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Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are merely documented ...
Generally, any event which causes death, permanent damage, birth defects, or requires hospitalization is considered a serious adverse event. [4] The results of trials are often included in the labelling of the medication to provide information both for patients and the prescribing physicians.
In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose Results in death; Is life-threatening; Requires inpatient hospitalization or causes prolongation of existing hospitalization; Results in persistent or significant disability/incapacity
The Leapfrog Group has announced that they will work with hospitals, health plans, and consumer groups to advocate reducing payment for "never events", and will recognize hospitals that agree to certain steps when a serious avoidable adverse event occurs in the facility, including notifying the patient and patient safety organizations, and ...
Serious Adverse Event Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
A 2001 study estimated that 1% of hospital admissions result in an adverse event due to negligence. [23] Identification or errors may be a challenge in these studies, and mistakes may be more common than reported as these studies identify only mistakes that led to measurable adverse events occurring soon after the errors.
A never event is the "kind of mistake (medical error) that should never happen" in the field of medical treatment. [1] According to the Leapfrog Group never events are defined as "adverse events that are serious, largely preventable, and of concern to both the public and health care providers for the purpose of public accountability." [2]
The Joint Commission disseminates "sentinel event alerts" identifying specific sentinel events, their underlying causes, and steps to prevent recurrence. [5] Further nursing research is ongoing at a number of "magnet" hospitals in the United States, especially to reduce the number of patient falls that may lead to sentinel events.
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