In May 2016, the British Medical Journal (BMJ) published an article with the headline: Medical error—the third leading cause of death in the U.S. The article estimated that as many as 250,000 deaths per year in the United States were caused by medical error. This was a sharp increase from the first major report on error-related deaths.
Not surprisingly, this garnered instant and worldwide attention from news outlets including CNN, the Washington Post, CBC, and the Guardian. The attention of physicians, hospitals, and patients was focused yet again on medical error. The “third leading cause of death” statistic has been referred to by organizations like Leapfrog Group whose business includes a focus on medical errors. It has also been used by others such as pro-gun activists to attack the credibility of doctors and the health care system.
More quietly, and starting almost immediately after the publication, some in the health safety and quality improvement field have expressed concern that the BMJ article grossly inflated the magnitude of deaths from medical error. They are concerned that the article is inaccurate and might lead many to question the scientific credibility of the field of health safety and quality improvement.
This article explores the controversy.
What are medical errors?
The term medical error typically refers to a preventable adverse event (negative outcome) that was caused by an error, such as the administration of the wrong medication. However, the term is also used by some to include all adverse events rather than just those caused by a health worker’s error, such as an allergic reaction to a medication. While some adverse events are clearly preventable errors, for others it is less clear. For example: a complication such as bleeding from surgery could be due to a surgeon’s error or because the patient was prone to bleeding. While the vast majority of errors are not fatal, errors causing death have been used as a proxy for the magnitude of the problem of medical error.
The field of health safety aims to minimize medical errors. Because most medical errors should at least theoretically be preventable, it is understandable why the patient safety movement has grown in the last years.
Measuring medical error
The BMJ article arrived at the number of 250,000 deaths per year in the United States by averaging the rate of preventable deaths from medical error from four previously published studies. The authors called for a better system of tracking deaths from medical error, and suggested that medical error be included on death certificates.
Many experts in the field of health safety were surprised by the high number of deaths attributed to medical error in the BMJ publication. Kaveh Shojania, a quality improvement researcher in Toronto and editor of the journal BMJ Quality and Safety, was one of them. He thinks a more accurate number is in the neighbourhood of two percent of deaths, based on studies which estimate deaths due to medical error make up 5.2 percent, 3.6 percent, and less than one percent of in-hospital deaths. This would correspond to 15,000–35,000 deaths per year in the U.S., an order of magnitude lower than the BMJ estimate.
Shojania and co-author Mary Dixon-Woods were concerned enough to publish an opinion piece shortly after the BMJ article was published, outlining the problems with the 250,000 figure. They pointed out that the four studies selected by the authors were not designed to measure deaths from medical error and did not accurately determine which deaths occurred because of medical error. The number of deaths that were included in three of the four studies were small (with only 14, 12, and nine deaths), and were extrapolated by the authors of the BMJ paper to much larger populations, leaving room for considerable error. In addition, the extrapolations were sometimes done incorrectly: The patient populations used to measure the rates of medical error and death excluded those admitted for childbirth or mental health, and yet, those rates were extrapolated to every hospitalization in the U.S. (of which childbirth is the most common).
The criticisms of the BMJ study included an issue that is common to all studies of death from medical error, which is that there is often a high degree of subjectivity in determining how much an error contributed to a patient’s death and to what extent that death was preventable. “If a frail older person comes to a hospital with pneumonia, gets antibiotics, and as a result gets C. difficile colitis (an infectious diarrhea that is a known complication of antibiotics) and dies, the question is: What caused that person’s death?” asks Alan Forster, vice-president of Innovation and Quality at the Ottawa Hospital. “Was it the antibiotic-associated diarrhea? Was it their frailty? Was it the pneumonia? And secondly, even if the death is classified as due to the antibiotic, was it really preventable, or not?” Many people wouldn’t consider this death preventable because C. difficile is a known complication of antibiotics, and the antibiotics were needed to treat the pneumonia. In the studies used to arrive at the 250,000 value, this death would have been considered preventable.
The authors of the BMJ articles responded to some of the initial criticisms, and continued to stand by their estimate. We reached out to them for comment but did not receive a response.
Fiona Godlee, editor of the BMJ, acknowledges that there are flaws with the methods used in the 2016 article. “The article itself perhaps doesn’t strongly enough state that the methodologies for trying to do this are problematic,” she says. But she believes readers of the BMJ will interpret the estimate with appropriate caution. “The research community recognizes [this article] is for debate,” she says. “The media may have picked it up and gone with it as a statement of fact, and the headline didn’t help with that.”
Forster speculated why the BMJ study may have been published despite the flawed methodology. “Some people in the patient safety world feel like they have to generate these statistics to help wake people up to the scale of the problem,” he says. The argument goes that as long as people recognize the flaws, the attention it generates is a good thing. Godlee seems to agree. “The methodology is a little bit misguided, and it’s hard to agree on the right methodology, but that shouldn’t stop us from trying,” she says. “It is a good thing that there is awareness and that this is raised.”
The risks of inaccurate estimates of deaths caused by medical error
While few would argue about the importance of drawing attention to the field of patient safety, some members of the health safety research community are concerned that there are repercussions from being inaccurate.
Over the past three years, the value generated by the 2016 paper has been used by some groups to undermine physicians and their credibility. In a recent online dispute between the National Rifle Association and physicians regarding gun control, supporters of the NRA used this statistic to argue that doctors are more harmful than guns, and to de-legitimize the concerns doctors were raising about gun safety. A similar argument has been made by some naturopathic organizations and reported by alternative news sites to “warn” readers about the dangers of the health care system.
The Leapfrog Group acknowledged that they are “aware that there is great debate over the true number of deaths due to medical errors.” However, they continue to feature the numbers from the BMJ article on their website currently. In their response to questions from Healthy Debate they said, “What we can all agree on is that any death from preventable medical harm is one too many.” They did not comment when asked about any potential harms from using contested values.
Some worry that an inaccurate and inflated estimate of preventable deaths risks reducing the credibility of the field of health safety within the health care and research community. “[It] can cause a backlash from providers who read it and think ‘it doesn’t make sense,’” says Forster. Rather than bolstering enthusiasm for tackling medical error, a grossly inflated statistic may hurt the field instead. “If you keep shouting inaccurate statistics, then maybe people will become increasingly skeptical and not take the field seriously,” says Shojania.
In-hospital deaths from medical error are a small subset of all medical errors, and non-fatal errors cause considerable harm to patients. Considering that most of health care occurs in the ambulatory setting, there is an even larger potential for error to cause harm outside of hospitals. The potential problem with focusing too much on in-hospital deaths from error is that hospitals may move resources away from other areas of quality improvement that deserve attention. Common problems including diagnostic delay, medication errors, under-treatment, and over-treatment run the risk of being neglected because they often do not lead to death. “When you keep trumpeting these deaths due to medical error you force the hospitals to take the precious time, human, and financial resources they have for doing any sort of quality improvement work to looking just at deaths,” says Shojania.
Despite the controversy about the number of deaths from in-hospital error, all would agree that medical errors occur more frequently than they should and their prevention is important. How errors are measured, tracked over time, and how much attention should be focused on deaths continues to be discussed. What appears clear is that deaths from medical error provide only part of the picture.
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We have a big problem in this country, this should not be but yet it is. Everything is becoming dumb down, all these morons that are being pumped out at these schools is sad. This is all by design.Hospital were getting 55000 for a patient to be put test for bullshit 19, plus a ventilator, which was killing many. So blood money is where we are at now in this dead rotting Country.
Actually the bigger issue is how medications are packaged. There is no universal packaging or dosing per drug. This includes all drugs even emergency medicines. Big pharma can and should be forced to comply with universal packaging. I personally have seen Lidocaine in bottles that resemble common blood thinners like heparin. Mixing these up in an IV injection is fatal.
It seems that Medical Errors Have Been Replaced By Covid For 2020-2021.
I had an out-patient repair surgery on my left shoulder, I remember the nurse and I were talking as she moved me from recovery to my outpatient room. After she got me settled in my room, she ask if there was ant thing she could get me, I asked for a cup of coffee. She replied it was old but she would bring me a cup of water. I remember her leaving the room and turning to her right. ( Note ) I felt very groggy and fuzzy headed feeling,,,,,
The next thing I knew was waking up with doctors all around me, they said I coded and Rebecca the nurse had to do CPR for 7 minutes but did not respond until NARCAN was given ( no EPY was given ) I then was moved to ICU they ran all the test on my heart including a medication induced stress test, every thing on my heart checked normal. Then I had to wear the MCOT monitor for 30 days, it also came back normal. Now I have been diagnosed with PTSD from dying, cant sleep even with taking TRAZODONE, waiting to get in to see a psychiatrist due to the Anxiety disorder / unspecified.
So was I given to much of something during surgery, and overdosed in the out patient room with my wife at my side. Why did my heart just stop ?? and no EPY was given. someone knew I had been overdosed is the reason for the NARCAN ???
My weght is 145 lbs. age is 60 my height is 5.5 ft. blood pressure usually runs around 135/76 pulse is normally around 72-75 never any problems with my heart in the past.
What made you think about such a topic. Its funny I am not the only one that feels that way about it. Keep it up!
The AMA has tried to discredit naturopathic organizations as “quackery” based off of assumptions and not backing it up with research. It’s funny that they can’t take it when someone turns the tables and attacks them. Stats can always be misinterpreted but John Hopkins also stated something very similar as far as annual deaths. The medical profession needs to face the fact that insurance companies dictate how they treat their patients and having someone “try” a pill to see what effects it has is not very scientific.
Lazarou at al showed 106,000 deaths yearly in US hospitals caused by prescription drugs alone. 0.32 % in1998. Does anyone think that number has gone down? Add to that all other errors and To Err is Human is credible.
It’s become a for profit industry run by the insurance company’s and big pharmaceutical. Sad but true. Just hope you don’t get sick
One of the worst errors…no unbiased nutritional research has been done and provided to medical schools. In my own life this created major health problems in my first child by following the information his pediatrician gave me. When poor nutrition creates malnutrition – no drug will solve the problem,
Why hasn’t nutritonal research been done by the U.S. government? In most cases it has been left to the food industries. They provide their research to nutriton schools. It has put America behind the blackball in world health.
Malnutrition leads to illness and a shorter life, even medical doctors suffer from lack of nutritional knowledge According to medical statistics the mortality of docors is 72 years.
Preventable medical-error related deaths are devastating. It does not matter the number of cases that happen, one to fifty, all should be considered an issue. Referenced in the article, “the term is also used by some to include all adverse events… such as an allergic reaction to a medication” (Dorian, 2019). Although these incidents are unfortunate, I do not believe that they should be added into the accounts of preventable medical errors and their related deaths because some are unavoidable and not always the physicians fault. This leads into where the inaccurate numbers of cases can occur. If preventable medical-error related deaths are not strictly defined, what some people consider a preventable error, others may not. In another article, Modern medicine, they state, “A recent Johns Hopkins study claims more than 250,000 people in the U.S. die every year from medical errors. Other reports claim the numbers to be as high as 440,000” (Sipherd, 2018). This is a 190,000 patient death difference. Those who conduct these experiments and take polls should include a strict guideline to the cases they include so a more accurate number can be developed. This would lead to restoring the credibility of the number of cases and can bring attention to the issue.
this is one of the best articles about medical error-causing death. i really thank you for giving this information…
Good article. Thanks!
I enjoyed this article as well as the range of reactions to it. But one thing is inescapable – unintended severe harm and death will continue to occur to patients if there is no analysis, learning or improvement based on the causes of these critical incidents. As long as we don’t have accurately reported, analysed and transparent data, the real number, causes and potential solutions will be speculative to some degree. A first step would be to remove the stigma practitioners and health safety professionals have around admitting fallibility, fatigue, distraction, under-staffing, poor labeling of drugs, illegible orders and instructions, misplaced case notes, faulty equipment, poor patient transfers and handoffs, etc. as causes of critical incidents. Let’s focus on systems that are not optimally coordinated, rather than the medical staff who are required to operate within them, as the things that need to be assessed and changed to improve patient safety.
Great article. It highlights how we have become inured to what these mass numbers really mean, whether 250,000 or 25,000, in the human context.
Building on the earlier comment citing the aviation industry, the former number would result in the crash of 1,250 Boeing 737 MAX aircraft with an average passenger capacity of 200 people. The latter number results in 125 crashes, or TWO crashes per WEEK.
It took TWO crashes of the MAX for the global aviation industry to ground all of the planes.
The debate over numbers is misleading, as I would think that there is general agreement that this is a serious problem. The more important question is, “why is there no public outcry over the lack of action from regulators, professionals, and policy makers to tackle a problem that is clearly killing lots of people”?
Guns kill people. And we have to take action against that. Let’s admit that health care also kills people and find the brave leadership with the will to take action to remedy that.
No one is denying there’s a problem. Even 1 preventable death is a tragedy.
Maybe you missed this in the article above: “Over the past three years, the value generated by the 2016 paper has been used by some groups to undermine physicians and their credibility. In a recent online dispute between the National Rifle Association and physicians regarding gun control, supporters of the NRA used this statistic to argue that doctors are more harmful than guns, and to de-legitimize the concerns doctors were raising about gun safety. A similar argument has been made by some naturopathic organizations and reported by alternative news sites to “warn” readers about the dangers of the health care system.”
That’s where the harm of inflated numbers occurs. And those are not the only two groups trumpeting the 250,000 number.
How many lives are saved by flying in an airplane. There are definitely to medical treatment or procedures, and yes some of those risk can be mitigated by not making mistakes, but let’s not forget most people dont go to the doctor just for the hell of it, they typically have an issue of some sort. Most people flying are doing it for leisure or work.
If the medical industry was as transparent as the aviation industry about safety incidents, we wouldn’t even be having this tangential conversation from the real issue of hidden data and denial of accountability.
It is curious that so few studies have been conducted on medical harm and death.
From what I understand, hospitals and physician organizations keep those numbers close to their chest. And government legislation in some jurisdictions prevents the data from being used in medical malpractice law suits.
In all likelihood, medical error (death, harm, near misses, etc) is vastly underreported. I interview victims / survivors of medical errors on my podcast (Medical Error Interviews) and each and every one them experienced multiple medical errors.
Compounding the harm and trauma of medical error, is the resistance and denial to make amends by hospitals and physician organizations. It only makes a bad situation worse for the harmed patient and their family.
I concur!
The problem with our broken, disfunctional health system has a great deal to do with a lack of accountability to the patients who rely on the training and expertise of the medical practitioners. In every business there is a mode of measurement to determine if operations are running the way they should be and the medical field should be no exception. Whether these stats are accurate or not in the writers opinion, is not the issue. The issue is that it does not take a special study to know that we are now having to rely on a medical system that is broken and sick people have to deal with doctors that may try to do their best, but rely heavily on 10 minute assessments and pharmaceutical drugs and have no time for the patient education or to properly assess the patients status, and that is just a remedy for mistakes. The attitudes of many healthcare practitioners, for whatever reason, are arrogant and cold, which does not promote a good patient doctor relationship in an industry that invades a person’s privacy to the extreme in order to do their job. The first stop to resolve these concerns is to the bean counters, that put the dollars before the life of patients, and the second to the doctors who are happy to earn very large dollars in lieu of taking less patients but doing a better job. There is also a distinct lack of effort for G.P. to update their education on diseases and alternatives to pharmaceutical drugs.
Instead of skirting the issues in favour of a healthy financial gain, doctors need to be in the medical field for the right reasons(do no harm). The status quo of “work to rule” mentality from medical staff should no longer be tolerated by the taxpayers that put those large dollars in their pockets every year, whether they do a good job or not.
There’s a much larger meta-analysis, also published in the BMJ in 2019, that used 70 studies with over 337,000 patients. The estimate number of people with preventable severe harm or death was just over 2400, i.e., about 0.7% of the patients.
Thanks for pointing that out. Yet nobody quotes that article, they continue with the erroneous claims. Look at how the false claim about vaccines and autism has persisted.
Great article. Research leading to demonstrably inaccurate results can never be justified, and this includes ill concieved attempts to raise awareness.