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In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects , an adverse event does not necessarily mean the medication directly caused the problem.
The Joint Commission's Annual Report on Quality and Safety 2007 found that inadequate communication between healthcare providers, or between providers and the patient and family members, was the root cause of over half the serious adverse events in accredited hospitals. [51]
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 ...
Based on these studies and others, the Report estimated that the total national costs of preventable adverse events, including lost income, lost household productivity, permanent and temporary disability, and health care costs to be between $17 billion and $29 billion, of which health care costs represent one-half.
Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of the healthcare facility; As of 2019, 11 states have mandated reporting for never events, and an additional 16 states have mandated reporting for serious adverse events including never events. [4]
MedWatch was founded in 1993 to collect data regarding adverse events in healthcare. An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary ...
Adverse effects, like therapeutic effects of drugs, are a function of dosage or drug levels at the target organs, so they may be avoided or decreased by means of careful and precise pharmacokinetics, the change of drug levels in the organism in function of time after administration. Adverse effects may also be caused by drug interaction. This ...