Contents
2. What models of safer supply currently exist (in Canada)?
3. What are the goals of safer supply programs?
4. Why are people calling for safer supply?
4.2 Because traditional therapies do not work for everyone
4.3 Because deprescribing of opioids has caused unintended harms
4.4 Because many health care providers treat PWUD poorly in existing systems
4.5 Because people are saying it is what they need
5. What are the benefits of safer supply?
5.1 Safer supply contributes to improved health
5.2 Safer supply reduces inequities
5.3 Safer supply reduces overdose deaths
5.4 Safer supply contributes to social benefits and stability
5.4.1 Data from heroin-assisted therapy
6. What harms might arise from safer supply?
6.1 Infections from injecting tablets
7. What are the challenges with current safer supply programs and models?
7.1 Current program models are time-consuming for participants
7.2 Current program models require extensive staffing
7.3 Missed doses are handled inconsistently
7.4 Current safer supply medications are not strong enough
7.5 Stimulants are not often included in current safer supply programs
7.6 Smokable opioids are often not included in current safer supply programs
7.7.1 Drug regulations and policies
8. What are the impacts of diversion of safer supply medications?
8.2 Social and structural contexts and motivators of diversion
8.3 Punitive approaches to diversion are counterproductive
8.4 Barriers to medicalized safer supply programs necessitate diversion practices
9. What are the next steps for safer supply?
Executive summary
Safer supply involves the provision of a regulated pharmaceutical drug of known quantity, potency, and quality. It is an emerging intervention that expands the options on the continuum of care for people who use drugs and who are at very high risk of overdose and other harms related to using drugs from the highly unpredictable contaminated drug supply. There is a growing body of evidence about this practice. However, "even though more research could help identify and develop strategies to address barriers to safe supply across a range of settings, we do not need any more evidence to know that illicit toxic drugs from unknown sources are unsafe relative to a regulated drug supply" (Bonn, Wildeman, and Herder, 2020).
Just as people take drugs for a variety of reasons, safer supply exists for a variety of reasons:
- Because people are dying from the toxic unregulated drug supply
- Because traditional therapies do not work for everyone
- Because the deprescribing of opioids that occurred in recent years has caused unintended harms
- Because many health care providers in existing systems treat people who use drugs poorly
- Because people are saying it is what they need.
Unlike traditional therapies, the goals of safer supply vary according to perspective and may or may not be abstinence-oriented. Different people have different goals. For some that simply means reducing their reliance on the toxic illegal drug supply and gaining some stability in their drug use, for others that means gradually reducing their drug use, and for some that means working towards sobriety.
Safer supply contributes to improved health, helps reduce inequities, reduces overdose risk and overdose deaths, and contributes to social benefits and stability for its recipients. The risk of infection from injecting tablets (safer supply often provides tablets not designed for injection) can be mitigated with harm reduction measures; safer supply does not appear to be driving recent increases in infection rates.
Safer supply programs and models do have challenges. Current models are time-consuming for participants, require extensive staffing, and cannot provide safer supply medications of the kind (e.g. smokable formulations or stimulants) and strength that people prefer or require. Current regulations and policies are limiting and conventional addiction medicine has not generally been supportive.
Diversion (the sharing, exchanging, and selling of prescribed safer supply drugs) is a harm reduction practice rooted in mutual aid that saves lives and improves quality of life. It has social and structural contexts and motivators: barriers to medicalized safer supply programs often necessitate diversion practices. Punitive approaches to handling diversion are counterproductive.
Next steps for safer supply include developing and exploring other models, including compassion clubs and supports for individual prescribers, and moving towards decriminalization and regulation.
1. What is safer supply?
People take drugs for a variety of reasons. Drugs can offer an experience of euphoria, relief, and comfort. Opioids, for example, can be "a refuge from physical and psychological trauma, concentrated disadvantage, isolation, and hopelessness" (Dasgupta, Beletsky & Ciccarone, 2018).
According to the Canadian Association of People who Use Drugs, a defining characteristic of safer supply medications are that they have “mind/body altering properties that traditionally have been accessible only through the illicit drug market” (CAPUD 2019).
"In the Safer Opioid Supply (SOS) program, clients are provided with a prescription for pharmaceutical opioids to replace street-acquired substances from the unregulated drug market. SOS medications are generally provided as a daily-dispensed prescription for take-home dosing by clients. In addition to the provision of pharmaceutical medications, all SOS program clients are also offered comprehensive health and social services by an interdisciplinary team consisting of primary care physicians, nurse practitioners, nurses, systems navigators, outreach workers, and care facilitators" (Kolla et al., 2021).
"Safer Opiod Supply is a low-barrier model intended to reach people who are alienated from other models of health care delivery as a result of structural barriers that prevent those impacted by homelessness, poverty, mental health issues, racism and stigma from accessing needed care. It is administered by a network of primary care clinicians and delivered out of Community Health Centres and primary care clinics" (Hales et al., 2020).
In recent years, some opioid agonist therapy (OAT) programs have expanded to include slow-release morphine and fentanyl patches (Government of British Columbia, 2021). In addition to methadone, these medications are often a component of safer supply. Stimulants and other regulated pharmaceuticals could also be included (Health Canada, 2019).
2. What models of safer supply currently exist (in Canada)?
Health Canada outlines a continuum of safer supply models: one end anchored in a traditional model for people with substance use disorder who are seeking treatment, and the other end in a non-medicalized model such as buyers clubs. In between, enhanced and flexible medical models offer options for people for whom traditional models have not been effective and/or whose needs are not met by such highly structured models (Health Canada, 2019).
- Traditional models serve people with substance use disorder (SUD) who are seeking treatment. These are medicalized opioid agonist therapy (OAT) programs embedded in addiction treatment and primary care systems . These models are well-established and use long-acting medications that are considered to be the gold standard for treatment of opioid use disorder (i.e.,. buprenorphine/naloxone and methadone). The categorization of OAT as safer supply is contested.
- Injectable opioid agonist therapy (iOAT) programs offer short acting injectable medications that are alternatives to substances from the illegal supply, yet provided within a structured medical program. Enhanced models adapt iOAT and tablet iOAT programs to have lower barriers to entry. They serve people with SUD for whom traditional treatment has been unsuccessful.
- Flexible models serve people who use illegal substances and whose needs are not met by more highly structured models. They include take home tablet models that are rooted in a harm reduction approach and often located within community health settings. The goal of these programs is to reduce illegal drug use and related risks.
3. What are the goals of safer supply programs?
Key design and implementation features for safer supply programs include a strong focus on the client’s needs and the extensive involvement of people with living and lived experience in program design and implementation. “This [input from people with lived experience] has ensured that our engagement with participants has been respectful, accessible, relevant, flexible and as responsive to their needs as possible” (McMurchy & Palmer, 2022, p. 36).
"...it's not about getting off drugs, that's not the end goal." (Participant in Waterloo Region Crime Prevention Council focus groups) (Waterloo Region Crime Prevention Council, 2019a)
The goal of safer supply is to reduce the harms related to the highly contaminated and unpredictable illegal drug supply and provide an entry point to care for those who may want it by developing a community-based, harm reduction focused safer supply program (Hales et al., 2020). Safer supply is an intervention, but it is up to the safer supply participant to decide if it is "treatment" or not. The goal must be set by each individual, whether it is stabilization, reducing drug use, or just avoiding the poisonous unregulated drug supply.
The goals of safer supply vary according to perspective and may or may not be abstinence-oriented. Different people have different goals, and not everyone on safer supply wishes to stop their drug use. People’s interpretations of success can be much broader, including improvements in physical and/or psychological well-being, relationships, role functioning, and decreased stigma and shame (Hooker et al., 2022).
"PWUD [people who use drugs] generally preferred aligning design elements with the goal of harm reduction for clients while other stakeholders valued treatment as a goal." (Kryszajtys et al., 2021)
At the London InterCommunity Health Centre, "the main objective of the Safer Opioid Supply program is to use a harm reduction approach to reduce some of the health risks associated with substance use, particularly overdose deaths related to fentanyl contamination within the unregulated opioid supply." (Kolla et al., 2022)
4. Why are people calling for safer supply?
4.1 Because people are dying
"Change the system completely, it's not working. It's obvious, you're wasting your time while people die!" (Christmas, 2021)
The number of people dying from toxic drug poisoning has increased dramatically since the year 2000, especially as fentanyl was becoming more common in the drug supply: "From 2000 to 2017, the adjusted opioid mortality rate in Canada (outside Quebec) increased significantly by 592.9% (from 20.0 opioid deaths per million in 2000 to 118.3 in 2017). The highest year-to-year increases were from 2015 to 2016 (31.8%) and from 2016 to 2017 (52.2%),” as fentanyl entered the market (Alsabbagh et al., 2021). "The increasing toxicity of substances on the illegal market is likely driving the recent rise in deaths in many Canadian jurisdictions" (Belzak & Halverson, 2018).
Public Health Infobase data agrees that the toxicity of the drug supply continues to be a major driver of the overdose crisis. In 2021, to the end of September, 82% of accidental apparent opioid toxicity deaths involved a non-pharmaceutical opioid and 86% of accidental apparent opioid toxicity deaths involved fentanyl. The BC Coroners Service reports very similar numbers.
It is not just the strength or adulteration of the unregulated drug supply that is an issue – “The opioid crisis was found to be more attributable to the constant risk of variability within drugs than to the occasional bad batch” (Larnder et al., 2022).
At London InterCommunity Health Centre, one of the prime motivations for wanting to be on safer supply was to reduce the risk of overdose. “I’m afraid that if I don’t get some help soon, I’m going to have to go to that fentanyl, and I don’t want to because too many people die, and I don’t really want to die yet” (Kolla et al., 2021). Indeed, Nielsen et al. (2022), looking at autopsies in Denmark, found that PWUD who were not in treatment died younger than people who were in treatment.
The need for safer supply is clear: "even though more research could help identify and develop strategies to address barriers to safe supply across a range of settings, we do not need any more evidence to know that illicit toxic drugs from unknown sources are unsafe relative to a regulated drug supply" (Bonn, Wildeman, and Herder, 2020).
4.2 Because traditional therapies do not work for everyone
Traditional opioid agonist therapy (OAT) works for the people for whom it works, but for many people it doesn't work – the highly-structured nature of OAT programs is hard to fit into people's lives (especially if they are experiencing homelessness or are street-involved), or the treatment itself doesn't alleviate cravings or withdrawal symptoms, or it just doesn't meet people's needs:
- “I’m on methadone and I’ve been put up to 100 ml of meth, and it’s not helping anything." (Kolla et al., 2021)
- "Methadone, people only use it as a safety net. Less than 10 percent of people use it as designed." (Waterloo Region Crime Prevention Council, 2019a)
- "I know a few people on methadone. It doesn't scratch the itch. … it's not what I actually want to be using." (Waterloo Region Crime Prevention Council, 2019a)
- "I'm on methadone, we still use drugs a lot. The methadone isn't working for me. I don't get high, all the methadone does is gets [sic] me from not getting sick." (Waterloo Region Crime Prevention Council, 2019a)
"We found low rates of completing OAT induction and, for those who did complete it, low rates of reaching the minimum effective dose" (Kurz et al., 2021). In Waterloo Region Crime Prevention Council’s survey of PWUD, they found 77% of respondents had tried methadone and/or buprenorphine treatment, yet 77% still use fentanyl regularly. Bailey et al., 2021 found that only about half (53%) of patients in the study stayed on buprenorphine for 6 months.
Disappointment is another reason some people discontinue first-line treatments. Halvorsen Brenna et al. (2021) found that people discontinue treatment with extended-release naltrexone injections often because of unfulfilled expectations that it would lead to a better quality of life, "including unexpected physical, emotional, or mental reactions as well as a lack of expected effects.…. A few participants ended treatment because they had reached their treatment goal, but … Most participants decided to leave treatment because they did not believe that XR-NTX had promoted their ultimate goal of recovery, or that life had been improved in any meaningful way."
OAT does lead to fewer expected overdose deaths, at least in one prospective study in Norway (Rogeberg, Bergsvik & Clausen, 2021): "At scale, the program reduced annual overdose mortality by 27% in 2016 (95% CI: 10% to 41%) relative to a no-OAT counterfactual, corresponding to 99 fewer expected fatal overdoses (95% CI: 28-180) in 2016. Analyzing fatal opioid-related and other drug overdoses separately found similar numbers for avoided opioid-related fatalities (921, with 95% CI: 373-1526) and no treatment effects on non-opioid related fatalities (-38, with 95% CI -193 to 154)."
Many of those attempting to access the Safer Opioid Supply program (as well as those on the SOS program) at the London InterCommunity Health Centre had current or previous experience with opioid agonist therapies (OAT) such as methadone or buprenorphine, and it had not been effective for them (Kolla et al., 2021).
Safer supply adds another option for people. Nordt et al. (2018) looked at methadone and buprenorphine but also at heroin-assisted therapy and SROM, noting "…the specific patient characteristics associated with each medication underline the need for diversified treatment options for opioid dependence." Strang, Groshkova & Metrebian (2012) found that for opioid users for whom first-line treatments such as methadone and buprenorphine did not succeed, “the supervised use of medicinal heroin can be an effective second-line treatment”.
“Many clients have stabilized on the safer supply program. This includes many of those for whom methadone or buprenorphine/naloxone did not work in the past and those who are still using some – but a reduced amount of – fentanyl. Many have stabilized with the addition of a backbone” (McMurchy & Palmer, 2022). As well, safer supply programs lose comparatively few clients to follow-up: “The safer supply programs reported a range from “very few” to about 10% of clients who started safer supply prescriptions but have not returned. Some have been lost to follow-up; others have moved away or been incarcerated. As well, a few programs reported a handful of clients transitioning to other addiction treatment or harm reduction programs” (McMurchy & Palmer, 2022).
4.3 Because deprescribing of opioids has caused unintended harms
In Canada, rapid deprescribing and tapering of opioid prescriptions happened after sudden policy changes in 2016 and 2017 (Martins et al., 2022), just as fentanyl was saturating the unregulated drug supply. Tapering can cause pain, distress, activity interference, and withdrawal symptoms for people who use opioids (McNeilage et al., 2022). Many people whose opioid prescriptions were tapered or stopped thus needed to switch to the unregulated drug market just as it was becoming more dangerous and unpredictable: "With the disappearance of a reliable supply of heroin and major cutbacks in opioid prescriptions, many thousands of Canadians have been put in a position where they must choose between purchasing potent and unpredictable street drugs or abstinence. For many people, abstinence is not an option" (Tyndall, 2020). In Vancouver, following the delisting of OxyContin in 2012, heroin use and non-prescribed prescription opioid use increased (Karamouzian et al., 2022). In one case, a man with PTSD and chronic pain resorted to making tea out of poppy seed pods after his doctors at the time deprescribed opioids for his pain (Hagan et al., 2021).
"Encouraging physicians to reduce their opioid prescriptions in an environment where the illegal alternatives are lethal is harmful. Abruptly cutting people off their prescription will likely lead to withdrawal. A reduction in the overall number of prescriptions creates a shrinking supply of diverted drugs, the unintended consequence of which may be to push people, many of whom were not even known to be chronic opioid users, into much more unstable and dangerous drug markets. People who once had consistent access to either prescribed or diverted pharmaceutical opioids are suddenly in grave danger of being poisoned by a single lethal purchase" (Tyndall, 2018). The lethality of the illegal market has skyrocketed as fentanyl has become prevalent (Alsabbagh et al., 2021)
4.4 Because many health care providers treat PWUD poorly in existing systems
Alberta Health Services, for example, has a substance use policy that focuses on harm reduction and says "Abstinence or a reduction in substance use is not required to receive equitable and compassionate health care services." In St. John, New Brunswick, the tertiary-care hospital’s infectious disease physicians include addiction medicine in their practices (Brothers et al., 2022). Yet people who use drugs are often treated poorly across Canada in health care settings and pharmacies. This poor treatment is believed to reflect views of people with SUD as morally culpable, intimidating, untrustworthy, and less valuable than other patients (Garpenhag & Dahlman, 2021). Negative perceptions about substance use in the health care system and during hospitalization has tangible effects: people who use drugs can receive sub-optimal pain control and withdrawal management, and for those on safer supply programs, it can influence continuity of care during hospitalization: “I had major surgery, and they didn’t agree with the [safer supply] program, so I went through withdrawals right after major surgery" (Kolla et al., 2021). In another study, participants “indicated that healthcare providers’ use of a constructed difficult patient identity shaped their experiences while admitted as hospital in-patients” (O’Leary et al., 2022).
Stigma in healthcare settings affects health care seeking behaviors, and could result in patients concealing their treatment status, preferences, or substance use history (Garpenhag & Dahlman, 2021; Austin et al., 2021). For many people who use drugs, the burden of healthcare-related stigma outweighs benefits of care (Austin et al., 2021). Moallef et al. (2022) found that 23% of their study participants (all people who use drugs) reported avoiding care due to past mistreatment in the health care system, reporting sub-optimal care particularly in the domains of prompt attention, communication, respect for dignity and autonomy. Poor quality communication and treatment is associated with treatment discontinuation as well as with SUD treatment outcomes, including drug use and risk factors for drug use (Liebmann et al., 2022).
On the other hand, safer supply programs intentionally take a supportive, non-judgemental approach. In the safer supply pilot program evaluation, McMurchy & Palmer (2022) notes that safer supply programs listen to clients, shifting the typical approach to health care: “an important aspect of the safer supply service has been the ability to successfully engage and retain clients. Critical to retention is finding the appropriate approach, especially for those who have failed or been shut out of other programs and services. Prescribers work with clients towards achieving the right dosage and combination [of drugs]. Staff identified the need to recognize the extent of client need and to be willing and able to prescribe what is being asked for/needed. … Almost all clients are extremely complimentary of the safer supply staff. They were said to be “amazing,” “open,” “knowledgeable,” “informative,” “very kind,” “attentive,” “respectful,” “sensitive” and “cool.” They make the clients feel “comfortable” and “at ease,” while working to gain their trust. Clients appreciate that staff try to be available when needed and take the time required to discuss their concerns without their fearing stigma or judgement. … we are rebuilding trust with the people who did not trust the health care system.’”
Supportive, non-judgemental pharmacists are also an important factor in safer supply client retention (McMurchy & Palmer, 2022, p. 35). Boone et al., 2021 notes "In caring for all clients, and in particular those who continue to experience systemic oppression, pharmacists must aim to provide clients with a non-judgmental, compassionate, respectful and safe environment that is free of stigma. It is highly recommended that all pharmacists undertake training in opioid use disorder to ensure an understanding of the nature of addiction and to reflect on their own biases and stigmatizing behaviours. ... Ultimately, clients should guide their goals of care and pharmacists should provide a supportive, inclusive environment."
4.5 Because people are saying it is what they need
People are asking for a consistent, accessible, regulated drug supply. Drug user groups like the Vancouver Area Network of Drug Users and the Canadian Association of People Who Use Drugs have been organizing in their communities and across the country for decades for decriminalization and a regulated drug supply (CAPUD, 2019; VANDU, 2022).
Research demonstrates that people use diverted prescription opioids largely because they have "insufficient access to certain prescription medications and treatment" for harm reduction & therapeutic purposes (May et al., 2020). Participants in the NAOMI heroin maintenance trial hoped that their experiences “will guide future research studies and the setting up of permanent heroin maintenance programs in Canada and elsewhere" (Boyd & NAOMI Patients Association, 2013). Expanded access to diacetylmorphine and other high-dose opioid formulations (including injectable hydromorphone, diacetylmorphine and prescription fentanyl formulations) is urgently needed (Kolla et al., 2021).
5. What are the benefits of safer supply?
Evidence for the benefits of safer supply draws on evidence supporting iOAT and unsupervised OAT. Evidence for iOAT is considerable. Evidence for ‘flexible models,’ including unsupervised and tablet-based programs, remains scarce because these are new approaches. Research is currently underway which will evaluate various safer supply models.
Preliminary findings show that safer supply does help people reduce their reliance on the toxic street drug supply: “Many clients have stopped using illegal drugs; others are still using them, although at a progressively decreasing rate. As this is early in the program, one would anticipate that this downward trend would continue if prescriptions can be adjusted to match clients’ needs” (McMurchy & Palmer, 2022, p. 10).
Other benefits are much broader in scope. In a preliminary report, safer supply clients name increased access to health care and social services, better relationships with health care and social services, better quality of life, improved overall health, improved relationships, reduced injection use, improved sleep, improved relationships with family and friends, more free time, increased housing stability, reduced engagement in criminalized activities such as sex work and petty theft, reduced involvement with police and the criminal justice system, fewer overdoses, and increased uptake of harm reduction practices and equipment (Kolla et al., 2021).
Overall, “having access to a safer supply of drugs has had tremendous immeasurable (and measurable) positive impacts on many clients’ lives. Many are more positive and happier, and have better health outcomes, greater stability and improving relationships with family and friends. Some have secured housing and/or employment. They are highly appreciative of having these services available to them” (McMurchy & Palmer, 2022).
5.1 Safer supply contributes to improved health
A 2-year study in Spain showed that patients who received heroin-assisted therapy had better health outcomes than those not on HAT, showing that HAT can improve and stabilize the health of long-term heroin users with severe comorbidities and high mortality (Oviedo-Joekes et al., 2010).
People who receive a safer supply are more likely to engage in treatment, creating more opportunities to reduce harm and to improve their quality of life (Ivsins et al., 2021). Most safer supply participants reported that their overall health had improved. Staff agreed, reporting that they were now able to provide care to clients whose other acute and chronic health issues previously went unmet (McMurchy & Palmer, 2022). An analysis of 82 safer supply clients (Gomes et al., 2022b) suggests that the safer supply program led to important declines in emergency department visits, inpatient hospital admissions, admissions for incident infections, and health care costs not related to primary care or outpatient medications in the year after program initiation, with no corresponding change observed in a matched group of individuals who did not access the program.
In initial assessments (a program evaluation is in progress), Klaire et al. (2022) suggested that "participants note benefits from having new options when conventional forms of treatment and harm reduction have not been efficacious, and program clinicians describe improved chronic disease management and increased medication adherence.”
5.2 Safer supply reduces inequities
People experiencing social inequality and oppression are disproportionately and inequitably at risk of toxic drug poisoning and overdose death. "Individuals with low education and receipt of social welfare had higher risks of incident opioid overdose and individuals with criminal conviction were identified as a risk group for both incident and fatal opioid overdose" (Dahlman et al., 2021). Safer supply takes a harm reduction approach, with underlying values of harm reduction including social justice, equity, caring, inclusion, respect, and human rights. The priority is to meet all clients where they are (McMurchy & Palmer, 2022).
A Vancouver study found that a safer supply program improved not only people’s health and wellbeing (including pain management), but also involved economic improvements. Overall, “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” (Ivsins et al., 2021).
5.3 Safer supply reduces overdose deaths
Prescribed safer supply does not contribute to a significant number of overdoses. Fatal overdoses in BC from 2015-2017 (before and during the deprescribing of opioids) had a low prevalence of prescribed opioids, suggesting that "strategies to address the current overdose crisis in Canada must do much more than target deprescribing of opioids" (Crabtree et al., 2020). Pharmaceutical fentanyl was involved in a very small percentage of overdose deaths, compared to illicitly manufactured fentanyl -- "Among deaths with fentanyl detected, 89.3% were defined as probable or suspected illicitly manufactured fentanyl and 1.0% as probable pharmaceutical fentanyl" (O'Donnell et al., 2021). In 2021, the BC Coroners Service concluded "There is no indication that prescribed safe supply is contributing to illicit drug deaths" (BC Coroners Service, 2022).
Looking at safer supply directly, one paper that looked at nearly 3,000 participants beginning a safer supply program involving injectable hydromorphone or diacetylmorphine found that there were only 5 adverse events requiring naloxone, all of which were treated onsite. There were no deaths or lasting harms from those events (Oviedo-Jokes et al., 2019). More broadly, “reliable access to prescription alternatives addressed overdose vulnerability by reducing engagement with the illicit drug market while allowing greater agency over drug use” (McNeil et al., 2022).
In short: "Nothing about this program is going to kill me today" (Waterloo Region Crime Prevention Council, 2019a).
5.4 Safer supply contributes to social benefits and stability
“I was on safe supply in BC and it was life-changing.” (Christmas, 2021)
Image: McMurchy & Palmer, 2022
5.4.1 Data from heroin-assisted therapy
Current safer supply initiatives build on an extensive foundation of data that indicates that heroin-assisted therapy (HAT) contributes to social benefits and stability (as does methadone treatment) (Smart & Reuter, 2021), providing options for people when methadone and other traditional treatments do not meet their needs.
In the Netherlands, studies concluded that “supervised co-prescription of heroin is feasible, more effective, and probably as safe as methadone alone in reducing the many physical, mental, and social problems of treatment resistant heroin addicts” (Van den Brink et al., 2003) and “long-term HAT is an effective treatment for chronic heroin addicts who have failed to benefit from methadone maintenance treatment. Four years of HAT is associated with stable physical, mental and social health and with absence of illicit heroin use and substantial reductions in cocaine use. HAT should be continued as long as there is no compelling reason to stop treatment” (Blanken et al., 2010).
In Germany, Verthein et al (2008) found that 2 years of HAT was associated with improvements in health and social stabilization, as well as reduced illegal drug use. Similarly, a study in the UK of both injectable methadone and heroin noted people experienced personal and social benefits including reduction or cessation of illegal drug use, health gains, a more ‘normal’ lifestyle, and reduced criminal activity, and they valued the stability this option had brought to their lives (Orgel et al., 2009). HAT led to less use of street heroin than did methadone (Strang et al., 2010, Demaret et al., 2015) and better improvements in physical and mental health (Demaret et al., 2015).
In Canada, the NAOMI trial compared heroin-assisted treatment (HAT) with methadone and found that, as well as HAT participants reducing their use of illegal drugs more significantly than those receiving methadone, there were other health and social benefits (Health Canada, 2019, p. 12):
- The HAT group showed significantly greater improvements in their medical and psychiatric status, economic status, employment situation, and family and social relations compared to the group receiving methadone;
- The HAT group experienced reduced mortality, reductions in needle sharing, increased treatment retention, reduced risk of acquiring HIV, hepatitis B and C, improved housing and employment stability, and dramatic reductions in criminal activity.
5.4.2 Prospective data
Several projects have examined the benefits people expect they would incur with access to safer supply. Interviewing potential participants, Christmas (2021) reports:
- “It would change things dramatically, I wouldn’t have to do crime to support the habit, I would be able to get a job.”
- “It would make life way better, fear would be gone completely, and the game of ‘chase’ would be over.”
The Waterloo Region Crime Prevention Council (2019a), also interviewing PWUD, found that safer supply programs were thought to "have very positive impacts on both individual and community health, safety, and well-being. By stabilizing and decriminalizing the withdrawal-acquisition-purchase-use-withdrawal cycle, participants suggested other opportunities would become possible. Key to 'settling the noise and chaos' was obtaining the optimal dose and formulation, and ensuring people who use unregulated drugs are involved in program design and delivery to avoid initiation and perpetuation of structural barriers".
Staff in safer supply programs agree: “Staff … are now the first first-responders in the drug poisoning crisis. If we had access to a safe supply program, we could reduce significant suffering to the people we serve and the staff that serve them by dramatically reducing the number of overdoses, preventing fatalities, and offering a substitution therapy that would provide people the opportunity to rebuild meaningful lives. This would also decrease incidents of acquired brain injuries, decrease vicarious trauma, decrease costs on 'the system,' and ultimately acknowledge what the research already shows - people are going to use [drugs] because they are in pain. Until we can truly provide people an opportunity to ease their emotional and spiritual pain, we need to stop blaming people for easing it themselves, in possibly the only way they know how. Offering safe supply is not enabling anyone. Rather, we are currently withholding a life-saving alternative” (Christmas, 2021).
5.4.3 Evaluation data
Evaluation data is now available from some safer supply projects and is generally positive. Looking at existing evidence, (Banerjee & Wright, 2020) found studies that demonstrated:
- When compared to patients treated with other treatments (i.e., methadone, or any other treatment program), those treated with injectable diacetylmorphine (DAM) (with or without the addition of methadone) had statistically significantly greater retention in treatment, reduction in illegal drug use, reduction in criminal activities, and fewer convictions and imprisonments, but no statistically significant difference in mortality and greater occurrence of adverse events.
- There was statistically significant improvement after injectable DAM treatment compared to before treatment with respect to anxiety, anger, emotional excitement and well-being, and statistically significantly less heroin craving with injectable DAM compared to injectable placebo.
Safer supply is not necessarily more expensive than traditional methadone treatment. Bansback et al. (2018) found that both diacetylmorphine and hydromorphone provide more benefits than methadone at lower cost, with drug costs being offset by costs saved from reduced involvement in criminal activity.
A Vancouver-based program evaluation of a hydromorphone tablet program (Ivsins et al., 2021) identified that participants had reduced street drug use and overdose risk, improvements to health and well-being, improvements in co-management of pain, and economic improvements.
In Ottawa, participants showed high retention in care and substantive improvements in patient-centered health and social well-being outcomes (Harris et al., 2021).
Most recently, the London InterCommunity Health Centre (Kolla et al., 2021) released its Safer Opioid Supply program evaluation. Echoing the Ivsins et al. (2021) results above, LIHC reported numerous health and social benefits, including reductions in overdose risk and improvements in health and social wellbeing:
- 59.6% of SOS clients stated their physical health improved since starting safer supply: "If it wasn’t for this program, I really don’t think I’d be here right now... and feeling as healthy as I do."
- Increased access to health and social services, including primary care, counselling, and housing support: “I got my Hep C taken care of...now I can walk with my head held high.”
- Reduction in criminal activities: 47.4% of SOS clients reported decreased involvement in criminal activities as a means to obtain substances since starting safer supply: “We don’t have to go to the streets anymore to make our habit, to make money to pay for our pills. Since I’ve been on it [the SOS program], I haven’t gone to jail in three and a half years. So, that’s a good thing. I’m pretty much not working [in sex work] at all anymore, so. It saved my life."
- The improved stability provided by safer supply led to improved relationships with family members and friends: "For myself, it’s helped my relationship with my family now. I can go take my daughter’s kids out, which she wouldn’t let me before. I’ve been on the program – almost 4 years, 3 and a half years. For me, it’s the relationships I’ve gotten with people that I haven’t had before."
6. What harms might arise from safer supply?
An international study concluded that supervised injectable heroin may be less safe than methadone and, therefore, requires more clinical attention, and notes that heroin-assisted treatment is for clients “previously considered unresponsive to treatment” (Strang et al., 2015).
Safer supply’s lower threshold approach has not increased drug-related harms. “…We demonstrated that it is feasible to provide iOAT outside the community clinic with no apparent negative consequences. Improving upon and making permanent these recently introduced risk mitigating guidance during COVID-19, have the potential not just to protect during the pandemic, but also to address long-overdue barriers to access evidence-based care in addiction treatment” (Oviedo-Joekes et al., 2021). However, many of the potential harms of safer supply are caused by larger systemic issues including medicalized models and the criminalization of drugs. Some of these potential harms include:
- The requirement for daily pick-ups and daily appointments constrains people’s time.
- Safer supply clients need to stay close to their clinic and/or pharmacy. Vacations and moves to other areas, particularly rural or remote regions, are difficult.
- People may experience pressure from others to share or sell their safer supply pharmaceuticals (McMurchy & Palmer, 2022). This is particularly a problem for women in coercive relationships.
- For some safer supply clients, low program capacity leads to tension with others because friends/family are still on waiting lists or are not able to access safer supply programs. “It is impossible for me to sit there and have my husband do a drug that I want.” (McMurchy & Palmer, 2022)
- There is a risk of theft or attack, particularly for women and/or when carrying take-home prescriptions away from the pharmacy.
6.1 Infections from injecting tablets
There are concerns that people crushing and injecting tablets – which are not designed for injection – leads to elevated infection rates and other physical damage. Reasonably effective filters have been developed as well as other harm reduction resources and guidelines to help clinicians better provide care to clients who may inject tablets (Alhusein et al., 2016; BCCSU, 2020).
Infections among people who use opioids are indeed increasing very significantly, especially since 2016. However, infections among people with a recent history of controlled-release hydromorphone have not increased (Gomes et al., 2021). There was a small (but statistically significant) rise in infections in people with recent history of immediate-release hydromorphone, but they make up only a small percentage of people hospitalized for infections. (A majority of people with infections had a recent history of standard OAT.)
On the other hand, a study of safer supply clients specifically (Gomes et al., 2022b) found that hospital admissions for infections dropped significantly in the year after safer supply cohort entry.
These data do not support the assertion that safer supply hydromorphone is driving the increase in infection rates. The rise in infections does correlate with the advent of fentanyl in the unregulated drug supply, although given that the 2021 study used administrative data it was not designed to determine which drug had been injected.
Injecting tablets does not seem to raise the odds of acquiring Hepatitis B or C (Werb et al., 2022). In fact, “one study found that participants who reported exclusively injecting prescription opioids were significantly less likely to be HCV-seropositive compared to other participants that injected other substances (Patra et al., 2009).
7. What are the challenges with current safer supply programs and models?
7.1 Current program models are time-consuming for participants
Needing to go to a clinic or pharmacy daily (or several times a day) is unwieldy, although some clients appreciate the routine (McMurchy & Palmer, 2022). During the pandemic, more flexible models emerged, generally allowing more take-home doses. Overdoses did not increase (Gomes et al., 2022a) and this added flexibility seems to have encouraged some people to pursue treatment (Meyer et al., 2022).
7.2 Current program models require extensive staffing
Programs do not have sufficient funds to staff programs to a comfortable and (from a work-life balance and staff-stress point of view) sustainable level, or to open for a useful number of hours, especially when providing a range of much-needed wrap-around services as part of the model. Recruiting and hiring can be a significant challenge. Given these capacity constraints, eligibility criteria are designed to give clients at the highest risk access to safer supply, but that means that many others are left out who would also benefit. Community demand for safer supply services is high: “one program estimated 6,000 people in their region would benefit from these services; they are only serving 300” (McMurchy & Palmer, 2022, p. 49).
7.3 Missed doses are handled inconsistently
Programs handle missed safer supply doses in a wide variety of ways, some of which are interpreted by participants as more punitive than protective (McMurchy & Palmer, 2022). Guidelines balancing safety (as people’s opioid tolerance can decrease rapidly) with client needs, and clear communication materials explaining the guidelines, are needed.
7.4 Current safer supply medications are not strong enough
In regions where fentanyl is prevalent in the unregulated drug supply, many safer supply participants have tolerances that are not met by currently available safer supply medications – primarily hydromorphone. "Some participants discussed not liking their prescription medications and felt they do not adequately manage withdrawal …. a high tolerance level coupled with an inadequate prescription of an extended release formulation that is not providing the desired effect led this participant to seek fentanyl" (Bardwell et al., 2021a). In an interview with TalkingDrugs on the results of the June 2021 study, Bardwell says “It’s either [that] people are not getting enough, or people are not getting the right drugs,” likely as a result of prescribers’ austerity mindset. “It’s not just that they’re prescribed opioids and buying others; it's that they want other ones” (Kuwabara Blanchard, 2021).
The evaluation of Canada’s safer supply pilot projects (McMurchy & Palmer, 2022) agrees.
- “It was reported that client needs are evolving and increasingly unsupported by recommended approaches in the existing prescribing guidance and the medications that are currently available. Safer supply programs are finding it difficult to manage client tolerance levels as a result of their fentanyl use.”
- “Access to the desired medications has been hindered by the regulatory environment, lack of coverage by provincial formularies, and supply interruptions (with generics proving to be less effective).”
Offering higher doses (Selfridge et al., 2022) and fentanyl patches as safer supply can help solve this problem, although most programs only prescribe them for people with chronic pain (McMurchy & Palmer, 2022). British Columbia included fentanyl patches in their expanded policy in July 2021.
Safer supply doses provide withdrawal management, but not the euphoric effect many clients are seeking. “Participants were very clear that not feeling the effect of the hydromorphone, and not having access to hydromorphone earlier in the day, shaped their continued use of street-purchased illicit drugs” (Ivsins et al., 2020).
The London InterCommunity Health Centre’s evaluation report recommends expanding coverage for high-dose injectable opioid formulations and expanding access to diacetylmorphine (which holds potential as a safer supply option for people who smoke fentanyl) (Kolla et al., 2021).
7.5 Stimulants are not often included in current safer supply programs
Safer supply programs need access to stimulants for clients with polysubstance needs. Substitution therapy is a promising avenue for treating cocaine dependence (Mariani & Levin, 2012). Additional pharmaceuticals needed include amphetamine (Ritalin, Adderall), methamphetamine (Desoxyn), and cocaine (McMurchy & Palmer, 2022).
As many existing treatments are mostly abstinence-based, safer stimulant supply programs would be an "appealing alternative to many of the existing treatment options for stimulant use". (Health Canada, 2019)
7.6 Smokable opioids are often not included in current safer supply programs
In British Columbia, many people who die of overdoses consumed drugs by smoking them. However, “more services were reported to be available for those who injected methamphetamine or opioids, leaving those who used via other routes (i.e. smoking) underserviced” (Corser et al., 2022). Safer supply programs need to include smokable options, as people who prefer to smoke their opioids are very vulnerable to overdose (Bardwell, 2022).
7.7 System-level challenges
7.7.1 Drug regulations and policies
The evaluation of safer supply pilot projects (McMurchy & Palmer, 2022) identified a number of policy-related barriers at federal, provincial, and territorial levels. Some pharmaceuticals are not available in Canada, aren’t approved for OUD (so must be prescribed off-label), and/or aren’t covered by provincial/territorial formularies:
- For example, injectable hydromorphone is federally approved for OUD, but hydromorphone tablets are not approved for that purpose and no company has asked for that approval.
- Injectable diacetylmorphine is on the List of Drugs for an Urgent Public Health Need so it could be imported by provinces/territories.
As provinces/territories are mostly responsible for health services, approaches to safer supply and pharmaceutical coverage varies widely across Canada. Provincial regulatory colleges have not issued much official safer supply guidance or clear protocols, which has led safer supply providers and pharmacists to worry about liability on several fronts. Requiring prescribers to monitor for diversion (typically using urine drug screens) leads to distrust and possibly disengagement.
7.7.2 Conventional addiction medicine is often unwelcoming to safer supply participants and providers
“Much of addictions medicine language does not fit with the safer supply approach” (McMurchy & Palmer, 2022)
Conventional addiction treatment offers many barriers to safer supply participants who have stabilized and who wish to pursue it. Often, abstinence is required at recovery centres, so any use of safer supply medications is not accepted. Additionally, couples are generally not seen together (McMurchy & Palmer, 2022).
Some providers of conventional addiction medicine express negative opinions about safer supply to clients, telling them that safer supply “is not appropriate,” “would not benefit me” and “you will come back with your tail between your legs.” (McMurchy & Palmer, 2022)
It has been suggested that because conventional addiction medicine providers are remunerated well for providing OAT services, they may have an incentive to deter clients from alternative safer supply services – but as they could include safer supply in their own practice if they chose to do so, in the absence of evidence on this issue, it is reasonable to assume philosophical differences are likely a larger issue than remuneration.
8. What are the impacts of diversion of safer supply medications?
At this point, the majority of relevant research has been conducted with participants of OATs, such as prescribed methadone and buprenorphine. Research from OAT programs and emerging research from safer supply programs are demonstrating that:
- We have an obligation to evaluate internal and external sources of evidence and information, to determine whether we have accurate information about options and their effects in the short and long term, and to act on the best information available.
- The diversion of prescribed OAT and safer supply medications is a harm reduction practice rooted in mutual aid.
- Diversion of prescribed OAT and safer supply medications saves lives and improves quality of life for both the person for whom safer supply is prescribed and for those who use diverted medications.
- Many social and structural contexts motivate diversion practices among people who use drugs.
- Punitive approaches to diversion are counterproductive, restrictive, and stigmatizing. These approaches create barriers to safer supply program access and put people who use drugs at greater risk of drug poisoning from the toxic illegal supply.
- Barriers to medicalized safer supply programs necessitate diversion practices among people who use drugs.
Evidence-based research on the successes and challenges of safer supply programs is now underway. Emerging research on the diversion of prescribed medications has highlighted key insights.
8.1 Diversion is a harm reduction practice rooted in mutual aid that saves lives and improves quality of life
The benefits of providing pharmaceutical alternatives that may be diverted far outweigh the risks and harms associated with diversion and accessing toxic and volatile illegal drug supplies (Bardwell et al., 2021a; Bardwell et al., 2021b; Kolla & Strike, 2020; Socias et al., 2021, Sud et al., 2021). Both the provision and purchase of diverted prescribed medications support user-defined risk reduction strategies to avoid withdrawal, reduce heroin use, and satiate opioid cravings in periods of lowered tolerance. (Kavanaugh & McLean, 2020)
The diversion, sharing, exchanging, and selling of prescribed drugs must be reframed as protective practices of caring and mutual aid in communities of people who use(d) drugs (Bardwell et al., 2021a; Kolla & Strike, 2020):
- Higher frequency of diverted buprenorphine use is associated with lower risk of drug overdose. (Carlson et al., 2020)
- Giving one’s prescription opioids to an individual in withdrawal was indeed seen as an act of helping, something that takes on particular significance for couples in which only one partner is included in Opioid Maintenance Treatment and the other is using illegal heroin. (Havnes et al., 2013)
- Diverted buprenorphine serves a variety of functions for people who do not have access to prescribed buprenorphine: “To get high, manage withdrawal sickness, as a substitute for more preferred drugs, to treat pain, manage psychiatric issues and as a self-directed effort to wean themselves off opioids.” (Cicero et al., 2014)
- Diverted and prescribed safer supply medications may both serve as a means of overdose prophylaxis during the COVID-19 pandemic, allowing people to self-isolate and use drugs alone without resorting to the illegal drug supply. (del Pozo & Rich, 2020)
8.2 Social and structural contexts and motivators of diversion
- Diversion is not a homogenous practice and occurs for a variety of complex and valid reasons. Social and structural contexts frame diversion practices. People who use(d) drugs have divergent perspectives on diversion practices. (Bardwell et al., 2021a; Bardwell et al., 2021b; Kolla & Strike, 2020; Harris & Rhodes, 2013; Havnes et al., 2013; Sud et al., 2021)
- Diversion may indicate that the medications being prescribed are not the adequate medications or doses for the participant. For some, the safer supply medications that are currently permitted do not adequately or appropriately address the expressed needs of people who use drugs. In their current forms, safer supply programs are not adequate replacements for legal and regulated drug supplies. (Bardwell et al., 2021a; Bardwell et al., 2021b; LeBlanc et al., 2021)
- Participants of a research study on the use of diverted buprenorphine noted four main motivators for their diversion practices: perceived demands of formal treatment, the desire to utilize non-prescribed buprenorphine in combination with a geographic relocation, to self-initiate treatment while preparing for formal services, and to bolster a sense of self-determination and agency in their recovery trajectory. (Silverstein et al., 2020)
8.3 Punitive approaches to diversion are counterproductive
- Punitive measures used against safer supply participants suspected of diversion are contraindicated and can increase risks of overdosing and other drug use-related harms (McLean & Kavanaugh, 2022; Ranger et al., 2021; Victoria SAFER Initiative, 2022)
- Market demand in the form of unmet needs for buprenorphine was the major driver of diversion, suggesting that ‘supply-side interventions’ intended to again limit access to buprenorphine may be counterproductive. (McLean & Kavanaugh, 2022)
- Restrictive prescribing practices may increase harms and risks to people who use drugs who are incarcerated as they attempt to self-medicate with other potentially harmful illegal substances or diverted medications in the prison drugs market. (Duke & Trebilcock, 2022)
- Less restrictive prescribing practices for buprenorphine-naloxone have not been a major driver of diversion practices for non-prescribed use among cohorts of people who use drugs. (Bach et al., 2022)
8.4 Barriers to medicalized safer supply programs necessitate diversion practices
Barriers related to availability, accessibility, and acceptability may explain low rates of prescribed buprenorphine use among certain groups of people who use drugs. Even as most participants expressed an interest in the utilization of buprenorphine to stop heroin and/or prescription opioid misuse, geographic, temporal, financial, and institutional barriers deterred formal entry into or retention in buprenorphine treatment. (McLean & Kavanaugh, 2019)
Barriers and lack of access to healthcare providers who are able and willing to prescribe buprenorphine increases the likelihood of diversion practices among people who use drugs. (Cicero et al., 2018)
9. What are the next steps for safer supply?
9.1 Decriminalization
"[C]onversations about safe supply must expand to take more seriously the prospect of regulating and enabling safe access to all drugs used recreationally" (Bonn, Wildeman, and Herder, 2020).
Groups and coalitions across Canada have been advocating for decriminalization and a safer supply of regulated drugs for many years. Civil society platforms like Decriminalization Done Right: A Rights-Based Path for Drug Policy campaigns for the decriminalization of drugs, regulated safer supplies of drugs, and the reallocation of resources in communities.
No-one is suggesting a complete lack of control – that would perpetuate the same problems we are currently seeing with the quality and consistency of the drug supply, for one thing. Regulation and quality control is clearly necessary, as with alcohol, tobacco, cannabis, and other substances. Our regulatory system is not perfectly balanced to minimize harms and maximize benefits, but criminalization of drugs has proven untenable and we cannot let the perfect be the enemy of the good in our policies. Safer supply is another step on the continuum, as is the decriminalization of drugs and the people who use, share, and sell them.
Laws criminalizing drugs and drug users have not worked. Arrests for drug-related offences have not decreased over time (except for cannabis, post-legalization) (Statistics Canada, 2021, looking at 1986 to 2020). Furthermore, courts in several countries have found that drug laws violate human rights (Bonn & Chu, 2021).
After Portugal decriminalized personal possession of all drugs in 2001, drug-related deaths remained below the EU average, the proportion of prisoners sentenced for drugs has fallen from 40% to 15%, and rates of drug use have remained consistently below the EU average. (Transform Drug Policy Foundation, 2021)
Criminalization itself causes many unnecessary harms: in Canada, some 17% of violent crimes and 25% of nonviolent crimes with Federal sentences occurred because people didn't have an accessible, safe, affordable, legal drug supply (Young et al., 2021). "Many of the harms of illicit drug use are in fact related to the prohibition of these substances and our societal response to their use." (Ryan, Sereda & Fairbairn, 2020)
Decriminalization would save people from having to engage in petty crimes to support their addictions, being further traumatized in jail, and it would de-stigmatize substance use (Ryan, Sereda & Fairbairn, 2020):
- “Yes!... it’s like a promise saying: ‘You will live, you will not go to jail, you are okay, there is nothing wrong with you’.” (Ryan, Sereda & Fairbairn, 2020)
- “It’s not complicated – everyone would be better off.” (Ryan, Sereda & Fairbairn, 2020)
- “I would not have to be out stealing shit in the middle of the night.” (Ryan, Sereda & Fairbairn, 2020)
- “There would be less worry, less criminal charges, but you would still have to be careful having drugs in a house with kids." “ (Christmas, 2021)
- "The NAOMI Patients Association (NPA) members advocate for the end of drug prohibition so that other people will not be subject to the social and legal discrimination that they face daily. Nor will people feel compelled to participate in research projects in order to have essential goods, drugs, services, and supports provided to them." (Boyd & NAOMI Patients Association, 2013)
9.2 Other models
"Given strong consensus among experts that safe supply is among the most promising measures to curb the drug poisoning crisis, it is critical to remove barriers to access, expand coverage, conduct rigorous evaluation and refine delivery approaches to maximize potential impacts" (Klaire et al., 2022).
Current models of safer supply are not the only possible models. Non-medicalized buyer’s clubs or compassion clubs, targeting people who use opioids and/or stimulants, would provide a non-medicalized, public health approach to provide a safer supply of regulated drugs (Health Canada, 2019).
The Drug User Liberation Front (DULF) and the Vancouver Area Network of People Who Use Drugs (VANDU) are one example of an episodic compassion club located in the Downtown Eastside of Vancouver. Currently, they are working towards providing a community-based, peer-led, non-medical safer supply that can be accessed daily by club members. Compassion clubs prefer to purchase pharmaceutical-grade drugs from a properly licensed and regulated producer (BCCSU, 2019), but this is not possible under Canada’s current regulatory framework. In the absence of legal ways to obtain substances, groups like DULF and VANDU search for and obtain substances in the illegal market through community connections and darknet markets, sourcing from vendors in Canada.
Models that would expand and support safer supply practice within primary care are also possible. One example (for buprenorphine, not safer supply, but the principle is transferable) is The Puget Sound SUpporting Primary care Providers in Opioid Risk reduction and Treatment (SUPPORT) team, which helps primary care providers in the US to manage prescribing within a primary care model, not as a separate addiction treatment program (Hagan et al., 2021).
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About this document
This evidence brief was developed by the National Safer Supply Community of Practice (NSS-CoP). Please visit https://www.nss-aps.ca/ to learn more.
Contributors: Robyn Kalda (lead writer), Alexandra Holtom (editing), Rebecca Penn (concept, editing), the NSS-CoP Reframing Diversion Working Group (diversion section research and writing)
Suggested Citation: National Safer Supply Community of Practice. (2022). Safer Supply: What Does the Evidence Say? Canada. https://www.nss-aps.ca/lit-review
Version: 27 September 2022
Translation: Traductions Rhizome
Production of this document has been made possible through a financial contribution from Health Canada. The views expressed herein do not necessarily represent the views of Health Canada.
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