Feasibility of Pharmacy-based Research Opportunity to Enhance Community Testing and Surveillance (PROTECTS).

BACKGROUND: Approximately 89% of the US population lives within five miles of a community pharmacy, which provides a network of geographically distributed recruitment nodes for testing and surveillance of infection and disease. OBJECTIVES: Establish feasibility of Pharmacy-based Research Opportunities To Enhance Community Testing and Surveillance (PROTECTS) in the context of SARS-CoV-2 infection in a community pharmacy setting with University of Kentucky serving as the coordinating center and research hub for sample analysis. METHODS: Two community pharmacies in Kentucky served as community-based recruitment sites to assess SARS-CoV-2 exposure through longitudinal (5 visits over 56 days) collection of nasal swabs and blood samples from subjects. RESULTS: Fifty subjects were recruited between May 2022 and December 2023 for longitudinal sample collection. Three phases of recruitment were investigated by first establishing standard operating procedures in an urban pharmacy, then expanding recruitment at a second pharmacy in a rural setting, and finally increasing recruitment at the urban pharmacy. During the first phase of recruitment, 12 participants were recruited. Of these participants, two never scheduled a visit after the initial screening. The median time for study completion from first to last visit within this phase was 59 days (IQR: 56-68 days). During the second phase of recruitment, eight of nine participants completed all five visits. The median time to complete all visits was 105 days (IQR: 98-112 days). During the ongoing third phase, 29 subjects were recruited, and 19 participants completed all required visits and the remainder continue to schedule follow-up appointments. CONCLUSION: Community pharmacies have a significant role in promoting public health. The geographic distribution of community pharmacies makes them appealing locations for recruitment of outpatient cohorts for local surveillance of infections and chronic inflammatory conditions with opportunities for broad implementation of this project for clinical trials in underserved communities.

Rapid jail-based implementation of overdose education and naloxone distribution in response to the COVID-19 pandemic.

BACKGROUND: People incarcerated in jails are highly impacted by the opioid epidemic, and overdose education and naloxone distribution (OEND) is an effective strategy to reduce opioid overdose deaths. This study examines barriers and facilitators of fast-track OEND implementation within the jails in the Wave 1 Kentucky counties of the HEALing Communities Study during the COVID-19 pandemic. METHODS: Meeting minutes with jail stakeholders were qualitatively coded using the Practical, Robust Implementation and Sustainability Model (PRISM) as the coding framework. The analysis highlighted the top barriers and facilitators to fast-track OEND implementation within the PRISM framework. RESULTS: Space and staffing shortages related to the COVID-19 pandemic, disruptions in interorganizational programming from pandemic-related service suspensions, and a lack of technological solutions (e.g., reliable Internet access) for socially distanced delivery were the top barriers to fast-track OEND implementation. In addition, there were limitations on non-jail staff access to jails during COVID-19. Top facilitators included jail leadership support, the option to prioritize high-risk groups, and the incorporation of OEND processes into existing communications and management software. While the COVID-19 pandemic strained jail infrastructure, jail and partner agency collaboration led to creative implementation strategies for the successful integration of OEND into jail operations. Urban jails were more likely than rural jails to be early adopters of OEND during the public health emergency. CONCLUSIONS: Understanding the barriers to and facilitators of OEND within jails will improve implementation efforts seeking to curb opioid overdose deaths. Jail leadership support and interorganizational efforts were key facilitators to implementation; therefore, it is recommended to increase buy-in with multiple agencies to promote success. Challenges brought on by COVID-19 have resulted in a need for innovative solutions for implementation. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov, NCT04111939, Submitted 30 September 2019, https://clinicaltrials.gov/study/NCT04111939?titles=HEALing%20Communities%20Study&rank=1 .

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

BACKGROUND: Evidence-based practices for reducing opioid-related overdose deaths include overdose education and naloxone distribution, the use of medications for the treatment of opioid use disorder, and prescription opioid safety. Data are needed on the effectiveness of a community-engaged intervention to reduce opioid-related overdose deaths through enhanced uptake of these practices. METHODS: In this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population. The primary outcome was the number of opioid-related overdose deaths among community adults. RESULTS: During the comparison period from July 2021 through June 2022, the population-averaged rates of opioid-related overdose deaths were similar in the intervention group and the control group (47.2 deaths per 100,000 population vs. 51.7 per 100,000 population), for an adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; P = 0.30). The effect of the intervention on the rate of opioid-related overdose deaths did not differ appreciably according to state, urban or rural category, age, sex, or race or ethnic group. Intervention communities implemented 615 evidence-based practice strategies from the 806 strategies selected by communities (254 involving overdose education and naloxone distribution, 256 involving the use of medications for opioid use disorder, and 105 involving prescription opioid safety). Of these evidence-based practice strategies, only 235 (38%) had been initiated by the start of the comparison year. CONCLUSIONS: In this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths, death rates were similar in the intervention group and the control group in the context of the Covid-19 pandemic and the fentanyl-related overdose epidemic. (Funded by the National Institutes of Health; HCS ClinicalTrials.gov number, NCT04111939.).

Medicare Medication Therapy Management: beneficiary characteristics and utilization patterns in a national CMS Medicare fee-for-service sample (2013-2016).

BACKGROUND: The Medicare Medication Therapy Management (MTM) program has been available to eligible Medicare Part D beneficiaries since 2006, but research regarding program utilization and characterization is limited. OBJECTIVE: To describe enrollee and MTM program characteristics in a national sample of Medicare fee-for-service (FFS) beneficiaries (2013-2016). METHODS: Using a 5% random sample of Medicare FFS beneficiaries, we conducted a descriptive time series analysis to examine annual MTM enrollment and describe the type of MTM criteria at enrollment (Center for Medicare and Medicaid Services [CMS] vs. expanded). We investigated the offer of Comprehensive Medication Review (CMR) along with CMR receipt status, and delivery characteristics, as well as frequencies of Target Medication Reviews (TMR). RESULT: Beneficiaries who met CMS enrollment criteria, compared to those eligible under expanded criteria, were significantly older, more likely to be of white race, more likely to be female, and had a significantly higher number of comorbidities. Of those meeting CMS criteria, the proportion receiving TMR increased from 95% in 2013 to 98.1% in 2016, and over 97% were offered a CMR. Although the proportion of beneficiaries offered a CMR was stable over the study period, the proportion who received a CMR increased from 17% in 2013 to 35.4% in 2016. Telephone CMR delivery was the most common method used (87.8% to 89.1% of CMRs over the study period). Over 95% of the CMRs were delivered by a pharmacist. CONCLUSION: During the years 2013-2016, enrollment in the MTM program increased, as did the proportion of enrollees receiving TMRs and CMRs. However, uptake remained low and the main factors driving participation remain unclear. Significant differences in demographic characteristics between beneficiaries enrolled under the CMS MTM enrollment criteria and the expanded criteria suggest the need to further investigate the optimal provision of such programs.

Utilization of long-acting injectable monthly depot buprenorphine for opioid use disorder (OUD) in Kentucky, before and after COVID-19 related buprenorphine access policy changes.

INTRODUCTION: Long-acting injectable buprenorphine (LAI-bup) formulations have advantages over transmucosal buprenorphine (TM-bup), but barriers may limit their utilization. Several policies shifted during the COVID-19 pandemic to promote buprenorphine access. The federal government expanded telemedicine treatment for opioid use disorder and Kentucky (KY) Medicaid lifted prior authorization requirements (PAs) for LAI-bup (i.e., Sublocade®). This retrospective cohort study evaluated changes in LAI-bup access, utilization, and retention before and after these policy changes in KY. METHODS: Individual-level TM-bup and LAI-bup dispensing record data from KY's prescription drug monitoring program examined LAI-bup utilization and retention, without a >30-day gap in coverage, for patients starting a new episode of LAI-bup treatment. Two key time periods were examined: pre-policy changes (Apr 1, 2019 - Dec 31, 2019) and post-policy changes (Apr 1, 2020 - Dec 31, 2020). Data on PA requests among Medicaid managed care organizations and availability of LAI-bup Risk Evaluation and Mitigation Strategy (REMS)-certified pharmacies were also obtained. A multivariable Cox proportional hazard regression model analysis compared pre- versus post-policy period treatment discontinuation. RESULTS: The number of patients initiating LAI-bup increased from 211 to 481 over the two periods. By the end of the post-policy period, 24.3 % of eligible patients were retained on LAI-bup, versus 12.5 % in the pre-policy change period. The adjusted hazard ratio, comparing discontinuation during the post- versus pre-policy change periods, was 0.70 (95 % confidence interval: 0.55-0.89). There were also more REMS-certified pharmacies and providers in the post-policy change period. CONCLUSIONS: LAI-bup access, utilization, and retention increased after several policy changes.

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.

Higher First 30-Day Dose of Buprenorphine for Opioid Use Disorder Treatment Is Associated With Decreased Mortality.

OBJECTIVE: Buprenorphine is a medication for opioid use disorder that reduces mortality. This study aims to investigate the less well-understood relationship between the dose in the early stages of treatment and the subsequent risk of death. METHODS: We used Kentucky prescription monitoring data to identify adult Kentucky residents initiating transmucosal buprenorphine medication for opioid use disorder (January 2017 to November 2019). Average daily buprenorphine dose for days covered in the first 30 days of treatment was categorized as ≤8 mg, >8 to ≤16 mg, and >16 mg. Patients were followed for 365 days after the first 30 days of buprenorphine treatment. Endpoints were opioid-involved overdose death and death from other causes. Causes and dates of death were obtained using Kentucky death certificate records. Associations were evaluated using multivariable Fine and Gray models adjusting for patient baseline characteristics. RESULTS: In the cohort of 49,857 patients, there were 227 opioid-involved overdose deaths and 459 deaths from other causes. Compared with ≤8 mg, the adjusted subdistribution hazard ratio (aSHR) of opioid-involved overdose death decreased by 55% (aSHR, 0.45; 95% confidence interval [CI], 0.34-0.60) and 64% (aSHR, 0.36; 95% CI, 0.25-0.52) for patients receiving doses of >8 to ≤16 mg and >16 mg, respectively. The incidence of death from other causes was lower in patients receiving >8 to ≤16 mg (aSHR, 0.78; 95% CI, 0.62-0.98) and >16 mg (aSHR, 0.62; 95% CI, 0.47-0.80) versus ≤8 mg dose. CONCLUSIONS: Higher first 30-day buprenorphine doses were associated with reduced opioid-involved overdose death and death from other causes, supporting benefit of higher dosing in reducing mortality.

Alternatives to dental opioid prescribing after tooth extraction (ADOPT): protocol for a stepped wedge cluster randomized trial.

BACKGROUND: Dentists and oral surgeons are leading prescribers of opioids to adolescents and young adults (AYA), who are at high risk for developing problematic opioid use after an initial exposure. Most opioids are prescribed after tooth extraction, but non-opioid analgesics provide similar analgesia and are recommended by multiple professional organizations. METHODS: This multi-site stepped wedge cluster-randomized trial will assess whether a multicomponent behavioral intervention can influence opioid prescribing behavior among dentists and oral surgeons compared to usual practice. Across up to 12 clinical practices (clusters), up to 33 dentists/oral surgeons (provider participants) who perform tooth extractions for individuals 12-25 years old will be enrolled. After enrollment, all provider participants will receive the intervention at a time based on the sequence to which their cluster is randomized. The intervention consists of prescriber education via academic detailing plus provision of standardized patient post-extraction instructions and blister packs of acetaminophen and ibuprofen. Provider participants will dispense the blister packs and distribute the patient instructions at their discretion to AYA undergoing tooth extraction, with or without additional analgesics. The primary outcome is a binary, patient-level indicator of electronic post-extraction opioid prescription. Data for the primary outcome will be collected from the provider participant's electronic health records quarterly throughout the study. Provider participants will complete a survey before and approximately 3 months after transitioning into the intervention condition to assess implementation outcomes. AYA patients undergoing tooth extraction will be offered a survey to assess pain control and satisfaction with pain management in the week after their extraction. Primary analyses will use generalized estimating equations to compare the binary patient-level indicator of being prescribed a post-extraction opioid in the intervention condition compared to usual practice. Secondary analyses will assess provider participants' perceptions of feasibility and appropriateness of the intervention, and patient-reported pain control and satisfaction with pain management. Analyses will adjust for patient-level factors (e.g., sex, number of teeth extracted, etc.). DISCUSSION: This real-world study will address an important need, providing information on the effectiveness of a multicomponent intervention at modifying dental prescribing behavior and reducing opioid prescriptions to AYA. CLINICALTRIALS: GOV: NCT06275191.

Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV, HCV and overdose risk in rural Appalachia.

INTRODUCTION: Many rural communities bear a disproportionate share of drug-related harms. Innovative harm reduction service models, such as vending machines or kiosks, can expand access to services that reduce drug-related harms. However, few kiosks operate in the USA, and their implementation, impact and cost-effectiveness have not been adequately evaluated in rural settings. This paper describes the Kentucky Outreach Service Kiosk (KyOSK) Study protocol to test the effectiveness, implementation outcomes and cost-effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C and overdose risk in rural Appalachia. METHODS AND ANALYSIS: KyOSK is a community-level, controlled quasi-experimental, non-randomised trial. KyOSK involves two cohorts of people who use drugs, one in an intervention county (n=425) and one in a control county (n=325). People who are 18 years or older, are community-dwelling residents in the target counties and have used drugs to get high in the past 6 months are eligible. The trial compares the effectiveness of a fixed-site, staffed syringe service programme (standard of care) with the standard of care supplemented with a kiosk. The kiosk will contain various harm reduction supplies accessible to participants upon valid code entry, allowing dispensing data to be linked to participant survey data. The kiosk will include a call-back feature that allows participants to select needed services and receive linkage-to-care services from a peer recovery coach. The cohorts complete follow-up surveys every 6 months for 36 months (three preceding kiosk implementation and four post-implementation). The study will test the effectiveness of the kiosk on reducing risk behaviours associated with overdose, HIV and hepatitis C, as well as implementation outcomes and cost-effectiveness. ETHICS AND DISSEMINATION: The University of Kentucky Institutional Review Board approved the protocol. Results will be disseminated in academic conferences and peer-reviewed journals, online and print media, and community meetings. TRIAL REGISTRATION NUMBER: NCT05657106.

Equity of overdose education and naloxone distribution provided in the Kentucky HEALing Communities Study.

Background: Opioid overdoses differentially affect demographic groups. Strategies to reduce overdose deaths, specifically overdose education and naloxone distribution (OEND), are not consistently delivered equitably. Methods: The HEALing Communities StudySM (HCS) is a cluster-randomized trial designed to implement evidence-based practices, including OEND, to reduce overdose deaths across communities. Individuals receiving OEND in eight Kentucky counties between January 2020 and June 2022 provided demographics and overdose history. Recipient characteristics were compared to opioid overdose decedent characteristics to evaluate whether OEND was equitably delivered to the target population. Recipient characteristics were also analyzed based on whether OEND was delivered in criminal justice, behavioral health, or health care facilities. Results: A total of 26,273 demographic records were analyzed from 137 partner agencies. Most agencies were in behavioral health (85.6 %) or criminal justice sectors (10.4 %). About half of OEND recipients were male (50.6 %), which was significantly lower than the 70.3 % of overdose decedents who were male, (p<0.001). OEND recipients tended to be younger than overdose decedents, but there were not significant differences in race/ethnicity between OEND recipients and overdose decedents. Over 40 % of OEND recipients had overdosed, and 68.9 % had witnessed a prior overdose. There were notable differences across facility types, as males and Black individuals accounted for fewer OEND recipients in addiction treatment facilities compared to jails. Conclusion: Although OEND recipients' demographics resembled those of decedents, specific attention should be paid to ensuring equitable OEND access. Variation in OEND uptake by facility type may reflect biases and barriers to care.

Relationships Between Stigma, Risk Tolerance, and Buprenorphine Dispensing Intentions Among Community-Based Pharmacists: Results From a National Sample.

BACKGROUND: Concerns have been raised that pharmacists sometimes act as barriers to patients with opioid use disorder (OUD) accessing buprenorphine treatment. The present research explores how community pharmacists' endorsement (vs non-endorsement) of stigmatizing beliefs about patients taking buprenorphine relate to intentions, comfort, and decisions regarding dispensing buprenorphine for OUD. In addition, we assessed attitudes toward risk in pharmacy practice as a novel correlate of dispensing intentions and decisions. METHODS: A sample of 207 active community-based pharmacists practicing in the United States responded to survey items measuring stigma, risk tolerance, and intentions to dispense buprenorphine. The survey included 2 vignettes in which patients presented to the pharmacy with a prescription for buprenorphine, and respondents rated their comfort with dispensing and decisions regarding dispensing in the vignette. RESULTS: Results suggest that both stigma toward patients taking buprenorphine to treat OUD and tolerance for risk in pharmacy settings are related to differences in pharmacists' intentions to and willingness to dispense buprenorphine for OUD. CONCLUSIONS: Findings support the need for interventions to reduce stigma associated with buprenorphine use among pharmacists and suggest that risk tolerance is an important determinant of pharmacists' behavior that merits further study.

Drug disposal deserts: An assessment of receptacle availability in Kentucky community pharmacies.

PURPOSE: The purpose of this study was to describe the county-level availability of drug disposal receptacles in Kentucky community pharmacies and show the relationship between installed receptacles and opioid analgesic (OA)/controlled substance dispensing rates, stratifying where possible by urban-rural classification. METHODS: Using 2020 data from the Kentucky All Schedule Prescription Electronic Reporting program and disposal receptacle data from the US Drug Enforcement Agency, county-level comparisons were made between number of receptacles and OA/controlled substance dispensing rates. Logistic and negative binomial regression models were used to assess for differences between rural/urban county designation and odds of ≥1 disposal receptacle and compare the rates of receptacles per dispensed OA dose in rural/urban counties. FINDINGS: While rural counties saw higher OA and controlled substance dispensing rates, the majority (55.6%) of disposal receptacles were in urban locations. The odds of having at least 1 receptacle were higher in urban counties (OR 2.60, 95% CI: 1.15, 5.92) compared to rural. The estimated rate of disposal receptacles per million dispensed OA doses was found to be 0.47 (95% CI: 0.36, 0.61) in urban counties compared to 0.32 (95% CI: 0.25, 0.42) in rural counties, with an estimated rate ratio of 1.45 (95% CI: 1.01, 2.10). CONCLUSIONS: A mismatch between the availability of county-level disposal receptacles in community pharmacies and the volume of dispensed OAs/controlled substances exists, resulting in fewer receptacles per dispensed OA in rural counties compared to urban counties. Future efforts are necessary to increase access to convenient disposal receptacles located in community pharmacies, particularly in rural communities.

Willingness to utilize a mobile treatment unit in five counties at the epicenter of the US rural opioid epidemic.

INTRODUCTION: US federal policies are evolving to expand the provision of mobile treatment units (MTUs) offering medications for opioid use disorder (MOUD). Mobile MOUD services are critical for rural areas with poor geographic access to fixed-site treatment providers. This study explored willingness to utilize an MTU among a sample of people who use opioids in rural Eastern Kentucky counties at the epicenter of the US opioid epidemic. METHODS: The study analyzed Cross-sectional survey data from the Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE) study covering five rural counties in the state. Logistic regression models investigated the association between willingness to utilize an MTU providing buprenorphine and naltrexone and potential correlates of willingness, identified using the Behavioral Model for Vulnerable Populations. RESULTS: The analytic sample comprised 174 people who used opioids within the past six months. Willingness to utilize an MTU was high; 76.5 % of participants endorsed being willing. Those who had recently received MOUD treatment, compared to those who had not received any form of treatment or recovery support services, had six-fold higher odds of willingness to use an MTU. However, odds of being willing to utilize an MTU were 73 % lower among those who were under community supervision (e.g., parole, probation) and 81 % lower among participants who experienced an overdose within the past six months. CONCLUSIONS: There was high acceptability of MTUs offering buprenorphine and naltrexone within this sample, highlighting the potential for MTUs to alleviate opioid-related harms in underserved rural areas. However, the finding that people who were recently under community supervision or had overdosed were significantly less willing to seek mobile MOUD treatment suggest barriers (e.g., stigma) to mobile MOUD at individual and systemic levels, which may prevent improving opioid-related outcomes in these rural communities given their high rates of criminal-legal involvement and overdose.

Scaling up overdose education and naloxone distribution in Kentucky: adoption and reach achieved through a "hub with many spokes" model.

BACKGROUND: Scaling up overdose education and naloxone distribution (OEND), an evidence-based practice for reducing opioid overdose mortality, in communities remains a challenge. Novel models and intentional implementation strategies are needed. Drawing upon the EPIS model's phases of Exploration, Preparation, Implementation, and Sustainment (Aarons et al. in Adm Policy Ment Health 38:4-23, 2011), this paper describes the development of the University of Kentucky's unique centralized "Naloxone Hub with Many Spokes" approach to implementing OEND as part of the HEALing Communities Study (HCS-KY). METHODS: To scale up OEND in eight Kentucky counties, implementation strategies were utilized at two levels: a centralized university-based naloxone dispensing unit ("Naloxone Hub") and adopting organizations ("Many Spokes"). Implementation strategies varied across the EPIS phases, but heavily emphasized implementation facilitation. The Naloxone Hub provided technical assistance, overdose education resources, and no-cost naloxone to partner organizations. Implementation outcomes across the EPIS phases were measured using data from internal study management trackers and naloxone distribution data submitted by partner organizations. RESULTS: Of 209 organizations identified as potential partners, 84.7% (n = 177) engaged in the Exploration/Preparation phase by participating in an initial meeting with an Implementation Facilitator about the HCS-KY OEND program. Adoption of the HCS-KY OEND program, defined as receipt of at least one shipment of naloxone, was achieved with 69.4% (n = 145) of all organizations contacted. During the Implementation phase, partner organizations distributed 40,822 units of naloxone, with partner organizations distributing a mean of 281.5 units of naloxone (SD = 806.2). The mean number of units distributed per county was 5102.8 (SD = 3653.3; range = 1057 - 11,053) and the mean county level distribution rate was 8396.5 units per 100,000 residents (SD = 8103.1; range = 1709.5-25,296.3). Of the partner organizations that adopted the HCS-KY OEND program, 87.6% (n = 127) attended a sustainability meeting with an Implementation Facilitator and agreed to transition to the state-funded naloxone program. CONCLUSIONS: These data demonstrate the feasibility of this "Hub with Many Spokes" model for scaling up OEND in communities highly affected by the opioid epidemic. Trial registration ClinicalTrials.gov, NCT04111939. Registered 30 September 2019, https://clinicaltrials.gov/ct2/show/NCT04111939 .

Bystander preference for naloxone products: a field experiment.

BACKGROUND: Bystander administration of naloxone is a critical strategy to mitigate opioid overdose mortality. To ensure bystanders' willingness to carry and administer naloxone in response to a suspected overdose, it is critical to select products for community distribution with the highest likelihood of being utilized. This study examines bystanders' preference for and willingness to administer three naloxone products approved by the FDA for bystander use and identify product features driving preference. METHODS: The population was a convenience sample of individuals who attended the Kentucky State Fair, August 18-28, 2022, in Louisville, Kentucky. Participants (n = 503) watched a standardized overdose education and naloxone training video, rated their willingness to administer each of three products (i.e., higher-dose nasal spray, lower-dose nasal spray, intramuscular injection), selected a product to take home, and rated factors affecting choice. RESULTS: After training, 44.4% chose the higher-dose nasal spray, 30.1% chose the intramuscular injection, and 25.5% chose the lower-dose nasal spray. Factors most influencing choice on a 10-point Likert scale were ease of use (9 [7-10]), naloxone dose (8 [5-10]), and product familiarity (5 [5-9]). CONCLUSIONS: Bystanders expressed high willingness to administer all studied formulations of naloxone products. Product choice preference varied as a function of product features. As the number and variety of available products continue to increase, continuous evaluation of formulation acceptability, in addition to including individuals with lived experience who are receiving and administering overdose reversal agents, is critical to support adoption and save lives.

Drugs involved in Kentucky drug poisoning deaths and relation with antecedent controlled substance prescription dispensing.

BACKGROUND: The shift from prescription to illicit drugs involved in drug poisoning deaths raises questions about the current utility of prescription drug monitoring program (PDMP) data to inform drug poisoning (overdose) prevention efforts. In this study, we describe relations between specific drugs involved in Kentucky drug poisoning deaths and antecedent controlled substance (CS) dispensing. METHODS: The study used linked death certificates and PDMP data for 2,248 Kentucky resident drug poisoning deaths in 2021. Death certificate literal text analysis identified drugs mentioned with involvement (DMI) in drug poisoning deaths. We characterized the concordance between each DMI and the CS dispensing history for this drug at varying timepoints since 2008. RESULTS: Overall, 25.5% of all decedents had dispensed CS in the month before fatal drug poisoning. Over 80% of decedents were dispensed opioid(s) since 2008; the percentage was similar regardless of opioid involvement in the poisoning death. One-third of decedents had dispensed buprenorphine for treatment of opioid use disorder since 2008, but only 6.1% had dispensed buprenorphine in the month preceding death. Fentanyl/fentanyl analogs were DMI in 1,568 (69.8%) deaths, yet only 3% had received a fentanyl prescription since 2008. The highest concordance in the month preceding death was observed for clonazepam (43.6%). CONCLUSION: Overall, concordance between CS dispensing history and the drugs involved in poisoning deaths was low, suggesting a need to reevaluate the complex relationships between prescription medication exposure and overdose death and to expand harm reduction interventions both within and outside the healthcare system to reduce drug poisoning mortality.

Competitive effects of federal and state opioid restrictions: Evidence from the controlled substance laws.

A significant concern in the policy landscape of the U.S. opioid crisis is whether supply-side controls can reduce opioid prescribing without harmful substitution. We consider an unstudied policy: the federal Controlled Substance Act (CSA) restrictions placed in August 2014 on tramadol, the second most popular opioid medication. This was followed seven weeks later by CSA restrictions for hydrocodone combination products, the leading opioids on the market. Using regression discontinuity design (RDD) models, based on the timing of the (up-)scheduling changes, to explore spillover effects, we find that tightening prescribing restrictions on one opioid reduces its use, but increases prescribing of close competitors, leading to no reduction in total opioid prescriptions.This suggests that supply restrictions are not effective in reducing opioid prescribing the presence of close substitutes that remain unrestricted.

Early implementation of full-practice authority: A survey of Massachusetts nurse practitioners.

BACKGROUND: In January 2021, Massachusetts granted nurse practitioners (NPs) full-practice authority (FPA). Little is known about how FPA changes the day-to-day work of NPs. PURPOSE: To examine changes in practice barriers and care delivery in the early stages of FPA. METHODOLOGY: Descriptive analysis of a web-based survey of clinically active NPs in Massachusetts from October to December 2021, using Fisher exact tests to examine the associations between the perception that FPA improved work and other variables. RESULTS: Survey response rate was 50.3% ( N = 147). Overall, 79% of NPs believe that clinical work is unchanged by FPA. Practicing outside institutions is a significant predictor of FPA improving work ( p < .05). Larger proportions of respondents feel that efficiency (22%), patient centeredness (20%), and timeliness (20%) are improved by FPA compared with effectiveness (16%), equity (14%), and safety (10%). Almost half of those reporting that FPA improves overall care also report improved efficiency (50%, p < .0001), but only 22% report improved safety ( p < .05). Of those believing that FPA improved work, a minority no longer need physician review of new controlled substance prescriptions (29%, p < .01), a practice agreement (32%, p < .05), or physician signature on clinical documentation (22%, p < .05). CONCLUSIONS: Almost 1 year after FPA was passed in Massachusetts, the large majority of NPs report no changes in their day-to-day work, suggesting that FPA implementation is slow. IMPLICATIONS: Concerted efforts by regulators, employers, and individual NPs are needed to ensure that legislated FPA is effectively implemented inside organizations and among payers.

Community selected strategies to reduce opioid-related overdose deaths in the HEALing (Helping to End Addiction Long-term SM) communities study.

The Helping End Addictions Long Term (HEALing) Communities Study (HCS) seeks to significantly reduce overdose deaths in 67 highly impacted communities in Kentucky (KY), Massachusetts (MA), New York (NY), and Ohio (OH) by implementing evidence-based practices (EBPs) to reduce overdose deaths. The Opioid-overdose Reduction Continuum of Care Approach (ORCCA) organizes EBP strategies under three menus: Overdose Education and Naloxone Distribution (OEND), Medication Treatment for Opioid Use Disorder (MOUD), and Safer Prescribing and Dispensing Practices (SPDP). The ORCCA sets requirements for strategy selection but allows flexibility to address community needs. This paper describes and compiles strategy selection and examines two hypotheses: 1) OEND selections will differ significantly between communities with higher versus lower opioid-involved overdose deaths; 2) MOUD selections will differ significantly between urban versus rural settings. METHODS: Wave 1 communities (n = 33) provided data on EBP strategy selections. Selections were recorded as a combination of EBP menu, sector (behavioral health, criminal justice, and healthcare), and venue (e.g., jail, drug court, etc.); target medication(s) were recorded for MOUD strategies. Strategy counts and proportions were calculated overall and by site (KY, MA, NY, OH), setting (rural/urban), and opioid-involved overdose deaths (high/low). RESULTS: Strategy selection exceeded ORCCA requirements across all 33 communities, with OEND strategies accounting for more (40.8%) than MOUD (35.1%), or SPDP (24.1%) strategies. Site-adjusted differences were not significant for either hypothesis related to OEND or MOUD strategy selection. CONCLUSIONS: HCS communities selected strategies from the ORCCA menu well beyond minimum requirements using a flexible approach to address unique needs.

The policy landscape for naloxone distribution in four states highly impacted by fatal opioid overdoses.

Background: Expanding access to naloxone is one of the most impactful interventions in decreasing opioid-related mortality. However, state distribution rates of naloxone are insufficient to meet community need. The current study sought to better understand this gap by focusing on state policies that may facilitate or impede naloxone distribution in four states highly impacted by fatal opioid overdoses - Kentucky, Massachusetts, New York, and Ohio. Methods: We provide a descriptive analysis of the policy landscape impacting naloxone distribution through pharmacy and community channels in the four states participating in the HEALing Communities Study (HCS). Publicly available data and the expertise of the research team were used to describe each state's naloxone access laws (NALs), Medicaid coverage of naloxone, and community overdose education and naloxone distribution infrastructure. Data presented in this study represent the most current policy landscape through September 2022. Results: Variation exists between specific components of the NALs of each state, the structure of Medicaid coverage of naloxone, and the community distribution infrastructure networks. Massachusetts and New York have a statewide standing order, but other states use different strategies short of a statewide standing order to expand access to naloxone. Quantity limits specific to naloxone may limit access to Medicaid beneficiaries in some states. Conclusion: States participating in the HCS have developed innovative but different mechanisms to ensure naloxone access. Policies were dynamic and moved towards greater access. Research should consider the policy landscape in the implementation and sustainability of interventions as well as the analysis of outcomes.