Issues
Volume 166 Issue 10
Editorials Alternative medicine: an expanding health industry Gillian M Shenfield, Philip A Atkin, Sean S Kristoffersen (MJA 1997; 166: 516-517)Sydney 2000: guarding against disasters Gordian W O Fulde (MJA 1997; 166: 517-518)The taxanes: miracles for breast cancer treatment or just more chemotherapy? Phillip Claringbold (MJA 1997; 166: 518-519) Research Australian multicentre phase II trial of paclitaxel in women with metastatic breast cancer and prior chemotherapy Michael Michael, James F Bishop, John A Levi, David R Bell, John R Zalcberg, Michael L Friedlander, Ian N Olver, Jennifer G Smith, Guy C Toner (MJA 1997; 166: 520-523)Relationship of peak expiratory flow rate with mortality and ischaemic heart disease in elderly Australians Leon A Simons, John McCallum, Judith Simons, Yechiel Friedlander (MJA 1997; 166: 526-529)Detection of antibodies to Bartonella henselae in clinically diagnosed cat scratch disease James P Flexman, Sharon C A Chen, David J Dickeson, John W Pearman, Gwendolyn L Gilbert (MJA 1997; 166: 532-535) Medicine and the Community Safety issues in herbal medicine: implications for the health professions Anna K Drew, Stephen P Myers (MJA 1997; 166: 538-541) Notable Cases The St Marys fragmentation grenade explosion Antony Nocera (MJA 1997; 166: 545-548) Clinical Practice Management of haematemesis and melaena Stuart K Roberts, Frank J Dudley (MJA 1997; 166: 549-553) MJA Practice Essentials - Respiratory Medicine Chest imaging: indications and interpretation Greg M Briggs (MJA 1997; 166: 555-560)
Editorials
Alternative medicine: an expanding health industry
Alternative medicine: an expanding health industry As many Australians are using alternative medicines, it is essential for doctors to ask their patients about such use MJA 1997; 166: 516-517 This article has been cited in Easthope G, et al. Acupuncture in Australian general practice: practitioner characteristics. MJA 1998; 169: 197-200. Rey JM, Walter G. Hypericum perforatum (St John's wort) in depression: pest or blessing? MJA 1998; 169: 583-586. ©MJA1997 What form of therapy is used by at least 50% of Australian patients, costs them more than $900 million a year and is increasingly being supported by health insurance funds? Is it antibiotics, prescribed at 15.1% of all general practice encounters1 and targeted by the Pharmaceutical Benefits Branch of the Department of Health and Family Services as overused? No. Is it non-steroidal anti-inflammatory drugs, which are subject to prescribing restrictions, and are taken by an estimated minimum of 630 000 Australians at any one time (Peter McManus, Secretary, Drug Utilisation Sub-Committee, 1997, personal communication)? No. The form of therapy is something not included in the medical curriculum and rarely considered by most medical practitioners -- described by various terms, it is collectively referred to as "alternative medicine". If 50% of Australians are using alternative treatments each year, it is essential that doctors recognise this fact A South Australian survey of more than 3000 people aged 15 or older found that 48.5% used at least one non-medically prescribed alternative medication annually (excluding calcium, iron and medically prescribed vitamins), and 20.3% of those in the survey had visited at least one alternative practitioner during the year.2 Extrapolated to the Australian population, the overall out-of-pocket costs were almost three times the patient contributions for all classes of pharmaceutical drugs purchased during 1992-1993.2 Our own smaller survey of the use of alternative medicine by people attending a Sydney teaching hospital emergency department revealed remarkably similar results in a predominantly white middle-class population.3 It is perhaps not surprising to learn of the high usage of alternative therapies in children4 and adults5 with cancer, or in people with chronic rheumatoid arthritis.6 However, the high usage in generally "healthy" populations cannot be attributed to desperation about an incurable disease or to reliance on traditional remedies by certain ethnic groups. Other reasons given in our study (apart from consultations for specific conditions) for consulting alternative therapists were to "feel better", "clean up the system", or other, general, reasons. In both the Sydney and the South Australian surveys, consumers of alternative medicine were more likely to be female, better educated and employed.2,3 If these statistics are of concern to the medical profession, then the profession should be even more disturbed to learn that fewer than 50 per cent of both our study population3 and parents of children with cancer4 had informed their doctors of their use of alternative therapies -- yet many were simultaneously taking prescribed medications for the same indications. The startling usage figures are for therapies for which there is, in most cases, no evidence of efficacy beyond "traditional use". Moreover, there are numerous documented problems with the safety of alternative preparations -- their content is uncontrolled, and hence very variable;7 they may be adulterated, as with the Chinese medicines for arthritis that contain corticosteroids;8 and the substances themselves may be intrinsically toxic.9 In Australia, there have been reports of acute hepatitis due to ingestion of chaparral,10 and deaths caused by anaphylactic reactions to royal jelly11 (as summarised by Drew and Myers in this issue of the Journal). The popular perception that alternative medicines are harmless may be true of many preparations, but the more extensive their use, the greater the potential for toxicity. What is being done about this situation? Should more controls be introduced? Prescribed drugs go through an extensive and exhaustive evaluation of their efficacy and safety, but this is not the case for most alternative medicines. Under the Therapeutic Goods Act 1989 (Cwlth) they can be "listed" for a small fee, without evaluation, provided that no specific claim is made for efficacy and there is no available evidence of problems with quality or safety. More than 4500 "herbal" preparations are on this list. Those substances which have been registered as a result of a full evaluation of safety and efficacy may be counted on the fingers of one hand. It is unlikely that the Government will increase its vigilance. The recent review of the Therapeutic Goods Administration (TGA) included the investigation of "approval processes for alternative medicines with a view to ensuring any inappropriate existing impediments are removed."12 The final report has been submitted and, while some recommendations have not been accepted, it is hard to see how these medicines can be any less restricted than they are at present. In his media release in response to the recent TGA review, Senator Christopher Ellison (Parliamentary Secretary to the Federal Minister for Health and Family Services) stated that, with a new range of initiatives, "the Federal Government has ensured that patients can have confidence that their [alternative] medicines will work in the way they are intended to". It is difficult to see how this can be the case when in the same document he states that the approval processes of the TGA should not prevent people obtaining alternative medicines "where the intrinsic safety of the product is not in doubt but the therapeutic effectiveness is unproven". These products should be scientifically assessed so that patients do not unwittingly delay their own access to proven effective therapy. We believe it is up to doctors and other health professionals to address the situation as a matter of urgency. In our survey, the main reasons given for not telling medical practitioners about the use of alternative therapies were the perception that doctors would probably reject the therapies, and a belief that individuals were "in charge of their own health". If 50% of Australians are using alternative treatments each year, it is essential that doctors recognise this fact and be prepared to discuss such use with their patients in a non- judgemental manner. As a minimum step, questions about alternative treatments must be included as a routine part of history-taking. Eliciting the reasons for their use might indicate where conventional medicine is perceived to be failing, and allow supportive discussion with patients. In addition, any unusual or unexplained symptom or sign should raise the possibility of an adverse reaction to, or interaction with, an alternative medication, and if there is a suggestive temporal association the event should be reported to the Australian Adverse Drug Reactions Advisory Committee (Commonwealth Department of Health and Family Services). We need to acknowledge what is happening in the community. It has been suggested that the normal doctor-patient encounter lacks "time, empathy, personalisation, expectation of a cure in chronic disease states, counselling and a general emphasis on health rather than disease".2 While this is not always the case, it is time for us to recognise that a complementary system for trying to achieve a state of well-being exists in Australia and is widely used by our patients. We cannot ignore it and should record and collect objective data about its use. Gillian M Shenfield Clinical Professor in Clinical Pharmacology Philip A Atkin Research Associate in Clinical Pharmacology Sean S Kristoffersen Honours Student, Department of Clinical Pharmacology, Royal North Shore Hospital, Sydney, NSW. Bridges-Webb C, Britt H, Miles DA, et al. Morbidity and treatment in general practice in Australia 1990-1991. Med J Aust 1992; 157 (suppl): 1S-56S. MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Kristoffersen SS, Atkin PA, Shenfield GM. Uptake of alternative medicine [letter]. Lancet 1996; 347: 972. Sawyer MG, Gannon AF, Toogood IR, et al. The use of alternative therapies by children with cancer. Med J Aust 1994; 160: 320-322. Begbie SD, Kerestes ZL, Bell DR. Patterns of alternative medicine use by cancer patients. Med J Aust 1996; 165: 545-548. 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. Myers SP, Smith AJ. Cardioprotection and garlic. Lancet 1997; 349: 131-132. Huxtable RJ. The harmful potential of herbal and other plant products. Drug Saf 1990; 5: 126-136. Pillans PI. Toxicity of herbal products. NZ Med J 1995; 108: 469-470. Smith BC, Desmond PV. Acute hepatitis induced by ingestion of the herbal medication chaparral. Aust N Z J Med 1993; 23: 526. Harmless herbals? ADRAC Bull 1993; 12: 11. KPMG Management Consulting. Review of Therapeutic Goods Administration on behalf of the Department of Health and Family Services. Canberra: AGPS, Jan 1997 p2. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.
Gillian M Shenfield · Philip A Atkin · Sean S Kristoffersen
Sydney 2000: guarding against disasters
Sydney 2000: guarding against disasters Planning for the unexpected and practising responses is the critical task now MJA 1997; 166: 517-518 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 In this issue of the Journal, Nocera describes the consequences of a grenade explosion in a munitions factory that injured four women, two of them critically. The report is a reminder of the ingenious creativity of the human race in weapons and war, with its impetus to do as much harm as possible -- but it might also remind us that some major advances in care for trauma patients have been spawned by wars, particularly methods to decrease the time from injury to first aid and advanced resuscitation techniques. In the incident described by Nocera, the prompt response by emergency services was the key to the survival of the injured. The first ambulance arrived five minutes after the explosion, followed by two more in the next six minutes. As part of the controlled response, a helicopter was put on stand-by nine minutes after the accident and took off five minutes later, carrying universal donor (O Rh-negative) blood, a paramedic and an emergency medicine doctor. The obvious cooperation between all personnel involved -- including police, fire, ambulance officers and helicopter staff -- enabled appropriate deployment of resources, prompt triage and transportation (making allowances for peak hour traffic and matching the capabilities of the hospitals in the area with the patients' conditions). "it is too late to plan a response once a disaster occurs" On a more general note, the article prompts us to review our preparations for disasters in general. Sydney is hosting the Olympics and many other mass gatherings in 2000. What if something happens: explosion, fire or mass transport accident . . . ? Are we prepared? A disaster may be defined as "Any incident, involving large numbers of casualties, which overwhelms the capacity of available resources to cope with it."1 A disaster is, obviously, unexpected, but we might expect Murphy's Law to operate. The recent history of the Olympics includes the tragedies of Munich (1972) and Atlanta (1996). Disaster preparedness was part of our successful bid for the Games in 2000. The response plan was based on DISPLAN/MEDPLAN. MEDPLAN has now been superseded by HEALTHPLAN,2 which defines the command structure and standard operating procedures to be followed in a disaster by the New South Wales health services (ambulance, medical, mental health and public health). These disaster-response plans have been tested and refined through the challenges of bushfires, the Newcastle earthquake, bus crashes and mass gatherings such as visits by two Popes, Royalty and United States Presidents, at rock concerts,3 City to Surf runs and many other occasions. The New South Wales State Emergency and Rescue Management Act 1989 has required increased disaster planning and preparedness at local government, district, area health and State levels. Training and certification of selected health professionals and practical texts4 are now readily available. A glimpse of the complexity of the overall picture of disaster response is provided by the table of contents (10 pages) of the Commonwealth's Australian emergency manual: disaster medicine,5 which covers all aspects of disasters through to recovery. Both this manual and the New South Wales HealthPlan2 have been revised for 1997. Disaster planning brings forth apathy, denial, squabbles about resources, turf battles and many committees representing various disciplines creating camels,* as well as serious professionals trying to plan for "What if . . . ?". The Olympic Health and Medical Working Committee, with senior representatives from the Sydney Olympic Games Organising Committee, the NSW Department of Health and other agencies, is setting up the framework for events in 2000. There are several established principles in disaster planning: In disasters, do the greatest good for the greatest number (a reversal of the usual clinical emphasis on quality of care for the individual). This explains why any disaster scene has to be declared safe by fire officers, why police are in charge overall, why systems are set up to evacuate "walking wounded" before attention is given to the mortally injured. Both military and civilian experience has confirmed that in a disaster a rigid chain of command is essential (doctors, with their individualistic training and professional independence, are poor at this), and that personnel should perform tasks similar to their normal duties (e.g., that surgeons should continue in surgery and not be called upon to organise transport). Overall service command must be led by a controller off site . Each service must have liaison officers from all other major agencies involved. The biggest problem is always communication: this must be organised by those agencies with the relevant expertise and equipment. Emergency physicians are the appropriate controllers of the medical response to a disaster: ". . . they are familiar with the system and personnel providing care before hospitalization; they are practiced in rapid assessment, basic treatment, and triage; and they have a good working rapport with other specialists needed during the response."6 As Waeckerle states in an article on disaster planning, it is too late to plan a response once a disaster occurs.6 Disaster response will always be a team collaborative effort which must be planned and practised. As everybody's time and resources are short, we have to use tabletop exercises, mass gatherings and even expensive exercises with moulaged victims to practise to get it right well before 2000. Gordian W O Fulde Director, Emergency Department St Vincent's Hospital, Sydney A Senior Commander, NSW Healthplan . * "A camel is a horse designed by a committee and an elephant is a mouse built to military specifications" -- Caxton C Foster Ambrose G. Disaster medical planning. In: Fulde GWO, editor. Emergency medicine: the principles of practice. 2nd ed. Sydney: Maclennan and Petty, 1992: 13-19. NSW Healthplan . Functional area supporting plan to the NSW State Disaster Plan (NSW DISPLAN). Sydney: Department of Health, 1997. Fulde GW, Forster SL, Preisz P. Open air rock concert: an organised disaster. Med J Aust 1992; 157: 820-822. Hodgetts TJ, Mackway-Jones K, editors. Major incident medical management and support. The practical approach. London: BMJ Publishing, 1995. Australian emergency manual: disaster medicine. Canberra: Commonwealth Department of Human Services and Health, 1995. Waeckerle J. Disaster planning and response. N Engl J Med 1991; 324: 815-821. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.
Medicine and the community
Safety issues in herbal medicine: implications for the health professions
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. J Trop Med Hyg 1992; 95: 296-298. Perharic L, Shaw D, Colbridge M, et al. Toxicological problems resulting from exposure to traditional remedies and food supplements. Drug Saf 1994; 11: 284-294. Bullock RJ, Rohan A, Straatmans, J-A. Fatal royal jelly-induced asthma [letter]. Med J Aust 1994; 160: 44. Takahashi M, Matsuo I, Ohkido M. Contact dermatitis due to honeybee royal jelly. Contact Dermatitis 1983; 9: 452-455. Anonymous. Royal jelly: warning label required. TGA News 1994; 16: 4. Bensoussan A, Myers SP. Towards a safer choice. The practice of traditional Chinese medicine in Australia. Sydney: Faculty of Health, University of Western Sydney (Macarthur), 1996: 54. De Smet PAGM. Health risks of herbal remedies. Drug Saf 1995; 13: 81-93. Huxtable RJ. The harmful potential of herbal and other plant products. Drug Saf 1990; 5 (Suppl 1): S126-S136. Rawlins MD, Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM, editor. Textbook of adverse drug reactions. 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
Notable cases
The St Marys fragmentation grenade explosion
The St Marys fragmentation grenade explosion Antony Nocera The accidental explosion of a fragmentation grenade in a munitions factory at St Marys injured four workers, two critically. The prompt response by ambulances and physician-staffed helicopter emergency medical service prevented deaths, but the incident suggests lessons for the future handling of urban explosions. (MJA 1997; 166: 545-548) For editorial comment see Fulde 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 - Patient records - What makes a grenade - Discussion - Acknowledgement - References - Authors' details Make a comment - Register to be notified of new articles by e-mail - Current contents list - ©MJA1997 Introduction On 14 November 1995 an F1 fragmentation hand grenade exploded in a grenade testing facility in a munitions factory on a 1600 hectare site at St Marys, NSW. Seven employees were in the room. The grenade exploded at 8:36 am on a work bench and injured four workers around the bench (Figure 1). None were wearing body armour and there were no blast shields in the work area. Figure 1: Immediate area of the explosion. Patient C was sitting in the chair in the foreground, with Patient A in the chair immediately behind, while Patient B was standing behind the two. Patient D was sitting on the other side of the bench, opposite Patient C. The pallet to the left carried 1000 live grenades and was 1.85 m from the grenade burst point. Forty-eight grenades were damaged in the explosion and represented an explosive hazard during recovery operations. Photograph courtesy of the New South Wales Police. The first ambulances arrived at 8:41, 8:44 and 8:47. The four injured workers were extricated from the factory building to an adjacent courtyard by other employees and ambulance personnel. NRMA CareFlight, a Bell 412 HP helicopter emergency medical service (HEMS) with a physician on board, was placed on standby at 8:45 and dispatched at 8:50, landing at the site at 9:06. Two patients were transported by air to a trauma centre with full cardiothoracic facilities about 24 km (10 minutes' flying time) from the factory. Access to this centre by road would have encountered peak hour traffic flowing into Sydney via the major western arterial road routes. Two patients were transported by road to a local trauma centre (10 minutes' travelling time) which has limited cardiothoracic surgical facilities. Patient records Patient A Patient A was a 44-year-old woman sitting 0.25 m from the grenade burst point. On arrival of the HEMS, she had a Glasgow coma score of 12-13 and no recordable blood pressure. Only carotid pulses were palpable after an infusion of 1.5 L of polygeline by ambulance personnel; an additional 500 mL polygeline and 500 mL normal saline were infused. The patient's conscious state began to fluctuate, and a rapid sequence induction and endotracheal intubation were performed before transport by helicopter. The patient received a further two units of O negative blood during transport. On arrival at hospital, Patient A had a heart rate of 100/min, systolic blood pressure, 118 mmHg; haemoglobin level, 79 g/L (normal range, 115-165 g/L); pH, 7.29 (normal range, 7.35-7.45); PO2, 518 mmHg (normal range, 75-100 mmHg); PCO2, 30 mmHg (normal range, 35-45 mmHg); HCO3, 14 mmol/L (normal range, 22-26 mmol/L); and serum lactate, 3.04 mmol/L (normal range, 0.63-2.44 mmol/L). She was taken to theatre for thoracotomy and laparotomy, enucleation of left orbit, amputation of right ring and little fingers, debridement of right forearm and thigh, with internal fixation of her right forearm fractures. By the end of her first theatre session she had received (in addition to her prehospital fluids) 6.5 L of polygeline, 4 L of crystalloid, 24 units of packed red blood cells, 8 units of frozen plasma and 6 units of platelets. Patient A's injuries were: Multiple puncture wounds to the face, neck, chest and abdomen Singed hair and eyebrows Grenade fragments in the right maxillary antrum and right side of the nasopharynx Multiple puncture wounds to the left eye Bilateral perforated tympanic membranes Multiple fractured teeth Subtotal traumatic mastectomies (Figure 2a) Bilateral haemothoraces, with contusions of the right middle lobe and both lower lobes of the lungs Perforation of the right ventricle and apex of the heart, with a 250 mL pericardial haematoma Perforations of the stomach, left lobe of the liver, and splenic flexure of the colon Haematomas of the head of the pancreas, lesser omentum and left perinephric region Comminuted compound fracture of the right radius and ulna, with major soft tissue disruption to the dorsal surface of the right forearm (Figure 2b) Subtotal amputation of the right ring and little fingers A large skin and muscle defect to the anterior aspect of the right thigh (Figure 2c). After her initial surgery, Patient A required mechanically assisted ventilation for 11 days and underwent five additional operative procedures during her initial 39 days in hospital. In the next year she underwent another five operative procedures, with a further five reconstructive procedures scheduled for the following year. Patient B Patient B was a 45-year-old woman standing behind and to the left of Patient A, about 0.6 m from the grenade burst point. On arrival of the HEMS, she was in severe respiratory distress, with a heart rate of 105/min, systolic blood pressure of 60 mmHg, and Glasgow coma score of 10. Patient B was treated by ambulance personnel with 1.7 L of polygeline and transported to hospital by road. On arrival at hospital, Patient B had a heart rate of 88/min; systolic blood pressure, 140 mmHg; Glasgow coma score, 15; haemoglobin level, 83 g/L; pH, 7.30; PO2, 331 mmHg; PCO2, 36.6 mmHg; HCO3, 17.8 mmol/L; and base excess, - 7.2 (normal range, - 3 to 3). Patient B was taken to theatre for laparotomy and cholecystectomy. Her injuries were: Multiple puncture wounds to the face, neck, thorax and abdomen Forehead laceration and fractured nose Grenade fragments in the ethmoid and sphenoid sinuses, plus a fragment in the occipital lobe of the brain. Contusion of the lower lobe of the left lung Multiple perforations of the liver and gallbladder Lacerated right kidney and retroperitoneal haematoma Fragments adjacent to the abdominal aorta and the right L3 nerve root Delayed third-nerve palsy. She was discharged from intensive care after 1.5 days and discharged home after 18 days. She underwent six subsequent day procedures to repair soft tissue injuries and extract fragments. Patient C Patient C was a 54-year-old woman sitting to the right of patient A, 1.3 m from the burst point. On arrival of the HEMS, she had a heart rate of 80/min, systolic blood pressure of 130 mmHg and Glasgow coma score of 14. She was treated with 1 L of Hartmann's solution and 250 mL of polygeline and transported by air. On arrival at hospital, Patient C's heart rate was 83/min; systolic blood pressure, 151 mmHg; Glasgow coma score, 14; and haemoglobin level, 125 g/L. Her injuries were: Multiple small puncture wounds to the left upper limb and left side of the thorax A chin laceration and left periorbital haematoma; there were no perforations of the tympanic membranes A closed fracture of the left ulna A small left retinal tear and preretinal haematoma A fragment in the medial rectus of the left orbit. Patient C was discharged home after two days. Patient D Patient D was a 50-year-old woman sitting diagonally opposite Patient A about 1.6 m from the grenade burst point. On arrival of the HEMS, she had a heart rate of 105/min, systolic blood pressure of 70 mmHg and Glasgow coma score of 11. She was treated with 1 L of polygeline and transported by road. On arrival at hospital, Patient D had a heart rate of 90/min; systolic blood pressure, 150 mmHg; Glasgow coma score, 15; and haemoglobin level, 108 g/L. Her injuries were: Multiple fragment wounds to the right side of the face, neck, thorax and upper limb, including an intracapsular fragment in the right shoulder joint and a 4 cm scalp laceration Bilateral perforations of the tympanic membranes Right pneumothorax requiring drainage with an intercostal catheter, plus pulmonary contusions of the right mid and lower zones. She was discharged after seven days and subsequently underwent two outpatient procedures to extract fragments. Discussion The injuries of the four accident victims demonstrate the capability of military weapons to inflict serious physical injury -- but the potential psychological impact of these weapons extends well beyond their injury radius. The grenade exploded on a bench top, which directed most of the blast and fragments onto the upper torso of the victims, but it also blew a hole in the bench top, producing the wound to the right thigh of patient A. Any bomb or blast scene should always be considered dangerous until declared safe from the risk of secondary explosion by appropriate technical personnel. Specialist bomb disposal personnel were not part of the initial response to the St Marys incident, which contributed to the delayed recognition of a potential secondary explosion hazard from 48 damaged grenades at the site. The size and shape of modern military weapons often belie their wounding potential. Explosive devices may contain fuse mechanisms that detonate in response to stimuli other than that of direct impact. The bodies of victims may conceivably hold unexploded devices that pose a threat to rescue, medical and mortuary personnel.11,12 Major injuries and deaths occurred during the Gulf War among medical and service personnel handling souvenired battlefield ordnance.13 Injury from military weapons is uncommon in Australia. Army ammunition technical officers can provide expert advice on the composition and function of a particular device. This information is vital in the assessment of individuals wearing body armour, or who have been potentially exposed to either radiolucent fragments or items of ordnance which have become airborne.11,12 Early on-site specialist technical advice is critical to safe operations at the scene of an urban explosion. Helicopter emergency medical services have been used in the primary and secondary transport of blast victims.14,15 In this incident the HEMS rapidly provided a doctor on-site to assist in trauma triage. This allowed patients to be referred immediately for specialist surgical care, while dispersing casualties over a wider network of receiving hospitals (thus Patient A and Patient B were sent to different hospitals so that both could receive immediate surgical treatment; this would not have occurred under ambulance protocols). In addition, on-site medical care went beyond the scope of paramedic protocols16 (e.g., in performing a relaxant-assisted intubation and giving a blood transfusion). The NSW Ambulance Service Disaster Plan (December 1995) precludes the immediate dispatch of physician-staffed helicopter emergency medical services to potential multicasualty incidents. This may introduce avoidable delays in delivering seriously injured patients to definitive surgical care, especially in incidents geographically removed from designated trauma centres. Acknowledgement I thank Mr Mike Etzel for generously providing some of the background material. References Owen J. Infantry weapons of the world 1979. London: Brassey's 1979. Hogg IV. The illustrated encyclopaedia of ammunition. Sydney: Colporteur Press, 1985. Gander TJ, editor. Jane's infantry weapons. 22nd ed. 1996-97. London; Jane's Information Group, 1995. Rawlins JSP. Physical and pathophysiological effects of blast. Injury 1978; 9: 313-320. Huller T, Yaacov B. Blast injuries of the chest and abdomen. Arch Surg 1970; 100: 24-30. Cooper GJ, Maynard RL, Cross NL, Hill JF. Casualties from terrorist bombings. J Trauma 1983; 23: 955-967. Bellamy RF. The medical effects of conventional weapons. World J Surg 1992; 16: 888-892. Mellor SG. The relationship of blast loading to death and injury from explosion. World J Surg 1992; 16: 893-898. Handbook on weaponry. 2nd ed. Dsseldorf: Rheinmetall GmbH, 1992. Courtney-Green PR. Ammunition for the land battle. London: Brassey's 1991. Clark MA. A fatal wound from an unusual military projectile: potential dangers of live military ordnance to the autopsy pathologist. J Forensic Sci 1987; 32: 793-797. Spencer JD. Accidental death by light anti-tank weapon: a dangerous autopsy? J Forensic Sci 1979; 24: 479-482. Thomson JD, Lisecki EJ. Injuries and deaths from collecting war souvenirs in Operation Desert Storm. Mil Med 1993; 158: 505-507. Brown MG, Marshall SG. The Enniskillen bomb: A disaster plan. BMJ 1988; 297: 1113-1116. Merriman M. Emergency medical response teams react swiftly to the Philips Plant tragedy. Occup Health Saf 1990; 59: 32-37. NSW Ambulance Service protocols, procedures and pharmacology. Sydney: NSW Ambulance Service, 1993. (Received 17 Jul 1996, accepted 18 Feb 1997) Authors' details NRMA CareFlight, Westmead, NSW. Antony Nocera, MB BS, Emergency Medicine Registrar. No reprints will be available. Correspondence: Dr Antony Nocera, NRMA CareFlight, PO Box 159, Westmead, NSW 2145. E-mail: tonynoceATozemail.com.au <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.
Anthony Nocera
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