It was out of fear for their lives that Nanky Rai decided, about eight months ago, to start prescribing hydromorphone tablets to a handful of her patients. They were patients who were using the ever-more potent drugs available on the street, drugs which are considered responsible for the overdose deaths of 11,500 Canadians between 2016 and 2018 and for halting the country’s life expectancy for the first time in 40 years. “At one point, it started to feel really unethical of me to watch people die,” says Rai, a primary care doctor at Parkdale-Queen West Community Health Centre in downtown Toronto. “As a prescriber, I had access to tools, and I needed to use whatever was available to me to respond.”
What’s available right now are the tablets, albeit on an “off-label” basis. Officially, they are indicated for people with severe pain; unofficially, they are swallowed or crushed and injected by people who are dependent on opioids. By prescribing the tablets—which are covered by Ontario’s drug benefits plan and thus affordable for people on social assistance—Rai is trying to offer an alternative to the illicitly manufactured opioids which contain unknown amounts of fentanyl and, increasingly, carfentanil, that have overtaken the street market. She and co-authors recently urged other prescribers to do the same. “We cannot wait,” they wrote. “Communities need us to act courageously now.”
But there are many questions about this practice. There is no published data directly supporting its safety or benefits or cost-effectiveness. There is little indication as to whether the provincial medical and nursing colleges will support it, and some prescribers fear being disciplined if they adopt it, especially given the fact that professional guideline panels have been encouraging less use of opioids and the tapering of high-dose opioid prescribing. When asked whether the College of Physicians and Surgeons of Ontario has a position on safe supply, its chief medical adviser, Sheila Laredo, provided a statement explaining that the CPSO is aware of the practice and is generally supportive of harm reduction strategies while at the same time expecting physicians who prescribe narcotics to be conscious of their own clinical limitations, prescribe based on evidence-based research or consensus protocols, and document their actions carefully. With specific reference to safe supply, the CPSO notes that physicians should “review any previous interventions the patient has undergone and explore the development of a comprehensive treatment plan that can effectively help the patient while minimizing risks and unintended consequences.”
There are also some concerns that consuming the pills by crushing and injecting them contributes to serious health complications including endocarditis, an infection of the heart valve which is already common among injection drug-users.
The question of carries
Andrea Sereda, a family physician in London, Ont., started prescribing hydromorphone tablets to a handful of her patients three years ago. The patients were women who had been living on the street and using street drugs, and they had all been recently hospitalized for endocarditis. While in hospital, they were given injectable hydromorphone (a different formulation of the drug) to stave off withdrawal, and when they were discharged, they were given prescriptions for hydromorphone tablets to help them wean off the injectable. For the two or three months that they were taking the tablets, the patients showed marked improvements in their health and well-being: They did not contract infections; they remained out of hospital; and they were able to sustain their housing. But when their prescriptions ran out, things went downhill. One woman lost her housing. One woman returned to being heavily involved in sex work. One woman resumed a pattern of being admitted two or three times a month with infection.
Gradually, Sereda offered the tablets to more and more patients. Today, Sereda oversees a program at the London InterCommunity Health Centre that offers tablets to about 100 people, the majority of whom are or have been homeless. They all have what Sereda describes as severe opioid use disorder, and they have all previously been in opioid agonist therapy (OAT) programs, which offer substitute opioids such as methadone and buprenorphine in an effort to wean people off higher-dose, faster-acting opioids.
The tablets program is currently being evaluated, so Sereda cannot release specific numbers, but she reports that they have seen “profound gains in health and social markers,” including a significant uptake in HIV-positive patients taking treatment; reductions in hospital visits and admissions; and reductions in incarceration. “And increased engagement with primary care,” says Sereda. “This can include lots of health treatments, things like Pap smears, hepatitis C, and mammograms.” No one has died of an overdose.
Sereda’s patients, like Rai’s, receive prescriptions for take-home doses, or “carries,” meaning supervision of consumption is not required, and patients can take the tablets where and when they choose (though prescribers often encourage patients to take their pills at a supervised consumption site). Typically, they get a day’s worth of tablets at a time which they pick up from a pharmacy; a few of Sereda’s patients have week-long carries.
This is one aspect of safe supply that makes it very different from OAT programs, in which patients’ consumption is carefully tracked. Methadone maintenance programs, for example, require patients to take their daily doses under supervision for the first several months and to routinely provide urine samples. Many patients receive their prescriptions at high-volume clinics and have very little face-time with prescribers.
A more recently developed opioid agonist therapy is injectable hydromorphone, which was the subject of the 2016 SALOME randomized control trial. SALOME compared injectable hydromorphone with prescription heroin in people who had opioid addictions and had previously stopped taking other treatments, such as methadone. An earlier study, the NAOMI trial, had found heroin to be more effective than methadone at helping people with opioid addictions who had not responded to other treatments; SALOME showed injectable hydromorphone to have similar outcomes to heroin when used as an injectable opioid agonist therapy, or iOAT. This past May, on the strength of this evidence and in light of the worsening opioid crisis, Health Canada approved the use of injectable hydromorphone as an iOAT, becoming the first country in the world to add this indication for the drug.
Safe supply proponents point to the NAOMI and SALOME trials, which showed that participants in those programs reduced their use of street drugs, as the evidence base from which they “push for an emergent response to the crisis by prescribing hydromorphone.” It is important to note that these were trials that used injectable hydromorphone or heroin as part of treatment programs with the ultimate goal of participants reducing their use of opioids (participants were observed taking the drugs), whereas providers of safe supply are using the drug primarily for harm reduction and the stabilization of problematic drug use, with the goal of decreasing the risk that participants will take contaminated street drugs. IOAT programs—which Crosstown Clinic in Vancouver, where both trials were held, continues to run, with 116 participants taking prescription heroin and 17 taking injectable hydromorphone—require supervised consumption; there are no carries. (Ontario does not have iOAT programs currently; heroin is virtually inaccessible here, and injectable hydromorphone is not covered by the provincial drug formulary and is prohibitively expensive for most patients.)
One Ontario physician with a history of prescribing OATs worries that the ease of access to safe supply—including the fact that it offers carries from the outset—could dissuade people from trying OATs such as methadone and buprenorphine, and deprive them of a chance at becoming less dependent on opioids. “If there are more barriers to treatment than there are to safe supply, you’re going to prejudice against treatment and you’re actually going to make people not as good as they can be,” says the physician.
The physician also wonders whether the positive outcomes seen in safe supply programs may, in part, be due to the fact that patients are making money from diversion, or selling the tablets on the street. “If you give people a basic income, they’re going to get better,” says the doctor. “You can’t separate out the fact that take-home doses of the hydromorphone tablets gives them a basic income.”
But Jessica Hales, a nurse practitioner who works with people living on the street in Toronto and who advocates for safe supply, thinks safe supply reduces the risk of diversion. “People are desperate for an option other than street drugs,” she says. “They are very worried about overdose and are tired of using from an unpredictable street supply which also carries risks of many adverse effects and frequently leaves them in withdrawal. I think the population being prescribed to is interested in using hydromorphone over street drugs and is less likely to divert the medication.”
Hales also thinks that some opioid users may have a tolerance that is too high to be met with a tablet program. “For these people, injectable hydromorphone is a needed option,” she says.
The issue of the street supply’s potency and of users’ tolerance to it is another concern for the Ontario physician. “Do we know if giving hydromorphone tablets to people who are acclimatized to fentanyl is going to help them? That’s an assumption that a lot of people are making, but hasn’t been proven.”
The urgency of finding solutions
Evidence may be coming. Parkdale-Queen West CHC will shortly launch a more formal safe supply program—in which two colleagues will join Nanky Rai in prescribing hydromorphone tablets—and it, together with Sereda’s program in London, are the subject of a forthcoming study to be led by Carol Strike at the Dalla Lana School of Public Health at the University of Toronto, which is expected to begin in 2020. Rai is also part of a working group of Toronto-area health care providers that is drafting a set of protocols for prescribing take-home tablets in primary care, addressing questions of criteria and titration. Their intention is to form a community of practice through which prescribers can consult with and support each other.
Even the Ontario physician quoted in this story who has concerns about safe supply is leaning toward prescribing it. “It’s the right thing to do,” says this doctor.
But the doctor is still struggling with the carries. While comfortable with safe supply being consumed under the supervision of a health professional, this doctor thinks that carries change everything about the current opioids landscape—how they are prescribed, the illicit street supply, where people get opioids and what they do to get them, what the expectations of treatment are.
Still, with the street supply becoming more and more deadly, the physician thinks that prescribers might need to come to terms with the end of “contingency prescribing” in OAT treatment, such as rules-heavy programs like methadone management. Though contingency management was meant to help address loss of control, which is often seen as a defining feature of addiction, says the physician, “perhaps some of the boundaries are part of the problem.”
But this doctor has another concern, which is that when clinicians (both physicians and nurse practitioners can prescribe) write scripts that serve as an alternative to illicit drugs, they are effectively decriminalizing opioids. And while decriminalization may be what needs to happen, says the physician, it shouldn’t happen by way of doctors’ prescriptions. “I don’t think that is a good way to implement drug policy reform,” the doctor says.
Rai thinks decriminalization is important and that it needs to be talked about at the policy level, as well as broadly across society. “We can’t prescribe our way out of this crisis,” she says. “Physicians play such a small part.” She also argues that decriminalization would not address the problem of the toxic drug supply on the street. “We really need to talk about policy-level efforts to establish a regulated drug supply, with known quantity and quality, that’s available for people who use drugs, and in a setting that respects their dignity,” she says.