Federal opioid agonist therapy policy: interrupted time series analysis of the impact of the methadone exemption removal across eight provinces in Canada.

BACKGROUND: Federal deregulation of opioid agonist therapies are an attractive policy option to improve access to opioid use disorder care and achieve widespread beneficial impacts on growing opioid-related harms. There have been few evaluations of such policy interventions and understanding effects can help policy planning across jurisdictions. METHODS: Using health administrative data from eight of ten Canadian provinces, this study evaluated the impacts of Health Canada's decision in May 2018 to rescind the requirement for Canadian health professionals to obtain an exemption from the Canadian Drugs and Substance Act to prescribe methadone for opioid use disorder. Over the study period of June 2017 to May 2019, we used descriptive statistics to capture overall trends in the number of agonist therapy prescribers across provinces and we used interrupted time series analysis to determine the effect of this decision on the trajectories of the agonist therapy prescribing workforces. RESULTS: There were important baseline differences in the numbers of agonist therapy prescribers. The province with the highest concentration of prescribers had 7.5 more prescribers per 100,000 residents compared to the province with the lowest. All provinces showed encouraging growth in the number of prescribers through the study period, though the fastest growing province grew 4.5 times more than the slowest. Interrupted time series analyses demonstrated a range of effects of the federal policy intervention on the provinces, from clearly positive changes to possibly negative effects. CONCLUSIONS: Federal drug regulation policy change interacted in complex ways with provincial health professional regulation and healthcare delivery, kaleidoscoping the effects of federal policy intervention. For Canada and other health systems such as the US, federal policy must account for significant subnational variation in OUD epidemiology and drug regulation to maximize intended beneficial effects and mitigate the risks of negative effects.

Chronic pain trials often exclude people with comorbid depressive symptoms: A secondary analysis of 346 randomized controlled trials.

BACKGROUND: 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. METHODS: Studies were extracted from an umbrella review of interventions for chronic pain that reported depression outcomes. Screening and data extraction were completed in duplicate and conflicts were resolved by a third author. Randomized controlled trials with at least 50% adult participants and validated depression scales were included, and randomized controlled trials with populations whose mean scores were at or above depression thresholds at baseline were considered to have included participants with depression. RESULTS: Of the 346 randomized controlled trials analyzed, 142 (41%) included participants with depression. Eight pain-type groups and nine intervention types were identified. Randomized controlled trials investigating fibromyalgia and mixed chronic pain had the highest proportion of participants with depression, whereas studies of arthritis and axial pain had among the lowest. Randomized controlled trials from the United States had a significantly lower inclusion proportion compared with non-US studies, especially for studies on arthritis. The increase in inclusion proportion by publication year was driven by the increase in fibromyalgia studies. DISCUSSION AND CONCLUSION: This study highlights opportunities to improve the conduct of chronic pain clinical trials. The majority of randomized controlled trials s analyzed evaluated participants without significant depressive symptoms at baseline, thus the findings synthesized in systematic reviews and subsequent guidelines are most applicable to the subset of real-world populations that do not have significant depressive symptoms. As well, systemic biases around psychological conditions and gender may be important contributors to differences in the study of depression in fibromyalgia compared with common conditions such as arthritis and axial pain. In order to better inform clinical practice, future research must intentionally include individuals with comorbid depression in trials of common chronic pain conditions, and consider methods to mitigate biases that may distort study design.

Sudarshan Kriya Meditation Reduces Substance Abuse Cravings and Improves Physical and Emotional Well-Being of Individuals With Opioid Use Disorder: A Pilot Study.

Opioid use disorder (OUD) is widely prevalent in the United States and there are high levels of comorbidity between OUD and mental illnesses, such as depression, anxiety, and posttraumatic stress disorder. Psychotherapy, in addition to medication-assisted therapy, are considered important components of long-term OUD treatment. Sudarshan Kriya Yoga (SKY) is a breathing-based mind-body intervention that has been demonstrated to have multiple physiological and psychological benefits. In the current study, participants (N = 8) recruited from a rural community were offered SKY in addition to treatment-as-usual. Physical and psychological well-being were measured using the Behavior and Symptom Identification Scale-24, Short Form-36, Perceived Stress Scale, and participant logs and journals. Of eight participants, seven (87.5%) successfully completed the SKY intervention. Compared to baseline, there was a significant decrease in substance use cravings (p = 0.04) and depression (p = 0.01). In addition, physical functioning and emotional well-being significantly increased after SKY. SKY demonstrated efficacy in improving physical and social functioning along with enhancing mental and emotional well-being. Larger-scale trials should be performed to validate these findings. [Journal of Psychosocial Nursing and Mental Health Services, 61(8), 51-59.].

Chronic Pain and Opioid Prescribing: Three Ways for Navigating Complexity at the Clinical‒Population Health Interface.

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).

Interventions for Depressive Symptoms in People Living with Chronic Pain: A Systematic Review of Meta-Analyses.

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.

A Conceptual Framework for Continuing Medical Education and Population Health.

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 social 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.

Assessment tools for problematic opioid use in palliative care: A scoping review.

BACKGROUND: Screening for problematic opioid use is increasingly recommended in patients receiving palliative care. AIM: To identify tools used to assess for the presence or risk of problematic opioid use in palliative care. DESIGN: Scoping review. DATA SOURCES: Bibliographic databases (inception to January 31, 2020), reference lists, and grey literature were searched to find primary studies reporting on adults receiving palliative care and prescription opioids to manage symptoms from advanced cancer, neurodegenerative diseases, or end-stage organ diseases; and included tools to assess for problematic opioid use. There were no restrictions based on study design, location, or language. RESULTS: We identified 42 observational studies (total 14,431 participants) published between 2009 and 2020 that used questionnaires (n = 32) and urine drug tests (n = 21) to assess for problematic opioid use in palliative care, primarily in US (n = 38) and outpatient palliative care settings (n = 36). The questionnaires were Cut down, Annoyed, Guilty, and Eye-opener (CAGE, n = 8), CAGE-Adapted to Include Drugs (CAGE-AID, n = 6), Opioid Risk Tool (n = 9), Screener and Opioid Assessment for Patients with Pain (SOAPP; n = 3), SOAPP-Revised (n = 2), and SOAPP-Short Form (n = 5). Only two studies' primary objectives were to evaluate a questionnaire's psychometric properties in patients receiving palliative care. There was wide variation in how urine drug tests were incorporated into palliative care; frequency of abnormal urine drug test results ranged from 8.6% to 70%. CONCLUSION: Given the dearth of studies using tools developed or validated specifically for patients receiving palliative care, further research is needed to inform clinical practice and policy regarding problematic opioid use in palliative care.

A retrospective quantitative implementation evaluation of Safer Opioid Prescribing, a Canadian continuing education program.

BACKGROUND: Continuing health professions education (CHPE) is an important policy intervention for the opioid epidemic. Besides effectiveness or impact, health policy implementation should be studied to understand how an intervention was delivered within complex environments. Implementation outcomes can be used to help interpret CHPE effects and impacts, help answer questions of "how" and "why" programs work, and inform transferability. We evaluated Safer Opioid Prescribing (SOP), a national CHPE program, using implementation outcomes of reach, dose, fidelity, and participant responsiveness. METHODS: We conducted a retrospective quantitative implementation evaluation of the 2014-2017 cohorts of SOP. To measure reach and dose, we examined participation and completion data. We used Ontario physician demographic data, including regulatory status with respect to controlled substances, to examine relevant trends. To measure fidelity and participant responsiveness, we analyzed participant-provided evaluations of bias, active learning, and relevance to practice. We used descriptive statistics and measures of association for both continuous and categorical variables. We used logistic regression to determine predictors of workshop participation and analysis of covariance to examine variation in satisfaction across different-sized sessions. RESULTS: Reach: In total, there were 472 unique participants, 84.0% of whom were family physicians. Among Ontario physician participants, 90.0% were family physicians with characteristics representative of province-wide demographics. Dose: Webinar completion rate was 86.2% with no differences in completion based on rurality, gender, or controlled substance prescribing status with medical regulatory authorities. Fidelity and participant responsiveness: Nearly all participants rated the three webinars and workshop as balanced, and each element of SOP was also rated as highly relevant to clinical practice. CONCLUSIONS: This evaluation demonstrates that Safer Opioid Prescribing was implemented as intended. Over a short period and without any external funding, the program reached more than 1% of the Ontario physician workforce. This suggests that the program may be a good model for using virtual CHPE to reach a critical mass of prescribers. This study represents a methodological advance of adapting evaluation methods from health policy and complex interventions for continuing health professions education. Future studies will assess effectiveness and impact on opioid prescribing and utilization within evaluation models of complex interventions.

Reframing conceptualizations of primary care involvement in opioid use disorder treatment.

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.

Methadone Prescribing Regulation for Opioid Use Disorder in Canada: Evidence for an East-West Policy Divide.

Opioid agonist therapy (OAT) is a key element in the response to opioid-related harms in Canada. In May 2018, Health Canada rescinded the requirement for obtaining a federal exemption for methadone prescribing. This comparative analysis examined provincial OAT policies and policy changes in response to this federal policy change. Policies and changes were regionalized; despite having lower rates of opioid-related harms, eastern provinces had looser regulatory regimes compared with western provinces, which became even looser after the federal policy change. Diverse knowledge and policy networks need to be fostered to bridge this east-west divide in substance use care policy.

Attending to Marginalization in The Chronic Pain Literature: A Scoping Review.

Background: There has been a recent and, for many within the chronic pain space, long-overdue increase in literature that focuses on equity, diversity, inclusion, and decolonization (EDI-D) to understand chronic pain among people who are historically and structurally marginalized. Aims: In light of this growing attention in chronic pain research, we undertook a scoping review of studies that focus on people living with chronic pain and marginalization to map how these studies were carried out, how marginalization was conceptualized and operationalized by researchers, and identify suggestions for moving forward with marginalization and EDI-D in mind to better support people living with chronic pain. Methods: We conducted this scoping review using critical analysis in a manner that aligns with dominant scoping review frameworks and recent developments made to scoping review methodology as well as reporting guidelines. Results: Drawing on 67 studies, we begin with a descriptive review of the literature followed by a critical review that aims to identify fissures within the field through the following themes: (1) varying considerations of sociopolitical and socioeconomic contexts, (2) conceptual conflations between sex and gender, and (3) differing approaches to how people living with chronic pain and marginalization are described. Conclusion: By identifying strengths and limitations in the research literature, we aim to highlight opportunities for researchers to contribute to a more comprehensive understanding of marginalization in chronic pain experiences.

Contexte: La littérature mettant l'accent sur l'équité, la diversité, l'inclusion et la décolonisation (EDI-D) pour mieux comprendre la douleur chronique chez les personnes historiquement et structurellement marginalisées a récemment connu une augmentation, attendue depuis longtemps par de nombreux spécialistes de la douleur chronique.Objectifs: À la lumière de cette attention croissante dans la recherche sur la douleur chronique, nous avons entrepris un examen approfondi des études portant sur les personnes vivant avec une douleur chronique et la marginalisation, afin de déterminer comment ces études ont été menées, comment la marginalisation a été conceptualisée et opérationnalisée par les chercheurs, et de recenser des suggestions pour aller de l'avant en gardant à l'esprit la marginalisation et l'EDI-D afin de mieux soutenir les personnes vivant avec la douleur chronique.Méthodes: Nous avons mené cet examen de la portée en utilisant l'analyse critique, conformément aux cadres dominants et aux développements récents de la méthodologie de l'examen de la portée, ainsi qu'aux lignes directrices relatives aux rapports.Résultats: En nous appuyant sur 67 études, nous commençons par un examen descriptif de la littérature, suivi d'un examen critique visant à déterminer les lacunes dans le domaine, en fonction des thèmes suivants : (1) les diverses interprétations des contextes sociopolitiques et socioéconomiques, (2) les confusions conceptuelles entre sexe et genre, et (3) les approches différentes concernant la manière dont les personnes vivant avec la douleur chronique et la marginalisation sont décrites.Conclusions: En cernant les points forts et les limites de la littérature de recherche, nous visons à mettre en évidence les possibilités pour les chercheurs de contribuer à une meilleure compréhension de la marginalisation dans les expériences de douleur chronique.Abréviations: TUO : trouble lié à l'utilisation d'opioïdes; DSM-5 : Manuel diagnostique et statistique 5; BPI : Questionnaire concis sur la douleur; NIDA : National Institute on Drug Abuse; IASP : Association internationale pour l'étude de la douleur; MTUO : Médicaments pour le trouble lié à l'utilisation des opioïdes; EIQ : Écart interquartile.

Critical appraisal of evidence supporting prescription of psychedelics from clinic websites in Ontario, Canada.

Psychedelics, including ketamine, 3,4-Methyl enedioxy methamphetamine (MDMA), and psilocybin, have gained attention for their potential therapeutic role in mental health treatment. While recreational use is prohibited in Canada, medicinal exemptions can be granted. There are several psychedelic clinics in Ontario, Canada, promoting the use of psychedelics for a variety of medical indications. Our objective was to identify the indications for which psychedelics are being prescribed in Ontario clinics and assess the quality of evidence used to support these claims. Internet searches were conducted using Google and Bing to identify psychedelic clinics in Ontario. Inclusion criteria was as follow: clinics were physically located in Ontario, had a functioning website link, and demonstrated involvement of a licensed physician or nurse practitioner. Identified clinics were evaluated for their claims of effectiveness, the quality of evidence used to support these claims, and statements on psychedelic-related harms. The cited studies were appraised for quality using Oxford Centre for Evidence-Based Medicine Levels of Evidence, "level 5" being the lowest quality and "level 1" being the highest quality. Out of 200 search results, 10 psychedelic clinic websites met our inclusion criteria. These clinics advertised psychedelics for 47 medical conditions, most commonly for depression. Only 2 out of 10 clinics described potential risks associated with psychedelic use. There were 29 studies cited by these websites, majority coming from "level 4" evidence consisting of case-series and case-control studies. Overall, the cited evidence quality was low to moderate. Psychedelic clinics in Ontario promote a wide range of medical indications for psychedelics using primarily low to moderate "level 4" evidence. There is limited information shared on the potential adverse effects of psychedelics. Our study emphasizes the importance of using transparent and high-quality evidence by clinics and clinicians to ensure safe and effective use of psychedelics in mental health treatments.

An international comparative policy analysis of opioid use disorder treatment in primary care across nine high-income jurisdictions.

BACKGROUND: Opioid use disorder (OUD) and opioid-related harms are current health priorities in many high-income countries such as Canada. Opioid agonist therapy (OAT) is an effective evidence-based treatment for OUD, but access is often limited. AIMS: To describe and compare OUD treatment policies across nine international jurisdictions, and to understand how they are situated within their primary care and health systems. METHODS: Using policy documents, we collected data on health systems, drug use epidemiology, drug policies, and OUD treatment from Australia, Canada, France, Germany, Ireland, Portugal, Sweden, Switzerland, and Taiwan. We used the health system dynamics framework and adapted definitions of low- and high-threshold treatment to describe and compare OUD treatment policies, and to understand how they may be shaped by their health systems context. RESULTS: Broad similarities across jurisdictions included the OAT pharmacological agents used and the need for supervised dosing; however, preferred OAT, treatment settings, primary care and specialist physicians' roles, and funding varied. Most jurisdictions had elements of lower-threshold treatment access, such as the availability of treatment through primary care and multiple OAT options, but the higher-threshold criteria of supervised dosing. CONCLUSIONS: From the Canadian perspective, there are opportunities to improve accessibility of OUD care by drawing on how different jurisdictions incorporate multidisciplinary care, regulate OAT medications, remunerate healthcare professionals, and provide funding for services.

The impact of chiropractic care on prescription opioid use for non-cancer spine pain: protocol for a systematic review and meta-analysis.

BACKGROUND: In recent studies, receipt of chiropractic care has been associated with lower odds of receiving prescription opioids and, among those already prescribed, reduced doses of opioids among patients with non-cancer spine pain. These findings suggest that access to chiropractic services may reduce reliance on opioids for musculoskeletal pain. OBJECTIVE: To assess the impact of chiropractic care on initiation, or continued use, of prescription opioids among patients with non-cancer spine pain. METHODS: We will search for eligible randomized controlled trials (RCTs) and observational studies indexed in MEDLINE, Embase, AMED, CINAHL, Web of Science, and the Index to Chiropractic Literature from database inception to June 2024. Article screening, data extraction, and risk-of-bias assessment will be conducted independently by pairs of reviewers. We will conduct separate analyses for RCTs and observational studies and pool binary outcomes (e.g. prescribed opioid receipt, long-term opioid use, and higher versus lower opioid dose) as odds ratios (ORs) with associated 95% confidence intervals (CIs). When studies provide hazard ratios (HRs) or relative risks (RRs) for time-to-event data (e.g. time-to-first opioid prescription) or incidence rates (number of opioid prescriptions over time), we will first convert them to an OR before pooling. Continuous outcomes such as pain intensity, sleep quality, or morphine equivalent dose will be pooled as weighted mean differences with associated 95% CIs. We will conduct meta-analyses using random-effects models and explore sources of heterogeneity using subgroup analyses and meta-regression. We will evaluate the certainty of evidence of all outcomes using the GRADE approach and the credibility of all subgroup effects with ICEMAN criteria. Our systematic review will follow the PRISMA statement and MOOSE guidelines. DISCUSSION: Our review will establish the current evidence informing the impact of chiropractic care on new or continued prescription opioid use for non-cancer spine pain. We will disseminate our results through peer-reviewed publication and conference presentations. The findings of our review will be of interest to patients, health care providers, and policy-makers. TRIAL REGISTRATION: Systematic review registration: PROSPERO CRD42023432277.

From Two Dimensions to Multidimensions: A Mechanistic Model to Support Deliberate CPD Development, Coordination, and Evaluation.

INTRODUCTION: The effectiveness of continuing professional development as an intervention to improve health professional behavior and patient health is variable and contentious. To clarify the causal relationships underlying program outcomes and facilitate a necessary shift from outcomes-only-based approaches to outcome-based and theory-based approaches in program development and evaluation, we developed a model of mechanisms mapped to relevant outcomes. METHODS: Mechanisms identified in a prior realist synthesis of opioid agonist therapy continuing professional development programs were iteratively tested and refined using purposive and opportunistic sampling and realist approaches against two systematic reviews of programs in analgesic prescribing and palliative care. Further testing involved practical application within programs in sustainable health care and pain management. RESULTS: Ninety reports on 75 programs and practical application to multiple additional programs informed the final model consisting of five distinct mechanisms: motivation transformation, expert influence, confidence development, self-efficacy facilitation, and community of practice expansion. The mechanisms and related analysis emphasize that continuing professional development is heterogeneous, complex, and context dependent. DISCUSSION: Shifting toward outcome-based and theory-based approaches facilitates further conceptual shifts at intraprogram and interprogram and interintervention levels toward more deliberate program development and evaluation, increased program complementarity and subsequent collaboration. It clarifies opportunities for intercalation of continuing professional development with other intervention sciences. The model presents a resource for practitioners, researchers, and policymakers to advance continuing professional development planning, coordination, and evaluation.

Principles-Focused Evaluation: A Promising Practice in the Evaluation of Continuing Professional Development.

ABSTRACT: Outcome-based evaluations still dominate in continuing professional development (CPD) despite the availability of evaluation approaches that address program processes and contexts. Our continued reliance on outcomes-based evaluation fails to respect the importance of complexity and the human element of program planning and implementation. Therefore, it is time that the field of CPD embrace complementary approaches to program evaluation that consider the complexity and maturity of programs and their contexts, while providing credible and relevant information to inform strategic decisions regarding the future of a program. Principles-focused evaluation provides a complement to traditional evaluation approaches through the articulation of a program's values that can be actioned. These "actionable values," known as principles, become the focus of the evaluation for the purposes of program decision-making. This paper describes how one CPD program, designed as a response to growing opioid-related harms, adopted a principles-focused evaluation to inform ongoing iteration of the program. The process used to design the principles, how the principles are informing the transportability of the program, and implications for CPD evaluation are discussed.

The Impact of Suboxone's Market Exclusivity on Cost of Opioid Use Disorder Treatment.

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.