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 an analysis of data from a nationally representative sample of hospitals in the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project, researchers estimated that 97,648 ED visits occurred annually during a 5-year period among adults with type 2 diabetes who presented with hypoglycemia-related shock, loss of consciousness, seizure, injury or fall, or altered mental status.
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.
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.
An adverse drug event is an injury resulting from the use of a drug, which may or may not result from an error.
Finally, there needs to be a greater awareness of what an adverse drug event actually is.
It is the only resource that utilizes the RxFilter process to combine all the varied designations for a medication found in AERS into a single report, and standardizes the AERS data for improved accuracy of adverse drug event information.
Studies show that adverse drug event reporting integrated into EHRs increases the convenience, content and volume of adverse event reports.
In 2003, the CDC worked with the Consumer Product Safety Commission and the Food and Drug Administration to develop the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance (NEISS-CADES) project.
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.
Teams report that rates for adverse drug events (events that result in harm or injury to the patient due to medication use) are being reduced by nearly 50 percent, and many cite specific instances when a life-threatening adverse drug event was identified and resolved.
Thomson Reuters Pharmacy Intervention compares clinical profiles with data pulled from disparate hospital IT systems to automatically identify patients who are at-risk of an adverse drug event, such as someone who is on a potentially lethal combination or dosage of medications.
Through the use of a novel approach to analyzing a preventable adverse drug event (ADE) -- by linking types of drugs, types of associated adverse outcomes, and types of errors to organize apparently unrelated and disparate preventable ADEs -- the specific high-priority prevalent and preventable clinically significant ADEs could be targeted, identified and better understood for future quality-improvement efforts.