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Richard I Horowitz,1,2 Phyllis R Freeman2 1Health and Human Services, Tick-Borne Disease Working Group, Washington, DC 20201 USA; 2Hudson Valley Healing Arts Center, Hyde Park, NY 12538, USA Purpose: We collected data from an online survey of 200 of our patients, which evaluated the efficacy of dapsone (diaminodiphenyl sulfone, ie, DDS) combined with other antibiotics and agents that disrupt biofilms for the treatment of chronic Lyme disease/post-treatment Lyme disease syndrome (PTLDS). We also collected aggregate data from direct retrospective chart review, including laboratory testing for Lyme, other infections, and associated tick-borne coinfections. This helped us to determine the frequency of exposure to other infections/coinfections among a cohort of chronically ill Lyme patients, evaluate the efficacy of newer “persister” drug regimens like DDS, and determine how other infections and tick-borne coinfections may be contributing to the burden of chronic illness leading to resistant symptomatology. Patients and methods: A total of 200 adult patients recruited from a specialized Lyme disease medical practice had been ill for at least 1 year. We regularly monitored laboratory values and participants’ symptom severity, and the patients completed the online symptom questionnaire both before beginning treatment and after 6 months on DDS combination therapy (DDS CT). Paired-samples t-tests and Wilcoxon signed-rank nonparametric test were performed on each of eight major Lyme symptoms, both before DDS CT and after 6 months of therapy. Results: DDS CT statistically improved the eight major Lyme symptoms. We found multiple species of intracellular bacteria including rickettsia, Bartonella, Mycoplasma, Chlamydia, Tularemia, and Brucella contributing to the burden of illness and a high prevalence of Babesia complicating management with probable geographic spread of Babesia WA1/duncani to the Northeast. Borrelia, Bartonella, and Mycoplasma species, as well as Babesia microti had variable manifestations and diverse seroreactivity, with evidence of persistence despite commonly prescribed courses of anti-infective therapies. Occasional reactivation of viral infections including human herpes virus 6 was also seen in immunocompromised individuals. Conclusion: DDS CT decreased eight major Lyme symptoms severity and improved treatment outcomes among patients with chronic Lyme disease/PTLDS and associated coinfections. Keywords: Lyme disease, babesiosis, bartonella, tick-borne co-infections, Multiple Systemic Infectious Disease Syndrome, MSIDS, persister bacteria, immune deficiency

Maryalice Citera,1 Phyllis R Freeman,2 Richard I Horowitz2 1Department of Psychology, State University of New York at New Paltz, New Paltz, NY, 2Hudson Valley Healing Arts Center, Hyde Park, NY, USA Purpose: Lyme disease is spreading worldwide, with multiple Borrelia species causing a broad range of clinical symptoms that mimic other illnesses. A validated Lyme disease screening questionnaire would be clinically useful for both providers and patients. Three studies evaluated such a screening tool, namely the Horowitz Multiple Systemic Infectious Disease Syndrome (MSIDS) Questionnaire. The purpose was to see if the questionnaire could accurately distinguish between Lyme patients and healthy individuals.Methods: Study 1 examined the construct validity of the scale examining its factor structure and reliability of the questionnaire among 537 individuals being treated for Lyme disease. Study 2 involved an online sample of 999 participants, who self-identified as either healthy (N=217) or suffering from Lyme now (N=782) who completed the Horowitz MSIDS Questionnaire (HMQ) along with an outdoor activity survey. We examined convergent validity among components of the scale and evaluated discriminant validity with the Big Five personality characteristics. The third study compared a sample of 236 patients with confirmed Lyme disease with an online sample of 568 healthy individuals.Results: Factor analysis results identified six underlying latent dimensions; four of these overlapped with critical symptoms identified by Horowitz – neuropathy, cognitive dysfunction, musculoskeletal pain, and fatigue. The HMQ showed acceptable levels of internal reliability using Cronbach’s coefficient alpha and exhibited evidence of convergent and divergent validity. Components of the HMQ correlated more highly with each other than with unrelated traits.Discussion: The results consistently demonstrated that the HMQ accurately differentiated those with Lyme disease from healthy individuals. Three migratory pain survey items (persistent muscular pain, arthritic pain, and nerve pain/paresthesias) robustly identified individuals with verified Lyme disease. The results support the use of the HMQ as a valid, efficient, and low-cost screening tool for medical practitioners to decide if additional testing is warranted to distinguish between Lyme disease and other illnesses. Keywords: Lyme disease, Borrelia burgdorferi, Babesia, MSIDS, Multiple Systemic Infectious Disease Syndrome, factor analysis, PTLDS, Post-Treatment Lyme Disease Syndrome

Objective: Identify characteristics of Kentucky community pharmacists and community pharmacists’ practice environment associated with utilization of the Kentucky All Schedule Prescription Electronic Reporting Program (KASPER). Methods: Surveys were mailed to all 1,018 Kentucky pharmacists with a KASPER account and an additional 1,000 licensed pharmacists without an account. Bivariate analyses examined the association between KASPER utilization and practice type (independent or chain) and practice location (rural or urban). A multivariate Poisson regression model with robust error variance estimated risk ratios (RR) of KASPER utilization by characteristics of pharmacists’ practice environment. Results: Responses were received from 563 pharmacists (response rate 27.9%). Of these, 402 responses from community pharmacists were included in the analyses. A majority of responding pharmacists (84%) indicated they or someone in their pharmacy had requested a patient’s controlled substance history since KASPER’s inception. Bivariate results showed that pharmacists who practiced in independent pharmacies reported greater KASPER utilization (94%) than pharmacists in chain pharmacies (75%; p

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

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., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Sharon Walsh reports financial support was provided by National Institutes of Health and the Substance Abuse and Mental Health Services Administration. Lindsey Hammerslag reports administrative support and data access were provided by Kentucky Cabinet for Health and Family Services (KASPER Data Access). Michelle Lofwall reports a relationship with Berkshire Biomedical that includes: consulting or advisory. Michelle Lofwall reports a relationship with Braeburn Pharmaceuticals Inc. that includes: consulting or advisory. Michelle Lofwall reports a relationship with Journey Colab that includes: consulting or advisory. Sharon Walsh reports a relationship with Braeburn Pharmaceuticals Inc. that includes: consulting or advisory. Sharon Walsh reports a relationship with Astra Zeneca that includes: consulting or advisory. Sharon Walsh reports a relationship with Cerevel Therapeutics Inc. that includes:. Sharon Walsh reports a relationship with Opiant Pharmaceuticals Inc. that includes: consulting or advisory. Sharon Walsh reports a relationship with Pocket Naloxone that includes: consulting or advisory. Sharon Walsh reports a relationship with Titan Pharmaceuticals that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)

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 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 (interquartile range: 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 (interquartile range: 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., Competing Interests: Disclosure Vincent J. Venditto is supported by grants from the National Institutes of Health (R01HL152081, P20GM130456). The authors declare no other relevant conflicts of interest or financial relationships., (Copyright © 2024 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

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 ., (© 2024. The Author(s).)

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.

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., (Copyright © 2024 Written work prepared by employees of the Federal Government as part of their official duties is, under the U.S. Copyright Act, a “work of the United States Government” for which copyright protection under Title 17 of the United States Code is not available. As such, copyright does not extend to the contributions of employees of the Federal Government.)

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., (© 2024. The Author(s).)

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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., Competing Interests: Declaration of competing interest None., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., Competing Interests: Competing interests: AF-B is a co-founder of Voices of Hope, the contracted recovery community organisation providing the recovery coaching services. The device to facilitate syringe disposal and dispensing that will be installed in conjunction with the kiosk is intellectual property of the University of Kentucky, with AMY designated as the inventor. CC is a paid consultant on the implementation of harm reduction vending machines, including on the described project., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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 Study SM (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., Competing Interests: The authors have no conflicts of interest., (© 2024 The Authors. Published by Elsevier B.V.)

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., (© 2023 National Rural Health Association.)

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 ., (© 2023. The Author(s).)

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., (© 2023. The Author(s).)

Twenty-five patients with relapsing and remitting Borreliosis, Babesiosis, and bartonellosis despite extended anti-infective therapy were prescribed double-dose dapsone combination therapy (DDDCT), followed by one or several courses of High Dose Dapsone Combination Therapy (HDDCT). A retrospective chart review of these 25 patients undergoing DDDCT therapy and HDDCT demonstrated that 100% improved their tick-borne symptoms, and patients completing 6-7 day pulses of HDDCT had superior levels of improvement versus 4-day pulses if Bartonella was present. At the completion of treatment, 7/23 (30.5%) who completed 8 weeks of DDDCT followed by a 5-7 day pulse of HDDCT remained in remission for 3-9 months, and 3/23 patients (13%) who recently finished treatment were 1 ½ months in full remission. In conclusion, DDDCT followed by 6-7 day pulses of HDDCT could represent a novel, effective anti-infective strategy in chronic Lyme disease/Post Treatment Lyme Disease Syndrome (PTLDS) and associated co-infections, including Bartonella , especially in individuals who have failed standard antibiotic protocols.

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., (© 2023. BioMed Central Ltd., part of Springer Nature.)

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., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Introduction: Since 2017, a total of 10 states have mandated naloxone coprescribing intended to prevent fatal opioid overdoses. This study aims to assess the association between naloxone coprescribing/offering mandates and opioid-involved overdose deaths on the basis of the opioid type., Methods: Data on overdose deaths from 1999 to 2020 came from the National Center for Health Statistics CDC WONDER Online Database. This study examined deaths stratified by illicit/synthetic opioids and prescription/treatment opioids. Difference-in-difference negative binomial regression models estimated average marginal effects and 95% CIs. Covariates included opioid dispensing rate, Good Samaritan law, pharmacy-based naloxone access law, mandatory use of prescription drug monitoring program, and recreational cannabis dispensaries. Data collection and analysis were conducted in 2022., Results: Ten states implemented naloxone coprescribing/offering mandates during the period. Coprescribing/offering mandates significantly reduced the number of prescription/treatment overdose deaths by 8.61 per state per quarter (95% CI= -15.13, -2.09), a 16% reduction from the counterfactual estimates. Coprescribing/offering mandates did not significantly impact illicit/synthetic overdose deaths (average marginal effect=0.32; 95% CI= -18.27, 18.91)., Conclusions: Coprescribing/offering mandates prevent overdose deaths for its target population, individuals using prescription/treatment opioids. These mandates do not appear to impact populations using illicit/synthetic opioids; thus, expanded efforts are needed to reach these individuals., (Copyright © 2022 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: Conflict of interest statement No conflicts to declare., (Published by Elsevier B.V.)

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., Competing Interests: Declaration of Competing Interest No conflicts declared.

Purpose: The opioid crisis remains a major public health concern in the United States. Naloxone is used to reverse opioid overdoses. This study examined Medicaid expansion on naloxone prescriptions in retail pharmacies in metropolitan (metro) and nonmetropolitan (nonmetro) areas (2011-2017)., Methods: We used population average models to evaluate the association of Medicaid expansion at the state level on the number of naloxone prescriptions dispensed and the percentage paid by Medicaid, including adjustment for opioid-related and state-level policy covariates. Difference-in-difference modeling was performed as a sensitivity analysis., Findings: States that expanded Medicaid had higher unadjusted naloxone dispensing rates and Medicaid-paid percentage of naloxone in metro and nonmetro areas. Medicaid expansion was not associated with the number of naloxone dispensed in either metro (adjusted rate ratio (ARR) = 1.26, 95% CI: [0.80, 1.97]) or nonmetro (ARR = 0.67, 95% CI: [0.37, 1.19]) areas after covariate adjustment. In metro areas, Medicaid expansion was associated with a significant increase of 3.86 percentage points (95% CI: [0.09, 7.63]) in the Medicaid-paid percentage of naloxone dispensing compared to nonexpansion states, but this association was not significant in nonmetro areas. There was also a significant time by Medicaid expansion interaction on the Medicaid-paid percentage of naloxone dispensed (metro: estimate = 0.74, 95% CI: [0.36, 1.12]; nonmetro: estimate = 0.68, 95% CI: [0.17, 1.18])., Conclusions: Medicaid expansion increased naloxone access by increasing the Medicaid-paid percentage of naloxone prescriptions in metro areas. States with Medicaid expansion had a faster rate of increase in the Medicaid-paid percentage of naloxone than states without Medicaid expansion in nonmetro areas., (© 2022 National Rural Health Association.)

Background: Increasing buprenorphine prescribing for opioid use disorder (OUD) has been a major focus of U.S. opioid response efforts. However, concerns related to dispensing buprenorphine have been identified among pharmacists., Objectives: This study aimed to describe perceptions, policies, and practices reported by community-based pharmacists in relation to dispensing buprenorphine for OUD and to compare these responses by practice setting., Methods: A cross-sectional online survey was administered to a random sample of 6376 pharmacists. Responses were collected anonymously from October 16, 2021, to November 7, 2021., Results: A response rate of 5.1% was achieved with 325 responders, and 281 were eligible to complete the survey. Most reported practicing in a chain (50.9%) or independent pharmacy (34.7%) as a staff pharmacist (39.7%) or pharmacist-in-charge (37.0%). Most (68.1%) indicated they could usually or always fill a buprenorphine prescription promptly. The most common pharmacy policies related to buprenorphine dispensing were checking the prescription drug monitoring program (71.3%), validating the prescriber's X-waiver (44.9%), accepting only local prescribers (37.4%), and prohibiting refills more than one day early (35.8%). Policies limiting buprenorphine access to local prescribers, local patients, and established patients varied by practice setting and were most common in independent pharmacies. The strongest barriers to buprenorphine dispensing were insurance prior authorization, difficulty reaching prescribers with questions, and concerns about buprenorphine diversion. The strongest facilitators of buprenorphine dispensing were increased communication with prescribers, increased trust with prescribers, increased trust with patients, and increased education for pharmacists., Conclusion: Most respondents indicated they were willing and able to dispense buprenorphine products for OUD promptly. However, they also reported discomfort dispensing when factors representing potential risk of diversion are present. Mitigating this hypersensitivity to diversion risk among pharmacists should be a focus of regulatory agencies and professional organizations. Efforts to address the unique concerns of independent pharmacists will also be essential to improve access., (Copyright © 2022 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Objectives: Increased drug overdose mortality among non-Hispanic Black people in the United States in the past 5 years highlights the need for better tailored programs and services. We evaluated (1) changes in drug overdose mortality for various racial and ethnic groups and (2) drug involvement to inform drug overdose prevention efforts in Kentucky., Methods: We used Kentucky death certificates and postmortem toxicology reports from 2016-2020 (provisional data) to estimate changes in age-adjusted drug overdose death rates per 100 000 standard population., Results: The age-adjusted drug overdose death rate per 100 000 standard population among non-Hispanic Black residents doubled from 2016 (21.2) to 2020 (46.0), reaching the rate among non-Hispanic White residents in 2020 (48.7; P = .48). From 2016 to 2020, about 80% of these drug overdose deaths involved opioids; heroin involvement declined about 20 percentage points; fentanyl involvement increased about 30 percentage points. The number of psychostimulant-involved drug overdose deaths increased 513% among non-Hispanic Black residents and 191% among non-Hispanic White residents. Cocaine-involved drug overdose deaths increased among non-Hispanic Black residents but declined among non-Hispanic White residents. Drug overdose death rates were significantly lower among Hispanic residents than among non-Hispanic White residents., Conclusions: Increased opioid-involved overdose deaths among non-Hispanic Black residents in Kentucky in combination with rapidly expanding concomitant psychostimulant involvement require increased understanding of the social, cultural, and illicit market circumstances driving these rapid trend changes. Our findings underscore the urgent need to expand treatment and harm reduction services to non-Hispanic Black residents with substance use disorder.

Purpose: With surging opioid-involved overdoses, maintaining access to opioid use disorder (OUD) treatment is critical during the COVID-19 pandemic. We examined changes in transmucosal buprenorphine prescribing for OUD treatment in Kentucky after the national COVID-19 emergency declaration, with a focus on rural-urban differences., Methods: Using 2019-2020 prescription monitoring data, we performed segmented regression analysis for an interrupted time series design to evaluate changes in weekly rates (per 100,000 residents) of dispensed prescriptions, unique individuals with dispensed prescriptions, and average days' supply for dispensed prescriptions of transmucosal buprenorphine., Findings: The weekly rates of dispensed prescriptions and unique individuals with dispensed prescriptions were higher for rural residents than urban residents. After the national COVID-19 emergency declaration, rural and urban residents experienced similar immediate drops in the rate of dispensed prescriptions (rural -33.4; urban -24.3) and unique patients with dispensed prescriptions (rural -25.0; urban -17.1), followed by similar sustained increases. Both measures surpassed the prepandemic levels in mid-June 2020. Patients residing in urban areas received averagely longer prescriptions at baseline (urban: 11.0 days; rural: 10.5 days). The average weekly days' supply increased in the week after the national emergency declaration, but the estimated increase was higher (P = .004) for urban (0.8 days) versus rural (0.5 days) residents., Conclusions: Transmucosal buprenorphine utilization increased during the COVID-19 pandemic after experiencing interruption during the initial weeks of the pandemic. Future studies should evaluate the contribution of the relaxed telemedicine buprenorphine prescribing regulations during the COVID-19 national emergency on initiation and maintenance of buprenorphine treatment., (© 2022 National Rural Health Association.)

Purpose: The primary objective of this study was to estimate the percentage of opioid analgesic (OA) prescriptions dispensed by Kentucky independent pharmacies with correctly entered days' supply in the state prescription drug monitoring program (PDMP) system in 2019., Methods: Using a two-stage cluster design, pharmacies were sampled with probabilities proportional to the volume of dispensed OAs; 100 random OA prescriptions were sampled from PDMP records submitted by each pharmacy. Following recruitment, demographic information and hard-copy prescription data for sampled records were abstracted on-site. Days' supply was independently calculated by two pharmacists using a standard formula with disagreements adjudicated blindly by a third pharmacist. Adjudicated days' supply was compared with that submitted to the PDMP and classified as accurate/inaccurate. Descriptive statistics were used to characterize the sample and a multivariable logistic regression model was used to assess the relationship between accuracy and prescription/practice-related factors., Results: A total of 1281 OA prescriptions were reviewed at 13 participating pharmacies. Accuracy of reported OA days' supply was 89.85%, (95% CI: 86.90, 92.80). Factors associated with accuracy were presence of special instructions from the prescriber (OR 3.13 [95% CI: 1.43, 6.82]), presence of 'as-needed' directions (OR 0.29 [95% CI: 0.18, 0.47]), and billing to a third-party payer (OR 1.43 [95% CI: 1.01, 2.02])., Conclusions: Accuracy of OA days' supply reported to the state PDMP was found to be moderately high. Certain prescription-related factors influence accuracy and should be accounted for in future studies. Patterns, including opioid 'split-billing' were identified and may impact validity of PDMP and administrative claims studies., (© 2022 John Wiley & Sons Ltd.)

Background: Despite pharmaceutical industry promise and enthusiasm, abuse-deterrent formulation (ADF) opioid use is relatively low. While some barriers to use have been addressed through state laws and policy, pharmacists' experiences with and opinions of ADF opioids are unclear., Objectives: The objective of this study was to evaluate pharmacists' perceptions of dispensing ADFs., Methods: This was a cross-sectional survey of community pharmacists licensed and practicing in Kentucky conducted in late 2019. The survey asked about perception, experience dispensing, and insurance coverage of 5 ADF opioids available at the time., Results: Most respondents (421/629, 67.9%) were familiar or very familiar with ADFs, and 63.1% agreed that all opioids should meet U.S. Food and Drug Administration standards for abuse deterrence. Aside from OxyContin, most ADF opioid formations were not stocked (range: 46.7%-73.6%). Third-party payer claims were occasionally or almost always rejected for most ADFs (range: 56.3%-75.4%). Contrary to intended mechanism of deterrence, ADFs were rated as the least effective strategy to reduce opioid misuse/abuse, with over half (51.2%) of respondents believing ADFs were not effective or somewhat effective. ADFs were rated as effective or very effective at reducing opioid abuse by swallowing intact by 37.4% of respondents., Conclusion: Pharmacists are familiar with ADFs but do not dispense them frequently. Pharmacists appear skeptical about the effectiveness of ADFs but support policies that could increase ADF uptake., (Copyright © 2022 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Purpose: In response to the COVID-19 pandemic, the US DEA allowed controlled substance prescriptions to be issued following a telemedicine encounter. This study evaluated changes in opioid prescribing in Kentucky counties with low and high rates of broadband subscription before, during, and after a series of statewide emergency declarations that may have affected health care access., Methods: The study used the prescription drug monitoring program to analyze records of opioid analgesic prescriptions dispensed to opioid-naïve individuals in high (N = 26) and low (N = 94) broadband access counties during 3 periods: before a state of emergency (SOE) and executive order (EO) limiting nonemergent health care services (January 2019-February 2020), while the EO was active (March-April 2020), and after health care services began reopening (May-December 2020). Marginal generalized estimating equations-type negative binomial models were fit to compare prescription counts by broadband access over the 3 periods., Findings: Rates of opioid dispensing to opioid-naïve individuals decreased significantly during the EO, but increased nearly to pre-SOE levels after health care services began reopening. Dispensing rates in low broadband counties were higher than those in high broadband counties during all time periods, although these differences were negligible after adjusting for potential confounders. During the EO, prescriptions were written for longer days' supply in both county types., Conclusions: The overall dramatic reduction in opioid prescribing rates should be considered when evaluating annual opioid prescribing trends. However, broadband subscription rate did not appear to influence opioid prescriptions dispensed in Kentucky during the EO., (© 2022 National Rural Health Association.)

Purpose: Developing effective deprescribing interventions relies on understanding attitudes, beliefs, and communication challenges of those involved in the deprescribing decision-making process, including the patient, the primary care clinician, and the pharmacist. The objective of this study was to assess patients' beliefs and attitudes and identify facilitators of and barriers to deprescribing., Methods: As part of a larger study, we recruited patients ⩾18 years of age taking ⩾3 chronic medications. Participants were recruited from retail pharmacies associated with the University of Kentucky HealthCare system. They completed an electronic survey that included demographic information, questions about communication with their primary care clinician and pharmacists, and the revised Patients' Attitudes Toward Deprescribing (rPATD) questionnaire., Results: Our analyses included 103 participants ( n  = 65 identified as female and n  = 74 as White/Caucasian) with a mean age of 50.4 years [standard deviation (SD) = 15.5]. Participants reported taking an average of 8.4 daily medications (SD = 6.1). Most participants reported effective communication with clinicians and pharmacists (66.9%) and expressed willingness to stop one of their medications if their clinician said it was possible (83.5%). Predictors of willingness to accept deprescribing were older age [odds ratio (OR) = 2.99, 95% confidence interval (CI) = 1.45-6.2], college/graduate degree (OR = 55.25, 95% CI = 5.74-531.4), perceiving medications as less appropriate (OR = 8.99, 95% CI = 1.1-73.62), and perceived effectiveness of communication with the clinician or pharmacist (OR = 4.56, 95% CI = 0.85-24.35)., Conclusion: Adults taking ⩾3 chronic medications expressed high willingness to accept deprescribing of medications when their doctor said it was possible. Targeted strategies to facilitate communication within the patient-primary care clinician-pharmacist triad that consider patient characteristics such as age and education level may be necessary ingredients for developing successful deprescribing interventions., Plain Language Summary: Are patients willing to accept stopping medications? Sometimes, medicines that a patient takes regularly become inappropriate. In other words, the risks of adverse effects might be greater than a medicine's potential benefits. The decision to stop such medicines should involve the patient and consider their preferences. We surveyed a group of patients taking multiple medicines to see how they felt about having those medicines stopped. We also asked patients whether and how much they talk to their primary care clinician and pharmacists about their medicines. To qualify for this study, patients had to be at least 18 years old and to take three or more medicines daily; they also needed to speak English. Participants provided demographic information and answered questions about their medicines, their communication with primary care clinicians and pharmacists, and their feelings about having one or more of their medicines stopped. We recruited 107 people and were able to use responses from 103 of them. Their average age was 50 years; 65 of them identified as female, and 75 identified as White/Caucasian. Most of our participants mentioned having conversations with primary care clinicians and pharmacists and said they would be willing to stop a medication if their clinician said it was possible. Older participants, those with more years of education, those who thought their medications might lead to side effects, and those who communicated with their clinician or pharmacists were more willing to have one of their medicines stopped.Our results indicate that patient characteristics and communication with clinicians and pharmacists are factors to consider when designing interventions to reduce the use of inappropriate medicines., Competing Interests: Competing interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s), 2022.)

Lyme disease and associated co-infections are increasing worldwide and approximately 20% of individuals develop chronic Lyme disease (CLD)/Post-Treatment Lyme Disease Syndrome (PTLDS) despite early antibiotics. A seven- to eight-week protocol of double dose dapsone combination therapy (DDDCT) for CLD/PTLDS results in symptom remission in approximately 50% of patients for one year or longer, with published culture studies indicating higher doses of dapsone demonstrate efficacy against resistant biofilm forms of Borrelia burgdorferi . The purpose of this study was, therefore, to evaluate higher doses of dapsone in the treatment of resistant CLD/PTLDS and associated co-infections. A total of 25 patients with a history of Lyme and associated co-infections, most of whom had ongoing symptoms despite several courses of DDDCT, took one or more courses of high dose pulsed dapsone combination therapy (200 mg dapsone × 3-4 days and/or 200 mg BID × 4 days), depending on persistent symptoms. The majority of patients noticed sustained improvement in eight major Lyme symptoms, including fatigue, pain, headaches, neuropathy, insomnia, cognition, and sweating, where dapsone dosage, not just the treatment length, positively affected outcomes. High dose pulsed dapsone combination therapy may represent a novel therapeutic approach for the treatment of resistant CLD/PTLDS, and should be confirmed in randomized, controlled clinical trials.

Purpose: In 2016, the US rate of opioid use-associated infective endocarditis (OUA IE) hospitalizations was 3.86/100,000 for rural and 3.49/100,000 for urban residents. This study estimates the Kentucky OUA IE hospitalization rates, 2016-2019, describing differences in rural-urban residency trends, demographics, relevant comorbidities, and discharge disposition. OUA IE hospitalization rates between counties with and without syringe services programs (SSPs) are also compared., Methods: We used Kentucky statewide inpatient discharge records from 2016 to 2019. An OUA IE hospitalization was identified by an infective endocarditis discharge diagnosis in any diagnosis field and a concurrent diagnosis indicating opioid use. Rurality was determined based on the 2013 Rural-Urban Continuum Codes (RUCC)., Findings: Kentucky's rate of OUA IE hospitalizations in 2016 was 8.9/100,000, with no significant variation between rural and urban residents. By 2019, the average rate for urban residents doubled to 17.9/100,000, significantly higher than the rural resident rate, 13.2/100,000. There were no significant rural-urban differences in percentages of those with concurrent diagnoses of HIV (<1%) or HCV (>60%). Counties that established SSPs in 2017-2018 had a 39.4% increase in OUA IE rates from 2016 to 2019, while counties without SSPs had a 79.5% increase., Conclusion: The estimated 2016 Kentucky rates of OUA IE hospitalizations are 2 times higher than reported national rates, highlighting Kentucky as one of the areas most affected by this particular opioid use disorder complication. Despite challenges and barriers to the effectiveness of SSPs as a harm reduction measure, our study suggests a positive effect that should be further investigated., (© 2021 National Rural Health Association.)

Objective: Evaluate beliefs and behaviors pertaining to abuse-deterrent opioids (ADFs)., Design: Survey in 2019 by invitation to all licensed physicians., Setting: Commonwealth of Kentucky., Participants: 374 physicians., Methods: Descriptive statistics, and hypothesis test that early adopter prescribers would have greater endorsement of opioid risk management., Results: Of all prescribers, 55% believed all opioid analgesics should have ADF requirements (15% were unsure); 74% supported mandating insurance coverage. Only one-third considered whether an opioid was ADF when prescribing, motivated by patient family diversion (94%) and societal supply reduction (88%). About half believed ADFs were equally effective in preventing abuse by intact swallowing, injection, chewing, snorting, smoking routes. Only 4% of OxyContin prescribers chose it primarily because of ADF properties. Instead, the most common reason (33%) was being started by another prescriber. A quarter of physicians chose not to prescribe ADFs because of heroin switching potential. Early adopters strongly believed ADFs were effective in reducing abuse (PR 3.2; 95% CI 1.5, 6.6) compared to mainstream physicians. Early-adopter risk-management practices more often included tools increasing agency and measurement: urine drug screens (PR 2.0; 1.3, 3.1), risk screening (PR 1.3; 0.94, 1.9). While nearly all respondents (96%) felt that opioid abuse was a problem in the community, only 57% believed it was a problem among patients in their practice. Attribution theory revealed an externalization of opioid abuse problems that deflected blame from patients on to family members., Conclusions: The primary motivator for prescribing ADFs was preventing diversion by family members, not patient-level abuse concerns., (© 2021. The Author(s).)

Background: Expanding access to sterile syringes in rural areas is vital, as injection-related epidemics expand beyond metropolitan areas globally. While pharmacies have potential to be an easily accessible source of sterile syringes, research in cities has identified moral, legal and ethical barriers that preclude over-the-counter (OTC) sales to people who inject drugs (PWID). The current study builds on prior urban-based research by elucidating (1) pharmacy OTC policies and (2) pharmacists' rationale for, and barriers and facilitators to, OTC syringe sales in a US rural area hard hit by drug-related epidemics., Methods: We conducted 14 semi-structured interviews with pharmacists recruited from two Eastern Kentucky health districts. Interview domains included experiences with, and attitudes toward, selling OTC syringes to PWID. Constructivist grounded theory methods were used to analyze verbatim transcripts., Results: Most pharmacists operated "restrictive OTC" pharmacies (n = 8), where patients were required to have a prescription or proof of medical need to purchase a syringe. The remainder (n = 6) operated "open OTC" pharmacies, which allowed OTC syringe sales to most patients. Both groups believed their pharmacy policies protected their community and pharmacy from further drug-related harm, but diverging policies emerged because of stigma toward PWID, perceptions of Kentucky law, and belief OTC syringe sales were harmful rather than protective to the community., Conclusion: Our results suggest that restrictive OTC pharmacy policies are rooted in stigmatizing views of PWID. Anti-stigma education about substance use disorder (SUD), human immunodeficiency virus (HIV), and Hepatitis C (HCV) is likely needed to truly shift restrictive pharmacy policy., (© 2022. The Author(s).)

Background and Aims: Prescription drug-seeking (PDS) from multiple prescribers is a primary means of obtaining prescription opioids; however, PDS behavior has probably evolved in response to policy shifts, and there is little agreement about how to operationalize it. We systematically compared the performance of traditional and novel PDS indicators., Design: Longitudinal study using a de-identified commercial claims database., Setting: United States, 2009-18., Participants: A total of 318 million provider visits from 21.5 million opioid-prescribed patients., Measurements: We applied binary classification and generalized linear models to compare predictive accuracy and average marginal effect size predicting future opioid use disorder (OUD), overdose and high morphine milligram equivalents (MME). We compared traditional indicators of PDS to a network centrality measure, PageRank, that reflects the prominence of patients in a co-prescribing network. Analyses used the same data and adjusted for patient demographics, region, SES, diagnoses and health services., Findings: The predictive accuracy of a widely used traditional measure (N + unique doctors and N + unique pharmacies in 90 days) on OUD, overdose and MME decreased between 2009 and 2018, and performed no better than chance (50% accuracy) after 2015. Binarized PageRank measures however exhibited higher predictive accuracy than the traditional binary measures throughout 2009-2018. Continuous indicators of PDS performed better than binary thresholds, with days of Rx performing best overall with 77-93% predictive accuracy. For example, days of Rx had the highest average marginal effects on overdose and OUD: a 1 standard deviation increase in days of Rx was associated with a 6-8% [confidence intervals (CIs) = 0.058-0.061 and 0.078-0.082] increase in the probability of overdose and a 4-5% (CIs = 0.038-0.043 and 0.047-0.053) increase in the probability of OUD. PageRank performed nearly as well or better than traditional indicators of PDS, with predictive performance increasing after 2016., Conclusions: In the United States, network-based measures appear to have increasing promise for identifying prescription opioid drug-seeking behavior, while indicators based on quantity of providers or pharmacies appear to have decreasing utility., (© 2021 Society for the Study of Addiction.)

Purpose: Rural areas of the United States have experienced outbreaks of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections among people who use drugs (PWUD). Pharmacy-based interventions may play a crucial role in prevention and entry into care, especially when traditional health care access is limited. The willingness of rural PWUD to use pharmacies for HIV/HCV-related services remains unknown. The purpose of this study was to describe the factors associated with the perceived likelihood of participating in free pharmacy-based HIV and HCV testing among PWUD living in rural Kentucky., Methods: Baseline data from the CARE2HOPE study in five Appalachian counties in eastern Kentucky were used. Participants were recruited using respondent-driven sampling and completed interviewer-administered surveys. Guided by the Andersen and Newman Framework of Health Services Utilization, we examined distributions and correlates of items regarding willingness to participate in free pharmacy-based HIV/HCV testing using logistic regression. Analyses included individuals who reported being HIV (N = 304) or HCV (N = 185) negative., Findings: Seventy-five percent of PWUD reported being "very likely" to participate in free pharmacy-based HIV testing and 80% for HCV testing. Two factors were associated with being less willing to participate in free HIV testing: PWUD who previously tested for HIV (OR: 0.47, CI: 0.25-0.88) and PWUD who obtained a high school diploma or equivalent compared to those who completed less (OR: 0.50, CI: 0.26-0.99)., Conclusion: Free pharmacy-based HIV and HCV testing was invariably acceptable among most of the rural PWUD in our sample, suggesting that pharmacies might be acceptable testing venues for this population., (© 2021 National Rural Health Association.)

Background: Although Kentucky pharmacists recently gained authority to provide protocol-driven care for 13 conditions, provision of prescription hormonal contraception (HC) services is not currently authorized. A board-approved protocol allowing for provision of nonprescription over-the-counter (OTC) emergency contraception (EC) was recently approved by the Kentucky Board of Pharmacy but has yet to be implemented., Objectives: The objectives of this study were (1) to assess Kentucky pharmacists' interest in providing prescription HC and OTC EC services via protocol and (2) to identify perceived benefits/barriers regarding provision of prescription HC., Methods: An online questionnaire was disseminated electronically to a convenience sample of Kentucky pharmacists. The questionnaire collected (1) demographic information, (2) opinions regarding provision of prescription HC and OTC EC, and (3) perceived benefits and barriers regarding provision of prescription HC. For analysis, responses were limited to pharmacists in community-based practice. McNemar's test was used to identify statistically significant differences in support by dosage form. In addition, a multivariable logistic regression model was used to examine associations between demographic factors and support for pharmacist provision of prescription HC., Results: We received 151 responses from community-based pharmacists. Support for provision of prescription HC was highest for oral (61%) and transdermal (54%) forms. We found no statistically significant differences in support among demographic factors other than number of years in practice, with more recent graduates being at higher odds of support. In addition, time, reimbursement, training, and belief in the need for pelvic exams were the most commonly cited barriers to implementation. With regard to OTC EC provision, pharmacists were largely supportive (62%) and confident in their abilities., Conclusions: Community-based pharmacists in Kentucky are supportive of provision of oral, vaginal, and transdermal prescription HC as well as OTC EC via protocol. Barriers, including time, reimbursement, training, and belief in the need for pelvic exams, should be addressed to increase support for prescription HC provision., (Copyright © 2021 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

The factors associated with chronic opioid therapy (COT) in patients with HIV is understudied. Using Medicaid data (2002-2009), this retrospective cohort study examines COT in beneficiaries with HIV who initiated standard combination anti-retroviral therapy (cART). We used generalized estimating equations on logistic regression models with backward selection to identify significant predictors of COT initiation. COT was initiated among 1014 out of 9615 beneficiaries with HIV (male: 10.4%; female: 10.7%). Those with older age, any malignancy, Hepatitis C infection, back pain, arthritis, neuropathy pain, substance use disorder, polypharmacy, (use of) benzodiazepines, gabapentinoids, antidepressants, and prior opioid therapies were positively associated with COT. In sex-stratified analyses, multiple predictors were shared between male and female beneficiaries; however, chronic obstructive pulmonary disease, liver disease, any malignancy, and antipsychotic therapy were unique to female beneficiaries. Comorbidities and polypharmacy were important predictors of COT in Medicaid beneficiaries with HIV who initiated cART., (© 2021. The Author(s).)

Background: Owing to increasing concern over the potential for gabapentin misuse, gabapentin was reclassified as a schedule V controlled substance in Kentucky (July 2017)., Objective: This study aimed to characterize gabapentin use among Kentucky residents in the first year after its scheduling., Methods: This study used Kentucky All Schedule Prescription Electronic Reporting data (2018). Gabapentin use was defined as having at least 1 dispensed gabapentin prescription, and high-dose gabapentin use was defined as an average daily dose of more than 3600 mg at the patient level. The prevalence of gabapentin use, concurrent use of gabapentin with opioid analgesics (OAs) (gabapentin-OA), and gabapentin with OAs and benzodiazepines (BDZs) (gabapentin-OA-BDZ) were assessed. Estimated prevalence rate ratio and its 95% CI were reported to compare gabapentin use rates across different demographic groups., Results: A total of 16% of all 2018 controlled substance prescriptions were for gabapentin, and approximately 20% of Kentucky residents with controlled substance prescriptions received gabapentin at least once in 2018. The overall prevalence of gabapentin use was 63 per 1000 residents, with the highest rates among residents aged 55-64 years (126.9 per 1000). The prevalence of gabapentin use was higher in females (74.6 per 1000) versus males (50.6 per 1000) and in residents living in the Appalachian region (88.57 per 1000) versus Central (51.78 per 1000) and Delta (66.41 per 1000) regions. Among gabapentin users, 1% were high-dose users; 27.4% and 11.9% received gabapentin-OA or gabapentin-OA-BDZ concurrently, respectively. As the average daily dose increased from less than 900 mg to high-dose, the percentage of concurrent gabapentin-OA use increased from 13.4% to 50.7%., Conclusion: Gabapentin is widely prescribed in Kentucky, with higher rates of use observed in females, those older than 55 years and individuals living in the Appalachian region. Concurrent use of gabapentin and OAs is common, especially in those receiving high-dose gabapentin. Future studies are needed to assess the risks associated with gabapentin use., (Copyright © 2021 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: The term "doctor and pharmacy shopping" colloquially describes patients with high multiple provider episodes (MPEs)-a threshold count of distinct prescribers and/or pharmacies involved in prescription fulfillment. Opioid-related MPEs are implicated in the global opioid crisis and heavily monitored by government databases such as U.S. state prescription drug monitoring programs (PDMPs). We applied a widely-used MPE definition to examine U.S. trends from a large, commercially-insured population from 2010 to 2017. Further, we examined the proportion of enrollees identified as "doctor shoppers" with evidence of a cancer diagnosis to examine the risk of false positives., Methods: Using a large, commercially-insured population, we identified patients with opioid-related MPEs: opioid prescriptions (Schedule II-V, no buprenorphine) filled from ≥5 prescribers AND ≥ 5 pharmacies within the past 90 days ("5x5x90d"). Quarterly rates per 100,000 enrollees (two specifications) were calculated between 2010 and 2017. We examined the trend in a recently published all-payer, 7 state cohort from the U.S. Centers for Disease Control and Prevention for comparison. Cancer-related ICD-9/10-CM codes were used., Results: Quarterly MPE rates declined by approximately 73 % from 18.2-4.9 per 100,000 enrollee population with controlled substance prescriptions. In 2017, nearly one fifth of these commercially-insured enrollees identified by the 5x5x90d algorithm were diagnosed with cancer. Approximately 8% of this sample included patients with ≥ 1 buprenorphine prescriptions., Conclusions: Opioid "shopping" flags are a long-standing but rapidly fading PDMP signal. To avoid unintended consequences, such as identifying legitimate medical encounters requiring high healthcare utilization or opioid treatment, while maintaining vigilance, more nuanced and sophisticated approaches are needed., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Practice guidelines recommend urine drug monitoring (UDM) at least annually in the setting of chronic opioid therapy as an objective assessment of substance use. However, empirical evidence on who gets tested and how often testing occurs is lacking., Objectives: This study investigates 10-year UDM trends in the United States based on 2 factors: (1) the duration of prescription opioid treatment, and (2) having an opioid use disorder (OUD) diagnosis and medications for opioid use disorder (MOUD) prescriptions., Study Design: Observational cross-sectional study., Setting: Research was conducted using administrative claims data from Optum's deidentified Clinformatics Data Mart Database for the period 2007 to 2016. The dataset contained information on the plan enrollment and health care claims from 50 states and the District of Columbia., Methods: To examine trends in UDM based on the duration of prescription opioid treatment, persons receiving prescription opioid analgesics were categorized into 4 groups based on the number of days covered: (a) less than 90 days, (b) 90 to 179 days, (c) 180 to 269 days, and (d) at least 270 days. To examine trends based on an OUD diagnosis and MOUD prescriptions, persons diagnosed with OUD were identified and categorized based on the presence of MOUD prescriptions as follows: (a) OUD with buprenorphine (BPN) and naltrexone (NTX) in the same year; (b) OUD with BPN only; (c) OUD with NTX only; (d) OUD with chronic prescription opioid analgesics (>= 90 days); (e) OUD without prescription opioid analgesics, BPN, or NTX; and (f) chronic prescription opioid analgesics (>= 90 days) without an OUD diagnosis. For analysis, the percent receiving UDM was estimated per group per year. Then the data were restricted to those receiving at least one UDM to estimate the average number of UDM per person., Results: Data included an average of 364,485 persons per year receiving prescription opioid analgesics for chronic use, and 10,277 per year receiving an OUD diagnosis. Among those receiving prescription opioid analgesics, less than 50% received UDM. For those receiving at least one UDM, one additional UDM was performed per person as the duration of opioids increased by 90 days. Among persons with OUD, the percent receiving UDM was the highest for those receiving both BPN and NTX (87%), followed by those receiving BPN only (80%), chronic opioids (79%), NTX only (72%), and those not receiving any MOUD/opioids (54%)., Limitations: Methadone dispensing for OUD treatments was not captured in administrative claims data., Conclusions: Although recommended for patients with chronic pain, UDM is provided less than half of the time for these patients. However, once patients received at least one UDM, they would continue to receive it on a fairly regular basis. Compared with those with chronic pain, persons diagnosed with OUD are more likely to receive UDM at a more frequent interval.