MEDICATIONS: CONTROVERSY OVER ACCURACY OF REPORT ON DEATHS ATTRIBUTABLE TO MEDICAL ERRORS

All agree that systems need to be instituted to help clinicians avoid medical mistakes

The high number of deaths due to medical errors in hospitals reported in a 1999 Institute of Medicine (IOM) report requires additional context that could lower the estimate of deaths due to medical errors, according to an article of the July 5 issue of The Journal of the American Medical Association.

Clement J. McDonald, M.D., and colleagues from Indiana University School of Medicine in Indianapolis, analyzed the data used in the recent Institute of Medicine report on medical errors, which was based on a published study.

The authors agreed with the report's call for understanding the cause of medical errors and for developing mechanisms to reduce error rates. They argue, however, that the two studies used in the IOM report were observational studies not designed to describe causal relationships. The authors suggest that the death rate due to adverse events could be only a small increment above the baseline death rate.

"We also assert that the available data do not support IOM's claim of large numbers of deaths caused by adverse events (preventable or otherwise)," the researchers write.

"Most patients admitted to hospitals have high disease burdens and high death risks even before they enter the hospital," the authors argue. "Although some hospital deaths are preventable, most will occur no matter how many 'accidents' we avoid. Of course, medical errors are never excusable, but the baseline death risk has to be known and factored out before drawing conclusions about the real effect of adverse reactions on death rates, preventable or otherwise."

IOM report co-author: Error figures are not exaggerated

In a second article, however, Lucian L. Leape, M.D., of the Harvard School of Public Health in Boston, says the IOM report on medical errors is accurate and that the currently error-prone system must be fixed. Dr. Leape is a member of the IOM committee and a co-author of the study.

Dr. Leape refutes the criticism of the methodology of the studies, writing that the patients studied most probably would have survived had medical errors not been committed. In fact, Dr. Leape notes, the screening criteria eliminated patients who were extremely ill or had complicated conditions.

The author asserts that the record review studies probably underestimated the extent of injury because many adverse events and errors are never placed in the medical record. The studies did not examine injuries that occur outside of the hospital, Dr. Leape writes, noting that prospective studies of specific events - such as medication errors - almost invariably reveal still higher rates. He adds that more than half of surgical procedures, numbering now in the tens of millions, take place outside of a hospital setting; none of these were included in the estimates.

"But what are the ethical implications of this search for 'excess' mortality?" Dr. Leape writes. "Does the fact that some patients would have died anyway somehow lessen the significance of their deaths? Not for this patient, his/her family or for anyone who faces hospital admission. But it does for many physicians, and the reason is instructive. Knowing that some of the patients 'would have died anyway' is important for physicians because it lessens their burden of guilt. Physicians feel responsible for deaths due to errors, which is appropriate, but they also feel shame and guilt, which is inappropriate, since errors are rarely due to carelessness

"The transforming insight for medicine from human factor research is that errors are rarely due to personal failings, inadequacies and carelessness," writes Dr. Leape. "Rather, they result from defects in the design and conditions of medical work that lead careful, competent, caring physicians and nurses to make mistakes that are often no different from the simple mistakes people make every day, but which can have devastating consequences for patients. Errors result from faulty systems not from faulty people, so it is the systems that must be fixed. Errors are excusable; ignoring them is not.

"The IOM report has galvanized a national movement to improve patient safety," he concludes. "Although the initial impact of the IOM report is in part due to the shocking figures (which, unfortunately, are not exaggerated), its long-term impact will result from the validity of its message that errors can be prevented by redesigning medical work. Rather than attempting to assuage guilt or outrage about errors by punishing, discounting or self-flagellation, physicians need to look to preventing recurrence of errors. Errors and "excess" mortality can be eliminated, but only if concern and attention is shifted away from individuals and toward the error-prone systems in which clinicians work."