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 ?
The Clinical Research Information eXchange (CRIX) International today announced their participation with Pfizer, Partners HealthCare and the Clinical Data Interchange Standards Consortium (CDISC) in the ASTER (Adverse Drug Event Spontaneous Triggered Electronic Reporting) study, which is exploring ways to improve the current spontaneous reporting system (SRS), the primary source of information for adverse drug events.
Studies suggest that up to 50% of persons in a nursing home have some kind of adverse drug event every 6 months, and while many of those are relatively minor events, they can be serious.
In 2003, the CDC collaborated with the Consumer Product Safety Commission and the Food and Drug Administration in developing the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance (NEISS-CADES) project.
Among the patients, 298 -or 20 percent--experienced at least one antibiotic-associated adverse drug event.
Another 30% of patients had at least one potential adverse drug event, she said.
Mso, patients discharged from hospitals with the highest percentage of Black patients had a significantly higher risk of hospital-acquired infection or adverse drug event than patients discharged from hospitals with the lowest percentage of Black patients.
5 times more likely to experience an adverse drug event than younger people and seven times more likely to be hospitalized for an adverse drug event.
In the study, the researchers calculated an overall score (percentage of test orders identified) as well as scores for each category of adverse drug event for all hospitals in aggregate.
The manufacturer, GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company," the report said.
Each medical chart was checked for an occurrence, or flag, that would "trigger" further investigation to determine the presence or absence of an adverse drug event.
9) In addition, approximately two thirds of nursing facility residents will experience an adverse drug event over a 4-year period of time, with 1 in 7 of these residents requiring hospitalization.
Although definitions vary, an adverse drug event can be described as an injury resulting from a medical intervention related to a drug.