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Adverse event. In pharmaceuticals, an adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended symptom or sign ...
Serious adverse event. 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.
Pharmacology. An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. [ 1 ] An adverse effect may be termed a " side effect ", when judged to be secondary to a main or therapeutic effect. The term complication is similar to adverse effect, but the latter is typically used in ...
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. [1]: 1.1 Adverse Drug Reaction (ADR) [2] ADRs may occur following a single dose or prolonged administration of a drug or may result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side ...
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. [ 1 ]: 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep ...
The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and haematology), vital signs, clinical adverse events (diseases, signs and symptoms), and other special safety tests (e.g. ECGs, ophthalmology).
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration 's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might ...
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 ...