Editorials

Stimulants increase the risks of psychosis and stroke Stimulant use disorders (rather than recreational use) account for most of the harms associated with illicit stimulant use, and are more likely to occur with frequent use and more efficient routes of administration (ie, injection and smoking rather than oral or intranasal use).1 A driving factor behind many of the problems associated with stimulant use in Australia is the long-standing history of methamphetamine injection.2 The majority of dependent methamphetamine users in Australia inject the drug and have been using for a decade or longer.1 In this issue of the Journal, Sara and colleagues highlight the substantial number of heavy stimulant users in Australia.3 They estimate that almost half the people who report taking stimulants on more than five occasions progress to problematic levels of use, meeting criteria for either misuse or dependence. This amounts to around 97 000 Australians in the past year. Such findings are a timely reminder that heavy stimulant use is an ongoing issue in Australia that cannot be ignored. Heavy stimulant use is associated with a number of public health concerns, the most salient of which is stimulant-induced psychosis. As Sara and colleagues point out, stimulant use disorders are concentrated among young men, who are the population subgroup at highest risk for developing psychosis, and the least likely to seek professional help for a mental disorder.4 Stimulants also exacerbate existing psychotic disorders and, in this context, they hinder the efficacy of antipsychotic drugs and increase the risk of violent behaviour.5 Heavy users are not only at increased risk of contracting HIV and other blood-borne viruses from injecting stimulants, but they are also at elevated risk of sexually transmitted diseases (including HIV) because stimulants increase libido.6 This situation creates a nexus for the spread of HIV between drug users and the broader population. Stimulants can further increase the risk of HIV transmission through immunopathological processes.6 As such, HIV prevention efforts for stimulant users need to focus on both safe injecting and safe sex practices. Stimulants increase the risk of cerebrovascular events,7 particularly young ischaemic stroke, as emphasised by Phillips and colleagues,8 also in this issue of the Journal. Stimulants increase the risk of stroke as a consequence of hypertension and other catecholamine-mediated vascular changes that occur during intoxication, while vascular abnormalities and cardiac pathology that occur with chronic use are also risk factors.7 Heavy tobacco and cannabis smoking, as well as the risk of infectious endocarditis as a result of intravenous use, compound the risk of cerebrovascular incidents in this population. Such public health concerns highlight the importance of early detection and intervention efforts. However, illicit stimulant use increasingly spans a broad segment of the population, including people who are well educated, employed and whose life situation would not otherwise point toward drug use. This “mainstreaming” of stimulant use, coupled with the community’s reluctance to disclose illegal drug consumption, can make stimulant use difficult to detect. Given that stimulant users commonly seek help from general practitioners for a range of health issues, offering a safe environment to talk about drugs, where confidentiality is assured and patients do not feel judged, is a critical first step in identifying harmful use. This can be done in a non-confronting way by discussing how stimulant use (both legal and illicit) might be a factor in the aetiology of certain conditions (eg, sleep problems, mood disturbances, hypertension), and whether such use is contraindicated for prescribed medications. Being proactive in this way, at the very least, imparts knowledge with which patients can self-manage their health. Once detected, it is important to appreciate that stimulant use disorders do not occur in isolation; they tend to co-occur with heavy use of cannabis, alcohol and tobacco, as well as with other mental disorders. Stimulant use can increase heavy drinking because it negates the sedating effects of alcohol intoxication. Cannabis and sedative drugs are often taken as a means of coping with the “come-down”, or after effects, of stimulant intoxication. Stimulants can also increase the risk of toxicity from medications prescribed to manage symptoms of depression that are almost ubiquitous among heavy stimulant users.9 The potential involvement of heavy stimulant use in physical and psychiatric problems seen within medical health care settings needs to be considered. Patients who desire treatment for stimulant use can be referred to generic drug and alcohol services (eg, counselling and residential rehabilitation), and specialised treatment programs have been established in some locations (eg, NSW Health’s stimulant treatment clinics10). There is little available in terms of evidence-based treatments. Intensive psychological interventions (eg, tailored cognitive behaviour therapy, contingency management) have shown some promise,6 although these interventions have not been widely implemented. More work is needed to develop and implement effective treatment options for heavy users of stimulants.

Rebecca McKetin BSc(Psychol)(Hons), PhD · Dan I Lubman PhD, FRANZCP, FAChAM

Time to find a systems-level model for a serious, undermanaged, but preventable problem For over 20 years, we have known that osteoporotic fractures predispose to further fractures and significant morbidity.1,2 We also understand that first and subsequent fragility fractures are associated with premature death.2-4 However, surprisingly little has happened over the past two decades to translate this knowledge into good clinical practice for our patients. Of course, anyone presenting with a low-trauma fracture to an Australian hospital will get it fixed in due time. But little happens after that. Nobody seems to ask why that person had a low-trauma fracture (or a second or third one) to begin with. Indeed, 75%–80% of patients who have had an osteoporotic fracture are neither being investigated nor treated for their underlying condition — osteoporosis.5,6 This systematic failure is all the more shocking as we have available to us not only one of the world’s best medical systems, but also subsidised pharmacotherapies with proven efficacy to reduce the risk of (re)fracture.7 Recent data from New South Wales reveal that 35% of patients admitted to hospital with an osteoporotic fracture were readmitted with another fragility fracture, often within 1–2 years of the initial event. This accounted for 16 225 essentially unnecessary admissions with a startling average length of stay of 22 days. Of those with refractures, 17% died during the period studied.8 These numbers represent a medical nightmare and a health care systems failure of huge and growing dimensions. Because the Australian population is ageing, the prevalence of osteoporosis has been steadily rising over the past few decades. Currently, 2.2 million Australians live with osteoporosis, and this number is projected to increase to 3 million by 2021.9 While 67 000 osteoporotic fractures were recorded in Australia in 2001, this figure had risen to more than 87 000 in 2007.9 In 2001, the annual total cost of osteoporosis to the Australian health system was estimated at $7.4 billion,10 and it does not require much imagination to anticipate that we will soon spend an even larger amount of our nation’s income on a medical problem that can be treated and, more importantly, effectively prevented. The reasons for such management failures are complex, and include inadequate awareness among doctors and patients of the health hazards related to osteoporosis, and the almost complete lack of effective medical postfracture care.6 While the fundamental need to improve osteoporosis recognition and management has been acknowledged worldwide, attempts to tackle this issue through simple educational campaigns have clearly not translated into improvements in treatment rates.11 In contrast, there is now high-quality evidence that the implementation of system-level models of care reduces refracture rates, morbidity and mortality, hospital bed days and other health system use. The most effective of these interventions are “fracture liaison services” that include targeted case-finding, systematic assessment, appropriate treatment and follow-up, and access to self-management education programs and support systems.12-15 While such programs have been developed by individual clinicians in Australia, most health services seem reluctant to meet the financial and logistical requirements for secondary fracture prevention services. Are we asking for too much? Would public funding for such services be justified? Let us look at the evidence. We recently reported on the clinical effectiveness of a fracture liaison service established in 2005 at Concord Repatriation General Hospital in Sydney.12 This outpatient service is available to all patients with osteoporotic fractures and, over 4 years, reduced the risk of refracture by 80% compared with standard care. Obviously, the service involves human resources and more use of bone densitometry, laboratory testing and medications. The question therefore was whether the benefits provided by the service would be cost-effective. A health-economic analysis published in the latest issue of Osteoporosis International shows that even though the service is comprehensive, it is also highly cost-effective.16 The economic model used for the analysis accounted for all major osteoporotic fractures (ie. hip, forearm, and humerus), their associated direct costs, changes in health utility and, in the case of hip fractures, increases in mortality. Fracture probabilities were calculated from the clinical data, and medical costs for the service and the control arm were derived from reported health resource consumption data. The (very conservative) analysis showed that reducing subsequent fractures through a fracture liaison service led to significant improvements in quality-adjusted life-years (QALYs). Despite higher treatment costs, the total cost of the intervention was only $1300 per patient over a 10-year period, that is, $130 per patient per year. The incremental cost-effectiveness ratio for the service (versus no intervention) was $20 210 per QALY gained, which means that the intervention represents excellent value for money. Indeed, when lower medication costs were introduced (as would be expected over time), the service was cost-saving; that is, the money saved by preventing fractures would be more than the cost of the service.16 The Concord fracture liaison service is one of various possible models, but conceptually can be implemented in any Australian health service. Its proven clinical and cost-effectiveness leave no excuses for not attempting to close the appalling gap in the postfracture care of patients at high risk of fracture.

Markus J Seibel MD, FRACP, PhD

Recent studies build a strong case to suggest that there is a clear risk Clearly, stroke prevention is preferable to the currently available treatments, particularly for haemorrhagic stroke. The burden of stroke is substantial, so all strategies to reduce risk must be considered. The traditional risk factors, especially hypertension, are well recognised, but there is also increasing interest in identifying and modulating novel risks1 and precipitant causes. In this issue of the Journal, an important article by Caughey and colleagues2 adds to the growing literature concerning the risk of stroke related to the use of non-steroidal anti-inflammatory drugs (NSAIDs), particularly those with selective cyclooxygenase (COX)-2 inhibition. If the use of these agents is a clear and substantial risk, then avoiding such medications, particularly in high-risk patients, may be an important preventive strategy. But is the risk clear and substantial, or are other factors involved? Is there a potential for abandoning useful medications and also creating undue anxiety for patients currently using them to treat painful chronic conditions? The lessons regarding the cardiovascular risk of rofecoxib must be heeded,3 and the pharmacological basis for increased risk of thrombosis and elevation of blood pressure (and thus haemorrhagic stroke risk) is well founded. Surprisingly, recent guidelines4 pertaining to patients with extracranial large arterial stenosis, who are at high risk of stroke, made no specific comment for or against the use of NSAIDs because of a lack of evidence. This was based on some earlier studies5 that did not show increased stroke risk. Two more recent studies6,7 from different populations demonstrated an increased stroke risk, especially for haemorrhagic stroke. Combined with the results of Caughey et al,2 these studies build a strong case to suggest that there is a clear risk. There are consistencies across the studies, including the observation that adverse outcomes seem to vary with different NSAID classes. The population studied by Caughey et al2 was elderly, with comorbidities and, frequently, a combination of arthritis and vascular disease. This is precisely the group of patients where the dilemma commonly arises, making the study clinically valuable. The data appear robust, and feature a sensitivity analysis that strengthens the initial findings. It should be remembered, however, that the conclusions do not apply to younger and healthier populations. Additionally, the absolute stroke risk is small, and may be exceedingly small, particularly if NSAID exposure is brief. What is not clear from these studies is the role of confounding variables. The use of a prescription medication database and hospitalisation codes might suggest an association, but will not provide all the answers to a complex clinical scenario. Although the crude sequence ratio is robust to confounders that are stable within individuals over time, cardiovascular and stroke risk are unlikely to be stable over time and probably fluctuate. Intercurrent infection, inflammation, immune response and blood pressure variability are dynamic factors that may precipitate vascular events, particularly in predisposed individuals. Blood pressure variability8 is under increasing scrutiny as a provoking factor for stroke events. Given the important impact of COX-2 inhibition on increased blood pressure,9 this may be the true link in the relationship. The reasons for NSAID prescription would be of great interest. Suppose, for example, that an NSAID is prescribed for analgesia in an older patient with vascular disease who has a painful arthritic condition. The NSAID may well raise blood pressure, and fluctuations in pain may result in blood pressure fluctuations; thus providing two risks for stroke. Several NSAIDs were shown by Caughey and colleagues2 to carry stroke risk similar to the cardiovascular risk of the now-withdrawn rofecoxib. Low-dose preparations of several NSAIDs are available in Australia without prescription. The findings of Caughey and colleagues further emphasise the need for great care in the use of these agents in patients with hypertension and other stroke risks.

David J Blacker MB BS, FRACP

The growing infection control challenges facing an ageing population In this issue of the Journal, a study of multiresistant bacterial intestinal carriage by Stuart and colleagues adds important detail to the emerging picture of multiple antibiotic resistance in non-hospital settings.1 The higher colonisation rate they found for Escherichia coli than for vancomycin-resistant enterococci (VRE) or Clostridium difficile in residential aged care facilities is a timely reminder that our surveillance and infection control resources should not be exclusively targeted at VRE or C. difficile. The simultaneous presence of these potential pathogens in the same aged care population raises the ugly spectre of carriage of two or more resistant organisms. The risk of contemporaneous multiresistant E. coli, C. difficile-associated diarrhoea and faecal incontinence might be considered the perfect infection control storm. As Stuart and colleagues rightly point out, data are lacking on the prevalence of community-acquired multiresistant gram-negative bacteria in Australia. By extrapolation from northern hemisphere studies, it appears that nursing homes and other long-term care facilities can function as potent reservoirs of multiresistant E. coli.2 Measuring the duration of enteric carriage after initial colonisation by a multiresistant strain may help determine the potential window for onward transmission, but we can anticipate variable and possibly strain-dependent transmissibility. The relatively small size of Stuart et al’s study, the presence of a single-strain case cluster and other specific features make it difficult to generalise from their results. However, observation of a dominant genotype of multiresistant E. coli in one aged care facility concords with a previous observation of single genotype clusters in long-term care facilities.3 The observed dominance of CTX-M (cefotaxime-hydrolysing) β-lactamase-mediated resistance is also consistent with the wider international trend, as noted in a recent nationwide study from Belgium.4 The mechanism of antibiotic resistance designated CTX-M-15 has been particularly successful on a global scale — the result of carriage of resistance-determining genes on multireplicon plasmids, combined with international travel.5 CTX-M-15 has become a prominent multiresistance determinant detected in the faeces of international travellers, particularly those returning from the Indian subcontinent or Africa.6 The route followed by multiresistant gram-negative bacteria brought to Australia by healthy, young international travellers to reach the residents of aged care facilities is unclear. But once aged care residents are colonised, Stuart et al’s data suggest spread of resistance among them, possibly assisted by transmissible bacterial genetic elements.1,3 In a survey of resistant E. coli in western Sydney, where CTX-M-15 predominates, 11 different conjugative plasmids were found, most of which had multiresistance regions.7 The challenges of aged care are many and will continue to grow as the number of people in need of residential care expands. There are many potential contributors to the emergence of multiresistant bacteria in residents of aged care facilities: multiple hospital admissions, excessive use of antibiotics (in terms of courses, duration and antimicrobial spectrum), incontinence, dementia, venous stasis ulcers, and difficulty implementing infection control practices in institutions where residents are free to move outside their rooms and mingle with others. Well established multiresistant bacteria such as community-acquired methicillin-resistant Staphylococcus aureus (MRSA) pose a significant problem in some aged care facilities and other long-term care units. Our failure to hold the MRSA threat at bay, even with the most stringent measures, should make us wary of trying to apply failed control strategies to a group of bacteria with a substantially different ecology. The “search-and-destroy” approach to infection control, with its heavy reliance on screening swabs and decolonisation, risks interfering with movement of aged care facility residents to and from hospital (when admission or discharge depends on documented screening status or completion of decolonisation) for little, if any, demonstrable benefit. The value of alternative approaches is also uncertain. To date, attempts to control intestinal carriage of multiresistant E. coli in long-term care residents using probiotic E. coli have been unsuccessful.8 This indicates the durability of multiresistant E. coli as a gastrointestinal coloniser. A control method for multiresistant bacteria that relies on surveillance and targeted infection control measures may seem appealing, but in reality is likely to be costly, impractical and ineffective. An alternative strategy9 is to use multiple measures targeting improvements in the skilled nursing care of those at identifiably higher risk of multiresistant bacterial infection, without prior surveillance culture. We recognise that this proposal will not sit comfortably with those who have long advocated a post-hoc, species-specific, search-and-destroy approach to organisms of interest. But with an estimated multimillion dollar annual cost of multiresistant bacteria control measures, and a residential aged care sector facing many challenges, we will be forced to explore all options. This should include considering a more public health-based approach, as long-term care facilities lie outside the remit of conventional hospital infection control. These options cannot be properly debated without additional, nationally representative data addressing the key questions raised by Stuart and colleagues, particularly the duration of gastrointestinal colonisation, the relationship between colonisation and subsequent infection, and the consistency of epidemiological data across a wider range of residential aged care facilities. Their timely study highlights a need for informed discussion of new measures to control multiresistant gram-negative bacteria in long-term residential care facilities. This could include a gamut of aged care measures aimed at reducing transmission, such as decreasing long-term care facility–hospital transfers through the use of advance care planning10 and hospital-in-the-home treatment.

Timothy J J Inglis DM, PhD, FRCPA · Christopher D Beer MB BS, PhD, FRACP

Pharmacists have an important role in protecting the public from regulatory loopholes If the 2011 Readers Digest survey can itself be trusted, pharmacists are the sixth most trusted profession in Australia, coming in marginally behind nurses (fifth) and before medical specialists (eighth) and general practitioners (ninth), and well ahead of car salesmen (43rd) and politicians (44th).1 What qualities inspire trust? The Concise Oxford dictionary defines trust as “firm belief in reliability, honesty, veracity ...”, so presumably these are the characteristics recognised in pharmacists and applauded by the survey respondents. The advice of community pharmacists in response to customers’ enquiries is widely relied upon, but events in the past few months raise serious questions about the trustworthiness of some in the profession. The first episode involved the marketing of SensaSlim (SensaSlim Australia, Sydney, NSW) a complementary medicine promoted as a new approach to achieving weight loss2 and sold largely through community pharmacies. In September 2010, the Therapeutic Goods Administration (TGA) included the medicine in the Australian Register of Therapeutic Goods (ARTG) as a listed product (labelled with an AUST L number). This means it had been evaluated for quality and safety but not efficacy. The product’s website claimed that a clinical trial involving more than 10 000 patients demonstrated its effectiveness, but requests from many health professionals to SensaSlim Australia failed to produce this evidence. Following complaints from doctors and pharmacists over the ensuing months, SensaSlim was discredited, although the associated legal battles are still unresolved.3 Despite widespread adverse publicity in the media, some community pharmacists continue to promote and sell the product, galvanised perhaps by the 65% profit margin on sales4 rather than the strength of the evidence for efficacy. The second event was the much publicised intention of the Pharmacy Guild of Australia (“the leading advocate for community pharmacy and a vital contributor to improving health outcomes for all Australians”5) to add its “Gold Cross” endorsement to complementary medicines marketed by Blackmores (Sydney, NSW) as “companion products” to prescription medicines for common medical disorders. Justifications for this concept included that some antihypertensive medicines are associated with reduced plasma concentrations of zinc; coenzyme Q10 concentrations are lowered in patients taking statins; hypomagnesaemia has been reported in patients taking long-term proton pump inhibitors; and probiotics might prevent some cases of antibiotic-associated diarrhoea.6 It is a short jump from these observations to the idea that supplements of zinc, coenzyme Q10, magnesium or probiotics should be given routinely when using these medicines. If implemented, this would be a remarkable marketing coup for Blackmores and the community pharmacy. But is there any evidence of possible benefit? A team at the National Prescribing Service published an excellent summary of the available evidence on its website on 30 September.7 They found nothing to support the routine use of these companion products. Under pressure from many pharmacists (including the Pharmacist Coalition for Health Reform) and other health professionals, the Pharmacy Guild announced on 5 October that the plan to endorse the Blackmores products had been dropped. These two disturbing events are symptoms of two underlying problems. First, community pharmacies still rely significantly on product sales for income, rather than a fee-for-service model. This results in a tension between being a health care professional and being a retailer. While recent agreements between the Pharmacy Guild and the Australian Government are trying to address this issue by providing payments to pharmacists for cognitive services such as medication reviews, the uptake of this program has been variable.8 Second, there are regulatory issues around complementary medicines that are yet to be acted upon by the Australian Government and its regulators. For many years, Australia led the world in regulation of complementary medicines. However, the regulations have not kept pace with trends, especially in the case of listed products. In particular, the loophole that allows sponsors to have products such as SensaSlim included on the ARTG without any review of evidence to support their claims is an affront to any regulatory body. When regulation of complementary medicines began in the 1990s, it was agreed that “low-risk” (AUST L) medicines would be allowed onto the market without independent review of efficacy, provided they were safe and of good quality. In 1999, it became a requirement that sponsors of listed products must “hold” the evidence to substantiate their claims. In 2003, a report on complementary medicines in the health system recommended that, as part of the listing process, sponsors should submit a summary of the evidence for efficacy to the TGA.9 The government accepted this recommendation,10 but no implementation has resulted. Enacting this recommendation may protect us from future SensaSlims, and would give a proper basis for the provision of sorely needed evidence-based consumer information about complementary medicines. A positive aspect of the Pharmacy Guild’s forced U-turn is that it demonstrates there are sufficient numbers of alert and concerned people in this country, including many pharmacists, who are prepared to put pressure on the peddlers of untrustworthy proposals. It is presumably these pharmacists who have earned the accolades of trustworthiness for the profession as a whole.

Anthony J Smith BM BCh, DM, FRCP · David A Newby BPharm, PhD

A sustained and coordinated multisectoral approach is vital Recent research has shown a striking association between gender-based violence (GBV) and lifetime mental disorders among Australian women.1 Data from the 2007 National Survey of Mental Health and Wellbeing2 offer important lessons for advancing policy and practice in this key area of human rights and public health. More than a quarter of the 4451 women surveyed had experienced one of the common forms of gender-based violence (GBV): rape (8.1%), other forms of sexual assault (14.7%), physical intimate partner violence (7.8%) and stalking (10.0%). Sexual assault and rape often occurred for the first time at an early age (median 12 and 13 years, respectively). GBV was strongly associated with a wide range of mental disorders including mood, anxiety and substance-use disorders; women exposed to one form of GBV had double the rate of any lifetime mental disorder (58%) of unexposed women (27%). GBV was also strongly associated with severity and comorbidity of mental disorder, suicide attempts, disability, poor quality of life, unemployment and overall socioeconomic disadvantage. Although major advances have been made in developing practice guidelines and policy to prevent and respond to GBV in Australia, there has been little focus on the mental health component. This oversight continues to be evident in the Australian Government’s 12-year action plan,3 which otherwise offers a comprehensive approach to the problem. The prevalence and consequences of GBV mean that it needs to be regarded as a mainstream problem for all health care providers. The primary care level is of pivotal importance. General practitioners need to be aware of the likelihood that undisclosed GBV may underlie unexplained physical injuries and mental health symptoms, particularly among repeat attenders. There is a risk that the culture of silence on this issue will hinder detection of the problem.4 Women justifiably fear that they will not be believed or that their disclosures will put them at risk of further abuse, and clinicians may be hesitant to raise this sensitive topic. The presence of partners at consultations can further inhibit disclosure. GPs may benefit from additional training in gender-sensitive interviewing techniques, to ensure accurate detection of GBV in a manner that builds trust.5 National protocols need to be implemented for referral and coordination among agencies so that women have access to protection (shelters and/or the removal of perpetrators from the household), legal advice, support for at-risk children, and financial assistance. Access to quality mental health services should be a priority, given that the disorders identified by the national study were complex in nature, disabling and associated with suicide risk. Specialised agencies, including mental health, rape crisis and domestic violence services, need to recognise more fully the close interaction between GBV and mental disorder. Mental health professionals should maintain a high level of suspicion that GBV may underlie common mental disorders. Sensitive inquiry into a history of abuse is an integral part of assessment. Abused women should be protected from situations that increase feelings of insecurity; for example, mixed-gender facilities or settings where male partners can gain ready access. Services for sexual assault and domestic violence require better resourcing to ensure seamless referral to mental health professionals with the necessary skills to address the psychological consequences of gender-related abuse. The process of referral needs to allay the woman’s fear of being labelled in a context where perpetrators commonly try to discredit reports of abuse by claiming the survivor is mentally disturbed. The study findings1 point to the importance of childhood, adolescence and early adulthood as targets for interventions. It is during these early developmental phases that women commonly are first exposed to sexual abuse, which is the harbinger of further violations as well as of a lifetime of mental disorder and disability. A greater focus on school-level and family interventions may prove valuable. The family is the setting of highest risk, but it is also the unit with the greatest potential to provide protection. At a wider level, public health campaigns are needed to change attitudes and mores that sanction the culture of patriarchy and silence surrounding GBV in our society.6,7 The strength of the nationwide epidemiological study1 is that it offers a lifespan perspective on the recursive problem of GBV, in which women are at risk of repeated exposure to abuse of various forms, and of developing a range of comorbid mental disorders and associated disabilities. Socioeconomic disadvantage and marginalisation compound the problem. Women with limited resources and alternatives are less able to leave a violent relationship. Indigenous women and women from refugee backgrounds may be confronted with additional problems related to discrimination and isolation.8-10 A sustained and coordinated multisectoral approach, in which mental health has an integral role, is vital to bringing about fundamental change to the life-course trajectory of adversity associated with GBV. The overarching aim should be to provide a comprehensive approach to intervention that empowers women to make the changes required to promote recovery and resilience.

Susan J Rees MSocPol(Hons), PhD · Derrick M Silove MD, MB ChB(Hons), FRANZCP

It is never too late, or too early, to listen to patients about what they want How people die remains in the memories of those who live on. Cicely Saunders, Pain and impending death1 Isn’t it rather odd that, only a few decades ago, dying was a normal part of life? You would most likely be cared for and die at home, surrounded by family. While all the advances in medicine that treat disease and enable us to live much longer have been welcomed, what has been pushed off the agenda is that the mortality rate for all of us remains at 100%. It is in this context that advance care planning is beginning to be recognised as a pivotal part of end-of-life care. In the 19th century, when little was understood about disease processes and few effective treatments existed, Sir William Osler famously said, “It is much more important to know what sort of a patient has a disease than what sort of a disease a patient has”. As modern medicine evolved, with rapid scientific discoveries and technological advances, the focus shifted profoundly to cure — to defeating disease and saving or prolonging life at all costs. Early in the 21st century, it has become increasingly apparent that one of these costs has often been the quality of the patient’s survival. Modern medicine has started to focus equally on the disease and the patient. There is much wisdom in the code of ethics for Catholic health and aged care services, which clearly states that if a treatment is overly burdensome or the burdens outweigh the benefits, the patient may legitimately forgo the treatment.2 To do everything possible just because it is possible, without regard to the patient’s goals, values and wishes, is ethically unsound and not good medical practice. Yet it is remarkable how often this occurs. How many times have doctors, both senior and junior, said that they were continuing or commencing treatment because the family wanted it, and not because they thought that it was right for the patient and was supported by evidence in the medical literature? Our common law duty of care as doctors is to always act in the patient’s best interests. One of the most practical ways to put this into action is to regularly ask ourselves, “Am I caring for this patient or family the way that I would want myself or my family to be cared for, by taking the time to identify their personal, spiritual or religious views and take these into account when I am making decisions?”. There are three opportunities to check whether the care we are providing is patient-centred. The first is with competent patients, by ensuring that their consent to treatment is fully informed, by understanding their goals and values that are relevant to their current or future treatment, and by identifying their wishes regarding treatment if they become seriously ill and can no longer decide or communicate what they want. This process of enquiry is called advance care planning. It may be as simple as identifying who the patient’s substitute decisionmaker would be and ensuring that this person is someone who has a clear idea about the patient’s goals, values and wishes. It may also include assisting patients to put their future wishes in writing. It is crucial to enquire what the patient would regard as an acceptable outcome, rather than make a shopping list of acceptable versus unacceptable treatments. Where is the patient’s line in the sand — his or her acceptable level of ability to communicate or of cognitive or physical function? The second opportunity is when caring for a patient who is no longer competent. At this time, we need to look for any documents, such as an advance care plan, that record the patient’s wishes, and speak to the family and the substitute decisionmaker, if appointed. We should ask them what the patient would want rather than what they want, with the focus on what the patient would regard as an acceptable outcome,3 through questions such as, “If your father could sit with us here, right now, what would he tell us to do?”. The third opportunity is when caring for a patient approaching the end of life. A study in which patients were interviewed identified five factors that patients regard as important to having a “good death”: avoiding suffering, avoiding the prolongation of dying, achieving a sense of control, relieving burdens placed on the family, and strengthening relationships with loved ones.4 Apart from providing good palliative care, the most effective way to achieve these goals is to know ahead of time what a person would want. More than half of us are not in a position to express these preferences at the end of life. In a randomised controlled trial published last year, we showed that advance care planning improved end-of-life care for elderly patients admitted to hospital, increased respect for the patients’ wishes at the end of life, improved patient and family satisfaction with regard to hospital care, and reduced the likelihood of anxiety, depression and post-traumatic stress in the surviving relatives of patients who died.5 The skills needed to effectively facilitate advance care planning are learnable. Through the Respecting Patient Choices Program, medical and non-medical health professionals can be trained to discuss these personal, intimate subjects with patients and their families in a sensitive, compassionate way.6 It is never too late, or too early, to listen to patients about what they want. The importance of involving patients in decisions about their care was acknowledged by a maxim in a recent white paper from the Department of Health in the United Kingdom: “no decision about me without me”.7

William Silvester MB BS, FRACP, FCICM · Karen Detering MB BS, FRACP, MHEth

Will children be “crowded out” of non-acute and preventive care visits? As a society ages, adults become a larger proportion of the population. However, in Australia, the demographic reality is that while children have become a smaller proportion of the population, their absolute number has increased modestly.1,2 Thus, solutions for the increased care requirements for older people cannot be intentionally or unintentionally associated with a diminution of the medical workforce required for children. Ensuring an adequate health care workforce is of vital importance to all countries. Much interest is being focused on the importance of caring for the increasing numbers of the aged in many developed nations.1,3 The proportion of the populations of both the United States and Australia who are aged over 65 years is increasing rapidly1,2 and the health care needs of these individuals will require additional workforce resources.1,4 In Australia, primary care is delivered by general practitioners.5 To address the growing needs of the older population, there has been a significant effort to increase the number of GPs to ensure primary care access.6 At the same time, there are unrecognised demographic trends currently taking place in the composition of GP practices nationally that parallel the demographic trends of the population as a whole. These trends have important implications for the current and future care of children in Australia. One of these demographic trends is also occurring in the US among family physicians. For example, as older people have increasing life expectancy, and family physicians have relatively static numbers of patients in their patient panels, “turnover” in general practices and the opportunity to add new (paediatric) patients is increasingly limited.7 In Australia, examination of Bettering the Evaluation and Care of Health (BEACH) data from the past decade demonstrates a significant decrease in the proportion of GP visits by patients under 15 years of age across the country. This is despite an increase in the survival of children with chronic diseases.8 Whether the absolute number of visits for children has fallen is currently unclear but must be investigated. Regardless, such findings demonstrate a change in the demography of GP practices, with a trend towards GPs providing proportionally less care to children relative to the care they provide to adults. Even with the expected increase in the overall number of GPs in Australia in the next decade, this finding raises significant issues for the health care system. As children become a smaller proportion of GP practices, it is realistic to question whether GPs will continue to devote the time and effort needed to stay up to date on paediatric issues when they will have fewer opportunities to use such knowledge. GPs will constantly be challenged with the ever-increasing complexity of caring for more adults with multiple chronic conditions in their practices. The situation also begs the question as to whether some GPs will begin to limit or discontinue providing care to children, especially in specific locations with smaller proportions of children and a more rapidly ageing population. New strategies may also emerge in which some GP practices become “adult only” or “older people only” to provide care for this population. This trend is already believed to be occurring among some family physicians in the US.7 Another related issue is whether the nature and duration of consultations that children receive in general practices are changing. Recent consumer satisfaction data in Australia demonstrate ready availability for acute paediatric problems (eg, ear infection).9 However, the increased complexity of multiple chronic conditions among the ageing population will require an increased number of longer consultations. If GPs’ patient bookings become more commonly filled with such visits for older people, questions arise as to whether children will receive fewer longer consultations for preventive care (eg, nutrition counselling, developmental assessments) and chronic illness. In other words, will children be “crowded out” of non-acute and preventive care visits? The decrease in the proportion of children in the overall population also has important implications for the future training of GPs. Already, some GP training programs are concerned about their ability to provide both inpatient and outpatient clinical settings with sufficient children having common chronic illnesses (eg, asthma) for their trainees to gain competency in their acute and longitudinal care. Such deficiencies may become more common as the ageing population trend continues. With childhood obesity, mental health problems and other antecedents of adult illness now occurring more frequently, this would be a worrisome trend. In the US, shortages in the health care workforce for children are mostly found in the paediatric subspecialties, especially in rural areas.10 There has been little research in Australia regarding the availability of paediatric subspecialty care, especially for Indigenous populations and children living in rural areas.6,8 With increasing survival of children with complex conditions and chronic diseases, the demand for paediatric subspecialty care in Australia is rising. The proportion of such care actually provided by paediatric-trained subspecialists rather than adult-trained subspecialists is currently unknown. This must be determined to assess the true need for such providers nationwide, both inside and outside major metropolitan areas. Exploration of these issues is important and urgent for medical workforce planning. Government and professional entities entrusted with assessing provision of the continuum of health care for the children of Australia, monitoring GP training, and overseeing the continuing education of GPs should investigate whether changes have been occurring that may lead to a decrease in the quality of care for this important segment of the population. Such efforts will ensure that the unique needs of children are not unintentionally lost in the current emphasis on the growing ageing population.

Gary L Freed MD, MPH · Jillian R Sewell MB BS, FRACP · Neil A Spike MB BS, FRACGP

Registries have an important role in monitoring outcomes of complex diseases In the 1950s, a diagnosis of cystic fibrosis (CF) brought with it a high likelihood of dying from lung disease and a low expectation of surviving beyond 10 years of age.1 By 2011, expectations of survival for people living with CF have been transformed; mean age at death now approaches 27 years,2 and over 90% of patients survive beyond 17 years of age.3 Two studies reported in this issue of the Journal provide a broad overview of recent outcomes achieved in the management of Australian patients with CF.2,3 Both of these Australian studies recognised improved survival among people with CF, but reasons for this improvement remain unclear. Many factors probably contribute, including improvements in medical care, such as anti-pseudomonas antibiotics and better chest therapy in general, and the proven benefit of a high-fat diet for maintaining normal growth and nutritional status.4 Improved socioeconomic status may be a factor: a recent analysis of mortality rates among people with CF in the United Kingdom emphasised that lower socioeconomic status (based on two UK government classifications) contributes to higher mortality rates.5 In addition, a fall in the number of early deaths from CF with the advent of newborn screening has been clearly demonstrated.6 Newborn screening was commenced in New South Wales in 1981 and is of particular significance in the Australian setting. Recent data demonstrate a significant survival advantage for a cohort of babies who were diagnosed with CF during the first 3 years of screening compared with a non-screened cohort. Mortality among the non-screened population after 25 years was nearly twice that among the screened population (66% v 32%).7 Unfortunately, the data for the studies reported in this issue2,3 did not allow calculation of the median survival age, which has been the accepted measure for assessing survival of patients with CF.8 However, to give a perspective on the Australian outcome, in a comparable German study that reported a median age of death of 23.7 years, the median age of survival in 2005 was 37.4 years.8 Considering the higher median age of death in the Australian study, the median age of survival could well approach 40 years. This would also compare favourably with data from France and the United States showing median ages of survival of 36.4 years in 2003 and 37.4 years in 2007, respectively.8 Nevertheless, it is likely that we are behind the Canadian achievement of a median age of survival in 2009 of 46.7 years.9 The Australian studies suggest that further research needs to answer two specific questions: Why does the greatest decline in lung function occur during adolescence? Why is there a “gender gap” of significant survival disadvantage among female patients (with the rate of mortality events among girls more than twice the rate among boys2)? Certainly, it would be important to assess adolescent behavioural issues, including compliance; and the described increase in energy expenditure of over 10% in females during adolescence similarly warrants further investigation.10 A 2009 Canadian Cystic Fibrosis Patient Data Registry report9 confirms that a higher proportion of female adolescents with CF are underweight, and the cause remains enigmatic. The databases used by the Australian investigators — the Australian Cystic Fibrosis Data Registry (ACFDR)3 and the General Record of Incidence of Mortality (GRIM)2 — have provided invaluable outcome data for comparison of Australian clinics and thus have a benchmark function. CF centres can measure their performance and, at least in part, justify the estimated annual government expenditure on care for patients with CF of A$67 million.3 The investigators emphasise the importance of known factors that influence the effectiveness of databases, including clinic compliance and the painstaking entry of confirmed and accurate data that conforms with standards for international databases. They also have concerns about the longevity of the ACFDR, given that it depends on ad-hoc private funding. Shortfalls in funding will necessitate shortcuts in data entry that will inevitably compromise the completeness and value of the project. It is essential that governments and the community ensure the sustainability of clinical registries that can identify and report on the cost-effectiveness of treatment plans in complex diseases such as CF.

Kevin J Gaskin MD, FRACP · Bridget Wilcken MB ChB, MD, FRACP

High public interest does not guarantee affordability Alcohol dependence is a common, disabling and costly medical condition that affects 4% of Australian adults.1,2 Several pharmacological therapies are now available in Australia to treat alcohol dependence, including disulfiram, acamprosate and naltrexone. While all three medicines are registered in Australia by the Therapeutic Goods Administration (TGA), only acamprosate and naltrexone are listed on the Pharmaceutical Benefits Scheme (PBS). Recent reviews show that supervised administration of disulfiram is both effective and safe. Accordingly, disulfiram should be made more available and accessible through PBS listing. Disulfiram helps to achieve abstinence by inhibiting aldehyde dehydrogenase. This leads to the temporary accumulation of acetaldehyde, which causes a potentially severe aversive reaction with nausea, flushing, agitation and dizziness, thereby usually deterring future drinking. Although the treatment has a logical basis, early studies found only mixed evidence for its efficacy.3 Consequently, disulfiram fell into disfavour. Recently, however, the original studies of the efficacy of disulfiram were reviewed. When studies of supervised and unsupervised dispensing of disulfiram were compared, well supervised treatment was far more effective, often achieving excellent results.4 Indeed, the few available direct comparisons of supervised disulfiram and other medications for alcohol dependence found disulfiram to be more effective.5-7 At first glance, this would seem like unqualified good news: a well known, registered, and relatively inexpensive medicine (costing about $70 per month, including pharmacy dispensing fees) has been found to be effective for a condition that is often ineffectively treated and is estimated to cost Australia as much as $36 billion per annum.2 But the definition of “inexpensive” is a relative one — many of the patients who need disulfiram cannot easily afford even $70 per month, especially on a continuing basis. At present, these patients can access subsidised disulfiram only through ad hoc mechanisms, such as appealing to hospital drug committees. Listing disulfiram on the PBS is the obvious solution — not only because the drug is effective and inexpensive, but because there is reasonable evidence that it is more effective and less expensive than other treatments listed for alcohol dependence. But therein lies the problem: because disulfiram is an inexpensive and old drug, there is little incentive for a pharmaceutical industry sponsor to underwrite the expensive process of applying to the PBS for listing. While professional associations (such as the Australasian Chapter of Addiction Medicine of the Royal Australasian College of Physicians) could submit an application, they too are likely to be deterred by the costs involved. The PBS is also unlikely to take this on, because it has an interest in controlling expenditure and because the cost of applications to the PBS is usually recovered by charges collected from the sponsor of the drug.8 We are left with a situation in which a treatment is not listed on the PBS despite being effective, relatively inexpensive, likely to save health care resources and, somewhat ironically, recommended for use in government-funded treatment guidelines.9 There is, however, a mechanism by which disulfiram could potentially be listed on the PBS that is analogous to the TGA’s “orphan drug” provisions:10 the PBS is willing to list certain drugs in the public interest and waive the associated application costs. For disulfiram to be listed in this way, an economic justification (however crude) would need to be made, support from the relevant clinical organisations would be required, and the sponsor would need to be willing to supply the drug under arrangements proposed by the Pharmaceutical Benefits Advisory Committee that might or might not be commercially appealing. PBS listing of disulfiram would have to be contingent on its proper clinical use. Disulfiram is not a first-line therapy; it should not be used in the elderly or in patients with cerebrovascular or cardiovascular disease; and patients must be able to understand the consequences of drinking alcohol when taking disulfiram. Most importantly, disulfiram is effective only when administered daily under strict supervision (by a health professional, family member, employer, police officer or probation and parole officer) for at least 12 months.4 While we would not wish to discourage the prescribing of disulfiram in general practice and in rural areas, prescribers would need to be familiar with its side effects and able to provide the necessary counselling. We believe that current evidence is more than sufficient to justify listing disulfiram on the PBS, but continued PBS listing of disulfiram would need to be contingent on further evidence demonstrating relative efficacy and cost-effectiveness. Improving treatment outcomes for patients with alcohol dependence is a very worthwhile goal — especially for critical populations such as Indigenous Australians, recidivist drink-drivers, and people with a long history of repeated alcohol-related violence. Increasing the affordability and use of disulfiram, by listing it on the PBS, would be an important step towards this goal.

Wendy L Lipworth MB BS, MSc, PhD · Alex D Wodak FRACP, FAChAM, FAFPHM · Paul S Haber MD, FRACP, FAChAM · Richard O Day MD, FRACP

As yet in Australia, there is no systematic provision of reliable guidance for practitioners Physicians are quite as intolerant as theologians. They never had the power of burning at the stake for medical opinions, but they certainly have shown the will. Harriet Beecher Stowe, Little foxes (1865)1 In a world populated by rapid-diffusion media, varied cultures, widespread literacy, extraordinary means of communication and media veneration of the might of the scientific method, one might expect that the “marketplace of ideas” would be extraordinarily open, lively and free from censorship or restrictions. In such a world, dogma would fail to develop roots and could not survive. Evidence would triumph and, in its absence, both experts and the broader citizenry would hold on to healthy doubt. In such a world, one might expect that medicine would shine like a beacon of open-mindedness and acceptance of new ideas and that it would foster the development of challenges to operative paradigms. Finally, one might even expect that we, the doctors, aware of the course of science, would know that all the dogmas of today are destined to be footnotes in the annals of the history of medicine. Alas, it is not so. We are not very good at letting go of dogma. There are several potential explanations for medicine’s persistent love affair with dogma. First, perhaps, is the fact that it is difficult to advocate major medical or surgical interventions by explaining to patients that serious uncertainty surrounds such decisions. Thus, doctors need “internal dogma” to function. Imagine a cardiac surgeon saying to a patient: “I intend to perform a bypass operation on your coronary arteries and intend to do it without using the heart–lung machine because I believe (internal dogma) it is a better operation”. Then imagine him saying: “Actually, in a large trial in the USA, more people having surgery without the heart–lung machine had worse outcomes than those who had surgery using the heart–lung machine.2 But, look here, that’s the way I was taught and I am a better surgeon than those US guys. Trust me. I will do a better job”. Not many patients would front up for the surgery next week. Or imagine an intensive care doctor saying to a mother: “Your child has an infection and low blood pressure. I am going to give him a whole lot of intravenous fluids because we know (internal dogma) that’s going to make him better”; or, “Look here, there has never been any comparative study of giving or not giving lots of intravenous fluids to children with low blood pressure and infection, and a recent study in more than 3000 children in Africa showed that it increased their chance of dying by 50%,3,4 but, hey, trust me, let me do it, that’s the way I was taught and Aussie kids are made of sterner stuff”. One wonders how many mothers would ask for a second opinion. The cognitive “illusion of knowledge” also plays a role. We have to believe we know the answer and that there is only one answer, the one we have. To accept that we do not know the answer, or that other people might know the answer while we do not, is emotionally challenging and calls into question our very professional essence. Best to believe that what we think we know is actually true. As Thomas Kuhn5 would have it, at any time in history we operate within “paradigms”, the “soft” (but often strongly enforced) dogmas — that blood-letting saves lives; that lobotomy cures mental illness; that radical mastectomy is necessary to cure breast cancer;6 that immediate fluid resuscitation will save lives in patients with penetrating torso injuries;7 that early oral feeding after colorectal surgery is dangerous;8 that tight glucose control will save lives in intensive care patients;9 and that fluid resuscitation will save children with severe sepsis.3,4 We use such paradigms as totems and make challenging them a professional taboo.10 Dogma is further protected by the emotional impact of physiological gain. Large randomised controlled trials that test effects on major clinical outcomes take years to complete and are difficult and expensive. Every day, however, doctors can see that something “works” because it changes physiology in front of their eyes. Thus, they can see the immediate physiological gain but are blind to the long-term consequences.11,12 Alas, the link between physiological gain and final outcome is tenuous, to say the least.3,4,6,11,12 Dogma probably protects patients from rogue behaviour. We need to make sure that not all treatments are allowed. Rules (dogmas) do exist for a reason. In 2011, it is not acceptable to treat meningitis without rapid and appropriate antibiotic therapy, manage myocardial infarction with ST-segment elevation without intervention, ignore persistently elevated arterial blood pressure, and so on. The difficulty, however, occurs in situations where the evidence that a particular action is needed is not so clear, or, just as frequently, when the practitioner is not aware that such evidence even exists. In a world where the evidence generated every week is substantial, we simply do not know what we do not know. In such a state of permanent flux, it is a lot easier to “stick to what you know” (received dogma) and never change until retirement. This is a problem, because while such a stance might have been justified in 1911, it seems spectacularly out of touch in 2011. Indeed, together with the obstinate adherence to such “medical school” dogma, knowledge management (knowing what one does not know and knowing what one should know) may now be one of the major challenges of modern medicine. Finally, in a world full of “experts”, controversy and opinion, holding on to dogma is reassuring and may well have life-saving functions. Yet, dogma has a dark side and its dangers may be as great as its benefits. Doctors would do well to maintain a degree of cautious skepticism for both bold new fashions and received wisdom, whether generated by the world or by the self. They would do even better to question what they do and see such questioning as an asset. It is everyone’s responsibility to find out how to ask questions systematically, find answers from searching the literature, critically appraise the literature and apply the results to practice. At a national level, Australia needs to think of better ways of providing doctors with reliable guidance. Resources need to be allocated to national bodies, such as the National Health and Medical Research Council, colleges and medical schools to make this process of questioning dogma and obtaining up-to-date high-quality evidence a national priority. Unless this is done, dogma will continue to rule medical hearts and minds.

Rinaldo Bellomo MD, FRACP, FCICM

Time to examine a system harming the health of both detainees and detention centre staff On 29 July this year, Commonwealth Ombudsman Allan Asher confirmed that his office would undertake an investigation into suicide and self-harm in Australian immigration detention facilities.1 The investigation will examine rates of suicide and self-harm relative to those in the broader Australian community, and factors such as length of time in detention and the design of mental health services for detainees. Our view is that the Ombudsman is right to undertake such an inquiry. Simply put, there is a crisis within the detention system, requiring an urgent need to identify contributory factors. More than 1100 incidents of threatened or actual self-harm across all places of detention were reported in the 2010–11 financial year.1 Fifty-four incidents of self-harm were reported during the first week of July this year alone. After a lengthy period of no suicides,2 there have been five since September 2010.3 There have been reports of many “near-miss” cases and of a culture of hopelessness and despair inside detention centres.3 Given that suicidal behaviour can be considered as a continuum of thoughts and behaviours, ranging from suicidal ideation to completed suicide,4 we think the need for such an investigation raises important questions about how much is known within immigration detention centres about: the determinants of detainee self-harm and suicide risk;5 a detainee’s preparatory acts toward imminent suicidal behaviour (eg, locating ligature points and assembling the necessary apparatus); how detainees are managed after a serious suicide attempt; the type and cultural appropriateness of the support being provided to detainees; the possibility of possible contagion surrounding suicide and self-harm; and how effective existing policies and staff training are in preventing suicidal behaviour. These considerations are important because the detention environment is known to harm both mental and physical health. Detainees express their distress in ways that are in keeping with their culture and the setting they are in. Strong evidence confirms poor health among immigration detainees, which deteriorates over time, and shows a clear association between time in detention and rates of mental illness.6 Overcrowding within immigration detention is a major concern and most likely magnifies mental ill health through factors such as tense patterns of interaction and an inability to buffer stressful events or uncomfortable physical factors such as heat. Living in limbo and uncertainty can manifest in feelings of fear, anxiety, sleep disturbance and self-harm, along with irritability and frustration. A recent systematic review of studies investigating the impact of immigration detention on the mental health of children, adolescents and adults identified high levels of mental health problems in detainees.7 Time in detention was found to be associated with severity of distress. Anxiety, depression and post-traumatic stress disorder were commonly reported, as were self-harm and suicidal ideation. There is evidence for an initial improvement in mental health shortly after release, although mental health effects may be prolonged, extending well beyond the point of release into the community.8 In the months leading up to the Commonwealth Ombudsman’s announcement, significant incidents had been unfolding, including detainees stitching their lips together, hunger strikes, violent confrontations and property damage. There are also reports of isolation cells being converted into full-time behaviour management units where detainees who are distressed or disturbed, or who try to kill themselves, are fitted with soft helmets and handcuffs to stop them cracking their heads against the floor or walls or harming themselves in other ways.9 Such claims must be examined. They raise serious issues about the commitment of the detention system to human rights. In addition to these matters, the detention environment is also known to impact heavily on the mental and physical health of the people who work there. A national humanitarian solution is critical. Without this, the consequences will be catastrophic for all who are engaged in this system. We urge the government to act swiftly to prevent more human tragedy.

Louise K Newman MB BS, PhD, FRANZCP · Nicholas G Procter PhD, MBA, RN · Michael J Dudley MB BS, BD, FRANZCP

A carbon price is vital for the public good; complementary policies should protect low-income households Anticipating the Australian Government’s announcement of a carbon tax, the Royal Australasian College of Physicians (RACP) stated that, while it accepted the need to take action on climate change, it recommended caution about a carbon tax because it could exacerbate health inequalities.1 Some in the media inferred that the RACP’s primary concern was the potentially negative health impact of a carbon tax.2 It is reasonable for health professionals to be concerned about the welfare of low-income households, because people in these households usually spend a disproportionate share of their income on energy and food. However, the larger policy issue is the incontrovertible evidence that climate change is occurring3 and will have profoundly negative health impacts.4,5 A longer lens tells us that a carbon price is especially in the interests of those with low incomes, whose lives will be more disrupted by climate change than will the lives of the wealthy, and among whom the negative health impacts will be greater.6 If the level of global warming is to be constrained below 2°C, all countries must take extraordinary policy actions. This temperature increase is the optimistic “guardrail” beyond which we are unlikely to be able to maintain the climatic stability on which our current civilisation depends. It is far from clear that we have the global geopolitical will to prevent warming in excess of this 2°C level. Because climate change is occurring at the same time as we have passed the peak of conventional oil supplies,7 and unconventional methods of oil extraction involve even more greenhouse gas emissions, all developed countries must now take urgent and effective policy action on climate change to protect human health and planetary ecosystems. Taxation is one of the most powerful policy tools avail-able to governments, but it is also one of the most politically controversial. Individuals who pay a particular tax are not necessarily those who will benefit from the revenue raised. Carbon taxes and other environmental taxes cannot be seen in isolation; such taxes should be judged by their overall distributional effect, as the revenues are disbursed through transfers or government expenditure. Putting a price on carbon will inevitably cause increases in energy prices, and failing to compensate low-income households for these increasing costs would be regressive and could lead to low-income households having to make unhealthy choices about whether “to heat or to eat”. However, governments with a clear strategic intent to reduce health inequalities have many policies available to ensure that their overall policy package is progressive, as well as effective in cutting emissions. At the same time as the Australian Government announced the carbon tax, they announced other tax changes, with more than half the money raised by the carbon tax to be redistributed to households by way of tax cuts and increases in pensions, allowances and family payments. The taxation, benefit and expenditure arrangements in developed economies constitute an integrated system, and the outcomes of any policies should be assessed by effects on overall measures of income and wealth distribution. For example, the roll-out of the United Kingdom’s Decent Homes Programme — requiring homeowners and landlords to bring their houses up to a decent standard — has made a positive contribution to lowering energy costs for low-income households.8 Similarly, American research has shown that home energy assistance programs for low-income households can reduce nutritional and health risks among children under 3 years of age.9 In New Zealand, in contrast to the recent Australian housing insulation debacle, successive governments have subsidised insulation and more effective, non-polluting heaters. This popular policy was based on evidence that these measures increased the energy efficiency of houses and lowered the household’s energy expenditure.10,11 There were also broader social and health benefits that outweighed the costs of subsidising these programs by local and national governments.12 These are all examples of policies that have required increased initial expenditure — in some cases by both households and governments — for medium- and long-term broad benefits. They are policies that balance targeting and universalism, and are appropriately proportionate to need. Putting a price on carbon, via a tax or other means, likewise enables societies to manage their carbon emissions more efficiently, creating incentives to reduce emissions where it is easiest to do so. The Intergovernmental Panel on Climate Change concluded that the greatest sectoral emission reductions can be made in the buildings sector.13 The World Health Organization has recently published a report highlighting that while there are inevitably costs involved in reducing carbon emissions in buildings and in household use of energy, the co-benefits for health are significant, particularly for low-income households.14 Health sector organisations should support putting a price on carbon and should take care with their media releases, lest any statements be taken out of context and misused by opponents of carbon pricing. These organisations need to highlight the potential health benefits of public policies15 while monitoring policy packages to ensure that, overall, they reduce inequalities in income and health.

Philippa L Howden-Chapman MA, DipClinPsych, PhD · Ralph B Chapman BE, MPA, PhD · Anthony G Capon MB BS, PhD, FAFPHM · Nick Wilson MB ChB, DIH, MPH

Australian database linkages could be used for postmarketing surveillance of antidiabetic therapy side effects Several incretin hormone-based therapies for type 2 diabetes are marketed in Australia. These are exenatide (the glucagon-like peptide-1 [GLP-1] analogue) and sitagliptin, vildagliptin and saxagliptin (inhibitors of the enzyme dipeptidyl-peptidase-4 [DPP-4]). These drugs are attractive because they improve blood glucose control without weight gain and with less hypoglycaemia than insulin and its secretagogues. Their distinct mode of action means that they improve glycaemic control when added to more established blood glucose-lowering therapies. This underlies their current Pharmaceutical Benefits Scheme listing as part of dual or, in the case of exenatide, triple therapy with metformin and/or sulfonylurea treatment. With increasing use of these drugs, more data relating to their adverse effects have emerged. A case linking pancreatitis with exenatide therapy was described 5 years ago,1 and further case reports have meant that specific warnings are now included in the product information for all GLP-1 analogues and DPP-4 inhibitors. Animal studies with the GLP-1 analogue liraglutide (registered but not currently available in Australia) raised the possibility of medullary (C-cell) thyroid cancer. Although an increased risk of this tumour was not evident in humans in preregistration trials, liraglutide is contraindicated in patients with a personal or family history of medullary thyroid cancer and in patients with multiple endocrine neoplasia syndrome type 2 (http://www.novo-pi.com/victoza.pdf). Inhibition of DPP-4 may predispose to hypersensitivity reactions through prolonged action of neuropeptides such as substance P,2 and alter immune function, with a possible increased risk of infections.3 However, the relative infrequency of adverse effects such as pancreatitis, C-cell cancer and severe allergy means that large case–control databases are needed to provide accurate estimates of their incidence and predictors. In an attempt to provide better information on incretin therapy-associated adverse effects, United States researchers led by Peter Butler recently used the US Food and Drug Administration (FDA) publicly available Adverse Event Reporting System (AERS). An initial accepted report containing the results of these analyses appeared in February 2011 on the website of the journal Gastroentrology. The main findings were of a significantly increased risk of pancreatitis and pancreatic cancer with exenatide and sitagliptin (the two most-used incretin-based therapies in the US), as well as an increased risk of all thyroid cancer (not just medullary) with exenatide. After the validity of these findings was challenged by the manufacturers,4 the paper was withdrawn but a modified version subsequently reappeared online and in print.5 The use of AERS to identify adverse drug effects is controversial and its substantial limitations are acknowledged by the FDA itself. Reporting is uncontrolled, voluntary, from multiple sources and often incomplete. Overreporting of events for new drugs, especially during the first 2 years and for serious outcomes, is well recognised.6 The choice of comparator treatments, from which odds ratios for the occurrence of index events are generated, has a bearing on the results, as does knowledge of other therapies or patient factors that might also increase the risk of an event. For pancreatitis, this includes the association between diabetes and obesity, as well as drugs that have relatively high use in type 2 diabetes, such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, statins and fibrates. Although mining of data from the AERS has successfully found previously unrecognised adverse effects, a study of 21 unrelated therapies suggests that only about 50% of the signals thus identified subsequently appear in the product information or lead to regulatory actions, while an equivalent number of clinically important signals are missed.7 In the case of incretin-based therapies, the FDA’s automated algorithm Empirica, which is designed to signal AERS safety alerts, did not do so. In addition, one unrelated retrospective analysis of a large US medical and pharmacy claims database, involving 786 656 patients, did not show either exenatide or sitagliptin to be associated with an increased pancreatitis risk.8 The Butler group state that their analyses do not establish that pancreatitis, pancreatic cancer and thyroid cancer are caused by incretin-based therapy but suggest that appropriate studies are required to rule out these associations.5 Accurate incidence of pancreatitis will be difficult to obtain without adequately powered long-term prospective studies, but at least the product information for these drugs warns of this infrequent potential adverse effect. For the possible association between cancer and incretin-based therapy (and since other diabetes treatments including glargine insulin9 and pioglitazone10 might be cancer-promoting), it seems sensible to urgently develop coordinated links between diabetes prescription databases and cancer registries. Available Australian databases and links mean that government agencies could take a lead in this and provide independent, postmarketing observational data for the two incretin-based classes and individual drugs that are more robust than those generated by systems such as AERS. The history of diabetes treatment, from phenformin to rosiglitazone and even newer compounds, illustrates the continuing requirement for comprehensive preclinical and clinical safety and efficacy data before registration. Robust multifaceted postmarketing surveillance and data for important adverse effects, even if they are uncommon, are also necessary. Analyses such as those by the Butler group4 should not direct clinical decision making, but are part of the pharmacovigilance process that aims to provide regulatory authorities, clinicians and patients with the best evidence of the risks and benefits of individual blood glucose-lowering therapies.

Timothy M E Davis MB BS, DPhil, FRACP

Asbestos manufacturers have never warned homeowners of the risks of renovation On the Australian mainland, there have only been two manufacturers of asbestos cement products used in home construction and renovation: James Hardie and Wunderlich, a subsidiary of CSR. Asbestos products were manufactured from the 1920s up until 1984, when Hardies ceased using asbestos in their building products (Wunderlich had been acquired by James Hardie in June 1977). In 1978, James Hardie boasted that their products were in most homes in Australia. The range of asbestos cement building products (once widely known as “fibro”) that were made in Australia include flat and striated walls, eaves and panels; corrugated panels (used primarily for fencing and roofing); flat sheets covered with crushed or artificial brick; flues for gas heaters; thick sheets for flooring or as tile underlay; and sheets covered with coloured or patterned vinyl used in bathrooms and other wet areas. As the country with the highest rate of mesothelioma in the world,1 Australia has lived through two “waves” of asbestos-related disease — the first from the mining of asbestos and the manufacturing of asbestos products, and the second from asbestos use in industry. In this issue of the Journal, Olsen and colleagues clearly reveal that the “third wave” of the asbestos disease epidemic in Australia comprises non-industrial users of asbestos products,2 and a significant contributor to this cohort are the non-professionals who cut and fixed asbestos cement products in home renovation or maintenance and other do-it-yourself activities, or who demolished asbestos cement products during renovations. Family members present during these activities are also part of this cohort. The most alarming feature of this third wave is its potential to continue to grow for many years to come. Neither James Hardie nor CSR have ever taken any steps to systematically warn people who have asbestos products in their homes — including products that contain the highly dangerous Wittenoom blue asbestos used by both manufacturers — of the potential for fatal consequences in 20–40 years if they demolish those products today. We contend that the manufacturers have a legal duty of care to these people (Box). Claims for compensation and damages for people with asbestos disease because a manufacturer breached a duty of care have been pursued for over 25 years. Many of the legal precedents derived from the early claims against CSR by workers at the Wittenoom mine, and against James Hardie by its employees, have been applied in these product-user claims. Most mesothelioma claims are now successfully resolved out of court without a trial. When this does not occur, the claims primarily involve one or two instances of construction or demolition. The major issues of controversy are (i) the claimant’s ability to prove that the manufacturer could, and should, have taken steps that would (before the time of exposure) have drawn the risk to the user’s attention; and (ii) proving, more probably than not, that the exposure in such limited circumstances was a cause of, or made a contribution to, the mesothelioma manifesting many years later. Almost from the first acceptance in 1960 of mesothelioma as a cancer uniquely related to asbestos, it has been recognised that this cancer could be caused by very low exposures.1 The argument is sometimes put that mesothelioma can occur without asbestos exposure at all, or can be caused by exposure to the very low “background” levels present in most urban environments and some non-urban environments. In reality, in an individual mesothelioma case, all cumulative asbestos exposure — “background”, unrecalled or unrecognised exposure, and specifically recalled exposure — must, on biological mechanistic grounds, be considered to be playing a part in causation.3 With acceptable evidence of specific exposure, no matter how slight, a claimant should succeed, as such exposure would add more than a minimal dose to any background exposure. No threshold for asbestos causation of mesothelioma has been demonstrated.4,5 The article by Olsen et al documents an upward trend in mesothelioma cases in home renovators.2 This trend was appearing in reports of the Australian Mesothelioma Register operated by the National Occupational Health and Safety Commission (NOHSC) up to 2001.6 However, until now, it has not been possible to statistically confirm the trend, because of incomplete coverage of the Register from 2001 onwards. This was a consequence of the drastic cutbacks in the scientific capacity of the NOHSC, and over-stringent privacy legislation preventing comparisons with state cancer registries and the collecting of data on exposure history. We hope that the newly reconstituted Australian Mesothelioma Registry collaboration, administered by the New South Wales Cancer Council, and covering all mesothelioma cases in Australia diagnosed after 1 July 2010, will enable continued monitoring across the whole of Australia of this tragic third wave of the mesothelioma epidemic. While the Western Australian Mesothelioma Register study2 and the new Australia-wide initiative will be of small comfort to those who already have or will develop mesothelioma, these initiatives may assist in maintaining an awareness of the risks of exposure during home maintenance, and of other possibly unrecognised exposures, and hasten regulatory and control activities both nationally and internationally. All asbestos use was banned in Australia in 2003, and it is also banned in 56 other countries. (There are a few very limited, technical exceptions to the ban; eg, for military use where no substitute is available.) However, there are a few countries where it is still being used in building products (eg, India, Thailand, Russia, China and Indonesia). Data from Australian registers serve a very important purpose in sending a global warning of the deadly nature of this substance and the need for a complete global ban on any future use.7 The legal duty of care A manufacturer of an asbestos cement building product owes a legal duty of care to users of the product. The duty obliges the manufacturer to take reasonable care that a person is not at risk of suffering a foreseeable injury from using the product. A foreseeable injury is one of which the manufacturer, knowing the way the product is used, and up to date with the literature concerning injury from use of such a product and any potentially dangerous components or ingredients of that product, is, or ought to be, aware. As asbestos cement building products were used in homes, people who used the new product in the construction or renovation of their homes were owed the duty, as will the people who later demolish and remove the product, as both uses should be contemplated by the product manufacturer. The steps required of the manufacturer to discharge this duty — ceasing manufacture, warning, and recall — will be proportionate to the likelihood, and the potential seriousness, of the injury. If a person is injured because of a breach of the duty of care, they are entitled to compensation commensurate with the loss and harm suffered.

John R C Gordon BJuris, LLB · James Leigh MD, FAFOEM, FAFPHM

Simple strategies can reduce harms from misuse of pharmaceutical opioids Sustained-release opioid drugs have been used increasingly over the past two decades to treat all types of chronic pain, including chronic non-cancer pain.1 Rates of prescribing have increased in developed countries such as Australia, Canada, the United Kingdom and the United States since the beginning of the 21st century.2-4 In the US, aggressive marketing of sustained-release formulations of oxycodone to primary care physicians and directly to patients between 1996 and 20075,6 resulted in a 10-fold increase in their per-capita use, and an alarming increase in the number of deaths from overdose with prescription opioids. In 2007, the number of deaths from oxycodone and other pharmaceutical opioids (11 499) outnumbered overdose deaths from illicit heroin and cocaine combined (around 8000).7 The article by Roxburgh and colleagues in this issue of the Journal8 provides an assessment of harms arising from recent increases in opioid prescribing in Australia.1 Roxburgh and colleagues show that pharmaceutical opioid prescribing has increased, with those for sustained-release forms of oxycodone supplanting those for morphine.8 Most oxycodone prescriptions have been to adults over the age of 50, with the steepest increases in rates of prescribing to patients aged over 70 years.8 These patterns suggest that most prescribing has been for chronic non-malignant pain, the prevalence of which increases steeply with age.1 Increased opioid prescribing has been accompanied by increases in the number of people seeking treatment for dependence on prescribed opioids in Australia. The number of fatal overdoses involving oxycodone has also increased, but, unlike in the US, the number of deaths in Australia from oxycodone reported by Roxburgh and colleagues was much lower (59) than the number of deaths from all other opioids (including heroin; 315) in 2005 (this was the most recent year in which the two could be directly compared). Roxburgh and colleagues report that in 90% of cases, deaths from oxycodone overdose involved either the use of the drug in combination with other opioids, benzodiazepines and alcohol, or the contribution of concomitant medical conditions. Just over half of the deaths (53%) occurred in people who were prescribed oxycodone, probably for the relief of chronic pain. A quarter of all these deaths, and those of a third of people with no history of illicit injecting drug use, were found to be suicides. Fatal overdoses among those with a history of injecting drug use were more likely to involve males, as is true of overdose deaths in this population more generally.9 Injecting drug users were more likely to be using diverted opioids at the time of their death, although a third were prescribed these drugs. There are a number of strategies available to governments to reduce pharmaceutical opioid misuse and the harms arising from it.1 Clinical recommendations are as follows: First, doctors and patients need to be educated about the risks of dependence on, and overdose of, these drugs, especially when higher doses are prescribed. Patients need to be informed by prescribers and pharmacists about the risk of fatal overdose if they use these drugs in combination with other drugs that depress the central nervous system, whether prescribed ones like benzodiazepines, or the more readily available alcohol. Second, clinical guidelines are needed on the place of opioids in the treatment of chronic pain, especially non-cancer pain. There is a need for clearer clinical guidelines for primary health practitioners to ensure that opioids are not used as first-line drugs for chronic pain, but are reserved for use when other forms of treatment have been tried.1,5,10 Third, clinical priority should be given to reducing suicides in patients who experience chronic pain and who are prescribed opioids. Prescribers need to be cautious in prescribing opioids to depressed patients. They should also enquire about suicidal ideation in patients who have chronic pain and who have been prescribed these drugs long term but have incomplete pain relief. Fourth, smaller quantities of these drugs should be prescribed to allow for more regular review of their effectiveness in relieving pain. Compliance with the prescribed medication regimen should be carefully recorded and a clear plan of action should be documented when significant non-compliance is identified. Referral to pain specialists should be considered if pain control is incomplete, and referral to addiction specialists should be considered if dependence on opioids is suspected. Policy recommendations are as follows: Enhanced prescription monitoring systems are needed to reduce both doctor-shopping by patients and imprudent prescribing by doctors. These systems should be computerised, nationally consistent and, ideally, real-time.1,5 It is also critical for doctors and pharmacists to monitor patterns of chronic opioid use in patients whom they see. The pharmaceutical industry needs to ensure that these drugs are marketed to prescribers in responsible ways, and that clinical information for patients advises about the risks of using these drugs in combination with other central nervous system depressants. Governments need to examine ways of increasing access to buprenorphine and methadone treatment for people who use opioids illicitly, and who may be using pharmaceutical opioids to self-treat.1 If Australian policymakers and doctors want to avoid the disastrous US experience with pharmaceutical opioids, these steps should be taken now while the misuse of these drugs is still a manageable problem. Whatever policies are implemented, it is essential that we assess rigorously their impacts on both the quality use of these medicines in relieving chronic pain and on the harms arising from their inappropriate use.

Wayne D Hall PhD · Michael P Farrell MB, FRCP, FRCPsych

Low infectivity but high mortality: strategies to minimise spread until the vaccine arrives are the key Hendra virus (HeV) infection in humans is an emerging zoonotic disease that has a high mortality rate, but low infectivity. In all cases to date, the infection has been transmitted to humans from bats of the genus Pteropus (flying foxes) via an intermediate equine host. HeV and Nipah virus are the only known members of a new genus, Henipavirus, within the family Paramyxoviridae. HeV was first described after an outbreak of severe respiratory disease in horses that led to the deaths of 14 of 20 infected horses and the death of a horse trainer — one of two humans infected — in Brisbane in 1994.2 There have been seven cases of HeV infection producing pneumonic or encephalitic illnesses in humans. Four of these people died, three soon after exposure and the fourth from fatal encephalitis caused by HeV, which developed 13 months after full recovery from an initial aseptic meningitis.3 Of the three survivors, two made complete recoveries while the third experienced ongoing complications of the initial encephalitis.4,5 Subsequent serological testing for HeV in a large number of human contacts of the first three cases of HeV infection was completely negative.6 Before 2011, there had been 14 events of spillover of HeV infection from flying foxes to horses, and subsequent transmission to humans in five of these events. All events occurred in coastal Queensland except for one in northern New South Wales. Forty-four horses were infected; 34 of these (75%) died and the remaining 10 survived but were later euthanased. Seroepidemiological studies of more than 2000 horses and more than 5000 samples from 46 other animal species in Queensland did not identify HeV infection.7 Spillover events have occurred through most months of the year, but with increased frequency from June to September. The virus can survive under ideal cool and moist environmental conditions (eg, in bat urine at 22°C in the laboratory) for up to 4 days, but is generally thought to survive for only hours. Horses are thought to be infected by ingesting food or water contaminated by urine, saliva or birthing products of infected flying foxes. The virus amplifies within the horse, and humans who are exposed to a large amount of the secretions or blood from an infected horse can become infected. Laboratory studies have shown that horses may excrete virus for up to 72 hours before showing clinical signs.8 All seven humans infected with HeV to date had high levels of exposure to body fluids of infected horses, such as during unprotected autopsy or by direct contact with respiratory secretions or aerosols. Not all people with high-level exposure have contracted the disease or seroconverted. There is no evidence that prolonged close contact with flying foxes engenders a risk of HeV infection in humans.9 A wide range of mammals carry the appropriate receptor enabling them to be infected with HeV experimentally.10 Yet, although HeV infects the endothelium of blood vessels in many species in the laboratory, resulting in systemic vasculitis, outside the laboratory setting, only flying foxes, horses and humans are known to have been infected. One dog is known to have seroconverted without any clinical illness or detection of virus. Flying foxes were identified as the natural host in 1996, and antibodies to HeV have been found in archived samples of flying fox serum dating back to 1982.11 Flying foxes do not develop overt disease. All four species of flying fox in Australia, from as far north as Madang in Papua New Guinea to as far south as Melbourne, have been found to carry the virus.12 HeV is genetically stable, and there is no evidence that the virus has changed significantly since it was first isolated in 1994.8 This year has been a major year for the detection of spillovers of HeV into horses, with 14 events being notified by 17 August. Eight of these occurred in Queensland, with one being the first event notified west of the Great Dividing Range, in Chinchilla. Ten horses had been infected in Queensland and, for the first time, a dog has seroconverted, probably through contact with an infected horse. Six spillover events had occurred in northern NSW, with seven horses becoming infected. No humans have been infected this year to date, although not all of those potentially exposed have reached the end of their incubation periods; no one had a high degree of exposure to infected secretions. The incubation period in humans is 5 to 21 days. The clinical presentation has been variable, with both respiratory and encephalitic symptoms. There has been no transmission of HeV between people, but routine droplet precautions are advised. There is no known effective treatment for Hendra virus infection, and clinical management is based on treating symptoms as they arise. When a person has had high-level exposure to body fluids of infected horses, an experimental human monoclonal antibody (mAb) can be made available for postexposure prophylaxis. Henipavirus mAb has been shown to be effective in preventing infection in ferrets if administered within 12 hours of intrathecal injection of a high dose of HeV.13 However, this product has not yet been trialled for safety or efficacy in humans. It has been administered to three humans. The first person was late into the progression of severe encephalitis and subsequently died. The second two had moderately high-risk exposure, but no evidence of infection, and they did not develop illness or seroconvert. Currently, despite its unknown safety or efficacy, mAb is offered to people who have had high-level exposure to infected horse blood or secretions, after obtaining ethics approval and appropriate consent for each individual. Preventive measures are essential. Horse owners are advised to keep horses away from flowering and fruiting trees, and to remove feed and water troughs from under trees. Vets are advised to wear appropriate personal protective equipment when attending a sick horse or when performing invasive or aerosol-generating procedures on any horse. Horse owners and the public are advised to isolate sick horses from people, horses and other animals. The most promising prospect for controlling HeV outbreaks in humans is the vaccine for horses that is expected to be marketed in 2013.14

Jeannette R Young MB BS, FRACMA, FFPH · Christine E Selvey MB BS, MSc · Rick Symons DSC, PhD, MACVS

Earlier concerns put to rest as new evidence confirms their safety and efficacy The three sentinel developments in percutaneous coronary intervention (PCI) have been the groundbreaking use of balloon angioplasty from 1977, the widespread uptake of bare metal stents (BMS) in the early 1990s, and the era of drug-eluting stents (DES) commencing in 2002. DES greatly reduce the incidence of vessel restenosis, and this has allowed the application of PCI to increasingly complex coronary anatomy that had previously been untreatable due to prohibitive restenosis rates. Uptake of this technology was immediate and widespread, with near ubiquitous use (95%) of DES for PCI in the Australian private sector by 2005 despite a fourfold higher cost and uncertain incremental cost-effectiveness over BMS.1 However, the initial unbridled optimism was tempered by case reports of “very late” stent thrombosis, and then shattered by the release of data at the 2006 World Congress of Cardiology in Barcelona suggesting DES were associated with higher mortality rates.2 This dramatically shook confidence in the use of this new technology with an immediate effect on DES use worldwide.3 In early 2007, the widely reported Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, in which outcomes were similar for medically and percutaneously treated patients with stable angina, further challenged the interventional paradigm.4 Criteria for drug-eluting stent use in Victorian state hospitals6 One or more of: Diabetes mellitus Chronic renal failure Small diameter target vessel (< 2.5 mm diameter) Long target lesion (> 20 mm in length) Ostial lesion Bifurcation lesion Chronic total occlusion Previous coronary artery bypass grafting In-stent restenosis So what was the effect on Australian DES use? In this issue of the Journal, the Melbourne Interventional Group (MIG) present their registry data for DES use in selected Melbourne public hospitals over a 4-year period spanning this crucial time.5 Even though there was already a selective policy in place restricting DES use to patients with lesions at high risk of restenosis (Box), DES implantation fell from a peak of 54% of all stents used between April 2004 and March 2005 to 32% in 2007–2008.5 Even more dramatic falls in DES use (91% to 34%) have been reported in the Melbourne private sector over this period.7 The change in DES use in public hospitals demonstrated by the MIG is revealing, as they have previously reported underuse of DES and calculated that greater than 65% of patients undergoing stent implantation met the criteria for selective use of DES.8 Of further interest is the decrease in the absolute number of patients undergoing PCI, and in particular elective PCI, that is perhaps related to the release of the COURAGE study. It is likely that the change in practice reflects uncertainty over safety of DES at that time. It is therefore reassuring that data reported from the MIG registry affirm the safety and efficacy of DES, with DES use being the only independent predictor of better clinical outcomes at 12 months (driven, as expected, by reduced target vessel revascularisation rates). Given this finding, we would have expected to have seen deterioration in clinical outcomes during the period of low DES use. Surprisingly, this did not happen — the MIG investigators report that the reduction in DES shown by their data was not associated with an adverse effect on overall clinical outcomes. One possible explanation for this is that there was concurrent change in several other variables including referral patterns, stent technologies, implantation techniques, and adjunctive pharmacological therapy (eg, increased use of dual antiplatelet therapy). These changes may have acted favourably on clinical outcomes, masking an adverse impact of reduced DES use. The inability to separate out these confounding influences is one of the limitations of registry data. Following the Barcelona Congress, there was a rigorous reappraisal of the available studies using patient-level data, review by regulatory authorities (including the Australian Therapeutic Goods Administration) and further randomised trials. The safety and efficacy of DES were reaffirmed. Analyses showed they were not associated with an increased rate of myocardial infarction or death, but were associated with a reduction in need for revascularisation of up to 70% compared with BMS.9,10 Moreover, there has been an evolution to “second generation” stent platforms with very low stent thrombosis and restenosis rates,11 and greater understanding of the importance of dual antiplatelet therapy. Indeed, new registry data have provocatively shown a mortality benefit with liberal utilisation of DES.12 So who should receive a DES? If there was no cost difference, it would be appropriate to implant DES in the majority of patients. The main exceptions would be patients unlikely to tolerate 12 months of dual antiplatelet therapy because of increased bleeding risk, an anticipated need for elective surgery, or poor medication compliance. However, a significant cost differential remains and, therefore, rationing to those most likely to benefit (Box) is appropriate. This will, nonetheless, still result in much higher DES utilisation rates than those documented in the MIG registry in 2007. The reassurance that DES are safe has had an effect on practice at our institution, with implantation rates increasing from 43% to 70% over the past 3 years, bringing us back in line with the proportion of patients reported to meet selective utilisation criteria in Victoria.8 The information presented by the MIG gives a fascinating insight into physician behaviour by documenting the local change of practice that followed concerns regarding DES. Confidence has been restored by evidence affirming DES safety, the introduction of “second generation” platforms, and a better understanding of the importance of optimal medical therapy. It would be interesting to see how these more recent developments have affected DES use, and we look forward to ongoing insights from this important local registry.

Christopher J K Hammett MBChB, FRACP, FCSANZ · Peter J Stewart MB BS, FRACP, FCSANZ · John J Atherton PhD, FRACP, FCSANZ

How can implementing a population-wide salt-reduction program be so hard? For most of human evolution, the average daily diet contained a fraction of a gram of salt and our physiology developed accordingly.1 A few thousand years ago, with the discovery that salt could preserve food, average intake started to rise. Now, with salt poured into the food supply, average Australian consumption levels are many times our physiological need.2 Populations eating the level of salt upon which we evolved are now few, but they provide a window into normal physiological processes. One of the most notable findings is that their blood pressure levels do not rise with age.3 Despite recent highly publicised reports,4 there is little debate about the adverse impact of salt on human health.5 The totality of the evidence is convincing and the unbiased findings from randomised trials of salt reduction particularly so. While a number of non-randomised studies have suggested health benefits of salt consumption,4 the publicity they receive greatly exceeds their real significance. Observational nutritional epidemiology is incredibly difficult to do well, and the diversity of findings almost certainly reflects methodological challenges, not discrepant science. Although direct evidence from a single adequately powered mortality and morbidity trial of salt reduction is lacking, the circumstantial evidence remains striking and the likelihood that reduction in salt intake will not reduce vascular risk is small. The strength of the evidence base has persuaded multiple national and international organisations of the need to reduce salt consumption.5 All hypertension guidelines advocate consuming less salt,6 and more than 30 countries now have some form of population-based salt-reduction program in place.7 A series of influential reports has highlighted the large health gains that might be achieved from such national programs and the low costs required to deliver them.8 The issue is no longer whether salt reduction should be a goal, but how it can be achieved. The reason salt reduction presents such a great public health opportunity is that almost everyone eats far more than they need. Average consumption in Australia is between 8 and 10 grams per day,1 with immediate and long-term implications for blood pressure. The early effects occur within weeks and the chronic effects over decades. As shown by Huggins and colleagues in this issue of the Journal,9 and previously noted by the Intersalt study,10 a daily intake 6 grams above physiological need will push up systolic blood pressure by a few millimetres of mercury in the short term and thereafter by about half a millimetre each year. This chronic effect translates into 25 mmHg over 50 years, with enormous implications for individual and population risks of vascular disease. Blood pressure is a leading cause of disease burden in Australia,11 and our strategy for preventing disease attributable to high blood pressure is hypertension control — individuals are diagnosed as hypertensive and treated within the medical system. Hypertension is currently the most frequent reason for a primary care consultation, with annual direct health care costs of more than a billion dollars.12 For those who need and receive it, antihypertensive therapy is a highly effective intervention. Unfortunately, the clinical approach also has some limitations. First and foremost among these is that half of all disease caused by high blood pressure occurs among people without hypertension.13 Risks start to accrue well below the blood pressure level of 140/90 mmHg that generally defines hypertension, and systolic blood pressure levels of 125–135 mmHg are associated with greater risks than a level of 120 mmHg. While more moderate than the risks faced by those with hypertension, these blood pressure levels cause a very large number of adverse events because these are the blood pressure levels of most of the population. The limited coverage achieved by the clinical hypertension control strategy further reduces its effectiveness. Only about half of hypertensive people are identified and treated;14 less than half of these get to target blood pressure levels,14 and almost none achieve a systolic pressure of 120 mmHg or below. Accordingly, clinical management of hypertension in Australia probably prevents only about a 10th of all blood pressure-related disease. A plausible population-wide salt-reduction program that removed salt at the source could within a few years avert a similar proportion of disease burden at an annual cost of just $10–20 million.5 To achieve this, the Australian Government simply needs to set and enforce salt targets for foods, as has been done in the United Kingdom.7 Average salt consumption would fall, mean population blood pressure would immediately follow, and the long-term rise in blood pressure with age would be attenuated. The real question is how this can be so hard. For almost no extra cost and at no risk, there is a high likelihood we could double the proportion of blood pressure-related disease averted within just a few years. With a proven overseas model to follow,7 our failure to take the action required is bordering on negligent. No one is going to lose their parliamentary seat and no one is going to go out of business if they make this happen. There are just going to be a lot of unnecessary strokes and heart attacks while the people pickling us figure this out.

Bruce C Neal MB ChB, PhD, FRCP

Improving health outcomes for mothers, children and families Mental health morbidity associated with the perinatal period — from conception to the end of the first postnatal year — is now recognised as a major public health issue, with depression affecting up to 15% of women during this period.1 It has been reported that 45% of postnatal depression begins in pregnancy,2 and about 38% of women with postnatal depression have a comorbid anxiety disorder.3 About 3% of women experience moderate to severe depression during the perinatal period and 0.2% experience a puerperal psychosis,4 and maternal suicide continues to be identified as one of the leading causes of indirect maternal mortality.5 There is growing evidence of the negative impact of poor mental health outcomes not only for the mother, but also for her child and family.6 The existence of well established maternal and infant health care systems across Australia has provided a unique opportunity for integrating mental health care into mainstream services. Increasingly, the maternal and infant health care sectors are introducing routine, universal psychosocial assessment aimed at detecting women who are at risk of, or suffering from, mental health morbidity. This approach, underpinned by a philosophy of prevention and early intervention, has been developed in the Australian perinatal setting over the past decade through the work and advocacy of leading clinicians and researchers, policymakers and beyondblue: the national depression initiative.7-9 Feasibility of widespread screening for depression in the perinatal period was evaluated in the National Postnatal Depression Research Program (2001–2005).7 It was concluded that screening for depression was feasible in routine clinical settings and acceptable to women and their health care providers (including general practitioners). In addition, maternal mental health morbidity often went undetected and untreated if routine screening was not used. The National Action Plan for Perinatal Mental Health (2008) went on to recommend implementing universal psychosocial assessment, training primary health care staff who administer the assessments, and establishing structures that optimise coordination of, and access to, appropriate services.8 This was followed by the establishment, by the Department of Health and Ageing, of the National Perinatal Depression Initiative (2008–2013), which enabled the introduction of a specific perinatal mental health Medicare stream (under the Access to Allied Psychological Services initiative) and the development of national clinical practice guidelines for depression and related disorders in the perinatal period.9 The clinical practice guidelines are aimed at all clinicians who have a “primary health care” role in detecting possible mental health morbidity in the perinatal period — including midwives, GPs, child and family health nurses, obstetricians and paediatricians. They are underpinned by a systematic literature review that points to a paucity of quality evidence, especially on routine psychosocial assessment and the safety of psychotropic medication in pregnancy. The guidelines recommend routine, universal screening for depression (antenatal and postnatal) using the Edinburgh Postnatal Depression Scale (EPDS)10 and treatment of mild to moderate postnatal depression with evidence-based psychological interventions (eg, cognitive behaviour therapy). Where there is insufficient evidence for recommendations, good practice points (based on lower-quality evidence and/or expert consensus) have been formulated. These include using comprehensive, universal psychosocial assessment (eg, the Antenatal Risk Questionnaire11) in addition to the EPDS, considering mother–infant interaction and risk to infant as integral parts of the assessment, monitoring women with an existing mood disorder closely to reduce risk of relapse, and providing specific advice about the safety of psychotropic medication during pregnancy and breastfeeding.9 While the guidelines recommend routine use of the EPDS in the perinatal period, they emphasise that it should only be used as an adjunct to clinical assessment in the primary care setting. They also highlight that universal psychosocial assessment is an area of debate, has significant resource implications (including training, service organisation and workload requirements), and needs to be closely integrated with access to mental health services. The clinical effectiveness of routine psychosocial assessment remains to be evaluated. A recent randomised controlled trial of early postnatal screening using the EPDS (including supportive counselling where indicated) demonstrated improved maternal mental health outcomes at 6 months postpartum for women receiving the intervention compared with those receiving usual care.12 In a meta-analysis of screening interventions for general depression, screening was found to be beneficial as long as it was integrated with clear pathways to care.13 This is in line with the National Action Plan for Perinatal Mental Health and the clinical practice guidelines — the first steps in translating evidence into practice and developing a broader evidence base. There is now a need to evaluate the effectiveness of combining psychosocial assessment with integrated pathways to care. In addition, an evaluation of the impact of the National Perinatal Depression Initiative on mental health outcomes for mothers is critical if we are to optimise the quality and uptake of services for this vulnerable, yet highly accessible, population.

Marie-Paule V Austin MB BS, FRANZCP, MD · Philippa F Middleton BSc(Hons), GradDipLibSt, MPH · Nicole J Highet DPsych

The difficulties of knowing when, and to whom, to refer patients with a mental disorder Recognising one’s clinical limitations and the need for them to be augmented by others’ specialised knowledge and experience is a key component of professional reflectiveness and humility. Referring a patient to a specialist should never be experienced as a reflection of inadequacy or as a slight upon the quality of one’s care. It is an opportunity to provide enhanced treatment and to draw collaboratively upon the specialisation and wisdom of a respected colleague.1 It is also an important ethical obligation.2 By contrast, a failure to be conscious of one’s limitations can lead to insensitivity to the repercussions of patients’ symptoms, erroneous diagnoses and treatment, and a failure to attend adequately to risk factors. There are many possible reasons for this, which have been described in some instances as potentially including narcissism, grandiosity or a sense of omniscience,3 or therapeutic nihilism.4 Depending on the clinical outcome, non-referral can result in actions for negligence and disciplinary consequences. Mental illness is, by nature, episodic, with symptoms waxing and waning at different periods of a patient’s life and in response to different triggers and vulnerabilities. This highlights the need for a longitudinal perspective on the course of a mental disorder to identify improvement, deterioration or the existence of cycles of symptoms, all of which can give rise to therapeutic opportunities. Continuing evaluation of the need for pharmacotherapy, psychotherapy or any other modality is important. Matters can be complicated by patients resorting to unorthodox forms of intervention, such as “vitamin therapies”, past-life therapy and counselling from unqualified practitioners, all of which have the potential to exacerbate or briefly camouflage symptoms and warning signs.5 Practitioners’ perspectives of their patients’ mental states are inevitably snapshots taken at times that might not be representative of the course or trajectory of the illness. This is especially so in relation to bipolar disorder. Bipolar II disorder poses particular clinical challenges because of the risk that a practitioner seeing a patient irregularly will fail to identify hypomanic episodes and misdiagnose by reference only to observed or reported depression or anxiety. This risk is graphically illustrated in this issue of the Journal by Parker, in the context of the coronial inquest into the death of Charmaine Dragun.6 It is incumbent upon practitioners to be alert to dangerously labile moods suggestive of bipolar I or II disorder. Where signs of bipolar disorder are identified, there is frequently a need to refer the patient to a psychiatrist to manage and to titrate medication. Such referrals must be informed and suitably selective. Indiscriminate referrals run the risk of using the services of a psychologist or a counsellor in cases where such practitioners may not be the most suitable providers of treatment. This can be a particular issue in the era of mental health care plans, in which there can be pressures on general practitioners, driven by financial considerations, to refer to non-medically qualified practitioners who may not be the best equipped to deal with psychiatric illness. A survey of psychiatrists in the United Kingdom and the United States identified early referral to appropriate specialist care as being one of the “highest priority needs” in the effective management of patients diagnosed with bipolar disorder.7 Such patients are at real and foreseeable danger of lifestyle harm (such as severe embarrassment and financial loss), of taking risks that might endanger their own or others’ safety, and of suicide. These dangers can be avoided by timely referral to specialists with experience in the diagnosis and treatment of patients with bipolar disorders. However, the advantages of suitable and timely referral go beyond the practice of prudent and defensive medicine. Such referral enables focused and intensive provision of treatment for patients who might have limited insight into their illness and the need for treatment, as well as ambivalence about seeking assistance for their symptoms. In the legal context, the scenarios in which failures to refer have most commonly been litigated have been in relation to cancer investigations, when malignant tumours have been misdiagnosed as benign or have not been identified at all,8 and when there has been the potential for, or reality of, a boundary blurring or transgression. An example of the latter is when moves have commenced toward the creation of an unethical romantic or sexual relationship between practitioner and patient, and the doctor has not referred the patient to another practitioner. The principle underlying the obligation to refer in both scenarios is the same — that another practitioner is better positioned to advance the patient’s interests and that non-referral will disadvantage the wellbeing of the patient, breaching the obligation to exercise reasonable care and skill in the provision of professional advice and treatment.9,10 However, the referral must be clinically appropriate. In a New South Wales case, this was illustrated by a GP being found civilly liable to his patient for referring him to a chiropractor from whom he received treatment that was foreseeably clinically contraindicated because the patient had degenerative cervical changes and neurological symptoms from a disc injury.11 The same issue arises in respect of patients who might have bipolar disorder. This is not to say that a suitably experienced GP might not be able to treat such patients adequately; rather, that it can be negligent not to take active steps to enable patients to avail themselves of the specialist care that might be able to manage their illness most intensively at the time. Such a referral is also a significant protection for the practitioner, should allegations of insufficient or inadequately informed care be made later by the patient or the patient’s dependants.

Ian R Freckelton SC, LLB, PhD · George Mendelson MD, FRANZCP, FFPMANZCA

New data from the Health in Men Study raise questions about the role of testosterone supplementation in ageing men Ageing of the “baby boomer” generation foreshadows a future shaped by demographic change, with increasing numbers of older Australians. The large, longitudinal Western Australian Health in Men Study (HIMS) is therefore timely, as it examines the endocrinology of male ageing and predictors of health in community-dwelling older men.1,2 As part of HIMS, my colleagues and I surveyed 3274 men aged 75–95 years in 2008–2009 using a questionnaire that included items on sexual activity.3 Of 2930 men who reported on the importance they attached to sex, 48.8% considered it important, and of the 2783 men who provided data on sexual activity, 30.8% had at least one sexual encounter (defined as any mutually voluntary activity with another person that involves sexual contact, whether or not intercourse or orgasm occurs4) in the previous 12 months.3 Of these older sexually active men, 56.5% were satisfied with the frequency of sex, while 43.0% would have preferred sex more frequently.3 These findings indicate that many older Australian men consider sexual activity important and desirable. In HIMS, factors that predicted reduced sexual activity were increasing age, osteoporosis, prostate cancer, diabetes, antidepressant use, β-blocker use, and partner’s lack of interest or physical limitations.3 Living with a partner and having a non-English-speaking background were associated with increased sexual activity. Interestingly, a 1 SD increase in testosterone level, measured in blood samples collected in 2001–2004, was associated with a 20% increased likelihood of being sexually active in 2008–2009. Therefore, while older men with lower testosterone levels are likely to report symptoms such as reduced frequency of sexual thoughts and erectile difficulties,5 higher testosterone levels predict sexual activity several years into the future. This raises the question of whether giving exogenous testosterone to induce a comparable increase in circulating total testosterone levels (+ 5.6 nmol/L) would increase the frequency of sexual activity for older men. Epidemiological studies such as HIMS show that men with testosterone levels in the low-normal range have poorer health outcomes; for example, those with testosterone levels in the lowest quartile (< 11.7 nmol/L) have increased risk of stroke or transient ischaemic attack.6 Lower testosterone levels are associated with mortality in older men.7 Studies of testosterone therapy in older men show favourable effects on body composition, with increased lean mass and bone mineral density and, to an extent, improved muscle strength.8 However, there is no evidence as yet that testosterone therapy reduces cardiovascular events or mortality, or that it increases sexual activity in older men. In fact, administering higher doses of testosterone to older men with limited mobility might result in an excess of adverse cardiovascular events.9 More data are needed to help design optimal studies to clarify the role of testosterone supplementation in ageing men. In HIMS, the mean serum total testosterone level in 3638 men aged 70–89 years was 15.4 nmol/L (reference range, 8–35 nmol/L), and only a minority would have been classified as having unequivocally low testosterone levels.1 Uncertainty remains around the extent to which lower testosterone levels reflect underlying comorbidity; appropriate testosterone thresholds for the diagnosis of androgen deficiency in older men; and effects of testosterone therapy on cardiovascular risk.8 The current Testosterone Trial (ClinicalTrials.gov identifier NCT00799617) in the United States, due for completion in 2015, is recruiting older men with lower testosterone levels and will examine the effect of transdermal testosterone gel on end points of walking speed, sexual activity, vitality, memory and anaemia correction. So while the question of whether testosterone therapy might protect against cardiovascular events remains unresolved, its impact on sexual activity in the setting of a randomised controlled trial might not be known for another 4 years. Under these circumstances, the clinical approach to ageing men with symptoms of testosterone deficiency must be prudent, taking both known risks and potential benefits into account.8 Testosterone supplementation could be considered in men who are clearly hypogonadal. Symptoms of androgen deficiency should be assessed, and the diagnosis based on at least two unequivocally low early-morning testosterone levels, preferably assayed using a mass spectrometry-based methodology.10 Men should be counselled as to the risks and benefits of testosterone therapy, and treatment should be accompanied by safety monitoring, including prostate evaluation and monitoring of prostate-specific antigen levels and haematocrit. The anticipated effect of testosterone therapy would be to increase libido, and this should be included in the discussion of benefit and risk. While higher testosterone levels are associated with sexual activity in older men, non-hormonal factors are also important. HIMS found that increasing age predicted declining sexual activity; after adjusting for this and other covariates, men were four times more likely to be sexually active if they were living with a partner.3 Conversely, they were much less likely to be sexually active if their partner lacked interest in sex or had physical limitations. Medical comorbidities including diabetes and use of antidepressants were also associated with reduced likelihood of being sexually active. Therefore, social and medical factors are key determinants of whether ageing men remain sexually active. The increasing numbers of men transitioning from middle to older age should be encouraged to maintain their personal health and the health of their relationships to maximise their chances of having sex in future years.

Bu B Yeap MB BS, FRACP, PhD

Building on a successful program to extend PBS copayment relief to more patients Cost is a well established influence on both access to medicines and medication adherence rates. Prescription fees can lead to patients forgoing essential medications and to a decline in health care status among needy populations,1,2 an observation that is very familiar to Aboriginal community-controlled health services (ACCHSs). While capped patient copayments and the Pharmaceutical Benefits Scheme (PBS) Safety Net minimise the medication cost burden on all Australians, these mechanisms are ineffective for many Aboriginal and Torres Strait Islander peoples. The reasons for this include high rates of unrecorded concession and Safety Net status, disproportionately higher rates of chronic disease and comorbidity, extended social and family obligations, “shame” in accessing prescriptions in culturally alienating settings, high patient mobility, and poor health literacy. PBS utilisation is further reduced in this population by factors that preclude medicines storage and adherence, such as overcrowding, and disease profiles that are inconsistent with medicines listed on the PBS. The Council of Australian Governments (COAG) National Indigenous Reform Agreement of November 2008 led to strategies designed to close the gap in Aboriginal and Torres Strait Islander people’s life expectancy.3 One of these strategies is the $88.7 million “Subsidising PBS Medicine Co-payments” measure,4 which commenced in July 2010 and is predicted to provide financial assistance to “over 70 000 Indigenous people”, to improve their access to PBS medicines.3 This measure was, in fact, built on an existing program — Quality Use of Medicines Maximised for Aboriginal and Torres Strait Islander Peoples (QUMAX)5 — the details and outcomes of which have been kept under wraps until the recent release of the findings of an independent evaluation.6 The QUMAX program, which commenced in November 2008, aimed to overcome a range of known barriers to Aboriginal and Torres Strait Islander peoples’ access to medicines, and was jointly developed and managed by the National Aboriginal Community Controlled Health Organisation and the Pharmacy Guild of Australia, and funded by the Australian Government under the Fourth Community Pharmacy Agreement (2005–2010). Aboriginal and Torres Strait Islander patients could access the QUMAX program through ACCHSs in rural, regional and urban (ie, non-remote) areas. The cost of medicines for eligible needy and disadvantaged patients (as defined in the business rules for the program6) was subsidised through an online system of coordinated, secure and accountable copayment relief arrangements between ACCHSs and participating community pharmacies. The program also supported local quality use of medicines (QUM) initiatives through support pharmacists assigned to each ACCHS, provided QUM education for ACCHS staff, provided dose-administration aids and transport for the delivery of medicines, focused attention on patients’ PBS Safety Net entitlements, and fostered collaboration with community pharmacies — all within the context of culturally appropriate primary health care. Administration of QUMAX was lean, with the majority of the funds appropriately devolved to supplying medicines. The independent evaluation showed almost universal participation by ACCHSs (69 of 70) and involvement of 541 community pharmacies. The capped nature of QUMAX funding to each ACCHS meant that only 20% of the services’ Aboriginal and Torres Strait Islander clients (nearly 34 000 of the 171 094 patients who attended the participating services annually) could receive support for medicines and medication aids. Over 271 000 medicines were dispensed to these patients with the PBS copayment waived.6 Between November 2009 and April 2010, the proportionate increase in the number of PBS medicines dispensed to patients of non-remote ACCHSs was nearly five times greater than the increase in medicines dispensed to all Australians, and exceeded the increase seen in remote areas by a factor of seven. Greater access to medicines for chronic disease (lipid-lowering, antihypertensive and asthma medications) accounted for most of the increase. This increase occurred on a background of substantial inequities in access to medicines. In the 2006–07 financial year, for every dollar per person spent on PBS medicines for non-Indigenous Australians, only 60 cents was spent on Indigenous Australians.7 Among Aboriginal and Torres Strait Islander peoples, geographical disparities in access to medicines had been the reverse of those expected — Aboriginal peoples in non-remote parts of Australia had lower PBS expenditure per person than those in remote locations ($159 in major cities versus $223 in remote and very remote areas).7 This is probably due to the enduring success of another scheme — the special PBS arrangements under section 100 of the National Health Act 1953 for the supply of medicines to remote-area Indigenous health services.8 It is unclear if QUMAX has alleviated the PBS expenditure inequities, but the evaluation report states that, for Aboriginal and Torres Strait Islander peoples, there is “strong evidence that the QUMAX program has helped to overcome the financial barrier to accessing PBS medicines in non-remote areas”.6 In addition to patients of non-remote ACCHSs, the new PBS medicine copayment measure now extends copayment relief to eligible Aboriginal and Torres Strait Islander people who have, or are at risk of, chronic disease and are patients of any private general practice. Although the QUMAX program no longer includes the copayment relief element, it has been extended until 2015 under the Fifth Community Pharmacy Agreement to continue to augment QUM within ACCHSs. PBS listings have also improved, with more medicines now available for conditions that predominate in the Aboriginal and Torres Strait Islander population.9 There is no doubt that ACCHSs have substantially improved access to medicines for their disadvantaged Aboriginal and Torres Strait Islander patients and will continue to do so — to a level likely to eliminate disparity. They are able to do this through multifaceted strategies built on their intense community knowledge and involvement. When gauging the impact of the Subsidising PBS Medicine Co-payments scheme, it will be crucial for data on PBS utilisation by Aboriginal and Torres Strait Islander peoples to be disaggregated by “service type”. While ACCHSs participating in QUMAX have transitioned readily to the new copayment measure, its effectiveness in the private general practice sector now needs to be explicitly understood.10

Sophie Couzos FRACGP, FACRRM, FAFPHM · Vicki Sheedy BA, BEd · Dea Delaney Thiele PGDipHlthMgt

No-fault compensation, based on the ethical principle of redistributive justice, should form a cornerstone of Australia’s immunisation strategy Australia has an enviable reputation for its publicly funded vaccine program — a program that has benefited Australian children and adults over many years. In 2010, the National Immunisation Program funded 12 vaccines, twice as many as a decade previously. To monitor outcomes from this program, the Australian Childhood Immunisation Register, which commenced data collection in 1996, provides a detailed record of vaccine uptake by children.1 Funding for the register and for incentives to general practitioners to improve vaccine uptake are part of the total budget for Australia’s vaccine program, estimated to exceed $400 million annually.2,3 One area for improvement in the vaccine program is monitoring of adverse events following immunisation (AEFI). Another would be the introduction of a no-fault compensation scheme for serious adverse events which can be confidently attributed to vaccination. An investigation into the unexpectedly high number of febrile convulsions in children aged less than 5 years after they had received the influenza vaccine in 2010 — in some cases, with devastating consequences4 — provided a forceful reminder that timely vaccine safety monitoring is needed in Australia.5 More active adverse event surveillance is certain to uncover more AEFI but many of these will only be coincidental, while others will be of a transient or relatively trivial nature. On rare occasions, a serious AEFI with long-term sequelae will be recognised. A decision will then need to be made on whether the vaccine was responsible for that serious event. The World Health Organization defines four categories of serious AEFI: hospital admission or prolongation of an existing hospital admission; permanent disability; any event that is life threatening; or death.6 Using these criteria, 8% (193/2396) of the AEFI reported by passive surveillance in Australia in 2009 were judged to be serious.7 However, unlike many countries where compensation schemes exist for adverse events attributed to a vaccine, Australia has no routine approach to making the assessment of attribution. Parents of children or adults who believe they deserve compensation for a serious adverse event that they attribute to a vaccine are therefore required to make their case through the adversarial legal system. This requires the demonstration that an individual or an organisation was at fault. However, fault is often difficult to demonstrate and an adverse event may be caused by vaccination through no fault of the vaccine manufacturer, the regulator or the person who administered the vaccine. We have previously argued that a Queensland child who developed transverse myelitis after receiving oral polio vaccine was an example of an adverse event following vaccination where no fault was attributable to any party.8,9 Despite detailed epidemiological evidence that was consistent in this case with the causal criteria for an AEFI promulgated by the Institute of Medicine of the National Academies in the United States,8 and despite laboratory evidence showing that the polio virus recovered from this child was similarly pathogenic to a polio virus that has been accepted as causing vaccine-associated paralytic polio,9 the polio expert committee concluded that the evidence was insufficient to support a causal relationship between the oral polio vaccine and transverse myelitis. As causality has not been accepted, this child has received no compensation. The general principles associated with this case raise a number of pertinent questions for Australia. First, should a child who may have been injured by a vaccine, which was endorsed and paid for by the community, be compensated by the community when the serious adverse event may be attributed to the vaccine? Second, what are the criteria for accepting an attributable relationship between receipt of the vaccine and a subsequent adverse event? Third, what is the best method for financing a compensation scheme? Each question may highlight a potential barrier to the implementation of a no-fault AEFI compensation scheme in Australia. By 2010, 19 countries around the world had implemented no-fault AEFI compensation, implicitly answering “yes” to the question of whether the community owes a duty of care to an individual injured by a vaccine.10 There is also a strong ethical argument for this position, based on the concept of redistributive justice. Any person who is injured while helping to protect the community — for instance, by contributing to herd immunity, such that there are sufficiently many people immunised to prevent widespread disease transmission within the community — should not bear the consequences of injury alone. In essence, the community owes a debt of gratitude to that person. Temporal association of an adverse event with receipt of a vaccine does not establish causality and the underlying notion of causation used in most compensation schemes is similar to that used in epidemiology.10 The World Health Organization has published guidelines on causality for an AEFI.11 An adverse event considered to be very likely or certainly due to a vaccine would comprise a “Clinical event with a plausible time relationship to vaccine administration, and which cannot be explained by concurrent disease or other drugs or chemicals”.11 To simplify and expedite determinations of causality in the US, a vaccine injury table is used to predetermine causality if a vaccine injury is included in the table.10 However, determining causation is a complex issue. Recognising this, most countries have a designated committee, comprising medical and legal members, which deliberates on the attributable relationship between receipt of the vaccine and subsequent adverse event.10 Concerns about funding a no-fault compensation scheme is another of the probable barriers to its implementation in Australia. Schemes are currently funded by one of four methods: a vaccine levy; compensation for AEFI as part of a much broader injury compensation scheme; specific AEFI compensation funded through general tax revenue; and funding in association with industry.10 Funding through a vaccine levy has been self-sustaining in the US. Despite compensation payments having been made to 2580 claimants since 1989, the compensation fund there has a surplus of about US$3 billion.12,13 No-fault vaccine-injury compensation programs are based on the premise that any adverse event attributable to vaccination is not due to the fault of a specific individual or organisation, but due to an unavoidable risk that is acknowledged as being associated with vaccines. Germany has been operating a no-fault AEFI compensation scheme for 50 years.10 France restricts its compensation to serious AEFI, since these are likely to have long-term implications for the injured party.10 Restricting compensation to events with long-term consequences, above a nominated clinical threshold, may be an acceptable model for Australia. We have previously argued that Australia should follow the lead of other advanced countries and implement a no-fault compensation scheme.14 We continue to argue that such a scheme, based on the ethical principle of redistributive justice, should form a cornerstone of Australia’s immunisation strategy. Disclaimer The views expressed are those of the authors and have not been endorsed by any institution or organisation with which the authors are affiliated or by any committees of which the authors are members.

Heath A Kelly BSc, MB BS, MPH · Clare Looker MB BS, MPH · David Isaacs MD, FRACP, FRCPCH