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15 Medication Errors inHealthcare
359
Sequestering physical access to high-alert
medications, allowing ADC searches by both
brand and generic names as well as multiple letters and implementing forcing functions and barriers in the EHR system are considered
high-leverage strategies that utilize principles of
human factors engineering.
5.3 Human Factors andSystem
Engineering
Human factors engineering is described as identifying the limitation of human capabilities and
designing the system to meet the needs of the
workers. It operates on the assumption that [29]:
Fallibility is part of human condition;
We cannot change the human condition,
however;
We can change the conditions under which peo-
ple work.
In the complex medication use process where
humans, technology, and systems processes are
inextricably intertwined, there are extensive
human factors that play a role in medication
errors. The focus is not only on preventing failures but also on controlling or enforcing constraints on system behavior [98]. Similar to the
previous descriptions of the systems approach,
human factors engineering approaches often add
the component of technology into the safety strategies, as viewed from ergonomics perspective that
is designed to reduce human error, increase productivity and comfort, and enhance safety.
5.4 Medication Error
Classication
When medication errors do occur, there are several ways to classify the error. The NCC MERP
Index for Categorizing Medication Errors classies errors by harm score. They range from
Categories A to I, with the least severe Category
A having the capacity to cause error and Category
B describing an error that did not reach the patient
to Category I referring to an error that may have
contributed to or resulted in the patient’s death
[99]. The US Veterans Health Administration
uses the Safety Assessment Code Matrix, which
adds levels of probability in addition to the harm
severity levels [100]. The categories are represented within a 4×4 matrix, in which medication
errors are scored on a range of 1–3 for probability
and severity, with 3 inferring the highest risk and
1 the lowest risk [100].
Another classication and metric system by
Healthcare Performance Improvement (HPI) utilizes the safety event classication (SEC) in combination with the serious safety event rate (SSER)
[101]. In addition to identifying the harm scores,
HPI SEC rst distinguishes all events into three
initial categories: serious safety event in which
the patient was harmed, precursor safety event in
which the medication error reached the patient
but did not result in serious harm, and near miss
safety event which did not reach the patient.
Then, based on the SEC information, SSER calculates the number of serious safety events for
the previous 12 months per 10,000 adjusted
patient days.The combination of SEC and SSER
presents a rate trend of the event and aims to
reward sustained, over episodic, improvements in
preventing serious safety events.
5.5 Risk Analysis Assessments
Regardless of the method used, the purpose of
medication event classication is to identify
those that have the most potential for patient
harm and room for improvement. Typically, the
cases that can lead to the biggest impact at the
institution, for instance in terms of the biggest
harm averted, extensive lessons learned, and creation of robust safety improvement plan, are chosen for further in-depth investigations using
techniques such as detailed root cause analysis
(RCA).
An RCA is a retrospective risk analysis whose
purpose is to determine what happened in an
unwanted event, how it happened, and how to
prevent it from happening again [102, 103]. A
comprehensive RCA assessment is conducted by
multidisciplinary frontline workers who are
most familiar with the situation and can help
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M. Ro et al.
delve into the one or few underlying rootcauses
cases of the problem by sequentially asking the
“why” questions. Oftentimes, the root causes of
a problem may not be readily apparent from the
initial error report and may be uncovered by
interviewing staff members, connecting the
pieces of the timeline, and understanding the
processes that occurred versus what should have
occurred. Due to its retrospective nature, RCAs
should be conducted in a timely manner in order
to capture the details of the past event as accurately as possible.
In contrast to its retrospective counterpart, the
failure modes and effects analysis (FMEA) is a
prospective risk analysis that anticipates all possible failures that may occur in response to the
introduction of new or modied processes.
Examples may be piloting of new compounding
technology, formulary changes amid drug shortages, or changes to the EHR order sets. Like the
RCA, the FMEA is performed by an interdisciplinary team that meets regularly to identify failure modes, failure causes, and failure effects
[104]. The team then scores the likelihood of
occurrence, the likelihood of detection, and the
severity of harm for each deviation from the
safety processes on a scale of 1–10. The product
of the three scores is calculated as the risk prole
number (RPN), which is synonymous with risk
priority. Failure modes with the highest RPN take
precedence over others and demand immediate
attention for error reduction strategies. The RPN
can also be used as an ongoing benchmarking
metric after safety action plans are brainstormed
and implemented at the institution.
Another type of a risk analysis model, which
is more commonly seen in aviation and petrochemical industries, is the bowtie analysis [105].
With the unintended event in question at the
middle of the analysis tree, the diagram is
divided on one side as the “fault tree” which
probes all potential causes leading to the unintended event and the other side as the “event
tree” which identies the potential downstream
consequences of the event [106]. Although there
are some published examples of the bowtie analyses used in the investigation of medication
safety events [105], more research may be
needed to delineate clear applicability and value
in healthcare. Some studies indicate that bowtie
analysis may be useful in combination with other
risk analyses such as the FMEA or the systemstheoretic accident model and processes
(STAMP), or as a starting project in a larger
safety improvement plan [105–107].
Because error report investigations and formal risk analysis assessments such as an RCA,
FMEA, or bowtie analysis can be time- and
resource-intensive, institutions must select judiciously which unintended events warrant follow- up attention from the error reports.
Furthermore, each risk analysis has its own
unique strengths, weaknesses, and applicability
to certain situations, and it is recommended that
safety experts and leaders are adequately trained
and prepared to conduct the risk assessments
and relay the ndings to the appropriate committees that will help to carry out tangible action
plans. In the UK, the nationally funded
Healthcare Safety Investigation Branch conducts numerous patient safety investigations
through collaborations with diverse stakeholders and healthcare experts [108].
5.6 Error Reporting Culture
Leadership should strive to create a safe culture
of error reporting, one that is nonpunitive, open,
efcient, and proactive [109]. In this environment, error reporting must be accompanied by
tangible and timely system changes that are supported by a multidisciplinary expert body that
can affect change from the top administration
[110]. Key attributes of an effective event reporting system should have: [111]
• A supportive environment that protects the
privacy of staff who report occurrences.
• Participation by a broad range of personnel.
• Dissemination of summarized reports in a
timely fashion.
• A structured mechanism for regularly review-
ing reports and developing action plans.
15 Medication Errors inHealthcare
361
An optimal, proactive, and resilient culture
of safety is created by incorporating elements of
Just Culture, reporting culture, and learning culture in an effort to promote a continuous environment of learning, exibility, and preparedness
[112]. To achieve this purpose, the National
Academy of Medicine has recommended two
separate national US reporting systems: a mandatory public reporting system that promotes
accountability and a voluntary condential system that encourages learning from errors [113].
However, as previously mentioned, the voluntary reporting systems have historically suffered
from severe under-utilization; in order to
increase the utilization of error reporting and
promote a safe reporting culture, ISMP recommends that the reporting systems be condential, clear, fair, and actionable [109].
Furthermore, ISMP encourages the designation
of a medication safety ofcer (MSO) at each
hospital for optimal medication safety culture
and practices [114].
5.7 Healthcare SystemsNeed
Medication Safety Ocers
An ofcial staff member who champions the priority, integration, and implementation of safe
medication practices across a healthcare institution is known as the Medication Safety Ofcer
(MSO) or Medication Safety Leader or
Medication Safety Manager or Medication Safety
Coordinator. According to the ASHP Statement
on the Role of the Medication Safety Leader,
MSOs are expected to [115]:
• Serve as the leader in medication safety initia-
tives and committee meetings for the
organization.
• Collect and review data on medication use
process, medication errors, drug reactions,
and continuous quality improvement (CQI)
data.
• Participate in risk analyses and quality
improvement efforts.
• Collaborate with interdisciplinary leaders on
actively nding solutions to drug shortages,
use of replacement drug products, HIT issues,
and other medication safety-related problems.
Additionally, ISMP describes an MSO as a
diplomat, information steward, proactive strategist, data optimizer, compassionate Just Culture
mentor, and agent of change in its article “A
Recurring Call to Action: Every Healthcare
Organization Needs a Medication Safety
Ofcer!” [114]. Having an MSO to advocate for
medication safety within the hospital leadership
can positively affect change, ensure continuous
learning moments from error reporting, encourage high-leverage strategies to reduce medication
errors, and promote Just Culture to achieve better
collective safety outcomes. In the United
Kingdom, all healthcare trusts are required to
appoint an MSO who champions medication
error- related learning and reporting and serves as
the main contact for National Medication Safety
Network, NHS, England, and the Medicines and
Healthcare Products Regulatory Agency
(MHRA) [116].
Depending on the unique safety needs and
delegations of roles at the hospital, the MSO may
be expected to oversee several technologies used
in medication safety. These may include updating
the smart pump library and periodically reviewing the data surrounding the smart pump users
and DERS overrides. When change requests for
EHR order sets are submitted, the MSO may
work in conjunction with informatics and clinical
support staff to design and implement appropriate, usable, and up-to-date changes to the system.
An MSO may also be expected to review, assess,
and oversee sterile compounding technologies
such as the IV workow software, automated
compounders, or IV robotics inside the pharmacy
clean rooms. Override and other usage data from
ADCs, compliance rate of the BCMA, and issues
with automated packaging machines may fall
within the scope of an MSO’s role depending on
the specic institution.
In addition, the MSO is expected to complement and collaborate alongside the institution’s
designated Patient Safety Ofcer (PSO) to continually identify risk, implement mitigating strategies, monitor for improvement, and lead the
362
M. Ro et al.
multidisciplinary safety efforts among various
care groups. TJC standard requires the identication of a clinician or a body of healthcare providers such as, but not limited to, physicians, nurses,
pharmacists, or other healthcare providers to
complete the tasks of the PSO [117, 118]. In the
United States, the local and state legislation
requiring the integration of a PSO may vary, such
as in the state of Pennsylvania which requires the
designation of a PSO and mandatory error reporting according to the Medical Care Availability
and Reduction of Error (MCARE) Act [119]. The
goal of a PSO and an MSO, in part, is to combine
the knowledge and skill sets beyond any one clinical specialization to make medication use and
other clinical practices safer for the patient.
An MSO understands that true reform toward
medication safety requires a systems approach.
For many decades, healthcare has been striving to
become high reliability organizations (HROs)
such as the nuclear power and commercial aviation industries in which the smallest errors can
lead to tragic consequences. HROs adhere to ve
primary principles: preoccupation with failure,
reluctance to accept “simple” explanations, sensitivity to operations, resilience, and deference to
expertise [120, 121]. In addition to robust process
improvements, HROs harness the predominant
safety culture to continuously anticipate emerging threats to safety, proactive detection of risk,
and immediate mitigation responses to deter catastrophic events.
5.8 Finding anImprovement
Methodology that Works
Generally, improvement in any process requires
focus and monitoring over an extended period of
time. In healthcare and other industries, improving quality over time requires a functional understanding of the concept of continuous quality
improvement (CQI). CQI, as used in healthcare,
can be dened as a “structured, organizational
process for involving personnel in planning and
executing a continuous ow of improvements to
provide quality healthcare that meets or exceeds
expectations” [122]. Various industries use CQI
models and methods; however, the most widely
used model is the Plan-Do-Study-Act (PDSA)
(sometimes also known as Plan-Do-Check-Act,
or PDCA) cycle. The PDSA model is comprised
of four steps that can be continuously repeated to:
(P) plan a process improvement, (D) implement
that improvement, (S) study the results of the
process change, and then (A) modify and spread
the improvement [123].
When using PDSA, the rst action is the
development of an action plan for implementation of the change. Often, a test or pilot study is
needed to prove the change will have a positive
impact. Using small tests of change is especially
important for processes involving patient care.
Using this approach allows organizations to
determine if any modications to the process will
lead to success while at the same time minimizing the potential for patient harm and organizational inefciency if a project fails. The action
plan should include the intended duration of the
project, the location of where the project will
occur, the measures developed previously, and an
operational plan to guide implementation.
Scoping the plan correctly is important. During
the do phase of PDSA, the action plan is implemented. Successful implementation can depend
on many factors. Generally, having the right team
members collaborating and communicating
effectively is a critical component of success.
Any data identied in the action plan should be
collected during the study phase of PDSA.The
data collected should be easy to retrieve and
timely and should be reported regularly to all
involved team members. Data collected should
be compared to baseline measures and reconciled
with what was predicted. Once analyzed, the data
will help the team determine whether the study
impact was positive, negative, or resulted in no
change. Data collection and analysis occurs during the study phase of the PDSA.In the nal step
in the PDSA cycle, the team uses the information
and analysis to make any potential changes to the
original intervention. Based on multiple PDSA
cycles and the establishment of a reasonable level
of success, the change should be adopted and
expansion of the changes into the organization
should be considered. Ongoing monitoring and
data analysis should be included as part of an
organization’s overall CQI plan.
15 Medication Errors inHealthcare
363
In addition to PDSA, the Lean Production
System and Six Sigma are improvement methodolo-
gies that are also used in CQI activities. Both models migrated to healthcare from other industries. The
Lean Management System (Lean) and the Toyota
Production System (TPS) are methods that focus on
value of a particular process and seek to maximize
the uninterrupted ow of that value to the end customer [124]. Unnecessary or wasteful steps that do
not add value are removed to make the resulting
process “leaner” and more efcient. Six Sigma is a
data-driven method that focuses on customer satisfaction and defect (error) reduction. Specically,
Six Sigma refers to six standard deviations from the
expected or desired process result (mean) [125].
This translates to reducing the error associated with
a specic process to no more than 3.4 defects or
errors per million opportunities or activities.
6 Summary andConclusions
Patients have a right to safe care across the healthcare continuum. Special attention should be given
to understanding, practicing, and systematically
employing the tools and concepts presented in
this chapter. Improving the safe delivery of medication-related care is the responsibility of all
healthcare professionals. Although preventing all
errors inherent in our systems may not be possible, eliminating preventable patient harmis possible and foundational to the delivery of healthcare.
“Primum non nocere” (First, do no harm).
7 Case Studies
7.1 Case Study 1
A patient was admitted to the emergency room
with a suspected stroke and administered an
overdose of tenecteplase.
The RCA found the following contributing
factors:
1. The patient’s most recent weight was not
recorded. The dose of tenecteplase was calculated using the weight documented from a
previous encounter.
2. The prescriber failed to use the designated
order set for tenecteplase for the treatment of
stroke.
3. The order set for tenecteplase for the treatment of stroke did not have the CDS that
would have provided the dosage
recommendations.
4. The tenecteplase is excluded from the list of
medications approved for the ADC
overrides.
5. The dosing instructions inside the tenecteplase
medication kit pertained to the dosing of acute
myocardial infarction, not stroke.
6. The institution lacked protocol for dispensing
and administering high-alert medications,
e.g., dual sign-out.
Possible error mitigation strategies include:
1. Obtain the most recent weight of the
patient to calculate the accurate dose of
tenecteplase.
2. Designated order sets for specic indications
should be readily available and easily
accessible. The order sets should prominently
display the intended indication and the full
generic name of the medication.
3. The order set should be equipped with the relevant CDS features to provide additional
instructions and guidance for prescribing, dispensing, administration, and monitoring of
the medication.
4. Medications that are intended for emergency
use need to be on the institution’s approved
ADC override list for safe and efcient dispensing of the medication.
5. The approved medication kit for tenecteplase
for stroke needs to be fully stocked with the
relevant supplies (e.g., syringe, needles, and
medication) including the accurate dosing
instructions.
6. Given their potential for serious harm if used
in error, high-alert medications need to be
identied and handled accordingly under
institutional protocol and guidelines.
Acknowledgments The authors would like to thank Dr.
Sarah McDowell for allowing us to reproduce a gure
(Fig. 15.1) included in the chapter.
364
M. Ro et al.
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