Commercialisation of regenerative human tissue : Regulation and reform in Australia and England, Wales and Northern Ireland

The commercialisation of therapeutic products containing regenerative human tissue is regulated by the common law, statute and ethical guidelines in Australia and England, Wales and Northern Ireland. This article examines the regulatory regimes in these jurisdictions and considers whether reform is required to both support scientific research and ensure conformity with modern social views on medical research and the use of human tissue. The authors consider the crucial role of informed consent in striking the balance between the interests of researchers and the interests of the public.

Knowing a donor and identifying as one : determinants of people's willingness for related and anonymous living donation in Australia

While LRD (living donation to a genetically/emotionally related recipient) is well established in Australia, LAD (living anonymous donation to a stranger) is rare. Given the increasing use of LAD overseas, Australia may likely follow suit. Understanding the determinants of people’s willingness for LAD is essential but infrequently studied in Australia. Consequently, we compared the determinants of people’s LRD and LAD willingness, and assessed whether these determinants differed according to type of living donation. We surveyed 487 health students about their LRD and LAD willingness, attitudes, identity, prior experience with blood and organ donation, deceased donation preference, and demographics. We used Structural Equation Modelling (SEM) to identify the determinants of willingness for LRD and LAD and paired sample t-tests to examine differences in LRD and LAD attitudes, identity, and willingness. Mean differences in willingness (LRD 5.93, LAD 3.92), attitudes (LRD 6.43, LAD 5.53), and identity (LRD 5.69, LAD 3.58) were statistically significant. Revised SEM models provided a good fit to the data (LRD: x2 (41) = 67.67, p = 0.005, CFI = 0.96, RMSEA = 0.04; LAD: x2 (40) = 79.64, p < 0.001, CFI = 0.95, RMSEA = 0.05) and explained 45% and 54% of the variation in LRD and LAD willingness, respectively. Four common determinants of LRD and LAD willingness emerged: identity, attitude, past blood donation, and knowing a deceased donor. Religious affiliation and deceased donation preference predicted LAD willingness also. Identifying similarities and differences in these determinants can inform future efforts aimed at understanding people’s LRD and LAD willingness and the evaluation of potential living donor motives. Notably, this study highlights the importance of people’s identification as a living donor as a motive underlying their willingness to donate their organs while living.

Queensland Emergency Medical System : a structural and organizational model for the emergency medical system in Australia

Objective: The emergency medical system (EMS) can be defined as a comprehensive, coordinated and integrated system of care for patients suffering acute illness and injury. The aim of the present paper is to describe the evolution of the Queensland Emergency Medical System (QEMS) and to recommend a strategic national approach to EMS development. Methods: Following the formation of the Queensland Ambulance Service in 1991, a state EMS committee was formed. This committee led the development and approval of the cross portfolio QEMS policy framework that has resulted in dynamic policy development, system monitoring and evaluation. This framework is led by the Queensland Emergency Medical Services Advisory Committee. Results: There has been considerable progress in the development of all aspects of the EMS in Queensland. These developments have derived from the improved coordination and leadership that QEMS provides and has resulted in widespread satisfaction by both patients and stakeholders. Conclusions: The strategic approach outlined in the present paper offers a model for EMS arrangements throughout Australia. We propose that the Council of Australian Governments should require each state and Territory to maintain an EMS committee. These state EMS committees should have a broad portfolio of responsibilities. They should provide leadership and direction to the development of the EMS and ensure coordination and quality of outcomes. A national EMS committee with broad representation and broad scope should be established to coordinate the national development of Australia's EMS.

Health law in Australia

Health Law in Australia is the first book to deal with health law on a comprehensive national basis. In a field of law that is becoming increasingly important and where the demand for expertise is rapidly expanding, Health Law in Australia takes a logical, structured approach to an examination of the law in all Australian jurisdictions. By covering all the major areas in this diverse field of law, Health Law in Australia enhances the understanding of the discipline as a whole. Beginning with an exploration of the general principles of health law, including chapters on “Medical Negligence”, “Children and Consent”, and “Confidentiality, Privacy, and Access to Health Records”, the book goes on to consider beginning-of-life and end-of-life issues before concluding with chapters on emerging areas in health law, such as biotechnology and medical research. The contributing authors include national leaders in the field who are specialists in these areas of health law and who can therefore reveal to readers the results of their research. Health Law in Australia has been written for those with a legal background and is essential reading for undergraduate law students, postgraduate law students, researchers and scholars in the disciplines of law, health and medicine, as well as legal practitioners, government departments and bodies in the health area, and private health providers.

A national framework for disaster health education in Australia

INTRODUCTION: Recent events have heightened awareness of disaster health issues and the need to prepare the health workforce to plan for and respond to major incidents. This has been reinforced at an international level by the World Association for Disaster and Emergency Medicine, which has proposed an international educational framework. ----------- OBJECTIVE: The aim of this paper is to outline the development of a national educational framework for disaster health in Australia. ----------- METHODS: The framework was developed on the basis of the literature and the previous experience of members of a National Collaborative for Disaster Health Education and Research. The Collaborative was brought together in a series of workshops and teleconferences, utilizing a modified Delphi technique to finalize the content at each level of the framework and to assign a value to the inclusion of that content at the various levels. ----------- FRAMEWORK: The framework identifies seven educational levels along with educational outcomes for each level. The framework also identifies the recommended contents at each level and assigns a rating of depth for each component. The framework is not intended as a detailed curriculum, but rather as a guide for educationalists to develop specific programs at each level. ----------- CONCLUSIONS: This educational framework will provide an infrastructure around which future educational programs in Disaster Health in Australia may be designed and delivered. It will permit improved articulation for students between the various levels and greater consistency between programs so that operational responders may have a consistent language and operational approach to the management of major events.

Pandemic (H1N1) 2009 Influenza Outbreak in Australia: Impact on Emergency Departments.

Executive summary Objective: The aims of this study were to identify the impact of Pandemic (H1N1) 2009 Influenza on Australian Emergency Departments (EDs) and their staff, and to inform planning, preparedness, and response management arrangements for future pandemics, as well as managing infectious patients presenting to EDs in everyday practice. Methods This study involved three elements: 1. The first element of the study was an examination of published material including published statistics. Standard literature research methods were used to identify relevant published articles. In addition, data about ED demand was obtained from Australian Government Department of Health and Ageing (DoHA) publications, with several state health departments providing more detailed data. 2. The second element of the study was a survey of Directors of Emergency Medicine identified with the assistance of the Australasian College for Emergency Medicine (ACEM). This survey retrieved data about demand for ED services and elicited qualitative comments on the impact of the pandemic on ED management. 3. The third element of the study was a survey of ED staff. A questionnaire was emailed to members of three professional colleges—the ACEM; the Australian College of Emergency Nursing (ACEN); and the College of Emergency Nursing Australasia (CENA). The overall response rate for the survey was 18.4%, with 618 usable responses from 3355 distributed questionnaires. Topics covered by the survey included ED conditions during the (H1N1) 2009 influenza pandemic; information received about Pandemic (H1N1) 2009 Influenza; pandemic plans; the impact of the pandemic on ED staff with respect to stress; illness prevention measures; support received from others in work role; staff and others’ illness during the pandemic; other factors causing ED staff to miss work during the pandemic; and vaccination against Pandemic (H1N1) 2009 Influenza. Both qualitative and quantitative data were collected and analysed. Results: The results obtained from Directors of Emergency Medicine quantifying the impact of the pandemic were too limited for interpretation. Data sourced from health departments and published sources demonstrated an increase in influenza-like illness (ILI) presentations of between one and a half and three times the normal level of presentations of ILIs. Directors of Emergency Medicine reported a reasonable level of preparation for the pandemic, with most reporting the use of pandemic plans that translated into relatively effective operational infection control responses. Directors reported a highly significant impact on EDs and their staff from the pandemic. Growth in demand and related ED congestion were highly significant factors causing distress within the departments. Most (64%) respondents established a ‘flu clinic’ either as part of Pandemic (H1N1) 2009 Influenza Outbreak in Australia: Impact on Emergency Departments. the ED operations or external to it. They did not note a significantly higher rate of sick leave than usual. Responses relating to the impact on staff were proportional to the size of the colleges. Most respondents felt strongly that Pandemic (H1N1) 2009 Influenza had a significant impact on demand in their ED, with most patients having low levels of clinical urgency. Most respondents felt that the pandemic had a negative impact on the care of other patients, and 94% revealed some increase in stress due to lack of space for patients, increased demand, and filling staff deficits. Levels of concern about themselves or their family members contracting the illness were less significant than expected. Nurses displayed significantly higher levels of stress overall, particularly in relation to skill-mix requirements, lack of supplies and equipment, and patient and patients’ family aggression. More than one-third of respondents became ill with an ILI. Whilst respondents themselves reported taking low levels of sick leave, respondents cited difficulties with replacing absent staff. Ranked from highest to lowest, respondents gained useful support from ED colleagues, ED administration, their hospital occupational health department, hospital administration, professional colleges, state health department, and their unions. Respondents were generally positive about the information they received overall; however, the volume of information was considered excessive and sometimes inconsistent. The media was criticised as scaremongering and sensationalist and as being the cause of many unnecessary presentations to EDs. Of concern to the investigators was that a large proportion (43%) of respondents did not know whether a pandemic plan existed for their department or hospital. A small number of staff reported being redeployed from their usual workplace for personal risk factors or operational reasons. As at the time of survey (29 October –18 December 2009), 26% of ED staff reported being vaccinated against Pandemic (H1N1) 2009 Influenza. Of those not vaccinated, half indicated they would ‘definitely’ or ‘probably’ not get vaccinated, with the main reasons being the vaccine was ‘rushed into production’, ‘not properly tested’, ‘came out too late’, or not needed due to prior infection or exposure, or due to the mildness of the disease. Conclusion: Pandemic (H1N1) 2009 Influenza had a significant impact on Australian Emergency Departments. The pandemic exposed problems in existing plans, particularly a lack of guidelines, general information overload, and confusion due to the lack of a single authoritative information source. Of concern was the high proportion of respondents who did not know if their hospital or department had a pandemic plan. Nationally, the pandemic communication strategy needs a detailed review, with more engagement with media networks to encourage responsible and consistent reporting. Also of concern was the low level of immunisation, and the low level of intention to accept vaccination. This is a problem seen in many previous studies relating to seasonal influenza and health care workers. The design of EDs needs to be addressed to better manage infectious patients. Significant workforce issues were confronted in this pandemic, including maintaining appropriate staffing levels; staff exposure to illness; access to, and appropriate use of, personal protective equipment (PPE); and the difficulties associated with working in PPE for prolonged periods. An administrative issue of note was the reporting requirement, which created considerable additional stress for staff within EDs. Peer and local support strategies helped ensure staff felt their needs were provided for, creating resilience, dependability, and stability in the ED workforce. Policies regarding the establishment of flu clinics need to be reviewed. The ability to create surge capacity within EDs by considering staffing, equipment, physical space, and stores is of primary importance for future pandemics.

A policy case study of blood in Australia

In 2008 the Australian government decided to remove white blood cells from all blood products. This policy of universal leucodepletion was a change to the existing policy of supplying leucodepleted products to high risk patients only. The decision was made without strong information about the cost-effectiveness of universal leucodepletion. The aims for this policy analysis are to generate cost-effectiveness data about universal leucodepletion, and to add to our understanding of the role of evidence and the political reality of healthcare decision-making in Australia. The cost-effectiveness analysis revealed universal leucodepletion costs $398,943 to save one year of life. This exceeds the normal maximum threshold for Australia. We discuss this result within the context of how policy decisions are made about blood, and how it relates to the theory and process of policy making. We conclude that the absence of a strong voice for cost-effectiveness was an important omission in this decision.

Access and Quality of Heart Failure Management Programs in Australia

Background/aim In response to the high burden of disease associated with chronic heart failure (CHF), in particular the high rates of hospital admissions, dedicated CHF management programs (CHF-MP) have been developed. Over the past five years there has been a rapid growth of CHF-MPs in Australia. Given the apparent mismatch between the demand for, and availability of CHF-MPs, this paper has been designed to discuss the accessibility to and quality of current CHF-MPs in Australia. Methods The data presented in this report has been combined from the research of the co-authors, in particular a review of the inequities in access to chronic heart failure which utilised geographical information systems (GIS) and the survey of heterogeneity in quality and service provision in Australian. Results Of the 62 CHF-MPs surveyed in this study 93% (58) centres had been located areas that are rated as Highly Accessible. This result indicated that most of the CHF-MPs have been located in capital cities or large regional cities. Six percent (4 CHF-MPs) had been located in Accessible areas which were country towns or cities. No CHF-MPs had been established outside of cities to service the estimated 72,000 individuals with CHF living in rural and remote areas. 16% of programs recruited NYHA Class I patients and of these 20% lacked confirmation (echocardiogram) of their diagnosis. Conclusion Overall, these data highlight the urgent need to provide equitable access to CHF-MP's. When establishing CHF-MPs consideration of current evidence based models to ensure quality in practice.

Understanding the role of knowledge in the practice of expert nephrology nurses in Australia

This paper, which is abstracted from a larger study into the acquisition and exercise of nephrology nursing expertise, aims to explore the role of knowledge in expert practice. Using grounded theory methodology, the study involved 17 registered nurses who were practicing in a metropolitan renal unit in New South Wales, Australia. Concurrent data collection and analysis was undertaken, incorporating participants' observations and interviews. Having extensive nephrology nursing knowledge was a striking characteristic of a nursing expert. Expert nurses clearly relied on and utilized extensive nephrology nursing knowledge to practice. Of importance for nursing, the results of this study indicate that domain-specific knowledge is a crucial feature of expert practice.

Palliative care, double effect and the law in Australia

Care and decision-making at the end of life that promotes comfort and dignity is widely endorsed by public policy and the law. In ethical analysis of palliative care interventions that are argued potentially to hasten death, these may be deemed to be ethically permissible by the application of the doctrine of double effect, if the doctor’s intention is to relieve pain and not cause death. In part because of the significance of ethics in the development of law in the medical sphere, this doctrine is also likely to be recognized as part of Australia’s common law, although hitherto there have been no cases concerning palliative care brought before a court in Australia to test this. Three Australian States have, nonetheless, created legislative defences that are different from the common law with the intent of clarifying the law, promoting palliative care, and distinguishing it from euthanasia. However, these defences have the potential to provide less protection for doctors administering palliative care. In addition to requiring a doctor to have an appropriate intent, the defences insist on adherence to particular medical practice standards and perhaps require patient consent. Doctors providing end-of-life care in these States need to be aware of these legislative changes. Acting in accordance with the common law doctrine of double effect may not provide legal protection. Similar changes are likely to occur in other States and Territories as there is a trend towards enacting legislative defences that deal with the provision of palliative care.