adverse drug event

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Also found in: Acronyms.

adverse drug event

(ad-vĕrs drug ĕ-vent'),
"an injury resulting from medical intervention related to a drug." [Institute of Medicine]
See also: adverse event.

adverse drug reaction

Any noxious and unintended response associated with the use of a drug in humans.

Adverse Drug Reaction

Any noxious, undesired, or unintended response to a therapeutic agent, which may be expected or unexpected, and may occur at dosages used for the prophylaxis, diagnosis, or therapy of disease, or for modifying physiologic function. ADRs do not include therapeutic failures, poisoning, accidental or intentional overdoses. ADRs occur in up to 15% of all drug administrations, but are rarely fatal. They can be divided into type A—dose-dependent or predictable—or type B—idiosyncratic or allergic—reactions.
Clinical findings Pruritus, nausea, vomiting, rash, confusion, lethargy, etc.
Culprits ADR are most commonly caused by analgesics and narcotics, antibiotics, cardiovascular agents, anticoagulants, and psychotherapeutics.
Regulatory process In the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions; a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility—i.e., the relationship cannot be ruled out.
References in periodicals archive ?
Of the 600 patients, 158 (26%) had 329 adverse drug events.
The most common class of medications causing adverse drug events was analgesics/opioids, which were linked to 51 percent of all the inpatient adverse events.
and colleagues showing that of 661 outpatients, 162 (25%) had adverse drug events, for a total of 181 events.
Research by AHRQ-supported investigators is helping to characterize these errors (called preventable adverse drug events, or ADEs) and suggest how to prevent them.
to implement its flagship software solution to reduce adverse drug events (ADEs) affecting V.
For example, after implementing a barcode-assisted dispensing system, one hospital pharmacy reduced the rate of potential adverse drug events (ADEs) from dispensing errors by 63 percent (from 0.
The number of serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration more than doubled between 1998 and 2005, according to a report in the Sept.
In a random sampling of 3,400 Epocrates physicians, more than 95 percent reported that clinical PDA software helps them provide better quality of care and save time; nearly 60 percent said they avoid one or more adverse drug events or medical errors per week, and 40 percent said they avoid one per month.
A new national active surveillance system designed to detect adverse drug events is good at picking up true cases, but not particularly sensitive--especially in detecting hypoglycemia caused by diabetes medications and bleeding associated with anticoagulants, the Centers for Disease Control and Prevention reported.
A substantial number of these were adverse drug events.