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

TLDR

Adverse drug events cause substantial morbidity and mortality, yet remain underappreciated and misunderstood, and the terminology surrounding medication errors and patient harm is confusing. The article uses a patient case with multiple adverse drug events to clarify key terminology such as adverse event, adverse drug reaction, adverse drug event, medication error, and side effect. The case discussion demonstrates how to analyze causal links between suspect drugs and adverse events and provides examples and rationale for documenting such events, including which types should be reported to regulators. The article offers examples and rationale for documenting adverse drug events and specifies which events should be reported to regulatory agencies.

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.