A new coalition for health reform?

In an era of active health reform, what might we expect from the new Australian Government?

Health systems around the world are grappling with many common challenges: rising costs and finite resources; the growing burden of chronic and lifestyle-related diseases; ageing populations; emerging technologies; and information-rich consumers with high expectations. Each nation’s approach to tackling these challenges is influenced by its history, societal values, legacy health systems and political environment.

Australia’s health system is in an era of active reform, but the journey is far from over.1 The election of the new federal Coalition government is an opportunity to advance reform with a new focus aligned with the Coalition’s priorities for our nation. So what might those priorities
be in relation to health?

Three broad policy themes articulated by the Coalition could form the practical and philosophical foundations
for significant reforms in the health sector. First, Prime Minister Abbott has declared his desire to be the “infrastructure Prime Minister” by investing in nation-building projects.2 Second, the Coalition has promised strong fiscal management and national debt reduction. And third, Coalition policy continues to support the role of the private sector in the financing and delivery of health services, within a mixed public–private system. These themes point to some areas where health reform priorities may align with the broader policy priorities of the new government.

Infrastructure — beyond hospitals

When considering infrastructure needs in health, we are likely to first think in terms of hospitals. But there are other strategic investments in national infrastructure — both physical facilities and system enablers — that would drive efficiency, support quality and enable a more agile and responsive health system for the future. Priorities worthy of consideration are subacute care services, national
e-health and data systems, and research infrastructure.

The National Health and Hospitals Reform Commission (NHHRC) described subacute services — including rehabilitation, geriatric evaluation and management services, and transition care — as a long-neglected “missing link” in the health system and a prime candidate for a major capital boost.3 In 2008 and 2011, two National Partnership Agreements provided an initial capital boost.4 The 2008 agreement alone increased subacute services by more than 600 000 extra bed-day equivalents by the 2011–12 financial year, representing an above-target increase of 25.9%.5 However, neither agreement has so far been extended. The 2008 agreement fell over the fiscal cliff in June 2013; the 2011 agreement will expire in June this year. Subacute services need further investment rather than being wound back. Without urgent attention, pressure will again build on public hospitals as the more costly “default” environment for care.

Australia’s e-health infrastructure was identified as
a national priority by the NHHRC3 and the National Primary Health Care Strategy,6 yet it is still woefully underdeveloped. Prime Minister Abbott has long recognised its importance: his first speech as health minister in 2003 was on the subject of e-health.7 The new Coalition government has provided strong in-principle support for shared electronic health records, starting with a review of the implementation of the personally controlled electronic health record initiative.

Beyond the concept of shared records, health is also lagging far behind other sectors in the smart use of data
for stronger systems management, quality improvement, and health services and health policy research. Recommendation 34 of the NHHRC, calling for national linkage of health data for access by clinicians, researchers and health managers,3 has not been implemented.

Increasingly, the “e-world” is offering innovative options for better access to information, advice, care and coordination. Telehealth provides another “setting” of care, while mobile health and digital health tools empower patients with timely advice. Australia’s infrastructure investment and financing systems need to recognise and support this shifting health delivery environment.

Fiscal management — best value for the
health dollar

Waste in health is an ethical issue, and getting the best value for every health dollar is a worthy priority. The good news is there are many opportunities to improve efficiency in the health sector.8

Health financing systems need to support appropriate and connected care across the continuum of care, whether delivered in acute, subacute or community settings. The Australian health system’s silos of funding and fragmented delivery remain unresolved challenges and often encourage care in an inappropriate setting (eg, in a hospital bed rather than in the community mental health service or outpatient rehabilitation program). Prevention, active management of health risks, early detection and intervention also play a role in the efficiency equation.

The desire to tackle waste and inefficiency is unquestioned. But policymakers and system managers are currently unable to fully harness and leverage the power
of data to make informed decisions. The smart use of data was a key recommendation of the NHHRC.3 Data linked from multiple sources, such as the Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, and public and private hospitals, could be analysed to show patterns of unwarranted clinical variation and to identify opportunities for improved efficiency and appropriate care. Providing comparative clinical performance data directly to clinicians offers information to those in the best position to change practice and to increase both quality and efficiency of care. By reducing errors and duplication, personally controlled electronic health records can be expected to increase real output in the hospital and medical services sector by up to 6%,8 as well as empowering and informing people in their own health care decisions.

Public–private system — next-generation Medicare

Although governments contribute two-thirds of the funding for Australia’s health care, two-thirds of health care is provided through the private sector (ie, through private and non-profit health service providers).9 Recognition of the private sector’s vital role is imperative for genuine health system reform. An immediate priority could be focusing on better linkages between public and private providers in the integrated delivery of health and aged care at a local level. The network of primary health care organisations (Medicare Locals) that has been established could play an important role in this. Contestability and contracting of public services to
achieve better value for the public health dollar should
be examined.

Medicare is and should continue to be the backbone of Australia’s universal health care entitlement. However, entitlement does not always translate to access. The public sector cannot always deliver on its promise or deliver the best value. The Coalition might also explore the NHHRC’s Medicare Select model, which potentially offers a better use of public and private health resources.3 Greater consumer choice in selecting a preferred health and hospital plan could drive innovation, responsiveness and efficiencies across the entire system.10 It is time to start preparing for the next generation of Medicare — a more agile, person-centred system, delivering the universal Medicare entitlement through active purchasing, with public, private and non-profit providers all competing
to deliver high-value, high-quality care.

Responding to the Christmas Island health care crisis

To the Editor: Recent media reports of unsafe maternal and child health practices at the Christmas Island immigration detention centre suggest an alarming contrast between the care available to asylum seekers and that available to Australian nationals.1,2 The reports also appear at odds with the Department of Immigration and Border Protection’s factsheet that states: “All detainees in immigration detention have access to health care at a standard generally comparable to the health care available to the Australian community”3 — though the use of “generally” allows for unqualified departure from the standard.

Australia’s low infant mortality rate (3.3/1000 births)4 is testament to high-quality specialist antenatal, perinatal and child health services. Yet on Christmas Island, where pregnant women are detained and for whom Australia has a duty of care, there is
no sonographer. A pregnant woman who was denied an ultrasound and miscarried was apparently told:
“They keep telling me that you are in detention centre and should not expect a lot”.1 This seems somewhat callous — since current policy appears designed to routinely detain pregnant women on Christmas Island. In our view, if this is to happen, then it is reasonable for a mother to expect access to appropriate antenatal and perinatal care, and for that care to be provided.

Doctors providing services on
the island have raised concerns that routine developmental screening and assessment does not occur for children, and that specialist paediatric mental health support is not available.2 While we oppose the detention of children,
if it occurs, then adequate child health services must be provided.

Remoteness is not an excuse: Australia has considerable history
and expertise in providing health
care services against geographical challenges, whether by specialist outreach services or by aeromedical retrieval. Australia also has one of the largest reported paediatric telemedicine services, which has provided specialist advice, including in perinatal care
and child and youth mental health, throughout Queensland since 1999.5 While local clinical resources clearly need to be increased, support could
and should be provided to clinicians through the appropriate use of telemedicine. It need not be technically complex or expensive, and the necessary resources exist within Australia.

Mental health emergency transport: the pot-holed road to care

Historically, police have had powers under successive mental health legislation to apprehend people with mental illnesses without a warrant. This is a widespread practice around the world and in all Australian states. Further, police are frequently the first point of contact for people with a mental illness in the Australian community, particularly after hours when mental health crisis team resources are limited.1 However, people living with mental illness are increasingly recognised as a vulnerable population with high rates of exposure to traumatic life events;2 and many are exposed to distressing experiences within mental health care systems. Being transported in handcuffs in a police vehicle has recurrently been reported as particularly distressing3 (see also John’s experience in the fictional scenario4). A submission to the Australian Human Rights Commission’s “Not for Service” inquiry summed up the experience within the context of perceived mental health service failures:

Because intervention comes so late, consumers and families report that once the police are involved and no matter how the police are, there is still a sense of not being treated with dignity . . . “I know when I get sick that I quickly lose insight and will resist treatment but I am sick and there I am being handcuffed by police. No other groups of people with an illness are treated like this. Why are we? Surely there can be a better way. I think it starts with me being able to say, I’m becoming unwell and clinicians taking me seriously”.5

Recent changes to legislation in New South Wales sought to reduce police involvement in mental health by expanding state coercive powers to paramedics and registered mental health practitioners. While paramedics are taking on more emergency mental health responsibilities, police involvement does not appear to have been substantively reduced. New ways of thinking about community mental health responses are required. The primary aim of this discussion is to explore factors that may contribute to ongoing reliance on police involvement in transporting people affected by mental illness, by examining the Mental Health Act and the ensuing interagency response to mental health incidents.

Current mental health legislation

Under the current Mental Health Act 2007 (NSW), police may apprehend and transport a person to a declared mental health facility (DMHF) for psychiatric assessment if the officer believes the person: is committing or has recently committed an offence; has recently attempted or is probably going to attempt to kill himself or herself or someone else; or will probably attempt to cause serious physical harm to himself or herself or someone else (s. 22(1)(a)); and that it would be “beneficial to the person’s welfare” to be dealt with under mental health, rather than criminal, legislation (s. 22(1)(b)). This is in keeping with the enacted mission statement of the NSW Police Force, which provides for “the protection of persons from injury or death . . . whether arising from criminal acts or any other way” (Police Act 1990 (NSW), s. 6(3)(b)). The Mental Health Act allows police to divert people whom they suspect have a mental illness to health system, rather than justice system, end points.

The remarkable revisions enacted in the 2007 Mental Health Act extended state coercive powers to NSW Ambulance paramedics (s. 20) and other accredited NSW Health practitioners (s. 19 and s. 23), authorising them to detain and transport people living with mental illness to a DMHF for assessment. Paramedics and mental health practitioners were given powers to use “reasonable force” (s. 81(2)(a)) and physical restraint (s. 81(2)(b)), and trained paramedics could administer sedation (s. 81(3)). Paramedics were given authority to request police involvement where there were serious concerns for safety (s. 20(2)), and both paramedics and mental health practitioners could request police assistance, where practicable (s. 21(1)).

Evaluating the outcomes of changes to the Mental Health Act

Statewide statistics provided by the NSW Mental Health Review Tribunal (MHRT)6 suggest that transport by police (under s. 22 of the Mental Health Act) has remained stable, at about 20% of all presentations to DMHFs. In contrast, transport by paramedics (under s. 20) has increased to 6% (Box). These data do not include transport by police under other sections of the Act.

The Ambulance Service of NSW has estimated that of all occasions of transporting people affected by mental illness in an ambulance, only about 2% per year involve involuntary transport (personal communication, Kevin McLaughlin, Manager Mental Health, Ambulance Service of NSW). This low scheduling rate may reflect NSW Ambulance policy that decisions undertaken by paramedics to transport a person against his or her will should be viewed as an option of last resort. Further, it may reflect people’s preference to be taken to the nearest health facility that has the resources to provide care, which may not necessarily be a DMHF if people agree to be transported voluntarily.

The NSW Police Force estimated that they responded to about 34 000 mental health-related incidents statewide in 2009.7 In 2012, there were 38 534 such incidents, with about two-thirds resulting in a designated police function under the Mental Health Act (eg, transfer from court, interhospital transport) and including about 12 000 occasions of police detaining people under s. 22 (data obtained by M I). In the 6 months to May 2013, police detained 6149 people under s. 22 of the Mental Health Act across NSW, according to the NSW Police database (Computerised Operational Policing System [COPS]; data obtained by M I). Police do not necessarily transport all people detained under s. 22. Increasingly, people detained by police are then transported by ambulance to a DMHF; however, no records of this are kept. Further, there is a significant discrepancy between the number of people detained involuntarily by police in 2012 recorded by NSW Police and the number recorded by the MHRT (12 000 v 3000, respectively) that challenges the veracity of the available data. High-quality baseline data are required for accurately estimating the extent of police and ambulance involvement in the transport of people with mental illness across regions, and for evaluating outcomes resulting from changes to policy.

Problems with the current legislation

Risk of serious harm is the guiding principle

Under the Mental Health Act, a mentally ill or mentally disordered person is a person who is suffering from mental illness (s. 14) and/or whose present behaviour is “so irrational” (s. 15) that immediate care, treatment or control is necessary to protect the person or others from serious harm. “Risk of serious harm” is the guiding principle in any decision by mental health practitioners, paramedics and police to invoke a non-consensual intervention under the Mental Health Act.

The most significant implication of the sole reliance on this criterion is that a person’s mental health must deteriorate to the point that they become a serious harm risk before intervention through non-consensual action is legitimate. At the point where a person living with mental illness reaches a point of risk of serious harm, the probability of police involvement appears to increase according to the severity of risk.

Lack of capacity is not taken into account

Decisional capacity refers in this context to the mental competence of a person to make his or her own health care decisions. Legally and ethically, it is argued that competence is essential for autonomy, as only competent decisions reflect a person’s free will.8 Two important assumptions regarding decisional capacity should be noted: first, capacity is not necessarily global to the person but may be relative to a situation or decision; and second, it is a threshold concept, perhaps best understood in terms of a degree of capacity.9 The formal assessment of capacity must be made by a trained clinician, but carers and people living with mental illness may become attuned to signs that a period of diminishing capacity may be approaching.

A strong proponent for the use of capacity as a criterion in mental health legislation, Ryan, argues that the loss of capacity is not an all-or-none phenomenon, and suggests that a range of supported decision-making processes, including advance directives, could be instigated.10 This may help fill the apparent gap in service provision between when a person loses decisional capacity and when they pose a risk of serious harm. Ryan and others have argued that using capacity to determine the threshold for non-consensual treatment would provide a legal and ethical justification for earlier intervention.10 Doctors, carers, mental health practitioners and people living with mental illness could activate a legal mechanism for non-consensual intervention for assessment before the onset of high-risk behaviour. In principle, this has the potential to increase the capacity of mental health services to assist people living with mental illness, and may reduce the necessity for emergency responses.

The Act embodies legal, not benevolent, paternalism

The current mental health laws have evolved from centuries-old English laws that originally served the purpose of protecting society (preventive detention).11 Over time, the focus became care and treatment for the person — benevolent paternalism (parens patriae)12 — by which “we decide for him as we assume he would decide for himself if he were of sound mind”.11

Under the current Mental Health Act, however, paternalism is based on criteria other than the individual’s own presumed choices. This legal paternalism, based on harm, is distinguishable from benevolent paternalism, which would be based on capacity. This is a disquieting ethical–legal contradiction deserving the attention of policymakers.

Implications for practice of the changes to the Mental Health Act

A memorandum of understanding (MOU) was developed between NSW Health, the Ambulance Service of NSW and the NSW Police Force to delineate interagency roles and responsibilities during a mental health emergency. It stipulates that police should be involved only in high-risk situations.13 Nevertheless, the capacity of the MOU to cover the complexities of real-world mental health emergencies is limited by practicalities — for instance, mental health practitioners may not be available after hours; there may not be onsite interagency agreement on the person’s presenting level of risk; nor may there be ready availability of an appropriate transport vehicle. Additionally, in the many regional and rural centres across NSW, the drive to the nearest DMHF may involve extreme distances and take a long time.

Advances in online technologies and the availability of videoconferencing call into question the transporting of people living with mental illness long distances for assessment. The Mental Health Emergency Care — Rural Access Program trialled the use of videoconferencing to provide rural and regional hospitals in western NSW with timely access to expert mental health assessments.14 Among other positive outcomes, there was a significant reduction in the referral rate (ie, transport) to the distant DMHF, from 73% to 52% of all admissions by the end of the 20-month study. The program has continued as usual practice at the trial site and is being extended to neighbouring areas.

A number of other strategies are being developed with the aim of limiting the occasions when police are the primary providers of transport for people living with mental illness and reducing police involvement to an interagency support role. For instance, NSW Health has developed a fabric mechanical restraint device that is now used by paramedics when physical restraint is required. This reduces the use of police handcuffs and caged vehicles, and enables clinical monitoring of the person during ambulance transport.

For people living with mental illness, access to voluntary inpatient services is an important consensual pathway to care; however, access is not universal. Regional and rural areas in particular are poorly served. For the foreseeable future at least, the pathway to inpatient assessment for many people continues to involve emergency transport to DMHFs. Limiting the need for police attendance may be achieved by developing a model of care that aims to prevent situations where police are involved in mental health interventions.

Ethics in practice: case scenario

In the accompanying scenario4 there is a point where John’s parents and his caseworker, Kate, are all concerned that John is showing signs of serious deterioration. At the point where Kate advises John’s parents that she cannot force John to receive care there may be strong ethical grounds for non-consensual intervention. It appears that John’s decisional capacity has been reduced by his illness, perhaps beyond the point where he could be considered competent enough to be self-determining. At this point, Kate could arrange for a clinician who is qualified to assess capacity to visit John to determine whether his decisional capacity is critically compromised. If so, the Mental Health Act could be invoked to transfer responsibility for care decisions temporarily from John to the state, to provide the care that John would presumably choose for himself were he of sound mind.

Conclusions

The issue of ongoing police involvement in mental health services beyond high-risk situations is vexed. Two major contributors to ongoing reliance on police involvement are the enacted risk-of-serious-harm criteria and rural and regional resourcing issues.

There is an ethical imperative for earlier intervention in mental health situations. While police will always need to attend situations involving high risk for any member of the community, an earlier, more therapeutic intervention is required for a person living with mental illness who is losing the capacity to determine his or her own health care needs. A legal mechanism for non-consensual assessment based on decisional capacity could be explored. People living with mental illness could be supported, during periods of capacity, to identify indicators of diminished capacity as key intervention points, and doctors making clinical assessments in chronic and potential first-episode psychosis could give serious consideration to capacity. Thinking about capacity at an earlier intervention point may reduce the number of people requiring an emergency response. Further, making telehealth programs available in more rural and regional areas could help minimise long-distance transport. The establishment of reliable incidence statistics for emergency mental health transport would enable accurate assessment of the effects of policy changes on practice.

Ideally, people living with mental illness should be able to access quality mental health services voluntarily, long before non-consensual intervention is required. Once voluntary options have been exhausted, the point at which a person loses decisional capacity may represent an earlier, more benevolent juncture for non-consensual intervention. Reaching the point of emergency services intervention in a mental health incident should be the last option along the pot-holed road to care.

Statewide statistics concerning people taken to a mental health facility under the Mental Health Act 2007 (NSW)7

	Police (s. 22),* no. (%)			Ambulance (s. 20),* no. (%)
Financial year	Admitted	Not admitted	Total†	Admitted	Not admitted	Total†	Total no. presentations‡

2008–09	2712 (80%)	682 (20%)	3394 (22%)	263 (99%)	4 (1%)	267 (2%)	15 496
2009–10	2536 (74%)	889 (26%)	3425 (23%)	494 (85%)	88 (15%)	582 (4%)	15 199
2010–11	2293 (71%)	940 (29%)	3233 (22%)	669 (69%)	301 (31%)	970 (7%)	14 566
2011–12	2150 (69%)	968 (31%)	3118 (20%)	742 (73%)	272 (27%)	1014 (6%)	15 765

* These data refer to the Mental Health Act ss. 20 (paramedics) and 22 (police) only and do not include mental health transports by police under other sections of the Act, including police assistance to ambulance (s. 21), doctors and accredited persons (s. 19), carers (s. 23 and s. 26), courts (s. 33), breach of Community Treatment Orders (s. 142 and s. 58), nor voluntary or informal transports by police or paramedics. † Proportion of total agency (police or ambulance) transports (under schedule) to total presentations at mental health facilities (NSW Health). ‡ Does not include people reclassified from informal to involuntary.

AMA Careers Advisory Service

From graduates preparing their first resume to experienced doctors seeking to carve out a new career path in the Commonwealth public service, the AMA Careers Advisory Service is been on hand to provide practical advice and information.

Since the Service was launched in September, AMA Careers Consultant, Kathryn Morgan, has handled dozens of inquiries from members looking for help and advice on advancing their careers, both within medicine and beyond.

The Careers website, which is at: http://careers.ama.com.au/, gives members access to both general and specific careers advice and information. In addition to direct links to external websites and specific sources of information, the Service also offers practical advice for medical professionals as their medical careers advance.

The Careers Service provides information and support relevant to all stages of an individual’s career, from medical students looking for assistance preparing internship applications – particularly writing resumes and covering letters – through to doctors in training who want to brush up their interview skills to give them a competitive edge at all-important medical college interviews.

But the Service is not only there for those in the early stages of their medical careers. It has also helped qualified medical professionals looking to apply their skills and expertise in jobs beyond medical practice. Among these have been those looking for non-clinical roles in Commonwealth and State public services that take advantage of their skills and experience.

The Service is constantly updating content on its website, including listings of career-related events being staged across the country, and uses feedback from members to help add and develop resources.

Members are encouraged to visit the website, if they haven’t done so already, and we welcome feedback, which can be submitted via the online feedback form on the website.

There will be further updates on developments in the Careers Service in coming months as we develop more ways to assist members along their medical career path.

If you or your colleagues would like to convene a skills workshop facilitated by Kathryn, please contact her at:

Phone: (02) 6270 5410; 1300 884 196 (toll free)

Email: careers@ama.com.au

Think before you insert an intravenous catheter

To the Editor: Dendle and colleagues1 challenge the well established and empirically based practice of the “idle IV” — an unused peripheral intravenous catheter (PIVC) inserted in the emergency department (ED) in
case it is needed subsequently, but which frequently remains unused. However, the risks associated with unused PIVCs are not the whole story.

The practice emerged because of adverse outcomes noted in patients who were admitted to hospital from the ED without a PIVC, who then required urgent PIVC insertion in the ward — when and where there were less optimal patient and staffing conditions.

The authors refer to unnecessary patient discomfort and financial costs resulting from the 43% of inserted PIVCs that remained unused at 72 hours at their hospital. However, they assume that ED staff can reliably predict which patients being admitted will not subsequently require a PIVC, and that unused PIVCs have an adverse risk profile comparable to that of used PIVCs. We need better data, comparing the risk–benefit profiles and clinical outcomes of patients whose PIVCs are inserted in the ED, used and unused, with those of patients whose PIVCs are inserted subsequently, often as an emergency, in the ward.

I do not advocate PIVC insertion for all patients admitted to hospital via the ED. However, we must not forget why the practice arose and should consider whether the less frequent but high-impact risks of not inserting a PIVC in the ED might outweigh the implied but unclarified risks of an unused PIVC.

Measuring the environmental cost of health-related travel from rural and remote Australia

To the Editor: The environmental impact of Australia’s health system needs to be assessed. Estimates from the United Kingdom indicate that travel is responsible for 13% of health care-related carbon emissions, with patient travel contributing 6%.1 Australia’s total emissions for the year to September 2012 were estimated to be 24.1 tonnes of carbon dioxide equivalent gas (tCO2e) per capita, with 16%
of all emissions being transport-related.2 In a recent study, we
sought to estimate the carbon cost associated with health-related travel from rural and remote Australia.

We conducted a population survey of residents of King Island, located in Bass Strait between Victoria and Tasmania. Of the island’s 1553 residents, 625 (40%) responded. Participants reported 511 health care travel events for a 12-month period in 2011–2012, spending 2298 nights away from the island. Excluding escorts and family members who accompanied the patients, their travel to health services generated emissions of 130.87 tCO2e (0.22 tCO2e per capita per year).
In terms of carbon offsets, these emissions represent growing 20 trees for 30 years.3 The carbon emissions attributable to a single person on a commercial flight were equivalent to using a medium or large petrol- or diesel-powered vehicle over the same distance.

We found that perceived time away from farming and seasonal businesses influenced whether participants would seek treatment for non-urgent problems or attend follow-up appointments. Rural general practitioners need to take this into consideration when arranging referrals. When travel
was inevitable, participants preferred to go to places where they had personal networks to assist with accommodation, transport and emotional support, or where all
of their health care needs could be met in the shortest time.

Telehealth is one solution that can allow rural and remote patients to access specialist care and follow-up closer to home. Many studies have aimed to establish its effectiveness for a broad range of specialties. The Australian College of Rural and Remote Medicine and the Royal Australian College of General Practitioners promote telehealth solutions and provide specialist provider directories on their websites.

Given the extensive use of large petrol- and diesel-powered cars in remote areas, these emissions data are relevant to all remote communities. Based on Australian Bureau of Statistics data in 2010,4 if all Australians in remote areas accessed health care similarly to our King Island sample, this could equate to 109 560 tCO2e per year, or offsets totalling 16 743 trees grown for 30 years.

Revalidation in the United Kingdom

To the Editor: Recent discussions about revalidation for doctors in Australia highlight the need for doctors to be aware of developments in countries such as the United Kingdom.1,2

The UK regulatory body for medical practitioners, the General Medical Council (GMC), has introduced a licensing system for medical practitioners. By law, doctors practising in the UK have to be both registered and licensed to practise in order to be able to work as a doctor. Implementation of a licence to practise was the first step towards revalidation. Revalidation in the UK then started in December 2012. The requirements for doctors to be revalidated are in accordance with the GMC good medical practice guidance. The revalidation cycle for the individual doctor is completed every 5 years. Annual professional appraisals are compulsory for doctors practising in the UK and form the basis of revalidation.3

Appraisal needs to cover six
areas: continuing professional development, quality improvement activities, significant events, feedback from colleagues, feedback from patients, and complaints and compliments. Appraisals also
need to include a portfolio about
the work the doctor does, including maintenance of professional standards. During appraisal, a qualified appraiser has a discussion with the doctor who is to be appraised. The principles of good medical practice apply.4 The appraiser then makes a recommendation to a responsible officer. The responsible officer makes a recommendation to the GMC, which then decides if the doctor is granted revalidation. Doctors working clinically or non-clinically both need to revalidate in the UK. Doctors working clinically need to work a minimum of 200 sessions during a 5-year cycle.5

The revalidation process for doctors working in the UK is complex, and its implications on
the workforce remain to be seen.
An introduction of revalidation in Australia should ensure professional standards, but could also cause a reduction of existing numbers of working doctors. It would be wise to monitor the impacts of revalidation in the UK, before implementing a similar system in Australia.

Let us decide when and how to die, say older Australians

A large majority of older people want the right to control the circumstances and timing of their death, and can envisage a situation in which they would seek help to end their life, a survey has found.

But, suggesting that talking about death remains a taboo topic for many, almost 36 per cent of 1804 people aged 50 years and older surveyed by the Council on the Ageing (COTA) NSW admitted they had not discussed their end-of-life care wishes with anyone.
Encouragingly, the online survey found that an overwhelming majority of older people (85 per cent) judged themselves to be in good or excellent health, while just two per cent rated their health as poor.

As part of the study, participants were asked about access to health care, and almost 80 per cent reported driving to see their GP, highlighting concerns about the health implications for the elderly if they lose their driver’s licence.
Reflecting this, 20 per cent said better public transport was needed in order to improve access to their GP, while more than 43 per cent thought there should be greater co-location of health services.

Among older people, consistency in GP care was rated highly – more than 40 per cent said the most important aspect of GP visits was seeing the same doctor every time. A further 22 per cent thought having their diagnosis and treatment explained so that they could manage their recovery was most important, while 19 per cent rated prompt service most highly.

When it came to hospital treatment, almost 50 per cent of those surveyed considered that having their diagnosis and treatment explained so that they could manage their recovery was most important, while almost 34 per cent set highest store on being treated with dignity and respect.
In a sign of unease among many about current arrangements, more than a quarter felt palliative care did not provide a comfortable end to life.
Of those who had discussed their end-of-life wishes with others, 64 per cent reported they had had such a conversation with their partner or carer, 58 per cent said they had discussed it with their children, 34 per cent had talked about it with friends, 22.6 per cent had discussed it with their GP and 20.6 per cent had had the conversation with their lawyer.

Most commonly (55 per cent), people wanted to die at home, while 12 per cent wanted to pass away in hospital, and many (26 per cent) remained unsure.
What was clear was that most (76.8 per cent) wanted the right to decide where and when they would die, including the possibility that they might be assisted in ending their life.

It is the latest survey suggesting that there is considerable support in the community for euthanasia laws.
COTA NSW said the survey showed that “older Australians are willing and able to take a high level of control over their lives, including the final phase of their lives”.

Adrian Rollins

Self-regulation of autologous cell therapies

A first step for a virtually unregulated industry

Autologous cell therapies are being used privately by increasing numbers of clinicians to treat a number of disorders including rheumatological conditions, sports injuries, strokes, Parkinson disease and multiple sclerosis.1 Sources of cells include stromal vascular fractions obtained during liposuction which contain mesenchymal stem cells,2 as well as platelet rich plasma obtained from peripheral blood.3

In Australia, prospective authorisation of autologous cell therapies by the Therapeutic Goods Administration (TGA) is often not required. The current regulations contain exceptionally broad exemptions permitting clinicians to treat their patients with autologous cells without restrictions either on the extent of manipulation (excluding genetic manipulation) or the intended final use of the cells. The TGA’s expectation is that the Australian Health Practitioner Regulation Agency (AHPRA) would regulate these clinical practices. In contrast, the United States’ Food and Drug Administration (FDA) requires minimum standards for manufacturing autologous cells, and more than minimal manipulation of cells requires both manufacturing and product approvals.

Some Australian companies have become concerned about the lack of oversight of the safety, efficacy and ethics of cell-based therapies and related advertising claims. To better understand the current situation in Australia, the New South Wales Stem Cell Network conducted its 17th Workshop in October 2012 on this subject.4 In the workshop, those using autologous cell therapies expressed a desire for more structured industry self-regulation than occurs at present. A steering committee to achieve this goal was established, which includes us and representatives from nine entities practising autologous cell therapies: Cell Innovations, Hunter Regenerative Medicine, Lakeside Sports Centre, Macquarie Stem Cells, Magellan Stem Cells, New Zealand Stem Cell Clinic, Regeneus, South Sydney Sports Medicine Centre and Stem Cell Solutions.

Six teleconferences were held, after which it was agreed a written code of conduct would be created. The code, currently being written, is to be modelled on that produced by Medicines Australia, using a template provided by the Australian Competition and Consumer Commission. Four goals were agreed t practise evidence-based medicine; ensure fully informed consent is obtained; manufacture injected autologous products using internationally accepted standards; and follow the advertising standards set for medical practitioners by AHPRA.

Most forms of regulation are external to an industry, and are often by governmental agencies. Medicines Australia, however, regulates aspects of the pharmaceutical industry through a code of conduct. The organisation imposes large financial penalties and publicly exposes phar maceutical companies breaching the code. A second example is fertility clinics, with fertility specialists banding together to decide the rules of conduct for in-vitro fertilisation.

However, examples abound of limited regulation not providing necessary checks and balances in medicine. For example, in France, the regulatory agency AFSSAPS (Agence française de sécurité sanitaire des produits de santé) was found to have responded too slowly to allegations of cardiotoxicity and patient deaths from the antidiabetes drug Mediator (benfluorex). In 2012, the French Government replaced AFSSAPS with a new agency with a stronger mandate to protect patients’ interests.5

Whether self-regulation will protect any patients receiving autologous cell therapies remains to be seen. Nevertheless, some form of regulation is needed urgently, and neither the TGA nor the AHPRA seem empowered or ready to engage actively in the matter. That provides an opportunity for clinicians and scientists to step in. It is true that the area is a commercially lucrative one, but then so are the Australian pharmaceutical industry and fertility clinics for which self-regulation appears to be working. However, one difference is that autologous cell therapies, though in high demand, are mostly unproven. This is a concern, but self-governance could be an interim solution, provided the code of conduct pursues the goal of evidence-based medicine and seeks input from regulatory and other bodies as well as potential consumers.

In the short time we have been working with members of the autologous cell therapy consortium, we have been heartened by the movement so far towards accepting and practising the goals of the code of conduct. Self-regulation of autologous cell therapies is a first step in an industry which would otherwise have virtually no regulation.

The power of systems thinking in medicine

The convergence of seemingly small events accruing over time can have severe consequences. This is
a central message of many aircraft accident investigations. For instance, an attempt to streamline maintenance procedures for an engine mount created the conditions for the United States’ deadliest aeroplane crash
in 1979 (http://www.airdisaster.com/reports/ntsb/AAR79-17.pdf). The investigation found a constellation of interacting factors — design deficiencies, faulty maintenance practice, failures of regulatory oversight and flawed aviation industry economics. As noted in relation
to a later aeroplane crash (http://www.theatlantic.com/magazine/archive/1998/03/the-lessons-of-valujet-592/306534), it was a “system accident”. The complexity of aviation systems creates conditions for small changes to interact with other system elements across technical, organisational and cultural domains to produce significant outcomes that are hard to predict and control.

All clinicians recognise the complexity of health care delivery. The system accident idea has been adopted enthusiastically by some exponents of ways to improve clinical safety, despite more recent reservations about its applicability (Health Serv Res 2006; 41: 1654-1676). Nevertheless, the assessment of clinical mishaps and adverse events requires a systems approach (not only technical, but also organisational, social and cultural).

As a starting point, registries are powerful tools for systematically detecting and monitoring clinical problems and adverse events, and for informing interventions. The study by Roxanas and colleagues of Australia and New Zealand Dialysis and Transplant Registry data (doi: 10.5694/mja13.10435) shows that the incidence of end-stage renal failure due to lithium therapy, although small, is growing. They express concern that accepted doses of lithium over a long time may result in irreversible renal impairment and end-stage disease, reinforcing the need for regular and frequent monitoring of renal function. Registry data analysis is the monitoring system providing the backbone for reducing risks for those receiving lithium therapy.

There is also a need for systems to oversee and analyse incidents in whole areas of health care. Cunningham
and colleagues (doi: 10.5694/mja13.11347) point out that, in the case of chiropractic practice, there is little in place for monitoring
for adverse incidents. Without such a system, proper investigation of incidents in chiropractic care cannot occur.

Significantly greater challenges exist in assessing
health impacts of activities with complex influences from societal and cultural practices in the community. Clenbuterol — a β2-adrenergic agonist with anabolic as well as bronchodilating properties, registered only for veterinary use and banned in sport — is now illicitly used in the community to aid bodybuilding and weight loss. Brett and colleagues (doi: 10.5694/mja13.10982) report a case series of clenbuterol toxicity reported to the NSW Poisons Information Centre. Details of cases suggest that it is also being used for deliberate self-harm,
and that accidental ingestion has occurred. While the authors acknowledge that the study presents an incomplete picture
of actual use in the community, would a deeper engagement with ideas from complexity science help in understanding the complexity of substance misuse? What additional systems need to be put in place for us to know and perhaps anticipate changing patterns of use?

No matter how complex the health problem, data registries will always have a central role in disease and health care monitoring and practice. Presently, patients often need to explicitly consent to their information being added to a registry. Olver (doi: 10.5694/mja13.10695) examines the ethical dimensions of opt-out consent, where patient data are automatically added unless consent is expressly refused. He argues that this approach is acceptable in the context of low-risk research and for improving clinical quality. Although not called a registry, the concept has been used for decades in civil aviation for mandatorily collecting flight data and operational feedback from aviation personnel. Only relatively recently have similar approaches taken hold across a broad range of health care activities.

Decades of research and application of safety assurance and improvement systems in aviation and other industries have resulted in a critical respect for the complexity of many human endeavours — the importance of monitoring outcomes and processes, understanding why and how incidents happen, and appreciating the multifaceted nature of the solutions. There are certainly limitations to mapping approaches to aviation safety to health care systems. But the analogy provides a useful starting point and source of ideas. Preventing adverse health outcomes and health care incidents matters enormously to the community. Just as a systems approach has led to civil aviation being appreciably safer, it should also be pursued by those wanting well founded solutions to complex, multidimensional problems in health.