General medicine

Facsimile communication between emergency departments and GPs, and patient data confidentiality David McD Taylor, John Chappell-Lawrence and Ian S Graham MJA 1997; 167: 575-578 Abstract - Introduction - Methods - Statistical analysis - Results - Discussion - References - Authors' details - - ©MJA1997 Abstract Objective: To assess general practitioners' perceptions of the effectiveness of facsimile notification of their patients being admitted from the emergency department (ED), and its adequacy in terms of patient confidentiality. Design: Questionnaire survey, before and after the initiation of facsimile notification. Setting: A provincial community of approximately 120 000 residents in Victoria. Main outcome measures: Changes in GPs' ratings of communication with the ED; acceptability of facsimile notification; and concerns about patient confidentiality. Results: 77 of 85 GPs participated; only 44 (57.1%) returned both questionnaires. ED-GP communication ratings of "adequate" or better increased from 48% to 100% ( P < 0.05). The proportion of GPs who were notified of all admissions increased from 0 to 41% ( P < 0.05). The proportion of GPs who preferred facsimile for notification increased from 39% to 68% ( P < 0.05). Most GPs found the initiative acceptable and reservations about confidentiality decreased from 36% to 16% ( P < 0.05). 38 of the 887 patients admitted from the ED (4.3%) refused facsimile notification. Conclusions: Facsimile improves ED-GP communications and may, in turn, improve the quality and continuity of patient care. Informed consent should be obtained from all patients. MJA 1997; 167: 575-578 Introduction With shorter hospital stays and a greater emphasis on same-day surgery and domiciliary or "hospital in the home" services, the involvement of general practitioners in coordinated patient management is increasingly important.1,2 Unfortunately, many GPs report progressive alienation from their community hospitals.1,2 Poor communication between public hospitals and GPs is a major cause of negative effects for both doctors and patients,1,3,4 and has been linked with discontinuity of treatment and patient dissatisfaction with the transition of care between hospitals and primary practice.1,3Anecdotal evidence suggested that there was room for improvement in communications between our hospital (Ballarat Base Hospital) emergency department and local GPs. In particular, a 1995 survey showed that 84.4% of the Ballarat GPs who responded wished to be notified of their patients' admissions (Dr Mark Fitzgerald, Emergency Department Director, St John of God Hospital, personal communication). Ballarat Base Hospital medical officers were required to notify GPs of patient admissions by telephone. However, as 62% of patients are admitted from the emergency department (ED) between 1800 and 0800 (unpublished data) and GPs can be difficult to contact after hours, GPs were often not notified. To rectify this problem, and to improve the relationship between the hospital and GPs, Ballarat Base Hospital and the Ballarat and District Division of General Practice aimed to establish a system of facsimile notification of GPs of patient admissions. Advantages of facsimile transmission of patient information include speed and accuracy of transfer, accessibility, low cost, and the possibility of direct transfer from the computer screen.5-9 However, there are potential problems of misdirection of transmissions and of document security at the transmission destination.10-14 In this study, we aimed, firstly, to examine the perceived success of this initiative in improving communications between the emergency department and GPs, and, secondly, to address potential problems and establish appropriate confidentiality protocols and controls governing the use of facsimile for this purpose. Methods The Ballarat Base Hospital is a community teaching hospital in provincial Victoria serving approximately 120 000 residents in both urban and rural areas. The Ballarat and District Division of General Practice includes all of the 85 GPs who serve this population. All of these GPs regularly refer to the hospital and often contribute to their patients' inpatient and postacute care. Details of our facsimile study were mailed to all these GPs, and they were advised that their participation would involve receiving facsimile admission notification and providing relevant patient information if required. The ED purchased a dedicated facsimile machine with a preprogrammable number dialling facility to ensure that, if an incorrect number were pressed, the facsimile would be sent only to another participating GP. The machine was positioned in a secure area of the ED clerical office where incoming and outgoing facsimiles could not be accessed by unauthorised people. To test the system, a test facsimile was sent to all preprogrammed numbers of participating practices, which were asked to verify the security of their machines and their commitment to the confidentiality of the study by endorsing the test facsimile with the practice stamp and refaxing it to the ED. Specially designed facsimile notification sheets recorded: The GP's name; Patient identification (name, age, date of birth, unit record number, address) and admission details (date, time, diagnosis, ward and inpatient unit); The patient's signature (indicating consent for their GPs to be notified and to provide any relevant medical information by facsimile); and A request from the ED for the GP to provide specific and any other relevant medical information in a space provided (the same facsimile could then be returned). Before each admission, an ED clerk completed the notification sheet, which was checked and signed by the patient. Only the patient, or a parent in the case of a minor, could consent to transmission. Family members were not permitted to sign on behalf of patients. For patients either physically or mentally incapable of consenting, facsimiles were not sent. The completed sheet was then checked and signed by the ED medical officer. If a notification sheet was not sent, the reason was noted in the space provided for the patient's signature. Facsimile notification of patient admission began on 6 June 1996; the study period ended on 31 July 1996. Perceptions of communication between the ED and GPs before and after the establishment of facsimile notification were assessed by two questionnaires, posted to participating GPs in the week before and immediately after the study period. The questionnaires were identical, except for an additional question in the one sent at the end of the study period. For each question, respondents were asked to select the most appropriate response, and were invited to elaborate descriptively. GPs who did not respond were reminded by mail, fax or telephone. Statistical analysis For Questions 1-5, the change in response as a result of the initiation of facsimile notification was used as the variable of interest. The sign test was used to test the null hypothesis ( if the intervention had no effect, the number of positive and negative differences should be similar ). Questions 6-8 required a "yes" or "no" response and the results were analysed using McNemar's test (α = 0.05; df, 1). SPSS 15 was used for all analyses. In all cases, the change from before to after the intervention was considered. Results Seventy-seven GPs (90.6%) agreed to participate in the study. A further seven had no facsimile machine in their surgeries, and one GP elected not to participate. During the study period, 887 patients were admitted from the ED. Facsimile notifications were sent to the GPs of 548 patients (61.8%). A further 74 patients (8.3%) were visitors or transferred from outside the area, 73 (8.2%) were unable to provide informed consent, 47 (5.3%) had GPs with no facsimile machine, 38 (4.3%) refused permission to send notification, 32 (3.6%) had no GP, and 14 (1.6%) had been admitted to the ward before authorising the notification. For the remaining 61 patients (6.9%), no explanation could be found for failure of notification. Usually, no attempt was made to notify GPs if a facsimile was not sent. Of the 77 participating GPs, 44 (51.7%) completed the first, 55 (71.4%) completed the second, and 44 (57.1%) completed both the questionnaires. The demographic characteristics of the 77 GPs, comparing the 44 who completed the study with the 33 who did not, are shown in Box 1. Responses to the questionnaires, before and after the intervention, by the 44 GPs who completed the study are compared in Box 2. After the intervention, there was a significant improvement in GPs' perception of overall communications from the ED (Question 1; P < 0.001). Similarly, GPs reported a significant improvement in the frequency of notification (Question 2; P < 0.001), and in communications (Question 3; P < 0.001) from the ED after one of their patients was admitted. Responses to Question 4 showed a significant change in GPs' preferred mode of communication after the intervention ( P < 0.01). Before the intervention, most preferred a direct telephone call from the admitting officer, while after the intervention most preferred a facsimile. When asked how notification of their patients' admissions from the ED would affect [had affected] their management of those patients (Question 5), most GPs stated, both before and after the intervention, that notification would encourage them to visit their patients in hospital and assist in planning postacute care. After recoding to adjust for the effect of multiple answers (more than one response was allowed), no statistically significant change was found as a result of the intervention. The number of GPs responding that they had recently been aggrieved or inconvenienced as a result of the ED not notifying them of the admission of one of their patients (Question 6) fell significantly after the intervention ( P < 0.001). After the intervention, only two additional GPs responded that prompt notification of a patient's admission was of significant importance to the ongoing management of that patient (Question 7); this was not statistically significant. The number of GPs who had reservations about confidentiality associated with patients' medical records being transmitted by facsimile with their consent (Question 8) fell after the intervention ( P < 0.05). Finally, the question included only in the second questionnaire showed that 43 GPs (97.7%) were prepared to support the continuation of the ED facsimile notification initiative. It also showed that 39 (88.6%) and 40 (90.9%) GPs, respectively, were prepared to support its use in all admissions and discharges at Ballarat Base Hospital. Discussion Our findings clearly show that GPs perceived an improvement in their communications with the ED after the advent of facsimile notification. At the end of the study period, there was a significant increase in the number of GPs who preferred to be notified by facsimile, and a significant reduction in the number of GPs who had reservations about patient confidentiality. Most GPs responded that notification allowed them to visit their patients in hospital, to contribute to inpatient care, to plan their patients' postacute care (e.g., home-help, meals-on-wheels, district nursing and family counselling), and to avoid interruption of the GP-patient relationship. Such continuity of care may affect readmission rates. Objective measurement of whether facsimile notification actually affects GP behaviour and patient outcomes may be worthy of further study. A drawback of our study was its low response rate. Despite encouragement, a considerable number of GPs did not complete both questionnaires. While there were no obvious differences between those who did and did not complete the study, the low response rate may have introduced bias into the results by selecting for more motivated GPs, or those with a special interest in the study. The fact that more GPs responded to the second questionnaire may have indicated some enthusiasm for the project. Lack of confidentiality has been identified as one of the most serious drawbacks of using facsimile machines in clinical practice. The sender loses control once a fax is transmitted, and information can be misdirected as a result of dialling wrong numbers.10,11,13,16,17 None the less, we considered facsimile notification a more appropriate initial step than other accepted methods, such as encrypted electronic data transfer. The infrastructure was easy and relatively cheap to establish. It was also easy for the ED staff to use, with completion and transmission of each notification sheet taking approximately five minutes. Finally, the method allowed the patients to view the notification document before its transmission. The safeguards we used in the facsimile transmission of patient med- ical information (Box 3) have been recommended by other investigators.6,11,12,14,16,17 We contend that, if these safeguards are established, the standard of care for the protection of patient information transmitted by facsimile should be at least as high as that provided by conventional mail. A message reaching a secure facsimile machine is no more susceptible to loss, misdirection or unauthorised access than an opened letter in a doctor's "in-tray". It has been suggested that an authorisation procedure should be in place to facilitate obtaining informed consent for any facsimile transmission of personal information.6,12,14,16,17 We felt that if patients were shown the information that was to be transmitted, its destination and the format in which it was to be sent they could make an informed decision about whether or not GP notification was appropriate. The number of patients who refused consent for facsimile notification (38, or 4.3%) was surprising; our study had not been designed to record the reasons for these refusals and this matter deserves further study. Regardless of the reasons for refusal, patients could suffer distress if medical information was transmitted without consent, and legal action could result from misdirection of unauthorised, non-urgent medical information. Our protocol represented a change in Ballarat Base Hospital's facsimile policy as consent had previously been assumed. In most hospitals, providing the name of the GP at registration or admission is considered implied consent for the hospital to communicate directly with the GP. Letters, discharge summaries and death notifications may be sent by facsimile, electronic transfer or mail. With increasing use of telecommunications and information technology, we contend that it may be appropriate to question some of the practices that are currently undertaken routinely with only the implied consent of patients. Other Australian emergency departments are developing facsimile and electronic data systems for the transfer of patient information. Facsimile remains a "paper-based" technology and is likely to become superseded by electronic data transfer systems. Indeed, the American College of Emergency Physicians believes that, along with facsimile, electronic data facilities should be available to all emergency departments.6 Various electronic data transfer systems have been developed to coordinate the shared care of patients,18 to establish electronic medical records,19 to facilitate communication between hospitals and GPs,20 and to streamline patient referrals.21 While these "paperless" systems may be superior to facsimile, they also raise confidentiality issues. These are being addressed with the use of cryptography,22 digital signatures,20 "need to know" staff clearances,20 and legislation.20,23 Meanwhile, facsimile is accessible and relatively inexpensive, and is likely to remain useful, at least in the near future, until electronic systems become more prevalent. We recommend the use of facsimile transmission for notification of patient admission, provided that adequate safeguards are in place, and that informed consent is obtained before transmitting medical information. Following the success of facsimile notification of admissions from the ED, Ballarat Base Hospital has continued its use and is considering extending it to all hospital admissions and discharges, ED discharge letters and, possibly, to service providers other than GPs. Presently, the hospital is investigating software which will allow computer-generated facsimile transmission and is looking ahead to electronic data transfer. References Bella JI, Jamieson WE. Improving the continuity of care between general practitioners and public hospitals. Med J Aust 1994; 161: 656-659. Freeman G. Continuity of care in general practice: a review and critique. Fam Practitioner 1984; 1: 245-252. Interaction with Fremantle Hospital: final report. Fremantle: Fremantle Regional Division of General Practice, 1994: 1-40. Morrison WG, Pennycook AG, Makower RM, Swann IJ. The general practitioner's use and expectations of an accident and emergency department. J R Soc Med 1990; 83: 237-240. Magennis AW. Fax units in general practice. Aust Fam Physician 1989; 18: 1259-1264. American College of Emergency Physicians. The use of facsimile machines and electronic data transfer in the emergency department [policy statement]. Ann Emerg Med 1993; 22: 266. Spigelman A. Faxed electronic summaries are valued by general practitioners [letter]. BMJ 1995; 311: 746-747. Cole DR, Johnson MS, Heaton CJ, Petti M. Fax/modem board communications decrease preceptor communication costs. Fam Med 1994; 26: 418-420. Yamamoto LG, Wiebe RA. Improving medical communication with facsimile (fax) transmission. Am J Emerg Med 1989; 7: 203-208. Marr P. Maintaining patient confidentiality in an electronic world. Int J Biomed Comput 1994; 35 Suppl: 213-217. Brent N. Facsimile systems revised: focus on confidentiality and privacy. Home Healthcare Nurse 1991; 9: 6-8. Larkin GL, Moskop J, Sanders A, Derse A. The emergency physician and patient confidentiality: a review. Ann Emerg Med 1994; 24: 1161-1167. Carman D, Britten N. Confidentiality of medical records: the patient's perspective. Br J Gen Pract 1995; 45: 485-488. Capen K. Facts about the fax: MDs advised to be cautious. Can Med Assoc J 1995; 153: 1152-1153. SPSS/PC+ statistics [computer program]. Version 4.0. Chicago: SPSS Inc., 1990. Genesen LB, Sharp HM, Genesen MC. Faxing medical records: another threat to confidentiality in medicine [letter]. JAMA 1994; 271: 1401-1402. Grant AE. Legal matters -- facsimile transmissions. Canadian Nurse 1996; 92: 47. Branger P, van't Hooft A, van der Wouden HC. Coordinating shared care using electronic data interchange. Medinfo 1995; 8: 1669-1674. Walker D. Transferring electronic medical records. Aust Family Physician 1997; 26: 48-55. Fisher F, Badge B. Data security and patient confidentiality: the manager's role. Int J Bio-Med Comp 1996; 43: 115-119. Gaudet LA. Electronic referrals and data sharing: can it work for health care and social service providers? J Case Management 1996; 5: 72-77. Biskup J, Bleumer G. Cryptographic protection of health information: cost and benefit. Int J Bio-Med Comp 1996; 43: 61-67. Cassidy SO, Sepulveda MJ. Health information privacy reform. J Occup Environ Med 1995; 37: 605-614. (Received 20 Feb, accepted 23 Jul, 1997) Authors' details Ballarat Base Hospital, Ballarat, VIC. David McD Taylor, MD, FACEM, Former Acting Director of Emergency Medicine (currently, Instructor in Emergency Medicine, University of Pittsburgh Medical Center, Pittsburgh, USA); Ian S Graham, MB BS, FRACMA, Executive Director, Clinical Services. Ballarat and District Division of General Practice, Ballarat, VIC. John Chappell-Lawrence, BBSc(Hons), DipEd, Project Consultant. No reprints will be available. Correspondence: Dr D McD Taylor, A2, 5237 Fifth Avenue, Pittsburgh, PA, 15232, USA. - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

John Chappell-Lawrence · Ian S Graham

Usefulness of a patient library in a suburban general practice Ian Charlton MJA 1997; 167: 579-581 Abstract - Introduction - Methods - Results - Discussion - Acknowledgements - References - Authors' details - - ©MJA1997 Abstract Objectives: To provide health information by means of a patient library in an Australian general practice, and to examine the effects of such information on patient knowledge, anxiety and behaviour. Design: Questionnaire survey of patients who borrowed library items and of doctors within the practice. Setting: A five-doctor suburban practice serving approximately 7000 patients. Results: 210 items were purchased and made available for loan over the two years of the study; 164 questionnaires were obtained after 229 borrowings in the first 15 months. Patients who borrowed items were mostly women (88%) and a high proportion of borrowers (47%) felt that the doctors' surgery was their main source of health information. 98% felt that borrowing an item had been "useful" or "very useful", 88% felt that it had increased their knowledge, 48% felt it had decreased their anxiety, and 79% felt it had changed their behaviour. The doctors were generally positive about the library. Conclusions: The practice library was a very useful addition to the surgery services and provided a valuable clinical tool for the doctors. MJA 1997; 167: 579-581 Introduction A s medical treatments become more complex, it has become more difficult for patients to absorb the information they need to make their therapies successful.1,2 Patient information booklets and sheets have been used to help overcome this problem,3-5 but a more organised approach may be for medical practices to have patient libraries.6 Libraries can contain books, audio and video cassettes and journal articles, enabling doctors to select relevant information in a format that patients can absorb. Patients can also be encouraged to select items for themselves. A United Kingdom study has evaluated the impact of establishing a patient library.7 A 200-book library covering 107 topics was established by a general practitioner and librarian at a cost of $1600. Each book contained a questionnaire, to be completed when the book was returned. Over 15 months, 243 books were borrowed; 163 questionnaires (67%) were returned. Sixty-five per cent of respondents in this UK study would not have sought the information elsewhere, and 98% found the books useful or very useful. Forty-four per cent felt their anxiety levels had reduced as a consequence of reading the book.7 My purpose was to replicate this work in an Australian setting, aiming to determine the value of providing health information by means of a patients' library in an Australian general practice, and to examine the effects of such information on patient knowledge, anxiety and behaviour. Methods A patient library was established in a five-doctor suburban partnership serving approximately 7000 patients on the Central Coast of New South Wales. Items for loan, including books, pamphlets, cassettes and videos, were chosen with the help of the consumer health information service (Health Link) at Westmead Hospital. Items were selected to suit patients' needs rather than those of doctors. The library was available to all patients based on both the recommendation of items by their doctors and on personal selection from a catalogue in the waiting room. The loan period was two weeks and a $2 lending fee was used to cover loss and damage. The study period was 24 months, during which time the number of items borrowed was recorded. Library items were classified into 22 subject categories and the number of items borrowed from each category was also recorded. Items were available for loan from 1 May 1994. During the first 15 months (i.e., until 31 July 1995) patient questionnaires were provided with each item when issued. To assess patients' usual reading habits (and modelled on the UK study) the questionnaire asked about their use of the public library service and whether or not they read books or articles on health matters. Patients were also asked how useful they had found the item from the library and whether they or their doctor had selected it. They were asked about their perceptions of their anxiety, knowledge and behaviour after borrowing an item from the library, and whether they would have sought health information elsewhere if it had not been so readily available in the practice library. Finally, they were asked to record the title, and to comment on the item they borrowed. At the end of the 24 months, the doctors in the practice were asked to complete a short questionnaire which sought information about their impressions of the library, how they used it, the problems they encountered, and the ways in which it could be improved. Results A total of $2400 was spent in acquiring 210 books, pamphlets, booklets, videos and cassettes. The price ranged from $3 to $38; the mean item cost was $12.70. At the end of 15 months, 229 items had been lent and 164 questionnaires returned (response rate, 72%). The findings, in comparison with the UK study, are summarised in Box 1. During the 24 months of the study, 322 items were borrowed, while the practice generated 52 076 consultations, giving a borrowing rate of one item for every 174 consultations. Box 2 illustrates the frequency of borrowings from the 22 categories of items available, and Box 3 lists the 10 most popular books. Patient questionnaire Thirteen per cent of patients (21/157) reported usually obtaining health information from the library, 29% (46/158) from newspapers, 47% (74/158) from the doctor's surgery, 46% (73/157) from magazines and journals, and 11% (18/159) felt the question was "not applicable" (patients could respond to more than one question). Thirty-nine per cent of patients (61/156) felt their knowledge had increased "a lot", while 49% (76/156) felt it had increased "a little". No patients reported feeling more confused as a result of borrowing a library item. Twenty-six per cent of patients (38/145) reported their behaviour had changed "a lot", while 53% (77/145) reported their behaviour had changed "a little", as a result of borrowing a library item. There was no difference in this regard between patients who had been recommended the item by their doctor and those who had selected it themselves. Doctors' questionnaire The doctors in the practice felt the library had been beneficial because it "enabled more detailed information to be provided", "saved time in explaining complex conditions" and "enabled the patient to set a more realistic agenda". All the doctors commented that they felt the library had given the patient a greater sense of control. The doctors' use of the library varied. One doctor liked to use the books to reinforce a message, another to use the books to increase the patient's understanding of their condition and so improve compliance, and another used the books for areas he personally found difficult to deal with. At times, books were used as a way of providing a second opinion. In so doing it was felt that the book reduced the need for a referral, investigation or prescription. The biggest frustration reported by the doctors was finding books out on loan or missing when they were required. With over 200 books in the library, it was not possible to be familiar with all the items in the library and their philosophies. One doctor commented that it was awkward when patients came back knowing more than the doctor. On one occasion, having become aware of the significance of her scaly scalp condition through reading a book on arthritis, a patient was able to raise the possibility of psoriasis. This was a symptom that had been overlooked by both doctor and patient in previous consultations. Discussion The value of the practice library was apparent from the high proportion of patients who reported that borrowing an item had been "useful" or "very useful", had increased their knowledge, changed their behaviour and reduced their anxiety. Although this study was based on patient self-report and cannot verify these reported changes, findings of other studies suggest that they may have occurred. Roland and Dixon found that an educational booklet on back pain significantly improved knowledge and patient behaviour up to a year after it had been issued.8 Similarly, Sorby et al. demonstrated that an anxiety management booklet significantly reduced anxiety.9 However, the value of using health information as a way of changing patient behaviour has been challenged. In a comprehensive review of health education material, Gatherer et al. commented that "written instructions appear to be inferior to most other sorts of instructions".10 Further, changes in behaviour as a result of the distribution of books may not always be desirable. A randomised controlled study evaluating a booklet for parents on childhood illnesses found that the number of day-time consultations in the intervention group fell by 28% but home visits rose by 173%!11 A possible source of bias in this study is that patients were able to borrow more than one item, and therefore might have completed more than one questionnaire. My intention was to evaluate specific items of health information and their effects on individuals rather than to evaluate individual patients. Only one book was deemed inappropriate and removed from the library. My findings were very similar to those of the Stevenage study,7 indicating that a patient library is an equally acceptable concept to Australian patients. A major difference between the studies was in the use of public libraries, with comparatively few Kincumber patients (13% v. 77% in Stevenage) reporting using the public library as a place to seek health information. This may reflect a different attitude towards public libraries in Australia, but may also be the result of the inaccessibility of public libraries in Kincumber, with the nearest public library about a 20-minute car journey away. As 47% of Kincumber patients saw their GPs as their main source of health information, a practice library seems an ideal way to help fulfil this need as well as to improve the profile of the practice within the community. As in the Stevenage study, the main users of our library were women (88%). This is no surprise as women attend surgeries more often than men. It does, however, raise the concern that men may be missing out on health information and that other strategies may need to be employed in communities to provide men with health information. Both doctors and staff found the exercise of running the patient library very satisfying, even though one staff member needed to spend time chasing up overdue books. Ten items were lost during the two years of the study, mostly because patients failed to register them with the reception staff after having had the item selected by their doctor. The $2 loan charge more than covered these losses and has enabled us to update and expand the library. A card index system, as used by most public libraries, proved an effective system for monitoring borrowing and was more acceptable to staff than a computerised database. The qualitative impression generated by the responses to the doctor questionnaire was that the library offered the doctors another option in their clinical management of patients. Although research has shown that simply increasing doctor (and patient) knowledge does little to improve patient care,12-14 a process that empowers patients to take control of their illness and reinforces a message presented by their GPs may be effective. A more sophisticated study would be required to determine if a practice library actually influenced management, compliance and outcomes. Practices wishing to establish a library may find our list of "top 10 books" helpful. Such was the demand for these books that three copies of each title were required. Other titles, such as Cleft lip and palate, were used only once in the two years of the study, but made a tremendous difference to a mother whose baby had been born with a cleft lip. As might be expected, the Stevenage practice had a different top 10 (menopause, cystitis, stress, Alzheimer's, bereavement/death and dying, child care, phobias, women's health, candidiasis, and diabetes), although a number of the topics were popular in both study groups. Our practice would recommend the patient library and we now wonder how we managed without it. We were fortunate to be able to purchase library items as part of a research project, although it would be possible to build up a collection without straining the practice finances by applying a borrowing fee. The outlay of $2000, with a $644 return over two years, together with the time it took one of our staff to administer the borrowing list, could not be seen as profitable. Nevertheless, the status the library gave to the practice and the help the library gave to both doctors and patients was worthwhile. Notably, we received only one complaint about the borrowing fee during the two years. Acknowledgements I thank the Royal Australian College of General Practitioners for the grant of financial support, Dr Allens for help with developing the computer program, Margaret Borg for her tireless work in administering the library, and Moira Bryant, of Health Link, Westmead Hospital, for her help in selecting library items. References Ackroyd E. The patient's complaint. Br J Hosp Med 1986; 36: 454. Hilton S, Sibbald B, Anderson HR, Freeling P. Controlled evaluation of the effects of patient education on asthma morbidity in general practice. Lancet 1986; i: 26-29. Ellis DA, Hopkin JM, Leitch AG, et al. "Doctors' orders": controlled trial of supplementary, written information for patients. BMJ 1979; 1: 456. Laher M, O'Malley K, O'Brien E, et al. Educational value of printed information for patients with hypertension. BMJ 1981; 282: 1360-1361. George CF, Waters WE, Nicholas JA. Prescription information leaflets: a pilot study in general practice. BMJ 1983: 287: 1193-1196. Varnaavides CK, Zermansky AG, Page C. Health library for patients in general practice. BMJ 1984; 288: 535-537. Collings LH, Pike LC, Binder AI, et al. Value of health information in the general practice setting. Br J Gen Pract 1991; 41: 466-467. Roland M, Dixon M. Randomised controlled trial of an educational booklet for the patients presenting with back pain in general practice. Br J Gen Pract 1989; 39: 244-246. Sorby NGD, Reavley W, Huber JW. Self help programme for anxiety in general practice: controlled trial of an anxiety management booklet. Br J Gen Pract 1991; 41: 417-420. Gatherer A, Parfit J, Porter E, Vessey M. Is health education effective? London: Health Education Council, 1979. (Monograph No. 2.) Usherwood TP. Development and randomised controlled trial of a booklet of advice for parents. Br J Gen Pract 1991; 41: 58-62. White PT, Pharoah CA, Anderson HR, Freeling P. Randomised controlled trial of small group education on the outcome of chronic asthma in general practice. J R Coll Gen Pract 1989; 39: 182-186. White P, Atherton A, Hewett G, Howells K. Using information from asthma patients: a trial of information feedback in primary care. BMJ 1995; 311: 1065-1069. Freemantle N, Harver EL, Grimshaw JM. Printed educational materials do not change physician behaviours or patient outcomes. Evidence Based Med 1977; 2: 395. (Received 8 Apr, accepted 11 Sep, 1997) Health Link Consumer Health Information Service Health Link was established at Westmead Hospital in 1984 as a drop-in centre supplying patients, carers and staff with health information from a medically reviewed collection of resources. In late 1995, Health Link relinquished this role, turning instead to providing PC-based electronic directories for practising GPs of accurate information about health-related services throughout Australia as well as details of a range of publications on health topics written for consumers. For more information, telephone: 02 9845 7307 Authors' details The Surgery, Kincumber, NSW. Ian Charlton, MB BS, MRCGP, General Practitioner. Reprints: Dr I Charlton, The Surgery, 7 Tilba Street, Kincumber, NSW 2251. - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

Ian Charlton

Telemedicine ophthalmology consultation in remote Queensland Nikki A M Blackwell, Graeme J Kelly and Lee M Lenton MJA 1997; 167: 583-586 Abstract - Introduction - Methods - Results - Discussion - Acknowledgements - References - Authors' details - - ©MJA1997 Abstract Objective: To assess the use of remote telemedicine ophthalmology in patients presenting to an emergency department with acute eye problems. Design: A prospective review from 1 December 1996 to 28 February 1997 of referral patterns and telemedicine consultations, comparing referral patterns with the same period one year before. Participants and setting: 24 patients presenting to the emergency department of a remote base hospital in Queensland with an acute ophthalmological problem requiring a specialist opinion. Main outcome measures: Clinical outcomes; use of the Patient Transit Scheme for isolated patients; acceptability to patients and doctors; and ophthalmologists' opinions of the system. Results: No adverse outcomes were identified. Patients transferred for urgent assessment fell from 17 for the corresponding period in the previous year to four during the study period, while respective numbers of patients requiring non-urgent transfers (for surgery or postoperative review) during the same periods were 41 and 30. Both patients and staff (including the ophthalmologists) found the telemedicine facility very acceptable. Conclusion: Ophthalmology is well suited to telemedicine for the diagnosis and management of acute conditions and postoperative assessment of patients in remote areas. It offers considerable potential benefits to patients, and enhances the skills of local practitioners. Introduction Telemedicine is "the use of transmitted images, voice and other data to permit consultation, education and integration in medicine over a distance".1 This technology is increasingly viewed as a means of improving specialist services to rural and remote parts of Australia,2 but there are few published studies about the clinical outcomes of telemedicine services.3,4 Critics often cite inability to examine the patient as a reason why telemedicine does not substitute for face-to-face specialist consultation.5 However, in medical specialties that depend heavily on visual observation, such as dermatology or radiology,3,4,6 telemedicine has been shown to be an effective means of providing accurate specialist opinion. Ophthalmology is another specialty which lends itself well to televised con sultation, and acute problems in ophthal mology are an area where telemedicine may augment existing specialist services. Many ocular conditions present acutely and require immediate specialist referral. While the remote town of Mt Isa, in central Queensland, has a visiting specialist ophthalmology service, the clinics are too infrequent to be useful for acute problems. Consequently, patients with acute ocular disease often require transfer to Townsville, 900 km away, for specialist consultation. In 1996, Mt Isa Base Hospital transferred 196 ophthalmology patients, representing almost 25% of the total patients transported under the Patient Transit Scheme in that year. Based on the cost of a return flight to Townsville of $500, and not allowing for the costs of patient escorts or accommodation, the cost to the hospital was approximately $100 000. Following the generous donation to Mt Isa Base Hospital of a slit lamp with a camera facility by OPSM (Optical Prescription Spectacle Makers Industries Limited) in October 1996, we conducted a three-month evaluation of remote consultation for ocular conditions. Our aim was to examine clinical outcome, the effect on Patient Transit Scheme use and expenditure, acceptability to both patients and doctors, the ophthalmologist's evaluation of the transmitted slit-lamp images, and any problems encountered with the system. Methods All patients presenting to Mt Isa Base Hospital (i.e., a non-metropolitan hospital serving a number of smaller health care facilities) with acute eye conditions from 1 December 1996 to 28 February 1997 were assessed by the Emergency Department Director. Patients with a clear indication for immediate referral (e.g., penetrating eye injury) were transferred to Townsville as usual. For those requiring specialist ophthalmological opinion, a telemedicine consultation was arranged during normal working hours within 24 hours of presentation. Each patient was examined by slit lamp at Mt Isa Base Hospital, while a high resolution televised image was assessed simultaneously by the specialist in Townsville, in voice and visual contact with the patient and local practitioner (see Figure). After the consultation, the recommended treatment was initiated and local follow-up was arranged as necessary. Patients could be discharged, referred to the visiting ophthalmology clinic, or transferred to Townsville if necessary. In addition, the ophthalmologists arranged for patients who required routine postoperative review during the study period to be assessed on the telemedicine link rather than having to travel to Townsville for an outpatient consultation. To gauge the impact of the telemedicine system on use of the Patient Transit Scheme by ophthalmology patients presenting to the emergency department, the study period was compared with the corresponding three-month period in the previous year. Acceptability of the telemedicine system to patients and doctors was assessed informally by staff in discussion with patients. Results During the three months of the study, 264 patients presented to the emergency department with an acute eye condition, of whom 24 (or 9%) were considered to require specialist ophthalmology referral, which was then carried out by telemedicine. By comparison, 315 patients had presented in the corresponding period in the previous year, with 17 (or 5.4%) having been transferred urgently to Townsville, and a further 5%-10% being managed after a telephone consultation with an ophthalmologist, without the use of telemedicine. Patient outcomes Our experience with the 24 patients who had telemedicine consultations (31 consultations in all) is shown in Box 1. No patient had an adverse clinical outcome as a result of being assessed by telemedicine rather than face-to-face in Townsville. For the first six patients in Box 1, management was altered as a result of the consultation, and transfer was avoided. For the next 12, management was continued locally as planned and transfer was avoided. For the next four patients, treatment was altered and urgent transfer arranged. For the remaining two patients, treatment was unchanged after telemedicine consultation. Patient transfer Box 2 shows number of ophthalmology patients transferred urgently and non-urgently (for surgery or postoperative review) during the study period and the corresponding period in the previous year. Overall, four patients were transferred for urgent assessment during the study period, compared with 17 for the corresponding period in the previous year. Another four patients were referred to the next local visiting ophthalmology clinic as their problems were not urgent. Comparing the numbers of patients requiring urgent transfer for the two periods (4 v. 17), and based on the costings described above, the hospital saved $6,500 over the three months of the study. In addition, five patients were reviewed locally after surgery (the two children with strabismus correction were seen twice) instead of returning to Townsville, representing a total saving to the Patient Transit Scheme budget of approximately $10 000 over the three months. Acceptability Frail elderly patients who had undergone cataract extractions were happy to avoid a further trip out of Mt Isa. Similarly, the patients who had strabismus correction were all young children with siblings, and it was very convenient for them to be seen locally. Indeed, as previously documented,7-9 all patients seemed to respond well to the new technology, with no patient refusing a teleconsultation, and all saying that in the future they would prefer such a consultation over travelling to Townsville for review. Medical and nursing staff in Mt Isa were enthusiastic about the new facility, often arranging their work so that they could be present at a teleconsultation. The ophthalmologists in Townsville found that the quality of the transmitted slit-lamp image was of sufficiently high quality to allow definite diagnosis in all cases. Discussion Our pilot study indicates that ophthalmology by telemedicine can provide a clinically effective and resource- efficient means of augmenting a specialist service in a rural area. There were no adverse outcomes related to the use of the technology. Indeed, the service for patients seemed to improve, with specialist consultation being provided within 24 hours, allowing appropriate management to be promptly initiated. The ophthalmology telemedicine system, which could be applied across rural Australia, needs local practitioners willing to acquire basic expertise in eye examination, and use of the slit lamp and tonometer. Successful use of the technology requires skilled practitioners at both ends of the transmission10 generating and interpreting slit-lamp images. Yellowlees and Kennedy have identified several key ingredients for successful telemedicine systems.2 Many of these already existed in Mt Isa: an ISDN (Integrated Services Digital Network) videoconferencing system had been in place for two years; many medical and nursing staff had received training in the use of the system; telemedicine remains an initiative strongly supported by the hospital executive; there was enthusiasm for the project in both Mt Isa and Townsville; and Mt Isa Base Hospital employs an Information Technology Coordinator. The success of this new service relied heavily on the enthusiasm and commitment of all involved to ensure that the time of specialists (who donated their services) was not wasted, and that busy practitioners could rely on agreed appointments reflecting accurately the timing and duration of consultations. We found proper notekeeping to be of major importance. Unlike Kavanagh and Yellowlees, who provided case management referral letters after televised psychiatry interviews,11 we have not yet been able to organise specialist letters after ophthalmology teleconsultation because of time, cost and reimbursement issues. Hence, it was the responsibility of the local practitioner who attended the consultation with the patient to document the diagnosis and management plan. The fact that telemedicine is not covered by Medicare is likely to act as a barrier to its widespread development. This has been shown to be the case with several telemedicine applications in the United States.2,11-13 While the ophthalmologists involved in this study donated their time, the question of remuneration must ultimately be addressed. The great sense of camaraderie generated by the improved contact between health professionals was an unexpected benefit of the telemedicine system. As has been suggested,2 the use of telemedicine may decrease the professional isolation of rural doctors by providing an interactive medium for medical education focused on immediate clinical management. The telemedicine facility at Mt Isa Base Hospital will continue to be used for informal ophthalmology teaching, with medical and nursing staff encouraged to attend consultations. In addition, a telemedicine link to a day surgery unit in Townsville is currently being used to train theatre staff for the planned introduction of cataract surgery to Mt Isa. Finally, all users of telemedicine should be encouraged to evaluate their services to ensure that they are meeting a clinical need and not just being driven by the technology. Users should be mindful of the lessons from the extraordinary growth of laparoscopic surgery,14 where practitioners have only recently begun to address clinical outcomes after laparoscopy in appropriately designed studies. Rather than being seduced by the promise of the new, technology must be harnessed to help improve patient care. Acknowledgements We thank Shaun Anderson and OPSM for donating the equipment. Disclaimer of conflict of interest: The authors declare no conflict of interest. OPSM donated the equipment, but had no part in planning the study, analysing the results or preparing the manuscript. References Merrell RC. Telemedicine in the 90's: Beyond the Future. J Med Sys 1995; 19: 15-18. Yellowlees PM, Kennedy C. Telemedicine: here to stay. Med J Aust 1997; 166: 262-265. Warren FM, Lesher JL, Hall JH, et al. Telemedicine. J Family Practice 1995; 41: 17-20. Ferrer-Roca O, Diaz-Cardama A, Pitti S, et al. Tele- medicine in the Canary Islands. Lancet 1995; 345: 1177-1178. Appleby C. Telemedicine -- a prison plugs in. Hosp Health Netw 1995; 69: 56. Binkhuysen FH, Ottes FP, Valk J, et al. Remote expert consultation for MRI procedures by means of teleradiology. Eur J Radiol 1995; 19: 147-150. Bergman R. Letting Telemedicine do the walking. Hosp Health Netw 1993; 67: 46-48. Harrison R, Clayton W, Wallace P. Can telemedicine be used to improve communication between primary and secondary care? BMJ 1996; 313: 1377-1380. Telemedicine: fad or future? [editorial]. Lancet 1995; 345: 73-74. Wootton R. Telemedicine: a cautious welcome. BMJ 1996; 313: 1375-1377. Kavanagh SJ, Yellowlees PM. Telemedicine -- clinical applications in mental health. Aust Family Physician 1995; 24: 1242-1247. Grigsby J. Current status of domestic telemedicine. J Med Systems 1995; 19: 19-27. Puskin DS. Opportunities and challenges to telemedicine in rural America. J Med Systems 1995; 19: 59-67. Johnson A. Laparoscopic surgery. Lancet 1997; 349: 631-635. (Received 17 Apr, accepted 29 Jul 1997) Authors' details Mt Isa Base Hospital, Mt Isa, QLD. Nikki A M Blackwell, MRCP(UK), Director of Emergency Department. Hyde Park Centre, Woolcock Street, Hyde Park, Townsville, QLD. Graeme J Kelly, FRACO, FRACS, Ophthalmologist; Lee M Lenton, FRACO, FRACS, Ophthalmologist. No reprints will be available. Correspondence: Dr N A M Blackwell, Director of Emergency Department, Mt Isa Base Hospital, Mt Isa, QLD 4825. - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

Graeme J Kelly · Lee M Lenton

Funding Australia's health and medical research A commitment to improving health through high quality research MJA 1997; 167: 608-609 In 1996, the National Health and Medical Research Council's research expenditure was approximately $142 million.1 According to official estimates, this is about a quarter of Australia's total outlay on health research.2 With this level of expenditure, it is reasonable to ask what we gain from this investment. In this issue of the Journal, Bourke and Butler show that in 1995 Australian research provided about 2.5% of new knowledge in medicine and the health sciences (Australian research produced 18390 publications, which were cited over 88000 times), a contribution that has strengthened in recent years.3 This is tangible evidence of our commitment to improving the health of people not only in Australia but in other countries. In one sense, this health research commitment is similar to our other international commitments, such as preserving world heritage areas or reducing emissions of gases causing ozone depletion. Apart from this international contribution to knowledge and new discoveries to improve health, research also benefits Australia itself. For example, health care practitioners with research training are of key importance in ensuring that Australian clinical practice is effective and of high quality because they can access, sift and digest new research findings here and elsewhere. Researchers active in public health are needed to provide informed advice on the benefits and costs of proposed public health measures; for example, the detection and prevention of cancer and cardiovascular disease. The strong base of Australian medical research is also helping to build our biotechnology industry. Finally, and less tangibly, Australians derive satisfaction and pride through the achievements of their health researchers, just as they are proud of high achievers in sport and the arts. The NHMRC now provides research funds across the spectrum of health and medical science via a single Research Committee formed in 1997 by a merger of the Medical Research Committee and the Public Health Research and Development Committee. As the largest single provider of peer-reviewed health research funds for the public good, the NHMRC has the responsibility of ensuring that Australia's health research effort is of high quality: the Research Committee provides funds on the basis of excellence (as judged by peer review), strives for fair, open and competitive processes, considers funding applications in all areas relevant to health, and attempts to ensure that research findings are translated into better health and health care delivery. Health research is conducted mainly in universities, hospitals and medical research institutes (Box 1, above). About 30% of total NHMRC research support is provided to medical research institutes, about half of which is via block funding to five institutes. Box 2 shows the support won by institutes receiving over $1 million, those which are block funded, and the proportion of institute funding going to each State (for institutes receiving over $100 000). NHMRC funding to the major universities is shown in Box 3. The Government provides additional support for hospital and university research via salaries for researchers doing academic or clinical research as part of their teaching and clinical duties, but this does not occur for all research institutes. The institutes also play a valuable role in gaining additional support for health research from private corporations and individuals. The report by Bourke and Butler3 shows that the medical research institutes produce some of our most highly regarded research. Ten of the 12 most cited Australian biomedical research articles are associated with institutes, and the overall citation rate for publications from institutes is impressively high: medical research institutes publish about 13% of all Australian health research articles, and these account for about 21% of the total citations of Australian health research. Underfunding the institutes would jeopardise this high quality output. Bourke and Butler comment that their results raise issues of the efficacy of block funding,3 but stress that conclusions about funding methods require further bibliometric studies. The NHMRC's Research Committee is actively reviewing all aspects of research support, including issues in block funding, such as how best to review institutes and how to increase competition between institutes. Some will argue that the data of Bourke and Butler show that substantial, longer term research support (e.g., block funding) is required in order to achieve the highest impact research. Others will point to examples such as St Vincent's Institute for Medical Research in Melbourne to argue that institutes can achieve outstanding publication results without block funding. The NHMRC supports a pluralistic system because the aims of health research extend well beyond quality research publication. It currently supports three-year project grants (about 48% of the current total NHMRC funding), and five-year program grants (9% of total NHMRC funding) and block grants (13% of total NHMRC funding) to provide for longer term research commitments. New researchers are supported via scholarships and postdoctoral awards (about 9% of funding), and outstanding individuals are supported by Fellowships (11% of funding, exclusive of Fellows on Programs and at block-funded institutes). Nothing in science or medicine is immune to change. The NHMRC's research support system must accord with the ways in which research is currently conducted and be relevant to contemporary health needs. One exciting plan for the triennium 1997-1999 is the introduction of multidisciplinary Health Research Networks in important health areas. This scheme will involve researchers at different locations working collaboratively on research in areas of major health importance. Part of the aim is to capitalise on the merger of the Medical Research Committee and the Public Health Research and Development Committee by creating teams of biomedical, clinical and public health researchers. The Networks will focus on effective delivery of health care or prevention. They will thus be integrated research teams (as in the NHMRC Program Grants Scheme), but multisite and multidisciplinary. Interestingly, Bourke and Butler's article3 shows that research collaborations, both local and international, are growing strongly. The NHMRC-sponsored Networks scheme acknowledges this trend and will help to build new collaborations. Bibliometric data are important for monitoring Australian research. We also need better indicators of the other outcomes of research (such as discoveries which benefit health or reduce health costs, better-informed medical and public health decision making, a vibrant biotechnology industry, and new generations of trained researchers in all areas) so that we can assure the Australian community that its financial investment in health and medical research is well placed. Warwick P Anderson Professor and Chairman, Research Committee (Public Health and Medical) National Health and Medical Research Council, Canberra, ACT National Health and Medical Research Council. 1996 Annual Report. Canberra: AGPS, 1997. Australian Institute of Health and Welfare. Health Expenditure Bulletin No 13, July 1997. Bourke PF, Butler L. Mapping Australia's basic research in the medical and health sciences. Med J Aust 1997; 167: 610-613. - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

Warwick P Anderson

Mapping Australia's basic research in the medical and health sciences Paul F Bourke and Linda Butler The Institute for Scientific Information indexes most of the major international basic research journals in science in the Science Citation Index (SCI). Australia's presence in the medical and health sciences journals in the SCI and the citations its published research receives in these journals show that Australia's basic medical research has high international "visibility". Mapping the source of the most highly "visible" Australian medical research articles shows high impact research coming from several different sectors (research institutes, universities, hospitals, etc.), but with a concentration in the member institutions of the Australian Association of Medical Research Institutes (AAMRI). Published research from the AAMRI is cited at a rate two-thirds higher than the Australian average for medical and health sciences. (MJA 1997; 167: 610-613) Introduction - Data source - To what extent is Australian basic research in the medical and health sciences covered by the REPP database? - Where is the research being conducted? - Are patterns of medical authorship changing? - How "visible" is Australian medical research? - Where is Australia's most "visible" medical research being conducted? - Where are Australia's most highly cited medical articles produced? - Discussion - References - Authors' details - - - ©MJA1997 Introduction A very high proportion of the articles reporting the results of basic research in the medical and health sciences are in the journals indexed by the Institute for Scientific Information (ISI) in the Science Citation Index (SCI). The SCI is therefore an excellent tool for identifying the sources of Australian published research in this field, while the citations received by (or references to) these articles can also be used to identify the source of the most-cited research. We have focused on Australia's basic research output, not its applied research. Data source The Research Evaluation and Policy Project (REPP) at the Australian National University (ANU) has constructed a database of all Australian research published in ISI-indexed journals for the period 1981-1995. This database has been well documented in several of our published studies, and a description is available on the Internet.1,2 Our analysis of this database is based on the addresses shown on the publications, which we have "cleaned" down to the level of university department. This has been done by ensuring all variants of a departmental, faculty or institutional address (sometimes running into hundreds) are grouped together and given the same "standard" address. The database also contains details of the citations in ISI journals received by these Australian research articles; that is, the number of times Australian articles are in the reference list of other ISI journal articles. We also code the sector -- universities, hospitals, medical research institutes, government institutions, and "other" -- of each address. The medical research institutes sector comprises the 25 members of the Australian Association of Medical Research Institutes (AAMRI). Medical research in the Government sector comes primarily from the Commonwealth Scientific and Industrial Research Organisation (CSIRO) and the State and Federal departments of health. The "other" sector includes industry and non-profit organisations. We acknowledge "grey areas" at the margins of these assignments to sectors. For example, where a research group based in a hospital with a university connection lists the university in the address, we consistently assign the publication to the university. Another example is the John Curtin School of Medical Research (JCSMR), a full-time medical research institute (though not a member of AAMRI), which is also a research school of the ANU funded from that university's operating grant. Its publications are assigned to the ANU and hence fall within the universities sector. Most publications can be unambiguously assigned, but some addresses are not precise guides to the source where the research was conducted. This arises particularly for researchers who hold conjoint or adjunct appointments in two institutions. If such an author nominates a single institution, we accept that this is the location of the research leading to that publication. If an author specifies two separate addresses, two records are created for that publication showing the two institutions (double-counting created by this procedure is removed for sectoral and national analysis, but remains when the individual institution is the focus of the analysis). If the address itself has multiple components, the publication can not be split into multiple records and has to be assigned to the apparent primary institution. Very few publications fall into this latter category, and their existence has little effect on the map of national, sectoral or institutional sites of research. We have used the standard bibliometric practice of ascribing an article to a particular field of research on the basis of the classification of the journal in which it appears. This procedure is not without problems, particularly in the case of analysis at the subfield level, but experience from our other studies has shown that the results are accurate if the data are being used to map research in a large field.3 To what extent is Australian basic research in the medical and health sciences covered by the REPP database? In this field, at least 70% of published research output from universities and medical research institutes is in the form of journal articles, and, of these, at least 70% appear in SCI journals.4,5 We therefore estimate that, as a minimum, the REPP database covers 50% of the published output in these two sectors. SCI coverage of research from the sectors hospitals and government institutions may be less complete in terms of their total research output, but their contributions to basic research will be well represented. In this article, we are using the REPP database to answer questions about the map of medical research in Australia, concentrating primarily on publications from 1990 onwards, but also introducing some time-series analysis. Where is the research being conducted? The sectoral distribution (Figure 1) shows that the bulk of Australia's basic medical research is located in universities and hospitals. Most of the research articles from the universities sector (75%) come from the 10 teaching medical schools and the JCSMR at the ANU. Our data also show that little has changed in the sectoral location of research over the past 15 years: the share of publications from the hospitals sector has remained constant, there has been a small drop in the universities share, and there has been a corresponding increase in the share from the medical research institutes. Are patterns of medical authorship changing? The REPP database enables us to distinguish publications by type of authorship, viz: Single author -- one author only (i.e., no collaboration); Group -- more than one author but sharing the same departmental address; Institutional -- more than one author from different departments/faculties; National -- more than one author from different institutions in Australia; and International -- more than one country listed in the author addresses. Figure 2 shows how the type of authorship of medical research articles has changed in the past 15 years. The two authorship types showing marked decline are "single author" articles, and "group" articles. Medical and health sciences in Australia appeared slow to exhibit the "internationalisation" of research apparent in other fields since the early 1980s, but the period since 1987 has seen a dramatic change. The proportion of publications involving international collaboration nearly doubled between 1987 and 1995. Collaboration with other Australian institutions has also become more common, increasing from 19% to 26% over the 15-year period. (A detailed analysis of Australia's international collaboration in basic research may be found in a monograph we prepared for the Australian Research Council.6 ) How "visible" is Australian medical research? We assess "visibility" by the number of research articles published and the citations those articles receive. Figure 3 plots Australia's share of "world" publications (i.e., of the total in the SCI) in the medical and health sciences and its share of all citations in SCI journals. The chart also plots Australia's Relative Citation Impact (RCI), which is calculated by dividing its share of "world" citations by its share of "world" publications. The most notable feature of this Figure is that Australia's share of publications in SCI medical journals increased by 25% between 1986 and 1995. The average RCI for the whole period was 1, indicating that Australian publications are attracting appropriate notice. Australia's RCI has not changed significantly over time, but remained at or marginally above 1. This is a strong performance as citation rates are influenced principally by publications from the major research centres of America and Europe. Where is Australia's most "visible" medical research being conducted? A standard measure used to compare the visibility of research in different sectors is the average number of citations received per publication (cpp). In Box 1 (below) we relate the number of publications produced by each sector in the period 1991-1995 to the number of citations those publications attracted in the same period. The leading position of the institutes making up the AAMRI is consistent with Richard Smith's impression of Australia's research institutes.7 Some of the differences in cpp rates can be attributed to the varied research profiles of different institutions. Data supplied by ISI enable us to quantify this, as we can calculate cpp rates for sets of journals. For example, articles in immunology journals for the same period attracted citations at the average rate of 6.21, while those in clinical sciences journals averaged 3.81. We would therefore expect hospitals, with their strong clinical focus, to have a lower cpp rate than those AAMRI establishments with a strong presence in immunology. However, the difference in cpp rates apparent in Box 1 (above) cannot be explained fully by differences in field concentrations; we calculate that differing citation rates across fields account for only a third of the gap in cpp rates between the AAMRI institutions and other sectors. The remainder is a measure of the differing visibility and impact of the research. Not all institutions within a given sector have similar visibility. In Box 2 we list the top five institutions (in terms of cpp rates) in each of the four sectors active in medical research. In the universities sector, we looked specifically at the teaching medical schools and for this reason have excluded JCSMR. The institutions in Box 2 are those with more than 100 SCI publications in the period. In this instance, we count publications in multidisciplinary journals such as Nature, Science and Proceedings of the National Academy of Sciences together with publications in medical and health sciences journals, on the assumption that for the listed institutions and faculties these articles would almost certainly relate to medical research. Sorting the institutions in Box 2 by cpp rates within sectors has the effect of allowing volume of publications to be moderated by impact. The consequences of the choice of the measure on which to rank institutions can be seen by a closer examination of the medical research institutes. While the Walter and Eliza Hall Institute of Medical Research has the largest number of publications and citations, and would be ranked first if these were the measures used, the Ludwig Institute for Cancer Research is top-ranked on the basis of average cpp rates. All three are measures of impact and visibility, but cpp rates take institutional size into account. We looked at the research focus of institutions to determine if the higher cpp rates of some institutions resulted from differing fields of concentration. Again, we found that while an institution's cpp rate was affected by the relative impact of the fields in which it was active, this accounted at most for only 30% of the variation in cpp rates between institutions in any given sector. Where are Australia's most highly cited medical articles produced? We identified a very small group of 12 articles, published since 1990, which have attracted more than 200 citations (Box 3). This Box does much to explain the ranking of the AAMRI institutes in Box 2. The Ludwig Institute for Cancer Research had only 135 publications satisfying our criteria of publication date and journal, yet three of these have attracted more than 200 citations. St Vincent's Institute of Medical Research had even fewer publications (130), but claimed authorship of the most highly cited publication for the period, with 551 citations, and another article with 256 citations. Seven of the listed articles, including the most highly cited publication, were "wholly" Australian; the other five articles involved international collaboration. Discussion Studying ISI journals in isolation does not permit conclusions to be drawn about quality. However, an analysis of citations can provide a guide to the source of Australia's most visible research, and there is a well established positive association8 between high visibility in ISI-indexed journals and research judged on other grounds, such as via peer evaluation and esteem measures, to be of high quality. The limitations of bibliometric analysis are well documented.9 Publications can attract large numbers of citations because they contain error, or because they report a new technique with wide application. Citation data are also highly skewed. Many publications attract no citations at all, and most of those that do receive only one or two. These and other problems are of little consequence when the focus is at the national or sectoral level, involving large numbers of publications.10 Our data provide only one approach to constructing a profile of Australian medical research. However, bibliometric or literature-based analysis cannot stand in isolation from historical and other kinds of evaluative judgements, and should not be used in a policy setting apart from those perspectives. That said, we believe that the information reviewed here does allow some interesting points to be made. The most encouraging inference we draw from our study is that, using the measure of Relative Citation Impact, Australian medical research stands relatively high in terms of international visibility. As Box 3 makes clear, Australian-based researchers publish in international journals and have well established links to collaborative projects in the major centres of work in the field.6 The bulk of Australia's basic research in the medical and health sciences comes from the universities and hospitals, but Australia's medical research institutes, the members of AAMRI, have the highest international profiles. Research from these institutions has had a major impact on the international community. However, high visibility is not confined to the AAMRI institutions, and, as we have shown, research achieving very high impact also comes from hospitals and universities. One of the most interesting policy issues which these data raise is the efficacy of block funding by comparison with direct project funding of research. Medical research in Australia is undertaken in a pluralist system, with major contributions from hospitals, universities, AAMRI and government institutions. While at first glance our data may appear to argue for block funding through the prominence of several AAMRI institutions funded in this way, the situation is more complex. Many of the AAMRI institutions are block-funded, but in some instances this accounts for as little as 35% of their total income. Any conclusions about funding await the completion of detailed bibliometric studies of the relative performance of medical research, in which we will attempt to identify the output of research supported by the varying modes of research funding. References Bourke P, Butler L. A Crisis for Australian science? Canberra: Performance Indicators Project, Australian National University, 1993. (Monograph Series No. 1.) < http://coombs.anu.edu.au/Depts/RSSS/REPP/repp.htm > Butler L, Bourke P, Biglia B. CSIRO: profile of basic research. Canberra: Research Evaluation and Policy Project, Australian National University, 1997. (Monograph Series No. 4.) National Board of Employment Education and Training (NBEET). Quantitative indicators of Australian academic research. Canberra: AGPS, 1994. (Commissioned Report No. 27.) Bourke P, Butler L. Monitoring research in the periphery. Canberra: Research Evaluation and Policy Project, Australian National University, 1996. (Monograph Series No. 3.) National Board of Employment Education and Training. International links in higher education research. Canberra: AGPS, 1995. (Commissioned Report No. 37.) Smith R. Top of the pile: the institutes. BMJ 1991; 302: 1006-1010. Narin F. Evaluative bibliometrics. Cherry Hill, NJ: Computer Horizons Inc, 1976. Van Raan AFJ, editor. Handbook of quantitative studies of science and technology. Amsterdam: Elsevier Science Publishers, 1988. Garfield E. In: Evered D, Harnett S, editors. Ciba Foundation Conference: the evaluation of scientific research. Chichester (UK): John Wiley & Sons, 1989. (Received 6 Jun, accepted 29 Sep, 1997) Authors' details Research Evaluation and Policy Project, Research School of Social Sciences, Australian National University, Canberra, ACT. Paul F Bourke, PhD, FASSA, Head of Research Evaluation and Policy Project; and Professor of History. Linda Butler, BEcon, Research Officer. Reprints: Professor P F Bourke, Research Evaluation and Policy Project, Research School of Social Sciences, Australian National University, ACT 0200. E-mail: paulb AT coombs.anu.edu.au - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

Paul F Bourke · Linda Butler

The Institute of Medical and Veterinary Science Brendon J Kearney Situated in the grounds of South Australia's principal teaching hospital, the IMVS provides a unique blend of statewide pathology services with comprehensive basic and clinical research programs. MJA 1997; 167: 614-617 Introduction - Growth of the IMVS - Core pathology services - Research at IMVS - The Hanson Centre for Cancer Research - The future of IMVS - References - Authors' details - - - ©MJA1997 Introduction The Institute of Medical and Veterinary Science (IMVS), in Adelaide, South Australia, began in 1938 as a development from the Royal Adelaide Hospital (RAH) laboratories largely because Sir Trent Champion de Crespigny, an eminent physician, Medical Superintendent of the RAH and Dean of Medicine from 1929 to 1947, had a vision for an institute which combined laboratory services, teaching and research.1,2 In this respect, the IMVS differs from pure research institutes and has continued to emphasise an integration of service, teaching and research in clinical medicine. Growth of the IMVS The steady development of the IMVS was interrupted in the late 1970s by a series of enquiries into management efficiency, services provided and internal policies, as well as a critical review of the care and control of animals used in scientific experiments. The result was a major redefinition of core services: the Division of Forensic Pathology and the Division of Biology became the Forensic Science Centre (and relocated elsewhere in Adelaide) and the Division of Veterinary Pathology was transferred to the South Australian Department of Agriculture. In July 1982, a new Act (with a new Council) defined and strengthened the relationships of the IMVS with the RAH and the University of Adelaide, allowing it to concentrate on the mainstream areas of medical pathology and their application to research, teaching and service. In 1986, an internal report (Review of Research) on the IMVS/RAH campus by Professors David Penington and Gustav Fraenkel outlined a framework for the development of research. The integration of service, teaching and research with the outcome of high quality care provided by clinicians actively engaged in research was endorsed in the report, but they also suggested the creation of separate basic science laboratories to support research and avoid disparate but duplicated facilities on the campus. They recommended that this development should be part of the IMVS/RAH campus because the benefits of a separate research centre would be diminished by the separation of research activities from service functions. The IMVS and RAH accepted the challenge, and by 1990 funds had been raised and the Hanson Centre (now the Hanson Centre for Cancer Research) had been established. Over the past decade, the IMVS has organised itself along business lines and become reliant on its ability to provide high quality patient services, attract grants and contract for service and research. About 80% of its $55 million expenditure annually is derived from contracts or grants (for public and private pathology services on a fee-for-service basis); the remaining 20% is derived from direct grants from the South Australian Government for statewide or specific pathology services. Therefore, the IMVS differs from pure research institutes that rely on government grants, research grants and donations. While this adds a complexity to its management, it is also a strength, ensuring that the IMVS remains competitive, efficient and relevant to the services for which it contracts. The strength of the IMVS is its collocation on the RAH and University of Adelaide medical school campus. This allows easy collaboration, integration and coordination with both the hospital and University, which has a symbiotic effect on achievement. This integration between hospital, university, service and research is exemplified by the organisational structure of the IMVS. Core pathology services The provision of a high quality general medical pathology service to the RAH remains the core service of the IMVS, and The Queen Elizabeth Hospital laboratories recently joined the IMVS. The IMVS also provides pathology services to metropolitan and rural areas in South Australia through a network of 12 country and regional laboratories. These comprehensive, regionally based laboratory facilities have ensured that a high quality pathology service is available to most communities in South Australia. In addition, services are provided to the Northern Territory and some areas in Victoria. The integration of the IMVS with a teaching hospital and university medical school has allowed the IMVS to develop a comprehensive teaching and training program in pathology and to become involved in education and training in collaboration with clinical disciplines. Research at IMVS Examples of the symbiotic relationship between pathology services, clinical services and research are illustrated by the research endeavours occurring within the Divisions of the IMVS. Division of Tissue Pathology The Division of Tissue Pathology, developed by Professor Barrie Vernon-Roberts, is one of the largest in Australia, with specialists in tissue pathology subspecialising and with the Division integrated into the University of Adelaide and RAH. The Adelaide Head Injury Group incorporates neuropathology from the IMVS, neurosurgery from the RAH and bio mechanical engineering from the University of Adelaide's Road Accident Research Unit. Together, they form a unique combination collaborating in basic laboratory and clinical research into the effects of head injury caused by road trauma. The research objective of the Adelaide Head Injury Group is to reduce the severity of brain injury from accidents by prevention and early intervention. Until recently, brain injury was believed to be instantaneous and irreversible. Work undertaken by the group suggests that axonal damage evolves over hours and may be modified by early interventions. They have developed techniques to identify the pathological changes occurring within an hour of a head injury. The increased production of an amyloid precursor protein is a sensitive indicator of brain injury and can be used to measure the effectiveness of treatments aimed at reducing axonal damage. The Spinal Research Group has won several national and international awards, including the prestigious Volvo Prize (twice), the International Society for Biomechanics Prize, the Amrad Award, and the Smith and Nephew Spine Research Award (twice). It is supported by the specialised bone and histoquantification laboratories of Dr Robert Moore and Dr Nicola Fazzalari. The group collaborates closely with the RAH Spinal Services and RAH Department of Orthopaedics and Trauma. They used a sheep model to reproduce the pathology of human disc lesions and showed how investigational studies of discs can inadvertently introduce bacteria, causing damage to the disc and adjacent bone,3 and the beneficial effect of prophylactic antibiotics to prevent this common complication.4 Other studies have analysed the damage to the disc resulting from cumulative wear and tear to the spine, and have defined the biomechanical and biochemical characteristics of this degeneration. The researchers are currently examining the vascularisation of the disc during ageing, the potential for allograft disc replacement, and the use of cultured osteogenic precursor cells in surgical fusion of the spine. The Bone and Joint Group, in collaboration with the RAH Department of Orthopaedics and Trauma, studies bone structure and remodelling, with an emphasis on osteoarthritis and osteoporosis, using computerised analysis and modelling.5 The findings are relevant to development of preventive treatment for osteoporotic fractures and osteoarthritis.6 The group has also shown that loosening of artificial joints is caused by particles of metal or plastic released from the articulating surfaces.7 Division of Medical Microbiology and Virology The Division of Medical Microbiology and Virology has a long and distinguished reputation. Dr J E McCartney, Medical Bacteriologist at the IMVS in the early 1950s, was a close colleague of Alexander Fleming (the discoverer of penicillin), who gave him some of the original Penicillium mould. Professor Barrie Marmion, Professor of Virology at the IMVS during the 1980s, worked on developing an effective Q fever vaccine and on hepatitis B. Professor Christopher Burrell, the current Head, is acclaimed for his cloning of the hepatitis B genome.8 This Division is the core of the South Australian Infectious Diseases Service. It provides statewide services in food and environmental testing, monitoring of viral diseases and food- borne microbial diseases as well as the State HIV/AIDS Reference Laboratory and national Salmonella Reference Laboratory. A first for the microbiology laboratories was recognition of the association between commercial potting soils and Legionella longbeachae infections.9 They have played a leading role in developing diagnostic procedures for Legionella spp., as well as researching virulence mechanisms and their source and role in infections in the community. The expertise of the Division in applying research into service was shown during the 1995 outbreak of haemolytic- uraemic syndrome in South Australia.10 Three days after receipt of the first specimen, the laboratories had implemented a gene amplification test to detect toxin in food and clinical specimens, identified the toxigenic Escherichia coli strain and traced its source. The tracing of the source of E. coli within days contrasts to the weeks and months needed in outbreaks in Japan and the United States and was significant in rapidly controlling its spread. Infectious diseases research programs. The Division also maintains programs of basic research related to infectious diseases, largely funded by the National Health and Medical Research Council. AIDS Research Laboratory is one of the component units of the National Centre for HIV Virology. Its goal is to define the early molecular events in the replication of HIV in the infected cell.11 This has led to clarification of the events in cell-to-cell transmission of the virus. A related area of research is the use of antisense molecules as a form of gene therapy to inhibit HIV replication. Hepatitis Research Laboratory is studying the mechanism of infection with hepatitis B and related viruses, including patterns of spread within the body, regulation of the carrier state and ways to interrupt it, and the mechanism of protection by vaccines and ways to improve it.12 Herpes simplex research on the pathogenesis of herpes simplex, with emphasis on latent infections within the nervous system and how the host response reacts to infection, is being directed by Dr Tony Simmons. Papillomavirus research into the replication of papillomavirus, the patterns the virus expresses during infection of epithelial surfaces and the factors controlling the different outcomes of the infection (e.g., warts, cancer) is being directed by Dr Geoff Higgins. Adelaide Infectious Diseases Centre. The Division of Medical Microbiology and Virology provides a continuum from patient diagnostic testing, reference test development and public health to basic research. To maximise synergy between these activities, the Adelaide Infectious Diseases Centre has been established, combining the IMVS Division of Medical Microbiology and Virology, the University of Adelaide Department of Microbiology and the infectious diseases services of the RAH and The Queen Elizabeth Hospital. This group is pre-eminent in South Australia in infectious disease surveillance, reference testing, epidemiological studies and disease outbreak investigation. Division of Clinical Biochemistry Bone research group. Professor Christopher Nordin, Associate Professor Allan Need and Associate Professor Howard Morris are addressing bone loss at the menopause, which, together with age-related bone loss, eventually leads to osteoporosis. Studies have established that increased urinary calcium excretion at menopause contributes significantly to bone loss.13 Increased dietary protein and salt exacerbate the urinary calcium "leak" and its effect on bone loss, while dietary restriction of these helps stabilise bone loss. Studies are being undertaken into the changes in the intestinal absorption of dietary calcium at menopause.14 Studies on new therapies for osteoporosis and on the most effective way of monitoring treatment are continuing. A longitudinal study of osteoporosis in men has found that bone loss commences at age 50 and that the pattern and causes of bone loss are different from those found in women.15 The effects of diet, physical activity, hormone and growth factor levels are being evaluated for their effect on the rate of bone loss. A sophisticated rat model of postmenopausal osteoporosis has allowed investigation of the influences on bone at the molecular level. Local factors have been identified which protect bone from the increased cellular activity induced by oestrogen deficiency.16 The Detectacol bowel screening program was one of the earliest Australian voluntary bowel screening programs using an immunologically based test to detect faecal occult blood.17 It has been running for 15 years and has been endorsed through randomised controlled trials showing a reduction in mortality from colorectal cancer as a result of such screening techniques.18 Bone metastasis research. In collaboration with the Department of Surgery of the University of Adelaide, the Division is using a rat tumour model to study how metastatic tumours develop at incision sites after laparoscopic surgery. They will investigate changes in the immune state of the peritoneum and the effect of the different gases used to expand the peritoneum during laparoscopy. Division of Haematology Bone marrow transplantation. Haemopoiesis research began in the early 1980s, led by Dr Chris Juttner and Dr Bik To. They pioneered blood stem cell mobilisation and transplantation, which has now almost replaced autologous bone marrow transplantation.19 The group is currently seeking to define the role of integrin and bone resorption in mobilisation. Work continues on using haemopoietic stem cells purified using immunomagnetic techniques to refine the application in allogeneic and autologous transplantation in leukaemia, lymphoma and myeloma. Ex-vivo expansion is another project for which the Division has a pioneering role as a way of improving the safety of transplantation.20 Dr Tim Hughes is leading a study of chronic myeloid leukaemia and has established a SCID-NOD model for characterising leukaemic stem cells.21 The group is currently involved in 12 clinical trials in transplantation for leukaemia and lymphoma. Research continues into mesenchymal stem cell and cellular therapies, cell death differentiation and oncogenesis and cellular interactions. The stromal group, led by Dr Paul Simmons, has made a major contribution on STRO-1-positive marrow stromal cell percursor and its role in bone formation, haemopoietic regulation and cellular therapies using marrow stromal tissue. Dr Sharad Kumar's group is studying apo ptosis, including the role, activation and regulation of caspases, the function of homologue(s) of C elegans CED-4 and the identification of CED-4M. The group is studying how integrins may modulate cytokine response and function of tetraspan and GPI-linked molecules. The Hanson Centre for Cancer Research The RAH Board and the IMVS Council have strongly supported the development of the Hanson Centre. Through fundraising, the RAH has provided $7.5 million over the past decade for the construction of buildings and provision of equipment for the Centre. The IMVS provides infrastructure funds from its operations and through its commercial company, Medvet Science Pty Ltd, created by the IMVS Council to commercialise the intellectual property and other biomedical activities of the IMVS/RAH campus, and has contributed in excess of $2 million in research grants and infrastructure funding to the Centre. When the Centre began, in 1991, the core research groups were the RAH Division of Human Immunology and the Division of Haematology, but other groups have since joined, including the University of Adelaide Department of Cardiology and the RAH Departments of Gastroenterology, Rheumatology and Thoracic Medicine. These groups have their research support within the Hanson Centre, but are integrated into the service and teaching activities of the IMVS, RAH and the University of Adelaide. Professor Mathew Vadas, appointed 10 years ago to head the Division of Human Immunology, has developed strong basic research groups of excellence which have become known as the Hanson Centre for Cancer Research. This Centre is now the jewel in the research crown of the IMVS. Professor Vadas's research is focused on vascular biology.22,23 Other groups, led by Dr Shannon and Dr Cockerill, have had success in gene regulation,24 and Dr Gonda's laboratory is working on oncogene research.25 The Lipid Research Laboratory has succeeded in understanding the structural principles that govern the assembly of high density lipoprotein.26,27 It was known from epidemiological studies that the human blood high density lipoprotein fraction was protective against atherosclerosis, but the structural and functional basis for this protection was largely unknown. In collaboration with the Vascular Biology Laboratory, they discovered a novel and likely vital function for this particle that directly regulates the function of the vessel wall, and hence the propensity for atherosclerosis.23 Significant progress has been made in understanding cell death. The orderly and timely death of cells is essential in giving shape to the body and renewing its worn parts. A disorder in this process leads to abnormal growth that is a component of cancer. Work in the Molecular Regulation Laboratory, headed by Dr Sharad Kumar, and the Cytokine Laboratory of Dr Angel Lopez has provided novel insights into this process.28 The signals that are involved in "sentencing" and "execution" leading to cell death have been elaborated, and a new therapeutic agent based on an actual growth factor has been discovered that induces this process in blood cells. It is likely that the clinical implications of these discoveries will be considerable. The future of IMVS The IMVS will maintain a business-like approach to the management of operations and to the continued development of Medvet Science. A recent external review of research on the IMVS/RAH/University of Adelaide campus, led by Professor Lawrie Powell, has commented on the excellent productivity of research on the campus. The IMVS intends to further enhance research through expansion of laboratories for basic research while maintaining the strong integration of teaching, patient services and clinical research. New areas of research are being developed in the neurosciences and in molecular pathology, with an emphasis on cancer genetics. References The Institute of Medical and Veterinary Science. Annual Report 1952. Adelaide, IMVS: 1952: 5. The Institute of Medical and Veterinary Science. 50th Anniversary Review 1938-88. Nicholson B, editor. Adelaide, IMVS: 1988: 33-34. Fraser RD, Osti OL, Vernon-Roberts B. Discitis following chemonucleolysis -- an experimental study. Spine 1986; 11: 679-687. Fraser RD, Osti OL, Vernon-Roberts B. Iatrogenic discitis -- the role of intravenous antibiotics in prevention and treatment. An experimental study. Spine 1989; 14: 1025-1032. Fazzalari NL, Crisp DJ, Vernon-Roberts B. Mathematical modelling of trabecular bone structure; the evaluation of analytical and quantified surface to volume relationships in the femur and iliac crest. J Biomech 1989; 22: 901-910. Moore RJ, Durbridge TC, McNeil PJ, et al. Trabecular spacing in postmenopausal Australian women with and without vertebral fractures. Aust N Z J Med 1992; 22: 269-273. Howie DW, Cornish BL, Vernon-Roberts B. Resurfacing hip arthroplasty classification of loosening and the role of prosthesis wear particles. Clin Orthop 1990; 255: 144-159. Burrell CJ, Mackay P, Greenaway PJ, Hofschneider MK. Expression in Escherichia coli of hepatitis B virus DNA sequences cloned in plasmid pBR322. Nature 1979; 279: 43-47. Steele P W, Lanser JA, Sangster N. Isolation of Legionella longbeachae serogroup I from potting mixes. Appl Environ Microbiol 1990; 56: 49-53. Paton AW, Ratcliff RM, Doyle RM, et al. Molecular microbiological investigation of an outbreak of hemolytic-uremic syndrome caused by dry fermented sausage contained within Shiga-like toxin-producing Escherichia coli . J Clin Microbiol 1996; 34: 1622-1627. Li P, Stephenson AJ, Kuiper LJ, Burrell CJ. Double-stranded strong-stop DNA and the second template switch in human immunodeficiency virus (HIV) DNA synthesis. Virology 1993; 194: 82-88. Triyatni M, Jilbert AR, Qiao M, et al. Protective efficacy of DNA vaccines against duck hepatitis B virus infection. J Virol. In press. Morris HA, Cleghorn DB, Need AG, et al. The 5-year reproducibility of calcium-related biochemical variables in postmenopausal women. Scand J Clin Lab Invest 1995; 55: 383-389. Nordin BEC, Morris HA, Need AG, et al. Dietary calcium and osteoporosis. In: Pietinen P, Nishida C, Khaltaev N, editors. Proceedings of the 2nd World Health Organization Symposium on Health Issues for the 21st Century: nutrition and quality of life. Kobe, Japan, 1993. Geneva: WHO, 1996: 181-198. Need AG, Horowitz M, Stiliano A, et al. Vitamin D receptor genotypes are related to bone size and bone density in men. Eur J Clin Invest 1996; 26: 793-796. Morris HA, Porter SJ, Durbridge TC, et al. Effects of oophorectomy on biochemical and bone variables in the rat. Bone Mineral 1992; 18: 133-142. Bone HA, Roder D, McCaul K, Milliken L. Epidemiology of cancer in South Australia. Adelaide: South Australian Cancer Registry, 1993: 57-63. Weller D, Thomas D, Hiller J, et al. Screening for colorectal cancer using an immunochemical test for faecal occult blood: results of the first 2 years of a South Australian programme. Aust N Z J Surg 1994; 64: 464-469. To LB, Haylock DN, Simmons PJ, Juttner CA. The biology and clinical uses of blood stem cells. Blood 1997; 89: 2233-2259. Haylock DN, To LB, Dowse TL, et al. Ex vivo expansion and maturation of peripheral blood CD34 + cells into the myeloid lineage. Blood 1992; 80: 1405-1412. Hughes T, Iverson PO, Lewis ID, et al. A second generation GM-CSF analogue that prevents dissemination and induces remission of human juvenile myelomonocytic leukaemia in engrafted immunodeficient mice. Blood. In press. Korpelainen EI, Gamble JR, Vadas MA, Lopez AF. IL-3 receptor expression, regulation and function in cells of the vasculature. Immunol Cell Biol 1996; 74: 1-7. Cockerill GW, Rye KA, Gamble JR, et al. High density lipoproteins inhibit cytokine-induced expression of endothelial cell adhesion molecules. Arterioscler Thromb Vasc Biol 1995; 15: 1987-1994. Cockerill PN, Osborne CS, Bert AG, Grotto JRM. Regulation of GM-CSF gene transcription by core-binding factor. Cell Growth Differ 1996; 7: 917-922. Gonda TJ, Favier D, Ferrao D, et al. The c-Myb negative regulatory domain. In: Wolff L, Perkins AS, editors. Molecular aspects of myeloid stem cell development. Curr Top Microbiol Immunol 1996; 211: 99-107. Rye KA, Hime N, Barter PJ. The influence of sphingomyelin on the structure and function of reconstituted high density lipoproteins. J Biol Chem 1996; 271: 4243-4250. Rye KA, Hime N, Barter PJ. Evidence that cholesteryl ester transfer protein-mediated reductions in reconstituted high density lipoprotein size involve particle fusion. J Biol Chem 1997; 272: 3953-3960. Kumar S, Kinoshita M, Noda M. Characterization of a mammalian cell death gene Nedd2. Leukemia 1997; 11 Supp 3: S385-S386. Authors' details The Institute of Medical and Veterinary Science, Adelaide, SA. Brendan J Kearney, FRACP, FRACMA, Director. Reprints: Professor B J Kearney, Director, Institute of Medical and Veterinary Science, PO Box 14, Rundle Mall, SA 5000. - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

Brendon J Kearney

The crossing "Come quick, Doc -- I think he's dead!" MJA 1997; 167: 630-631 I had not been looking forward to this trip right from the start. If you've got to spend a night in an aircraft seat, it's preferable if the seat is in an aircraft, not on the Liverpool-Dublin ferry. But the crossing had to be made, so I had asked my nearly-new Irish bride to book a cabin to make the journey almost tolerable. But she forgot. This led to an interesting discussion on the gangplank, during which she accused the medical profession in general, and me in particular, of bullying helpless midwives (surely a classic oxymoron?), whose only aim in life was to please their God-like masters. I refrained from pointing out that this view was somewhat different from the one she had been known to postulate on other occasions. We put our names down, with two hundred others, for a cancellation, but only a fool would have held any hope. While some passengers went to the bar for their sleeping draught, I took a couple of orange pills. By midnight, things were settling down in the "aircraft" area, with the significant exception of the two-year-old boy sitting next to me. He appeared set on staying awake for the night, and keeping me entertained too. Fortunately, his mother had no problem sleeping. I tried negotiating with him, but he seemed to share the Midwife's reluctance to concede any ground. Soon the pills overcame my homicidal instincts and I drifted off, despite the increasing motion of the ship. The next thing I knew an eyelid was being prised open and a voice a million miles away said, "Wake up, they're looking for a doctor!" She seemed to be confusing me with someone else. I muttered something about "only a medical student", but then the fog lifted. That was last month -- this month I was a doctor, albeit one with just two weeks' experience on the wards. I dragged the brain into gear. Already I was learning the knack of answering silly questions five seconds after being wakened. Irish explained patiently (she had had considerable experience in speaking slowly and clearly to half-awake doctors) that the ship's public address system was broadcasting the names of several doctors, obviously taken from the passenger list. I took her point: if I rendered some sort of service to the ship, they were bound to find us a cabin. So, trying to look both wide-awake and widely experienced, I set off for the Purser's office. I guess I failed in my attempts to rearrange my demeanour. "Are you looking for a doctor?" I asked the Purser in his little booth. He looked me up and down suspiciously, and conceded that he was. "Do you know where there is one?" he asked. "Well . . . actually, I'm a doctor." Frank disbelief crossed his face for a moment, then the solution dawned on him. "No, no, son -- a medical doctor, not music or anything." He seemed reassured when I told him I was tone deaf, and that I also had a first-aid certificate. We moved into his office, where he explained that the Captain had insisted that he get a doctor to look at a steward who had burnt his arm some days earlier. The Purser gave the impression that he was only following orders by getting medical attention. (I was later to see the same look on the faces of senior non-commissioned officers as they marched young men into my office -- several of whom were saved from the charge of "wasting the medical officer's time" only by urgent surgery.) The steward had a full thickness burn, badly infected. I thought I made a reasonable stab at cleaning it up and dressing it, although the Midwife clearly felt there was room for improvement. I wrote a note for the Mater casualty department in Dublin. Then I said that a good start to clearing the infection would be some intramuscular penicillin, if there was any on board. By this time the Purser had recovered his good humour (with the help of a glass of Jameson's Irish whiskey). "We've got the standard Board of Trade Medical Kit on the bridge, Doc. It's got everything you can think of -- even a big book that tells you how to use it all." Obviously, Irish's helpful critique during the dressing had rekindled the Purser's interest in my musical prowess. "I'm sure it'll have some penicillin," I said. And so we climbed six pitching ladders to the bridge, where the Navigating Officer unlocked the drug cupboard, and the first thing to hit the deck was a Webley .38 pistol. ("Well, where else would the Captain keep it?") A quick glance through the cupboard revealed the Board of Trade's thoroughness-- there were remedies for all of mankind's known ailments, even including some penicillin for injection, as well as penicillin tablets. Resisting the temptation to take the easy way out (I was very young), I lifted the penicillin G and some sterile water and started to look for syringes and needles. I found a bottle of Primaquine and couldn't help myself asking, "Good heavens, man, why have you got an antimalarial aboard the Liverpool-Dublin ferry?" The Navigating Officer looked me straight in the eye and said, "Well, to be sure, Doc, if we miss Ireland the next stop's the West Indies." I eventually unearthed a case of glass syringes, and asked for some place to sterilise them. (I didn't, at that stage of my career, have an anaesthetist's concept of asepsis -- that a wipe with an alcohol swab kills all known household germs.) Everyone looked a bit nonplussed at my request, until the Purser had an idea. "I know, we'll speak to Sean in the engine-room -- you could use his steam hose." By this time I was only too aware that the bridge was the furthest point from the ship's centre of gravity and that the Irish Sea was beginning to get angry. I succumbed to commonsense and took some penicillin tablets to give the patient. Once the needful had been done with the tablets, the Purser remembered his manners. "You'll be having a dram with me, Doctor -- and your good lady," he added hastily, as she subjected the poor man to most probably his very first feminist glare. So we both joined him in a very large Jameson's. As a Scot, I had never been able to take Irish whiskey seriously, but this didn't seem to be the time to discuss the finer points of "the water of life", as our host was obviously one of Jameson's better customers. I knew my "good lady" hated spirits of any sort, but there was no way she was going to let it show in front of what she now saw as a veritable pack of male chauvinist pigs, so she downed her drink (with tears in her eyes) as she broached the subject of a cabin for us. It seemed that all the cabins were genuinely taken, but our new friend offered us the use of some crew quarters when the watch changed at 0200. This was a great improvement on the aircraft seats with built-in toddlers, so we gratefully accepted. As he showed us to the quarters -- desperately needed now that the whiskey had combined with the sleeping pills -- my last conscious words were, "Well, you know where to find me if you need me again." Hence my rude awakening at 0415. As I groped for my shoes, I mumbled to Irish, who was already heading for the door, "I'll bet he was allergic to penicillin; I forgot to ask. Did you?" She gave me one of her withering looks in reply, and I ruled out anaphylaxis as a cause of death. I followed the Purser, swaying now with what I hoped was the ship's motion, along the corridor to the gents' toilets, where a large crowd was forming. Irish came too. Never one to stand on ceremony, she followed me into the toilets, where customers were using the facilities, washing, shaving, etcetera, as though nothing had happened. Mind you, there was some hasty zipping-up at her arrival. The Purser, who was showing the effects of a serious heart-to-heart with the Jameson's while we had been asleep, pointed to one of the stalls. "There he is, Doc -- looks pretty dead to me!" I couldn't fault his clinical judgement. The toilet door was closed, but from the eight-inch gap underneath it bulged a deeply cyanosed face. "It's not the boy with the burn!" I said to my wife, with relief in every word. "You're right," she replied. "Did you treat anyone else on this boat when I wasn't around?" What do you do with a body found face-down in a toilet stall on the Liverpool-Dublin ferry? Could it be foul play? Were we on the "high seas"? Did my Defence Union cover this? Had they even got my cheque yet? We were helped by a burly Irishman who had his ten-year-old son with him, but didn't see that as any sort of handicap to dislodging trapped bodies. We managed to open the stall door. Perhaps it was the position of the patient (he had fallen forward off the pedestal with his buttocks skyward) that made me think of my forensic lectures and the need to take the victim's temperature to establish the time of death. "Don't suppose the Board of Trade included a low- reading rectal thermometer in its box of tricks?" I muttered, more to myself than to anyone in particular. "What's that, Doc?" asked an increasingly confused Purser. "Never mind," I replied, when I saw the scathing look on the Midwife's face. Bang went my ambitions to be the young coroner. I assured myself that there were no bullet holes, assegai wounds or bottles clearly marked "poison" on the unfortunate man. We extricated him from the plumbing, restored his modesty and called for a stretcher. This gave the Purser something to do other than shake, and allowed Herself to take over traffic control at the door. I heard one or two interesting discussions between her and some potential patrons, intent on gaining access. I put it down to the Guinness, and the fact that Herself didn't acknowledge desperate men. None gained entry. The Purser returned in a few minutes with one of those terribly useful (in theory) stretchers that looks like a cricket pad on steroids. With help from the Irish father, I managed to lash the body into this, although it protruded at both ends, like a hot dog. We each took an end and, half-carrying, half-dragging the horrific-looking corpse, made our way through what seemed to be the entire passenger complement. "Next time, Irish, let me sleep," I warned. "Even a night of toddler-taming in the aircraft seats is easier than this." "Let this be a lesson to you," she replied, totally illogically. Before I could remind her whose idea it was to "volunteer", an agitated-looking man with a red face pushed through the crowd. He rushed up to her as she walked alongside me, and asked, "Is he a doctor?". Although the novelty of being the young doctor's wife was wearing thin, she nodded. "Well, I wonder if he could have a look at my wife -- I think she's gone into labour." Irish's face lit up, despite the long night with little sleep: "Now what would you want a doctor for? They know nothing about babies -- what you want is a good Irish midwife." And she strode off with him to run her own show at last. Douglas N Gow Specialist Anaesthetist, Valley Heights, NSW - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

Douglas N Gow

On the water's edge Rock-a-bye paralysis MJA 1997; 167: 632 The soporific benefits of waterbeds have been known for thousands of years, since Persian nomads first slumbered on sun-warmed goatskin waterbags. Cleopatra is said to have slept on a waterbed, and Leonardo da Vinci sketched designs for their construction. Their therapeutic value was championed by Neil Arnott in 1833, who visualised the ideal state of "repose on the surface of the water, like a swan on its plumage, without sensible pressure anywhere".1 In the late 1960s, waterbeds became commercially available, and they were soon popular for both restful and romantic reasons. There appear to have been few complaints on either score. However, some inherent perils deserve to be highlighted. I report three patients for whom sleeping on a waterbed was associated with the development of compression palsy of the common peroneal nerve. Clinical record Case one: A 45-year-old truck driver, with an unremarkable previous medical history, woke one Sunday morning "unable to walk". His wife described him, intoxicated after a Christmas party the night before, flopping into their waterbed with his legs lying across the edge of the bed for most of the night. On examination, he had a significant foot drop, owing to a left common peroneal nerve palsy. There was tenderness over the nerve at the level of the head of fibula. He was managed symptomatically and made a good functional recovery in five days, although reporting a "weak ankle" persisting for some weeks. Case two: A 55-year-old man with well controlled diabetes, with no history of neuropathy, retinopathy or nephropathy, woke on a Sunday morning alongside his wife and stumbled out of bed "unable to walk properly". He denied any alcohol intake the previous evening but had had "an uncomfortable night's sleep". On examination, he had a left common peroneal nerve palsy. Nerve conduction studies demonstrated a focal conduction block in the common peroneal nerve but no evidence of generalised peripheral neuropathy. At six months, he still has a "weak ankle" but has little evidence of a foot drop. Case three: A 33-year-old male physician woke with a "dead foot" after sharing a "smallish waterbed" with his partner one Saturday night. He had taken a small amount of alcohol before going to bed and had enjoyed a good night's rest. On examination, he had a right common peroneal nerve palsy, which symptomatically resolved over five days with no subjective residual ankle weakness. The physician and his partner are now married and have bought a conventional bed. Discussion There have been few documented medical complications arising from waterbed use. I found only four reports of complications (in the 61 articles published between 1966 and August 1997, accessed through MEDLINE, that include "waterbed" as a text word). Both hypothermia and hyperthermia have been described, the latter caused by an elevated heater setting on a waterbed and initially thought to be a nosocomial fever.2,3 In another case, a leaking waterbed mimicked prematurely ruptured fetal membranes.4 Other case descriptions have implicated waterbeds in the sudden death of some infants.5 There is no evidence that waterbeds cause seasickness or lead to increased gastro-oesophageal reflux.6 All three patients reported here had slept on waterbeds with a rigid "wooden-box" frame. It is likely that the firm edge of the bed contributed to their focal compression palsy. All had slept with a partner and developed weakness in the leg on the side of the bed that they normally slept on. It is possible that as a person rolls towards the middle of the bed and their body sinks, the near leg rides up and over the firm edge. Further "tidal movement" by the person or their partner damages the nerve at the fulcrum. Alternatively, if the legs are crossed on a waterbed, the weight of the top leg may push the near leg under and across into the submerged edge. Peroneal nerve palsy is usually caused by external compression, and may be seen after anaesthesia, intoxication, coma or prolonged bed rest. Many case reports, however, give no clear history of compression. The nerve palsy is often ascribed to abnormal sleep postures, as symptoms are usually first noticed on awakening.7 It is not clear how many of these patients may have slept on waterbeds. The intoxication in the first patient described here and the Sunday-morning onset in all three patients suggest similarities with compression neuropathy of the radial nerve (so-called "Saturday-night palsy"). Waterbeds certainly have benefits in some circumstances but we have every reason to be apprehensive about the cutting edge of technology. For, despite the evolution of "soft edge models", we have not yet realised Neil Arnott's ambitious hopes of slumber "without sensible pressure". Until we do, peroneal nerve palsy will continue to remain a matter of gravity. Merlin C Thomas Senior Registrar, Department of Medicine University of Otago, Dunedin, New Zealand E-mail: mdorbell AT es.co.nz Arnott N. Elements of physics or natural philosophy, vol 1. London: Longman, Rees, Orme, Brown and Green, 1833. Gonzalez EB, Suareze L, Magee S. Nosocomial (water bed) fever. Arch Intern Med 1990; 150: 687. Jones RF, Hatzidoulis C, Chestnutt U, Stewart L. The "Coast" hydrostatic bed. Med J Aust 1975; 1: 333-335. Merritt D. Leaking waterbed mimicking prematurely ruptured foetal membranes. New Engl J Med 1991; 324: 274. Ponsonby AL, Lyons TJ, Dwyer T, Carmichael A. Free-flow waterbeds are potentially dangerous to infants [letter]. Med J Aust 1995; 162: 391-392. Wang JC, Castell DU, Sinclair JW, Wu WC. Does sleeping on a waterbed promote gasto-oesophageal reflux? Dig Dis Sci 1989; 34: 1585. Berry H, Richardson PM. Common peroneal palsy: a clinical and electrophysiological review. J Neurol Neurosurg Psychiatry 1976; 39: 1162-1171. - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

Merlin C Thomas

MJA Practice Essentials, Mental Health: 7. Crisis management in the community Alan Rosen "Paradoxically, if you survive them, it's in the bad conditions that you learn most about yourself." -- Tim McCartney-Snape, mountaineer (quoted in The Weekend Australian, 18-19 May 1996) MJA 1997; 167: 633-638 Synopsis - Introduction - What is a crisis? - Types of crisis - Contention in the crisis literature - Stages of a crisis - When to intervene - Practical management of a crisis - Practical points in intervention - A crisis is different from an emergency - The place of crisis intervention in psychiatric services - Who should manage crises? - Gaps in services - Conclusion - Acknowledgements - References - Authors' details - Box 1: Stages of crisis - Box 2: The process of crisis assessment and intervention - Box 3: Useful crisis resources - Case history: Stages of crisis and "depathologising" - Case history: Crisis intervention early in the course of a psychiatric illness - - - ©MJA1997 Synopsis A psychological crisis is a brief, non-illness response to severe stress. When maladaptive responses to crisis are detected, crisis intervention is employed to achieve a more adaptive resolution and a more effective learning experience. Psychiatric services cannot provide the entire range of crisis interventions required in our society. As communities, we should be encouraged to "look after our own" partly through a network of formal and informal crisis support structures. These should be carefully distinguished from emergency services. General practitioners and others in a good position to do crisis intervention require higher levels of awareness of and training in its uses, with support from specialty services. Crises can precipitate or be a consequence of mental illness. There is strong evidence that more specialised 24-hour crisis response services are needed for individuals with mental illness and their families. Evidence is emerging for the importance of early detection and intervention for young people who may be developing signs of mental illness or suicidal intention for the first time, which may manifest as a life crisis. If there is a potential or existing mental illness, good outcomes are more likely to result from good teamwork between general practitioners, other clinicians and specialist mental health services. (MJA 1997; 167: 633-638) Introduction "Crisis" was first used as a specific term in psychiatry by Gerald Caplan1,2 after considering earlier evidence that survivors of severe trauma, such as those in Lindemann's study of the "Cocoanut Grove" nightclub fire in Boston in 1942, had much better outcomes if they received immediate psychiatric help.3 A "crisis" was seen as a brief non-illness response to severe stress, and "crisis intervention" emerged to detect maladaptive responses to crises and to convert them into effective coping and learning experiences. Caplan's concept of crisis was influenced by the theories of his time. It relied on concepts of disease rather than health, and on mechanistic theories from Freud and General Systems Theory regarding "homeostasis" and "equilibrium". But these limitations were far outweighed by Caplan's contribution in emphasising the importance of preventive care, achieving mastery of the crisis, the social, cultural and material "supplies" necessary to avoid or resolve a crisis, and his pioneering advocacy of a community mental health approach.1,2,4 What is a crisis? Caplan's1,2 classic definition of crisis is an upset in the person's steady state provoked when an individual finds an obstacle to important life goals. This obstacle seems insurmountable, at least for a good while, by use of customary methods of problem solving. A crisis is a period of transition in the life of the individual, family or group, presenting individuals with a turning point in their lives, which may be seen as a challenge or a threat, a "make or break" new possibility or risk, a gain or a loss, or both simultaneously. Most crises are part of the normal range of life experiences that most people can expect, and most people will recover from crisis without professional intervention. However, there are crises outside the bounds of a person's everyday experience or coping resources which may require expert help to achieve recovery. Types of crisis Developmental crises: These are the transitions between the stages of life that we all go through. These major times of transition are often marked by "rites of passage" at clearly defined moments (e.g., those surrounding being born, becoming adult, getting married, becoming an elder, or dying). They are crises because they can be periods of severe and prolonged stress, as described by Tyhurst, another pioneer in this field,5 particularly if there is insufficient guidance and support to prevent getting stuck while in transit.6 In small-scale cultures, there is a sense of continuity and retained value in transiting from before birth to beyond death (e.g., becoming an ancestral resource). In Western societies, rites of passage between these stages have become blurred, the extended kinship networks they depend upon for clear expression have become scattered, the cultural value ascribed to such transitions varies with occupational and economic status, and events surrounding birth and death tend to be experienced as clinical termini.6 Situational crises: Sometimes called "accidental crises", these are more culture- and situation-specific (e.g., loss of job, income and/or home, accident or burglary, or loss through separation or divorce). Complex crises: These are not part of our everyday experience or shared accumulated knowledge, so we find them harder to cope with. They include: Severe trauma , such as violent personal assault, natural or man-made disasters, often directly involving and affecting both individuals and their immediate and extended support network, observers and helpers. 3,7,8 Crises associated with severe mental illness , which can increase both the number of crises a person experiences and sensitivity to a crisis. Reciprocally, the stress of crises can precipitate episodes of mental illness in those who are already vulnerable. Post-traumatic stress syndromes similar to those resulting from a disaster have been reported in some individuals 9 after emergency treatment of acute episodes of mental illness. Developmental, situational and complex crises may overlap, and one may lead to the other (e.g., a train driver distracted by being in crisis may make an error, causing a disaster). Contention in the crisis literature Controversy still surrounds the concept of crisis. The term defies consistent definition, and "crisis theory" is just that: mainly theoretical speculation based on descriptive accounts, with the cultural and clinical concepts of crisis deriving from seemingly different fields of inquiry. A personal crisis is not a clinical disorder. However, a severe or protracted response to crisis may lead to one (e.g., major depression, or, more commonly, an "adjustment disorder",10 defined as the development of clinically significant emotional or behavioural symptoms in response to an identifiable psychosocial stressor). Adjustment disorder should be distinguished from bereavement and other non-pathological reactions to crises which do not lead to marked distress in excess of what is expected, and which do not cause significant or lasting impairment in social or occupational functioning. Stress is not a synonym for crisis11 as all people face stress as part of the human condition. By no means all stressful experiences produce crises and the same type of stressor may be linked to crises, or even clinical disorders, in some but not in others. In contrast to crisis theory, some crisis interventions have been subjected to rigorous empirical study, demonstrating their effectiveness with specific problems (e.g., individuals and families seriously affected by mental illness).12,13 Crisis intervention can no longer be seen as a unified strategy for care, as many divergent practices in different settings have developed since its origin, from walk-in clinics to mobile home intervention, but Waldron has identified a number of common features.14 These include rapid service, intense work in the short term, and a practical here-and-now therapeutic focus. Stages of a crisis Box 1 presents a summary of the main stages, from the pre-crisis steady state, to crisis disequilibrium, to re-establishment of a new steady state, hopefully at an equal or higher level of organisation.11 It is often reported that a crisis state lasts several weeks, usually subsiding within one to two months, if successful resolution occurs. (See also "Case history: Stages of crisis") When to intervene Primary prevention: Strategies aimed at preventing the development of psychiatric illness altogether may be appropriate for people experiencing developmental or situational crises who have limited personal, social or cultural resources. Bereavement counselling, telephone counselling services and "How to survive Christmas" seminars18 are examples of practical primary prevention interventions in the community. Critical incident counselling may be offered to survivors or witnesses of traumatic events and disasters to prevent emergence of protracted grief reactions or post-traumatic stress disorder (PTSD),8 although efficacy in preventing PTSD remains unclear. Secondary and tertiary prevention: Secondary prevention implies that a psychological disorder has already emerged, and aims at reducing the severity, duration or the risk of recurrent relapse. Tertiary prevention is aimed at reducing the disability attendant on a disorder that is already prolonged. Indications include: People with early or acute mental illness -- preventing suicide and promoting recovery for individuals whose constitutional vulnerability and life stressors may have tipped them into an episode of mental illness, which can be highly responsive to timely crisis intervention and appropriate treatment.9,10 So-called "chronic outpatient attenders" or "chronic crisis repeaters", unnecessarily pejorative terms highlighting the frustration and attitudes of clinical staff towards these individuals who make frequent demands on services. It is often more economical and effective to provide intensive intervention at times of acute crisis rather than continuing unchallenging support of a long term sickness role. Many of these individuals have been severely traumatised in childhood. Specific interventions to deal with the sequelae of past abuse are still being developed and researched. Patients with severe or prolonged psychiatric disorders presenting with an acute exacerbation that may be precipitated by or cause a situational crisis. Defusing stressors by prompt crisis management (in conjunction with timely treatment, continuity of care and psychosocial rehabilitation) may prevent the build-up of disturbing symptoms, repeated life-disrupting hospitalisations, or suicide.9,12,13,15,17 Practical management of a crisis Crisis management is the entire process of working through the crisis to the point of resolution (Box 2). It usually includes not only the activities of the individual in crisis but also the members of the person's social network.4 Not all crises require crisis intervention, which is that aspect of crisis management carried out by crisis workers (e.g., clinicians, counsellors, police or chaplains). Practical points in intervention: Intervention frequently involves a general practitioner and a community mental health team, possibly including a psychiatrist or inpatient unit. Negotiate early in the process to formally clarify who will coordinate it, and who will do which components of the assessment and intervention (whether general practitioner, mental health worker or psychiatrist). The hospital or community crisis service should carefully identify the general practitioner's needs, especially for prompt or extra support, while the general practitioner should respond promptly to the crisis worker's liaison calls. Include family or other social or cultural supports in both the assessment and the intervention if possible. Collaborate with the individual or family in crisis ("doing with" rather than "doing to") to promote their "ownership" of the crisis, and learning of new coping and communi cation skills. Allow tension -- allowing or even encouraging a tolerable degree of arousal, tension or dependence for a limited time is sometimes functional in promoting crisis resolution. The clinician's role in a crisis can sometimes involve undoing previous inappropriate or excessive clinical interventions (e.g., inappropriate diagnoses or types of treatment, or general overmedication causing unnecessary sedation and/or other side effects). When referring a person in crisis to a hospital psychiatric unit, ask for a crisis assessment rather than insisting on hospital admission, as home-based community management often results in a better outcome. Home visits, within defined parameters of safety, should be considered for accurate assessment and review, and more direct access to all participants in the crisis. A small list of the most important specific goals for the crisis intervention which are realistic and achievable within a limited time frame should be agreed in advance between all participants, with a copy to each, and with an interactive process and date for review. If acute inpatient psychiatric care is needed, the same mental health professional(s) who engaged with the person in the community should be involved in the inpatient team (if possible) to make the transition easier and to ensure consistency of the clinical management plan agreed with the individual and family. A crisis is different from an emergency An emergency is a life-threatening situation demanding an immediate response. A crisis is often not immediately life-threatening and the timing of the response should be such as to include all participants in the crisis and existing or potential personal supports. Appropriate personnel to respond to an emergency are Police, Ambulance, Fire or Hospital Emergency Departments and/or State Emergency Services. Appropriate people to call in a crisis include general practitioners, community mental health professionals, community services officers, or lay crisis response organisations. The appropriate type of early response in an emergency is life preserving: securing physical safety, removing the person from the source of danger, and defusing physical violence. In a crisis, the early response should be crisis assessment and support, defusing stress and interpersonal strife. The use of the terms "crisis intervention" and "emergency psychiatry" are often confused by clinicians, and used interchangeably in the names and descriptions of services.17 But what difference does it make to patients and their families when they feel distressed and just know they need help now?19 In fact, they benefit by more appropriate referrals and settings for intervention when these distinctions are clearly made, while professionals are able to deliver such services more safely and effectively when they know the difference between a crisis response and an emergency response. Sometimes there is an overlap between a crisis and an emergency. When there is any hint of a crisis turning into an emergency, it is considered a skill, not a failure, if a mental health professional or general practitioner chooses not to work alone and calls for expert advice, police assistance, or other emergency services. The place of crisis intervention in psychiatric services The evidence indicates that 24-hour home-visiting crisis response services should be integrated into local comprehensive services for people seriously affected by mental illnesses and their families. 9,12,13,15,20 The potential for new learning and personal growth in this population and their families has probably been vastly underestimated, often by the clinicians involved.17 Systematic interventions to promote such new learning out of "using the crisis" of acute psychiatric episodes are being developed to reverse the potentially erosive effects of early psychosis on self-esteem, identity and related maturational tasks.9,19 Family problem-solving techniques aimed at acquiring new coping techniques in crisis have been shown to prevent relapses.20,21The principles of effective crisis intervention are consistent with current good practice in mental health services, regardless of the phase of care. There is evidence that people severely affected by psychiatric illnesses are much more likely to cooperate with interventions which are tailored to their individual needs, and when they feel listened to, are consulted and offered choices regarding types of proposed interventions. Cooperation is further enhanced when they and their families are provided with sufficient information and explanation, when time is taken to negotiate intervention goals, when low-key and low-dose interventions are offered (at home on their own "turf", if possible, rather than ours) and when the traumatising effects of involuntary hospital admission and heavy sedation are avoided.6,9,12,13,22 Inpatient psychiatric care is sometimes essential but should be arranged on a voluntary basis if possible. (See also "Case history: Crisis intervention early in the course of a psychiatric illness") Who should manage crises? General practitioners, community workers, police, ministers of religion, counsellors, as well as mental health professionals, are all in a position to be involved in crisis intervention. General practitioners are particularly well placed to help people in crisis and their families. Should all crises be referred to psychiatric services? Emphatically no, although psychiatric services are most appropriate for people in crisis who have diagnosable psychiatric illnesses and who may be suicidal. Firstly, psychiatric services do not have the resources or mandate to handle all crises in the community. There are community services for domestic abuse, children at risk, and sexual assault crises, non-government and church organisations dealing with couple, family, existential and spiritual crises, and networks for bereavement and disaster counselling. Secondly, many people requiring help with crises do not wish to be seen by a psychiatric service or professional, which they may perceive as stigmatising, and therefore adding to their troubles. When the crisis is not complicated by significant psychiatric symptoms, it may be managed with significantly better outcome by a general practitioner who has the person's trust and does not need to label the person with a psychiatric diagnosis.23 Thirdly, some communal voluntary organisations run crisis hotlines (e.g., Lifeline) which may produce more timely referrals to clinical services, or care for people who would not present clinically . Whether they reduce the number of suicides is a more contentious issue. Peer-group and consumer-driven mutual support lines are developing further, via telephone "warm-lines", interactive radio, computer bulletin board chat-lines and the Internet. While these are a potential wellspring of support, they may make the caller feel more vulnerable through public exposure, and the recipients may feel helpless if their concern is ignored or abused by an anonymous caller. Arguably, basic training in crisis support and coping skills should be adopted as essential components of community and school education.14 Gaps in services There is still a lack of child and adolescent mobile crisis services operating extended hours to augment outpatient nine-to-five mental health services for these age groups. Adolescents are at a time of developmental transition and are particularly vulnerable to crisis. Early intervention services available on a 24-hour mobile basis which are specifically designed to deal with the crises and psychiatric problems of young people, their families and peers may help to reduce the exceptionally high youth suicide rates in Australia. Conclusion The National Mental Health Strategy24 has provided impetus to develop extended-hours mobile community psychiatric services integrated with local inpatient services in both urban and rural centres across Australia. Yet it is by no means possible, nor appropriate, for psychiatric services to provide the full range of crisis intervention services needed by our community. A broad network of formal and informal crisis support structures is required to enable us to more effectively "look after our own". Some useful crisis resources. Acknowledgements I thank Dr Kai Lin Lie, Dr Dorothy Kral, Dr Gary Walter, Mr Paul Clenaghan, Ms Vivienne Miller and Ms Sylvia Hands for advice on the text. References Caplan G. Principles of preventive psychiatry. London: Tavistock 1964. Caplan G. Support systems and community mental health. New York: Behavioural Publications, 1974. Lindemann F. Symptomatology and management of acute grief. Am J Psychiat 1944; 101: 141-148. Hoff LA. People in crisis: understanding and helping. 2nd ed. Menlo Park, California: Addison Wesley, 1984. Tyhurst JS. The role of transitional states -- including disaster -- in mental illness. Symposium on Preventive and Social Psychiatry, Walter Reed Army Institute of Research. Washington DC: US Government Printing Office, 1958. Rosen A. The stigmatized stand up: active involvement in our own mental health services . Mental Health Aust 1985; 4: 3-17. Rosen A. Review of Raphael B. When disaster strikes. ASW Impact 15-16 March 1988. Raphael B. When disaster strikes: a handbook for the caring professions. London: Hutchison, 1986. McGorry P, Rosen A, Carr V, Pantelis G. Innovations in the treatment of psychosis. In: Andrews G, editor. Specialization in Psychiatry. Geigy Psychiatric Symposium Proceedings 1994; XV. Diagnostic and statistical manual of mental disorders. 4th ed. (DSM-IV). Washington DC: American Psychiatric Association, 1994. Parad HJ, Parad LG. Crisis intervention: yesterday, today and tomorrow. In: Punukollu NR, editor. Recent advances in crisis intervention. Vol I. Thuddersfield: International Institute of Crisis Intervention, 1992. Hoult J, Rosen A, Reynolds I. Community orientated treatment compared to psychiatric hospital orientated treatment. Soc Sci Med 1984; 18: 1005-1010. Stein LI, Test MA. Alternative to mental hospital treatment. I. Conceptual model, treatment programme and clinical evaluation. Arch Gen Psychiatry 1980; 37: 392-397. Waldron J. Crisis intervention. Br J Hosp Med 1984; 31: 4283-4287. Scott RD. A family oriented psychiatric service to the London Borough of Barnet. Health Trends 1980; 12: 66-68. Bassuk E, Gerson S. Chronic crisis patients: a discrete clinical group. Am J Psychiat 1980; 137: 1513-1517. Szmuckler G. The place of crisis intervention in psychiatry. Aust N Z J Psychiatry 1987; 21: 24-34. Dunsmore J. "On surviving Christmas" Seminars. Sydney: Department of Health Promotion and Education, Royal North Shore Hospital, 1990, 1995. Phelan M, Strathdee G, Thornicroft G, editors. Emergency mental health services in the community. Cambridge: Cambridge University Press, 1995. (See chapters by Katschnig, Emergency mental health services; Birchwood et al, Using the crisis; Kingdon and Jenkins, Suicide prevention; Sutherby and Szmuckler, Safe community assessments of crisis). Falloon IRH, Fadden G. Integrated mental health care. Cambridge: Cambridge University Press, 1993. McFarlane WR, Lukens E, Link B, et al. Multiple-family groups and psychoeducation in the treatment of schizophrenia. Arch Gen Psychiat 1995; 52: 679-687. Hambridge J, Rosen A. Impact of a mobile community intensive case management team in surburban Sydney. Aust N Z J Psychiatry 1994; 28: 438-445. Goldberg D. A classification of psychological distress for use in primary care settings. Soc Sci Med 1992; 35: 189-193. National Mental Health Strategy, 3rd annual report. Canberra: Department of Health, Housing and Community Services, 1995. Authors' details Royal North Shore Hospital and Community Health Services, Sydney, NSW. Alan Rosen, FRANZCP, DPM, Director; Associate Professor, University of Wollongong; Clinical Senior Lecturer, University of Sydney. Reprints: Dr Alan Rosen, Royal North Shore Hospital and Community Health Services, St Leonards, NSW 2065. - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

Alan Rosen

Choking after inhaling a foreign body through a Ventolin puffer MJA 1997; 167: 651 To the Editor: A 10-year-old boy awoke with asthma. His mother, also an asthmatic, took her salbutamol inhaler from her purse and gave the boy a puff. The boy immediately became extremely distressed and was unable to speak. He mouthed to his mother, "I cannot breathe". His mother performed the Heimlich manoeuvre, during which a white object was expelled from the boy's mouth, immediately relieving his distress. The object was a cigarette filter. His mother is a cigarette smoker and rolls her own cigarettes. Loose cigarette filters and uncapped asthma inhalers were found in the clutter at the bottom of her purse (Figure). As she had previously propelled a filter into her own airway from an inhaler, with less severe consequences, she recognised the likely cause of her son's sudden inability to breathe. This frightening and potentially lethal episode illustrates the importance of keeping caps on asthma aerosol inhalers when not in use, so preventing objects from lodging in the aerosol mouthpieces. Michael J Mackay Senior Medical Officer, Emergency Department, Mackay Base Hospital Bridge Road, Mackay, QLD 4741 - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

Michael J Mackay

Out of the blue and into the pink A new litmus test for chlorine gas exposure MJA 1997; 167: 651 To the Editor: A 40-year-old man arrived at the emergency department by ambulance in respiratory distress. In his duties as a hotel maintenance worker, he had been mixing swimming pool chemicals in a dark, confined space. Inadvertently, he had mixed liquid pool "chlorine" (sodium hypochlorite) with a hydrochloric acid solution, forming an irritating yellow-green gas. Despite a brief exposure, he rapidly developed eye irritation, burning in his oropharynx, cough and chest pain. He noticed that the keys in his pocket had turned a dull colour. On arrival, about 20 minutes after the exposure, he had an irritating cough, but his vital signs were normal, oxygen saturation was 99%, and his chest was clear to auscultation. His clothing smelt of chlorine and was removed to prevent skin irritation. On removing his white overalls, it was noticed that his blue underpants had changed colour to a pink-mauve hue. Although he suffered acute embarrassment, he developed no acute clinical or radiographic signs and was discharged well after several hours' observation. Chlorine gas exposure is not an uncommon hazard of mixing household cleaners or pool chemicals. The addition of an acid to a chloride-containing base releases chlorine gas in an exothermic reaction. Chlorine gas is highly water soluble and on moist surfaces is transformed into hydrochloric acid and an oxygen radical. This mechanism explains the clinical manifestations, with the hydrochloric acid causing immediate irritation to mucosal surfaces, leading to lacrimation, burning sensations and cough. These symptoms usually serve as a warning to the victim to move away from the gas to prevent the more serious sequelae of laryngeal oedema, bronchospasm and adult respiratory distress syndrome. Presumably in this case, the elaboration of acid in the sweaty confines of his true-blue Y-fronts mimicked the classic pH indicator reaction of litmus paper. Perhaps he should have worn his underpants on the outside! Tim C Green Staff Specialist, Emergency Department, Royal Prince Alfred Hospital Missenden Road, Camperdown, NSW 2050. E-mail: timgreenATmpx.com.au Reference: Hoffman RS. Toxic inhalations. In: Rosen P, Barkin R, et al., editors. Emergency medicine -- concepts and clinical practice. 3rd ed. 1992: 2673-2682. - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

Tim C Green

A sad stool MJA 1997; 167: 654 To the Editor: With greater attention being given to improving communication between healthcare professionals and the public, the following incident is a simple yet worthy reminder that effective communication depends not only on the information that is transmitted but, more importantly, on the information that is received. A young woman came into my pharmacy with a prescription for Ferro-Gradumet (ferrous sulfate, Abbott), and it was obvious that she was reluctant to have it dispensed. During our conversation, she remarked that she was very concerned about becoming depressed because the doctor had told her that while taking this medicine her emotions would be black. This certainly wasn't the message that the doctor intended to transmit (viz. her motions would be black), and it could have led her to abandon the treatment. How can we ensure that the correct message is received? Failures in communication like this can be avoided if plain, straightforward words are used instead of outdated euphemisms. In this instance, the more direct word "faeces" is less likely to be misinterpreted and, if not understood, is more likely to prompt the question, "What do you mean by that?". Richard M Worrell Pharmacist, PO Box 274, Rose Bay, NSW 2029 - ©MJA 1997 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/> © 1997 Medical Journal of Australia.

Richard M Worrell

"Single use only": obfuscation or the necessary attainment of zero risk? Stringent reuse of medical devices could save us millions of dollars each year MJA 1997; 167: 519-520 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/MJA/>". Make a comment - - ©MJA1997 The revolution in plastics technology over the past 40 years has resulted in a wide variety of healthcare items produced as presterilised "single use only" disposables. In spite of the admonitions of many peak and government organisations in Australia and overseas,1-3 many hospitals are reprocessing single-use medical devices because staff feel this will result in substantial monetary savings.4 The labelling as "single use only" of non-critical items used exclusively on external body surfaces (as opposed to critical items used invasively), commented on by Stewart in this issue of the Journal, is an extremely relevant issue in the debate. Here, we argue that the global term "single use" provides a barrier to rational analysis by masking the complexity of the issues and the range of devices. Is a "single use only" item truly disposable, or is it a durable item that has been labelled "single use only" by the manufacturer according to certain criteria? Such criteria may include cost, life expectancy, potential physical or infection hazards after repeated use, minimisation of the manufacturer's legal liability, or even an expression of lack of confidence in the capability of hospitals to reprocess the item satisfactorily. Manufacturers would probably argue forcefully that all single-use labelling is appropriate Manufacturers would probably argue forcefully that all single-use labelling is appropriate, including that of non-critical items. Legal advice to many hospitals confirms the need to comply with manufacturers' instructions and thus precludes reprocessing. Nevertheless, infection control prin ciples suggest that, where an item of equipment is used externally against unbroken skin and does not penetrate a sterile site, thorough cleaning between uses is all that is required, and sterility is certainly not essential. Whether the reprocessing of such items is cost-effective may be questioned. However, if reuse of single-use, non-critical medical devices were prohibited by law, then logic demands that restaurants provide "single use only" crockery and cutlery to each patron -- as these items enter body cavities and are regularly contaminated with body fluids, they induce as much, if not more, risk of transmitting infection. Stewart advocates legislation to prohibit inappropriate labelling. As sensible as this suggestion appears, Australia constitutes less than 1% of the world market for single-use products, and overseas manufacturers are unlikely to change their labelling to meet requirements unique to our country. Reprocessing of "single use only" instruments that penetrate sterile body sites is an even more contentious issue. The recent National Health and Medical Research Council (NHMRC) expert report,5 which examined reuse of critical items, confirmed the economic rationality of reprocessing some "single use only" items by stating that if such reuse was not permitted in Australia "either appropriate resources (estimated at $100 million per annum) to purchase sufficient single use devices must be provided or a reduction in services be explicitly recognised". However, the NHMRC panel also concluded that "continuation of the current practice of re-use cannot be condoned", and suggested that either Australian health ministers make a decision to disallow reuse of medical devices labelled as "single use only", or allow reuse to continue but that it be subject to more stringent regulations. Although State and Commonwealth departments of health do not support reuse,6-8 the dilemma for many hospitals continues because they implicitly recognise that it is in their interests for services to continue without the imperative to obtain increased funding to purchase further stocks of single-use equipment. Therefore, reprocessing, although against written policy, is tolerated by governments. From the patient's perspective, there is both an expectation and a legal right to be assured that any equipment used is devoid of infection risk, as well as being non-toxic, non-pyrogenic, physicochemically stable and functionally reliable. To what extent does the healthcare consumer require this assurance? The outcome in the recent Sydney case of patient-to-patient transmission of HIV9 suggests that the judiciary, presumably reflecting a community view, believes that zero risk should be the accepted standard. By this precedent, any reprocessing of "single use only" items is likely to be unacceptable to the community, in spite of scientific argument to the contrary and the economic implications of such a decision. No one who has seriously considered this issue could deny that a policy on the reprocessing of critical items marked as "single use only" will be difficult to formulate, or that prospective and scientifically rigorous data on their potential transmission hazards are urgently needed. In response to the NHMRC document, the Australian Health Ministers Advisory Council (AHMAC) has commissioned detailed studies into the risk of disease transmission by cardiac electrophysiology catheters and their ability to be satisfactorily reprocessed (Dr H Wellington, Chair, NHMRC working party on re-use of medical devices labelled as single use, personal communication). The alternatives provided by the NHMRC expert panel represent two diametrically opposed solutions to the problem. To continue disposing of all items labelled as "single use only", regardless of their ability to be adequately re-processed, creates unnecessary expense at a time when healthcare dollars are scarce. To agree to the reprocessing of certain items may lead to opposition, particularly from manufacturers. Nevertheless, if, after expert advice, the community and its parliamentary representatives can agree on an acceptable, practical and economically attainable level of risk, then appropriate characterisation of those devices suitable for reprocessing under stringent conditions could save Australia's healthcare system millions of dollars each year. While acknowledging that it is a challenging question, it is one that Australia's health ministers must consider, and one on which they must develop and disseminate a collective view. We hope that the relevant issues will continue to be debated by AHMAC. R Michael Whitby Director, Department of Infectious Diseases Infection Control & Sexual Health, Princess Alexandra Hospital, Brisbane, QLD David F M Looke Senior Specialist, Department of Infectious Diseases Infection Control & Sexual Health, Princess Alexandra Hospital, Brisbane, QLD Federation of Sterilising & Research Advisory Councils of Australia. FSRACA policy statement: re-use of single-use items. Melbourne: FSRACA, 14 Feb 1994. Medical Industry Association of Australia. Statement of Industry Policy: re-use of single-use medical devices. Sydney: MMIA, 6 Aug 1991. United States Food and Drug Administration. Compliance Policy Guide. Re-use of medical disposable devices, 7124.6. Washington, DC: FDA, 24 Sept 1987. Collignon PJ, Graham E, Dreimanis DE. Re-use in sterile sites of single-use medical devices: how common is this in Australia? Med J Aust 1996; 164: 533-536. National Health and Medical Research Council. Report of the NHMRC expert panel on re-use of medical devices labelled as single use. Canberra: AGPS, 1997. Adams A (Chief Medical Adviser, Commonwealth Department of Human Services and Health). Communication: re-use of single-use devices. Canberra: DHSH, 1 Aug 1994. Owen JW (Director-General, New South Wales Health). Reuse of single-use medical devices. Sydney: NSW Health, 1994. (Draft Circular 83/62.) Lynch P (Acting Chief Medical Officer, Victorian Department of Health and Community Services). Re-use of disposable single-use items. Melbourne: DHCS, 29 January 1993. (Circular No. 2/1993.) Chant K, Lowe D, Rubin G, et al. Patient-to-patient transmission of HIV in private surgical consulting rooms [letter]. Lancet 1993; 342: 1548-1549. <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

"Single use only" labelling of medical devices: always essential or sometimes spurious? Ian Stewart While the medical disposables industry may benefit from labelling devices as "single use only", we all bear the costs of subsequent disposal and pollution. MJA 1997; 167: 538-539 For editorial comment see Whitby & Looke 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/MJA/>". Introduction - Conclusion - References - Authors' details Make a comment - - ©MJA1997 Introduction Earlier this year, the National Health and Medical Research Council (NHMRC) released its final report on the reuse of medical devices labelled as "single use only". Australia's health ministers will now be expected to decide which of the report's two main recommendations is most appropriate: that either reuse of single-use devices should cease altogether or, if reuse is condoned, the practice should be subject to enforceable standards for cleaning, resterilisation and quality control. The medical disposables industry is likely to lobby politicians to adopt the former strategy, one which will require our health ministers to find up to an estimated $100 million annually.1 In their deliberations, another issue which ministers may wish to consider, which the NHMRC report did not examine, is the process by which devices come to bear the label "single use only". Most of the debate about reuse of single-use devices has focused on expensive disposables such as cardiac catheters. Currently, such instruments are routinely reprocessed in many hospitals because the cost of disposal after each use would necessitate a reduction of services. The single-use status of devices such as angioplasty balloon catheters appears to be warranted, in that they are invasive devices with narrow lumens which may be difficult to clean and inspect. However, a randomised, double-blind, controlled clinical trial,2 cohort studies,3,4 and a risk-benefit assessment5 suggest that cardiac catheters can be safely reused if sound protocols for reprocessing are observed. There is not even any anecdotal evidence for the transmission of viral disease from the reuse of cardiac electrode catheters.6 Therefore, the evidence supporting the single-use status of apparently high risk cardiac catheters is unconvincing. Given this situation, how should we view the broad array of devices labelled "single use only" where criteria for disposability are tenuous at best, and most often knowingly inappropriate? Consider just a few examples from a long list of devices that I believe are spuriously labelled as "single use only". Disposable PVC oxygen masks. Used and discarded in considerable quantities every day in postoperative recovery rooms, most of these masks have a working life of about 10 minutes. They are not supplied as a sterile item (nor should they be) but the accompanying directions-for-use insert says "for single use only". In comparison, multiple-use black rubber anaesthetic masks (which are probably thought to do the same job from a microbiologist's perspective) are deemed safe for many uses. Disposable pressure infuser. This consists of a bladder with an external sleeve and an inflating bulb. A plastic bag of sterile fluid for flushing an artery or other vessel is placed inside the infuser sleeve and the bladder is inflated. The inside of the sealed bag is sterile; the external surface which is in contact with the infuser sleeve does not need to be sterile. The potential for nosocomial infection from this device is probably less than that of a blood pressure cuff, which is washed periodically, or immediately if soiled (a practice which should also apply to pressure infusers). Disposable nasal oxygen prongs. Even if staff insist on throwing away the nosepiece (which could be cleaned and pasteurised for reuse), why do the two metres of oxygen tubing need to be discarded? The answer is that the product is sold only as a single unit. It is difficult to see how design efficiency could be claimed to drive marketing decisions in this case because the oxygen tubing is of a larger diameter than the nasal prongs -- the two parts are bonded and sold as one. Single-patient-use oxygen transducers. A non-invasive device which is fitted to a finger or toe, this is a recent addition to the throw-away stable, and expensive at $26 (adult) or $34 (neonatal) each. They were formerly multiple-use devices that were easy to clean in detergent or with an alcohol swab. Pill cups, kidney trays, suction tubing, sequential calf compression cuffs and arm splints for intravenous lines also have low potential for cross-infection and would be easy to clean, inspect and, if necessary, resterilise. Perhaps little consideration is given to the mass consumption and disposal of such instruments because they are seen to be low-cost items. Yet this low cost is somewhat artificial, especially on the disposal side. In most hospitals, waste disposal is not costed to individual departments, so there are few incentives to minimise waste. Many of the indirect costs of waste disposal are passed on to the wider community. Incineration of chlorinated plastic releases carbon dioxide, dioxins and acid vapours into the atmosphere. The incremental costs of pollution monitoring and greenhouse warming, as well as the negative health effects and declining aesthetic value of decreased air quality, are not accounted for in the purchase price of biomedical disposables. Further, if it were a simple matter of supply and demand, clinicians would not be concerned about the opportunity costs of enforced disposal after one use, and health workers would not be worried about the environmental impact of all this unnecessary consumption and disposal of energy and resources. If there was a demand for durable, multiple-use devices, then surely entrepreneurial suppliers would rise to the occasion! However, the situation is more complex. John Kenneth Galbraith showed how suppliers can manipulate demand to suit their own ends.7 His exposure of the supply-and-demand myth is well represented by the culture of disposability which has taken root in modern healthcare over the last three decades, driven by the fear of litigation, so that non-invasive devices labelled "single use only" are treated as such without question. The infection-risk bogey and the spectre of litigation are raised in articles in nursing journals,8,9 central sterilising journals,10 pronouncements of the medical disposables industry,11 and in the mass media.12,13 The latter forum has a far-reaching capacity to muddy the waters; at least one television program linked the reuse of single-use medical devices with the HIV cross-infection of four women in a Sydney surgery, yet there was no suggestion that the surgeon involved deliberately reprocessed single-use devices.14 The virus was thought to have been transmitted through some unidentified breach of infection control guidelines,15 which is an entirely different issue. The process of cleaning, disinfecting and resterilising needs to be brought out into the open so that the current, somewhat surreptitious, practice of reprocessing single-use items can be guided by clear, commonsense protocols, quality controls and reporting of adverse events. However, the process by which biomedical devices come to carry the stamp of "single use only" should also be scrutinised. At present, these three words could be seen to be a licence to print money -- to my knowledge, manufacturers of single-use products do not have to explain why any device deserves to be labelled "disposable". The Industry Commission's 1996 report on the medical and scientific equipment industries16 reported that manufacturers have a financial incentive to label as "single use only" devices which may be safe to reuse. The Industry Commission suggested that market forces -- competition, threatened competition and the countervailing market power of more circumspect purchasing policies -- should put the brakes on this practice. With so much public money at issue, if governments decide to enforce single use more accountability should be required from the industry. If the industry has no interest in writing a code of labelling practice, then perhaps use of the words "single use only" should be regulated and licensed. Conclusion The NHMRC report on the reuse of medical devices labelled as "single use only" examines a small part of a problem that deserves much wider scrutiny; whether devices labelled "single use only" are to be discarded or reused is only tinkering at the margins. The real agenda should be a more thorough and open analysis of the costs and benefits of using and reusing biomedical devices, including: The question of how biomedical devices come to be labelled "single use only"; How to support the manufacture and marketing of durable, sophisticated devices that are designed for multiple use; How to favour best practice cleaning and resterilisation of all biomedical devices, whether labelled "single use only" or intended for multiple use; and How to develop economic indicators to account for the hidden costs of disposables -- storage space, waste disposal and pollution. References National Health and Medical Research Council. Report of the NHMRC expert panel on re-use of medical devices labelled as single use. Canberra: AGPS, 1997. Burton J, Tymchak W, Dzavik V, et al. Randomized controlled trial of reuse of PTCA balloon catheters [abstract]. Circulation 1995; 92 Suppl 1: 661. Frank U, Herz L, Daschner FD. Infection risk of cardiac catheterization and arterial angiography with single and multiple use disposable catheters. Clin Cardiol 1988; 11: 785-787. Mak KH, Eisenberg MJ, Plante S. Absence of increased in-hospital complications with reused balloon catheters. Am J Cardiol 1996; 78: 717-719. Conseil d'evaluation des technologies de la sante du Quebec. The reuse of single-use cardiac catheters: safety, economical, ethical and legal issues. Can J Cardiol 1994; 10: 413-421. Ross DL. Re-use of electrode catheters labelled as single use for clinical cardiac electrophysiological studies [editorial]. Aust N Z J Med 1996; 26: 632-635. Galbraith JK. Economics and the public purpose. London: Pelican, 1975: 150-161. Pickersgill F. Disposables: the case against re-use. Nurs Times 1988; 84: 45-48. Langslow A. Legal liability and the re-use of disposables. Aust Nurs J 1994; 2: 22-24. Milligan J. Sterilizing services perspective. Sterilisation Aust 1992; 11: 6-8. Medical Industry Association of Australia. Statement of industry policy on the reuse of single-use medical devices. Sydney: MIAA, 1991. Robinson M. The patient's right to know. The Sydney Morning Herald 1996 Feb 22: 15 . Australian Broadcasting Corporation. 7:30 Report (television program). 1994: 8 Sep. Chant K, Lowe D, Rubin G, et al. Patient-to-patient transmission of HIV in private surgical consulting rooms [letter]. Lancet 1993; 342: 1548-1549. Penny R. HIV exposure in health care [editorial]. Med J Aust 1995; 162: 509. Industry Commission. Report No. 56: medical and scientific equipment industries. Canberra: AGPS, 1996: 89-91. Authors' details Health Professionals for Global Responsibility,* Sydney, NSW. Ian Stewart, RN, BAppBiol, Environmental Health Co-ordinator; also NSW Co-ordinator for Nursing The Environment (a special interest group of the Australian Nursing Federation). Reprints will not be available from the author. Correspondence: Mr I Stewart, PO Box 72, Erskineville, NSW 2043. E-mail: I. Stewart AT unsw.edu.au * Health Professionals for Global Responsibility is the NSW affiliate of the Medical Association for Prevention of War (Australia), affiliated with International Physicians for Prevention of Nuclear War. <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

Immunisation -- lifting our game GPs must make the most of every vaccination opportunity MJA 1997; 167: 296-297 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/>". - - ©MJA1997 Immunisation is a core preventive activity in general practice, with general practitioners (GPs) being the major providers of childhood vaccination in Australia.1,2 The low immunisation coverage rates in Australia are a major public health problem, but one which GPs have ample opportunities to address. On average, children under six years of age attend GPs seven times a year for intercurrent illnesses, providing many vaccination opportunities.3 The National Childhood Immunisation Program, which commenced in 1995, is a coordinated national effort to address the problem of low vaccination coverage. The study by Herceg et al. in this issue of the Journal shows some encouraging trends in GPs' vaccination performance after the first two years of this Program.4 More GPs are now giving multiple vaccines at the same visit, injecting in the most appropriate site, and not inappropriately postponing vaccination if a child has a mild upper respiratory tract infection, or is taking antibiotics or using inhaled cortico steroids. However, few GPs reported consistently providing opportunistic vaccination. This is partly due to barriers inherent in the present system. GPs need better record systems to alert them to which children are due for vaccination, a greater commitment to providing opportunistic vaccination, as well as more flexible schedules so that they have the time to offer vaccination during family consultations. More GPs are now giving multiple vaccines at the same visit, injecting in the most appropriate site, and not inappropriately postponing vaccination To help overcome some of these barriers to vaccination, the Australian Childhood Immunisation Register was established by Federal and State governments in January 1996, as part of the National Childhood Immunisation Program. The Register sends vaccination reminders to parents and collects data on the vaccination status of individuals and the community. GPs, through their local Divisions of General Practice, have begun working in partnership with public health services to follow-up children who are overdue for vaccination. Unfortunately, some underreporting by vaccination providers has resulted in inappropriate reminders to parents and wasted effort in follow-up, but these problems could be overcome by streamlining the somewhat cumbersome reporting method (involving forms sent in batches to the Health Insurance Commission) and encouraging more GPs to install computer systems which report automatically to the Register. In addition, all providers need to be made more aware of the implications of not reporting. GPs' uncertainty about pertussis vaccination, as reported by Herceg et al., is likely to diminish with the introduction of acellular pertussis vaccine to the Australian schedule over the next few months, and the clarification about contra indications to pertussis vaccination which is included in the 1996 immunisation handbook. Herceg et al. emphasise the importance of providing GPs with unequivocal information, as well as practical skills in educating and informing parents. The Federal Government has also announced several initiatives to improve vaccination coverage which involve GPs, including vaccination days, public education programs, education for GPs, and support for projects initiated by Divisions of General Practice to improve immunisation coverage in local areas. An incentive payment through the Better Practice Program for GPs who achieve 90% immunisation coverage rates in their practices5 is another laudable initiative, but in the absence of some system of patient linkage it will be difficult to determine the appropriate denominator for such a calculation. One way to overcome this problem would be for parents to nominate their preferred vaccination provider when they register their child with Medicare (but this would not restrict their subsequent choice of GP for individual consultations). Thus, parents would be free to attend any GP, but one GP would be responsible for follow-up of their children for vaccination. This would also give GPs a clearer picture of which children they were responsible for. There is evidence that, with the aid of this information, GPs can improve vaccination levels even in lower socioeconomic and mobile population groups.6 The responsibility for immunisation coverage is divided between Federal, State and local governments, with multiple levels of administration which differ between States and even within States. These differences are a constant source of confusion for vaccination providers. The Divisions of General Practice are ideally placed to coordinate local vaccination responsibilities, and to address some of the barriers to improved immunisation coverage within existing systems. This may involve local vaccination campaigns, including promotion and outreach services (e.g., providing a mobile vaccination service to areas with poor immunisation coverage), follow-up of children overdue for vaccination, or recruitment of "hard to reach" children from population groups (low socioeconomic status, recently arrived migrants, non-English-speaking) that are traditionally underimmunised. Herceg et al. have shown that GPs' vaccination performance can improve with appropriate information and education. Education about vaccination should be a regular inclusion in GPs' continuing medical education and quality assurance programs organised by the Royal Australian College of General Practitioners and Divisions of General Practice. However, to achieve 95% coverage, educational interventions must be complemented by changes to the systems within which GPs operate, and concerted efforts at the local level, such as establishment of local immunisation coordinating groups involving Area Health Services, local government, Divisions of General Practice and consumer and community groups. The necessary commitment and collaboration between GPs and public health services can be achieved by financial and professional incentives, education and quality assurance. R S Brian Kable Chair, Preventive and Community Medicine Committee Royal Australian College of General Practitioners, Sydney, NSW Mark F Harris Professor of General Practice, University of New South Wales, Sydney, NSW Traynor V, Britt H, Bridges-Webb C, et al. Immunisation in general practice. Results from the Australian Morbidity and Treatment Survey 1990-1991. Aust Family Physician 1996; 25: 355-359. Australian Childhood Immunisation Register. Preliminary data on proportion of immunisations reported by providers. Immunization Quarterly. Canberra: Commonwealth Department of Health and Family Services, April 1997. Australian Bureau of Statistics. National Health Survey 1990. Canberra: ABS, 1990. Herceg A, Johns M, Longbottom H. Changes in general practitioner vaccination procedures. Med J Aust 1997; 167: 299-302. Wooldridge M. Immunise Australia. The Seven Point Plan. Commonwealth Minister for Health 1996. Canberra: Department of Health and Family Services, 1996. Cullen R. Improving childhood immunisation rates in general practice: problems that affect comparison. N Z Med J 1995; 108: 171-172. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Mark F Harris

Reported general practitioner vaccination procedures, 1994 and 1996 Ana Herceg, Monica B Johns and Helen M Longbottom For editorial comment, see Kable & Harris 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/>". Abstract - Introduction - Methods - Results - Discussion - References - Authors' details - - ©MJA1997 Abstract Objective: To determine general practitioner (GP) vaccination procedures during the first two years of implementation of the National Childhood Immunisation Program. Design: Two cross-sectional self-completion mail surveys of Australian GPs, in October/November 1994 (Survey 1) and April/May 1996 (Survey 2). Participants: 1417 systematically selected (Survey 1) and 1482 randomly selected (Survey 2) GPs. Intervention: Mailing of a package of publications on immunisation to all GPs, a community education campaign, and the introduction of the Australian Childhood Immunisation Register. State and Territory and local initiatives on immunisation, changes in vaccine distribution and funding, and media coverage of vaccination issues may also have affected GPs' procedures. Main outcome measures: Reported vaccination procedures consistent with National Health and Medical Research Council (NHMRC) recommendations. Results: Response rates were 77% (Survey 1) and 78% (Survey 2). There were statistically significant rises in the proportions of GPs who reported vaccination procedures consistent with NHMRC recommendations for simultaneous administration of vaccines, injection site, vaccination of children taking antibiotics or those with mild upper respiratory tract infection, and vaccine storage. There was a reduction in reported opportunistic vaccination, and no change in reported procedures regarding pertussis vaccination. Conclusions: Many factors may have contributed to these changes in GP vaccination procedures. While the changes mostly show an improvement in adherence to NHMRC guidelines, further progress needs to be made, particularly in the areas of opportunistic vaccination, pertussis vaccination and vaccine storage. The best method of informing GPs of current vaccination recommendations needs to be explored. MJA 1997; 167: 299-302 Introduction Vaccine-preventable diseases of childhood continue to occur in Australia, with large outbreaks of measles, pertussis and rubella occurring in 1993 and 1994.1 Vaccination coverage rates in Australia are still not high enough to prevent these outbreaks, with reported coverage varying from 60% for pertussis to 92% for measles.2 More than 60% of childhood vaccinations in Australia are given by general practitioners (GPs),2 and vaccination guidelines are published by the National Health and Medical Research Council (NHMRC) in The Australian immunisation handbook, which is updated regularly.3-5 Studies in the United States have shown that health care systems and immunisation provider services contain major barriers to childhood vaccination, including inaccessibility, insufficient staff, insufficient clinic hours, missed opportunities to vaccinate (i.e., not vaccinating children who present for another reason and are due or overdue for vaccination), and misconceptions about true and false contraindications to vaccination.6 The existence or otherwise of these barriers to childhood vaccination in Australian health care has not been well researched, but one study showed that many immunisation providers in Victoria were unaware of the NHMRC recommendations for diphtheria-tetanus-pertussis (DTP) vaccine and combined diphtheria-tetanus (CDT) vaccine.7 Other studies found that GPs frequently do not follow the NHMRC recommendations for site of injection of vaccines and vaccine storage.8,9 The National Childhood Immunisation Program was devised to address the problem of low vaccination cover - age through a coordinated national approach. The Program, which commenced in July 1994, involved Commonwealth, State and Territory health authorities, as well as professional and consumer bodies. Aspects of the Program included improving surveillance and reporting for vaccine-preventable diseases and vaccination coverage; improving vaccine purchasing, distribution and delivery; and educating parents, the general public and vaccination providers about vaccination. We conducted two national surveys of GPs to estimate changes in vaccination procedures during the first two years of the National Childhood Immunisation Program. Methods Sample selection and survey method Providers were systematically (Survey 1) and randomly (Survey 2) selected from GPs registered with the Health Insurance Commission who had lodged more than 50 services in the preceding quarter. A 10% sample was selected from each group, comprising 1843 GPs in Survey 1 and 1888 GPs in Survey 2. The sample for Survey 1 was created by selecting every tenth GP on the list; a modified classic synchronised sampling method was used for random selection for Survey 2.10 Both surveys were anonymous self-completion mail surveys. For each survey, an initial questionnaire and covering letter was sent to each GP, followed a week later by a reminder letter and a duplicate questionnaire. Practitioners were asked to ignore the reminder if they had already completed the questionnaire, and to return only one blank questionnaire if they did not wish to participate in the survey. The two surveys contained identical questions about GPs and their practices, vaccine storage methods and vaccination procedures. Questions on vaccination procedures and vaccine refrigeration were based on the NHMRC recommendations in the fifth edition of The Australian immunisation procedures handbook (1994). No identifying information was collected. Interventions Survey 1 was conducted in October/November 1994, one month before the National Childhood Immunisation Program sent a package of publications to all vaccination providers, including all GPs. The package included The Australian immunisation procedures handbook (fifth edition) and other publications on vaccine provision and storage. Survey 2 was conducted in April/May 1996, after the National Childhood Immunisation Program had been in place for almost two years. Activities of the Program during that time included distribution of the publications mentioned above (November 1994), a community education campaign (April to November 1995), and the introduction of the Australian Childhood Immunisation Register (January 1996). During the period between the two surveys, other activities which may have affected GP immunisation practices included State and Territory initiatives to inform immunisation providers about vaccination procedures, changes in vaccine distribution and funding systems, the development of school-entry vaccination record requirements in some jurisdictions, media coverage, and local promotion of vaccination issues through Divisions of General Practice and other agencies. Statistical analysis Data entry and analysis were done with Epi Info version 6. 11 The chi-squared test for independence in 2 x 2 tables was used to compare the results of the two surveys. Analyses were based on the number of respondents who completed each question rather than the total number of respondents. Results Response rates After exclusion of respondents who indicated they did not provide childhood vaccinations, response rates were 77% for Survey 1 and 78% for Survey 2. Ninety-eight per cent of respondents worked in general practice. The two samples did not differ significantly in type of practice or age groups, but, for number of vaccines given per week, significantly more respondents in Survey 2 gave between one and nine (Box 1, below). Vaccine administration procedures Reported vaccine administration procedures consistent with the NHMRC recommendations are compared in Box 2. The proportion of practitioners who would always opportunistically vaccinate fell from 32% to 28%, although an additional 47% of GPs in 1996 said they would frequently vaccinate children opportunistically. Simultaneous administration of DTP, oral polio vaccine and Haemophilus influenzae type b (Hib) vaccine increased from 49% to 68%. Recording of vaccine batch number and use of recommended injection sites also increased. There were statistically significant rises from 1994 to 1996 in reported willingness of GPs to vaccinate children with mild upper respiratory tract infections or who were taking antibiotics (Box 3), and there was a fall from 94% to 90% in the proportion of GPs who would not vaccinate a febrile child. There was no change between the two surveys regarding when CDT should be used to replace DTP, or vaccination for a child taking inhaled or topical steroids. Reported storage of vaccines according to NHMRC recommendations improved between the two surveys, including use of a maximum/minimum thermometer, storing vaccines only on the top and middle shelves of the refrigerator and not storing food or specimens in the same refrigerator (Box 4). Although reported daily checking of the vaccine refrigerator temperature increased, in 1996 only 27% of GPs reported that this was done. A further 30% reported that the refrigerator temperature was checked weekly. In November 1994, 15% of respondents reported their practices had immunisation recall/reminder systems functioning. In April 1996, 78% of GPs reported always contributing to the Australian Childhood Immunisation Register. Discussion Our study has a number of limitations, including the sampling methods, the number of non-respondents and the fact that it was based on self-reported behaviour. While the sampling methods for the two surveys were not identical, the two groups were demographically comparable, and we believe both samples are representative of the GP population. It is estimated that around 170 GPs would have received both surveys; however, as the surveys were conducted anonymously we have no record of this overlap. Thus, it is possible that a small proportion of the reported change in behaviour was because of this previously surveyed group who would have been more aware of the issues. Finally, self-reported behaviour does not necessarily correlate with actual behaviour. Hence, these surveys probably provide a conservative estimate of behaviour contrary to NHMRC guidelines. Our study showed a significant improvement in several reported GP vaccination procedures between 1994 and 1996. The reasons for these changes are probably multiple, and include the information provided through the National Childhood Immunisation Program, State and Territory immunisation provider information and other professional education sources, as well as community and media interest in the topic. The degree to which each of these sources may have influenced the change cannot be assessed from our study. However, the coordination and information dissemination role of the National Childhood Immunisation Program meant that the information conveyed from health authorities and professional organisations to GPs between the two surveys was consistently based on NHMRC recommendations. Our results indicate, however, that more progress needs to be made in some areas. Opportunistic vaccination, including in hospital emergency departments, has frequently been identified as a way of improving immunisation coverage.12 In 1996, many GPs potentially missed opportunities to vaccinate by infrequently or never checking children's immunisation status when they presented for another reason. The high use of the parent-held Personal Health Record identified in our survey was also found by Bailey et al.13 Recording of batch number on the Record and/or in practice records improved between the two surveys; this is recommended by the NHMRC to ensure that children potentially at risk of illness can be found if a faulty batch of vaccine is identified. Misconceptions about true and false contraindications to vaccination have previously been recognised as barriers to full vaccination; this especially applies to when it is appropriate to replace DTP with CDT.6,7 The NHMRC guidelines have previously not been clear about pertussis vaccination, and this is likely to have contributed to the confusion. Most GPs in our study would replace DTP with CDT if a child had a febrile convulsion or persistent screaming after the last dose of DTP. These are situations which were previously classed by the NHMRC as contraindications to DTP and which, in the 1994 recommendations, "may preclude" another dose of DTP. The 1997 sixth edition of The Australian immunisation handbook provides new, clear guidelines on pertussis vaccination.5 GPs need to be aware of these changes; following the new recommendations should increase pertussis vaccination rates and prevent more disease. Vaccine storage procedures have been previously shown in New South Wales to be inadequate in many immunisation provider practices.9,14 Although there were improvements between our two surveys, in 1996 only 27% of practices checked and recorded the refrigerator temperature daily. Correct vaccine storage is essential to maintain vaccine potency. Our study looked only at private vaccination providers. We currently have no information about immunisation procedures of public providers, who administer around 40% of vaccines, and further studies are needed to assess procedures in this sector. While many GPs have kept abreast of changing recommendations, further improvements are possible. In addition, because of the impending availability of new vaccines and combinations of vaccines, further changes to the vaccination schedule and recommendations are likely in the coming years. Our study has not identified the best way to inform GPs of changes in recommendations, and this must be determined. The 78% participation rate of GPs in the Australian Childhood Immunisation Register five months after its commencement shows that good communication channels with GPs are available. Further improvements in vaccination provider practices will result in more children receiving the correct, efficacious vaccines safely and on time. References Herceg A, Oliver G, Myint H, Andrews G, et al. Annual report of the National Notifiable Diseases Surveillance System, 1995. Commun Dis Intell 1996; 21: 440-464. Australian Bureau of Statistics. Children's immunisation, Australia. Canberra: ABS, April 1995. (Catalogue No. 4352.0.) National Health and Medical Research Council. Immunisation procedures. 4th ed. Canberra: AGPS, 1991. National Health and Medical Research Council. The Australian immunisation procedures handbook. 5th ed. Canberra: AGPS, 1994. National Health and Medical Research Council. The Australian immunisation handbook. 6th ed. Canberra: AGPS, 1997. Cutts FT, Orenstein WA, Bernier RH. Causes of low preschool immunisation coverage in the United States. Annu Rev Publ Health 1992; 13: 385-398. McIntyre CR, Nolan T. Attitudes of Victorian vaccine providers to pertussis vaccine. Med J Aust 1994; 161: 295-299. Rixon G, March L, Holt DA. Immunisation practices of general practitioners in metropolitan Sydney. Aust J Public Health 1994; 18: 258-260. Liddle JLM, Harris MF. How general practitioners store vaccines. A survey in south-western Sydney. Med J Aust 1995; 162: 366-368. Calcino G. Sampling from the HIC data set. Proceedings of the General Practice Evaluation Program 1993 work-in-progress conference, Canberra; 20-22 May 1993. Canberra: Department of Health, Housing, Local Government and Community Services, 1993. Dean AG, Dean JA, Couombier D, Brendel KA, et al. Epi Info, Version 6: a word processing, database, and statistics program for epidemiology on microcomputers. Atlanta, Ga: Centers for Disease Control and Prevention, 1994. Jones K, Fasher B, Hanson R, Burgess M, et al. Immunization status of casualty attenders: risk factors for non-compliance and attitudes to "on the spot" immunization. J Paediatr Child Health 1992; 28: 451-454. Bailey FK, Nossar V, Jeffs DA, et al. An evaluation of the NSW Personal Health Record. Sydney: NSW Health, 1992. Miles T. The integrity of the vaccine cold chain in the Hunter area of New South Wales. Aust J Public Health 1993; 17: 169-171. (Received 19 Sep 1996; accepted 21 Jul 1997) Authors' details National Centre for Disease Control, Department of Health and Family Services, ACT. Ana Herceg, MPH, MAppEpid, Medical Epidemiologist, Surveillance and Management Section. Monica B Johns, BAppSc; formerly, Senior Project Officer, National Childhood Immunisation Program. Helen M Longbottom, MPH, FAFPHM; formerly, Director, Surveillance and Epidemiology Section. Reprints will not be available from the authors. Correspondence: Ana Herceg, Surveillance and Management Section, National Centre for Disease Control, MDP 6, Department of Health and Family Services, GPO Box 9848, ACT 2601. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Ana Herceg · Monica B Johns · Helen M Longbottom

Doctors and healthcare reform To influence their own destiny, doctors need to participate in the design and management of healthcare reforms that are targeting value for money MJA 1997; 167: 184-185 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/>". - Register to be notified of new articles by e-mail - - ©MJA1997 Healthcare systems all over the world are undergoing substantial change as governments look for ways to constrain what appear to be inexorable cost increases while simultaneously searching for ways to increase value for money. Change is never easy, but the more that individuals participate in planning and implementing change, the more comfortable they feel with these changes. In the past, doctors probably felt they had a significant influence over their immediate work environment. However, this is changing, and, as Perkins et al. report in this issue of the Journal, there is a low level of congruence between the personal goals of individual medical specialists and organisational goals.1 Importantly, the medical specialists are less enthusiastic about their work since the introduction of healthcare system changes that involved resource restrictions and splitting the roles of purchasers and providers (although Perkins et al. did not control for other variables, such as salaries and promotion). the medical profession needs to recognise the legitimacy of funders' and purchasers' concerns about cost increases and value for money While Perkins et al. did not address differences in responses in relation to individual specialists' organisational roles, they did find that specialists in the United Kingdom reported a greater influence on management than their Australian and New Zealand counterparts; this may reflect the greater role for United Kingdom specialists as clinical managers. The study sample in New South Wales (whence the Australian sample was drawn) consisted mainly of visiting medical staff from one Area Health Service, and previous research has shown that visiting specialists identify less with an organisation than physicians who have adopted a managerial role, such as divisional directors.2 Of interest, in terms of health service reform, New South Wales was in a period of relative health policy stability at the time of the survey; nevertheless, the specialists reported decreased enthusiasm for their work. Perkins et al. show that medical specialists would like to influence the "management" of their healthcare organisations, but they have been unsuccessful at this, either because management is unwilling to be influenced, or the attempts at influence are ineffective. At the hospital level, attempts to ensure a greater clinician role in management may involve, as Perkins et al. and their respondents point out, a heavy but rewarding workload. Strategies to enhance clinician influence on policy directions in the wider environment are more difficult to devise. Managed care is the current "bogey" of the medical profession: the profession's current strategy is to run what the health insurance funds deride as a "managed scare" campaign. Governmental and funder concerns about the costs of care and about value for money keep managed care on the agenda in Australia, and political campaigns will not make these concerns disappear. What is needed is a more sophisticated response -- one that addresses the concerns of funders in a way that does not increase feelings of alienation in doctors. With such a response, the medical profession might unpack the many contemporary meanings of managed care and differentiate those elements which have some benefit (e.g., providing feedback to doctors about comparative practice matters) from those which would have a deleterious impact on the Australian health care system (e.g., imposing outdated or rigid treatment protocols). Any policy alternative to managed care must address the need to improve technical efficiency and value for money (technical and allocative efficiency) in the healthcare sector. The key way to address hospital technical efficiency issues is through casemix funding, paying hospitals on the basis of benchmark performance rather than on the basis of history or political influence. Increasing value for money relies on changing the behaviours of providers through funding and education strategies. The 1997 Budget strategy of limiting additions to the Medicare Schedule to cost-effective interventions is a step in the right direction. Providers will also need assistance in implementing best-practice approaches to care -- this can be done through the introduction of local guidelines to influence behaviour. Local guidelines should not be seen as idiosyncratic approaches based on the conventional wisdom of local providers, but rather should be based on the best available evidence,3,4 building on nationally established guidelines where these exist.5 Local guidelines can be supplemented by care paths or clinical pathways to reduce provider variation and lower costs. Care paths also have the benefit of defining appropriate practice and providing a framework for evaluation. The alternative to managed care thus requires a twofold approach: Improve the technical efficiency of healthcare provision; and Encourage and provide incentives for the adoption of local guidelines to influence practice patterns, to ensure effective and efficient care. Unfortunately, local strategies for behaviour change seem to have had limited success.6,7 Even when professional organisations support guidelines for cost-effective care, such guidelines cannot always be implemented, for reasons such as the strongly held beliefs of individual doctors in maintaining their own professional autonomy.8 However, local norms can influence practice,9 through peer pressure and systematic quality assessment processes. In addition, information given to doctors about resource consumption for specific conditions seems to play a part in reducing hospital costs,10 by, for instance, providing feedback to referring physicians about the costs and benefits of ordering particular diagnostic tests. For healthcare providers collectively, it would probably be more politically attractive to be able to influence their own destiny rather than have it determined without their professional involvement. A corollary to this is that the medical profession (and the other health professions) must be given the opportunity to engage in the reform process. To diminish the sense of alienation identified by Perkins et al., the medical profession needs to recognise the legitimacy of funders' and purchasers' concerns about cost increases and value for money. We need to develop strategies that respond to these needs in ways that do not undermine professional values or lead to alienation and loss of morale. Stephen J Duckett Professor of Health Policy; Dean, Faculty of Health Sciences La Trobe University, Melbourne, VIC. Perkins RJ, Petrie KJ, Alley PG, et al. Health services reform: the perceptions of medical specialists in Australia (New South Wales), the United Kindom and New Zealand. Med J Aust 1997; 167: 201-204. Abernethy MA, Stoelwinder JU. Goal orientations and the use of budgeting information: A comparison between physicians and non-physicians in public teaching hospitals. In: Butler JRG, Doessel DP, editors. Proceedings of the Eighth Australian Conference of Health Economists. Sydney: Australian Studies in Health Services Administration, 1987: 67-92. Grimshaw J, Freemantle N, Wallace S, et al. Developing and implementing clinical practice guidelines. Qual Health Care 1995; 4: 55-64. Eccles M, Clapp Z, Grimshaw J, et al. Developing valid guidelines: methodological and procedural issues from the North of England evidence-based guideline development project. Qual Health Care 1996; 5: 44-50. Smallwood RA, Lapsley HM. Clinical practice guidelines: to what end? Med J Aust 1997; 166: 592-595. Eisenberg JM. Doctors' decisions and the cost of medical care. Ann Arbor: Health Administration Press, 1986. Mittman BS, Siu AL. Changing provider behavior: Applying research on outcomes and effectiveness in health care. In: Shortell SM, Reinhardt UE, editors. Improving health policy and management: nine critical research issues for the 1990s. Ann Arbor: Health Administration Press, 1992: 195-226. Rappolt SG. Clinical guidelines and the fate of medical autonomy in Ontario. Soc Sci Med 1997; 44: 977-987. Westert GP. Variation in use of hospital care: an empirical and theoretical analysis of differences in the duration of hospital stay. Assen/Maastricht: Van Gorcum, 1992. Conrad D, Wickizer T, Maynard C, et al. Managing care, incentives and information: An exploratory look inside the "Black Box" of hospital efficiency. Health Serv Res 1996; 31: 235-259. To top of article - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Stephen J Duckett

Health service reform: the perceptions of medical specialists in Australia (New South Wales), the United Kingdom and New Zealand Rod J Perkins, Keith J Petrie, Patrick G Alley, Peter C Barnes, Malcolm M Fisher and Peter J Hatfield For editorial comment see Duckett 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/>". Abstract - Introduction - Methods - Results - Discussion - Disclaimer of conflict of interest - References - Authors' details - - ©MJA1997 Abstract Objective: To examine the effect of recent healthcare service changes (including significant resource constraint and a greater role for the non-medical manager) in the United Kingdom, Australia and New Zealand on medical specialists' perceptions of their healthcare organisation goals and service delivery, and their enthusiasm for their work. Design: Postal questionnaire survey, answered anonymously. Participants and setting: Medical specialists employed either part- or full-time in two United Kingdom National Health Service Trusts (one acute, one mental health/community service), an Australian Area Health Service and a New Zealand Crown Health Enterprise in 1995. Main outcome measures: Participants' rating of their knowledge of employers' organisational goals, ability to influence management, perceptions of changes in resources and service availability since 1990 and changes in enthusiasm for their work over the past four years. Results: 369 of 521 eligible specialists responded (71%); by country -- United Kingdom, 123/186 (66%); New Zealand, 123/160 (77%); Australia, 123/175 (70%). New Zealand specialists were less aware of their employers' organisational goals and had less congruence between these and their own personal goals than United Kingdom or Australian specialists (P < 0.05). Interest in influencing central management was similar in the three countries, but Australian specialists felt management was less likely to follow their advice compared with United Kingdom specialists (P < 0.05). New Zealand specialists perceived that waiting times for non-urgent patients were currently longer than in 1990 compared to United Kingdom specialists (P = 0.02). In all three countries, inpatient beds were perceived to be less available than in 1990, but less so in New Zealand. The ease of replacing equipment was better in New Zealand than in Australia and the United Kingdom (P = 0.00001). More than 50% of participants in all three countries (183/361; 50.7%) reported that their enthusiasm for their work had decreased in the past four years. Conclusion: The effects of health service reforms seem to have reduced enthusiasm for work among medical specialists in Australia, the United Kingdom and New Zealand. MJA 1997; 167: 201-204 Introduction In recent years, Australia, New Zealand and the United Kingdom have seen major structural changes in the way health services are funded and managed (Box 1), and these changes have altered relationships between doctors and managers.1,2 Whether the new structures deliver better services to populations -- in terms of cost, quality and access -- is currently debated, but little information is available on the impact of these changes on the working lives of specialists in hospital settings.3,4 We set out to determine whether the healthcare changes affected specialists' attitudes towards their work and practice. We assessed their perceptions of their current influence on central management, whether their enthusiasm for involvement in healthcare delivery had changed since the changes were instituted, and whether they believed that availability of resources and services to their patients had changed. Methods Participants In 1995 we mailed questionnaires to 521 specialists (individuals holding College postgraduate qualifications) employed full-time or part-time in two United Kingdom National Health Service Trusts (Salford Royal Hospitals and Newcastle City Health), a New Zealand Crown Health Enterprise (Capital Coast Health, Wellington) and an Australian Area Health Service (staff specialists or visiting medical officers in the Northern Sydney Area Health Service, New South Wales). Specialists from two National Health Service Trusts were surveyed to ensure that all specialties were represented from each country. The questionnaire (to be answered anonymously) was mailed with a covering letter from a senior colleague within their organisation. A second questionnaire was sent to all specialists approximately six weeks after the first (as we did not know who replied to the first mailout, we had to send everyone a second). Questionnaire Participants were asked to rate, on seven-point Likert scales: Their knowledge of their employer's goals, the congruence between what they like doing in their work and what their employer wants them to do, their interest in influencing hospital or service management, and the extent to which their advice is noted or acted upon. The time spent per week in hospital management meetings (from less than one hour to more than six hours), on a scale of less than one hour, one to two hours, two to three hours, etc. Their perception of changes in resource availability and service over the past four years; specifically, waiting time for non-urgent patients, availability of beds, and condition and ease of equipment replacement. They were also asked to rate whether their enthusiasm for their work had increased, stayed the same, or decreased. Open-ended questions (e.g., "If your enthusiasm for your work has changed in the past four years, please state why.") invited the participants to comment on the changes. Statistical analysis The results were analysed using the Statistical Package for the Social Sciences (SPSS) for Windows.5 Non-parametric tests were used to analyse the time spent in management meetings. Differences between specialists in the three countries were assessed using one-way analysis of variance and post-hoc Tukey B tests. Differences in the specialists' enthusiasm for work were evaluated using a contingency table and the chi-squared statistic. Results Three hundred and sixty-nine replies were received after the two mailings (overall response rate, 71%). By country, response rates were: United Kingdom, 123/186 (66.0%), Australia, 123/175 (70%) and New Zealand, 123/160 (77%). Twenty-four percent of the specialists were aged under 40 years, 35% were 40-49, 23% were 50-59 and 19% were 60 years or older. Women made up 19% of the total sample and were equally represented in the three countries (chi-squared = 2.92; df = 3; P = 0.23). There were more full-time specialists in the United Kingdom (56 full-time, 27 part-time) than in New Zealand (33 and 58) and Australia (40 and 47) (chi-squared = 17.53; df = 2; P = 0.0001). Time in management meetings There was no difference between New Zealand and Australian participants in the amount of time spent in meetings about hospital or service matters (median for both, less than one hour per week; Mann-Whitney U test = 6950.5; P = 0.18). United Kingdom specialists spent significantly more time in these meetings (median, one to two hours) compared to either New Zealand (Mann-Whitney U test = 5652.5; P = 0.0007) or Australian specialists (Mann-Whitney U test = 5652.5; P = 0.0007). This effect also held when answers for full-time staff only were examined. Knowledge of organisational goals and influence on management New Zealand specialists were significantly less aware of their health care organisation's goals than specialists in the United Kingdom and Australia, and New Zealand specialists had significantly less congruence between their personal goals and those of the organisation (Box 2). Specialists in the three countries were equally keen to influence management, but Australian participants felt their advice was less likely to be followed. Perceptions of changes in resources and availability of services since 1990 New Zealand specialists felt that waiting time for non-urgent patients was longer than in 1990 compared with their United Kingdom colleagues (Box 3). Beds were perceived to be relatively less available than in 1990 in all three countries, with availability much worse in Australia and the United Kingdom. There was no difference in specialists' perception of equipment condition across countries; most considered this to be fair to moderate. New Zealand specialists felt that equipment replacement was much easier than before 1990 compared with their counterparts in Australia or the United Kingdom. Enthusiasm for work The Figure shows that 50.7% of specialists in the three countries (183 of the 361 who answered the question) reported decreased work enthusiasm over the past four years. The decrease in the United Kingdom was smaller than that in either Australia or New Zealand, but with this size sample no between-country differences were demonstrated (chi-squared = 4.6; df = 2; P = 0.10). Responses to open-ended questions The specialists' comments reflected a divergence between their perceptions of adequate clinical practice and the requirements imposed by the healthcare service reforms (see Box 4). Discussion We found that more than half of hospital specialists in all three countries had decreased enthusiasm for their work in the past four years, coinciding with a greater role of non-medical managers and more restrictions on resources in the secondary (hospital) care sector. The responses to the open-ended questions were consistent with this finding. While all specialists acknowledged resource contraints, in the open-ended questions Australian and New Zealand specialists were more critical of their healthcare organisations than were the United Kingdom specialists. However, the consequent involvement of the United Kingdom specialists may result in a heavy workload: "Sometimes the clinical work and admin work is overwhelming, but on good days it's great. Sometimes I worry if I can keep this level of activity up in the long term" [United Kingdom specialist]. The management structures in the employing organisations are such that specialists in the United Kingdom Trusts, particularly at Salford Royal, seem to be more involved in the organisation and management of their services than are Australian and New Zealand specialists. In this Trust, there were 26 clinical directorates, and more than 30% (26/79) of all specialists were clinical directors; although this position implies extensive involvement in management, the clinical director may not be the manager of the service. A similar organisational structure did not exist in the Northern Sydney Area Health Service. At Capital Coast Health (New Zealand) only one of the three general managers was a medical specialist, and none of the departmental managers were clinicians. This may explain why there appears to be greater enthusiasm for work among the United Kingdom specialists and a greater acceptance of resource difficulties (i.e., although they perceived greater resource difficulties, they did not have less enthusiasm for work than their Australian and New Zealand counterparts). This involvement in management may also explain why United Kingdom specialists spend more time in committee work -- a level of involvement that is significant for their employer. On average, the United Kingdom specialists spent one hour more per week in management meetings than their Australian and New Zealand counterparts, and, given the standard working week of 40 hours, our study would suggest that a United Kingdom Trust employing 120 specialists could expect to receive an additional three full-time-equivalents of time commitment to management issues from those specialists compared with their Australian and New Zealand counterparts. The results of our study show that for many hospital specialists health service reform has come at a "cost" -- a loss of enthusiasm for their work. Specialists' involvement in the management of their hospitals or services seems to be related to higher levels of enthusiasm, even when resource constraints may make it difficult for them to perform their duties properly. Our study suggests that the greater involvement of doctors in management is working to the advantage of the United Kingdom specialists and their employers. This could provide lessons for Australian and New Zealand healthcare systems that have values and structures in common with the organisations employing the Australian and New Zealand specialists in this study. Disclaimer of conflict of interest The authors declare no conflict of interest. References Hunter DJ. Doctors as managers: Poachers turned gamekeepers? Soc Sci Med 1992; 35: 557-566. Scrivens E. The management of clinicians in the National Health Service. Soc Policy Admin 1988; 22: 22-34. Ham C. Health care reform; learning from international experience. Milton Keynes: Open University Press, 1997. Ham C. Reforming the New Zealand health reforms. Big bang gives way to incrementalism as competition is abandoned [editorial]. BMJ 1997; 314: 1844. SPSS: Statistical package for the social sciences for Windows [computer program], version 6.1. Chicago, Ill: SPSS Inc, 1995. (Received 28 Oct 1996, accepted 13 March 1997) Authors' details University of Auckland, Auckland, New Zealand. Rod J Perkins, BDS, MHA, Senior Lecturer in Health Management; Keith J Petrie, MA, PhD, Associate Professor in Health Psychology; Patrick G Alley, MB ChB, FRACS, Associate Professor, Department of Surgery. Royal Salford NHS Trust, Salford, United Kingdom. Peter C Barnes, MB ChB, FRCP, Physician and Clinical Director. Royal North Shore Hospital, Sydney, New South Wales, Australia. Malcolm M Fisher, MD, FFICANZCA, Clinical Professor, University of Sydney. Wellington Hospital, Wellington, New Zealand. Peter J Hatfield, MB ChB, FRACP, Renal Physician. Reprints: Dr R J Perkins, Senior Lecturer in Health Management, University of Auckland, Private Bag 92019, Auckland, New Zealand. E-mail: r.perkins@auckland.ac.nz ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Rod J Perkins · Keith J Petrie · Patrick G Alley · Peter C Barnes · Malcolm M Fisher · Peter J Hatfield

Antibiotic use in the Australian community, 1990-1995 Peter McManus, M Leigh Hammond, Susan D Whicker, John G Primrose, Andrea Mant and Steven R Fairall For editorial comment see Turnidge 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/>". Abstract - Introduction - Methods - Results - International comparisons of antibiotic usage - Types of antibiotics used in Australia and indications - Discussion - Acknowledgement - References - Authors' details Make a comment - - ©MJA1997 Abstract Objective: To determine the pattern of antibiotic use in the Australian community, 1990-1995, and compare it with the pattern in other developed countries. Design: Survey of data from the national database on drugs dispensed in Australia (1990-1995), an international database on retail drug sales (1985-1994), and Australian prescriber surveys (1994, 1995). Main outcome measures: National and international retail sales of oral antibiotics (defined daily doses [DDDs]/1000 population/day) and antibiotic prescriptions dispensed through community pharmacies by drug type; antibiotic prescribing profiles for common conditions. Results: Antibiotic use in Australia remained steady between 1990 and 1995, with an estimated 24.7 DDDs/1000 population/day dispensed through community pharmacies in 1990 and 24.8 DDDs/1000 population/day in 1995. Amoxycillin, although declining in use, remained the most dispensed antibiotic. Compared with the other countries surveyed, Australia had the highest percentage use of tetracyclines, such as doxycycline, and the lowest percentage use of fluoroquinolones. Use of trimethoprim-sulfamethoxazole and flucloxacillin declined in Australia. In new cases of upper respiratory tract infection or pharyngitis, an antibiotic prescription was recorded for 57% of urban patient encounters and 73% of rural patient encounters. Conclusions: Antibiotic use in Australia is high, as in many other developed countries, but did not increase between 1990 and 1995. The overall profile of antibiotic use in Australia by drug class was similar to that in the United Kingdom. Antibiotics were still commonly prescribed for upper respiratory tract infection (which is usually viral), more commonly by rural than by urban general practitioners. MJA 1997; 167: 124-127 Introduction Patterns of antibiotic prescribing in Australia between 1987 and 1989 were reported previously by the Drug Utilization Sub-Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee, Department of Health and Family Services.1 At the time, the Sub-Committee expressed concern over evidence of "inappropriate and unnecessarily expensive" practice, which was "directed too heavily towards the use of broad spectrum agents and newer more expensive drugs".1 To update these data, DUSC convened a working group in 1995, comprising representatives of DUSC, the Australian Pharmaceutical Manufacturers Association and the Therapeutics Resource and Educational Network for Doctors (TREND) project of the Royal Australian College of General Practitioners. This group reviewed Australian and international data on antibiotic sales and dispensing to determine patterns of antibiotic use in Australia between 1990 and 1995, and to compare these with patterns in similar developed countries. To understand trends in drug use, the group also analysed prescriber surveys of the indications for antibiotic use. Methods Data were derived from four sources: Prescription dispensing data: These were obtained from the database maintained by the DUSC secretariat which monitors dispensing of prescription medicines through community pharmacies in Australia. These data include dispensing to some private hospitals, but not public hospitals. The database contains information on all subsidised prescriptions processed by the Health Insurance Commission, together with an estimate of non-subsidised prescriptions from an ongoing survey of a sample of about 250 community pharmacies.2 Measurement units are either prescription volumes or number of defined daily doses (DDDs)/1000 population/day. The DDD is based on the assumed average daily dose of the drug when used for its main indication by adults. It is the unit approved by the World Health Organization for drug use studies and allows for comparisons independent of differences in price, preparation and quantity per prescription.3 Sales data: Data on sales of oral antibiotics to retail and hospital markets in a number of countries were obtained from Intercontinental Medical Statistics (IMS), Melbourne. This is a commercial market research organisation which collects sales data and surveys general practitioner (GP) prescribing in 33 countries.4 Data were retrieved as unit sales by form and strength and drug class and then converted to DDDs/1000 population/day. Prescriber survey: Diagnoses for which patients were prescribed anti biotics and patient ages were obtained from the Australian Medical Index (AMI), the survey of GP prescribing conducted by IMS. This uses a sample of 420 GPs stratified in line with the total Australian GP population by metropolitan/country location, age, year of graduation, and practice size (patient numbers). These GPs record all patient encounters over seven consecutive days in each quarterly survey period. The data are then projected to obtain quarterly estimates of prescribing patterns by diagnosis and by patient age and sex for the Australian GP population. At the end of a four-quarter cycle, GPs are invited to continue participating. About half agree, and the remainder are replaced by new recruits. As GPs start in various quarters of the year, there is continual turnover; GPs are not usually kept in the survey for more than two years. TREND project: Use of antibiotics for management of upper respiratory tract infection (URTI)/pharyngitis and influenza was examined using the database of 33 203 doctor-patient encounters recorded in August and September 1994 by the TREND project. This project was part of the development of a new practice assessment in therapeutics option within the RACGP Quality Assurance and Continuing Education Program. Participating GPs recorded prospectively their drug and non-drug management, including lifestyle advice, investigations and referrals, for 110 consecutive patient encounters of all types (including surgery and telephone consultations, home, hospital and nursing home visits). The GP sample was drawn from two urban and two rural areas in NSW which were selected randomly from all NSW Divisions of General Practice, after matching within urban (16 Divisions) and rural (11 Divisions) strata. Matching variables were the index of relative socioeconomic disadvantage (from the 1991 Census5 ) and GP-to-population ratios (from the Medicare claims database as at the end of June 1993) (Gordon Calcino, Acting Director, Technical Support Section of the General Practice Branch, Department of Health and Family Services, personal communication). The rural areas included both major and outlying towns, but not remote rural areas. All GPs from the four areas were eligible for the survey, based on a list provided by the General Practice Branch from the Medicare claims database. Of the 783 GPs approached, 303 (38.7%) completed the practice assessment in 1994. Participants had a similar sex distribution to the 1994 NSW GP population, but a somewhat younger average age.6 Results Between 1990 and 1995, there was little change in the level of antibiotics dispensed through Australian community pharmacies, with an estimated 24.7 DDDs/1000 population/day dispensed in 1990 and 24.8 DDDs/1000 population/day in 1995. Pharmaceutical industry sales data of 25.2 DDDs/1000 population/day in 1989 and 24.8 DDDs/ 1000 population/day in 1994 (0.3% fall on compound annual growth rate) confirm this stability in overall use. International comparisons of antibiotic usage Retail sales of oral antibiotics in Australia and seven major developed countries in 1985, 1989 and 1994 are compared in Figure 1. Like most developed countries, Australia had a high use of oral antibiotics. In 1994 retail sales in Australia were second to those in France and followed closely by those in the United States. However, between 1989 and 1994 sales in Australia did not show the compound annual growth seen in all the other countries except Canada -- France (up 2.8%), United States (up 2.3%), Italy (up 2.9%), West Germany (up 4.4%) and the United Kingdom (up 3%). Sales of oral antibiotics to hospitals in 1994 and the percentage this represented of the total market are shown in Box 1 (above). The percentage was similar in Australia, Canada and the UK (7%, 9% and 11%, respectively), lowest in the US (5%) and highest in West Germany (38%). Figure 2 shows the percentage split of the oral antibiotic market by drug class in 1994. Australia had the highest percentage use of tetracyclines (25.5% of total oral antibiotics), but the lowest use of fluoroquinolones (2.2%) and mid range use of penicillins -- both narrow spectrum (7.1%) and broad spectrum (35%). The overall profile of antibiotic use in Australia was similar to that in the UK. Types of antibiotics used in Australia and indications The top 10 antibiotics, on prescription volume, dispensed through Australian community pharmacies in 1990 and 1995 are shown in Box 2. Amoxycillin was the most-dispensed antibiotic in 1990 and, although declining in use, remained in this position in 1995. Dispensing of doxycycline and erythro mycin also declined, while that of amoxycillin-clavulanate increased. Cefaclor and roxithromycin were new additions to the top 10 dispensed antibiotics in 1995. Converting prescription volume to DDDs/1000 population/day altered the relative ranking of some drugs. For example, drugs in the tetracycline group, which have increased maximum quantities available for treatment of severe acne, rose in rank (1990). In contrast, cefaclor, which has a high DDD (1.5g) by Australian standards, fell from third to seventh position (1995). Box 2 also shows antibiotic prescribing profiles for various indications in 1995. For sinusitis, the most prescribed antibiotics were doxycycline (20.7%), amoxycillin-clavulanate (18.1%) and cefaclor (15.1%). For bronchitis, the most prescribed antibiotic was amoxycillin (18.1%), followed closely by roxithromycin (16.5%) and cefaclor (15.2%). In urinary tract infections, trimethoprim-sulfamethoxazole (28.5%) was most commonly prescribed, followed by cephalexin (18.9%) and amoxycillin-clavulanate (17.2%). Antibiotic prescribing for upper respiratory tract infection (URTI)/pharyngitis and influenza was examined in the TREND sample of GPs from the August-September 1994 audit; 11.6% of encounters were for URTI/pharyn gitis and 1.2% for influenza. For new cases of URTI/pharyngitis, an antibiotic prescription was recorded for 57% of urban patient encounters and for 73% of rural patient encounters. Corresponding figures for antibiotic prescribing in new cases of influenza without pneumonia were 30% of urban and 62% of rural patient encounters. The TREND project did not evaluate whether the prescription was to be filled only under certain conditions (e.g., if symptoms had not improved after a certain interval), but some GPs commented that this was their advice to patients. For symptomatic management, the most common choices were decongestants and analgesics. AMI survey data showed that overall antibiotic usage by age broadly followed the proportional representation of particular age groups in the community, with the exception of the 0-19 years age group. This group received 36.9% of antibiotic prescriptions, but made up only 28.7% of the population. However, for specific conditions the age patterns varied. For example, the TREND project showed that an antibiotic was less often prescribed for children aged 0-5 years with URTI (34.1%) than for adults aged 50 years and over (62.5%). Figure 3 shows quarterly fluctuations in dispensing of oral antibiotics compared with oral β-blockers -- a drug type used on an ongoing basis. Antibiotic dispensing was markedly seasonal, with higher levels in the winter quarters (April to June and July to September), while dispensing of oral β-blockers was low at the beginning of the year and high at the end. The second pattern was typical of "safety net" fluctuations.7 These result from Pharmaceutical Benefits Scheme (PBS) provisions that provide drugs free, or at lower cost, to the patient if they are dispensed after the patient has incurred a set expenditure on PBS items in a calendar year (the "safety net" threshold). Consequently, patients tend to fill repeat prescriptions towards the end of the safety net year, after they reach this threshold. Changes to reduce these fluctuations were introduced in November 1994. Discussion This report is a unique attempt by diverse groups to combine their data sources to give a more complete picture of antibiotic use in Australia than has previously been available. The comparison between seven major developed countries showed that community use of antibiotics in Australia between 1985 and 1994 was high -- second only to France, with the US a close third -- but did not increase during the 1990s, as it did in most of the other countries. In 1994, hospitals accounted for only 7% of retail sales of oral antibiotics in Australia, similar to the percentages seen in Canada and the UK. Similarly, a survey of cardiovascular drug use in Australian public hospitals found that hospital use accounted for less than 10% of the total use of all cardiovascular drug groups.8 The highest percentage of antibiotic use in the hospital sector was found in West Germany, where capping of GP prescribing budgets was introduced in 1993. It has been argued that these prescribing budgets for reimbursable drugs have increased hospital budgets.9 Australia had the highest percentage use of tetracyclines among the seven major developed countries, possibly because of its use in managing acne. In contrast, Australia had the lowest percentage use of fluoroquinolones, most likely because of PBS prescribing restrictions ("authority required"). Amoxycillin remains the antibiotic most dispensed through community pharmacies in Australia, but its use declined between 1990 and 1995, undoubtedly because of transfer prescribing to amoxycillin-clavulanate or other antibiotics. Concerns over an increased risk of severe adverse reactions with trimethoprim-sulfamethoxazole in the elderly10 and of hepatotoxicity with flucloxacillin11 were probably respon sible for the marked fall in use of these drugs and the rise in use of cephalexin, a substitute for flucloxacillin in skin and soft-tissue infections pending the availability of dicloxacillin (PBS listed in 1997).12 The winter increase in dispensing of oral antibiotics in Australia contrasted with the "safety net" fluctuations of the oral β-blockers, which are used on an ongoing basis, and probably reflected treatment of respiratory tract infections. In fact, antibiotics were prescribed for 57%-73% of new cases of URTI. This contrasts with peer consensus recommendations on the use of antimicrobial drugs in medical practice. The Antibiotic guidelines13 state that for URTI "the cause is almost invariably viral" and "antibiotics are not indicated". Furthermore, TREND data show that rural GPs are more likely to prescribe antibiotics for URTI than urban GPs. The difference may reflect rural GPs' concern for the greater patient travel and inconvenience in visiting the doctor in the country, with prescriptions being supplied for use if symptoms fail to resolve after a period of time. However, it may also reflect differences in access to continuing education and in industry promotion between rural and urban GPs. The data also provide insight into GPs' perceptions of antibiotic resistance among bacteria. For sinusitis, the most prescribed antibiotics were doxycycline, amoxycillin-clavulanate and cefaclor, which are recommended if resistance to amoxycillin issuspected or proven.13 For bronchitis, amoxycillin was most prescribed, followed closely by roxithro mycin and cefaclor, which are recommended if a b -lactamase producing organism is isolated or if the clinical response is slow. Our results indicate a strong perception among doctors that resistant organisms are a significant clinical problem, at least for sinusitis and bronchitis. Reasons for this are unclear and deserve investigation; they may include previous clinical experience of slow resolution of these infections with standard therapy, or awareness of the prevalence of resistant bacteria in the local community. A corollary to the study of antibiotic use is an examination of the patterns of antibiotic resistance in bacteria, which may be associated with levels of use of particular antibiotics and with total use. This issue is currently being explored in Australia by the Australian Group on Antimicrobial Resistance and by the National Antimicrobial Resistance Surveillance Program and internationally by the Alexander Project. Acknowledgement Members of the Antibiotic Working Group, which helped prepare these data were: Drug Utilization Sub-Committee: Julie Lindner, Peter McManus, John Marley, Andrew Parkes and John Primrose. Australian Pharmaceutical Manufacturers Association and pharmaceutical industry: Lee Ausburn, Roger Fraser, Steven Fairall, Mendel Grobler, Leigh Hammond, Peter Kofler and Jenny Winter. Royal Australian College of General Practitioners Therapeutics Resource and Educational Network for Doctors (TREND): Andrea Mant and Sue Whicker. The TREND project was funded by a grant from the Pharmaceutical Education Program of the Department of Health and Family Services. References Birkett DJ, Mitchell AS, Godeck A, et al. Profiles of antibacterial drug use in Australia and trends from 1987 to 1989. A report from the Drug Utilization Subcommittee of the Pharmaceutical Benefits Advisory Committee. Med J Aust 1991; 155: 410-415. Edmonds DJ, Dumbrell DM, Primrose JG, et al. Development of an Australian drug utilisation database. A report from the Drug Utilization Subcommittee of the Pharmaceutical Benefits Advisory Committee. PharmacoEconomics 1993; 3: 427-432. Nordic Council on Medicines. Nordic Statistics on Medicines 1990-1992. NLN publication number 34. Uppsala, Sweden: NLN, 1993. Hurley SF, McNeil JJ, Berbatis CG. Sources of Australian pharmacoepidemiology data. Community Health Studies 1988; 12: 82-96. Australian Bureau of Statistics. Index of relative socioeconomic disadvantage. Canberra: ABS, 1993. (Catalogue no 1356.0.) Australian Institute of Health and Welfare. Medical labour force 1992-93. National Health Labour Force Bulletin No. 3. Canberra: Australian Institute of Health and Welfare, Jul 1995. McManus P. Drug utilisation [letter]. Med J Aust 1993; 158: 724. Doecke C, Harvey R, Havas L. Cardiovascular drug use in Australian hospitals 1990. Summary report of a survey conducted by the Society of Hospital Pharmacists of Australia and the Australian Institute of Health for the Commonwealth Department of Community Services and Health. Canberra: the Department, Oct 1991. German drug caps boost hospital costs SCRIP 1993; 1877: 4. Adverse Drug Reactions Advisory Committee. Trimethoprim-sulphamethoxazole warning on elderly. Aust Adverse Drug React Bull 1990 Fed. Fairley CK, McNeil JJ, Desmond P, et al. Risk factors for development of flucloxacillin associated jaundice. BMJ 1993; 306: 233-235. Turnidge J. What to use instead of flucloxacillin [editorial]. Aust Prescriber 1995; 18: 54-55. Victorian Medical Postgraduate Foundation. Antibiotic guidelines 1996/97. 9th edition. Melbourne: The Foundation, 1996. (Received 19 Dec 1996, accepted 29 Apr 1997) Authors' details Department of Health and Family Services, Canberra, ACT. Peter McManus, BPharm, MMedSc, Secretariat, Drug Utilization Sub-Committee; John G Primrose, FRACR, Medical Advisor, Health Benefits Division. SmithKline Beecham (Aust), Melbourne, VIC. M Leigh Hammond, FRCPA, Medical Director. Therapeutics Unit, Royal Australian College of General Practitioners, Sydney, NSW. Susan D Whicker, PhD, Scientific Director. Drug and Alcohol Program, Eastern Sydney Area Health Service, Sydney, NSW. Andrea Mant, MD, FRACGP, Clinical Director. GPS Business Unit, Eli Lilly, Sydney, NSW. Steven R Fairall, BScAg, Associate Director. Reprints will not be available from the authors. Correspondence: Mr P McManus, Drug Utilization Sub-Committee, Department of Health and Family Services, GPO Box 9848, Canberra, ACT 2601. E-mail: peter.mcmanus @ health.gov.au Make a comment - - To top of article - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

Peter McManus · John G Primrose · Andrea Mant · Steven R Fairall

Australian trends in opioid prescribing for chronic non-cancer pain, 1986-1996 James R Bell 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/>". Abstract - Introduction - Methods - Results - Discussion - Acknowledgements - References - Authors' details - ©MJA1997 Abstract Objective: To identify trends in the use of opioid drugs for chronic non-cancer pain. Design: Review of three sets of official records -- the record of Schedule 8 (S8) opioid drugs used in Australia, 1984-1995, from the national Department of Health, Housing and Community Services; New South Wales Department of Health statistical summaries of the number of authorities to prescribe S8 drugs for cancer pain and non-cancer pain for each June from 1990 to 1996; and NSW Department of Health patient records for a cohort of patients first prescribed S8 drugs in 1991. Main outcome measures: Total quantities of opioids used in Australia; numbers of S8 authorities issued in NSW. Outcome measures for the cohort study were the proportion of patients remaining on opioids long-term, the proportion for whom dose escalated over time, and the diagnoses for which opioids were being prescribed. Results: Between 1986 and 1995, the amount of oral morphine used in Australia rose from 117 to 578 kg. Use of all other oral S8 opioids combined increased from 93 to 149 kg. In NSW, the number of authorities to prescribe for non-cancer pain rose from 3326 in June 1990 to 5743 in June 1996 (73% increase), while cancer pain authorities rose from 2652 to 4831 (82% increase). Sixty-nine of the 102 patients ceased to receive drugs on authority over the five year follow-up. These subjects received opioids for a mean of 19 months. Among the remaining 33 subjects, dose escalation was common. Diagnostic information indicated that many patients had significant psychological and social problems. Conclusions: There has been a dramatic increase in opioid prescribing, a substantial proportion of which is for non-cancer pain. In a sample of patients being treated for non-cancer pain, long term use and dose escalation occurred in one third of cases. MJA 1997; 167: 26-29 Introduction There is evidence that the use of opioids is increasing worldwide,1 and the increasing use of slow release morphine in Queensland has recently been reported.2 In recent years there has been a cautious reappraisal of the role of opioids in chronic non-cancer pain.3,4 A recent survey of members of the Australian Pain Society found that 85% of respondents felt that opioid drugs could be used in patients with chronic pain.5 However, it is well recognised that benefits of opioid use in terms of improved pain control and sense of well-being need to be weighed against the risk of an increase in drug dependence. The aims of this study were to describe trends in opioid prescribing for chronic non-cancer pain, to investigate whether a person who begins taking oral opioids regularly will continue to do so in the long-term, and to assess the extent to which opioid treatment is associated with dose escalation over time. Methods Three data sources were used: Records from the Commonwealth Department of Health, Housing and Community Services. This organisation maintains records of drugs consumed in each State, and officers of the department provided data on national and State consumption of Schedule 8 (S8) opioid drugs for the years 1984-1995. Figures on oral opioid consumption obtained from the Commonwealth give a State by State breakdown on all morphine preparations except morphine mixtures. For the years 1986-1988 use of these morphine mixtures in each State was documented State by State, and NSW accounted for 50%-66% of national consumption; after 1988 only figures for national consumption are available. For the purposes of this study, NSW consumption of morphine mixtures after 1988 was estimated to be 55% of national consumption. By 1995 morphine mixtures accounted for less than 20% of total oral morphine consumption, so inaccuracy in this estimate is unlikely to alter greatly the overall trend in oral morphine use. Monthly summaries of authorities to prescribe S8 drugs from the Pharmaceutical Services Branch (PSB) of the NSW Department of Health. It is a legal requirement in all Australian States that regular prescribing of S8 drugs to any individual patient beyond a certain minimum period requires an authority. The issued authorities specify whether opioids are prescribed for cancer pain or non-cancer pain, and trends in the issuing of authorities provide an indication of whether there has been an increase in prescribing for non-cancer pain. In NSW, the PSB issues these authorities, and since 1990 the department has prepared a monthly summary of all current authorities. Summaries for the month of June each year were used to estimate trends in the point prevalence of authorities to prescribe opioid drugs from 1990 to 1996. Individual patient files held by the PSB. Applications for an authority to prescribe S8 drugs are reviewed by a medical committee, and new applications are usually approved if supported by someone with specialist medical qualifications. Most authorities are issued for 6 or 12 months, at which time a repeat application must be lodged, usually accompanied by a clinical report on the patient's progress. Thus, there is a record of reports and letters which have been submitted supporting applications to prescribe S8 drugs. From these records a cohort of patients was identified for whom a new authority (i.e., not a continuation of a previous authority) was issued in February and March, 1991, to prescribe an opioid drug in non-cancer pain. Records for this cohort were followed up for five years. Files were studied to ascertain in each case whether the patient continued taking S8 drugs for the full five years, whether their daily dose of opioid escalated over time, and to identify their diagnoses and comorbidities. The study was approved by the ethics committee of the South Eastern Sydney Area Health Service. The collection of data from NSW Department of Health files was performed by two medical students. No information identifying patients or prescribing doctors was available to any clinician who could have been involved in the patient's care. Results Opioid consumption The national consumption of opioids for 1986-1995 is displayed in the Figure. This illustrates a dramatic increase in the use of oral morphine, a similar rate of increase in the use of methadone syrup (employed in the treatment of addiction), and a small increase in other S8 opioids (primarily oxycodone and codeine). During the same period, use of injectable opioids also rose, from 4.1 to 7.1 million ampoules per year. The Figure (below) suggests that the advent of slow release morphine in 1990 in Australia has had a marked effect on prescribing patterns, as the rate of increase in morphine prescribing accelerated from that point. However, although some individual opioid drugs have declined in use, the increase in oral morphine has not been accompanied by a decline in the use of other opioid drugs. Figure: Australian consumption of opioids, 1986-1995. Figures for NSW parallel the Australian rise. Between the years 1990 and 1995, total oral morphine use in NSW rose from 87 to 209 kg per year (a 140% increase). In the same interval, the consumption of other S8 drugs rose from 42 to 46 kg per year (10% increase). Injectable S8 drugs rose from 1.2 to 1.3 million ampoules (8% increase). Authorities The number of S8 authorities current each June in NSW rose between 1990 and 1996. In those years, the number of authorities to prescribe for non-malignant pain rose from 3326 to 5743 (73% increase), while cancer pain authorities rose from 2652 to 4831 (82% increase). Follow-up of authority applications There were 102 patients for whom new authorities to prescribe an S8 opioid for non-malignant pain were sought in February and March, 1991: 54 women (mean age, 57; range, 28-91) and 48 men (mean age, 51; range, 23-77) (see Box). Although these were new applications, 30 subjects were already receiving other S8 opioid drugs on authority. The clinical impression is that dose escalation may be more likely in patients taking the potent, short-acting drug dextromoramide, and less likely in those taking low potency codeine or long-acting methadone. Despite the small numbers (see Box), the difference in the proportion of patients taking these different drug types whose opioid dose escalated approached significance (P = 0.053). Thirty-three patients (32.4%; 95% CI, 23.4%-42.3%) were still receiving S8 opioids five years later (although many were receiving a different S8 opioid in 1996). Twenty-six of the 102 patients (25.5%; 95% CI, 17.4%-35.1%) received escalating doses of opioids: 21 of the 33 patients who were still receiving opioids on authority in 1996, and five of the 69 people not receiving opioids on authority in 1996 (chi-squared = 44.69; 1df; P < 0.005). Patients receiving opioids for the full five years were more likely to escalate their dose (odds ratio, 22.4; 95% CI, 7.1-71.0). It is unlikely that escalation was simply a function of patients beginning with a low initial dose of opioid. Converting initial doses to equivalents of oral morphine, the group whose doses did not escalate began with a mean dose of 80 mg of oral morphine per day, while the group whose doses did escalate began with a mean dose of 87 mg per day. The PSB records documented that 14 patients from this cohort died between 1991 and 1996 (7 men, 7 women; mean age, 70; age range, 42-91). Most were elderly, with serious underlying disease. It seems that in many of these patients, prescribing opioids was part of terminal care. Excluding subjects known to have died, 33 of the remaining 88 subjects (38%) were still receiving opioid drugs on authority five years later. The 55 no longer receiving opioids on authority had received opioids for a mean of 19 months. Clinical data from authority applications In 63 applications the primary diagnosis was musculoskeletal pain, specifically back pain in 48 of these. In five cases the diagnosis was simply "chronic pain". Several patients had multiple, unrelated diagnoses -- such as "chronic back pain and gunshot wound", "backache and migraine", or "myalgic encephalomyelitis and migraine". In 27 cases seemingly unrelated diagnoses were recorded. The presence of multiple sources of severe pain probably reflects the prevalence in this population of somatoform disorders (i.e., disorders in which physical complaints are not fully explained by known medical conditions, or in which complaints or impairment are in excess of what would be expected from the patient's medical condition). The comments in the patients' files suggest that in many cases prescribing opioids is a response to difficult and unmanageable problems. There is more than a hint of frustration in many of the comments -- such as the terse letter: The situation is unchanged. His back feels "like a bag of broken china". I am still at a loss to know what to do and I have arranged to see him again in six weeks with further x-ray. Or a general practitioner's bleak summation: This patient has been so adversely affected by her CFS [chronic fatigue syndrome] and migraine she has been rendered completely dysfunctional as a human being and mother. While many of the patients in this study had multiple medical problems and histories of extensive treatment, often there were strong intimations of concurrent psychological and adjustment difficulties. For example, one patient had a history of multiple back operations, with a background of social problems described as "marriage collapsing, alcoholic father living with them, and a history of overdoses on tricyclic antidepressants and on benzodiazepines". While some of the patients had clearly defined diseases, and several were seriously ill, in 62 cases (61%) there were poorly defined medical problems. In 22 cases there was no clinical information other than a diagnosis. Among the other 80 files, the presence of social and emotional problems was noted in 29 cases (36%). The quality and thoroughness of medical information documented in the health department files was very limited. Discussion There has been a dramatic increase in the prescribing of oral morphine over the past decade. To put this rise in perspective, it is useful to compare the increase in prescribed morphine with the increase as a result of government policy in prescribed methadone syrup. Between 1986 and 1995 there was a marked expansion of the methadone program for the treatment of addiction, with the number of patients in treatment Australia-wide rising from around 1000 in 1984 to 13 000 in 1995. However, the increase in morphine consumption, driven by changes in clinical practice rather than policy, has been comparable to the increase in consumption of methadone syrup. Total use of other S8 opioids also increased during this period, suggesting that morphine consumption has not grown through replacing another opioid. The national data on overall opioid use are an accurate measure of the quantity of these drugs being prescribed each year. However, there are limitations on the use of official records in determining how much of this increase was for terminal care, and how much for chronic pain. In this study, the increase in authorities current in NSW was about half as great as the increase in oral morphine use between 1990 and 1995. Given that oral morphine is seldom used in acute pain management, the disparity between authorities and total amount of drug used suggests that many patients receive morphine for prolonged periods without an authority to prescribe having been issued. There is no way of knowing how many doctors prescribe opioids long-term to individual patients without ever seeking authority. Furthermore, it is possible that there is a systematic bias, with doctors prescribing for terminal care being less likely to apply for an authority than when prescribing for chronic non-cancer pain. However, even with these reservations, it seems reasonable to conclude that the increase in authorities in both categories and the increase in overall use of morphine indicate a change in attitudes to opioids, with more liberal use in both terminal care and chronic pain. Might this more liberal approach contribute to a problem with iatrogenic drug dependence? The hallmark of opioid dependence is that it is a chronic, relapsing, long-term problem. Most of the 102 patients who began taking opioid drugs on authority in early 1991 were no longer doing so five years later. However, some of them may have continued to receive opioids without an authority. Patients who move interstate, find a new doctor who does not seek an authority to prescribe or who "doctor shop" to get prescriptions from multiple prescribers may not appear in the health department records even though they continue to receive opioids. Some may have switched to agents such as combined paracetamol-codeine, a drug containing a modest dose of opioid, but for which no authority is required. It is also possible that some patients died without this coming to the attention of the health department. However, even allowing for these possibilities, the figures suggest that fewer than half the surviving patients were still taking opioids regularly five years after first taking them. It is difficult to assess the extent of problems of tolerance and dependence from the incomplete clinical data in official records. Previous studies on selected groups being treated in specialist facilities have reported that opioids can be used safely and effectively,3,4 but these reports give little indication of the extent to which problems are likely to arise in more diverse samples of patients treated in a range of settings. Dose escalation may not be a reliable indication of dependence, but may reflect changes in pathology. However, previous reports indicate that most patients with non-cancer pain do not require escalating doses over time.6 Clinical experience with cancer pain management indicates that during the first weeks of dosing with opioids a degree of tolerance is reached, but this reaches a plateau and thereafter a stable dose can be beneficial for prolonged periods.7 The system of S8 authorities means that patients have usually been receiving opioids for a couple of months before authority application, and by then should usually be receiving a stable and effective dose. Most patients discontinued opioid use after quite prolonged periods without dose escalation. It is likely that among the 25% whose dose escalated there were many patients with problems of dependence. The comments and diagnoses in the files indicate that opioids are often prescribed for patients with social problems, high levels of emotional distress, and unclear medical diagnoses. It is likely that many of these subjects have a mixture of somatoform disorders and diverse medical and psychosocial problems. The benefits and risks of opioid use in this setting are poorly understood. A supportive doctor-patient relationship and attention to psychiatric and medical comorbidity are more important aspects of the management of somatoform disorders.8 The value of psychological treatment has been demonstrated in recent randomised trials.9 The implication for treating chronic pain states where there appear to be contributing psychological or social factors is the need for a comprehensive approach to treatment. Opioid drugs may have a useful role in such a comprehensive approach. The risks of opioid dependence, with escalating pain and drug use and diminished activity, need to be set against the potential benefits in terms of improved pain control and well being. It has been suggested that the risks of dependence can be minimised when the drugs are prescribed by experienced and skilled medical practitioners.3 It is also probable that the current system of requiring doctors to obtain authorities to prescribe opioids long term is a valuable restraint on inappropriate prescribing of these drugs. Acknowledgements Data from the NSW Department of Health files were gathered by two medical students (Amanda Mather and Sarah Baldwin). Mr John Lumby, Pharmaceutical Services Branch, NSW Department of Health, assisted with access to Branch files. Ms Cheryl Regan, Treaties and Monitoring Section, Commonwealth Department of Health and Family Services, assisted by providing summary data on opioid consumption in Australia. The federal and State departments do not necessarily endorse any of the conclusions or opinions drawn from any data. References Hiraga K, Mizuguchi T, Takeda F. The incidence of cancer pain and the improvement in pain management in Japan. Postgrad Med J 1991; 67 Suppl 2: S14-S25. Richards AH. The use of controlled-release morphine sulfate (MS Contin) in Queensland 1990-1993. Med J Aust 1995; 163: 181-182. Portenoy RK, Foley KM. Chronic use of opioid analgesics in non-malignant pain; report of 38 cases. Pain 1986; 25: 171-186. Zenz M. Morphine myths; sedation, tolerance, addiction. Postgrad Med J 1991; 266: 2392-2397. Australian Pain Society. Newsletter, July 1996. McQuay HJ. Opioids in chronic pain. Br J Anaesth 1989; 63: 213-226. Foley KM. Changing concepts of tolerance to opioids: what the cancer pain patient has taught us. In: Chapman CR, Foley KM, editors. Current and emerging issues in cancer pain; research and practice. New York: Raven Press, 1993: 331-350. Quality Assurance Project. Treatment outlines for the management of the somatoform disorders. Aust N Z J Psychiatr 1985; 19: 397-407. Guthrie E. Psychotherapy of somatization disorders. Curr Opin Psychiatr 1996; 9: 182-187. (Received 11 Oct 1996, accepted 6 Mar 1997) Authors' details Drugs and Alcohol Unit, Prince of Wales Hospital, Sydney, NSW. James R Bell, BA, FRACP, Director. No reprints will be available from the author. Correspondence: Dr J R Bell, Drugs and Alcohol Unit, Prince of Wales Hospital, High Street, Randwick, NSW 2031. E-mail: james.bell @ unsw.edu.au ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

James R Bell

The use of oral opioids in patients with chronic non-cancer pain Management strategies Paul J Graziotti and C Roger Goucke 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/>". Abstract - Introduction - Which patients? - Which doctors should prescribe? - Which drug? - Consent - How should these drugs be prescribed? - References - Authors' details - ©MJA1997 Abstract Background: The use of oral opioids in non-cancer pain is increasing, but it is not clear that this is improving outcomes for patients. These management strategies were developed as a consensus view between the two authors, who are both Directors of the Australian Pain Society. The strategies were subsequently reviewed and approved by the other Directors of the Society: four anaesthetists specialising in pain management, a pharmacist, a rheumatologist, two rehabilitation physicians and an occupational therapist. Evidence base: A Medline search of the literature since 1966 produced 163 relevant articles, including two randomised controlled trials of oral opioids in non-cancer pain. Management consensus A small group of patients with chronic non-cancer pain can benefit from the use of oral opioids. Thorough attention to diagnosis and patient history must precede any decision to prescribe opioids. Patients should be psychologically stable. Patient and doctor should agree beforehand on how to assess the outcome of therapy. Only one doctor (the patient's regular primary carer or pain specialist) should prescribe opioids and assess the response. Sustained release morphine preparations are the drug of choice. A trial of therapy, with goals and endpoint agreed between patient and doctor, should precede any decision to prescribe opioids in the long term. MJA 1997; 167: 30-34 Introduction Patients with chronic non-cancer pain present a number of challenges to their treating physicians. One such challenge is whether to use oral opioids in their treatment plan. The combination of poorly defined pathology, significant psychosocial factors, manipulative behaviour, dependence, tolerance and government regulations are formidable influences on management decisions. Because of these concerns, many doctors may decide not to prescribe opioids for patients with chronic non-cancer pain, and certainly current legislation discourages it. Arguments against the use of opioids in these patients have also been published.1,2 Yet, world-wide, there is a growing body of opinion that a small subgroup of patients with chronic non-cancer pain may function better and have less pain if treated with opioids, without requiring rapidly escalating doses or showing addictive behaviour. Data from recent randomised controlled trials3-5 support the finding of benefit in retrospective studies of patients treated with opioids for chronic non-cancer pain.6,7 This evidence suggests that a proportion of patients report an improvement in their level of analgesia and/or level of function.8 The prevalence of drug abuse, dependence and addiction has been estimated to be as low as 3.2%9 or as high as 18.9%,10 depending on definition. Fishbain et al. report that there is little evidence that addictive behaviours are common in the chronic pain population.11 There is evidence, however, that an increasing number of Australian patients are receiving prescribed oral opioids for both malignant and non-malignant pain.12 This may be filling a previously unmet need, but it is not clear if the increased prescribing for non-cancer pain is appropriate, whether there has been any increase in function, reduction of pain, reduction in suffering, or if any of these drugs will enter the illicit market. How then can we ensure the maximum benefit from the prescription of opioids for chronic non-cancer pain? Who are the appropriate patients? Who are the appropriate prescribing doctors? How should the drugs be prescribed? Which drugs should be prescribed? How and when should they be withdrawn? The aim of this article is to explore these issues and provide guidelines to assist practitioners in the appropriate use of oral opioids. Which patients? It is essential that all reasonable attempts be made to achieve a diagnosis for the cause of the pain, including nociceptive, neuropathic and psychological contributions. The demonstration of pathology commensurate with the degree of pain behaviour is desirable. However, patients often have pathology which is difficult to interpret (e.g., degenerative changes on spinal x-rays). Certain conditions result in neuropathic pain, which is usually a clinical diagnosis and may not be reflected in investigations such as radiographs or nerve conduction studies. This should not preclude a trial of opioids in these patients if otherwise appropriate. A thorough history of previous conservative therapy ( Box 1) should be taken before consideration is given to the medium to long term use of opioids. Previous drug therapy should include trials of non-opioid analgesics, tricyclic antidepressants and membrane-stabilising medications (e.g., sodium valproate, carbamazepine, mexiletine). Patients for whom opioids are being considered should be psychologically stable, although it is recognised that this is difficult to define. Patients in chronic pain may develop psychological problems as a result of the pain, and therein lies a dilemma for the physician. Will treating the pain reverse some of the psychological abnormalities? Or are the psychological abnormalities a significant contributor to the overall pain behaviour? Studies would suggest the former in most cases.13 A psychological assessment is essential for patients with poorly defined pathology, younger age, high levels of distress, or previous or ongoing substance abuse. Consideration should be given to managing these patients in a multidisciplinary pain centre ( Box 2). Which doctors should prescribe? The prescribing doctor should have an established therapeutic relationship with the patient. This excludes casualty officers, specialists who see a patient on one occasion only, after-hours locum services and (usually) junior medical staff working in outpatient departments. It is important that only one doctor prescribes the opioids and assesses the response. Patient and doctor must agree on how to assess the outcome of therapy before opioids are prescribed. Failure to reach the predetermined goals is an indication to cease prescribing. All patients who are considered suitable for the long term use of opioids in non-cancer pain should be assessed at some stage in a specialist pain management centre. Shared care between the general practitioner and the pain management centre is ideal. Which drug? Sustained release morphine preparations are the drugs of choice in patients with chronic non-cancer pain, because of their single- or twice-daily dosage and stable blood con centrations as a consequence of their more predictable pharmacokinetics. There is agreement internationally14 and within Australia15 that intramuscular opioids should not be used to treat chronic non-cancer pain. In particular, intramuscular pethidine should be avoided. It has a short half-life, possibly an increased risk of dependence due to its psychomimetic effects, and the potential for excitatory central nervous system effects from accumulated norpethidine concentrations after repeated doses. Codeine phosphate is a short-acting drug and as such has little place in chronic pain management. A controlled release preparation is available overseas and may prove useful. Immediate release morphine as morphine mixture (5-10 mg/mL) may be used for dose finding before beginning the use of sustained release morphine, but is generally unnecessary. It may be useful for breakthrough pain or exacerbations. Transdermal fentanyl patches may, in the future, provide a useful alternative for patients intolerant of morphine. Methadone and oxycodone rectal suppositories are useful alternatives to oral sustained release morphine preparations. Dietary advice should be given to minimise the problem of constipation and consideration should be given to the regular use of laxatives. Consent Patients prescribed opioids for the treatment of chronic non-cancer pain should be fully informed of the potential consequences of this therapy. There is increasing awareness that a written consent form* is a valuable tool, particularly when treating patients who for any reason are difficult to manage.16 Informed consent should include discussion of: Clearly defined specific goals of the treatment program. The likelihood of dependence and the risk of addictive behaviour. All patients will become dependent and are likely to experience withdrawal symptoms if opioid therapy is suddenly stopped. Addictive behaviour occurs in a much smaller proportion of patients and may be minimised by appropriate patient selection. The lack of published data on long term outcome of the effects of medically prescribed opioids. The potential for cognitive impairment, in particular that might affect driving ability. While there are few studies in non-cancer patients assessing cognitive function in the presence of opioids,17 the studies in cancer patients would suggest that cognitive function is actually improved when adequate analgesia is provided.18 The potentiating effect of opioids on the sedative effect of other medication. The possibility (for women) of physical dependence in children born to them if they continue to take opioids in late pregnancy. Indications for the cessation of treatment with opioids. The patient's responsibilities regarding the security of his or her medication. The consequences of aberrant behaviour ( Box 3) should be identified as clearly as possible. Side effects (e.g., constipation, nausea, sedation, dry mouth). How should these drugs be prescribed? Trial of oral opioid Before prescribing opioids on a long term basis, a trial should be undertaken over four to six weeks. Goals for the trial should be identified between doctor and patient, and the endpoint clearly stated. One doctor should institute and monitor the trial. The trial should commence with the equivalent of sustained release morphine 10-50 mg twice a day, with the outcome assessed after one week or less. Depending on response, the dose may be increased or decreased. In general, round-the-clock medication is the accepted regimen, although in patients with fluctuating pain conditions it may be more appropriate to consider a variable dosing regimen with oxycodone or morphine elixir.19 Patients must accept the responsibility of ensuring their supply of medication does not run out after hours. There is controversy regarding the expectation that patients will improve in function. Is it adequate for patients to achieve analgesia only? Is it adequate for patients to state that they feel better only? Certainly patients should reduce their use of other analgesics; ideally, they should show improved function. Perception of improved analgesia should be the minimal requirement, and failure to achieve at least partial analgesia at a moderate dose contraindicates any further long term opioid treatment. Most patients who experience minimal or no analgesic effect will stop taking the drug themselves before the end of the trial. Similarly, many patients who experience adverse side effects, such as severe nausea or constipation, will determine that these outweigh the analgesic benefits and stop taking the drug. Opioid-naive patients whose dose rapidly escalates within a month of starting treatment should generally be considered inappropriate for long term opioid therapy. At the end of the trial period, if the expected outcomes have not been achieved, the drug dose should be tapered over a few days and ceased. Ongoing reviews Patients who are then prescribed opioids on an ongoing basis should be reviewed at first fairly frequently (e.g., weekly), then monthly, by the prescribing doctor. A detailed review by a pain management centre should be undertaken annually. At each review, analgesic efficacy should be assessed, as should any improvement in the level of function. The responsible federal or State health department must be notified. Evidence of aberrant behaviour should be assessed. Aberrant behaviour is variable in its importance and relevance. Box 3 indicates factors which Portenoy20 has considered more or less predictive of the development of addictive behaviour. Patients identified with behaviour in the less predictive category indicate a need to assess the dose of drug, the psychological factors of relevance, the patient's expectations or the type of medication. If patients are identified with features in the more predictive category, the appropriateness of opioid prescription should be seriously reassessed. Often it will be necessary to reduce and then withdraw the opioid over a week. In other cases, a more regulated supply, such as daily or weekly prescriptions, may be appropriate. An initial written consent form indicating those factors for which supply will be withdrawn will make this easier. References Large RG, Schugg SA. Opioids for chronic pain of non malignant origin: caring or crippling. Health Care Anal 1995; 3: 5-11. Butler SH. Opiates for chronic pain: present American controversy. Regul Pept 1994; 52 Suppl 1: S295-S296. Jaddad AR, Carroll D, Glynn CJ, et al. Morphine responsiveness of chronic pain: double blind randomised crossover study with patient controlled analgesia. Lancet 1992; 339: 1367-1371. Arkinstall W, Sandler A, Goughnour B, et al. The efficacy of controlled release codeine in chronic non-malignant pain: a randomised placebo controlled trial. Pain 1995; 62: 169-178. Moulin DE, Iezzi A, Amireh R, et al. Randomised trial of oral morphine for chronic non-cancer pain. Lancet 1996; 347: 143-147. Portenoy RK, Foley KM. Chronic use of opioid analgesics in non-malignant pain: report of 8 cases. Pain 1986; 25: 171-186. Zenz M, Strumpf M, Tryba M. Long term oral opioid therapy in patients with chronic non-malignant pain. J Pain Symptom Manage 1992; 7: 69-77. Jamison RN. Comprehensive pretreatment and outcome assessment for chronic opioid therapy in non-cancer pain. J Pain Symptom Manage 1996; 11: 231-241. Tanb A. Opioid analgesics in the treatment of chronic intractable pain of non- neoplastic origin. In: Kitahata LM, Collins D, editors. Narcotic analgesics in anethesiology. Baltimore. Williams & Wilkins, 1982: 199-208. Tennant FS, Robinson D, Sagherian A, Seecof R. Chronic opioid treatment of intractable, non-malignant pain. NIDA Res Monagr 1988; 81: 174-180. Fishbain DA, Rosomoff HL, Rosomoff RS. Drug abuse, dependence and addiction in chronic pain patients. Clin J Pain 1992; 8: 77-85. Richards AH. The use of controlled-release morphine sulfate (MS Contin) in Queensland 1990-1993. Med J Aust 1995; 163: 181-182. Waddell G, Pilowski I, Bond MR. Clinical assessment and interpretation of abnormal illness behaviour in low back pain. Pain 1989; 39: 39-41. Hagen N, Flynne P, Hays H, McDonald N. Guidelines for managing chronic non-malignant pain. Canadian Fam Physician 1995; 41: 49-53. Cherry DA, Gourlay GK. Pharmacological management of chronic pain: A clinician's perspective. Agents Actions 1994; 42: 173-174. Burchman SL, Pagel PS. Implementation of a formal treatment agreement for outpatient management of chronic non-cancer pain with opioid analgesics. J Pain Symptom Manage 1995; 10: 556-563. Zacny JP. A review of the effects of opioids on psychomotor and cognitive function in humans. Exper Chem Psychopharm 1995; 3: 432-466. Vainio A, Ollila J, Matikainen E, at al. Driving ability in cancer patients receiving long term morphine analgesia. Lancet 1995; 346: 667-670. Savage SR. Long term opioid therapy: assessment of consequences and risks. J Pain Symptom Manage 1996; 11: 274-286. Portenoy RK. Opioid therapy for chronic nonmalignant pain: a review of the critical issues. J Pain Symptom Manage 1996; 11: 203-217. Authors' details Department of Pain Management, Sir Charles Gairdner Hospital, Perth, WA. Paul J Graziotti, FANZCA, FFARCS, Visiting Specialist; West Australian Director, Australian Pain Society. C Roger Goucke, FANZCA, Head; Secretary, Australian Pain Society. No reprints will be available from the author. Correspondence: Dr C R Goucke, Department of Pain Management, Sir Charles Gairdner Hospital, Perth, WA 6009. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Paul J Graziotti

Factors in accessibility of general practice in rural Australia John S Humphreys, Shari Mathews-Cowey and Herbert C Weinand 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/>". Abstract - Introduction - Methods - Results - Discussion - References - Authors' details - ©MJA1997 Abstract Objective: To ascertain the importance rural Australians attribute to different factors of accessibility in their decision to consult a general practitioner. Design: Survey by interview or delivery-and-collection questionnaire (participant's choice) based on the method of paired comparisons. Setting and participants: All residents of 10 small rural communities in north-west New South Wales aged over 16 years in July and August 1996. Main outcome measures: Rank order and relative importance of residents' preferences for choosing to consult a particular doctor. Results: Social accessibility or acceptability considerations were more important than geographical proximity in the choices of rural residents to consult a particular doctor. Elderly people, in particular, attributed most significance to acceptability and continuity of care. Geographical proximity ranked most highly for young and middle-aged people and men living in isolated communities. Conclusions: For rural inhabitants, geographical distance is not the sole or even the most important determinant in their choice of general practice care; rather, they will seek the services of a GP with whom they feel comfortable. Incentives programs designed to recruit and retain more GPs in rural practice must acknowledge the importance of attracting acceptable doctors. This requires that rural doctors acquire suitable clinical and communication skills to meet the diverse needs of their patients, as well as an understanding of rural culture. MJA 1997; 166: 577-580 Introduction The overwhelming importance attributed to health services, particularly medical services, by rural residents has been clearly demonstrated.1,2 Rural general practitioners, with their traditional involvement in cradle-to-grave activities, have assumed the role of healer, carer, counsellor and friend. Moreover, general practice is the first point of contact with the health care system, with 80% of Australians visiting a GP at least once each year, and 5.5 general practice attendances per capita in 1994-95.3,4 Compared with their urban counterparts, rural GPs see more patients but see them less often.5 The importance attributed to rural doctors, in particular, is influenced by two factors. Firstly, most rural dwellers (like most Australians) take health for granted. Invariably, their prime concern is with illness and sickness, so that the focus has traditionally been on the availability of curative treatment. Secondly, inaccessibility of GPs remains the greatest source of disuse and disadvantage for most rural residents. It is problems associated with lack of accessibility, combined with the shortage and mal distribution of GPs within rural Australia, that have contributed to the establishment of the General Practice Rural Incentives Program,3,6 designed to overcome the problem of lack of access to rural general practitioners and to improve their recruitment and retention in rural and remote areas. The importance of good access to health care services is not in dispute. However, we need a better understanding of specific criteria for measuring accessibility. Penchansky and Thomas identified five distinct factors underpinning access to a doctor.7 These were: availability (the existence of services in relation to patients' needs); accessibility (measured in terms of distance, time, cost and availability of transport); accommodation (how the service is organised to accept patients, measured in ways such as waiting time); affordability (in terms of economic access to the service); and acceptability (in terms of patients' attitudes towards a particular doctor). The issue of accessibility in relation to the decisions of rural people to consult a doctor has not been thoroughly investigated in Australia. As a result, ac cessibility is simply equated with geographical proximity. However, consumer perceptions of accessibility to health services are important considerations for policies designed to increase the availability and location of doctors in sparsely populated rural and remote areas. Here, we report some findings from a major study investigating ways of facilitating the provision of health care services to people in small rural and remote communities.8 In particular, we sought to identify the importance that consumers attribute to different factors of accessibility in their decision to consult a doctor. Methods The study area comprised ten small rural and remote communities located around Moree and Narrabri in the Barwon region of north-west New South Wales (see Box 1). The communities were Bellata, Boomi, Burren Junction, Croppa Creek, Garah, Gravesend, North Star, Pallamallawa, Warialda Rail, and Yetman. These communities, with populations of 50-300 residents, have neither a resident nor visiting doctor. To obtain medical services, residents must travel to larger regional centres (such as Moree and Narrabri in New South Wales or Goondiwindi in Queensland) or smaller intervening centres (like Warialda and Wee Waa in New South Wales). During July and August 1996, residents aged over 16 years from all occupied dwellings in these communities were invited to participate in a survey, either by interview or delivery-and-collection questionnaire. This choice was offered to maximise the response rate and to avoid inconvenience to participants. We asked respondents to consider the following five factors relating to social, geographical and economic factors of accessibility that were relevant to their decision to consult a doctor: A doctor who bulk bills; A doctor you can call any time; A doctor who is close or easy to get to; A doctor you feel comfortable with; and Being able to see the same doctor each visit. We chose these five factors on the basis of the importance attributed to them in the rural health literature,7,9 their ability to indicate the relative importance of geographical, social and economic factors of accessibility, and the constraints imposed by the paired comparison technique.10 We used paired comparisons to elicit respondents' attitudes relating to their decision to consult a doctor. The method involves presenting participants with pairs of stimuli, with instructions to choose one member of each pair on the basis of some criterion.10-12 Each factor is paired with every other factor in all possible combinations. The number of alternatives must be constrained as too many can result in fatigue for both respondents and researcher. The paired comparison method gives not only a rank order for the stimuli, but also an estimate of the interval separating the importance attributed to each, enabling a good deal of information to be obtained from a limited amount of material. The scale values for each of the factors reflect the characteristics of the data, and hence the origin is arbitrary. However, for purposes of comparison, the scaling is transformed to a base of zero. Thus, in this study, respondents were asked to choose, for each possible combination of our five factors, which of the two was more important in their decision to consult a doctor. To reduce bias, the pairs of alternatives were arranged so that each alternative appeared equally on the right and left (to control for space error), was alternated from right to left, and did not appear in consecutive pairs (instead, being spaced as far apart as conditions would permit).13,14 To ascertain any differences in the pattern of preferences, the data were broken down by age groups and the degree of isolation of the community. Consistent with previous research, the age groups used were: young (less than 35 years); middle age (35-54 years); and old age (55 years and over).1 A community's isolation was determined by the distance to the nearest doctor and the conditions of the roads. Isolated communities were designated as those located at least half an hour's drive from the nearest doctor (ranging between 55 and 100 kilometers), and whose residents were required to negotiate unsealed or minor roads regularly closed after rainfall. Results It was not possible to ascertain exactly from census data the total eligible population for this survey because of Australian Bureau of Statistics' confidentiality and anonymity regulations associated with small populations. However, of an estimated potential population of 455 people, 14% (63) refused to participate, 2% (8) were too sick to complete the interview, and a further 5% (25) failed to return the questionnaire. Overall, a total of 359 questionnaires were completed (response rate, 79%). Of these, 27 were eliminated from statistical analysis because of missing data, leaving 332 questionnaires. Box 2 shows the sex, age and degree of residential isolation of the participants, and the results of the paired comparison analysis together with the co- efficient of agreement (a measure of variation in responses) in each case.10 In all cases the coefficient of agreement was significant at the 99% confidence level, indicating that, within groups, the respondents showed significant agreement in the factors they considered most important in the decision to consult a doctor. The most important factor in deciding to consult a doctor was having a doctor with whom participants felt comfortable. Being able to see the same doctor generally ranked a close second. For people over 55 years, being able to see the same doctor was most important, especially for those whose place of residence was isolated. Being able to call a doctor at any time was the third most important factor, ahead of geographical proximity. This factor was very important for young and middle-aged people and for men living in more isolated communities (see Box 2). Geographical proximity to the doctor was consistently rated more highly for people living in isolated communities, and was the most important consideration for men from isolated communities. The significance of bulk billing (an indicator of economic access) did not rate highly among the five factors for any population subgroup. The importance attributed to the factors influencing participants' decisions to consult a doctor varied across age groups. For example, while geographical proximity to the doctor decreased in importance with increasing age, the significance of acceptability and continuity of care increased. Discussion It is important to recognise that the concept of accessibility comprises closely related factors that can influence both health care behaviour and use of general practice services. Geographical proximity is undoubtedly an important issue, more so at times when acute and emergency care are needed than in relation to more discretionary health care. It is interesting to note our finding that men from isolated communities rank geographical access to doctors as the most important consideration. This is consistent with recent studies that suggest rural men generally neglect their health, often choosing only to consult a doctor for acute medical care and invariably visiting the closest doctor to minimise work disruption.15 However, our findings show that, overall, rural residents consider social accessibility (or acceptability) and continuity of care to be more important than geographical proximity in both their decision to consult and their choice of a doctor. Rural Australians are prepared to travel further than necessary, often bypassing the closest GP, to consult a doctor with whom they feel more comfortable.16 This finding is also consistent with results of earlier research which showed that less than one-third of patients indicated proximity as the main reason for choosing their usual doctor.17 These results are particularly significant in regard to the rural elderly population. While it is commonly believed that elderly people are most disadvantaged by geographical distance (and hence that this factor might be the one they identify as most important), our results confirm findings from other studies showing that continuity of care and acceptability, rather than geographical proximity, are the more important aspects in explaining where rural elderly people seek medical care.7,18 The importance of acceptability and continuity of care over geographical accessibility has significant implications for recruitment and retention schemes, such as the General Practice Rural Incentives Program, as well as for rural general practice training programs generally. Our findings support the recommendations made at the 1994 Undergraduate Rural Curriculum Conference, which highlighted the importance of social factors, community issues and communication skills in developing a curriculum for rural general practice.19 It follows that a critical component of the evaluation of the effectiveness of the Rural Incentives Program should be the extent to which the program is attracting doctors who understand rural culture, the background and health needs of rural patients, and who appreciate and develop the personal skills and attitudes necessary to practise medicine effectively in rural communities. While acceptability is unquestionably an important factor in the decision to consult a doctor, exactly what determines acceptability requires further research. Results from a hospital-based consumer satisfaction survey undertaken in 1993-94 indicated information and communication, concern, respect and personalised attention, attention to the patient's condition, and skill were the most important variables affecting patients' satisfaction with doctors.20 One of the few Australian rural case studies into patients' attitudes to general practice services found that the most important qualities sought in a doctor were compassion and an ability to communicate.21 The authors of this study acknowledged that these priorities were not reflected in undergraduate medical education at the time. However, more focused and comprehensive research is required to identify the particular attributes patients value most highly from rural general practitioners. People use and choose health and medical services on the basis of not only their need for them, but also their perceptions of them and the value they place on them. A knowledge of the importance people attribute to the various factors associated with access to health services will assist policymakers in planning how best to allocate scarce resources, and the form those resources should take if they are to result in improved health outcomes in the community. References Humphreys JS, Weinand HC. Health care preferences in a country town. Med J Aust 1991; 154: 733-737. Humphreys JS, Weinand HC. Evaluating consumer preferences for health care services in rural Australia. Aust Geog 1991; 22: 44-56. Commonwealth Department of Health and Family Services. General practice in Australia 1996. Canberra: General Practice Branch of the Department, 1996. Australian Medical Workforce Advisory Committee. Australian medical workforce benchmarks. North Sydney: Australian Institute of Health and Welfare, 1996. Australian Medical Workforce Advisory Committee. The medical workforce in rural and remote Australia. North Sydney: Australian Institute of Health and Welfare, 1996. (AMWAC Report No. 1996.8.) Holub L, Williams B. The General Practice Rural Incentives Program, development and implementation: progress to date. Aust J Rural Health 1996; 4: 117-127. Penchansky R, Thomas JW. The concept of access: definition and relationship to consumer satisfaction. Med Care 1981; 19: 127-140. Humphreys JS, Mathews-Cowey S, Rolley F. Health service frameworks for small rural and remote communities -- issues and options. Armidale: University of New England, 1996. Buetow SA. What do general practitioners and their patients want from general practice and are they receiving it? A framework. Soc Sci Med 1995; 40: 213-221. Edwards A. Techniques of attitude scale construction. New York: Appleton Century Crofts Inc., 1957. Guildford JP. Psychometric methods. New York: McGraw-Hill, 1954. Kerlinger FN. Foundations of behavioral research. London: Holt Rinehart and Winston, 1970. Ross RF. Optimum orders for the presentation of pairs in the method of paired comparisons. J Educ Psychol 1934; 25: 375-382. Ross RF. Optimal orders in the method of paired comparisons. J Exp Psychol 1939; 25: 414-424. O'Hehir B. Men's health -- uncovering the mystery. Mt Gambier: SE Kingston Leader, 1995. Humphreys JS, Weinand HW. Health status and health care in rural Australia: a case study. Community Health Stud 1989; 13: 258-275. Humphreys JS, Rolley F. Health care behaviour and service provision in rural Australia. Armidale: University of New England, 1993. Williams SJ, Calnan M. Key determinants of consumer satisfaction with general practice. Fam Pract 1991; 8: 237-242. Commonwealth Department of Human Services and Health. Undergraduate Rural Curriculum Conference Report. Canberra: AGPS, 1995. Draper M, Hill S. The role of patient satisfaction surveys in a national approach to hospital quality management. Canberra: AGPS, 1995. Cymbalist Y, Wolff A. Patient attitudes to general practice services . Aust Fam Physician 1988; 17: 789-794 . (Received 14 Nov 1996, accepted 4 Apr 1997) Authors' details Department of Geography and Planning, University of New England, Armidale, NSW. John S Humphreys, PhD, Associate Professor; Shari Mathews-Cowey, BA(Hons), Junior Research Fellow; Herbert C Weinand, MS, Senior Lecturer. No reprints will be available from the author. Correspondence: Professor J S Humphreys, School of Health and Human Sciences, La Trobe University Bendigo, PO Box 199, Bendigo, VIC 3522. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

John S Humphreys · Shari Mathews-Cowey · Herbert C Weinand

New guidelines for management and prevention of meningococcal disease in Australia Mahomed S Patel, Peter J Collignon, Charles R Watson, Robert J Condon, Richard R Doherty, Angela Merianos and Gregory J Stewart (on behalf of the Meningococcal Disease Working Party of the National Health and Medical Research Council) The incidence of invasive meningococcal disease in Australia has increased over the past decade, and in April 1997 the National Health and Medical Research Council published guidelines for management of patients with meningococcal disease and their contacts. These guidelines emphasise the need for immediate intravenous antibiotic treatment of patients with suspected meningococcal disease, before transfer to hospital or lumbar puncture. When possible, blood for culture should be collected before antibiotic therapy, if this does not delay treatment. (MJA 1997: 166: 598-601) 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/>". Introduction - Epidemiology - Vaccines - Patient management - Management of contacts - Identification and management of an outbreak - Acknowledgements - References - Authors' details - ©MJA1997 Introduction The epidemiology of meningococcal disease in the industrialised world is changing, with increases in the incidence of both sporadic disease and outbreaks. These increases have been associated with the spread of virulent clones of meningococci belonging to serogroups B and C,1-6 leading to the suggestion that meningococcal disease should be regarded as an "emerging" infectious disease.4,5 Meningococcal disease affects mainly children under five years of age and adolescents, and can cause death in previously healthy children within several hours of onset. Guidelines for the management of patients with meningococcal disease and their contacts have been developed by the Meningococcal Disease Working Party of the National Health and Medical Research Council (NHMRC). Draft guidelines were distributed for comment in 1995, and the final version was published in April 1997.7 In this article, we summarise the guidelines document with the aim of providing succinct guidance for management of patients and their contacts and for identifying and managing outbreaks (see Box 1). Epidemiology In Australia, incidence of disease caused by meningo- coccus (Neisseria meningitidis) has increased over the past decade.6,8-10 With the decline of invasive disease caused by Haemophilus influenzae type b (Hib) since the introduction of the conjugate Hib vaccine in 1993, meningococcus has become the major cause of childhood meningitis in Australia. The incidence of meningococcal disease varies seasonally, rising in June and peaking in October each year.10 Most cases in the past decade were sporadic, but clusters and outbreaks were also reported.11-16 There are 13 serogroups of N. meningitidis, but serogroups A, B and C account for over 90% of invasive isolates, with serogroup B causing most disease. However, the incidence of disease caused by serogroup C has increased over the past decade. In 1995, 66% of isolates submitted to Australian reference laboratories were serogroup B and 28% were serogroup C.17 Serogroup A is often associated with epidemic disease and was responsible for a prolonged outbreak in Aboriginal communities in central Australia.11 Vaccines No one vaccine is effective against all strains of N. meningitidis. The quadrivalent polysaccharide vaccine against serogroups A, C, Y and W135 is effective in older children and adults, but less so in younger children, particularly those aged under two years.18 A conjugate vaccine against serogroups A and C was highly immunogenic in young infants in Gambia19 and is the subject of further immunogenicity studies in the United Kingdom and the United States. There are plans to start phase III, or clinical, trials, and the United Kingdom has signalled its intention to incorporate this vaccine into the routine childhood vaccination program.20 In contrast, an effective vaccine against serogroup B is not yet widely available, but trials of candidate vaccines against the outer membrane protein of some strains have shown efficacy of 50%-80%.21 In Australia, meningococcal vaccination with the combined A-C-Y-W135 vaccine is recommended for individuals with functional or anatomical asplenia, who are at increased risk of meningococcal, pneumococcal and other infections. They should receive meningococcal and pneumococcal vaccines every five years. About 600 splenectomies are performed each year in Australia; if this procedure is planned electively, the vaccines should be given two weeks before surgery. School- or community-based vaccination programs have also been used in Australia to manage clusters and outbreaks of meningococcal disease.6,11-16 Criteria for vaccination programs are described below. Patient management Effective management of an individual with meningococcal disease requires early intervention with effective antibiotics plus careful attention to associated manifestations, such as shock and coagulopathy. It therefore relies on early diagnosis. Clinical diagnosis The appearance of a petechial rash in association with fever, vomiting and drowsiness is highly suggestive of meningococcal meningitis and an indication for early empirical therapy. However, many patients may have a non-distinctive rash or no rash at all, and not all patients with invasive meningococcal disease have meningitis, many having only bacteraemia. Early recognition of meningococcal disease depends most of all on the clinical suspicion of the physician, and diagnosis can be difficult with sporadic cases unless there is high awareness of the problem in the community and among health care providers. Empirical therapy (before hospital admission) When meningococcal infection is suspected clinically, immediate empirical antibiotic therapy is indicated, before formal diagnosis, transfer to hospital or identification of an organism.22-23 This is particularly important in patients with signs of haemorrhagic disease or actual or incipient shock. However, to confirm the clinical diagnosis, blood for culture should be collected before the antibiotic is given, when this is possible without delaying treatment. The blood specimen should accompany the patient to hospital. At present, nearly all meningococcal isolates are sensitive to penicillin, but as other invasive pathogens may cause meningitis with symptoms similar to those of meningococcal meningitis (including a petechial rash), an antibiotic active against the common causes of meningitis is preferable. These include Streptococcus pneumoniae and H. influenzae type b. The immediate treatment of choice is therefore ceftriaxone, administered intravenously in one dose (see Box 2). Alternatively, intravenous cefotaxime may be used. Neither is available as an emergency ("doctor's bag") drug in Australia. Benzylpenicillin is available as a doctor's bag drug and should be used when ceftriaxone and cefotaxime are unavailable. If benzylpenicillin is not available, ampicillin or amoxycillin may be used, and when penicillin and third generation cephalosporins are contraindicated (e.g., because of hypersensitivity) chloramphenicol is also an alternative. All antibiotics should be given intravenously, unless intravenous access cannot be obtained. While an intravenous cannula is desirable, the dose can be given via a steel or "butterfly" needle. Intramuscular administration is not desirable, as supervening shock and hypotension may impair absorption of the injected antibiotics. Hospital therapy Antibiotic treatment: There should be no delay in starting or continuing treatment after hospital admission. Initial hospital therapy should be with ceftriaxone or cefotaxime, usually with benzylpenicillin.24 Therapy can then be modified depending on culture and sensitivity results. It should be continued for at least five days and, if meningitis is proven or probable, for at least five days after resolution of fever. Preventing transmission: Respiratory isolation of the patient is recommended for 24 hours after starting chemotherapy. The patient should also be given rifampicin before discharge if treatment did not include an antibiotic, such as ceftriaxone, that eradicates nasopharyngeal carriage of N. meningitidis . Diagnostic tests Therapy should not be delayed while awaiting results of diagnostic tests (such as computed tomography). Diagnosis of meningococcal disease is confirmed by isolation of N. meningitidis or detection of gram-negative diplococci or meningococcal antigen in cerebrospinal fluid, blood or another normally sterile site. Therefore, all patients with suspected meningococcal infection should have the following specimens taken and investigations after arrival at hospital: A blood sample taken as soon as possible for culture. A blood sample for neutrophil and platelet counts and, if petechiae or frank bleeding are evident, for formal coagulation studies. Gram-stained smears and culture from purpuric or other skin lesions, which may be helpful in confirming the diagnosis. Cerebrospinal fluid, collected by lumbar puncture, for microscopy and culture. Although once the mainstay of diagnosis, collection of cerebrospinal fluid may need to be deferred because of the association between meningitis and raised intracranial pressure, cerebral oedema, general or focal swelling and mass lesions, such as abscesses. For example, if there is evidence of raised intracranial pressure (e.g., clouded or impaired consciousness, papilloedema, focal neurological signs or vomiting), lumbar puncture should be deferred until therapy and supportive measures have been established and investigations such as computed tomography performed to define intracranial lesions. The patient's coagulation status should also be considered before lumbar puncture owing to the risk of haemorrhage with concomitant coagulopathy. A throat swab for culture. Its value is controversial, but in a patient who has received prior antibiotics this may be the only site from which N. meningitidis can be isolated. Other investigations, such as chest x-rays, electrolyte and acid-base studies, when clinically indicated. With the emphasis on antibiotic therapy before hospital admission, opportunities to prove a diagnosis by culture may decrease, increasing the importance of other diagnostic tests. Urinary antigen tests, while not helpful in diagnosing meningococcal disease because of low sensitivity and specificity, may be helpful if another organism is responsible, such as H. infuenzae type b and group B streptococci. Use of polymerase chain reaction to detect meningococcal DNA in cerebrospinal fluid and, more recently, in peripheral blood can increase the number of proven cases.25 However, this technique is still under development and not widely available. Serological tests of acute and convalescent blood showing a rising antibody titre may be of value in confirming the diagnosis retrospectively. Characterising Neisseria meningitidis Characterising isolates of N. meningitidis is not necessary for clinical management, but is indispensable for identifying and managing clusters and outbreaks of disease, and for following trends in the epidemiology of the disease. Therefore, every isolate of N. meningitidis should be characterised. This should be done urgently when an outbreak is suspected. Otherwise, isolates can be batched together for routine characterisation at about monthly intervals. Laboratories associated with the National Neisseria Network in each State or Territory can arrange testing for the serogroup, serotype and subtype of meningococcal isolates and for antibiotic sensitivities.16 They can also advise on availability of genetic and electrophoretic typing. Management of contacts Close contacts of patients with invasive meningococcal disease are at increased risk, including household members, dormitory contacts, staff and children in childcare facilities and those directly exposed to the patient's oral secretions (e.g., by mouth kissing, sharing food and drinks and performing mouth-to-mouth resuscitation). Health staff who provide clinical care but do not perform mouth-to-mouth resuscitation and are not involved with intubation are not at increased risk of disease, nor are classroom and casual contacts of a sporadic case. The risk of disease among close contacts can be reduced by chemoprophylaxis as soon as possible with rifampicin (10 mg/kg in children, to a maximum of 600 mg; and 600 mg in adults), twelve-hourly for two days.17 Alternative antibiotics include: ceftriaxone as a single intramuscular dose of 5 mg/kg, to a maximum of 250 mg (reduced to 125 mg in children under 15 years of age, and contraindicated in infants below six weeks of age), or ciprofloxacin 500 mg as a single oral dose (contraindicated in children under 12 years of age, people weighing less than 40 kg and pregnant women). Identification and management of an outbreak An outbreak of meningococcal disease is a public health crisis that calls for a rapid, coordinated public health response. Changes that suggest an outbreak is evolving include:6,13,16,26 Clustering of cases within an age or social group; Shift in disease from children under five years to older children and adolescents; and Phenotypic and genetic similarity among the strains causing disease. When an outbreak is caused by a vaccine-preventable strain, vaccination of people at risk should be considered. The decision will usually be complicated by the relatively small number of cases in the community and the high cost of vaccine. The decision-making process should therefore include firm confirmation of the outbreak, identification of the specific population at risk, estimation of the magnitude of risk26 and consideration of the level of community concern. The criteria for considering vaccination are: In a community setting, three or more cases of the same vaccine-preventable strain within three months in a defined population, where the attack rate exceeds 10/100 000 population. In institutions, such as schools or universities, two or more cases of the same vaccine-preventable strain occurring within a three-month period. When determining the number of cases for this purpose, secondary cases should not be included, as they represent the high risk of disease among close contacts rather than population risk.20 In Aboriginal communities, outbreaks of serogroup A and C meningococcal disease are of particular concern,11,13,15,16 and it is advisable to use vaccine earlier in such circumstances. In a remote Aboriginal community, two cases within five days has been used as an indication for a community-wide vaccination program.15 Public concern News of a child with fulminating meningococcal disease, or of outbreaks in schools, other institutions or the community, causes public anxiety and is rapidly taken up by the media. It is important to be proactive in informing the community and general practitioners about the outbreak and planned control measures, particularly if they include a vaccination campaign. The greatest challenge is to have cooperation from the media, so that they support initiatives to control the disease and do not generate unnecessary discord or controversy. Specific guidelines for informing the public and medical profession have been published elsewhere.27 In addition, the NHMRC guidelines describe a communication strategy and provide an information sheet on symptoms of the disease for lay people, sample letters for parents of children who may have been in contact with a patient, bulletins for health professionals and sample media releases.7 During outbreaks, public health units should consider setting up a telephone hotline for enquiries from the public and general practitioners. Politicians at local and State levels should also be kept informed about the course and management of an outbreak. Acknowledgements We acknowledge the excellent assistance provided by the secretariat of the Working Party in developing the guidelines, including Jenny Hargreaves, Barbara Sheppard, Evon Bowler and Leona Seib. Dr Jeff Hanna was a member of the NHMRC Working Party up to the stage it developed the draft guidelines. References Caugant DA, Froholm LO, Bovre K, et al. Intercontinental spread of a genetically distinctive complex of clones of Neisseria meningitidis causing epidemic disease. Proc Natl Acad Sci U S A 1986; 83: 4927-4931. Lystad A, Aasen S. The epidemiology of meningococcal disease in Norway 1975-91. Natl Inst Pub Health (Norway) Ann 1991; 14: 57-65. Whalen CM, Hockin JC, Ryan A, Ashton F. The changing epidemiology of invasive meningococcal disease in Canada, 1985 through 1992. Emergence of a virulent clone of Neisseria meningitidis . JAMA 1995; 273: 390-394. Jackson LA, Schuchat A, Reeves MW, Wenger JD. Serogroup C meningococcal outbreaks in the United States. An emerging threat. JAMA 1995; 273: 383-389. Serogroup B meningococcal disease--Oregon, 1994 [editorial]. MMWR Morb Mortal Wkly Rep 1995; 44: 121-124. Munro R, Kociuba K, Jelfs J, et al. Meningococcal disease in urban south western Sydney, 1990-1994. Aust N Z J Med 1996; 26: 526-532. National Health and Medical Research Council. Guidelines for the control of meningococcal disease in Australia. Canberra: AGPS, 1997. Clements DA, Gilbert GL. Increase in admissions for Neisseria meningitidis infection in Australia [letter]. Lancet 1989; 2: 1464. Levy M, Manning W, Rubin G. Bacterial meningitis makes a comeback. NSW Pub Health Bull 1991; 2: 5,9-10. Hargreaves J. Meningococcal infection -- national notifiable diseases data. Commun Dis Intell 1992; 16: 31-35. Patel MS, Merianos A, Hanna JN, et al. Epidemic meningococcal meningitis in central Australia, 1987-1991. Med J Aust 1993; 158: 336-340. Watson C, Gill J. Further cases of invasive meningococcal infection in the Katanning area of Western Australia. Commun Dis Intell 1990; 20: 12-13. Pearce M, Sheridan J, Jones D, et al. Control of group C meningococcal disease in Australian Aboriginal children by mass rifampicin chemoprophylaxis and vaccination. Lancet 1995; 346: 20-23. Chant K, Stewart G, Brown J, et al. A cluster of meningococcal cases in Campbelltown. NSW Pub Health Bull 1992; 3: 93-94. Hanna J, Alexander D. Invasive meningococcal disease in an Aboriginal community in north Queensland. Commun Dis Intell 1994; 18: 8-9. Hanna J, McCall B, Murphy D. Invasive meningococcal disease in north Queensland, 1990-1994. Commun Dis Intell 1996; 20: 320-324. National Neisseria Network. Meningococcal isolate surveillance, Australia, 1995. Commun Dis Intell 1996; 20: 422-424. National Health and Medical Research Council. The Australian immunisation procedures handbook. 5th ed. Canberra: AGPS, 1994. Twumasi PA, Kumah S, Leach A, et al. A trial of a group A plus group C meningococcal polysaccharide-protein conjugate vaccine in African infants. J Infect Dis 1995; 171: 632-638. Herbert MA, Heath PT, Mayon-White RT. Meningococcal vaccines for the United Kingdom. Commun Dis Rep CDR Rev 1995; 5: R130-R135. Poolman JT. Development of a meningococcal vaccine. Infect Agents Dis 1995; 4: 13-28. Strang JR, Pugh EJ. Meningococcal infections: reducing the case fatality rate by giving penicillin before admission to hospital. BMJ 1992; 305: 141-143. Tunkel AR, Scheld WM. Acute bacterial meningitis. Lancet 1995; 346: 1675-1680. Antibiotic Guidelines Subcommittee of the Victorian Drug Usage Advisory Committee. Antibiotic guidelines. 9th ed. Melbourne: Victoria Medical Postgraduate Foundation Inc., 1996. Kaczmarski EB, Borrow R, Gray SJ, et al. Optimising ascertainment of meningococcal infection in England and Wales. In: Zollinger W, Frasch C, Deal C, editors. Abstracts of the Tenth International Pathogenic Neisseria Conference; 1996 Sep 8-13; Baltimore: 475-476. Wenger JD, Jackson LA, Raj P, Tonelli MJ. Issues in the control of outbreaks of group C meningococcal disease in the United States. Infect Dis Clin Pract 1994; 3: 136-140. Watson C. Public communication during an outbreak of infectious disease. NSW Pub Health Bull 1993; 4: 73-74.(Received 18 Nov 1996, accepted 14 Mar 1997) Authors' details Meningococcal Disease Working Party of the National Health and Medical Research Council, Canberra, ACT. Mahomed S Patel, FRACP, FAFPHM, Fellow, National Centre for Epidemiology and Population Health, Australian National University, Canberra; Peter J Collignon, FRACP, FRCPA, FASM, Infectious Diseases Physician and Microbiologist, Canberra Clinical School, Canberra Hospital, ACT; Charles R Watson, MD, FAFPHM, Chair; and Professor of Public Health and Dean of the Faculty of Health and Behavioural Sciences, University of Wollongong, NSW; Robert J Condon, MApplEpid, FAFPHM, Senior Medical Officer, Royal Flying Doctor Service of Australia, Western Operations, Jandakot, WA; Richard R Doherty, FRACP, Professor of Paediatrics and Head of Paediatric Medicine, Department of Paediatrics, Monash Medical Centre, Melbourne, VIC; Angela Merianos, MApplEpid, FAFPHM, Head, Immunisation and Surveillance Section, Disease Control, Territory Health Services, Darwin, NT; Gregory J Stewart, FRACMA, FAFPHM, Director of Health Services, Central Sydney Area Health Services, Camperdown, NSW. No reprints will be available from the authors. Correspondence: Dr M S Patel, National Centre for Epidemiology and Population Health, Australian National University, Canberra 0200. E-mail: msp868 @ nceph.anu.edu.au ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Mahomed S Patel · Peter J Collignon · Charles R Watson · Robert J Condon · Richard R Doherty · Angela Merianos · Gregory J Stewart

Safety issues in herbal medicine: implications for the health professions Anna K Drew and Stephen P Myers The use of herbal medicines in Australia is widespread. A number of factors make assessment of adverse effects associated with these products more complex than for pharmaceuticals. Problems have resulted from contamination with heavy metals and adulteration with prescription drugs in overseas herbal products. A classification is proposed for adverse effects associated with herbal medicines, and medical practitioners are encouraged to include use of these preparations in a patient's drug history and in reports of suspected adverse drug reactions. It may be necessary to develop a separate database to promote adverse drug reaction reporting for herbal medicine and the wider field of complementary and alternative medicine. (MJA 1997; 166: 538-541) For editorial comment see Shenfield et al. Introduction - Regulation of herbal medicines in Australia - Safety of herbal medicines - Proposed classification of adverse effects of herbal medicines - Adverse drug reaction (ADR) reporting - Conclusion - References - Authors' details - ©MJA1997 Introduction The World Health Organization estimates that 65%-80% of the world's population use traditional medicine as their primary form of health care.1 The use of herbal medicine, the dominant form of medical treatment in developing countries, has been increasing in developed countries in recent years.2 Assessment of the safety and efficacy of these medicines is an important issue for the health professions. We focus here on the safety of these preparations; the issue of their efficacy is not addressed. A classification of potential adverse effects associated with these preparations is proposed, and we encourage the reporting of any adverse drug reactions (ADRs). Herbal medicine, in which plants (dried or in extract form) are used as therapeutic substances, is one of a number of practices encompassed by the term "complementary and alternative medicine" (CAM). Recent studies have highlighted the extent to which CAM is used in Australia. A 1993 survey of 3004 South Australians by MacLennan et al.3 found that, in the previous year, 48.5% had used at least one form of CAM preparation and 20.3% of all respondents had visited at least one alternative practitioner. Herbal medicine accounted for approximately 26% of CAM use in this survey. Estimates of the national cost of both CAM preparations and practitioner visits were about one billion dollars when extrapolated to the Australian population. Results for the use of CAM were similar in a survey of 325 patients attending a Sydney teaching hospital emergency department in 1994,4 and only 35.5% of users had informed their medical practitioner about any use of CAM. Of the women who had borne children, 12 (14.5%) had taken one to 18 herbal preparations during pregnancy, and eight of 34 (23.5%) patients under 16 had been given between one and eight herbal preparations. Evidence suggests that CAM preparations or therapies are used for conditions such as cancer, high blood pressure and allergies, as well as for general wellbeing.3,5,6 Regulation of herbal medicines in Australia In Australia, products for human medicinal use must be placed on the Register of Therapeutic Goods [Therapeutic Goods Act 1989 (Cwlth)] in one of two categories -- "listed" or registered. Formulations can be listed for a small fee if they contain substances regarded by the Therapeutic Goods Administration (TGA) as being of low public health concern and comply with the Therapeutic Goods Advertising Code. This restricts wording of claims to "assist" rather than "treat" and limits indications to minor self-limiting conditions. The products have to be manufactured by a TGA-licensed manufacturer following a recognised code of Good Manufacturing Practice. Labelling requirements are the same as those for registered products. Efficacy data have to be held by the manufacturer/distributor of such products and can be called on at any time by the TGA or the Australian Competition and Consumer (formerly, the Trade Practices) Commission. About 4500 plant-based products are listed; these are given an "AUST L" number, indicating their listing on the register and that they can be sold legally in Australia. Registered products, which bear an "AUST R" number, contain herbs that are either restricted by the federal Standards for the Uniform Scheduling of Drugs and Poisons, those for which efficacy claims are more substantial, or those which are specified by the TGA as being of some health concern. For registration, which is more costly, appropriate documentation outlining clinical trial work must be submitted to the Traditional Medicines Evaluation Committee (established in 1991 -- soon to be replaced by the Complementary Medicines Evaluation Committee) which advises the TGA. Fewer than five CAM products have been evaluated in this way. Although Australia has more regulatory controls than many other countries for CAM preparations, including herbals,7 most of these preparations are not exposed to the premarketing evaluation process that prescription and scheduled proprietary medicines undergo. Few CAM preparations can be patented, so they are not subject to the financial incentive that drives the pharmaceutical market. Safety of herbal medicines Although it is widely perceived that "natural" products are safe, the evidence suggests that CAM use is not without risk. Of 90 patients with rheumatoid arthritis, 82% had tried more than one form of alternative medicine or therapy, including dietary modification, and 31% of these patients had experienced at least one adverse effect.8 Of 1701 consecutive patients admitted to the Prince of Wales Hospital, Hong Kong, three (0.2%) had had adverse effects attributed to traditional Chinese medicines and 75 (4.4%) to "Western" medications.9 A review of 5563 enquiries received by the National Poisons Unit, London, showed that 77.7% involved vitamin preparations and 19.3%, herbal extracts, royal jelly, hormonal products and other natural products. Exposure was linked to adverse effects in 49 (0.9%) of these cases.10 In ascertaining whether a substance is associated with an adverse effect, the medical literature may be of limited help -- there may be no previous report of such an event, as was the case for fatal anaphylaxis which occurred in an 11-year-old child with asthma after her third exposure to royal jelly.11 Prior to this event, contact dermatitis had been documented with royal jelly (which contains proteins, carbohydrates, amino acids, vitamins, lipids and fatty acids), but the allergen had not been identified.12 At the time of the child's death, the Adverse Drug Reactions Advisory Committee (ADRAC) of the Commonwealth Department of Health and Family Services had three reports of adverse reactions to royal jelly on file: one of anaphylaxis and two of bronchospasm (Dr Ian Boyd, Adverse Drug Reactions Advisory Committee, Canberra; data, 1972-May 1993; personal communication). Raised awareness of this problem resulted in the TGA advising manufacturers to label royal jelly products to warn of their potential to cause severe allergic reactions in people who suffer from asthma or allergies.13 ADRAC have now received a total of 18 reports of allergic reactions to royal jelly, including two fatalities (Dr Ian Boyd, Adverse Drug Reactions Advisory Committee, Canberra; data, 1972-February 1997; personal communication). Proposed classification of adverse effects of herbal medicines Adverse effects of herbal medications may be intrinsic or extrinsic (Box 1). The patient's age, genetic constitution, nutritional state, concomitant diseases and concurrent medication may affect the risk and severity of adverse events, as can consumption of large amounts or a wide variety of herbal preparations, or long-term use.15,16 Intrinsic effects Intrinsic effects are those of the herb itself and are characterised, as for pharmaceuticals, as type A (predictable, dose-dependent) and type B (unpredictable, idiosyncratic) reactions.17 Yohimbine, an alkaloid found in Pausinystalia yohimbe bark that has α2 -adrenoceptor antagonist activity, is taken for male impotence, and can cause hypertension and anxiety in a predictable, dose-related manner (type A reaction); it has also been associated with the serious idiosyncratic reactions of bronchospasm and increased mucus production when taken in normal doses by a patient with severe allergic dermatitis (type B).18,19 Type A reactions with herbal preparations also include effects with deliberate overdose or accidental poisoning and interactions with pharmaceuticals. Extrinsic effects Extrinsic effects are not related to the herb itself, but to a problem in commercial manufacture or extemporaneous compounding. Potential failures to adhere to a code of Good Manufacturing Practice, while not specific to herbal medicine, can occur, particularly in developing countries where such a code is not in place. This makes it more difficult for medical practitioners and other health professionals to assess the adverse effects of herbal preparations compared with pharmaceuticals. Misidentification: It is difficult to track and identify adverse effects of herbal ingredients, as the plants can be named in four different ways -- the common English name, the transliterated name, the latinised pharmaceutical name, and the scientific name.20 It is essential that plants are referred to by their binomial Latin names for genus and species; misidentification can occur when other names are used. For example, the scientific name of the Chinese herb that is variously transliterated as "dong quai", "dong guai", "danggui" and "tang kuei" is Angelica polymorpha (formerly sinensis). The common English name "angelica" and the latinised name "Radix Angelica" could refer either to this species, which is used in Australia, or to the European species Angelica archangelica, depending on the country of origin. Misidentification can result in erroneous associations being made, with potential clinical implications. Plant material can be misidentified at the time of the manufacturer's bulk purchase or when wild plants are picked. Lack of standardisation: The therapeutic/toxic components of plants vary depending on the part of the plant used, stage of ripeness, geographic area where the plant is grown, and storage conditions. Therefore, batch-to-batch reproducibility of plant material should be assessed in the production of marketed products, but, in practice, product variation in herbal medicines can be significant. The content of ginsenoside, the glycosylated steroid to which most of the biological activity of ginseng (Panax ginseng) has been ascribed, was examined in 50 commercial brands of ginseng sold in 11 countries.21 In 44 of these products, the concentration of ginsenoside ranged from 1.9% to 9% w/w; six products contained no ginsenoside, and one of these six contained large amounts of ephedrine (for which a Swedish athlete was accused of doping). Contamination: During growth and storage, crude plant material can become contaminated by pesticide residues, microorganisms, aflatoxins, radioactive substances and heavy metals;22 lead, cadmium, mercury, arsenic and thallium have been reported as contaminants of some overseas herbal preparations.23-25 In a case series of five patients in the United Kingdom with lead poisoning from Asian traditional remedies, the preparations implicated contained 6%-60% w/w lead by weight.26 The Australian Code of Good Manufacturing Practice specifies detection of microorganisms and leaves estimation of other contaminants (not specified in internationally recognised pharmacopoeial standards) to the discretion of manufacturers.14 Substitution: A report of nine cases of rapidly progressive interstitial nephritis in young women taking a Belgian slimming treatment27 led to the discovery that Aristolochia fangchi, containing the nephrotoxic component aristolochic acid, had been introduced in place of Stephania tetrandra.20 Eighty cases have now been identified and more than half of these patients developed terminal renal failure.28,29 Adulteration: The intentional use of pharmaceutical adulterants has been reported. Cases of acute interstitial nephritis, reversible renal failure, loss of blood pressure control and peptic ulceration have been reported with a product called "Tung Shueh" pills, taken for arthritic complaints.30-32 The product contained mefenamic acid and diazepam, neither of which was included on the label. Adulterants can also be added by unethical herbalists compounding preparations for individual patients. In a recent Victorian court case, a Chinese herbalist was prosecuted for adding a steroid cream to a herbal preparation, which produced severe facial erythema in a patient. 33 Incorrect preparation/dosage: The processing of crude plant material carried out by a manufacturer, CAM practitioner or the patient is a major determinant of the pharmacological activity of the finished product. A Western Australian patient had a heart attack when he failed to follow a herbalist's instructions to boil aconite (a restricted plant in Australia) in three pints of water for one hour and take the decanted liquid; the patient increased the dose and shortened the boiling time. 34 Boiling changes the alkaloid composition, rapidly reducing the plant's toxicity, 35 and can substantially reduce microorganism contamination. 36 Another point to consider is that the activity of crude plant material may differ from that of the purified constituents, as some constituents may modify the toxicity of others. 35 Inappropriate labelling/advertising: In early 1996, a direct-mailing campaign to individuals who had purchased exercise bicycles included information on seaweed (Fucus vesiculosus) patches for weight loss. Seaweed, or kelp, contains iodine, and it was claimed that the patches would reverse hypothyroidism by releasing iodine into the body, speeding up the body's metabolism, resulting in weight loss. This claim was unproven. Hyperthyroidism has been reported in people who take kelp products orally,36 and if iodine were to be absorbed transdermally it could lead to hyperthyroidism in susceptible individuals. The TGA became aware of the product promptly and secured a promise that no further supplies would be imported, but keeping abreast of potentially unsafe products is a mammoth task. Adverse drug reaction (ADR) reporting ADR reporting is as essential for CAM products as it is for pharmaceuticals in providing postmarketing surveillance. In Australia, reporting of adverse effects of any medication, whether alternative or conventional, is usually undertaken by a medical practitioner, pharmacist or dentist, who completes and forwards a "blue card" to ADRAC. Although the person reporting need not assess the association between the medication and the adverse effect, this process enables trends to be spotted. ADRAC has received 154 reports relating to CAM in 25 years (Dr Ian Boyd, Adverse Drug Reactions Advisory Committee, Canberra; data, 1972-February 1997; personal communication). Given the widespread use of CAM, this low number of reports suggests that CAM has either a low risk of adverse effects or that such effects are significantly under-reported. Although limited evidence suggests that CAM products may be associated with a lower risk than conventional medicines, 9 under-reporting is likely, as: ADRAC does not actively encourage the reporting of adverse effects by practitioners and consumers of alternative medicine; CAM use is not routinely included in patients' drug histories or in reports of adverse effects; The public perception that "natural" products are safe biases against an association being made between CAM products and adverse effects. Conclusion The incidence of adverse effects of CAM products requires further study, and more education about CAM is needed. Medical practitioners should be encouraged to routinely ask for information about CAM use when they take a drug history and to include CAM products in ADR reports (Box 2, below). It is also important to promote an avenue for alternative practitioners and consumers to report adverse effects to CAM products, as a large proportion of alternative medicines are sold through health food outlets, supermarkets and by direct marketing (including via the Internet). Development of a separate or parallel database could fulfil this purpose. The Government response to recommendations arising from the recent TGA review accepts the need to extend the coverage of ADRAC to complementary and alternative medicines. 37,38 As there is increasing pressure to regulate CAM products to pharmaceutical industry standards of quality and safety, 7 the challenge for the Government and the CAM industry is to provide a level of postmarketing surveillance at least equivalent to that in place for pharmaceuticals. References Anonymous. Program Profile: international liaison brings global vision to OAM. Complementary and Alternative Medicine at the NIH 1996; 3: 3 . British Medical Association. Complementary medicine. New approaches to good practice. Oxford: Oxford University Press, 1993: 9-36. MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-572. Kristofferson SS, Atkin PA, Shenfield GM. Uptake of alternative medicine [letter]. Lancet 1996; 347: 972. Sawyer MG, Gannoni AF, Toogood IR, et al. The use of alternative therapies by children with cancer. Med J Aust 1994; 160: 320-322. Eisenberg DM, Ronald CK, Foster C, et al. Unconventional medicine in the United States; prevalence, costs, and patterns of use. New Engl J Med 1993; 328: 246-252. De Smet PAGM. Should herbal medicine-like products be licensed as medicines [editorial]? BMJ 1995; 310: 1023-1024. Kestin M, Miller L, Littlejohn G, Wahlqvist M. The use of unproven remedies for rheumatoid arthritis in Australia. Med J Aust 1985; 143: 516-518. Chan TYK, Chan AYW, Critchley JAJH. Hospital admissions due to adverse reactions to Chinese herbal medicines. 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Oxford: Oxford University Press, 1977: 44. Landis E, Shore E. Yohimbine-induced bronchospasm. Chest 1989; 96: 1424. De Smet PAGM, Smeets OSNM. Potential risk of health food products containing yohimbe extracts. BMJ 1994; 309: 958. But P P-H. Need the correct identification of herbs in herbal poisoning [letter]. Lancet 1993; 341: 637. Cui J, Garle M, Eneroth P, Bjorkhem I. What do commercial ginseng preparations contain? [letter] Lancet 1994; 344: 134. Bisset NG, editor. Herbal drugs and phytopharmaceuticals. Stuttgart: Medpharm Scientific Publishers, 1994. Schaumburg HH, Berger A. Alopecia and sensory polyneuropathy from thallium in a Chinese herbal medication [letter]. JAMA 1992; 268: 3430-3431. Kew C, Morris C, Aihie A, et al. Arsenic and mercury intoxication due to Indian ethnic remedies. BMJ 1993; 306: 506-507. Wu M-S, Hong J-J, Lin J-L, et al. Multiple tubular dysfunction induced by mixed Chinese herbal medicines containing cadmium. Nephrol Dial Transplant 1996; 11: 867-870. Bayly GR, Braithwaite RA, Sheehan TMT, et al. Lead poisoning from Asian traditional remedies in the West Midlands -- report of a series of five cases. Hum Exp Toxicol 1995; 14: 24-28. Vanherweghem J-L, Depierreux M, Tielemans C, et al. Rapidly progressive interstitial renal fibrosis in young women: association with slimming regimen including Chinese herbs. Lancet 1993; 341: 387-391. Vanhaelen M, Vanhaelen-Fastre R, But P, Vanherweghem J-L. Identification of aristolochic acid in Chinese herbs [letter]. Lancet 1994; 343: 174. van Ypersele de Strihou C, Vanherweghem JL. The tragic paradigm of Chinese herbs nephropathy [editorial]. Nephrol Dial Transplant 1995; 10: 157-160. Diamond JR, Pallone TL. Acute interstitial nephritis following use of tung shueh pills. Am J Kidney Dis 1994; 24: 219-221. Abt AB, Oh JY, Huntington RA, Burkhart KK. Chinese herbal medicine induced acute renal failure. Arch Intern Med 1995; 155: 211-212. Gertner E, Marshall PS, Dean Filandrinos, et al. Complications resulting from the use of Chinese herbal medications containing undeclared prescription drugs. Arthritis Rheum 1995; 38: 614-617. Adams D. Herbal tea made woman's face "stop light", court told. The Age (Melbourne ) 12 December 1995; 7. Dean A. Herbalist's patient had heart attack. The Sydney Morning Herald 21 July 1994; 4. De Smet PAGM, Tognoni G. Drugs used in non-orthodox medicine. In: Dukes MNG, editor. Meyler's side effects of drugs. 12th edition. Amsterdam: Elsevier, 1992: 1209-1232. De Smet PAGM. Toxicological outlook on the quality assurance of herbal remedies. In: De Smet PAGM, Keller K, Hansel R, editors. Adverse effects of herbal drugs, I. Heidelberg: Springer-Verlag, 1992: 1-72. Therapeutic Goods Administration. Government response to recommendations arising from the Therapeutic Goods Administration Review. Canberra: AGPS, April 1997: 37-38. KPMG Management Consulting. Review of Therapeutic Goods Administration on behalf of the Department of Health and Family Services. Canberra: AGPS, January, 1997: 126-127. (Received 11 September 1996; accepted 18 February 1997) Authors' details Hunter Drug Information Service, Department of Clinical Toxicology and Pharmacology, Newcastle Mater Misericordiae Hospital, Newcastle, NSW. Anna K Drew, BPharm(Hons), Director. School of Natural and Complementary Medicine, Southern Cross University, Lismore, NSW. Stephen P Myers, BMed, ND, Head. Medical Doctoral Student, Discipline of Clinical Pharmacology, Faculty of Medicine and Health Sciences, University of Newcastle. No reprints will be available. Correspondence: Anna Drew, Director: Hunter Drug Information Service, Locked Bag 7, Hunter Region Mail Centre, NSW 2310. E-mail: oudanATcc.newcastle.edu.au Make a comment - - To top of article - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments.

Anna K Drew · Stephen P Myers

Helping heart attack victims to save their own lives Reperfusion techniques can save both lives and heart muscle, but the key is prompt treatment MJA 1997; 166: 228 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/>". - - ©MJA1997 The outlook for a person in the early hours after the onset of a myocardial infarction remains grim. Of the 40% who will die in the first month, a third will die in the first hour and up to a half in the first day.1 While some deaths are sudden and not amenable to treatment, the outcome in many cases can be improved by appropriate modern medical treatment, such as defibrillation and coronary reperfusion strategies, if administered early enough. publicise the symptoms of a possible heart attack, emphasise the importance of reporting them, and ensure that the message is aimed at all educational levels The risk of sudden cardiac death from ventricular fibrillation can be reduced by access to and use of a defibrillator. Coronary care ambulances with skilled paramedical staff have saved many lives since their introduction to Australia in the late 1960s.2 Increasingly, strategic placement of semi-automatic defibrillators -- for example, in large passenger aircraft and football stadiums -- is being considered, to further improve out-of-hospital survival. Once the patient reaches hospital, modern reperfusion strategies such as thrombo lysis and acute angioplasty can save lives, limit myocardial damage and reduce subsequent cardiac disability.3,4 Improved understanding of myocardial infarction from angiographic and postmortem studies has reaffirmed that most cases are indeed due to coronary thrombosis. The need to achieve coronary reperfusion as early as possible has long been recognised from pathophysiological studies and clinical trial experience.3,4 Since the mid 1980s, thrombolytic therapy has been studied in over 200 000 patients,3 and a recent overview has shown very clearly that streptokinase and recombinant tissue plasminogen activator (t-PA) are effective thrombolytic agents in acute myocardial infarction. Their appropriate use in patients with suspected myocardial infarction can save 20-30 lives per 1000 patients treated over the first 35 days,3 and there is the prospect of even better outcomes with new thrombolytic agents. More recently, reperfusion with acute coronary angioplasty has been shown to be equivalent to thrombolysis in most centres and to have superior outcomes in some centres, particularly those with a high level of expertise and readily available angioplasty services.4 The use of intracoronary stents adjunctive to angioplasty may improve even further the early outcome, with a reduced risk of late restenosis. The average loss of life per hour of delay of thrombolytic therapy is 1.6 lives per 1000 patients treated.3 The myocardial infarction triage and intervention trial in Seattle demonstrated even more accurately the importance of urgent treatment in the first hour.5 For patients surviving to hospital and being treated within 70 minutes of symptom onset, the 28-day mortality rate was 1.2% and only 5% of the left ventricular mass was infarcted; those treated later than 70 minutes had a mortality rate of 8.7% and 11% of myocardium was infarcted. These benefits were demonstrated with thrombolytic regimens now known to achieve early patency and restoration of normal coronary blood flow in less than half the patients treated. With the more aggressive reperfusion strategies now available the prospects are even brighter. The first hour after the onset of coronary thrombosis is indeed the "golden hour" of opportunity for preserving heart muscle and saving lives. These developments represent a quantum shift in what can be achieved in treating coronary thrombosis. Clinical management which allowed a passive acceptance of inevitable cardiac damage and high mortality rates is now out of date. The aim now is preservation of both life and myocardium by early restoration of coronary blood flow. From a mortality rate for hospitalised patients of 30% in the 1960s to 10%-15% after the introduction of coronary care units, a 28-day death rate of below 5% should now be achievable for coronary care patients after their first myocardial infarct.6,7 Given what can be achieved with early treatment, the reluctance of patients who suffer a heart attack to present to hospital is disappointing. Previous Australian studies8,9 have shown avoidable delays in presentation of up to several hours from the onset of symptoms. In this issue of the Journal Dracup and colleagues provide further evidence of this risk-taking behaviour -- they report an unusually long median delay of 6.4 hours, even longer than the approximately two-hour delay reported by Leitch et al.8 in a Sydney-based study in 1989 and the approximately 1.2-hour delay found by Bett et al.9 in a study of 22 centres in 1988-89. The difference is probably partly due to differences in the definition of time of onset. Dracup et al. report the duration from onset of the first symptoms until hospital presentation, whereas Leitch et al. reported the time of onset of the symptom which initiated action until hospital presentation8 (which does not take into account the duration of any preceding intermittent symptoms), and Bett et al. reported the time from onset of the symptom which initiated action to when "help was first sought"9 (as opposed to hospital presentation). Thus, the latter studies would be expected to give a shorter average interval than that reported by Dracup et al. It is noteworthy that Dracup et al. conducted their study before the May 1996 Heart Foundation Heart Week campaign, which emphasised how to recognise symptoms of heart attack, with posters and television commercials depicting squeezing chest pain as a python-like grip, and the need for early action by patients suffering symptoms of a heart attack. Dracup et al. found that the patients who recognised their symptoms as cardiac in origin had only one-third the response time of those who did not. It would be interesting to see if a follow-up study showed any effect of the 1996 campaign. Although the complex human response to chest pain is more likely to be instinctive rather than knowledge-based,9 Dracup and colleagues provide further useful insight into factors that cause delay. The independent predictors of delay were educational status (slower response times in less educated patients), a desire not to cause trouble, failure to recognise symptoms as being cardiac in origin, and an intermittent pattern of symptoms. The message for future public education campaigns is clear -- publicise the symptoms of a possible heart attack, emphasise the importance of reporting them (no-one ever died of embarrassment), and ensure that the message is aimed at all educational levels. The message for health professionals is especially clear -- a third of patients reported that they learnt about heart attack symptoms from a health professional. Doctors and nurses dealing with existing heart patients or those with substantial risk factors for myocardial infarction have many opportunities to educate patients about heart attack symptoms and to give clear instructions on how -- and why -- they should summon an ambulance and get to a hospital fast. Paul E Langton Cardiology Research Fellow, Sir Charles Gairdner Hospital, Perth, WA Peter L Thompson Clinical Professor, Department of Cardiovascular Medicine, Sir Charles Gairdner Hospital, Perth, WA Tunstall-Pedoe H, Kuulasmaa K, Amouzel P, et al. Myocardial infarction and coronary deaths in the World Health Organization MONICA project. Circulation 1994; 90: 563-612. O'Rourke MF. Acute myocardial infarction: prehospital coronary care. In: Thompson PL, editor. Coronary care manual. London: Churchill-Livingstone, 1997: 429-433. Fibrinolytic Therapy Trialists Collaborative Group. Fibrinolytic therapy -- indications in suspected acute myocardial infarction. Lancet 1994; 343: 311-322. Ryan TJ, Anderson JL, Autman EM, et al. ACC/AHA Guidelines for the management of patients with acute myocardial infarction: executive summary. Circulation 1996; 94: 2341-2350. Weaver WD, Cerqueria M, Hallstrom AP, et al. for the MITI project group. Prehospital-initiated v. hospital-initiated thrombolytic therapy. The myocardial infarction triage and intervention (MITI) trial. JAMA 1993; 270: 1211-1216. DeVreede JJM, Gorgels AP, Verstraaten GMP, et al. Did prognosis after myocardial infarction change during the past 30 years? J Am Coll Cardiol 1991; 18: 698-706. Jamrozik K, Broadhurst R, Parsons RW, et al. Ten year trends in medical management and case fatality in acute myocardial infarction [abstract]. J Am Coll Cardiol 1996; 27: 278A. Leitch JW, Birbara T, Freedman B, et al. Factors influencing the time from onset of chest pain to arrival at hospital. Med J Aust 1989; 150: 6-8. Bett N, Aroney G, Thompson PL. Impact of a national education campaign to reduce patient delay in possible heart attack. Aust N Z J Med 1993; 23: 157-161. Reprints: Dr P E Langton, Sir Charles Gairdner Hospital, Verdun Street, Nedlands, WA 6009. - - To top of article - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Paul E Langton · Peter L Thompson