Reducing dietary salt intake and preventing iodine deficiency: towards a common public health agenda

Public health advocates coordinate programs to reduce salt intake and prevent iodine deficiency

After decades working in parallel, public health advocates for dietary salt reduction and those seeking to achieve the elimination of iodine-deficiency disorders through salt iodisation have harmonised their agendas.

The World Health Organization (WHO) promotes reducing dietary salt intake as a cost-effective strategy to reduce the burden of non-communicable diseases,1 but it also recommends universal salt iodisation to prevent and control iodine-deficiency disorders. Parallel implementation of both policies could be counterproductive.2 However, a meeting convened by the WHO and the George Institute for Global Health, in collaboration with the International Council for the Control of Iodine Deficiency Disorders Global Network (ICCIDD–GN), in Sydney in March 2013, agreed on a new approach to consolidate the two agendas. Technical experts came together with WHO representatives to discuss the potential for maximising the impact of dietary salt reduction and iodine-deficiency elimination programs through improved coordination.3

High salt intakes are a primary cause of high blood pressure, one of the main risk factors for heart attack, kidney disease and stroke, which are leading causes of death and disease worldwide. Member states of the United Nations endorsing the global monitoring framework and voluntary global targets for the prevention and control of non-communicable diseases at the United Nations World Health Assembly in 20134 agreed to achieve a 30% reduction in population salt intake by 2025. Working with the food industry to reduce the amount of salt added to processed foods and restaurant meals, campaigns to change consumer behaviour and efforts to improve the food environment through work in schools and the workplace will be the cornerstones of these efforts.5

Iodine-deficiency disorders are another major global health problem; they cause impaired cognitive development, reduced intelligence quotient (IQ), congenital anomalies, cretinism, and endemic goitre and other thyroid conditions. It is estimated that 1.9 billion people worldwide remain at risk of insufficient iodine intake. The WHO, United Nations Children’s Fund (UNICEF) and the ICCIDD–GN recommend an intake of 150 µg iodine daily for non-pregnant, non-lactating adults and 250 µg daily for pregnant and lactating women. Food-grade salt is the primary vehicle for dietary iodine fortification and is preferred because the technology is simple, iodine levels in salt can be easily monitored, salt consumption is mostly stable throughout the year, and salt is affordable. The estimated annual cost attributable to iodine-deficiency disorders in the developing world is $36 billion with just $0.5 billion required to deliver effective salt-iodisation programs.6

The public health goals of salt reduction and salt iodisation can both be achieved if the concentration of iodine in salt is increased as salt intake is reduced. The inherent challenge that salt will continue to be viewed as healthful for the iodisation program may remain, but can be overcome by full implementation of the universal salt iodisation strategy such that all salt used in both human and animal foods is iodised so that notionally ‘‘healthy” iodised salt does not have to be sought out by the population.

To date, dietary salt-reduction efforts and iodine-deficiency disorder elimination programs have largely operated independently. Improved coordination between programs will help to ensure consistent messaging, enhance implementation and reduce costs for monitoring. Both programs are also based on multistakeholder engagement, including close links with the food industry and civil society. Specific areas for future coordination of the two programs were identified as: policy development; research, monitoring and evaluation; and advocacy and communication.

It was proposed that the WHO and UNICEF would lead the development of the coordinated program, working with ICCIDD–GN, the World Health Organization Collaborating Centre on Population Salt Reduction at the George Institute for Global Health in Sydney and other technical advisers. The priority action will be to encourage national governments to develop strategies that ensure universal salt iodisation, reduce population salt consumption, and track levels of salt and iodine intake such that both sets of public health goals are achieved.

The Sydney forum was the last in a series of WHO meetings to provide countries with tools to reduce population salt intake. The collaborative program of work on salt reduction and iodine-deficiency elimination is the final plank in the strategy. A series of regional initiatives have since been held, and iodine levels are now being monitored as part of several national dietary salt-reduction projects. The coordinated approach has also been incorporated into the “SALT Toolkit” currently being developed by the WHO to provide practical advice to support countries to achieve the new global salt-reduction targets.

In 2009, we saw the introduction of mandatory iodine fortification of salt in bread in Australia to help solve the problem of re-emerging iodine deficiency.7 While this is a step in the right direction and has already corrected iodine deficiency in children and adults, although not in pregnant women, it will not detract from ongoing salt-reduction efforts in Australia. The fortification of all food-grade salt with iodine (universal salt iodisation) would be the most effective approach to ensuring that the benefits of fortification reach at-risk groups in Australia while remaining in harmony with initiatives to reduce dietary salt intake.8

Towards a sustainable and fit-for-purpose health workforce — lessons from New Zealand

This is a republished version of an article previously published in MJA Open

Reforms underway in New Zealand are designed to significantly increase workforce productivity

It is true that most ill and injured New Zealanders currently receive appropriate and timely health care, but viewed as a whole, and considering health outcomes in Maori and poorer urban and rural communities,1,2 the New Zealand health system is something of a “curate’s egg”. I suggest that the New Zealand health workforce is neither sustainable nor fit-for-purpose. This situation is largely a result of systemic issues, which are being addressed. Any perception of system inadequacy is exaggerated by New Zealanders’ high expectations for health care relative to the country’s small population and modest wealth (by OECD [Organisation for Economic Co-operation and Development] standards).

As is true for all OECD member nations, New Zealand is affected by a global mismatch of health service demand, supply and affordability.3 The World Health Organization estimates a worldwide health worker shortage greater than New Zealand’s total population.4 Another OECD report in this context argued that New Zealand’s reliance on immigrant health workers is unsustainable.5 Consequently, new national health agencies have adopted “responsive” health workforce planning principles.

Citizenship and living forever well

New Zealand is a social democracy. Generally shared values of citizenship arise from a common history of immigration, in response to fundamental legislation, such as the 1938 Social Security Act, and from a treaty between indigenous Maori and the colonising British.6 These values include an inherent contract to work, and hence to contribute directly and indirectly to society, and to support those who cannot. There are also expectations of social mobility, largely by way of state-funded education, and a similar assumed birthright of unlimited access to necessary, excellent and unconstrained health care. The latter establishes the milieu of health service and related workforce planning.

Health demand in New Zealand in ten years’ time

On the basis of the ageing of the New Zealand community alone, the New Zealand Institute of Economic Research (NZIER) predicted in 2005 that between 40% and 70% more health workers would be needed by 2021 to maintain the then current health service levels.7 This prediction was based on an incorrect assumption of stable worker productivity,8 and the 40% to 70% range was contingent on various scenarios of disease compression, and so on. The NZIER predictions are demonstrably very optimistic if the following factors are included in any demand forecast: ongoing workforce feminisation;9 the shifts towards part-time work and retirement, and in migration trends;5,10 the increase in high-technology and often low-utility but expensive end-of-life care measures; and increasing health service consumption by an increasingly affluent and “health-anxious” worried-well middle class.11 Finally, and somewhat perversely, medicine’s success in managing “acute” disease is manifest to some degree as an increased prevalence of complicated and costly chronic diseases in older people.

The sobering observation here for health workforce planning, however, is that on the basis of the number of health-service providers and trainees in New Zealand in 2010, and modelling for effects of feminisation, part-time work, recruitment and career choice, migration and retirement, none of the medical disciplines will have enough practitioners in 2021 to meet even the best-case NZIER scenario (ie, 140% of the 2005 base).7 The status quo is not an acceptable option to meet the demand challenge, and many, if not most, health services will need to be changed; this will necessarily require a reform of service configurations and models of care. This recognition also leads to the need to adopt the core design processes of development of an inclusive health system intelligence12 and clinician-led disruptive innovations of business-as-usual.6,13,14

Clinician-led disruptive innovations of health care

Many argue that the solution to any health service demand–supply mismatch lies in management of waste, better integration of primary and secondary care and in a sequential shift of care setting from the hospital to the community clinic and into the home.15 However, such a distributed model of care is only affordable if it results in fewer new hospital beds and hospital-based specialists. Some enabling technologies and a revision of funding and reward systems are also essential.16

Consider this scenario:

Mary is an elderly widow who lives in a remote area of Northland and has insulin-dependent diabetes mellitus. She is unwell and has frequent falls. Her daughter consequently takes a day off work and drives her to see her family doctor. The family doctor is worried and orders some blood tests. Two days later, the results are available and the nurse from the clinic rings and asks Mary to come back. Mary’s daughter takes another day off and returns with her to see the family doctor, and a decision is made there to refer Mary to a physician who has an interest in diabetes and who visits a local regional hospital. The next appointment is in 3 months. Mary goes home, continues to have falls and two of these result in short-term hospitalisations at the local community hospital. Three months elapse and Mary’s daughter takes a third day off work to drive her to see the specialist. A complete change in insulin regimen is decided. Mary and her daughter go home via the hospital pharmacist, and Mary will be visited by a district health nurse.

This vignette is an exposition of slow, low-quality, “transactional”, and consequently expensive, care. Thankfully, it also involves a compliant patient and attentive family member.

Compare it with the following:

Because of a request from Mary’s daughter, a district nurse visits and pricks Mary’s finger to measure blood glucose and glycated haemoglobin levels with a small test unit she has in her car. The results are uploaded onto Mary’s “Facebook-type” health record through the nurse’s phone. The nurse texts the family doctor who goes online, uses the password Mary has provided, and looks at the values. The family doctor then texts the diabetes specialist, who looks at Mary’s record on his phone. A complete change in insulin regimen is decided and an e-prescription is sent to the local pharmacist.

In this scenario, Mary does not leave home and her daughter does not have any time off work. The entire process takes a few hours. Mary does not fall and the local hospital does not admit her. Two enabling technologies are needed here — the testing unit, which already exists and is cheap to operate, and an accessible shared health care record. A single patient identifier is needed and each provider similarly needs coding, both of which exist in New Zealand. Another essential enabler here is a reward system, which is not rigidly transactional and is based on, but is not limited to, remuneration. The track record of paying health care providers for performance is not good.16 Simple fee-for-service systems often result in relative overservicing, are counter-innovative, as the model of care is defined by the fee schedule, and are transactional, and hence encourage competition as compared with collaboration. An actuarial approach is needed for chronic disease, along with a “tight (quality outcome determinations)-loose (service delivery models)-tight (measurement of outcomes against the agreed quality criteria)” approach by core funding agencies to capitation. Providers should be predominantly incentivised for quality outcomes, as compared with outputs, and this outcome performance should be measured, as much as possible, at the organisational as compared to the individual provider level. The ambition is that provider “groups” own both the quality health outcome risk and the financial risk.

As an illustration, the capitation rate for a cohort of patients with diabetes could be determined by two related outcome measures: the hospital admission and attendance rate for those people registered with the providers and who are admitted for a problem related to diabetes; and the incidence of people registered with the providers who have diabetes and who go into renal failure.17 Achievement of contracted outcomes within a 5- or 10-year financial capitation period will by necessity require innovative, collegial and interprofessional practice, and a shift to patient-centred and patient-directed care. The latter warrants another essay.

The affordability of health care in New Zealand

The discussion above is based on a “simple” supply-and-demand consideration. The other element here is that of affordability. New Zealand’s per capita spending on health is lower than the OECD average, but the trends have been parallel since 1980. Treasury data for 2012 show that health spending was almost 10% of gross domestic product (GDP); it was about 20% of total government expenditure; and almost 50% of all the new money in the 2009, 2010, 2011 and 2012 budgets was allocated to funding for “public” health services, marking the “tipping point” of affordability. From 1950 to 2011, the wealth of New Zealand, as measured by GDP, grew by 144%, whereas spending on health over the same period increased by 412%. There are only two fundamental responses available to the government in this context, and these are to reduce the demand for health services and/or to reduce the cost of meeting that demand. A triad of strategies are consequently in place in New Zealand. In addition to attending to reform of governance and management systems, there is clinician-led reform of service configurations and models of care, and the related management of waste, and reform of service funding and provider reward systems.12,16

Health workforce planning under conditions of uncertainty

Evidence is the core of good health practice. The problem for health workforce planning is that scrutiny of relevant track records suggests that no one has ever got it right. Planning failures are made manifest by endemic cycles of feast and famine in regard to the number of workers and the job market. Feasts may coexist with famines, and the cycle is often rapid. Some aspects of the health workforce, such as the vacancy rates in public hospitals for nurses and midwives, are very sensitive to the overall economy and general labour market conditions. “Medical” discoveries, such as the infectious cause of peptic ulcers, are essentially unpredictable and can render large parts of the health workforce redundant, literally overnight.18 It is probable that the only truism about planning the health workforce is that any plan will inevitably be wrong.

This recognition can either be seen as an excuse to give up, resort to serendipity and rely on the vagaries of the marketplace, or as a stimulus to adopt principles that enable effective planning under conditions of uncertainty. Health Workforce New Zealand has adopted a clinical scenario-based planning approach.12 The logic is that health need drives planning and that subsequent service configurations and models of care determine the interactive solutions of information technology (IT) and other resources, capital investment and workforce. Sadly, much extant planning allows the “capital investment tail” (which is usually less that 10% of total health costs) to wag the “health planning dog”. Archaic models of practitioner-centred care that are still perpetuated in our hospitals are largely the result of planning that begins with existing IT, capital and workforce — so that ending up where the process started is hardly surprising. The New Zealand clinical vignette model of planning is service-aggregated and not conducted in professional silos (Box; full version); it is clinician-led and patient-centred, and results in a forecast of future possible models of care. These possibilities are culled against the following criteria: there can be no loss of quality or access and both ethnic and socioeconomic gaps must be closed; and services that can meet a doubling of demand over the next decade must cost no more than 140% of today’s base (derived from expected growth in GDP). Training purchases and practices are then considered against the requirement that all of the surviving forecasts are adequately addressed. The process is ongoing and iterative, and the consequent planning is consequentially responsive.

Three key principles have been identified with respect to managing the uncertainty inherent in shaping future health workforces. The first is that the health system has a dynamic intelligence. This must apply to the whole of the sector, and in New Zealand it is being created as a virtual agency.

Second, if uncertainty is inevitable, then most of the health workforce needs to be able to be flexibly employed, and quickly retrained and redeployed. An example would be the training of fewer occupational therapists, physiotherapists and speech language therapists and the creation of a large number of new “rehabilitation health workers”. The latter would have generic health science education and skills in all three of these areas of therapy. In small centres, their employment would be as a generic rehabilitation worker; in slightly larger centres they may well specialise in cardiac, neurological or mental health rehabilitation; and in a large tertiary centre the specialisation might be as narrow as speech recovery after stroke in a specialised stroke unit. These rehabilitation workers clearly satisfy the criteria for being able to be flexibly employed, and quickly retrained and redeployed. Traditional occupational therapists, physiotherapists and speech language therapists would be consultants in this model of care.

Third, health workers who are slow or expensive to train and expensive to employ, such as doctors, need to be employed in as general a scope of practice as possible and should be limited to roles that can only be satisfactorily performed by someone with their skills and knowledge — the aptly-cited “work at the top end of their licence” situation. In addition to future-proofing through generalism, the quality and cost of health care appear to be favourably influenced by an increased concentration of general medical practitioners, and unfavourably influenced by an increased concentration of specialist medical practitioners.19 Advocacy of general medical practice requires a recovery of relative status for doctors so employed and this in turn will require a portfolio of attractive role models and enjoyable student exposures, well supported training schemes — the new general medical practice training program in New Zealand is to be introduced in December 2012 — and of relatively generous productivity-related reward schema.19–22

Towards a sustainable and fit-for-purpose New Zealand health workforce

An affordable, sustainable and fit-for-purpose New Zealand health workforce can only be achieved by way of a clinician-led and intelligence-informed innovative reform of funding and reward systems, and of service configurations and models of care across the health and disability sector. Given the intrinsic uncertainty, this intelligence must be both inclusive and dynamic, and any consequent planning needs to create and maintain a core workforce that can be employed flexibly and redeployed quickly, and to ensure that those necessary elements of the health workforce that are slow and expensive to train have a scope of practice that is as general as possible, while such practitioners work at the top end of their licence.

Key recommendations of the Health Workforce New Zealand Service Forecast Teams that have been established to date*

Service aggregate

Key service recommendations

Key workforce recommendations

Common recommendations

Employ funding models that support interdisciplinary care and innovative practice and where consumers and providers manage the outcome and financial risk.

Improve community health literacy and reward appropriate help-seeking and preventive health behaviour.

Enhance communication between consumers and providers to enhance care coordination

Employ doctors in roles that can only be undertaken effectively and safely by someone trained as a doctor.

Extend the roles of nurse practitioners and allied health professionals.

Upskill and support carers.

Anaesthesia

Establish regional oversight groups to recruit and deploy anaesthetists across health regions.

Extend the roles of anaesthesia technicians and medical officers to improve operating theatre productivity.

Cancer

—

Expand the role of nurse specialists.

Diabetes

Establish a coordinated national population-based diabetes prevention program to reduce the burden of type-2 diabetes and screen for eye and renal complications.

Diabetes nurse specialist prescribers to lead diabetes care using an integrated primary care model.

Eye health

Change the New Zealand Medicines Act 1981 to enable optometrists to prescribe glaucoma medications.

Develop an eye health community model that includes an increase in the role of optometrists.

Rationalise and standardise child eye health screening services.

Investigate the role and career pathway of ophthalmic nurse specialists within hospitals and other settings.

Ensure everyone with macular degeneration and low vision is assessed by an eye health professional with low vision expertise.

Develop a postgraduate diploma in ophthalmology for general practitioners and nurses.

Support an undergraduate degree in orthoptics.

Gastroenterology

Provide teleconferencing to reduce health inequities in rural areas.

Recruit gastroenterology nurse specialists for areas such as inflammatory bowel disease, hepatitis, colorectal cancer screening and surveillance, and colon polyp follow-up.

Use a mobile clinic in rural areas to address access issues.

Expand the gastroenterology workforce using nurses, allied health practitioners, dietitians and a range of assistants to provide assessment and management, including endoscopy.

Mental health and addictions

Shift resources to enable earlier intervention for at-risk families, children and adolescents where there is evidence that such intervention reduces the burden and cost of disease.

Build capacity of specialist clinical workforces (psychiatry, psychology and mental health nursing) to support areas of future development and a significant change in roles.

Integrate primary and secondary services using stepped-care approaches to improve access and recovery in the community, and to reduce the burden and cost of concurrent mental and physical conditions.

Expand the role of e-health and related “virtual” mental health initiatives.

Reduce system-wide costs by influencing pathways through high-risk mental health, care and protection, and justice services.

Proactively manage the impact of mental health problems on care for older people.

Develop the capacity and capability of the spectrum of self-care support by enabling e-therapies, self-care or whanau (extended family) care and peer support.

Mothers and babies

—

Implement a comprehensive midwifery internship.

Musculoskeletal health problems

Invest in and standardise telemedicine to enable the remote assessment of patients referred for tertiary-level services.

Ensure that conservative management of musculoskeletal disorders, including pain, is a core competency for all general practitioners.

Begin postoperative adult orthopaedic trauma rehabilitation at admission.

Increase emphasis on musculoskeletal teaching.

Invest in public health measures, including early interventions to improve fitness and diet in young adults and throughout adulthood.

Develop a workforce of non-operative clinicians expert in conservative management of minor musculoskeletal disorders.

Screen patients for potential osteoporosis and obesity.

Increase the number of staff with expertise in geriatric management for postoperative medical care.

Increase the number of doctors trained in rehabilitation, including tertiary-level rehabilitation specialists and GPs with rehabilitation medicine as a special interest.

Develop and consolidate advanced scopes of practice for physiotherapists, especially in hospital outpatient roles.

Extend musculoskeletal training of clinical nurse specialists.

Older people

Increase the focus on home and community-based prevention and rehabilitative service options for older people, especially short-term interventions that maximise the potential for independence.

Invest in specific training for formal and informal caregivers and develop a career path for formal (and informal) caregivers.

Use clinical specialists to increase the knowledge and skills of other health and support workers in the community and primary care (leveraging).

Gear up service and facility design within acute care to meet the needs of people over 65 years of age.

Palliative care

Develop managed clinical networks that are linked nationally.

Develop advanced nursing roles (nurse practitioner, clinical nurse specialist) and allied health practitioner roles in multidisciplinary palliative care teams.

Develop a funding model for primary care-based community palliative care.

Youth health

Fund school-based health services, and youth health community services to meet specific communities’ needs.

Ensure all school nurses are competent and skilled to deliver safe, quality nursing care.

Do not focus health services for young people on a single issue (such as reducing violence, crime, alcohol and drugs, including tobacco use, and risky sexual behaviour); collaborate with other government departments, non-government organisations and voluntary services to deliver a holistic service.

Employ public health nurses in primary care and allocate to schools to deliver school based services and effective health promotion.

Shift resources into supporting those working with youth in the community.

Use social media to promulgate specific, positive public health messages for young people in the context of their wider needs, rather than in a problem-specific way.

Paying for the health workforce

This is a republished version of an article previously published in MJA Open

Payment systems should be considered more often as a policy intervention to improve health system performance

Payment and funding are often regarded as administrative transfers; and yet, funding is rarely provided without strings attached. Where funding and remuneration are made conditional on certain behaviours (eg, working a set number of hours, seeing
a certain number of patients, undertaking specific tasks
or tasks of a certain standard, or “doing a good job”), financial incentives are created. These can have material impacts on health professionals’ behaviour, access to health care, performance of the health system and population health. Changing the level and method by which health professionals are paid, therefore, has the potential to be used to redress health workforce shortages and the maldistribution of health professionals across specialties, sectors and geographic areas, and to improve the quality and costs of the health care that is provided.

Many countries have experienced recent growth in pay-for-performance schemes and changes in the level and methods of remuneration of health professionals, mainly doctors.1,2 Health policy focuses less on how salaried employees, such as nurses, are paid, although arguments about the importance and role of pay apply equally, given the current growth in the number of salaried employees such as practice nurses.3

A key issue that often prevents research in this area, and therefore prevents an evidence base from developing, is that changing the level and method of payment for health professionals is contentious. National data on earnings
are difficult to come by. Reform is viewed as risky by politicians, given the often protracted and difficult industrial negotiations that may be required because health professionals view change as not only a potential threat to their earnings but also to their autonomy. The Australian report on realigning the relativities of rebates in the Medicare Benefits Schedule is one example where the results were not acted upon because of strong professional interests favouring the status quo.4 In practice, many changes to doctors’ remuneration in other countries have not resulted in a loss in earnings and, indeed, have often delivered large gains in earnings, such as through the Quality and Outcomes Framework for general practitioners in the United Kingdom.1 The issue for governments and employers is the extent to which the additional payments result in improved performance or increased access to health care.5

What does the health workforce cost?

There is no single source of information on the national cost of the health workforce in Australia. The variety of state, federal and private employers, insurers and patients who provide funds makes it difficult to separate out remuneration of the health workforce from other revenue (non-capital) expenditure. The opportunity costs of the health workforce should be a measure of the value of health professionals’ time, usually their gross (before tax) personal earnings, and any on-costs for employees (eg, superannuation) incurred by employers. This is difficult to estimate for self-employed health professionals as they may also receive a share of profits from their business
as personal income. The main source of data is the Australian Institute of Health and Welfare (AIHW), which splits health expenditure into a number of sources.6,7 However, payments from Medicare and private health insurers are gross payments and will include an element of non-salary practice expenses, and so may overestimate health professionals’ personal earnings. The AIHW supplies aggregated data and does not provide detailed information on the source of its estimates. For example,
it is not clear whether AIHW data include the costs of salaried health professionals and administrative staff in private sector organisations, such as small businesses in general practice and allied health. Although Australian census data include the earnings of a range of health professional groups, this is by category, with the highest salary category including earnings over $100 000 per annum, so they do not provide good estimates for many groups such as medical practitioners, dentists and senior managers who may earn well above this level. Data on the salary bills for companies, partnerships and trusts are available on the Australian Taxation Office website.8 They are the most comprehensive national source of data on the income and earnings of health professionals, although data are difficult to access apart from some summary data on the website.9

The opportunity cost of a new health professional does not just include their lifetime earnings, but also their training costs. However, there are no national data covering the spectrum of training from undergraduate education, prevocational training, vocational training, and training and supervision of migrants. The lack of data is very surprising — decisions are being made about training extra doctors and nurses without knowledge
or evidence of the costs or the benefits in terms of improvements in population health. Training costs are borne by a mix of federal and state governments, educational institutions, and individuals paying for some or all of their own educational expenses. These funders face different sets of incentives with little coordination between them. Postgraduate training and its costs are integrated into the delivery of public hospital services, and so are difficult to separate out from the figures on the costs of public hospital staffing. Given the major growth in the number of medical students and other types of health professional, the costs of training are expected to grow substantially, with an uncertain impact on health expenditures.

Do different levels of payment matter?

Changes in the level of pay have been shown to influence hours worked by doctors and nurses, doctors’ choice of specialty, and recruitment and retention.3,9–12 The impact of higher hourly earnings is an increase in hours worked and in workforce participation. This effect is relatively small but usually statistically significant in most labour supply models for both doctors and nurses.3,11,13 There is also the possibility, but little strong evidence, of “backward bending” labour supply among doctors on relatively high incomes, where higher earnings cause a fall in hours worked as doctors prefer to spend their higher income on more leisure time. Aggregate data for Australian doctors provide weak evidence that the average number of hours worked is falling, while the costs of medical services are increasing and fewer patients are being seen.14 The effect of relative earnings
on specialty choice is particularly important for doctors choosing to work in primary care, where more doctors are needed because of the growing burden of chronic disease that should be treated outside of hospitals.

How levels of pay are set can also influence recruitment and retention and, therefore, access to health services. Pay that is set under bargaining agreements and is relatively fixed across a large geographical area provides a stable income for employees, but employers are not able to alter pay in order to solve local recruitment and retention problems. Other employers compete for the skills of nurses and other health professionals, and there is evidence that when competing wage rates are high in the private sector, public hospitals experience recruitment and retention problems and higher vacancy rates, as well as higher patient mortality rates and lower quality of care.15–17
A degree of pay flexibility could therefore ease recruitment and retention difficulties, potentially improving the health status of patients and quality of care, but at the cost of potentially higher health expenditures and increased inequity of pay between staff with similar experience. Incentives for performance are embedded in the salary scales for employees. Gaps between each increment in the scale, combined with opportunities for promotion, create financial incentive for improved performance and clearly define career trajectories.18 For some health professionals, such as practice nurses, these career structures are not well developed. Unions prefer equity of pay through “short” scales with small gaps between each increment, while employers prefer longer scales with larger gaps to encourage higher and increasing levels of performance. Evidence on these issues exists for other industries,18 but
is limited for health care. The important issue is that how salaries are set and the outcome of wage or fee bargaining can have important effects on recruitment, retention, health care access, costs and population health that often go unrecognised.

Different levels of payment across geographical areas can be used to improve recruitment and retention into underserved areas. In Australia, this is a significant issue, yet careful evaluation of Australian schemes has not been conducted. Evidence is very weak and plagued by poor study design,19 resulting in a large gap in evidence in this important policy area.

Do different methods of paying health professionals matter?

There is a large body of literature examining changes in methods by which health professionals, largely doctors, are paid. Although the evidence is mixed and of variable quality, Cochrane reviews have found that different methods of payment (eg, fee-for-service, capitation, salary, and pay-for-performance or bonuses) all influence clinical behaviour and the quality of health care provided.20–24 There is an emerging consensus that fee-for-service payment does not encourage optimal care for patients with chronic disease. Recent models in Australia (eg, the Co-ordinated Care for Diabetes Pilot) and experience in the United States with the “patient-centred medical home”, also known as “accountable care organizations”, are introducing blended payments that include a capitation payment and an element of pay for performance.25
These have existed for some time in the UK for general practitioners, who now receive 25% of their earnings through the Quality and Outcomes Framework pay-for-performance scheme.1

The reported doubts about the effectiveness of schemes such as pay for performance are concerned not only with the poor methodological design of evaluative studies,
but also with the poor design of the payment schemes themselves.26 Avoiding unintended and undesirable consequences (there may also be some unintended but desirable consequences27) can be partly achieved through careful design and implementation. For example, payments should be risk-adjusted to avoid the selection of healthy patients so providers are properly compensated for high-cost patients.25 Exception reporting, where providers can exclude patients from the denominator of payment calculations, can be avoided by paying only for the numerator; that is, a payment for each patient hitting a target, rather than for the proportion of patients hitting
a target.28 Schemes should also reward for measured improvements in quality between two time periods, rather than for the achievement of a given level of quality.29

Current challenges in paying health professionals

The first long-term challenge is to reorient remuneration schemes to reward for improving the health status of patients and improving access to health care, and to recognise, especially in primary care, the need to appropriately manage the growing burden of chronic disease. Moving away from reliance on fee for service as more care needs to be provided outside of hospitals is the biggest political challenge. Historically, the only way this has occurred in other countries is by ensuring that doctors’ incomes do not fall, but, more often than not, rise substantially. The challenge for governments is to ensure that such inevitable increases in expenditure are matched by improvements in population health and better access
to health care. This depends on first producing better measures of organisational and system performance
and also deciding which treatment interventions and behaviours should be incentivised. Current health reform initiatives seeking to produce data on health services performance are a belated step in the right direction.

A second challenge is to evaluate carefully any changes
to remuneration levels or different types of remuneration. Opportunities for randomised trials are rare, but they are possible. In the absence of randomisation, it then becomes important to use the vast amounts of administrative data that exist. For example, it would make sense to link hospital personnel records with data on a range of risk-adjusted performance measures (eg, mortality rates, adverse events, quality of life). The linkage of data on inputs (and their costs) to outputs and outcomes is fundamental in improving efficiency, health outcomes and access to care. However, linking the characteristics of the health workforce (hours worked, qualifications, experience, pay) to quality of care and costs is still a distant dream in Australia, but it has
been possible in other countries.

A third challenge relates to legal and industrial issues that determine workforce flexibility (or inflexibility). Flexibility refers to the ability to quickly change roles, scopes of practice, training paradigms, pay and conditions to respond to changes and shifts in demand, such as the growing burden of chronic disease and new technologies. This is fundamental in the private sector, and there are, undoubtedly, good reasons why the health sector is much less flexible, but these reasons should be revisited and challenged. For example, it is unclear exactly how autonomous the recently introduced Local Hospital Networks will be. The inflexibility of pay-setting arrangements may contribute to preventing the networks from responding to the incentives within activity-based funding. A further example is the many workforce innovation pilot studies of new and expanded roles of staff and new types of staff, which are being funded by Health Workforce Australia and state governments. The sustainability and rollout of successful pilots depends heavily on having a supportive and flexible industrial and legal framework in place that should be redesigned at a national rather than individual pilot level. Patient safety is a key issue in the development of new roles, but the potential loss of life and high costs caused by inflexibilities in workforce roles and payment systems also needs to be considered. Trade-offs exist but are seldom examined.

The establishment of Health Workforce Australia in 2010 has given a clearer policy focus to health workforce issues. Although Health Workforce Australia is partly responsible for paying for some undergraduate clinical training, other issues about pay and remuneration are not currently within their remit but cut across a number of other state and federal government departments and a range of other organisations responsible for determining the amount and method of health professional remuneration (eg, the private and not-for-profit sectors). The final and most significant challenge is, therefore, to provide national leadership in reforming the institutional structures that influence the payment and remuneration of health professionals to achieve better health outcomes for the population at lower cost.

Medical tourism raises questions that highlight the need for care and caution

Medical tourism: future boon or future bane for Australia’s consumers and health care system?

Medical tourism is being actively promoted in Australia in a way we have not seen previously. Health care is now a commodity that consumers can obtain locally and, increasingly, in foreign countries. Seeking medical treatment in other countries has been termed “medical tourism”, where treatment is combined with recreational experiences in resorts and hotels. Treatments may be for cosmetic procedures, chronic illnesses and assisted reproduction, including dental, cardiac, orthopaedic and bariatric surgery, organ and tissue transplantation, and in-vitro fertilisation.1 There are few reliable statistics on the size and scope of the medical tourism market, but reports value it in the hundreds of millions to billions of dollars for individual countries, and globally as an industry it is valued at over US$20 billion.2 In Australia, medical tourism is believed to be a growing dimension of health care, with both inward-bound and outward-bound consumers. However, there is a lack of hard evidence on medical tourism in countries within the Organisation for Economic Co-operation and Development,1 including Australia.

At face value, medical tourism presents as a positive avenue for sufficiently wealthy consumers to obtain health care without being limited by what is available to them locally. However, medical tourism cannot be judged without considering ethics, safety, costs to the community and continuity of care.

Whether it is ethical for consumers from developed countries to access health care in developing countries has been debated.1 Further, developing countries targeting medical care to wealthy consumers at the expense of treating local residents is both ethically and morally concerning.3

We do not know how consumers make their decisions to seek health care overseas. It is believed that they pursue medical tourism because of high health care costs, lengthy waiting periods or lack of access to treatments in their home countries.2 Current empirical evidence to support this is based on a small number of participants from a few countries, and needs to be verified. Furthermore, there is a dearth of Australian research in this area. Just what information consumers obtain about medical tourism, its credibility, and the decision-making processes and rationales that they use are all unknown. What level of health literacy is necessary to make an “informed decision” about the various treatments available? What does “informed decision” mean in the field of medical tourism? There is a lack of standardisation and providers make a range of unsubstantiated claims.4

These questions raise concerns about the safety and quality of the care being accessed by Australian consumers overseas. What care planning is done before, during and after an episode of medical tourism? Do consumers discuss their idea to seek medical care overseas with their local general practitioner and other primary health care professionals? Do they ask about the care by the organisation, an individual physician or the health care team? We know that care is shaped by the clinical governance of all three.5 The very limited research that exists reveals confusion and strained relationships between consumers and their health care practitioners when having such conversations.6 Evidence-based decision-making frameworks or tools for medical tourism are lacking. Models that have been proposed have not been empirically tested, so their usefulness remains speculative.

We know that continuity of care is disrupted when consumers travel overseas for medical treatment.3 We know neither what local health records are available to overseas health professionals before they treat a patient, nor what overseas health records are available to Australian professionals for follow-up care. We do not know whether or how safety, quality and continuity of care are achieved when consumers seek treatment overseas.

Medical tourism raises the prospect of serious infection concerns for individuals and biosecurity issues for the Australian health system.7 Medical tourism consumers visit medical institutions and are exposed to microbial pathogens that are different from those in their country of origin. Rates of health care-associated infections in developing countries are recognised to be higher than those in developed countries and, within adult intensive care units, infection rates are at least three times higher.8 Risks of nosocomial infection are real, having been reported in Australia and overseas.7,9 A tangential problem is the potential for political and trade conflict between countries when such nosocomial infections are reported.10

Individual harm becomes organisational harm when infected medical tourists return to Australia for further treatment. This transfers the responsibility, costs and risks of care to the Australian health care system. What is the consumer’s responsibility to disclose information about overseas treatment and possible infection risks before attending an Australian health care facility? How many consumers return to Australia with nosocomial infections? What types of infections are being introduced into primary care and hospitals? What are the risks for health professionals? What infection control strategies need to be introduced? What are the costs associated with managing and removing introduced pathogens in different settings? Health professionals and hospital environments could be exposed to significant infection risks and costs of treating infections with foreign drug-resistant organisms.

These questions lead directly into considering what regulation is needed for medical tourism to maintain the safety and quality of the Australian health system. At present, limited and untested regulatory frameworks exist for any country.3 How are stakeholders, including governments, insurance companies, health professional bodies, individual health professionals and consumers, to assess the quality and safety claims of overseas health care organisations? What legal protection is there for consumers who receive poor medical care? How are consumers protected from or compensated for malpractice? What care or services will be available to solve any ongoing medical or cosmetic problems? What will be the responsibility of insurance agencies, and how will they be held accountable if they support or facilitate medical tourism? While medical tourism facilities are promoted as being accredited by writers in this field,4 the impact of these accreditation systems remain untested. An Australia health insurance provider now actively supports medical tourism, reinforcing the need for a surveillance mechanism to collect information on care outcomes, how local health care providers manage adverse outcomes, and the associated costs.

The main problem with medical tourism is that it currently has no robust empirical evidence base.1,2,10 Hence, we do not know if medical tourism will be a future boon or bane for Australia’s consumers and health care system. Care and caution are needed, because the potential negative consequences for individuals and the community remain profound.

Peers or pariahs? The quest for fairer conditions for international medical graduates in Australia

Implementing recommendations of the parliamentary inquiry and international codes of practice on employment of IMGs

It has been more than 2 years since the final report of the inquiry into the registration processes and support for overseas-trained doctors1 was tabled in Parliament. The scope of the inquiry was extensive, involving over 200 submissions and 22 public hearings held in 12 different locations across Australia. In the foreword of the report, entitled Lost in the labyrinth, Steve Georganas, Chair of the Committee, acknowledged that “whilst IMGs [international medical graduates] generally have very strong community support, [they] do not always receive the same level of support from institutions and agencies that accredit and register them”.1 The report outlined 45 recommendations which, if implemented, would create a fairer registration and accreditation system without compromising patient safety.

In spite of the significant cost of the inquiry, borne by taxpayers, its recommendations have yet to be formally endorsed by the federal government. This is not a new situation. Over the past 25 years, a number of major inquiries have investigated the fairness and/or effectiveness of the registration and accreditation system, but have largely failed to produce meaningful improvements.2 For instance, in 2005 the Australian Competition and Consumer Commission and Australian Health Workforce Officials’ Committee recommended fairer methods of assessing and recognising the credentials of overseas-trained specialists, but those recommendations were not fully implemented either.

The failure to implement meaningful reforms in line with the recommendations has meant that the current two-tier system for IMGs and Australian-trained doctors persists. These differences arise from a complex array of registration, accreditation, immigration and workforce policies, which perpetuates a multifaceted process of discrimination and exploitation of qualified medical practitioners.3

A case in point is section 19AB of the Health Insurance Act 1973 (Cwlth), more widely known as the 10-year moratorium. The moratorium stipulates that IMGs must work in underserviced areas for up to 10 years. This restriction is unparalleled in the developed world. Not only does it cause significant personal hardship, family stress and cultural isolation, it also places limits on professional development and career opportunities.

In addition, the 10-year moratorium may be ineffective as a strategy to sustainably increase the number of doctors in rural Australia. Results of a study examining career progressions of doctors 5 years after they completed their training in rural practices showed that 73% of Australian-born doctors remained working in rural practice, whereas only 23% of IMGs followed a similar career path.4 Australian-born doctors choose to remain in rural practice because of their familiarity with a country lifestyle and the presence of a support network for spouses and children. However, “lack of familiarity with rural living and isolation from family and friends”4 were reasons mentioned to account for the relocation of most of IMGs to urban settings after they had satisfied the regulatory mechanisms that compelled them to remain in rural areas.

The author of a Prairie Centre of Excellence for Research on Immigration and Integration working paper stated that, in Canada, placement schemes under which IMGs from overseas are recruited to work under limited registration in remote regions “have not provided a long-term solution for provinces seeking to address the needs of under served areas”.5 He concluded that placing IMGs in underserved areas has produced a “medical carousel” of IMGs leaving rural areas once they obtain their unrestricted licenses.5 Given the failure of such a policy to produce its intended results in a country with an arguably comparable health care system, the 10-year moratorium should be progressively phased out in Australia. In the Lost in the labyrinth report, the Chair concluded that “a review of the 10 year moratorium would be appropriate and timely”.1

Many of the doctors recruited to redress health care workforce shortages were never informed about the restrictions they would be subject to on their arrival in Australia. Yet, pursuant to section 72 of the Health Practitioner Regulation National Law (enacted in all states and territories), any IMG on a Temporary Work (Skilled) (subclass 457) visa who, for any reason, ceases to be registered with the Medical Board of Australia, will be left with only 28 days to find an immediate alternative or leave the country. Also, there is no fair appeal and grievance process for IMGs with 457 visas, many of whom work in designated Area of Need (AoN) positions. The impact of restrictive policies on the personal and professional lives of IMGs in Australia has been ruinous. For example, doctors with 457 visas and their families do not qualify for health care services under Medicare. In a recent case in rural Queensland, a United States-born doctor had to pay a thousand dollars for treating his own daughter’s broken arm while he was on duty at the local hospital.6 Overseas-trained doctors and nurses are intrinsically involved with providing health services under Medicare, a characteristic not shared with any other group of temporary worker in Australia.

An independent integrity review commissioned by the Ministry for Immigration and Citizenship7 confirmed that 457 visa holders are potentially vulnerable to exploitation. For example, IMGs have reportedly been forced to work up to 80 hours per week, as documented in one of the submissions to the parliamentary inquiry1 (submission 101, page 75). The current system contravenes recommendations of major government policy reviews. The first recommendation of the final report of the Visa Subclass 457 Integrity Review advises that subclass 457 visa holders should “have the same terms and conditions of employment as all other employees in the workplace”.7

In addition, the Commonwealth code of practice for the international recruitment of health workers, adopted by Commonwealth Health Ministers in 2003, determined that IMGs should be “protected by the same employment regulations and have the same rights” as their local counterparts.8 Similarly, The World Health Organization Global code of practice on the international recruitment of health personnel, adopted by the 63rd World Health Assembly in 2010, of which Australia was a signatory member, established that migrant health personnel should “enjoy the same legal rights and responsibilities as the domestically trained health workforce in all terms of employment and conditions of work”.9

In Australia, IMGs who attained medical qualifications in the United Kingdom, United States, Canada, New Zealand and Ireland are entitled to an accelerated registration process (competent authority pathway), whereas IMGs who qualified elsewhere must undergo a multiple choice examination and a structured clinical assessment (standard pathway). Local graduates are not required to undergo a similar formal assessment. The waiting period to sit for the clinical component can be long, which may curtail employment opportunities for many IMGs. The procedures involved in the registration and integration of IMGs have been described as not ideal.10

Workplace based assessment (WBA) is an alternative route based on a 6-month assessment process, which can also be delivered in regional Australia. Entry into the WBA program has the same eligibility criteria as the standard pathway, which includes an English language proficiency test. It has been shown that the WBA is a cost-effective form of assessment that facilitates a straightforward integration of doctors into the local health care system.10 The committee that conducted the parliamentary inquiry recommended that colleges of specialists also adopt the WBA model to assess the clinical competence of specialist IMGs (recommendation 8, chapter 4, page 96), given that this assessment methodology is “a much more reliable and accurate evaluation of clinical skills of the IMG” (chapter 4, page 84).1

Notwithstanding the recommendations of the parliamentary enquiry,1 the WBA remains available only in a limited number of training sites for non-specialists, and only a limited number of colleges of specialists have incorporated the WBA into their evaluation processes. Many overseas-trained specialists remain working in AoN positions for years when this period could have counted towards their registrations through WBA. There remain colleges who still insist on using simulated assessment conditions to determine whether a colleague and specialist in his or her own right is sufficiently qualified to practise in a jurisdiction where he or she has in fact been practising competently for several years.

There is no argument that patient safety must be the number one consideration in recommending reforms to the system. A central conclusion of the Lost in the labyrinth report was that “improvements in registration processes for IMGs must be achieved without compromising the high standards that Australians expect from medical practitioners”. Yet, there remain the flagrant breaches of the codes of practice mentioned above, which buttress a de-facto two-tier system in Australia whereby disempowered IMGs have to bear the burden of hindrances that do not apply to local graduates. These discriminatory policies are ethically indefensible, given the overt violations of principles of non-maleficence, beneficence and justice that result.

The unfair hindrances faced by IMGs are irreconcilable with principles of equity and mateship that are at the core of Australian society. There is still an opportunity for political leaders and medical authorities to rectify these inequities by implementing the recommendations from the parliamentary inquiry and the principles sanctioned in international codes of practice.

Lessons learned in developing new postgraduate medical specialist training programs for Australia and New Zealand

What can be learned from the process of introducing major postgraduate medical education reform?

Considerable changes in the processes of medical student education have been occurring for the past 20 years. Such changes began with the recognition that the curriculum was becoming increasingly full, leading to fatigue and loss of enthusiasm for the craft of medicine in medical students just as they were entering the medical workforce.1 Changes in medical student education have included limitations on curriculum content; new ways of learning, such as inquiry-driven learning using problem-based learning principles; formative assessments; more feedback on student performance; emphases on ethics, communication and clinical reasoning; and greater integration of preclinical and clinical learning opportunities.2–4

Have these changes been mirrored in postgraduate medical training? In a general sense, changes in postgraduate training for graduates of these new medical courses have been limited.5 It could be argued that, as postgraduate trainees are already “trained” and have commenced work, such reforms are not really necessary. However, the changing health care environments in which trainees work have placed the traditional apprenticeship model under severe duress. Erosion of the apprenticeship model has weakened the previously strong links between trainee and trainer, lessening the capacity to train our medical workforce at the very time that the community is demanding greater competence and accountability.

The Royal Australasian College of Physicians (RACP) trains many of the medical specialists in Australia and New Zealand, with more than 6000 trainees currently spread across 60 different training programs. Most trainees are training in internal medicine (and its many subspecialty components) or paediatrics, but training in public health, occupational and environmental medicine, rehabilitation, sexual health and addiction medicine are also covered under the RACP’s programs.6 As such, the RACP is a highly complex medical education enterprise. In 2004, the Australian Medical Council undertook its first external review of the RACP training programs. This review recommended changes to the education programs of the RACP, hastening the process of educational reform.

Principles underlying the new RACP training programs

Design of a new postgraduate training framework for the RACP was predicated on ensuring, wherever possible, that processes and principles of training had resonance with medical school education reforms. A “handshaking” process, by which trainees feel familiar with postgraduate training as it resembles what they encountered in medical school, strengthens the vertical nature of medical training, even if that training is spread across different training bodies and locations.

Foundational to the changes introduced by the RACP in the new Physician Readiness for Expert Practice (PREP) program7 has been the principle that workplace-based education is highly effective, provided there are scaffolds for both trainees and their supervisors to articulate such learning. These supporting frameworks should:

enable trainees to know what it is they need to learn;
enable trainees to recognise that they are learning the required material;
provide educational evidence of attainment of the learning objectives, for the benefit of both trainees and their supervisors; and
ensure that reflective learning (ie, trainees thinking about their learning and the impact they are having on their patients and the health care team) is developing the trainees into mature and competent professionals.

Another key consideration in the design of the PREP program has been the development of a wide range of discipline-specific curricula, together with a Professional Qualities Curriculum that runs across all the training programs.8 The Professional Qualities Curriculum places emphasis on matters such as quality and safety, leadership, education, communication, ethics and cultural competency.

The key principles underpinning the educational developments are:

The trainee is an active participant in the learning process, as opposed to being a passive recipient of information.
The role of the teacher is no longer to only deliver factual information, but also to facilitate the trainee’s learning.
The trainees, by taking ownership of and responsibility for their own knowledge and skills acquisition, can direct, manage and organise their own learning needs within a supportive and clearly defined curriculum framework that will guide them through a defined learning pathway.
By thinking reflectively about what they need to learn and how they learn, the learning process becomes personalised and the trainees become self-motivated to achieve their own academic goals.
The programs reflect current Australian and New Zealand workplace practices and changing regulatory requirements. They emphasise the provision of exemplary patient care within the context of an increasingly complex, multidisciplinary team-based working environment.

Lessons learned

The introduction of major educational changes across the clinical and medical education sectors involves extensive planning and resourcing. Several key lessons have been learned throughout this reform process.

First, educational change requires a narrative — a description of why things need to change and the value of the new way of supporting and educating trainees in their learning and professional development.

Second, educational change requires time. Under the PREP program, clinicians need to have an understanding of the new educational tools and processes, and health services need to be aware of and support the reforms. Developing a deep understanding of educational and training processes, and their interface with clinical service delivery, takes time and persistence. Slow and progressive implementation of the PREP program was needed to enable trainees and supervisors to become familiar with the new requirements over time and to enable health services to adapt.

Third, educational change requires extensive investment. The RACP invested heavily in these training reforms, including establishing an Education Deanery to support the development of a completely new postgraduate training program. The RACP also provided support for hundreds of workshops around Australia and New Zealand and extensive communication processes with trainees, Fellows and health departments. Beyond these initial investments, supervisors and trainees must invest time and energy to understand and participate in the components of the new training program. The most common response from supervisors has been the request for their employers (mostly health departments) to provide the resources needed to allow them the time and capacity to fulfil the duties of supervision and documentation of their trainees’ performance.

Finally, educational change requires lots of communication and clinician participation. Simply providing information on the educational changes is not sufficient — active processes are needed to engage clinicians in the reform process itself, along with the narrative of the changes, using many communication channels as frequently as possible.

Conclusions

As these training program changes are still being progressively introduced, it is too early to conclude what their impact on training outcomes and clinical practice will be. Anecdotal reports of the individual experiences of many trainees suggest that documenting their learning, observation and systematic feedback on their educational journey is helpful. Moving to an electronic platform to document their training and the construction of learning plans by trainees have been less acceptable.

Australia and New Zealand have excellent medical training at all levels, and postgraduate vocational medical training is moving rapidly towards being structured along a continuum from medical school programs. Changes in the health services, changes in the profession of medicine and medical educational reforms are kept in balance through active reforms in postgraduate medical education processes. These postgraduate training reforms are extensive and expensive. Most of this “cost” is borne by the supervisory workforce — clinicians who are committed to ensuring not just their own practice of medicine, but also that of the future professional workforce, is of the highest order. What remains is the need for careful evaluation of the effectiveness of these educational changes and their impact on health service and individual clinical practice.

Self-regulation of autologous cell therapies

To the Editor: Tuch and Wall describe the process by the New South Wales Stem Cell Network in October 2012 of creating a national code of conduct for the self-regulation of autologous cell therapies.1 While Regeneus was an observer at the event, we were not involved in any discussions about industry self-regulation. Subsequently we were approached to participate in a committee to work on various topics, including a self-regulatory framework.

It was clear in the initial teleconferences and discussions with Tuch that the committee, while wishing to establish a code, would not meet Regeneus’ views of best practice for the autologous cell therapy industry. In particular, best practice includes:

generating clinical trial and registry evidence;
defining the range or extent of conditions being treated;
ensuring that treatment is delivered in appropriate point-of-care clinical settings; and
ensuring that the medical specialists in the diagnosis and treatment of the condition are the primary providers of patient care.

Little has changed since 2012, and these key requirements still define our approach, which remains focused on musculoskeletal treatment and the principle that patients should be in the care of relevant specialists. Since early 2013, Regeneus has had no involvement in the committee and played no role in drafting the as yet unfinished self-regulation code.

The article by Tuch and Wall correctly argues that self-regulation can be effective. Interestingly, their in-vitro fertilisation example was driven by fertility specialists.

Our view is that an effective code of practice for autologous cell therapy must require medical treatment by specialist practitioners in the condition being treated, appropriate point-of-care facilities where the treatment is conducted, and independent safety and efficacy outcome measurement of the specific treatment protocol being applied.

Self-regulation of autologous cell therapies

In reply: We agree with Vesey on the need for clinical governance, but urge him to remain involved with the development of a national code of conduct in this area. His company’s experience would be invaluable. Our observations regarding self-regulation were qualified because, unlike the fertility treatments, many of the therapeutic claims of autologous cell therapies are unproven. Consequently, there should be a goal of developing an evidence framework.

Our concern remains that this is an unregulated industry, and thus self-regulation seemed a sensible first step to reduce risk. Indeed it is astonishing to note the differences in regulation between Australia and the United States, which recently reaffirmed the Food and Drug Administration’s oversight of certain autologous cell therapies in the US Court of Appeals.1

If adverse events arise from the use of autologous cells in Australia, all practitioners of the art are likely to be adversely affected. It is in the interest of all — companies, clinicians and their patients — to limit the risks of this unregulated industry.

The NSW Safe Sedation Project

To the Editor: About 300 000 episodes of procedural sedation occur annually in New South Wales public hospitals. Much of this sedation is supervised by non-anaesthetists.

Complications of procedural sedation are usually related to airway obstruction or depressed ventilation and can be life-threatening. Therefore, clinicians who administer sedation and care for sedated patients should have adequate knowledge and skills to assess, manage and provide rescue to these patients.

The Australian and New Zealand College of Anaesthetists has addressed the issue of procedural sedation since 1984 via policy statement PS09.1 Many specialist groups are cosignatories to PS09; however, its implementation has been incomplete.

Anaesthetists in NSW have long been aware of adverse outcomes from procedural sedation, and of reports from nursing staff who care for sedated patients and who feel poorly trained and unsupported for the tasks required.

The NSW Safe Sedation Project was established to support the safe provision of non-anaesthetist-administered intravenous procedural sedation. The project included development of minimum standards of care, a survey of NSW hospitals to confirm feasibility of the standards and raise awareness of PS09, and development of a toolkit including an audit tool.2

The minimum standards agreed to early in the project were (i) preprocedure: assessment and risk stratification of all patients who receive procedural sedation; (ii) intraprocedure: the constant presence of a dedicated clinician, to monitor and provide airway management for the sedated patient; and (iii) postprocedure: arrangements for monitoring the patient recovering from sedation.

The project team visited over 50 procedural departments in 17 hospitals in a range of metropolitan, regional and rural local health districts (LHDs) between 2012 and 2014. Some units reported underresourcing regarding direct anaesthetist availability, but this was the exception. There was considerable variation in the skill level of nursing staff caring for sedated patients (corresponding with scenario 1 in appendix 3 of PS09). This has also been observed by other authors.3

As project leaders, we recommend that consistent, high-quality education and training be developed and implemented for all clinical staff who regularly manage sedated patients. This training should be aligned with competency-based assessment.

We also recommend the development of hospital- or LHD-wide systems of governance and support for provision of sedation by non-anaesthetists.

To maximise the efficient use of highly skilled clinicians, hospitals and LHDs should consider developing processes that enable the triage of higher-risk patients to anaesthetists for sedation, and support appropriately trained and skilled non-anaesthetist sedation providers for lower-risk patients.

The Safe Sedation Project toolkit is available via the NSW Agency for Clinical Innovation website.2

Do death certificates accurately record deaths due to bloodstream infection?

To the Editor: Sepsis and bloodstream infection (BSI) are associated with significant morbidity and mortality although they are amenable to targeted intervention in the hospital setting. The Australian Bureau of Statistics (ABS) reported 1463 deaths due to septicaemia in Australia in 20121 — a number that is likely an underestimate.2

These statistics are based on reporting of cause of death on death certificates by medical practitioners. However, previous studies in Australia have found inaccuracies in reporting, with major revision of cause of death required in half of cases referred for coronial review.3 The need for education of reporting doctors and supervision by senior clinicians has been highlighted.4

A review of BSI at our institution during 2012 identified 571 patient episodes of BSI. We were able to analyse death certificates for 65 of 73 patients who died within 30 days of a clinically significant blood culture. The mortality from BSI reported in the literature is high, with a 30-day mortality rate of up to 23% for BSI with any organism, and up to 43.9% for BSI involving methicillin-resistant Staphylococcus aureus.5,6We thus assumed that BSI was likely to have contributed to mortality in deaths where there was evidence of BSI within 30 days of death. Our observed mortality rate of 13% was lower than reported figures, suggesting that BSI was likely contributory in these deaths.

In our series, BSI was reported as an underlying cause of death in 15 of 65 cases (23%), while only 39 death certificates (60%) identified the presence of BSI in any field. Seventeen death certificates (26%) did not reflect the presence of BSI at all. The BSI events not recorded as the underlying cause of death may not have been captured in ABS statistics as contributing to cause of death. Trends in the incidence of and mortality from BSI may therefore not be detected. This is a particular concern in an era of increasing global antibiotic resistance, when rising mortality due to BSI may signal increasing antibiotic resistance in the community.

Several systemic deficiencies likely contribute to underreporting. Events leading to death, but reported as following from the recorded underlying cause of death, are not reflected in cause of death data collected by the current system, which focuses on reporting the underlying cause of death. This approach fails to identify potentially preventable or reversible intermediary events, such as BSI, during complex and advanced medical care. Inaccuracies may be compounded by lack of training and experience and poor supervision of junior doctors who complete death certificates.7 As a result, it is likely that national death statistics are heavily biased towards single events such as road traffic accidents, or “upstream” diagnoses, like malignancy. We agree that increased and structured supervision and training of medical students and junior doctors in this area appears to be required. However, it may also be necessary to revise the reporting process itself to identify potentially preventable intermediary causes of death, that may then be more effectively targeted with research funding, awareness campaigns and clinical care bundles.