Health services administration

Medicine and the Community Economic costs of urinary incontinence in community-dwelling Australian women Christopher M Doran, Pauline Chiarelli and Jill Cockburn MJA 2001; 174: 456-458 For editorial comment, see Moore Abstract - Methods - Results - Discussion - References - Authors' details - - More articles on Obstetrics & gynaecology and women's health - More articles on Urology - More articles on Economics Abstract Objective: To estimate the economic cost of urinary incontinence in community-dwelling Australian women aged 18 years and over for the year 1998. Design: Extrapolation of data from studies of women with incontinence to the Australian population of women aged 18 years and over in 1998. Main outcome measures: Estimated prevalence of urinary incontinence in 1998, and estimated cost in Australian dollars of resource use and personal costs related to management of incontinence. Results: An estimated 1 835 628 community-dwelling women over the age of 18 years had urinary incontinence in 1998. The total annual cost of this urinary incontinence is estimated at $710.44 million, or $387 per incontinent woman, comprising $338.47 million in treatment costs and $371.97 million in personal costs. An estimated 60% of women with incontinence in 1998 were aged 40 years or over. Assuming the prevalence of incontinence remains constant and, allowing for inflation, we project that the total annual cost in 20 years' time will be $1267.85 million, 93% ($1.18 billion) of which will constitute costs associated with women aged over 40 years. Conclusions: Urinary incontinence imposes a considerable drain on Australian healthcare resources. More research is needed to understand the magnitude of the problem and potential gains from continence promotion. Urinary incontinence is a major clinical problem that has a profound effect on quality of life and activities of daily living.1-3 Women with urinary incontinence report fear, shame and humiliation, and worry about the odour of urine from pads and wet underclothing.4 Urinary incontinence is physically debilitating and socially incapacitating, and is associated with loss of self-confidence, feelings of helplessness, depression and anxiety.3Studies of the prevalence of urinary incontinence suggest that it is widespread among women of all ages.5 Australian community-based studies have reported incontinence in 19% of women aged 10-29 years, 40% of women aged 30-44 years, 50% of women aged 45-59 years, 30% of women aged 60-74 years, and 42% of women aged over 75 years.6 Recent data from the Women's Health Australia (WHA) project, a longitudinal study of three age cohorts (18-23 years, 45-50 years and 70-75 years), conducted by staff of the universities of Newcastle and Queensland and funded by the Commonwealth Department of Health and Aged Care, support these findings.7,8 The probability of incontinence increases with age,9-11 and the nature of incontinence changes from stress incontinence to urge incontinence12 as a result of an increasing prevalence of multiple disorders and organ dysfunction with age. This change has significant implications for clinical management.13 While stress incontinence is typically managed with strengthening exercises for pelvic floor muscles, with or without neuromuscular electrostimulation and surgery, management of urge incontinence might also include a bladder-training program, transcutaneous electrostimulation aimed at the spinal micturition reflex centre and drugs.14 Urinary incontinence has a considerable financial impact on both individuals and the healthcare system. One United States study has reported costs of US$26.3 billion in 1995 for individuals aged 65 years and over, or US$3565 per incontinent individual.15 Little is known of the economic impact of urinary incontinence in Australia, but the Australian National Women's Health Policy Statement estimated that individuals may pay up to $1200 a year for incontinence pads, and that 25% of nursing time in nursing homes was spent managing incontinence, at an annual cost of $450 million.16 A recent study of 100 community-dwelling Australian women aged between 25 and 85 years reported a median total direct cost (including personal and treatment costs) of $12.89 per week.17 Our aim was to comprehensively examine the economic costs of urinary incontinence in community-dwelling women in Australia for the year 1998. Methods We used a similar approach to that used by Hu et al in the US,15,18,19 in that we used information from a variety of sources in our estimates. However, rather than using national utilisation figures19 and a "top-down" approach, we used a "bottom-up" approach, taking estimates derived from relevant studies and extrapolating them to the 1998 population of Australian women aged over 18 years. We estimated the cost of urinary incontinence as the total value of all resources used or lost by ill individuals, treatment providers or others as a result of the illness.15 Direct costs include resources used for diagnosis, treatment and care of urinary incontinence, while indirect costs include the value of lost earnings and time spent by carers. Intangible costs20 related to psychological, physical and social effects were not included. Estimating prevalence The WHA project provides the most comprehensive information on the prevalence of urinary incontinence in Australian women.7,8 It reported incontinence in 12.8% of women aged 18-23 years, 36.1% of women aged 45-50 years and 35% of women aged 70-75 years, and a prevalence of help-seeking among incontinent women in each cohort of 22.9%, 45.5% and 44.6%, respectively.21We assumed that the prevalence of incontinence and help-seeking in the three age cohorts could be applied to broader age groups of 18-39 years, 40-69 years and over 70 years, and used Australian Bureau of Statistics (ABS) figures for the resident population in these age groups22 to estimate the total number of incontinent Australian women who did and did not seek help in 1998. Resource use and personal costs A recent study developed the Dowell-Bryant Incontinence Cost Index (DBICI) to measure the total direct costs of urinary incontinence.17 This study applied the DBICI to 100 consecutive community-dwelling women attending continence clinics for treatment of their urinary incontinence. Personal cost estimates included weekly expenditure on pads, incontinence-related laundry and miscellaneous costs (such as dry cleaning, replacement of urine-soaked carpets and clothing), while treatment-cost estimates included visits to healthcare professionals, surgical procedures, medications and costs associated with travel and time off work in the previous year. We costed these resources by using standard fees from the Medical Benefits Schedule and Pharmaceutical Benefits Scheme or by actual costs incurred if women had private health cover. We used the data from this study17 in conjunction with the prevalence estimates from the WHA project to estimate the resource implications and personal cost of urinary incontinence among women aged 18 years and over in Australia in 1998. Results We estimate that 1 835 628 community-dwelling women over the age of 18 years in Australia had urinary incontinence in 1998, and that 60% (1 109 506) of these women were aged 40-69 years (Box 1). An estimated 742 348 women sought help for their incontinence, of whom 68% were aged 40-69 years. Box 2 shows that we estimate total annual treatment costs at $338.47 million, 48% of which was for visits to health professionals, and 25% of which was for investigations. Further, we estimate that total personal costs in 1998 were $371.97 million, 56.5% of which was borne by women who did not seek help (Box 3). The total annual cost of urinary incontinence in 1998 is estimated at $710.44 million, or $387 per woman with urinary incontinence. Up to 90% ($640.98 million) of the total annual costs were incurred by women aged over 40 years. Given Australia's ageing population, assuming the same prevalence and taking inflation into account, the total cost of urinary incontinence in community-dwelling women is projected to be $1267.85 million in 20 years' time; 93% of this ($1.18 billion) will constitute costs associated with women aged over 40 years. Discussion Our estimates represent the first attempt to quantify the total economic impact of urinary incontinence in community-dwelling Australian women. However, our analysis has some limitations that need to be kept in mind when interpreting the results. Importantly, our data sources differ in methodological rigour and comparability, so we have had to make a number of assumptions. Prevalence rates of incontinence reported from the WHA project have been extrapolated to a wider age range than originally measured.7 We applied the data of Dowell et al on treatment resource use universally to all age groups in our analysis, and without considering socioeconomic and demographic variations. Given that the type and severity of incontinence varies with age,9-12 this assumption may not provide an accurate picture. We also applied the personal costs reported in Dowell et al17 to slightly different age groups. Finally, although the sample of 100 women used in Dowell et al represented a wide spectrum of age and severity of leakage, it may not have been representative of all community-dwelling women.17 Despite these limitations, our analysis is the most comprehensive assessment of the annual costs of urinary incontinence in community-dwelling women conducted in Australia to date. The total cost of $710.44 million is a conservative estimate of the cost of resources used in treatment and care of women with urinary incontinence. If we were to consider the reduced quality of life, lost earnings and the burden imposed on family, friends and carers, the total cost would be considerably higher. From a woman's perspective, there are substantial personal costs involved in managing incontinence; research has found that women are willing to pay considerable amounts to reduce the symptoms of urinary incontinence.23,24 From a health system perspective, the high cost of treatment and care of urinary incontinence clearly demonstrates that this is a serious medical condition that imposes a considerable drain on scarce healthcare resources. We need more and better information on the consequences of urinary incontinence so that we do not have to make as many assumptions to estimate economic impact. In particular, we need to know the resource implications of the different types of incontinence, the effect on quality of life and the potential benefits from reducing the prevalence of urinary incontinence among Australian women. We also need to alert women to the risk factors for incontinence, strategies that may minimise or prevent incontinence, and the support and treatment options available. Given the demographic shift towards an older population and the escalating costs of healthcare provision and technology, this is an urgent need. References Wyman J. The psychiatric and emotional impact of female pelvic floor dysfunction. Curr Opin Obstet Gynecol 1994; 6: 336-339. Hollywood B, O'Dowd T. Female urinary incontinence: another chronic illness. Br J Gen Pract 1998; 48: 1727-1728. Grimby A, Milson I, Molander U, et al. The influence of urinary incontinence on the quality of life of elderly women. Age Ageing 1993; 22: 82-89. Lam G, Foldspang A, Elving LB, Mommsem S. Social context, social abstention, and problem recognition correlated with adult female urinary incontinence. Dan Med Bull 1992; 39: 565-570. Hunskar S, Arnold EP, Burgio K, et al. Epidemiology and natural history of urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2000; 11: 301-319. Millard R. The prevalence of urinary incontinence in Australia. Aust Continence J 1998; 4: 92-99. Chiarelli P, Brown W. Leaking urine: prevalence and associated factors in Australian women. Neurourol Urodyn 1999; 18: 567-577. Brown W, Bryson L, Byes J, et al. Women's Health Australia: recruitment for a national longitudinal cohort study. Womens Health 1998; 28: 23-40. Thomas T. Prevalence of urinary incontinence. BMJ 1980; 281: 1243-1245. Outlander J. Urinary incontinence in nursing homes. J Am Geriatr Soc 1990; 3: 289-291. Milos I, Eke Lund P, Molander U, et al. The influence of age, parity, oral contraception, hysterectomy and menopause on the prevalence of urinary incontinence in women. J Urol 1993; 149: 1459-1462. Herzog A, Fultz N. Prevalence and incidence of urinary incontinence in community dwelling populations. J Am Geriatr Soc 1990; 38: 273-281. Whishaw M. Urinary incontinence in the elderly: establishing a cause may allow a cure. Aust Fam Physician 1998; 27: 1087-1090. Wall L, Norton P, Delaney J. Practical Urodynamics. Baltimore: Williams and Wilkins, 1993. Wagner T, Hu T. Economic costs of urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1998; 9: 127-128. National policies and priorities for women's health. Canberra: National Women's Health Policy, 1989. Dowell C, Bryant C, Moore K, Simons A. Calculation of the direct costs of urinary incontinence: the DBICI. Br J Urol 1999; 83: 596-606. Hu T. The economic impact of urinary incontinence. Clin Geriatr Med 1986; 2: 673-687. Hu T. Impact of urinary incontinence on health care costs. J Am Geriatr Soc 1990; 38: 292-295. Drummond M. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press, 1997. Chiarelli P, Brown W. Leaking urine in Australian women: prevalence and associated conditions. Womens Health 1999; 29: 1-13. Population by age and sex, Australian States and Territories. Canberra: Australian Bureau of Statistics, 1998. (Catalogue no. 3201.0.) Johannesson M, O'Conor R, Kobelt-Nguyen G, Mattiasson A. Willingness to pay for reduced incontinence symptoms. Br J Urol 1997; 80: 557-562. O'Conor R, Johannesson M, Hass S, Kobelt-Nguyen G. Urge incontinence: quality of life and patients' valuation of symptom reduction. Pharmacoeconomics 1998; 14: 531-539. (Received 28 Jun, accepted 18 Dec, 2000) Authors' details School of Population Health Sciences, Faculty of Medicine and Health Sciences, University of Newcastle, Newcastle, NSW. Christopher M Doran, PhD, Research Fellow. Pauline Chiarelli, MMedSci, Doctoral candidate. Jill Cockburn, PhD, Professor of Behavioural Science in Relation to Medicine. Reprints will not be available from the authors. Correspondence: Professor J Cockburn, Locked Bag 10, Wallsend, NSW 2287. jillcATmail.newcastle.edu.au Make a comment 1: Estimated numbers of women aged 18 years and over with urinary incontinence and those who sought help for their incontinence in Australia, 1998 Age group No. of women in Australia No. of women with incontinence No. of women with incontinence who sought help 18-39 years 40-69 years 70+ years Total 3114215 3073424 935720 7123359 398620 (12.8%) 1109506 (36.1%) 327502 (35.0%) 1835628 91424 (22.9%) 504798 (45.5%) 146175 (44.6%) 742348 Back to text 2: Estimated cost of resource use for management of urinary incontinence in community-dwelling Australian women aged 18 years and over in 1998 Resource % Of women with incontinence using resource Average annual cost Annual total cost of resource Health professionals General practitioner 54% $48.56 $19465060 Urogynaecologist, Nurse continence advisor, Urologist 53% $327.70 $127960547 Physiotherapist 3% $334.00 $7438324 Other (herbalist, acupuncturist) 2% $18.50 $27466 Travel/parking 75% $12.24 $6813837 Subtotal $161705234 Investigations Midstream urine culture 8% $89.92 $5340078 Urodynamics (cystometry) 29% $359.02 $77288109 Urinary tract ultrasonography 1% $98.75 $733068 Intravenous pyelogram 1% $128.25 $952061 Subtotal $84313316 Medications Hormone replacement therapy (for bladder symptoms only) 19% $33.91 $4782794 Anticholinergics 17% $58.34 $7145837 Laxatives (for anticholinergic-related constipation) 2% $134.05 $1990160 Antibiotics (for urinary tract infection) 19% $28.77 $4057503 Urinary antiseptics 2% $15.22 $225896 Other (for bladder symptoms only) 6% $77.97 $3472702 Subtotal $21674892 Surgery Colposuspension 4% $2200.00 $65326603 Cystoscopy 3% $132.51 $2950980 Phenol injection 2% $168.85 $2506908 Subtotal $70784491 Total treatment costs $338477933 Back to text 3: Personal costs of urinary incontinence for community-dwelling Australian women aged 18 years and over, 1998 Annual cost Average weekly personal costs* Women who sought help Women who did not seek help Age group 18-39 years 40-69 years 70+ years $1.34 $3.38 $8.76 $6370453 $88714515 $66585778 $21405354 $106292270 $82597933 Subtotal $161670746 $210295557 Total personal costs $371966303 *Includes costs of pads, protection, laundry and miscellaneous items. Note that average personal costs reported in Dowell et al were for age groups 24-39, 40-64 and 65-88 years.17 These average rates have been applied to the age groups used in this analysis. Back to text

Christopher M Doran · Pauline Chiarelli · Jill Cockburn

Editorial Vocational part-time training: jobs for the girls and boys There is a clear demand from many levels of the medical profession that part-time training be available, viable and valuable MJA 2001; 174: 376-377 Medicine is different today — isn't it? Changing knowledge, changing technology, changing disease patterns, changing service delivery, changing consumer expectations — and a changing medical workforce. The medical workforce is changing in terms of gender balance, expectations regarding lifestyle, working conditions, ethnic/cultural background and age of entry to medical school. Medicine is the same as ever — isn't it? The same hierarchical structure, with men dominating at senior levels; the same culture of heroic individualism; the same male-female inequalities with selection/promotion/retention procedures; the same difficulties for women to reach their professional potential. Women are clustered in the lower-status areas of medicine, earn less money on average, make less contribution to the profession outside direct medical care, experience higher levels of stress, have many more family responsibilities, and are much more likely to modify their careers to accommodate the needs of their partners and families.1 One outcome is very clear — part-time trainees report satisfaction with their job and lifestyle. Less clear is the training outcome. Medicine, like society in general, is both different and the same. What is clear is that our younger colleagues, both women and men, are demanding real change in the structure, organisation and practice of medicine to allow them to have a more balanced lifestyle. One very important structural and organisational issue is the availability of part-time training during the long and demanding medical vocational pathway. Two articles2,3 in this issue of the Journal discuss job-sharing, which is one way of achieving part-time training. Job-sharing often involves more than one sharing arrangement — for example, alternating periods of a week or a fortnight, or splitting the week. Whitelaw and Nash2 note that job-sharers in paediatric training are more likely to share work on a weekly basis while raising children, but to share in longer blocks if preparing for exams. Gun3 found a job-sharing colleague with similar needs that meshed over some, but not all, of her training years. Whitelaw and Nash note that the perceptions of hospital managers and doctors-in-training differ on the availability of particular units for job-sharing; they also note that there are different eligibility requirements between hospitals, implying judgement about what are "acceptable" and "unacceptable" reasons for job-sharing.2 Whether a reason is "acceptable" may depend on the sex of the trainee, but, increasingly, men as well as women are beginning to request part-time training to give them the opportunity to combine training with care of children, study, and hobbies. There has been a gradual increase in the number of part-time trainees in recent years (especially in emergency medicine, paediatrics and psychiatry) — in 1999, part-time trainees made up 6.5% of the total.4 Interestingly, in general practice, traditionally considered a very flexible training area, there was a 50% drop in part-time training over the period 1995-2000. The specialties with minimal numbers of part-time trainees include anaesthetics, dermatology, obstetrics and gynaecology, radiology and surgery. The two articles illustrate a major difficulty in assessing part-time training: while Gun states that there were 17 part-time paediatric trainees in 1998 (a figure quoted from a report of the Medical Training Review Panel),3Whitelaw and Nash's survey identified 34 such trainees in the same year.2 The true proportion of trainees working part-time remains unclear, with differing periods of time per year spent in part-time training, and differing information provided by institutions and Colleges. More accurate collection of data and a clear definition of "part-time" training that differentiates it from "interrupted" training (eg, three months on and three off) are required. Perceived problems continue to be canvassed: Whom do you share with? Will the College agree (in practice as well as in principle)? Is your reason "good enough"? Are your colleagues resentful ("Why should s(he) have 'time off'? "What if I have to do extra to cover?")? Are your consultants cautious ("What about continuity of care?" "What about continuity of meeting the needs of my busy lifestyle?")? Will the hospital bear potential extra costs? Can you and your childcare arrangements cope with converting to full-time work to cover your partner's leave or sickness? Can you get to the 7 am ward round or journal club? Will you miss that special clinic or unit meeting that is always on your day off? Should you refuse secondment? What will happen next year? One outcome is very clear — part-time trainees report satisfaction with their job and lifestyle.2,3 Less clear is the training outcome. There is no intrinsic reason why part-time training, if appropriately balanced, should be less effective than full-time training. However, institutional satisfaction with part-time training is hard to measure given the barriers to implementation, the variable number of trainees from year to year, the different specialties and consultants involved, and the rapid, concurrent changes to service delivery and the organisation of the junior medical workforce (including changes associated with implementing "safe hours" policies). Obvious benefits to the hospital of part-time work include having a potential pool of trainees to cover each other for illness or holidays, and improving the work contribution of trainees.2 There is a clear demand from many levels of the profession that part-time training be available, viable and valuable. The reality is that availability is highly variable, viability often still depends on the trainees "proving themselves", but value is clear. The need for part-time training is part of a much wider debate about vocational medical training. We continue to grapple with the traditional needs of training organisations versus the personal and professional needs of trainees, the conflict between education and service in a tight fiscal environment, and the overall size, setting, distribution and safety of the junior medical workforce. Cultural change is required; a change of core values and norms "from within" to achieve commitment to new organisational structures5 so that the medical profession better meets the needs of, and thus reaps the most benefit from, its entire medical workforce. Jillian R Sewell President, Paediatrics and Child Health Division, Royal Australasian College of Physicians Member, Australian Medical Workforce Advisory Committee Working Party — Career Choice and Workforce Participation Dennerstein L. Roles and achievements: a survey of medical graduates. Melbourne: Key Centre for Women's Health in Society, 1989. Whitelaw CM, Nash MC. Job-sharing in paediatric training in Australia: availability and trainee perception. Med J Aust 2001; 174: 407-409. Gun MT. Part-time specialty training — my experience. Med J Aust 2001; 174: 410-412. Medical Training Review Panel. Fourth report. Canberra : MTRP and Commonwealth Department of Health and Aged Care, August 2000. Sinclair A. Doing leadership differently: gender power and sexuality in a changing business culture. Melbourne: Melbourne University Press, 1998. Make a comment

Jillian R Sewell

The Profession Job-sharing in paediatric training in Australia: availability and trainee perceptions Charlotte M Whitelaw and Margot C Nash MJA 2001; 174: 407-409 For editorial comment, see Sewell; see also Gun Abstract - Methods - Results - Discussion - References - Authors' details - - More articles on Education Abstract Objective: To examine the current availability of job-sharing in paediatric training hospitals in Australia and to evaluate job-sharing from the trainees' perspective. Design: National survey with structured telephone interviews and postal questionnaires. Setting: The eight major paediatric training hospitals in Australia. Participants: Directors of Paediatric Physician Training (DPPTs) at each hospital (or a staff member nominated by them) provided information by phone interview regarding job-sharing. All paediatric trainees who job-shared in 1998 (n = 34) were sent written questionnaires, of which 25 were returned. Results: Hospitals differed in terms of whether a trainee was required to give a reason for wishing to job-share, and what reasons were acceptable. One hospital stated that two specialty units (Intensive Care and Neonatal Intensive Care) were excluded from job-sharing, and another stated that certain units were unlikely to be allocated job-sharers. The remaining six hospitals said that all units were available for job-sharing, but the majority of their trainees disagreed. Only one hospital had a cap on the number of job-share positions available yearly. Trainees perceived benefits of job-sharing to include decreased tiredness, increased enthusiasm for work, and the ability to strike a balance between training and other aspects of life. Trainees believed job-sharing did not adversely affect the quality of service provided to patients, and that part-time training was not of lower quality than full-time training. Conclusions: Job-sharing in Australian paediatric training hospitals varies in terms of the number of positions available, eligibility criteria, and which units are available for job-sharing. In our survey, trainees' experience of job-sharing was overwhelmingly positive. In Australia there is increasing interest in developing more flexibility in the postgraduate training and work environments of medical practitioners. Much of this interest comes from women, for whom "access to flexible training and work opportunities emerges as one of the most important determinants of career choice".1 In 1999, 70% of final-year paediatric trainees were women and their average age was 35 (Gary Disher, Senior Executive Officer, RACP Medical Workforce Advisory Committee, personal communication). It is likely that a significant number of women are balancing training with family commitments. A societal shift has also seen young male doctors increasingly working part-time for family reasons,1 and doctors of both sexes seeking part-time work for a variety of other reasons. Flexible medical training is well established in the United Kingdom,2-4 but relatively new in medical training in Australia. Case reports of job-sharing (ie, two people sharing the duties, responsibilities and benefits of one full-time job) in Australia have been positive;5,6 a study by Valentine and Martin7 found broad support for job-sharing among medical staff in a Perth children's hospital. All Australian medical colleges indicate that they offer part-time training.1 The Royal Australasian College of Physicians "strongly recommends" that basic paediatric training (the first three years) be full-time, while, for advanced training (the last three years), "work sharing is acceptable" and "part-time training is available".8 We set out to determine what is currently available in terms of job-sharing in paediatric training in Australia and whether job-sharing is satisfactory from the trainees' perspective. Methods Setting The eight major paediatric training hospitals in Australia took part in our study: The New Children's Hospital, John Hunter Hospital, Sydney Children's Hospital (NSW); Royal Children's Hospital/Monash Medical Centre (VIC); Adelaide Women's and Children's Hospital/Flinders Medical Centre (SA); Princess Margaret Hospital (WA); Royal Children's Hospital and Mater Misericordiae Children's Hospital (QLD). Interviews and questionnaires We approached the Directors of Paediatric Physician Training (DPPTs) at the eight major paediatric training hospitals. They (or a staff member nominated by them) answered standard questions by phone interview about job-sharing at their hospital. We designed a trainee questionnaire (incorporating some of the statements from a UK instrument9), which we sent to all paediatric trainees who job-shared in Australia in 1998. Multiple-choice and open questions were included. Responses to statements regarding job-sharing were obtained using a five-point Likert scale: strongly agree, agree, neutral, disagree, or strongly disagree. Responses were subsequently collapsed down to a three-point scale (agree, neutral, or disagree). A pilot was performed on job-sharers at our hospital. Confidentiality was assured. Results Trainee demographics Twenty-five of the 34 trainees job-sharing in paediatrics in 1998 returned questionnaires (74% response rate). (No information is available about non-respondents.) Twenty-three respondents were female and 2 male; 11 were in basic training, 11 in advanced training, and three were FRACP qualified but included because their job was usually offered as a training position. Job-share availability and eligibility The results of the hospital survey are presented in Box 1. The DPPT survey indicated that only one of the eight hospitals restricted the number of job-share positions available per year. Only one hospital formally excluded specific units (Intensive Care and Neonatal Intensive Care) from job-sharing. At another hospital, although no units were formally excluded, trainees had to get consultant approval in advance (several consultants known to be "resistant" were unlikely to be approached). The other six hospitals indicated that all units were available for job-sharing; however, 10 of 17 trainees at these hospitals did not believe this. Five of eight hospitals indicated that trainees were not required to give a reason for wishing to job-share. Hospitals that required or preferred to be given a reason tended to regard "childcare responsibilities" as a more acceptable reason for job-sharing than "exam preparation". Reasons for job-sharing When asked to cite their main reason for job-sharing, 13 trainees nominated childcare responsibilities, nine cited exam preparation, and three gave other reasons: personal ill health, desire for more leisure time, and completion of a Master of Public Health degree. Job-share history The time trainees had spent job-sharing in paediatric training positions to the end of 1998 varied from three to 36 months (mean, 18 months). Trainees sharing because of exam preparation shared for shorter periods (mean, 11 months) than those sharing for childcare reasons (mean, 25 months). Job-sharing had taken place in a variety of non-surgical units: General Medicine, Emergency, Neurology, Neonatology, Oncology, Gastroenterology, Endocrinology, Community Medicine, Child Psychiatry, Renal Medicine, Cardiology, Intensive Care, Rehabilitation, Metabolic Diseases, Respiratory Medicine and Allergy/Immunology. Sharing methods Trainees were asked to describe the way they shared jobs in 1998 and to comment on how well it worked for them. Several had used more than one method during the year. Sharing patterns included the following (the number of trainees who had used each method is given in brackets): three weeks on / three off (2); two weeks on / two off (5); one week on / one off (11); splitting the week (13). Trainees sharing for 2-3-week blocks of time commented that there were few continuity-of-care issues and that a block of time off allowed for concentrated study or holidays (none of these trainees were sharing for childcare). All trainees who split the week were sharing for childcare reasons. Some worked the same days each week (an arrangement they felt was optimal for family routine/childcare), and some swapped days during term (allowing for equal exposure to outpatient clinics, teaching rounds, etc). Trainees' perspective Trainees' responses to statements regarding job-sharing are shown in Box 2. Perceived benefits of job-sharing included decreased tiredness, increased enthusiasm for work, and the ability to strike a balance between training and other aspects of life. Trainees did not believe job-sharing adversely affected the quality of service provided to patients, or that part-time training was of lower quality than full-time training. However, some felt that job-sharers were viewed by consultants as "less committed" than full-time trainees. Regarding attendance at educational sessions, six of the 13 trainees sharing for childcare reasons believed they often missed sessions, while only one of the nine trainees sharing for exam preparation believed they did. Discussion Successful job-sharing in a clinical training position must be of educational value to the trainee, provide quality care to patients and their families, and not have a negative impact on other staff. The experience of the job-sharers in our survey was overwhelmingly positive; however, the perceptions of trainees may be biased by the considerable personal investment most have in their positions. It should also be borne in mind that the accuracy of information provided by DPPTs may vary according to their level of involvement with job-sharing. As the total number of respondents in our survey was small, any conclusions must be somewhat tentative, but we believe some general trends are clear. The legality of requiring trainees to provide an "acceptable" reason for wishing to work part-time is questionable; as is the practice of giving trainees wishing to share for childcare reasons precedence over trainees with other reasons for sharing. Although most hospitals stated that all units were available for job-sharing, the majority of their trainees disagreed. Perhaps trainees are misinformed in some instances. An alternative and more likely explanation is that hospitals, wishing to appear progressive, claim that all units are available but do not appoint job-sharers to reluctant consultants. Trainees sharing for short periods (usually exam candidates) can compensate for restricted opportunities when they return to full-time training, but those sharing for longer periods (ie, those with childcare responsibilities) can not. Trainees in the latter group are also more likely to miss educational sessions, presumably because family commitments prevent them from attending on certain days. Demand for flexible training arrangements is likely to rise in future. Specialist medical colleges must become directly involved in the development of flexible training positions rather than simply providing reluctant permission. Hospitals must formulate clear policies regarding job-sharing and make this information available to prospective employees. Further evaluations of job-sharing are needed to ensure arrangements are satisfactory for all concerned. References Australian Medical Workforce Advisory Committee. Influences on participation in the Australian medical workforce. Sydney: AMWAC, 1998. Goldberg I. Postgraduate medical education and flexible training. Br J Hosp Med 1996; 56: 241-242. Goldberg I, Paice E. New approaches to job sharing of training posts in the North Thames region. Br J Hosp Med 1997; 58: 193-196. Montgomery S. Part time work: one year's job share in Bristol. BMJ 1984; 289: 1240-1241. York J. Job sharing — it works! Fellowship Affairs. RACP. 1993; 12(1): 33. Preston S. Job sharing — the trainee's perspective. Fellowship Affairs. RACP. 1993; 12(1): 34. Valentine J, Martin C. Job Sharing at a children's hospital. BMJ 1996; 312: 115-116. The Royal Australasian College of Physicians. Requirements for physician training guidelines. Sydney: RACP, 1998. Fiander A. Evaluation of flexible senior registrar training in obstetrics and gynaecology. Br J Obstet Gynaecol 1995; 102: 461-466. (Received 28 Aug 2000, accepted 18 Jan 2001) Authors' details Royal Children's Hospital, Melbourne, VIC. Charlotte M Whitelaw, MB BS, B MedSc, Advanced Paediatric Trainee; Margot C Nash, FRACP, MD, Director of Paediatric Physician Training. Reprints will not be available from the authors. Correspondence: Dr C M Whitelaw, Department of General Paediatrics, Royal Children's Hospital, Flemington Road, Parkville, VIC 3052. Make a comment 1: Availability of job-sharing positions for paediatric trainees in eight major Australian paediatric hospitals in 1998 Hospital No. of job- sharers in 1998 No. of job-share positions avail- able yearly Units unavailable for sharing (DPPT response) A 12 No set limit ICU and NICU B 2 No set limit None C 0 No set limit At consultants' discretion D 6 No set limit None E 4 No set limit None F 4 2 None G 4 No set limit None H 2 No set limit None No. of trainees who believe some units at their hospital unavailable (total respondents) Requirement for trainee to give reason for job- sharing (DPPT response) 3 (8) No reason required 0 (1) No reason required na No reason required 5 (6) No reason required 3 (4) No reason required 1 (2) Reason required 0 (3) Reason preferred 1 (1) Reason required DPPT = Director of Paediatric Physician Training. ICU = intensive care unit. NICU = neonatal intensive care unit. na = not applicable. Back to text 2: Paediatric trainee responses to job-share statements (n=25) Statement Agree/neutral/disagree (% of respondents) Job-sharing allowed me to strike a balance between my training and other things in my life 100 / 0 / 0 I would recommend job-sharing to other trainees 100 / 0 / 0 I found discussions with my partner during hand-over provided an opportunity to compare and contrast management decisions and share knowledge 88 / 8 / 4 I found discussions with my partner during hand-over were of benefit in solving clinical problems (two heads better than one) 80 / 12 / 8 While job-sharing I felt less tired at work than when I worked full-time 80 / 8/ 12 While job-sharing I was more likely to read up on clinical problems I encountered at work than when I worked full-time 68 / 24 / 8 Job-sharers are viewed as less committed than full-time trainees by consultants 68 / 24 / 8 While job-sharing I felt I had "more to give" to families than when I worked full-time 68 / 16 / 16 While job-sharing I felt more enthusiastic about going to work than when I worked full-time 64 / 36 / 0 While job-sharing I felt more willing to spend time teaching medical students and junior staff than when I worked full-time 52 / 24 / 24 Job-sharers have limited training opportunities compared with full-time trainees 44 / 12 / 44 While job-sharing I often missed important educational sessions during the week 28 / 50 / 22 Job-sharers are viewed as less committed than full-time trainees by their peers 24 / 24 / 52 Arranging a job-share in 1998 was difficult 16 / 12 / 72 Job-sharing has adversely affected my career prospects 16 / 8 / 76 Job-sharing is an easy option 12 / 32 / 56 The quality of job-share training is not as good as full-time training for half as long 8 / 16 / 76 I was often unable to find out what happened to my patients after I handed them over 4 / 4 / 92 The quality of service provided to patients and their families is adversely affected by job-sharing 0 / 4 / 96 Being unable to follow all patients until the end of their hospital stay adversely affected my training 0 / 0 / 100 Inadequate hand-over of information was a significant problem 0 / 0 / 100 I regret job-sharing 0 / 0 / 100 Back to text

Charlotte M Whitelaw · Margot C Nash

Personal Perspective Part-time specialty training — my experience Meegan T Gun MJA 2001; 174: 410-412 For editoral comment, see Sewell; see also Whitelaw & Nash The problem - The idea - The experience - Changing attitudes - References - - More articles on Education It is almost four years since I completed my training in radiology and, now that I have the time, I feel it is important to share my experiences with others, particularly women wishing to pursue specialty training. Both the medical literature and popular press draw our attention to the statistics on women in medicine and particularly the lack of women in postgraduate training programs. In 1998, 57.8% of general practice trainees but only 33.8% of trainees in other specialties were women;1 in 1999, 44.1% of vocational trainees (GP and specialist) were women, but there were marked differences in the proportion of women training in individual specialties (ranging from 12.6% of surgery trainees to 66.7% of paediatrics trainees2) (Box 1). Between 1989 and 1999 the proportion of women commencing medical training increased from 43.6% to 52.7%, while the proportion of female vocational trainees in the same period increased only marginally, from 43% to 43.7% (including trainees in general practice).2 Thus, the increasing number of women entering the medical workforce is not reflected in the proportion of women in specialist training. The problem It is very difficult to fulfil the rigorous requirements for specialist training and maintain a "normal" life. After five or six years at medical school, the thought of undertaking another four or five years of training is daunting. The Medical Labour Force 1998 report1 revealed that about 20% of specialists-in-training worked more than 65 hours per week, and the highest proportion of doctors working more than 80 hours per week were surgeons, internal medicine specialists, specialists-in-training and vocationally registered GPs. Male medical practitioners are more likely to be in a relationship than women, and female practitioners in a relationship are more likely to work part-time (rather than full-time) than those not in a relationship.3 It has been noted that "female practitioners are more likely than male practitioners to have curtailed their careers for family reasons".3 This may involve suppressing career expectations, restricting choice in favour of career paths that provide greater flexibility and allow part-time work, prolonging the training process and/or limiting their role within the profession. Barriers to career advancement that influence the structure of the medical workforce occur most noticeably during vocational training and the child-rearing period of a woman's life.3 Women in training programs who want to have children are at a great disadvantage. When is the best time? — during an intern year, before the Part 1 examination, between Parts 1 and 2, before or after a PhD or master's degree? Or perhaps during an overseas fellowship? I was fortunate at the start of my radiology training to be assigned to a department with a very supportive director. After completing my internship I began my training immediately (this is now not allowed — at least one year of hospital work is required). After about four months I became pregnant. Members of the department, including my fellow registrars, were supportive. At that stage they were all ahead of me in the training program. I did all the work that I could comfortably and safely perform, passed my Part 1 examination, and had my baby. After seven months of maternity leave, I reluctantly returned to full-time work. This was extremely difficult for me — I wanted to continue my training, but not at the expense of spending little or no time with our daughter. The idea In the program at the same time was a female colleague who had already had one child during her training and was having similar thoughts about the difficulty of balancing job and family commitments. We decided to approach the heads of our departments and broach the idea of job sharing. The head of my department was extremely supportive of our plan. Our proposal was put to the warden of the College and accepted, and so began a long and successful partnership between myself, my colleague and the training program. The experience Our working arrangements changed from time to time depending on our hospital placements and on the need to fit in with fellow colleagues. We tried to cover each other's holidays where possible. Issues such as overtime payments, long service leave entitlements and holiday pay were not satisfactorily addressed — they remain important, outstanding items that will require resolution. The system worked very well for both of us, allowing time with our children and continuation of our training. Initially there was some opposition to our arrangement from our contemporaries in the program, who were concerned that we would not fulfil our duties and that it would add to their workload. I do not believe this occurred. My working partner completed her training almost two years before I finished and, as there was no one to continue to job-share with, I was permitted to work alone part-time. Training took over seven years (instead of the usual five), and had I not been given the opportunity to work part-time I would probably not have completed the training. Some women have described the "elongated journey" to specialist qualification in negative terms, but others have found it more "rewarding".3 Certainly, my experience was not negative; the reward for me lay in the fact that at the end of the journey I had maintained a relationship, built a family and completed my training, so the extra time taken was well worth it. During the period of our training, my colleague and I between us had five children (almost six, as I completed the last six months pregnant). I now work two and a half days per week in a public hospital, which is far more flexible than working in private practice. Although my priorities lie mainly with my family, I make a significant contribution to my work environment and my input will probably increase as my children get older. The problems for women doing specialist training are similar worldwide. For example, in the United Kingdom, Maingay and Goldberg found that the "combination of four factors — manpower, duration of specialist training, working hours and maternity provisions — means that in the UK it is particularly difficult for women doctors with families to combine successful full-time specialist training with raising a family".4 Importantly, they noted that "the health care system cannot afford to waste these doctors". The Flexible Training Scheme has been introduced in the UK in an attempt to redress the situation. Changing attitudes The need for revised working patterns and part-time training posts not only arises because of the increased female representation in medicine, but also from changing perceptions of what is expected from all doctors, whether men or women, and the desire for a reasonable lifestyle. A 1994 survey of doctors in the Netherlands (most of whom were working full-time) found that only one-third of female doctors and two-thirds of male doctors wanted to work full-time in the future.5 In 1999, in Australia, only 6.8% of trainees were undertaking part-time training2 (Box 2). Opinions on the issue of allowing part-time specialist training are divided. The Medical Training Review Panel has stated that "Change is required in the organisation and management of many of the specialist training programs so that female practitioners can have the opportunity to better participate in the training program and then, ultimately, within the medical workforce".2 Yet, general opinion among the leaders of the medical profession continues to favour full-time training. At a workshop in 19996 to assess progress in implementing the recommendations of the Brennan Report,7 there was a strong view expressed that any changes to training schemes should not increase the overall length of vocational training "in the process of making work practices and training schemes flexible for women".2 There is also a concern that "With the increasing proportion of female medical undergraduates, if the current preference for [postgraduate training in] general practice continues to predominate, it could be expected to contribute to a continued shortage of specialists and to increase the gender imbalance between general practice and specialist practice".8 It is not just women who are asking for more flexible training arrangements. The career expectations of male doctors also appear to be changing, with choices influenced by flexibility and manageable hours. My training was certainly different from that of my contemporaries. I can not judge whether it was better or worse, or neither, but it certainly allowed me to fulfil my ambitions to become a qualified radiologist and to have a family. I can only hope more women will have the opportunity to do the same. References Australian Institute of Health and Welfare. Medical Labour Force 1998. Canberra: AIHW, 2000. (National Health Labour Force Series, No. 16) (AIHW Catalogue No. HWL 15.) Medical Training Review Panel. Third Report. Canberra: MTRP and Commonwealth Department of Health and Aged Care, August 1999. Australian Medical Workforce Advisory Committee. Influences on participation in the Australian medical workforce. Sydney: AMWAC, 1998. (AMWAC Report 1998.4.) Maingay J, Goldberg I. Flexible training opportunities in the European Union. Med Educ 1998; 32: 543-548. Cohen-Schotanos J, Huisjes HJ. [Status of the job market of physicians who started their education in Groningen in 1982 and 1983.] Ned Tijdschr Geneesk 1994; 138: 1434-1437. Medical Workforce Training and Employment Workshop — April 1999. Summary of outcomes. Sydney: Australian Medical Workforce Advisory Committee, 2000. Summary available at <http://amwac.health.nsw.gov.au/corporate-services/amwac/movingforward.html>. Accessed 5 February 2001. Brennan PJ and Associates. Trainee selection in Australian medical colleges. Canberra: Medical Training Review Panel and Commonwealth Department of Health and Family Services, January 1998. (Publication No. 2291.) Australian Medical Workforce Advisory Committee. Female participation in the Australian medical workforce. Sydney: AMWAC and Australian Institute of Health and Welfare, 1996. (AMWAC Report 1996.7.) Authors' Details Department of Radiology, North Western Adelaide Health Service The Queen Elizabeth Hospital Campus, Adelaide, SA. Meegan T Gun, MBBS, FRANZCR, Radiologist. Reprints will not be available from the author. Correspondence: Dr M T Gun, Department of Radiology, The Queen Elizabeth Hospital Campus, 28 Woodville Rd, Woodville South, SA 5011. olmtosiATchariot.net.au Make a comment 1: Female vocational trainees (%), by College and State/Territory, 19992 College NSW VIC QLD SA WA TAS NT ACT Total Anaesthetists 54.5 43.0 51.6 45.6 51.1 54.5 0 30.8 49.0 Dermatologists 40.0 33.3 36.4 25.0 33.3 - - - 36.0 Emergency Medicine 47.6 39.0 34.7 38.2 24.2 35.0 * * 39.4 General Practitioners 63.2 63.1 49.1 57.3 61.8 61.0 53.2 52.3† 58.9 Medical Administrators‡ 38.7 13.0 25.0 60.0 23.1 0 0 25.0 25.7 Obstetricians and Gynaecologists 56.3 60.0 56.6 54.1 55.5 42.9 100.0 60.0 56.8 Ophthalmologists 21.1 33.3 9.1 0 16.7 0 0 - 19.8 Pathologists 44.4 54.1 34.5 47.1 61.1 60.0 0.0 28.6 42.7 Physicians - Adult Medicine 31.9 39.7 46.2 29.7 39.5 25.0 33.3 25.0 36.7 Physicians - Paediatrics 67.4 56.8 63.0 77.8 76.9 100.0 100.0 100.0 66.7 Physicians - Occupational Medicine 16.0 25.0 33.3 0 11.1 - - - 16.3 Physicians - Public Health Medicine‡ 50.0 50.0 43.7 60.0 50.0 0 66.7 50.0 50.7 Physicians - Rehabilitation Medicine 20.0 36.4 0 66.7 - - - - 26.8 Psychiatrists 46.2 41.5 47.4 46.9 49.4 50.0 40.0 44.4 45.9 Radiologists 32.9 25.7 25.0 51.7 19.0 25.0 * 20.0 30.4 Surgeons 10.5 15.0 12.1 19.0 9.1 0 0 33.0 12.6 Total 44.8 43.3 41.6 44.7 45.1 45.1 50.6 45.2 44.1 - Indicates no trainees at all (male or female). * NT is included in the SA total and ACT is included in the NSW total. † Includes southern NSW. ‡ The data provided are for 1998. Back to text 2: Number of trainees undertaking part-time training, by College, 1995 to 19992 College 1995 1996 1997 1998 1999 Anaesthetists 2 1 4 1 1 Dermatologists 0 0 0 0 0 Emergency Medicine* - - - 67 65 General Practitioners 327 234 247 183 215 Medical Administrators† - - - - - Obstetricians and Gynaecologists 2 2 5 0 2 Ophthalmologists 0 0 1 0 1 Pathologists 1 2 2 3 3 Physicians - Adult Medicine‡ 21 23 2 6 8 Physicians - Paediatrics‡ - - 12 17 15 Physicians - Occupational Medicine 0 0 0 - 2 Physicians - Public Health Medicine 3 6 5 5 Physicians - Rehabilitation Medicine 0 0 2 3 4 Psychiatrists 16 28 16 52 70 Radiologists 1 1 - - 1 Surgeons 0 0 0 0 0 Total 372 296 296 337 387 % Of total trainees - - 5.2% 6.1% 6.8% *Unknown because College database does not record this information. Figures for 1998 and 1999 are an estimate based on 10% of total trainees. † Unknown because College database does not record this information, as hospital employing the trainee makes these arrangements. ‡ Includes paediatric medicine for 1995 and 1996. Back to text

Meegan T Gun

Editorial Changes to the Pharmaceutical Benefits Advisory Committee Any proposed change in the Committee's role should be communicated widely MJA 2001; 174: 209-210 On 31 December 2000, the Pharmaceutical Benefits Advisory Committee (PBAC) and its Economics and Drug Utilisation subcommittees were dissolved under legislation passed precipitately through the Federal Senate. PBAC members, the media and some politicians were surprised by this legislative haste;1,2 such urgency and resolve appeared incongruous for legislation of an apparently routine nature. A review group (including PBAC representatives), convened by the Parliamentary Secretary for Health to review aspects of the Committee's operations, had recommended that PBAC members should come from a broader range of constituencies, and that membership tenure should be limited. To ensure the continued effectiveness of the Committee, they also recommended a transitional phase for implementing the changes. Thus, the legislative amendment appeared innocuous and the principles had been agreed to. ... advisory bodies such as the PBAC need the strong and unambiguous support of government, and a guarantee of independence. The legislation initially proposed clauses setting maximum terms of membership, and making this retrospective. This was a key issue -- it had the effect of making some members ineligible for further membership, including the chairs of the PBAC and its two subcommittees. These amendments were withdrawn after opposition in the Senate. Unexpectedly, the Government used the surviving amendment concerning membership to spill the committees. In the weeks that followed, the Government appointed a pharmaceutical industry lobbyist to the PBAC. So what is going on? Why would a government move against its own advisory committee in this way? Had the committees not been performing their legislated functions satisfactorily? No one has claimed that the committees did not perform adequately. The PBAC received a supportive review by the Australian National Audit Office, and international commentaries have been generally favourable.3-5 A recent independent review, part-funded by the pharmaceutical industry, commented positively on the general approach to the operation of the Pharmaceutical Benefits Scheme (PBS).6 A striking feature of the relationship between the present Government and the PBAC has been the Government's ambiguity. The committee chairs have been informed that the Government is concerned about the rising costs of the PBS ($3.2 billion in the 1999-2000 financial year, a 14% rise over the previous year7), but, at the same time, wishes to support the pharmaceutical industry. The roles of the PBAC are spelled out in the National Health Act 1953 (Cwlth) (amended 1987).8 The principal task of the committee is to make recommendations regarding the listing of new drugs on the PBS. The PBAC is required by law to consider both "the effectiveness and cost of therapy involving the use of the drug"; the committee can not list a pharmaceutical product that is substantially more costly than alternatives unless it provides "a significant improvement in efficacy or reduction of toxicity over the alternative therapy". The current interpretation of the Act by the Federal Court allows a role for the PBAC in considering total costs to the community, including the financial impact of "leakage" (wide prescribing for patients not covered by the listed indications).9 The Act does not provide a mechanism for companies to appeal the substance of PBAC decisions, but they may seek a judicial review of the decision (as in the case brought by Pfizer Pty Ltd when sildenafil [Viagra] was not listed).9 Importantly, the PBAC places no limits on the number of resubmissions that it will consider. The evaluation methodology developed by the committees, with the strong support of the Department of Health and Aged Care, is rigorous in its evidentiary demands, and has withstood both administrative scrutiny and legal challenge.3,9 Why has the Government sent mixed messages to the PBAC? A possible explanation is that it was under pressure from the international pharmaceutical manufacturers lobbying to have their products listed at higher prices on the PBS.10 Perhaps the PBAC is viewed as being too demanding, making recommendations that result in prices that set "undesirable" international precedents? It is difficult to get accurate information on the level of contact between the present Government and the pharmaceutical industry. However, in 1998, a Pharmaceutical Industry Working Group was formed, comprising the ministers of Health and Aged Care, and Industry, Science and Resources, and senior staff from the Australian Pharmaceutical Manufacturers' Association. This group has met regularly and been responsible for initiating reviews of PBAC activities. Worldwide, the pharmaceutical industry has enjoyed a period of unparalleled profitability and influence. It has been among the best performers in the share market. Unlike other products of technology-based industries (eg, computers), the medicinal drug market has become a "sellers' market", with some new products offering only marginal clinical benefits at much higher prices than the agents they replace. It may be difficult for the industry to sustain recent levels of growth in the face of increasingly critical purchasers around the world. Pharmaceutical benefits schemes like the one in Australia are being considered, or have been adopted, in other countries, including Canada, United Kingdom, Netherlands, Italy, Portugal, Sweden, Norway and Finland.12,13 In response, some sections of the pharmaceutical industry have aggressively defended their positions, with tactics that have been widely criticised.14-17 These have included legal challenges and threats to governments, advisory bodies and individuals in Canada, United States, United Kingdom and Australia.9,18-23 In developing countries, the relentless pursuit of intellectual property rights has denied the rights of local manufacturers to produce much-needed drugs.11,15-17,24,25 The health needs of these countries receive scant attention, as companies prefer the more secure business of developing "me too" drugs, fixed combinations of existing agents, or drugs for the "problems" of affluent societies, such as hair loss or obesity.11,14,24,25 It is significant that criticism has come, not from radical sources, but from conservative journals, such as The Wall Street Journal and the New England Journal of Medicine.11,14 These are not judgements on the morals of the individuals who work for the companies, but rather the corporate culture that develops when there is widespread market failure and weak intervention by governments.26 When faced with the lobbying powers of pharmaceutical companies with market values of hundreds of billions of dollars, advisory bodies such as the PBAC need the strong and unambiguous support of government, and a guarantee of independence. The Department of Industry, Science and Resources has a degree of responsibility to support the pharmaceutical industry, but many would consider that the Department of Health and Aged Care does not. The members of the PBAC deserve and need the Health Minister's support, even though their recommendations may sometimes be unpopular with the pharmaceutical industry. But the Government can do even more. The reasons for the PBAC's decisions (positive and negative) should be available to everyone. Information that is truly sensitive, such as manufacturing details, should be protected, but a summary of data forming the clinical and economic case for listing, or not listing, a drug (with the arguments and reasoning behind the PBAC's final recommendation) should be placed on the PBS website.27 Interested parties should be free to criticise these decisions, and the PBAC should be able to respond publicly and, if justified, to modify its recommendations. Presently, such openness is prevented by secrecy provisions in the National Health Act and has been opposed by industry. Where should the medical profession stand on these issues? The PBAC committees' roles and activities need to be better communicated to health professionals and consumers. Doctors should be well represented on the "new" PBAC through nominations from the Colleges, the Australian Medical Association and the Doctors' Reform Society. Doctors, particularly specialists, sometimes lobby the PBAC to have new drugs listed. When unsolicited and motivated by concern for patients such approaches are welcome, particularly if they contain arguments based on evidence and experience. However, some letters appear to have ghost authors; this is inappropriate, particularly if the issue is a dispute over pricing rather than interpretation of clinical data. Some doctors may perceive their responsibility to patients as consistent with a close relationship with industry, for instance through membership of "advisory panels". In reality these roles are often in conflict. In the past decade the medical profession has become enmeshed to an unprecedented extent in the affairs of the drug manufacturers. This was exemplified by the difficulty experienced recently by the New England Journal of Medicine in locating an independent editorialist to comment on a therapeutic trial.28 Perhaps the time has come for a searching review of the ethics of relationships between the medical profession and the health industry in Australia. Perhaps, if the profession develops a different view of its responsibilities to the community, we may read letters from doctors criticising the inordinate prices requested by drug companies, rather than complaining when the PBAC does not accede immediately to their demands for a drug's listing on the PBS. Considering the recent imbroglios accompanying the changes to the PBAC, the Government might wish to more fully inform the medical profession and the community on the reasons for these changes and whether it wants a fundamental change in the Committee's role. David A Henry Past Chair Economics Sub-Committee of the Pharmaceutical Benefits Advisory Committee Professor of Clinical Pharmacology, University of Newcastle, NSW Donald J Birkett Past Chair, Pharmaceutical Benefits Advisory Committee Professor of Clinical Pharmacology Flinders University of South Australia, SA Meddling with drugs [editorial]. The Sydney Morning Herald 2000; 2 Dec. Drugs scheme has its benefits [editorial]. Australian Financial Review 2000; 13 Dec. The Auditor-General Audit Report No. 12, 1997-98: Peformance Audit -- Pharmaceutical Benefits Scheme, Department of Health and Family Services. <http://www.anao.gov.au> (accessed February 2001). Cookson R. ASTEC non-EU case study on Australia. London: LSE Health, London School of Economics, 2000 <http://www.lse.ac.uk/Depts/lse_health/res_ projects/oz.pdf> (accessed February 2001) Witcher SK. In the land down under, a model for national drug insurance. The Wall Street Journal 2000; 6 Sept. M-TAG Pty Ltd. Report on the Australian System of Pharmaceutical Financing and Delivery. Vol 1: Efficiency and equity implications of public versus private funding of pharmaceuticals. Chatswood, NSW: Medical Technology Assessment Group, Nov 1999. PBS expenditure and prescriptions. <www.health.gov.au/haf/docs/ pbbexp/index.htm> (accessed February 2001). National Health Act (1953, amended 1987). <http://www.austlii.edu.au> (accessed February 2001). Pfizer Pty Ltd v Birkett. Federal Court of Australia 20 March 2000. <http://www.fedcourt.gov.au/judgments/judgmts.html> (accessed February 2001). Moynihan R. A dose of drama in debate on drugs. Australian Financial Review 2000; 8 Dec. Angell M. The Pharmaceutical Industry -- to whom is it accountable? N Engl J Med 2000; 342: 1902-1904. Mullins CD, Ogilvie S. Emerging standardization in pharmaco-economics. Clin Ther 1998; 20: 1194-1202. Yamey G. NICE to rule on influenza flu drug zanamivir. BMJ 1999; 319: 937. Harris G. Drug firms, stymied in the lab, become marketing machines. The Wall Street Journal 2000; 6 July. le CarrŽ J. The biggest pushers of all. The Spectator (London) 2000; 16 Dec. Schoofs M. Glaxo attempts to block access to generic AIDS drugs in Ghana. The Wall Street Journal 2000; 1 Dec. Gellman G. A turning point that left millions behind. Washington Post 2000; 28 Dec. Korcok M. Cheap prescription drugs creating new brand of US tourist in Canada, Mexico. CMAJ 2000; 162: 1869-1870. Silverman E. Drug makers on attack in Maine. The Star Ledger (New Jersey) 2000; 24 Sep. Shuchman M. Drug company threatens legal action over Canadian guidelines. BMJ 1999; 319: 1388. Nathan DG, Weatherall DJ. Academia and industry: lessons from the unfortunate events in Toronto. Lancet 1999; 353: 771-772. Rennie D. Thyroid storm. JAMA 1997; 277: 1238-1243. Dyer C. Viagra guidance declared unlawful. BMJ 1999; 318: 1509. McNeil DG. Drug companies and the Third World: a case study in neglect. The New York Times; 2000: 21 May. Silverstein K. Millions for Viagra. Pennies for the poor. The Toronto Star 1999; 13 Aug. Mansfield P. Sickening sales pitch of the drug marketers. The Sydney Morning Herald 2000; 3 July. Department of Health and Aged Care. Pharmaceutical Benefits Branch. <http://www.health.gov.au/haf/docs/pbacrec.htm> (accessed February 2001). Angell M. Is academic medicine for sale? N Engl J Med 2000; 342: 1516-1518.

David A Henry · Donald J Birkett

Abstract - Methods - Results - Discussion - Acknowledgement - References - Authors' details - - More articles on Administration and health services Abstract Objective: To quantify the morbidity and mortality associated with acute interhospital transfer of critically ill patients requiring intensive care (ICU) services. Design: Three-year (1 July 1996 - 30 June 1999) retrospective case-control study based on review of patients' medical records. Setting: Metropolitan hospitals in Melbourne, Victoria. Participants: 73 (of 75) consecutive, critically ill patients from one metropolitan teaching hospital who were transferred to other hospitals because ICU services were not available. Outcome measures: Primary endpoints included inhospital mortality and length of stay in ICU and hospital. Secondary endpoints included time from study entry to ICU admission and the change in predicted mortality risk after resuscitation and transfer to ICU (inter- or intrahospital transfer). Results: The Transfer Group experienced a significant delay in admission to ICU (5.0 [4.0-6.0] v 3.0 [2.0-5.5] hours; P = 0.001), and a longer stay in ICU (48 [33-111] v 44 [25-78] hours; P = 0.04), and hospital (10 [3-14] v 6 [3-13] days; P = 0.02). Hospital mortality in the Transfer Group (24.7%) was not statistically different from that in the Control Group (17.8%; P = 0.41; OR, 1.5; 95% CI, 0.68-3.4). Conclusion: Acute interhospital transfer is associated with a delay in ICU admission and a longer stay in ICU and hospital, but no statistically significant difference in mortality. A study of over 300 patient transfers would be required to clarify the morbidity and mortality risk of acute interhospital transfer. Acute interhospital transfer of critically ill patients carries potential risks, including complications during transfer and delay in providing definitive care. There are two categories of acute interhospital transfer. Category A: The primary (sending) hospital is unable to provide the expertise, diagnostic services or therapeutic procedures required by a patient (eg, transfer of a patient with extensive burns to a hospital with specialised treatment facilities for burns); and Category B: The primary hospital is temporarily unable to provide intensive care unit (ICU) services for a patient because of resource limitations (eg, lack of ICU beds). Measuring the impact of transfer risk on patient outcomes is complex. Reports without control data suggest that acute interhospital transfer increases both morbidity1,2 and mortality,3 but there are many confounding variables that influence outcome (eg, severity of illness, extent of resuscitation, and the expertise available before and during transfer). To our knowledge, no comparative outcome study of critically ill patients undergoing acute interhospital transfer has been published. A randomised trial of Category A transfer would be complicated by the difficulty of finding a clinically and ethically appropriate control group. An alternative is to compare outcomes of patients undergoing Category B transfer with outcomes of matched patients not transferred. Both these groups of patients are resuscitated and managed with similar expertise and support. It is therefore possible to reduce bias from some of the confounding variables, and to identify a suitable control group. We performed a retrospective case-control comparison of outcomes in critically ill adult patients undergoing Category B transfer. We hypothesised that acute interhospital transfer increases morbidity and mortality and sought to answer four questions: Does acute interhospital transfer of critically ill patients delay admission to an ICU; increase severity of illness before admission; increase ICU and hospital length of stay; and increase mortality? Methods The primary hospital was the Northern Hospital, a Melbourne metropolitan teaching hospital providing all acute-care health services (except cardiac surgery and organ transplantation).* Transfer Group All adult patients requiring intensive care services between 1 July 1996 and 30 June 1999 were entered in the study if they were deemed by the intensivist on-duty to require intensive care services; were transferred to a (public or private) metropolitan hospital for those services; and received diagnostic and therapeutic interventions that could otherwise have been provided at the primary hospital. All patients were transferred by road ambulance with an experienced medical escort from the primary hospital. Patients were excluded if they were transferred with the intention of receiving services not available at the primary hospital (Category A transfer), or if insufficient data were available. Control Group Control patients were selected from patients admitted to the ICU of the primary hospital, who did not undergo acute interhospital transfer at any time during the study period. Matching of Control Group patients with patients in the Transfer Group was undertaken according to a hierarchy of criteria deemed most likely to influence patient outcome (Box 1). Due to difficulties matching for all criteria, priority was placed on the first four. Matching was undertaken by one author (J V G), who was blinded to the identity and outcome of the patients. Endpoints These included inhospital mortality, time from study entry to ICU admission, length of stay in ICU and hospital, and the change in predicted mortality risk after resuscitation and transfer to ICU (Box 2). Patient data (Box 2) Patients' data recorded prospectively in the medical records at all the hospitals involved were reviewed retrospecively by one investigator (G J D). Physiological and laboratory data were used to calculate predicted mortality risk (pm) at three time points (t1, t2 and t3; Box 2), as an index of illness severity, using the Acute Physiology and Chronic Health Evaluation (APACHE) II method.4 Length of stay and pm were chosen as surrogate markers of patient morbidity. Because of the broad range of pm within the Transfer Group (0.01-0.86), we also undertook a post-hoc analysis of the change in pm (Δpm) during each interval as a measure of the change in physiological status. Since pm is an indicator of illness severity, and since calculations were performed before and after resuscitation and transfer, the physiological impact of resuscitation ([pm at t2] - [pm at t1]) and of transfer ([pm at t3] - [pm at t2]) was quantified. Statistical analysis Graph-Pad PRISM statistical package was used for data analysis.5 We used Fisher's exact test to compare group mortality. Non-parametric tests were used to compare length of stay in ICU and in hospital, and for intergroup comparison of pm and Δm (Mann-Whitney; P < 0.05). Wilcoxon signed rank test was used for post-hoc intragroup comparisons of Δm (P < 0.01). Data are presented as median (interquartile range) unless otherwise indicated. Based on studies without control data,3,6 which showed a doubling of mortality after acute interhospital transfer and a Control Group mortality of 18%, we calculated that a sample size of at least 50 patients would be required (α = 0.05, β = 0.80.) Ethical approval Ethics committee approval was obtained from each of the 14 hospitals involved. Results During the 36 months, 1470 patients required intensive care services at the primary hospital. Of these, 1338 (91%) were admitted and were the source of the Control Group patients. Of the 132 (9%) patients not admitted to the primary hospital ICU, 75 consecutive patients (5.1%) underwent a Category B transfer (Transfer Group), 35 (2.4%) were managed elsewhere within the same hospital (eg, general ward) and 22 (1.5%) were transferred for services not available at the primary hospital (Category A transfers). The last two groups were excluded from the study. Two eligible patients in the Transfer Group were excluded because insufficient data were available from the receiving hospitals, leaving 73 patients. The destinations of the transferred patients were determined by the proximity of the other hospitals and the bed availability. Sixty-four patients were transferred to nine public hospitals, and 11 patients were transferred to five private hospitals (eight of these patients had no private health insurance, but no public hospital ICU bed was available within the metropolitan region at that time). The reasons for transfer were closure of beds in 61 patients (84%), and equipment problems, all beds occupied and patient request in six, five and one patient, respectively. Demographic and other data for the Transfer and Control group patients, as well as the accuracy of case-control matching, are summarised in Box 3, and the diagnostic categories of the patients are shown in Box 4. Both groups had a high mortality risk at the time of study entry (commencement of resuscitation -- pm at t1) and immediately before transfer (pm at t2) (Box 5). Post-hoc analysis of Δpm revealed a significantly greater fall in pm during resuscitation and during transfer to ICU in the Control Group patients (P < 0.01). Thirty-seven patients (51%) undergoing acute interhospital transfer experienced a rise in pm (t3), compared with only 20 (27%) of the control group (P = 0.006). No deaths occurred during transfer. The higher observed mortality in the Transfer Group (Box 4) was not statistically different from that in the Control Group (odds ratio [OR], 1.5; 95% CI, 0.68-3.4). The diagnostic group (Box 4) and severity of illness (pm) were the most important univariate factors associated with outcome. Acute interhospital transfer was associated with a significant delay in ICU admission (Box 5), although some of the control patients also experienced admission delays (range, 0.5-9.5 hours). The Transfer Group was also found to have a significantly prolonged length of stay in ICU and hospital when compared with the Control Group. These length-of-stay increases were independent of outcome, diagnosis, age and hospital destination. Discussion We found that critically ill patients undergoing acute interhospital transfer experience a delay in admission to ICU, and a longer length of stay in ICU and hospital. However, there was no significant difference in hospital mortality between the two groups, and there were no deaths during transfer. As indicated by their primary diagnoses, need for life-support and high mortality risk, all patients in our study were critically ill at the time of study entry. The apparent safety of acute interhospital transfer is likely to be the combined result of factors such as resuscitation and stabilisation before transfer; the use of staffed and equipped ambulance vehicles; the provision of intensive care medical expertise and monitoring before, during and after transfer; and triage to appropriate hospitals.7 Why did the Transfer Group have an increased length of stay? The rise in pm after acute interhospital transfer in 37 patients (51%) suggests that it may increase morbidity in some patients. Other researchers have also reported adverse physiological effects during transfer of critically ill patients,1,2 and a higher mortality in patients admitted after interhospital transfer.3,6 Delay in ICU admission inevitably delays diagnostic and therapeutic procedures. The increased sedation and analgesia to ensure patient safety and comfort during interhospital transfer may prolong recovery time. The slower rate of fall of pm in the Transfer Group is consistent with this premise. Patient management and discharge practices may vary between institutions and thus increase length of stay independent of diagnosis and patient origin. Our study has several important limitations. Retrospective chart analysis carries potential for observer bias and systematic error. We attempted to minimise this by sampling data at predetermined fixed time points and using the same data collector. Patient selection was unavoidably biased because the Transfer Group constituted a heterogeneous and non-randomised group of critically ill patients. Because of the small number of subjects in some diagnostic categories, the matching of Control Group patients with patients in the Transfer Group was not perfect, but we attempted to optimise matching by using a criteria hierarchy. The Control Group patients had a greater median pm at study entry, and some experienced a clinically significant delay in ICU admission, both factors which may have reduced the outcome difference between the groups. Although the APACHE-II scoring system4 has been used in the prehospital setting,3,8 it assumes patients are in an intensive care environment receiving optimal therapy, and therefore it may not be a valid tool for use outside an ICU. However, this potential systematic error applied equally to both groups. The study size had insufficient power to establish a difference in mortality. If the observed difference in outcome is clinically significant it would require a sample size of over 300 transfers to exclude a type II statistical error. A trial of sufficient power could be achieved with a 12-month multicentre study of all Category B transfers within metropolitan Melbourne. During 1998-1999, 369 critically ill adults (3.5% of metropolitan adult intensive care admissions) underwent a Category B transfer (Department of Human Services, Critical Care Inter-Hospital Transfer Monitoring and Advisory Group, personal communication). At best, our results indicate that acute interhospital transfer does not affect hospital outcome; at worst, they suggest that it may adversely affect the outcome of one in every 25 critically ill patients transferred. Extrapolating our results to the metropolitan region, acute interhospital transfer may adversely affect the outcome of 15 patients (95% CI, 0-48) per annum, and require an additional 1100 hospital bed-days (95% CI, 960-1266 days) per annum -- half in ICU, where the primary resource limitation exists.9,10 Acknowledgement We would like to thank Professor B Jackson and Dr P Cranswick for their constructive criticism of the manuscript. References Waddell G, Scott PDR, Lees NW, Ledingham IM. Effects of ambulance transport in critically ill patients. BMJ 1975; 1: 386-389. Karipis H, Scheinkestel CD, Tuxen DV, et al. Safety of transportation of critically ill patients. Anaesth Intensive Care 1993; 21: A7111. Bristow P, Brown D, Lee A, Buist M. Transfer of severely ill patients. Anaesth Intensive Care 1995; 23: A399. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med 1985; 13: 818-829. GraphPad PRISM, version 1. San Diego: GraphPad Software Inc, 1998. Metcalf A, McPherson K. Study of provision of intensive care in England, 1993. London: School of Hygiene and Tropical Medicine, 1995. Faculty of Intensive Care, Australian and New Zealand College of Anaesthetists and Australasian College of Emergency Medicine. Minimum standards for transport of the critically ill (IC-10). Melbourne: Australian and New Zealand College of Anaesthetists and Australasian College of Emergency Medicine, 1996. Bion JF, Edlin SA, Ramsay G, et al. Validation of a prognostic score in critically ill patients undergoing transport. BMJ 1985; 291: 432-434. Acute Health Services Branch, Department of Health and Community Services Review of emergency and critical care services in Victoria. Melbourne: Department of Health and Community Services, 1994. Acute Health Division, Department of Human Services. Review of intensive care in Victoria [Phase 1 report]. Melbourne: Department of Human Services, 1997. (Received 3 Apr, accepted 15 Sep, 2000) Authors' details Intensive Care Department, The Northern Hospital, Melbourne, VIC. Graeme J Duke, MB BS, FFICANZCA, Director; John V Green, MB BS, FFICANZCA, Staff Specialist. Reprints will not be available from the authors. Correspondence: Dr G J Duke, Intensive Care Department, The Northern Hospital, 185 Cooper Street, Epping, VIC 3076. graeme.dukeATnh.org.au 1: Criteria for matching Control Group patients with Transfer Group patients Discharge diagnosis (APACHE-III diagnostic code) Need for mechanical ventilation on admission to Intensive Care Unit Glasgow coma score (GCS) at t1 - within 2 points Predicted mortality (pm; APACHE-II methodology4) at t1 - within 10% Age - within 10 years Sex Source of initial referral (emergency ward, inpatient ward, operating theatre) Date of admission - within 12 months Time (t1): day (8:00 to 18:00) or night APACHE=Acute Physiology and Chronic Health Evaluation. Time, t1=study entry at commencement of resuscitation. Back to text 2: Patient dataset Demographic information, including age, sex, and postcode of residence Relevant medical data, including past history and final diagnosis Dates and times of primary admission, initial referral, interhospital transfer, ICU discharge and hospital discharge Referral source Treatment and personnel required during transfer Interventions required (at both hospitals) Data for APACHE II predicted mortality (pm) score4* Physiological data: blood pressure, heart rate, respiratory rate, Glasgow coma score, urine output Pathological data: haematocrit and total white cell count; serum levels of sodium, potassium, creatinine, urea, albumin, and glucose; and arterial pH and blood gas analysis Clinical data: age, diagnosis, use of mechanical ventilation, presence of acute renal failure, chronic health status Time of APACHE II predicted mortality (pm) calculations (see time line) t1= study entry at commencement of resuscitation. t2= before transfer to ICU, after initial resuscitation. t3= on arrival in ICU after transfer. APACHE=Acute Physiology and Chronic Health Evaluation. *Formula for pm score: logn(pm/12pm)=-3.517+0.146 (k1+k2+k3)+k4+k5, where k1=a variable score based on physiological and pathological data; k2=a variable weighting for age; k3=a variable weighting for chronic health status; k4=a constant weighting for emergency surgical patients; and k5=a variable weighting for principal diagnostic category. Back to text 3: Comparison of patient data (Transfer Group v Control Group - data are median and interquartile range unless indicated otherwise) and percentage matching between the two groups Criterion Transfer Group Control Group Percentage matching* Diagnostic group (see Box 4) (see Box 4) 100% Need for mechanical ventilation (no [%] of patients) 51 (73%) 51 (73%) 100% Predicted mortality at start of resuscitation (pm at t1) 0.30 (0.09-0.62) 0.37 (0.09-0.60) 69% GCS: patients with neurological problems (n=39) 7 (6-9) 7 (6-8) 100% GCS: all patients (n=73) 9 (6-14) 8 (6-12) 96% Age (years) 54.8 (36.4-67.2) 57.4 (38.0-70.4) 67% Source of referral (no [%] of patients) 61 (83%) from ED 59 (81%) from ED 79% Sex ratio (no. of men:women) 39:34 46:27 78% Date of admission (baseline) 3 (1-15) months 75% Time (t1) (8:00-18:00) (no. [%] of patients) 28 (38%) 36 (49%) 60% *Percentage of Control Group patients matched according to criteria given in Box 1. GCS=Glasgow Coma Score. ED=emergency department. Back to text 4: Diagnostic categories and inhospital mortality Deaths Discharge diagnosis No. (%) patients Transfer Group Control Group Trauma Drug overdose Cardiac arrest Cardiogenic shock Exacerbation of COPD Status asthmaticus Pneumonia Cerebrovascular coma Metabolic coma Neurological conditions Gastrointestinal conditions Septicaemia Malignancy Aortic aneurysm Total 12 (16%) 11 (15%) 8 (11%) 7 (10%) 5 (7%) 3 (4%) 4 (5%) 4 (5%) 4 (5%) 4 (5%) 4 (5%) 4 (5%) 2 (3%) 1 (1%) 73 (100%) 0 0 6 0 0 0 2 2 1 1 2 3 1 0 18 (24.7%) 0 0 5 1 0 0 1 1 2 1 1 1 0 0 13 (17.8%) 95% CI 11-25 7-20 COPD=Chronic obstructive pulmonary disease. Back to text 5: Acute Physiology and Chronic Health Evaluation (APACHE) II predicted risk of death (pm; median and interquartile range) and outcomes Transfer Group Control Group P* APACHE II risk of death pm at t1 (at study entry) 0.30 (0.09-0.62) 0.37 (0.09-0.60) 0.87 pm at t2 (before transfer) 0.24 (0.06-0.40) 0.25 (0.06-0.47) 0.69 pm at t3 (at ICU entry) 0.21 (0.06-0.46) 0.16 (0.04-0.46) 0.63 Outcomes Admission delay (t3 - t1; hours) 5.0 (4.0-6.0) 3.0 (2.0-5.5) 0.001 Length of stay ICU (hours) 48 (33-111) 44 (25-78) 0.04 Hospital (days) 10 (3-14) 6 (3-13) 0.02 Mortality (no. of patients) 18 (95% CI, 11-25) 13 (95% CI, 7-20) 0.41 ICU=Intensive Care Unit. * Mann-Whitney test. Back to text

Graeme J Duke · John V Green

Viewpoint Economic sanctions and public health: the case of Iraq Susan J Wareham We have a duty to speak out MJA 2000; 173: 438-439 Economic sanctions have often been thought of as a humane alternative to war, a way of bringing undesirable governments into line without the loss of innocent lives. The situation in Iraq, however, demonstrates that comprehensive economic sanctions can, in effect, be a weapon of mass destruction, with devastating consequences for public health. Sanctions were imposed against Iraq in August 1990 after Iraq invaded Kuwait, and they were reimposed to force Iraq's disarmament after the 1991 Gulf War. All goods entering Iraq require authority from the United Nations Security Council Sanctions Committee, and Iraq's exports of oil are severely limited. (While the Security Council has now removed the ceiling on Iraq's oil exports, the oil industry is severely damaged and lacking essential supplies.) The effects of the sanctions on the health of the people of Iraq, particularly the children, have been documented repeatedly by the UN's humanitarian agencies and other bodies, and ignored repeatedly by policymakers. In July 1993, the Food and Agriculture Organization and the World Food Programme reported that the sanctions had ". . . generated persistent deprivation, chronic hunger, endemic undernutrition, massive unemployment and widespread human suffering" and that ". . . a grave humanitarian tragedy is unfolding".1 A World Health Organization study released in March 1996 stated that health conditions were deteriorating at an alarming rate, and that malnutrition among young children was widespread.2 In 1999, UNICEF conducted a child and maternity mortality survey of nearly 40 000 households throughout Iraq. The child mortality results indicated a major increase in mortality rates in the preceding decade, both in infants and in children under five years.3 This should be seen in the context of the steady reductions in child mortality before the imposition of sanctions, from an under-five mortality rate of 127 per 1000 livebirths in 1970, to 83 in 1980 and to 50 in 1990. The rates then rose to 117 per 1000 livebirths in 1995 and to 125 in 1998. On the basis of these results, Executive Director Carol Bellamy reported UNICEF's conclusion: if the substantial reduction in child mortality throughout Iraq during the 1980s had continued through the 1990s, there would have been half a million fewer deaths of children under five.4 In April 1999, I took part in an international delegation to Iraq, with representatives of the United States, Canada, the United Kingdom, Palestine and Australia, sponsored by International Physicians for the Prevention of Nuclear War. The purposes were to observe conditions, to deliver medical and pharmaceutical supplies, and to make contact with professional colleagues who have been internationally isolated. In the hospitals we visited, most of the basic drugs and medical and surgical supplies, including antibiotics and intravenous fluids, were in short supply or unavailable. At Saddam Paediatric Hospital, in Baghdad, clinicians we spoke to said that cholera, gastroenteritis, tuberculosis, measles, pertussis, rubella, poliomyelitis and other infectious illnesses have become more common since the imposition of sanctions. Vaccination programs have suffered from a lack of refrigerated transport. A nauseating stench from blocked and broken sewerage pipes pervaded many hospital wards. With adequate plumbing supplies and chlorine and other chemicals for water purification either blocked by the sanctions5 or unaffordable, it is very difficult to control faecal-oral spread of infections. Colleagues we met at Baghdad University College of Medicine also spoke of the major effect that the lack of textbooks, and even paper for photocopying, had had on medical education. For the medical profession in Iraq, such shortages and Third World conditions are a new phenomenon. Before the sanctions, Iraq, with its vast oil wealth, had an abundance of medical supplies and one of the best healthcare systems in the region. Malnutrition was not a major public health problem in Iraq before 1990.6 The Harvard Study Team that visited Iraq in April and May 1991 reported that many of the young physicians they spoke to had never seen a case of marasmus before the 1991 Gulf Crisis, and even the older physicians had not seen many.7 We heard several reports from doctors that the incidence of childhood leukaemia and of major congenital abnormalities has risen sharply, especially in southern Iraq near the 1991 war zone. Some suspected that depleted uranium weapons used in that war may be a contributing factor. (Depleted uranium, a by-product of the uranium enrichment process, was used in armour-piercing shells both in the 1991 Gulf War and against Serbia in 1999.) UN cancer statistics for southern Iraq between 1989 and 1994 have shown a sevenfold increase in cancer rates.8 Professor Doug Rokke, a health physicist at Jacksonville State University, Alabama, who was responsible for the clean-up of US depleted uranium equipment in Iraq, argues strongly that its use should be banned.9 Research on this subject is urgently needed. Most of the Iraqi children with leukaemia die. According to Professor Karol Sikora, Professor of International Cancer Medicine, Imperial College School of Medicine, London, radiotherapy equipment, chemotherapy drugs and analgesics for Iraq are consistently blocked by the United States and Britain.10 Morphine is generally unavailable, and even aspirin is severely rationed. Denis Halliday was the UN Humanitarian Coordinator in Iraq until his resignation in 1998 in protest at the effects of the sanctions. (His successor, Hans Von Sponeck, resigned in February this year for precisely the same reason.) Halliday was in Australia in April this year, at the invitation of the Medical Association for Prevention of War, for discussions with the Australian government, which still supports the sanctions policy. He says that the sanctions are a form of genocide, that they have done nothing but target civilians, and that they strengthen Saddam Hussein. The elimination of Iraq's weapons of mass destruction is an essential step towards peace in the Middle East. However, while such weapons remain elsewhere in the region, and the ongoing suffering, degradation, humiliation and resentment of the Iraqis is ignored, peace prospects remain grim. For our profession, the defence and promotion of public health is one of the greatest contributions we can offer humanity. Policies which deprive whole populations of food, clean water and basic healthcare are anathema to public health principles and must be condemned outright. For all those who suffer the effects of this deprivation -- those who die needlessly and their relatives and our professional colleagues who must watch them die -- we have a duty to speak out. References Food and Agriculture Organization of the United Nations. Special Alert No. 237 -- FAO/WFP Crop and Food Supply Assessment Mission to Iraq. Rome: FAO/WFP, July 1993. World Health Organization. Health conditions in Iraq "serious", WHO study finds. Press release WHO/23. Geneva: WHO, 25 March 1996. UNICEF/Ministry of Health. Child and Maternal Mortality Survey 1999: Preliminary report. Iraq: UNICEF, July 1999. UNICEF. Iraq surveys show "humanitarian emergency". Press release. UNICEF, 12 August, 1999. Office of the Humanitarian Co-ordinator, Baghdad. The Secretary-General's 90-Day Report to the UN Security Council, 15 March 1999. Situation analysis of children and women in Iraq. UNICEF Report. 30 April 1998. The Harvard Study Team. The effect of the Gulf crisis on the children of Iraq. Special report. N Engl J Med 1991; 325: 977-980. Ciment J. Iraq blames Gulf war bombing for increase in child cancers. BMJ 1998; 317: 1612. Rokke D. Depleted uranium and its effects in Iraq. Proceedings of the conference hosted by the Campaign Against Sanctions on Iraq. Cambridge, UK, 13-14 November 1999. Cambridge, UK: Campaign Against Sanctions on Iraq, 2000. (Distributed by Barque Press.) Sikora K. Cancer services are suffering in Iraq [personal view]. BMJ 1999; 318: 203. Authors' details Medical Association for Prevention of War (Australia), Canberra, ACT. Susan J Wareham, MB BS, President. Reprints will not be available from the author. Correspondence: Dr S J Wareham, 3 Katz Place, Spence, ACT 2615. warehamsATozemail.com.au Make a comment

Susan J Wareham

For Debate Should we conduct a trial of distributing naloxone to heroin users for peer administration to prevent fatal overdose? Simon R Lenton and Kim M Hargreaves MJA 2000; 173: 260-263 Abstract - Should there be a trial - Suggested trial design - Conclusion - References - Authors' details - - More articles on Drugs and alcohol Abstract Heroin overdose is a major cause of death among heroin users, and often occurs in the company of other users. However, sudden death after injection is rare, giving ample opportunity for intervention. Naloxone hydrochloride, an injectable opioid antagonist which reverses the respiratory depression, sedation and hypotension associated with opioids, has long been used to treat opioid overdose. Experts have suggested that, as part of a comprehensive overdose prevention strategy, naloxone should be provided to heroin users for peer administration after an overdose. A trial could be conducted to determine whether this intervention improves the management of overdose or results in a net increase in harm (by undermining existing prevention strategies, precipitating naloxone-related complications, or resulting in riskier heroin use). The rate of fatal heroin overdose in Australia has risen from 10.7 per million in 1979 to 67.0 per million in 1995; similar increases have been reported in other developed countries.1 Heroin users have an excess mortality about 13 times that of their age-matched peers,2 with annual mortality rates of between 1% and 3%.3 Although non-fatal overdoses are common among heroin users, overdose remains a major cause of death among this group,4 even in countries with high rates of HIV among injecting drug users.5 The central nervous system (CNS) depressants benzodiazepines and/or alcohol are often also present in the blood of people who died of heroin-related overdose.3,6In many fatal heroin overdoses there is ample opportunity for intervention: approximately 60% of deaths occur in the company of others,3,4,6-8 mostly other users, and sudden death after injecting is rare (about 15% of deaths).6,9 Death occurs more than three hours after injection in 22%-52% of cases.3 Furthermore, most overdoses occur in a home or other dwelling.9 Witnesses to fatal overdoses only call an ambulance in about 10% of cases,6 and there is no intervention before death in 79% of cases.3 Reasons for not calling an ambulance include fear of police involvement,8,10 ambulance costs,7 and previous negative experiences with hospital staff.10 Since the early 1990s, experts have suggested that naloxone hydrochloride, an opioid antagonist (Box), which has long been used to treat opioid overdose, should be provided to heroin users for administration by their peers in an overdose situation.8,24,38-40 This is one of a range of interventions aimed at reducing the incidence of fatal overdose, including: overdose prevention (eg, educating heroin users about risk factors for overdose and ways of reducing the risks, and increasing numbers in methadone maintenance treatment); and overdose management (eg, providing basic first aid training to heroin users, with emphasis on the need to call an ambulance).41 Naloxone has been available over-the-counter from pharmacies in Italy since 1995 and therefore available for peer administration. There are unpublished reports of authorised distribution for peer administration in Jersey (UK) and Berlin (Germany), and underground distribution through needle exchanges in San Francisco and Chicago, USA. However, to our knowledge, its use by heroin users and their peers has not yet been evaluated. In July 1998, the Health Department of Western Australia (HDWA) commissioned the National Drug Research Institute to explore the feasibility of conducting a trial of naloxone provision for peer administration. We discuss the issues to be considered in deciding whether or not a trial should proceed. The views expressed here are ours and not necessarily those of the HDWA. Should there be a trial of naloxone for peer administration? Distribution of naloxone for peer administration is clearly an intervention with potential to reduce the number of fatal heroin overdoses. However, from a public health perspective, questions remain regarding the impact of naloxone on the uptake and effectiveness of other overdose prevention strategies. Additionally, there is a risk of subsequent morbidity or mortality if no medical follow-up occurs after naloxone administration. These concerns can best be addressed by a multisite longitudinal study of naloxone provision within a carefully monitored group. Below, we summarise the issues to be considered in recommending such a trial. Method of administration The preferred route for peer administration would be intramuscular (see Box). Shelf life and stability Naloxone has a shelf life of 18 months to 2 years, depending on the product form and preparation. Because of this short shelf life, a trial would attempt to determine whether drug users replace expired stock. Furthermore, there are concerns about naloxone's stability and susceptibility to environmental factors. If it is made available for peer administration, it is likely to be left in the glove box of cars or carried in pockets or bags for extended periods of time. Although it is preferable that naloxone be stored in accordance with the manufacturers' recommendations, one manufacturer reports it has been stored at 40ºC for six months, and frozen for up to a month, without compromising its chemical stability (Brenda Fox, Medical Affairs Pharmacist, Fauldings Ltd, 1998, personal communication). Half-life and recurrent overdose Another major concern about the wider availability of naloxone relates to its short duration of effect: its elimination half-life is estimated to be 30-90 minutes, with individual differences due to variations in metabolism.12 Although evidence to date suggests that recurrent overdose is rare,18,23,42 there is the potential for resedation to occur, particularly when longer-acting opioids such as methadone have been used, or additional drugs have been consumed after naloxone administration. Thus, it will often be necessary to administer subsequent doses of naloxone. Research in Victoria suggests that, when ambulance staff administer an intramuscular dose of up to 1.6 mg total dose, few, if any, problems arise, with 90% of patients regaining consciousness (Dr Paul Dietze, Senior Research Fellow, Turning Point Drug and Alcohol Centre Inc, 1999, personal communication). As part of a trial, it may be appropriate to supply two 0.8 mg/2 mL prefilled syringes of naloxone for intramuscular administration (to allow a subsequent dose if necessary), accompanied by appropriate instructions on administration, polydrug intoxication, and the need for medical review. Airway management and first aid In many overdose situations all that is necessary to improve an individual's condition is to provide ventilatory support.27 Even after naloxone is administered, ventilatory support is required until it takes effect. The ability to administer first aid, in particular expired air resuscitation, should therefore be viewed as an integral part of any education provided for peer-administered naloxone. Information about possible complications and how to identify them should also be included. Polydrug use The use of other CNS depressants, particularly alcohol and benzodiazepines, is common in overdoses involving heroin,3,6,8,43,44 but should not preclude a trial of naloxone. Removal of the opioid effect with naloxone could prevent a fatality,40 minimise associated morbidity, and provide time in which to use other interventions. If CNS stimulants are used in conjunction with opioids, naloxone has the potential to unmask their associated toxicity and produce aggression, hypertension, acute pulmonary oedema, cardiac arrhythmia, or seizures.45,46 This may be more of a concern where cocaine use, particularly "speedballs" (heroin mixed with cocaine), is increasingly common among heroin users.47 Overdose prevention strategies should continue to warn users about polydrug use. Solitary heroin users Using heroin alone is a significant risk factor for overdose, as is using heroin in the company of others and then being left to "sleep it off". One of the arguments against the distribution of naloxone for peer administration is that it will have no impact on the death rate among solitary injecting drug users. The dangers of using drugs alone or failing to monitor sleeping drug users should be emphasised in a trial of naloxone. Naloxone administration by intoxicated peers Concern has been expressed that peers available to administer naloxone may be intoxicated, but this is also likely with other overdose management strategies. Some current strategies are quite complex and require vigilance, such as expired air resuscitation, monitoring, checking the pulse, and so on. Naloxone administration, particularly with a prefilled syringe, seems no more complicated, and its use should not be precluded because the person administering it may be affected by drugs. Undermining other overdose strategies Availability of naloxone for peer administration may undermine existing overdose prevention and management strategies, notably calling an ambulance. Research supports this, with many heroin users believing that peer administration of naloxone would negate the need to call an ambulance.8,40,48 Thus, some non-fatal overdose victims may not be transported to hospital.48 This is similar to what occurs in many Australian States after naloxone administration -- overdose patients refuse to be transported to hospital or, alternatively, leave hospital against medical advice. In these situations, wherever possible, the individual is placed in the care of a "responsible person", and in several States ambulance staff provide a pamphlet which outlines potential risks and gives basic first aid information. A similar intervention should be included in any trial of naloxone provision, with users encouraged to seek medical review after peer-administration of naloxone. Impact on heroin use among current users It has been suggested that some heroin users, if they believe that their peers can revive them with naloxone, might take more risks with their use of heroin.38 It is unlikely that this behaviour would become widespread, not least because of the unpleasant effect of naloxone in precipitating withdrawal in opioid-dependent people.8,24,39 According to heroin users, factors other than the likelihood of overdose or strategies available to prevent it influence drug use.48 Removing barriers to first use Naloxone provision could make heroin use appear safer and therefore encourage its uptake by novices. However, similar concerns were raised about the wider availability of needles and syringes, and there is no evidence that these measures have encouraged injecting among those previously not using needles.49 Rapid detoxification There is anecdotal evidence to suggest that some people take opioid antagonists to lower their tolerance and reduce the amount of heroin needed to achieve their desired level of intoxication. This has the potential to increase the individual's risk of overdose. Naltrexone, an oral opioid antagonist, is now more readily available for the treatment of opioid dependence and therefore people are more likely to use this treatment to lower their opioid tolerance than naloxone. However, the extent to which naloxone is used to reduce dependence should be assessed as part of a trial. Suggested trial design As peer administration of naloxone would take place within drug-using networks, a network sampling strategy is appropriate. This would recruit heroin users (and their peers) who have experienced and/or witnessed multiple overdose events. The trial could compare "first aid plus naloxone access and training" with "first aid only" across three Australian States over a 12-month period. An initial intake of 450 heroin users should produce a final sample of 250 individuals at 12 months, and about 180 overdose events for investigation.48 Power calculations for logistic regression analyses on a final sample of 250 would produce a power of 97% for events with a probability of 0.2, and 88% for events with a probability of 0.1, with an odds ratio of 2.0 with variables correlated at 0.4. Contamination between the intervention and control groups is a potential problem. In States with large populations of users in regional centres, geographical distance could be used to counteract this. It may also be possible to have a larger control group and place control respondents who gain access to naloxone into a third group. This would maintain the integrity of the control group, while allowing some analysis of the diffusion of the "naloxone training and access" intervention into other groups. Economic cost We estimate the cost of running a trial at three sites to be about $300 000, of which the cost of naloxone would be about $25 000 (1250 doses) at full retail price. Trial results could contribute to an economic modelling of the potential cost effectiveness of naloxone distribution. Dietze et al50 have estimated the cost of ambulance attendance for heroin overdoses in Victoria at over $1 million per annum, which they regard as cost effective in terms of preventing serious injury and death. If naloxone is recommended for more widespread distribution in the future, research suggests that many heroin users (75%) would be willing to pay for their own naloxone,51 which would further reduce the cost of the intervention. Legal issues A number of legal issues are raised by the possibility of conducting a trial of peer-administered naloxone. Central to this is the mechanism of providing naloxone to trial participants. If provided on prescription under Schedule 4, both the patient and the prescriber would be legally compromised when, as is likely, a third person administers the drug. Trial participants could be issued with a permit to access the drug, but this would compromise confidentiality. The drug could be rescheduled from Schedule 4 to Schedule 3 (dispensed by pharmacists only and stored out of public access) for the purposes of the trial, although the requirement for supervised dispensing could not be guaranteed given that the drug is likely to be passed to a third person. The drug could be removed from scheduling for persons involved in a possible future trial under an agreement between the research consortium and the relevant statutory body. While, to our knowledge, this has not been done before, it would enable the identity of trial participants to remain confidential. This would simplify the issue of naloxone provision and/or administration by a third person, and may also limit the exposure of participating agencies to civil action. Conclusion Faced with increasing heroin overdose deaths, the provision of naloxone to heroin users for peer administration is one of a range of interventions worth trialling. However, questions remain as to whether it can appropriately be used by peers as part of a comprehensive first aid intervention, and whether it improves outcomes, or results in net increases in harm. Net harm could increase as a result of undermining existing strategies, naloxone-related complications, or riskier heroin use. Many of these questions could be answered by a multisite longitudinal study of naloxone provision within a carefully monitored group. References Darke S, Ross J. Fatal heroin overdoses resulting from non-injecting routes of administration, NSW, Australia, 1992-1996. Addiction 2000; 95: 569-573. English DR, Holman CDJ, Milne E, et al. The quantification of drug caused morbidity and mortality in Australia. 1995 edition. Canberra: Commonwealth Department of Human Services and Health, 1995. Darke S, Zador D. Fatal heroin "overdose": a review. Addiction 1996; 91: 1765-1772. Darke S, Ross J, Hall W. Overdose among heroin users in Sydney Australia. 1. Prevalence and correlates of non-fatal overdose. Addiction 1996; 91: 405-411. Davoli M, Perucci CA, Rapiti E, et al. A persistent rise in mortality among injection drug users in Rome, 1980 through 1992. Am J Public Health 1997; 87: 851-853. Zador D, Sunjic S, Darke S. Heroin-related deaths in New South Wales, 1992: toxicological findings and circumstances. Med J Aust 1996; 164: 204-207. Loxley W, Davidson P. Forgetting to breathe: opioid overdose and young injecting drug users in Perth. Perth: Curtin University of Technology, National Centre for Research into the Prevention of Drug Abuse, 1998. McGregor C, Darke S, Ali R, Christie P. Experience of non-fatal overdose among heroin users in Adelaide, Australia: circumstances and risk perceptions. Addiction 1998; 93: 701-711. Darke S, Ross J. Heroin-related deaths in South Western Sydney: 1992-1996. Sydney: The University of New South Wales, National Drug and Alcohol Research Centre; 1998. Gore C. Report of the Pilot Heroin Overdose Peer Education project -- March 1997. NSW: Centre for Education and Information on Drugs and Alcohol, 1997. MIMS (Australia). 1998 MIMS Annual. Sydney, NSW: Intercontinental Medical Statistics (Australasia), 1998: 1176-1177. Chamberlain JM, Klein BL. A comprehensive review of naloxone for the emergency physician. Am J Emerg Med 1994; 12: 650-660. David Bull Laboratories (Australia). Naloxone hydrochloride injection. USP product information. Melbourne Vic: David Bull Laboratories; 1992. Boots Pharmaceuticals (Australia). Narcan injection and Narcan Neonatal injection. Product information. Sydney, NSW: The Boots Company (Australia) Pty Ltd, 1993. Moore RA, Rumack BH, Conner CS, Peterson RG. Naloxone: underdosage after narcotic poisoning. Am J Dis Child 1980; 134: 156-158. Jasinski DR, Martin WR, Haertzen CA. The human pharmacology and abuse potential of N-allylnoroxymorphone (naloxone). J Pharmacol Exp Ther 1967; 157: 420-426. Barsan WG, Olinger CP, Adams HP, et al. Use of high dose naloxone in acute stroke: Possible side-effects. Crit Care Med 1989; 17: 762-767. Jacobs I, Oxer H. The use of naloxone in the pre-hospital management of narcotic overdose. Perth: Western Australian Pre-Hospital Care Research Unit; 1998. Bernard S, Barger W. An audit of two different doses of intramuscular naloxone in prehospital narcotic overdose. Melbourne: Melbourne Ambulance Service, 1995. Sporer KA, Firestone J, Isaacs SM. Out-of-hospital treatment of opioid overdoses in an urban setting. Acad Emerg Med 1996; 3: 660-667. Schwartz JA, Koenigsberg MD. Naloxone-induced pulmonary edema. Ann Emerg Med 1987; 16: 1294-1296. Osterwalder JJ. Naloxone -- for intoxications with intravenous heroin and heroin mixtures: harmless or hazardous? A prospective clinical study. Clin Toxicol 1996; 34: 409-416. Seidler D, Sthülinger GH, Fischer G, et al. After antagonization of acute opiate overdose: a survey at hospitals in Vienna. Addiction 1996; 91: 1479-1487. Strang J, Darke S, Hall W, et al. Heroin overdose: the case for take-home naloxone. BMJ 1996; 312: 1435. Kanof PD, Handelsman L, Aronson MJ, et al. Clinical characteristics of naloxone-precipitated withdrawal in human opioid-dependent subjects. J Pharmacol Exp Ther 1992; 260: 355-363. Reisine T, Pasternak G. Opioid analgesics and antagonists. In: Hardman JG, Limbird LE, Molinoff PB, et al, editors. Goodman & Gilman's the pharmacological basis of therapeutics. 9th edition. New York: McGraw Hill, 1996: 549-551. Moss J. Ambulances say "no" to Narcan. Connexions 1997; 17: 29. Gaddis GM, Watson WA. Naloxone-associated patient violence: an overlooked toxicity? Ann Pharmacother 1992; 26: 196-198. Judson BA, Himmelberger DU, Goldstein A. The naloxone test for opiate dependence. Clin Pharmacol Ther 1980; 27: 492-501. Neal JM. Complications of naloxone. Ann Emerg Med 1988; 17: 765-766. Ward S, Corall IM. Hypertension after naloxone. Anaesthesia 1983; 38: 1000-1001. Andree RA. Sudden death following naloxone administration. Anesth Analg 1980; 59: 782-784. Azar I, Turndorf H. Severe hypertension and multiple atrial premature contractions following naloxone administration. Anesth Analg 1979; 58: 524-525. Flacke JW, Flacke WE, Williams GD. Acute pulmonary edema following naloxone reversal of high-dose morphine anesthesia. Anesthesiology 1977; 47: 376-378. Brimacombe J, Archdeacon J, Newell S, Martin J. Two cases of naloxone-induced pulmonary oedema -- the possible use of phentolamine in management. Anaesth Intensive Care 1991; 19: 578-580. Harrington LW. Acute pulmonary edema following use of naloxone: a case study. Crit Care Nurse 1988; 8: 69-73. Yealy DM, Paris PM, Kaplan RM, et al. The safety of prehospital naloxone administration by paramedics. Ann Emerg Med 1990; 19: 902-905. Darke S, Hall W. The distribution of naloxone to heroin users. Addiction 1997; 92: 1195-1199. Strang J, Farrell M. Harm minimisation for drug misusers: when second best may be best first. BMJ 1992; 304: 1127-1128. Strang J, Powis B, Best D, et al. Preventing opiate overdose fatalities with take-home naloxone: pre-launch study of possible impact and acceptability. Addiction 1999; 94: 199-204. Hall W. Reducing the toll of opioid overdose deaths in Australia. Drug Alcohol Rev 1999; 18: 213-220. Vilke GM, Buchanan J, Dunford JV, Chan TC. Are heroin overdose deaths related to patient release after prehospital treatment with naloxone? Prehosp Emerg Care 1999; 3: 183-186. Bammer G, Sengoz A. Non-fatal heroin overdoses. Med J Aust 1994; 161: 572-573. Coleridge J, Cameron PA, Drummer OH, McNeil JJ. Survey of drug-related deaths in Victoria. Med J Aust 1992; 157: 459-462. Hsu W, Rao RB, Nelson LS. Naloxone hazards overstated. Clin Toxicol 1997; 35: 215-217. Buchwald A. Naloxone use: side effects may occur. Ann Emerg Med 1988; 17: 765. Hando J, Darke S. NSW Drug Trends 1997. Findings from the Illicit Drug Reporting System (IDRS). Sydney: The University of New South Wales, National Drug and Alcohol Research Centre, 1998. Hargreaves K, Lenton S. The Naloxone Feasibility Study. Perth, Western Australia: National Drug Research Institute, Curtin University of Technology, 2000. In press. Des Jarlais DC, Friedman SR. AIDS and the use of injected drugs. Sci Am 1994; February: 56-62. Dietze PM, Cvetkovksi S, Rumbold G, Miller P. Ambulance attendance at heroin overdose in Melbourne: the establishment of a database of Ambulance Service records. Drug Alcohol Rev 2000; 19: 27-33. Darke S, Ross J, Cohen J, Hall W. Context and correlates of non-fatal overdose among heroin users in Sydney. Sydney: The University of New South Wales, National Drug and Alcohol Research Centre, 1994. Authors' details National Drug Research Institute, Curtin University, Perth, WA. Simon R Lenton, MPsych(Clin), Research Fellow. Kim M Hargreaves, BA, Research Associate. Reprints: Mr S R Lenton, National Drug Research Institute, GPO Box U1987, Perth, WA 6845. simonATndri.curtin.edu.au Make a comment Naloxone hydrochloride NALOXONE HYDROCHLORIDE is an opioid antagonist that competitively binds to µ-opiate receptors to reverse the respiratory depression, sedation and hypotension associated with opioids. It does not reduce the respiratory depression caused by non-opioid central nervous system (CNS) depressants, such as alcohol and benzodiazepines, and lacks pharmacological activity in the absence of opioids.11 Naloxone is classified under Schedule 4 of the Poisons Schedule (prescription only) and is available either as ampoules or prefilled syringes (Min-I-Jet [CSL Ltd]). It is effective when given by intravenous, intramuscular or subcutaneous injection,12 being rapidly distributed to the brain and other body tissues. Effects are observed within 1-2 minutes of intravenous administration and 2-5 minutes of intramuscular or subcutaneous administration.13,14 Naloxone has been administered millions of times in emergency departments for opioid overdose;12 in very large doses (eg, 20 times the recommended dose in a 30-month-old15 and up to 24mg/70kg in adults16); and over a number of weeks to evaluate efficacy and toxicity in patients with acute stroke,17 without major complications. Naloxone in the prehospital setting When used to treat opioid overdose, naloxone has been reported to improve consciousness and alertness in 64%-80% of patients within 10 minutes of administration,18,19 and in other patients it improved respiration. As long as blood pressure can still be recorded, its administration can be beneficial.20 Naloxone-related complications have been reported after treatment of opioid overdose.20-22 However, many of the apparent drug reactions observed could also have resulted from the overdose itself.22,23 Treatment of heroin overdose in the United Kingdom and Australia suggests that such reactions are rare, with no significant problems reported after hundreds of administrations.24 Naloxone does have the potential to precipitate opioid withdrawal symptoms when administered to opioid-dependent people,25,26 and may result in generalised convulsions.11,22 Those in acute withdrawal can become aggressive and endanger themselves and others.27,28 Withdrawal symptoms are typically less severe after intramuscular than intravenous administration.29 With the correct equipment (eg, prefilled syringes), intramuscular administration is also easier to perform and has a longer duration of action. The disadvantage of intramuscular administration is the delayed onset of action. Naloxone in the postoperative setting Naloxone is used after surgery to reverse the CNS depression caused by opioids administered during the procedure. Naloxone complications have been documented in this setting,30 with an increased risk when pre-existing hypertension and cardiovascular disease are present.31 Many of the complications reported - hypertension, atrial and ventricular tachycardia, fibrillation, left ventricular failure, pulmonary oedema, and sudden death12,32-34 - occurred in patients with underlying cardiac or pulmonary disease. Pulmonary oedema attributed to naloxone administration has also been reported among individuals with no underlying medical conditions.21,34-36 Many patients who experience adverse effects do so after an operation when multiple medications have been administered, so the causal role of naloxone is uncertain.12,37 Back to text

Simon R Lenton · Kim M Hargreaves

Research A randomised crossover trial of chemotherapy in the home: patient preferences and cost analysis Danny Rischin, Michelle A White, Jane P Matthews, Guy C Toner, Kathryn Watty, Anthony J Sulkowski, Jan L Clarke and Lois Buchanan MJA 2000; 173: 125-127 Abstract - Methods - Results - Discussion - References - Authors' details - - More articles on Oncology Abstract Objectives: To determine patient preferences and cost differences between home-based and hospital-based chemotherapy. Design: Randomised crossover trial. Setting: A tertiary cancer hospital in Melbourne, Victoria. Participants: 20 patients who required chemotherapy suitable for administration at home. Interventions: Patients were assigned at random to receive their first chemotherapy treatment in either the home or the hospital and the second treatment in the alternative setting. Main outcome measures: Patient preference, costs. Results: There was universal agreement by the 20 patients in the randomised trial that home-based chemotherapy was the preferred option (P < 0.0001). No problems were nominated by the patients as being associated with home-based chemotherapy. Home-based treatment was estimated to result in an increased cost of $83 (P = 0.0002) for each chemotherapy treatment compared with hospital-based treatment. Reported advantages for chemotherapy in the home included the elimination of travel, reduction in treatment-associated anxiety, reduction in the burden on carers and family, and the ability to continue other duties. There were no significant complications associated with administration of chemotherapy in the home. Conclusions: Patients prefer home-based chemotherapy to hospital-based treatment. The future of chemotherapy-in-the-home programs in Australia will depend on whether patient preferences are deemed to offset any potential increase in costs. Patients with cancer who require treatment with chemotherapy will experience major changes in lifestyle and overall well-being. Some intravenous chemotherapy regimens require frequent visits to hospital to receive treatment. This may be time-consuming and inconvenient for a patient, and may also disrupt the lives of other family members and carers. The concept of home-based therapy is not new,1-3 but there have been few reports on chemotherapy-in-the-home programs, and these have had a different emphasis from our study (eg, costs [in a US paediatric population];4 costs and safety [in a retrospective review of an Australian adult population]5). We performed a randomised crossover trial, the aim of which was to compare (i) patient preference for hospital-based versus home-based chemotherapy; and (ii) the cost of therapy administered in hospital versus that in the home. Methods Patient eligibility Patients were considered eligible if they met the following criteria: they were to receive chemotherapy that was suitable to be given at home; their first two treatments were planned to be identical; they had not received chemotherapy in the preceding 12 months; they lived in an area that was geographically suitable for treatment at home; and they were aged 18 years or over. Patients gave written informed consent and the study was approved by the ethics committee of the Peter MacCallum Cancer Institute. Study design At enrolment, patients were randomly assigned to receive their first chemotherapy treatment in hospital and the second at home, or their first treatment at home and the second in hospital. They were assigned according to a computer-generated randomisation chart, using an allocation scheme based on a biased coin design.6Chemotherapy treatment refers to the first two administrations of chemotherapy. Following completion of the first two treatments, patients filled out a questionnaire regarding the two different locations of therapy. Questions focused on (i) patients' preference for where to receive their remaining chemotherapy after completing their two study treatments; and (ii) any perceived difficulties or advantages of treatment in hospital or in the home. Chemotherapy nurse specialists who also worked in the chemotherapy day ward at the hospital administered all home chemotherapy treatments. Patients were reviewed by a doctor before each chemotherapy cycle. Cost assessment Cost comparisons for hospital-based versus home-based therapy were made specifically from the perspective of the treating hospital, not the patient or society in general. Costs were estimated using Transition software (Eclipsys Transition Systems, Boston, MA), which distributes direct and indirect costs for an entire financial year between patient episodes on the basis of the services received. It was decided to compare only those components of the cost for which there could be a genuine difference to the hospital attributable to the site of delivery of the chemotherapy. Thus, costs related to patient records, allied health, medical staff and pharmacy were excluded. All overheads associated with the chemotherapy-in-the-home program, including vehicle costs and travelling time, were apportioned by Transition to nursing costs on the basis of time spent with each patient. Similarly, hospital overheads were apportioned on the basis of nursing times. The cost of providing a single meal was included in the hospital costs. Statistical methods A target sample size of 20 eligible patients with identical chemotherapy for their first two treatments was chosen, to provide 84% power to test the null hypothesis that no one setting is preferred versus the alternative hypothesis that at least 85% of patients prefer one setting over the other, using a two-sided test of significance at a significance level of 0.05. To determine if significantly more patients preferred treatment at home rather than in hospital, or vice versa, the proportion of patients preferring to have their third treatment in the same location as their first treatment was compared between the two randomisation arms using Fisher's exact test for 2 x 2 contingency tables. This test is valid even if there are "period" effects -- that is, if patients tolerate their second chemotherapy treatment better than their first, or vice versa.7 Standard methods for a 2 x 2 crossover trial7 were used to compare costs of chemotherapy in hospital with costs in the home, and costs between the first and second chemotherapy given ("period" effects), after ensuring there were no significant carryover effects. (Carryover effects were tested by comparing the sum of the costs in the home and hospital for patients in the "hospital first" arm with patients in the "home first" arm.) Statistical significance and 95% confidence intervals (CIs) were estimated from the means and standard errors assuming a Student's t-distribution. Two-sided P-values have been given throughout. All statistical tests were carried out using Stat Xact 4 (CYTEL Software Corporation, Cambridge, MA, 1998) and Microsoft Excel (Microsoft Corporation, Redmond, WA, 1996) software. Results Patient selection and profile The trial accrued the target 20 patients, out of a total of 64 registered on the chemotherapy-in-the-home program, between February 1996 and March 1997 (see Box 1). Patient demographics are shown in Box 2. Patient preferences When asked where they would have preferred to receive their first two treatments if they had had their time again, 70% of patients expressed a preference for having both treatments at home, while none said they would have preferred to have both treatments in hospital (Box 3). Patients were then asked to nominate their preferred site for the remaining treatments (the primary endpoint of the trial). All 20 patients (100%; 95% CI, 83%-100%) preferred to have their remaining therapy given at home (P < 0.0001). None of the patients in the trial reported concerns with chemotherapy being given in their home; however, four (20%) reported concerns with treatment in hospital, relating to transport difficulties and waiting times. Eighteen (90%) of the patients felt there were advantages with treatment in the home. The reasons given included convenience; avoidance of travel and parking problems (particularly not having to travel while feeling unwell); reduction in treatment-associated anxiety; not burdening their carers and family; and being able to continue other duties, such as caring for their dependants. Only one patient felt there were specific advantages to chemotherapy in the hospital. This patient felt it was good to see other people who were worse off. No major complications of chemotherapy administration (eg, hypersensitivity reactions or extravasation) were reported. Costing Overall, chemotherapy in the home was associated with an estimated average increased cost of $83 (95% CI, $46-$120; P = 0.0002) relative to the cost of chemotherapy in the hospital. The average cost of the first treatment was estimated to be $57 more than the cost of the second (95% CI, $20-$94; P = 0.0044). There was no carryover effect (P = 0.16). Discussion This study has demonstrated that patients have an overwhelming preference for home-based therapy. Clearly, home-based therapy is not possible, or indeed appropriate, for all patients. Patients living outside designated geographical areas or having special needs that can be met in the hospital setting (eg, need for an interpreter) would be more easily treated at the hospital.8 Complex or prolonged chemotherapy regimens or those associated with a risk of an immediate serious complication are more appropriately administered in the hospital day ward setting. Nevertheless, many commonly administered chemotherapy regimens are suitable for administration in the home, and this study clearly demonstrates that, given the choice, patients prefer to have such treatments at home. While in our study the cost of home-based treatment was on average $83 higher than the cost of hospital-based therapy, this estimate did not include costs to the patient (such as travelling costs, lost time for the patient or carers, and childcare costs). These could all have made the hospital episode more costly relative to the home episode. Furthermore, given that the cost per visit for any chemotherapy-in-the-home program is dependent on the throughput of patients and the geographical spread of the patients, an increase in the frequency of home visits or a more limited geographical spread of patients might further reduce the difference between home and hospital costs. Unlike some other hospital-in-the-home programs, chemotherapy in the home does not necessarily result in cost savings to the administering hospital, as treatment in the hospital does not require overnight admission. The future of chemotherapy-in-the-home programs in Australia will depend on how governments, hospital administrators, oncologists and nurses balance the overwhelming patient preference for treatment at home with any potential increase in costs. References Grayson ML, Silvers J, Turnidge J. Home intravenous antibiotic therapy. A safe and cost effective alternative to inpatient care. Med J Aust 1995; 162: 249-253. Koopman MMW, Prandoni P, Piovella F, et al. Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low molecular weight heparin administered at home. N Engl J Med 1996; 334: 682-687. Bielory L, Long GC. Home health care costs: intravenous immunoglobulin home infusion therapy. Ann Allergy Asthma Immunol 1995; 74(3): 265-268. Close P, Burkey E, Kazak A, et al. A prospective, controlled evaluation of home chemotherapy for children with cancer. Pediatrics 1995; 95: 896-900. Lowenthal RM, Piaszczyk A, Arthur GE, et al. Home chemotherapy for cancer patients: cost analysis and safety. Med J Aust 1996; 165: 184-187. Wei LJ, Lachin JM. Properties of the urn randomization in clinical trials. Control Clin Trials 1988; 9: 345-364. Jones B, Kenward MG. Design and analysis of cross-over trials. London: Chapman and Hall Ltd, 1989. Zalcberg JR, Siderov J, Petty M. Outpatient chemotherapy: there's no place like home - sometimes. Med J Aust 1996; 165: 182. (Received 11 Oct 1999, accepted 24 May, 2000) Authors' details Peter MacCallum Cancer Institute, Melbourne, VIC. Danny Rischin, MB BS(Hons), FRACP, Consultant Medical Oncologist, Division of Haematology and Medical Oncology; Michelle A White, MB BS(Hons), FRACP, Clinical Fellow, Division of Haematology and Medical Oncology; Jane P Matthews, BSc(Hons), PhD, AStat, Director, Statistical Centre; Guy C Toner, MD, BS, FRACP, Head of Medical Oncology, Division of Haematology and Medical Oncology; Kathryn Watty, RN, RM, Clinical Nurse Consultant, Division of Nursing; Anthony J Sulkowski, RN, BEd, Clinical Nurse Consultant, Division of Nursing; Jan L Clarke, RN, Clinical Nurse Consultant, Division of Nursing; Lois Buchanan, RN, RM, Clinical Nurse Consultant, Division of Nursing. Reprints will not be available from the authors. Correspondence: Dr D Rischin, Division of Hematology and Medical Oncology, Peter MacCallum Cancer Institute, Locked Bag 1, A'Beckett Street, Melbourne, VIC 8006. drischinATpetermac.unimelb.edu.au Make a comment Click in box for larger version Back to text 2: Patient demographics, by randomisation arm (first chemotherapy treatment given at hospital vs first treatment at home). Values are number of patients unless otherwise stated Hospital first Home first Total (%) Sex Male Female 1 8 4 7 25% 75% Age Median (years) Range (years) 40-49 50-59 60-69 70 61 47-71 0 2 1 5 1 59 26-69 1 4 1 5 0 -- -- 5% 30% 10% 50% 5% Diagnosis Breast cancer Colon cancer Non-Hodgkin's lymphoma Pancreatic cancer 5 3 0 1 5 5 1 0 50% 40% 5% 5% Chemotherapy CMF(P)* 5-FU† ± folinic acid or levamisole CHOP‡ 5 4 0 5 5 1 50% 45% 5% Support at home Spouse/parent Parent Son/daughter Other Not specified 4 1 3 0 1 7 0 1 3 0 55% 5% 20% 15% 5% * Cyclophosphamide, methotrexate, 5-fluorouracil ±prednisolone. † 5-Fluorouracil. ‡Cyclophosphamide, doxorubicin, vincristine and prednisolone. Back to text 3: Preferred location for chemotherapy treatments, by randomisation arm (first chemotherapy treatment given at hospital vs first treatment at home). Values are number of patients Hospital first Home first Total (%) For first 2 treatments Both at home First at home, second at hospital No preference First at hospital, second at home Both at hospital 7 0 1 1 0 7 2 1 1 0 14 (70%) 2 (10%) 2 (10%) 2 (10%) 0 For subsequent treatments Home Hospital 9 0 11 0 20 (100%) 0 Back to text

Danny Rischin · Michelle A White · Jane P Matthews · Guy C Toner · Kathryn Watty · Anthony J Sulkowski · Jan L Clarke · Lois Buchanan

Caring For Older People Healthcare for older people in residential care -- who cares? Leon Flicker MJA 2000; 173: 77-79 Increasing needs should be met with improved organisation of services Recently in Melbourne, several older people in a high-level-care residential facility (nursing home) were reportedly found to have an infestation with the mite Sarcoptes scabiei. They were supposedly treated with a dilute topical application of a mixture of volatile hydrocarbons, commonly known as kerosene. Quite rightly, this practice was widely condemned,1 as it does not conform to accepted evidence-based guidelines, which recommend the topical application of compounds such as permethrin, which are safer and more effective.2 This incident has raised questions as to whether the standard of healthcare is adequate throughout the residential care industry. The residential care system has undergone major changes over the past 15 years. It is a system that has traditionally been divided into two tiers: high-level care (nursing home care) and low-level care (hostel care). This situation has been somewhat muddled by legislative changes enacted in October 1997 allowing residential care facilities to house residents of any degree of dependency, and in fact 18% of residents in hostels are classified as requiring "high-level" care (Commonwealth Department of Health and Aged Care, WA Branch, personal communication), a situation that should mean that nursing attention is available 24 hours a day.3 However, statistics analysed and reported by the Federal Government over the period 1985-1997 demonstrate a consistent trend towards fewer nursing home beds and slightly more hostel beds,3 a trend which has probably continued over the past three years. Despite a rapidly ageing population, there has been virtually no growth in the number of nursing home places. In Australia there were 71 503 nursing home beds in 1985 and 74 233 in 1997 -- a reduction in the ratio of beds per 1000 persons aged 70 years and over from 66.5 to 47.6. Over the same period, there has been real growth in the number of hostel places from 34 885 to 64 825 places, or an increase in the ratio from 32.5 to 41.6 beds per 1000 persons aged 70 years and over. These changes have produced predictable results, with a notable and sustained increase in levels of dependency of residents in nursing homes and hostels. In 1987, 30% of permanent nursing home residents were categorised as "high dependency" (Residential Classification Scale Index 1 or 2); in 1997, this proportion was 56%. In 1992, only 54% of hostel residents required assistance with personal care, whereas in 1997, 80% of residents required such assistance.3 Older people in residential care are the sickest and frailest subsection of an age group that manifests the highest rates of disability in the Australian population. For example, in 1998, only 5.2% of people aged 65-69 years required assistance with self-care activities (eg, bathing, dressing, grooming), while in the age group 80 years and over 31.4% of people required such assistance.3 As people age, they are not only more likely to have a severe or profound disability but are also more likely to be cared for in residential care. Approximately 15% of Australians aged over 65 years living in the community have a severe or profound disability, whereas 93% of people in residential care have such a disability. While one-third of older Australians aged 65 years and over with severe or profound disability live in non-private dwellings, the rates rise from only 13% of the 65-69-year-old group to over 50% of women over the age of 80 years. This increase is almost certainly due to two main factors: the decreased availability of informal carers for the oldest age group, and the increasing level of disability. What are the medical conditions underlying these dependency statistics? Unfortunately, although the Federal Government is responsible for both medical and residential care, few data are available on the common medical conditions of elderly people in residential care. Probably the commonest condition seen in these people is some form of dementia. In 1996, there were an estimated 134 809 people with dementia in Australia (this estimate does not include all people with mild disease).4 Approximately half of these individuals were housed in residential care.3 Estimates of the prevalence of dementia in people in hostels and nursing homes were 28% and 60%, respectively, although rates of cognitive impairment were even more alarming, at 54% and 90%, respectively.5 The main disabling conditions of the 707 600 people aged 65 years and over with a profound, severe or moderate disability (less than 20% of whom were housed in residential care) were arthritis, other musculoskeletal conditions, dementia, eye disease and stroke.3 It would appear that much of the disability suffered by people in residential care is related to chronic degenerative conditions. The pressure of caring for people with increasingly complex and disabling conditions within the residential care system may place other parts of the healthcare system under stress -- for example, the readmission of nursing home patients to the acute hospital system with acute complications of chronic medical problems. Such admissions (eg, the referral to an acute hospital of a nursing home resident with severe Alzheimer's disease complicated by hypostatic pneumonia) may be precipitated by avoidance of ethically difficult management decisions. Another part of the health and welfare system that may come under pressure is community care, despite substantial real increases in Commonwealth expenditure on Home and Community Care (HACC). This expenditure has increased, in inflation-adjusted terms, from $561 million in the financial year 1991-92 to $799 million in 1997-98.3 The pressure exerted by reduced availability of residential care has led to a waiting time of several weeks for community care in many parts of Australia, despite the necessity of providing care to patients discharged from a crowded acute hospital system. How should the provision of healthcare for people in nursing homes and hostels be organised? This issue has essentially not been addressed to date, and improvement in this area will require more than increased funding. Over the past 15 years, the focus of aged care services has been to prevent or delay the need for residential care by comprehensively assessing patients to identify those who might benefit from multidisciplinary rehabilitation and community services. The rationale for this approach is sound and clearly evidence based,6 and the policy has been very successful. While cynics may claim that the Federal Government has promoted the policy to halt the previous exponential growth in nursing home care, there is no doubt that older people themselves eschew the residential care option to remain in their own homes, if at all possible.7 However, the healthcare of people who go into residential care seems to be far less coordinated. Recent developments (part of the Enhanced Primary Health Care Initiative) that support medical practitioners in screening the over-75-years group and in care planning, exclude people in nursing homes. Furthermore, the organisation and proposed evaluation of this initiative do not appear ideal.8The very high prevalence of cognitive impairment among people in residential care limits the usefulness of surveying residents about their perceived needs and decreases their ability to be effective advocates for their own care. I believe several steps need to be taken to improve healthcare for people in residential facilities: We need to recognise that most older people do not choose residential care for "social" reasons. They do so because of chronic medical conditions resulting in permanent disability. Healthcare professionals need professional development involving training, peer review and transparency of operations, something that is apparent from the experience of acute care hospitals. (While accreditation of facilities may be a useful and long overdue stage in the development of residential care facilities, it is unlikely to improve the quality of healthcare provided.) Educational institutions, expert groups and professional organisations need to form strategic partnerships to establish what is currently accepted best practice in residential care and where investment should be made in targeted research. Health professionals working in the residential care environment should be trained in dealing with people who have major disabilities. This particularly applies to general practitioners, who should be encouraged to acquire specific qualifications and rewarded by increased remuneration. We need to develop a multidisciplinary team approach to healthcare delivery in residential facilities. Appropriate agencies, such as governments and private health insurers, need to provide sufficient funding to support the level of professional care required. Medical practitioners and some other health professionals may be able to get expert support from regional aged care teams; however, these services are currently under considerable stress because their funding has not kept pace with the increasing number of older people requiring care.3 A wider role for geriatricians and psychogeriatricians in supporting these developments is crucial.9 There is no need for the widespread nihilism that has pervaded the issue of healthcare in residential facilities -- indeed, it has been shown that legislative changes10 and educational initiatives11 can decrease the rate of inappropriate psychotropic drug use in nursing home residents. Healthcare for people in residential care is provided not only by medical practitioners, but also by other professionals. The largest group of professional carers are nurses, for whom professional and best practice guidelines are similarly underdeveloped. For example, there are no guidelines specifying which of the available care strategies for people with dementia (such as validation therapy,12 reality orientation13 or reminiscence therapy14) works best, and for whom. Similarly, other healthcare workers, such as dentists, pharmacists and allied health practitioners, all need to pay special attention to this vulnerable section of the population. A recent survey of Adelaide dentists15 revealed that their interest in and provision of services to people in residential care were low and that dentists provided little educational assistance for staff of nursing homes. A concurrent survey of the needs of the residents found a high level of standard dental treatment needs, with the severely cognitively impaired residents having the highest incidence of oral disease.15 Clearly, a diverse range of best practice guidelines for the care of residents of nursing homes and hostels is needed, together with appropriate resources to implement them. It is sometimes argued that these residents have "reached the end of the road" and that further attention to their needs is unjustified. This argument is usually rejected by the very many Australians whose relatives and friends are housed in residential care. Perhaps more telling is the realisation that entry into residential care is a common occurrence in our society, and in fact any individual who lives to the age of 65 years has a 33% chance of requiring a nursing home bed during their remaining life and a 20% chance of requiring a hostel bed.3 It is in the interests of all members of society to provide more adequate healthcare in this challenging environment. Disclosure statement: No conflict of interest. References Kerin J. Care for aged: a kerosene dip. The Australian Feb 25, 2000: 5. Walker GJA, Johnstone PW. Interventions for treating scabies. The Cochrane Library. Issue 1. Oxford: Update Software, 2000. Updated quarterly. Gibson D, Benham C, Racic L, editors. Older Australia at a glance. Canberra: Australian Institute of Health and Welfare, 1999. (Catalogue No. AGE 12.) Henderson AS, Jorm AF. Dementia in Australia. Canberra: AGPS, 1998. Rosewarne R, Opie J, Bruce A, et al. Care needs of people with dementia and challenging behaviour living in residential facilities. Canberra: AGPS, 1997. Stuck AE, Siu AL, Wieland GD, et al. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet 1993; 342: 1032-1036. McAllister NL, Hollander MJ. Seniors' perceptions of and attitudes towards the British Columbia continuing care system. Health Rep 1993; 5: 409-418. Byles JE. A thorough going over: evidence for health assessments for older persons. Aust N Z J Public Health 2000; 24: 117-123. Draper BM. Medical care in aged-care facilities: new directions. Med J Aust 1999; 171: 94-96. Hughes CM, Lapane KL, Mor V. Impact of legislation on nursing home care in the United States: lessons for the United Kingdom. BMJ 1999; 319: 1060-1063. Snowdon J. Follow-up survey of psychotropic drug use in Sydney nursing homes. Med J Aust 1999; 170: 299-301. Neal M, Briggs M. Validation therapy for dementia. The Cochrane Library. Issue 1. Oxford: Update Software, 2000. Updated quarterly. Spector A, Orrell M, Davies S, Woods B. Reality orientation for dementia. The Cochrane Library. Issue 1. Oxford: Update Software, 2000. Updated quarterly. Spector A, Orrell M, Davies S, Woods RT. Reminiscence therapy for dementia. The Cochrane Library. Issue 1. Oxford: Update Software, 2000. Updated quarterly. Australian Institute of Health and Welfare Dental Statistics and Research Unit. The Adelaide dental study of nursing homes. Research report. [Adelaide]: AIHW, October 1999. (Catalogue No. DEN 50.) Make a comment

Leon Flicker

Looking Forward The future of Medicare and health service financing Stephen R Leeder and Ian A McAuley MJA 2000; 173: 48-51 If we can afford to pay for healthcare, we can afford Medicare - - More articles on Administration and health services "Never make predictions, particularly about the future", was George Bernard Shaw's advice to futurologists. Shaw saw more of the future than most -- he died in 1950, aged 94, when the life expectancy of men in Britain was 67 years. Two years earlier, Aneurin Bevan,* Minister for Health in the Attlee Government,† had introduced the National Health Service (NHS) Act, the prototype for universal tax-funded healthcare like Australia's Medibank and Medicare. When the NHS was introduced, the prevailing view was that healthcare expenditure would stabilise once unmet need had been satisfied. But, from 1900 to 1950, the life expectancy of men in Britain had risen from 49 to 67 years, because of improved living standards and, latterly, cures for infections.1 Prescient indeed would have been the academic in 1950 who could have foreseen that lengthened life would result in a host of new healthcare needs, that technologies would be developed to meet those needs, and that Bevan's stability of expenditure on health would prove to be illusory. Speculating on the future of healthcare delivery is no less hazardous now than it was in 1948. Nevertheless, the major forces shaping the future generally are manifest in present trends. If we were developing scenarios about commodity prices we might well accept that, in a globalised world economy, the policies of national governments have, at most, a marginal effect. In the case of healthcare, however, this is no easy task. The experience of the past 25 years suggests we might expect at least four changes of government over the next 25 years. That would indicate an on/off sequence for Medicare, much as we have seen in the past 25 years, and this has not been totally related to which side of politics is in power. During Labor's time in office, the governments of Bob Hawke and Paul Keating reintroduced universal hospital care, but also brought in a much higher level of patient copayments in healthcare, particularly for pharmaceuticals. The present Liberal-National Coalition Government has reasserted a commitment to Medicare, and has tended to shy away from market forces in the private sector, encouraging community-rated insurance rather than self-reliance.2 Yet, at the same time, the present government suggests strongly that those who can afford to have private insurance should do so. A similar sentiment was evident in the proposals of the Labor Health Minister, Graham Richardson, in 1993. The vision of Medibank, and of Medicare, as defined by Neal Blewett when Minister for Health in the Hawke Government,‡ was as a universal shared system. During the 1990s, however, there was political pressure within both parties to redefine Medicare, in particular as regards access to public hospitals, as a charity system for the old and indigent. Because the basic principles of Medicare are not regularly articulated, Medicare becomes pliable to the fashions of government policy and subject to expedient interventions to solve real or perceived problems. Forty years ago, Charles Lindblom coined the term "muddling through" to describe a policy-making process which has no clear end or objective, but which lurches, reacting to one crisis after another.3 The Productivity Commission's modest proposal -- that the Commonwealth Government hold a broad public inquiry into Australia's healthcare system -- which might have led to a less muddled health policy, met with rejection.4 As an alternative to muddling, we can take account of probable changes in demand (especially ageing) and supply (especially technology) of healthcare and build a policy for the future. Demand -- an ageing population Box 1 shows population projections to 2025 for the 80 years and over age group. This age group will almost double in size over the next 25 years. Simple extrapolations of expenditure based on these projections are alarmist, for several reasons. For a start, many countries are already coping successfully with older populations (Box 2). The Scandinavian countries, especially, already have a population structure similar to that predicted for Australia in 2025, and are delivering healthcare for less than 10% of gross domestic product (GDP). These countries demonstrate the capacity of a single, national insurance scheme (similar to Medicare) to keep costs under control while providing quality care to an aged population. A further factor that may diminish demand for care among older people may be changes in lifestyle -- smoking, diet, and exercise are all major determinants of healthcare needs. Dr Wendy Everett, Director of the Robert Wood Johnson Foundation's health programs, suggests (as have many others) that behaviour contributes to 50% of our health status.7 These effects take decades to manifest. Thus, it is the "baby boomers", who grew up in the Golden Age of postwar prosperity and equality, whose lifestyle choices will become apparent when they are around the age of 70 to 80 in the year 2025. Another determinant is consumer attitudes to healthcare. Daniel Callahan, in his book False hopes, predicts the implosion of healthcare under the weight of grasping demand for perfect health unless all of us (in the case of the United States, especially older people) modulate our demands.8 He fears that the commercial imperatives that drive new pharmaceutical, biotechnological and bioengineering industries will further push demand for tinkering and spare parts to completely unsustainable levels. As an alternative, he posits education of the public that they cannot have it all, and this must begin now if a shred of equity in how healthcare is provided is to be retained. Thus, while the arithmetic of ageing is not complex, much depends on background economic capacity and the sociology of demand of the country concerned. Unless demand is disciplined, it is easy to see market forces overwhelming healthcare budgets. In that case, a scramble for care will occur, with only the rich doing well, further widening the already depressing gradients in health and healthcare between the rich and the poor.9,10 Presuming instead a more civilised society with a central health insurance agency such as Medicare, the omens are by no means bleak, as our Scandinavian colleagues demonstrate. Supply -- the role of technology Technological growth is blamed for much of the increase in health costs. Dr Joseph Newhouse, of Harvard University, told a National Health Summit in Sydney in 1991 that he attributed the increase in healthcare expenditure in the United States principally to technological change.11 He referred to the "march of science and the increased capabilities of medicine" as a large part of the cause, and cited renal (kidney) dialysis, transplantation, artificial joints and monoclonal antibodies (and other products of genetic engineering) as examples of this. However, the role of new technology is a mixed one, and, while there may be a Galbraithian "technological imperative", to suppose that it cannot be modified with time according to human design seems a defeatist position. Many technologies have revolutionised patient comfort, especially the replacement of old diagnostic procedures with new, far less invasive ones. The same can be said for many therapies that have enabled the massive movement away from prolonged inpatient care to ambulatory service. A step in the direction of the sane use of new technology is the development, in 1998, of processes of critical appraisal for services that might be supplied by Medicare. We have not yet seen what clinical care based on insights into the human genome may achieve, but not to consider this as a significant aspect of demand for future healthcare would be foolish. The other aspect of technology likely to have a profound effect is the Internet. It is shifting the locus of information in healthcare.12 Will it result in more shopping around, more time spent in argument, or will it result in more self-help displacing the need for formal care? Will it result in more mishaps through partial knowledge? How will it relate to Medicare? Can we afford Medicare? If we can afford to pay for healthcare, we can afford Medicare. That may sound glib, but, if we choose to share all or some of our healthcare costs, then Medicare is both the fairest and most efficient means of sharing. Community-rated private health insurance (a "privatised" tax) is a clumsy way to do what the taxation system does well. There is nothing that community-rated private health insurance does that Medicare and the taxation system cannot do better. The administrative expenses of private health insurance are $0.6 billion per annum, or 12.4% of premiums, compared with 3.7% for the Health Insurance Commission.13,14 The taxation system achieves community rating without the need for complex arrangements (such as apply with private health insurance), with "lifetime cover" and reinsurance, and because taxation is progressive it is fairer than private insurance. What would be the financial consequences of doing away with private insurance? Health insurance funds pay out $3.1 billion a year in hospital benefits.13 Of that, 30% is subsidised by the Commonwealth Government. Therefore, $2.2 billion of additional public funding could substitute for this funding. That could be met with a 0.75% increase in the Medicare levy. Its immediate effect would be to eliminate a large private bureaucracy. Its longer term effect would be to bring to the healthcare market the discipline of a single national insurer. Box 3 shows that countries with a larger proportion of healthcare funding passing through the public sector, through universal national health schemes like Medicare and Britain's NHS, tend to have much lower total healthcare costs. Would eliminating private insurance represent "socialised medicine"? No. It is quite possible to fund a private hospital system without private insurance. Medicare funds can just as easily go to private hospitals as to public hospitals. Would it be possible politically to raise taxes to pay for a universal Medicare? The evidence seems strongly to suggest it would. In both the 1993 and 1996 elections, healthcare was a major issue among voters. In 1993, the Coalition had promised private health insurance initiatives, while Labor did not, being more committed to Medicare. Polling researchers asked people which party was closest to their own views on various issues, including health policy. In response to that question, Labor had a 19% lead over the Coalition. In 1996 both parties promised support for private health insurance and the same polling found Labor's lead on healthcare had fallen to 5%.15 This year, in a multination poll, a small majority of Australians said they were in favour of higher taxes and higher public spending, with healthcare, at 75%, the second-highest priority (after education, at 78%).16 The last line of defence for private insurance is that, because it is "private", it is somehow superior to a "public" system -- a belief, known as "private sector primacy", which is grounded more in ideology than in economic rationality. The case does not rest on any economic analysis of whether a function is more efficiently carried out in the private or public sector; rather, it is a matter of faith that, if at all possible, it is always preferable for a function to be in the private sector. This argument has merit where private provision is accompanied by the discipline of price signals. But insurance, private or public, acts to suppress price signals, except for those of the premiums. At the point of use, there is no difference between the perception "Medicare will pay" and "private health insurance will pay". Insurers know this phenomenon by the quaint term "moral hazard". It applies whenever there is third-party funding. The real debate that we have to have If we dwell too long on the issues of private versus public insurance, we overlook more basic issues in health financing. We need now to address wider issues; the longer we defer this debate the harder it will be, as even uninformed views tend to become entrenched in a state of serious muddlement. This is especially so in a country with a large first- and second-generation migrant population, who have come from countries with a variety of contracts between citizen and government, from cradle-to-grave welfare through to a culture of laissez faire. We offer three issues for this debate. First, let us clarify the government's role in healthcare; is it charity or is it something we share? On that point we tend to the latter view. Even if we are generally inegalitarian, accepting the slings and arrows of life as a matter of private fortune, we may have a different attitude to healthcare. We may know our inheritances of material wealth and of physical and intellectual talent, but we do not know what lies around the corner when it comes to health. In the terminology of the Harvard philosopher John Rawls, when it comes to our healthcare needs we are in an "original position", and are more likely to choose to share our lot with others to the extent that we can.17 The second issue relates to the boundary between third-party funding and the market. The debate should not be between private and public insurance, but between insurance and the market. The final issue, after the first two have been settled, is how to rationalise the complex set of programs in healthcare. To those in the healthcare professions or who study healthcare from an academic perspective, it is complex. To the consumer it is bewilderingly unintelligible. Some programs have copayments, some do not. Simple procedures like ambulatory care usually require visits to several establishments, with different payment systems. Why, for example, is pharmacy separated from general practice? Why does a public hospital stay attract no copayment, while much less expensive procedures attract large patient contributions? Why is medical care separated from nursing care in private hospitals and nursing homes? Why does one have to wait days for test results which are generated instantly with new technology? Program divisions reflect ancient demarcations between crafts, and the complexities of Federal-State relations. Advances in medical technology have not been matched in structures and organisations providing healthcare. If Shaw had lived to 150, he would have found them surprisingly familiar. Will they be the same on his 175th birthday? Acknowledgements We extend our thanks to Professor John Deeble for helpful comments on drafts of this paper and to Amanda Dominello for assistance with editing. Footnotes * Aneurin Bevan, Minister for Health in the Labour Party (United Kingdom), 1945-1951. † Clement Attlee, Leader of the Labour Party (United Kingdom), 1935-1955. ‡ Bob Hawke, Labor Prime Minister, 1983-1991. References Organisation for Economic Co-operation and Development. Financing and delivering health care. Paris: OECD; 1987. McAuley I. Private health Insurance. Redefining the issues. Australian Rationalist 1988; 1 Spring: 47. Lindblom C. The science of muddling through. Public Admin Rev 1959; 19: 79-88. Industry Commission. Private health insurance. Canberra: Industry Commission, 1997. Australian Bureau of Statistics. Population projections. Canberra: ABS, April 2000. (Catalogue No. 3220.0.) Organisation for Economic Co-operation and Development. OECD health data 99 [on CD-ROM]. Paris: OECD, 1999. Stapleton S. New technology, smarter patients augur vast change. American Medical News 2000; March 13: 33. Callahan D. False hopes. New York: Simon and Schuster, 1997. Marmot M. Social determinants of health: from observation to policy. Med J Aust 2000; 172: 379-382. Mathers C, Vos T, Stevenson C. The burden of disease and injury in Australia. Australian Institute of Health and Welfare. Canberra: AIHW, 1999. Newhouse JP. Keynote address: The costs of medical care and consumer willingness to pay for new medical technologies: how much should we be spending on health care? National Health Summit, Nov 15, Sydney 1991. Clarke RL. Hard times and great expectations. Healthcare Financial Management 2000; March: 16. Private Health Insurance Administration Council (PHIAC). Operations of the registered health benefits organisations. Canberra: PHIAC, 1999: 87. Health Insurance Commission (HIC). Annual report 1998-99. Canberra: HIC, 1999: 79. Bean C, McAllister I. Short-term influences on voting behaviour in the 1996 election. In: Bean C, Simms M, Bennett S, Warhurst J, editors. The politics of retribution -- The 1996 Federal Election. Sydney: Allen and Unwin, 1997: 198. Peering into 2010 -- a survey of the future of medicine. The Economist 1994; March 19: 63. Rawls JA. Theory of justice. Cambridge: Harvard University Press, 1971. Authors' details Stephen Leeder is Dean of the Faculty of Medicine and Professor of Public Health and Community Medicine at the University of Sydney. He was foundation professor of Community Medicine at the University of Newcastle (1977-1985), and Director of the Division of Public Health and Community Medicine at Westmead Hospital in the Western Sydney Area Health Service (1985-1997). He was the foundation chair of the Board of Censors of the Australasian Faculty of Public Health Medicine 1990-1994, and has served two terms as National President of the Public Health Association of Australia. He chaired the Health Advisory Committee of the National Health and Medical Research Council, 1997-1999. Ian McAuley has worked as an engineer, as a diplomat in the foreign service, and in the Commonwealth public service. He studied public administration at Harvard, and since 1987 has been at the University of Canberra, researching and teaching in public sector finance. Faculty of Medicine, University of Sydney, Sydney, NSW. Stephen R Leeder, PhD, FRACP, FFPHM, FAFPHM, Dean, and Professor of Public Health and Community Medicine. School of Management and Policy, University of Canberra, Canberra, ACT. Ian A McAuley, BE, DipBus, MPA, Lecturer. Reprints will not be available from the authors. Correspondence: Professor S R Leeder, Dean, Faculty of Medicine, Edward Ford Building, University of Sydney, NSW 2006. steveATmedicine.usyd.edu.au Make a comment Back to text Back to text Back to text

Stephen R Leeder · Ian A McAuley

Looking Foward Medicare: options for the next 25 years Richard B Scotton. MJA 2000; 173: 41-43 The best long-term option for healthcare in Australia would be a system of managed competition - - More articles on Administration and health services While it is difficult to predict the evolution of healthcare over as long a period as 25 years, we can be reasonably sure that some of the trends of the past 25 years will continue, and possibly accelerate. Thus, medical knowledge and the technology and techniques for its application will continue to advance and, on balance, this will increase costs. Two consequences will be that: equitable access, regardless of capacity to pay (ie, universality) will continue to be a basic component of living standards in an economically developed society, especially in the context of widening income disparities; and efficiency -- doing what is done at least cost (technical efficiency) and using scarce resources to maximise health outcomes (an aspect of allocative efficiency) -- will become an increasingly important component of health policy. Equity and efficiency Despite the theoretical trade-off between equity and efficiency, which applies in certain circumstances, these two objectives are not inconsistent. In fact, a universal national health insurance program gives the government a level of capacity to constrain total health expenditures, which is a necessary (but not sufficient) component of a strategy to increase efficiency. On the other hand, I am convinced that advocacy of improving efficiency by abandoning universal coverage is mistaken, and/or is the product of ideology or self-interest. Consequently, health policy options need to have as their goal the maximisation of efficiency within the framework of the overall equity goal. "Efficiency" in the economic sense means not only producing at minimum cost, but also managing the system so that it produces, at any given level of cost, that mix of outputs which contributes most to social goals and improved health outcomes. This will inevitably involve changes in industry structure. More complex technology and wider appreciation of the intricate interrelationships between epidemiological and social factors in health will call for an ever-increasing scale and more sophisticated interconnections between various parts of the healthcare sector. These factors impose increasing stresses on present structures for financing and delivering health services in all developed countries. The Australian scene In Australia, multiple program and funding streams, overlapping jurisdictions in the federal system of government and poorly articulated relationships between public and private sectors add layers of complexity to the problem. It is a tribute to the funders, managers and providers of health services that our system works as well as it does. On the whole, it provides universal and equitable access to most clinically effective health services, at an overall cost which compares well with those in most comparable countries, and is lower than some. The average citizen requiring health services would be as well treated in the Australian system as anywhere in the world. In other words, there is no "crisis" which constitutes a case for radical reform in the short term, but rather gradually increasing stresses -- organisational, financial and cultural -- flowing from changing patterns of morbidity and medical care. These stresses are largely or wholly unrelated to universality of access, to the present extent of public/private funding and service provision, or to the overall responsibility of public authorities for regulation of the system. A rational response to the current situation seems to justify a twofold strategy: first, implement some relatively straightforward measures to deal with specific difficulties, and second, work toward changes in management and funding arrangements to facilitate the evolution of delivery systems to achieve better health and related social outcomes from the available resources (the amount the community is prepared to allocate to these ends). Many of the options floated in recent years do not meet this specification. To my mind there are only two sensible directions for future reform: Limited reforms designed to ameliorate some systemic problem areas, while maintaining Medicare in more or less its present form; and More substantial reconfiguration of the legal and financial framework of the universal program in the direction of managed competition as a means of promoting increased efficiency of purchasing and service delivery. These options are not mutually exclusive. Rather, the first might stand alone, or could constitute a preliminary stage towards implementing the second. In fact, if one intended to move to managed care, solving some of the systemic problem areas would be a logical first step. The short term -- limited reforms There are several useful reforms which could be undertaken without amending the basic structure of Medicare. The most obvious and important deficiency of the present system relates to access to free hospital treatment, which is currently subject to widespread and lengthy waiting periods. This is largely due to the unsatisfactory nature of the financial arrangements, in which Commonwealth Government funding has never been tied to performance. The original Medibank cost-sharing arrangements allowed only limited control of total costs, and the subsequent method of block grants to the States, which have been in operation since 1981, have enabled some State governments to reduce their level of hospital funding to the point at which access to services has been significantly affected. This situation could be justified when there was no workable measure of hospital output, but since the development of casemix funding and the Australian national diagnosis-related groups (AN-DRGs) in the early 1990s this excuse no longer holds. The performance of the public hospital system, and the incentives for State governments to treat patients, could be greatly enhanced by replacing most or all Commonwealth Medicare grants to the States by DRG-adjusted case payments direct to hospitals. These payments could be calculated as a percentage of the cost per DRG episode, up to a volume of services determined by the Commonwealth Government. This payment system would have many benefits beyond the demonstrated increase in efficiency within hospitals. In particular, it would provide a basis for including hospital costs in the pooling of funds for coordinated care arrangements. It would also inhibit (but not eliminate) cost-shifting, and would facilitate detection of abuses, such as the partial diversion of public inpatients to private status. In the longer term, the substitution of case payments for Commonwealth grants would extend the options for more substantial structural reform of the universal program. The implementation of such payments lies well within the readily available powers of the Commonwealth Government. Other serious deficiencies of the present arrangements have been graphically described by a former State health administrator.1 They include the fragmentation of programs, poor articulation between public and private sector arrangements, and lack of comprehensive data on service utilisation at the individual patient level. The consequences include incapacity to control overservicing, receipt of benefits by ineligible persons, and barriers to developing coordinated care. The causes are partly the jurisdictional overlaps between Commonwealth and States, partly restrictions imposed by privacy legislation and its interpretation, and partly a general paralysis in policy development. A determined Commonwealth Government might be able to achieve a good deal in all the above respects within the framework of a totally public program, but there would be widespread reservation about the extent to which the Australian people would wish to concede to a government authority, however benign, the implied degree of control over their service use. The British National Health Service, whatever its virtues, is not a model for Australia in the 21st century. Perhaps, more importantly, a monolithic public program would lack incentives to increased allocative efficiency. In my view, increasing the efficiency with which scarce resources are used to produce health services is the most important determinant of our capacity to provide universal access to state-of-the-art healthcare in the long term. The standard means of achieving this is to increase the exposure of the participants to market incentives. For these reasons, I have become convinced that the best long-term option for Australia would be a system of managed competition. The longer term -- managed competition? In a managed competition system, private organisations would be free to compete with public provider(s) in the provision of services covered by public benefit programs such as Medicare, free public hospital care, pharmaceutical benefits, nursing home benefits and so on. The idea is a simple one. However, the formulation of a model in which a private market in healthcare would maximise efficiency in producing good health outcomes, free of risk shifting and other types of gaming, has been a more complex exercise. It has been said that there are lots of simple answers to complex questions, and that they are all wrong. All health systems are complex, and the Australian system, in several respects, is more complex than most. Any realistic solution is bound also to be complex, and, in the present context, it is possible to offer only the baldest outline of the managed competition model which I have developed progressively over the past decade (Box).2,3 In conclusion, the point has to be made that the rise in real costs of state-of-the-art healthcare will make it increasingly necessary to limit total expenditures on health. Raising the efficiency of resources used to produce services is the only way to minimise the consequent stresses. The managed competition model offers a framework within which higher efficiency can be pursued without sacrificing the principle of universal access, which remains as much as ever a core component of a humane society. References Paterson J. National healthcare reform: the last picture show. Melbourne: Department of Human Services (Victoria), 1996. Scotton R. Managed competition. In: Mooney G, Scotton R, editors. Economics and Australian health policy. Sydney: Allen & Unwin, 1998: 214-231. Scotton R. Managed competition: the policy context. Aust Health Rev 1999; 22(9): 103-121. Authors' details Richard Scotton is a health economist. He and John Deeble, as Research Fellows at the Institute of Applied Economic Research, University of Melbourne, between 1965 and 1970, formulated the program that became Medibank. From 1972 to 1979, Scotton was centrally involved in implementing Medibank, as Special Adviser to Minister for Social Security Bill Hayden and first Chairman of the Health Insurance Commission. Later appointments were Director (Planning) and Commissioner, Health Commission of Victoria; member of the Medicare Planning Committee appointed by Minister for Health Neal Blewett; General Manager (Policy and Planning), Victorian Accident Compensation Commission; and board member, Australian Institute of Health. Health Economics Unit, Centre for Health Program Evaluation, Monash University, Melbourne, VIC. Richard B Scotton, AO, BA, BEc, PhD, Honorary Professorial Fellow Make a comment Essential features of a managed competition model2,3 All current publicly supported programs - Medicare, free public hospital care, pharmaceutical/nursing home benefits, etc - to be rolled into one, so that all services and benefits for each individual would be paid from the same budget, thus eliminating much cost shifting and encouraging efficient service use. Defined roles for Commonwealth and State governments: the Commonwealth responsibilities limited to financing and the legislative/regulatory framework, and the States to public service provision and overseeing public budget holders. Organisation and management of health service delivery deputed to organisations entitled budget holders, which would be paid (by the Commonwealth Government) a risk-rated capitation for each person enrolled with them, and which would be required to meet all program costs incurred by their enrollees. Risk rating at the individual level is essential to minimise "cream skimming" and other forms of risk selection by budget holders. All persons not opting to be covered by a private budget holder would be covered automatically by a regional budget holder or, as a last resort, by the Health Insurance Commission. Private budget holders would be required to cover all services included in the public program, plus a minimum private hospital entitlement. They would be free to provide wider entitlements to private care, at unsubsidised additional cost. All providers (public and private) would depend for their incomes on payments from budget holders, under contracts or other arrangements (ie, there would be no government benefits or subsidies payable directly to service providers). It could be expected that basic tables (ie, those offering a minimum package of services) would involve some exposure to managed care (ie, medically directed restriction of choice) as incentives to efficient resource use become effective. Another outcome would be that services would be increasingly geared to the needs of people with greater health problems, since they would carry larger capitations. Over time, managed competition could be expected to result in profound structural changes in service provision. Back to text

Richard B Scotton

Looking Forward Medicare's maturity: shaping the future from the past John S Deeble MJA 2000; 173: 44-47 By any objective standards Medicare has performed extremely well - - More articles on Administration and health services There are almost as many suggestions for reform of Medicare as there are participants in the system. Depending on the perspectives, ideologies and interests of the proponents, these calls for reform range from its extension and consolidation under either Commonwealth or State management, through various permutations of private and public operation, to relegation of Medicare to a welfare safety net. Some people hold any universal program to be "unaffordable", although for whom is rarely made clear. Some see Medicare's open-ended medical insurance as wasteful, while others (and often the same people) view any limits to hospitalisation as a major fault. Doctors complain about fee levels, the Commonwealth and State governments argue over funding shares, and consumers blame "the system" for the fragmentation of their care. None of these viewpoints are surprising. Medicare is an insurance program, but all of the delivery systems it supports are also seen as part of it, and these will rarely meet all the demands of funders, providers and patients. Given the different perspectives of each group, no system ever could, and Medicare's ability to respond is often limited by factors outside the insurer's control. Political scientists like to point out that in public policy the relevant question is rarely "where do we go?" but more often "where do we go from here?". So first we need to explore where we are now. Medicare since 1986 The summary data for Medicare and the services it covers for 1985-86 and 1997-98 (the most recent year for which full information is available) are shown in Box 1. Expenditure for all health services has risen from 7.5% to 8.4% of gross domestic product (GDP), and most of the increase was in the recession years 1990-1992. However, for Medicare-covered services (medical, public hospitals and optometry), the rise has been very small -- only 0.2% of GDP. In 1995, Australia's health spending as a proportion of GDP was in the middle of the range of health spending of comparable First World countries. Medical services: On the medical side, average benefits paid per person rose by 31% (in constant 1997-98 prices) and the number of services increased by an almost identical amount (30% per person).1 Average fees per service were therefore almost constant in relation to general price changes, and fell by only about 2% when compared with consumer prices (ie, much less than is often argued). On average, fees charged were lower than the schedule level in every year,1 despite the common impression of widespread over-schedule billing. The latter is mostly by specialists, largest for insured patients in private hospitals, and a greater problem for private health insurers than for Medicare. Hospital services: Overall hospital admissions per person rose by nearly 50% over the 12-year period. That was an extraordinary rate of growth, mostly occurring after 1992, and all a result of same-day treatments; overnight admissions per person were almost unchanged (Box 2). Total hospital outlays per person increased by 52% in 1997-98 prices, but the public and private sector experiences were quite different. Per person, public hospital expenditures rose 39.5%, comprising a 34.5% increase in admissions and a rise of about 4% in real costs per admission.1 Nearly all of the increases in admissions were in public patient use (Box 2). In contrast, private hospital outlays per person rose by 115%, the product of a 90% increase in admissions per person and a 13% rise in unit costs. About half the increase in usage was a result of private patients switching from the public hospitals to private hospitals. The underlying growth in private hospital admissions was nevertheless substantial, particularly since the proportion of the population covered by private insurance fell by 18%. Financing Apart from complaints from doctors over fees, the main issue has been the roles of the Commonwealth and State governments in public hospital funding, with each party blaming the other for any perceived shortfall. The details are complex, but the essential data are summarised in Box 3. This shows annual changes in public hospital expenditure and changes in the Commonwealth Government's share. The three time periods shown are the five-year Medicare agreement periods, which set the level of Commonwealth funding. There were clear links between the two variables -- when the Commonwealth share was less than 50% the growth in total outlays fell -- and, despite all the rhetoric, that division in source of funding still underlies the system's behaviour. The level of Commonwealth grants is therefore crucial and their inadequacy in one particular period (1988-1993) has been the main destabilising factor. The other and more popular issue is the role of the Medicare levy, which is often criticised for funding only a small proportion of Medicare's costs. But no one ever claimed that it should do otherwise. It was intended to cover only that part of the medical benefits side, which had previously been met by private insurance -- about half of the total amount paid before Medicare was introduced in 1984. The politics of the time demanded a demonstrable linkage between new outlays and the Medicare levy. This still applies. In 1997-98, the yield of $3760 million was almost exactly half the Medicare benefit payout. The hospital side had always been funded from general taxation via grants to the States and that continued, ironically funded partly by the withdrawal of a 30% tax concession on private insurance, very similar to the subsidy reintroduced last year.2 Medicare today By any objective standards Medicare has performed extremely well. As I have said elsewhere,1 in any other context an industry which increased its output by 30%-35%, with almost no increase in its share of the national product, would be acclaimed as a major success story! Costs have risen almost exactly in line with prices generally and, except for pathology and imaging, growth in medical service use has stabilised since 1994. All of this was achieved in a healthcare system which gives patients and providers more freedom than almost any other system worldwide. But the clamour for change continues. Not all of the exploding demand for hospital admissions has been met and the impact of that demand, plus the costs of upgrading private hospital technology, has threatened private insurance viability. The 30% premium subsidy for private health insurance introduced in 1999, and recent changes from community rating to risk rating, attest to this -- no funding system, public or private, could long sustain an annual growth in hospital admissions of 3.5% per person, nearly twice the growth in GDP. The problem is a medicotechnological one, not one for Medicare alone. People do not admit themselves to hospital, doctors do -- and that is where the explanations must be found. However, some groups have contrived to present it as a crisis on which governments must act and which threatens the whole existence of a universal insurance scheme. What should be done As might be guessed, I am not among those supporting major structural changes to the present system. Special interests apart, the most substantive criticisms concern division of responsibilities for management and funding between the Commonwealth and State governments, institutions and professionals. All these predate Medicare. Its acceptance of the delivery systems, payment methods and reward structures of the time has also been criticised. Badly coordinated care, wasteful cost-shifting and weak incentives for efficiency are held to result. For many people, timidity rather than excessive zeal would be the main complaint. There is truth in this contention, although the Australian experience is not unique. No national insurance scheme has greatly changed the culture and practices which preceded it. The historical and constitutional divisions between the Commonwealth and State governments over medical and hospital services, insurance powers and revenue raising are so deeply intrenched that they could never have been resolved within the time frame which political action required, particularly in the circumstances of 1973-75 (see the articles by Scotton, and Hayden). Almost all proposals for payment change have met strong opposition from the medical profession, although some very modest progress has been made with program-based payments to general practitioners. How much this matters is debatable. The governmental (Commonwealth-State) division is certainly complicated, sometimes irrational and the source of much angst over cost shifting. The latter fascinates the bureaucrats and absorbs a disproportionate amount of their time. However, it works both ways, and I am not convinced that divided financial responsibility has as much effect on the fragmentation of services as many critics claim. The recent coordinated-care trials have shown that, at the operational level, pooling funds is not a sufficient condition for high-quality, efficient care.3 Poor management skills, rivalries and professional myopia are equally important problems. At a higher level, it should be possible to separate "desirable" cost rearrangements from stratagems, although distrust between the Commonwealth and States does not help. It would be naive to expect any major realignment of governmental roles in the foreseeable future. However, the climate could be changed if the Commonwealth Government were to take responsibility for all medical costs, including those in public hospitals and medical training. It would mean no more than setting the Federal-State financial division slightly differently, with no immediate implications for budgets or administrative responsibilities -- existing public hospital appointments would continue with only cost-neutral grant adjustments. That would be much more logical than the present situation in which the Commonwealth supports medical costs directly in the private hospitals, but has no role at all in the public sector. Separate government funding for all medical costs is standard practice in the Canadian system, and there are considerable advantages in it. Among other things, it would change much of the debate over cost shifting, but that would be only one of the anomalies addressed. Commonwealth funding of in-hospital medications has already been mooted on the pharmaceuticals side. The efficiency arguments are more fundamental. For the most radical reformers, any system in which providers both select and deliver services must be inherently flawed. In theory, competitive markets achieve efficiency by separating these two functions. Emulating their operation should therefore be the aim, at least as far as possible. The practical manifestations are schemes for separating purchasers from providers (even funder-purchaser-provider splits) with arm's-length dealing and varying degrees of competitive behaviour. Governments are entitled to mandate insurance and how its costs should be borne, but both the insurance function and the supply of services should be diversified. State hospital systems and single insurance authorities like Medicare are incompatible with such models. These are the same arguments and issues as were traversed 25 years ago, and, like most debates in which the evidence is a mixture of empirical data and behavioural assumptions, they can rarely be settled. My view is that, while there are some supporting services in which standards and outcomes can be sufficiently defined and measured for arm's-length dealing, they cannot be applied to healthcare as a whole. The basic problems of uncertainty and inequalities of information between users and providers were first explored by the Nobel Prize-winning economist, Kenneth Arrow, nearly 40 years ago.4 For patients, they imply a level of trust and delegation to providers unparalleled elsewhere, and the same is ultimately true for purchasers on their behalf. The United Kingdom and New Zealand were the first countries to embrace purchaser-provider separation and internal markets within their public systems. Their experience has shown that, at a general level, it is impossible to write contracts which sufficiently define the obligations of each party, and that the information costs of trying to monitor such contracts have been extremely high for very modest gains. Both systems have now been modified considerably. I am therefore sceptical about most market solutions, and equally doubtful about isolating funders from both user and provider contact. In the Australian context, that doubt is particularly relevant to proposals which would create more "independent" authorities outside the present system. It might be worthwhile, but it could also serve to simply shift responsibility. As it is, Medicare depends for adequate funding on a network of political obligations -- on the Commonwealth in return for money collected through the levy, and on the States in return for Commonwealth grants. These commitments could easily be avoided if government contributions became discretionary and there was someone else to blame. What changes are most likely For the foreseeable future, the medical side of Medicare will almost certainly remain, although technology and corporatisation will force some changes. The diagnostic services are prime examples. They are the fastest-growing expenditure group and the least satisfactory subjects for fee-for-service payment. Per person outlays for pathology and imaging have risen by 38% over the past five years, compared with a growth of only 5% for all other medical services.5 Recent attempts to cap growth have had only a limited effect, and, in pathology, a few corporate providers are now so dominant that their relationship with Medicare is more like commercial contracting than professional fee reimbursement. Imaging is heading in much the same way and commercial interests are making inroads into general practice as well. Potential responses by government and the medical profession cannot be canvassed here, but they can not wait too long. It is on the hospital side, and particularly the relationship between the public and private sectors, that there is most controversy. Australia is unique in having substantial private hospital and private insurance industries operating alongside a universal public program. Both Medibank and, originally, Medicare provided subsidies to private hospitals. They and the regulated private insurance were seen as supplementary to the public system for people who valued choice of doctor, hospital and time of treatment, but they were still regarded as a part of the Medicare system. As shown earlier, the result has been a slow decline in the proportion of the population holding private insurance, but not in the absolute number of patients treated privately and, paradoxically, a very large increase in private hospital admissions. Both perceptions and policy have changed significantly in recent years. Rhetorically, the emphasis has been on the competitive independence of private insurance, with a shift in its depiction from being supplementary to Medicare to being first a complement and then, most recently, an alternative to it. That is the thrust of the current recruitment campaign, however obliquely expressed. The purchase of advantage is recognised and an explicitly two-tier system encouraged by such devices as the levy surcharge on uninsured higher income earners and the portrayal of private insurance membership as a civic duty which assists the poor. There are many people who believe that these measures and the $1.7 billion premium rebate are simply precursors to either means testing Medicare or allowing people to opt out of it. Some realities It is hard to predict political decisions. But it is also easy to exaggerate the impact of current policies. In reality, all the present activity will not raise private insurance membership to much beyond a third of the population -- the same as in 1996 -- and the best estimate is that, although savings to the public hospital system in the long run might reach about $450 million (still only 3% of its total outlays), that is a long way off. None of the big-picture parameters will change. However, both costs and hospital use will rise. Costs -- in its rush to facilitate medical gap insurance, the Government's present restriction to "contracting" doctors will be removed. Average charges will inevitably increase (with the 30% Commonwealth funding) and, in the process, challenge the legitimacy of Medicare's whole schedule fee system and cost control. How can two levels of officially sanctioned charges both be right? Hospital use -- utilisation must rise because unrestricted hospital access is what private insurance offers and is bought for. But Australians are already among the highest hospital users in the world. In 1997-98, our rate of overnight admissions was 159 per 1000 population. In Canada it was 105 per 1000, down from 145 per 1000 in 1986.6 In the United States, the 1996 rate was 117 per thousand and falling.6 These are very substantial differences. It would be a pity if expediency and the demon of managed care prevented any serious thinking about their justification and how they came to be. As it is, one side of the Australian system is trying to contain hospitalisation as much as possible, while the other is effectively promoting it. References Deeble JS. Medicare: Where have we been? Where are we going? Aust N Z J Public Health 1999; 23: 563-570. Deeble JS. Health care under universal insurance: the first three years of Medicare. In: Butler JRC, Doessel DP, editors. Health economics: Australian readings. Sydney: Australian Professional Publications, 1989. Department of Health and Aged Care. The Australian Coordinated Care Trials: Interim Technical Report, Canberra: The Department, 1999. Arrow KJ. Uncertainty and the welfare economics of medical care. Am Econ Rev 1963; 53(5): 941-973. Department of Health and Aged Care, Medicare Statistics, 1984-85 to December Quarter 1999. Canberra: The Department, 98, 99, 106. Organisation for Economic Co-operation and Development. OECD health data 99 [on CD-ROM]. Paris, OECD, 1999. Authors' details John Deeble is Adjunct Professor of Economics in the National Centre for Epidemiology and Population Health, at the Australian National University. He was a Senior Research Fellow at the Institute of Applied Economic and Social Research (University of Melbourne) when he and Richard Scotton formulated the first proposals for universal health insurance. During the Medibank period he was a Special Adviser to the Minister for Social Security, Chairman of the Health Insurance Planning Committee and Deputy Chairman of the Health Insurance Commission. From 1977 to 1983, he was Director of the NHMRC Health Economics Research Unit and was appointed Special Adviser to the Minister for Health, Dr Neal Blewett, and Chairman of the Medicare Task Force in 1983-84. Subsequent appointments included Founding Director of the Australian Institute of Health and Welfare, and First Assistant Secretary of the Department of Health and Community Services. He was a Health Insurance Commissioner for 15 years to 1999. National Centre for Epidemiology and Public Health, Australian National University, Canberra, ACT. John S Deeble, AO, PhD, BCom, DipHospAdmin, Adjunct Professor of Economics. Reprints: Professor J S Deeble, National Centre for Epidemiology and Population Health, Australian National University, Canberra, ACT 0200. Make a comment 1: Vital statistics of Medicare, 1985-86, 1997-98* 1985-86 1997-98 Percentage increase Outlays as a percentage of GDP All health services Medicare only 7.5% 3.7% 8.4% 3.9% 0.9% 0.2% Outlays per person (1997-98 prices) Medical At fees charged At schedule fees At benefits paid $277 $300 $250 $386 $391 $328 39% 30% 31% Hospital Total Public Private $575 $483 $92 $875 $678 $197 52% 39% 115% Services per 1000 population Medical 7580 9850 30% Hospital admissions Total Public Private 193 142 51 288 191 97 49% 35% 90% *Data from Deeble 1999.1 GDP=Gross domestic product. Back to text Back to text Back to text

John S Deeble

Looking Forward Medicare: diagnosis and prognosis Frances C Cunningham MJA 2000; 173: 52-55 The system of mixed public-private healthcare funding works well in Australia and offers the best foundation for the future - - More articles on Administration and health services Australians have now experienced 16 years of national health insurance with Medicare, although the program implemented in 1984 was largely a renamed version of its predecessor, Medibank, introduced 25 years ago. How will the healthcare industry and its external environment change over the next 25 years, and what will be the impact on Medicare? How should we best appraise Medicare's strengths and weaknesses, take account of the fundamental changes that have occurred in healthcare delivery, and apply the better intelligence we now have on financial incentives and delivery mechanisms to develop a more effective national health insurance program for the future? Appraising Medicare How do Australians view Medicare? In a 1998 survey conducted to measure public satisfaction with healthcare, only 19% of Australians agreed that, on the whole, the system works well and only minor changes are needed to make it better.1 Forty-nine per cent wanted fundamental changes, and waiting times for specialist care and non-emergency surgery was reported as the most important consumer issue. The survey also revealed a substantial loss of public confidence in the healthcare system compared with a decade earlier, when 34% of Australians felt that the system needed only minor changes. On the plus side, Medicare has established affordable universal coverage for publicly funded, public hospital services and largely publicly funded, privately provided medical and optometrical services. Australians also have excellent coverage for mainstream pharmaceuticals. With a view to controlling health expenditure, at present at $50 billion and 8.4% of gross domestic product (GDP),2 these services were seen by government as the boundaries of publicly funded Medicare. While our health expenditure is at the median for OECD countries, our life expectancy is above the average. Weaknesses in the Medicare public program are evident: universal coverage only includes medical practitioners and optometrists, and the provision of other publicly funded ancillary services and community health services varies substantially within the various State or Territory health systems. Medicare's financial incentives A valid concern with implementing a national health insurance program is that it tends to lock in place the existing healthcare system. In Australia, this has meant the maintenance of the open-ended, traditional fee-for-service approach to financing medical and optometrical services, with little change in the delivery system structure. There are increasing concerns about the geographic maldistribution of medical services, especially in rural areas. With an administered pricing system, it is difficult to get the prices "right", especially with the rapid technological changes affecting healthcare. Moreover, the structure of such systems can have powerful effects (some intended and undesirable) on services delivered. For example, payment of general practitioners under Medicare has created incentives for shorter patient visits and higher patient throughput. In addition, preventive services -- health screening and disease management programs, and patient education and health outcomes monitoring -- tend not to be as effectively implemented in non-managed systems as in managed systems. Although trials of coordinated care have been implemented in Australia in recent years, they have been primarily public-sector oriented, whereas the major overseas examples of long-term, financially viable care management systems are in the private domain. In the United States, in addition to the coverage that private sector managed health insurance firms provide for those with private insurance, the government has contracted extensively with these health insurers to provide care to beneficiaries in government programs as an alternative to traditional coverage. Split responsibilities and inefficiencies Medicare creates a separation of payment of most ambulatory medical care from inpatient care, with non-hospital medical services and pharmaceutical services funded by the Commonwealth, and hospital and day-surgery services funded through the States and through private health insurance. This means that there are major structural impediments to the provision of a "seamless" web of services through all levels of care. This separation of payment has also made it difficult to move away from an emphasis on inpatient care and the resultant high levels of hospital utilisation. In 1997-98, overall Australian hospital utilisation was 1075 bed-days per thousand population (excluding same-day admissions).3 This compares with the 1996-97 rates of 318 and 335 days per 1000 population in the United States for health maintenance organisations (HMOs) and non-HMOs, respectively.4 The 1997-98 Australian hospital admission rate (excluding same-day admissions) of 16%3 was almost three times the 1996 US health insurance rate of 5.7% (for both managed care and non-managed care).5 In the United States, this reduction in acute inpatient care has been accompanied by an increase in subacute, home health and skilled nursing facility care. This has not happened in Australia, with the result that we have excess hospital bed capacity in both the public and private sectors. An important general caveat about measuring service use is that the assumption "more is better" does not necessarily hold true in healthcare consumption. It is inappropriate to assume that more care -- or more costly care -- is better, or that reductions in service use necessarily indicate reductions in quality. Hospital utilisation in Australia thus presents a conundrum: in spite of having such high levels (by international comparisons) of inpatient admissions and bed-day utilisation, as well as excess bed capacity, there are significant problems with public-hospital waiting lists. The solution lies in better care management and in appropriate care at the appropriate level, rather than in funding for additional beds. Reform of private health insurance Although 10% of total health expenditure is funded through private health insurance,2 the role of private health insurance within Australia's healthcare system has not been clearly delineated. Is private health insurance a supplement to or an alternative to the public health system? Initial estimates of the cost of Medicare assumed that at least 40% of Australians would maintain their private health insurance cover.6 Levels of private cover declined from 60% immediately pre-Medicare in 1983 to 30.1% in 1998.7 The legislative changes introduced in 1995 were intended to make insurance better value for money through agreements made between health insurers and hospitals and health insurers and medical practitioners. These changes have resulted in more effective negotiations between insurers and private hospitals. Since coming into power in 1996, the Howard Liberal-National Coalition Government has made significant progress in modernising the regulation of private health insurance. Within a short timeframe, most of the key recommendations of the 1997 Industry Commission Inquiry8 into private health insurance have been introduced, with the exception of the recommendation for a broad public inquiry into Australia's health system. Australians value choice, whether it be in education, airlines or healthcare. Australians also value a fair go. The Howard Government has introduced strategies to ensure that we maintain a viable mixed private and public healthcare system in Australia. Compared with the financial contribution of those relying totally on the public system, the contribution of privately insured Australians was inequitable. The 30% tax rebate on health insurance premiums for consumers is one part of an overall strategy to ensure the continuation of a mixed public and private health system in Australia. There is bipartisan support for the rebate, with the Leader of the Opposition, Kim Beazley, promising its retention by a Labor Government.9 The rebate ensures that there is a fairer, more equitable approach to financing healthcare for those who choose to pay for private cover, in addition to their Medicare levy payments and their contributions through taxable income (estimates for which range from 5% to 10%). The Private Health Insurance Administration Council reports that a record 187 000 Australians have joined health funds in the first three months of this year, with the fastest-growing membership being in the age bracket 30-34 years.7 This means that more than six million Australians now have health insurance, the highest level since 1996. There has also been stronger growth in no-gap cover for hospital-related medical costs, after the Harradine* amendment. The latter requires health insurers to have no-gap products in place by 1 July 2000 in order to offer the 30% rebate to their members. The legislation, just passed by Federal Parliament (the Health Legislation Amendment (Gap Cover Schemes) Act 2000), will allow the private health industry to develop "no gap" or "known gap" schemes which will operate without the need for contracts. The introduction of Lifetime Health Cover on 1 July 2000 is currently resulting in continued growth in private health insurance membership. Major changes relating to the capital adequacy and solvency requirements of health insurers are to be introduced shortly to provide more clearly defined safeguards for consumers. Major impacts over the next 25 years The fundamental challenge for Medicare, with its financing and delivery systems belonging to the last century, will be coping with the impact of key trends envisaged for 2025. Most of these trends will affect the future costs of Medicare. The health insurance system of the future will also be shaped by the wider sociopolitical, moral and ethical environment, in terms of what is politically feasible and acceptable to the electorate. In particular, what will be the trade-off between the extent of public coverage and the tax burden? Also relevant will be our capacity to reduce behavioural risk factors across societal groups to achieve reductions in morbidity and increases in life expectancy. The magnitude of the contribution of the behavioural risk factors to the disease burden in Australia has recently been estimated, with tobacco smoking causing an estimated 10% of the disease burden in Australia, followed by physical inactivity (7%).10 The Internet, electronic commerce and information technology The Medicare system will be strongly affected by information technology and the Internet. At present, a depressingly large fraction of healthcare processes are still mediated by paper (medical records, prescriptions, appointments, bills and claims). According to Goldsmith,11 an eminent US healthcare forecaster and strategist, what the Internet promises healthcare managers and clinicians is a flexible information architecture that can reach down into the dozens, even hundreds, of healthcare information "silos" and extract, analyse, aggregate and redirect the data clinicians or managers require to make decisions. E-commerce also promises to reduce administration costs. Beyond clinical uses, promising Internet applications in healthcare include: Paperless transmission, assessment and payment of medical and hospital claims; Paperless prescribing of and payment for pharmaceutical items; Medical product ordering and inventory management; Outsourcing of data processing and other management functions; and Smart cards will permit the compiling and updating of standardised patient information using a common platform. The challenges in achieving such uses lie in standardising the coding and formats for clinical and health-related data and in standardising patient identification while protecting privacy. The National Health Information Management Advisory Council has developed a national plan of action for information management in the health sector.12 However, gaps in private sector representation on the Council need to be addressed urgently. Further, the Commonwealth must take the lead in legislatively mandating the development of such electronic standardisation requirements. This would accelerate progress to be made in efficiencies from e-commerce and from performance measurement across the health system. Rising consumer expectations As the post-war "baby boomers" become key healthcare consumers, they will demand more for themselves and for their frail, aged parents. Consumers have aggressively embraced the Internet to acquire health information. The Internet will also strengthen the role of consumers in their interactions with practitioners and healthcare institutions, and create a powerful new tool to help people manage their own health risks. These empowered consumers will demand better information to ensure quality and safety in healthcare. Consumerism will also foster a demand for a wide range of choice of new services and products, many of which will not be paid for by public Medicare. Medical advances, technological change and clinical practice Medical advances and new technologies are likely to continue to develop and will put pressure on cost growth. The Human Genome Project will dramatically alter healthcare. In an era of "individual medicine", genetic screening will identify health risks, and new treatments and precisely targeted pharmaceuticals will emerge. Advances will occur with bioengineered organs, organ transplantation, artificial skin and bones, methods of promoting and inhibiting angiogenesis, and new vaccines. Point-of-care testing, such as hand-held blood and saliva analysers, will move testing to the bedside, the clinic and the home. Telemonitoring in the home will alter demand for home health aides. Berwick envisages that, in the information age, medical practice will be a "knowledge producing" enterprise and not the "contact producing" enterprise of the last century.13 That knowledge will include the best evidence for diagnosis and treatments. There will be a greater focus on the development of standards of care, clinical guidelines and protocols, and on prevention, as well as ambulatory or home care. A greying Australia Compared with the uncertainties of other future impacts, the consequences of demographic change are more certain. The Australian Bureau of Statistics14 projects that the share of the population over age 65 will rise from 12.4% in 2001 to 18% in 2021 as the first wave of the "baby boomers" reaches 75 years. In 2021, the median age will be 40.4 years. Under current arrangements, the burden of increased future health costs would fall on the relatively diminished numbers of non-elderly. Combined with the increased burden of social security, the load may be too great. Governments will need to decide what core elements the tax-funded health system will cover. It is likely that some of the increased costs will have to be reallocated to the elderly. It is likely too that they will aim to protect their superannuated livelihoods through long term care insurance as they enjoy longer life expectancy. The ideal future financing model An ideal model for future healthcare financing is outlined in the Box. I have described this model in greater detail elsewhere.15Advocates for one single health funder, while largely driven by ideology, are campaigning for all health services to be funded through a government-run, single government payer system. Debate over whether government funding or private insurance constitutes the ideal financing model is reaching resolution in a number of overseas countries. The answer seems to be both. On average, private insurance pays about 10% of healthcare costs in OECD countries and is growing at a rate of 5%-7% a year. According to the report HealthCast 2010: smaller world, bigger expectations,16 these trends mean that most of the industrialised world will have both a strong publicly funded government health program and a private, market-based one. While acknowledging areas for improvement in both sectors, on balance the mixed public-private system works well in Australia and offers the best foundation for the future. This aspect of the overall framework of Medicare allows for choice by consumers, rather than the alternative of a totally government-controlled, nationalised health system. In addition, with proposals such as that of the Democrats for regional health authorities to pay medical practitioners on a capitation or salaried basis,17 it could be wise for medical practitioners themselves to have the option of another payer. Ideally, within the future Medicare framework, private health insurers should be able to offer their members a comprehensive range of health services, which should include, as a minimum, ambulatory medical services and inpatient services. This would extend the benefits of a mixed system to both consumers and medical practitioners. Footnotes* Brian Harradine, Independent Tasmanian Senator in Federal Parliament (from 1975 to the present). References Donelan K, Blendon RJ, Schoen C, et al. The cost of health system change: public discontent in five nations. Health Affairs 1999; 18(3): 206-216. Australian Institute of Health and Welfare. Australia's health services expenditure to 1997-98. Canberra: AIHW, 1999 (Health and Welfare Expenditure Series -- Health Expenditure Bulletin No. 15). Australian Institute of Health and Welfare. Australian hospital statistics 1997-98. Canberra: AIHW, 1999. (Health Services Series AIHW Catalogue No. HSE 6.) Tu HT, Kemper P, Wong HJ. Do HMOs make a difference? Use of health services. Inquiry 2000; 36(4): 400-410. Weinick RM, Cohen JW. Levelling the playing field: managed care enrolment and hospital use, 1987-1996. Health Affairs 2000; 19(3): 178-184. Australian Department of Health, Housing, Local Government and Community Services. Reform of private health insurance. A discussion paper. Canberra: AGPS, 1993. Private Health Insurance Administration Council. Quarterly statistics. March 2000. Canberra: PHIAC (May 14), 2000 <www.phiac.org.au> (accessed 7 June 2000). Industry Commission. Private health insurance. Canberra: AGPS, 1997. (Report No. 57.) Beazley K. Health insurance rebate. 4QR Radio: 09:00 News, 22 Feb, 2000. Mathers CD, Vos ET, Stevenson CE, Begg SJ. The Australian Burden of Disease Study: measuring the loss of health from diseases, injuries and risk factors. Med J Aust 2000; 172: 592-596. Goldsmith J. How will the Internet change our health system? Health Affairs 2000: 19(1): 148-156. National Health Information Management Advisory Council. Health Online: a health information action plan for Australia. Canberra: AusInfo, 1999 <www.health.gov.au/healthonline> (accessed 7 June 2000). Berwick D. Knowledge always on call. Modern Healthcare 1999; 29(39) Suppl: 2-4. Australian Bureau of Statistics. Population projections: 1997 to 2051. Canberra: ABS, 1998. (Catalogue No. 3222.0.) Cunningham FC. Medicare reform: via managed care or managed competition? Healthcover 1997; February-March: 8-16. PricewaterhouseCoopers. HealthCast 2010: smaller world, bigger expectations. Dallas, Tex: PricewaterhouseCoopers, 1999. Australian Democrats. Health reform: delivering a remedy. Canberra: Australian Democrats (April 17), 2000 <www.democrats.org.au/campaigns/health/> (accessed 7 June 2000). Authors' details Frances Cunningham is the Executive Director of the New South Wales Health Funds Association, and a member of the NSW Private Health Forum. She has a background as a healthcare consultant, health manager, health policy analyst and health services researcher. She was formerly Senior Policy Adviser to two NSW Ministers for Health, and a member of the NSW Senior Executive Service. She headed the Commonwealth Task Force which developed the discussion paper "Health maintenance organisations: a development program under Medicare" for former Federal Minister for Health, Dr Neal Blewett. NSW Health Funds Association, Sydney, NSW. Frances C Cunningham, ScD, Executive Director. Reprints: Dr F C Cunningham, NSW Health Funds Association, PO Box A2572, Sydney South, NSW 1235. francescATtpgi.com.au The views expressed are solely those of the author, and no endorsement by the NSW Health Funds Association is intended or should be inferred. Make a comment A future national health insurance porgram15 The objectives of a national insurance program should include: Universal coverage; A financially stable and viable program; Choice - and adequate information for Australians to make informed choices; and Comprehensiveness of coverage. Comprehensiveness of coverage will need to include: Better coverage for aged healthcare services; Access to quality healthcare; and Affordability for both those covered and those financing the program. Funding of the program should ensure: Macroeconomic efficiency - the costs of healthcare should not exceed an acceptable share of national resources; Microeconomic efficiency - the mix of services chosen should secure health outcomes and consumer satisfaction at minimum cost; and that Funding arrangements are transparent to the public. Financing mechanisms for Medicare will need to be reviewed: the levy, the tax regime, including relevant income-tax credits and debits, the Commonwealth-State grants arrangements; and the Australian Health Care Agreements. Other aspects of the model: Tax-based financing - an appropriate vehicle for those choosing public Medicare could be the existing Medicare levy (essentially an income-tax), although it should be adjusted on a sound actuarial basis to reflect the true health contribution, with an adjustment to financing from general income tax. Health insurance premiums - for those choosing to directly pay for private health insurance, premiums would be paid to health insurers. Financing for them could include a levy exemption or, if they did pay a levy, their risk-adjusted Medicare funds would flow on to the health insurer. Community rating would continue to apply to individual premium contributions. As at present, people would continue to contribute to social support through their general tax dollars. Ultimately, health insurance contributions should probably be a combination of employee and employer contributions, analogous to superannuation. The fringe benefits tax on employer contributions should be removed. Competition - under this model, strong competition would be possible between public and private health funders, both providing coverage for at least a standard comprehensive benefits package. Both sectors would be able to contract on a competitive basis for the most cost-effective quality providers, whether in the public or private sector. Back to text

Frances C Cunningham

Australia has a long history of vital registration, with excellent statistics on causes of death. These have been widely used to describe and monitor major public health issues, ranging from the progression (and decline) of chronic disease epidemics1 to the emergence of recent threats to health such as HIV/AIDS.2 Mortality data have been used to demonstrate the success of public health interventions, a good example of which is their use to document Australia's extraordinary success in reducing road traffic deaths since the early 1970s.3The use of mortality data as a fundamental component of the public policy process is related in part to their widespread availability and timeliness. While statistics on causes of death are undoubtedly useful for public health surveillance, they do not adequately represent a population's level of health, as they disregard the importance of widely prevalent, severely disabling conditions. An ideal health metric is therefore one which simultaneously measures and contrasts both fatal and non-fatal health outcomes. Indeed, such a measure is needed to assess the benefits of health interventions, which may reduce both mortality and the period of life lived in a disabled state. Tobacco use alone accounts for about 10% of the entire national burden of disease... It was precisely these considerations which motivated the development of disability-adjusted life years (DALYs) and disability-adjusted life expectancy (DALE) as the principal summary measures of population health in the Global Burden of Disease Study.4 DALYs are a gap measure; they measure the gap between a population's actual health and some defined health goal, while DALE belongs to the family of health expectancies, summarising the expected number of years to be lived in the equivalent of "full health". Both DALE and DALYs require a number of social value choices relating, among other things, to the valuation of time spent in less than perfect health, the definition of an implied norm for population health, and the differential weighting of years of life lived at different ages. Murray and Lopez have described in some detail how these social value choices were made in the Global Burden of Disease Study,5 arguing for the use of age weighting, discounting, and deliberative procedures which emphasise societal perspectives on health-state valuation, rather than individual preferences. After the publication of the Global Burden of Disease Study, much work has been done in several countries to improve upon the methods and databases which were used to estimate disease burden in 1990. In this issue of the Journal, the results of the Australian Burden of Disease Study are reported by Mathers et al, summarising the health of Australians in 1996.6 The complete, extensive report and summary document were published by the Australian Institute of Health and Welfare in November 1999.7,8 With this ground-breaking analysis, debates about public health priorities in Australia will be markedly better informed. Not only do policymakers now have a comprehensive and comparative view of the disease burden from 176 diseases and injuries, but, using DALYs as a common metric, the contribution of major risk factors to that burden has been quantified. The results, if perhaps not surprising, confirm the need to incorporate non-fatal health outcomes into health policy debates. For females, depression and dementia, neither of which are leading causes of death, are leading causes of disease burden, ranked 3rd and 4th, respectively, after ischaemic heart disease and stroke. Osteoarthritis and asthma are also among the top 10 causes of disease burden. Among males, the leading causes of disease burden (ischaemic heart disease, stroke, lung cancer, chronic obstructive pulmonary disease, suicide and road traffic accidents) are also leading causes of death. The importance of sequelae among non-fatal incident cases (eg, after stroke or chronic obstructive pulmonary disease) and the younger-age pattern of deaths in males (eg, from suicide or road traffic accidents) clearly increase the contribution of these causes to DALYs. This is precisely what one would hope a health metric would accomplish. Much effort has been devoted to health promotion in Australia in recent decades, with considerable success, but the results of this study suggest that much more remains to be done. Tobacco use alone accounts for about 10% of the entire national burden of disease and injury in Australia, and, although much of this is attributable to past smoking, significant progress in further reducing the disease burden from tobacco must remain a public health priority. Interestingly, of the other attributable risk factors, both physical inactivity and obesity were found to contribute importantly (4%-6%) to disease burden, suggesting that the public health implications of the worldwide trend towards a higher prevalence of overweight adults may well have been seriously underestimated.9 Contrasting the leading causes of disease and injury burden with the contributions of the various risk factors provides a clear and objective statement about health priorities in Australia. Are burden of disease studies useful? Do they justify the extra time and resources needed over and above a review of cause of death statistics, and, where available, health survey data on the incidence and prevalence of diseases, injuries and disabilities? Surely they do. The value of comparative assessments of the causes of health loss, be they fatal outcomes or otherwise, is obvious. Simultaneously quantifying disease burden from several causes minimises the tendency to "inflate" the burden from specific conditions viewed in isolation. Moreover, burden of disease studies provide an accounting tool to assess the quality, availability and relevance of data collection systems for the purpose for which they were intended -- namely, to guide and inform public health policy and action. The work of Mathers and colleagues will not only enrich public health debates in Australia, but their methodological advances will be of considerable relevance to similar efforts under way or contemplated elsewhere. Alan D Lopez Coordinator, Epidemiology and Burden of Disease World Health Organization, Geneva, Switzerland lopezaATwho.ch d'Espaignet E, van Ommeren M, Taylor F, et al. Trends in Australian mortality, 1921-1988. Canberra: Australian Institute of Health and Welfare/AGPS, 1991. (Mortality Series No. 1.) Gold J, Li Y, Kaldor JM. Premature mortality in Australia 1983-1992: the first decade of the AIDS epidemic. Med J Aust 1994; 161: 652-656. Lopez AD. Competing causes of death: a review of recent trends in mortality in industrialized countries. Trends in cancer mortality in industrial countries. Ann N Y Acad Sci 1990; 609: 58-74. Murray CJL, Lopez AD. Progress and directions in refining the global burden of disease approach: a response to Williams. Health Econ 2000; 9: 69-82. Murray CJL, Lopez AD. The Global Burden of Disease: a comprehensive assessment of mortality and disability from diseases, injuries and risk factors in 1990 and projected to 2020. Cambridge, Mass: Harvard University Press on behalf of the World Health Organization and the World Bank, 1996. Mathers CD, Vos ET, Stevenson CE, Begg SJ. The Australian Burden of Disease Study: measuring the loss of health from diseases, injuries and risk factors. Med J Aust 2000; 172: 592-596. Mathers C, Vos T, Stevenson C. The burden of disease and injury in Australia. Australian Institute of Health and Welfare. Canberra: AIHW, 1999. Also at: <http://www.aihw.gov.au/publications/health/bdia.html> (accessed 12 May 2000). Mathers C, Vos T, Stevenson C. The burden of disease and injury in Australia: summary report. Australian Institute of Health and Welfare. Canberra: AIHW, 1999. Also at: <http://www.aihw.gov.au/publications/health/bdiasr.html> (accessed 12 May 2000). World Health Organization. Obesity: preventing and managing the global epidemic. Geneva. World Health Organization, 1998. (WHO/NUT/NCD/08.1.)

Alan D Lopez

Recommendations from the Australasian Society of Thrombosis and Haemostasis Abstract The anticoagulant effect of warfarin should be kept at an international normalised ratio (INR) of about 2.5 (desirable range, 2.0-3.0), although a higher level may be better in a few clinical conditions. The risk of bleeding increases exponentially with INR and becomes clinically unacceptable once the INR exceeds 5.0. Warfarin therapy should be continued for around six weeks for symptomatic calf vein thrombosis, and for 3-6 months after proximal deep vein thrombosis (DVT) that occurs after surgery or limited medical illness. Therapy for six months or longer could be considered for DVT occurring without an obvious precipitating factor, proven recurrent venous thromboembolism (VTE), or if there are continuing risk factors. Oral anticoagulants prevent ischaemic stroke in atrial fibrillation (AF). Maximum efficacy requires an INR > 2.0, but some benefit remains at an INR of 1.5-1.9. Patients aged over 75 years are at greatest risk of intracranial bleeding during warfarin therapy for AF, and the target INR may be reduced to 2.0-2.5, or perhaps as low as 1.5-2.0, in such patients. Warfarin should be withheld if it is more likely to cause major bleeding than to protect from stroke (eg, in young people with isolated AF where the annual baseline risk of stroke is < 1%). In patients with AF, aspirin is less effective than warfarin (much less effective after such patients have had a stroke or transient cerebral ischaemia). In people with prosthetic heart valves, an INR of 2.5-3.5 is probably sufficient for bileaflet or tilting disc valves, but a higher target INR is necessary for caged ball or caged disc valves. The addition of aspirin (100 mg/day) further decreases the risk of embolism but increases the risk of gastrointestinal bleeding. Warfarin is used for preventing and treating venous or arterial thrombosis and embolism. It is a potentially hazardous drug, causing major bleeding in 1%-2% of people treated, and intracranial bleeding in about 0.1%-0.5% during each year of therapy. These risks are well recognised, but strong recent evidence that many otherwise healthy people with atrial fibrillation (AF) or venous thromboembolism (VTE) can benefit from long term warfarin therapy has led to a major increase in its use. These consensus guidelines offer advice on the selection of patients for warfarin therapy and management of such patients. The recommendations draw on proceedings of the Fifth American College of Chest Physicians Consensus Conference on Antithrombotic Therapy,1 and are consistent with the most recent Guidelines on oral anticoagulation developed for the British Society for Haematology.2 Warfarin therapy and management of complications The INR The INR (international normalised ratio) is a good indicator of effectiveness and risk of bleeding during warfarin therapy and is best kept at about 2.5, with a target range of 2.0-3.0, for most clinical indications, although higher levels may be better for certain patients (Box 1). The lower limit of this target range recognises a threshold level for effectiveness, while the upper limit is set to minimise bleeding. Starting and maintaining warfarin therapy The daily maintenance dose of warfarin differs greatly between individuals, commonly between 0.5 mg/day and 15 mg/day, and often fluctuates over time. The average maintenance dose is about 4.5 mg/day, although this is lower in the elderly. The drug is rapidly and completely absorbed and immediately blocks further hepatic synthesis of the functional vitamin K-dependent haemostasis factors (II, VII, IX, X, protein C, protein S). However, its impact on the INR is delayed until preformed coagulation factors are removed, so dose adjustment must allow for these delayed effects. The plasma half-life of warfarin is about 36 hours.3 In the past, it was customary to use a loading dose of 10 mg. However, for most situations, a reduced starting dose of 5 mg per day will achieve an INR of 2.0 in four to five days.4 INR is measured daily or every second day during the first week of treatment, with the dose of warfarin (taken in the evening) titrated against the morning's INR. It is then measured at increasing intervals depending on response. Many patients, once the dose is stable, can be well controlled with 4-6-weekly testing and dose adjustment, but others need more frequent assessment. An empirical approach to warfarin dosing can be smooth and effective but published dose-adjustment tables can help.2 Old age, reduced body weight, and impaired cardiac or liver function all predict a smaller than average dose requirement. Multiple comorbidities and a need for many drugs increase the risk of an unstable anticoagulant response. The effect of warfarin is subject to multiple interactions. These include the dietary content or extent of absorption of vitamin K, the absorption of warfarin and its effect on the liver (which are increased or decreased by many other drugs), and the clearance of blood-clotting factors.1,3 Intercurrent illness, starting or stopping therapy with other drugs (especially antibiotics and amiodarone) and changes in diet or bowel function can all influence the INR. Rechecking the INR within a few days of any change in medication or clinical condition is prudent. Bleeding is minimised by regular monitoring to avoid an excessive INR and by educating patients about how warfarin works, why their dose requirement may change, and the likely settings and symptoms of bleeding complications. Successful warfarin therapy requires a partnership with patients, who should be encouraged to have their INR checked soon after any change in their normal routine. Clinics should periodically audit their results with warfarin therapy and review exceptional cases. Between 50% and 75% of INRs are likely to fall into their designated therapeutic range.5 Two recent Australian case reports are reminders that bioequivalence has not been formally demonstrated for Coumadin and Marevan (both from Boots Healthcare Australia, Sydney, NSW), the two locally available formulations of warfarin.6 Warfarin and bleeding Major bleeding has been reported in 1.1%-8.1% of patients during each year of long-term warfarin therapy (1.1%-2.7% by anticoagulant clinics managing patients with prosthetic heart valves,7-9 1.3% in atrial fibrillation trials, and 2.8%-8.1% after a stroke or transient ischaemic attack10-12). Risk factors include old age, serious illness (cerebral, cardiac, kidney or liver disease), cerebrovascular or peripheral vascular disease, and an unstable anticoagulant effect. Forgetfulness, non-steroidal anti-inflammatory drugs and alcohol abuse may also contribute.7,9,13-15 Warfarin appears to be especially hazardous after a transient ischaemic attack or minor stroke; in one trial, 14 months of warfarin therapy with a relatively high target INR of 3.0-4.5 increased major bleeding from 0.9% to 8.1%, intracranial bleeding from 0.5% to 4.1%, and fatal intracranial bleeding from 0.2% to 2.6% (relative to low dose aspirin therapy).12 Bleeding is most likely during the first three months of treatment, and often follows trauma or unmasks a previously unsuspected comorbidity.8,13-15Age alone is not a contraindication to warfarin therapy. Although one report showed that each decade above the age of 40 raised the risk of major bleeding by almost 50%, with a maximum effect above 70 years,7 others have found that age below 70 years has no influence.8,15 The INR is the dominant determinant, whether bleeding is expressed as the absolute risk per annum (Box 2) or as relative risk. In a 1996 study, the bleeding rate was doubled as the INR increased from 2.0-2.9 to 3.0-4.4, quadrupled between 4.5-6.0, and was multiplied by five when the INR was above 7.0.15 There is a consistent increase in major bleeding (including intracranial bleeding16) when the INR exceeds 4.0-5.5.7,11,14 A 1997 trial found that each increase in INR by 0.5 multiplied the risk of major bleeding (mostly intracranial) by 1.43.12 Managing an excessively prolonged INR or bleeding caused by warfarin therapy An INR above 5.0 requires close monitoring and often needs intervention, as determined by the level of the INR and the presence or absence of bleeding (Box 3). The INR often remains elevated for some days, even if warfarin is withheld, but small amounts of vitamin K1 quickly correct the INR to safer levels. In most patients, 1-2.5 mg of oral vitamin K1 reduces the INR from 5.0-9.0 to 2.0-5.0 within 24-48 hours; this intervention is usually sufficient in the absence of bleeding.17,18 These small doses are obtained by withdrawing the desired amount from a 10 mg vial of injectable vitamin K1 and giving this orally or parenterally. When the INR is > 9.0, then 5 mg vitamin K1 may be more appropriate and can be given orally, subcutaneously or intravenously (very rarely, the last may cause a serious anaphylactoid reaction). In people with a massive accidental or self-inflicted warfarin overdose, the long half-life of warfarin means that the INR may rebound over several days as the effects of vitamin K1 wear off. In any case, the response to vitamin K1 needs to be monitored. Bleeding caused by a warfarin overdose is controlled with clotting factor replacement (Box 3), and this may also be indicated in the absence of bleeding when the risk is very high.19 Bleeding or an unstable dose-response should trigger a review of the need for warfarin. Continued treatment will require closer monitoring of the INR, both to detect the transient warfarin resistance caused by too much vitamin K1, and to avoid further overanticoagulation. Heparin treatment may be required to cover a prolonged period of warfarin resistance. Interrupting warfarin therapy for surgery When there is a need for surgery, the risk of perioperative bleeding under continued warfarin therapy must be balanced against the risk of thromboembolism if warfarin therapy is stopped.20Most surgery, including hip or knee replacement and many thoracic or abdominal operations, can proceed under continued warfarin cover without undue bleeding (provided the INR during and soon after surgery is about 1.5-2.0). Warfarin therapy is a contraindication for regional anaesthesia (eg, spinal, epidural, brachial blocks) and is unacceptable where even minor bleeding might cause critical damage (as in neurosurgery and some plastic surgery). It is also unpopular with most surgeons. However, the absolute daily risk of a serious thromboembolic event is small in most people with AF, previous systemic embolism or a prosthetic heart valve (the hazard is greatest from mitral and older-model prosthetic valves, and in patients with more than one prosthetic valve). Thus, it is safe to stop warfarin therapy for several days before and after surgery in such patients. High-dose heparin cover for these indications is rarely indicated as the risk of bleeding is usually prohibitive.20 The risk of recurrence is greatest during the first four weeks after VTE, so warfarin therapy should not be interrupted during this time if at all possible. If anticoagulants must be stopped for surgery soon after VTE, a vena cava filter can be placed to minimise the risk of life-threatening pulmonary embolism. Specific indications for warfarin therapy Deep vein thrombosis and pulmonary embolism Prevention: Heparins are now usually the preferred drugs for the prevention of perioperative VTE, but warfarin retains a limited role when the risk of thrombosis is very high. Its main role is in long-term therapy. Warfarin is no less effective than low molecular weight heparins after hip or knee replacement, and the risk of bleeding is similar or lower when therapy is started at about the time of surgery and continued at least until patients are fully mobile.21 Treatment: Anticoagulants prevent early thrombus extension and embolism and minimise late recurrence. Heparin treatment can be stopped after a minimum of five days when warfarin therapy is also being given, provided that the two drugs are overlapped for at least four days and the INR has exceeded 2.0 for two or more days.22 Increasingly, deep vein thrombosis (DVT) is now managed at home -- an approach preferred by many patients and made possible by trials which found that initial treatment with low molecular weight heparins given in a fixed dose by subcutaneous injection is no less effective or safe after DVT than standard heparin therapy. Home heparin therapy requires close monitoring to ensure compliance and a safe and effective start for warfarin therapy.23,24 Although warfarin is now usually given for 3-6 months after VTE, there is growing evidence that the optimal duration of treatment is determined by the patient's clinical presentation. Six to 12 weeks of warfarin therapy is probably enough when DVT follows surgery or transient immobilisation ("secondary" DVT), as recurrence is minimised by six weeks of treatment after symptomatic calf vein DVT,7 and by three months of treatment after proximal DVT.25,26 However, warfarin therapy for longer than six months may be required after "idiopathic" DVT, recurrent VTE, or when there is a continuing cause like cancer or an inherited or acquired "hypercoagulable" state.27-30 Whether, in these circumstances, warfarin should be given for 12 months, two years, or longer, remains under active investigation. For individuals, the choice will also be influenced greatly by risk of bleeding. Controversies in the management of DVT and VTE Calf vein thrombosis: Although calf vein DVT poses little immediate threat and is commonly believed to be clinically unimportant, it has the potential to extend and embolise. In a randomised comparison where 51 patients with symptomatic calf DVT were treated for five days with heparin only or with heparin followed by ongoing warfarin therapy, there was a recurrence during the next three months in eight of 28 patients from the first group (23%: seven clinically suspected and confirmed; five with proximal extension and one with embolism), but none in the second.31 Therefore, patients with calf vein thrombosis should be treated with warfarin unless there are contraindications. Accuracy of diagnostic tests for DVT: Venous ultrasonography has now replaced venography as the first-line diagnostic test for clinically suspected DVT. Despite its limited sensitivity to small calf vein DVTs, a negative ultrasound result almost excludes thrombosis when there is a low pretest clinical probability for DVT (a DVT score of zero on a checklist of clinical features obtained before ultrasonography, such as active cancer, immobilisation, major surgery, entire leg swelling, localised tenderness, calf swelling, pitting oedema and collateral superficial veins).32 However, for patients in whom the pretest clinical probability is moderate (DVT score of 1-2) or high (score, > 3), a negative ultrasound result does not exclude a small DVT, and they should have either early venography or further ultrasonography once or twice within the next seven days in case there is proximal extension of an undetected calf thrombus. This approach is validated by extensive clinical follow-up.33 Recurrent or idiopathic DVT or VTE: In a randomised trial of patients presenting with recurrent DVT, oral anticoagulant therapy for six months was followed by a recurrence in 21% during four years of follow-up, compared with 3% when treatment was continued. However, ongoing warfarin therapy increased the rate of major bleeding during the four years from 2.7% to 8.6%, while mortality remained unchanged.27 Similarly, in a separate trial of management after a first "idiopathic" VTE, warfarin therapy for three months was followed by recurrence in 16 of 77 patients during 10 months of follow-up, compared with only one of 76 patients in whom warfarin therapy was continued.30 However, the use of warfarin increased the annual risk of major bleeding from zero to 4%.30 These high rates of bleeding reinforce the need for careful risk assessment when considering patients for long term anticoagulant therapy after VTE. The results of these trials suggest that warfarin therapy should be continued for one year after an "idiopathic" or recurrent VTE if the risk of bleeding is acceptable, and that treatment should be extended to two years if warfarin control is straightforward and the bleeding risk remains low. Atrial fibrillation Warfarin is now widely used to prevent systemic embolism in otherwise healthy patients with atrial fibrillation (AF). In clinical trials, warfarin consistently reduced the annual risk of a first ischaemic stroke (including stroke with a residual functional deficit) by almost 70% (from 7% to 3% per annum) and mortality by 33%, at the cost of a small increase in serious bleeding (from 1.0% to 1.3% per annum).10,34,35 The prevalence of AF rises from about 3% at 65 years to more than 10% by 85 years, and AF accounts for about 1.5% of all strokes in people aged 50-59 years, and almost 25% of strokes in people aged 80-89 years. Age is therefore an important determinant of ischaemic stroke in AF (the relative risk [RR] of stroke in AF rises by 1.4 with each decade).35 Previous stroke or transient ischaemic attack (RR, 2.5), diabetes (RR, 1.7), and treated hypertension (RR, 1.6) also contribute, as do heart failure, ischaemic heart disease, a large left atrium, and left ventricular dysfunction.10 Stroke is unlikely in isolated AF but becomes more likely as additional risk factors accumulate (Box 4). This makes warfarin therapy inappropriate for young people with AF alone and no other cardiac risk factor (isolated AF), as their annual risk of stroke (< 1%) is low enough to ensure that risk of bleeding always equals or exceeds any likelihood of gain. Because of the risk of bleeding, these reports raise important questions about the best target level of INR, and about which patients with AF should be offered long-term warfarin therapy. The incidence of stroke is minimised by an INR > 2.0 and increases exponentially below this level, but some benefit remains while the INR is 1.5-1.9. When considering warfarin therapy for AF, each candidate requires a formal estimate of the relative risks of stroke (Box 4) and bleeding (Box 2). Controversies about the use of warfarin or aspirin to prevent stroke in atrial fibrillation Stroke and the INR: The risk of stroke during warfarin therapy for AF is dictated by the INR. Below 2.0, the relative risk doubles at 1.7, triples at 1.5, sextuples at 1.3, and reaches 18 times once the INR is normal, but nothing is gained by increasing the INR beyond its therapeutic threshold of 2.0.36 Results were similar when warfarin was given for secondary stroke prevention in patients with AF who had already developed a stroke or transient cerebral ischaemia.11 Again, in a randomised trial in which patients with AF plus at least one other risk factor for stroke were given either warfarin in a dose to prolong their INR (INR, 2.0-3.0; median, 2.4) or aspirin combined with a low dose of warfarin (0.5-3.0 mg/day; INR, 1.2-1.5; median, 1.3), the dose aiming for the higher INR was clearly superior.37 Aspirin or warfarin for AF? The 30% risk reduction in stroke from aspirin treatment is well below the 70% achieved with warfarin therapy.10 In a blinded analysis of clinical outcomes when the two drugs were compared, warfarin was better at preventing cardioembolic strokes and strokes of uncertain cause.38 This is consistent with the small effect observed with aspirin for secondary stroke prevention in patients with AF and who have had a stroke or TIA -- warfarin reduced the risk of recurrence by 62%, compared with only 16% for aspirin.39 It may be a useful compromise to reserve aspirin for patients with uncomplicated AF whose baseline risk of embolism is low. Warfarin, INR and aspirin in elderly patients with AF: Age above 75 years and a high INR both increase the hazard from intracranial and other major bleeding during warfarin therapy. Because there is some residual benefit at an INR of 1.5-1.9, this reduced target range may offer an acceptable exchange of safety for benefit in some elderly patients. Where the risk of bleeding is high, aspirin is less effective, but safer than warfarin. Cardioembolic stroke prevention in conditions other than AF There is evidence that cardioversion to correct a recent cardiac arrhythmia should be delayed until after three weeks of anticoagulant cover to prevent systemic embolism.35 Warfarin prevents embolic stroke and other arterial embolism, as well as VTE, after myocardial infarction (MI), and is often given for 3-6 months when MI is followed by intraventricular thrombus formation (risk factors include transmural anterior infarction and ventricular dysfunction).40 A good case also exists for long term warfarin therapy in some patients with ongoing left ventricular dysfunction.41,42Prosthetic heart valves Improved design has greatly reduced the thrombogenicity of mechanical prosthetic heart valves, but the need for effective, lifelong warfarin therapy remains because systemic embolism is still the main source of late mortality and morbidity. The risk is determined by the type of valve and its position (higher for mitral than aortic valves, greatest when both are replaced). Tissue valves, by contrast, are almost free of thromboembolic complications, except during the first three months.43The American College of Chest Physicians recommends an INR of 2.0-3.0 for recent-model bileaflet or tilting disc valves, and 2.5-3.5 for older and more thrombogenic valves that have a caged ball or disc; patients with a newly placed bioprosthetic (tissue) valve require three months of warfarin and an INR of 2.0-3.0.43 However, in our view, because the evidence is incomplete, it remains prudent to retain a target range of 2.5-3.5 for most ("low-risk") prosthetic valves while aiming higher (3.0-4.5) for older and more thrombogenic models, provided there is no contraindication (Box 1). This view is consistent with recent recommendations from the British Society for Haematology.2 Antiplatelet drugs alone are ineffective, but combining dipyridamole or aspirin (100 mg/day) with warfarin reduces the risk of systemic embolism. Meta-analysis suggests that the penalty for adding aspirin is a 2.5-times increase in major gastrointestinal bleeding,44 so the combination is perhaps best avoided, except in patients considered to be at unusually high risk of systemic thromboembolism (more than one mechanical valve, previous embolism, associated AF).43 Special circumstances for anticoagulation Antiphospholipid antibody syndrome and factor V Leiden: Two retrospective surveys of clinical outcomes in patients with antiphospholipid antibody syndrome and venous and/or arterial thrombosis suggest that warfarin therapy fails to prevent recurrent thromboses unless the INR is prolonged above 3.0.45,46 This contrasts with a more recent report of few recurrences while the INR was 2.0-3.5.47 Without better information, and until randomised trials are complete, it is not possible to make a firm recommendation about the optimal target range for this condition. The effect of aspirin alone in preventing thrombosis in the antiphospholipid antibody syndrome is unclear.45-47 There is no current evidence to suggest that patients with factor V Leiden-heterozygous abnormality should require more intense anticoagulation. It is still uncertain whether the duration of therapy should be increased in these patients, as evidence from reports about the risk of recurrent VTE is conflicting.28,29,48 Oral anticoagulants in pregnancy: Oral anticoagulants cross the placenta and should be avoided throughout pregnancy, especially during the first and third trimesters.49 Treatment at 6-12 weeks' gestation causes calcified epiphyses (chondrodysplasia punctata) and a characteristic nasal hypoplasia in offspring,50 while later exposure is associated with central nervous system abnormalities, including microcephaly.51 In one report, almost 30% of children (10 of 35) born to mothers with a prosthetic heart valve were malformed if acenocoumarol was taken through 6-12 weeks' gestation, but none of 19 developed a malformation when this drug was replaced with heparin before the sixth week.52 Continuing warfarin therapy until term also exposes infants to the risk of intracranial and other major bleeding during birth. Heparins do not cross the placenta and do not cause these problems.53-55 It is safe to breastfeed during warfarin therapy as there is minimal excretion into breast milk.56 References Hirsh J, Dalen JE, Anderson D, et al. Oral Anticoagulants. Mechanism of action, clinical effectiveness and optimal therapeutic range. Chest 1998; 114 Suppl: 445S-469S. Walker ID, Machin S, Baglin TP, et al. Guidelines on oral anticoagulation. 3rd ed. Br J Haematol 1998; 101: 374-387. Holbrook AM, Wells PS, Crowther NR. Pharmacokinetics and drug interactions with warfarin. In: Poller L, Hirsh J, editors. Oral anticoagulants. Sydney: Arnold, 1996: 30-48. Crowther MA, Ginsberg JB, Kearon C, et al. A randomized trial comparing 5 mg and 10 mg warfarin loading doses. Arch Intern Med 1999; 159: 46-48. Rose P. Audit of anticoagulant therapy. J Clin Pathol 1996; 49: 5-9. Coumadin and Marevan are not interchangeable. Aust Adverse Drug React (ADRAC) Bull 1999; 18: 6. van der Meer FJM, Rosendaal FR, Vandenbroucke JP, Briet E. Bleeding complications in oral anticoagulant therapy: an analysis of risk factors. Arch Intern Med 1993; 153: 1557-1562. Cannegieter SC, Rosendaal FR, Wintzen AR, et al. Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med 1995; 333: 11-17. Levine M, Raskob GE, Landefeld S, Kearon C. Hemorrhagic complications of anticoagulant treatment. Chest 1998; 114 Suppl: 511S-523S. Laupacis A, Boysen G, Connolly S, et al. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med 1994; 154: 1449-1457. The European Atrial Fibrillation Trial Study Group. Optimal oral anticoagulant therapy in patients with nonrheumatic atrial fibrillation and recent cerebral ischemia. N Engl J Med 1995; 333: 5-10. The Stroke Prevention in Reversible Ischemia Trial (SPIRIT) Study Group. A randomized trial of anticoagulants versus aspirin after cerebral ischemia of presumed arterial origin. Ann Neurol 1997; 42: 857-865. Landefeld S, Beyth RJ. Anticoagulant-related bleeding: clinical epidemiology, prediction and prevention. Am J Med 1993; 95: 315-328. Fihn SD, McDonnell M, Martin D, et al. Risk factors for complications of chronic anticoagulation. A multicenter study. Ann Intern Med 1993; 118: 511-520. Palareti G, Leali N, Coccheri S, et al. Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT). Lancet 1996; 348: 423-428. Hylek EM, Singer D. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med 1994; 120: 897-902. Weibert RT, Le DT, Kayser SR, Rapaport SI. Correction of excessive anticoagulation with low-dose oral vitamin K1. Ann Intern Med 1997; 125: 959-962. Crowther M, Donovan D, Harrison L, et al. Low-dose oral vitamin K reliably reverses over-anticoagulation due to warfarin. Thromb Haemost 1998; 79: 1116-1118. Makris M, Greaves M, Philips W, et al. Emergency oral anticoagulant reversal: the relative efficacy of infusions of fresh frozen plasma and clotting factor concentrate on correction of the coagulopathy. Thromb Haemost 1996; 77: 477-480. Kearon C, Hirsh J. Management of anticoagulation before and after elective surgery. N Engl J Med 1997; 336: 1506-1511. Clagett GP, Anderson FA, Geerts WH, et al. Prevention of venous thromboembolism. Chest 1998; 114 Suppl: 531S-560S. Hyers TM, Agnelli G, Hull RD, et al. Antithrombotic therapy for venous thromboembolic disease. Chest 1998; 114 Suppl: 561S-578S. Koopman MMW, Prandoni P, Piovella F, et al. Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home. N Engl J Med 1996; 334: 682-687. Levine M, Gent M, Hirsh J, et al. A comparison of low-molecular-weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep-vein thrombosis. N Engl J Med 1996; 334: 677-681. Schulman S, Rhedin A-S, Lindmarker P, et al. Comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. N Engl J Med 1995; 332: 1661-1665. Levine MN, Hirsh J, Gent M, et al. Optimal duration of oral anticoagulant therapy: a randomized trial comparing four weeks with three months of warfarin in patients with proximal DVT. Thromb Haemost 1995; 74: 606-611. Schulman S, Granqvist S, Holmstrom M, et al. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. N Engl J Med 1997; 336: 393-398. van den Belt AGM, Sanson B-J, Simioni P, et al. Recurrence of venous thromboembolism in patients with familial thrombophilia. Arch Intern Med 1997; 157: 2227-2232. Simioni P, Prandoni P, Lensing AWA, et al. The risk of recurrent venous thromboembolism in patients with an Arg506 to Gln mutation in the gene for factor V (Factor V Leiden). N Engl J Med 1997; 336: 399-403. Kearon C, Gent M, Hirsh J, et al. A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism. N Engl J Med 1999; 340: 901-907. Lagerstedt CI, Olsson C-G, Fagher BO, et al. Need for long-term anticoagulant treatment in symptomatic calf-vein thrombosis. Lancet 1985; 2: 515-518. Wells PS, Anderson DR, Bormanis J, et al. Value of assessment of pretest probability of deep-vein thrombosis in clinical management. Lancet 1997; 350: 1795-1798. Heijboer H, Buller HR, Lensing AW, et al. A comparison of real-time compression ultrasonography with impedance plethysmography for the diagnosis of deep-vein thrombosis in symptomatic outpatients. N Engl J Med 1993; 329: 1365-1369. Singer DE. Overview of the randomized trials to prevent stroke in atrial fibrillation. Ann Epidemiol 1993; 3: 563-567. Laupacis A, Albers GW, Dalen JE, et al. Antithrombotic therapy in atrial fibrillation. Chest 1998; 114 Suppl: 579S-589S. Hylek EM, Skates SJ, Sheehan MA, Singer DE. An analysis of the lowest effective intensity of prophylactic anticoagulation for patients with nonrheumatic atrial fibrillation. N Engl J Med 1996; 335: 540-546. Stroke Prevention in Atrial Fibrillation Investigators. Adjusted-dose warfarin versus low-intensity, fixed-dose warfarin plus aspirin for high-risk patients with atrial fibrillation: Stroke Prevention in Atrial Fibrillation III randomised clinical trial. Lancet 1996; 348: 633-638. Miller VT, Pearce LA, Feinberg WM, et al. Differential effect of aspirin versus warfarin on clinical stroke types in patients with atrial fibrillation. Neurology 1996; 46: 238-240. European Atrial Fibrillation Trial Study Group. Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. Lancet 1993; 342: 1255-1262. Cairns JA, Theroux P, Lewis HD Jr, et al. Antithrombotic agents in coronary artery disease. Chest 1998; 114 Suppl: 611S-633S. Fuster V, Gersh BJ, Giuliani ER, et al. The natural history of idiopathic dilated cardiomyopathy. Am J Cardiol 1981; 47: 525-531. Al-Khadra AS, Salem DN, Rabd WR, et al. Warfarin anticoagulation and survival: a cohort analysis from the studies of left ventricular dysfunction. J Am Coll Cardiol 1998; 31: 749-753. Stein PD, Alpert JS, Dalen JE, et al. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest 1998; 114 Suppl: 602S-610S. Cappelleri JC, Fiore LD, Brophy MT, et al. Efficacy and safety of combined anticoagulant and antiplatelet therapy versus anticoagulant monotherapy after mechanical heart-valve replacement: a metaanalysis. Am Heart J 1995; 130: 547-552. Rosove MH, Brewer PM. Antiphospholipid thrombosis: clinical course after the first thrombotic event in 70 patients. Ann Intern Med 1992; 117: 303-308. Khamashta MA, Cuadrado MJ, Mujic F, et al. The management of thrombosis in the antiphospholipid-antibody syndrome. N Engl J Med 1995; 332: 993-997. Krnic-Barrie S, O'Connor CR, Looney SW, et al. A retrospective review of 61 patients with antiphospholipid syndrome: analysis of factors influencing recurrent thrombosis. Arch Intern Med 1997; 157: 2101-2108. Eichinger S, Pabinger I, Stumpflen, et al. The risk of recurrent venous thromboembolism in patients with and without Factor V Leiden. Thromb Haemost 1997; 77: 624-628. Ginsberg J, Barron W. Pregnancy and prosthetic heart valves. Lancet 1994; 344: 1170-1172. Koren G, Pastuszak A, Ito S. Drugs in pregnancy. N Engl J Med 1998; 338: 1128-1137. Hall JG, Pauli RM, Wilson KM. Maternal and fetal sequelae of anticoagulation during pregnancy. Am J Med 1980; 68: 122-140. Iturbe-Alessio I, del Carmen Fonseca M, Mutchinik O, et al. Risks of anticoagulant therapy in pregnant women with artificial heart valves. N Engl J Med 1986; 315: 1390-1393. Ginsberg JS, Kowalchuk G, Hirsh J, et al. Heparin therapy during pregnancy. Risks to the fetus and mother. Arch Intern Med 1989; 149: 2233-2236. Fejgin MD, Lourwood DL. Low molecular weight heparins and their use in obstetrics and gynecology. Obstet Gynecol Surv 1994; 49: 424-431. Sanson B-J, Lensing AWA, Prins MH, et al. Safety of low-molecular-weight heparin in pregnancy: a systematic review. Thromb Haemost 1999; 81: 668-672. Orme ML, Lewis PJ, de Swiet M, et al. May mothers given warfarin breast-feed their infants? BMJ 1977; 1: 1564-1565. Background and evidence basis of recommendations The Australasian Society of Thrombosis and Haemostasis Consensus Guidelines for Warfarin Therapy were written on behalf of the Australasian Society of Thrombosis and Haemostasis (ASTH). The writing committee was commissioned by council and consisted of Associate Professor A S Gallus (Chairman), Dr R I Baker, Professor B H Chong, Dr P A Ockelford and Associate Professor A M Street. The guidelines were developed after extensive consultation with the membership of the ASTH, including several workshops and teleconferences. The draft recommendations were open for comment and discussion at the 1998 annual scientific meeting of the ASTH in Sydney. They draw upon review of all available evidence from published studies and from clinical experience. The aim is to provide an Australian perspective on the evidence to guide all practitioners in the safe and effective use of oral anticoagulants in hospital and the community. We are grateful for the help of Dr K McGrath, Dr M Herzberg (Quality Assurance Program in Haematology, Royal College of Pathologists of Australasia), Dr P Montanaro (Royal Australian College of General Practitioners), Dr P Steele (Australia and New Zealand Cardiac Society) and Professor J Fletcher (International Union of Angiology). Authors' details Australasian Society of Thrombosis and Haemostasis, Perth, WA. Alex S Gallus, FRACP, FRCPA, Chairman; Ross I Baker, FRACP, FRCPA; Beng H Chong, FRACP, FRCPA; Paul A Ockelford, FRACP, FRCPA; Alison M Street, FRACP, FRCPA. Reprints will not be available from the authors. Correspondence: Professor A S Gallus, Director, SouthPath, C/- Flinders Medical Centre, Bedford Park, SA 5042. 1: Range of international normalised ratio (INR) recommended for specific applications of warfarin therapy* Condition INR range Preventing DVT (high risk patients, like those who have had hip replacement) 2.0-3.0 Therapy after DVT or pulmonary embolism 2.0-3.0 Preventing systemic embolism Atrial fibrillation Valvular heart disease After myocardial infarction Tissue heart valves (first 3 months) 2.0-3.0 2.0-3.0 2.0-3.0 2.0-3.0 Bileaflet mechanical heart valve (aortic) 2.5-3.5 Mechanical prosthetic heart valve (high risk) 3.0-4.5 Preventing recurrence of myocardial infarction 3.0-4.5 Thrombosis in antiphospholipid antibody syndrome 3.0-4.5 DVT=deep vein thrombosis . *Based largely on the 5th American College of Chest Physicians Consensus Conference1 and consistent with current recommendations of the British Society for Haematology.2 2: Risk of major bleeding (% per annum) and international normalised ratio (INR) - findings of two studies23,30 INR Study 130 Study 223 < 2.0 2.0-2.9 3.0-3.9 4.0-4.9 5.0-5.9 ≥ 6 3% 2%-3% 2%-3% 4% 5% 5%-13% 0 1% 3% 4% 50% 3: Managing overdose and bleeding during warfarin therapy* Clinical setting Action INR >5.0 but < 9.0 (no bleeding) Stop warfarin, give 1-2.5mg vitamin K1, measure INR in 6-12 hours, restart warfarin at reduced dose once INR is < 5 INR ≥9.0 (no bleeding) Stop warfarin, give 5mg vitamin K1, measure INR in 6-12 hours, restart warfarin at reduced dose once INR is < 5, clotting factor replacement? if high risk of bleeding Major bleeding (any level of INR) Stop warfarin, give 5mg vitamin K1, clotting factor replacement, measure INR as required, assess need to restart warfarin INR=international normalised ratio. *Based on Makris et al, 1996.19 ?Blood products available in Australia for clotting factor replacement after warfarin overdose include fresh frozen plasma and Prothrombinex-HT (CSL Limited), a factor II, IX and X concentrate. 4: Risk of ischaemic stroke in patients with atrial fibrillation (AF), grouped by age and other risk factors* (derived from Laupacis et al10) Risk categories Patients affected per annum Lone atrial fibrillation† Age < 60 years Age 60-69 years Age 70-79 years Age ≥80 years 0 1.6% 2.1% 3.0% Age < 65 years No risk factors One or more risk factors 1.0% 4.9% Age 65-75 years No risk factors One or more risk factors 4.3% 5.7% Age >75 years No risk factors One or more risk factors 3.5% 8.1% *Hypertension, diabetes, previous stroke or transient ischaemic attack. †Atrial fibrillation without transient ischaemic attack or stroke, myocardial infarction, hypertension or heart failure.

Alex S Gallus · Ross I Baker · Beng H Chong · Paul A Ockelford

Matters Arising Doctors' working hours Three articles (and a controversial cover photo) in our 15 June issue, highlighting the perennial problem of excessive working hours for doctors, have inspired comment from junior and senior doctors, and even doctors' family. MJA 1998; 169: 339-341 Shorter hours reduces training - William B Molloy Family concern - Annie Lee The forgotten generation - Terry G Coupland Treat the cause, not the symptoms - Michaela J Farrall In reply: Long hours are a financial reality - Leslie G Olson Smoking among doctors - Mark C J Craddock In reply: Recollections of smoking among doctors - Martin B Van Der Weyden ª 1999 Medical Journal of Australia.

Editorial Reconciliation, social equity and Indigenous health A call for symbolic and material change MJA 2000; 172: 468-469 The current state of health of Indigenous Australians is a cause for national shame, and has its roots in the wholesale exclusion of Indigenous people from Australian society since 1788. A comprehensive approach to improving the health of Aboriginals and Torres Strait Islanders involves understanding the close relationships between their social and economic status and their health. At some point in our growth as a nation there must be a commitment by all Australians to social and educational equity and economic prosperity for Indigenous Australians. Only then will there be significant improvements in the health of Indigenous Australians. There is a growing body of knowledge about the social determinants of health,1-3 and evidence that relates disease patterns to the organisation of society and the way society invests in its human capital. Evidence worldwide shows a clear relationship between poverty, deprivation, social exclusion and ill-health. Socioeconomic disadvantage in childhood, inadequate nutrition, poor education, unemployment, and psychosocial factors (such as lack of self-esteem and social support, often associated with addictive behaviours) are causative of ill-health, and this can occur with or without access to good-quality medical care.1-3 Recognition of Indigenous people's prior ownership of the land is central to their achieving social and economic equity in Australia A child raised in an affluent home is likely to succeed educationally, which in turn favours entry to more privileged sectors of the labour market, with financial security in old age. A child from a disadvantaged home is likely to achieve few educational qualifications, leave school at the minimum age, and enter the unskilled labour market, where pay is low, the work often hazardous, and old age means reliance on the welfare system. A number of longitudinal studies confirm these relationships and show that they result in higher morbidity and mortality for the more socially disadvantaged.1,2 There are biologically plausible links between social and economic disadvantage and health. If the biological stress response is activated too often and for too long, there are multiple health effects -- depression, increased susceptibility to infection, glucose intolerance leading to diabetes, and high blood pressure and accumulation of cholesterol in blood vessel walls leading to heart attack and stroke. A life-course perspective views a person's physiological status as a marker of their past social position. Thus, past social experiences become written into the body's physiology and pathology.1-3 The situation for Indigenous Australians is further exacerbated by racism and prejudice, which have marginalised them from various aspects of social and community life, with additional detrimental effects on health. What evidence is there that this relationship between health and social disadvantage has adversely affected Australia's Indigenous people? Life expectancy at birth, which is an overall measure of health status, is 56.9 years for Indigenous men and 61.7 years for Indigenous women, compared with 75.2 years and 81.1 years, respectively, for non-Indigenous men and women.4 In 1997, fewer than 31% of Indigenous students remained in Year 12, compared with over 72% of non-Indigenous students. In the 1996 Census, while Indigenous people made up only 2.1% of the Australian population, they accounted for 19% of the adult prison population,4,5 and 41% of the inmates of juvenile corrective institutions4 (and the proportion of young Indigenous people in detention has increased further since the introduction of the mandatory detention laws in Western Australia and the Northern Territory5). The unemployment rate for all Indigenous Australians is likely to increase from 39% to 47% by the year 2006.6 Indigenous households are more likely to be overcrowded, but, despite this, have a lower median weekly income. Similarly, other measures of social disadvantage also show an over-representation of Indigenous people. Understanding the social determinants of health and these disturbing figures and taking the Indigenous health debate to the next level has always been fraught with misconceptions. A common myth concerns the high levels of spending on Indigenous health, and this has been debunked in a recent report showing that, for all health services, recurrent expenditure on a per-person basis was only 8% higher for Indigenous compared with non-Indigenous people. Furthermore, Indigenous people benefit very little from Medicare and the Pharmaceutical Benefits Scheme, with drawing rates only 27% and 22%, respectively, of non-Indigenous levels.7 Another major myth is that Indigenous people do not want to help themselves. It is true that you cannot help people unless they want to help themselves, but, in relation to education, numerous reviews, inquiries and consultations in recent years have reported that, contrary to popular belief, Indigenous people do place a high priority on education: "They want for themselves and their children no less than is afforded other Australians. They expect that educational processes should lead them to acquire the knowledge and skills necessary to realise their individual potential, lead satisfying lives, and contribute actively to the community."6 The current approach to Indigenous health is exemplified by the Western Australian Indigenous Child Health Survey. This is a population survey of an estimated 3150 children, aged from 0 to 17 years, which aims to improve our understanding of the health and educational needs of Indigenous children. The results will be used to develop a planned approach to the desired improvements in this area. For example, the initial WA Child Health Survey resulted in an improved range of State and national programs. These programs placed an emphasis on early intervention and prevention in child and adolescent mental health services, parenting strategies and programs, school programs for students at educational risk and promotion of mental health in schools. These data are also required for Australia to meet its obligations to the United Nations to report on the health status of Indigenous children. At a national level one of the most significant recent developments has been the establishment of the Office for Aboriginal and Torres Strait Islander Health Services in the Commonwealth Department of Health. Since it was established in 1995, there has been a more comprehensive planning and funding strategy targeting Indigenous health issues, with improved focus on primary healthcare and Aboriginal community involvement in healthcare delivery. While these efforts in health and education are encouraging, they do not address the prevailing attitudes in Australian society which marginalise and disempower Indigenous people. T S Eliot wrote: "We shall not cease from exploration And the end of all our exploring Will be to arrive where we started And know the place for the first time."8 Since arriving in Australia, the non-Indigenous population have wanted to believe that this was a "Terra Nullius", an uninhabited land that they could possess and use to their advantage without recognising the rights of the Indigenous peoples.9 Non-Indigenous Australians might gain a better understanding of Australia when they fully appreciate the inherent truth in Indigenous people's claims to land, justice and livelihood in this nation. Recognition of Indigenous people's prior ownership of the land is central to their achieving social and economic equity in Australia. In March 1999 the United Nations Committee on the Elimination of Racial Discrimination found that the Federal Government's 1998 amendments to the Native Title Act 1993 are in breach of Australia's obligations under the Convention on the Elimination of All Forms of Racial Discrimination. It is argued that these amendments fail to respect the cultural identity of Indigenous people and fail to promote the preservation of their culture, as required by the United Nations.10 The Council for Aboriginal Reconciliation continues working to achieve its vision of "A united Australia which respects this land of ours; values the Aboriginal and Torres Strait Islander heritage; and provides justice and equity for all."11 The cause of reconciliation has been furthered in recent years by improved spending on health services and health programs, particularly by the Commonwealth Government. These efforts need to continue and to become more appropriate and focused. The major challenges of the future centre on the reconciliation process, and the willingness of all Australians to take the actions that bring symbolic and material change. Facing these challenges with integrity and courage will benefit Australia's Indigenous people and the nation as a whole. Sandra J Eades Indigenous Health Research Unit, Population Sciences Division TVW Telethon Institute for Child Health Research Derbarl Yerrigan Health Service; and Department of Paediatrics University of Western Australia, Perth, WA sandyATichr.uwa.edu.au Marmot M, Wilkinson RG, editors. Social determinants of health. New York: Oxford University Press, 1999. Keating DP, Hertzman C, editors. Developmental health and the wealth of nations: social, biological and educational dynamics. New York: The Guildford Press, 1999: 25-35. The relationship between fetal malnutrition and chronic diseases in later life [editorial]. BMJ 1997; 315: 825-826. Australian Bureau of Statistics. Health and welfare of Australia's Aboriginal and Torres Strait Islander peoples. Canberra: ABS, 1999. (Catalogue No. 4704.0.) Human Rights and Equal Opportunity Commission. Mandatory detention laws in Australia. <http://www.hreoc.gov.au/human_rights/child_rights/h5_1_7.htm> (Accessed 19 April 2000). Commonwealth Department of Education, Training and Youth Affairs. Indigenous school to work transitions, 1998. <http://www.detya.gov.au/publications/schooltowork/default.htm> (Accessed 19 April 2000). Commonwealth Department of Health and Family Services. Expenditure on Health Services for Aboriginal and Torres Strait Islander People. Canberra: DHFS, 1998. Four Quartets: Little Gidding: V, lines 26-29. The complete poems and plays of TS Eliot. London: Faber & Faber, 1969: 197. Reynolds H. Why weren't we told? A personal search for the truth about our history. Ringwood: Penguin books, 1999. Human Rights and Equal Opportunity Commission. Submission to the United Nations Committee on the Elimination of Racial Discrimination: Response to the request for information in relation to Decision 1(53) concerning Australia 1998. <http://www.hreoc.gov.au/social_justice/native_title/index.html> (Accessed 19 April 2000). Council for Aboriginal Reconciliation. <http://www.austlii.edu.au/au/orgs/ car/index.htm> (Accessed 19 April 2000). Make a comment

Sandra J Eades

Editorial Clinical pathways and fractured neck of femur The generalisability and cost effectiveness of clinical pathways need further research MJA 2000; 172: 415-416 The proportion of Australians aged 65 and over is projected to continue increasing for the next 50 years.1 Fractures of the neck of femur are common in this age group and are associated with increased risk of morbidity and mortality, long-term institutionalisation and costly management. Their impact on a public healthcare system funded by an ever-diminishing number of tax-paying workers is a major concern. Increasing attention is being given to improving management of these fractures and rehabilitation of patients.2-5 Morbidity and mortality rates have been reduced through increased surveillance for and treatment of complications, such as wound and other infections, pressure sores and deep venous thrombosis. Early involvement of multidisciplinary teams in patient rehabilitation and early mobilisation have been used in large hospitals to reduce delays and optimise treatment for previously ambulatory patients. These programs result in fewer perioperative complications and enable patients to return home and resume functional independence earlier, reducing the number who need long term residential aged care.2,3 However, these improvements come at a cost -- direct costs, such as salaries of additional staff for multidisciplinary teams,6 and indirect costs, such as when patients are sent home early, and postdischarge care is assumed by family and community.7 Pressure on hospital administrations to contain or reduce costs may result in outcomes of little, if any, benefit to the patient, but which may have a substantial impact on others living with or looking after the patient. Little is known about the nature and extent of this potential impact. Implementation of these efforts needs to be both preceded and accompanied by careful evaluation and assessment. Among strategies that attempt to achieve savings is the development and use of clinical pathways, as outlined by Choong and colleagues8 in this issue of the Journal. A clinical pathway is a type of management plan formulated for a specified condition, which defines expected daily activities, identifies lines of responsibility for those activities, and indicates goals for the patient to achieve along the way.9 These pathways are based on a multidisciplinary perspective and collaboration. Introduction of a clinical pathway requires considerable commitment and investment of time from many departments within the hospital, as well as substantial changes to the medical record. It also raises concerns about the medicolegal implications of non-compliance with the pathway in the event of an adverse outcome. All these issues require further study.10,11 Clinical pathways have been successfully implemented for a variety of conditions and settings, overseas and in Australia. However, patient groups have been relatively homogeneous, such as those having elective hip, knee or other surgery. In contrast, hip-fracture patients are very heterogeneous, ranging from the fit, active (albeit osteoporotic) "young" elderly, to the very frail, bedridden 90-years-plus residents of nursing homes. A clinical pathway developed from evidence-based practices may be the most efficient way to restore the mobility of elderly patients and ensure their discharge back to their pre-admission residence. However, because of the high level of comorbidities in these patients, the potential for variation from the pathway is high.2 Choong and colleagues describe a controlled trial of a clinical pathway for patients with proximal femoral fracture in a major teaching hospital.8 Modest benefits were found for the hospital budget, and clinical outcomes for patients on the pathway appeared no worse than for patients who received standard hospital treatment. Use of the pathway seemed to have little real effect on shortening stay in comparison with the control group; the major difference in stay was found for patients who required review by the Aged Care Assessment Team and were therefore likely to be frailer. The frail elderly have not usually been seen as a target group for clinical pathways, but future studies of this group may show that they benefit from this approach without adverse outcomes on complications or discharge destinations. This study illustrates the problems of assessing the usefulness of clinical pathways, which should be addressed in the design of future studies. The clinical relevance of short reductions in length of hospital stay (1.4 days in this instance) is open to question. Economic aspects need to be documented as part of study design to allow analysis of cost effectiveness. The real effectiveness of the pathway for the community, rather than just the hospital, remains unclear, and future studies need to include strategies to assess that effect. The overall economic benefit to the community should take into account the increased use of community services, use of interim or permanent residential care, and extra costs and stress for families who provide a large proportion of the care after discharge from hospital.3 Clinical pathways have developed primarily in large metropolitan hospitals with resources to research and implement the process, while proximal femoral fractures are treated in a wide range of hospitals with varying levels of funding and allied health support. These pathways may have the potential to improve clinical outcomes and costs in hospitals where the number of femoral fracture patients is too small to warrant an orthogeriatric unit or where there is no access to a designated rehabilitation unit. Ultimately, the generalisability of this approach will become evident as more research in this area is reported. Recent reports in the Journal highlight the difficulties in transforming evidence into practice.12,13 Despite these difficulties, compliance with evidence-based best practice in the management of fractured neck of femur, together with preventive measures such as early management of osteoporosis and falls prevention programs, should help lessen the current and future economic and personal burden of hip fracture in Australia. Cheryl E Swanson Research Scientist, Division of Orthopaedic Surgery Catherine E Yelland Director, Geriatric Assessment and Rehabilitation Unit Gregory A Day Senior Lecturer, Division of Orthopaedic Surgery University of Queensland and Royal Brisbane Hospital Brisbane, QLD Cooper C, Campion G, Melton IJ III. Hip fractures in the elderly: a world-wide projection. Osteoporosis Int 1992; 2: 285-289. March LM, Chamberlain AC, Cameron ID, et al. How best to fix a broken hip. Med J Aust 1999; 170: 489-494. Swanson CE, Day GA, Yelland CE, et al. The management of elderly patients with femoral fractures. A randomized controlled trial of early intervention versus standard care. Med J Aust 1998; 169: 515-518. Dowsey M, Kilgour M, Santamaria N, Choong PFM. A prospective study of clinical pathways in hip and knee arthroplasty. Med J Aust 1999; 170: 59-62. Sanders KM, Nicholson GC, Ugoni AM, et al. Health burden of hip and other fractures in Australia beyond 2000. Med J Aust 1999; 170: 467-470. Farnsworth MG, Kenny P, Shiell A. The costs and effects of early discharge in the management of fractured hip. Age Aging 1994; 23: 190-194. Caplan G, Board N, Paten A, et al. Decreasing lengths of stay: the cost to the community. Aust N Z J Surg 1998; 68: 433-437. Choong PFM, Langford AK, Dowsey MM, Santamaria NM. Clinical pathway for fractured neck of femur: a prospective controlled study. Med J Aust 2000; 172: 423-427. Tallis G, Balla JI. Critical path analysis for the management of fractured neck of femur. Aust J Pub Heath 1995; 19: 155-159. Kitchiner DJ, Bundred PE. Clinical pathways: a practical tool for specifying, evaluating and improving the quality of clinical practice. Med J Aust 1999; 170: 54-55. Dwyer P. Legal implications of clinical practice guidelines. Med J Aust 1998; 169: 292-293. Doust JA, Silagy CA. Applying the results of a systematic review in general practice. Med J Aust 2000; 172: 153-156. Rubin GL, Frommer MS, Vincent NC, et al. Getting new evidence into medicine. Med J Aust 2000; 172: 180-183. Make a comment Choong

Cheryl E Swanson · Catherine E Yelland · Gregory A Day

Editorials Open invitation from the International Poverty and Health Network to all healthcare professionals Help reduce the burden of ill-health due to poverty MJA 2000; 172: 356-357 The International Poverty and Health Network (IPHN) was created in December 1997, following a series of conferences organised by the World Health Organization with the aim of integrating health into plans to eradicate poverty. The network's formation was a response to the evidence of the persistent and growing burden of human suffering due to poverty. We invite others to join the endeavour. Around 1.3 billion people live in absolute, grinding poverty, on less than $1 per day.1 This is despite the overall substantial growth of the world economy, which doubled over the 25 years before 1998 to reach $24 trillion. Of the 4.4 billion people in developing countries, nearly three-fifths lack access to sanitation, a third do not have clean water, about a fifth lack access to healthcare of any kind, and a fifth do not have enough dietary energy and protein. Economic disparities both within and between countries have grown. In about 100 countries, incomes are lower in real terms than they were a decade ago.2 By 1995, the richest fifth of the world's population had 82 times the income of the poorest fifth. The world's 225 richest people have combined wealth equivalent to the annual income of the poorest 2.5 billion people in the world (nearly half of the world's population).1 At the same time, the world is facing a growing scarcity of renewable resources from deforestation, soil erosion, water depletion, declining fish stocks, and lost biodiversity. The impact of these problems will be felt most by poor populations. Despite overall dramatic increases in life expectancy over the last century, healthcare professionals should be concerned about growing inequalities in health and wealth.3 The precipitous decline in life expectancy in Eastern Europe, particularly in Russia, is a graphic example of how health may deteriorate as societies face sudden social and economic change accompanied by growing poverty. Even among prosperous nations, there are many examples of growing socioeconomic inequalities in health over the past 20 years.4 Health inequalities in Britain have recently been declared the worst ever.5 In Australia, socioeconomic inequalities in health are also significant. For the period 1985-1987, death rates were consistently highest for those living in the most socioeconomically disadvantaged areas.6 This pattern was evident for both males and females and in each of the three age groups studied (0-14 years, 15-24 years, and 25-64 years) and was observed for all-cause mortality and selected causes of mortality. Despite overall declines in mortality rates between 1985-1987 and 1995-1997 for most conditions, the differentials observed in the earlier period were still evident a decade later. For example, during 1995-1997, infants and children living in the most disadvantaged areas experienced the highest mortality rates for perinatal conditions and sudden infant death syndrome, and for injury and poisoning. Similarly, men and women aged 25-64 years residing in the most disadvantaged areas experienced the highest death rates for all-cause mortality, for specific causes such as circulatory, respiratory and digestive system diseases, and for selected causes such as coronary heart disease and stroke, motor vehicle accidents and pneumonia/bronchitis. Although deaths of Indigenous Australians contribute substantially to the higher death rates in the most disadvantaged areas, they are unlikely to be the sole cause of these differentials, particularly in the cities. Rates of premature death (deaths before age 65) are consistently highest for those living in the most socioeconomically disadvantaged areas of the capital cities and other major urban centres (population 100 000 or more) (Box).7 This pattern is evident in both 1985-1989 and 1992-1995 and for all-cause mortality and selected causes of mortality. Death rates for males and females, as well as for most major causes, increase for each quintile of socioeconomic status of area (from the lowest rates in the highest socioeconomic status areas to the highest rates in the lowest socioeconomic status areas). Disturbingly, the gap between the rates in the most well-off and in the most disadvantaged areas has also increased. Internationally, in the 20th century, development has usually been equated with economic growth, but the link between economic prosperity and health, a key component of human development, is not automatic. A recent World Bank study showed that income improvement contributed only about a fifth of the decline in mortality between 1960 and 1990.8 Education of women and the generation and use of new knowledge were more significant factors. Recent work in Canada and elsewhere shows that the early years of child development are also important contributors to health inequalities.9 The International Poverty and Health Network is a worldwide network of people and organisations from health, business, non-government organisations and government who seek to influence policy to protect and improve the health of the world's poor, particularly the poorest in all countries. The network urges that a balance must be struck between social development and growth in income; between the human and financial dimensions of poverty; and between redistribution and market reforms. Our aspiration is to achieve a balance between biomedical and social approaches; between population-based health development and a response to individuals; between prevention of disease, promotion of health, and treatment; and between physical and mental health. Over the next few years supporters of the network will strive to reduce the burden of ill-health due to poverty by: engaging in strategic discussions with the International Monetary Fund, the World Bank, the World Health Organization and national governments to ensure that health is put at the centre of development. We urge health impact assessments of all policies; promoting action for health locally, regionally and nationally by working with sectors such as education, business, agriculture and transport; building the evidence base on effective interventions that reduce inequalities in health and on how improved health can reduce poverty; facilitating exchange among healthcare professionals in North and South about effective ways of working; ensuring that education programs for healthcare professionals include information on the impact of socioeconomic inequalities on health and what they can do to reduce these inequalities; encouraging healthcare professionals to work with local communities to improve the health of the poorest; and monitoring trends in health inequalities and using the data to influence policy. We invite others to join us in this endeavour. Why not you? Iona Heath General Practitioner, and Chair Intercollegiate Forum on Poverty and Health, Royal College of General Practitioners, London, UK Andy Haines Professor, Department of Primary Care and Population Sciences Royal Free and University College Medical School, London, UK John Glover Director, Public Health Information Development Unit, University of Adelaide, SA Diana Hetzel Senior Researcher, Public Health Information Development Unit, University of Adelaide, SA For more information, please contact the International Poverty and Health Network (IPHN). Tel: +44 207 539 1570. Fax: +44 207 539 1580. (Roger Drew) Email: drew.rAThealthlink.org.uk United Nations Development Programme. Human Development Report 1998. New York: Oxford University Press, 1998. United Nations Development Programme. Human Development Report 1996-97. New York: Oxford University Press, 1997. McCally M, Haines A, Fein O, et al. Poverty and ill health: physicians can and should make a difference. Ann Intern Med 1998; 129: 726-733. Whitehead M, Diderichsen F. International evidence on social inequalities in health. In: Drever F, Whitehead M, editors. Health inequalities. Office of National Statistics, London: The Stationery Office, 1996. Yamey G. Study shows growing inequalities in health in Britain. BMJ 1999; 319: 1453. Turrell G, Mathers CD. Socioeconomic health inequalities in Australia. Med J Aust 2000. In press. Glover J, Harris K, Tennant S. A social health atlas of Australia. Adelaide: Public Health Information Development Unit, University of Adelaide. In press. Wang J, Jamison D, Bos E, et al. Measuring country performance on health: selected indicators for 115 countries. Washington DC: World Bank, 1999. Mustard JF. Early years of development are important contributors to health inequalities [letter]. BMJ 1999; 319: 319. Make a comment Association between death rates and socioeconomic disadvantage* in major urban centres in Australia There is clear evidence in Australia of an association at the small-area level between high premature death rates and socioeconomic disadvantage, both for deaths from all causes (Figure) and from most selected causes. These associations are generally evident not only between the most advantaged (Quintile 1) and disadvantaged (Quintile 5) areas, but also at each of the intervening levels. The following figures are limited to comparisons for the capital cities and other major urban centres (population 100000 or more). Similar data are being collated for non-metropolitan areas. For male residents aged 15-64 years, the differential in death rates between Quintile 1 and Quintile 5 increased, from 1.53 times higher in the most disadvantaged areas in 1985-1989 to 1.76 times higher in 1992-1995. The increase for females was from 1.30 times higher in 1985-1989 to 1.40 times higher in 1992-1995. In the 15-64 years age group, increases in the differential in death rates for selected causes of death between the most well-off and the most disadvantaged areas were: all cancers: increased from 1.14 to 1.28 times higher; lung cancer: increased from 1.53 to 1.93 times higher; circulatory system diseases: increased from 1.55 to 1.94 times higher (despite an overall decline in death rates of 40%); respiratory system diseases: increased from 1.79 to 2.41 times higher; and accidents, poisonings and violence: increased from 1.42 to 1.53 times higher. *Socioeconomic disadvantage is measured by the Index of Relative Socio-Economic Disadvantage, Australian Bureau of Statistics, 1991 Census. Back to text

Iona Heath · Andy Haines · John Glover · Diana Hetzel

For Debate The hospitalist: a third alternative The role of hospitalist is already evolving in Australia, being filled by Career Medical Officers John M Egan, Mary G T Webber, Michael R D King, Michael Boyd, Gabrielle du Preez-Wilkinson and David Brock MJA 2000; 172: 335-338 The need for the "hospitalist" - The role of the hospitalist - Who best fills this role? - References - Authors' details - - More articles on Administration and health services - More articles on General medicine - More articles on Emergency medicine The hospitalist debate began in the Journal in April 1999, when we published an article by Hillman on how acute-care hospitals are changing. In September 1999, Scott and Phillips suggested that general physicians should take on the role of hospitalist. The start of the debate1 . . . in some countries [there has been] the emergence of a "hospitalist" who has a wide range of expertise, but concentrating more on acute hospital medicine -- more like a general physician, but specialising in acute and serious illness rather than chronic and mainly ambulant medicine. The hospitalist also has advanced resuscitation and procedural skills. They are familiar with the medical comorbidities increasingly associated with surgical patients and understand how different organs fail and interact in acute illness. They are a move back to the generalist physician. The equivalent in Australia is probably the intensive care or emergency physician. The hospitalist also understands about continuity and coordination of patient care, managing the patient's inpatient course and arranging a seamless transition to a community setting. . . . A hospitalist could enable community-based specialists to devote more time to what they do best, rather than being continuously confronted by the dilemma of maintaining a busy professional practice with tight appointment schedules and having seriously ill in-hospital patients who might require their attention day or night in an unpredictable way. Having skilled clinical cover 24 hours a day would also help guarantee patient safety. . . . Australia could explore other ways of achieving the same standards. (Hillman K. MJA 1999; 170: 325-328) The general physician as hospitalist2 . . . patients are more likely to be assured of continuous, integrated and efficient care for a multiplicity of concurrent problems if attended to by general physicians from the time of admission via emergency departments right through to the time of discharge and beyond into ambulatory care. Adequate resourcing of general medical units, greater involvement of general physicians in emergency and intensive care settings, ready access to specialised medical, nursing and allied health expertise as needed . . . (Scott IA, Phillips PA. MJA 1999; 171: 312-314) THERE HAS BEEN AN ONGOING DEBATE in the Journal1-6 on the changing role of the acute-care hospital and, associated with this change, the desirability of a new type of doctor, the hospitalist. It is argued that in the hospital of the near future there will be fewer patients, who will, generally, be more seriously ill than at present.7,8 Leaving aside discussion of the likelihood of this scenario,9 we believe there needs to be a change in the role and experience of doctors who work in this hospital setting: the hospitalist is one suggestion for this change. We argue here that this role is already evolving and currently functioning in a variety of clinical situations in the Australian healthcare system.10The doctor delivering those aspects of seniority, experience and permanence relevant to a hospital generalist is a Career Medical Officer (CMO) (see Box). There are two interrelated parts to this debate: What problems are there with current medical staffing of acute care hospitals? What solutions are available? The need for the "hospitalist" The present model of a Visiting Medical Officer (VMO) who has overall responsibility for the patient and who delegates this responsibility to more junior medical staff in a hierarchical manner (registrars, Resident Medical Officers [RMOs]) while out of the hospital, has a long tradition in medicine. This model, while having some excellent features, may have outlived its usefulness at the beginning of the 21st century. There is increasing evidence of major inadequacies in the functioning of our hospitals.11 This may reflect the way we educate and organise our medical staff. An analysis of the causes of adverse events reported in the Quality in Australian Health Care Study12 showed that human error was involved in 82% of adverse events and that the most common causes were failure in technical performance and cognitive failure: failure to act on available information, failure to consult or investigate, and failure to attend or provide adequate attention. A recent study of critical events (ie, cardiac arrest or unplanned admission to ICU) in an Australian metropolitan teaching hospital13 found that these episodes are frequently preceded by documented clinical instability of the patient and multiple medical review before admission to ICU or cardiac arrest ensued. The authors commented that the patients in their study (generally those with complex medical and surgical conditions) were usually managed initially by the most junior member on the ward (intern or resident). We do not suggest that junior medical officers should not be involved in direct care of the very sick, but there appear to be problems with current hospital practice: the major deficiencies appear to us to be the understandable lack of experience of the junior medical staff and their rapid turnover. This outdated way of organising medical staffing has long caused problems with our nursing colleagues14-16 and others, who assist the overworked and inexperienced medical officers organise their time and energies to most effectively care for and investigate sick patients -- and then repeat this education once again with the next rotation. Is it right to give increasing responsibility to our junior doctors, but leave them at times relatively unsupervised, unsupported and responsible for major medical decisions when their level of training may be inadequate for the task? The Postgraduate Medical Councils in the various states provide increasingly good-quality support for first- and second-year graduates, but this is in a logistical and educational role rather than a directly supportive clinical role. The role of the hospitalist We argue that hospital wards may run more smoothly and there may be greater satisfaction by patients, nursing staff, consultant medical staff and, importantly, junior medical staff if there is rapid access at all times to an onsite experienced medical officer. This senior doctor would be conversant with the dynamics of the ward, have good relationships with and an appreciation of the role of ancillary staff, and have a relatively long-term commitment to the hospital. These attributes would enable him or her to deal with evolving clinical situations before they became major problems. An additional benefit would be the provision of extra educational opportunities for interns and RMOs during their "apprenticeship" years. Hillman1 and Scott and Phillips2 appear to be attempting to address the problems by placing another specialist physician into the increasingly fragmented world of hospital medicine. There are examples of this in the United States,17-19 where the hospitalist is usually (but not always20) a specialist in internal medicine who works predominantly in the hospital setting. Physicians who work outside of the hospital relinquish their responsibility for the patient at the hospital entrance and take it up again on discharge. The unstated but underlying expectation is that the hospitalist would usurp the primary role and responsibility of the attending doctor. We believe this vision of a hospitalist to be fundamentally flawed. On the one hand, it sidelines doctors who should be intimately involved in the inpatient care of patients (including specialist physicians, general practitioners and paediatricians) whose main area of practice remains office based; on the other, it may miss out on providing a "new deal" of care for many patients who are in hospital and whose particular problems might not necessarily fall within the expertise of the intensivist/physician (eg, falls in hospital, paediatric problems, or dementia). Our contention is that this role demands not the narrow focus of the specialist but the broad-based knowledge of the generalist -- someone who can be a "jack of all trades". The preceding contributions to this debate1,2 appear to have as their central vision a hospital filled with medical patients or seriously ill surgical patients who would be better managed by a physician. Most hospitals have, and will continue to have, a much wider range of patients and conditions, including all the major and minor acute problems that one finds in paediatric, gynaecological, obstetric and psychiatric wards. We believe the role calls for a "middle management" doctor who has a breadth of knowledge and experience gained from working in hospitals and who is proficient in as many branches of hospital medicine as possible. The optimal solution is to have someone who is conversant with and experienced in treating seriously ill patients expeditiously, who is quite at home in managing the multiple minor problems that beset hospital patients, and who is used to consulting with a wide range of medical and surgical specialties as needed. The role of hospitalist should be complementary to, not in confrontation with, the established Australian model of inpatient care. That is, it seems to us better to have an experienced doctor "on site" to organise -- not take over -- the management of the hospital inpatient. There is some evidence that hospitalists who have complete control of inpatient care increase, rather than decrease, the length of stay in hospital.21 In the model we propose, the consultant physician, surgeon, paediatrician, gynaecologist, or, increasingly, general practitioner would retain primary responsibility for the patient's management, but would be actively supported by someone who had worked in the hospital system for many years and could competently manage most problems that may arise, at least in the short term. This doctor should also have the trust of, and rapid access to, the consultant staff, and good working relationships with the nursing and paramedical staff (mutual respect of each other's role and abilities) as well as a good understanding of the "mechanics" (eg, layout, routine, and regular practices) of the hospital. Who best fills this role? We believe that Scott and Phillips2 are right in having major reservations about intensivists being responsible for general ward patients. The prevention of a slow deterioration of a general medical or surgical patient to serious illness does not require the considerable skills of an intensivist -- most doctors with experience and education, alerted by protocols that highlight dangerous trends, can quite adequately look after these cases and refer to the intensive care or cardiac care unit if appropriate. The opposite and far more common scenario, that of a relatively minor problem, may well lead to the over-investigation and treatment of a condition that could have been easily handled by a broadly experienced medical officer. Although the general physician may have a better claim to this role (especially rural physicians, who are, by necessity, well-rounded generalists), there is still the problem of a doctor who may be overeducated for some aspects of the work, and undereducated for others. Many of the problems outlined above have in the past been handled by registrars, RMOs and interns. Senior registrars are usually quite able to manage patients without the direct supervision of the VMO; however, this is not necessarily the case with more junior registrars and RMOs. Again, frequent rotation takes well-performing doctors out of the loop just as they attain a level of familiarity and experience with a particular group of patients. Although doctors who performed similar roles had been in the health systems throughout Australia for many years, CMOs were initially brought into service in New South Wales in the early 1980s to maintain experienced medical practitioners in the public hospital system. These doctors were working in posts as unaccredited medical registrars or emergency medical officers, particularly in suburban and rural hospitals. The New South Wales Department of Health10 noted in 1989 that there had been a positive response to the introduction of CMOs: it had increased retention rates of hospital doctors, improved middle grade medical staffing in peripheral hospitals, and addressed the service needs of these hospitals, and the individuals were able to undertake more clinical responsibilities and required less supervision. Many CMOs have now been working in these positions for well over 12 years, and have developed considerable expertise in their area of practice. A recent study in Queensland,22 addressing the training needs and career paths of this cohort of doctors, noted their wide range of practice -- predominantly in emergency medicine ("they make up the majority of the senior emergency work force in Queensland"22), but also in orthopaedics, sexual health, community health, and other areas. The report also pointed out the experience of those who worked in emergency medicine: 73% had worked for more than three years full-time since their third postgraduate year, and 25% had worked for 10 or more years in this capacity. Furthermore, a large proportion (69%) of CMOs had postgraduate qualifications. The study also commented on a major flaw in the Australian Medical Workforce Advisory Committee report The Emergency Medicine Workforce in Australia,23 which totally ignored the role played by CMOs in the staffing of emergency departments. This omission seems to be symptomatic of a "blind spot" by some in the profession to the valuable service provided by these doctors. Many modern private hospitals are turning to CMOs to fill a demand in the medical care of hospitalised patients. In the Sydney area the Hills, Kareena and the Sydney Adventist private hospitals have significant CMO staffing (Dr Stephen Delprado, Deputy Director, Emergency Department, Hills Private Hospital, personal communication), and seven private hospitals in Queensland have CMO cover.22 Most CMOs report that they are quite happy to continue to work in these roles (J M E and M R D K, unpublished survey of 32 rural CMOs in NSW, presented to Directors of Clinical Training meeting, Postgraduate Medical Council, Sydney, May 1996). Recently, some have formed themselves into organised subgroups of the medical workforce. The largest of these (the Career Medical Officers Association) is now taking responsibility for initiating educational and industrial policies for CMOs. Examples of these are the provision of continuing medical education (in association with the Royal College of Pathologists of Australasia); discussions with universities and others about more formal training, qualifications and accreditation; and representations on various committees, including the Hospital Medical Officer Subcommittee of the Medical Training Review Panel. We believe that this broad-based experience and commitment is what makes the CMO the ideal person to take on the role of the hospitalist. Furthermore, the changes necessary to do this are relatively minor and merely a continuation of recent trends in medical workforce utilisation in the modern Australian hospital. In our opinion, CMOs are well able to fulfil such future requirements and do it in the most efficient and cost-effective way. We note the invitation by Scott and Phillips to put the respective views of hospitalist practice to the test in a randomised trial comparing the intensivist or internal medicine models of hospitalist.2 Although we have some misgivings about the applicability of this methodology, we firmly believe that any rigorous evaluation of the various hospitalist models on offer would be incomplete without the inclusion of CMOs. References Hillman K. The changing role of acute-care hospitals. Med J Aust 1999; 170: 325-328. Scott IA, Phillips PA. Hospitals and hospitalists: an alternative view. Med J Aust 1999; 171: 312-314. Denaro CP, Bennett CJ. The changing role of acute-care hospitals [letter]. Med J Aust 1999; 171: 224. Hillman K. Hospitals and hospitalists: an alternative view [letter]. Med J Aust 2000; 172: 299. Sartain JB. Hospitals and hospitalists: an alternative view [letter]. Med J Aust 2000; 172: 299. Phillips PA, Scott IA. Hospitals and hospitalists: an alternative view [letter]. Med J Aust 2000; 172: 299. Komesaroff PA, Clunie GJA, Duckett SJ. What is the future of the hospital system? Med J Aust 1997; 166: 17-22. Braithwaite J. The 21st-century hospital [editorial]. Med J Aust 1997; 166: 6. Braithwaite J, Hindle D. Research and the acute-care hospital of the future. Med J Aust 1999; 170: 292-293. Career Medical Officers (CMOs). Circular no. 89/156. Sydney: NSW Health, 1989. Wilson RMcL, Runciman WB, Gibberd RW, et al. The Quality in Australian Health Care Study. Med J Aust 1995; 163: 458-471. Wilson RMcL, Harrison BT, Gibberd RW, Hamilton JD. An analysis of the causes of adverse events from the Quality in Australian Health Care Study. Med J Aust 1999; 170: 411-415. Buist MD, Jarmolowski E, Burton PR, et al. Recognising clinical instability in hospital patients before cardiac arrest or unplanned admission to intensive care. A pilot study in a tertiary-care hospital. Med J Aust 1999; 171: 22-25. Lublin J, Gething L. RNs as teachers of junior doctors. Aust J Advanced Nursing 1992; 10(2): 3-9. Agnew T. Just rewards on the wards. Nursing Times. 1995; 91(34): 19. Junior doctors turn to nurses for help. Nursing Standard 1999; 13(47): 8. Wachter RM. An introduction to the hospitalist model. Ann Intern Med 1999; 130: 338-342. Sox HC. The hospitalist model: perspectives of the patient, the internist, and internal medicine. Ann Intern Med 1999; 130: 368-372. Schroeder SA, Schapiro R. The hospitalist: new boon for internal medicine or retreat from primary care? Ann Intern Med 1999; 130: 382-387. NAIP affiliates with the American College of Physicians. <http://www.naipon line.org/hist.htm>. Accessed 2 March 2000. Jackson JL. The international experience with hospitalists. The Hospitalist 1997; Summer. Available at <http://www.naiponline.org/archives/guest.htm>. Accessed 2 March 2000. Bricknall B, Daly M, Catchpole M. The career paths, training needs and future role of non-specialist senior medical officers in the Queensland public health care system. An exploratory study. Brisbane: Health Advisory Unit, Queensland Health, 1999. Australian Medical Workforce Advisory Committee. The Emergency Medicine Workforce in Australia. Sydney: AMWAC, 1997. Summary available at <http://amwac.health.nsw.gov.au/corporate-services/amwac/emerg.htm>. Accessed 2 March 2000. Authors' details Goulburn Base Hospital, Goulburn, NSW. John M Egan, MB BS, Career Medical Officer, Emergency Department. Kareen Private Hospital, Sydney, NSW. Mary G T Webber, MB BS, Career Medical Officer, Emergency Department, and President Career Medical Officers Association. Coffs Harbour Base Hospital, Coffs Harbour, NSW. Michael R D King, FRACGP, FACRRM, Director of Emergency Services. Camden Hospital, Sydney, NSW. Michael Boyd, MB BS, Co-ordinator of Emergency Department. Prince Charles Hospital, Brisbane, QLD. Gabrielle du Preez-Wilkinson, FRACMA, AFCHSE, Medical Officer, Emergency Department. Tweed Heads Hospital, Tweed Heads, NSW. David Brock, MB BS, Career Medical Officer, Emergency Department. Reprints: Dr J M Egan, PO Box 131, Goulburn, NSW 2580. eganjATinteract.net.au Make a comment What is a Career Medical Officer? Officially, a Career Medical Officer (CMO) is a grade of medical officer employed by the New South Wales Department of Health. Unofficially, and more accurately, CMOs are: "middle management" doctors who increasingly perform in responsible and demanding clinical roles; doctors beyond the second postgraduate year and working in clinical medicine; not general practitioners (although some work in both roles), nor specialists, nor in training for these roles; a distinct subgroup within the wider medical community, with their own aspirations, experience and educational needs. In different parts of Australia doctors in this role have different designations: Senior Medical Officer (SMO: Qld, WA, SA, NT); Hospital Medical Officer (HMO: Vic); Career Medical Officer (CMO: NSW, but this title also known and occasionally used in other states). In practice, awards for these medical officers range from registrar to staff specialist range. How many CMOs are there? No accurate numbers are available. Recent medical workforce surveys show 652 "other hospital career" doctors in NSW. In Queensland, there are 149 funded SMO positions. These figures are almost certainly an underestimate as they do not take into account community CMOs who may be labelled as GPs or specialists, and self-reporting of some hospital CMOs as registrars or staff-specialists. Likely "ball-park" figures are 1000 in NSW, and 2000 Australia-wide, but there may be significantly more. Where do CMOs work? About 60%-70% of CMOs work in emergency departments in rural, suburban and private hospitals. CMOs also work in psychiatry, sexual health, women's health, police forensic, intensive care, neonatal, orthopaedics, and other areas. In rural Queensland and NSW, CMOs are the predominant senior doctors in emergency departments. What education do CMOs have? No formal qualifications are required at present, but at least half have postgraduate qualifications. Many (especially in emergency departments) have early management of severe trauma (EMST), emergency life support (ELS), or advanced paediatric life support (APLS) qualifications. Discussions are in progress with the University of Newcastle regarding more formal postgraduate qualifications for CMOs. The Postgraduate Medical Councils may have an advisory or other role in CMO education and training. The Career Medical Officers Association (CMOA) website <http://www.cmoa.ican.net.au/> has details of current interest for CMOs and others. The information in this Box comes from many sources, including the NSW Medical Labour Force Annual Survey 1998, the CMOA website, the CMOA database, Bricknall et al22 and discussions with CMOs. Back to text

John M Egan · Michael Boyd · David Brock

Healthcare Implementing clinical practice guidelines: a community-based audit of breast cancer treatment Paul S Craft, Yanping Zhang, Jennifer Brogan, Noel Tait, John M Buckingham, and the Australian Capital Territory and South Eastern New South Wales Breast Cancer Treatment Group MJA 2000; 172: 213-216 For editorial comment, see Redman & Reeve Abstract - Methods - Results - Discussion - Acknowledgement - References - Authors' details - - More articles on Oncology Abstract Objective: To improve breast cancer management by facilitating implementation of treatment guidelines. Design: A prospective, longitudinal study (developed by clinicians and consumers) of all patients with newly diagnosed breast cancer. Four locally agreed breast cancer management guidelines were established (based on 1995 National Health and Medical Research Council guidelines) as practice indicators. Setting: Breast cancer treatment facilities and medical practices in the Australian Capital Territory and South Eastern New South Wales, May 1997 to July 1998. Main outcome measures: Actual treatment received by patients for primary breast cancer during the study period. Results: During the 14 months of the study, 19 clinicians registered 221 new patients with a proven diagnosis of breast cancer. Of 191 women with localised invasive breast cancer, 112 (59%) had tumours 2 cm or less in diameter. Axillary surgery in 173 (91%) of these women showed 107 (56%) had no axillary lymph node involvement. Of 87 women treated with breast-conserving surgery for locally invasive cancer, 85 (98%) also received postoperative radiotherapy. Some form of systemic adjuvant therapy was indicated in 99 women (axillary nodes positive or tumours > 2 cm diameter) and this treatment was received by 95 (96%). All 27 women aged under 50 years with node-positive disease received adjuvant chemotherapy. Conclusions: Enhancing uptake of breast cancer management guidelines is feasible at a regional level with an audit program and broad support among clinicians and consumers. Breast cancer is a major health problem in Australia, with 9800 new cases diagnosed each year.1 Management guidelines for early breast cancer were developed in 1995 by the National Health and Medical Research Council (NHMRC) to assist clinicians and consumers make decisions about treatment and thus to improve health outcomes.2 Observed differences in treatment outcome between populations suggest that opportunities for improvement are available.3 Moreover, potentially important variations in clinical practice are well documented in Australia and elsewhere.4-6 Treatment practice which appears to be informed by evidence, for example greater use of breast-conserving surgery, has been observed more frequently among clinicians who regularly treat patients with breast cancer.7 Furthermore, congruence of treatment practice with published guidelines has been directly associated with improved patient survival;8 improved treatment practice has the potential to improve survival by up to 10%.8,9 Therefore, enhanced implementation of soundly developed, evidence-based treatment guidelines is an appropriate goal for health services and individual clinicians. In 1996, clinicians and consumers involved in breast cancer diagnosis and treatment in the Australian Capital Territory (ACT) and South Eastern New South Wales (SE NSW) formed a cooperative group aimed at improving breast cancer management and facilitating implementation of treatment guidelines. A prospective, longitudinal, community-based study of breast cancer treatment was established to assist with guidelines implementation. Our report describes the results of the first 14 months of this ongoing project. Methods Breast Cancer Treatment Group All surgeons, radiation oncologists, medical oncologists, radiologists, pathologists, nurses and other health professionals who were known by the ACT Breast Screen Program to be involved in the treatment of breast cancer in the ACT and SE NSW were invited by mail to participate in a multidisciplinary breast cancer treatment group. Consumer representatives from "The Bosom Buddies", a community organisation of women with a history of breast cancer, were also invited to join the group. Fifty consumers and clinicians expressed interest and continue to receive all correspondence, with meetings every two months attracting between 15 and 30 attendees. A general practitioner representative from the ACT Division of General Practice also participated. The Breast Cancer Treatment Group adopted treatment guidelines based on the NHMRC Clinical Practice Guidelines, commenced a community-based audit, and later developed a set of agreed practice indicators against which treatment decisions could be compared. The 1998 estimated populations of the ACT and South Eastern NSW were 311 000 and 118 000 respectively (source: Australian Bureau of Statistics, Estimated Residential Populations, 30 June 1998). Practice indicators The group adopted four indicators for which unanimous local agreement about the relevant guideline was available: Women with operable invasive breast cancer should undergo some form of axillary surgery sufficient to develop a prognosis based on axillary node status; Women undergoing less than total mastectomy for operable invasive breast cancer should receive postoperative adjuvant radiotherapy; Women with a completely resected invasive breast cancer tumour greater than two centimetres in diameter or with involved axillary lymph nodes should receive adjuvant systemic therapy (either chemotherapy, endocrine therapy or both); and Women under the age of 50 years with completely resected axillary lymph node positive breast cancer should receive adjuvant chemotherapy. Audit A prospective study of breast cancer treatment was commenced in May 1997. The study was designed as a quality assurance project and notified as such under Section 7 of the Health Act 1993 (ACT) in June 1997. The study was approved by the Ethics Committee of the ACT Department of Health and Community Care. All clinicians involved specifically with the care of patients with breast cancer were invited to participate in the study. Participating clinicians agreed to approach all of their patients presenting with newly diagnosed breast cancer requesting permission to include them in the study. Eligible patients were women or men with newly diagnosed invasive or in-situ breast cancer. For each eligible patient a brief notification form was completed and submitted by mail to the study centre at the Women's Health Program of ACT Community Care. Written informed consent was obtained from the patient by the notifying clinician, and subsequently a detailed data form was completed giving details of presentation, clinical and pathological staging, and treatment. The dataset was based on a prior survey conducted by the Provincial Surgeons of Australia (Dr David Adamthwaite, President of the Provincial Surgeons of Australia, personal communication). Additional data relating to enrolled patients were obtained from treatment units in the region. Information from the audit forms, supplemented where necessary from pathology reports and treatment facility records, was entered into a secure database developed by the project officer. As well as facilitating project management, the database allows individualised, confidential reports to be produced for each participating clinician, providing detailed feedback about each clinician's practice, with comparisons across the group and against the agreed criteria. Aggregated data across the whole clinician group are presented at regular meetings of the treatment group. Data collected during the first 14 months of the project, and analysed to provide an initial report to contributing clinicians, form the basis of our report. Accrual of patients to the project is ongoing. Results Specialist participation Since commencement of the project, 23 of 24 medical specialists known to treat breast cancer within the region have registered as participants, with 19 specialists contributing data to the study to date (13 surgeons, three radiation oncologists and three medical oncologists). All of the radiation and medical oncologists were based in Canberra, while the principal practices of six surgeons were based in SE NSW. Patient accrual During 14 months from May 1997 to July 1998, 221 patients, including four men, with a diagnosis of primary breast cancer were registered for the study (Box 1). Some 123 new cases of invasive breast cancer (excluding male patients and patients with in-situ disease only) were registered with ACT addresses. In comparison, the observed mean annual incidence of breast cancer in the ACT during 1993-1996 was 134.1 Thus, during the 14-month study period, about 156 incident cases would be expected. The project therefore detected 79% of predicted ACT incident cases during the study period. Of the 221 registered patients, there were 10 with distant metastases, 16 with carcinoma-in-situ only and four men, leaving 191 women with primary, localised, invasive breast cancer. It is to these women that the treatment guidelines apply. In five women with bilateral synchronous tumours, details are given of the tumour judged by the treating clinician to have the worse prognosis. Eighty-one per cent of tumours were oestrogen receptor (ER) positive or progesterone receptor (PgR) positive by immunohistochemical analysis done in routine diagnostic histopathology laboratories. The pathological characteristics of the tumours in these 191 women are presented in Box 2. Comparisons with practice indicators (Box 3) Axillary surgery was undertaken in 173 women. One elderly patient declined to have any surgery. Thus, 17 of 190 patients did not undergo any form of axillary surgery, at variance with the guideline. Of these women, six were aged 80 years or older. Seven of the remaining 11 patients had tumours less than 1 cm in diameter. Among women having axillary surgery, five (3%) had four or fewer nodes resected. Only two of 87 women who underwent breast-conserving surgery did not also receive postoperative radiotherapy. Of the 191 patients with invasive breast cancer, 103 (54%; 95% CI, 47-61) underwent mastectomy. The overall concordance of treatment with the practice indicators relating to systemic adjuvant therapy was strong. Of 33 women with tumours greater than 2 cm in diameter and negative or unknown axillary lymph node status, 32 (97%) received either tamoxifen (18), chemotherapy (4), or both (10). Of 66 women with axillary lymph node involvement, 63 (95%) received systemic adjuvant therapy with either tamoxifen (14), chemotherapy (19) or both (30). Thus, only four of 99 women for whom adjuvant systemic therapy was considered appropriate under the guidelines did not receive such therapy. All 27 women under 50 years of age with axillary lymph node involvement received adjuvant chemotherapy. Data quality The project officer actively sought clarification of ambiguous or missing data items. Initial notification forms required clarification for 192 of 221 registrations. Of these queries, one follow-up data request was required for 91 patients, two requests for 60 patients and three requests for 41 patients. After these data requests, 3.6% of records remained incomplete in some way. Initial under-reporting of adjuvant treatments received was noted, particularly in regard to postoperative radiotherapy. Discussion Our report demonstrates the feasibility of regionally based multidisciplinary groups adopting treatment guidelines and then assessing their implementation. Strong concordance of practice with the four practice indicators was observed. Despite a third of our patients living in rural areas, there were high rates of postoperative radiotherapy after breast-conserving surgery. The rate of axillary surgery was lower than recommended, but in almost all of these women a partial explanation was available (advanced age or very small primary tumour). Whether the decision not to perform axillary surgery in these patients was appropriate is the subject of debate and ongoing clinical trials. Given the degree of involvement of clinicians in establishing the data collection and practice indicators, the strong concordance with actual practice observed is not surprising. The practice indicators chosen were not particularly controversial, enabling rapid consensus among the group members. Indicators relating to the use of breast-conserving surgery for early breast cancer and to the use of adjuvant chemotherapy for node-negative disease, although more contentious, are appropriate further areas for local consensus and audit. Observed concordance with guidelines for adjuvant chemotherapy in node-negative breast cancer has been relatively low, presumably because of the more modest benefits of treatment (in absolute terms) in this group.11 Implementing guidelines successfully can be difficult. Just producing and publishing guidelines for breast cancer treatment does not ensure their uptake into clinical practice.12 Over time clinical practice may adhere more closely to published guidelines, although a causal relationship cannot be easily proven.13 In a survey of clinicians in Sydney, most respondents supported the NHMRC Clinical Practice Guidelines, but only 20% believed the guidelines had influenced clinical practice.14 The introduction of guidelines has been a stimulus for institutionally focused audits of surgical practice.15 Audits incorporating structured feedback to clinicians may be a critical strategy in implementing guidelines. Organisations such as the Royal Australasian College of Surgeons have recognised audit as an important tool in the treatment of breast cancer, and Clinical Indicator 7.1 of the Australian Council of Healthcare Standards Internal Medicine Indicators, version 2, measures the proportion of premenopausal women with node-positive early breast cancer receiving chemotherapy.16 Many factors affect treatment decisions in primary breast cancer. Women bring to the process their own preferences and needs. Many of the treatment decisions require trade-offs between long term gain and unpleasant treatments, such as chemotherapy. We did not examine the decision-making processes followed by these patients and their attending health professionals. Entry of any individual patient into the audit was voluntary, both for the clinician and for the patient. Participating clinicians undertook to offer enrolment to all of their patients, and every effort was made to enhance compliance. Nevertheless, complete enrolment was not achieved and this may have introduced bias, with patients receiving multimodality care possibly being more likely to be enrolled. An advantage of our audit was that it was community based and prospective. Surgical audits have generally been based on retrospective casenote review and, as such, have sometimes been hampered by missing data.17 Some community-based studies assessing the process of treatment have relied on the secondary analysis of administrative data with linkage to population-based cancer registries.18 In Canada, a population-based cancer registry has been linked to clinical records to obtain treatment details and allow comparisons with treatment guidelines.19 Successful collection of community-based audit data requires both enthusiasm and trust on the part of the treating clinicians voluntarily submitting information about their own practice. We believe this may be best achieved within a framework of agreed treatment guidelines and indicators. An enthusiastic project officer and involvement of practice staff and institutional data managers is crucial. As new ways of managing breast cancer (and other diseases) become available, an ongoing implementation process with agreed, clinically relevant indicators and guidelines, and a regionally based audit, can be an effective tool. Members of the Australian Capital Territory and South Eastern New South Wales Breast Cancer Treatment Group contributing to the study Chairperson Dr Doris Zonta. Surgeons Bega, NSW: Dr Andrew Thomson. Canberra, ACT: Dr Guan Chong, Dr Ian Davis, Dr Dennis Dyason, Dr Diarmid McKeown, Dr John Stuchbery Goulburn, NSW: Dr Margaret Beevors, Dr John Hayman. Moruya, NSW: Dr Peter Gough, Dr John Groome, Dr David Thomson. Medical Oncologists Canberra, ACT: Associate Professor Robin Stuart-Harris, Dr William Coupland. Radiation Oncologists Canberra, ACT: Dr Deborah Thornton, Dr George Jacob, Dr Kenneth Sunderland. Epidemiologist Canberra, ACT: Dr Bruce Shadbolt. Pathologists Canberra, ACT: Dr Jane Dahlstrom, Dr Sanjiv Jain. Acknowledgement Initial funding was provided by the Commonwealth Department of Health and Aged Care Cancer Screening Unit. References Australian Institute of Health and Welfare. Breast and cervical cancer screening in Australia 1996-1997. Canberra: AIHW, 1998: 33. (Cancer Series no. 8.) National Health and Medical Research Council. Clinical practice guidelines. The management of early breast cancer. Canberra: NHMRC, 1995. Richards M, Sainsbury R, Kerr D. Inequalities in breast cancer care and outcome. Br J Cancer 1997; 76: 634-638. Craft PS, Primrose JG, Lindner JA, McManus PR. Surgical management of breast cancer in Australian women in 1993: analysis of Medicare statistics. Med J Aust 1997; 166: 626-629. Nattinger AB, Goottlieb MS, Veum J, et al. Geographic variation in the use of breast-conserving treatment for breast cancer. N Engl J Med 1992; 326: 1102-1107. Samet JM, Hunt WC, Farrow DC. Determinants of receiving breast-conserving surgery. The surveillance, epidemiology and end results program 1983-1986. Cancer 1994; 73: 2344-2351. Hill DJ, White VM, Giles GG, et al. Changes in the investigation and management of primary operable breast cancer in Victoria. Med J Aust 1994; 161: 110-122. Sainsbury R, Haward B, Rider L, et al. Influence of clinician workload and patterns of treatment on survival from breast cancer. Lancet 1995; 345: 1265-1270. Gillis CR, Dole D. Survival outcome of care by specialist surgeons in breast cancer: a study of 3786 patients in the west of Scotland. BMJ 1996; 312: 145-148. Elston CW, Ellis IO. Pathological prognostic factors in breast cancer. I. The value of histological grade in breast cancer: experience from a large study with long-term follow-up. Histopathology 1991; 19: 403-410. Sawaka C, Olivotto I, Coldman A, et al. The association between population-based treatment guidelines and adjuvant therapy for node-negative breast cancer. Br J Cancer 1997; 75: 1534-1542. Chouillet AM, Bell CM, Hiscox JG. Management of breast cancer in southeast England. BMJ 1994; 308: 168-171. Ray-Coquard I, Philip T, Lehmann M, et al. Impact of a clinical guidelines program for breast and colon cancer in a French cancer center. JAMA 1997; 278: 1591-1595. Ward JE, Boyages J, Gupta L. Local impact of the NHMRC early breast cancer guidelines: where to from here? Med J Aust 1997; 167: 362-365. McCarthy DO, Blamey RW, Robertson JF, Mitchell AK. A one-year audit of 255 operable breast cancers. Eur J Surg Oncol 1997; 23: 399-402. Australian Council on Healthcare Standards. Clinical indicators in summary. Revised edition. Sydney: ACHS, 1998. Clamp SE. Management of breast cancer. Incomplete case notes hamper research. BMJ 1994; 308: 715. Hillner BE, McDonald MK, Penberthy L, et al. Measuring standards of care for early breast cancer in an insured population. J Clin Oncol 1997; 15: 1401-1408. Olivotto IA, Coldman AJ, Hislop TG, et al. Compliance with practice guidelines for node-negative breast cancer. J Clin Oncol 1997; 15: 216-222. (Received 29 Jul, accepted 4 Dec, 1999) Authors' details Medical Oncology Unit, The Canberra Hospital, Canberra, ACT. Paul S Craft, MPH, FRACP, Director. Women's Health Program, ACT Community Care, Canberra, ACT. Yanping Zhang, Project Officer; Jennifer Brogan, Director. The Calvary Clinic, Canberra, ACT. Noel Tait, FRACS, Consultant Surgeon; John M Buckingham, FRACS, Consultant Surgeon. Reprints: Dr P S Craft, Medical Oncology Unit, The Canberra Hospital, PO Box 11, Woden, ACT 2606. Paul_CraftATact.gov.au Make a comment 1: Patient and tumour characteristics for all registered breast cancer patients (n=221)nPercentage (95% CI)Median age, 57 years (range, 25-88)SexMale42% (1%-5%)Menopausal statusPremenopausal63 29% (23%-35%)Postmenopausal12557% (50%-63%)Perimenopausal2712% (8%-17%)Unknown or male63% (1%-6%)Place of residenceAustralian Capital Territory14767% (61%-73%)DiagnosisIn-situ disease only167% (4%-11%)Invasive carcinoma20593% (89%-96%)Tumour extentDistant metastases at diagnosis105% (3%-9%)Synchronous bilateral tumours52% (1%-5%) Back to text 2: Pathological characteristics of the tumour in 191 women with invasive breast cancer and no distant metastases CharacteristicnPercentage (95% CI)Tumour size (mm)0-103016% (11%-22%)11-208243% (36%-50%)21-506233% (27%-40%)>50147% (4%-12%)Unknown32% (1%-5%) Axillary lymph node statusNegative107 56% (49%-63%)Positive66 35% (29%-42%)No axillary surgery168% (5%-13%)Unknown21% (1%-5%) CharacteristicnPercentage (95% CI)Tumour type and grade*Invasive ductalGrade 12915% (11%-21%)Grade 26635% (29%-42%)Grade 35328% (22%-35%)Invasive lobular2010% (7%-15%)Special types†2312% (8%-17%)Receptor statusER positive or PgR positive15581% (75%-86%)ER negative and PgR negative3016% (11%-22%)Unknown63% (1%-6%) *See Elston and Ellis.10 †Includes seven tubular, four mucinous, six cribriform, one papillary, one medullary, one squamous cell, and one metaplastic carcinoma. There was also one spindle cell tumour and one cystosarcoma phylloides tumour reported. ER=Oestrogen receptor. PgR=Progesterone receptor. Back to text 3: Women with breast cancer - comparison of treatment received with practice indicators Indicatorn Percentage (95% CI)Breast-conserving surgeryRadiotherapy8598% (92%-99%)No radiotherapy22% (1%-8%)Total87 100%Surgery for invasive cancerAxillary surgery17391% (86%-94%)No axillary surgery179% (6%-14%)Total190 100%Axillary nodes positive or tumours >2 cmSome form of adjuvant systemic therapy95 96% (90%-98%)No adjuvant systemic therapy44% (2%-10%)Total99100%Women aged less than 50 years with positive axillary nodesAdjuvant chemotherapy27100%No adjuvant chemotherapy00Back to text

Paul S Craft · Yanping Zhang · Jennifer Brogan · Noel Tait · John M Buckingham

Editorial Allies or enemies? Evidence-based medicine and consumer choice MJA 2000; 172: 5-6 In this era of promoting evidence-based medicine, the study by Fitzgerald and Phillipov in this issue of the Journal on consumers' attitudes to three "best practice" recommendations raises key questions:1 How do consumers respond to the medical profession's determination of "best practice"? Are there tensions between the movements for evidence-based medicine and for greater consumer choice? Although not immediately addressed by this study, other important questions include: Should "best practice" be determined only by professionals' judgements? Could the use of evidence in fact enhance consumers' ability to make healthcare choices that suit them best? Fitzgerald and Phillipov suggest that patients may be more averse to risks of interventions, particularly preventive ones, than are doctors. Consequently, the course of action recommended by the profession may not be seen as the best option by patients, and, Fitzgerald and Phillipov argue, disclosing risks may run counter to the goal of implementing best-practice recommendations.1 This should come as no surprise. The values and concerns of patients and doctors are often quite different. Studies comparing the concerns of patients with what their practitioners believe are most important to patients show at least discrepancies, and often great gulfs, between doctors and patients.2-6 This must at times translate into different value judgements about healthcare treatments, and a different attitude to individual risks, benefits, and the trade-offs between them. Part of the problem in translating evidence-based recommendations into action is that the evidence often does not reflect the major concerns of the person who has to make a choice. Trials on the effects of healthcare often measure mortality and other easily measured outcomes, and often overlook key issues of concern to patients, such as quality of life and long term effects. Researchers exploring people's experiences of healthcare, or charting long term progress, are more likely to be using methods other than trials. These will be given less weight by the individuals determining "best practice" according to the hierarchies of evidence that count the randomised controlled trial as the "gold standard".7 Some guideline developers, such as the National Health and Medical Research Council in Australia7 or the Agency for Health Care Policy and Research in the United States,8 consider evidence from literature on consumers' experiences, and include consumer representatives in guideline development groups. However, that is not the way that researchers, medical colleges, and other organisations involved in guideline development traditionally function. To assess consumer attitudes to three such professionally derived "best practice" recommendations, Fitzgerald and Phillipov presented risk-benefit scenarios to various groups of people.1 Each group was presented with scenarios related to hormone replacement therapy (HRT), thrombolysis after myocardial infarction, and coronary artery bypass surgery. The drugs and procedure were not named. However, bypass surgery would have been recognisable to many, and thus they would be able to call on frames of reference other than simply the information presented by the researchers. This is important, as only some of the risks and benefits of these interventions were discussed. For example, HRT was presented solely as a therapy to prevent heart disease, with no mention of its principal effects and purpose. The three scenarios were presented together, perhaps leading survey participants to compare them directly as options for preventing heart attacks. One scenario was a long term daily drug where there was no real disease, one a single injection for dissolving clots after a heart attack, and the third scenario was presented as one-off surgery to correct a diagnosed problem. The study was hypothetical: imagine you are someone of a specific age, sex, and medical history that may be unfamiliar territory, and an intervention you do not really have to face. The individuals surveyed were by no means a representative sample of the population, nor were they necessarily candidates for these interventions (for example, a third of those being asked if they would take HRT were men). This seriously undermines the ability to extrapolate the results to people's real lives. People's willingness to accept the risk of an intervention can be very different if they are living with the risks and effects of the disease itself.6 The authors considered the effect of risk-framing techniques on people's potential reactions, and so presented absolute risk information rather than the more dramatic relative risk equivalent. This is critical, as, for example, it has been shown that these different ways of framing risks even affect doctors' willingness to prescribe HRT.9 However, there are many other ways to bias framing, and some are exemplified in Fitzgerald and Phillipov's study. Consider this somewhat emotive statement about coronary artery bypass surgery: "Unfortunately as well as having to endure major surgery, there is a 1 in 20 chance that the surgery will cause death or a stroke."1 This highlights another of the main issues at the heart of this debate. If evidence is to be an ally rather than an enemy to consumers, then it needs to be used to help inform people's decisions, rather than dictate what should be done or manipulate people down certain tracks. If this is to be achieved, healthcare practitioners need to become far more skilled at communicating meaningfully and objectively about the relative benefits and risks of treatments. Although many aspects of their study undermine the weight that can be given to its results, Fitzgerald and Phillipov raise some critical issues. At its best, evidence-based medicine will expose many of the value differences between doctors and the individuals and communities they serve. This is to be welcomed. So too is the challenge to improve health professionals' communication skills. The answer to these challenges is not, as the authors appear to suggest, to question whether information should be provided. It is to question who gets to decide "best practice" for the whole community, how evidence is best used, and whose values are driving the evidence-based medicine agenda. Hilda Bastian Chairperson, Consumers' Health Forum of Australia Convenor, Consumer Network of the Cochrane Collaboration Blackwood, SA hilda.bastianATflinders.edu.au Fitzgerald SP, Phillipov G. Patients' attitudes to commonly promoted medical interventions. Med J Aust 1999; 172: 9-12. Catalan J, Brener N, Andrews H, et al. Whose health is it? Views about decision-making and information-seeking from people with HIV infection and their professional carers. AIDS Care 1994; 6: 349-356. Freda MC, Anderson HF, Damus K, Merkatz IR. What pregnant women want to know: a comparison of client and provider perceptions. J Obstet Gynecol Neonatal Nurs 1993; 22: 237-244. Jachuk S, Brierley H, Willcox P. The effect of hypotensive drugs on quality of life. J R Coll Gen Pract 1982; 32: 103-105. Orth-Gomer K, Britton M, Rehnqvist N. Quality of care in an outpatient department: the patients' view. Soc Sci Med 1979; 13A: 347-351. Slevin ML, Stubbs L, Plant HJ, et al. Attitudes to chemotherapy: comparing views of patients with cancer with those of doctors, nurses, and general public. BMJ 1990; 300: 1458-1460. National Health and Medical Research Council. A guide to the development, implementation and evaluation of clinical practice guidelines. Canberra: Commonwealth of Australia, 1999. Agency for Health Care Policy and Research. Using clinical practice guidelines to evaluate quality of care, vol 1: Issues. US Department of Health and Human Services and Public Health Service, 1995. Nikolajevic-Sarunac J, Henry DA, O'Connell DL, Robertson J. Effects of information framing on the intentions of family physicians to prescribe long term hormone therapy: results of a randomised controlled trial. J Gen Intern Med. In press. Make a comment

Hilda Bastian

For Debate An integrated electronic health record and information system for Australia? Christopher D Mount, Christopher W Kelman, Leonard R Smith and Robert M Douglas An integrated health record and information system, although costly and difficult to implement, would provide benefits for clinicians and patients through better clinical care, and for the healthcare system through better data for policy development and resource allocation. MJA 2000; 172: 25-27 Introduction - Health records - The Integrated Health Record and Information System - Benefits - Implementation - Conclusion - Acknowledgements - References - Authors' details - - More articles on Informatics and computers

Christopher D Mount · Christopher W Kelman · Leonard R Smith · Robert M Douglas

For Debate Integrated electronic health records and patient privacy: possible benefits but real dangers Strategies to develop integrated electronic health records must address consumer concerns, not dismiss them with claims of the "public good" Meredith Carter MJA 2000; 172: 28-30 Introduction - Newspeak - Global claims - New uses of data - Attention to consumer and community - References - Authors' details - - More articles on Informatics and computers

Meredith Carter