Caution needed in introduction of provisional approvals for medicines.

The Australian government recently released its response to the Review of Medicines and Medical Devices Regulation, accepting most recommendations. One recommendation involves the introduction of provisional approvals for perceived life-saving and innovative new treatments, allowing these to be approved on the basis of more limited data on the condition that further safety and efficacy data (including real-world evidence) are collected to determine whether full approval should be granted. However, experience with similar schemes overseas raises significant questions about the safety and efficacy of products made available through these pathways. These uncertainties are compounded by the challenges associated with the collection and use of 'real-world' data and the difficulty of withdrawing products from the market once patients and clinicians become familiar with them. Although there may be good reasons to provide patients with earlier access to medicines on the basis of provisional evidence (including providing treatment options and hope to patients with serious illnesses), we must exercise caution in order to protect both current and future patients from potentially harmful and futile treatments and ensure that healthcare systems use their resources wisely.

LEGITIMACY OF MEDICINES FUNDING IN THE ERA OF ACCELERATED ACCESS.

OBJECTIVES: In recent years, numerous frameworks have been developed to enhance the legitimacy of health technology assessment processes. Despite efforts to implement these "legitimacy frameworks," medicines funding decisions can still be perceived as lacking in legitimacy. We, therefore, sought to examine stakeholder views on factors that they think should be considered when making decisions about the funding of high-cost breast cancer therapies, focusing on those that are not included in current frameworks and processes. METHODS: We analyzed published discourse on the funding of high-cost breast-cancer therapies. Relevant materials were identified by searching the databases Google, Google Scholar, and Factiva in August 2014 and July 2016 and these were analyzed thematically. RESULTS: We analyzed fifty published materials and found that stakeholders, for the most part, want to be able to access medicines more quickly and at the same time as other patients and for decision makers to be more flexible with regards to evidence requirements and to use a wider range of criteria when evaluating therapies. Many also advocated for existing process to be accelerated or bypassed to improve access to therapies. CONCLUSIONS: Our results illustrate that a stakeholder-derived conceptualization of legitimacy emphasizes principles of accelerated access and is not fully accounted for by existing frameworks and processes aimed at promoting legitimacy. However, further research examining the ethical, political, and clinical implications of the stakeholder claims raised here is needed before firm policy recommendations can be made.

Informal Dementia Caregiving Among Indigenous Communities in Ontario, Canada.

Recent studies suggest dementia is an emerging health issue for Indigenous peoples in Canada. In this article, we explore findings concerning informal dementia caregiving in Indigenous communities. Our research has been carried out in partnership with Indigenous communities in Ontario, Canada, over the past 4 years. Semistructured in-depth interviews were carried out with informal Indigenous caregivers (primarily family) to Indigenous people with dementia at 7 geographically and culturally diverse research sites (n = 34). We use a critical interpretive and postcolonial lens to explore common caregiving experiences and patterns to gain insight into Indigenous models of care and better understand how to appropriately support Indigenous families dealing with a dementia diagnosis. Themes from the interview data are explored through a storyline beginning with why and how participants came to the caregiving role; the challenges, struggles, and decisions along the way; and reflections on the rewards and benefits of caring for a loved one with dementia. The findings suggest that underlying Indigenous values created a consistent family caregiving model across the Indigenous cultures and geographic contexts included in the study. Family caregiving was found to facilitate cultural continuity through intergenerational contact and the transmission of cultural knowledge. Diverse community contexts presented significant challenges most immediately attributable to the nature of relations between Indigenous and non-Indigenous Canadians and the continued colonial policies governing access to services.

Self-Reflection and Peer-Assessments Effect on Pharmacy Students' Performance at Simulated Counselling Sessions.

INTRODUCTION: Verbal communication is a vital skill for pharmacists and essential for improving patient care. The aim of this study was to explore students' perception of the impact of self-reflection and self- and peer-assessment on simulated patient counselling sessions. METHODS: Focus groups explored student perceptions of how this course and way of learning has impacted their performance at counselling patients. Data were analysed using iterative inductive thematic analysis procedures and mapped to the self-determination theory. RESULTS: Nine focus groups with 47 pharmacy students. We identified three main themes and ten associated subthemes. These were learning style (sub-themes gradual introduction to assessment, learning through self-reflection videos, authentic assessment, individual learning compared to group learning, and learning through observation of best practice), feedback (sub-themes inconsistent feedback, summative feedback, perception of self and relationship with peers informing peer assessment) and benefits in real life practice. These themes mapped well to self-determination theory and highlighted that additional focus may be required for benefits in real-life practice. CONCLUSION: Students' perceptions of self-reflection and self- and peer-assessment centred on learning style, feedback, and benefits in real-life practice. Additional focus on benefits of this unit of study in real-life practice and work integrated learning on placements may further strengthen the impact of these learning activities.

Physicians' attitudes towards accelerated access to medicines.

In recent years, a variety of 'accelerated access' schemes have been introduced by pharmaceutical regulators and funders globally. These schemes aim to overcome perceived regulatory and reimbursement barriers to accessing medicines - particularly for patients with limited time or therapeutic options. However, patient access to approved medicines is mediated by a number of third parties including regulators and payers, and physicians who act both as gatekeepers and guides to prescribed medications. It is therefore essential to know how physicians think about accelerated access as they are responsible for advising patients on and prescribing medicines made available via these pathways. We conducted semi-structured interviews with 18 Australian physicians focusing on their attitudes towards accelerated access. We identified three 'archetypes' of physicians: 'confident accelerators', 'cautious accelerators', and 'decelerators'. Although all acknowledged the potential risks and benefits of accelerated access, they disagreed on their magnitude and extent and how they should be balanced in both policy formation and clinical practice. Overall, our results illustrate the diversity of clinical opinions in this area and the importance of monitoring both the prescribing and clinical outcomes that result from accelerated access programmes to ensure that these are both clinically and morally acceptable.

Consumer perspectives of accelerated access to medicines: a qualitative study.

PURPOSE: In this study, the authors aimed to explore consumer perspectives on accelerated access to medicines. The authors were particularly interested in how they balance competing considerations of safety, efficacy, equity and access; whether and how their views change when there are different levels of uncertainty surrounding the safety and efficacy of new medicines; and the procedures that they think should be used to make decisions about accelerated access to new medicines. DESIGN/METHODOLOGY/APPROACH: This was an exploratory qualitative study. Thirteen semi-structured interviews with patient advocates and two focus groups with patients were conducted and analysed thematically. Interviews and focus groups were audio recorded and transcribed verbatim. Data were analysed through inductive thematic analysis. FINDINGS: Participants outlined a range of justifications for accelerated access, including addressing unmet medical needs and encouraging further research and development. However, they were also cognisant of the potential risks and viewed ongoing data collection, disinvestment and market withdrawal as ways to address these. They also emphasised the importance of transparent decisions being made by people with relevant expertise, based on a thorough consideration of scientific evidence and stakeholder perspectives. ORIGINALITY/VALUE: This is the first study to comprehensively explore Australian consumers' views of accelerated access to medicines. The results suggest that consumers want timely access to new medicines, but not at the expense of safety, efficacy, equity and sustainability. While accelerated access programs are likely to be welcomed by consumers, they must be fully informed of their conditions and limitations, and robust post-market data surveillance must be implemented and enforced to protect the interests of both individual patients and the broader community.

A survey of Australian public attitudes towards funding of high cost cancer medicines.

BACKGROUND: In the past decade many novel, and in some cases transformative, cancer medicines have entered the market. Their prices and the amount spent on them by governments have increased rapidly, bringing to the forefront trade-offs that must be made. In this paper we explore the Australian public's attitude towards the funding of high cost cancer medicines (HCCM) to inform reimbursement and health technology assessment (HTA) policy. METHODS: A survey consisting of 49 questions about the funding of HCCMs was developed by the investigators. Recruitment was conducted via Qualtrics. 1039 Australian adults completed the survey. RESULTS: The Australian public overwhelmingly supports funding of HCCMs (95.5 %) to enhance equity of access (97.8 %), and to respond to patients' needs (98 %). When respondents were challenged to balance equity versus access in different contexts inconsistencies emerged. Different demographic factors were important in predicting support for various strategies. CONCLUSION: Our results suggest that the Australian public strongly supports government funding of HCCMs and values both equity and access. Equally, however, the public is uncertain about how equity and access are to be balanced and achieved, and such ambivalence needs to be both further explored and accommodated in policy processes. Our results may be used by policymakers in Australia, and countries with similar systems and values, to further develop policies and processes for funding HCCMs.

"Place-ing" Dementia Prevention and Care in NunatuKavut, Labrador.

Le vieillissement de la population autochtone du Canada a mis en évidence l'importance du milieu de vie et de la culture sur la santé et la résilience dans le parcours de vie. La présente étude expose les résultats d'un projet Photovoix portant sur les expériences des Inuits du Sud lors de transitions associées au troisième âge et à la démence au NunatuKavut (Labrador). Dans cette région, la culture et l'environnement naturel occupent une place prépondérante dans les descriptions des activités de promotion de la santé et des trajectoires de soins. Ces facteurs peuvent contribuer au vieillissement en santé, offrir une protection contre le déclin cognitif et favoriser le maintien de l'identité des personnes atteintes de démence. Or, les modes de vie ancrés dans la terre ancestrale font l'objet de fortes pressions. Ces pressions affectent les perspectives des aînés Inuits du Sud de vieillir et d'être soignés « dans leur milieu ¼. Les résultats de cette recherche reflètent la nécessité d'élaborer des approches de soutien pour les aînés Inuits du Sud désirant vieillir dans leur milieu, en considérant les conceptions culturelles de la personne et les politiques et programmes qui promeuvent l'engagement envers la nature et la culture.As the Indigenous population in Canada ages, there is a need to recognize the role of place and culture in supporting health and resilience over the life course. This article draws on the findings of a Photovoice project about Southern Inuit experiences of transitions into aging and dementia in NunatuKavut, Labrador. Here, culture and the natural environment are prominent in descriptions of health promotion and care trajectories. These factors may contribute to healthy aging, protect against cognitive decline, and support the maintenance of identity for people living with dementia. However, significant pressures on ways of living embedded in the land are also evident. Such forces are impacting Southern Inuit older adults' ability to age and be cared for "in place". The findings of this research reflect a need to consider ways to support Southern Inuit older adults to age in place, which might include reflecting on culturally grounded understandings of personhood, and policy and programming which promote engagement with the nature and culture.

Formulating an Ethics of Pharmaceutical Disinvestment.

There is growing interest among pharmaceutical policymakers in how to "disinvest" from subsidized medicines. This is due to both the rapidly rising costs of healthcare and the increasing use of accelerated and conditional reimbursement pathways which mean that medicines are being subsidized on the basis of less robust evidence of safety and efficacy. It is crucial that disinvestment decisions are morally sound and socially legitimate, but there is currently no framework to facilitate this. We therefore reviewed the bioethics literature in order to identify ethical principles and concepts that might be relevant to pharmaceutical disinvestment decisions. This revealed a number of key ethical considerations-both procedural and substantive-that need to be considered when making pharmaceutical disinvestment decisions. These principles do not, however, provide practical guidance so we present a framework outlining how they might be applied to different types of disinvestment decisions. We also argue that, in this context, even the most rigorous ethical reasoning is likely to be overridden by moral intuitions and psychological biases and that disinvestment decisions will need to strike the right balance between respecting justifiable moral intuitions and overriding unjustifiable psychological impulses.

An ethical framework for the creation, governance and evaluation of accelerated access programs.

There are increasing demands on regulators and insurers internationally to provide access to medicines more quickly, and often on the basis of less robust evidence of safety, efficacy or cost-effectiveness than have traditionally been required. These demands arise from a number of sources, including those advocating for access to medicines for patients with life-threatening diseases, rare diseases, or subsets of common diseases and where entire populations are threatened in the context of public health emergencies. In response to these demands, policymakers have instituted a number of initiatives aimed at speeding up access to medicines, which we refer to collectively as "accelerated access" programs. While there are strong arguments for accelerated access programs, these programs also raise a number of socio-political, epistemic and moral issues. Some of these issues are common to all types of accelerated access programs, while others are specific to particular types of accelerated access. Here, we offer a conceptual framework that highlights ethically relevant similarities and differences among different kinds of accelerated access processes for the purpose of enabling ethically and politically-informed policy making.

Expanding the Circle of Knowledge: Reconceptualizing Successful Aging Among North American Older Indigenous Peoples.

OBJECTIVES: Indigenous older peoples' voices and experiences remain largely absent in the dominant models and critical scholarship on aging and late life. This article examines the relevance of the model of successful aging for Indigenous peoples in North America. METHOD: This article presents the results of a review of the published conceptual literature on successful aging among Indigenous peoples. Our intent was to explore the current state of the field of successful aging among Indigenous peoples and suggest dimensions that may be more reflective of Indigenous voices and experiences that leads to a more inclusive model of successful aging. RESULTS: Based on our review, we suggest four dimensions that may broaden understandings of successful aging to be more inclusive of Indigenous older people: health and wellness, empowerment and resilience, engagement and behavior, and connectedness. DISCUSSION: Our review suggests that Indigenous peoples' voices and experiences are beginning to be included in academic literature on successful aging. However, we suggest that understandings of successful aging be broadened based on our summative findings and a process of community involvement. Such processes can lead to the development of models that are more inclusive to a wide range of older people, including Indigenous older peoples.

Accelerated Access to Medicines: An Ethical Analysis.

In recent years, a range of initiatives have been introduced to provide patients with access to medicines outside of traditional regulatory and/or funding channels; we term these processes "accelerated access to medicines." These generally take 1 of 3 forms: those that provide access by making existing regulatory and funding processes more efficient, those that provide access despite uncertainties surrounding safety or efficacy, and those that provide access despite uncertainties surrounding cost-effectiveness. These latter 2 types are the subject of intense debate, as they generally require us to suspend or override accepted standards of evidence of safety, effectiveness, and/or cost-effectiveness. Ethical analysis provides valuable insights into these debates and highlights the risks and benefits that may accrue as a consequence of different accelerated access schemes. In this article, we use the principle-based approach to ethical analysis described by Beauchamp and Childress (sometimes called the "four principles approach" because it frames analysis by reference to beneficence, non-maleficence, autonomy, and justice) to analyze initiatives that provide accelerated access to medicines. We identify a number of ethical issues that may arise in the context of accelerated access initiatives, including potential patient harms, impacts on patient autonomy and informed consent, and effects on research and regulatory systems. The complex ethical issues at play emphasize that there is no single answer to questions as to whether such schemes are "ethical"; rather, ethical principles will need balancing, context will be critically important, and discussion among the various stakeholder groups will be needed to reach an "ethically good" outcome.

Improving the Legitimacy of Medicines Funding Decisions: A Critical Literature Review.

Many health care systems globally provide publicly subsidized access to prescribed medicines. Decisions about which medicines to fund affect a range of stakeholders, and it is not reasonable to expect that medicines funding decisions are supported by all stakeholder groups all the time. A more realistic aim may be for decisions to be understood and accepted as legitimate by stakeholders; however, several shortcomings of existing processes make it difficult to achieve this aim. To date, the main strategy to address these shortcomings has been to increase stakeholder involvement in decision making, either by eliciting stakeholder values or increasing stakeholder participation in decision making. Despite these efforts, there is growing evidence that decision makers are falling short when it comes to the perceived legitimacy of their resource allocation processes and decisions. As such, there is a pressing need for decision makers to think seriously and creatively about ways to increase the legitimacy of their processes and to make them more acceptable to a wider range of stakeholders. In this article we summarize and critique existing literature on the legitimacy of public resource allocation processes, and we make some practical suggestions for those who are concerned about this issue.