adverse drug event

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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 ?
In "Incidence and Preventability of Adverse Drug Events Among Older Persons in the Ambulatory Setting," Jerry Gurwitz of the University of Massachusetts Medical School and his colleagues conclude that problems are common and that many of them can be prevented.
Hanlon found that one-third of the patients had an adverse drug event, and most of those events occurred within 3 months of the hospitalization.
To report suspected adverse drug events for Osurnia, contact Elanco US Inc.
Synowledge specializes in pharmacovigilance, regulatory affairs and information technology services to support biopharma companies with recording, analyzing and reporting adverse drug events.
As part of an update in September 2014 to the ONC Health IT Safety Program--Progress on Health IT Patient Safety Action and Surveillance Plan, the agency noted that a study published in the summer of 2014 funded by HHS' Agency for Healthcare Research and Quality (AHRQ) found that Florida hospitals that adopted all five core measures of Meaningful Use for medication management in 2010 had the lowest rate of adverse drug events of all hospitals in the state.