Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting.
Adverse drug events cause substantial morbidity and mortality, yet they remain underappreciated and misunderstood. The terminology to describe errors and patient harm associated with medications causes much confusion. This article uses the case study of a patient with multiple adverse drug events to clarify key terms, such as adverse event, adverse drug reaction, adverse drug event, medication error, and side effect. The case discussion illustrates clinical approaches to analyzing the causal connection between a suspect drug and an adverse event. Examples and rationale for meaningful documentation of adverse drug events are provided, along with an outline of the types of events that should be reported to regulatory agencies.
Nebeker
Jonathan R
JR
Veterans Affairs Salt Lake City Health Care System and University of Utah School of Medicine, Salt Lake City, Utah, USA.
Barach
Paul
P
Samore
Matthew H
MH
D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D004282:Documentation; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008297:Male; D008508:Medication Errors; D009626:Terminology as Topic