MEDICAL ERRORS...MORE
editor's note- Recently, as indicated here and elsewhere, in Texas, a CRAZY thing happened, well, more like, a horrible abuse of the legal system happened. The Texas Medical Association, which has no mandate to oversee any profession (The Texas Medical Board, http://www.tmb.state.tx.us/ oversees practice of medicine in Texas) , filed a lawsuit against the Texas Board of Chiropractic Examiners, claiming , among other things, that Chiropractic Doctors should not be allowed legally to diagnose their own patients. The Texas Meddlesome Assn...er..uh "Texas Medical ASSn" says they did so, in order to "protect citizens of Texas".
This is ridiculous to the point of absurdity.
The Quality of Health CareMedical Error and Patient Injury: Costly and Often Preventable
Research Report
Andrew H. Smith, AARP Public Policy Institute
September 1998
Table of Contents:
Public Perception of Patient Safety and Medical Error
Incidence of Medical Error and Injury
Drugs and Medical Injury
Costs Resulting from Medical Injury
Why Do Medical Errors Happen, and How Should the Problem Be Addressed?
Addressing the Problem from a Systems Approach
Current Efforts to Address Medical Error From a Systems Perspective
Conclusion
Footnotes
Patient injuries that result from preventable medical errors are widespread
and costly.1
One recent study found that more than one in six hospitalized patients suffered
medical injuries that prolonged their hospital stays.2
It has been estimated that total annual costs associated with injuries resulting
from medical error may be as high as $200 billion, the equivalent of nearly one
out of every five dollars spent on health care in America.3
Estimates of the frequency of medical errors and injuries and the costs
associated with them vary considerably, but even the most conservative estimates
indicate that the problem is widespread, very costly, and requires serious
attention.4
Preventable medical error and injury are of particular concern for older
people because there is evidence that they are injured at a substantially higher
rate than patients in other age groups. As
Figure 1 indicates, patients age 65 and older experience medical injury two
to four times as often as patients in age groups under the age of 45, according
to a landmark study published in 1991, the most recent age-specific data
available.5
Advancing age was the only demographic characteristic -- not gender, race,
ethnicity, or income -- associated with a significantly increased incidence of
medical injury and of injury due to "negligence."6
The evidence suggests that costs associated with preventable medical error and
injury, both in terms of human suffering and dollars spent by the Medicare
program to treat injured beneficiaries, are very significant.
Public Perception of Patient Safety and
Medical Error
There is a substantial amount of public concern about patient safety.7
In a 1997 national survey, respondents rated the current health care system as
only "moderately safe" -- safer than nuclear power and food handling, but less
safe than airplane travel and the workplace.8
(See
Table 1.) Forty-two percent of those surveyed said that they had been
involved, either personally or through a friend or relative, in a situation
where a medical mistake was made. Fifty-two percent of respondents stated that
they were satisfied with the measures currently in place to prevent medical
mistakes, but a large minority, 42 percent, said they were not satisfied.9
Not surprisingly, most of those who reported that they were not satisfied with
current measures were those who had been involved in some way with a medical
mistake.10
 |
| Table 1. Perceived Safety of Various Environments | |
| Environment | Mean Scores |
| Airline travel | 5.2 |
| Workplace | 5.2 |
| Health care | 4.9 |
| Food handling | 4.4 |
| Nuclear power | 4.2 |
| Scores: 7=Safe, 1=Unsafe. Source: National Patient Safety Foundation at the AMA, "Public Opinion of Patient Safety Issues." Survey conducted by Louis Harris & Associates, September 1997. | |
Incidence of Medical Error and Injury
in injuries11
reach as high as 17.7 percent of hospitalizations.12
One important study of medical injury is the 1990 Harvard Medical Practice Study
(Harvard Study), a population-based study of injuries resulting from medical
care during hospitalizations in New York. This study found that nearly 4 percent
of patients suffered an injury that caused their hospital stays to be prolonged,
or resulted in measurable disability.13
The Harvard Study, which used reviews of medical records to detect medical
injuries, found that almost 14 percent of those identified as having suffered
medical injury died as a result of their injuries. If the rate of deaths
resulting from medical error identified by the Harvard Study in New York were
consistent with rates in the other 49 states, that would mean that 180,000
Americans die annually as a result of medical injuries.14
That figure would be comparable to the number of deaths that would occur if
three jumbo-jets crashed every two days,15
and is approximately four times the number of traffic fatalities that occur
annually in America.16
Consistent with other studies that have found that most medical injuries are
due to errors, the Harvard Study determined that 69 percent of the medical
injuries identified were due to error, and were, therefore, preventable.17
Studies conducted more recently indicate that medical injury may be
substantially more common than suggested in the Harvard Study. Using a method
more likely to capture incidents of medical error than the earlier study,
Andrews and her colleagues found that 17.7 percent of patients whose care was
observed experienced at least one serious adverse event per hospitalization.18
The frequency of medical injuries was linked to severity of illness and length
of hospital stay, with the likelihood of experiencing a medical injury
increasing by 6 percent per day of hospitalization. One or more causes19
of medical injuries were determined in just over one half of cases in the study.
In 37.8 percent of cases, the adverse events were found to have been caused by
an individual; 15.6 percent had interactive causes; and 9.8 percent were due to
administrative decisions. Although 17.7 percent of patients experienced medical
injuries that prolonged their hospital stays, the study found that only 1.2
percent filed claims for compensation for their injuries.
Drugs have been found to be among the most common causes of medical injury.
In the Harvard study, 19.4 percent of the injuries detected were related to the
use of drugs, while the Andrews study determined that 9.3 percent of injuries
were medication-related.20
A large percentage of adverse drug events (ADEs) have serious consequences,
and many of them are preventable. Bates and his colleagues found that of all
ADEs identified in their study, 1 percent were fatal, 12 percent
life-threatening, 30 percent serious, and 57 percent significant. Of ADEs that
were determined to have been preventable, 20 percent were life- threatening, and
43 percent were serious. (See
Figure 2.) Overall, 28 percent of the ADEs were judged preventable, but of
life-threatening and serious ADEs, 42 percent were determined to have been
preventable.21
Bates found rates of 6.5 ADEs and 5.5 potential ADEs per 100 non-obstetrical
admissions to tertiary-care hospitals. Classen and colleagues found that adverse
drug events complicated 2.43 percent of hospital admissions, adding
significantly to length of hospital stays and to costs.22
 |
TopCosts Resulting from Medical Injury
The costs associated with injuries resulting from medical error are quite
substantial. As noted above, one recent estimate placed the total costs
associated with medical injury at as much as $200 billion annually.23
Most studies that attempt to estimate costs associated with medical error
have focused on injuries resulting from the use or misuse of medications. In
their 1995 study, Johnson and Bootman estimated that costs associated with
drug-related illness and death that resulted primarily from patient
non-compliance, and inappropriate prescribing, and/or monitoring by health care
professionals equal $76.6 billion annually.24
The costs calculated for drug-related illness and death were limited to those
that arose from medication use or misuse in an outpatient setting, with the
largest component of costs resulting from drug-related hospitalizations.25
The ADEs identified in the Classen study, half of which were identified as
preventable, added 1.91 days to the mean length of hospital stays and resulted
in increased costs per stay of $2,262.26
In a follow up to their earlier study, Bates and colleagues determined that
an additional 2.2 days of hospitalization were required for patients
experiencing an ADE, at an average added cost of $3,244. For ADEs identified as
preventable, patients stayed in the hospital an average of 4.6 extra days, at an
average additional cost of $5,857.27
Why Do Medical Errors Happen, and How Should the
Problem Be Addressed?
1. Negligent and/or incompetent providers
As a recent survey reveals, many people believe that medical errors and
injuries occur because there are just too many "bad doctors" and other health
care professionals performing in a negligent manner.28
Medical injury is viewed as primarily the result of allowing incompetent and/or
careless providers to continue in the practice of medicine, and of hospital
under-staffing and other cost-cutting practices.29
It has frequently been observed that relatively few providers are sanctioned by
the medical profession and/or state entities charged with enforcing standards of
medical practice despite evidence of widespread negligence.30
Those who believe that medical negligence and an ineffective oversight system
are largely responsible for medical error and injury have responded in a number
of ways. For example, they promoted the development and use of a practitioner
databank. As a result, the National Practitioner Data Bank (NPDB) was created.
The NPDB collects and releases information (to authorized entities) relating to
medical malpractice payments, adverse licensure actions, certain types of
professional review actions, and reports of Medicare and Medicaid sanctions
taken against physicians, dentists, and some other health care practitioners.31
They have also defended the laws that govern medical malpractice actions against
a strong effort from the medical community to enact legal reforms that would
curtail malpractice litigation.32
2. Inevitable human error and systems failures
A contrasting view holds that the problem of medical error and injury results
primarily from systems failures. Proponents of this view acknowledge that there
are incompetent and impaired providers who commit errors that result in patient
injury, and that few physicians face disciplinary actions. However, they
observe, there is little evidence that negligence is the major cause of medical
error, or that rooting out negligent and incompetent providers would solve the
problem.
Those who subscribe to a "systems approach" to medical error, drawing on
psychological and human factors research, argue that human beings, no matter how
careful and conscientious they are, will make mistakes.33
They also note that because the practice of medicine is complex, there are a
great many opportunities for mistakes to occur, and that the high level of
complexity makes it unrealistic to depend on promoting individual perfection as
the method to avoid mistakes that result in patient injury. For example, in one
study of an intensive care unit, it was determined that patients received an
average of 178 "activities" each day.34
The average number of errors per patient per day was 1.7, or slightly less than
1 percent. Thus, the unit was functioning correctly 99 percent of the time.35
Leape notes, however, that even an accuracy rate of 99.9 percent may not prove
adequate, noting that a 99.9 percent accuracy rate would translate to:
- Two unsafe landings at O'Hare airport each day;
- 16,000 pieces of lost mail per hour; and
- 32,000 bank checks deducted from the wrong account every hour.36
Addressing the Problem from a Systems
Approach
One medical specialty, anesthesiology, has already made significant
improvements in its safety record. Mortality resulting from errors in anesthesia
has been reduced by 95 percent over the past 15 years.37
Recognizing system factors, rather than carelessness or incompetence as the
most important causes of medical error, anesthesiologists designed fail-safe
systems and developed and implemented training programs to avoid errors.38
The success story in anesthesiology illustrates the possibilities and
problems for other areas of medical practice. Errors and the resulting injuries
in anesthesiology, unlike those in many areas of medical practice, tend to be
dramatic and severe.39
Information about incidents and the circumstances surrounding them were,
therefore, available to those attempting to understand the problems, and the
reasons the errors occurred were often transparent. These factors were conducive
to understanding the problems and developing approaches to correct them.
A number of scholars believe that the most important reason that medicine has
failed to develop more effective ways to prevent error is that, except in the
case of the practice of anesthesiology, there has been little opportunity to
study the reasons that errors occur. Information about medical error is
inadequate for researchers because most errors go unreported. Unlike errors in
anesthesiology, which, as noted above, cannot easily be hidden, errors occurring
in other areas of medical practice tend to be less frequently obvious and
dramatic in effect. In what some call medicine's culture of blame, there
is good reason not to volunteer information that an error has occurred when it
might otherwise remain undiscovered. In the medical culture, error cannot be
accepted; physicians are taught in medical school and during residency to learn
and practice error-free medicine, i.e., to be perfect. Error is treated
as a moral failing,40
and it is not surprising that mistakes are driven "underground."
Advocates of the systems approach argue that, for medicine to enjoy the
success observed in anesthesiology, it is essential to overcome the barriers to
full reporting of medical errors. For researchers to devise ways to prevent
and/or to absorb41
errors and prevent injuries, they must learn precisely how and why errors and
their resulting injuries take place. They must have access to detailed and
comprehensive information on errors, and full information can be obtained only
if there is full disclosure of errors.
Current Efforts to Address Medical Error
From a Systems Perspective
A number of initiatives have been developed to study and address the problem
of medical error using a systems approach. Examples include:
- The National Coordinating Council for Medication Error Reporting and
Prevention (NCC MERP), an organization of pharmacy and health care
professional groups, the U.S. Food and Drug Administration, the U.S.
Pharmacopoeia, and consumer organizations, among others, has developed
numerous recommendations to prevent medication errors. These recommendations,
addressed to pharmaceutical manufacturers, packagers and repackagers,
hospitals and hospital pharmacies, outpatient pharmacies, physicians and other
health care personnel, should lead to the safer use of drugs in all settings.Among NCC MERP's recommendations: (1) print warnings only on caps and
ferrules of injectables; (2) make intravenous drug names visible on both sides
of the container; and (3) print drug names in type that is at least as large
as company names and logos.42The organization is also encouraging the use of its "Medication Error Index
for Categorizing Errors," a new indexing system that will help researchers to
track medication errors in a consistent, systematic manner.43
Widespread use of the index should result in the efficient collection and
compilation of data on medication error, and thereby allow the development of
recommendations that could lessen the chance for patient injury. - The National Patient Safety Foundation at the AMA (NPSF) and the National
Patient Safety Partnership (NPSP) constitute two major initiatives to (1)
study medical error and (2) develop systems-based responses to reduce the
incidence of medical error and absorb errors when they do occur so that the
errors do not reach the patient. - The NPSF was founded by the American Medical Association in 1997, but is
now an independent foundation supported by a broad range of organizations,
including health care professional organizations, consumer organizations,
insurance companies, managed care organizations, and academicians. The NPSP
was founded by the U.S. Veterans Administration, and like the NPSF, has a
broad range of participating organizations. The NPSF and NPSP have recently
linked their efforts to promote research into the causes and cures for medical
error and injury. Among the projects they are working on together are: - (1) an effort to design a voluntary, confidential, non-punitive system
that would promote the reporting of essential data that would allow
researchers to learn the nature of systems failures that lead to injury; and - (2) a survey of health care providers and the medical culture as it
relates to patient safety.
The systems approach has been successfully employed in non-health care
settings that are, like health care, high risk enterprises. Both the airline
industry's Aviation Safety Reporting System (ASRS) and the National Aeronautics
and Space Administration's (NASA) "Close-Call" reporting system were developed
through use of the systems approach.44
As noted above, the success achieved in anesthesiology through the use of a
systems approach to improve patient safety strongly suggests that applying that
approach would be appropriate in other areas of medical practice. Before systems
changes to prevent medical error and patient injury can be devised and
implemented, the weaknesses in the complex systems of medical care that allow,
or even promote, medical errors must be identified and understood. A great deal
of research must be performed before the goal of substantially reducing rates of
preventable injury can be realized.
The systems approach promises significant reductions of preventable medical
error and injury in the future. It cannot, however, eliminate current and future
needs for patient compensation when a preventable injury does occur, despite
systems improvements. Neither can it adequately address errors/injuries that
arise from provider incompetence and/or impairment. Those are matters that must
continue to be addressed through legal and administrative mechanisms.
The work of the NPSF, NPSP, and NCC MERP, among other organizations, to
coordinate and support research and disseminate its results, should lead to
safer medical practice, fewer patient injuries, and reduced health care costs.
Success in preventing or absorbing medical error should prove beneficial to
Medicare beneficiaries, who most frequently suffer medical injuries, and could
save the Medicare program billions of dollars currently devoted to treating
preventable medical injuries.
Footnotes
1 "Medical error" may be defined as "an unintended act (either of
omission or commission) or one that does not achieve its intended outcomes."
Leape, Lucien. "Error in Medicine." Journal of the American Medical
Association 272(23):1851-57 (Dec. 21, 1994).
2 Andrews, Lori B., Carol
Stocking, Thomas Krizek, et al. "An Alternative Strategy for Studying Adverse
Events in Medical Care." Lancet 349:309-13 (Feb. 1, 1997).
3 Perrone, J. "Designing a Safer, Smarter Health Care System: AMA
Foundation Looks at Ways to Prevent Mistakes," American Medical News
40(40):1 (Oct. 27, 1997).
4 Reduction of medical error
is listed as one of "Six National Aims" in the Report of the President's
Advisory Commission on Consumer Protection and Quality in the Health Care
Industry (March 1998).
5 Patients, Doctors, and Lawyers: Medical Injury, Malpractice
Litigation, and Patient Compensation in New York. The Report of the Harvard
Medical Practice Study to the State of New York. Harvard Medical Practice
Study, 1990, 6-23.
6 Ibid.
7 "Public Opinion of Patient Safety Issues: Research Findings,"
National Patient Safety Foundation at the AMA, September 1997.
8 Ibid.
9 Ibid.
10 Ibid.
11 "Medical injuries" here refer to "iatrogenic injuries," i.e.,
injuries or conditions resulting from treatment by physicians or surgeons.
12 Andrews, et al. (1997).
13 Harvard Medical Practice Study (1990).
14 Leape (1994).
15 Ibid.
16 There were 43,910 deaths in 1997 resulting from motor vehicle
accidents. National Center for Health Statistics. "Births, Marriages, Divorces,
and Deaths for February 1997. Monthly Vital Statistics Report." 46: 2. (1997).
17 Leape (1994).
18 Andrews and her colleagues used a prospective, observational
approach that followed the care of all patients admitted over a period of time
to three units of a teaching hospital, as opposed to the Harvard Medical
Practice Study that used retrospective reviews of medical records. Andrews, et
al. (1997).
19 "Interactive causes" refers to "interactions between individuals,
or between individuals and hospital entities, or between hospital entities, such
as the failure of a consultant team to communicate adequately with the
requesting team." Andrews, et al. (1997) at p. 311.
20 Harvard Medical Practice
Study (1990).
21 Bates, David W., David J. Cullen, Nan Laird, et al. "Incidence of
Adverse Drug Events and Potential Adverse Drug Events: Implications for
Prevention." Journal of the American Medical Association 274(1): 29-34
(July 5, 1995).
22 Classen,, David C., Stanley L. Pestotnik, R. Scott Evans, et. al.
Adverse Drug Events in Hospitalized Patients," Journal of the American
Medical Association 277(4):301-06 (Jan. 22/29, 1997).
23 Perrone (1997).
24 Johnson, Jeffrey A. and J. Lyle Bootman. "Drug-Related Morbidity
and Mortality: A Cost-of-Illness Model," Archives of Internal Medicine
155:1949-56 (Oct. 6, 1995). This estimate includes all types of medication
error, both preventable and non-preventable. It does not include costs
associated with injuries that are the result of unforseeable
allergic/idiosyncratic responses or those that occur when the provider knows
that there are risks associated with a drug but prescribes it anyway because, in
his/her judgment, the potential benefits outweigh the risks.
25 When indirect costs due to non-compliance are added to the direct
cost figures, total economic costs rise to approximately $100 billion. Berg, J.S.,
J. Dischler, J.J. Raia, and N. Palmer-Shevlin, "Medication Compliance: A
Healthcare Problem," Annals of Pharmacotherapy 27(9):S3-S22 (1993).
26 Ibid.
27 Bates, David W., Nathan Spell, David J. Cullen, et al. "The Costs
of Adverse Drug Events in Hospitalized Patients," Journal of the American
Medical Association 277(4):307-11 (Jan. 22/29, 1997).
28 See Richards, Edward P. and Katharine C. Rathbun, Law and the
Physician: A Practical Guide. Little, Brown, and Co.:New York (1996).
29 Ibid.
30 See, for example, Public Citizen, "16,638 Questionable Doctors."
(March 1998). It is noted that, although there have been more disciplinary
actions taken against physicians recently, few have been required to stop
practicing medicine, even for a short time. In 1996, 16,638 physicians were
disciplined by state boards or federal agencies. The rate of "serious
disciplinary actions" was 3.96 per 1,000 doctors (2,731 actions).
31 Title IV of the Health Care Quality Improvement Act of 1986 (P.L.
99-660) established the National Practitioner Data Bank (NPDB). Regulations
governing the NPDB may be found at 45 CFR Part 60. The information in the NPDB
is available only to state licensing boards, hospitals and other health care
entities, professional societies, certain Federal agencies, and others as
specified in the law. Only hospitals are mandated by law to query the Data Bank.
32 Nonetheless, many states passed "tort reform" measures in the wake
of the alleged medical malpractice insurance crisis of the late 1980s. They
included such measures as placing caps on possible damage awards (particularly
on awards for "pain and suffering"), restrictions on statutes of limitations,
limitations of plaintiff attorneys' fees, and other measures to discourage
potential complainants from filing malpractice actions.
33 For a brief overview of relevant developments in cognitive
psychology and human factors research, see Leape, p. 1853 (1994).
34 An "activity" is defined as any interaction between health care
personnel and patients that presents an opportunity for an adverse patient
outcome.
35 Leape (1994).
36 W.E. Deming, written communication quoted in Leape (1994).
37 Orkin, P.K. "Patient Monitoring During Anesthesia as an Exercise
in Technology Assessment." In Saidman, L. J. and N.T. Smith, eds. Monitoring in
Anesthesia 3rd Ed. London, England: Butterworth Publishers, Inc. (1993).
38 See Gaba, D.M., "Human Errors in Anesthetic Mishaps,"
International Anesthesiology Clinics 27(3):137-47 (Fall 1989). Also see
Cooper, J.B., R.S. Newbower, and P.J. Kitz, "An Analysis of Major Errors and
Equipment Failures in Anesthesia Management: Considerations for Prevention and
Detection," Anesthesiology 60(1):34-42 (Jan. 1984).
39 Leape, p. 1856 (1994).
40 Ibid.
41 It is recognized that errors are inevitable in any human endeavor,
including the provision of health care. Error "absorption" refers to the notion
that well-designed error prevention systems will "absorb" errors, keeping them
from reaching the patient and causing injury.
42 See U.S.P., "Medications Errors Council Recommends Changes to
Medical Product Packaging and Labeling," The Standard (Sep. 16, 1997).
43 U.S.P., "Medication Errors Council Promotes Categorization Index,"
The Standard (October 1996).
44 See Helmreich, R.L. "Managing Human Error in Aviation,"
Scientific American 276(5):62-67 (May 1997).
Written by Drew Smith, AARP Public Policy Institute
September 1998
©1998 AARP
May be copied only for noncommercial purposes and with attribution; permission
required for all other purposes.
Public Policy Institute, AARP, 601 E Street, NW, Washington, DC 20049
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