Faculty publications - Department of Family and Community Medicine

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Reframing conceptualizations of primary care involvement in opioid use disorder treatment
(Springer Nature, 2024-09-30) Chiu, Kellia; Sud, Abhimanyu
Background Opioid-related harms and opioid use disorder (OUD) are health priorities requiring urgent policy responses. There have been many calls for improved OUD care in primary care, as well as increasing involvement of primary care providers in countries like Canada and Australia, which have been experiencing high rates of opioid-related harms. Methods Using Starfield’s 4Cs conceptualization of primary care functions, we examined how and why primary care systems may be suited towards, or pose challenges to providing OUD care, and identified health system opportunities to address these challenges. We conducted 14 semi-structured interviews with 16 key informants with experience in opioid use policy in Canada and Australia. Results Primary care was identified to be an ideal setting for OUD care delivery due to its potential as the first point of contact in the health system; the opportunity to offer other health services to people with OUD; and the ability to coordinate care with other health providers (e.g. specialists, social workers) and thus also provide care continuity. However, challenges include a lack of resources and support for chronic disease management more broadly in primary care, and the prevailing model of OUD treatment, where addictions care is not seen as part of comprehensive primary care. Additionally, the highly regulated OUD policy landscape is also a barrier, manifesting as a ‘regulatory cascade’ in which restrictive oversight of OUD treatment passes from regulators to health providers to patients, normalizing the overly restrictive nature and inaccessibility of OUD care. Conclusions While primary care is an essential arena for providing OUD care, existing sociocultural, political, health professional, and health system factors have led to the current model of care that limits primary care involvement. Addressing this may involve structurally embedding OUD care into primary care and strengthening primary care in general.
Buprenorphine deregulation as an opioid crisis policy response - A comparative analysis between France and the United States
(2023-08-22) Sud, Abhimanyu; Chiu, Kellia; Friedman, Joseph; Dupouy, Julie
Background In passing the Maintstreaming Addiction Treatment Act, the United States has abolished its federal X waiver, considered a major barrier to the wider buprenorphine prescribing needed to respond to opioid-related harms. Advocates for this policy have drawn on the French response of deregulating buprenorphine prescribing to address increasing overdose mortality around the turn of the millennium. So far, such policy advocacy has incompletely accounted for contextual and health system differences between the two countries. Methods Using the health system dynamics framework, this analysis compares France from 1995 to 2003 (the relevant period of buprenorphine reform) to the US from 2018 until today (the comparison period to explore potential impacts of reform). We used it to guide examination of a) contextual issues relating to opioid use epidemiology and b) health system factors including prescriber supply, sector organization, and insurance coverage for primary care to draw relevant policy learning for the contemporary US. Results We identified that the US had a 22.5-fold higher mortality rate and a 2.3-fold higher opioid use disorder (OUD) rate compared to France, despite having rates of prescribed buprenorphine per-capita higher than, and per-person with OUD comparable to, than that of France. These wide gulfs between the scales and nature of the problems between France and the US suggest that relaxing restrictions on buprenorphine prescribing through abolishing the X waiver will be insufficient for achieving hoped-for reductions in overdose mortality. Conclusion Health system strengthening with a focus on improvements in primary care prescriber supply, coverage, and coordination are likely higher yield policy complements to relaxing buprenorphine regulation. Such an approach would better prepare the US to adapt to ongoing dynamics and uncertainties in the opioid crisis and to optimize the already relatively high levels of buprenorphine prescribing.
Chronic pain trials often exclude people with comorbid depressive symptoms: A secondary analysis of 346 randomized controlled trials
(Sage, 2023-06-22) Cheng, Darren K; Ullah, Maarij Hannan; Gage, Henry; Moineddin, Rahim; Sud, Abhimanyu
Chronic pain and depression are common comorbid conditions, but there is limited evidence-based guidance for management of the two conditions together. In recent years, there has been an increase in the number of chronic pain randomized controlled trials that collect depression outcomes, but it is unknown how often these trials include people with depression or significant depressive symptoms. If trials do not include participants representative of real-world populations, evidence and guidance generated from these trials risk being inapplicable for large proportions of the target population, or worse, risk harm. Thus, in order to identify pathways to improve the conduct of clinical trials, the aims of this study were to (1) estimate the proportion of randomized controlled trials evaluating chronic pain interventions and reporting depression outcomes that include participants with significant depressive symptoms; and (2) assess the variability of inclusion proportions by pain type, intervention type, gender, country of origin, and publication year.
How policy problems and solutions travel in the scientific literature: An international scientometric analysis of the French Model of opioid use disorder care
(2023-03-07) Kankanam Gamage, Kasunka; Chiu, Kellia; Ryk, Justin; Grundy, Quinn; Sud, Abhimanyu
Rationale The 2007 article ‘Why buprenorphine is so successful in treating opiate addiction in France’ has been widely cited to promote various solutions to growing opioid-related harms across multiple jurisdictions globally. However, selective promotion of aspects of the French experience or promotion of the French experience without considering relevant contextual factors may inform policies that will not bring the same outcomes as in France, including the introduction of possible unintended negative consequences. The scientific literature is one important arena in which policy solutions are identified, evaluated, promoted and disseminated. Scientific communication of the French opioid use disorder care model offers a timely and relevant example through which to examine how problem representations travel and to consider the effects of these representations. Aims and Objectives We aimed to explore where, when, and how the content of this 2007 index article has travelled through the scientific literature. Method Informed by Bacchi's understanding of problem representation, we conducted a scientometric analysis of the index article. This included categorical analyses using a combination of citation metadata and content data to identify patterns across locations and time. Results Researchers in the United States and Anglophone countries affirmatively cited specific index study content, namely less stringent regulations and positive outcomes, such as reductions in overdose deaths and increases in buprenorphine utilization. These citations were more common after 2015 and were more likely to be in discussion sections of nonempirical publications. Researchers from France cited similar content but did so nonaffirmatively, and throughout the study period. Likewise, the French citations were mostly agenda-setting citations in the introductory sections of empirical studies. US studies received the highest attention based on number of citations and Altmetric scores. Conclusion US studies, by focusing on less stringent buprenorphine regulation as the primary solution of concern, have constructed opioid-related harms as a problem of restrictive regulations for buprenorphine. This selective focus on regulation, as opposed to other aspects of the French Model elucidated in the index article such as changes pertaining to the values and financing that structure health service delivery, represents an important missed opportunity for evidence-informed policy learning across jurisdictions.
The Impact of Suboxone’s Market Exclusivity on Cost of Opioid Use Disorder Treatment
(2023-01) McGee, Meghan; Chiu, Kellia; Moineddin, Rahim; Sud, Abhimanyu
Background Buprenorphine-naloxone is an essential part of the response to opioid poisoning rates in North America. Manipulating market exclusivity is a strategy manufacturers use to increase profitability, as evidenced by Suboxone in the USA. Objective To investigate excess costs of buprenorphine-naloxone due to unmerited market exclusivity (no legal patent or data protection) in Canada. Methods Using controlled interrupted time-series, this study examined changes in the cost of buprenorphine-naloxone before and after the first generics were listed on public formularies. Methadone cost was the control. Public data from the Canadian Institute of Health Information in British Columbia, Manitoba, and Saskatchewan were used. All buprenorphine-naloxone and methadone claims (2010–2019) accepted for payment by the provincial drug plan/programme were collected. Primary outcome was mean cost per mg of buprenorphine-naloxone after the first listing of generics. Results Mean cost per mg of buprenorphine-naloxone before the first listing of generics was $1.21 CAD in British Columbia, $1.27 CAD in Manitoba, and $0.85 CAD in Saskatchewan. Following the introduction of generics, the cost per mg decreased by $0.22 CAD (95% CI − 0.33 to − 0.10; p = 0.0014) in British Columbia, $0.36 CAD (95% CI − 0.58 to − 0.13; p = 0.004) in Manitoba, and $0.27 CAD (95% CI − 0.50 to − 0.05; p = 0.03) in Saskatchewan. Mean cost per mg decreased by $0.26 CAD (95% CI − 0.38 to − 0.13; p = 0.0004) after a third generic was introduced in British Columbia. Excess costs to public formularies during the 4- to 5-year period prior to the listing of generics were $1,992,558 CAD in British Columbia, $80,876 CAD in Manitoba, and $4130 CAD in Saskatchewan. If buprenorphine-naloxone cost $0.61 CAD (mean cost after the third generic entered) instead of $1.21 CAD per mg during the pre-generics period, public payers in British Columbia could have saved $5,016,220 CAD between 2011 and 2015. Conclusions Unmerited 6 years of market exclusivity for brand-name buprenorphine-naloxone in Canada resulted in substantial excess costs. There is an urgent need to implement policies that can help reduce costs for high-priority drugs in Canada.
Cannabis companies and the sponsorship of scientific research: A cross-sectional Canadian case study
(2023-01) Grundy, Quinn; Imahori, Daphne; Mahajan, Shreya; Garner, Gord; Timothy, Roberta; Sud, Abhimanyu; Soklaridis, Sophie; Buchman, Daniel Z
Corporations across sectors engage in the conduct, sponsorship, and dissemination of scientific research. Industry sponsorship of research, however, is associated with research agendas, outcomes, and conclusions that are favourable to the sponsor. The legalization of cannabis in Canada provides a useful case study to understand the nature and extent of the nascent cannabis industry's involvement in the production of scientific evidence as well as broader impacts on equity-oriented research agendas. We conducted a cross-sectional, descriptive, meta-research study to describe the characteristics of research that reports funding from, or author conflicts of interest with, Canadian cannabis companies. From May to August 2021, we sampled licensed, prominent Canadian cannabis companies, identified their subsidiaries, and searched each company name in the PubMed conflict of interest statement search interface. Authors of included articles disclosed research support from, or conflicts of interest with, Canadian cannabis companies. We included 156 articles: 82% included at least one author with a conflict of interest and 1/3 reported study support from a Canadian cannabis company. More than half of the sampled articles were not cannabis focused, however, a cannabis company was listed amongst other biomedical companies in the author disclosure statement. For articles with a cannabis focus, prevalent topics included cannabis as a treatment for a range of conditions (15/72, 21%), particularly chronic pain (6/72, 8%); as a tool in harm reduction related to other substance use (10/72, 14%); product safety (10/72, 14%); and preclinical animal studies (6/72, 8%). Demographics were underreported in empirical studies with human participants, but most included adults (76/84, 90%) and, where reported, predominantly white (32/39, 82%) and male (49/83, 59%) participants. The cannabis company-funded studies included people who used drugs (37%) and people prescribed medical cannabis (22%). Canadian cannabis companies may be analogous to peer industries such as pharmaceuticals, alcohol, tobacco, and food in the following three ways: sponsoring research related to product development, expanding indications of use, and supporting key opinion leaders. Given the recent legalization of cannabis in Canada, there is ample opportunity to create a policy climate that can mitigate the harms of criminalization as well as impacts of the "funding effect" on research integrity, research agendas, and the evidence base available for decision-making, while promoting high-priority and equity-oriented independent research.
Chronic Struggle: An Institutional Ethnography of Chronic Pain and Marginalization
(Elsevier, 2022-10-14) Webster, Fiona; Connoy, Laura; Sud, Abhimanyu; Rice, Kathleen; Katz, Joel; Pinto, Andrew D; Upshur, Ross; Dale, Craig
There have been several recent calls to re-think chronic pain in response to the growing awareness of social inequities that impact the prevalence of chronic pain and its management. This in turn has resulted in new explorations of suffering as it relates to pain. While laudable, many of these clinically oriented accounts are abstract and often fail to offer a critical theoretical understanding of social and structural inequities. To truly rethink pain, we must also reconsider suffering, beginning in the everyday expert knowledge of people with chronic pain who can offer insights in relation to their bodies and also the organization of the social circumstances in which they live. Our team undertook a sociological approach known as institutional ethnography (IE) to explicate the work of people in managing lives beset by chronic pain and the inequities that stem from marginalization. In keeping with our critical paradigm, we describe participant accounts as situated, rather than lived, to de-emphasize the individual in favour of the social and relational. Through our analysis, we offer a new concept of chronic struggle to capture how pain, illness, economic deprivation, and suffering constitute a knot of experience that people living with chronic pain are obliged to simplify in order to fit existing logics of medicine. Our goal is to identify the social organization of chronic pain care which underpins experience in order to situate the social as political rather than medical or individual. Perspective: This article explicates the health work of people living with chronic pain and marginalization, drawing on their situated experience. We offer the concept of chronic struggle as a conceptualization that allows us to bring into clear view the social organization of chronic pain in which the social is visible as political and structural rather than medical or individual.
Virtually-delivered Sudarshan Kriya Yoga (SKY) for Canadian veterans with PTSD: A study protocol for a nation-wide effectiveness and implementation evaluation
(2022-10) Ryk, Justin; Simpson, Robert; Hosseiny, Fardous; Notarianni, MaryAnn; Provencher, Martin D; Rudnick, Abraham; Upshur, Ross; Sud, Abhimanyu
Background Post-traumatic stress disorder (PTSD) remains a significant treatment challenge among Canadian veterans. Currently accessible pharmacological and non-pharmacological interventions for PTSD often do not lead to resolution of PTSD as a categorical diagnosis and have significant non-response rates. Sudarshan Kriya Yoga (SKY), a complementary and integrative health (CIH) intervention, can improve symptoms of PTSD. In response to the COVID-19 pandemic, this intervention has pivoted to virtual delivery and may be reaching new sets of participants who face multiple barriers to care. Objective To evaluate the implementation and effectiveness of virtually delivered Sudarshan Kriya Yoga (SKY) on decreasing PTSD symptom severity, symptoms of depression, anxiety, and pain, and improving quality of life in Canadian veterans affected by PTSD. Methods and analysis Using a mixed-methods approach guided by the RE-AIM framework, we will conduct a hybrid type II effectiveness and implementation study of virtually delivered Sudarshan Kriya Yoga (SKY) for Canadian veterans. Effectiveness will be evaluated by comparing virtually delivered SKY to a waitlist control in a single-blinded (investigator and data analyst) randomized controlled trial (RCT). Change in PTSD symptoms (PCL-5) is the primary outcome and quality of life (SF-36), symptoms of depression (PHQ-9), anxiety (GAD-7), and pain (BPI) are secondary outcomes. The SKY intervention will be conducted over a 6-week period with assessments at baseline, 6-weeks, 12-weeks, and 30 weeks. The reach, effectiveness, adoption, implementation, and maintenance of the intervention will be evaluated through one-on-one semi-structured interviews with RCT participants, SKY instructors, health professionals, and administrators that work with veterans. Discussion This is the first investigation of the virtual delivery of SKY for PTSD in veterans and aims to determine if the intervention is effective and implementable at scale.
Bridging the Macro-micro Divide: A Qualitative Meta-synthesis on the Perspectives and Experiences of Health Care Providers on the Extramedical Use and Diversion of Buprenorphine
(2022-08-01) Kankanam Gamage, Kasunka; Tejpar, Serena; Majid, Umair; Dixon, Kirsten; Sabioni, Pamela; Sud, Abhimanyu
Objectives Opioid agonist therapy using buprenorphine is one of the most effective treatments for opioid use disorder. However, concerns regarding its extramedical use and diversion, such as adverse patient outcomes and damage to the legitimacy of addictions practice, are persistent. The aim of this review is to synthesize the perspectives and experiences of health care providers around the extramedical use of buprenorphine. Methods A qualitative meta-synthesis was conducted based on a systematic search of 8 databases. All primary qualitative and mixed-methods studies relating to the views of health care providers on the extramedical use of buprenorphine were included. A qualitative analysis informed by the constant comparative method was conducted, using NVivo for data management. Results Sixteen studies were included in this review. Findings were organizedunder 2 key themes: (1) Harm-producing versus harm-reducing effects of extramedical buprenorphine use and (2) driving forces of and responses to extramedical buprenorphine use. Conclusions The studies included in our review identified a disconnect—health care providers noted that macro, health care system–level challenges drove extramedical use whereas the recommended solutions for prevention and management were primarily aimed at the micro, individual level. This study emphasizes the critical role that health care providers can play, in partnership with patients, in informing appropriate policies and health care system design to optimize the care for people with opioid use disorder.
Education as drug policy: A realist synthesis of continuing professional development for opioid agonist therapy
(Elsevier, 2022-08-02) Sachidanandan, Grahanya; Bechard, Lauren E; Hodgson, Kate; Sud, Abhimanyu
Background Continuing professional development (CPD) for opioid agonist therapy (OAT) has been identified as a key health policy strategy to improve care for people living with opioid use disorder (OUD) and to address rising opioid-related harms. To design and deliver effective CPD programs, there is a need to clarify how they work within complex health system and policy contexts. This review synthesizes the literature on OAT CPD programs and educational theory to clarify which interventions work, for whom, and in what contexts. Methods A systematic review and realist synthesis of evaluations of CPD programs focused on OAT was conducted. This included record identification and screening, theory familiarization, data collection, analysis, expert consultation, and iterative context-intervention-mechanism-outcome (CIMO) configuration development. Results Twenty-four reports comprising 21 evaluation studies from 5 countries for 3373 providers were reviewed. Through iterative testing of included studies with relevant theory, five CIMO configurations were developed. The programs were categorized by who drove the learning outcomes (i.e., system/policy, instructor, learner) and their spheres of influence (i.e., micro, meso, macro). There was a predominance of instructor-driven programs driving change at the micro level, with few policy-driven macro-influential programs, inconsistent with the promotion of CPD as a clear opioid crisis policy-level intervention. Conclusion OAT CPD is challenged by mismatches in program justifications, objectives, activities, and outcomes. Depending on how these program factors interact, OAT CPD can operate as a barrier or facilitator to OUD care. With more deliberate planning and consideration of program theory, programs more directly addressing diverse learner and system needs may be developed and delivered. OAT CPD as drug policy does not operate in isolation; programs may feed into each other and intercalate with other policy initiatives to have micro, meso, and macro impacts on educational and population health outcomes.
How the Suboxone Education Programme presented as a solution to risks in the Canadian opioid crisis: a critical discourse analysis
(2022) Sud, Abhimanyu; Strang, Matthew; Buchman, Daniel Z; Spithoff, Sheryl; Upshur, Ross E G; Webster, Fiona; Grundy, Quinn
Objectives Pharmaceutical industry involvement in medical education, research and clinical practice can lead to conflicts of interest. Within this context, this study examined how the ‘Suboxone Education Programme’, developed and delivered by a pharmaceutical company as part of a federally regulated risk management program, was presented as a solution to various kinds of risks relating to opioid use in public documents from medical institutions across Canada. Setting These documents were issued during the Canadian opioid crisis, a time when the involvement of industry in health policy was being widely questioned given industry’s role in driving the overprescribing of opioid analgesics and contributing to population-level harms. Design A critical discourse analysis of 69 documents collected between July 2020 and May 2021 referencing the Suboxone Education Program spanning 13 years (2007–2021) from medical, nursing and pharmacy institutions sourced from every Canadian province and territory. Discursive themes were identified through iterative and duplicate analyses using a semistructured data extraction instrument. Results Documents characterised the Programme as addressing iatrogenic risks from overprescribing opioid analgesics, environmental risks from a toxic street drug supply and pharmacological risks relating to the dominant therapeutic alternative of methadone. The programme was identified as being able to address these risks by providing mechanisms to surveil healthcare professionals and to facilitate the prescribing of Suboxone. Medical institutions legitimised the Suboxone Education Programme by lending their regulatory, epidemiological and professional authority. Conclusions Addressing risk is considered as a central, moral responsibility of contemporary healthcare services. In this case, moral imperatives to address opioid crisis-related risks overrode other ethical concerns regarding conflicts of interest between industry and public welfare. Failing to address these conflicts potentially imperils efforts of mitigating population health harms by propagating an important driving force of the opioid crisis.
Interventions for Depressive Symptoms in People Living with Chronic Pain: A Systematic Review of Meta-Analyses
(2022-05) Cheng, Darren K; Lai, Ka Sing Paris; Pico-Espinosa, Oscar Javier; Rice, Danielle B; Chung, Chadwick; Modarresi, Golale; Sud, Abhimanyu
Objective This review investigated the effectiveness of clinical interventions on depressive symptoms in people with all types of chronic pain. Methods We searched seven electronic databases and reference lists on September 15, 2020, and included English-language, systematic reviews and meta-analyses of trials that examined the effects of clinical interventions on depressive outcomes in chronic pain. Two independent reviewers screened, extracted, and assessed the risk of bias. PROSPERO registration: CRD42019131871. Results Eighty-three reviews were selected and included 182 meta-analyses. Data were summarized visually and narratively using standardized mean differences with 95% confidence intervals as the primary outcome of interest. A large proportion of meta-analyses investigated fibromyalgia or mixed chronic pain, and psychological interventions were most commonly evaluated. Acceptance and commitment therapy for general chronic pain, and fluoxetine and web-based psychotherapy for fibromyalgia showed the most robust effects and can be prioritized for implementation in clinical practice. Exercise for arthritis, pharmacotherapy for neuropathic pain, self-regulatory psychotherapy for axial pain, and music therapy for general chronic pain showed large, significant effects, but estimates were derived from low- or critically low-quality reviews. Conclusions No single intervention type demonstrated substantial superiority across multiple pain populations. Other dimensions beyond efficacy, such as accessibility, safety, cost, patient preference, and efficacy for non-depressive outcomes should also be weighed when considering treatment options. Further effectiveness research is required for common pain types such as arthritis and axial pain, and common interventions such as opioids, anti-inflammatories and acupuncture.
Beyond harm-producing versus harm-reducing: A qualitative meta-synthesis of people who use drugs' perspectives of and experiences with the extramedical use and diversion of buprenorphine
(Elsevier, 2022) Sud, Abhimanyu; Salamanca-Buentello, Fabio; Buchman, Daniel Z; Sabioni, Pamela; Majid, Umair
Introduction This review synthesizes the literature on the perspectives and experiences of people who use drugs to better understand motivations and behaviors related to the extramedical use and diversion of buprenorphine. Given the particular social construction of buprenorphine against methadone, and the centrality of concerns around extramedical use in delivering opioid agonist therapies, a focus on extramedical buprenorphine use can provide an important lens through which to analyze treatment for opioid use disorder. This review is framed within persistent tensions between potential harm-producing versus harm-reducing effects of extramedical use that have long been described for opioid agonist therapies. Methods The research team conducted a qualitative meta-synthesis based on a systematic search of eight databases as well as hand searching. The review includes all primary qualitative and mixed-methods studies related to the perspectives and experiences of people who use drugs on extramedical buprenorphine use. The study team carried out three rounds of qualitative coding using NVivo 12, and constructivist grounded theory and the constant comparative method informed the synthesis. Results The review includes twenty-one studies. Findings are organized into the following three themes: 1) the experiences of people who use drugs (PWUD) with extramedical use of buprenorphine and their motivations to engage in it (including the desire to self-medicate and achieve “stability”, to manage ongoing use of other opioids, and to “get high”); 2) the relationship between extramedical use and formal medical opioid agonist therapy programs; and 3) the established drug economy of extramedical buprenorphine. Conclusions The review identified varied and often divergent perspectives and experiences with extramedical buprenorphine use. An examination of the reported “normalizing” effects of extramedical buprenorphine suggests this practice as extending medicalized discipline beyond the clinical environment. Taken together, these findings identify a need to move beyond the tension of harm-reducing versus harm-producing effects toward forms of health care and promotion that focus on the needs, perspectives, and priorities of people who use drugs.
Chronic Pain and Opioid Prescribing: Three Ways for Navigating Complexity at the Clinical‒Population Health Interface
(American Public Health Association, 2022) Sud, Abhimanyu; Buchman, Daniel Z; Furlan, Andrea D; Selby, Peter; Spithoff, Sheryl M; Upshur, Ross E G
Clinically focused interventions for people living with pain, such as health professional education, clinical decision support systems, prescription drug monitoring programs, and multidisciplinary care to support opioid tapering, have all been promoted as important solutions to the North American opioid crisis. Yet none have so far delivered substantive beneficial opioid-related population health outcomes. In fact, while total opioid prescribing has leveled off or reduced in many jurisdictions, population-level harms from opioids have continued to increase dramatically. We attribute this failure partly to a poor recognition of the epistemic and ethical complexities at the interface of clinical and population health. We draw on a framework of knowledge networks in wicked problems to identify 3 strategies to help navigate these complexities: (1) designing and evaluating clinically focused interventions as complex interventions, (2) reformulating evidence to make population health dynamics apparent, and (3) appealing to the inseparability of facts and values to support decision-making in uncertainty. We advocate that applying these strategies will better equip clinically focused interventions as complements to structural and public health interventions to achieve the desired beneficial population health effects. (Am J Public Health. 2022;112(S1):S56-S65. https://doi.org/10.2105/AJPH.2021.306500).
Permissive regulation: A critical review of the regulatory history of buprenorphine formulations in Canada
(Elsevier, 2022) Sud, Abhimanyu; McGee, Meghan; Mintzes, Barbara; Herder, Matthew
Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada for the treatment of opioid use disorder. The drug is considered an important response to the opioid overdose epidemic with consistent calls for wider prescribing and deregulation. The history of Suboxone regulation in Canada has not been critically examined. Part of the rationale for doing so stems from the US regulatory experience, with documented irregularities, or what some have called abuses, that support profit-making by Suboxone's manufacturers. This regulatory analysis allows us to determine how opportunities to address health crises through drug innovation are managed at a federal level. We used public drug and patent registries to critically examine Suboxone's Canadian history. First, we investigated Suboxone's entry into the Canadian market to understand how it achieved market exclusivity. Second, we examined Health Canada's risk mitigation process to address extramedical use and diversion to understand the intersection of regulation and brand promotion. Insights from these two analyses were then extended to the recent approval of two related buprenorphine-containing products and their specific pathways to Canadian market exclusivity. We identified inconsistencies in Suboxone's regulatory history that suggest Health Canada's functions of health protection and promotion were compromised in favour of an “innovations” agenda that supports profit-making. Despite six years of market exclusivity in Canada, there was no evidence suggesting Suboxone achieved formal exclusivity (i.e., through patent or data protection). Health Canada's process to address safety concerns of Suboxone were compromised by reliance on the manufacturer to carry out post-market education, allowing the manufacturer to create and market a branded “education” program for its product. Similar inconsistencies have afforded market exclusivity for two related products despite marginal innovation. These analyses reveal a case of permissive regulation, where principles of health protection are compromised by economic imperatives. Such a regulatory approach has the potential to adversely impact public health due to unnecessarily high costs for medicines deemed essential to stem a major health crisis. Alternative pharmaceutical policies are urgently needed to safely and efficiently expand treatment access for opioid use disorder.
Shifting interpretations in evidence and guidance in pain and opioids research: A bibliometric analysis of a highly cited case series from 1986
(2022) Tafreshi, Sina; Steiner, Adam; Sud, Abhimanyu
Rationale, aims, and objectives: Portenoy and Foley’s 1986 landmark study “Chronic use of opioid analgesics in non-malignant pain: report of 38 cases” has been reproached for opening the floodgates of opioid prescribing for chronic non-cancer pain and the attendant harms. This influential article has been cited over 500 times in the scientific literature over the last four decades. This study seeks to understand the impact of Portenoy and Foley’s article on subsequent discussions and research about opioids. Methods: We conducted a multi-method bibliometric analysis of all citations of this article from 1986 through 2019 using quantitative relational and qualitative content analysis to determine how uses and interpretations of this case series and associated prescribing guidance have changed over time, in relationship to the evolution of the North American opioid crises. Results: Using time series analysis, we identified three periods with distinct interpretations and uses of the index study. In the first “exploration” period (1986-1996), the index study was well-received by the scientific community and motivated further study of the effects of opioids. In the second “implementation” period (1997-2003, coinciding with the release of OxyContin®), this study was used as evidence to support widespread prescribing of opioid analgesics, even while it was recognized that long-term effects had not yet been evaluated. The third “reassessment” period (2004-2019) focused on how opioid-related harms had been overlooked, and in many cases these harms were directly attributed to this study. Conclusion: These changes in interpretation demonstrate shifting currents of the use and mobilization of evidence regarding pain and opioids, and how these currents both impact and are impacted by clinical practices and major sociohistorical phenomena such as the opioid crisis. Researchers and clinicians must account for these shifting dynamics when developing and interpreting scientific knowledge, including in the form of clinical practice guidelines.
Mal/adaptations: A qualitative evidence synthesis of opioid agonist therapy during major disruptions
(Elsevier, 2022-03) Salamanca-Buentello, Fabio; Cheng, Darren K.; Sabioni, Pamela; Majid, Umair; Upshur, Ross; Sud, Abhimanyu
Opioid agonist therapy (OAT) has been severely disrupted by the COVID-19 pandemic. The risks of opioid withdrawal, overdose, and diversion have increased, so there is an urgent need to adapt OAT to best support people who use drugs (PWUD). This review examines the views and experiences of PWUD, health care providers, and health system administrators on OAT during major disruptions to medical care to inform appropriate health system responses during the current pandemic and beyond.
Time series-based bibliometric analysis of a systematic review of multidisciplinary care for opioid dose reduction: exploring the origins of the North American opioid crisis
(Springer, 2021-11) Sud, Abhimanyu; Cheng, Darren K; Moineddin, Rahim; Zlahtic, Erin; Upshur, Ross
Bibliometric analyses of systematic reviews offer unique opportunities to explore the character of specific scientific fields. In this time series-based analysis, dynamics of multidisciplinary care for chronic pain and opioid prescribing are analyzed over a forty-four year time span. Three distinct periods are identified, each defined by distinct research areas, as well as priorities regarding the use of opioids and the appropriate management of chronic pain. These scientometrically defined periods align with timelines identified previously by narrative historical accounts. Through cross-correlation with a mortality time series, a significant two-year lag between opioid overdose mortality and citation dynamics is identified between 2004 and 2019. This analysis demonstrates a bidirectional relationship between the scientific literature and the North American opioid overdose crisis, suggesting that the scientific literature is both reflective and generative of an important health and social phenomenon. A scientometric phenomenon of memory lapse, namely an overt and prolonged failure to cite older relevant literature, is identified using a metric of mean time to citation. It is proposed that this metric can be used to analyze changes in emerging literature and thus predict the nature of clinical and policy responses to the opioid crisis, and thus potentially to other health and social phenomena.
A Conceptual Framework for Continuing Medical Education and Population Health
(Taylor and Francis, 2021) Sud, Abhimanyu; Hodgson, Kate; Bloch, Gary; Upshur, Ross
Issue: Health systems have been increasingly called upon to address population health concerns and continuing medical education (CME) is an important means through which clinical practices can be improved. This manuscript elaborates on existing conceptual frameworks in order to support CME practitioners, funders,and policy makers to develop, implement, and evaluate CME vis-a-vis population health concerns. Evidence: Existing CME conceptual models and conceptions of CME effectiveness require elaboration in order to meet goals of population health improvement. Frameworks for the design, implementation and evaluation of CME consistently reference population health, but do not adequately conceptualize it beyond the aggregation of individual patient health. As a pertinent example, opioid prescribing CME programs use the opioid epidemic to justify their programs, but evaluation approaches are inadequate for demonstrating population health impacts. CME programs that are built to have population health outcomes using frameworks intended primarily for physician performance and patient health outcomes are thus not able to recognize either non-linear associations or negative unintended consequences. Implications: This proposed conceptual framework draws on the fields of clinical population medicine, the social determinants of health, health equity, and philosophies of population health to build conceptual bridges between the CME outcome levels of physician performance and patient health to population health. The authors use their experience developing, delivering, and evaluating opioid prescribing and poverty-focused CME programs to argue that population health-focused CME must be re-oriented in at least five ways. These include: 1) scaling effective CME programs while evaluating at population health levels; 2) (re)interpreting evidence for program content from a population perspective; 3) incorporating 2social determinants of health into clinically-oriented CME activities; 4) explicitly building fluency in population health concepts and practices among health care providers and CME planners; and 5) attending to social inequity in every aspect of CME programs.
Evaluations of Continuing Health Provider Education Focused on Opioid Prescribing: A Scoping Review
(Association of American Medical Colleges, 2021-06-01) Sud, Abhimanyu; Molska, Graziella R; Salamanca-Buentello, Fabio
Purpose: Continuing health provider education (HPE) is an important intervention supported by health policy to counter the opioid epidemic; knowledge regarding appropriate program design and evaluation is lacking. The authors aim to provide a comprehensive understanding of evaluations of opioid-related continuing HPE programs and their appropriateness as interventions to improve population health. Method: In January 2020, the authors conducted a systematic search of 7 databases, seeking studies of HPE programs on opioid analgesic prescribing and overdose prevention. Reviewers independently screened the titles and abstracts of all studies and then assessed the full texts of all studies potentially eligible for inclusion. The authors extracted a range of data using categories for evaluating complex programs: the use of theory, program purpose, inputs, activities, outputs, outcomes, and industry involvement. Results were reported in a narrative synthesis. Results: Thirty-nine reports on 32 distinct HPE programs met inclusion criteria. Of these 32, 31 (97%) were U.S./Canadian programs and 28 (88%) were reported after 2010. Measurements of changes in knowledge and confidence were common. Performance outcomes were less common and typically self-reported. Most studies (n = 27 [84%]) used concerns of opioid-related harms at the population health level to justify the educational intervention, but only five (16%) measured patient- or population-level outcomes directly related to the educational programs. Six programs (19%) had direct or indirect opioid manufacturer involvement. Conclusions: Continuing HPE has been promoted as an important means of addressing population-level opioid-related harms by policy makers and educators, yet published evaluations of HPE programs focusing on opioid analgesics inadequately evaluate patient- or population-level outcomes. Instead, they primarily focus on self-reported performance outcomes. Conceptual models are needed to guide the development and evaluation of continuing HPE programs intended to have population health benefits.

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