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 ?
When a pet has an unexpected reaction to a veterinary drug, it is important to file an Adverse Drug Event (ADE) report.
The objectives of signing MoU were development of capacity proficiency in skills amongst pharmacists and other healthcare professionals in healthcare system and have a collaborative approach towards the enhanced adverse drug event reporting culture, analysis of safety profile of drug and its rational use
The label change was made due to the potential for adverse neurologic events (muscle tremors, ataxia, and seizures), which was taken from Adverse Drug Event (ADE) reports.
Among the patients, 298 -or 20 percent--experienced at least one antibiotic-associated adverse drug event. Also, every additional 10 days of antibiotics resulted in a 3 percent increased risk of an adverse drug event.
CMS recently initiated "Medication Adverse Drug Event" focus surveys noting that one in three SNF residents is harmed by an adverse event or temporary harm event within the first 35 days of a SNF stay, and 37 percent of those adverse events are related to medication.
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.
A new study presented at the Annual Congress of the European League Against Rheumatism in July suggests that one in eight patients at risk of developing a serious adverse drug event (ADE) is taking over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs), often to treat a musculoskeletal complaint such as arthritis.
If three or more criteria were met, then it was considered as an adverse drug event (ADE) case (criteria one and/or criteria two must be fulfilled by all cases).
Literature does cite that the higher the number of providers, the more likely the incidence of polypharmacy and subsequently an adverse drug event. This study also cited that the presence of four to five chronic health conditions increased the risk of an adverse drug event two-fold.42
During 2010-2011, the National Electronic Injury Surveillance System--Cooperative Adverse Drug Event Surveillance project (2) identified 68 cases involving buprenorphine product ingestions (out of 226 cases of opioid product ingestions) by children aged <6 years.* Based on these cases, CDC estimates that, during 2010-2011, an average of 1,499 (95% confidence interval [CI] = 905-2,092) children aged <6 years were evaluated each year in U.S.
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.