National Research Council. Preventing Medication Errors: Quality Chasm Series.

Washington, DC: The National Academies Press, 2007, pages 36-38.

Medication Error, Adverse Drug Event, and Adverse Drug Reaction

The terms medication error, adverse drug event, and adverse drug reaction denote related
concepts (see Figure 1-1) and are often used incorrectly. To Err Is Human (IOM, 2000, p. 28)
defined error and adverse event as follows:

 An error is defined as the failure of a planned action to be completed as intended (i.e.,

error of execution), or the use of a wrong plan to achieve an aim (i.e., error of
planning).
 An adverse event is an injury caused by medical management rather than the
underlying condition of the patient.

The Committee on Data Standards for Patient Safety was concerned that the phrase medical
management did not embrace acts of omission. The committee gave considerable thought to
expanding on these two definitions and produced the following (IOM, 2004, p. 30, 32):

 An error is defined as the failure of a planned action to be completed as intended (i.e.,

error of execution), or the use of a wrong plan to achieve an aim (i.e., error of
planning). An error may be an act of commission or an act of omission.
 An adverse event results in unintended harm to the patient by an act of commission or
omission rather than by the underlying disease or condition of the patient.

FIGURE 1-1 Relationship among medication errors, adverse drug events, and potential adverse drug
events. SOURCE: Gandhi et al., 2000.

The Committee on Data Standards for Patient Safety wanted to make clear that the potentially
avoidable results of an underlying disease or condition—for example, a recurrent myocardial
infarction in a patient without a contraindication who was not given a beta-blocker (an error of
omission)—should be considered an adverse event (IOM, 2004). The Committee on Identifying
and Preventing Medication Errors discussed the adverse event definition given in the Patient
Safety report and decided to adopt this definition. Further attempts to operationalize the
definition of adverse event may well lead eventually to additional modifications of the definition.

Consistent with the above definitions:

 A medication error is defined as any error occurring in the medication use process (Bates
et al., 1995a).
 An adverse drug event is defined as any injury due to medication (Bates et al., 1995b).
An injury includes physical harm (for example, rash), mental harm (for example,
confusion), or loss of function (for example, inability to drive a car).

Medication errors and adverse drug events have multiple sources. They may be related to
professional practice; health care products, procedures, and systems, including prescribing; order
communication; product labeling, packaging, and nomenclature; compounding; dispensing;
distribution; administration; education of the patient or health care professional; and monitoring
of use.

Implicit in the definition of medication errors is that they are preventable. However, most
medication errors do not cause harm. Some do cause harm and are either potential adverse drug
events or preventable adverse drug events (see Figure 1-1), depending on whether an injury
occurred (Gandhi et al., 2000). Potential adverse drug events are events in which an error
occurred but did not cause injury (for example, the error was detected before the patient was
affected, or the patient received a wrong dose but experienced no harm) (Gandhi et al., 2000).

Adverse drug events can be preventable (for example, a wrong dose leads to injury) or
nonpreventable (for example, an allergic reaction occurs in a patient not known to be allergic)
(seeFigure 1-1). Nonpreventable adverse drug events are also often termed adverse drug
reactions3(Gandhi et al., 2000).

The World Health Organization has defined an adverse drug reaction as a response to a drug that
is noxious and unintended and occurs at doses normally used in man for prophylaxis, diagnosis,
or therapy of disease or modification of physiological function (WHO, 1975). This definition
excludes injuries due to drugs that are caused by errors, which are of obvious interest. As a
result, drug safety researchers coined the term adverse drug event to include both adverse drug
reactions (which are nonpreventable), and preventable adverse drug events (Bates et al., 1995b).
From the safety perspective, preventable adverse drug events are most important because they
are known to be preventable today; adverse drug reactions are also important, however, since it
may become possible to prevent them in the future by using new approaches, such as
pharmacogenomic profiling.