Despite these efforts to identify the extent of patient harm over more than 20 years, and many attempts to reduce patient harm, the healthcare system remain surprisingly tolerant to continuing high levels of preventable patient harm. While there appears to be widespread acceptance in medicine of the maxim that a doctor should “First, do no harm”, in 2008 the World Health Organisation stated that “Unsafe medical care is a major source of morbidity and mortality throughout the world”47.
In those countries, which have had data on the frequency of harm for the longest, the story is little changed. Using the results from the New York based Harvard Medical Practice Study and the Utah-Colorado study set out in Table 1.2 above, the 1999 US Institute of Medicine Report To Err is human stated:
When extrapolated to the over 33.6 million admissions to U.S. hospitals in 1997, the results of the study in Colorado and Utah imply that at least 44,000 Americans die each year as a result of medical errors. The results of the New York Study suggest the number may be as high as 98,000. Even when using the lower estimate, deaths due to medical errors exceed the number attributable to the 8th-leading cause of death. More people die in a given year as a result of medical errors than from motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516). … In terms of lives lost, patient safety is as important an issue as worker safety. Every year, over 6,000 Americans die from workplace injuries. Medication errors alone, occurring either in or out of the hospital, are estimated to account for over 7,000 deaths annually.48
The goal of the report was to “break the cycle of inaction” and to produce a health system for patients that did not cause harm49. The four-tiered approach recommended looked at systemic responses in the main and proposed, among other things, a nationwide mandatory
47 World Health Organisation (WHO) World Alliance for Patient Safety. Summary of the evidence on
patient safety: implications for research. Prepared by the Research Priority Setting Working Group of the World Alliance for Patient Safety. 2008 WHO, Geneva: page XIII.
48 Kohn LT. Corrigan JM. Donaldson M. (editors). To err is human: building a safer health system.
Committee on Quality of Healthcare in America. Institute of Medicine. 1999 National Academy Press, Washington DC: pages 1-2.
Chapter 1 – Preventable Patient Harm
reporting system for all “adverse events that result in death and serious harm”50. More than a decade later in 2011, the US Commonwealth Fund noted that:
[Despite] national, statewide and professional campaigns to persuade hospitals to adopt practices that have been shown to reduce patient mortality … nevertheless, the nation appears to be far from realizing the goal of eliminating unintentional harm to some patients resulting from healthcare. For example, a recent study found no significant change from 2002 to 2007 in the overall rate of patient harm or of preventable harm recorded in patient records drawn from a random sample of 10 hospitals in North Carolina.51
There have been only a few studies looking at the longitudinal recording of patient harm data, and these confirm that there has been little progress. A study of patient harm levels in 10 hospitals in North Carolina, noted above, was published in 2010. This used the IHI Trigger Tool methodology (which gave a rate of preventable patient harm around 25% of admissions), and showed that there was no significant change in the rate of harm identified by internal reviewers over the six-year period, and that there was no reduction in rates of harm judged to be preventable52. A 2013 Dutch study showed an increase in adverse events over the period 2004-2008, from 4.1% to 6.2%. While the study considers that some of the increase arose from changed patient case-mix, the authors conclude that the patterns of adverse events over the period remain consistent, and that “patient harm related to
healthcare is a persistent problem that is hard to influence” and that continuing to measure over time “stresses the continuing urgency” for action on patient safety.53
Action has also been slow both in the US and Australia on one of the acknowledged prerequisites for accurately measuring progress on preventable patient harm: the regular
50 Institute of Medicine. To Err is human: building a safer health system summary. November 1999:
page 3.
51 McCarthy D. Klein S. Keeping the Commitment: a progress report on four early leaders in patient
safety improvement – synthesis report. Publication 1478, volume 10. March 2011 The Commonwealth Fund, Washington DC.
52 Landrigan CP. Parry GJ. Bones CA. Hackbarth AD. Goldman DA. Sharek PJ. Temporal trends in
rates of patient harm resulting from medical care. 2010 New England Journal of Medicine, 25 November, volume 363(22), pages 2124-2134: at page 2127.
53 Baines RJ. Langelaan M. de Bruijne MC. Asscheman H. Spreeuwenberg P. van de Steeg L.
Siemerink KM. van Rosse F. Broekens M. Wagner C. Changes in adverse event rates in hospitals over time: a longitudinal retrospective patient record review study. 2013 BMJ Quality and Safety, April, volume 22(4), pages 290-298.
Chapter 1 – Preventable Patient Harm
recording of individual patient harm and patient outcomes of care as a normal incident of healthcare. In the US, for example, one commentator noted that a decade on from the Institute of Medicine’s report that “hard evidence of improved outcomes remains elusive because of our rudimentary measurement capacity in safety”54. The lack of effective, and appropriately sensitive measurement of the incidence and types of preventable patient harm was recently identified as one of the probable explanations for the lack of progress in patient safety, combined with the lack of proven effective, “dispersible” interventions, low levels of financial investment and the “newness” of the patient safety “discipline”55. The authors of the 2016 estimate that medical error was now the third highest cause of death in the US noted that:
currently deaths caused by errors are unmeasured and discussions about prevention occur in limited and confidential forums, such as a hospital’s internal root cause analysis committee or a department’s morbidity and mortality conference. These forums review only a fraction of detected adverse events and the lessons learnt are not disseminated beyond the institution or department.56
In Australia, two decades after the publication of the Quality in Australian Health Care Study, there have been repeated calls for the regular collection of reliable data on adverse events but little action. The Final Report of the Professional Indemnity Review that commissioned the Australian study57first recommended this in 1995. In 2010, the
Australian Commission for Quality and Safety in Healthcare, echoing the earlier reports of the previous 15 years, stated that:
Measuring the safety of healthcare is a key step .... However, currently, there is a lack of reliable and consistently reported national data on patient safety in
Australian hospitals which quantifies the levels of harm or the rate of adverse events. One of the essential tools in improving patient safety in Australian hospitals is the provision of routine, accurate data on the severity and types of patient harm to clinicians, hospitals and policy makers. Sentinel events are reported annually by
54 Wachter RM. Patient safety at ten: unmistakable progress, troubling gaps. 2010 Health Affairs.
January, volume 29(1), pages 165-173: at page 172.
55 Shojania KG. Thomas EJ. Trends in adverse events over time: why are we not improving? 2013 BMJ
Quality and Safety, April, volume 22(4), pages 273-277.
56 Makary et al 2016 – see note 3: at page 2.
57 The need for effective data on preventable patient harm was called for in the Final Report of the
Professional Indemnity Review (the overseeing and funding body of the Quality in Australian Health Care Study) in 1995, the Taskforce in Quality and Safety in Australian Healthcare in 1996 (See eg Recommendations 7 and 17 and others), the National Expert Action Group on Quality and Safety in Australian Healthcare in 1999 (Action 5), the Australian Council on Quality and Safety in Healthcare and the Paterson Review of the Council in 2006.
Chapter 1 – Preventable Patient Harm
jurisdictions, by the Productivity Commission, and in this publication. Such reporting, however, does not constitute the timely, routine feedback of key
information required to support change at all levels of the system. The need to go beyond sentinel events and understand the magnitude of those events which occur far more often but result in relatively lower patient harm (sometimes referred to somewhat dismissively as ’mundane’ events) has been argued for some time. These
events cause significant harm to patients.58
In 2012, the Australian Commission for Quality and Safety in Healthcare, stated in its new Accreditation standards that:
Although most healthcare in Australia is associated with good clinical outcomes, patients still do not always receive all the care that is recommended to them, and preventable adverse events continue to occur across the Australian healthcare system.
Presently, the data that measures the extent to which problems are occurring are unavailable or unreliable. This prevents the establishment of a baseline value from which improvements in safety and quality of care can be measured.59
While there have been many activities directed at safer healthcare, these do not appear to have been effective in the reduction of preventable harm to patients, despite the extensive focus on “system improvement”. Even where these efforts may have had success,
understanding of this and dissemination of lessons remain hampered by inadequate patient outcome recording.
58 Australian Commission on Safety and Quality in Health Care (ACSQHC). Chapter 10 - Reporting
for Safety: Use of Hospital Data to monitor and improve patient safety in ACSQHC. Windows into Safety and Quality in Health Care. 2010ACSQHC, Sydney: page 86.
59 Australian Commission on Safety and Quality in Healthcare (ACSQHC). National Safety and