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Abstract: Objectives: Shared decision‐making (SDM) is an approach where patients and clinicians share evidence and patients are supported to deliberate options resulting in preference‐based informed decisions. The aim of this study was to describe community pharmacists’ perceptions and awareness of SDM within their provision of general diabetes management [including Ontario's MedsCheck for Diabetes (MCD) programme], and potential challenges of implementing SDM within community pharmacy. Methods: This qualitative study used semistructured interviews with a convenience sample of community pharmacists. Data were analysed using thematic analysis. Key findings: We conducted 16 interviews. Six participants were male, and nine were certified diabetes educators. When providing a MCD, participants used aspects of a patient‐centred approach focusing on providing education. Variation was evident in participants’ description and use of SDM, as well as in their perceived level of training in SDM. Participants also highlighted challenges surrounding implementing a SDM approach in practice. Conclusion: Pharmacists are well positioned to apply SDM within community settings; however, implementation barriers exist. Pharmacists will require additional training as well as perceived patient and physician barriers should be addressed to encourage uptake. [ABSTRACT FROM AUTHOR]

Objectives: We developed specific evaluation criteria to assess patient and public involvement in resource allocation decisions in health care. Methods: We reviewed the literature from health and other sectors relevant to stakeholder involvement and conducted twenty-seven key informant interviews with stakeholders knowledgeable about patient and public involvement in Canadian drug resource allocation decisions. We used an inductive qualitative thematic approach to analyze the interviews with codes and categories developed directly from individuals' interview transcripts. Results: Integrating respondents' comments and the literature review, we identified nine evaluation criteria of patient and the public involvement in healthcare resource allocation decision making: clarity regarding rationale and roles of patient and public members, sufficient support, adequate representation of relevant views, fair decision-making processes, legitimacy of committee processes, adequate opportunity for participation, meaningful degree of participation, noticeable effect on decisions, and considerations of the efficiency of patient and public involvement. Conclusions: Our results will help to develop methods to evaluate patient and public involvement in healthcare decision making. [ABSTRACT FROM AUTHOR]

Introduction: During the COVID-19 pandemic, patients with opioid use disorder (OUD) struggled with access to prescribers and opioid agonist therapy (OAT). Recognizing this gap in care, Health Canada issued a short-term subsection 56(1) class exemption from the Controlled Drugs and Substances Act authorizing pharmacists to independently manage controlled substances. The purpose of this study was to explore the expanded role of Canadian pharmacists in providing care to patients with OUD during the pandemic., Methods: We conducted qualitative key informant telephone interviews in the fall of 2020 with Canadian pharmacists who used the exemption. We included community or primary healthcare team-based pharmacists who managed opioid medication under the exemption. We recorded, transcribed verbatim, and de-identified all transcripts. Data was analyzed using a thematic approach involving line-by-line coding and constant comparison., Results: We interviewed nineteen pharmacists with representation from all provinces and urban and rural practice settings. Three major themes emerged that captured the pharmacists' perspectives when providing care for patients with OUD during the pandemic: (i) continuity of care; (ii) harm reduction; and (iii) access to care. Pharmacists used the exemption to extend prescriptions, transfer prescriptions, receive verbal orders, and deliver OAT., Conclusions: Throughout the pandemic, pharmacists were able to provide continuity of care to patients with OUD who would have otherwise been unable to access care. The exemption permitted pharmacists to assess patients and provide OAT through this expanded role. Other countries should look to the Canadian experience and leverage the expertise of the pharmacist to expand their scope so that they can help fill the gap in care for patients with OUD., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Purpose: Transitions in care (TiC) often involves managing medication changes and can be vulnerable moments for patients. Medication support, where medication changes are reviewed with patients and caregivers to increase knowledge and confidence about taking medications, is key to successful transitions. Little is known about the optimal tools and processes for providing medication support. This study aimed to identify describe patient or caregiver-centered medication support processes or tools that have been studied within 3 months following TiC between hospitals and other care settings., Methods: Rapid scoping review; English-language publications from OVID MEDLINE, OVID EMBASE, Cochrane Library and EBSCO CINAHL (2004-July 2019) that assessed medication support interventions delivered within 3 months following discharge were included. A subset of titles and abstracts were assessed by two reviewers to evaluate agreement and once reasonable agreement was achieved, the remainder were assessed by one reviewer. Eligibility assessment for full-text articles and data charting were completed by an experienced reviewer., Results: A total of 7671 unique citations were assessed; 60 studies were included. Half of the studies (n = 30/60) were randomized controlled trials. Most studies (n = 45/60) did not discuss intervention development, particularly whether end users were involved in intervention design. Many studies (n = 37/60) assessed multi-component interventions with written/print and verbal education components. Few studies (n = 5/60) included an electronic component. Very few studies (n = 4/60) included study populations at high risk of adverse events at TiC (eg, people with physical or intellectual disabilities, low literacy or language barriers)., Conclusion: The majority of studies were randomized controlled trials involving verbal counselling and/or physical document delivered to the patient before discharge. Few studies involved electronic components or considered patients at high-risk of adverse events. Future studies would benefit from improved reporting on development, consideration for electronic interventions, and improved reporting on patients with higher medication-related needs., Competing Interests: Dr Lisa M McCarthy reports grants from Canadian Institutes for Health Research during the conduct of the study. The authors have declared no potential conflicts of interest., (© 2022 Varghese et al.)

Background: This study explored the perceptions of Canadian pharmacists about the barriers and facilitators of providing opioid stewardship activities in pharmacy practice, considering the subsection 56(1) class exemption under Health Canada's Controlled Drugs and Substances Act (CDSA)., Methods: Qualitative key informant telephone interviews were conducted with a convenience sample of pharmacists from across Canada. We included community or primary health care team-based pharmacists who self-identified as having experience with providing care for patients using opioids via the exemptions. All transcripts were de-identified, and thematic analysis was conducted to identify themes. Ethics approval was obtained., Results: Twenty pharmacists from community and primary health care teams, from all provinces and from urban and rural practices were interviewed. The following themes emerged: 1) optimization of opioid-related patient care, 2) jurisdictional impact and 3) awareness and education. Barriers and facilitators for opioid stewardship activities were identified., Discussion: The exemptions facilitated the pharmacists' ability to provide opioid stewardship and positively affect patient care by providing continuity of and timely access to care. Our research demonstrated that pharmacists can responsibly and independently manage opioid prescriptions within this expanded scope, demonstrating the valuable contribution pharmacists can have in opioid stewardship., Conclusion: Pharmacists were willing and able to care for patients receiving opioid medication and thereby played a role in helping address the opioid crisis. The benefits of these exemptions were demonstrated beyond situations related to the COVID-19 pandemic and warrant consideration for consistent implementation across provincial and territorial jurisdictions, thereby ensuring equitable access to care for all Canadians., Competing Interests: Declaration of Conflicting Interests: L. Bishop received honoraria to present the findings of this research at national events and conferences (2020, 2021); she also served as an expert witness to provide expert opinion evidence for fentanyl (2018). Z. Rosenberg-Yunger was a consultant for CPhA during the time the research was conducted. S. Dattani was a staff member at CPhA at the time the research was conducted and serves on the advisory board for EBSI (Emergent Biosolutions)., (© The Author(s) 2021.)

Background: Canada legalized assisted dying with the passing of Bill C-14, Medical Assistance in Dying (MAiD), in June 2016. This legislation has implications for health care professionals participating in MAiD. This research aims to understand the effect that MAiD has on pharmacists and pharmacy technicians in Canada., Methods: We conducted a thematic document analysis of pharmacy guidelines, position statements and standards of practice from pharmacy regulatory authorities across Canada. In addition, the Ontario Pharmacists Association surveyed its members (including pharmacists, pharmacy technicians and pharmacy students) about their perceptions of MAiD., Results: Our thematic analysis of the reviewed documents resulted in 3 major themes: pharmacists' role in quality assurance, practice considerations when implementing MAiD and resources for pharmacy staff involved in MAiD. Survey responses illustrated that most (68%) pharmacy staff would dispense MAiD medications. Nonetheless, many respondents perceived that they lacked knowledge or comfort with different aspects of the MAiD process. Overall, 80% of participants reported a desire for professional development about MAiD., Conclusion: Despite the rapidly changing landscape surrounding medical assistance in dying within the past year, most pharmacy regulatory authorities have provided direction and resources to their pharmacists. Ontario pharmacists and pharmacy technicians are willing to dispense MAiD medications; however, additional support in the form of professional development may be necessary based on participants' desire for education coupled with their perceived lack of knowledge. Future research may focus on the efficacy of provincial guidelines in supporting pharmacists' participation in MAiD., Competing Interests: Declaration of Conflicting Interests:The authors have no conflicts of interest to declare.

Objectives: Decision aids are tools designed to help patients make choices about their health care. We explored pharmacists' perceptions of an evidence-based diabetes decision aid developed by the Mayo Clinic, Diabetes Medication Choice (DMC). Using DMC as a reference, we aimed to explore pharmacists' perspectives on decision aids, their place in a community pharmacy setting and the implementing of a decision aid, such as DMC, in Ontario., Methods: We used semistructured interviews with a convenience sample of community pharmacists from Ontario. We applied a thematic analysis to the data., Results: We conducted 16 interviews with pharmacists, of whom 9 were certified diabetes educators, and 10 were female. Three themes emerged from the data: pharmacists' knowledge and awareness of decision aids; pharmacists' perceptions of the DMC decision aids, and implementation of the DMC decision aids in Ontario pharmacies. Participants discussed their limited experience with and training in the use of decision aids. Although many participants agreed that the DMC decision aids may contribute to patient-centred care, all agreed that significant changes were needed to be made to implement this tool in practice., Conclusions: Pharmacists felt that the use of decision aids in community pharmacies in Ontario may improve patient-centred care. Modifications, however, are needed to improve the applicability to their context and fit into their workflow. Empirical data concerning the impact of decision aids in community pharmacy is needed., (Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.)

Purpose: To develop and validate scales to measure constructs that survivors of childhood cancer report as barriers and/or facilitators to the process of transitioning from paediatric to adult-oriented long-term follow-up (LTFU) care., Methods: Qualitative interviews provided a dataset that were used to develop items for three new scales that measure cancer worry, self-management skills and expectations about adult care. These scales were field-tested in a sample of 250 survivors aged 15-26 years recruited from three Canadian hospitals between July 2011 and January 2012. Rasch Measurement Theory (RMT) analysis was used to identify the items that represent the best indicators of each scale using tests of validity (i.e. thresholds for item response options, item fit statistics, item locations, differential item function) and reliability (Person Separation Index). Traditional psychometric tests of measurement performance were also conducted., Results: RMT led to the refinement of a 6-item Cancer Worry scale (focused on worry about cancer-related issues such as late effects), a 15-item Self-Management Skills scale (focused on skills an adolescent needs to acquire to manage their own health care), and a 12-item Expectations scale (about the nature of adult LTFU care). Our study provides preliminary evidence about the reliability and validity of these new scales (e.g. Person Separation Index ≥ 0.81; Cronbach's α ≥ 0.81; test-retest reliability ≥ 0.85)., Conclusion: There is limited knowledge about the transition experience of childhood cancer survivors. These scales can be used to investigate barriers survivors face in the process of transition from paediatric to adult care., (© 2014 The Authors Health Expectations Published by John Wiley & Sons Ltd.)

Purpose: Adolescent and young adult (AYA) survivors of cancers in childhood experience cancer worry, defined as concerns about cancer-related issues such as relapse and late effects of treatment. Cancer worry is an important determinant of successful transition to long-term follow-up care. The primary aim of this study was to identify patient-, cancer-, and treatment-related factors associated with cancer worry in AYA survivors. A secondary aim was to explore and understand inappropriate cancer worry (e.g., worry of developing a late effect when not at risk) in this population., Methods: Two hundred and fifty AYA survivors, aged 15–26 years, completed a 6-item Cancer Worry Scale. Selection of factors potentially associated with cancer worry was guided by literature and expert opinion for inclusion in univariable and multivariable regression analyses., Results: Female survivors reported significantly more cancer worry than males did (b=-9.4; 95% CI -14.4 to -4.5; p < 0.001). Survivors treated with the most intensive therapies reported more cancer worry compared with those who received the least intensive therapies (b=-18.5; 95% CI -31.2 to -5.9; p = 0.004). Thirty-one percent of participants had inappropriate worry regarding infertility and/or secondary malignancy., Conclusions: In AYA survivors, female sex and higher treatment intensity were associated with increased cancer worry. Inappropriate worry was prevalent among survivors and may contribute to unnecessary distress. These findings can help identify survivors who are more likely to worry and support the development of appropriate services to reduce the effect of cancer worry on survivor well-being.

Background: Transparency in health care resource allocation decisions is a criterion of a fair process. We used qualitative methods to explore transparency across 11 Canadian drug advisory committees., Methods: We developed seven criteria to assess transparency (disclosure of members' names, disclosure of membership selection criteria, disclosure of conflict of interest guidelines and members' conflicts, public posting of decisions not to fund drugs, public posting of rationales for decisions, stakeholder input, and presence of an appeals mechanism) and two sub-criteria for when rationales were posted (direct website link and readability). We interviewed a purposeful sample of key informants who were conversant in English and a current or past member of either a committee or a stakeholder group. We analyzed data using a thematic approach. Interviewing continued until saturation was reached., Results: We examined documents from 10 committees and conducted 27 interviews. The median number of criteria addressed by committees was 2 (range 0-6). Major interview themes included addressing: (1) accessibility issues, including stakeholders' degree of access to the decision making process and appeal mechanisms; (2) communication issues, including improving internal and external communication and public access to information; and (3) confidentiality issues, including the use of proprietary evidence., Conclusion: Most committees have some mechanisms to address transparency but none had a fully transparent process. The most important ways to improve transparency include creating formal appeal mechanisms, improving communication, and establishing consistent rules about the use of, and public access to, proprietary evidence., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Objectives: To describe stakeholder involvement in the priority setting and appeals processes across five drug reimbursement recommendation committees., Methods: We conducted qualitative case studies of how five independent drug advisory committees from Canada, Israel, England and Wales, Australia, and the USA made funding decisions for six expensive drugs. Interviews with 48 informants were conducted with committee members, patient groups, and industry representatives., Results: Different stakeholders were allowed, in varying degrees, to participate in the formal mechanisms for revisions and appeals of decisions. Participants identified a number of stakeholder groups who were already involved in the process, as well as stakeholders whom they believed should be included in the decision-making process., Conclusions: A central component of a legitimate and fair priority setting process is to make priority setting explicit and to involve both pertinent values and stakeholders in decision-making. Study participants believed that the involvement of multiple stakeholder groups within the deliberative and appeals/revisions processes would contribute to a fair and legitimate drug reimbursement process., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Objectives: To describe the process of priority setting for two orphan drugs - Cerezyme and Fabrazyme - in Canada, Australia and Israel, in order to understand and improve the process based on stakeholder perspectives., Methods: We conducted qualitative case studies of how three independent drug advisory committees made decisions relating to the funding of Cerezyme and Fabrazyme. Interviews were conducted with 22 informants, including committee members, patient groups and industry representatives., Results: (1) DESCRIPTION: Orphan drugs reimbursement recommendations by expert panels were based on clinical evidence, cost and cost-effectiveness analysis. (2) EVALUATION: Committee members expressed an overall preference for the current drug review process used by their own committee, but were concerned with the fairness of the process particularly for orphan drugs. Other informants suggested the inclusion of other relevant values (e.g. lack of alternative treatments) in order to improve the priority setting process. Some patient groups suggested the use of an alternative funding mechanism for orphan drugs., Conclusions: Priority setting for drugs is not solely a technical process (involving cost-effective analysis, evidence-based medicine, etc.). Understanding the process by which reimbursement decisions are made for orphan drugs may help improve the system for future orphan drugs., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Governments around the world have focused on issues of sustainability, innovations and priority setting within their health systems. Tension exists between governments' desire to increase biotechnology innovation and the need to address health system sustainability. This commentary will: (1) review government initiatives in biotechnology in health innovation; (2) discuss how innovation, specifically biopharmaceuticals, challenges health system sustainability; and (3) explore how the tension between innovation and sustainability can be addressed using fairness and legitimacy. It is evident that a uni-jurisdictional approach may not be optimal in promoting innovation while ensuring a sustainable health system. Harmonization of biotechnology policies across the federal, provincial, and territorial governments will ensure consistent policies across all branches in order to circumvent the possibility of one governmental branch refusing to reimburse the very innovations other branches are promoting.