A medical error is a preventable
adverse effect
An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complica ...
of care ("
iatrogenesis
Iatrogenesis is the causation of a disease, a harmful complication, or other ill effect by any medical activity, including diagnosis, intervention, error, or negligence. "Iatrogenic", ''Merriam-Webster.com'', Merriam-Webster, Inc., accessed 27 ...
"), whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete
diagnosis
Diagnosis is the identification of the nature and cause of a certain phenomenon. Diagnosis is used in many different disciplines, with variations in the use of logic, analytics, and experience, to determine " cause and effect". In systems engin ...
or
treatment of a
disease
A disease is a particular abnormal condition that negatively affects the structure or function of all or part of an organism, and that is not immediately due to any external injury. Diseases are often known to be medical conditions that a ...
,
injury
An injury is any physiological damage to living tissue caused by immediate physical stress. An injury can occur intentionally or unintentionally and may be caused by blunt trauma, penetrating trauma, burning, toxic exposure, asphyxiation, o ...
,
syndrome
A syndrome is a set of medical signs and symptoms which are correlated with each other and often associated with a particular disease or disorder. The word derives from the Greek σύνδρομον, meaning "concurrence". When a syndrome is paired ...
,
behavior
Behavior (American English) or behaviour (British English) is the range of actions and mannerisms made by individuals, organisms, systems or artificial entities in some environment. These systems can include other systems or organisms as wel ...
,
infection
An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable dise ...
, or other ailment.
Definitions
The word ''error'' in medicine is used as a label for nearly all of the clinical incidents that harm patients. Medical errors are often described as
human error
Human error refers to something having been done that was " not intended by the actor; not desired by a set of rules or an external observer; or that led the task or system outside its acceptable limits".Senders, J.W. and Moray, N.P. (1991) Human ...
s in healthcare. Whether the label is a medical error or human error, one definition used in medicine says that it occurs when a
healthcare
Health care or healthcare is the improvement of health via the prevention, diagnosis, treatment, amelioration or cure of disease, illness, injury, and other physical and mental impairments in people. Health care is delivered by health profe ...
provider chooses an inappropriate method of care, improperly executes an appropriate method of care, or reads the wrong
CT scan. It has been said that the definition should be the subject of more debate. For instance, studies of hand hygiene compliance of physicians in an ICU show that compliance varied from 19% to 85%.
The deaths that result from infections caught as a result of treatment providers improperly executing an appropriate method of care by not complying with known safety standards for hand hygiene are difficult to regard as innocent accidents or mistakes.
There are many types of medical error, from minor to major,
and causality is often poorly determined.
There are many taxonomies for classifying medical errors.
Definitions of diagnostic error
There is no single definition of diagnostic error, reflecting in part the dual nature of the word diagnosis, which is both a noun (the name of the assigned disease; diagnosis is a label) and a verb (the act of arriving at a diagnosis; diagnosis is a process). At the present time, there are at least 4 definitions of diagnostic error in active use:
Graber et al. defined diagnostic error as a diagnosis that is wrong, egregiously delayed, or missed altogether. This is a 'label' definition, and can only be applied in retrospect, using some gold standard (for example, autopsy findings or a definitive laboratory test) to confirm the correct diagnosis. Many diagnostic errors fit several of these criteria; the categories overlap.
There are two process-related definitions: Schiff et al. defined diagnostic error as any breakdown in the diagnostic process, including both errors of omission and errors of commission. Similarly, Singh et al. defined diagnostic error as a 'missed opportunity' in the diagnostic process, based on retrospective review.
In its landmark report, Improving Diagnosis in Health Care, The National Academy of Medicine proposed a new, hybrid definition that includes both label- and process-related aspects: "A diagnostic error is failure to establish an accurate and timely explanation of the patient's health problem(s) or to communicate that explanation to the patient." This is the only definition that specifically includes the patient in the definition wording.
Impact
A 2000
Institute of Medicine
The National Academy of Medicine (NAM), formerly called the Institute of Medicine (IoM) until 2015, is an American nonprofit, non-governmental organization. The National Academy of Medicine is a part of the National Academies of Sciences, E ...
report estimated that medical errors result in between 44,000 and 98,000 preventable deaths and 1,000,000 excess injuries each year in U.S. hospitals.
In the UK, a 2000 study found that an estimated 850,000 medical errors occur each year, costing over £2 billion.
Some researchers questioned the accuracy of the IOM study, criticizing the statistical handling of
measurement errors in the report, significant subjectivity in determining which deaths were "avoidable" or due to medical error, and an erroneous assumption that 100% of patients would have survived if optimal care had been provided.
A 2001 study in the ''
Journal of the American Medical Association
''The Journal of the American Medical Association'' (''JAMA'') is a peer-reviewed medical journal published 48 times a year by the American Medical Association. It publishes original research, reviews, and editorials covering all aspects of bio ...
'' of seven
Department of Veterans Affairs
The United States Department of Veterans Affairs (VA) is a Cabinet-level executive branch department of the federal government charged with providing life-long healthcare services to eligible military veterans at the 170 VA medical centers an ...
medical centers estimated that for roughly every 10,000 patients admitted to the select hospitals, one patient died who would have lived for three months or more in good cognitive health had "optimal" care been provided.
A 2006 follow-up to the IOM study found that medication errors are among the most common medical mistakes, harming at least 1.5 million people every year. According to the study, 400,000 preventable drug-related injuries occur each year in hospitals, 800,000 in long-term care settings, and roughly 530,000 among Medicare recipients in outpatient clinics. The report stated that these are likely to be conservative estimates. In 2000 alone, the extra medical costs incurred by preventable drug-related injuries approximated $887 millionand the study looked only at injuries sustained by Medicare recipients, a subset of clinic visitors. None of these figures take into account lost wages and productivity or other costs.
According to a 2002
Agency for Healthcare Research and Quality
The Agency for Healthcare Research and Quality (AHRQ; pronounced "ark" by initiates and often "A-H-R-Q" by the public) is one of twelve agencies within the United States Department of Health and Human Services (HHS). The agency is headquartered i ...
report, about 7,000 people were estimated to die each year from medication errors – about 16 percent more deaths than the number attributable to work-related injuries (6,000 deaths). Medical errors affect one in 10 patients worldwide. One extrapolation suggests that 180,000 people die each year partly as a result of
iatrogenic
Iatrogenesis is the causation of a disease, a harmful complication, or other ill effect by any medical activity, including diagnosis, intervention, error, or negligence. "Iatrogenic", ''Merriam-Webster.com'', Merriam-Webster, Inc., accessed 2 ...
injury.
One in five Americans (22%) report that they or a family member have experienced a medical error of some kind.
The World Health Organization registered 14 million new cases and 8.2 million cancer-related deaths in 2012. It estimated that the number of cases could increase by 70% through 2032. As the number of cancer patients receiving treatment increases, hospitals around the world are seeking ways to improve patient safety, to emphasize traceability and raise efficiency in their cancer treatment processes.
Difficulties in measuring frequency of errors
About 1% of hospital admissions result in an adverse event due to
negligence
Negligence (Lat. ''negligentia'') is a failure to exercise appropriate and/or ethical ruled care expected to be exercised amongst specified circumstances. The area of tort law known as ''negligence'' involves harm caused by failing to act as a ...
.
However, mistakes are likely much more common, as these studies identify only mistakes that led to measurable adverse events occurring soon after the errors. Independent review of doctors' treatment plans suggests that decision-making could be improved in 14% of admissions; many of the benefits would have delayed manifestations.
Even this number may be an underestimate. One study suggests that adults in the United States receive only 55% of recommended care.
At the same time, a second study found that 30% of care in the United States may be unnecessary.
For example, if a doctor fails to order a mammogram that is past due, this mistake will not show up in the first type of study.
In addition, because no adverse event occurred during the short follow-up of the study, the mistake also would not show up in the second type of study
because only the principal treatment plans were critiqued. However, the mistake would be recorded in the third type of study. If a doctor recommends an unnecessary treatment or test, it may not show in any of these types of studies.
Cause of death on United States death certificates, statistically compiled by the
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...
(CDC), are coded in the
International Classification of Disease
The International Classification of Diseases (ICD) is a globally used diagnostic tool for epidemiology, health management and clinical purposes. The ICD is maintained by the World Health Organization (WHO), which is the directing and coordinatin ...
(ICD), which does not include codes for human and system factors.
Causes
The research literature showed that medical errors are caused by errors of commission and errors of omission.
Errors of omission are made when providers did not take action when they should have, while errors of commission occur when decisions and action are delayed.
Commission and omission errors have also been attributed with communication failures.
Medical errors can be associated with inexperienced physicians and nurses, new procedures, extremes of age, and complex or urgent care. Poor communication (whether in one's own language or, as may be the case for
medical tourists, another language), improper documentation, illegible handwriting, spelling errors, inadequate nurse-to-patient ratios, and similarly named medications are also known to contribute to the problem. Misdiagnosis may be associated with individual characteristics of the patient or due to the patient
multimorbidity
Multimorbidity, also known as multiple long-term conditions (MLTC), means living with two or more chronic illnesses. For example, a person could have diabetes, heart disease and Depression (mood), depression at the same time. Multimorbidity can h ...
. Patient actions or inactions may also contribute significantly to medical errors.
Healthcare complexity
Complicated technologies, powerful drugs, intensive care, rare and multiple diseases, and prolonged hospital stay can contribute to medical errors.
Complexity makes diagnosis especially challenging. There are less than 200 symptoms listed in Wikipedia, but there are probably more than 10,000 known diseases. The World Health Organization's system for the International Classification of Disease, 9th Edition from 1979 listed over 14,000 diagnosis codes. Textbooks of medicine often describe the most typical presentations of a disease, but in many conditions patients may have variable presentations instead of the classical signs and symptoms. To add complexity, the signs and symptoms of a given condition change over time; in the early stages the signs and symptoms may be absent or minimal, and then these evolve as the condition progresses. Diagnosis is often challenging in infants and children who can't clearly communicate their symptoms, and in the elderly, where signs and symptoms may be muted or absent.
There are more than 7000 rare diseases alone, and in aggregate these are not uncommon: Roughly 1 in 17 patients will be diagnosed with a rare disease over their lifetime. Physicians may have only learned a handful of these during their education and training.
System and process design
In 2000, The Institute of Medicine released "
To Err is Human," which asserted that the problem in medical errors is not bad people in health care—it is that good people are working in bad systems that need to be made safer.
Poor communication and unclear lines of authority of physicians, nurses, and other care providers are also contributing factors.
Disconnected reporting systems within a hospital can result in fragmented systems in which numerous hand-offs of patients results in lack of coordination and errors.
Other factors include the impression that action is being taken by other groups within the institution, reliance on automated systems to prevent error.,
and inadequate systems to share information about errors, which hampers analysis of contributory causes and improvement strategies.
Cost-cutting measures by hospitals in response to reimbursement cutbacks can compromise
patient safety
Patient safety is a discipline that emphasizes safety in health care through the prevention, reduction, reporting and analysis of error and other types of unnecessary harm that often lead to adverse patient events. The frequency and magnitude of a ...
.
In emergencies, patient care may be rendered in areas poorly suited for safe monitoring. The American Institute of Architects has identified concerns for the safe design and construction of health care facilities.
Infrastructure failure is also a concern. According to the
WHO
Who or WHO may refer to:
* Who (pronoun), an interrogative or relative pronoun
* Who?, one of the Five Ws in journalism
* World Health Organization
Arts and entertainment Fictional characters
* Who, a creature in the Dr. Seuss book '' Horton He ...
, 50% of medical equipment in developing countries is only partly usable due to lack of skilled operators or parts. As a result, diagnostic procedures or treatments cannot be performed, leading to substandard treatment.
The
Joint Commission
The Joint Commission is a United States-based nonprofit tax-exempt 501(c) organization that accredits more than 22,000 US health care organizations and programs. The international branch accredits medical services from around the world. A majori ...
's Annual Report on Quality and Safety 2007 found that inadequate communication between healthcare providers, or between providers and the patient and family members, was the
root cause Root cause may refer to:
* "Root Cause" (''Person of Interest''), a TV show episode
* Root cause analysis
In science
Science is a systematic endeavor that builds and organizes knowledge in the form of testable explanations and predic ...
of over half the serious adverse events in accredited hospitals. Other leading causes included inadequate assessment of the patient's condition, and poor leadership or training.
Competency, education, and training
Variations in healthcare provider training & experience
and failure to acknowledge the prevalence and seriousness of medical errors also increase the risk. The so-called
July effect
The July effect, sometimes referred to as the July phenomenon, is a perceived but scientifically unfounded increase in the risk of medical errors and surgical complications that occurs in association with the time of year in which United States ...
occurs when new residents arrive at teaching hospitals, causing an increase in medication errors according to a study of data from 1979 to 2006.
Human factors and ergonomics
Cognitive errors commonly encountered in medicine were initially identified by psychologists
Amos Tversky
Amos Nathan Tversky ( he, עמוס טברסקי; March 16, 1937 – June 2, 1996) was an Israeli cognitive and mathematical psychologist and a key figure in the discovery of systematic human cognitive bias and handling of risk.
Much of his ...
and
Daniel Kahneman
Daniel Kahneman (; he, דניאל כהנמן; born March 5, 1934) is an Israeli-American psychologist and economist notable for his work on the psychology of judgment and decision-making, as well as behavioral economics, for which he was award ...
in the early 1970s.
Jerome Groopman
Jerome E. Groopman has been a staff writer in medicine and biology for ''The New Yorker'' since 1998. He is also the Dina and Raphael Recanati Chair of Medicine at Harvard Medical School, Chief of Experimental Medicine at Beth Israel Deaconess Me ...
, author of ''
How Doctors Think
''How Doctors Think'' is a book released in March 2007 by Jerome Groopman, the Dina and Raphael Recanati Chair of Medicine at Harvard Medical School, chief of experimental medicine at Beth Israel Deaconess Medical Center in Boston, and staff wri ...
'', says these are "cognitive pitfalls", biases which cloud our logic. For example, a practitioner may overvalue the first data encountered, skewing their thinking. Another example may be where the practitioner recalls a recent or dramatic case that quickly comes to mind, coloring the practitioner's judgement. Another pitfall is where
stereotypes
In social psychology, a stereotype is a generalized belief about a particular category of people. It is an expectation that people might have about every person of a particular group. The type of expectation can vary; it can be, for example ...
may prejudice thinking. Pat Croskerry describes clinical reasoning as an interplay between intuitive, subconscious thought (System 1) and deliberate, conscious rational consideration (System 2). In this framework, many cognitive errors reflect over-reliance on System 1 processing, although cognitive errors may also sometimes involve System 2.
Sleep deprivation
Sleep deprivation, also known as sleep insufficiency or sleeplessness, is the condition of not having adequate duration and/or quality of sleep to support decent alertness, performance, and health. It can be either chronic or acute and may vary ...
has also been cited as a contributing factor in medical errors.
One study found that being awake for over 24 hours caused
medical interns
A medical intern is a physician in training who has completed medical school and has a medical degree but does not yet have a license to practice medicine unsupervised. Medical education generally ends with a period of practical training similar ...
to double or triple the number of preventable medical errors, including those that resulted in injury or death. The risk of car crash after these shifts increased by 168%, and the risk of
near miss by 460%.
[When Doctors Don't Sleep](_blank)
Talk of the Nation, National Public Radio, 13 December 2006. Interns admitted falling asleep during lectures, during rounds, and even during surgeries.
Night shifts are associated with worse surgeon performance during laparoscopic surgeries.
Practitioner risk factors include fatigue,
depression,
and burnout.
Factors related to the clinical setting include diverse patients, unfamiliar settings, time pressures, and increased patient-to-nurse staffing ratio increases.
Drug names that look alike or sound alike are also a problem.
Errors in interpreting medical images are often perceptual instead of "fact-based"; these errors are often caused by failures of attention or vision.
For example, visual illusions can cause radiologists to misperceive images.
A number of Information Technology (IT) systems have been developed to detect and prevent medication errors, the most common type of medical errors. These systems screen data such as ICD-9 codes, pharmacy and laboratory data. Rules are used to look for changes in medication orders, and abnormal laboratory results that may be indicative of medication errors and/or adverse drug events.
Examples
Errors can include misdiagnosis or delayed diagnosis, administration of the wrong
drug
A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insuffla ...
to the wrong patient or in the wrong way, giving multiple drugs that
interact
Advocates for Informed Choice, dba interACT or interACT Advocates for Intersex Youth, is a 501(c)(3) nonprofit organization using innovative strategies to advocate for the legal and human rights of children with intersex traits. The organizati ...
negatively,
surgery
Surgery ''cheirourgikē'' (composed of χείρ, "hand", and ἔργον, "work"), via la, chirurgiae, meaning "hand work". is a medical specialty that uses operative manual and instrumental techniques on a person to investigate or treat a pat ...
on an incorrect site, failure to remove all
surgical instruments, failure to take the correct blood type into account, or incorrect record-keeping. A 10th type of error is ones which are not watched for by researchers, such as RNs failing to program an IV pump to give a full dose of IV antibiotics or other medication.
Errors in diagnosis
According to a 2016 study from Johns Hopkins Medicine, medical errors are the third-leading cause of death in the United States. The projected cost of these errors to the U.S. economy is approximately $20 billion, 87% of which are direct increases in medical costs of providing services to patient affected by medical errors. Medical errors can increase average hospital costs by as much as $4,769 per patient. One common type of medical error stems from x-rays and medical imaging: failing to see or notice signs of disease on an image.
The retrospective "miss" rate among abnormal imaging studies is reported to be as high as 30% (the real-life error rate is much lower, around 4-5%, because not all images are abnormal), and up to 20% of missed findings result in long-term adverse effects.
A large study reported several cases where patients were wrongly told that they were HIV-negative when the physicians erroneously ordered and interpreted HTLV (a closely related virus) testing rather than HIV testing. In the same study, >90% of HTLV tests were ordered erroneously.
It is estimated that between 10 and 15% of physician diagnoses are erroneous.
Misdiagnosis of lower extremity cellulitis is estimated to occur in 30% of patients, leading to unnecessary hospitalizations in 85% and unnecessary antibiotic use in 92%. Collectively, these errors lead to between 50,000 and 130,000 unnecessary hospitalizations and between $195 and $515 million in avoidable health care spending annually in the United States.
Misdiagnosis of psychological disorders
Female sexual desire sometimes used to be diagnosed as
female hysteria
Female hysteria was once a common medical diagnosis for women, which was described as exhibiting a wide array of symptoms, including anxiety, shortness of breath, fainting, nervousness, sexual desire, insomnia, fluid retention, heaviness in the ...
.
Sensitivities to foods and
food allergies
A food allergy is an abnormal immune response to food. The symptoms of the allergic reaction may range from mild to severe. They may include itchiness, swelling of the tongue, vomiting, diarrhea, hives, trouble breathing, or low blood pressure ...
risk being misdiagnosed as the
anxiety disorder
Anxiety disorders are a cluster of mental disorders characterized by significant and uncontrollable feelings of anxiety and fear such that a person's social, occupational, and personal function are significantly impaired. Anxiety may cause physi ...
orthorexia Orthorexia nervosa (also known as orthorexia) (ON) is a proposed eating disorder characterized by an excessive preoccupation with eating healthy food. The term was introduced in 1997 by American physician Steven Bratman, M.D. He suggested that som ...
.
Studies have found that
bipolar disorder
Bipolar disorder, previously known as manic depression, is a mental disorder characterized by periods of depression and periods of abnormally elevated mood that last from days to weeks each. If the elevated mood is severe or associated with ...
has often been misdiagnosed as
major depression
Major depressive disorder (MDD), also known as clinical depression, is a mental disorder characterized by at least two weeks of pervasive low mood, low self-esteem, and loss of interest or pleasure in normally enjoyable activities. Introdu ...
. Its early diagnosis necessitates that clinicians pay attention to the features of the patient's depression and also look for present or prior
hypomanic
Hypomania (literally "under mania" or "less than mania") is a mental disorder, mental and Abnormal behaviour, behavioural disease#Disorder, disorder, characterised essentially by an apparently non-contextual elevation of Mood (psychology), mood (e ...
or
manic symptomatology.
The misdiagnosis of
schizophrenia
Schizophrenia is a mental disorder characterized by continuous or relapsing episodes of psychosis. Major symptoms include hallucinations (typically hearing voices), delusions, and disorganized thinking. Other symptoms include social withdra ...
is also a common problem. There may be long delays of patients getting a correct diagnosis of this disorder.
Delayed sleep phase disorder
Delayed sleep phase disorder (DSPD), more often known as delayed sleep phase syndrome and also as delayed sleep–wake phase disorder, is a delaying of a person's circadian rhythm (biological clock) compared to those of societal norms. The diso ...
is often confused with: psychophysiological insomnia;
depression; psychiatric disorders such as
schizophrenia
Schizophrenia is a mental disorder characterized by continuous or relapsing episodes of psychosis. Major symptoms include hallucinations (typically hearing voices), delusions, and disorganized thinking. Other symptoms include social withdra ...
,
ADHD or ADD; other sleep disorders; or
school refusal
School refusal is a child-motivated refusal to attend school or difficulty remaining in class for the full day. Child-motivated absenteeism occurs autonomously, by the volition of the child. This behavior is differentiated from non-child-motivated ...
. Practitioners of
sleep medicine
Sleep medicine is a medical specialty or subspecialty devoted to the diagnosis and therapy of sleep disturbances and sleep disorder, disorders. From the middle of the 20th century, research has provided increasing knowledge and answered many ...
point out the dismally low rate of accurate diagnosis of the disorder, and have often asked for better physician education on sleep disorders.
Cluster headache
Cluster headache (CH) is a neurological disorder characterized by recurrent severe headaches on one side of the head, typically around the eye(s). There is often accompanying eye watering, nasal congestion, or swelling around the eye on the a ...
s are often misdiagnosed, mismanaged, or undiagnosed for many years; they may be confused with migraine, "cluster-like" headache (or mimics), CH subtypes, other TACs ( trigeminal autonomic cephalalgias), or other types of primary or secondary headache syndrome. Cluster-like head pain may be diagnosed as secondary headache rather than cluster headache.
Under-recognition of CH by health care professionals is reflected in consistent findings in Europe and the United States that the average time to diagnosis is around seven years.
Asperger syndrome
Asperger syndrome (AS), also known as Asperger's, is a former neurodevelopmental disorder characterized by significant difficulties in Interpersonal relationship, social interaction and nonverbal communication, along with restricted and re ...
and
autism
The autism spectrum, often referred to as just autism or in the context of a professional diagnosis autism spectrum disorder (ASD) or autism spectrum condition (ASC), is a neurodevelopmental condition (or conditions) characterized by difficulti ...
tend to get undiagnosed or delayed recognition and delayed diagnosis or misdiagnosed. Delayed or mistaken diagnosis can be traumatic for individuals and families; for example, misdiagnosis can lead to medications that worsen behavior.
The DSM-5 field trials included "test-retest reliability" which involved different clinicians doing independent evaluations of the same patient—a new approach to the study of diagnostic reliability.
Outpatient vs. inpatient
Misdiagnosis is the leading cause of medical error in outpatient facilities.
Since the National Institute of Medicine's 199
report "To Err is Human," found up to 98,000 hospital patients die from preventable medical errors in the U.S. each year, government and private sector efforts have focused on inpatient safety.
Medical prescriptions
While in 2000 the Committee on Quality of Health Care in America affirmed medical mistakes are an "unavoidable outcome of learning to practice medicine", at 2019 the commonly accepted link between prescribing skills and
clinical clerkships
Clinical clerkships encompass a period of medical education in which students – medical, nursing, dental, or otherwise – practice medicine under the supervision of a health practitioner.
Medical clerkships
In medical education, a clerksh ...
was not yet demonstrated by the available data
and in the U.S.
legibility of handwritten prescriptions has been indirectly responsible for at least 7,000 deaths annually.
Prescription errors concern ambiguous abbreviations, the right spelling of the full name of drugs: improper use of the nomenclature, of decimal points, unit or rate expressions; legibility and proper instructions; miscalculations of the
posology
Pharmacology is a branch of medicine, biology and pharmaceutical sciences concerned with drug or medication action, where a drug may be defined as any artificial, natural, or endogenous (from within the body) molecule which exerts a biochemica ...
(quantity, route and frequency of administration, duration of the treatment, dosage form and dosage strength); lack of information about patients (e.g.
allergy
Allergies, also known as allergic diseases, refer a number of conditions caused by the hypersensitivity of the immune system to typically harmless substances in the environment. These diseases include hay fever, food allergies, atopic derma ...
, declining
renal function
Assessment of kidney function occurs in different ways, using the presence of symptoms and signs, as well as measurements using urine tests, blood tests, and medical imaging.
Functions of a healthy kidney include maintaining a person's fluid ...
) or reported in the medical document.
There were an estimated 66 million clinically significant medication errors in the British NHS in 2018. The resulting adverse drug reactions are estimated to cause around 700 deaths a year in England and to contribute to around 22,000 deaths a year. The British researchers did not find any evidence that error rates were lower in other countries, and the global cost was estimated at $42 billion per year.
Medication errors in hospital include omissions, delayed dosing and incorrect medication administrations. Medication errors are not always readily identified, but can be reported using case note reviews or incident reporting systems. There are pharmacist-led interventions that can reduce the incident of medication error.
Electronic prescribing
Electronic prescription (e-prescribing or e-Rx) is the computer-based electronic generation, transmission, and filling of a medical prescription, taking the place of paper and faxed prescriptions. E-prescribing allows a physician, physician assista ...
has been shown to reduce prescribing errors by up to 30%.
After an error has occurred
Mistakes can have a strongly negative emotional impact on the doctors who commit them.
Recognizing that mistakes are not isolated events
Some physicians recognize that adverse outcomes from errors usually do not happen because of an isolated error and actually reflect system problems.
This concept is often referred to as the
Swiss Cheese Model
The Swiss cheese model of accident causation is a model used in risk analysis and risk management, including aviation safety, engineering, healthcare, emergency service organizations, and as the principle behind layered security, as used in com ...
.
This is the concept that there are layers of protection for clinicians and patients to prevent mistakes from occurring. Therefore, even if a doctor or nurse makes a small error (e.g. incorrect dose of drug written on a drug chart by doctor), this is picked up before it actually affects patient care (e.g. pharmacist checks the drug chart and rectifies the error).
Such mechanisms include:
Practical alterations (e.g.-medications that cannot be given through IV, are fitted with tubing which means they cannot be linked to an IV even if a clinician makes a mistake and tries to),
systematic safety processes (e.g. all patients must have a Waterlow score assessment and falls assessment completed on admission),
and training programmes/continuing professional development courses
are measures that may be put in place.
There may be several breakdowns in processes to allow one adverse outcome.
In addition, errors are more common when other demands compete for a physician's attention.
However, placing too much blame on the system may not be constructive.
Placing the practice of medicine in perspective
Essayists imply that the potential to make mistakes is part of what makes being a physician rewarding and without this potential the rewards of medical practice would be diminished. Laurence states that "Everybody dies, you and all of your patients. All relationships end. Would you want it any other way?
..Don't take it personally"
Seder states "
..if I left medicine, I would mourn its loss as I've mourned the passage of my poetry. On a daily basis, it is both a privilege and a joy to have the trust of patients and their families and the camaraderie of peers. There is no challenge to make your blood race like that of a difficult case, no mind game as rigorous as the challenging differential diagnosis, and though the stakes are high, so are the rewards."
Disclosing mistakes
Forgiveness
Forgiveness, in a psychological sense, is the intentional and voluntary process by which one who may initially feel victimized or wronged, goes through a change in feelings and attitude regarding a given offender, and overcomes the impact of th ...
, which is part of many cultural traditions, may be important in coping with medical mistakes.
Among other healing processes, it can be accomplished through the use of communicative disclosure guidelines.
To oneself
Inability to forgive oneself may create a cycle of distress and increased likelihood of a future error.
However, Wu et al. suggest "...those who coped by accepting responsibility were more likely to make constructive changes in practice, but
lsoto experience more emotional distress."
It may be helpful to consider the much larger number of patients who are not exposed to mistakes and are helped by medical care.
To patients
Gallagher et al. state that patients want "information about what happened, why the error happened, how the error's consequences will be mitigated, and how recurrences will be prevented."
Interviews with patients and families reported in a 2003 book by Rosemary Gibson and Janardan Prasad Singh, put forward that those who have been harmed by medical errors face a "wall of silence" and "want an acknowledgement" of the harm. With honesty, "healing can begin not just for the patients and their families but also the doctors, nurses and others involved." In a line of experimental investigations,
Annegret Hannawa
Annegret Friederike Hannawa (born April 27, 1979 in Konstanz, Germany) is a German communication scientist and founding director of the Center for the Advancement of Healthcare Quality and Safety (CAHQS) at the Università della Svizzera italian ...
et al. developed evidence-based disclosure guidelines under the scientific "Medical Error Disclosure Competence (MEDC)" framework.
A 2005 study by
Wendy Levinson
Wendy Levinson Doctor of Medicine, MD is a Canadians, Canadian physician and academic. She is the Chair of Choosing Wisely Canada, "a campaign to help physicians and patients engage in conversations about unnecessary tests, treatments and procedu ...
of the
University of Toronto
The University of Toronto (UToronto or U of T) is a public research university in Toronto, Ontario, Canada, located on the grounds that surround Queen's Park. It was founded by royal charter in 1827 as King's College, the first institution ...
showed surgeons discussing medical errors used the word "error" or "mistake" in only 57 percent of disclosure conversations and offered a verbal apology only 47 percent of the time.
Patient disclosure is important in the medical error process. The current standard of practice at many hospitals is to disclose errors to patients when they occur. In the past, it was a common fear that disclosure to the patient would incite a
malpractice
In the law of torts, malpractice, also known as professional negligence, is an "instance of negligence or incompetence on the part of a professional".Malpractice definition,
Professionals who may become the subject of malpractice actions inc ...
lawsuit. Many physicians would not explain that an error had taken place, causing a lack of trust toward the healthcare community. In 2007, 34 states passed legislation that precludes any information from a physician's apology for a medical error from being used in malpractice court (even a full admission of fault). This encourages physicians to acknowledge and explain mistakes to patients, keeping an open line of communication.
The American Medical Association's Council on Ethical and Judicial Affairs states in its ethics code:
:"Situations occasionally occur in which a patient suffers significant
medical complication
A complication in medicine, or medical complication, is an unfavorable result of a disease, health condition, or treatment. Complications may adversely affect the prognosis, or outcome, of a disease. Complications generally involve a worsening in ...
s that may have resulted from the physician's mistake or judgment. In these situations, the physician is ethically required to inform the patient of all facts necessary to ensure understanding of what has occurred. Concern regarding legal liability which might result following truthful disclosure should not affect the physician's honesty with a patient."
From the American College of Physicians Ethics Manual:
:"In addition, physicians should disclose to patients information about procedural or judgment errors made in the course of care if such information is material to the patient's well-being. Errors do not necessarily constitute improper, negligent, or unethical behavior, but failure to disclose them may."
However, "there appears to be a gap between physicians' attitudes and practices regarding error disclosure. Willingness to disclose errors was associated with higher training level and a variety of patient-centered attitudes, and it was not lessened by previous exposure to malpractice litigation".
Hospital administrators may share these concerns.
Consequently, in the
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...
, many states have enacted laws excluding expressions of sympathy after accidents as proof of liability.
Disclosure may actually reduce malpractice payments.
To non-physicians
In a study of physicians who reported having made a mistake, it was offered that disclosing to non-physician sources of support may reduce stress more than disclosing to physician colleagues.
This may be due to the finding that of the physicians in the same study, when presented with a hypothetical scenario of a mistake made by another colleague, only 32% of them would have unconditionally offered support. It is possible that greater benefit occurs when spouses are physicians.
To other physicians
Discussing mistakes with other physicians is beneficial.
However, medical providers may be less forgiving of one another.
The reason is not clear, but one essayist has admonished, "Don't Take Too Much Joy in the Mistakes of Other Doctors."
To the physician's institution
Disclosure of errors, especially 'near misses' may be able to reduce subsequent errors in institutions that are capable of reviewing near misses.
However, doctors report that institutions may not be supportive of the doctor.
Use of rationalization to cover up medical errors
Based on anecdotal and survey evidence, Banja
states that
rationalization (making excuses)
Rationalization is a defense mechanism (ego defense) in which apparent logical reasons are given to justify behavior that is motivated by unconscious instinctual impulses. It is an attempt to find reasons for behaviors, especially one's own. Ration ...
is very common among the medical profession to cover up medical errors.
By potential for harm to the patient
In a survey of more than 10,000 physicians in the United States, when asked the question, "Are there times when it's acceptable to cover up or avoid revealing a mistake if that mistake would not cause harm to the patient?", 19% answered ''yes'', 60% answered ''no'' and 21% answered ''it depends''. On the question, "Are there times when it is acceptable to cover up or avoid revealing a mistake if that mistake would potentially or likely harm the patient?", 2% answered ''yes'', 95% answered ''no'' and 3% answered ''it depends''.
Cause-specific preventive measures
Traditionally, errors are attributed to mistakes made by individuals, who then may be penalized. A common approach to respond to and prevent specific errors is requiring additional checks at particular points in the system, whose findings and detail of execution must be recorded. As an example, an error of free flow IV administration of heparin is approached by teaching staff how to use the IV systems and to use special care in setting the IV pump. While overall errors become less likely, the checks add to workload and may in themselves be a cause of additional errors. In some hospitals, a regular
morbidity and mortality conference
Morbidity and mortality (M&M) conferences are traditional, recurring conferences held by medical services at academic medical centers, most large private medical and surgical practices, and other medical centers. Their use in psychiatric medicine ...
meeting is scheduled to discuss complications or deaths and learn from or improve the overall processes.
A newer model for improvement in medical care takes its origin from the work of
W. Edwards Deming
William Edwards Deming (October 14, 1900 – December 20, 1993) was an American engineer, statistician, professor, author, lecturer, and management consultant. Educated initially as an electrical engineer and later specializing in mathematical ...
in a model of
Total Quality Management. In this model, there is an attempt to identify the underlying system defect that allowed the error to occur. As an example, in such a system the error of free flow IV administration of heparin is dealt with by not using IV heparin and substituting subcutaneous administration of heparin, obviating the entire problem. However, such an approach presupposes available research showing that subcutaneous heparin is as effective as IV. Thus, most systems use a combination of approaches to the problem.
In specific specialties
The field of medicine that has taken the lead in systems approaches to safety is
anaesthesiology
Anesthesiology, anaesthesiology, or anaesthesia is the medical specialty concerned with the total perioperative care of patients before, during and after surgery. It encompasses anesthesia, intensive care medicine, critical emergency medicine, ...
. Steps such as standardization of IV medications to 1 ml doses, national and international color-coding standards, and development of improved airway support devices has the field a model of systems improvement in care.
Pharmacy
Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. It is a miscellaneous science as it links heal ...
professionals have extensively studied the causes of errors in the prescribing, preparation, dispensing and administration of medications. As far back as the 1930s, pharmacists worked with physicians to select, from many options, the safest and most effective drugs available for use in hospitals. The process is known as the Formulary System and the list of drugs is known as the Formulary. In the 1960s, hospitals implemented
unit dose
Dosage forms (also called unit doses) are medication, pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components (excipients), in a particular configuration (su ...
packaging and unit dose drug distribution systems to reduce the risk of wrong drug and wrong dose errors in hospitalized patients; centralized sterile admixture services were shown to decrease the risks of contaminated and infected intravenous medications; and pharmacists provided drug information and clinical decision support directly to physicians to improve the safe and effective use of medications. Pharmacists are recognized experts in medication safety and have made many contributions that reduce error and improve patient care over the last 50 years. More recently, governments have attempted to address issues like patient-pharmacist communication and consumer knowledge through measures like the
Australian Government
The Australian Government, also known as the Commonwealth Government, is the national government of Australia, a federal parliamentary constitutional monarchy. Like other Westminster-style systems of government, the Australian Government i ...
's
Quality Use of Medicines policy.
Legal procedure
Standards and regulations for medical malpractice vary by country and jurisdiction within countries. Medical professionals may obtain
professional liability insurance
Professional liability insurance (PLI), also called professional indemnity insurance (PII) but more commonly known as errors & omissions (E&O) in the US, is a form of liability insurance which helps protect professional advice-, consulting, and ser ...
s to offset the risk and costs of lawsuits based on medical malpractice.
Prevention
Medical care is frequently compared adversely to
aviation
Aviation includes the activities surrounding mechanical flight and the aircraft industry. ''Aircraft'' includes fixed-wing and rotary-wing types, morphable wings, wing-less lifting bodies, as well as lighter-than-air craft such as hot air ...
; while many of the factors that lead to errors in both fields are similar, aviation's error management protocols are regarded as much more effective. Safety measures include
informed consent
Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatme ...
, the availability of a second practitioner's opinion, voluntary reporting of errors,
root cause analysis
In science
Science is a systematic endeavor that builds and organizes knowledge in the form of testable explanations and predictions about the universe.
Science may be as old as the human species, and some of the earliest archeologic ...
, reminders to improve patient medication adherence,
hospital accreditation, and systems to ensure review by experienced or specialist practitioners.
A template has been developed for the design (both structure and operation) of hospital medication safety programmes, particularly for acute tertiary settings, which emphasizes safety culture, infrastructure, data (error detection and analysis), communication and training.
Particularly to prevent the medication errors in the perspective of the intrathecal administration of local anaesthetics, there is a proposal to change the presentation and packaging of the appliances and agents used for this purpose. One spinal needle with a syringe prefilled with the local anaesthetic agents may be marketed in a single blister pack, which will be peeled open and presented before the anaesthesiologist conducting the procedure.
Physician well-being has also been recommended as an indicator of healthcare quality given its association with patient safety outcomes. A meta-analysis involving 21517 participants found that physicians with depressive symptoms had a 95% higher risk of reporting medical errors and that the association between physician depressive symptoms and medical errors is bidirectional
Reporting requirements
In the United States, adverse medical event reporting systems were mandated in just over half (27) of the states as of 2014, a figure unchanged since 2007.
In U.S. hospitals error reporting is a condition of payment by Medicare. An investigation by the Office of Inspector General, Department of Health and Human Services released January 6, 2012 found that most errors are not reported and even in the case of errors that are reported and investigated changes are seldom made which would prevent them in the future. The investigation revealed that there was often lack of knowledge regarding which events were reportable and recommended that lists of reportable events be developed.
Misconceptions
Some common misconceptions about medical error include:
* Medical error is the "third leading cause of death" in the United States. This canard stems from an erroneous 2016 study which, according to
David Gorski
David Henry Gorski is an American surgical oncologist, professor of surgery at Wayne State University School of Medicine, and a surgical oncologist at the Barbara Ann Karmanos Cancer Institute, specializing in breast cancer surgery. He is an out ...
, "has taken on a life of its own" and fuelled "a myth promulgated by both quacks and academics".
* "Bad apples" or incompetent health care providers are a common cause. (Although human error is commonly an initiating event, the faulty care delivery process invariably permits or compounds the harm and so is the focus of improvement.)
* High-risk procedures or medical specialties are responsible for most ''avoidable'' adverse events. (Although some mistakes, such as in surgery, are harder to conceal, errors occur in all levels of care.
Even though complex procedures entail more risk, adverse outcomes are not usually due to error, but to the severity of the condition being treated.)
However,
United States Pharmacopeia
The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that ...
has reported that medication errors during the course of a surgical procedure are three times more likely to cause harm to a patient than those occurring in other types of hospital care.
* If a patient experiences an adverse event during the process of care, an error has occurred. (Most medical care entails some level of risk, and there can be complications or side effects, even unforeseen ones, from the underlying condition or from the treatment itself.)
See also
*
Serious adverse event A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose
#Results in death
#Is life-threatening
#Requires inpatient hospitalization or causes prolongation of existing hospitalization
#Results ...
*
Adverse drug reaction
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term ...
*
Biosafety
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health.
These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidel ...
*
Emily's Law
Emily's Law (Emily's Act) is an informal name given to Ohio Senate Bill 203 (SB 203), which was signed into law in 2009. The law is named in honor of Emily Jerry, a two-year-old who died in 2006 from a medication error during her last round of chem ...
*''
Fatal Care: Survive in the U.S. Health System'' (book)
*
Medical malpractice
Medical malpractice is a legal cause of action that occurs when a medical or health care professional, through a negligent act or omission, deviates from standards in their profession, thereby causing injury or death to a patient. The negligen ...
*
Medical resident work hours
Medical resident work hours refers to the (often lengthy) shifts worked by medical interns and residents during their medical residency.
As per the rules of the Accreditation Council for Graduate Medical Education in the United States of America, ...
*
Sleep deprivation
Sleep deprivation, also known as sleep insufficiency or sleeplessness, is the condition of not having adequate duration and/or quality of sleep to support decent alertness, performance, and health. It can be either chronic or acute and may vary ...
*
Patient Safety and Quality Improvement Act
The Patient Safety and Quality Improvement Act of 2005 (PSQIA): , 42 U.S.C.&nbsch. 6A subch. VII part C established a system of patient safety organization
A Patient Safety Organization (PSO) is a group, institution, or association that imp ...
of 2005
*
Patient safety organization
A Patient Safety Organization (PSO) is a group, institution, or association that improves medical care by reducing medical errors. Common functions of patient safety organizations are data collection and analysis, reporting, education, funding, ...
*
Quality Use of Medicines
References
Further reading
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{{Authority control
Medical error,
Medical diagnosis
Patient safety