennsylvania Pharmacies.

OBJECTIVE: To assess the availability and price of naloxone as well as pharmacy staff knowledge of the standing order for naloxone in Pennsylvania pharmacies. METHODS: We conducted a telephone audit study from December 2016 to April 2017 in which staff from Pennsylvania pharmacies were surveyed to evaluate naloxone availability, staff understanding of the naloxone standing order, and out-of-pocket cost of naloxone. RESULTS: Responses were obtained from 682 of 758 contacted pharmacies (90% response rate). Naloxone was stocked (ie, available for dispensing) in 306 (45%) pharmacies surveyed. Of the 376 (55%) pharmacies that did not stock naloxone, 118 (31%) stated that they could place an order for naloxone for pickup within 1 business day. Responses by pharmacy staff to questions about key components of the standing order for naloxone were collected from 581 of the 682 pharmacies who participated in the survey (85%). Of the 581 pharmacy staff members who stated that they either stocked or could order naloxone, 64% correctly answered all questions pertaining to understanding of the naloxone standing order. The respective median out-of-pocket prices stated in the audit varied by formulation and ranged from $50 to $4000. Staff from national pharmacies were significantly more likely than staff from regional/local chain and non-chain pharmacies to correctly answer that a prescription was not required to obtain naloxone (68.5%, 57.7%, and 52.4% respectively, (P = 0.0045). CONCLUSIONS: Multiple barriers to naloxone access exist in pharmacies across a large, diverse state, despite the presence of a standing order to facilitate such access. Limited availability of naloxone in pharmacies, lack of knowledge or understanding by pharmacy staff of the standing order, and variability in out-of-pocket cost for this drug are among these potential barriers. Regulatory or legal incentives for pharmacies or drug manufacturers, education efforts directed toward pharmacy staff members, or other interventions may be needed to increase naloxone availability in pharmacies.

Dispensing Naloxone Without a Prescription: Survey Evaluation of Ohio Pharmacists.

BACKGROUND: The Centers for Disease Control and Prevention (CDC) reports a 200% escalation in the rate of opioid overdose deaths in the United States. Unfortunately, Ohio has been deemed the epicenter of the nation's opioid epidemic. In 2015, Ohio passed a bill that permits a pharmacist to distribute naloxone without a prescription. OBJECTIVES: This survey was aimed to discover pharmacists' knowledge of naloxone and Ohio law, perceived barriers that may prohibit naloxone dispensing, and Ohio pharmacists' general confidence, comfort, perception, and experience dispensing naloxone per physician protocol. METHODS: Pharmacists' knowledge of naloxone and Ohio law pertaining to dispensing naloxone; perceived barriers to naloxone distribution; and overall experience, willingness, comfort, and perceptions of personally supplying naloxone were assessed using multiple-choice and Likert-type scale questions through an e-mail survey. RESULTS: Overall, Ohio pharmacists were knowledgeable about naloxone and displayed confidence in their training and ability to provide patient education on naloxone. Pharmacists were less certain about Ohio law pertaining to naloxone distribution, especially those who have been in practice longer. Pharmacists indicated several barriers to dispensing naloxone and the need for more training. Younger pharmacists were more likely to report a concern with clientele who would frequent their pharmacy and moral and ethical concerns as barriers to dispensing naloxone. CONCLUSION: Additional educational programs should be delivered to Ohio pharmacists to inform them of the state law and policies. Continuing education programs that review substance abuse and attempt to reduce social stigma may assist with increasing naloxone distribution to those in need, especially, if directed toward younger pharmacists in Ohio.

Opioid use disorder: A public health emergency.

The treatment of patients with acute and chronic pain not attributed to cancer or end-of-life conditions is a challenge for many clinicians. Although CDC guidelines that focus on the primary care setting have provided critical recommendations, evidence-based guidance is lacking on optimal duration of opioid treatment for postoperative and acute care in specialty settings. Over the last 2 decades, the liberal use of opioids has resulted in many unintended consequences, including dependence and abuse, illicit distribution of legally and illegally prescribed opioid medication, progression to IV heroin and an epidemic of overdoses, and most recently an increase in the incidence of HIV among patients sharing syringes, frequently in communities with historically low HIV rates. This article analyzes these complex issues and proposes strategies to help clinicians improve patient care through education and responsible prescribing.

Government Patent Use to Address the Rising Cost of Naloxone: 28 U.S.C. § 1498 and Evzio.

The rising cost of the opioid antagonist and overdose reversal agent naloxone is an urgent public health problem. The recent and dramatic price increase of Evzio, a naloxone auto-injector produced by Kaléo, shows how pharmaceutical manufacturers entering the naloxone marketplace rely on market exclusivity guaranteed by the patent system to charge prices at what the market can bear, which can restrict access to life-saving medication. We argue that 28 U.S.C. § 1498, a section of the federal code that allows the government to use patent-protected products for its own purposes in exchange for reasonable compensation, could be used to procure generic naloxone auto-injectors, or at least bring Kaléo to the negotiating table. Precedent exists for the use of § 1498 to procure pharmaceuticals, and it could give meaning to the federal government's recent declaration of a public health emergency around the opioid epidemic, discourage new market entrants from charging exorbitant prices, and yield important public health benefits.

State Responses to the Opioid Crisis.

This paper focuses on the most common state policy responses to the opioid crisis, dividing them into six broad categories. Within each category we highlight the rationale behind the group of policies within it, discuss the details and support for individual policies, and explore the research base behind them. The objective is to better understand the most prevalent state responses to the opioid crisis.

The Opioid Epidemic in Indian Country.

The national opioid epidemic is severely impacting Indian Country. In this article, we draw upon data from the Centers for Disease Control and Prevention to describe the contours of this crisis among Native Americans. While these data are subject to significant limitations, we show that Native American opioid overdose mortality rates have grown substantially over the last seventeen years. We further find that this increase appears to at least parallel increases seen among non-Hispanic whites, who are often thought to be uniquely affected by this crisis. We then profile tribal medical and legal responses to the opioid epidemic, ranging from tribally-operated medication-assisted therapy to drug diversion courts rooted in traditional tribal cultures.

Buprenorphine Supply, Access, and Quality: Where We Have Come and the Path Forward.

Buprenorphine is a form of opioid agonist treatment that has been demonstrated to be an effective medication for opioid addiction. It is available in different formulations and marketed under various trade names, including commonly as a buprenorphine/naloxone combination. This paper provides an overview of existing literature on the supply of buprenorphine treatment, the ability of people to access treatment with buprenorphine, and the quality of treatment received. We argue that better data for each of these aspects of treatment could inform policy to expand effective treatment with buprenorphine, and we suggest steps to obtain and act on such data.