Difference between revisions of "Adverse drug event"
From Clinfowiki
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− | '''An adverse event''' is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is: | + | '''An adverse event (ADE)''' is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to [[U.S. Food and Drug Administration (FDA)]] when the patient outcome is: |
* Death | * Death | ||
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* Required Intervention to Prevent Permanent Impairment or Damage (Devices) | * Required Intervention to Prevent Permanent Impairment or Damage (Devices) | ||
* Other Serious (Important Medical Events) | * Other Serious (Important Medical Events) | ||
+ | |||
+ | == Clinical Decision Support == | ||
+ | |||
+ | Rules for ADE are often used in [[CDS|clinical decision support systems]]. | ||
== Important interactions == | == Important interactions == |
Revision as of 18:41, 17 November 2011
An adverse event (ADE) is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to U.S. Food and Drug Administration (FDA) when the patient outcome is:
- Death
- Life-threatening
- Congenital Anomaly/Birth Defect
- Required Intervention to Prevent Permanent Impairment or Damage (Devices)
- Other Serious (Important Medical Events)
Clinical Decision Support
Rules for ADE are often used in clinical decision support systems.
Important interactions
- Drug-drug interaction
- Drug-allergy interaction
- Drug-food interaction
- Drug-laboratory interaction
- Drug-tobacco interaction
References
- What is a Serious Adverse Event? FDA. [1]