The iatrogenic‐harm cost equation and new technology (2005)

Health care is one of the last complex, high-technology industries to adopt a systematic approach to safety, and typically relies heavily on the resolve and vigilance of individual clinicians to avoid bad outcomes for the patient. The Institute of Medicine in the United States has claimed, ‘health care is a decade or more behind other high-risk industries in its attention to ensuring basic safety’[1]. Although the vast majority of patients clearly benefit from modern health care, and such care may be safer than it has ever been, the rate of injury and death inadvertently caused by medical treatment remains too high and exacts enormous human and financial costs [2]. Each year, in Britain and the United States alone, hundreds of thousands of patients are injured, tens of thousands are killed and billions of Euros are spent on additional health care because of treatment-caused harm [1]. The dominant paradigm for safety in health care remains that of the so-called person approach, in which the onus for safety is placed squarely on the shoulders of the individual clinician [3]. However, doctors and other clinicians are human, and error is a statistically inevitable and non-negotiable concomitant of being human. Thus, under the person approach, when mistakes are inevitably made, individuals are blamed for their carelessness, or other character weakness, and told to try harder to avoid error in the future. After such censure, typically little or nothing is done to remove or redesign the error-prone aspects of the work environment that precipitated the error. Thus, it is guaranteed that similar errors will continue to be made in the future and that further clinicians will be blamed for their carelessness. By contrast, safety cultures, such as that in the aviation industry, employ the system approach, which interprets accidents or failures as indicators of faulty work systems that require redesign. Removing or appropriately redesigning an error-prone aspect of the work environment permanently eliminates one source of error or system failure. Thus, employing the system approach long-term will gradually make work environments error-proof and increase the safety and efficiency of the organisation. Unfortunately, the persistence of the person approach in health care often leads to claims that it is prohibitively expensive to adopt new technologies intended to improve the safety of patient care. In 1973, despite several pleas from the British Diabetic Association, the Department of Health in Britain declared that the provision of disposable syringes and needles for diabetics involved an expense that could not be justified [4]. Despite significant patient trauma and death, similar objections on the basis of cost have been made against antihypoxic devices on anaesthetic machines [5], safer intravenous drug tubing sets [6] and, more recently, depth-of-anaesthesia monitoring systems [7]. In many cases, patients are prepared to pay considerably more than clinicians believe in order to access safer medical care [7]. Clearly, the introduction of new technology should involve a cost–benefit analysis. However, claims that new, safer technologies are prohibitively expensive almost never include, or even attempt to estimate, the potentially very large cost savings resulting from avoiding patient harm in the medium to long-term. Omitting the savings side of the iatrogenic-harm cost equation is becoming increasingly unacceptable and this change will have a significant impact on the adoption of future safety technologies throughout health care [2]. A persistent and concerning problem in anaesthesia is that of drug administration error, as highlighted in recent papers in this journal, including an in-depth review [8-11]. Between 1978 (the year of Cooper et al.'s landmark safety paper [12]) and the present, I have been able to find only five prospective incident studies which include a denominator and so allow the calculation of a rate of drug error per anaesthetic[13-17](Table 1). These relatively accurate rates show that, over a period of 20 years, and despite significant advances in almost all aspects of anaesthesia, the reported rate of drug administration error has not decreased. Despite this, at least until very recently, two kinds of objections were typically made to the introduction of safer drug administration systems. The first were the usual cost objections, but the second were made on the basis of what I have called the culture of denial and effort (proposed as the antithesis of the culture of safety in aviation and other industries [2]). This view holds that no safety devices are needed because the presence of the doctor is seen as the ultimate safety device. An extension of this view holds that safety will actually be improved by work environments that are deliberately made more error-prone, thus forcing doctors to be at their most vigilant. An example of this view appeared in a comment by a then editor of this journal in 1981, following a letter by Dr Nott [18], and stated, ‘there are very sound arguments for recommending that all ampoules should be identical in appearance…Such a practice would compel users to read the inscription’. A similar example that I have heard many times over the years after safety presentations is that all drug ampoules should be placed in a fish bowl and mixed – again this is intended to increase safety by ensuring that the anaesthetist reads the label properly during an anaesthetic. In a 1996 editorial we see another example of this view: ‘we must continually retrain ourselves to read the words. We should ensure that we do not read what we expect, but inspect what we read’[19]. Even more recently, in 2002, we are informed that ‘Doctors must read drug labels, not whinge about them’[20]. Thus the culture of denial and effort is an extreme version of the person approach that puts more pressure on the doctor to ‘get it right’, while deliberately maintaining a work environment that makes it easier to get it wrong. This approach is diametrically opposite to that of modern organisational safety programmes in all other industries with which I am familiar and can only be described as an ergonomic nightmare [2]. It is heartening therefore to read of the significant safety advances which have recently occurred involving the redesign of drug administration systems[10]. Despite being told as late as 2002 that there was ‘no realistic possibility of an “international” scheme’ for the colour-coding of syringe labels [21], Britain has now adopted the ‘international’ colour standard used in the United States, Australia, New Zealand and Canada, and has done so without significant incident [22]. This colour-coding standard is now being adopted in other countries. Other safety improvements include the development of systems which physically prevent the potentially fatal cross connection of drug administration tubing, the possibility of the standardisation of ampoule colour-coding to match the ‘international’ syringe-label colour-standard, and numerous other system-based changes [10]. Widespread adoption of such multifactorial changes to the systems with which anaesthetists must work can be expected to finally reduce the persistent problem of drug administration error below the rates in Table 1. Now is therefore an ideal time to begin collecting high-quality incident data with which to detect, monitor and analyse this historically important paradigm shift in practice. These data will also allow a relatively accurate estimate of the cost savings associated with the reduction in patient harm, thereby allowing both sides of the iatrogenic-harm cost equation to be addressed. However, it is important to realise that this is just the beginning for the construction of a stronger safety culture in anaesthesia. A great deal more can be learnt from successful safety programmes in other high-reliability organisations [2, 3, 23-25]. For example, many other well-developed techniques exist, such as Root Cause Analysis, which allow faulty work systems to be analysed and re-designed much more quickly than by requiring the collection of incident data sufficient to show a significant reduction in a particular type of error [24, 25]. In addition, the threshold for the reporting of incidents in anaesthesia must be lowered to include more accident precursors. For example, in the nuclear power industry, the threshold for the reporting of significant accident precursors is defined as any incident with a probability of at least 1 × 10−6 (or one in one million) of causing damage to the reactor core [26]. By contrast, in health care, patients often have to die, sometimes year after year from the same system fault, before anything is done about it [27]. The reporting of accident precursors can allow dangerous medical systems to be identified and redesigned before patient harm occurs. A significant cultural barrier to the systematic improvement of patient safety remains that of the compartmentalisation of hospital budgets. Managers in many hospitals are concerned only with the budget into the next year. Such short-sighted financial planning makes it difficult to justify expenditure on new safety systems which are likely to incur significant cost immediately, but which will reap savings on a time scale considerably longer than managers care to measure. Even the relatively accurate estimation of large future savings from the avoidance of iatrogenic harm may seem unconvincing to some managers because of the difficulty in tracking and quantifying cost savings throughout the hospital resulting from a particular safety initiative. For example, an anaesthesia department might spend money on a new safety system that results in significant cost savings in other hospital departments – through perhaps shorter patient stay or fewer occurrences of a particular complication. Although a net reduction in iatrogenic harm and expenditure has been achieved at a hospital-wide level, the anaesthesia department may still be censured for being ‘over budget’ because cross-crediting of savings from other hospital departments is not carried out. Culture change and system improvement must therefore occur at the managerial and financial levels, as well as at the clinical. Another common barrier to the improvement of patient safety is the deeply ingrained desire to blame those who report incidents and accidents. I recently published a paper that attempted to stimulate anonymous incident reporting and system redesign on the hospital ward, and was pleased when a ward nurse contacted me and asked further questions about the setting up of such a scheme [28]. However, senior nurses and managers later thwarted plans to introduce the scheme because they were concerned that it might identify large numbers of undesirable events occurring on the ward and that anonymous reporting would not allow the identification of the person making them! Unfortunately, the prospect of blame also lingers in anaesthesia. This explains why Hazel Adams was cautioned by her colleagues when she recently attempted to record every error she made during anaesthesia in a single year and why none of her colleagues would join her in the exercise [8]. However, everyone should report incidents, because everyone makes mistakes, particularly in error-prone workplaces like hospitals. No news is not good news in terms of system redesign. It is a myth to suppose that only one or two ‘bad apples’ make mistakes or report incidents. Some individuals probably do report more incidents than others, but this may indicate only that they work in a more error-prone environment, or that they are, ironically, more conscientious about the improvement of patient safety. Genuinely negligent acts can be dealt with through the usual regulatory channels, and negligent individuals are unlikely to complete incident forms in any case. It is often claimed that anaesthesia is a leader in patient safety [29]. This is a reputation of which to be proud. It is, of course, a reputation that also requires considerable work to maintain. Establishing a stronger safety culture in anaesthesia will require a greater emphasis on systems and less emphasis on blame. It will require the widespread collection of high-quality incident data with which to identify faulty systems, and the use of a number of analytical techniques to better understand how to fix such faults. It will require the lowering of the threshold for the reporting of system problems to include many accident precursors currently considered inconsequential. However, most of all, establishing a stronger safety culture in anaesthesia will require considering both the cost and savings sides of the iatrogenic-harm cost equation. The cost of a single case of significant iatrogenic harm would pay for a great deal of patient safety. Avoiding safety initiatives simply because they cost a little more will become increasingly untenable in the future.