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Part II
Safer Prescribing and Drug use in Practice
Medication Errors inHealthcare
MyungsunRo, DanielDegnan, andJohnHertig
15
Abstract
Medication errors occur throughout the medication use process and carry the potential to
cause severe patient harm. This chapter discusses various types of medication errors,
methods of detection, components of error,
and strategies for risk mitigation. Terminology
frequently used in medication safety such as
“adverse drug event,” “adverse drug reaction,”
and “near miss” or “close call” is dened, and
James Reason’s Swiss Cheese Model is
explained as relating to active and latent failures. Various error detection methods such as
voluntary error reporting, trigger tools, direct
observation, and technology-generated data as
well as diverse factors that contribute to medication errors are presented. Medication safety
ofcers play a critical role in preventing medication errors by implementing proactive and
retrospective strategies such as failure modes
and effects analysis and root cause analysis.
M. Ro (*)
Patient Safety Authority, Harrisburg, PA, USA
e-mail: mro@pa.gov
D. Degnan
Purdue University College of Pharmacy,
West Lafayette, IN, USA
J. Hertig
Butler University College of Pharmacy and Health
Sciences, Indianapolis, IN, USA
Additionally, the importance of patient education, human factors and systems engineering,
and the safety culture of an institution cannot
be underestimated. Patients have a right to
safe care, and providers must rst do no harm.
Special attention is given to understanding,
practicing, and systematically employing the
tools and concepts presented in this chapter.
Keywords
Medication error · Medication errors · Adverse
event · Adverse drug reaction · Adverse drug
event · Near miss · Medication use process
Medication safety · Drug safety · Patient
safety · Pharmacovigilance
Learning Objectives
• Dene medication error and other terms fre-
quently used in medication safety.
• Explain the medication use process and the
Swiss Cheese Model as they relate to active
and latent failures in the systems process.
• Identify various methods to detect errors and
factors that contribute to medication errors.
• Describe the position of a medication safety
ofcer and their role in preventing and mitigating medication errors.
• Recognize the impact of patient education,
human factors and systems engineering, and
culture on medication safety.
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024
J. Jose et al. (eds.), Principles and Practice of Pharmacovigilance and Drug Safety,
https://doi.org/10.1007/978-3-031-51089-2_15
341
342
Key Points
• Medication errorscan occur during various stages of the medication use process.
It is important to recognize the potential
safety gaps that healthcare providers
may encounter during the process.
• It is essential to distinguish between
commonly used terms in medication
safety, such as medication error, adverse
drug event, adverse drug reaction, and
near miss,when describing a medication
error event.
• The Swiss Cheese model is a conceptual
framework thatillustrates how multiple
layers of defense within healthcare systems can fail, leading to errors reaching
patients. Errors could be due to active
and latent failures, and addressing latent
failures is crucial for preventing errors
from reaching patients.
• Healthcare professionals have an important role in remaining vigilant for potential errors. Different types of methods
that are used in healthcare to detect
errors include incident reporting systems, trigger tools, direct observation,
and technology- generated data.
• There are several components to a
medication error, such as technology
failures, human error, at- risk behavior,
and reckless behavior. An understanding of the ten key elements of medication use will help healthcare providers
identify the root causes of a medication
error event.
• Healthcare providers are encouraged to
nd an improvement methodology that
is appropriate for their practice setting
and workow. It is vital to consider
implementing error mitigation strategies
with a focus on patient and consumer
education, risk reduction strategies in
healthcare settings, human factors and
system engineering, medication error
classication, risk analysis assessments,
and error reporting culture.
M. Ro et al.
1 Introduction
The eld of medication safety as it relates to
the formalized study of medication errors dates
back to the work of Michael Cohen and Kenneth
Barker, both of whom were inuenced by Avedis
Donabedian. Dr. Donabedian became renowned
following the publication of a lengthy paper titled
Evaluating the Quality of Medical Care in 1966.
This seminal work introduced the concepts of
structure, process, and outcome to the evaluation
of healthcare quality [1]. Subsequently, in 1981,
Cohen published a leading textbook in the area of
medication errors, while Barker established the
rst research methods for studying medication
errors, still used widely today [2]. Also, in the late
1980s, a Harvard-trained physician, Lucian Leape,
discovered an alarming number of medical errors
in his research on the utilization of cardiac procedures [3]. This work led him to focus on medical errors, culminating in the Institute of Medicine
(IOM, now the National Academy of Medicine)
report, To Err is Human: Building a Safer Health
System [4]. This report introduced the concept that
medication errors are the result of faulty systems
and not solely due to human mistakes. The IOM
report describes the widespread problem of medication errors, the barriers preventing improvement,
and the strategies needed to make healthcare safer
for all patients. These concepts were inuenced
by the advances in safety demonstrated by areas
outside of healthcare, such as the aviation and
automobile industries [5]. A comparison of risk in
healthcare with respect to other safety industries is
shown inFig. 15.1.
The World Health Organization (WHO) estimates that at least one death every day and 1.3
million injuries occur per year in the United States
as a result of medication errors [6]. Although the
rates of medication error may be similar in lowand middle-income countries compared with
high-income countries, the number of years of
healthy life lost may be approximately twice as
highbased on the available data [6]. In addition to
the lives lost, the economic cost of medication
errors has been estimated at US$42 billion [6].
The Joint Commission (TJC)and other accrediting agencies acknowledged the harmful implica-
Number of encounters for each fatality
Total lives lost per year
Healthcare is hazardous
15 Medication Errors inHealthcare
343
100,000
10,000
1,000
Fig. 15.1 Comparison of healthcare to other safety industries. Healthcare is generally highly regulated, yet relatively dangerous when compared to other industries.
Reproduced with permission (See acknowledgment sec-
tions of medication error and required hospitals to
establish programs to identify and prevent medication errors and adverse drug events (ADEs). To
meet these regulatory requirements, programs
have been developed, often led by Departments of
Pharmacy and pharmacists to review medication
errors and work with various disciplines (physicians, nurses, and administrators) to design interventions to increase medication error reporting
and reduce harmful events. Most hospitals did not
have specic medication safety programs, and the
programs that were in place were centered on
medication processes instead of the broad medication use system (e.g., procurement and inventory
management, nursing unit processes, and physician prescribing) [7]. Given the challenge to ensure
medication safety is a priority in all aspects of care
delivery, combined efforts of interdisciplinary
teams are frequently used to prevent patient harm.
To assist in an interdisciplinary focus and to promote fundamental understanding of data, a variety
of denitions, tools, and resources can help pharmacy and other health professionals as they take
leadership roles in medication safety [8].
Describing differences among the various definitions used in medication safety became such a
prevalent issue that scholars have frequently
highlighted the problem as hindering progress in
100
10
1
HAZARDOUS
110
(>1/1000)
Bungee
Jumping
REGULATED
Health Care
Mountain
Climbing
100 10,000 100,000
1,000
Driving
Chartered
Flights
Chemical
manufacturing
tion). The gure extrapolates from earlier work by: R
Amalberti. The paradoxes of almost totally safe transportation systems Saf Sci, 37 (2001), pp. 109–126
improving care. Yuetal. attempted to categorize
a hypothetical event using various denitions on
publicly available websites [9]. The process identied more than 119 denitions for 25 medication safety-related terms. In the study, there were
10 denitions for adverse drug event, 11 different
denitions for adverse drug reaction, and 7 different denitions collected for the term medica-
tion error. Although the authors were quick to
point out that some of these were functionally the
same, the issue of developing a common denition of key terms used in medication safety is a
fundamental tenement to improving the systems
around medication use.
In order to create a safe medication use process for all patients around the world, it is essential to understand related denitions, identication
of errors, and practices to analyze and mitigate
harm. Medication errors are common throughout
all healthcare systems and occur during all stages
of the use of a medicine, such as prescribing, dispensing, and administration. This chapter will
cover the etiology of medication errors and the
burden they produce on patients and healthcare
systems. It will outline the operation of key medication error systems. It will also focus on the
methods of learning from error, at an international, national, and local level.
ULTRA-SAFE
(<1/100K)
Scheduled
Airlines
European
Railroads
Nuclear
Power
1million10million
344
Note: Frequently “procurement”
M. Ro et al.
2 The Medication Use Process
Originally developed through TJC to evaluate
the use of medications in hospitals, the medication use process (Fig.15.2) has since been established as a systematic way to measure the
effectiveness of the use of medications and to
review potential safety mitigation strategies.
Generally, the ve steps of the medication use
process can be dened as prescribing, transcribing, dispensing, administration, and monitoring.
With the advent of computerized provider order
entry (CPOE), the step of transcribing may be
combined with the prescribing step of the process [10]. As supply chain issues have become
more prevalent with regard to medication safety,
the step of medication procurement has been
added by some organizations when evaluating
the medication use process.
A classic pair of studies completed in 1995
attempted to identify the frequency of ADEs in
each segment of the medication use process [11,
12]. The two frequently cited studies identied
the incidences of breakdown of events occurring
in each segment of the medication use process at
a major US medical center as: ordering (39–49%),
administering (26–38%), transcribing (11–12%),
and dispensing (11–14%). It is important to note
that the prevalence may vary depending on the
therapeutic areas, as observed in one study that
attributed 78% of all medication errors involving
direct-acting oral anticoagulants to the prescrib-
ing stage [13]. The studies were conducted before
any signicant adoption of CPOE technology.
Using the conceptual framework of the medication use process can help to identify complimenting medication event mitigation strategies. The
two studies identied underlying system errors
associated with the medication use process. In the
Leape study, the most common system failures
identied included the inadequate availability of
patient information and thepoor dissemination of
drug knowledge throughout the medication use
process [10]. The Bates study found that ADEs
most frequently occurred in the ordering and
administering stage of the medication use process
and were often preventable according to the denitions used in the study [11].
2.1 Medication Safety
Terminology
A fundamental element of improving a system or
a process is the need to quantify or measure the
progress. In the eld of healthcare improvement,
particularly in medication safety, a challenge exists
in providing accurate comparators and denitions.
The international multitude of denitions related
to medication safety-related terms and the resulting confusion have led to challenges in developing
evidence associated with specic improvement
strategies. The problem of a lack of common taxonomy for medication-related events and the harm
Fig. 15.2 The
medication use process.
The medication use
process consists of
(procurement),
prescribing, transcribing,
dispensing,
administering, and
monitoring
is included in the medication
use process steps, but is not
depicted here
Prescribing
Monitoring
The
Medication
Use Process
Administering Dispensing
Transcribing
15 Medication Errors inHealthcare
345
caused to patients is an important component of
evidence analysis. When denitions are operationalized by individual healthcare organizations
and even healthcare practitioners, as well as the
pharmaceutical industry and regulatory agencies,
additional taxonomy drift can occur.
The confusion that exists when analyzing medication safety-related terms is not new. As early as
1989, Dr. Henri Manasse described the challenges
that existed with regard to “terminology associated with the negative effects of drugs” [14]. The
problem with regard to denitions related to medication safety has been perpetuated to date and
identied by authors such as Yu and Lisby [9–16].
In the case of Yu, more than 119 denitions for
medication safety terms were encountered when
reviewing 33 safety-related websites. Both
authors identied frequently used denitions
across a variety of sources and then applied casebased scenarios to identify commonalities and
differences among the denitions used.
A frequently used denition for the term med-
ication error is provided by the American organization, the National Coordinating Council for
Medication Error Reporting and Prevention
(NCC MERP), an independent body composed
of 27 national and international organizations
[17]. A key aspect of the NCC MERP denition
is that a medication error can be identied by
asking three questions:
1. Was this a preventable event?
2. Could the event cause harm or lead to inap-
propriate medication use or patient harm?
3. Was the medication in the control of a health-
care professional, the patient, or the consumer?
Outside of the United States, the European
Medicines Agency (EMA) is well known for
establishing its own denition of the term medi-
cation error and issuing guidance on pharmacovigilance and reporting of errors in Europe [18].
Adverse drug reaction is another frequently
used term in medication safety. The denition
commonly used by healthcare practitioners was
one that was proposed by the WHO in 1972 and
widely accepted by other healthcare groups [19].
The term adverse drug reaction and its associ-
ated denitions have undergone scrutiny and
attempts at modication since its inception [20,
21]. The International Council for Harmonisation
of Technical Requirements for Pharmaceuticals
for Human Use (ICH) has established its own
denition and guidance on adverse drug reaction
that are widely accepted in Europe, especially for
pre-marketing and post-marketing clinical safety
in the regulatory and pharmaceutical sectors [22].
Perhaps the broadest proposed denition of a
medication safety-related term is that of adverse
drug event which has its historical roots in the
1999 report, To Err is Human, where it is
described as “any injury resulting from medical
intervention related to the drug.” This denition
was further rened and discussed by Nebecker in
2004 using the denition “any injury resulting
from the use of a drug.” This is by nature a broad
denition and encompasses primary questions:
1. Was the medication administered to the
patient?
2. Did patient injury or harm, in any form, result
from the use of the medication?
It is important to note that ADEs are not
always preventable using the denition expanded
upon by Nebecker. In addition, the ICH, with
input from the WHO Collaborative Centre,
denes adverse event or adverse experience (AE)
as any untoward medical occurrence that may
present during treatment with a medicine, but
which does not necessarily have a causal relationship with this treatment [22].
A near miss medication event, sometimes also
called a close call event, is a medication situation
that did not produce patient injury but was prevented by active intervention or chance detection.
A common source for this denition comes from
the Agency for Healthcare Research and Quality
(AHRQ) in the United States [23]. It should be
noted that a near miss event could also be dened
as a medication error using the NCC MERP denition of a medication event that could have led to
harm but never reached the patient.
While the four basic denitions used in the
taxonomy of medication safety are medication
error, adverse drug reaction, adverse drug event,
346
M. Ro et al.
Table 15.1 Common denitions used in medication
safety [24]
Medication
safety term Common denition
Medication
error
Adverse drug
event
Adverse drug
reaction
Near miss
event or close
call event
Table 15.2 Other terms frequently used in medication
safety
Adverse event Medical error
Adverse medication event Medication incident
Adverse reaction Medication-related problem
Associated factor Potential adverse drug event
Contributory factor Potential adverse event
Drug problem Potential error
Drug-related problem Risk factor
Error Root cause
Incident Side effect
Any preventable event that may cause
or lead to inappropriate medication use
or patient harm while the medication is
being handled by the healthcare
professional, patient, or consumer
Patient harm (injury) that resulted from
the use of a medication
A response to a medicine which is
noxious and unintended at doses
normally used in man for prophylaxis,
diagnosis, or therapy of disease or the
modication of physiologic function
Any medication event that could have
had adverse consequences for the
patient but did not
and near miss event or close call event, other medication safety-related terms are pervasive in practice and the literature [9, 25–27]. These terms and
denitions can be seen in Tables 15.1 and 15.2.
2.2 The Swiss Cheese Model
andActive andLatent Failures
Human errors can occur throughout the various
steps of the medication use process and are most
likely to occur when (1) an individual healthcare
practitioner makes a mistake, (2) the process subsequently fails to deliver the desired outcome,
and (3) a high-risk procedure is involved. This is
frequently explained using James Reason’s
“Swiss Cheese Model” of human error, as shown
in Fig. 15.3 [28]. The Swiss Cheese Model is
based on the premise that each process step in a
system is prone to varying likelihood of error. As
each process step is completed, there may be a
hole (similar to a hole identied in Swiss cheese)
where a potentially harmful event can be perpetuated and move on to the next step of the process.
Often these environmental factors result in
process step failures and errors that may ultimately affect a patient. These failures can occur
in each step—pieces of Swiss cheese—of any
process and are represented by the holes in each
piece of cheese. When the holes in each piece of
cheese all align perfectly, harmful patient events
can occur.
Using Reason’s model, there are two general
strategies for reducing errors. The rst strategy is
to prevent the initial source of the error. This is
not always possible given the desired outcome.
The second, and more commonly used, strategy
is to nd and x the system problems. In this case,
additional pieces of Swiss cheese are added, and
the holes in each piece are made smaller. In other
words, strategies are employed to decrease the
probability of failure at each step. Examples of
failure reduction strategies for each step in the
medication use process will be evaluated later on
in this chapter.
Thinking of healthcare processes as multiple
pieces of Swiss cheese—with holes representing
the potential for errors that may result in harm to
the patient—is the basis for a healthcare improvement model known as “Systems Thinking.”
Systems Thinking requires the evaluation of the
whole process rather than focusing on just one
step or individual. This approach suggests all
process parts are interrelated, and adverse outcomes are comprised of both active failures and
latent failures. Active failures are errors committed at the “sharp end,” usually inadvertently by
healthcare practitioners and staff. These take the
forms of slips, lapses, mistakes, and procedural
violations [29]. Unlike active failures that are
more apparent and obviously attributable to the
error, latent failures are underlying weaknesses
in the structure of the system, environment, or
equipment that are hidden and much more difcult to detect, known as the “blunt end” of errors.
Latent failures will always be present in a process, and therefore the entire system must be
Tr
Latent failures
or
15 Medication Errors inHealthcare
igger
Active failure
Medication err
Fig. 15.3 Swiss cheese model. James Reason proposed that individual holes of the Swiss cheese represent failures and
that multiple failures must align for a medication error to reach the patient
347
evaluated to ensure all identied points of both
active and latent failures can be reduced or eliminated altogether [29]. An example of a latent
failure would be storing the hydroxyzine and
hydralazine medications next to one another
without any obvious identiable differences on
the bottles; this circumstance is an accident waiting to happen. The active failure, then, is the
human action of selecting and lling the wrong
medication. “Systems Thinking” involves evaluating this situation in its entirety, assessing both
active and latent failures inherent in a system,
and then employing strategies to reduce the likelihood of either occurring.
noted that Ms. Lehman received a fourfold overdose of cyclophosphamide which induced cardiac
damage and resulted in her tragic death.
Signicant lessons in safe medication systems
and improvement strategies have occurred since
Betsy’s death in 1994 [30–32]. Both signicant
awareness regarding the need to seek out the
reporting of medication errors and near misses,
and the technology and analytical capabilities to
detect medication errors have grown signicantly.
In fact, during the improvement journey at DanaFarber Institute, a former executive at the facility,
James Conway, identied the need to continually
and actively seek out medication errors with an
eye for improvement. Conway elaborated that the
work of creating safe care is a continual journey
3 Detection ofErrors
inHealthcare
and that comprehensive, multidimensional error
detection methods are an important component
[33]. No one error detection method will identify
3.1 The Case ofBetsy Lehman
all medication errors, and they should be used in
combination to be truly effective.
In Boston, Massachusetts, United States, sits a
patient safety center called Betsy Lehman Center,
which is named after a former healthcare reporter
for the newspaper The Boston Globe. Betsy
3.2 Medication Error Detection
Methods
Lehman, the mother of two young daughters,
sought treatment for metastatic breast cancer at
the Dana-Farber Institute, which is also located in
as a result of the treatments she received. The rea-
Boston. In December 1994, Betsy Lehman died
sons for Ms. Lehman’s death were not initially
known and were thought to have been a result of
her cyclophosphamide treatments. A subsequent
but routine review of the medication administered
A variety of sources should be used to determine
the relative safety of the medication use process.
It is important to identify and collect many data
in order to obtain a comprehensive picture of
medication safety. Data may include (1) voluntary error reports submitted through formal
reporting programs; (2) automated trigger tools—
such as the administration of reversal agents fol-
348
M. Ro et al.
lowing the administration of opioids; (3) direct
observation of process errors; (4) peer review of
electronic or paper-based medical records; and
(5) information from technology applications and
hardware such as bar code medication administration (BCMA) systems, smart infusion pumps,
automated dispensing cabinets (ADCs), and
CPOE systems. There are strengths and weaknesses with each of these data sources, which is
why multiple strategies are necessary to obtain a
more accurate assessment of safety in an organization [34]. Four common collection methods are
voluntary error reports, trigger tools, direct
observation, and technology-generated data as
described below. Their advantages and disadvantages are listed inTable 15.3.
Table 15.3 Advantages and disadvantages of drug event
detection methods
Drug event
detection
method Advantages Disadvantages
Voluntary
error report
Automated
trigger tool
Direct
observation
Technologygenerated
data
• Frequently
detects
harmful
patient errors
• Efciently
collects
information
without human
intervention
• Frequently
provides
comprehensive
process data
• Expensive to
implement
• May not have
end user
buy-in
regarding
accuracy and
efciency
• Laborintensive
process
• May not be
effective
without a
healthy
reporting
culture
• Provides
nonspecic
information
which may
require
follow-up
• Laborintensive
process that
requires
trained
observers
• Cover
multiple
areas of the
medication
use process
• Produce
large
amounts of
data to
compensate
for
weaknesses
3.2.1 Voluntary Error Reports
Voluntary incident reporting systems are commonly used in health systems to collect information on errors that occur. These reports are
often submitted voluntarily by those who were
involved in, or witnessed, the actual event.
When completing an error report, it is important
to include as much information as possible,
which will aid in the review and possible investigation of the incident. Many reporting systems
allow the reporter to remain anonymous; however, providing contact information can help
enable follow-up and evidence gathering.
Voluntary reporting systems traditionally have
resulted in signicant underreporting of medication errors [35]. Thus, voluntary error reporting data should be supplemented with
information from other sources [36].
3.2.2 Trigger Tools
The use of automated trigger tools to detect
ADEs was originally reported by Classen in
1991 [37]. An ADE trigger can be dened as a
“clue” that an ADE may have occurred. The
original tool was adapted and further rened
by the Institute for Healthcare Improvement
(IHI). In 2003, Rozich and colleagues suggested additional ADE detection methods and
categories using electronic triggers. Rozich
also suggested that trigger tools could be an
efcient method to collect ADE information
within an organization [38]. Trigger tools can
be identied using a wide variety of electronic
information to retrospectively examine particular errors without examining the actual event
specically. Another advantage to the use of
trigger tools is that it removes the reporting
burden from an individual practitioner.
Examples of triggers that might be used by a
hospital can be found in Table15.4.
While the automated collection of trigger data
is frequently utilized at healthcare institutions,
manual methods are also available to detect similar types of events. The specic trigger data often
gathered from retrospective review of patient
charts can be manually characterized and organized. The data is presented in three formats:
adverse events per 1000 patient days, adverse
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