Clients' experiences on North America's first take-home injectable opioid agonist treatment (iOAT) program: a qualitative study.

BACKGROUND: To support public health measures during the COVID-19 pandemic, oral opioid agonist treatment (OAT) take-home doses were expanded in Western countries with positive results. Injectable OAT (iOAT) take-home doses were previously not an eligible option, and were made available for the first time in several sites to align with public health measures. Building upon these temporary risk-mitigating guidelines, a clinic in Vancouver, BC continued to offer two of a possible three daily doses of take-home injectable medications to eligible clients. The present study explores the processes through which take-home iOAT doses impacted clients' quality of life and continuity of care in real-life settings. METHODS: Three rounds of semi-structured qualitative interviews were conducted over a period of seventeen months beginning in July 2021 with eleven participants receiving iOAT take-home doses at a community clinic in Vancouver, British Columbia. Interviews followed a topic guide that evolved iteratively in response to emerging lines of inquiry. Interviews were recorded, transcribed, and then coded using NVivo 1.6 using an interpretive description approach. RESULTS: Participants reported that take-home doses granted them the freedom away from the clinic to have daily routines, form plans, and enjoy unstructured time. Participants appreciated the greater privacy, accessibility, and ability to engage in paid work. Furthermore, participants enjoyed greater autonomy to manage their medication and level of engagement with the clinic. These factors contributed to greater quality of life and continuity of care. Participants shared that their dose was too essential to divert and that they felt safe transporting and administering their medication off-site. In the future, all participants would like more accessible treatment such as access longer take-home prescriptions (e.g., one week), the ability to pick-up at different and convenient locations (e.g., community pharmacies), and a medication delivery service. CONCLUSIONS: Reducing the number of daily onsite injections from two or three to only one revealed the diversity of rich and nuanced needs that added flexibility and accessibility in iOAT can meet. Actions such as licencing diverse opioid medications/formulations, medication pick-up at community pharmacies, and a community of practice that supports clinical decisions are necessary to increase take-home iOAT accessibility.

Estimated Reductions in Opioid Overdose Deaths With Sustainment of Public Health Interventions in 4 US States.

Importance: In 2021, more than 80 000 US residents died from an opioid overdose. Public health intervention initiatives, such as the Helping to End Addiction Long-term (HEALing) Communities Study (HCS), are being launched with the goal of reducing opioid-related overdose deaths (OODs). Objective: To estimate the change in the projected number of OODs under different scenarios of the duration of sustainment of interventions, compared with the status quo. Design, Setting, and Participants: This decision analytical model simulated the opioid epidemic in the 4 states participating in the HCS (ie, Kentucky, Massachusetts, New York, and Ohio) from 2020 to 2026. Participants were a simulated population transitioning from opioid misuse to opioid use disorder (OUD), overdose, treatment, and relapse. The model was calibrated using 2015 to 2020 data from the National Survey on Drug Use and Health, the US Centers for Disease Control and Prevention, and other sources for each state. The model accounts for reduced initiation of medications for OUD (MOUDs) and increased OODs during the COVID-19 pandemic. Exposure: Increasing MOUD initiation by 2- or 5-fold, improving MOUD retention to the rates achieved in clinical trial settings, increasing naloxone distribution efforts, and furthering safe opioid prescribing. An initial 2-year duration of interventions was simulated, with potential sustainment for up to 3 additional years. Main Outcomes and Measures: Projected reduction in number of OODs under different combinations and durations of sustainment of interventions. Results: Compared with the status quo, the estimated annual reduction in OODs at the end of the second year of interventions was 13% to 17% in Kentucky, 17% to 27% in Massachusetts, 15% to 22% in New York, and 15% to 22% in Ohio. Sustaining all interventions for an additional 3 years was estimated to reduce the annual number of OODs at the end of the fifth year by 18% to 27% in Kentucky, 28% to 46% in Massachusetts, 22% to 34% in New York, and 25% to 41% in Ohio. The longer the interventions were sustained, the better the outcomes; however, these positive gains would be washed out if interventions were not sustained. Conclusions and Relevance: In this decision analytical model study of the opioid epidemic in 4 US states, sustained implementation of interventions, including increased delivery of MOUDs and naloxone supply, was found to be needed to reduce OODs and prevent deaths from increasing again.

Acceptability of a Fentanyl Vaccine to Prevent Opioid Overdose and Need for Personalized Decision-Making.

BACKGROUND: The opioid epidemic worsened during the coronavirus disease 2019 (COVID-19) pandemic. Synthetic opioids (primarily fentanyl) comprise the most common drugs involved in overdose (OD) death. A vaccine that blocks fentanyl from reaching the brain to prevent OD is under development, and insight is needed into its acceptability. METHODS: Using a semi-structured interview guide, persons with opioid use disorder (OUD), family, professionals, and the public were interviewed about attitudes and concerns regarding a fentanyl vaccine. Reactions to fictional clinical vignettes of persons at risk of OUD because of pain and/or substance use histories were collected, analyzed, and quantified for favorability. Interviews were transcribed, coded, and analyzed thematically. RESULTS: Among N = 64 participants, (70.3% female, average age 32.4 years), attitudes were favorable toward a fentanyl vaccine, with preference for lifelong durability (76% of n = 55 asked). Perceived benefits centered on the potential for a life-saving intervention, suffering averted, healthcare dollars saved, and the utility of a passive harm reduction strategy. Concerns centered on uncertainty regarding vaccine safety, questions about efficacy, worry about implications for future pain management, stigma, and need for supportive counseling and guidance to personalize decision making. Reactions to vignettes revealed complex attitudes toward fentanyl vaccination when considering recipient age, health history, and future risks for addiction and pain. CONCLUSIONS: Positive responses to a fentanyl vaccine were found along with appreciation for the complexity of a vaccine strategy to prevent OD in the setting of pain and uncertain durability. Further research is needed to elucidate operational, ethical, and communications strategies to advance the model.

Are we ready to manage an opioid epidemic in the intensive care unit?

The current opioid epidemic has had a massive impact on the critical care sector. This is due to an increase in the number of acute opioid overdose-related admissions and the number of opioid-dependent and opioid-tolerant patients admitted to intensive care units (ICUs). This review discusses the challenges that intensive care physicians face when caring for patients suffering from opioid-related disorders and analyses existing solutions. Preference for non-opioid analgesics, treatment of acute pain in the ICUs to avoid chronic pain syndrome, and education of patients and caregivers are critical to preventing this pandemic.

Expanding the accessibility of harm reduction services in the United States: Measuring the impact of an automated harm reduction dispensing machine.

BACKGROUND: In 2021, approximately 107,622 Americans died from drug overdose in the United States. With overdose deaths rising rapidly, it is imperative that prevention efforts focus on expanding proven, evidence-based strategies to curb overdose death rates such as targeted naloxone distribution and syringe service programs (SSPs). The COVID-19 pandemic placed additional strain on SSPs, increasing the need for programs that minimize direct contact and potential COVID-19 exposure. The purpose of this study is to evaluate the impact of an automated harm reduction dispensing machine on the local accessibility of harm reduction services. OBJECTIVES: The primary outcome of the study is the number of harm reduction supplies distributed to the community by the dispensing machine in its first year compared to the number of supplies distributed by the same organization in the previous year. Secondary outcomes include the countywide incidence of fatal drug overdose and human immunodeficiency virus (HIV) compared to previous years. METHODS: The machine is located outside, in the same location as a once weekly, in-person SSP. Clients register with the program over the phone with a harm reduction coordinator. Each client is connected to products and services such as naloxone, sharps containers, safer injection/smoking kits, pregnancy tests, HIV tests, substance use disorder treatment, and more. RESULTS: Since installation, 637 individuals registered with the program, 12% of whom had never reportedly used harm reduction services before. Within its first year of use, the machine dispensed 3360 naloxone doses and 10,155 fentanyl test strips, more than any other SSP in the county. CONCLUSION: The implementation of an automated harm reduction dispensing machine led to an increased accessibility of harm reduction products and services and was associated with a lower countywide incidence of unintentional overdose death and HIV. The association with decreased overdose death and HIV incidence should be further investigated to assess causality.

Evaluating the impact of naloxone dispensation at public health vending machines in Clark County, Nevada.

INTRODUCTION: Implementing public health vending machines (PHVMs) is an evidence-based strategy for mitigating substance use-associated morbidity and mortality via the dispensation of essential supplies to people who use drugs, including overdose prevention resources. PHVMs have been implemented throughout the world; however, their implementation in the United States (US) is a recent phenomenon. In 2017, Trac-B Exchange (a syringe services program in Clark County, Nevada) installed three PHVMs. In 2019, naloxone dispensation was launched at PHVMs in Clark County. The purpose of this research is to examine the extent to which naloxone dispensation at PHVMs was associated with changes in opioid-involved overdose fatalities. METHODS: Monthly counts of opioid-involved overdose fatalities among Clark County residents that occurred from January 2015 to December 2020 were used to build an autoregressive integrated moving averages (ARIMA) model to measure the impact of naloxone dispensation at PHVMs. We forecasted the number of expected opioid-involved overdose fatalities had naloxone dispensation at PHVMs not occurred and compared to observed monthly counts. Interrupted time series analyses (ITSA) were used to evaluate the step (i.e. the immediate impact of naloxone dispensation at PHVMs on opioid-involved overdose fatalities) and slope change (i.e. changes in trend and directionality of monthly counts of opioid-involved overdose fatalities following naloxone dispensation at PHVMs). RESULTS: During the 12-months immediately following naloxone dispensation at PHVMs, our model forecasted 270 opioid-involved overdose fatalities, but death certificate data indicated only 229 occurred, suggesting an aversion of 41 deaths. ITSA identified a significant negative step change in opioid-involved overdose fatalities at the time naloxone dispensation at PHVMs was launched (B = -8.52, p = .0022) and a significant increasing slope change (B = 1.01, p<.0001). Forecasts that extended into the COVID-19 pandemic suggested worsening trends in overdose fatalities. CONCLUSION: Naloxone dispensation at PHVMs was associated with immediate reductions in opioid-involved overdose fatalities. Key MessagesNaloxone dispensation at PHVMs was associated with immediate reductions in opioid-involved overdose fatalities.Communities should consider implementing public health vending machines in efforts to prevent opioid-involved overdose fatalities.The COVID-19 pandemic worsened the overdose crisis.

Civil commitment for opioid misuse: do short-term benefits outweigh long-term harms?

In response to a sharp rise in opioid-involved overdose deaths in the USA, states have deployed increasingly aggressive strategies to limit the loss of life, including civil commitment-the forcible detention of individuals whose opioid use presents a clear and convincing danger to themselves or others. While civil commitment often succeeds in providing short-term protection from overdose, emerging evidence suggests that it may be associated with long-term harms, including heightened risk of severe withdrawal, relapse and opioid-involved mortality. To better assess and mitigate these harms, states should collect more robust data on long-term health outcomes, decriminalise proceedings and stays, provide access to medications for opioid use disorder and strengthen post-release coordination of community-based treatment.

Lessons Learned in Implementing a Chronic Opioid Therapy Management System.

OBJECTIVES: Opioid misuse has resulted in significant morbidity and mortality in the United States, and safer opioid use represents an important challenge in the primary care setting. This article describes a research collaborative of health service researchers, systems engineers, and clinicians seeking to improve processes for safer chronic opioid therapy management in an academic primary care center. We present implementation results and lessons learned along with an intervention toolkit that others may consider using within their organization. METHODS: Using iterative improvement lifecycles and systems engineering principles, we developed a risk-based workflow model for patients on chronic opioids. Two key safe opioid use process metrics-percent of patients with recent opioid treatment agreements and urine drug tests-were identified, and processes to improve these measures were designed, tested, and implemented. Focus groups were conducted after the conclusion of implementation, with barriers and lessons learned identified via thematic analysis. RESULTS: Initial surveys revealed a lack of knowledge regarding resources available to patients and prescribers in the primary care clinic. In addition, 18 clinicians (69%) reported largely "inheriting" (rather than initiating) their chronic opioid therapy patients. We tracked 68 patients over a 4-year period. Although process measures improved, full adherence was not achieved for the entire population. Barriers included team structure, the evolving opioid environment, and surveillance challenges, along with disruptions resulting from the 2019 novel coronavirus. CONCLUSIONS: Safe primary care opioid prescribing requires ongoing monitoring and management in a complex environment. The application of a risk-based approach is possible but requires adaptability and redundancies to be reliable.

Aversion liquid-filled drug releasing capsule (3D-RECAL): A novel technology for the development of immediate release abuse deterrent formulations using a fused deposition modelling (FDM) 3D printer.

COVID19 has caused a significant socioeconomic burden worldwide. Opioid crisis was further intensified with the increasing number of opioid overdose/misuse related deaths in last two years. Abusers have adopted newer/efficient methods for manipulating and abusing commercial opioid formulations. Food and Drug Administration (FDA) has been strategizing tirelessly to prevent misuse/abuse of prescription opioids. One of the strategies is to develop an abuse deterrent formulation (ADF). The current study aims to develop a novel 3D printed drug-releasing capsule shell filled with an aversion liquid (3D-RECAL). Primarily, metformin hydrochloride (MT, model drug) loaded printable filaments of polyvinyl alcohol was prepared using hot melt extrusion. Following extrusion, a 3D printed capsule shell was designed and fabricated using a single nozzle fuse deposition modelling 3D printer. An aversion liquid to be filled in 3D-RECAL capsules was prepared by combining sudan black and sodium polyacrylamide starch in oil base. Mechanical analysis of extruded filaments suggested that the filaments with 20%w/w MT had a higher mechanical strength compared to other drug loadings. Instantaneous gelling and large black non-snortable particles were formed during solvent extraction and physical manipulation studies, respectively. Due to the drug being embedded in the capsule shell, MT release was immediately started with >85% of MT release within 45 mins in 0.1 N HCl. Due to the everlasting need for the newer efficient ADF technologies, 3D-RECAL can be a step in the right direction towards saving lives, providing safe and effective measures to deterring abusers.

Opioid treatment program safety measures during the COVID-19 pandemic: a statewide survey.

BACKGROUND: Opioid treatment programs (OTPs) serve as daily essential services for people with opioid use disorder. This study seeks to identify modifications to operations and adoption of safety measures at Pennsylvania OTPs during the COVID-19 pandemic. METHODS: A 25-min online survey to clinical and administrative directors at all 103 state-licensed OTPs in Pennsylvania was fielded from September to November 2020. Survey domains included: 1) changes to services, client volume, hours and staffing during the COVID-19 pandemic 2) types of services modifications 3) safety protocols to reduce COVID-19 transmission 4) challenges to operations during the pandemic. RESULTS: Forty-seven directors responded, for a response rate of 45%. Almost all respondents reported making some service modification (96%, n = 43). Almost half (47%, n = 21) of respondents reported reductions in the number of clients served. OTPs were more likely to adopt safety protocols that did not require significant funding, such as limiting the number of people entering the site (100%, n = 44), posting COVID-safety information (100%, n = 44), enforcing social distancing (98%, n = 43), and increasing sanitation (100%, n = 44). Only 34% (n = 14) of OTPS provided N95 masks to most or all staff. Respondents reported that staff's stress and negative mental health (86%, n = 38) and staff caregiving responsibilities (84%, n = 37) during the pandemic were challenges to maintaining OTP operations. CONCLUSION: OTPs faced numerous challenges to operations and adoption of safety measures during the COVID-19 pandemic. Funding mechanisms and interventions to improve adoption of safety protocols, staff mental health as well as research on patient experiences and preferences can inform further OTP adaptation to the COVID-19 pandemic and future emergency planning.

Opioids in the United Kingdom: safety and surveillance during COVID-19.

PURPOSE OF REVIEW: Opioid use is prevalent in the United Kingdom and prior to the COVID-19 pandemic it had been recognized that the safety of opioids was an important issue to be monitored by the UK medicines regulatory agency. With the emergence of COVID-19, this requirement has been even greater. This review was undertaken to determine the impact of the pandemic on safety and surveillance of opioids in the United Kingdom. RECENT FINDINGS: During the COVID-19 pandemic, the surveillance of opioids in the United Kingdom continued, although primary research was often conducted with data prior to the pandemic. Of those studies that were conducted while the pandemic was ongoing, access to opioids (or opioid substitution therapy) and the subsequent effect on patient safety was the main theme. SUMMARY: In the United Kingdom, changes in accessibility to the healthcare system and how healthcare providers operated during the COVID-19 pandemic may have had unintended consequences on use and safety of opioids, due to the shift in focus to preventing COVID-19 from overwhelming the healthcare system. The findings from this review support the need to continue surveillance in the United Kingdom, including the impact of the COVID-19 pandemic on opioid utilization and safety.

Reducing the stigma surrounding opioid use disorder: evaluating an opioid overdose prevention training program applied to a diverse population.

BACKGROUND: The opioid epidemic is a rapidly growing public health concern in the USA, as the number of overdose deaths continues to increase each year. One strategy for combating the rising number of overdoses is through opioid overdose prevention programs (OOPPs). OBJECTIVE: To evaluate the effectiveness of an innovative OOPP, with changes in knowledge and attitudes serving as the primary outcome measures. METHODS: The OOPP was developed by a group of medical students under guidance from faculty advisors. Training sessions focused on understanding stigmatizing factors of opioid use disorder (OUD), as well as protocols for opioid overdose reversal through naloxone administration. Pre- and post-surveys were partially adapted from the opioid overdose attitudes and knowledge scales and administered to all participants. Paired t-tests were conducted to assess differences between pre- and post-surveys. RESULTS: A total of 440 individuals participated in the training; 381 completed all or the majority of the survey. Participants came from a diverse set of backgrounds, ages, and experiences. All three knowledge questions showed significant improvements. For attitude questions, significant improvements were found in all three questions evaluating confidence, two of three questions assessing attitudes towards overdose reversal, and four of five questions evaluating stigma and attitudes towards individuals with OUD. CONCLUSIONS: Our innovative OOPP was effective not only in increasing knowledge but also in improving attitudes towards overdose reversal and reducing stigma towards individuals with OUD. Given the strong improvements in attitudes towards those with OUD, efforts should be made to incorporate the unique focus on biopsychosocial and sociohistorical components into future OOPPs.

Piloting a statewide emergency department take-home naloxone program: Improving the quality of care for patients at risk of opioid overdose.

BACKGROUND: Emergency department (ED) patients with nonfatal opioid overdose are at high risk for subsequent fatal overdose, yet ED programs aimed at reducing harm from opioid use remain underdeveloped. OBJECTIVES: The objective was to pilot a statewide ED take-home naloxone program and improve the care of patients with opioid use disorder (OUD) and risky drug use through training and interprofessional network building. METHODS: Nine hospital EDs with pharmacy, nurse, and physician champions were recruited, surveyed, and trained. Take-home naloxone rescue kits were developed, disseminated, and tracked. Two overdose prevention summits were convened prior to the COVID pandemic, and two X-waiver training courses aimed at emergency physicians and advanced practice providers were arranged, both in person and virtual. RESULTS: A total of 872 naloxone rescue kits were distributed to ED patients at risk of opioid overdose during the first phase of this project, and more than 140 providers were trained in the use of medications for OUD in acute care settings. CONCLUSIONS: A statewide ED take-home naloxone program was shown to be feasible across a range of different hospitals with varying maturity in preexisting OUD resources and capabilities. Future work will be aimed at both expanding and measuring the effectiveness of this work.