The Medicines Repurposing Program - a critical perspective.

The Medicines Repurposing Program was launched on 1 March 2024. It provides a pathway for registering and subsidising off-label medicines of significant public health benefit but which sponsors have no financial incentive to pursue. This article provides a short overview and critical analysis of the program. One concern that emerges is that commercial sponsors still retain de facto veto power over which off-label uses are prioritised and so have the capacity to sway the process. Simple suggestions are proposed to help mitigate this risk.

The increasing costs of medicines and their implications for patients, physicians and the health system.

Most new medicines entering the market are high-cost speciality drugs. These drugs can cost tens to hundreds of thousands of dollars per course of treatment and in some cases millions of dollars per dose. Approximately half of all spending on medicines is projected to target only 2-3% of patients, raising important questions about resource allocation. While there is no doubt that breakthrough innovations have transformed clinical care in some disciplines, it is also true that cost is becoming one of the primary barriers to treatment access and that many new medicines do not provide value commensurate with their prices. This article examines pricing trends, the reasons for high prices and their implications for access and clinical practice.

Cost-Related Non-Adherence to Prescribed Medicines: What Are Physicians' Moral Duties?

As the price of pharmaceuticals and biologicals rises so does the number of patients who cannot afford them. In this article, we argue that physicians have a moral duty to help patients access affordable medicines. We offer three grounds to support our argument: (i) the aim of prescribing is to improve health and well-being which can only be realized with secure access to treatment; (ii) there is no morally significant difference between medicines being unavailable and medicines being unaffordable, so the steps physicians are willing to take in the first case should extend to the second; and (iii) as the primary stakeholder with a duty to put the individual patient's interests first, the medical professional has a duty to address cost-barriers to patient care. In articulating this duty, we take account of important epistemic and control conditions that must be met for the attribution of this duty to be justified.

The incidence of personal importation of prescription medicines among Australians 45 and older: a cross-sectional survey.

Objective This study is the first to investigate the incidence of personal importation of prescription medicines among Australians aged 45 years or older, and the reasons driving this behaviour. Methods An online survey was distributed to Australians, aged 45 years or older, who were taking prescription medicines. Recruitment was conducted via Qualtrics. The survey was completed by 1180 respondents. Results In our sample, 1.8% of respondents had imported prescription medicines in the previous 12 months, 21.9% had not taken, or had delayed taking, a prescribed medicine due to cost, 21.9% described medicines as unaffordable/very unaffordable, and 17.7% took some budgetary measure to pay for their medicines. The most significant predictors (P < 0.001) of importation were doctors raising it as an option (1.0% vs 42.9%), awareness of the Personal Importation Scheme (0.8% vs 22.6%), believing that importing was safe (1.6% vs 20.9%), paying more than the maximum PBS co-payment for any individual medicine (0.4% vs 8.1%), higher monthly spend on medicines (1.0% vs 6%), and delaying or not taking a medicine due to cost (0.9% vs 5.0%). Almost half (44.4%) would consider importing medicines to save money. Conclusions Potentially hundreds of thousands of Australians are importing prescription medicines from abroad, and many Australians indicate they are willing to import medicines to save money.

Clinicians' Perspective on Implementing Virtual Hospital Care for Low Back Pain: Qualitative Study.

BACKGROUND: Alternate "hospital avoidance" models of care are required to manage the increasing demand for acute inpatient beds. There is currently a knowledge gap regarding the perspectives of hospital clinicians on barriers and facilitators to a transition to virtual care for low back pain. We plan to implement a virtual hospital model of care called "Back@Home" and use qualitative interviews with stakeholders to develop and refine the model. OBJECTIVE: We aim to explore clinicians' perspectives on a virtual hospital model of care for back pain (Back@Home) and identify barriers to and enablers of successful implementation of this model of care. METHODS: We conducted semistructured interviews with 19 purposively sampled clinicians involved in the delivery of acute back pain care at 3 metropolitan hospitals. Interview data were analyzed using the Theoretical Domains Framework. RESULTS: A total of 10 Theoretical Domains Framework domains were identified as important in understanding barriers and enablers to implementing virtual hospital care for musculoskeletal back pain. Key barriers to virtual hospital care included patient access to videoconferencing and reliable internet, language barriers, and difficulty building rapport. Barriers to avoiding admission included patient expectations, social isolation, comorbidities, and medicolegal concerns. Conversely, enablers of implementing a virtual hospital model of care included increased health care resource efficiency, clinician familiarity with telehealth, as well as a perceived reduction in overmedicalization and infection risk. CONCLUSIONS: The successful implementation of Back@Home relies on key stakeholder buy-in. Addressing barriers to implementation and building on enablers is crucial to clinicians' adoption of this model of care. Based on clinicians' input, the Back@Home model of care will incorporate the loan of internet-enabled devices, health care interpreters, and written resources translated into community languages to facilitate more equitable access to care for marginalized groups.

How therapeutic advances have transformed the medical landscape: a primer for clinicians.

Novel medicines are entering the market rapidly and are increasingly being used alone or in combination to treat illnesses of every sort. While transforming the lives of many patients, these new therapies have also forced us to reconsider the way we evaluate, use and fund medicines. This article offers a primer to help practitioners understand how the therapeutic landscape is changing and how this might impact the evidence generation, access to interventions, patient experience and quality of care.

'First ensure no regret': a decision-theoretic approach to informed consent in clinical practice.

Decision theorists recognise that information is valuable only insofar as it has the potential to change a decision. This means that since acquiring more information is time-consuming and sometimes expensive, judgements need to be made about what information is most valuable to acquire, and whether it is worth acquiring at all. In this article I apply this idea to informed consent and argue that the most valuable information relates not to what the best treatment option may be but to possible futures a patient may regret. I conclude by proposing a regret-minimisation framework for informed consent that I contend better captures the true nature of shared decision making than existing formulations.

Physicians' legal duty to disclose more cost-effective treatment options: an examination of Australian civil law applied to personal importation.

Objective A significant proportion of Australians defer or do not fill prescriptions they require due to cost. This article explores whether, and under what circumstances, physicians have a duty to assist these patients by disclosing how they can access more affordable medicines via personal importation. Methods This study involved a critical examination of Australian statutory and case law pertaining to physicians' duty to disclose material information to identify key principles applicable to the context of cost-motivated personal importation. Results There are several legal principles that suggest that physicians have a duty to advise patients of options for accessing more affordable medicines, including via personal importation. These include a duty to warn of inherent and non-inherent risks, a duty to disclose treatments that offer clear advantages, and a duty to facilitate access to the means for achieving patients' health goals. However, it is unclear whether, and on what grounds, responsibility for harm arising from a patient's inability to afford prescribed medicines should be attributed to the prescribing physician. Arguments supporting attribution of such a responsibility are proposed to motivate further legal, policy and ethical debate. Conclusions Physicians have a duty to take reasonable steps to mitigate foreseeable harm to their patients, however the law is silent on whether this duty extends to taking steps to help patients access medicines that they can afford. This investigation provides a framework to guide the development of sound policy and law on informed financial consent and economically motivated prescribing.

Promoting the personal importation of therapeutic goods: recent legislative amendments to advertising regulations may impact consumer access and understanding.

Objective The personal importation scheme is a legislative mechanism that allows health consumers to import unapproved medicines under certain conditions. This article analyses the legal and policy basis for the scheme and considers how reforms to advertising laws for therapeutic goods may restrict communications about it. The article represents the first published analysis of the personal importation scheme's interaction with the communications of health professionals and buyer's clubs. It considers how these communications may be affected by legal amendments, particularly where unapproved medicines may be accessed through the scheme. Methods An examination of Australian therapeutic goods law concerning the personal importation scheme was conducted, including both the historical law and recent regulatory reforms. Illustrative tables were prepared to identify scheme-related advertising that may contravene therapeutic goods law. Risk estimates were allocated to several new legal rules to indicate whether health professionals or buyer's clubs would contravene these laws when promoting the scheme to health consumers for unapproved medicines. Results Representations made directly to the public by health practitioners or on buyer's clubs websites about accessing unapproved therapeutic goods through the personal importation scheme are likely to contravene one or more advertising laws. Conclusions The Therapeutic Goods Administration has very strong powers to initiate compliance or enforcement action for advertising breaches in Australia for many promotional practices. Arguably, in the age of the internet and in the context of emerging expensive medicines, these powers should not be used to restrict health practitioners or buyer's clubs from sharing information about the lawful personal importation scheme to health consumers in need. Nevertheless, the study finds that health practitioners who promote or refer to the availability of unapproved medicines through the personal importation scheme outside of a consultation are likely to contravene the law and may be subject to disciplinary or enforcement action.

Do doctors have a responsibility to help patients import medicines from abroad?

Almost any medicine can be purchased online from abroad. Many high-income countries permit individuals to import medicines for their personal use. However, those who import medicines face the risk of purchasing poor-quality products that may not work, or that may even harm them. Many people are willing to accept this risk for the opportunity to purchase more affordable medicines. This is especially true of individuals from low socioeconomic backgrounds who already struggle to afford the medicines they need if they are not subsidised by insurers or if copayments are high. As medicine prices and out-of-pocket healthcare spending continue to climb, the online marketplace provides an important alternative for individuals in high-income countries to source medicines. In this article, I argue that doctors have a responsibility to help patients access medicines online and I propose a framework that can be used to facilitate responsible personal importation.

Situating commercialization of assisted reproduction in its socio-political context: a critical interpretive synthesis.

BACKGROUND: In many countries, ART service provision is a commercial enterprise. This has benefits, for example, creating efficiencies and economies of scale, but there are also concerns that financial imperatives can negatively impact patient care. The commercialization of ART is often conceptualized as being driven solely by the financial interests of companies and clinicians, but there are in fact many complex and intersecting socio-political demands for ART that have led to, sustain and shape the industry. OBJECTIVE AND RATIONALE: To use the academic and policy discourse on the commercialization of ART to build a theoretical model of factors that influence demand for ART services in high-income countries in order to inform potential policy responses. SEARCH METHODS: We searched electronic databases for journal articles (including Web of Science, Scopus, PubMed) and websites for grey literature, carried out reference chaining and searched key journals (including Human Reproduction, Fertility and Sterility). The terms used to guide these searches were 'assisted reproductive technology' OR 'in vitro fertilization' AND 'commerce' OR 'commercialisation' OR 'industry' OR 'market'. The search was limited to the English language and included articles published between 2010 and 2020. We used an established method of critical interpretive synthesis (CIS) to build a theoretical model of factors that influence demand for ART services in high-income countries. We developed initial themes from a broad review of the literature followed by iterative theoretical sampling of academic and grey literatures to further refine these themes. OUTCOMES: According to contemporary academic and broader socio-political discourse, the demand for ART has arisen, expanded and evolved in response to a number of intersecting forces. Economic imperatives to create sustainable national workforces, changing gender roles and concerns about the preservation of genetic, national/ethnic and role-related identities have all created demand for ART in both public and private sectors. The prominence given to reproductive autonomy and patient-centred care has created opportunities to (re)define what constitutes appropriate care and, therefore, what services should be offered. All of this is happening in the context of technological developments that provide an increasing range of reproductive choices and entrench the framing of infertility as a disease requiring medical intervention. These socio-political drivers of demand for ART can be broadly organized into four theoretical categories, namely security, identity, individualization and technocratization. LIMITATIONS REASONS FOR CAUTION: The primary limitation is that the interpretive process is ultimately subjective, and so alternative interpretations of the data are possible. WIDER IMPLICATIONS: Development of policy related to commercial activity in ART needs to account for the broad range of factors influencing demand for ART, to which commercial ART clinics are responding and within which they are embedded. STUDY FUNDING/COMPETING INTERESTS: This work was supported by a National Health and Medical Research Council Ideas Grant (APP1181401). All authors declare that they have no conflict of interest in relation to this work.

Personal Importation and the Law: Protecting Patients Who Import Medicines for Legitimate Health Care Needs.

Australians who cannot access medicines locally are able to find most medicines for sale online. Australia's therapeutic goods legal regime permits individuals to purchase medicines directly from overseas suppliers via the Personal Importation Scheme. Individuals can either import medicines for their own use or that of an immediate family member. For some patients, importing medicines is the only way they can access the medicines they need due to lack of availability or affordability in Australia. This article analyses the therapeutic goods law to clarify offences that may apply to those who import medicines for their own use or that of an immediate family member. Considering the findings, legislative amendments are recommended for the purpose of protecting patients who import medicines for legitimate health care needs.

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.

Regulating autologous stem cell interventions in Australia: updated review of the direct-to-consumer advertising restrictions.

Objective This paper provides an update and overview of the law governing direct-to-consumer (DTC) advertising of autologous stem cell interventions (ASCIs) in Australia. It follows significant changes to the advertising regulations made in 2018. Methods The paper reviews the three primary sources or 'centres' of law regulating ASCIs in Australia, together with the relevant guidance documents that supplement these sources. It provides analysis of how the post-2018 advertising regulations, contained in the Therapeutic Goods Act 1989 (Cwlth), apply to all 'biologicals', including ASCIs. It demonstrates how these three sources of law interact with one another and outlines the new tiered offence regime that applies to contraventions of these prohibitions. Results The analysis demonstrates that DTC advertising of ASCIs in Australia is strictly controlled, with primary legislation prohibiting the advertising of biologicals altogether. Conclusions The polycentric legal regime regulating biologicals in Australia clearly makes DTC advertising of ASCIs unlawful. Health practitioners who promote ASCIs, either online, in print or in other media forms, may be penalised in different ways and by different authorities. What is known about the topic? Although several analyses have examined the regulation of ASCIs in Australia, no analysis has studied the reforms made in 2018 relating to the advertising of biologicals. As such, this analysis contributes a fresh examination of these relatively recent reforms. What does this paper add? This analysis clarifies the effects of these new advertising regulations, providing clear guidance on the relevant legal provisions for the benefit of health practitioners and health professionals more generally. What are the implications for practitioners? Health practitioners, especially those who offer ASCIs, should be aware that civil and criminal penalties are likely to be imposed on individuals who promote biologicals in Australia by any means.

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.

Death, dying and donation: community perceptions of brain death and their relationship to decisions regarding withdrawal of vital organ support and organ donation.

Despite brain death (BD) being established as a definition of death for over 50 years, the concept remains controversial. Little is known about public perception of death determination in decision-making about withdrawal of organ support and organ donation (OD), and the importance of the 'Dead Donor Rule' (DDR). We examined perceptions about death in a BD patient and their relationship to decisions about withdrawal of vital organ support, OD and the DDR, using an online survey of 1017 Australian adults. A BD patient scenario was presented, followed by a series of questions. Statistically significant differences in responses were determined using repeated measures analyses of variance and t tests. Seven hundred and fourteen respondents (70.2%) agreed that a hypothetical BD patient was dead. Those disagreeing most commonly cited the presence of heartbeat and breathing. Seven hundred and seventy (75.7%) favoured removal of 'life support', including 136 (13.3%) who had not agreed the patient was dead. Support for OD was high, but most favoured organ removal only after heartbeat and breathing had ceased. Where OD was in keeping with the patient's known wishes, 464 (45.6%) agreed that organs could be removed even if this caused death. Forty-one (20%) of those who had indicated they considered the patient was not dead agreed to organ removal even if it caused death. Australian public views on BD, withdrawal of 'life support' and OD are complex. Emphasis on prognosis and the impact of significant brain injury may be more appropriate in these situations, rather than focussing on death determination and upholding the DDR.

Emergency department care for low back pain: Should we adopt recommendations from primary care guidelines?

ED visits for low back pain are increasing, but the lack of specific guidance for emergency physicians impedes evidence-based care, and adopting primary care recommendations may not be appropriate. The ED sees a different spectrum of low back pain presentations, where physicians are likely to encounter a larger proportion of patients with an underlying serious pathology or non-spinal diseases than in primary care. Current low back pain guidelines do not adequately cover screening for these conditions, but making a differential diagnosis is crucial in emergency patients with low back pain. In this article, we also discuss the challenges in developing specific ED guidelines for low back pain, the limited evidence on the profile of these patients and the surprising dearth of randomised trials.