Providing medication for opioid use disorder and HIV pre-exposure prophylaxis at syringe services programs via telemedicine: a pilot study.

BACKGROUND: People who inject drugs (PWID) are at high risk for opioid overdose and infectious diseases including HIV. We piloted PARTNER UP, a telemedicine-based program to provide PWID with medication for opioid use disorder (MOUD) with buprenorphine/naloxone (bup/nx) and oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine through two syringe services programs (SSP) in North Carolina. We present overall results from this project, including participant retention rates and self-reported medication adherence. METHODS: Study participants met with a provider for an initial in-person visit at the SSP, followed by weekly telemedicine visits in month 1 and then monthly until program end at month 6. Participants were asked to start both MOUD and PrEP at initiation but could choose to discontinue either at any point during the study. Demographics and health history including substance use, sexual behaviors, and prior use of MOUD/PrEP were collected at baseline. Follow-up surveys were conducted at 3- and 6-months to assess attitudes towards MOUD and PrEP, change in opioid use and sexual behaviors, and for self-reported medication adherence. Participant retention was measured by completion of visits; provider notes were used to assess whether the participant reported continuation of medication. RESULTS: Overall, 17 persons were enrolled and started on both bup/nx and PrEP; the majority self-identified as white and male. At 3 months, 13 (76%) remained on study; 10 (77%) reported continuing with both MOUD and PrEP, 2 (15%) with bup/nx only, and 1 (8%) with PrEP only. At 6 months, 12 (71%) remained on study; 8 (67%) reported taking both bup/nx and PrEP, and 4 (33%) bup/nx only. Among survey participants, opioid use and HIV risk behaviors decreased. Nearly all reported taking bup/nx daily; however, self-reported daily adherence to PrEP was lower and declined over time. The most common reason for not continuing PrEP was feeling not at risk for acquiring HIV. CONCLUSIONS: Our study results show that MOUD and PrEP can be successfully administered via telemedicine in SSPs. PrEP appears to be a lower priority for participants with decreased continuation and adherence. Low perception of HIV risk was a reason for not continuing PrEP, possibly mitigated by MOUD use. Future studies including helping identify PWID at highest need for PrEP are needed. TRIAL REGISTRATION: Providing Suboxone and PrEP Using Telemedicine, NCT04521920. Registered 18 August 2020. https://clinicaltrials.gov/study/NCT04521920?term=mehri%20mckellar&rank=2 .

Patient-Centered Outcomes Associated With a Novel Office-Based Opioid Treatment Program in a District Health Department: Mixed Methods Pilot Study.

BACKGROUND: Granville and Vance counties have some of the highest opioid-related death rates in North Carolina, and have significant unmet needs with regard to opioid treatment. Medication for opioid use disorder (MOUD) is the most effective evidence-based approach to address opioid use disorder. Despite demonstrated efficacy and substantial need, access to MOUD is still insufficient in many parts of the United States. In order to connect patients with needed MOUD services, the district health department, Granville Vance Public Health (GVPH), established an office-based opioid treatment (OBOT) program. OBJECTIVE: In this formative pilot study, we sought to describe patients' goals and outcomes in a program delivered at a rural local health department using an integrated care approach. METHODS: We used a mixed methods concurrent nested research design. The primary method of investigation was one-on-one qualitative interviews with active OBOT patients (n=7) focused on patients' goals and perceived impacts of the program. Trained interviewers followed a semistructured interview guide developed iteratively by the study team. The secondary method was a descriptive quantitative analysis (79 patients; 1478 visits over 2.5 years) of treatment retention and patient-reported outcomes (anxiety and depression). RESULTS: Participants in the OBOT program were 39.6 years of age on average, and 25.3% (20/79) were uninsured. The average retention in the program was 18.4 months. The proportion of individuals in the program with moderate to severe depression (Patient Health Questionnaire-9 scores ≥10) decreased between program initiation (66%, 23/35) and at the most recent assessment (34%, 11/32). In qualitative interviews, participants credited the OBOT program for reducing or stopping the use of opioids and other substances (eg, marijuana, cocaine, and benzodiazepines). Many participants noted how the program helped them manage withdrawal symptoms and cravings, which helped them feel more in control of their use. Participants also attributed improvements in quality of life to the OBOT program, such as improved relationships with loved ones, improved mental and physical health, and improved financial stability. CONCLUSIONS: Initial data show promising patient outcomes for active GVPH OBOT participants, including reduction in opioid use and improvements in quality of life. As a pilot study, a limitation of this study is a lack of a comparison group. However, this formative project demonstrates promising patient-centered outcome improvements for GVPH OBOT participants.

Impact of Policy Change on Access to Medication for Opioid Use Disorder in Primary Care.

OBJECTIVES: The opioid overdose epidemic is escalating. Increasing access to medications for opioid use disorder in primary care is crucial. The impact of the US Department of Health and Human Services' policy change removing the buprenorphine waiver training requirement on primary care buprenorphine prescribing remains unclear. We aimed to investigate the impact of the policy change on primary care providers' likelihood of applying for a waiver and the current attitudes, practices, and barriers to buprenorphine prescribing in primary care. METHODS: We used a cross-sectional survey with embedded educational resources disseminated to primary care providers in a southern US academic health system. We used descriptive statistics to aggregate survey data, logistic regression models to evaluate whether buprenorphine interest and familiarity correlate with clinical characteristics, and a χ2 test to evaluate the effect of the educational intervention on screening. RESULTS: Of the 54 respondents, 70.4% reported seeing patients with opioid use disorder, but only 11.1% had a waiver to prescribe buprenorphine. Few nonwaivered providers were interested in prescribing, but perceiving buprenorphine to be beneficial to the patient population was associated with interest (adjusted odds ratio 34.7, P < 0.001). Two-thirds of nonwaivered respondents reported the policy change having no impact on their decision to obtain a waiver; however, among interested providers, it increased their likelihood of obtaining a waiver. Barriers to buprenorphine prescribing included lack of clinical experience, clinical capacity, and referral resources. Screening for opioid use disorder did not increase significantly after the survey. CONCLUSIONS: Although most primary care providers reported seeing patients with opioid use disorder, interest in prescribing buprenorphine was low and structural barriers remained the dominant obstacles. Providers with a preexisting interest in buprenorphine prescribing reported that removing the training requirement was helpful.

Participant perceptions on the acceptability and feasibility of a telemedicine-based HIV PrEP and buprenorphine/naloxone program embedded within syringe services programs: a qualitative descriptive evaluation.

BACKGROUND: People who inject drugs (PWID) are at risk for HIV and opioid overdose. We piloted PARTNER UP, a telemedicine-based program to provide PWID with access to both oral pre-exposure prophylaxis (PrEP) for HIV prevention and medication for opioid use disorder (MOUD) through two syringe services programs (SSPs) in North Carolina. We conducted a qualitative evaluation to assess the acceptability and feasibility of PARTNER UP from the participant perspective. METHODS: PARTNER UP participants met with a provider for an initial in-person visit at the SSP, followed by weekly telemedicine visits in month 1 and then monthly telemedicine visits until program end at month 6. Using a qualitative descriptive study design, we conducted in-depth interviews with a subsample of PARTNER UP participants at 1 month and 4 months. Informed by the technology acceptance model, we assessed participant perceptions of the usefulness and ease of use of PARTNER UP, as well as their intent to continue to use the program's components. We audio-recorded all interviews with participants' permission and used applied thematic analysis to analyze the verbatim transcripts. RESULTS: We interviewed 11 of 17 people who participated in PARTNER UP-10 in the month 1 interview and 8 in the month 4 interview. Nearly all participants were motivated to join for consistent and easy access to buprenorphine/naloxone (i.e., MOUD); only a few joined to access PrEP. Most were comfortable accessing healthcare at the SSP because of their relationship with and trust toward SSP staff, and accessing services at the SSP was preferred compared with other healthcare centers. Some participants described that telemedicine allowed them to be honest and share more information because the visits were not in-person and they chose the location, although the initial in-person meeting was helpful to build provider trust and rapport. Most participants found the visit schedule to be feasible, although half described needing to reschedule at least once. Nearly all participants who were interviewed intended to continue with MOUD after the program ended, whereas none were interested in continuing with PrEP. CONCLUSIONS: Participant narratives suggest that the PARTNER UP telemedicine program was acceptable and feasible. Future studies should continue to explore the benefits of embedding both PrEP and MOUD into SSPs with larger numbers of participants. Trial registration Clinicaltrials.gov Identifier: NCT04521920.

Low barrier medication for opioid use disorder at a federally qualified health center: a retrospective cohort study.

BACKGROUND: Medication for opioid use disorder (MOUD) reduces mortality, but few patients access MOUD. At a Federally Qualified Health Center (FQHC), we implemented a low barrier model of MOUD, including same-day MOUD initiation and a harm reduction philosophy. OBJECTIVE: To investigate whether low barrier MOUD improved retention in care compared to traditional treatment. DESIGN AND PARTICIPANTS: Retrospective cohort study of patients with at least one visit seeking MOUD at the FQHC during a historical control period (3/1/2018-3/31/2019) and a low barrier intervention period (11/1/2019-7/31/2020). MAIN MEASURES: Primary outcomes were any MOUD prescription within 6 months of the index visit and 3- and 6-month retention in treatment without care gap, with care gap defined as 60 consecutive days without a visit or prescription. Secondary outcomes were all-cause hospitalization and emergency department visit within 6 months of the index visit. KEY RESULTS: Baseline characteristics were similar between the intervention (n = 113) and control (n = 90) groups, except the intervention group had higher rates of uninsured, public insurance and diabetes. Any MOUD prescription within 6 months of index visit was higher in the intervention group (97.3% vs 70%), with higher adjusted odds of MOUD prescription (OR = 4.01, 95% CI 2.08-7.71). Retention in care was similar between groups at 3 months (61.9% vs 60%, aOR = 1.06, 95% CI 0.78-1.44). At 6 months, a higher proportion of the intervention group was retained in care, but the difference was not statistically significant (53.1% vs 45.6%, aOR 1.27, 95% CI 0.93-1.73). There was no significant difference in adjusted odds of 6-month hospitalization or ED visit between groups. CONCLUSIONS: Low barrier MOUD engaged a higher risk population and did not result in any statistically significant difference in retention in care compared with a historical control. Future research should determine what interventions improve retention of patients engaged through low barrier care. Primary care clinics can implement low barrier treatment to make MOUD accessible to a broader population.

Community Readiness to Prevent Opioid Overdose.

Effective community-based actions are urgently needed to combat the ongoing epidemic of opioid overdose. Community readiness (CR) has been linked to communities' support for collective action, which in turn has been associated with the success of community-wide prevention strategies and resulting behavior change. Our study, conducted in North Carolina, assessed the relationship between CR and two indices of opioid overdose. County-level data included a survey of health directors that assessed CR to address drug overdose prevention programs, surveillance measures of opioid overdose collected from death records and emergency departments, and two indicators of general health-related status. We found that counties' rates of CR were positively associated with their opioid-related mortality (but not morbidity) and that this relationship persisted when we controlled for health status. North Carolina counties with the highest opioid misuse problems appear to be the most prepared to respond to them.

A statewide evaluation of seven strategies to reduce opioid overdose in North Carolina.

BACKGROUND: In response to increasing opioid overdoses, US prevention efforts have focused on prescriber education and supply, demand and harm reduction strategies. Limited evidence informs which interventions are effective. We evaluated Project Lazarus, a centralised statewide intervention designed to prevent opioid overdose. METHODS: Observational intervention study of seven strategies. 74 of 100 North Carolina counties implemented the intervention. Dichotomous variables were constructed for each strategy by county-month. Exposure data were: process logs, surveys, addiction treatment interviews, prescription drug monitoring data. Outcomes were: unintentional and undetermined opioid overdose deaths, overdose-related emergency department (ED) visits. Interrupted time-series Poisson regression was used to estimate rates during preintervention (2009-2012) and intervention periods (2013-2014). Adjusted IRR controlled for prescriptions, county health status and time trends. Time-lagged regression models considered delayed impact (0-6 months). RESULTS: In adjusted immediate-impact models, provider education was associated with lower overdose mortality (IRR 0.91; 95% CI 0.81 to 1.02) but little change in overdose-related ED visits. Policies to limit ED opioid dispensing were associated with lower mortality (IRR 0.97; 95% CI 0.87 to 1.07), but higher ED visits (IRR 1.06; 95% CI 1.01 to 1.12). Expansions of medication-assisted treatment (MAT) were associated with increased mortality (IRR 1.22; 95% CI 1.08 to 1.37) but lower ED visits in time-lagged models. CONCLUSIONS: Provider education related to pain management and addiction treatment, and ED policies limiting opioid dispensing showed modest immediate reductions in mortality. MAT expansions showed beneficial effects in reducing ED-related overdose visits in time-lagged models, despite an unexpected adverse association with mortality.

Reducing Opioid Misuse: Evaluation of a Medicaid Controlled Substance Lock-In Program.

Opioid misuse, abuse, and overdose are a rapidly growing public health epidemic. Medicaid Lock-In Programs (MLIPs) are designed to prevent overutilization of controlled substances by Medicaid patients. However, despite widespread use, there is little information on their effect. Using North Carolina (NC) Medicaid claims data from October 2008 through June 2013, we examined changes in Medicaid-reimbursed opioid prescriptions by patients enrolled in NC's MLIP. We used mixed effects models to examine the effect of MLIP enrollment on monthly opioid claims, number of pharmacies, total days' supply, total units (ie, pills), and total Medicaid payments for opioids. In our sample of 6,148 MLIP patients, the odds of having any opioid claim in a given month was 84% lower during MLIP enrollment relative to the period before enrollment (odds ratio = .16). MLIP enrollment also corresponded with a reduction in monthly number of opioid prescriptions by 1.13, monthly number of pharmacies by .61, and monthly Medicaid expenditures by $22.78. Although MLIPs may constitute a successful component of comprehensive efforts to reduce the potential overutilization of opioids, care should be taken to ensure that programs such as MLIPs do not constrain patients' legitimate needs for analgesic medications. PERSPECTIVE: Enrollment in NC's MLIP reduced the likelihood that patients would present a claim for an opioid prescription, and the number of opioid prescriptions patients secured each month. MLIPs may constitute a successful strategy for reducing the misuse, abuse, and diversion of prescription opioids. However, further research is needed to examine the program's potential unintended consequences.

Use of syndromic surveillance data to monitor poisonings and drug overdoses in state and local public health agencies.

BACKGROUND: The incidence of poisoning and drug overdose has risen rapidly in the USA over the last 16 years. To inform local intervention approaches, local health departments (LHDs) in North Carolina (NC) are using a statewide syndromic surveillance system that provides timely, local emergency department (ED) and Emergency Medical Services (EMS) data on medication and drug overdoses. OBJECTIVE: The purpose of this article is to describe the development and use of a variety of case definitions for poisoning and overdose implemented in NC's syndromic surveillance system and the impact of the system on local surveillance initiatives. DESIGN, SETTING, PARTICIPANTS: Thirteen new poisoning and overdose-related case definitions were added to NC's syndromic surveillance system and LHDs were trained on their use for surveillance purposes. Twenty-one LHDs were surveyed on the utility and impact of these new case definitions. RESULTS/CONCLUSIONS: Ninety-one per cent of survey respondents (n = 29) agreed or strongly agreed that their ability to access timely ED data was vital to inform community-level overdose prevention work. Providing LHDs with access to local, timely data to identify pockets of need and engage stakeholders facilitates the practice of informed injury prevention and contributes to the reduction of injury incidence in their communities.

North Carolina's Operation Medicine Drop: Results From One of the Nation's Largest Drug Disposal Programs.

INTRODUCTION: In 2013, a total of 1,085 North Carolina residents died due to unintentional poisoning; 91% of these deaths were attributed to medications or drugs (over-the-counter, prescription, or illicit). Proper disposal of unused, unneeded, and/or expired medications is an essential part of preventing these unintentional deaths, as well as averting the other adverse consequences of these drugs on the environment and population health. METHODS: Operation Medicine Drop is a medication take-back program coordinated by Safe Kids North Carolina, a county-level, coalition-based injury prevention organization. The Operation Medicine Drop program and event registration system were used to review and validate the number of events, the counties where the events were held, and the number of unit doses (pills) collected from March 2010 to June 2014. SAS version 9.4 was used to generate basic counts and frequencies of events and doses, and ArcGIS version 10.0 was used to create the map. RESULTS: From March 2010 to June 2014, Operation Medicine Drop held 1,395 events with 245 different participating law enforcement agencies in 91 counties in North Carolina, and it collected 69.6 million unit doses of medication. More than 60 local Safe Kids North Carolina community coalitions had participated as of June 2014. Every year, Operation Medicine Drop has witnessed increases in events, participating agencies, participating counties, and the number of doses collected. CONCLUSION: Operation Medicine Drop is an excellent example of a successful and ongoing collaboration to improve public health. Medication take-back programs may play an important role in preventing future overdose deaths in North Carolina.

The use of a prescription drug monitoring program to develop algorithms to identify providers with unusual prescribing practices for controlled substances.

The misuse, abuse and diversion of controlled substances have reached epidemic proportion in the United States. Contributing to this problem are providers who over-prescribe these substances. Using one state's prescription drug monitoring program, we describe a series of metrics we developed to identify providers manifesting unusual and uncustomary prescribing practices. We then present the results of a preliminary effort to assess the concurrent validity of these algorithms, using death records from the state's vital records database pertaining to providers who wrote prescriptions to patients who then died of a medication or drug overdose within 30 days. Metrics manifesting the strongest concurrent validity with providers identified from these records related to those who co-prescribed benzodiazepines (e.g., valium) and high levels of opioid analgesics (e.g., oxycodone), as well as those who wrote temporally overlapping prescriptions. We conclude with a discussion of a variety of uses to which these metrics may be put, as well as problems and opportunities related to their use.

North Carolina Medicaid recipient management lock-in program: the pharmacist's perspective.

BACKGROUND: The misuse and abuse of prescription opioids have become an urgent health issue in North Carolina (NC), particularly among Medicaid patients who suffer high rates of morbidity and mortality due to abuse and overdose. The NC Division of Medical Assistance (DMA) implemented a recipient management lock-in program, which limits identified patients for a 12-month period to 1 prescriber and 1 pharmacy for benzodiazepine, opiate, and certain anxiolytic prescriptions in order to prevent misuse and reduce overutilization of Medicaid benefits.  OBJECTIVES: To (a) evaluate pharmacists' perceptions of the implementation of the NC recipient management lock-in program (MLIP) and (b) determine how the beliefs and attitudes of pharmacists could promote or inhibit its success.  METHODS: We conducted 12 structured phone interviews with NC pharmacists serving lock-in patients. Interview responses were analyzed through construct analysis, which identified themes organized into 3 domains: organization and implementation, perceived effectiveness, and acceptability.  RESULTS: Most respondents reported a positive experience with the program but expressed doubt concerning its impact on prescription drug abuse. The program successfully utilized the pharmacist role as a gatekeeper of controlled substances, and the procedures of the program required no active effort on pharmacists' part. However, respondents suggested that the DMA improve communication and outreach to address pharmacists' lack of knowledge about the program's purpose and confusion over remediating problems that arise with lock-in patients. The DMA should also address the ways in which the program can interfere with access to health care and treatment, allow patients to see multiple physicians within the same clinic, and clarify procedures for patients whose complex health issues require multiple specialists.  CONCLUSIONS: Although possible improvements were identified, the NC MLIP has strong potential for success as it utilizes pharmacists' medication gate-keeping role, while minimizing the effort required for successful implementation.