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Medical Error
1988-2000
Preventable deaths: who, how often, and why?
"Using a majority rules criterion (at least two of three physicians agreed), we found that 27% of the deaths might have been prevented. Using a unanimity criterion (all three physicians independently agreed), we found a 14% rate of probably preventable deaths."
Dubois and Brook. Ann Intern Med 1988 Oct 1;109(7):582-9
The Impact of Computerized Physician Order Entry on Medication Error Prevention
"During the study, the non-missed-dose medication error rate fell 81 percent, from 142 per 1,000 patient-days in the baseline period to 26.6 per 1,000 patient-days in the final period (P < 0.0001). Non-intercepted serious medication errors (those with the potential to cause injury) fell 86 percent from baseline to period 3, the final period (P = 0.0003). Large differences were seen for all main types of medication errors: dose errors, frequency errors, route errors, substitution errors, and allergies. For example, in the baseline period there were ten allergy errors, but only two in the following three periods combined (P < 0.0001)."
Bates et. al., J Am Med Inform Assoc. 1999 July; 6 (4): 313321
Reliability and validity of judgments concerning adverse events suffered by hospitalized patients
"These results indicate that a two-step review process of medical records can produce judgments about adverse events that are both reliable and valid."
Brennan et al. Med Care 1989 Dec;27(12):1148-58
Identification of adverse events occurring during hospitalization. A cross-sectional study of litigation, quality assurance, and medical records at two teaching hospitals
"A significant number of adverse events (20 of 172) among hospitalizations never gave rise to litigation or risk management investigation. Six of the twenty were due to negligent care. Quality assurance efforts at the level of the clinical departments in one hospital led to review of only 12 out of 82 risk management records."
Brennan et al. Ann Intern Med 1990 Feb 1;112(3):221-6
Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I
"There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care."
Brennan et al. N Engl J Med 1991 Feb 7;324(6):370-6
The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II
"Drug complications were the most common type of adverse event (19 percent), followed by wound infections (14 percent) and technical complications (13 percent). Nearly half the adverse events (48 percent) were associated with an operation. Adverse events during surgery were less likely to be caused by negligence (17 percent) than nonsurgical ones (37 percent). The proportion of adverse events due to negligence was highest for diagnostic mishaps (75 percent), noninvasive therapeutic mishaps ("errors of omission") (77 percent), and events occurring in the emergency room (70 percent). Errors in management were identified for 58 percent of the adverse events, among which nearly half were attributed to negligence"
Leape et al. N Engl J Med 1991 Feb 7;324(6):377-84
Hospital characteristics associated with adverse events and substandard care
"Univariate analyses of AEs [adverse events] revealed that primary teaching institutions had significantly higher rates (4.1%) and rural hospitals had significantly lower ones (1.0%). The percentage of AEs due to negligence was lower in primary teaching (10.7%) and for-profit (9.5%) hospitals and was significantly higher in hospitals with predominantly (greater than 80%) minority patients who had been discharged (37%)"
Brennan et al. JAMA 1991 Jun 26;265(24):3265-9
Iatrogenic complications in high-risk, elderly patients
"Iatrogenic complications are likely to be an extremely common experience for elderly medicine service patients with long lengths of stay. A significant portion of these complications may be potentially preventable with closer attention to initial assessment and documentation of patients' functional status."
Lefevre et al. Arch Intern Med 1992 Oct;152(10):2074-80
A quality-of-care analysis of cascade iatrogenesis in frail elderly hospital patients
"Cascade iatrogenesis was found to occur most frequently among the oldest patients, the most functionally impaired, and those with a high severity of illness on admission. Closer examination of these findings suggests that there is significant potential for improving physicians' initial functional and diagnostic assessment skills when treating frail elderly patients."
Potts et al. QRB Qual Rev Bull 1993 Jun;19(6):199-205
Evaluation of screening criteria for adverse events in medical patients.
Bates et al. Med Care 1995 May;33(5):452-62
Drug-related morbidity and mortality. A cost-of-illness model
"Drug-related morbidity and mortality was estimated to cost $76.6 billion in the ambulatory setting in the United States. The largest component of this total cost was associated with drug-related hospitalizations. When assumptions of the model were varied, the estimated cost ranged from a conservative estimate of $30.1 to $136.8 billion in a worst-case scenario."
Johnson JA, Bootman JL., Arch Intern Med 1995 Oct 9;155(18):1949-56
Complications, adverse events, and iatrogenesis: classifications and quality of care measurement issues
"Accountability in the healthcare system demands the development of valid and reliable measures of quality, particularly outcome measures that have been risk-adjusted for factors that increase the probability of a poor outcome. Although the literature documents the existence of complications, adverse events, and iatrogenic illness, these concepts have not been compared and discussed thoroughly."
Fleming. Clin Perform Qual Health Care 1996 Jul-Sep;4(3):137-47
The costs of adverse drug events in hospitalized patients
"[W]e estimate that the annual costs attributable to all ADEs [adverse drug events] and preventable ADEs for a 700-bed teaching hospital are $5.6 million and $2.8 million, respectively...Moreover, these estimates are conservative because they do not include the costs of injuries to patients or malpractice costs."
Bates et al. JAMA 1997 Jan 22-29;277(4):307-11
Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality
"The attributable lengths of stay and costs of hospitalization for ADEs are substantial. An ADE is associated with a significantly prolonged length of stay, increased economic burden, and an almost 2-fold increased risk of death."
Classen et al. JAMA 1997 Jan 22-29;277(4):301-6
Preventable adverse drug events in hospitalized patients
"The rate of preventable and potential adverse drug events was twice as high in ICUs compared with non-ICUs. However, when adjusted for the number of drugs ordered, there was no greater likelihood for preventable adverse drug events and potential adverse drug events to occur in ICUs than in non-ICUs. Preventable adverse drug events and potential adverse drug events occurred in units that functioned normally and involved caregivers who were working under reasonably normal circumstances, not at the extremes of workload, stress, or a difficult environment."
Cullen et al. Critical Care Medicine. 1997;25:1289-1297
An alternative strategy for studying adverse events in medical care
"The incidence of adverse events, measured prospectively by concurrent observation, was close to 45·8% in surgical units, of which 20% were truly serious. Most of these events were system failures and in only a few would disciplining a single person have changed anything."
Andrews et al. Lancet. 1997 Feb 1;349(9048):309-13
Incidence of Adverse Drug Reactions in Hospitalized Patients
"We estimated that in 1994 overall 2216000 (1721000-2711000) hospitalized patients had serious ADRs and 106000 (76000-137000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death."
Lazarou et al. JAMA. 1998;279:1200-1205
Prevalence of Articles With Honorary Authors and Ghost Authors in Peer-Reviewed Medical Journals
"A substantial proportion of articles in peer-reviewed medical journals demonstrate evidence of honorary authors or ghost authors."
Flanagin et al. JAMA. 1998;280:222-224
Reviewing the Reviews: The Example of Chronic Fatigue Syndrome
"Of 89 reviews, 3 (3.4%) reported on literature search and described search method. Authors from laboratory-based disciplines preferentially cited laboratory references, while psychiatry-based disciplines preferentially cited psychiatric literature (P=.01). A total of 71.6% of references cited by US authors were from US journals, while 54.9% of references cited by United Kingdom authors were published in United Kingdom journals (P=.001)."
Joyce et al. JAMA. 1998;280:264-266
Phenomena of Retraction: Reasons for Retraction and Citations to the Publications
"A total of 235 articles had been retracted. Error was acknowledged in relation to 91 articles; results could not be replicated in 38; misconduct was evident in 86; and no clear reason was given in 20. Of the 235 articles, 190 were retracted by some or all of the authors; 45 were retracted by a person or organization other than the author(s). The 235 retracted articles were cited 2034 times after the retraction notice. Examination of 299 of those citations reveals that in only 19 instances was the retraction noted; the remaining 280 citations treated the retracted article either explicitly (n=17) or implicitly (n=263) as though it were valid research. Conclusion. Retracted articles continue to be cited as valid work in the biomedical literature after publication of the retraction; these citations signal potential problems for biomedical science."
Budd et al. JAMA. 1998;280:296-297
Incidence of Adverse Drug Reactions in Hospitalized Patients
Reseachers analyzed 39 prior studies from American hospitals. They concluded that 1.7 to 2.7 million people had serious adverse drug reactions and that 76,000 to 137,000 people died from those reactions. This, they said, makes adverse drug reactions between the fourth and sixth leading cause of death.
Lazarou et al.; JAMA. 1998;280:1200-1205
Drugs and Adverse Drug Reactions: How Worried Should We Be?
David W. Bates, 1998;280 (Editorial)
Antibiotic Resistance: Squeezing the Balloon?
"The need for responsible antibiotic use stewardship to quell microbial resistance should have no disputants. Indeed, there have been so many clarion calls for action1 to halt the increasing resistance to antimicrobials that further emphasis seems redundant."
John P. Burton, JAMA. 1998;280 (Editorial)
Autopsy Diagnoses of Malignant Neoplasms: How Often Are Clinical Diagnoses Incorrect?
"The discordance rate between clinical and autopsy diagnoses of malignant neoplasms is large and confirms the importance of the postmortem examination."
Burton et al. JAMA. 1998;280:1245-1248
Legibility of doctors' handwriting: quantitative comparative study
"This study suggests that doctors, even when asked to be as neat as possible, produce handwriting that is worse than that of other professions. This provides supportive evidence for the commonly held belief that the legibility of doctors' handwriting is unusually poor."
Lyons et al., BMJ 1998;317:863-864
Broadcasting clinical guidelines on the Internet: will physicians tune in?
"The Internet is a marvelous gateway to discovery of information. For a busy physician, a quick logon to a medical website can produce a guideline, a professional evaluation of that guideline and even the comments of other physicians who have tried to apply a generic guideline in practice. It is an instant library. With compact lightweight computers, it will soon become an obligatory research tool for managed care physicians. Inevitably, the ease of access will mean that the standard of practice will be measured by whether a practitioner considered a particular guideline, analyzed its applicability and used or rejected it for sound clinical reasons. The Web is a comfortable tool that is likely to become a source of constant pressure on physicians to improve medical practice."
Barry R. Furrow, American Journal of Law & Medicine, Summer-Fall, 1999
Pharmacist Participation on Physician Rounds and Adverse Drug Events in the Intensive Care Unit
"The presence of a pharmacist on rounds as a full member of the patient care team in a medical ICU was associated with a substantially lower rate of ADEs caused by prescribing errors. Nearly all the changes were readily accepted by physicians."
Leape et al., JAMA. 1999;282:267-270
Reducing errors in medicine: it's time to take this more seriously
"Luckily, the safety statistics in airline travel are far, far better than these figures. Between 1990 and 1994 United States airline fatalities were 0.27 per 1 000 000 aircraft departures, less than one third the rate in mid-century, despite vast increases in the complexity and volume of our aviation systems. One estimate is that a modern passenger would have to fly continuously for 20 000 years in order to reach a 50% chance of injury in an airplane accident.
In health care it is a totally different story. With the rising complexity and reach of modern medicine have come startling levels of risk and harm to patients. One recent study in two of the most highly regarded hospitals in the world discovered serious or potentially serious medication errors in the care of 6.7 out of every 100 patients,1 and the Harvard Medical Practice Study, which reviewed over 30 000 hospital records in New York state, found injuries from care itself ("adverse events") to occur in 3.7% of hospital admissions, over half of which were preventable and 13.6% of which led to death.2 If these figures can be extrapolated to American health care in general then over 120 000 Americans die each year as a result of preventable errors in their hospital care. The costs of medical errors are high in financial terms as well, estimated to be almost $4700 per preventable adverse drug event in one American teaching hospital."
Donald M Berwick and Lucian L Leape, BMJ 1999;319:136-137
How should efficacy be evaluated in randomized clinical trials of treatments for depression?
 A massive number of Americans are acting as Guinea pigs by taking psychiatric drugs to lift their spirits. This physician offers a bleak assessment of the proof that these drugs are effective, concluding, "... it is remarkable how little clinicians know about a new antidepressant at the time it is first approved for general use." J Clin Psychiatry 1999;60 Suppl 4:23-31
By comparison, in 1999 researchers found that "after 16 weeks of treatment exercise was equally effective [as taking drugs] in reducing depression among patients with MDD [major depressive disorder]."
Effects of Exercise Training on Older Patients With Major Depression
Why, then, is "depression" considered a medical condition, and why are "depressed" people not told to exercise instead of taking drugs whose effectiveness is inadequately proven?
Blumenthal et al. Arch Intern Med. 1999;159:2349-2356
A Trade-off Analysis of Routine Newborn Circumcision.
"Because circumcision is not a lifesaving procedure,[6] and its modest medical benefits may be offset by its complications, its indications are discretionary...Overall, routine newborn circumcision appears to be a relatively safe procedure. It is not without some risks, however, and these risks do not seem to be mitigated by the hands of more experienced physicians."
Christakis et al. Pediatrics 2000 Jan;105(1 Pt 3):246-9
See also:
Circumcision Information for Parents
"Scientific studies show some medical benefits of circumcision. However, these benefits are not sufficient for the American Academy of Pediatrics (AAP) to recommend that all infant boys be circumcised."
American Academy of Pediatrics, 2001.
Adverse drug events: the magnitude of health risk is uncertain because of limited incidence data
"Although it is clear that a wide range of commonly used drugs cause ADEs with potentially serious consequences for patients, relatively little is known about their frequency. Data routinely collected on ADEs during clinical trials or after drugs are marketed are intended to identify the ADEs that are associated with particular drugs and do not focus on their
frequency. Information on the overall incidence of ADEs from all drugs is limited to a few research studies that typically examined the experience of patients in one or two specific institutions—generally hospitals or sometimes nursing homes—leaving the overall incidence of ADEs in outpatient care largely unexplored." General Accounting Office, Jan 2000.
Risk factors for the development of adverse drug events in hospitalized patients
"In this study, the most important risk factors are the number of drugs used per patient and the starting of a new drug during hospitalization."
van den Bemt et al. Pharm World Sci 2000 Apr;22(2):62-6.
Adverse events in health care: issues in measurement
"...although adverse events in health care provide important and useful insights into the healthcare process which can certainly be used to great effect in promoting quality and performance improvements, some caution should be exercised, especially when they are used in measurement, either quantitatively or qualitatively."
Walshe. Quality in Health Care 2000;9: 47-52
Safe health care: are we up to it?
"Are we ready to change? Or will we procrastinate and dissembleto lament later when the inevitable regulatory backlash occurs? It may seem to some that the race for patient safety has just begun, but the patience of the public we serve is already wearing thin. They are asking us to promise something reasonable, but more than we have ever promised before: that they will not be harmed by the care that is supposed to help them. We owe them nothing less, and that debt is now due."
Lucian L. Leape and Donald M. Berwick, BMJ 2000;320:725-726 (18 March)
On error management: lessons from aviation
"Pilots and doctors operate in complex environments where teams interact with technology. In both domains, risk varies from low to high with threats coming from a variety of sources in the environment. Safety is paramount for both professions, but  cost issues can influence the commitment of resources for safety efforts. Aircraft accidents are infrequent, highly visible, and often involve massive loss of life, resulting in exhaustive investigation into causal factors, public reports, and remedial action. Research by the National Aeronautics and Space Administration into aviation accidents has found that 70% involve human error...In contrast, medical adverse events happen to individual patients and seldom receive national publicity. More importantly, there is no standardised method of investigation, documentation, and dissemination. The US Institute of Medicine estimates that each year between 44 000 and 98 000 people die as a result of medical errors. When error is suspected, litigation and new regulations are threats in both medicine and aviation."
Robert L Helmreich, BMJ 2000;320:781-785 (18 March)
Error, stress, and teamwork in medicine and aviation: cross sectional surveys
"Pilots were least likely to deny the effects of fatigue on performance (26% v 70% of consultant surgeons and 47% of consultant anaesthetists). Most pilots (97%) and intensive care staff (94%) rejected steep hierarchies (in which senior team members are not open to input from junior members), but only 55% of consultant surgeons rejected such hierarchies. High levels of teamwork with consultant surgeons were reported by 73% of surgical residents, 64% of consultant surgeons, 39% of anaesthesia consultants, 28% of surgical nurses, 25% of anaesthetic nurses, and 10% of anaesthetic residents. Only a third of staff reported that errors are handled appropriately at their hospital. A third of intensive care staff did not acknowledge that they make errors. Over half of intensive care staff reported that they find it difficult to discuss mistakes."
J Bryan Sexton, Eric J Thomas, Robert L Helmreich. BMJ 2000;320:745-749 (18 March)
Epidemiology of medical error
"Despite rare examples of malevolent providers, there is little evidence that much medical error is due to 'bad apples.' Although anaesthesiologists pioneered modern research into the safety of patients, no specialty is immune to error. Procedural mishaps are common in surgical specialties, perhaps because they are hard to disguise. Mistakes may be more common when the clinician is inexperienced and when new techniques are introduced.31 Misread radiographs and pathology specimens, laboratory errors, and mistakes made in administering radiation therapy also threaten the safety of patients."
Weingart et al. BMJ 2000;320:774-777 (18 March)
Detecting and reporting medical errors: why the dilemma?
"Errors in medicine are a major cause of harm to patients. Though there is little controversy among clinicians about the importance of accurate and reliable clinical data and the imperative of correct diagnosis, that commitment to exactitude dissolves when errors happen. Then, clinicians and managers may behave in a way that limits investigation. We often use the subjectivity and complexity of medicine to rationalise and justify error."
Pietro et al. BMJ 2000;320:794-796 (18 March)
System changes to improve patient safety
"Researchers have documented the extent of errors and their effect on patient safety. Like the card forgotten at the automated teller machine, many of the adverse events resulted from an error made by a person who was capable of performing the task safely, had done so many times in the past, and faced significant personal consequences for the error. Although we cannot change the aspects of human cognition that cause us to err, we can design systems that reduce error and make them safer for patients. My aim here is to outline an approach to designing safe systems of care based on the work of human factors experts and reliability engineers."
Thomas W. Nolan BMJ 2000;320:771-773 (18 March)
Using information technology to reduce rates of medication errors in hospitals
"Data continue to show that medication errors are frequent and that adverse drug events, or injuries due to drugs, occur more often than necessary. In fact, the frequency and consequences of iatrogenic injuries seems to dwarf the frequency of other types of injuries that have received more public attention, such as aeroplane and automobile crashes. A recent meta-analysis reported an overall incidence of 6.7% for serious adverse drug reactions (a term that excludes events associated with errors) in hospitals. Between 28% and 56% of adverse drug events are preventable....Though the reasons this issue has received so little attention are complex, the reasons that medical injuries occur with some frequency are perhaps less so; medicine is more or less a cottage industry, with little standardisation and relatively few safeguards in comparison to, say, manufacturing. In fact, most of the systems in place in medicine were never formally designed, and this holds for the entire process of giving drugs."
David W. Bates BMJ 2000;320:788-791 (18 March)
Diagnostic errors in three medical eras: a necropsy study
The frequency of major diagnostic errors in unselected patients who died in hospital was halved over 20 years, probably because of improved clinical skills and new diagnostic procedures.
Sonderegger-Iseli et al. Lancet 2000; 355: 2027-31
Improving Adherence to Hand Hygiene Practice: A Multidisciplinary Approach
 For 150 years the importance of handwashing by medical staff has been know, yet compliance is still poor, and many hospital patients are getting sick and dying as a result.
"Hand hygiene is the simplest, most effective measure for preventing nosocomial [hospital acquired] infections Despite advances in infection control and hospital epidemiology, Semmelweis' message is not consistently translated into clinical practice, and health-care workers' adherence to recommended hand hygiene practices is unacceptably low. Average compliance with hand hygiene recommendations varies between hospital wards, among professional categories of health-care workers, and according to working conditions, as well as according to the definitions used in different studies. Compliance is usually estimated as <50%"
Didier Pittet, Emerging Infectious Diseases, Vol. 7, No. 2 Mar–Apr 2001
See also: Using Alcohol for Hand Antisepsis - Dispelling Old Myths
John M. Boyce, Infect Control Hosp Epidemiol 2000;21:438-441.
Chicago Tribune special report: Nursing hidden role in medical error (site requires free sign-up)
Nurses' mistakes kill, injure thousands
"The Tribune analyzed 3 million state and federal computer records to create a database that, for the first time, quantifies the hidden role registered nurses play in medical errors. Because of incomplete reporting in the medical field, these numbers only hint at the full scope of the problem."
Nursing accidents unleash silent killer
"Since 1995, registered nurses have fatally overdosed 39 patients and injured 373 others while handling infusion pumps capable of delivering rapid, uncontrolled bursts of medicine through intravenous lines, a Tribune investigation has found ... In each of these cases, a nurse switched off the pump but failed to manually engage a small roller clamp on the IV line, which stops the flow of medicine, state and federal health-care records show ... Health-care investigators have a name for this silent killer: free flow."
Watchdog gets tough on hospital IV devices
In a safety bulletin that is being sent to 5,000 hospitals nationwide, the Joint Commission on Accreditation of Healthcare Organizations for the first time is warning of the dangers of the infusion pumps and telling hospitals they could lose accreditation for Medicaid if they cannot document their safe use.
Problem nurses escape punishment
"Lax government oversight and a shoddy system of reporting medical errors allow negligent, incompetent and impaired registered nurses to return to work in Illinois even after committing deadly errors. In Chicago, registered nurses have injected themselves with heroin and cocaine, then committed dozens of errors. They have stolen prescribed medications, then left patients to suffer in pain for hours."
Oversight panels don't see all facts of medical mistakes cases
"The full extent of medical errors in hospitals—made by nurses, doctors and others—is shrouded by a haphazard system of regulatory oversight that allows hospitals to voluntarily report problems and provide only the sketchiest of information when they do."
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When Ann Berwick was hospitalized in 1999 with symptoms of a rare autoimmune disorder of the spinal cord, she fell victim to many of the flaws in the U.S. health-care system ... Mrs. Berwick was scheduled for immediate treatment with a crucial drug. But even though she was gravely ill, she didn't get the first dose for 60 hours...Again and again, as new doctors got involved in the case, they repeated orders for other drugs that had already been tried unsuccessfully. Hospital staff gathered Mrs. Berwick's vital data, such as blood counts, body temperature and weight, in a disorganized way. And, on three occasions, they left her frightened and alone on a gurney late at night in a hospital subbasement..."Nothing I could do ... made any difference," recalls her husband, Donald Berwick, a Harvard-trained physician. "It nearly drove me mad."