Volume 168 Issue 12

Abstract Objective: To assess the feasibility of offering the choice of prescribing injectable heroin (diamorphine) or injectable methadone to opiate-dependent injecting drug users and to assess whether there are health and social gains associated with prescribing injectable opiates. Design: A protocol-driven prospective observational study. Type of injectable opiate received was based on self-selection. Setting: A large west London drug clinic. Patients: Fifty-eight patients admitted to the clinic between 1 June 1995 and 31 December 1996, who were long term opiate-dependent injecting drug users, who had previously tried and failed oral methadone and who were apparently unable or unwilling to give up injecting. Main outcome measures: Retention in treatment, illicit drug use, HIV risk behaviour, criminal activity, social functioning, health and psychological status as measured by self-report, urinalysis and doctors' ratings. Results: Thirty-seven patients (64%) chose heroin and 21 (36%) chose injectable methadone. Fifty (86%) were retained in treatment after three months, 40 (69%) after six months and 33 (57 %) after 12 months. Among those in treatment at three months, there were significant reductions in illicit drug use, illicit drug-injecting risk behaviour, and criminal activity, and significant improvements in social functioning, health status and psychological adjustment. Generally, these gains were sustained between three, six and 12 months. Doctors' ratings of health and urinalysis results further supported these findings. Conclusions: Injectable heroin is not always the drug of choice. This intervention retained most patients in treatment with substantial benefits to both patients and the community. Prescribing injectable opiates to long term injecting drug users is a feasible treatment option. Introduction Opiate dependency is a major public health and social problem. Oral methadone treatment is the most common form of treatment for opiate dependency, and its effectiveness has been well demonstrated.1 However, Britain is one of the few countries where doctors can legally prescribe pharmaceutical heroin (diamorphine) and injectable methadone, and injectable opiates have been prescribed for opiate dependency since the 1920s in the case of heroin, and since the 1970s in the case of methadone.2Despite the legality of this practice, numbers of patients receiving such treatment remain small. Methadone accounts for 96% of all opiate prescriptions for treating drug dependency in the United Kingdom;3 injectable heroin accounts for only 2% of the total number of prescriptions for opiates;4 and methadone ampoules make up 9% of all methadone prescriptions.3 While injectable methadone is prescribed by doctors attached to specialist drug services, general practitioners and private doctors, a special licence from the Home Office is required to prescribe injectable heroin, and most doctors with such licences work in specialist drug services.5 Injectable opiate prescribing has not been guided by clinical protocols, but has been characterised by a high level of flexibility in decisions about eligible patients and dosage. The prescribing of injectable opiates has been the source of international controversy and debate. A large research trial has been undertaken in Switzerland6 and, in Australia, a heroin trial was designed to determine the impact of offering the choice of an injectable opiate prescription.7 However, the Australian Federal Government has decided that this trial will not proceed. It has been argued that injectable opiate prescribing may attract resistant opiate-dependent users into, and retain them in, treatment, with potential health and social benefits, including a reduction in crime,8 but there is a lack of scientific evidence on which to base these claims. The Swiss trial found that heroin prescribing retained drug users in treatment, with reductions in crime and improvements in health status.6 However, results of the most influential research carried out in the UK -- a randomised controlled trial comparing maintenance with oral methadone with heroin -- were inconclusive.9 In that study, the heroin group were better retained in treatment, but they continued to inject regularly and use illicit opiates in small amounts, which could lead to increasing clinic caseloads. On the other hand, the oral methadone group were more likely to either drop out of treatment or become abstinent. There were higher arrest rates and higher levels of drug involvement and criminal activity among those who did not become abstinent. Other studies have also found conflicting results.10-12 In this study we aimed to assess the feasibility of offering opiate-dependent injecting drug users the choice of treatment with injectable heroin (diamorphine) or injectable methadone, and to examine possible health and social gains associated with prescribing injectable opiates. Methods This pilot study was carried out at a west London drug treatment clinic. The clinic's protocol aimed to reduce illicit drug use and HIV risk behaviours; to improve physical, psychological and social functioning; and to move patients on to oral methadone treatment en route to abstinence. Eligible patients met the following criteria: aged over 21 years; dependent on opiates; unable or unwilling to give up injecting (defined by injecting for a minimum of three years with consistent injecting over the previous nine months and evidence of injecting over the past three months); previously failing oral methadone treatment (defined by regular continued use of illicit opiates while receiving oral methadone, continuing to inject regularly and receiving doses of oral methadone in excess of 80 mg/day); and problems relating to drug use in areas of health, social functioning or crime. Patients chose treatment with either injectable diamorphine (heroin) or injectable methadone. After a one-month induction period, they were required to stay with their drug of choice. A ceiling dose of 200 mg/day of either drug was set, and the treatment dose was achieved through tolerance testing over one week and stabilisation over the first month; after this time doses could only be reduced. Drugs were dispensed at the clinic daily (Monday to Friday with weekend doses taken home) for the first few weeks and then less frequently (a few times a week or weekly). After their initial tolerance test, patients were not permitted to inject on-site. To reduce the risk of injectable opiates being diverted to others, patients had to return used ampoules (batch numbers were checked) before receiving further ampoules. Criteria for disciplinary discharge from the study were evidence of "double-scripting" (receiving an additional prescription for opiates for drug dependency outside the clinic), dealing in the injectable opiates prescribed in this study, violence in the clinic, continual and persistent evidence of illicit drug use, consistently failing to return used ampoules, and injecting outside the clinic in the hospital grounds. The Australian Opiate Treatment Index (OTI)13 -- a multidimensional scale measuring illicit drug use, HIV risk behaviour, criminal activity, social functioning, physical and psychological health -- was administered to patients at entry and at three-monthly intervals. This instrument, which has been validated in both Australia13 and the UK,14 has a high correlation with doctors' and nurses' reports and with urine results at opiate treatment settings.14 Clinic doctors used standardised instruments to rate patients' health and psychological well-being at entry and at three-monthly intervals. These instruments included a physical rating scale for recording doctors' opinions of patients' physical health, including cardiovascular, respiratory, gastrointestinal, central nervous system and injecting-related health (Tallack F, Metrebian N, The Centre for Research on Drugs and Health Behaviour, London, 1996), and the Brief Psychiatric Rating Scale15 for recording doctors' judgements of patients' psychopathology. In addition, illicit drug use was measured through random urine tests throughout the treatment. Statistical analysis Tests of significance included t tests for related samples, and McNemar's chi-squared tests for dichotomous and ordinal data. Results from parametric and non-parametric tests were compared where normal approximations to the underlying distributions were suspect. We considered a P value of 0.05 to be significant. Results Fifty-eight subjects were recruited to the study. Forty-two (72%) were male, 50 were white (86%), and their median age was 38 years (range, 24-49 years). Their median duration of injecting heroin was 19.5 years (range, 4-30 years), and they had been in opiate treatment a median of four times previously (range, 2-17 times). Thirty-seven (64%) chose to receive diamorphine, 21 (36%) chose methadone. A higher mean dose of diamorphine was prescribed over three months (diamorphine, 181.43 mg/day [SD, 22.2; range, 120-200] v. methadone, 148.18 mg/day [SD, 45.1; range, 100-200) and over 12 months (185.24 mg/day [SD, 15.7; range, 150-200 v. 161.25 mg/day [SD, 46.4; range, 90-200]). Fifteen of the patients prescribed heroin (71%) reported experiencing night-time withdrawal symptoms as a result of heroin's shorter duration of action and were thus given an additional prescription for oral methadone. The mean dose of additional oral methadone was 24 mg/day (SD, 5.2; range, 20-30). A number of patients were found loitering in the vicinity of the clinic after their prescriptions were dispensed, and one was found injecting the prescription while still on hospital premises. No other major postdispensing problems were reported in the surrounding community. Fifty patients (86%) were still in treatment after three months, 40 (69%) after six months and 33 (57%) after 12 months. Reasons for discontinuing treatment are given in Box 1. Patients still in treatment at three months had significantly reduced their consumption of illicit drugs (with the exception of amphetamines, which did reduce, but not significantly), and made positive changes in all health and social domains. Self-reported criminal behaviour was initially low and further significantly reduced. There were significant improvements in social functioning (employment, housing, relationships and involvement in drug-using networks), health status and psychological adjustment. HIV risk behaviour (injecting and sexual risk behaviour -- the OTI considers any injecting as risk behaviour), and illicit drug-injecting risk behaviour (frequency of injecting and sharing of illicit drugs) reduced significantly. Although not significant, levels of sexual risk behaviour reduced slightly. There were no significant differences in measures of health and social behaviour between three and six months (data not shown), except for illicit drug injecting, which increased, although at six months it was still significantly less than at entry (1.13 [SD, 2.06] v. 5.66 [SD, 4.11]; P < 0.0001). Between six and 12 months, there were significant reductions in HIV risk behaviour, illicit drug-injecting risk behaviour and sexual risk behaviour, but no other significant changes. Results of urinalysis suggest that there were (non-significant) reductions in tranquilliser, amphetamine, and cocaine use between entry and three months, and between three and six months, which were sustained between three and 12 months. Few patients receiving injectable methadone were using illicit opiates. Measures of health and psychological status as reported by clinic doctors suggest health and psychological well-being had significantly improved at three months and these improvements were generally sustained. These findings were similar to measures of self-report. All measures reported at six and 12 months had significantly improved or reduced compared with measures obtained for the same sample at entry, with the exception of HIV risk, sexual risk and doctors' rating of psychological well-being, which had not significantly reduced or improved at six months but did reach significance again at 12 months. There were no differences found in drug use, health or social status reported at entry between those leaving treatment before 12 months and those remaining. Discussion These pilot study findings showed that opiate-dependent injecting drug users with long injecting careers (most started between 1970 and 1982) and for whom opiate treatment had failed multiple times previously were attracted into and retained by therapy with injectable opiates. Compared with drug users in a national UK study of oral methadone maintenance programs,16 our patients were older (38 v. 29 years) and had been injecting for longer (19.5 v. 9 years). While some clinicians17 and drug users' forums perceive a high demand for heroin treatment, our findings suggest that heroin is not always the drug chosen by users, with over one-third choosing injectable methadone. There has been much discussion about the correct dose of heroin.18 Over 12 months doses remained within the limit of 200 mg/day. In the Swiss study patients were stabilised on much higher doses of 500-600 mg/day.19 While interpretation of our findings is limited by the absence of a control group receiving oral methadone therapy and by reliance on self-report data, this is one of few studies to systematically examine the use of injectable opiates in treating opiate dependence, and the results will be used to inform a multicentre randomised controlled trial. In our study, at six months, 31% of patients had left treatment, and 40% of the 25 who left over the full 12 months were discharged because they violated the study protocol. Only two (16%) requested a move to oral methadone therapy and one became abstinent. There was one fatality (from hepatic failure) but no overdoses. By comparison, in the Swiss study of 366 patients receiving injectable heroin,20 18% had left treatment at six months and, of these, 48% switched to another treatment modality (mostly methadone maintenance) and 25% were excluded for threat of violence or other inappropriate behaviour. Four died and there were no overdoses. The retention rate in our study was higher than that reported by a national study of oral methadone maintenance programs at one month15 (86% v. 78%), and similar at six months (69% v. 67%).21 This suggests that the long-term opiate-dependent drug users in our study were well retained in treatment. Other studies have found similar high retention levels.9-11 There are concerns that prescribing injectable opiates might encourage drug users to continue injecting and discourage them from accepting oral methadone treatment or becoming abstinent.9 It is impossible to know whether our patients would have been more likely to move towards abstinence had they received oral methadone. However, these patients were long-term opiate-dependent drug users who had had a median of four previous opiate treatments and had tried and failed at least two oral methadone treatments without achieving abstinence. Our patients made significant health and social gains and experienced significantly reduced drug-related harm in the first three months. These gains were generally sustained between three and six, and six and 12 months. At entry, there were no significant differences in health and social status between patients later discharged from treatment and those who remained in the study. There has been some concern that patients' health might deteriorate while receiving prescribed injectable drugs.10 Previous research has shown little improvement in health and social wellbeing.9-11 The study by Battersby et al10 of drug users at high risk from serious physical illness, including HIV, found one individual developed a life-threatening illness (cervical spine osteomyelitis resulting from intravenous drug use) but survived, several injected into their femoral vein (a highly dangerous practice which carries a high risk of causing deep venous thromboses) and the health of 20% deteriorated. However, the authors concluded that "it was not possible to determine the nature of risk taking that would have occurred ... in the absence of the present treatment intervention". By contrast, we found that, although some patients were also injecting into their femoral vein, two moved to oral methadone because of poor health related to injecting and one died, for those remaining in treatment significant improvements were made in health, psychological adjustment and social functioning. These improvements were seen between entry and three months, and sustained between three, six and 12 months. There was also a reduction in illicit drug-injecting risk behaviour. Doctors' ratings of patients' health and psychological well-being verified these improvements. The problems of vein care associated with injectable opiates need to be weighed up against benefits in client attraction and retention, and in the provision of clean pharmaceutical drugs and injecting equipment, and advice on safer injecting practices and healthcare. Our findings do not support the suggestion that prescribing injectable opiates eliminates illicit drug use and criminal activity,22-24 as both declined significantly, but neither was eliminated. Similar results have been obtained by other studies.9-11 Results of urinalysis corroborated self-reported non-opiate drug use. However, it was not possible to corroborate self-reported opiate use as we could not differentiate between illicit and prescribed heroin. Diversion of prescribed opiates to others is of particular concern when there is no observed on-site injecting. While the clinic attempted to reduce the risk of such diversion, ways of corroborating self-reported compliance with prescription and illicit opiate use are needed. Prescribing injectable opiates is one of many options in a range of treatments for opiate-dependent drug users. In showing that it attracts and retains long term resistant opiate-dependent drug users in treatment and that it is associated with significant and sustained reductions in drug use and improvements in health and social status, our findings endorse the view that it is a feasible option. Further research is needed to examine the potential benefits of this treatment at both an individual and community level. Randomised controlled trials comparing alternative treatments and their relative cost effectiveness are required to fully assess this treatment option. Acknowledgements The Centre for Research on Drugs and Health Behaviour is core funded by the North Thames Office of the NHS Executives Research and Development Directorate. Riverside Mental Health Trust Substance Misuse Service, Ealing, Hammersmith and Hounslow and Kensington, Chelsea and Westminster Health Authorities funded this study. Thanks to all the clients who took part in the research, and to the clinic staff: Colin Small, Mark Lee, Victor Mtutu, Sue Byers, Movena Lucus, Gail Jones, Nicky Meux and Sam Nyeck. References Farrell M, Ward J, Mattick R, et al. Methadone maintenance treatment in opiate dependence: a review. BMJ 1994; 309: 997-1001. Strang J, Gossop M, editors. Heroin addiction and drug policy: the British system. Oxford: Oxford Medical Publications, 1994. Strang J, Sheridan J, Barber N. Prescribing injectable and oral methadone to opiate addicts: results from the 1995 national postal survey of community pharmacies in England and Wales. BMJ 1996; 313: 270-272. Strang J, Sheridan J. Heroin prescribing in the "British System" of the mid 1990s: data from the 1995 national survey of community pharmacies in England and Wales. Drug Alcohol Rev 1997; 16: 7-16. Sell L, Farrell M, Robson P. Prescription of diamorphine, dipipanane and cocaine in England and Wales. Drug Alcohol Rev 1997; 16: 221-226. Uchtenhagen A. Summary of the synthesis report. In: Uchtenhagen A, Gutzwiller F, Dobler-Mikola A, editors. Programme for a medical prescription of narcotics: final report of the research representatives. Zurich: Institute for Social and Preventive Medicine, University of Zurich, 1997. Bammer G. Should the controlled provision of heroin be a treatment option? Australian feasibility considerations. Addiction 1993; 83: 467-475. Metrebian N, Shanahan W, Stimson GV. Heroin prescribing in the UK: an overview. Eur Addict Res 1996; 2: 194-200. Hartnoll RL, Mitcheson MC, Battersby A, et al. Evaluation of heroin maintenance in controlled trial. Arch Gen Psych 1980; 37: 877-883. Battersby M, Farrell M, Gossop M, et al. "Horse trading": prescribing injectable opiates to opiate addicts. A descriptive study. Drug Alcohol Rev 1992; 11: 35-42. McCusker C, Davis M. Prescribing drug of choice to illicit heroin users: the experience of a UK Community Drug Team. J Subst Abuse Treat 1996; 13; 6: 521-531. Stimson GV, Oppenheimer E. Heroin addiction treatment and control in Britain. London: Tavistock Publications, 1982; 229-252. Darke S, Hall W, Wodak A, et al. Development and validation of a multi-dimensional instrument for assessing outcome of treatment among opioid users: the Opiate Treatment Index. Br J Addict 1992; 87: 733-742. Adelekan M, Green A, DasGupta N, et al. Reliability and validity of the Opiate Treatment Index among a sample of opioid users in the United Kingdom. Drug Alcohol Rev 1996; 15: 261-270. Overall JE, Gorham DR. The brief psychiatric rating scale. Psych Rep 1962; 10: 799-812. The Task Force to Review Services for Drug Misusers. Report of an independent review of drug treatment services in England. London: Department of Health, 1996; 61-64. Marks J. Who killed the British System? Druglink 1995; 10: 21. Strang J, Farrell M. Treatment of heroin users [letter]. BMJ 1994; 308: 718. Farrell M, Hall W. The Swiss heroin trials: testing alternative approaches [letter]. BMJ 1998; 316: 639. Uchtenhagen A, Dobler-Mikola A, Gutzwiller F. Medical prescription of narcotics. Eur Addict Res 1996; 2: 201-207. Gossop M, Marsden J, Stewart D, et al. The National Treatment Outcome Research Study in the United Kingdom: six month follow-up outcomes. Psych Addict Behav 1997; 11: 324-337. Beckett D. Prescription of controlled drugs to addicts. BMJ 1983; 287: 127. Connell PH. Drug dependence in Great Britain: a challenge to the practice of medicine. In: Steinberg, editor. Scientific basis of drug dependence. London: Churchill Livingstone, 1969. Marks J. Opium the religion of the people. Lancet 1985; i: 1439-1440. (Received 9 Sep 1997, accepted 24 Apr 1998) Authors' details The Centre for Research on Drugs and Health Behaviour, Department of Social Science and Medicine, Imperial College School of Medicine, London, United Kingdom. Nicky Metrebian, BA(Hons), Research Fellow; Gerry V Stimson, PhD, Professor, and Director. Chelsea and Westminster Drug Treatment Unit, Riverside Mental Health Trust Substance Misuse Service, London, United Kingdom. William Shanahan, MRCPsych, Lead Clinician, and Clinic Director. Riverside Mental Health Trust, London, United Kingdom. Brian Wells, MRCPsych, Trust Medical Director. Reprints: Ms N Metrebian, The Centre for Research on Drugs and Health Behaviour, Department of Social Science and Medicine, Imperial College School of Medicine, 200 Seagrave Road, London SW6 1RQ, United Kingdom. E-mail: n.metrebian@cxwms.ac.uk Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia ".

Nicky Metrebian · William Shanahan · Brian Wells · Gerry V Stimson

Fatigue and performance in hospitals Patients in hospital don't stop requiring medical care at night. That means either overtime or shift work for somebody. "Somebody" is usually a junior doctor. The early postgraduate years are not easy -- the problems of professional responsibility, study and combining a career and a personal life are difficult enough, but to these challenges are added hours of work that society does not expect of any other occupational group. The routine 50- hour shifts of not so long ago have, we believe, disappeared, but hospital doctors still commonly work long hours and unreasonable shifts. What impact this has had in our hospitals -- how it contributes to mistakes, suicides, drop-outs and divorces -- is unknown. However, fatigue undoubtedly impairs professional performance, learning and quality of life. For legal, educational and humanitarian reasons, hospitals need to do whatever can be done to limit excessive hours of work. A physiological, not an industrial, problem How many hours are "excessive"? We do not know. It depends on what we are trying to achieve, and the answer will be different if we want to maximise teaching and learning than if we just want to avoid disastrous errors. How many hours are doctors working? We do not know that either. Most data derive from retrospective self-reports, which is obviously unsatisfactory, and concern average hours per week, which is not the issue. The issue is the existence of any work weeks that do not allow adequate recovery between shifts or which impose excessive periods of continuous work. The Association of American Medical Colleges has suggested that residents should not work more than 80 hours per week averaged over four weeks.1 This approach is irrational -- it is like saying you are fit to drive at any time if your blood alcohol level averaged over four weeks is less than 0.05%. We have practically no data on the frequency with which doctors work exceptionally long hours. Hospitals may have data on rostered hours, but this is only a portion of the total hours worked, and the information is not entirely accurate. Rosters change because swaps are unregulated, and unrostered overtime is usually not included in hospital estimates of hours worked. Time sheets would be a better source of data, but their use raises confidentiality problems, and they miss unpaid overtime. Unrostered overtime, whether obligatory or self-imposed, is unregulated and mostly unrecorded because the pressure to work and not complain is overwhelming. The only accurate source of data on total hours worked would be direct observation, and no such study has been done. It is critical that this is seen not as an industrial issue but as a physiological problem. An 80-hour work week including 40 hours of unpaid overtime and no days off, however unacceptable industrially, could be acceptable physiologically if the worker had eight hours' sleep between shifts. A 24-hour shift at double-time with paid meal breaks is not acceptable physiologically, however attractive it may be to a junior doctor with a mortgage. Imposing a 24-hour shift once a year because all the other medical staff are off sick may not be unfair, but it is unsafe. The body clock keeps ticking at night Humans have a marked circadian preference for sleep at night and, even under optimal conditions, being awake at night is associated with impaired performance. When long hours and sleep deprivation are added to the circadian problem, the performance deficit is exacerbated. The effects of fatigue on performance are well defined.2 Concentration, data processing and short-term memory are impaired. The variability of performance increases, so that normal performance alternates with periods of poor work, and astute decisions are mixed with lapses of judgement. Performance declines sharply as the duration of a task increases, and fatigued workers sacrifice accuracy to speed. Fatigue causes less performance decrement in workers with more control over their work because they can schedule non- urgent tasks for periods when they are at their best. Doctors will thus cope better than staff with less job flexibility, such as nurses. Effort can compensate for fatigue, but as fatigue worsens the ability to summon an effort of concentration declines and the time for which it can be maintained shortens. Performance in crises, however, is preserved until fatigue is extreme. Mistakes caused by fatigue are most likely to occur during routine tasks and tasks which require sustained vigilance, especially when the factors that trigger an effort of concentration (such as an obviously ill patient) are absent. Fatigue mistakes characteristically involve failure to recognise the existence of a serious problem. Giving the wrong antibiotic to a patient recognised as having sepsis is not a typical fatigue mistake, but failing to recognise sepsis at all is. For this reason fatigue-related errors of judgement are difficult to prevent and often disastrous. Are doctors seriously impaired by fatigue? We are not sure. Some studies have found performance decrements attributable to fatigue,3 but others have not.4 The methodological issues that make most existing studies of limited use are twofold. Firstly, the psychometric tests usually used to assess fatigue have never been shown to predict real-life medical performance.2Secondly, many studies use unrealistic definitions of fatigue. In one often-quoted study of junior doctors with work weeks of 100 hours, "fatigued" was defined as less than four hours' sleep in 24 hours, and "rested" as more than four hours' sleep in 24 hours.4 It is little wonder that no difference was discernible between the "fatigued" and "rested" doctors! Doctors and army officers are the only occupational groups reported to be unaffected by fatigue,2 but this is generally regarded as an artefact of methodology.2,5 A "healthy worker effect" is a possible explanation (people who need a lot of sleep don't last very long as surgical registrars or army cadets), but not needing a lot of sleep is hardly the best basis for choosing doctors. Willingness to work when fatigued is widely seen as "professional". This view goes back to acts of genuine heroism in wars and epidemics and to some of the noblest traditions of medicine. But the diurnal rhythm of alertness and the drive to sleep are basic physiological processes, and commitment does not affect physiology. Heroic workloads are out of place in the routine organisation of the urban teaching hospital. Many doctors, junior and senior, voluntarily undertake long hours of work for reasons of money, professional advancement or altruism. Neither money nor seniority is an antidote to fatigue, however, and fatigue is no less damaging to performance when it is incurred voluntarily. It is just as inappropriate for a consultant surgeon to perform emergency operations all night and a routine list the next morning as it is for a junior doctor to be forced to stay at work to assist. Hospitals must not only stop forcing staff to work dangerous hours, they must also prevent them choosing to do so. Hours ain't hours Given that night work is inevitable, and that it inevitably impairs performance and quality of life, it seems obvious to insist on the use of minimally damaging patterns of shift work. The reality in hospitals is different: a number of practices known to cause particularly severe impairment are common. The most obvious suspicion about shifts is true: long ones are worse than short ones.6 Data from a number of occupational groups suggest that eight-hour night shifts are optimal and that 12-hour night shifts are acceptable only if workloads are light. Night shifts longer than 12 hours, and daytime shifts longer than 16 hours, have consistently been found to be associated with reduced productivity and more accidents.6 It is also important to note that the later the night shift ends, the less sleep is obtained that day.7 Even when the night shift has officially ended, casual extension of night shifts into the morning for hand-over rounds and morning report is common. In addition, libraries and medical administration offices rarely have opening hours that allow night workers access without intruding on their sleep time. Physiological adaptation to night work is largely a myth8 and there is no reason to extend periods of night work in the hope that adaptation will occur. For intellectually demanding tasks, short periods of night work (one or two shifts) are better tolerated than longer periods because the accumulated sleep deficit is less. It is easy to demonstrate that the progressive sleep loss of a seven-night roster causes a progressive rise in accidents and a fall in productivity.9 Sleep deficits cannot be repaired immediately. Night-shift workers seldom sleep more than five or six hours in each 24- hour period, so that after seven nights the accumulated sleep deficit is 15 to 20 hours. At least 48 hours off duty are usually needed to recover this deficit,7,10and rosters that require workers to go from night shifts to day or afternoon shifts with no break are dangerous. The pattern of long work days followed by nights interrupted by calls is regarded as normal by the medical profession. These calls are, at best, simple telephone calls. At worst, they may entail returning to the hospital several times a night. Few other workers do this, and data on its long-term effects are entirely lacking. Being on-call impairs sleep even when there are no calls,11 and as five or six hours' uninterrupted sleep is needed to avoid performance decrement10 perpetual or frequent on-call work is probably damaging. Solving the problem We have very little of the knowledge that we need to understand fatigue in medical work. Studies are required to determine whether there is a serious problem of fatigue-related impairment of performance in some or all Australian hospitals. Such studies need to focus on how learning and quality of life, as well as professional performance, are affected by fatigue. Junior doctors are not the only ones affected by fatigue, and senior staff also need to be studied. We need controlled trials to determine optimal work schedules and to test countermeasures to fatigue (eg, benzodiazepines to assist daytime sleep, and bright light and caffeine for stimulation). We do know enough, however, to eliminate the worst abuses of the human sleep-wake cycle, and we need to see a shift by both hospital employers and the medical profession towards addressing this issue. References Executive Council, Association of American Medical Colleges. Resident supervision and hours: recommendations of the Association of American Medical Colleges. J Med Educ 1988; 63: 417-426. Dinges DF, Kribbs NB. Performing while sleepy: effects of experimentally induced sleepiness. In: Monk TH, editor. Sleep, sleepiness and performance. Chichester: Wiley, 1991: 97-128. Rubin R, Orris P, Lau SL, et al. Neurobehavioural effects of the on-call experience in housestaff physicians. J Occup Med 1991; 33: 13-18. Deaconson TF, O'Hair DP, Levy NW, et al. Sleep deprivation and resident performance. JAMA 1989; 260: 1721-1727. Leung L, Becker CE. Sleep deprivation and house staff performance. J Occup Med 1992; 34: 1153-1160. Rosa RR. Extended work shifts and excessive fatigue. J Sleep Res 1995; 4 (Suppl 2): 51-56. Kecklund G, kerstedt T. Effects of timing of shifts on sleepiness and sleep duration. J Sleep Res 1995; 4 (Suppl 2): 47-50. Dahlgren K. Long-term adjustment of circadian rhythms to a rotating shiftwork schedule. Scand J Work Environ Health 1981; 7: 141-151. Knauth P. Speed and direction of shift rotation. J Sleep Res 1995; 4 (Suppl 2): 41-46. Carskadon M, Roth T. Sleep restriction. In: Monk TH, editor. Sleep, sleepiness and performance. Chichester Wiley, 1991: 155-167. Torsvall L, Akerstedt T. Disturbed sleep while being on call. An EEG study of apprehension in ships engineers. Sleep 1988; 11: 35-38. Authors' details Sleep Disorders Centre, Royal Newcastle Hospital, Newcastle, NSW. Leslie G Olson, FRACP, Sleep and Respiratory Physician. Department of Medicine, University of Newcastle, Newcastle, NSW. Antonio Ambrogetti, MD, FRACP, Sleep and Respiratory Physician. Reprints will not be available from the authors. Correspondence: Dr L G Olson, Department of Medicine, University of Newcastle, John Hunter Hospital, Locked Bag 1, Hunter Region Mail Centre, NSW 2310. Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>".

Leslie G Olson · Antonio Ambrogetti

Doctors' working hours: can the medical profession afford to let the courts decide what is reasonable? Antony Nocera and Diana Strange Khursandi Fatigue is no defence for negligence by a doctor in an action by a patient MJA 1998; 168: 616-618 For editorial comment, see Holmes See also Olson & Ambrogetti Fatigue caused by long working hours can impair doctors' judgement and competence, and may result in harm to both patients and doctors. Preventable errors resulting from fatigue may lead to patient mishap, which may in turn lead to litigation. The impact of litigation upon individual doctors is enormously stressful. Fatigue is no defence for negligence by a doctor in an action by a patient.1,2 The courts, both in Australia and overseas, have already expressed concern about the role of fatigue as a contributing factor in medical mishap. A nationwide policy on doctors' hours must be preferred to the current practice, where legal judgments impose recommendations on an individual basis after mishaps. Out-of-court settlements may be economically expedient for insurers, but not necessarily to the advantage of either doctors or their patients. Fatigue results in bad medicine Arduous duty schedules for doctors have traditionally been viewed as part of the rites of passage into the medical profession. Doctors work long hours, sometimes extending into meal breaks, rest and leisure time. The effect of lost sleep (sleep debt) accumulates over time and does not dissipate.3 The cognitive psychomotor impairment after 17 hours of sustained wakefulness is equivalent to that caused by a blood alcohol concentration of 0.05%; after 24 hours of sustained wakefulness it is equivalent to a blood alcohol concentration of 0.1%.4In the first 4000 reports to the anonymous voluntary register of anaesthetic adverse incidents (Australian Incident Monitoring Study [AIMS]),5 20% of adverse incident reports identified "stress-related" factors (Table 1). Incident reports relating to errors in drug administration or equipment checks were disproportionately associated with reports of fatigue (Table 2). Medicolegal aspects of fatigue Doctors have an ethical and medicolegal obligation to provide an acceptable standard of medical care. A doctor's professional obligations are not abrogated by hospital directives or policy. Tired doctors may make errors, fail to spend adequate time with patients, fail to communicate effectively with patients and fail to complete appropriate case notes.6 Psychological mismanagement of patients can generate complaints and litigation even when the medical management has been exemplary.7 The impact upon a doctor's professional and private life of receiving a complaint must not be underestimated. The enormity of an error, whether fatigue-related or not, can lead to the doctor committing suicide.8-11Hospital management has a duty of care in preventing fatigue-related incidents, and a vicarious liability for actions by employees. The hospital also has a legal obligation to provide a safe working environment for its staff. Work-related travel accidents, or events such as needlestick injuries, could result in significant liability issues for hospital management if they occur after excessive periods of duty. The following cases illustrate aspects in the division of responsibility between doctor and hospital management in litigation involving fatigue. Case 1: Brotherson v Royal Perth Hospital (Australia)12 Robert Brotherson was a 12-year-old boy who underwent open heart surgery in 1978 for congenital heart disease. His postoperative course was complicated by hepatic dysfunction and renal failure requiring peritoneal dialysis. While on dialysis, he developed glucose intolerance which was treated with an insulin infusion. Eight days after his initial surgery, Robert's condition improved, and dialysis was ceased at about 0600. During the medical hand-over between 1800 and 1900 that evening, a consultant decision was made to reduce the frequency of blood sugar monitoring. The decision was based on blood sugar levels (13.1 mmol/L at midnight and 9.05 mmol/L at 0700), and the desire to give Robert an opportunity to sleep. A further blood sugar level of 4.2 mmol/L had been measured at 1612, but not recorded in the notes until the following day. As a result of this omission, the significance of the downward trend in blood sugar level may not have been fully appreciated. At 0550 the following morning Robert had a hypoglycaemic fit resulting in permanent brain damage. In 1995, when Robert was 29 years old, the District Court of Western Australia awarded damages of $2.75 million against Royal Perth Hospital. After a trial which lasted four weeks, Judge French observed that it was difficult to avoid the conclusion that the long shifts the staff worked, with an overwhelming workload, had contributed to their oversight. Case 2: The Libby Zion case (USA)13 Libby Zion was an 18-year-old woman who died in a New York hospital in March 1984. In January 1984, Ms Zion had begun psychiatric treatment for stress, and was taking phenelzine up to the day before her admission. She was admitted by an emergency department junior resident with a tentative diagnosis of "viral syndrome with hysterical symptoms". At the time of her admission at 0200, both the emergency department resident and the medical intern had been on duty for 18 hours. At 0330 Ms Zion received pethidine 25 mg intramuscularly for agitation and shivering. Between 0400 and 0430 she became increasingly agitated, confused and began thrashing around in bed. The medical intern, attending another patient, was twice notified about the patient. He first gave a telephone order for physical restraint, then another for haloperidol 1 mg intramuscularly. At 0630 Ms Zion was found to have an axillary temperature of 42¡C, for which the intern ordered cold compresses and a cooling blanket. Shortly afterwards she had a respiratory arrest and could not be resuscitated. The postmortem findings were bilateral bronchopneumonia with presumptive evidence of cocaine use. Her father, an attorney and a writer for the New York Times, claimed that his daughter had received inadequate care from overworked and undersupervised medical staff. He successfully lobbied for a grand jury investigation into his daughter's death. The grand jury returned no criminal indictments against the hospital or its physicians, but found much at fault with resident training and staffing. As a result of these findings, New York State implemented legislation which limits a doctor's shift in emergency services to a maximum of 12 consecutive hours. Case 3: Johnstone v Bloomsbury Health Authority (UK)14 An obstetric senior house officer was employed in 1988 by University College Hospital in London to work a basic 40-hour week with an additional 48 hours per week "on-call" (working overtime while residing in the hospital). He was subsequently required to work 32 hours over one weekend, with only 30 minutes' sleep. On another weekend he worked for 49 continuous hours, taking over 60 calls, and was able to sleep for only seven hours. In 1989, Dr Johnstone took the Bloomsbury Health Authority to court, successfully arguing that he had sustained personal injury as a result of his work schedule. In upholding the damages awarded, the court of appeal found that the health authority could not lawfully require the doctor to work so much overtime in a manner which constituted a threat to his health. In this case, the court rejected the argument that "if you cannot stand the heat in the kitchen, you should get out, or not go in". It noted that it was "a matter of grave public concern that junior doctors should be required to work such long hours without proper rest that not only their own health may be put at risk but that of their patients as well". Case 4: Wilsher v Essex Health Authority (UK)15 Martin Wilsher was born in December 1978, nearly three months premature. At birth he was described as a "very floppy blue baby". He was initially intubated, but was able to be extubated after eight minutes and was admitted to the Special Care Baby Unit on supplemental oxygen via a face mask. In the Special Care Baby Unit, a junior resident doctor mistakenly inserted a catheter into an umbilical vein for arterial blood gas sampling. The error was subsequently missed by both a senior registrar and a consultant radiologist. The resident and registrar involved were either working continuously or had been "on call" (working overtime) every second night and weekend. When the catheter was changed by the senior registrar after 24 hours, it was again placed into an umbilical vein instead of the artery. Due to being supersaturated with oxygen for approximately 32 hours, the baby developed retrolental fibroplasia, resulting in near-total blindness. The court of appeal dismissed an application by the health authority contesting the damages awarded in the subsequent action by the child's parents. The judge concluded that "a health authority which so conducts its hospital that it fails to provide doctors of sufficient skill and experience to give the treatment offered at the hospital may be directly liable in negligence to the patient... I can see no reason why, in principle, the health authority should not be so liable if its organisation is at fault". Looking forward While the effect of fatigue on performance is being increasingly recognised, traditional attitudes to working hours have become inappropriate, especially in the current climate of growing complexity of medical practice and increasing patient expectations. Other bodies, such as the airline industry, have already recognised the importance of regulating working hours and rest periods to minimise fatigue. At present, none of the Australian specialty colleges has recommendations on duty hours, despite the adverse effect fatigue could have on training. Based on overseas experiences, the introduction of duty time limits in Australia would require an upward revision of the current estimates for future medical workforce requirements. In the Netherlands, the introduction of duty time limits for doctors in training increased medical employment, while in the United Kingdom it has resulted in the creation of over 1000 new consultant positions.16 The Wilsher v Essex Health Authority judgment centred on the issue of inadequate supervision of junior doctors. The health authority was found to be at fault because its organisation failed to provide appropriate care. This principle of hospital management liability due to organisational failure is even more applicable to an incident occurring due to doctors being required to work excessive hours, thus exposing patients to the potential risk of injury.2 Hospital indemnity insurers would have grounds to introduce penalty premiums if a hospital "organisational failure" resulted in an increased risk of litigation due to either fatigued medical staff or undersupervised junior doctors. The medical profession must take the initiative and accept the responsibility for continued investigation of the impact of fatigue on performance. There is an urgent need for widespread discussion involving government, the health authorities, the AMA and the specialty colleges so that strategies may be developed to minimise the potential for fatigue-related incidents. Setting duty time limits (together with mandatory rest periods, and rostering that minimises fatigue) will represent a practical and timely investment in patient care, sensible risk management for hospitals, and a safer working environment for doctors. It would give physician and patient safety a clear priority in a climate of increasing financial constraint and conflicting political pressures upon the healthcare system. Unless the medical profession and the health authorities introduce and police "safe working hours", they risk both compromising patient care, and increasing scrutiny by the courts. References Powers MJ, Harris NH, Lockhart-Mirams A (editors). Medical negligence. 2nd ed. London: Butterworths, 1994. Jones MA. Medical negligence. London: Sweet and Maxwell, 1991. Dement WC. The perils of drowsy driving. N Engl J Med 1997; 337: 783-784. Dawson D, Reid K. Fatigue, alcohol and performance impairment. Nature 1997; 388: 235. Garden AL, Currie M, Gander PH. Sleep loss, performance and the conduct of anaesthesia. Aust Anaesthesia 1996; 43-51. McCall TB. The impact of long working hours on resident physicians. N Engl J Med 1988; 318: 775-778. Condon JT. Medical litigation. The aetiological role of psychological and interpersonal factors. Med J Aust 1992; 157: 768-770. Charles SC, Wilbert JR, Kennedy EC. Physicians' self reports of reactions following malpractice litigation. Am J Psychiatry 1984; 141: 563-565. Charles SC, Wilbert JR, Franke KJ. Sued and nonsued physicians' self-reported reactions to malpractice litigation. Am J Psychiatry 1985; 142: 437-440. Birmingham PK, Ward RJ. A high risk suicide group: the anesthesiologist involved in litigation. Am J Psychiatry 1985; 142: 1225-1226. Wenokur B, Campbell L. Malpractice suit emotional trauma. JAMA 1991; 266: 2834. Templeman D. Oversight by tired doctors, not failure to keep up-to-date, caused brain damage. Aust Health Law Bull 1996; 5: 35-36. Asch DA, Parker RM. The Libby Zion case. N Engl J Med 1988; 318: 771-775. Johnstone v Bloomsbury Health Authority [1991] 2 All ER 293. Wilsher v Essex Health Authority [1986] 3 All ER 801. Federal Secretariat. Overview of overseas experience in regulating hours of work of doctors in training. Canberra: Australian Medical Association, 1998. (Received 15 December 1997, accepted 20 April 1998) Authors' details Careflight, Westmead Hospital, Westmead, NSW. Antony Nocera, FACEM, Emergency Physician. PO Box 1105, Caboolture, QLD. Diana Strange Khursandi, FANZCA, Anaesthetist. Reprints will not be available from the authors. Correspondence: Dr Antony Nocera, Careflight, PO Box 159, Westmead, NSW 2145 E-mail: tonynoce@ozemail.com.au Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/>

Antony Nocera