Near-miss medication errors provide a wake up call.

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Hippocrates discussed the concept of medical harm and the word iatrogenesis came from the Greek for doctor.In the centuries since, the topic has received attention from physicians.The phrase "iatrogenic disease" was used in a book that evolved from a New England Journal of Medicine paper about diseases of medical progress.

The California Medical Association and the California Hospital Association funded the Medical Insurance Feasibility Study to quantify the incidence of iatrogenic harm.The model for the Harvard Medical Practice Study was found in this study.The immediate goal of the California study was to obtain adequate information about patient disabilities.The study focused on adverse outcomes to patients in the course of health care management, but did not use the term adverse event.4.5 injuries were reported to patients per 100 hospitalizations.More than 10% of patients experience harm while in the hospital, with half of these events being considered preventable.

The Harvard Medical Practice Study defined an adverse event as an injury that was caused by medical management and that resulted in a disability at the time of discharge."Unintended physical injury resulting from or contributed to by medical care (including the absence of indicated medical treatment) that requires additional monitoring, treatment, or hospitalization or that results in death" is the definition used by the Institute for healthcare improvement.

Adverse events can be preventable or not.One definition refers to preventable adverse events as "avoidable by any means currently available unless that means was not considered standard care."It is defined as "care that fell below the standard expected of physicians in their community."Both the Medical Insurance Feasibility Study and the Harvard Medical Practice Study focused on adverse events.The Box contains examples of preventable adverse events from the Harvard Medical Practice Study.

A patient had an embolic cerebrovascular accident while undergoing an arteriosclerosis test.The patient was not at high risk for a stroke because the angiography was done in standard fashion.The stroke may have been the result of medical management.The event was not due to carelessness.

A middle-aged man had rectal bleeding.A limited sigmoidoscopy was done by the patient's physician.The physician was reassured by the patient's continued rectal bleeding.He was admitted to a hospital for an evaluation after a weight loss of 30 lbs.He was found to have cancer in his colon.The physicians who reviewed his medical record thought proper diagnostic management might have found the cancer when it was still curable.substandard medical care was blamed for the advanced disease.The event was considered bad and careless.

There are two other terms in the literature.Errors are defined as "an act of commission (doing something wrong) or omission (failing to do the right thing) leading to an undesirable outcome or significant potential for such an outcome."The Swiss Cheese Model of accident causation is summarized in the Systems Approach Patient Safety Primer.Any event that could have had adverse consequences but did not and was indistinguishable from fully fledged adverse events in all but outcome is a near miss.The related terms "potential adverse event" and "close call" are used in some studies.The patient did not experience clinical harm, even though an error was committed, because of early detection or sheer luck.Consider a patient who is admitted to the hospital and placed in a shared room.The nurse gave the pills to the other patient while he was in the room.The other patient knows that these are not his medications, does not take them, and alert the nurse so that they can be given to the correct patient.This situation had a high potential for harm as a patient may have taken the wrong medication.

The ameliorable adverse event is a final subcategory of adverse events.The severity of the injury could have been reduced if different actions or procedures had been followed.A patient with a new diagnosis of heart failure is discharged from the hospital with no instructions for follow-up or laboratory tests.The patient presents to the emergency department with a serious injury.The adverse effects of diuresis are not preventable, but the severity could have been reduced by having the patient come in for lab testing within a week of discharge.

The Office of the Inspector General uses a two-stage record review process in which patient charts are independently reviewed by two clinically experienced reviewers in order to determine whether or not an adverse event occurred.The level of agreement between reviewers regarding the presence of an adverse event is usually only moderate, even with highly trained reviewers.Reviewers may disagree about whether the event was preventable.