Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing: A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial.

Importance: Buprenorphine significantly reduces opioid-related overdose mortality. From 2002 to 2022, the Drug Addiction Treatment Act of 2000 (DATA 2000) required qualified practitioners to receive a waiver from the Drug Enforcement Agency to prescribe buprenorphine for treatment of opioid use disorder. During this period, waiver uptake among practitioners was modest; subsequent changes need to be examined. Objective: To determine whether the Communities That HEAL (CTH) intervention increased the rate of practitioners with DATA 2000 waivers and buprenorphine prescribing. Design, Setting, and Participants: This prespecified secondary analysis of the HEALing Communities Study, a multisite, 2-arm, parallel, community-level, cluster randomized, open, wait-list-controlled comparison clinical trial was designed to assess the effectiveness of the CTH intervention and was conducted between January 1, 2020, to December 31, 2023, in 67 communities in Kentucky, Massachusetts, New York, and Ohio, accounting for approximately 8.2 million adults. The participants in this trial were communities consisting of counties (n = 48) and municipalities (n = 19). Trial arm randomization was conducted using a covariate constrained randomization procedure stratified by state. Each state was balanced by community characteristics including urban/rural classification, fatal opioid overdose rate, and community population. Thirty-four communities were randomized to the intervention and 33 to wait-list control arms. Data analysis was conducted between March 20 and September 29, 2023, with a focus on the comparison period from July 1, 2021, to June 30, 2022. Intervention: Waiver trainings and other educational trainings were offered or supported by the HEALing Communities Study research sites in each state to help build practitioner capacity. Main Outcomes and Measures: The rate of practitioners with a DATA 2000 waiver (overall, and stratified by 30-, 100-, and 275-patient limits) per 100 000 adult residents aged 18 years or older during July 1, 2021, to June 30, 2022, were compared between the intervention and wait-list control communities. The rate of buprenorphine prescribing among those waivered practitioners was also compared between the intervention and wait-list control communities. Intention-to-treat and per-protocol analyses were performed. Results: A total of 8 166 963 individuals aged 18 years or older were residents of the 67 communities studied. There was no evidence of an effect of the CTH intervention on the adjusted rate of practitioners with a DATA 2000 waiver (adjusted relative rate [ARR], 1.04; 95% CI, 0.94-1.14) or the adjusted rate of practitioners with a DATA 2000 waiver who actively prescribed buprenorphine (ARR, 0.97; 95% CI, 0.86-1.10). Conclusions and Relevance: In this randomized clinical trial, the CTH intervention was not associated with increases in the rate of practitioners with a DATA 2000 waiver or buprenorphine prescribing among those waivered practitioners. Supporting practitioners to prescribe buprenorphine remains a critical yet challenging step in the continuum of care to treat opioid use disorder. Trial Registration: ClinicalTrials.gov Identifier: NCT04111939.

The impact of the national stay-at-home order on emergency department visits for suspected opioid overdose during the first wave of the COVID-19 pandemic.

BACKGROUND: Although national syndromic surveillance data reported declines in emergency department (ED) visits after the declaration of the national stay-at-home order for COVID-19, little is known whether these declines were observed for suspected opioid overdose. METHODS: This interrupted time series study used syndromic surveillance data from four states participating in the HEALing Communities Study: Kentucky, Massachusetts, New York, and Ohio. All ED encounters for suspected opioid overdose (n = 48,301) occurring during the first 31 weeks of 2020 were included. We examined the impact of the national public health emergency for COVID-19 (declared on March 14, 2020) on trends in ED encounters for suspected opioid overdose. RESULTS: Three of four states (Massachusetts, New York and Ohio) experienced a statistically significant immediate decline in the rate of ED encounters for suspected opioid overdose (per 100,000) after the nationwide public health emergency declaration (MA: -0.99; 95 % CI: -1.75, -0.24; NY: -0.10; 95 % CI, -0.20, 0.0; OH: -0.33, 95 % CI: -0.58, -0.07). After this date, Ohio and Kentucky experienced a sustained rate of increase for a 13-week period. New York experienced a decrease in the rate of ED encounters for a 10-week period, after which the rate began to increase. In Massachusetts after a significant immediate decline in the rate of ED encounters, there was no significant difference in the rate of change for a 6-week period, followed by an immediate increase in the ED rate to higher than pre-COVID levels. CONCLUSIONS: The heterogeneity in the trends in ED encounters between the four sites show that the national stay-at-home order had a differential impact on opioid overdose ED presentation in each state.

Challenges and Facilitators of Implementing a Physician-approved Naloxone Protocol: A Mixed-methods Study.

OBJECTIVES: In 2015, the State of Ohio passed legislation to allow pharmacists to dispense naloxone under a physician-approved protocol. The legislation allows all individuals authorized under a physician-approved protocol to personally furnish naloxone without requiring clients to be seen by a licensed prescriber, thus expanding the capacity of Ohio's community distribution programs. We aimed to evaluate the implementation of legislation allowing for a physician-approved protocol in pharmacies and other naloxone distribution sites in Ohio, and to compare barriers and facilitators of implementing the law changes among sites that implemented a physician-approved protocol versus sites that did not. METHODS: The study used a convergent parallel mixed-method design. Random samples from all pharmacies registered with the State of Ohio Board of Pharmacy and community naloxone distribution sites were selected. Quantitative data were collected via survey (n = 168) and qualitative data were collected via semi-structured interviews (n = 17). RESULTS: Most survey respondents agreed that the policy has expanded access to naloxone at their site for individuals who want or need the medication. Both pharmacies and other naloxone distribution sites identified that leadership and organizational support facilitated protocol implementation and cost, stigma, and lack of naloxone demand challenged protocol implementation. CONCLUSIONS: The study identified barriers and facilitators to the implementation of a physician-approved protocol within Ohio. The majority of respondents stated they could implement a protocol. However, barriers of cost, lack of public awareness of naloxone availability, and stigma remain for pharmacies and other naloxone distribution sites.

Association Between a State Law Allowing Pharmacists to Dispense Naloxone Without a Prescription and Naloxone Dispensing Rates.

Importance: Between 2015 and 2017, Ohio had the second highest number of opioid-related deaths. In July 2015, the Ohio General Assembly approved a law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol. This change in the law allowed pharmacists to have more opportunity to participate in the management of patients who were addicted to opioids. Objective: To determine the association between the implementation of an Ohio law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol and naloxone dispensing rates. Design, Setting, and Participants: A segmented regression analysis of an interrupted time series was performed for 30 consecutive months to evaluate the change in the naloxone dispensing rate before and after the implementation of the state law. Ohio Medicaid naloxone claims and Kroger Pharmacy naloxone claims for all 88 counties in Ohio were examined. Any patient 18 years or older with at least 1 naloxone order dispensed through Ohio Medicaid or by a Kroger Pharmacy in Ohio during the study period of July 16, 2014, to January 15, 2017, was included in the study. Data were analyzed from April 23, 2018, to July 7, 2019. Exposures: The primary independent variable was implementation of an Ohio law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol, which took effect in July 2015. Main Outcomes and Measures: The primary outcome measure was the naloxone dispensing rate per month per county. Results: In the Ohio Medicaid population, the number of naloxone orders dispensed after the policy was implemented increased by 2328%, from 191 in the prepolicy period to 4637 in the postpolicy period. The rate of naloxone orders dispensed per month per county after the policy was implemented increased by 4% in the Ohio Medicaid population and 3% in the Kroger Pharmacy population compared with the prepolicy period. The rate of naloxone orders dispensed after the policy was implemented increased by 18% per month in low-employment counties compared with high-employment counties in the Ohio Medicaid population. Conclusions and Relevance: The implementation of a state law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol was associated with an increase in the number of naloxone orders dispensed in the Ohio Medicaid and Kroger Pharmacy populations. Moreover, a significant increase was observed in the naloxone dispensing rate among the Ohio Medicaid population in counties with low employment and high poverty.

Emergency Physicians' Perception of Barriers and Facilitators for Adopting an Opioid Prescribing Guideline in Ohio: A Qualitative Interview Study.

BACKGROUND: Ohio has the fifth highest rate of prescription opioid overdose deaths in the United States. One strategy implemented to address this concern is a state-wide opioid prescribing guideline in the emergency department (ED). OBJECTIVE: Our aim was to explore emergency physicians' perceptions on barriers and strategies for the Ohio ED opioid prescribing guideline. METHODS: Semi-structured interviews with emergency physicians in Ohio were conducted from October to December 2016. Emergency physicians were recruited through the American College of Emergency Physicians Ohio State Chapter. The interview guide explored issues related to the implementation of the guidelines. Interview data were transcribed and thematically analyzed and coded using a scheme of inductively determined labels. RESULTS: In total, we conducted 20 interviews. Of these, 11 were also the ED medical director at their institution. Main themes we identified were: 1) increased organizational responsibility, 2) improved prescription drug monitoring program (PDMP) integration, 3) concerns regarding patient satisfaction scores, and 4) increased patient involvement. In addition, some physicians wanted the guidelines to contain more clinical information and be worded more strongly against opioid prescribing. Emergency physicians felt patient satisfaction scores were perceived to negatively impact opioid prescribing guidelines, as they may encourage physicians to prescribe opioids. Furthermore, some participants reported that this is compounded if the emergency physicians' income was linked to their patient satisfaction score. CONCLUSIONS: Emergency physicians interviewed generally supported the state-wide opioid prescribing guideline but felt hospitals needed to take additional organizational responsibility for addressing inappropriate opioid prescribing.

Statewide cross-sectional survey of emergency departments' adoption and implementation of the Ohio opioid prescribing guidelines and opioid prescribing practices.

STUDY OBJECTIVE: To evaluate the implementation of the Ohio Emergency and Acute Care Facility Opioids and Other Controlled Substances Prescribing Guidelines and their perceived impact on local policies and practice. METHODS: The study design was a cross-sectional survey of emergency department (ED) medical directors, or appropriate person identified by the hospital, perception of the impact of the Ohio ED Opioid Prescribing Guidelines on their departments practice. All hospitals with an ED in Ohio were contacted throughout October and November 2016. Distribution followed Dillman's Tailored Design Method, augmented with telephone recruitment. Hospital chief executive officers were contacted when necessary to encourage ED participation. Descriptive statistics were used to assess the impact of opioid prescribing policies on prescribing practices. RESULTS: A 92% response rate was obtained (150/163 EDs). In total, 112 (75%) of the respondents stated that their ED has an opioid prescribing policy, is adopting one or is implementing prescribing guidelines without a specific policy. Of these 112 EDs, 81 (72%) based their policy on the Ohio ED Opioid Prescribing Guidelines. The majority of respondents strongly agreed/agreed that the prescribing guidelines have increased the use of the prescription drug monitoring programme (86%) and have reduced inappropriate opioid prescribing (71%). CONCLUSION: This study showed that the Ohio ED Opioid Prescribing Guidelines have been widely disseminated and that the majority of EDs in Ohio are using them to develop local policies. The majority of respondents believed that the Ohio opioid prescribing guidelines reduced inappropriate opioid prescribing. However, prescribing practices still varied greatly between EDs.

State Injury Programs' Response to the Opioid Epidemic: The Role of CDC's Core Violence and Injury Prevention Program.

The Centers for Disease Control and Prevention's (CDC's) Core Violence and Injury Prevention Program (Core) supports capacity of state violence and injury prevention programs to implement evidence-based interventions. Several Core-funded states prioritized prescription drug overdose (PDO) and leveraged their systems to identify and respond to the epidemic before specific PDO prevention funding was available through CDC. This article describes activities employed by Core-funded states early in the epidemic. Four case examples illustrate states' approaches within the context of their systems and partners. While Core funding is not sufficient to support a comprehensive PDO prevention program, having Core in place at the beginning of the emerging epidemic had critical implications for identifying the problem and developing systems that were later expanded as additional resources became available. Important components included staffing support to bolster programmatic and epidemiological capacity; diverse and collaborative partnerships; and use of surveillance and evidence-informed best practices to prioritize decision-making.

Increases in Fentanyl-Related Overdose Deaths - Florida and Ohio, 2013-2015.

In March and October 2015, the Drug Enforcement Administration (DEA) and CDC issued nationwide alerts identifying fentanyl, particularly illicitly manufactured fentanyl (IMF), as a threat to public health and safety (1,2). IMF is pharmacologically similar to pharmaceutical fentanyl (PF), but is unlawfully produced in clandestine laboratories, obtained via illicit drug markets, and includes fentanyl analogs. Fentanyl is a synthetic opioid 50-100 times more potent than morphine and approved for the management of surgical/postoperative pain, severe chronic pain, and breakthrough cancer pain.* DEA's National Forensic Laboratory Information System (NFLIS) collects drug identification results from drug cases analyzed by federal, state, and local forensic laboratories throughout the United States.(†) In 2014, 80% of fentanyl submissions (i.e., drug products obtained by law enforcement that tested positive for fentanyl) in NFLIS were identified from 10 states, including Florida and Ohio (2), and seven of these 10 states reported sharp increases in fentanyl-related overdose deaths (fentanyl deaths) (3). This report presents findings of increased fentanyl deaths during 2013-2015 from investigations conducted by the University of Florida and the Ohio Department of Public Health, in collaboration with CDC. Analyses examined the association between trends in fentanyl-related law enforcement submissions and fentanyl deaths and describes groups at risk for fentanyl death using medical examiner and coroner reports. The marked increases in fentanyl death in Florida and Ohio during 2013-2015 were closely associated with parallel increases in fentanyl submissions, with the largest impact on persons who use heroin, consistent with reports that IMF is commonly mixed with or sold as heroin (1,4). In Ohio, circumstances associated with fentanyl deaths included a current diagnosed mental health disorder(§) and recent release from an institution such as a jail, rehabilitation facility, or hospital.