The changing landscape of pharmaceutical alternatives to the unregulated drug supply during COVID-19.

BACKGROUND: The dual COVID-19 and overdose emergencies amplified strain on healthcare systems tasked with responding to both. One downstream consequence of the pandemic in the USA and Canada was a surge in drug overdoses resulting from public health-restricted access to services and an increasingly toxic unregulated drug supply. This study aimed to describe changes implemented by programs prescribing pharmaceutical alternatives to the drug supply during the early stages of the COVID-19 pandemic. METHODS: An environmental scan used surveys and qualitative interviews with service providers across Canada to examine pharmaceutical alternative prescribing practices and programs before and during the pandemic. This study summarized the nature, frequency, and reasons for pandemic-driven service delivery changes using directed content analysis, counts, and thematic analysis. RESULTS: Eighty-two of the 103 participating sites reported 1193 unique changes in physical space (368), client protocols (347), program operations (342), ancillary services (127), and staffing (90). Four qualitative themes describing the reasons for these changes emerged, namely (1) decreasing risk of COVID-19 infection; (2) decreasing risk of overdose; (3) prioritizing acute care of COVID-19 patients; and (4) improving client access to treatment. CONCLUSIONS: While most changes were aimed at decreasing risk of COVID-19 infection, some were found to be at odds with the measures needed to combat the overdose crisis; others met dual objectives of decreased risk of both overdose and infection. Further research should examine which changes should be kept or reversed once COVID-19-related public health measures are lifted.

"It's Helped Me a Lot, Just Like to Stay Alive": a Qualitative Analysis of Outcomes of a Novel Hydromorphone Tablet Distribution Program in Vancouver, Canada.

North America is experiencing an overdose crisis driven by fentanyl, related analogues, and fentanyl-adulterated drugs. In response, there have been increased calls for "safe supply" interventions based on the premise that providing a safer alternative (i.e., pharmaceutical drugs of known quality/quantity, non-adulterated, with user agency in consumption methods) to the street drug supply will limit people's use of fentanyl-adulterated drugs and reduce overdose events. This study examined outcomes of a hydromorphone tablet distribution program intended to prevent overdose events among people who use drugs (PWUD) at high risk of fatal overdose. Semi-structured qualitative interviews were conducted with 42 people enrolled in the hydromorphone distribution program. Additionally, over 100 h of ethnographic observation were undertaken in and around the study site. Transcripts were coded using NVivo and based on categories extracted from the interview guides and those identified during initial interviews and ethnographic fieldwork. Analysis focused on narratives around experiences with the program, focusing on program-related outcomes. Our analysis identified the following positive outcomes of being enrolled in the hydromorphone tablet distribution program: (1) reduced street drug use and overdose risk, (2) improvements to health and well-being, (3) improvements in co-management of pain, and (4) economic improvements. Our findings indicate that the hydromorphone distribution program not only is effective in responding to the current overdose crisis by reducing people's use of illicit drugs but also addresses inequities stemming from the intersection of drug use and social inequality. Safe supply programs should be further implemented and evaluated in both urban and rural setting across North America as a strategy to reduce exposure to the toxic drug supply and fatal overdose.

"If I knew I could get that every hour instead of alcohol, I would take the cannabis": need and feasibility of cannabis substitution implementation in Canadian managed alcohol programs.

BACKGROUND: While there is robust evidence for strategies to reduce harms of illicit drug use, less attention has been paid to alcohol harm reduction for people experiencing severe alcohol use disorder (AUD), homelessness, and street-based illicit drinking. Managed Alcohol Programs (MAPs) provide safer and regulated sources of alcohol and other supports within a harm reduction framework. To reduce the impacts of heavy long-term alcohol use among MAP participants, cannabis substitution has been identified as a potential therapeutic tool. METHODS: To determine the feasibility of cannabis substitution, we conducted a pre-implementation mixed-methods study utilizing structured surveys and open-ended interviews. Data were collected from MAP organizational leaders (n = 7), program participants (n = 19), staff and managers (n = 17) across 6 MAPs in Canada. We used the Consolidated Framework for Implementation Research (CFIR) to inform and organize our analysis. RESULTS: Five themes describing feasibility of CSP implementation in MAPs were identified. The first theme describes the characteristics of potential CSP participants. Among MAP participants, 63% (n = 12) were already substituting cannabis for alcohol, most often on a weekly basis (n = 8, 42.1%), for alcohol cravings (n = 15, 78.9%,) and withdrawal (n = 10, 52.6%). Most MAP participants expressed willingness to participate in a CSP (n = 16, 84.2%). The second theme describes the characteristics of a feasible and preferred CSP model according to participants and staff. Participants preferred staff administration of dry, smoked cannabis, followed by edibles and capsules with replacement of some doses of alcohol through a partial substitution model. Themes three and four highlight organizational and contextual factors related to feasibility of implementing CSPs. MAP participants requested peer, social, and counselling supports. Staff requested education resources and enhanced clinical staffing. Critically, program staff and leaders identified that sustainable funding and inexpensive, legal, and reliable sourcing of cannabis are needed to support CSP implementation. CONCLUSION: Cannabis substitution was considered feasible by all three groups and in some MAPs residents are already using cannabis. Partial substitution of cannabis for doses of alcohol was preferred. All three groups identified a need for additional supports for implementation including peer support, staff education, and counselling. Sourcing and funding cannabis were identified as primary challenges to successful CSP implementation in MAPs.

A Low-Barrier and Comprehensive Community-Based Harm-Reduction Site in Vancouver, Canada.

"The Molson" is a low-barrier, peer-staffed, supervised consumption site located in Vancouver, Canada. In addition to overdose response, this site offers drug checking and a colocated injectable hydromorphone treatment program, and it distributes tablet and liquid hydromorphone to service users at high risk of overdose. Our evaluation suggests benefits of this program in creating service continuums and preventing overdose deaths. From September 2017 to August 2019, the site had 128 944 visits, reversed 770 overdoses, and had no overdose deaths.

Impact of unstable housing on all-cause mortality among persons who inject drugs.

BACKGROUND: Illicit drug injecting is a well-established risk factor for morbidity and mortality. However, a limited number of prospective studies have examined the independent effect of unstable housing on mortality among persons who inject drugs (PWIDs). In this study we sought to identify if a relationship exists between unstable housing and all-cause mortality among PWIDs living in Vancouver, Canada. METHODS: PWIDs participating in two prospective cohort studies in Vancouver, Canada were followed between May 1996 and December 2012. Cohort data were linked to the provincial vital statistics database to ascertain mortality rates and causes of death. We used multivariate Cox proportional hazards regression to determine factors associated with all-cause mortality and to investigate the independent relationship between unstable housing and time to all-cause mortality. RESULTS: During the study period, 2453 individuals were followed for a median of 69 months (Inter-quartile range [IQR]: 34 - 113). In total, there were 515 (21.0%) deaths for an incidence density of 3.1 (95% Confidence Interval [CI]: 2.8 - 3.4) deaths per 100 person years. In multivariate analyses, after adjusting for potential confounders including HIV infection and drug use patterns, unstable housing remained independently associated with all-cause mortality (adjusted hazard ratio [AHR] = 1.30, 95% CI: 1.08 - 1.56). CONCLUSIONS: These findings demonstrate that unstable housing is an important risk factor for mortality independent of known risk factors including HIV infection and patterns of drug use. This study highlights the urgent need to provide supportive housing interventions to address elevated levels of preventable mortality among this population.

An emergency-department-initiated outreach program for patients with opioid use disorder is associated with an increase in agonist therapy and engagement in addictions care: a one-year cohort study.

BACKGROUND: People with opioid use disorder (OUD) are high-risk for short-term mortality and morbidity. Emergency department (ED) interventions can reduce those risks, but benefits wane without ongoing community follow-up. OBJECTIVE: To evaluate an ED-based intensive community outreach program. METHODS: At two urban EDs between October 2019 and March 2020, we enrolled patients with OUD not currently on opioid agonist therapy (OAT) in a prospective cohort study evaluating a one-year intensive community outreach program, which provided ongoing addictions care, housing resources, and community support. We surveyed patients at intake and at scheduled outreach encounters at one, two, six, and twelve months. Follow-up surveys assessed OAT uptake, addictions care engagement, housing status, quality of life scores, illicit opioid use, and outreach helpfulness. We used descriptive statistics for each period and conducted sensitivity and subgroup analyses to account for missing data. RESULTS: Of 84 baseline participants, 29% were female and 32% were housed, with a median age of 33. Sixty participants (71%) completed at least one follow-up survey. Survey completion rates were 37%, 38%, 39%, and 40% respectively at one, two, six, and twelve months. Participants had a median of three outreach encounters. Among respondents, OAT was 0% at enrolment and ranged from 38% to 56% at follow-up; addictions care engagement was 22% at enrolment and ranged from 65% to 81% during follow-up; and housing was 40% at enrolment and ranged from 48% to 59% during follow-up. Improvements from baseline to follow-up occurred for all time periods. OAT and engagement in care benefits were maintained in sensitivity and subgroup analyses. Respondents rated the outreach program as helpful at all time periods, CONCLUSION: An ED-initiated intensive outreach program for patients with OUD not yet on OAT was associated with a persistent increase in OAT use and engagement in care, as well as housing.

Translating the lived experience of illicit drinkers into program guidance for cannabis substitution: Experiences from the Canadian Managed Alcohol Program Study.

A small but growing body of research has suggested the potential for cannabis substitution to support Managed Alcohol Program (MAP) service users to reduce acute and chronic alcohol-related harms. In 2022, researchers from the Canadian Managed Alcohol Program Study (CMAPS) noted a dearth of accessible, alcohol-specific educational resources to support service users and program staff to implement cannabis substitution pilots at several MAP sites in Canada. In this essay, we draw on over 10-years of collaboration between CMAPS, and organizations of people with lived experience (the Eastside Illicit Drinkers Group for Education (EIDGE) and SOLID Victoria) to describe our experiences co-creating cannabis education resources where none existed to support MAP sites interested in beginning to provide cannabis to participants. The research team relied on the unique lived experiences and informal cannabis-related harm reduction strategies described by EIDGE and SOLID members to create cannabis education resources that were accurate and relevant to MAP sites. EIDGE was familiar with creating peer-oriented educational resources and convened meetings and focus groups to engage peers. CMAPS research team members created standard cannabis unit equivalencies to support program delivery, and clinical advisors ensured that the stated risks and benefits of cannabis substitution, as well as tapering guidance for withdrawal management, were safe and feasible. The collaboration ultimately produced tailored client-facing and provider-facing resources. Our experience demonstrates that the lived expertise of drinkers can play an integral role in creating alcohol harm reduction informational materials, specifically those related to cannabis substitution, when combined with data from rigorous, community-based programs of research like CMAPS. We close by listing additional considerations for cannabis substitution program design for MAP settings emerging from this process of collaboration between illicit drinkers, service providers, clinicians, and researchers for consideration by other programs.

Supervised Tablet Injectable Opioid Agonist Therapy (TiOAT): A Strategy to Address Safer Supply for Individuals With an Opioid Use Disorder?

North America is in the midst of an overdose crisis, with up to 130 Americans dying daily from a preventable drug overdose. Opioids account for 70% of overdose deaths. Despite government efforts to improve access to opioid use disorder (OUD) treatment and the implementation of various harm reduction initiatives, overdose mortality remains unacceptably high. Although effective treatments exist for OUD (eg, opioid agonist therapies like buprenorphine/naloxone and methadone), many individuals do not achieve stabilization with these medications. Tablet injectable opioid agonist therapy (TiOAT) is an initiative being piloted in British Columbia to provide witnessed access to a safer opioid supply for individuals with treatment-refractory OUD. The program offers participants a safer opioid supply through physician-prescribed pharmaceutical-grade hydromorphone tablets. TiOAT is suitable for individuals with severe OUD who are actively injecting opioids and are refractory to conventional OUD treatment. As such, a scale-up of the TiOAT program may be a feasible alternative to address persistent opioid-related deaths in North America, while minimizing potential harms associated with unwitnessed safer supply opioid prescribing (eg, diversion and overdose). Although a comprehensive evaluation of TiOAT is of critical importance (including an assessment of the program's adverse events), completion of the evaluation should not preclude scale-up of the program in the interim as a strategy to reduce opioid-related harms.

"COVID just kind of opened a can of whoop-ass": The rapid growth of safer supply prescribing during the pandemic documented through an environmental scan of addiction and harm reduction services in Canada.

OBJECTIVES: In the context of the ongoing overdose crisis, a stark increase in toxic drug deaths from the unregulated street supply accompanied the onset of the COVID-19 pandemic. Injectable opioid agonist treatment (iOAT - hydromorphone or medical-grade heroin), tablet-based iOAT (TiOAT), and safer supply prescribing are emerging interventions used to address this crisis in Canada. Given rapid clinical guidance and policy change to enable their local adoption, our objectives were to describe the state of these interventions before the pandemic, and to document and explain changes in implementation during the early pandemic response (March-May 2020). METHODS: Surveys and interviews with healthcare providers comprised this mixed methods national environmental scan of iOAT, TiOAT, and safer supply across Canada at two time points. Quantitative data were summarized using descriptive statistics; interview data were coded and analyzed thematically. RESULTS: 103 sites in 6 Canadian provinces included 19 iOAT, 3 TiOAT and 21 safer supply sites on March 1, 2020; 60 new safer supply sites by May 1 represented a 285% increase. Most common substances were opioids, available at all sites; most common settings were addiction treatment programs and primary care clinics, and onsite pharmacies models. 79% of safer supply services were unfunded. Diversity in service delivery models demonstrated broad adaptability. Qualitative data reinforced the COVID-19 pandemic as the driving force behind scale-up. DISCUSSION: Data confirmed the capacity for rapid scale-up of flexible, community-based safer supply prescribing during dual public health emergencies. Geographical, client demographic, and funding gaps highlight the need to target barriers to implementation, service delivery and sustainability.

Advancing virtual primary care for people with opioid use disorder (VPC OUD): a mixed-methods study protocol.

INTRODUCTION: The emergence of COVID-19 introduced a dual public health emergency in British Columbia, which was already in the fourth year of its opioid-related overdose crisis. The public health response to COVID-19 must explicitly consider the unique needs of, and impacts on, communities experiencing marginalisation including people with opioid use disorder (PWOUD). The broad move to virtual forms of primary care, for example, may result in changes to healthcare access, delivery of opioid agonist therapies or fluctuations in co-occurring health problems that are prevalent in this population. The goal of this mixed-methods study is to characterise changes to primary care access and patient outcomes following the rapid introduction of virtual care for PWOUD. METHODS AND ANALYSIS: We will use a fully integrated mixed-methods design comprised of three components: (a) qualitative interviews with family physicians and PWOUD to document experiences with delivering and accessing virtual visits, respectively; (b) quantitative analysis of linked, population-based administrative data to describe the uptake of virtual care, its impact on access to services and downstream outcomes for PWOUD; and (c) facilitated deliberative dialogues to co-create educational resources for family physicians, PWOUD and policymakers that promote equitable access to high-quality virtual primary care for this population. ETHICS AND DISSEMINATION: Approval for this study has been granted by Research Ethics British Columbia. We will convene PWOUD and family physicians for deliberative dialogues to co-create educational materials and policy recommendations based on our findings. We will also disseminate findings via traditional academic outputs such as conferences and peer-reviewed publications.

Service delivery models for injectable opioid agonist treatment in Canada: 2 sequential environmental scans.

BACKGROUND: Injectable opioid agonist treatment (iOAT) is an emerging evidence-based option in the continuum of care for opioid use disorder in parts of Canada. Our study objective was to identify and describe iOAT programs operating during the ongoing opioid overdose crisis. METHODS: We conducted 2 sequential environmental scans. Programs were eligible to participate if they were in operation as of Sept. 1, 2018, and Mar. 1, 2019. Information was collected over 2-3 months for each scan (September-October 2018, March-May 2019). Programs that participated in the first scan and newly established programs were invited to participate in the second scan. The scans included questions about location, service delivery model, clinical and operational characteristics, numbers and demographic characteristics of clients, and program barriers and facilitators. Descriptive analysis was performed. RESULTS: We identified 14 unique programs across the 2 scans. Eleven programs located in urban centres in British Columbia and Ontario participated in the first scan. At the time of the second scan, 2 of these programs were on hold and 2 of 3 newly established programs were in Alberta. The total capacity of all participating programs was 420 clients at most. Four service delivery models were identified; iOAT was most commonly integrated within existing health and social services. All programs offered hydromorphone, and 1 program also offered diacetylmorphine. In the first scan, 73% of clients (133/183) were male; the mean age of clients was 47 years. Limited capacity, pharmacy operations and lack of diacetylmorphine access were among the most frequently reported barriers. The most commonly reported facilitators included client-centred care, client relationships and access to other health and social support. INTERPRETATION: Evidence indicates that iOAT can be successfully implemented using diverse service delivery models. Future work should facilitate scale-up of this evidence-based treatment where gaps persist in high-risk communities.

HIV Treatment Initiation and Retention Among Individuals Initiated on Injectable Opioid Agonist Therapy for Severe Opioid Use Disorder: A Case Series.

OBJECTIVES: Injectable opioid agonist therapy (iOAT) has previously been demonstrated to be an effective treatment option for individuals with a severe opioid use disorder (OUD) who have been unsuccessful on first line therapy (eg, buprenorphine/naloxone or methadone). Many individuals with severe OUD may also have HIV infection. Despite this, no literature currently exists examining the relationship between antiretroviral therapy (ART) initiation and adherence following iOAT initiation in the outpatient setting. METHODS: Retrospective case series (n = 3) of HIV-infected individuals with a severe OUD who were refractory to oral opioid agonist treatment and were started on iOAT in a community setting in Vancouver, Canada. Outcomes of interest included: (1) iOAT induction and maintenance dosing schedules; (2) ART adherence demonstrated by change in HIV viral load. RESULTS: All 3 patients initiated and successfully reached iOAT maintenance doses with significant reduction in illicit opioid use. Stable iOAT was associated with increased ART initiation and adherence, and decreased HIV viral loads. Conversely, poor retention or discontinuation of iOAT was associated with reduced adherence to ART and in 1 patient, increased HIV viral loads. CONCLUSIONS: The individual cases presented suggest that among individuals with severe OUD and HIV infection, iOAT may improve HIV treatment uptake and retention in care.

Use of a novel prescribing approach for the treatment of opioid use disorder: Buprenorphine/naloxone micro-dosing - a case series.

INTRODUCTION AND AIMS: Buprenorphine/naloxone is an evidence-based treatment for opioid use disorder, but an identified limitation is the period of required opioid abstinence prior to induction on the medication. 'Micro-dosing', or using incrementally increasing doses of buprenorphine/naloxone over time, may be a way to overcome this challenge as it can be done in parallel with the ongoing use of other opioids (either illicit or prescribed). DESIGN AND METHODS: A retrospective case series (January to December 2018) was completed of seven participants who underwent buprenorphine/naloxone induction using micro-dosing at two outpatient addiction clinics in Vancouver, Canada. RESULTS: Seven participants completed a 7-day buprenorphine/naloxone micro-dosing protocol. Prior to and during the induction, one participant was prescribed methadone, three were prescribed slow release oral morphine and three used only illicit fentanyl. Participants were prescribed sublingual buprenorphine/naloxone: 0.5 mg once daily (day 1), 0.5 mg twice daily (BID; day 2), 1 mg BID (day 3), 2 mg BID (day 4), 3 mg BID (day 5), 4 mg BID (day 6) and 12 mg once daily (day 7). On day 7, all prescribed or illicit full opioid agonists were discontinued. Buprenorphine/naloxone was subsequently titrated to a daily dose of between 12 and 32 mg. All patients reported success with buprenorphine/naloxone induction with no precipitated withdrawal. DISCUSSION AND CONCLUSIONS: Buprenorphine/naloxone micro-dosing may offer a promising alternative approach for successful induction for individuals with opioid use disorder who desire treatment with buprenorphine/naloxone, and further research to determine effectiveness is warranted.