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2003 15090 TAYLOR ANTHONY MAXEY ET AL
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COURT FILE NUMBER 2003 15090
COURT COURT OF QUEEN’S BENCH OF ALBERTA
JUDICIAL CENTRE EDMONTON
PLAINTIFFS TAYLOR ANTHONY MAXEY, AMANDA FRANCES MARIE ERVIN, BYRON BIRD, CAITLYNN WESTGARD, DUSTIN WESLEY ANDERSON, FABIAN POLE, GARY WAYNE FIDDLER, GREGORY LORNE CREOR, KEIGAN TIERNEY, MICHAEL SHANE CARSON, and SHANE PAUL MONETTE
DEFENDANT HER MAJESTY THE QUEEN IN RIGHT OF ALBERTA
DOCUMENT AFFIDAVIT OF ELAINE HYSHKA
ADDRESS FOR SERVICE NANDA & COMPANY AND CONTACT 3400 Manulife Place INFORMATION OF PARTY Edmonton, AB, T5J 4K1 FILING THIS DOCUMENT Tel.: (780) 801-5324 Fax: (587) 318-1391 Email: [email protected] File: 289.00001
AFFIDAVIT OF ELAINE HYSHKA
Sworn on January 22, 2021
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I, Elaine Hyshka, of the City of Edmonton, in the Province of Alberta, MAKE OATH AND SAY THAT: 1. This is a supplemental affidavit to the affidavits I swore on October 1, 2020 (“Initial Affidavit”) and November 22, 2020 (“Second Affidavit”).
2. I am an Assistant Professor in the University of Alberta’s School of Public Health, with expertise in improving health systems’ responses to substance use. Between May 31 2017 and November 30 2019, I was appointed by the provincial Minister of Health as Co-Chair of the Minister’s Opioid Emergency Response Commission (“MOERC”) alongside Alberta’s Chief Medical Officer of Health.
3. As discussed in my Initial Affidavit, MOERC’s mandate was to make recommendations to the Minister of Health on how to reduce opioid-related morbidity and mortality in Alberta. During our tenure, MOERC made 32 recommendations for urgent action, including the recommendation to provide funding to Alberta Health Services (“AHS”) for a phased implementation of a supervised injectable opioid agonist treatment (“iOAT”) program. This recommendation was designed to address a significant gap in care for patients with severe, refractory opioid use disorder who have not adequately benefited from oral opioid agonist medications.
4. Counsel for the Plaintiffs has provided me with affidavits of Dr. Charl Els (sworn on January 8 2021), Mr. John Cabral (sworn on January 8 2021), Mr. Mark Snaterse (sworn on January 8 2021), and Dr. Kathryn Todd (sworn on January 8, 2020), which I have reviewed. I am writing this supplemental affidavit to address claims about iOAT and Alberta’s iOAT program that appear in these affidavits, and provide my expert opinion on the potential risks associated with transitioning iOAT patients to a new and untested model of care.
Injectable opioid agonist treatment is an established treatment for severe, refractory opioid use disorder in Canada
5. The affidavits of Dr. Els and Mr. Cabral assert that iOAT is an emerging, rather than established, treatment in Canada. This is incorrect for several reasons, outlined below.
6. iOAT has been the subject of two high-quality, Canadian randomized clinical trials. The North American Opiate Medication Initiative (“NAOMI”), first introduced iOAT to Canada in 2005.1 This phase III randomized clinical trial enrolled a total of 226 participants
1 A copy of “Oviedo-Joekes, E., Brissette, S., Marsh, D. C., Lauzon, P., Guh, D., Anis, A., & Schechter, M. T. (2009). Diacetylmorphine versus methadone for the treatment of opioid addiction. New England Journal of
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in Vancouver and Montreal to compare the effectiveness of iOAT using diacetylmorphine with an optimized oral methadone program. A subgroup of patients (n = 25) in the iOAT arm were given injectable hydromorphone instead of diacetylmorphine (i.e. pharmaceutical-grade heroin) on a double-blind basis to facilitate validation of self- reported illegal heroin use via urine testing. In addition to medication, participants in the trial received on-site access to a comprehensive range of psychosocial and primary care services, that included a personal psychosocial support worker. The time-limited nature of the treatment was disclosed to participants, and all provided informed consent acknowledging this fact, prior to being enrolled.
7. NAOMI measured two main treatment outcomes: 1) reductions in illegal drug use or other illegal activities, and 2) retention in treatment. The study found that patients assigned to receive iOAT with diacetylmorphine were more likely to stay in treatment and reduce their use of illegal drugs and other illegal activity as compared to patients receiving oral methadone. The researchers also found that patients in the iOAT arm of the trial could not tell whether they were receiving diacetylmorphine or hydromorphone, and that the later appeared to be as effective as the former for achieving positive outcomes. However, the study was not sufficiently powered to formally test this hypothesis.2
8. The Study to Assess Longer-term Opioid Medication Effectiveness (“SALOME”) was conducted as a follow-up to NAOMI, and investigated whether injectable hydromorphone was non-inferior to diacetylmorphine.3 This randomized clinical trial launched in Vancouver in 2011, and enrolled 202 patients. SALOME participants were prescribed either injectable hydromorphone or diacetylmorphine and were provided with on-site access to registered nurses, addiction counselors, social workers, physicians, and allied health professionals. Again, the potentially time-limited nature of the iOAT treatment, including the possibility of being switched to oral opioid agonist treatment after six months (as a study condition), was disclosed to participants and all provided informed consent acknowledging this fact, prior to being enrolled.
Medicine, 361(8), 777–786. https://doi.org/10.1056/NEJMoa0810635” is found in my October 1, 2020 affidavit at Exhibit 54. 2 A copy of “Oviedo-Joekes, E., Brissette, S., Marsh, D. C., Lauzon, P., Guh, D., Anis, A., & Schechter, M. T. (2009). Diacetylmorphine versus methadone for the treatment of opioid addiction. New England Journal of Medicine, 361(8), 777–786. https://doi.org/10.1056/NEJMoa0810635” is found in my October 1, 2020 affidavit at Exhibit 54. 3 A copy of “Oviedo-Joekes, E., Guh, D., Brissette, S., Marchand, K., MacDonald, S., Lock, K., Harrison, S., Janmohamed, A., Anis, A. H., Krausz, M., Marsh, D. C., & Schechter, M. T. (2016). Hydromorphone Compared With Diacetylmorphine for Long-term Opioid Dependence: A Randomized Clinical Trial. JAMA Psychiatry, 73(5), 447. https://doi.org/10.1001/jamapsychiatry.2016.0109” is found in my October 1, 2020 affidavit at Exhibit 39.
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9. SALOME’s results demonstrated that where diacetylmorphine is currently unavailable or for patients for whom it is contraindicated, hydromorphone could be offered as an alternative as it was noninferior for achieving reductions in street opioid use, and was associated with fewer adverse events than diacetylmorphine.4
10. Since the completion of the NAOMI and SALOME studies, an escalating opioid overdose epidemic has prompted many jurisdictions in Canada to strengthen their continuum of care for patients with opioid use disorder. This has included removing barriers to iOAT access for the relatively small but highly vulnerable population of patients with severe, refractory opioid use disorder.
11. At the federal level, iOAT has been formally approved by Health Canada, which authorizes the sale and availability of all pharmaceutical drugs in Canada. After a rigorous review of scientific and medical evidence on iOAT, the agency formally approved injectable hydromorphone for the treatment of severe, refractory opioid use disorder in May 2019.5
12. According to the agency, “studies have shown that injectable hydromorphone and diacetylmorphine have been successful in helping stabilize and support the health of some patients with opioid use disorder, including increased retention in treatment programs. Both of these drugs are used in the treatment of substance use disorder in other countries with recognized success.”6
13. Sandoz’s hydromorphone HP 10, hydromorphone HP 20, hydromorphone HP 50, hydromorphone HP Forte are all now approved for iOAT in adult patients with severe opioid use disorder, but accompanying prescriber information notes that medication use should be monitored and “provided within a framework of medical, social, and
4 A copy of “Oviedo-Joekes, E., Guh, D., Brissette, S., Marchand, K., MacDonald, S., Lock, K., Harrison, S., Janmohamed, A., Anis, A. H., Krausz, M., Marsh, D. C., & Schechter, M. T. (2016). Hydromorphone Compared With Diacetylmorphine for Long-term Opioid Dependence: A Randomized Clinical Trial. JAMA Psychiatry, 73(5), 447. https://doi.org/10.1001/jamapsychiatry.2016.0109” is found in my October 1, 2020 affidavit at Exhibit 39. 5 Government of Canada. Government of Canada approves new treatment options for opioid use disorder and supports research, treatment and harm reduction projects in Ontario. Available from: https://www.canada.ca/en/health-canada/news/2019/05/government-of-canada-approves-new-treatment-options-for- opioid-use-disorder-and-supports-research-treatment-and-harm-reduction-projects-in-ontario.html. Attached as Exhibit “1” to this Affidavit. 6 Government of Canada. Government of Canada approves new treatment options for opioid use disorder and supports research, treatment and harm reduction projects in Ontario. Available from: https://www.canada.ca/en/health-canada/news/2019/05/government-of-canada-approves-new-treatment-options-for- opioid-use-disorder-and-supports-research-treatment-and-harm-reduction-projects-in-ontario.html. Attached as Exhibit “1” to this Affidavit.
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psychological support” as part of a comprehensive opioid use disorder treatment program.7 Prior to this approval, injectable hydromorphone had been prescribed ‘off-label’ to treat severe opioid use disorder in Canada.8
14. Health Canada has also taken action to reduce regulatory and market/supply-side barriers to injectable formulations of diacetylmorphine, by enabling provincial governments to directly import the drug for treatment of severe opioid use disorder. For decades, international drug control treaties have complicated the manufacture and sale of diacetylmorphine for medical purposes, and as a result, there are relatively few pharmaceutical companies producing it globally. To my knowledge, no pharmaceutical company has sought approval to market and sell diacetylmorphine in Canada. However, one non-profit firm (Fair Price Pharma) is currently fundraising for the capital required to manufacture diacetylmorphine domestically, in order to ensure adequate and equitable access for Canadian patients with severe, refractory opioid use disorder.9
15. In addition to regulatory support, provision of iOAT has been endorsed by the Canadian Research Initiative in Substance Misuse (“CRISM”), Canada’s national expert body on the clinical care of substance use disorders, via two published, national peer-reviewed clinical practice guidelines.
16. In 2018, CRISM published the National Guideline for the Clinical Management of Opioid Use Disorder.10 The guideline was also peer-reviewed, and published in the Canadian Medical Association Journal (‘CMAJ’), which is the leading medical and health sciences journal in Canada. This guideline focused on treatment options applicable for the majority of Canadians experiencing opioid use disorder, but excluded detailed consideration of the needs of special populations, including people with severe, refractory opioid use disorder. Despite this, the guideline acknowledged the evidence supporting iOAT, and endorsed a need for “urgent action” at multiple levels to “reduce barriers to accessing specialist-led
7 Sandoz Canada. Prescribing Information Including Patient Medication Information. Hydromorphone HP. Available from: https://pdf.hres.ca/dpd_pm/00050892.PDF. Attached as Exhibit “2” to this Affidavit. 8 Government of Canada. Government of Canada approves new treatment options for opioid use disorder and supports research, treatment and harm reduction projects in Ontario. Available from: https://www.canada.ca/en/health-canada/news/2019/05/government-of-canada-approves-new-treatment-options-for- opioid-use-disorder-and-supports-research-treatment-and-harm-reduction-projects-in-ontario.html. Attached as Exhibit “1” to this Affidavit. 9 Woo, A. The Globe and Mail - Vancouver. Prof, former public health officer launch company to produce legal heroin for treatment. Available from: https://www.theglobeandmail.com/canada/british-columbia/article-prof- former-public-health-officer-launch-company-to-produce-legal/. Attached as Exhibit “3” to this Affidavit. 10 Canadian Research Initiative in Substance Misuse. CRISM National Guideline for the Clinical Management of Opioid Use Disorder. Available from: https://crism.ca/wp- content/uploads/2018/03/CRISM_NationalGuideline_OUD-ENG.pdf. Attached as Exhibit “4” to this Affidavit.
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treatment interventions that are not reviewed here, such as [iOAT] with diacetylmorphine and hydromorphone.”11
17. The following year, CRISM released its Injectable Opioid Agonist Treatment for Opioid Use Disorder: A National Clinical Guideline, which was also peer-reviewed and published in CMAJ.12 This clinical guideline critically appraised the evidence on the potential benefits and harms of iOAT to provide “3 key recommendations focused on defining the patient population that should be considered for injectable opioid agonist treatment, and outlin[es] considerations for medication selection and length of treatment.”13
18. Dr. Els’ affidavit suggests that CRISM’s iOAT guideline is less credible because it rates the evidence supporting its three recommendations as either of moderate or low quality.14 But in the relatively understudied field of addiction medicine, low or moderate quality evidence often guides clinical practice. For example, multiple recommendations advanced in CRISM’s National Guideline on the Clinical Management of Opioid Use Disorder (which, Dr. Els acknowledges is the main national opioid use disorder guideline) are made on the basis of moderate quality evidence.15
19. Further, the evidence base supporting the use of residential treatment programs for opioid use disorder is weak compared to that supporting pharmacological treatments. No large clinical trials have compared outcomes of residential treatment relative to other established treatment options, and no rigorous studies have identified specific features of an effective residential treatment program. Unlike iOAT, no systematic reviews have been conducted on the effectiveness of residential treatment for opioid use disorder.16 However, despite the limited scientific basis for the use of psychosocial residential treatment for opioid use disorder, large investments in these programs have become a major component of Her
11 Canadian Research Initiative in Substance Misuse. CRISM National Guideline for the Clinical Management of Opioid Use Disorder. Available from: https://crism.ca/wp- content/uploads/2018/03/CRISM_NationalGuideline_OUD-ENG.pdf. Attached as Exhibit “4” to this Affidavit. 12 A copy of “Fairbairn N, Ross J, Trew M, et al. Injectable opioid agonist treatment for opioid use disorder: a national clinical guideline. CMAJ 2019 September 23; 191: E1049-56” is found in my October 1, 2020 affidavit at Exhibit 25. 13 A copy of “Fairbairn N, Ross J, Trew M, et al. Injectable opioid agonist treatment for opioid use disorder: a national clinical guideline. CMAJ 2019 September 23; 191: E1049-56” is found in my October 1, 2020 affidavit at Exhibit 25. 14 Affidavit of Charl Els – Sworn on January 8, 2021, page 7.. 15 Canadian Research Initiative in Substance Misuse. CRISM National Guideline for the Clinical Management of Opioid Use Disorder. Available from: https://crism.ca/wp- content/uploads/2018/03/CRISM_NationalGuideline_OUD-ENG.pdf. Attached as Exhibit “4” to this Affidavit. 16 Canadian Research Initiative in Substance Misuse. CRISM National Guideline for the Clinical Management of Opioid Use Disorder. Available from: https://crism.ca/wp- content/uploads/2018/03/CRISM_NationalGuideline_OUD-ENG.pdf. Attached as Exhibit “4” to this Affidavit.
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Majesty the Queen in the Right of Alberta’s (“HMQA”) provincial opioid overdose response.17
20. In addition to CRISM’s clinical guidelines, the College of Physicians and Surgeons of Alberta has recognized iOAT as an established treatment for opioid use disorder and it is included in their Safe Prescribing for Opioid Use Disorder standard of practice. As mentioned in my Second Affidavit, a companion document to this standard of practice, entitled Advice to the Profession: Safe Prescribing for Opioid Use Disorder, describes iOAT as “an integral component of the continuum of care for opioid use disorder” and urges clinicians to ensure patients have sustainable access to this treatment once initiated.18
21. The aforementioned policy developments, research evidence, and clinical guidelines on iOAT illustrate that although only a small minority of patients meet criteria for this program, it is considered an established treatment for severe, refractory opioid use disorder in Canada.
22. Prior to HMQA’s decision to cancel the phased implementation of iOAT, two clinics and one small hospital program were delivering access to this treatment in Alberta. Additionally, British Columbia has multiple iOAT clinics operating, and there are also iOAT clinics in Ontario and New Brunswick. There are many efforts under way in Canada to implement new iOAT clinics, as opioid-related morbidity and mortality worsen, and more patients seek care for severe, refractory opioid use disorder. Dr. Els notes accurately in his affidavit that the Centre for Addiction and Mental Health (‘CAMH’) in Ontario is not currently delivering iOAT. But CAMH’s gap in care should not be interpreted as a lack of support for iOAT as an established treatment for opioid use disorder. Dr. Bernard Le Foll, the medical head of CAMH’s Concurrent Outpatient Medical and Psychosocial Addiction Support Service is a co-author of the CRISM national iOAT guideline. Further, in a recent letter to Health Canada, the organization stated:
First-line treatments for opioid use disorder (buprenorphine, methadone) may not be effective for every individual, and for some with severe opioid use disorder, iOAT is an appropriate evidence-based intervention. As of 2019, there are national clinical and operational guidelines for iOAT. But serious barriers to iOAT remain. Hydromorphone and diacetylmorphine are difficult to acquire due to complex regulatory requirements as well as lack of comprehensive coverage
17 Krugel, L. Kenny announces funding for 4,000 addictions treatment spaces in Alberta. The Canadian Press - Global News. Available from: https://globalnews.ca/news/5890263/alberta-ucp-funding-addiction-treatment/. Attached as Exhibit “5” to this Affidavit. 18 A copy of “College of Physicians and Surgeons of Alberta. Safe prescribing for opioid use disorder: Advice to the Profession. Available from: http://www.cpsa.ca/wp-content/uploads/2019/03/AP_Safe-Prescribing.pdf” is found in my November 22, 2020 affidavit at Exhibit 6.
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for specific concentrations on provincial formularies. We encourage Health Canada to help make these evidence-based interventions become more accessible.19
23. In implementing iOAT in Alberta, HMQA and Alberta Health Services (“AHS”) navigated many of the challenges described by CAMH. This included working with the professional colleges to ensure clinicians adhered to best practices; negotiating with the Alberta College of Pharmacists and the College of Physicians and Surgeons of Alberta to remove the requirement for prescribers to complete triplicate prescribing forms; establishing compounding pharmacies to prepare the injectable hydromorphone syringes in compliance with the National Association of Pharmacy Regulatory Authorities’ standards; and working with Alberta Works, the federal Non-insured Health Benefits (NIHB) program for Indigenous People; and Alberta Health to identify and secure medication coverage options for iOAT patients. Their efforts have served as a model for other Canadian jurisdictions planning to implement and scale up access to iOAT.20
Alberta’s iOAT program
24. In it’s November 16, 2020 letter to the Plaintiffs, discussed in my Second Affidavit,21 HMQA states that Edmonton and Calgary’s iOAT clinics were implemented as part of a two-year, “pilot study.” The affidavits of Dr. Els, Dr. Todd, and Mr. Cabral also state that Alberta’s ($14,122,748) iOAT program was originally implemented as a “pilot study.”22 This is inaccurate for several reasons, outlined below.
25. In health services and clinical research, pilot studies are small-scale, time-limited investigations deployed “to examine the feasibility of an approach that is intended to be used in a larger scale study,” and a first step in “exploring novel interventions and novel applications of interventions--whether in a new patient population or with a novel delivery system.”23
19 CAMH. Submission to Health Canada: Consultation to inform proposed new regulations for supervised consumption sites and services. Available from: https://www.camh.ca/-/media/files/pdfs---public-policy- submissions/supervised-consumption-sites-submission-health-canada-oct2020- pdf.pdf?la=en&hash=BDFF6C6D40ADBA423005B0FB9687444D5562B66C. Attached as Exhibit “6” to this Affidavit. 20 A copy of “AHS Grant ID # 008264 Injectable Opioid Agonist Treatment: Interim Report for Alberta Health April 1, 2019 - June 30, 2019” is found in the affidavit of John Cabral - Sworn on January 8, 2021 at Exhibit H. 21 A copy of “Alberta Justice and Solicitor General to Nanda & Company, Re: Maxey et al vs Her Majesty the Queen in Right of Alberta Court of Queen’s Bench of Alberta File No. 2003 15090” is found in my November 22, 2020 affidavit at Exhibit 1. 22Affidavit of John Cabral - Sworn on January 8, 2021. 23 Leon, A. C., Davis, L. L., & Kraemer, H. C. (2011). The Role and Interpretation of Pilot Studies in Clinical Research. Journal of Psychiatric Research, 45(5), 626–629. https://doi.org/10.1016/j.jpsychires.2010.10.008. Attached as Exhibit “7” to this Affidavit.
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26. However, as outlined earlier in this affidavit, iOAT is already an established treatment for severe, refractory opioid use disorder. It is not a novel or emerging intervention. Alberta’s iOAT clinics were not implemented on a small-scale, but have operated at or close to full- capacity24 enrolling more than 100 unique patients in purpose-built facilities that required over $3,000,00025 of capital investment since the end of 2018. The clinics are also not a novel application of iOAT. Both are comprehensive and dedicated iOAT programs modelled off of Vancouver’s Crosstown Clinic,26 which has already been rigorously studied.
27. The assertion that iOAT was only a pilot study, is also not consistent with MOERC’s recommendation to provide funding to AHS funding for a phased implementation of an iOAT program in Edmonton and Calgary.”
28. HMQA accepted MOERC’s recommendation and directed AHS to implement iOAT in September 2017. I attended a meeting in January 2018 where AHS representatives presented to MOERC and outlined their phased implementation and evaluation plan. The slides from this presentation are appended to the affidavit of Mr. Cabral as Exhibit C.27 AHS’ presentation states that scientific evidence on iOAT already “demonstrates positive patient and organizational outcomes: clinically effective and cost effective treatment for individuals with severe opioid use disorder leading to improved health/quality of life.”28 Rather than studying an emerging intervention, AHS stated that it was planning to conduct an “on-going evaluation of the services, processes and outcomes,” including cost- effectiveness, and that these findings would be used “to transition towards carefully planned expansion of the program into additional community locations and the potential to move to siOAT as a 1st line treatment.” MOERC provided feedback to AHS following their presentation, and HMQA and AHS executed a grant agreement to fund the “Supervised Injectable Opioid Agonist Therapy (siOAT)29 Program” on March 27 2018.
24 A copy of “AH Grant ID #008264 Injectable Opioid Agonist Treatment, Year 2 Annual Report for Alberta Health, April 1, 2019 - September 30, 2019” is found in the affidavit of John Cabral at Exhibit M, pg. 471. 25 A copy of “Agreement made effective March 27, 2018 between Her Majesty the Queen in Right of Alberta and Alberta Health Services” is found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibit F, pg. 67. 26 A copy of “Alberta Health Services. Form A: A non-claim based grant funding proposal - 20505(2016-10)” is found in the affidavit of Dr. Kathryn Todd - Sworn January 8, 2021 at Exhibit B. 27 A copy of “Alberta Health Services. Addiction and Mental Health. AHS Supervised Injectable Opioid Agonist Therapy (siOAT) Program. MOERC. January 30, 2018” is found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibit C. 28 A copy of “Alberta Health Services. Addiction and Mental Health. AHS Supervised Injectable Opioid Agonist Therapy (siOAT) Program. MOERC. January 30, 2018” is found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibit C, pg. 22. 29 AHS and HMQA refer to iOAT as supervised injectable opioid agonist treatment and as such, use the acronym (“siOAT”), however most people in the addiction medicine field use the acronym iOAT.
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29. The language used in the grant agreement is consistent with the information AHS and HMQA presented to MOERC on how iOAT would be implemented (and potentially scaled up) as part of a phased implementation plan, and not a short-term “pilot study.”
30. The agreement contains a detailed proposal outlining the scope of the funded program.30 The opening text states:
Highly specialized services such as supervised injectable opioid agonist therapy (siOAT) are an important piece of a comprehensive addiction treatment system. Although the population of individuals with severe opioid use disorder who would benefit from siOAT may be a small proportion of opioid users, they are a marginalized population at high risk for overdose. It is important that the health care system works to mitigate the risk of overdose and supports the treatment needs of all Albertans.31
31. The second page of the proposal explains the impetus for the iOAT program and the program’s objectives:
The siOAT Program was presented to the Minister’s Opioid Emergency Response Commission in September 2018 (sic) and January 2018 and received support. Edmonton and Calgary were selected to commence this work and evaluate the feasibility, processes and outcomes in order to advise future spread to community partner agencies and other sites across AHS.
There are two main objectives this project will accomplish:
1) To plan, develop, and implement a phased implementation strategy for the establishment of two AHS clinics in Alberta (Edmonton & Calgary) that provide supervised injectable hydromorphone and/or diacetylmorphine (heroin) as a second-line treatment option for patients with severe opioid use disorder (OUD) that have been previously unsuccessful with current OAT.
2) To gather evidence to determine whether siOAT should be considered as a first-line treatment for severe OUD patients, and potential expansion of the service to partner community agencies and other sites across AHS.
30 A copy of “Agreement between Her Majesty the Queen in Right of Alberta and Alberta Health Services” is found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibit F, pg. 54. 31 A copy of “Agreement between Her Majesty the Queen in Right of Alberta and Alberta Health Services” is found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibit F, pg. 63.
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The project is divided into two Phases: Phase one is the planning phase that includes meetings with experts, further engagement of community agencies and persons with lived experience, review of the evidence, determining the needs of the population, creating an evaluation framework, creating a model of care, site selection, development of the clinic sites (e.g. functional program, leasing space, renovations, equipment and furniture purchases) and hiring and training the site managers/staff and recruiting/training physicians. Phase two is the opening of the two AHS clinics and the implementation of the new program and evaluation of the care and services. The clinics will be open 12 hours/day for 7 days per week. This phase, based [on] evaluation findings, will determine movement towards objective #2, including expansion into additional community locations and the potential expansion of siOAT as a 1st line treatment.32
32. The grant agreement notes that funding to accomplish Objective 2 and expand iOAT to other service settings or other patient populations in Alberta is outside the scope of the agreement. However, the excerpts above indicate that the intent of the funding agreement was to establish two iOAT clinics in Alberta and evaluate their performance as means to build a case for expanding access to iOAT into other settings, or to a broader patient population (e.g. those with severe opioid use disorder who have not tried oral opioid agonist treatment, and for whom iOAT would thus be first-line).
33. Further, the term “pilot study” does not appear anywhere in the original grant agreement between HMQA and AHS, nor does the proposal describe any plans to discontinue the iOAT clinics at the end of the two-year funding term, or to transition iOAT patients to oral medications. According to the timeline included in the proposal the final stage of the grant is the ‘evaluate services & report’ stage where
the services are evaluated and the data and outcomes are reported. Quality improvement is undertaken as appropriate and required to ensure safe, quality care for patients. Needs assessment for expansion and next steps, etc. is completed.33
34. The iOAT patient consent form34 also indicates that the program was not implemented as a two-year “pilot study.” The Patient Agreement for Injectable Opioid Agonist Therapy -
32 A copy of “Agreement between Her Majesty the Queen in Right of Alberta and Alberta Health Services” is found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibit F, pg. 64. 33 A copy of “Agreement between Her Majesty the Queen in Right of Alberta and Alberta Health Services” is found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibit F, pg. 69. 34 A copy of “Patient Agreement for Injectable Opioid Agonist Therapy (iOAT) Program - Community Setting” is found in the affidavit of Mark Snaterse - Sworn January 8, 2021 at Exhibit A, pg. 7.
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Community Setting is appended to the affidavit of Mr. Snaterse and describes the terms of iOAT treatment, including risks and benefits, services offered, and program expectations and rules. Patients sign their names at the bottom of the agreement to indicate informed consent. The form is also signed by an AHS iOAT staff member. The form states that iOAT may be discontinued “for many reasons, including safety considerations and interference with medical and psychiatric conditions.” The form does not describe iOAT as an emerging or untested treatment, nor does it provide patients with any indication that the program is part of a “pilot study” or has a fixed end date.
35. As Dr. Els’ notes in his affidavit that prior to enrollment in a pilot study participants must provide informed consent, which “is contingent upon reasonable understanding of the nature of the intervention, the risks and potential benefits, as well as the duration of the intervention.”35 By this standard, it is clear that iOAT patients did not provide informed consent to participate in a pilot study. iOAT patients are at very high risk for overdose when discharged from treatment.36 Enrolling 100 high risk, complex patients in an iOAT pilot study without first obtaining their free and informed consent, would constitute a breach of medical and research ethics.
HMQA’s decision to cancel the iOAT program
36. Mr. Cabral’s affidavit appends several interim and annual reports authored by AHS and submitted to HMQA on the iOAT program’s progress.37 In reviewing these reports it is clear that AHS was conducting an evaluation of an evidence-based intervention with the intent of optimizing its implementation, rather than a pilot study.
37. Program evaluations are commonly deployed within health systems to ensure optimal implementation of new interventions, and can be used to: measure fidelity to the planned service model; confirm expected benefits; monitor for any unanticipated negative or positive outcomes; support quality improvement; and ensure cost-effectiveness. If the results of the evaluation are for internal use, sharing with funders, or otherwise not intended for broad dissemination, then human research ethics approval and participants’ informed consent is not required.38
35 Affidavit of Charls Els - Sworn January 8, 2021, pg. 11. 36 A copy of “Amending Agreement #1 made to be effective March 10, 2020 between Her Majesty the Queen in Right of Alberta Health Services” is found in the affidavit of Dr. Kathryn Todd - Sworn January 8, 2021 at Exhibit E, pg. 64. 37 A copy of “Alberta Health Services grant reports” are found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibits G-O. 38 However, if patients or staff are interviewed as part of the evaluation protocol, informed consent is sometimes collected anyways to ensure their participation is voluntary and that they are aware of potential risks and benefits of participating.
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38. According to AHS’ January 1, 2020 - March 31, 2020 interim report, the iOAT program evaluation framework was finalized in September 2019 and including following objectives:
1. To assess the need for iOAT and the appropriateness of the program for clients. 2. To examine the accessibility of the iOAT program and factors impacting client retention in the program. 3. To examine the safety of the iOAT program, including adverse events. 4. To measure program acceptability and treatment outcomes for clients enrolled in the iOAT program, including health and social outcomes (e.g. quality of life and illicit drug use). 5. To assess the sustainability of the iOAT program, including cost-effectiveness and potential for expansion across the province.39
39. The evaluation is still ongoing and final results will not be available until later this year. However, preliminary data (from patient surveys and qualitative interviews with patients and staff) indicate that the “since October 2018, the iOAT treatment program has achieved positive patient outcomes and has prevented harm or the potential deaths from accidental opioid poisoning of this extremely high risk population.”40 This includes improvements in quality of life for patients and reductions in illegal drug use and criminal activity.41 No cost-effectiveness data are presented in the AHS reports appended to Mr. Cabral’s affidavit. However, the AHS October 1, 2019 - December 31, 2019 interim report includes a statement suggesting they are not significantly concerned about iOAT costs:
In November 2019, AHS leadership requested a review and reporting on the cost effectiveness of the iOAT program in comparison to an ambulatory clinic. A request was submitted to AHS Finance: Activity and Costing Department and Performance Management: Provincial Addiction and Mental Health. Here are the results: patients attending the iOAT program are in the program long-term and attend the clinic 7 days/week for 365 days/year up to three times per day. The cost of the visit to the iOAT program is estimated to be between $54 (clients seen three times per day) and $162 (clients seen only once per day). Even the higher
39 A copy of “AH Grant ID #008264 Injectable Opioid Agonist Treatment - Interim Report for Alberta Health: January 1, 2020-March 31, 2020” is found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibit K, pg. 392. 40 A copy of “AH Grant ID #008264 Injectable Opioid Agonist Treatment - Interim Report for Alberta Health: October 1, 2019-December 31, 2019” is found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibit J, pg. 290. 41 A copy of “AH Grant ID #008264 Injectable Opioid Agonist Treatment - Interim Report for Alberta Health: October 1, 2019-December 31, 2019” is found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibit J, pgs. 322-333.
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estimate is well below the cost of an average ambulatory visit ($359) or the current Alberta billing rate.42
40. Despite these promising early evaluation results, in the first week of March 2020, HMQA announced that it would be cancelling the phased implementation of Alberta’s iOAT program. HMQA indicated that the program funding would be extended by one year to enable patients to transfer to other treatment options by March 31, 2021.43 AHS was advised that iOAT funding would not be renewed past March 31 2021 and that “the funding for the next year will utilize existing [program] surpluses.”44
41. According to AHS, the cancellation of iOAT
impacts 118 patients in the program, 69 people on the waitlist, two managers, more than 48 staff and 10 physicians. As the Alberta iOAT program is recognized as highly successful, the decision was received by the iOAT patients, managers, staff, physicians and community partners with expressions of confusion, sadness and concern.45
42. The amended grant agreement executed between AHS and HMQA to extend the funding period further notes that upon its expiration:
There will be over 100 high risk complex patients registered in the two clinics that will require the siOAT treatment and “wrap-around” services such as social services, primary care and counselling. siOAT is a highly complex treatment that requires physicians and staff specially trained in emergency interventions to address overdoses and seizures, and a unique setting that allows for safe patient flow, close monitoring of the treatment and patient responses and urgent intervention as necessary. These patients, if discharged, will be at very high risk for overdose within the illicit drug market and will once again start to place very high demands on the health care and criminal justice systems due to their
42 A copy of “AH Grant ID #008264 Injectable Opioid Agonist Treatment - Interim Report for Alberta Health: October 1, 2019-December 31, 2019” is found in the affidavit of John Cabral - Sworn January 8, 2021 at Exhibit J, pg. 294. 43 Omstead, J. Alberta government to end funding for intensive opioid therapy program. CBC News. Available from: https://www.cbc.ca/news/canada/edmonton/injectable-opioid-treatment-alberta-1.5490566. Attached as Exhibit “8” to