Every time I hear Pharma dispensers like Paul Ofitt or Pharma trolls like Biden accusing non-vaccinated people of murder, this study comes to mind first thing.
This British Medical Journal analysis used to be one of the first shadow-banned links on Facebook, years before the term was even coined. Together with Google, they managed to fade it out from public attention and references, but it’s a staple of medical journalism and criticism.
Medical error—the third leading cause of death in the US
British Medical Journal 03 May 2016
-Death certificates in the US, used to compile national statistics, have no facility for acknowledging medical error
-If medical error was a disease, it would rank as the third leading cause of death in the US
-The system for measuring national vital statistics should be revised to facilitate better understanding of deaths due to medical care
Medical error is not included on death certificates or in rankings of cause of death. Martin Makary and Michael Daniel assess its contribution to mortality and call for better reporting
The annual list of the most common causes of death in the United States, compiled by the Centers for Disease Control and Prevention (CDC), informs public awareness and national research priorities each year. The list is created using death certificates filled out by physicians, funeral directors, medical examiners, and coroners. However, a major limitation of the death certificate is that it relies on assigning an International Classification of Disease (ICD) code to the cause of death.1 As a result, causes of death not associated with an ICD code, such as human and system factors, are not captured. The science of safety has matured to describe how communication breakdowns, diagnostic errors, poor judgment, and inadequate skill can directly result in patient harm and death. We analyzed the scientific literature on medical error to identify its contribution to US deaths in relation to causes listed by the CDC.2
Death from medical care itself
Medical error has been defined as an unintended act (either of omission or commission) or one that does not achieve its intended outcome,3 the failure of a planned action to be completed as intended (an error of execution), the use of a wrong plan to achieve an aim (an error of planning),4 or a deviation from the process of care that may or may not cause harm to the patient.5 Patient harm from medical error can occur at the individual or system level. The taxonomy of errors is expanding to better categorize preventable factors and events.6 We focus on preventable lethal events to highlight the scale of potential for improvement.
Case history: role of medical error in patient death
A young woman recovered well after a successful transplant operation. However, she was readmitted for non-specific complaints that were evaluated with extensive tests, some of which were unnecessary, including a pericardiocentesis. She was discharged but came back to the hospital days later with intra-abdominal hemorrhage and cardiopulmonary arrest. An autopsy revealed that the needle inserted during the
pericardiocentesis grazed the liver causing a pseudoaneurysm that resulted in subsequent rupture and death. The death certificate listed the cause of death as cardiovascular.
The role of error can be complex. While many errors are
non-consequential, an error can end the life of someone with a
long life expectancy or accelerate an imminent death. The case
in the box shows how error can contribute to death. Moving
away from a requirement that only reasons for death with an
ICD code can be used on death certificates could better inform
healthcare research and awareness priorities.
How big is the problem?
The most commonly cited estimate of annual deaths from
medical error in the US—a 1999 Institute of Medicine (IOM)
report7—is limited and outdated. The report describes an
incidence of 44 000-98 000 deaths annually.7 This conclusion
was not based on primary research conducted by the institute
but on the 1984 Harvard Medical Practice Study and the 1992
Utah and Colorado Study.8 9 But as early as 1993, Leape, a chief
investigator in the 1984 Harvard study, published an article
arguing that the study’s estimate was too low, contending that
78% rather than 51% of the 180 000 iatrogenic deaths were
preventable (some argue that all iatrogenic deaths are
preventable).10 This higher incidence (about 140 400 deaths due
to error) has been supported by subsequent studies which suggest
that the 1999 IOM report underestimates the magnitude of the
A 2004 report of inpatient deaths associated with the
Agency for Healthcare Quality and Research Patient Safety
Indicators in the Medicare population estimated that 575 000
deaths were caused by medical error between 2000 and 2002,
which is about 195 000 deaths a year (table 1⇓).11 Similarly, the
US Department of Health and Human Services Office of the
Inspector General examining the health records of hospital
inpatients in 2008, reported 180 000 deaths due to medical error
a year among Medicare beneficiaries alone.12 Using similar
methods, Classen et al described a rate of 1.13%.13 If this rate
is applied to all registered US hospital admissions in 201315 it
translates to over 400 000 deaths a year, more than four times
the IOM estimate.
Similarly, Landrigan et al reported that 0.6% of hospital
admissions in a group of North Carolina hospitals over six years
(2002-07) resulted in lethal adverse events and conservatively
estimated that 63% were due to medical errors.14 Extrapolated
nationally, this would translate into 134 581 inpatient deaths a
year from poor inpatient care. Of note, none of the studies
captured deaths outside inpatient care—those resulting from
errors in care at home or in nursing homes and in outpatient
care such as ambulatory surgery centers.
A literature review by James estimated preventable adverse
events using a weighted analysis and described an incidence
range of 210 000-400 000 deaths a year associated with medical
errors among hospital patients.16 We calculated a mean rate of
death from medical error of 251 454 a year using the studies
reported since the 1999 IOM report and extrapolating to the
total number of US hospital admissions in 2013. We believe
this understates the true incidence of death due to medical error
because the studies cited rely on errors extractable in
documented health records and include only inpatient deaths.
Although the assumptions made in extrapolating study data to
the broader US population may limit the accuracy of our figure,
the absence of national data highlights the need for systematic
measurement of the problem. Comparing our estimate to CDC
rankings suggests that medical error is the third most common
cause of death in the US (fig 1⇓).2
Human error is inevitable. Although we cannot eliminate human
error, we can better measure the problem to design safersystems
mitigating its frequency, visibility, and consequences. Strategies
to reduce death from medical care should include three steps:
making errors more visible when they occur so their effects can
be intercepted; having remedies at hand to rescue patients 17;
and making errors less frequent by following principles that
take human limitations into account (fig 2⇓). This multitier
approach necessitates guidance from reliable data.
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
There are several possible strategies to estimate accurate national
statistics for death due to medical error. Instead of simply
requiring cause of death, death certificates could contain an
extra field asking whether a preventable complication stemming
from the patient’s medical care contributed to the death. An
early experience asking physicians to comment on the potential
preventability of inpatient deaths immediately after they
occurred resulted in an 89% response rate.18 Another strategy
would be for hospitals to carry out a rapid and efficient
independent investigation into deaths to determine the potential
contribution of error. A root cause analysis approach would
enable local learning while using medicolegal protections to
maintain anonymity. Standardized data collection and reporting
processes are needed to build up an accurate national picture of
the problem. Measuring the consequences of medical care on
patient outcomes is an important prerequisite to creating a
culture of learning from our mistakes, thereby advancing the
science of safety and moving us closer towards the Institute of
Medicine’s goal of creating learning health systems. (19)
We have estimated that medical error is the third biggest cause
of death in the US and therefore requires greater attention.
Medical error leading to patient death is under-recognized in
many other countries, including the UK and Canada.20 21
According to WHO, 117 countries code their mortality statistics
using the ICD system as the primary indicator of health status.22
The ICD-10 coding system has limited ability to capture most
types of medical error. At best, there are only a few codes where
the role of error can be inferred, such as the code for
anticoagulation causing adverse effects and the code for
overdose events. When a medical error results in death, both
the physiological cause of the death and the related problem
with delivery of care should be captured.
To achieve more reliable healthcare systems, the science of
improving safety should benefit from sharing data nationally
and internationally, in the same way as clinicians share research
and innovation about coronary artery disease, melanoma, and
influenza. Sound scientific methods, beginning with an
assessment of the problem, are critical to approaching any health
threat to patients. The problem of medical error should not be
exempt from this scientific approach. More appropriate
recognition of the role of medical error in patient death could
heighten awareness and guide both collaborations and capital
investments in research and prevention.
Contributors and sources: MM is the developer of the operating room
checklist, the precursor to the WHO surgery checklist. He is a surgical
oncologist at Johns Hopkins and author of Unaccountable, a book about
transparency in healthcare. MD is the Rodda patient safety research
fellow at Johns Hopkins and is focused on health services research.
This article arose from discussions about the paucity of funding available
to support quality and safety research relative to other causes of death.
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2 Deaths: final data for 2013. National vital statistics report. http://www.cdc.gov/nchs/fastats/
3 Leape LL. Error in medicine. JAMA 1994;272:1851-7. doi:10.1001/jama.1994.
4 Reason J. Human error. Cambridge University Press, 1990. doi:10.1017/
5 Reason JT. Understanding adverse events: the human factor. In: Vincent C, ed. Clinical
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6 Grober ED, Bohnen JM. Defining medical error. Can J Surg 2005;48:39-44.pmid:15757035.
7 Kohn LT, Corrigan JM, Donaldson MS. To err is human: building a safer health system.
National Academies Press, 1999.
8 Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in
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11 HealthGrades quality study: patient safety in American hospitals. 2004. http://www.
12 Department of Health and Human Services. Adverse events in hospitals: national incidence
among Medicare beneficiaries. 2010. http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf.
13 Classen D, Resar R, Griffin F, et al. Global “trigger tool” shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff 2011;30:581-9doi:
14 Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal
trends in rates of patient harm resulting from medical care. N Engl J Med
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15 American Hospital Association. Fast facts on US hospitals. 2015.http://www.aha.org/
16 James JTA. A new, evidence-based estimate of patient harms associated with hospital
care. J Patient Saf 2013;9:122-8. doi:10.1097/PTS.0b013e3182948a69 pmid:23860193.
17 Ghaferi AA, Birkmeyer JD, Dimick JB. Complications, failure to rescue, and mortality with
major inpatient surgery in Medicare patients. Ann Surg 2009;250:1029-34. doi:10.1097/
18 Provenzano A, Rohan S, Trevejo E, Burdick E, Lipsitz S, Kachalia A. Evaluating inpatient
mortality: a new electronic review process that gathers information from front-line providers.
BMJ Qual Saf 2015;24:31-7. doi:10.1136/bmjqs-2014-003120 pmid:25332203.
19 Institute of Medicine of the National Academies. Continuous improvement and innovation
in health and health care. Round table on value and science-driven health care. National
Academies Press, 2011.
20 Office for National Statistics’ Death Certification Advisory Group. Guidance for doctors
completing medical certificates of cause of death in England and Wales. 2010.
21 Statistics Canada. Canadian vital statistics, death database and population estimates.
22 World Health Organization. International classification of diseases.http://www.who.int/
To be continued?
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