Research in Social and Administrative Pharmacy xxx (xxxx) xxx

Contents lists available at ScienceDirect

Research in Social and Administrative Pharmacy

journal homepage: www.elsevier.com/locate/rsap

Human factors and ergonomics methods for pharmacy research and

clinical practice
Richard J. Holden a, b, c, *, Ephrem Abebe a, d, Alissa L. Russ-Jara d, Michelle A. Chui e
a
Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA
b
Center for Aging Research, Regenstrief Institute, Indianapolis, IN, USA
c
Center for Health Innovation and Implementation Science, Indiana Clinical and Translational Sciences Institute, Indianapolis, IN, USA
d
Department of Pharmacy Practice, College of Pharmacy, Purdue University, West Lafayette, IN, USA
e
Social & Administrative Sciences, School of Pharmacy, University of Wisconsin-Madison, Madison, WI, USA

A R T I C L E I N F O A B S T R A C T

Keywords: Background: Human factors and ergonomics (HFE) is a scientific and practical human-centered discipline that
Human-centered design studies and improves human performance in sociotechnical systems. HFE in pharmacy promotes the human-
Usability centered design of systems to support individuals and teams performing medication-related work.
Medication safety
Objective: To review select HFE methods well suited to address pharmacy challenges, with examples of their
Sociotechnical systems
application in pharmacy.
Human factors/ergonomics
Methods: We define the scope of HFE methods in pharmacy as applications to pharmacy settings, such as
inpatient or community pharmacies, as well as medication-related phenomena such as medication safety,
adherence, or deprescribing. We identify and present seven categories of HFE methods suited to widespread use
for pharmacy research and clinical practice.
Results: Categories of HFE methods applicable to pharmacy include work system analysis; task analysis; workload
assessment; medication safety and error analysis; user-centered and participatory design; usability evaluation;
and physical ergonomics. HFE methods are used in three broad phases of human-centered design and evaluation:
study; design; and evaluation. The most robust applications of HFE methods involve the combination of HFE
methods across all three phases. Two cases illustrate such a comprehensive application of HFE: one case of
medication package, label, and information design and a second case of human-centered design of a digital
decision aid for medication safety.
Conclusions: Pharmacy, including the places where pharmacy professionals work and the multistep process of
medication use across people and settings, can benefit from HFE. This is because pharmacy is a human-centered
sociotechnical system with an existing tradition of studying and analyzing the present state, designing solutions
to problems, and evaluating those solutions in laboratory or practice settings. We conclude by addressing
common concerns about the implementation of HFE methods and urge the adoption of HFE methods in
pharmacy.

Human factors and ergonomics (HFE) in pharmacy
Human factors and ergonomics (HFE) is a scientific and practical
human-centered discipline that studies and improves human perfor­
mance in sociotechnical systems.1 HFE in pharmacy promotes the
human-centered design of systems to support individuals and teams
performing medication-related work.2
HFE methods are effective3 and therefore constitute standard prac­
tice in several industries, especially safety-critical arenas of aviation,
surface transportation, military, and energy.4,5 They are also routinely
applied in office settings, service industries, leisure, consumer products,
and medical devices.6–9 HFE first appeared in healthcare in 1960s
studies of hospital medication safety.10 Later that century HFE grew in
other inpatient settings such as anesthesiology and surgery.11,12
Turn-of-the-century reports from the National Academy of Medicine
(then the Institute of Medicine),13–15 including the seminal To Err is
Human report, accelerated the application of HFE to patient safety and
quality, particularly the discipline’s incident analyses, team training,

* Corresponding author. Regenstrief Institute (RF) 421, 1101 W 10th Street, Indianapolis, IN, 46202, USA.
E-mail address: rjholden@iu.edu (R.J. Holden).

https://doi.org/10.1016/j.sapharm.2021.04.024
Received 23 November 2020; Received in revised form 28 April 2021; Accepted 29 April 2021
Available online 2 May 2021
1551-7411/© 2021 Elsevier Inc. All rights reserved.

Please cite this article as: Richard J. Holden, Research in Social and Administrative Pharmacy, https://doi.org/10.1016/j.sapharm.2021.04.024
R.J. Holden et al. Research in Social and Administrative Pharmacy xxx (xxxx) xxx

and aviation tools such as checklists.16 Mass adoption of health infor­
mation technology (IT) paved the path for applying HFE methods for
user-centered design and usability testing.17,18 HFE methods have been
used to study and improve the work and outcomes of healthcare pro­
fessionals, clinical teams, and patients or families.19 The application of
HFE to study and improve the health-related work of patients, families,
and other nonprofessionals—called patient ergonomics20—grows in par­
allel to broader paradigm shifts toward patient engagement and
empowerment, consumer health IT, data democratization, and shared
decision making.21
HFE methods have gained some penetration and success in health­
care22–26 but are not yet widespread in pharmacy. The goal of this paper
is to review select HFE methods well suited to address pharmacy chal­
lenges, with examples of their application in pharmacy.
Opportunities for HFE in pharmacy
Pharmacy as an HFE application area includes pharmacy settings,
such as inpatient or community pharmacies, as well as medication-
related phenomena such as medication safety,27 adherence,28 or
deprescribing.29
Several long-standing issues and emerging trends in pharmacy argue
for the need for HFE methods. The practice of community pharmacy is
evolving to embrace provision of specialized services in addition to its
traditional dispensing role, including in the areas of immunization,
medication therapy management, and point of care testing.30,31 The
pharmacy profession is increasingly pushing for prescriptive authority,
through collaborative practice agreements or autonomous prescrib­
ing.32 Pharmacy technicians’ roles and responsibilities are expanding in
community and health-system pharmacy settings, requiring perfor­
mance of complex tasks traditionally assumed by pharmacists.33–35
These and other changes demand better, more human-centered design of
tasks, processes, teams, job roles, organizations, environments, and
tools—the classic design challenges solved by HFE methods.36
HFE methods could for instance contribute to safer dispensing of the
4.4 billion annual prescriptions in the approximately 67,000 retail/
community pharmacies in the US. Despite best efforts, evidence esti­
mates a medication error rate of 1.7%–22%, of which 6.5% are clinically
significant.37–39 Using the most conservative estimate, for a typical US
community pharmacy dispensing 250 prescriptions per day, this means
approximately 4 errors per day, including 2 clinically significant errors
per week—or 51.5 million dispensing errors annually nationwide. HFE
offers tools to examine and address the systems factors contributing to
errors in these complex environments.40,41 Indeed, HFE methods have
already been applied to address community pharmacy challenges con­
cerning e-prescribing workflow and cognitive needs,42,43 medication
safety problems,44 stress and workload during dispensing,45–47 and
over-the-counter (OTC) medication decisions.48,49
HFE methods can address medication use or medication safety across
settings and people. Table 1 illustrates how studies using HFE methods
have been performed across the medication use process,50 to better
understand or improve the medication-related performance of pre­
scribers, pharmacy workers, nurses, and patients.
HFE methods for pharmacy research and clinical practice
HFE offers a broad toolkit of methods taught to and practiced by HFE
professionals but learnable by others.55 At an introductory level, there
are over 100 individual HFE methods, some with over 100 variations
each.56–58 We present seven categories of HFE methods suited to wide­
spread use for pharmacy research and clinical practice, with examples of
their use.
To choose the seven categories and present examples from published
pharmacy research, we performed a narrative review of the literature.
Narrative reviews are “selective in that they do not involve a systematic
and comprehensive search of all of the relevant literature” and
“opportunistic in that they survey only that literature and evidence that
are readily available to the researchers.”59 Narrative reviews uniquely
filter and sort large amounts of information by relying on subject-matter
experts whose contribution adds subjectivity—for better or worse.60 For
this review, the four authors served as the subject-matter experts; three
are on faculty in schools of pharmacy and a third has nearly 20 years’
relevant research experience. The authors collected empirical and re­
view papers from: a) their individual libraries; b) convenience searches
of scholarly databases (e.g., Google Scholar, PubMED/MEDLINE); and c)
keyword searches of top HFE and pharmacy research outlets. Prior to
writing, the authors prepared a list of HFE methods applied to pharmacy
in published works and grouped them into broader categories. Some
methods or categories were combined, and others were eliminated due
to insufficient published examples. This resulted in six categories of
methods deemed distinct, exemplified by published works, and typical
of HFE research in healthcare. A seventh category suggested by a peer
reviewer was added to more thoroughly cover the scope of applicable
HFE methods. During writing, the authors read additional articles cited
by or citing included papers on the topic and conducted supplementary
database searches on specific topics. Counting included or excluded
papers fell outside of present objectives.
Work system analysis methods
Work system analysis identifies, defines, and analyzes factors
contributing to performance in sociotechnical systems.61 Several models

Table 1
Examples of human factors/ergonomics (HFE) research and methods applied at each step of the medication use process.
Medication use Example study objective Human factors method(s) used Key findings
process step50

1. Prescribing Identify factors contributing to prescribing errors in
pediatric intensive care units.51
2. Transcribing Quantify pharmacists’ workload for transcribing
free-text, patient directions from e-prescriptions
and assess the quality of directions before and after
transcription.52
3. Dispensing Improve label design for 6 solid oral medications to
increase accurate dispensing by retail
pharmacists.53
4.Administration Apply the HFE approach to explore medication
administration in nursing homes and prevent
adverse drug events.54
5. Monitoring Identify, describe, and analyze medication non-
adherence events using HFE classification
methods.28
Hierarchical task analysis.
Keystroke level modeling.
Failure modes and effects analysis (FMEA),
expert review by HFE specialists, and
usability testing via simulations.
Direct observation and interviews using
the SEIPS framework.
Taxonomies and models for classifying and
understanding the performance shaping
factors contributing to errors and
violations.
Identified 30 subtasks for PICU prescribing; cognitive
burden was the main contributory factor for errors.
Pharmacy staff edited 83.8% of all e-prescription
directions; readability increased by 68.6% after
pharmacists’ transcription.
With the final label, no errors occurred among 450 filled
prescriptions.
Identified 6 stages of medication administration in
nursing homes and more than 60 associated facilitators
and barriers.
Identified 70 events, half classified as errors and half as
violations, along with performance shaping factors
related to person or team, task, tools and technologies,
and organizational, physical, and social context.

HFE = Human factors and ergonomics; PICU = Pediatric intensive care unit; SEIPS = Systems Engineering Initiative for Patient Safety.

2
R.J. Holden et al.
of work systems are available,62 each depicting broad categories of
interacting performance-shaping factors; for example, the Systems En­
gineering Initiative for Patient Safety (SEIPS) model’s factors are per­
sons, tasks, tools/technologies, organization, and environment.63–65
These models are often used to structure data collection or analyze
data.66 Work system analysis is also used to examine interactions be­
tween factors, such as the degree of alignment between a tool, its user,
and the associated task. Work system analyses in pharmacy have pri­
marily used interview or focus group data collection and applied
deductive qualitative analysis to code findings using an existing work
system model such as SEIPS,63 SEIPS 2.0,64 or others.1,67,68 Quantitative
analysis can be used, as in a nationwide survey of Australian community
pharmacists69 or a nursing home study correlating adverse drug events
to clinicians’ perceptions of work system factors assessed via surveys.70
The work system analysis method has been used to study factors
affecting antipsychotic medication use by patients with serious mental
illness,71 barriers and facilitators to e-prescribing errors in community
pharmacies,72,73 barriers to providing safe OTC medication recom­
mendations to older adults,72 and performance of persons caring for
patients with dementia.74 Other applications in pharmacy include
studying implementation (e.g., of collaborative practice agreements75 or
cognitive pharmaceutical services76) or developing interventions (e.g.,
for interruptions management in inpatient pediatric pharmacies77 or
medication use in nursing homes78). Holden and colleagues67 also argue
work system analysis can be leveraged “to better understand patient
work systems and performance in a way that is comprehensive,
theory-based, and methodologically rigorous.”
Another type of work analysis, cognitive work analysis (CWA), is a
comprehensive framework to identify requirements, constraints, and
affordances for individuals’ cognitive work within a system of interest,
known as a “work domain.”79,80 CWA follows five phases, beginning
with a high-level work domain analysis resembling the work system
analysis above.81,82 Subsequent analysis progressively narrows to
characterize individual tasks (control task analysis), strategies used to
perform tasks (strategies analysis), allocation of tasks across individuals
(social organization and cooperation analysis), and cognitive re­
quirements of workers (worker competencies analysis). As an example,
researchers used CWA to model the medication management system in
ambulatory care settings.83,84
Task analysis methods
Task analysis encompasses methods to deeply understand the tasks
performed by individuals or teams. Task analysis can be used to model
the work of pharmacy professionals, identify training needs, and
formulate requirements for the design of work settings, processes, and
job aids.
Cognitive task analysis (CTA) allows analysts to capture cognitive
processes (e.g., information processing, decision making) underlying
observable behaviors.85 CTA has three aspects: knowledge elicitation;
data analysis; and data representation. A popular knowledge elicitation
approach is the critical incident technique or critical decision method,
wherein interviewers ask probing questions to gather details about an
incident: what happened, strategies used to detect problems, why a
decision was made. A limitation of this method is reliance on individuals
recalling past events, often spontaneously. To minimize recall bias, Russ
et al. collected information about medication safety incidents prospec­
tively from healthcare professionals.86 They conducted follow-up crit­
ical decision method interviews with healthcare professionals, where
healthcare professionals could access the electronic health record (EHR)
to aid their recall as they responded to interview questions. This CTA
adaptation was used to identify healthcare professionals’
decision-making process for detecting and responding to medication
safety incidents.86,87 Similarly, Holden et al. developed a
patient-centered CTA adapted for older adults, with whiteboard draw­
ings to facilitate incident recall and interactive scenarios to simulate
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Research in Social and Administrative Pharmacy xxx (xxxx) xxx
real-time decision making.88,89 These studies analyzed elicited data to
produce models of naturalistic decision making87,89 and “personas”
depicting different approaches to decision making.88 Other common
uses of CTA are comparing cognitive work of experts versus novices90
and identifying which cognitive processes are involved in routine tasks
such as medication adherence.91
Another popular task analysis is hierarchical task analysis (HTA).
HTA is used to depict the hierarchy of tasks or goals, decomposing these
into sub-tasks or sub-goals until they are described at a level of resolu­
tion fit for the intended purpose, such as for training workers or
designing decision support tools.92 Different data collection approaches
can be used to inform HTA including observations, interviews, focus
group discussions, and document reviews. For example, Lane et al.
performed HTA to model inpatient medication administration errors.93
Link analysis is another specific type of task analysis used to examine
how people interact with their physical environment. Lester and Chui
used link analysis to describe the impact of the physical layout of a
community pharmacy on pharmacist task performance.94 Using obser­
vation data, they developed a link diagram depicting movement of
pharmacists between locations within a pharmacy.
Workload assessment methods
Workload is a multidimensional, multifaceted concept affecting
performance outcomes such as error and healthcare professional out­
comes such as stress and burnout.95 Workload in healthcare has been
defined as the ratio of demands to resources.96,97 It depends on in­
teractions of real or perceived work demands, the circumstances under
which work is performed, and worker characteristics (e.g., pharmacist’s
years of experience, patient’s skill level).98
Workload can be assessed at multiple levels, including organiza­
tional unit, job, and task levels.97–99 At the organizational level, work­
load may be conceptualized as the amount or volume of work versus
staffing resources. Job-level workload could be measured by the amount
and kind of work required for a role (e.g., hospital pharmacist) relative
to the training and tools provided. Task-level workload can be measured
as the complexity, difficulty, and multi-tasking requirements of specific
tasks relative to cognitive capacity or tools for the tasks.47,97,99 Thus,
HFE measures of workload extend beyond the number of prescriptions
dispensed at a pharmacy or medications prescribed to a patient; instead,
both demands and resources, across all levels of analysis, should be
assessed.100
Demands contributing to workload may be physical or cognitive (i.e.,
mental workload). Physical workload is measured using subjective and
objective methods, the former including validated measures of self-
reported exertion.101 More objective measures of physical workload
include assessing physiologic variables (e.g., oxygen consumption, heart
rate), task outcomes (e.g., time to perform tasks), worker outcomes (e.g.,
fatigue), and the ratio of physical demands (e.g., task load, frequency,
duration, distance) to available resources such as a person’s work ca­
pacity, skill or fitness, or access to assistive equipment and tools.102
Increasingly, changes in pharmacy work such as new technologies
and greater supervision have primarily increased cognitive demands.
Cognitive (or mental) workload measures include the popular, validated
NASA Task Load Index (TLX), one of several self-report approaches
scholars have used to study pharmacy workload.47,99,103,104 Other
measures use physiological markers such as a person’s pupillary dila­
tion, brain activity, or heart rate105; task performance indicators used to
infer workload106; or analytic modeling of demands inherent to known
tasks.107
Medication safety and error analysis methods
Various HFE techniques inform the analysis of medication errors and
safety incidents to generate interventions and sustainable safety solu­
tions. Failure modes and effects analysis (FMEA) is one technique used
R.J. Holden et al.
to prospectively identify safety vulnerabilities and assess strengths of
safety interventions, with the goal of preventing errors.108 Other pro­
spective HFE techniques applicable to healthcare include probabilistic
risk assessment and proactive hazard analysis,109 and some have applied
these methods to medication safety.110–112 Root cause action and anal­
ysis (RCA2) is used to retrospectively investigate an incident to identify all
plausible causes and generate actionable solutions.113,114 RCA2, which is
endorsed by the American Society of Health-System Pharmacists, was
developed by HFE and clinical experts to explicitly overcome flaws in
the traditional use of root cause analysis.115 The hierarchy of hazard
control is a complementary tool to evaluate the relative strengths of
proposed safety solutions prior to implementation.116
To investigate or model past incidents or prospective risks, one could
use task analysis methods described in a prior section. For example, the
critical decision method can be used to retrospectively reconstruct a
safety incident.117 An interviewer and subject-matter expert (e.g.,
healthcare professional involved in the incident) would create a basic
timeline of events, then uncover goals, decision-making cues, cognitive
challenges, and other factors that may have influenced the incident.
These data can be subsequently used to elucidate decision-making re­
quirements relevant to the incident type and to generate medication
safety interventions.86,87
User-centered and participatory design methods
Design-based approaches are increasingly adopted to address press­
ing healthcare quality and safety challenges. User-centered (or human-
centered) and participatory design approaches are used to develop so­
lutions that fit users’ tasks, needs, and contexts.
In typical user-centered design, designers and researchers conduct
user needs assessment from observation, interviews, analysis of artifacts
and documents, and secondary data analysis. It is best to derive needs
from studying actual (or future) users doing actual work in actual set­
tings.118 Needs assessment forms the basis for iteratively developing a
form of the design, progressing from early ideas and sketches to more
interactive prototypes, which will be subsequently evaluated by target
end users to ensure the product is usable and useful.119 Other commonly
used design tools are use-case scenarios, journey maps depicting the user
journey over time and settings,65 and personas—empirically derived
archetypes of user types.120
In participatory design, end-user representatives co-design an
intervention that meets the user population’s unique needs.121,122 That
means end users take the role of designer and can be involved in
different stages of the design process, often working in a team.122 For
example, Reddy et al. used participatory design with pharmacy staff and
older adults to develop an OTC medication safety intervention in a
community pharmacy setting.121 The researchers employed an iterative,
multi-step process of problem identification, solution generation and
convergence, prototyping, and evaluation. Siek et al. used participatory
design to develop a digital personal health application to help older
adults manage and share their medication regimens during care
transitions.123
Usability evaluation methods
An important component of user-centered design is conducting us­
ability evaluations of devices, technologies, software, and other solu­
tions.124 Usability is defined as the “measure of the quality of a user’s
experience when interacting with a product or system”125 and refers to
the degree to which a product or system “[supports] users [in their ef­
forts] to achieve specified goals with effectiveness, efficiency, and
satisfaction ….”126 Usability is vital for all healthcare devices, technol­
ogies, and tools, to ensure their effectiveness for healthcare delivery,
efficiency for users, and safety for patients. To date, usability evalua­
tions have been conducted on a range of pharmacy-related technologies,
including computerized provider order entry,127 hospital128 and
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Research in Social and Administrative Pharmacy xxx (xxxx) xxx
community pharmacy medication alerts,129 and infusion pumps.130
Usability evaluation can be accomplished through techniques such as
heuristic evaluation,131,132 cognitive walkthrough,133 usability ques­
tionnaires,134 and usability testing,135,136 sometimes used in combina­
tion. These and other usability techniques are further examined in other
healthcare literature.17,133–135,137
Formal usability testing is recognized as the most rigorous usability
testing approach.124 During usability testing, a moderator with usability
expertise asks an end user (e.g., pharmacist, technician) to complete
realistic clinical tasks, without assistance, using one or more systems
being tested. Guidance exists on selecting clinical task scenarios, as they
are central to the quality of usability findings.137 Performance is typi­
cally captured by video/screen recording.135 Multiple usability mea­
sures are collected, assessing effectiveness (e.g., number and type of
usability problems encountered); efficiency (e.g., time on task, number
of mouse clicks); and/or satisfaction (e.g., debrief interview with
pharmacist). Eye-tracking technology can be used to estimate usability
and cognitive load from gaze patterns.138,139 Other sophisticated us­
ability techniques might include concurrent think aloud protocol
(verbalizing reactions during use),140 patient actors,141 and safety
probes.142 As an example of safety probes, one study inserted artificial
but realistic medication discrepancies into a medication reconciliation
task for healthcare professionals and assessed the extent to which the
software supported professionals’ and patients’ detection of discrep­
ancies.142 The probes for discrepancies included a missing medication,
inappropriate medication, and incorrect dose. Usability testing can
range from brief quality improvement projects in healthcare in­
stitutions135,143 to sophisticated research studies.128,144
Physical ergonomics methods
Physical ergonomics is the study and design of physical work, by
attending to the interaction of human anatomical, anthropometric,
physiological, and biomechanical characteristics with work system el­
ements such as lighting, noise, vibration, layout, tools, furniture, forces,
hazards, and climate. Many specific HFE theories, methods, and design
guidelines are available, in service of improving physical safety (e.g.,
reducing falls or work-related musculoskeletal disorders), performance
(e.g., accuracy and speed of lifting or fine-motor tasks), and comfort.145
In pharmacy work with a physical component—for instance, medication
dispensing146,147—HFE methods can be used to assess:
• Lighting needed (vs. provided) for accurate label-reading under
variable pace of work;
• Noise levels and other disruptive or interruptive conditions (e.g.,
overheard conversations) that might increase risk of error;
• Seated and standing work postures of pharmacists and technicians,
including frequency and duration of each posture;
• Walking patterns and steps or distances traveled as a function of
potentially modifiable conditions such as work processes, policies,
layout, and storage design;
• Physical workload, fatigue, stress, strain, and worker physical com­
plaints over a time (e.g., day, week, year) for various tasks or roles;
• Loads and other contributing factors (e.g., posture, distance, object
shape) of supply lifting and carrying tasks;
• Available vs. used equipment for repeated physical tasks such as
sitting, typing, screen (or paper) reading and navigation, or waste
disposal;
• Visual angles and field of view between customers and staff, to
identify any obstructions or other barriers to greeting, helping, or
communicating with customers;
• Hazards in the environment such as vibration, spills, sharp objects,
studied proactively or reactively (based on incidents or reports).
Just as important are HFE methods for the design of the physical
workplace and other work system factors that shape the performance of
R.J. Holden et al.
physical work.148 These methods address the design of physical tools
and equipment (hardware, software, automation), workstations and
workplace layout, the environment (e.g., changing temperature, vibra­
tion, noise, lighting, surface materials), tasks (e.g., to reduce repetition,
fatigue, workload), processes (e.g., introducing break schedules or
teamwork), and organizational programs (e.g., training, incentives,
staffing levels). One example is supporting the physical work of phar­
macists and technicians working in a hazardous drug compounding fa­
cility of a central pharmacy. Some institutions are redesigning their
facilities to comply with the new USP 800 standards for handling haz­
ardous drugs. Rather than treating hazard control as an afterthought,
HFE experts can collaborate with facility planners and designers to
ensure that implementation of appropriate engineering controls and the
workspace fully consider the physical work demands of these workers.
Comprehensive application of HFE methods in pharmacy
research and practice
HFE methods are used in three broad phases of human-centered
design and evaluation (Fig. 1).149 They are used in the study phase to
help understand the problem or situation to be addressed. For example,
task analysis and cognitive workload assessment can be used to deter­
mine the cognitive tasks performed in an inpatient pharmacy and the
demands of each task. Methods are used in the intervention design phase
to create a solution or adapt existing solutions to the problem at hand.
Methods in the evaluation phase are used to test a solution in a laboratory
setting, through simulation, or when implemented in a clinical or patient
setting, with measures often focusing on human-centered outcomes such
as usability, use errors, mental workload, and effect on workflow. HFE
measures can be collected alongside traditional measures of clinical
effectiveness, safety, and cost to comprehensively assess the in­
tervention’s consequences. The most robust applications of HFE involve
the combination of methods across all three phases: study, design, and
evaluation. Such comprehensive application of HFE involves both
research and solution development,150 as illustrated by the two cases
below and elsewhere.149,151,152
Case 1: medication package, label, and information design
HFE researchers have studied human processing of medication in­
formation to design and evaluate patient-centered instructions and la­
bels.153 Findings show, for instance, that designs matched with older
and younger adults’ mental schema for taking medications enhance
their memory of medication information,154–156 and consequently
improve their medication adherence.157 As another example, people
prefer larger print and line spacing, additional white space, instructions
organized as lists, and extended surface areas (pull-out labels) on
medication containers.158–161 Labels incorporating such designs led to
an improvement in patients’ response time and knowledge
Fig. 1. The three phases of human-centered design and evaluation.
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Research in Social and Administrative Pharmacy xxx (xxxx) xxx
acquisition.162–164 Pictorials and icons were found to be useful to those
patients with low health literacy or inadequate reading skills.165,166
Researchers have also used eye tracking to evaluate how the design
of medication labels may impact understanding and safety. One study
focused on child resistant and product tampering warnings on OTC pain
relievers.167 They used eye tracking to quantify three measures related
to the relative prominence and conspicuousness of the warnings: time
spent examining the warnings compared to other areas of the label,
recall of information from the OTCs viewed, and legibility of the
warnings (how decipherable was the message) relative to the other label
elements. Results showed fewer than 20% of participants registered any
time in the product tampering warning zone and fewer than 50% of
participants viewed the child resistant warning zone. Among all label
information types, child resistant and product tampering warnings were
least likely to be recalled and least legible. Therefore, despite legal re­
quirements to highlight these warnings, the study demonstrated that the
current design of OTC pain reliever packaging failed to effectively
convey these important safety messages.
In a follow-up study, the team investigated how different OTC label
designs attract attention to critical information, affect decision making,
and facilitate rapid cross-product comparisons.168 They sought to pro­
duce a medication label that successfully communicated critical drug
information to at-risk older adults, thereby empowering them to make
better medication selection decisions, and ultimately reducing adverse
drug events. This study demonstrated improved patient attention to
interactive and horizontal warning placements versus auxiliary labels
placed vertically on prescription vials.168
Case 2: Human-centered design of a digital decision aid for medication
safety
A multidisciplinary team, including HFE and pharmacy experts,
sought to improve safety and brain health for older adults by addressing
use of potentially unsafe prescription and OTC anticholinergic medica­
tions. In the study phase, the team conducted interviews with older
adults who take anticholinergic medications and observed people’s
shopping behavior in retail pharmacy OTC aisles. They also conducted a
simulation study of OTC decision making among older adults using
standard scenarios169 and a realistic OTC aisle mockup.49 The goal was
to understand how older adults made decisions, the barriers to making
safe choices, and their knowledge about anticholinergics. To study
cognitive decision making, the researchers used the contextual inquiry
technique as individuals made decisions in actual pharmacies or in
scenario-based simulations; this entailed opportunistically asking
questions about a person’s thoughts while observing their behavior. In
the simulation study, the team also had participants rank order eight
factors (e.g., cost, effectiveness, safety) influencing their OTC choices.
In the project’s intervention design phase, the team analyzed data to
create personas and workflow maps depicting decision steps and bar­
riers.49 Using findings from this and a parallel study,48,170 the team and
its professional designers iteratively created multimedia content and
mobile app software.171 A prototype app was formatively tested with a
sample of older adults (n = 11), iteratively refined over three
design-then-test cycles, then programmed as working software.171
In the testing phase, the team performed summative usability testing
on the Brain Buddy app with 23 older adult anticholinergic users and
feasibility tested the app with a subset (n = 17) at medium or high risk of
anticholinergic brain harm.171 Usability testing combined task-based
testing with observation of performance as well as a self-report ques­
tionnaire, a Simplified System Usability Scale (SUS) for Older and
Cognitively Impaired Adults.172 The Brain Buddy app performed well on
usability, scoring in the “Good” to “Excellent” range for the SUS, while
uncovering opportunities for further redesign. Feasibility findings
showed 100% felt better informed, 94% indicated planning to talk to
their physician about anticholinergic medication, and for 82% their
physician confirmed having the conversation in an actual visit.171 The
R.J. Holden et al.
app was further refined, rebranded as the Brain Safe app, and is being
evaluated for efficacy and safety in an ongoing clinical trial, which also
includes measures of self-reported usability and passively logged
usage.173 Developed multimedia content was also included in a clinical
trial of a multi-component intervention in a safety-net primary care
system.174
Conclusions and considerations
Pharmacy, including the places where pharmacy professionals work
and the multistep process of medication use across people and settings,
can benefit from HFE. This is because pharmacy is a human-centered
sociotechnical system with an existing tradition of studying or
analyzing the present state, designing solutions to problems, and eval­
uating those solutions in laboratory or practice settings. To put it simply,
HFE fits pharmacy.
HFE can be implemented in pharmacy as a mindset or set of princi­
ples that drive research or clinical practice operations. HFE principles
and underlying theories175–177 can be usefully adopted as an operating
system or culture, the way some organizations strive to become lean,178
agile,179 patient-centered,180 or high-reliability181 organizations.
HFE methods can be used to operationalize the HFE mindset or as
tools for individual research or clinical practice projects. We presented
some, but not all, varieties of HFE methods suitable for studying and
improving pharmacy phenomena. We recommend interested readers
consult other comprehensive methods texts.4,16,55,90,148,182–185 Training
on HFE methods is also available, from webinars and workshops to short
courses and degree-granting programs. In the US, several health pro­
fessional schools now offer HFE courses or degrees. In the UK, HFE ed­
ucation has been proposed as part of the pharmacy curriculum to
address patient safety.186 The best learning opportunities will most
likely come from hands-on applications, especially when applying the
methods in field settings.187,188 A few articles and books have been
written specifically about practical considerations and uses of HFE and
related methods in the field,119,189 but most HFE textbooks assume the
methods will be used in both laboratory research and practice settings.
Those considering HFE methods or using them for the first time often
wonder whether their use requires an HFE professional’s involvement,
special training or certification, or a level of practical experience. When
formal training or education is available, it is advisable to obtain it,
because HFE methods are grounded in theories and mindsets that take
longer to learn and internalize. Moreover, we believe collaborating with
HFE professionals generally strengthens the quality of work. Indeed,
many HFE professionals are available and motivated to partner with
researchers, clinicians, administrators, and other pharmacy stake­
holders to design, implement, or guide the use of HFE methods in
pharmacy. These HFE professionals—and professionals from other
human-centered disciplines or branches of HFE such as human-
computer interaction—can also serve as consultants, mentors, and col­
laborators. Furthermore, the increasing community of pharmacy experts
who have used HFE methods (some for decades!) can be the bridge for
those just beginning to use HFE approaches. It is important to engage
HFE professionals not only for their education but for their experience
modifying and implementing the methods across application areas. HFE
experts can also help newer users select and customize “off-the-shelf”
methods to fit the circumstances.171
At the same time, many HFE methods can be taught to and learned by
novices.190 One might be able to learn the rudiments of a method by
reading about it and experimenting with its use (preferably with some
input from more masterful users). Some HFE experts are also developing
do-it-yourself (DIY) HFE method supports (e.g., software, how-to books,
video content) to help early-stage users adopt HFE methods without
committing “malpractice.”191
Whatever the path, we urge the adoption and use of HFE methods for
pharmacy research and practice, towards improved medication-related
outcomes and better health.
6
Research in Social and Administrative Pharmacy xxx (xxxx) xxx
Funding
Dr. Abebe received support from the National Institutes of Health
(NIH), National Center for Advancing Translational Sciences, Clinical
and Translational Sciences Award, Grant Numbers, KL2TR002530 (PI:
Carroll), and UL1TR002529 (PI: Shekhar). For some studies described in
this article, Dr. Russ-Jara received funding support from the Department
of Veterans Affairs (VA), Veterans Health Administration, Health Ser­
vices Research and Development Service (HSR&D), Center for Health
Information and Communication CIN 13–416 (PI: Weiner) at the
Richard L. Roudebush Veterans Affairs Medical Center in Indianapolis,
IN, and from a VA HSR&D Career Development Award 11–214 (PI: Russ-
Jara). Work presented in Case Study 2 was supported by Agency for
Healthcare Research and Quality (AHRQ) grants P30 HS024384 (PI:
Callahan) and R18 HS024490 (PI: Chui) and NIH grant R01AG056926
(PI: Holden). Views expressed in this article are those of the authors and
do not necessarily represent the views of the NIH, AHRQ, Department of
Veterans Affairs, or the U.S. government.
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