Clarifying Adverse Drug Events: A Clinician's Guide to Terminology, Documentation, and Reporting

The case of an actual patient is used as a framework to explain the recognition, treatment, documentation, and reporting of drug-related harm and to provide context for the more clinically useful term adverse drug reaction.

Abstract

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.