Letters

To the Editor: The entertaining history of Sydney Hospital by Kappagoda1 illustrates the risk of accepting local lore as fact. The assertions that Sydney Hospital “hosted the first operation [in Australia] under general anaesthetic” and that it was “a leg amputation under chloroform” are both incorrect. The first surgical operations under general anaesthesia in Australia took place in Launceston, Tasmania, on Monday 7 June 1847, using ether administered with apparatus that had been depicted in the Illustrated London News.2,3 Two patients were successfully anaesthetised by Dr William Russ Pugh — both walked home and were completely happy with the procedure. The operation referred to by Kappagoda was reported in the Sydney Morning Herald (SMH) on Monday 28 June 1847 as having occurred “a few days back”4 — at least 2 weeks after Pugh’s patients were anaesthetised. Further, ether, not chloroform, was used in Sydney. The SMH reporter had also seen ether used to anaesthetise patients on other occasions, but these patients were undergoing dental extraction. The decision to operate may have been precipitated by a news item in the SMH on Thursday 24 June 1847. The paper reported that “The medical men at Launceston have made several successful experiments in performing surgical operations on patients who have inhaled ether.”5 To local readers, it would have been obvious that this had occurred at least several days, and possibly several weeks, before the Sydney surgery, because of the delay in transmitting news from Launceston to Sydney. Perhaps this news spurred the Sydney surgeons to act.

John D Paull

To the Editor: The first recorded use of an anaesthetic in Australia was not at Sydney Hospital, as stated by Kappagoda,1 but was at Dr John Belisario’s rooms in Spring Street, Sydney. Belisario, with Dr Charles Nathan (honorary surgeon to Sydney Infirmary), administered ether to two patients having dental extractions on 6 June 1847, and possibly to other patients a day or two earlier.2,3 The first recorded use of an anaesthetic for surgery was in Launceston, Tasmania, by Dr William Russ Pugh on 7 June 1847, when he administered ether for removal of an epulis from a woman’s jaw, followed by excision of a cataract from a man. Pugh published these cases in the Australian Medical Journal — the first medical journal in Australia, of which the Medical Journal of Australia is the direct descendant,4 and which only existed for 15 months. The Editor, Dr Isaac Aaron, was one of the first surgeons at Sydney Infirmary. Ether was the sole anaesthetic available in Australia for 10 months before chloroform was introduced. The first recorded death under ether occurred in Sydney on 9 April 1848. Two days later, on Tuesday 11 April, Nathan gave evidence in the morning at the inquest of this death and, in the afternoon, gave the first chloroform anaesthetic in Australia at Sydney Infirmary, to a young girl. The first recorded death under chloroform anaesthesia in Australia occurred on 19 July 1848 at Windsor, New South Wales.2 Sydney Infirmary, later Hospital, was closely involved in the early days of anaesthesia in Australia, both on site and through its staff, but cannot claim priority.

Michael G Cooper

To the Editor: In reply to my critics whose letters were published in the 20 February issue of the Journal1-4 after the publication of my article “What is wrong with Medicare?”,5 I would ask them to look broadly at Australia’s health care dollar and how it may be misspent. It is clear that the percentage of practitioners who wilfully set out to defraud Medicare, Veterans’ Affairs, workers compensation and other forms of insurance is relatively small. However, the current structure of Medicare, which is the result of poor policy decisions, allows inappropriate practice, as well as inefficiency and cost-shifting. Inertia in health care reform will continue to diminish our ability to deliver a first-world standard of care into the future. My critics would do well to consider this.

Tony D Webber

To the Editor: Non-surgical cosmetic procedures have rapidly increased over the past 15 years, and although there are no reliable figures for Australia, there was an eightfold increase in such procedures in the United States between 1997 and 2010.1 Practitioners in the cosmetic field are seeing more frequent complications (eg, burns, scarring) from laser treatments that have been performed by untrained or inexperienced operators, including beauty therapists. These treatments are often performed as walk-in procedures in shopping centres. A cosmetic surgery report to the New South Wales Minister for Health in 1999 outlined a number of issues with laser use in Australia.2 More than 12 years later, very few of these issues have been addressed. There are more regulations on the sale and use of laser pointers in Australia than there are for lasers in health care. The Australian/New Zealand Standard 4173:2004, Guide to the safe use of lasers in health care, limits and classifies lasers used for medical purposes according to the degree of hazard. The Standard recognises that all personnel using and handling lasers should have training appropriate to the task they perform.3 Queensland, Western Australia and Tasmania have some regulations regarding medical grade lasers, but there are currently no regulations enforcing the Standard in other jurisdictions. There is also no industry standard for the necessary skills, qualifications and training for use of lasers, or regulation of these. National guidelines for the use of medical grade (Class 3B and 4) lasers need to be developed urgently and should address several issues to protect consumers: Medical grade lasers should only be sold to medical practices where the operator can be observed by a doctor at least some of the time, and complications can be discussed with the doctor. Medical practices should be licensed under the relevant Radiation Act in each jurisdiction (eg, Radiation Control Act 1990 in NSW) and listed on a website. All users of the laser in each licensed practice should be registered and individually licensed. National guidelines for accredited laser-safety courses should be established, ensuring adequate training and certification for obtaining a licence.

Charles Cope

To the Editor: A 12-year-old boy presented to a regional emergency department with a 3-day history of progressing bilateral conjunctival injection, fevers (39°C), a widespread erythematous bullous rash, and superficial erosions to his lips, oral mucosa and urethral meatus. The patient was admitted to hospital for management of Stevens–Johnson syndrome (SJS). Initial treatment included intravenous f luids, intravenous ceftriaxone and oral azithromycin before transfer to a tertiary referral hospital. The patient had not taken any oral medications or over-the-counter therapies. He had no preceding viral symptoms. However, 2 weeks before onset of symptoms, he had received vaccination against varicella-zoster virus. On Day 1 of admission, intravenous immunoglobulin (Intragam P, CSL, Melbourne, VIC; batch numbers 3740600696, 3740500668, 3740600690, 3740600679) was administered at a dose of 1 mg/kg and repeated 20 hours later. On Day 2, oral prednisolone therapy (1 mg/kg/day) was initiated and continued for 5 days, and antibiotics were administered for 8 days (cefotaxime [50 mg/kg] and azithromycin [10 mg/kg]). Mycoplasma pneumoniae serological testing of blood samples taken on admission was negative. Bilateral conjunctival ulcers were managed with topical chloramphenicol eye ointment, topical 0.5% prednisone, lubricant drops and normal saline washes. The patient developed further areas of bullae and erosions to his cheeks and ears (Box). He also developed palmar papules, and dusky finger tips and toes. Skin bullous lesions were managed with daily sterile aspiration, and erosions were managed with silver-impregnated silicone dressings (Mepilex Ag, Mölnlycke Health Care, Gothenburg, Sweden). The patient’s rash and fevers abated, and he was discharged on Day 12 with advice from the dietitian and physiotherapy-assisted mobilisation. Sequelae at 2 months included cutaneous post-inflammatory hyperpigmentation. SJS after varicella infection has been reported,1,2 and a single case after varicella vaccination was included in a case series of six possible cases of SJS after vaccinations.3 SJS after medication use or infection with M. pneumoniae is well documented; however, cases where no clear cause can be documented result in increased parental anxiety. This case of SJS was preceded by varicella-zoster vaccination performed as part of school protocol. In the absence of any other obvious cause, it has been reported to alert practitioners of the possibility of a link (Therapeutic Goods Administration adverse drug reaction no. 291111). Patient with Stevens–Johnson syndrome after varicella vaccination

Elizabeth M Christou · Orli Wargon

To the Editor: Neal and Irwig1 argue that more precise measurement of blood pressure using ambulatory blood pressure monitoring is unlikely to deliver the clinical and economic benefits that could be achieved by switching to a risk-based strategy, such as that advocated by the National Vascular Disease Prevention Alliance.2 Moreover, they question: do you need to “know your numbers”? However, all risk-based strategies are based on numbers for blood pressure and various lipid parameters. Furthermore, despite a wealth of evidence that numbers-based approaches reduce cardiovascular events, I am not aware of any randomised controlled trial demonstrating the superiority, or even the equivalence, of a strategy based on 5-year absolute risk for cardiovascular prevention. Is a strategy based on 5-year absolute risk best for the individual patient? Clinicians treat lifetime risk,3 taking into account family history and, for women, the prospect of pregnancy. A low 5-year risk is not sufficient justification for withholding treatment of elevated lipids or blood pressure. Although the 44-year-old, male non-smoker without diabetes and with a systolic blood pressure of 170 mmHg may have a 5-year cardiovascular risk of 5%, clinicians will investigate and provide aggressive blood pressure treatment to reduce his lifetime risk. Treating according to the numbers will ensure that the choice of therapy offers the greatest risk reduction. Clinicians treat individuals, not populations. Management of the individual patient with cardiovascular risk is neither exclusively numbers-based nor exclusively risk-based, but a combination of the two approaches. We should use the approach that works best for the individual patient.

Duncan J Campbell

To the Editor: The prevalence of obesity in Australia is increasing, with a quarter of Australians currently obese and two-thirds overweight.1 The fast-food industry is particularly implicated in this, because it offers cheap, high-calorie and low-nutrient food and employs branding that can alter taste preferences.2 Despite considerable lobbying from health groups, Australian governments have not elected to regulate the fast-food industry, instead leaving it to self-regulate. Predictably, a recent industry self-regulatory initiative aiming to decrease advertising to children failed.3 Suggested methods of regulating the fast-food industry have included taxing unhealthy foods, limiting advertising to children, and mandatory nutritional labelling. However, recent research has suggested a more creative solution. Instead of restricting the industry, perhaps the effective branding strategies of fast-food companies could be used for health promotion. It has been shown that children prefer food in McDonalds-branded wrapping over the identical item in plain wrapping.2 Even typically healthy items, like milk and carrots, are preferred when given McDonalds branding. New research has taken this idea a step further and shown that the branding of a fun, health-themed television show can be used to make healthy foods more appealing.4 These findings may motivate a new population-level strategy to reduce obesity. Established fast-food brands could be given incentives to apply their branding to healthy items. This would allow the fast-food industry to contribute to a healthier food environment, while avoiding the market restriction of taxation. Another option is to establish a government-funded enterprise that uses fast-food marketing to sell healthy items. Costs of such ventures may be outweighed by future reductions in health spending. With regard to obesity, perhaps it is time we started looking on the outside of the box for the solution.

Dugal B S Smith

To the Editor: The past decade has seen significant change in the management of major haemorrhage, including earlier and more aggressive use of fresh frozen plasma (FFP). Australian guidelines now advocate high ratios of FFP to packed red blood cells (PRBC) from the outset of resuscitation.1 Preparation of one unit of FFP for every two units of PRBC is recommended. This approach is supported by a recent meta-analysis demonstrating a reduction in organ failure and mortality with high FFP : PRBC ratios.2 In Australia, 40% of major trauma incidents originate in rural areas,3 some distance from tertiary or even secondary care. Initial resuscitation often falls to general practitioners (with no blood bank) or aeromedical services. In a 2010 international survey of 29 aeromedical services conducted by the Royal Flying Doctor Service (RFDS) (Western Operations), the seven responding Australian services reported difficulty accessing blood products. Only three had immediate access to PRBC, although all could obtain it within 45 minutes. None could obtain FFP without delaying departure, and only four had access within 45 minutes. This difficulty in obtaining blood products, particularly FFP, was evident in an analysis of major haemorrhage management by the RFDS (Western Operations). Of 7585 patients transferred in the 2009–10 financial year, 610 (8%) had a diagnosis that put them at risk of major haemorrhage; of these, 58 (9.5%) demonstrated physiological derangement predictive of requiring massive transfusion and did receive transfusion in flight. However, the FFP : PRBC ratios fell short of accepted standards (Box), particularly in patients originating from non-regional hospital locations. As logistical difficulties with storage and preparation render FFP impractical in remote Australia, alternative sources of coagulation factors must be explored. European groups have proposed replacing FFP with freeze-dried factor preparations (fibrinogen concentrate and prothrombin complex concentrate),4 which are currently available in Australia. These are easier to store, transport and deliver, and may be safer and more efficacious than FFP.4 Evidence that tranexamic acid significantly reduces mortality in trauma-related haemorrhage5 has been met with a guarded response in Australia. The study was conducted in developing countries with limited access to blood products and its applicability here has been questioned, although it may be highly applicable to remote and regional areas where FFP is scarce. Ongoing research and the planned Australian Massive Transfusion Registry will contribute further to the debate. When devising major haemorrhage strategies, however, it should be remembered that managing bleeding in Melbourne and managing bleeding in Meekatharra (in remote Western Australia) are two very different prospects. Ratio of fresh frozen plasma (FFP) to packed red blood cells (PRBC) in patients at risk of requiring massive transfusion, 2009–10 Origin of patient All patients (n = 58) Regional hospital (n = 35) Non-regional hospital (n = 23) Mean number of FFP units delivered: In referring hospital 0.9 1.3 0.3 During transport 0.2 0.3 0.1 Mean number of PRBC units delivered: In referring hospital 2.5 3.3 1.3 During transport 1.8 1.6 2.0 Overall FFP : PRBC ratio 1 : 3.9 1 : 3.1 1 : 8.3

Stuart A Gillon · Cem R Kibar

To the Editor: An evaluation of 3390 prevocational progress assessment forms in New South Wales suggested that the assessment instrument appears unable to detect underperforming doctors, and may not aid their professional development.1 Similarly, Queensland interns undertake five terms per year and, in each of these, they are assessed against 11 items in three domains: clinical competence, communication, and personal and professional skills. The purpose of the assessment is to identify underperformers and subsequently to help improve their performance. However, there is limited literature on the psychometric properties of the instruments used. Our study aimed to evaluate the construct validity and reliability of the instrument as a measure of interns’ performance. We performed principal component analysis (PCA) of the assessment items from all 72 interns who completed the five assessment forms during their intern year of the University of Queensland (2005 to 2007), working in one teaching hospital. A reliability test was performed using generalisability theory, which measured the variation in scores due to differences in performance between interns. It is generally expressed as a G coefficient ranging from 0 to 1 (no reliability to perfect reliability). Supervisors assess interns using the rating scale: “requires substantial assistance”; “requires further development”; “consistent with level of appointment”; “performance better than expected”; “performance exceptional”; or “not applicable or not observed”. Supervisors’ ratings were coded from 1 to 5 for the data analysis. Our examination of the assessment forms found that the mean of the skill items ranged from 3.69 to 4.16 (SD, 0.31–0.41). PCA identified only one factor from the 11 assessed items, and it explained 71% of variance in scores. The loadings of the coefficients ranged from 0.80 to 0.93 (Box) and the G coefficient was 0.16. These data show that the instrument in this setting only measures a single global work performance factor, has low reliability, does not discriminate well between interns, and does not differentiate well between the different domains and assessment items, raising the question as to whether it is fit for purpose. The assessment program should be able to assess all these required attributes of junior doctors as outlined in the Australian Curriculum Framework for Junior Doctors in order to work safely in Australian hospitals and other health care settings.2,3 Other assessment methods involving direct observation, such as the mini clinical evaluation exercise4 and direct observation of procedural skills,5 could be integrated into the assessment to enhance its validity, but would require trained assessors and substantial time commitment for development and delivery. Domains, assessed items, descriptive statistics and factor loading of principal component analysis of the assessment instrument used on 72 graduates Domain Skill items Mean (range) SD Factor loading Clinical skills Knowledge base: demonstrates adequate knowledge of basic and clinical science 3.72 (3.00–4.40) 0.33 0.84 Clinical skills: elicits and records accurate, complete history and clinical examination 3.87 (2.80–4.60) 0.37 0.90 Clinical judgement/decision-making skills: applies knowledge base and clinical findings; organising, synthesising and acting on information 3.88 (2.80–4.80) 0.39 0.90 Emergency skills: acts effectively and, when appropriate, acknowledges own limitations and seeks help 3.79 (3.15–4.40) 0.34 0.76 Procedural skills: performs procedures competently 3.70 (3.20–4.40) 0.38 0.72 Communication skills Patient and family: interacts effectively and sensitively with patients and families/caregivers 4.07 (3.40–4.80) 0.33 0.79 Medical records/clinical documentation: provides clear, comprehensive and accurate records 3.92 (2.80–4.60 0.41 0.88 Personal and professional skills Professional responsibility: demonstrates appropriate attitudes and behaviour, including punctuallity, reliability, honesty and self-care 4.15 (3.20–5.00) 0.34 0.85 Teaching: demonstrates commitment to learning, reflective thinking, and teaching others 3.69 (3.20–4.40) 0.34 0.80 Time management skills: organises and prioritises tasks to be undertaken 3.97 (3.20–4.60) 0.36 0.89 Teamwork and colleagues: works and communicates effectively within a team 4.16 (3.20–4.80) 0.31 0.93

Jianzhen Jenny Zhang · David Wilkinson · Malcolm H Parker · Andrew Leggett · Jill Thistlethwaite

To the Editor: Since the publication of Knight and colleagues’ case report on the topic, five more patients have presented with burns caused by Grevillea pyramidalis ssp. leucadendron, or maangga berry.1 Traditionally, these berries have been used by Aboriginal Australians for tattooing.1 As in the cases described by Knight and colleagues,1 these burns were sustained by Indigenous children aged 8–11 years in northern Western Australia and required specialist burn care. Two patients sustained 1.5% total body surface area, deep partial-thickness burns to their left forearms, which required surgical management. Three patients presented with superficial partial-thickness left forearm burns, which were managed non-operatively via telehealth. Four of the five patients were only referred to the state burns unit 7 days after the initial injury, and one patient was lost to follow-up. Management of these patients’ injuries was limited by compliance issues. Grevillea seeds can be responsible for deeper burns, which require surgical intervention, and superficial burns, which can be treated non-operatively. In this series, the burns occurred in Indigenous children with darker skin, which often has poorer scar outcomes. This demographic, coupled with compliance issues and late referral, make grevillea seed burns a difficult clinical entity to treat. Community education and health staff awareness is imperative in helping us provide optimal treatment in the future.

Joseph Luo · Tania McWilliams · Fiona Wood

To the Editor: We welcome the article by Williams and colleagues on conflicts of interest in clinical guidelines,1 and agree that such conflicts can undermine trust in guidelines, compromise patient care and skew health care spending. One challenge in managing conflicts is the lack of evidence that disclosure minimises their impact. For example, research at the United States Food and Drug Administration found that, despite disclosure, for every committee member with a conflict, there was a 10% greater likelihood of the meeting favouring the drug reviewed.2 Recusal (self-disqualification) is also problematic, especially in Australia where there may be a relatively small pool of experts available. Given these problems, we are concerned that some of the recommendations made by Williams and colleagues lack supporting evidence and fail to adequately address conflicts of interest. One of their recommendations, a tiered system within guideline panels limiting those with conflicts to contributions regarding the nature of the disease under discussion, for example, ignores what we know about the way that conflicts of interest operate. Research has shown that this apparently innocuous element of guideline development is not immune to influence, as conflicts of interest can influence how disease is defined, leading to broader disease definitions and lower treatment thresholds.3 A second recommendation was that guideline developers declare that “any benefits received have not influenced their professional opinion”. But surely this misses the real danger of such conflicts, which is not that of making deliberately biased decisions. Rather, the issue is that professional opinion may be unconsciously swayed by conflicts.4 Finally, they suggest an exclusion period of 3 years between receipt of industry support and involvement in guideline development. But no evidence is provided to ensure that this is “sufficient time for the conflict to have lost its potential for ‘undue influence’”. Without supporting evidence, the choice of 3 years, rather than 4 or 2 and a half, appears arbitrary. We need more research into the way conflicts of interest operate, and perhaps we need to seek a fresh pool of experts who, while less experienced, may be significantly less conflicted.

A Jane Johnson · Wendy A Rogers

In reply: We thank Johnson and Rogers for their letter. A tiered system has benefits but is not foolproof; vigilance by panels is needed to ensure disease definitions are appropriate. Delphi methodology, which can make participants anonymous via use of a facilitator, may prevent the influence of senior panel members over more junior ones in this and other regards. Although declarations would not affect conflicts operating at a subconscious level, turning one’s attention to conflicts at the time of recommendations may lead to greater awareness in some panelists. Declarations have almost no cost. We welcome more research into the length of time that “cures” conflicts. Including less experienced but less conflicted people on panels is a reasonable suggestion, though significant industry relations begin during trainee years, and expert input is likely to be beneficial for authority and take-up. Conflicts are a thorny issue, with undeniable tension between a purist approach and pragmatic considerations, particularly in a small pond. Given the present lack of transparency, we should urgently trial proposals supported by logic or evidence, and look forward to guidance from the National Health and Medical Research Council.

Michael J Williams · Dev A S Kevat · Bebe Loff

To the Editor: The perspective by Williams and colleagues,1 based on analysis of guidelines hosted on the National Health and Medical Research Council (NHMRC) portal (http://www.clinicalguidelines. gov.au), highlights the need for a culture of transparency and disclosure to effectively manage conflicts of interest. With the current health reform agenda being dependent on the availability of clear and unbiased clinical guidance, the NHMRC continues to actively address this persisting challenge. In July 2011, new standards for guideline developers seeking NHMRC approval were released. The standards make it mandatory for guideline developers to publish all sources of funding for the guideline; to publish a complete list of all the people involved, including professions, organisational affiliation and role in the guideline development process; and to publish how potential competing interests are identified, managed and documented. A competing interest declaration must be completed by each member of the guideline development group.2 The NHMRC is committed to implementing management practices for improving transparency of the development of evidence-based health advice. We recently conducted public consultation on policies for identifying and managing conflicts of interest in relation to NHMRC committees and working groups who are developing guidelines. Submissions to the consultation will be taken into account for the finalised policies, to be released in 2012. The draft policies can be viewed at http://consultations.nhmrc.gov.au/open_public_consultations/conflict-of-interest. The NHMRC has also established the Australian Guideline Developers Network and holds national workshops to help guideline developers identify and manage issues, including conflict of interest, with the aim of reducing the variability in the quality of guidelines (http://www.nhmrc.gov.au/guidelines/nhmrc-initiatives-support-high-quality-clinical-practice-guideline-development). These strategies, combined, will strengthen the role of the NHMRC in supporting the translation of health research into trustworthy clinical guidance, in areas that will most benefit the health of the Australian population.

Warwick P Anderson · John McCallum

To the Editor: Since the claims made by Webber in his recent article1 were, in his own words, not based on any substantiated data, it is disappointing that the Medical Journal of Australia did not seek to contact either the Australian Society of Ophthalmologists (ASO) or the Royal Australian New Zealand College of Ophthalmologists (RANZCO) for comment. Certainly, considerable work can be done to improve the operation of Medicare. We are on record as having raised our concerns with successive governments.2 However, Webber’s generalised, sensationalist and unsubstantiated claims add nothing to constructive debate about Medicare. It is disappointing that the Journal would risk damaging its reputation, by choosing to publish a perspective without offering an alternative view to demonstrate balance and evidence, as one would expect in a peer-reviewed journal. Ophthalmology involves more than just removing cataracts, and while technology has made cataract procedures safer and less invasive, they remain complex and the technology very expensive.3 The RANZCO and ASO have worked with government through the Medicare Benefits Schedule Review to address concerns and shortcomings, as well as providing supportive evidence.4 On at least two occasions, we have offered revisions to the funding of treatment of macular degeneration that could save many millions of dollars in the health budget. Additionally, our proposal to reinvigorate the key subspecialty of paediatric ophthalmology has been accepted by government.

Arthur Karagiannis · William J H Glasson

To the Editor: Webber raises some well meaning points in his recent viewpoint article, some of which were taken out of context by the media.1 With respect to his comments on ophthalmologists, I would like to place on record some facts. The Access Economics ophthalmology practice costs survey,2 commissioned by the Australian Society of Ophthalmologists (ASO) in 2011, analysed the costs of delivering ophthalmic services for the financial year 2008–09. The report showed that the average overhead cost per full-time-equivalent ophthalmologist was $506 000, compared with $232 617 in 19993 — an average annual increase of 9%, during which time fees for ophthalmology items on the Medicare Benefits Schedule (MBS) increased by only 2.1% annually.4 Thus, the MBS items become increasingly irrelevant in the context of a small private ophthalmic business model. The cost to the taxpayer of a cataract procedure in New South Wales public hospitals is about $3500 (diagnosis-related group), compared with a Medicare schedule fee of $731 (item 42702). Thus, the procedure can be performed privately for about 20% of the taxpayer cost. Clearly, private surgery is a very efficient use of taxpayer money for an operation with a quality-of-life-adjusted score of about 30 times what is considered cost-beneficial.5 The average eye surgeon performs fewer than half the cataract procedures per week than the 20 which Webber anecdotally claimed (and then multiplied by the entire cost of the procedure, presumably including the theatre fee and prosthesis). Webber is to be congratulated for speaking his mind, but ought to factually balance his writings. The ASO encourages other craft groups to commission their own practice-cost surveys when fiction needs to be separated from fancy.

Peter M Sumich

To the Editor: The “thinking doctor’s” Journal has degenerated to one for doctor’s random thoughts. The commissioned and peer reviewed article by Webber1 was disappointing. For many disenfranchised colleagues, the usual whinge over a cuppa at the local meeting is now plainly inadequate after this Medical Journal of Australia offering. The unsubstantiated claim about billions in Medicare “wastage”1 was reckless. The implication that the current cataract surgery rebate was poor value and had never changed was just plain wrong. Since the introduction of the Schedule of Medical Benefits, cataract surgery now requires entirely different surgical skills, implants a lens, and requires expensive, sophisticated equipment (for examples, see websites2-4). Patients can now expect vastly improved vision without the need for full-time visual aids. The rate of significant sight-threatening complications is now less than 7 in 1000 — one of the lowest complication rates in surgery. The rebate was reduced by about 40% in 1987, 10% in 1996, and 12% in 2009. Even before the last reduction, the total cost provided a significantly better gain (that is, lowest cost) in quality-adjusted life-years than any other surgical procedure,5 something conveniently ignored by the then Health Minister Roxon when cutting costs. With more than 500 ophthalmologists performing over 200 000 operations a year, the statistical distribution will certainly include the few surgeons performing high volumes of procedures or charging high fees, as it does with any other procedure listed on the MBS. Webber’s implied generalisation is totally invalid, as the distribution tail in no way represents the average. I am afraid that Webber has only provided us with sloppy commentary and cheap shots — nice if you can get away with it, but it is poor editorial policy.

Nigel Morlet

To the Editor: Webber is to be congratulated for his concise statement of the ills of Professional Services Review (PSR) audit,1 but his estimate of multiple billions being wasted each year is unsupported by evidence. This remark has already been picked up by several of the nation’s daily newspapers, and well suits those of certain political persuasions. However, it is also essential that the operation of the PSR be subject to scrutiny. The past performance of the PSR must be examined — including the correctness and consistency of the information it uses, its investigative processes, the defence evidence it does and does not accept, and the available avenues of appeal. These issues are all of great concern to doctors who have come to the PSR’s attention. I note that the most recent edition of Medicare’s Forum promises more Medicare audits.2 The fun has only just begun.

A Stuart Reece

To the Editor: After our recently published article1 and subsequent criticism2 that shortages in benzylpenicillin were a “storm in a teacup”, we would like to detail the increasing number of drug shortages at John Hunter Hospital. Not only does this pose increasing costs to pharmacy but there are escalating threats to patient care. As part of our routine formulary management, records are kept on drug shortages, collected to communicate urgent pharmaceutical issues and not designed as a research tool (Box). All shortages recently experienced in this hospital have been in generic medicines, particularly injectables, although any drug is potentially vulnerable. There are shortages that recur; thiopentone has twice been in short supply in recent months, noradrenaline has had recurrent periods of short supply, and intravenous labetalol is currently critically low and has previously been discontinued by a supplier in Australia, requiring a new manufacturer to be found. At the time of writing, midazolam 5 mg/5 mL injection is in short supply despite there being three generic brands in Australia, suggesting that all products come from the same source. The shortages we are experiencing are similar to but less extensive than those described in the United States.3 However, our list is far from complete as we cannot detect suppliers’ shortages that are resolved before our hospital shelves are affected. Hospitals cope in the usual ways — stockpiling (which protects some networks and harms others), switching to alternatives where possible, and finding new suppliers. Not only does this directly compro-mise patient care, it has been shown that subsequent changes in formulary increase medication errors4,5 — not to mention the economic impact, which is not known in Australia but has been estimated to cost $216 million each year in the US.3 Governments in the US and United Kingdom are taking decisive action to rectify this problem. However, the issue remains unrecognised in Australia and the Therapeutic Goods Administration has indicated to the authors that monitoring shortages is not its legislative responsibility. In the interests of national health care security, this issue needs to be resolved immediately by the federal government. Urgent action must be taken to identify medicines that are “essential” and to safeguard their supply through all possible avenues to ensure short-term health care sustainability. Number of different medicines in short supply at John Hunter Hospital, 2006–2011

Robert Pearce · Simon Quilty · Jacqueline Kewley · Lisa M Harris

To the Editor: As an author, researcher and lecturer on the safety of drugs used in the obstetric setting for over 30 years — during which I participated in successive Medicines in Pregnancy Working Parties of the Australian Drug Evaluation Committee and Therapeutic Goods Administration (TGA) — I share Kennedy’s concerns about the alphabetical drug categorisation system currently used in Australia.1 I am also concerned that, since the demise in 2008 of the Prescribing Medicines in Pregnancy TGA Advisory Group (which provided ongoing external clinical expertise to the TGA), there has been a complete lack of action, preparation and consultation with external sources of expertise and experience by the TGA with regard to the safety of drugs used in pregnancy. Expert consultation would be invaluable in preparing for the overseas “game-changing” developments in labelling relating to safety of drugs used during pregnancy, as identified by Kennedy. These changes in labelling are primarily being driven in the United States, with the aim of providing definitive, well substantiated advice to patients and health professionals — advice that reflects the consensus of expert opinion in a way that the alphabetical system, by its inherent structural and functional limitations, is unable to do.

Ronald P Batagol

To the Editor: Kennedy highlights a major source of frustration for mothers and health professionals — the accuracy of information regarding the safety of medications in pregnancy.1 The current categorisation system is inaccurate and outdated. Labetalol, used safely throughout pregnancy to treat hypertension for more than 30 years, has a Category C label because atenolol was associated with intrauterine growth retardation in one study.2,3 Proton pump inhibitors remain in Category C despite large studies demonstrating their safety in pregnancy.4 Hydroxychloroquine is in Category D despite extensive use in pregnancy without any adverse effect.5 The present A to X system could be simplified to three categories — safe, uncertain and definite risk, with a brief description of the information available, together with the references on which the evaluation is made. This could be freely available online and regularly updated as new information is published. In addition, more rapid accumulation of evidence regarding the safety of newer medications in pregnancy and lactation is needed. At present, we rely on the publication of case reports and case series by single institutions. It would be valuable if a national or international database of de-identified information could be kept on mothers and babies who are exposed to drugs for which the safety is uncertain, so that outcomes may be followed, to better guide future parents and their health professionals regarding the safety of these medications in pregnancy and lactation.

Adam P Morton

In reply: As a practising physician, Morton clearly understands the issues faced by prescribers and consumers regarding drug categorisation in pregnancy.1 Currently, the Therapeutic Goods Administration provides no references for the data on which it bases its drug categorisations for pregnancy. It is therefore left to the conscientious prescriber to try to find the data (not always easy or obvious) and then attempt to interpret it in a clinically relevant way. The more narrative approach suggested by Morton is an improvement but would still need clinical context and interpretation for optimal use. The system proposed by the United States Food and Drug Administration (FDA) would provide appropriate referenced data so that clinicians and consumers could see the latest available evidence (and not, as Morton points out, just the limited studies performed up to 30 years ago) about the safety (or otherwise) of medication to enable rational decision making regarding medication use during pregnancy and breastfeeding. The FDA’s proposed new labelling would include contact details of any pregnancy registries, if applicable, for the agent in question.2 At present, there are over 20 pregnancy registries collecting prospective data on the effects of exposures, including antiepileptic drugs and vaccines, as well as registries for pregnant women being treated for chronic medical conditions such as rheumatoid arthritis and HIV/AIDS.3 It is unfortunate that Australian regulators have not properly discussed these issues with interested professionals in the past few years. Even if we cannot remain world leaders in this field, it behoves us to at least embrace innovation occurring in other parts of the world.

Debra S Kennedy

To the Editor: The decline in the number of National Health and Medical Research Council (NHMRC) scholarships awarded to general practitioners over the past 9 years reflects continuing problems in Australia’s capacity to produce a good base of general practice researchers. Since 1998, 20 GPs have received NHMRC doctoral scholarships; nine of these were granted in 2002 and six were granted after 2002....

Gerard F Gill