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Nearly two years ago, Dr. Tyndall advocated in this Commentary for prescribing of hydromorphone by physicians as a response to the presence of illicitly manufactured fentanyl in the street opioid supply. The rationale is that fentanyl is toxic and unpredictable, whereas hydromorphone is a pharmaceutical product, uncontaminated, and is available in known dosing. Nearly two years later, the opioid crisis has not abated. Between Jan 1st 2018 and March 31st 2019, 5670 Canadians died an apparent opioid-related death.(1) Fentanyl in the illicit opioid supply continues to be pervasive. The scale of grief and loss for their families and communities of individuals represented in these statistics is horrifying. In response, some physicians have started prescribing hydromorphone tablets to people using illicit fentanyl with the intent to reduce the risk of exposure to this poisonous drug supply.(2) A term to describe this practice is hydromorphone maintenance therapy (HMT). HMT is dispensed at a pharmacy at intervals of one to several days, all as take-home doses for use by the person in their home. Doses are in the ranges of 16 to 24 tablets of 8 mg hydromorphone daily. Most patients prescribed HMT will crush and inject the tablets.(3) The practice of HMT has not been peer-reviewed.
Current accessible options to treat Opioid Use Disorder for people using fentanyl are oral Opioid Agonist Treatments (OAT) with buprenorphine, methadone, or Slow Release Oral Morphine (SROM). For patients retained in these treatments, the benefits are incontrovertible. All-cause mortality is reduced, and health and social functioning are improved.(4) For people who have not succeeded in oral OAT, Supervised Injectable Opioid Agonist Treatment (SIOAT) has been proven safe and effective.(5) SIOAT is intensive in terms of resources required, since health professionals prepare and oversee all patient self-administration of injectable opioids. The injectable medications, diacetylmorphine (DAM) or hydromorphone (HM), are costly in themselves. HMT is presented as a scalable version of SIOAT which could be implemented without the investments in staffing and medication costs necessary for SIOAT.
It is beguiling for practitioners and funders to think that with HMT, they can reap all the health and social benefits of SIOAT, without excess risks, at a fraction of the cost. It is important to look at HMT through the lenses of safety, effectiveness, and risks, and potential adverse changes in the larger treatment ecosystem which, while intended to reduce risks of use of illicit fentanyl, could expose people using opioids and the public to additional risks.
Injecting crushed tablets exposes a patient to risk of infection compared to a pharmaceutical injectable preparation. It’s impossible to make injected tablets as sterile as a medication intended for injection. If pharmacists prepare an injectable medication, the practice must be compliant with NAPRA standards.(6)
Take-home opioid maintenance programs expose patients to excess risks compared to OAT with buprenorphine or methadone. In an epidemiological study from France by Bertin et al, compared to standard treatments, the group accessing take-home morphine had higher overall mortality, more overdoses, and more infections.(7) Overdoses are not limited to just the person receiving the prescription. A study from the US showed that opioid overdoses were almost three times higher in family members of people prescribed opioids for home use compared to families where opioids were not prescribed.(8)
Hydromorphone tablets are very appealing to people using opioids. It’s not easy for some people to let go of the feelings and rituals of injection opioid use to go to an oral-only treatment. Defining features of Opioid Use Disorder are an overwhelming craving/ desire to use the substance which can eclipse other functional goals, loss of control over the use of opioids, and use despite harmful consequences (some related to criminalization and stigma, but many directly related to the opioid and injection use itself).(9) People may choose to turn away from a proven safe treatment with oral medication, for an unproven and riskier option. There are already signs of this happening in the communities where safer supply prescribing is practiced.(10) There can be real barriers to making traditional oral treatment like methadone work for patients: these should be addressed before prescribing HMT.
Prescriber competencies are important. The National Clinical Guideline on injectable opioid agonist treatment for opioid use disorder recommends(11) that prescribers of SIOAT be well-versed in, and be providing oral OAT, including methadone. SIOAT is positioned as part of a treatment continuum which includes oral options, from more to less intensive. 20-30% of people on SIOAT choose to de-escalate their treatment to oral-only options in the first year. Few, if any, of the practitioners currently offering HMT prescribe methadone, and HMT is positioned as separate from the treatment system. This has the effect of ghettoizing patients and limiting options for them. Patients engaged in HMT face unnecessary barriers if they are ready to try methadone again when it means they have to go to a different doctor and location to do so.
We must not be naïve about the harms to the community from diverted hydromorphone tablets. There is a presumption inherent in HMT that prescription hydromorphone tablets will completely displace illicit fentanyl use. An alternative possibility is that patients prescribed HM can sell tablets to buy fentanyl. This would have the effect of increasing the overall opioid burden in the community and increase the availability of hydromorphone for new initiates to opioid use, a replication of the conditions which created the opioid crisis in the first place. The National Clinical Guideline on SIOAT does not endorse any take-home doses of hydromorphone. With HMT positioned as a separate entity from the treatment continuum, there is no incentive for patients to de-escalate their treatment, especially when a supply of HM tablets can be used to generate income. For HMT patients who decide to use their supply this way, there is no simple way to monitor this, and no exit strategy. The issue of diversion of HM tablets also confounds the benefits seen in current programs with provision of a basic income. Medications diverted from a prescription are rarely given away for free. For a true comparator, patients in HMT programs should be compared with groups using drugs who have been provided a guaranteed basic income.
Proponents of HMT use the language of Trauma and Violence-Informed Care and patient engagement, with the message that People Who Use Drugs (PWUD) have expertise to bring to the way they wish to receive care. It is fundamental that patients have a voice in their own care. The NAOMI trial(5) and existing SIOAT programs consulted extensively with PWUD on design and implementation. However, if we frame patient preference as the only criterion for medical suitability of a treatment, it means that raising safety concerns can be construed as an attack on PWUD. The implication from HMT prescribers is that as physicians, we should use our power and privilege to provide an alternative to the toxic drug supply, and not to do so is to participate in opioid-related deaths and the oppression of PWUD. As physicians, we must bring science to bear and be very mindful of unintended consequences of the prescribing choices we make, especially in the case of opioids, a lesson we have learned at great cost.
HMT in the model as currently practised is a direct challenge to the fundamental principles of addiction medicine where structure is applied to mitigate risks and harms of prescribing opioids to patients who use them in risky ways.
The emergence of HMT is a result of the dismal failure of our federal and provincial governments to enact rational drug policy and fund an adequate response to the opioid crisis. Now MDs are faced with the impossible task of drug policy reform through prescribing.
The most medically rational response of physicians faced with the epidemic of opioid related deaths is to work to lower barriers to proven oral OAT and ensure these treatments are effortless to access. Oral OAT should be available in every Supervised Consumption Site for anyone who wants a dose. SIOAT should also be provided under supervision at drug consumption sites as an alternative to toxic fentanyl, so people have a choice to use a safer drug if they wish. This would require leadership from provincial and federal governments to expand access to Supervised Consumption Sites and fund access to treatments there, meeting people who use drugs where they’re at. Physicians and other health professionals can take steps in this direction even now.
If we are to add HMT as another tool in the OAT toolbox, it must be done in consideration of the larger context of the broad treatment landscape and of individual and public safety. Part of the privilege and power of the physician role is founded in our dedication to evidence. In our treatment decisions, we must limit harms and advocate for lowering systemic barriers to the safest treatments for the people who need them the most.
References
1. National report: apparent opioid-related deaths (September 2019). Ottawa: Government of Canada; 2019. Available: https://health-infobase.canada.ca/datalab/national-surveillance-opioid-m..., (accessed 2019 Oct 30)
2. Safe supply: The debate around prescribing opioids to people who use drugs. Healthy Debate, Aug 15 2019, Izenberg, D, Marwaha, S. Available: https://healthydebate.ca/2019/08/topic/safe-supply (accessed 2019 Oct 30)
3. Emergency Safer Supply Programs Guiding Document. Hales, J, Kolla G, Man T, O’Reilly E, Rai N, Sereda A; available: https://docs.google.com/document/d/1hXRmNaOTB60wbmNqhBi5P_xxktEZnXFDWKMk... (accessed 2019 Oct 30)
4. CRISM National Guideline for the Clinical Management of Opioid Use Disorder, found at https://crism.ca/wp-content/uploads/2018/03/CRISM_NationalGuideline_OUD-..., accessed Nov 9 2019. Cited: Bruneau J, Ahamad K, Goyer ME, Poulin G, Selby P, Fischer B, Cameron Wild T and Wood E, Management opioid use disorder: a national clinical practice guideline; CMAJ March 05, 2018 190 (9) E247-E257; DOI: https://doi.org/10.1503/cmaj.170958
5. Oviedo-Joekes E, Brissette S, Marsh DC, Lauzon P, Guh D, Anis A, Schechter MT Ph.D. Diacetylmorphine versus Methadone for the Treatment of Opioid Addiction. N Engl J Med 2009; 361:777-786 DOI: 10.1056/NEJMoa0810635
6. Supervised Injectable Opioid Agonist Treatment Guidance Committee. Guidance for injectable opioid agonist treatment for opioid use disorder. Vancouver: Ministry of Health, British Columbia, and British Columbia Centre on Substance Use; 2017. Available: www.bccsu.ca/wp-content/uploads/2017/10/BC-iOAT-Guidelines-10.2017.pdf (accessed 2019 Oct 30)
7. Bertin C, Delorme J, Riquelme M, Peyrière H, Brousse G, Eschalier A, Ardid D, Chenaf C, Authier N, Risk assessment of using off-label morphine sulfate in a population-based retrospective cohort of opioid-dependent patients. Br J Clin Pharmacol. 2019 Aug 6. doi: 10.1111/bcp.14082.
8. Khan, NF, Bateman, BT, Landon, JE, et al, Association of Opioid Overdose With Opioid Prescriptions to Family Members, JAMA Intern Med. 2019;179(9):1186-1192. doi:10.1001/jamainternmed.2019.1064
9. DSM V criteria for Substance Use Disorder; ASAM Definition of addiction, available: https://www.asam.org/resources/definition-of-addiction
10. Personal communication from Dr. Sharon Koivu at London Health Sciences Centre.
11. Fairbairn N, Ross J, Trew K, Meador K, Turnbull J, MacDonald S, Oviedo-Joakes E, LeFoll B, Goyer ME, Perreault M, Sutherland C, Injectable opioid agonist treatment for opioid use disorder: a national clinical guideline, CMAJ September 23, 2019 191 (38) E1049-E1056; DOI: https://doi.org/10.1503/cmaj.190344