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Communication and Cultural Issues in Medication Error Reports

A dissertation submitted in partial fulfillment of the requirements for the degree of


Doctor of Philosophy at George Mason University

By

Mary Ann Friesen


Master of Science in Nursing
University of Texas at El Paso, 1992

Director: Dr. Kathleen F. Gaffney


Department of Nursing

Summer Semester 2008


George Mason University
Fairfax, VA
3323707

3323707
2008
Copyright 2008 Mary Ann Friesen
All Rights Reserved

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DEDICATION

This dissertation is dedicated to all those affected by medication errors, all those who
report medication errors so others may learn and seek to prevent future errors and all
those who continuously strive to promote patient safety and provide patient-centered
compassionate care.

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ACKNOWLEDGEMENTS

Undertaking this examination of medication errors would not have been possible without
the support of the United States Pharmacopeia (USP), which was the source of data used
in this study. The USP Center for the Advancement of Patient Safety granted access to
this data in order to allow greater understanding of the causes and consequences of
medication errors. I am grateful to Diane Cousins for approving my request to utilize the
USP data and to Dr. Rodney Hicks for his support of this project and Marilyn Storch for
her assistance. I am indebted to Shawn C. Becker for her review of this manuscript.

I have told many my committee was “the A team” or the “Dream Team” and indeed it
was. My thanks to my advisor and chair Dr. Kathleen F. Gaffney who provided support
and guidance in navigating the research process from inception to conclusion. Thanks to
Dr. Sorrell who taught me so much about qualitative research both in the classroom and
during the dissertation process. And to Dr. Kreps whose expertise contributed to my
greater understanding and appreciation of studying communication processes within
healthcare.

I want to thank Dr. Sally Bulla of George Mason University who conducted coding
checks with me as I proceeded with the content qualitative analysis process. I must
extend my gratitude to Dr. Robert Reilly who served as the pharmacologic consultant for
this research project.

This dissertation was made possible through support and guidance from many colleagues
who inspired me and encouraged this journey including Evonne Taylor, Dian Cassidy,
Marcia Zorn and Dr. Letty Lantican. I am indebted to Dr. Ronda Hughes who greatly
expanded my knowledge of national patient safety initiatives. My thanks to Colleen
Spears for her gentle optimism.

I was privileged to have been part of the George Mason University community for the
past several years. I am grateful to a truly outstanding faculty who encouraged creative
thinking and allowed me to develop my research skills in a wonderful learning
environment especially: Dr. Rita Carty, Dr. Carole Jennings, Dr. Katherine Rowan and
Dr. Jean Moore for their insight. I can not thank my fellow students enough. Together we
learned and grew in both scholarship and friendship—with special recognition to Vernell
DeWitty, Kathi Huddleston, Nancy Falk, Kae Livsey and Amanda Rosenkranz.

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I was blessed by colleagues, friends and a family who supported me through this process.
My children Peter and Malia and mother provided unwavering support. My late father’s
gentleness and kindness was most appreciated as he watched this process with great
interest. I want to thank Lee and John Wilson, who never doubted this project would be
finished. Special appreciation to Mary BV, Laurel, Valerie, Wylecia, Diane, Asher,
Patrick, John, Mary, Bob, Ellen, John, Roxie, Sara, Maureen, Margaret, and Evan for all
your encouragement. I am truly grateful. In a class by himself is my husband, Peter,
whose love and support made this journey possible and who has my undying gratitude.

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TABLE OF CONTENTS

Page
List of Tables .......................................................................................................................x
List of Figures ................................................................................................................... xii
Abstract ............................................................................................................................ xiii
1. Introduction ....................................................................................................................1
Background ....................................................................................................................1
Statement of Problem .....................................................................................................3
Significance....................................................................................................................8
Conceptual Framework ..................................................................................................8
Latent Failures .............................................................................................................11
Active Failures .............................................................................................................12
Cultural Influences .......................................................................................................13
Communication ............................................................................................................17
Statement of Purpose ...................................................................................................19
Research Questions ......................................................................................................19
Definitions....................................................................................................................20
Summary ......................................................................................................................22
2. Review of the Literature ..............................................................................................24
Medication Errors and Patient Safety ..........................................................................26
Frequency of Medication Errors ............................................................................26
Harmful Outcomes of Medication Errors ..............................................................29
Costs of Medication Errors ....................................................................................29
Causes of Medication Errors ..................................................................................30
Types of Errors by Stage........................................................................................31
Medication Errors and Nurse Staffing ...................................................................32
Reporting of Errors ................................................................................................32
Barriers to Reporting Errors...................................................................................33
Medication Errors and Communication .................................................................38
Medication Errors and Handoffs ............................................................................39
Reaction to Medication Errors ...............................................................................40
Communication and Patient Safety ..............................................................................41
Communication Among Healthcare Team Members ............................................41
Communication Interruptions and Distractions .....................................................45
Communication and Handoffs ...............................................................................46
Communication and Technology ...........................................................................47
Communication and Verbal Interaction .................................................................48

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Communication, Intimidation and Disruptive Behavior........................................49
Communication Disruption....................................................................................50
Summary ......................................................................................................................51
3. Methodology ................................................................................................................53
Methods........................................................................................................................53
Data Collection: Medication Errors Reporting (MER) Program .................................54
Sampling ......................................................................................................................55
Quantitative Data Analysis ..........................................................................................57
Answering Research Questions ...................................................................................58
Qualitative Data Analysis ............................................................................................60
Content Analysis ....................................................................................................61
Reliability and Validity – Content Analysis ..........................................................65
Content Analysis Method in This Study ................................................................67
Study Assumptions .....................................................................................................70
Ethical Considerations .................................................................................................70
Summary ......................................................................................................................71
4. Findings........................................................................................................................72
Descriptions of Attributes of Medication Errors .........................................................72
Location of Error....................................................................................................72
Initiation of Error by Individual or Group .............................................................73
Discovery of Error by Individual or Group ...........................................................75
Research Question One: What Are the Patient Outcomes in the Medication Errors
Reported in This Sample? ........................................................................................78
Analysis and Coding of Qualitative Data ....................................................................82
Initial Selection Criteria .........................................................................................82
Initial Coding .........................................................................................................83
Final Criteria for Selection of Medication Error Report ........................................85
Second Round of Coding .......................................................................................85
Taxonomy ..............................................................................................................88
Research Question Two: What Are the Communication Issues That Are
Identified in the Medication Error Reports? ............................................................91
Non-Verbal Communication: Written/Printed Communication ............................92
Verbal Communication: Oral Communication ......................................................98
Threats to Communication Process and Transmission of the Message ...............101
Technology Challenges ........................................................................................113
Healthcare Provider and Patient/Family/Significant Other Communication.......116
Communication Issues Involving Lack of Knowledge........................................119
Swiss Cheese Model Error Trajectory .................................................................123
Summary ..............................................................................................................126
Research Question Three: What Attributes Supportive of a Culture of Safety
Are Present in the Medication Error Reports? .......................................................129
Open Communication – Healthcare Providers ....................................................130
Open and Flexible Communication – Being Present ...........................................131

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Open Communication – Patient and/or Family and/or Significant Other
Intervention .....................................................................................................133
Teamwork ............................................................................................................134
Learning Culture ..................................................................................................136
Just Culture ..........................................................................................................137
Reporting Culture.................................................................................................139
Systems Approaches ............................................................................................140
Support From Leadership ....................................................................................141
Summary ..............................................................................................................142
Research Question Four: What Attributes Not Supportive of a Culture of Safety
Are Present in the Medication Error Reports? .......................................................143
Lack of Open Communication .............................................................................144
Lack of Teamwork ...............................................................................................146
Process/Systems Problems ...................................................................................147
Not Reporting Errors............................................................................................148
Summary ..............................................................................................................149
Research Question Five: What Types of Interpersonal Issues Are Evident in a
Review of the Medication Error Reports? .............................................................150
Healthcare Provider Interpersonal Issues.............................................................150
Patient/Family/Friend/Significant Other Interpersonal Issues .............................153
Summary ..............................................................................................................161
Research Question Six: What “Actions Taken” and/or “Recommendations” to
Address Errors Are Described in the Medication Error Reports? .........................162
Education .............................................................................................................165
Checking and Verification ...................................................................................166
Technological Applications .................................................................................168
Change and Improvement Process .......................................................................170
Summary ..............................................................................................................176
Other Findings: Label and Packaging Issues .............................................................177
Descriptions of Errors ..........................................................................................178
Reactions to Labeling and Packaging Issues .......................................................180
Actions Taken/Recommendations Related to Labeling and Packaging ..............180
Themes .......................................................................................................................184
Risking Patient Safety Through Behaviors and Systems That Breach
Defenses ..........................................................................................................184
Standing Watch for Errors ...................................................................................186
Stepping in to Prevent Harm ................................................................................188
Experiencing the Human Impact of Medication Errors .......................................189
Seeking to Prevent Reoccurrence of Medication Errors ......................................190
Summary of Results ...................................................................................................193
5. Study Summary, Discussion, Implications, and Conclusions....................................195
Summary ....................................................................................................................195
Research Question One: What Are the Patient Outcomes in the Medication
Errors Reported in This Sample? ...........................................................................196

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Findings................................................................................................................196
Discussion ............................................................................................................198
Research Question Two: What Are the Communication Issues That Are
Identified in the Medication Error Reports? ..........................................................199
Findings................................................................................................................199
Discussion ............................................................................................................200
Research Question Three: What Attributes Supportive of a Culture of Safety
Are Present in the Medication Error Reports? .......................................................205
Findings................................................................................................................205
Discussion ............................................................................................................206
Research Question Four: What Attributes Not Supportive of a Culture of Safety
Are Present in the Medication Error Reports? .......................................................209
Findings................................................................................................................209
Discussion ............................................................................................................209
Research Question Five: What Types of Interpersonal Issues Are Evident in a
Review of the Medication Error Reports? .............................................................210
Findings................................................................................................................210
Discussion ............................................................................................................211
Research Question Six: What “Actions Taken” and/or “Recommendations” to
Address Errors Are Described in the Medication Error Reports? .........................212
Findings................................................................................................................212
Discussion ............................................................................................................213
Limitations .................................................................................................................220
Thematic Analysis and Implications ..........................................................................222
Practice and Delivery of Care – Implications ......................................................224
Education of Healthcare Providers – Implications ..............................................242
Policy – Implications ...........................................................................................246
Research – Implications .......................................................................................249
Conclusions ................................................................................................................253
Appendices
A. George Mason University Office of Research Subject Protections Letter ...........256
B. Summary of Categories, Subcategories, Taxonomy for Other Findings’ 85
Label and/or Packaging Cases ..............................................................................257
C. Summary of Research Questions, Categories, Subcategories, Taxonomy for
322 Medication Error Reports ..............................................................................259
References ........................................................................................................................263

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LIST OF TABLES

Table Page
1. Comparison of Barriers to Reporting by Nurses..........................................................36
2. Categories Adapted From National Coordinating Council for Medication Error
Reporting and Prevention (NCC MERP) Index for Categorizing Medication
Errors............................................................................................................................58
3. Research Questions as Related to Medication Errors Reporting Form .......................59
4. Steps for Content Analysis...........................................................................................62
5. Description of Six Components of Qualitative Analysis (Krippendorf, 2004) ...........64
6. Location of Error..........................................................................................................73
7. Initiation of Error by Individual or Group ...................................................................75
8. Error Discovered by Individual or Group ....................................................................76
9. Most Frequently Identified Medications by Generic Name in 322 Medication
Error Reports ................................................................................................................77
10. Patient Outcomes From Medication Errors .................................................................78
11. Patient Outcomes From Medication Errors in Rank Order .........................................79
12. National Coordinating Council for Medication Error Reporting and
Prevention (NCC MERP) Index for Categorizing Medication Errors and Patient
Outcomes by Category .................................................................................................80
13. Coding Check for Selection of Narratives and Congruence for Coding Data
Between First Reviewer and Student Researcher ........................................................84
14. Initial Review Congruence Between Student Researcher and Second Reviewer
With Revised Criteria ..................................................................................................86
15. Review After Meeting With Student Researcher and Reviewer Congruence
Between Student Researcher and Second Reviewer With Revised Criteria................87
16. Taxonomy of Communication Failure, Success and Context ......................................89
17. Examples of Look-Alike/Sound-Alike Medications Identified by Reporters of
Medication Errors .....................................................................................................109
18. Summary of Findings for Research Question Two – Communication Issues
Identified in Reported Medication Errors ..................................................................128
19. Summary of Findings for Research Question Three – Attributes Supportive of a
Culture of Safety ........................................................................................................143
20. Summary of Findings for Research Question Four – Attributes Not Supportive
of a Culture of Safety .................................................................................................150
21. Summary of Cases Described by Patient/Family Member/Friend ............................155
22. Summary of Findings for Research Question Five – Interpersonal Issues ................162
23. Summary of Findings for Research Question Six – Categories and Subcategories:
“Actions Taken” and “Recommendations” ...............................................................164

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24. Occurrence of Harm in Errors Involving Manufacturer Labeling and/or
Packaging ...................................................................................................................178
25. Comparison of Patient Outcomes From 897,369 MEDMARX Data and
322 Reports From Medication Error Reporting (MER) Program Data .....................197
26. Comparison of Errors Resulting in Patient Harm From 897,369 MEDMARX
Data and 322 Medication Error Reporting (MER) Program Reports ........................198
27. Actions Taken and Recommendations: Categories and Subcategories .....................215
28. Examples of Medication Errors and Improvement Strategies in the Literature .......241

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LIST OF FIGURES

Figure Page
1. Human Contributions to Breakdown of Systems.........................................................10
2. Summary of the Psychological Varieties of Unsafe Acts ............................................13
3. Berlo’s S-M-C-R Model ..............................................................................................18
4. Components of Content Analysis ................................................................................63
5. Qualitative Content Analysis .......................................................................................65
6. Patient Outcomes From Medication Errors by Category .............................................81
7. “Swiss Cheese” Model: The Ideal and the Reality for Defences-in-Depth ..............126
8. Themes and Implications ...........................................................................................223

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ABSTRACT

COMMUNICATION AND CULTURAL ISSUES IN MEDICATION ERROR


REPORTS

Mary Ann Friesen, Ph.D.

George Mason University, 2008

Dissertation Director: Dr. Kathleen F. Gaffney

Because medication errors pose a major threat to patient safety, it is essential that

their causes be studied and addressed in order to identify strategies to decrease the

incidence of medication errors and encourage a culture of safety. Communication issues,

in particular, have been implicated as a cause of medication errors. This research

explored communication and cultural issues within a sample of medication errors

involving nurses reported between 2002 and 2005 to the Medication Errors Reporting

Program operated by the United States Pharmacopeia in cooperation with the Institute for

Safe Medication Practices. Qualitative content analysis and quantitative descriptive

methods were used to study the reported medication errors in order to identify categories

and themes. A total of 322 errors were analyzed with 21 patient deaths reported. Fifteen

categories and 65 subcategories were identified. An additional group of errors related to

labeling issues were analyzed separately. Five themes emerged from the analysis: Risking
patient safety through behaviors and systems that breach defenses, standing watch for

errors, stepping in to prevent harm, experiencing the human impact of medication errors

and seeking to prevent reoccurrence of medication errors.

The findings indicated many communication causes and contributors to

medication errors. However, medication errors were deflected when effective “open”

communication processes among healthcare providers were utilized. The findings suggest

there are numerous implications for practice, education, policy, and research.
I. INTRODUCTION

Background

The Institute of Medicine report To Err is Human has served as a catalyst for

change in the field of patient safety. It reported the problem of medical errors with

sobering statistics and alerted both healthcare consumers and providers that actions were

needed to address a threat to patient safety (Institute of Medicine [IOM], 2000). The

concern with patient safety issues in the United States attracted attention from various

stakeholders both within and outside the healthcare community. While progress has been

made in addressing concerns with patient safety, various experts indicated that more

needed to be done (Altman, Clancy, & Blendon, 2004; Leape & Berwick, 2005; Wachter,

2004).

One aspect of the current problem with patient safety was the fact that safety

breaches were not always disclosed to the public because of cultural influences (Gibson

& Singh, 2003), and/or the fear of punishment and litigation (Uribe, Schweikhart, Pathak,

& Marsh, 2002). These factors are present in an environment of fear. More specifically, a

culture of blame retards efforts to address openly, analyze, and learn from errors affecting

patient safety (Larson, 2000). This fear of reporting must be addressed if considerable

healthcare improvements are to be made (Cohen, 2000; Lawton & Parker, 2002).

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The federal government has undertaken initiatives related to patient safety since

the 1999 release of the Institute of Medicine (IOM) report To Err is Human as evidenced

by federal funding allocated to research “to improve patient safety” (Agency for

Healthcare Research and Quality, 2004, p. 1) and passing the Patient Safety and Quality

Improvement Act in the summer of 2005 (Patient Safety and Quality Improvement Act,

2005; White House, 2005). Additionally, accrediting agencies such as The Joint

Commission (formerly known as the Joint Commission on Accreditation of Healthcare

Organizations) are placing increased efforts on patient safety initiatives (O'Leary, 2003).

There has been a proliferation in the number of articles, books, seminars, websites, and

research activities related to patient safety in recent years, especially after the release of

the IOM report To Err is Human (Stelfox, Palmisani, Scurlock, Orav, & Bates, 2006).

Yet the problems with patient safety are not solved; threats to patients continue.

The healthcare environment is complex and constantly changing, creating opportunities

for new types of errors. Medication errors have many causes, and one of the causes of

such errors is ineffective communication and communication failures (Cohen, 2007b;

IOM, 2007). The aim of this study, therefore, was to explore communication and cultural

issues within a sample of medication errors that were reported between 2002 and 2005 to

the Medication Errors Reporting (MER) Program.

The Medication Errors Reporting Program, operated by [United States

Pharmacopeia] USP in cooperation with the Institute for Safe Medication

Practices, allows healthcare professionals to report potential and actual

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medication errors directly to USP on a confidential and anonymous basis. (United

States Pharmacopeia [USP], n.d.a)1

This chapter includes a statement of the problem, significance, and the study’s conceptual

framework and research questions.

Statement of Problem

Since publication of the Institute of Medicine (IOM) report To Err is Human

(IOM, 2000) medical errors have garnered widespread attention (Agency for Healthcare

Research and Quality, 2004; Stelfox, Palmisani, Scurlock, Orav, & Bates, 2006). The

IOM reported that medical errors are a threat to the public’s health and safety, and it

estimated that there are 44,000-98,000 related deaths annually. The annual costs

associated with such errors range from $17 billion to $29 billion (IOM, 2000). Yet,

several years after the release of the IOM report, appraisals by leading safety experts on

the state of patient safety indicated there was still much progress needed (Altman et al.,

2004; Leape & Berwick, 2005; Wachter, 2004).

This research focuses on medication errors a specific type of medical error.

Medication errors are ranked among the top 10 common reasons for malpractice claims

against hospitals (Glabman, 2004), and are among the top reasons for negligence cases

against nurses (Aiken, 2004). Medication errors pose a threat to patient safety and have

been implicated in adverse outcomes for patients, including death (Golz & Fitchett, 1999;

Hicks, Becker, & Cousins, 2006b; Hicks, Santell, Cousins, & Williams, 2004; Knox,

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United States Pharmacopeia (USP) operates the Medication Errors Reporting (MER) Program in
cooperation with the Institute for Safe Medication Practices. Throughout this document, the Program will
be referred to as either the Medication Errors Reporting Program or the MER Program.

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1996; Morrissey, 1995; Santell, Hicks, & Cousins, 2005; Wolf, 2007). The number of

deaths attributable to medication errors is difficult to quantify, although the IOM

estimated 7,000 deaths annually related to medication errors based on an earlier study by

Phillips and colleagues (IOM, 2000; Phillips, Christenfeld, & Glynn, 1998). Deaths

related to medication prescription errors were reported to have increased from 2,876 in

1983 to 9,856 in 1998 (Phillips & Bredder, 2002), and medication administration has

been categorized as “probably the highest-risk task a nurse can perform” (Anderson &

Webster, 2001, p. 34). Medication errors and related adverse events have been associated

with increased length of hospital stays and increased healthcare costs (Bates et al., 1997;

IOM, 2000). The IOM has designated medication management, including “preventing

medication errors”, as a priority area for improvement (IOM, 2003b, p. 5).

This research also focuses on communication processes and cultural influences

associated with medication errors. Communication encompasses exchanges and

information sharing both between healthcare providers, and between healthcare providers

and patients and family members. Due to complexity of the communication process, there

are many opportunities for miscommunication and breakdowns in exchanging accurate

information. Healthcare organizations are extremely complex by nature and present

numerous barriers to successful communication among healthcare providers and patients

and their significant others (Gosbee, 1998; Kreps, 1988). Communication is a critical

process in providing safe patient care (American Association of Critical-Care Nurses,

2005; Evanoff et al., 2005; IOM 2004a; Leonard, Graham, & Bonacum, 2004; Lingard et

al., 2004; Sutcliffe, Lawton, & Rosenthal, 2004) and has been implicated as a cause of

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medication errors (Cohen, 2007b; Hicks et al., 2004; IOM, 2007; Santell et al., 2005;

Taxis & Barber, 2003a). Communication has been identified as a root cause in over 60%

of medication error sentinel events (Joint Commission, 2007g). A sentinel event is

defined as “an unexpected occurrence involving death or serious physical or

psychological injury, or the risk thereof” (Joint Commission, 2007h). A subset of

communication issues that is garnering increasing attention is handoffs: “It is in

inadequate handoffs that safety often fails first” (IOM, 2001, p. 45). Handoffs are defined

as “the transfer of information (along with authority and responsibility) during transitions

in care across the continuum; to include an opportunity to ask questions, clarify and

confirm” (Agency for Healthcare Research and Quality, 2006b, p. 31). The concerns with

communication and handoffs have become so significant that the Joint Commission has

developed and implemented patient safety goals that specifically address communication

and handoffs (2007a) and has also established a patient safety standard related to

medication reconciliation (2007a). Effective use of this medication reconciliation can

help address communication issues related to medication therapy (Joint Commission,

2006).

Understanding factors contributing to medication errors is critical if they are to be

addressed and remedied. Yet, there has been a tendency to blame individuals in

healthcare rather than analyze the problem or error (IOM, 2004a; Reason, 2000). Efforts

to mitigate errors must be undertaken to improve patient safety.

In the present healthcare environment there is an increasing focus on addressing

communication deficiencies that contribute to errors. After the release of the IOM To Err

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is Human report, the Senate Committee on Appropriations “directed AHRQ [Agency for

Healthcare Research and Quality] to lead the national effort to combat medical errors and

improve patient safety” (Agency for Healthcare Research and Quality, 2004, p. 1). An

investigative series in the Chicago Tribune highlighted errors related to nursing care and

the consequences, including patient deaths (Berens, 2000a, 2000b, 2000c). Another IOM

report, Crossing the Quality Chasm, called for safety in healthcare delivery: “patients

should be safe from injury caused by the care system” (IOM, 2001, p. 8). The tragedy of

medical errors was explored and discussed from multiple perspectives in Wall of Silence:

The Untold Story of the Medical Mistakes That Kill and Injure Millions of Americans

(Gibson & Singh, 2003) which includes poignant and compelling stories from patients

and families who have experienced the consequences of medical errors. The IOM report

Keeping Patients Safe: Transforming the Work Environment of Nurses highlighted the

link between nursing care and patient safety and cited numerous factors impacting on

patient safety related to the work environment (IOM, 2004a). Walshe and Shortell, both

experts in health policy, noted the “major failures in healthcare are, more than anything

else, a product of the distinctive cultures of the organizations, the healthcare professions,

and the health system…. There is endemic secrecy, deference to authority, defensiveness,

and protectionism” (2004, p. 110). There needs to be a change in the culture of healthcare

from a culture of blame to a culture of safety; in fact “promoting a culture of safety has

become one of the pillars of the patient safety movement” (Nieva & Sorra, 2003, p. ii17).

A culture of safety rests upon being able to communicate and “report events without fear

of punishment” (Zhan et al., 2005, p. I-43). As mentioned earlier, the political interest

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generated in the area of patient safety and the desire to promote a culture of safety

resulted in the Patient and Safety Quality Improvement Act, signed by President Bush

July 29, 2005 (Office of Press Secretary, 2005). But there are still many challenges to

meet in order to improve patient care (Leape & Berwick, 2005; Wachter, 2004).

In fact, medication errors have warranted an entire IOM report addressing this

threat to patient safety: Preventing Medication Errors (2007). This report analyzes the

prevalence, causes and cost of medication errors in human and financial terms. The IOM

provides seven recommendations to address patient safety related to the problem of

medication errors, the recommendations are summarized below:

1. Efforts need to be undertaken to “strengthen patients’ capacities for sound

medication self management” (IOM, 2007, p. 11).

2. Government agencies need to improve resources for consumer drug

information and self-management.

3. Healthcare providers and patients should have to access to patient information

and reference data. All prescriptions should be written electronically by 2010.

4. Improve medication labeling and packaging.

5. Develop standards for health information technology (HIT) related to

medication therapy.

6. Research safe medication use, error prevention and reporting strategies across

the continuum of care.

7. Adopt strategies to reduce errors. Encourage reporting of medication errors

using a national taxonomy for data analysis (IOM, 2007).

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Medication errors are a subset of medical errors and remain a serious problem

years after the release of the IOM report To Err is Human.

Significance

As noted previously, medication errors pose a threat to patient safety, and

communication is a cause of 63% of medication error sentinel events (Joint Commission,

2006). The IOM report addressing medication errors noted that “patient safety can best be

achieved through the adoption of a culture of safety—an organizational commitment to

continually seeking to improve safety” (IOM, 2007, p. 15). This study adds to the body of

research on communication processes and cultural influences related to medication

errors. Its qualitative approach allowed an in-depth exploration of selected medication

error narratives. The study’s findings can aid others in understanding the complexity and

range of communication issues causing and contributing to medication errors.

Additionally, the study findings describe attributes of cultures of safety and those cultures

not supportive of safety. The findings can contribute to appreciating the challenges within

the present healthcare environment and why multi-faceted strategies and interdisciplinary

collaboration are needed to address the problems of medication errors.

Conceptual Framework

Understanding factors contributing to medical errors—specifically medication

errors—are critical if they are to be addressed and remedied. Lessons from other

industries can be applied to healthcare in seeking to understand events that can lead to

catastrophic outcomes (IOM, 2000). Numerous factors have been identified across

industries and systems that contribute to accidents and undesirable outcomes (IOM,

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2000). The IOM has highlighted the work of both Perrow and Reason in understanding

the dynamics of errors (IOM, 2000, 2004a). Perrow, a sociologist, notes accidents may be

a consequence of “multiple failures,” and identifies six organizational components known

as the DEPOSE Model: design, equipment, procedures, operators, supplies and materials,

and environment (Perrow, 1984).

James Reason is widely regarded as the “dean of safety researchers” (Leape &

Berwick, 2005, p. 2387). Reason’s work on understanding human error has been applied

in healthcare to help explain why errors occur (Brown, 2001; Dennison, 2005;

Edwardson, 2007; IOM, 2000, 2004a, 2007; Leape, 1994; Meurier, 2000, Reason, 2001,

2004, 2005). Reason’s work has been used by others in addressing medication errors

(Brown, 2001; Burkhardt, Lee, Taylor, Williams, & Bagain, 2007; Dennison, 2005).

Reason’s framework describing a safety culture is also being used in healthcare (IOM,

2004b; McCarthy & Blumenthal, 2006). Reason describes a “person approach” and a

“systems approach” to explain human errors (Reason, 2000). The person approach

focuses on the individual as a reason for the error; the error may have occurred due to

“forgetfulness, inattention, poor motivation, carelessness, negligence, and recklessness”

(Reason, 2000, p. 768). Focusing just on human shortcomings does not help improve

care, as most of the threats to patient safety are related to systems problems (IOM, 2000).

Reason does not advocate “blanket immunity” of individuals and acknowledges there are

instances (violations) where individuals are culpable for their own “bad behaviours”

(Reason, 1997, p. 205). However, events related to bad behaviors are not common

(Reason, 1997, 2000). In the systems approach the emphasis is on understanding how

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defenses and “barriers,” if breached, can contribute to an accident (2000). Reason’s

explanation of breakdowns in a system has been labeled the “Swiss Cheese Model”

because it illustrates the path of an accident that is not stopped and flows through “holes”

in the layers of defenses (2000). Both latent and active failures contribute to holes in the

defenses (Reason, 1997). A detailed delineation of the human contributions to breaching

system defenses is illustrated in Figure 1. If defenses are not adequate, the trajectory for

an accident actually penetrates a window of opportunity, resulting in the occurrence of an

accident.

Figure 1. Human contributions to breakdown of systems. From Human Error (p.


202), by J. Reason, 1990, Cambridge: Cambridge University Press. Reprinted
with permission of Cambridge University Press.

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Latent Failures

Errors occur for many reasons. The error trajectory in some instances can be

impacted by latent failures, which are associated with systems and can contribute to

accidents and patient injury when defenses are penetrated (IOM 2004a; Reason, 2000,

2001, 2004). Additionally certain types of decisions can contribute to various types of

errors and accidents (Reason, 2005).

To apply the latent failure explanation described by Reason (1990, 2000, 2001) to

a medication error, take a hypothetical case where administration makes the decision not

to involve healthcare providers in selecting and acquiring computerized patient care

technology. The decision may contribute to a latent failure. For example, a doctor writes

an order that is illegible. The nurse and pharmacist misunderstand the order and the

patient receives a fatally high dose of the wrong medication. A computerized system

could have allowed inputting a legible order versus a handwritten illegible order, and

could have included an alert function to warn the pharmacist and nurse of the

dangerously high dose of medication. While the nurse administered the fatal dose and the

pharmacist dispensed the fatal dose, the administration’s decision to avoid incurring the

cost of a technology that could improve patient safety contributed to the error in this

hypothetical case. The system issues could be classified as a latent failure or latent error.

Latent errors “may lie dormant within the system for a long time” (Reason, 1990,

p. 173). In the hypothetical case, although there were many contributors to this error, one

was lack of a technological system to help prevent such an error. Although the nurse and

11
pharmacist should arguably be aware of the danger of unusually high doses of a

medication, a system alert could have derailed this error from reaching the patient.

Active Failures

A number of types of unsafe acts with different causes can lead to different types

of errors. Reason has dissected the process of human error and identified several types of

“unsafe acts,” including, errors and violations, these are categorized as active failures

(1990, 1997, 2001, 2004, 2005) made by persons at the “sharp end” (Reason, 2001,

2005). The person responsible for an active failure is the person involved in the task

directly, such as a nurse or doctor performing a procedure in the process of providing

care (2001). Incidents occurring at the “sharp end” can have immediate consequences

(2001). Violations are a unique category separated from other unsafe acts as being

intentionally committed by the practitioner (2001). The model developed by Reason

(Figure 2) illustrates in clear detail the many different types of unsafe acts that may be

observed. Reason describes the model as “a summary of the psychological varieties of

unsafe acts, classified initially according to whether the act was intended or unintended

and then distinguishing errors from violations” (1990, p. 207).

12
Figure 2. Summary of the psychological varieties of unsafe acts. From Human
Error (p. 207), by J. Reason, 1990, Cambridge: Cambridge University Press.
Reprinted with permission of Cambridge University Press.

It is important to understand the context in which unsafe actions occur, and

Reason’s framework addresses the organizational context of errors and accidents. It also

provides a framework for analyzing how latent and active failures can lead to an accident

(Reason, 1990, 2001).

Cultural Influences

In this study, the analysis of reported medication errors was focused on

communication and attributes of the organizational culture that either promote or detract

from safety. Communication as an aspect of an organizational culture was examined in

13
the context of a culture of safety when possible. Reason has identified attributes of a

safety culture, including:

• “reporting culture”

• “just culture”

• “flexible culture”

• “learning culture”

• “informed culture.” (1997)

The “reporting culture” fosters openness in communicating errors so that others

may learn and such errors can be prevented. This culture relies on incentives to promote

reporting and leaders who provide feedback, and is linked to a “just culture” in which

“staff can raise their hand when they have seen a risk, or made a mistake. It is a culture

that puts a high value on open communication” (Marx, 2005, p. 1). A just culture is not a

“no-blame culture” (Reason, 1997) nor one that is “blame-free” (Marx, 2005). Because

not all unsafe acts are systems related (Reason, 1997), errors must be examined carefully

in order to determine the causes. The context in which the act occurred must be examined

especially because; “the majority of unsafe acts” are considered “blameless” (Reason,

1997). Therefore, punishment is not indicated in the vast majority of unsafe acts;

however, a few situations may warrant sanctions, such as “malevolent” behavior (Reason,

1997).

A “flexible culture” fosters the ability to respond and adapt to changing situations.

The “learning culture” requires “observing,” “reflecting,” “creating” and “acting;”

(Reason, 1997 p. 218). Most importantly, the organization must implement what it has

14
learned (Reason, 1997). The “informed culture” is “one in which those who manage and

operate the system have current knowledge about the human, technical, organizational

and environmental factors that determine the safety of the system as a whole” (Reason,

1997, p. 195). Together, these attributes contribute to a culture of safety.

A culture of safety has also been defined by the Advisory Committee on Safety of

Nuclear Installations as:

the product of individual and group values, attitudes, perceptions, competencies

and patterns of behavior that determine the commitment to, and the style and

proficiency of, an organization’s health and safety management. Organizations

with a positive safety culture are characterized by communications founded on

mutual trust, by shared perceptions of the importance of safety, and by confidence

in the efficacy of preventive measures. (as cited in Nieva & Sorra, 2003, p. ii18)

A definition developed by Mary Lanning Memorial Hospital defines a culture of

safety, “as a pattern of behavior, both individual and organizational, and an underlying

philosophy that seeks to minimize hazards and harm to patients that result from the

processes of care” (Lindblad, Chilcott, & Rolls, 2004, p. 551).

For Singer et al. (2003), the culture of safety includes components contributing to

the greater good and encompasses the following:

• “commitment to safety articulated at the highest levels of the organization and

translated into shared values, beliefs and behavioral norms… ” (2003, p. 113)

• resources are made available to promote safety

• a top priority is safety

15
• there is open communication

• “unsafe acts are rare”

• errors and problems are reported

• “learning is valued; the response to a problem focuses on improving system

performance rather than on individual blame. (Singer et al., 2003, p. 113)

Another description of a culture of safety includes many of the components

identified by Singer et al., (2003) including the focus on systems and communication

issues:

• belief that harm is untenable

• ability to speak up when members have concerns

• obligation to listen when others have a concern

• recognition of personal and organizational hazards

• obligation to work as a team

• use of systems approach to analyzing safety issues…

• acceptance of responsibility for the system. (Paine, Baker, Rosenstein, &

Pronovost, 2004, p. 543)

There are different types of cultures described in the healthcare literature,

including both a culture of placing blame (Farquhar, Friesen, & Hughes, 2005; Hickam et

al., 2003; IOM, 2000, 2004a, 2004b; Larson, 2000; Reason, 2000, 2005) and a culture of

safety (Benner, 2001; Beyea, 2002; ECRI Institute, 2005; Friesen, Farquhar & Hughes,

2005; Hickam et al., 2003; Institute for Healthcare Improvement, 2005; IOM, 2004a,

2004b; Lindblad et al., 2004; Nieva & Sorra, 2003; Paine et al., 2004; Pizzi, Goldfarb, &

16
Nash, 2001; Pronovost, Weast, Hotzmueller, et al., 2003; Singer et al., 2003; Smetzer,

2007; Yates et al., 2005). Some of the characteristics seen in a culture of blame include

ineffective communication and a fear of reporting errors (Larson, 2000). The emphasis in

a culture of safety is prevention, whereas the emphasis in a culture of blame is

punishment (U.S. Department of Veterans Affairs National Patient Safety Center, 2006).

Leape noted there is a need to evolve away from a punitive response to errors and to

promote safety (1994).

Healthcare needs to move from a culture of blame to an organizational approach

that supports and fosters preventing errors (Barach, 2003; IOM, 2000, 2004). According

to Cohen, reporting can only happen when one can “feel safe doing so and it becomes

culturally accepted within the healthcare community” (2000, p. 729). Reporting errors is

also necessary in order to learn and prevent a reoccurrence (Leape, 2002). The culture of

safety as described by Reason (1997) fosters reporting errors. There are many initiatives

in progress to improve patient safety across the nation, but fundamental to meaningful

change and enhancing patient safety is the need for culture changes to promote safety in

patient care delivery and reduce the occurrence of errors (ECRI Institute, 2005; IOM,

2000, 2004a, 2007; Ruchlin, Dubbs, & Callahan, 2004).

Communication

A number of theories address the components of communication, including

theoretical conceptions related to the sender/receiver, the message, channel, decoding and

encoding (Buttle, 1995; Dayton & Henriksen, 2007; Shannon & Weaver, 1975). Berlo’s

theory of communication, being used in this research, identifies the components of the

17
communication process as the source, message, channel and receiver in the S-M-C-R

model (1960). Communication can occur through verbal, written or electronic

technology. But the “meaning” comes from people: “we cannot transfer or transmit

meanings. All we can do is encode messages intended to elicit the meanings we desire”

(Berlo, 1960, p. 188). This is the challenge in communication: The meaning received

may not be the meaning intended by the source. Both the receiver and source can be

influenced by communication skills, attitudes, knowledge, social system and culture

(Berlo, 1960). Both the source and receiver may be engaged in both encoding and

decoding during a dynamic communication process (Berlo, 1960). Communication is an

ongoing interdependent process. The message is the “physical product of the source-

encoder” (Berlo, p. 54). A message can be the spoken word, or written communication.

The ingredients of communication contribute to the complexity of the communication

process. Berlo’s model lends itself to the study of communication associated with

medication errors as it acknowledges the role of cultural influences on the message’s

source and receiver and numerous other factors. This model’s adaptability and relevance

become apparent in the qualitative analysis of the medication errors in this sample.

Source Message Channel Receiver


Communication Skills Content Hearing Communication Skills
Attitudes Elements Seeing Attitudes
Knowledge Treatments Touching Knowledge
Social System Structure Smelling Social System
Culture Code Testing Culture
Figure 3. Berlo’s S-M-C-R Model. Adapted from Berlo (1960).

18
Statement of Purpose

The purpose of this research project was to perform an analysis of medication

errors and to explore safe and unsafe communication processes within the narratives of

those errors. This research also explored the cultural attributes that emerge in reported

medication errors. The study’s focus was on identifying and understanding

communication issues that have contributed to an error and/or averted an error. An

analysis of incidents/errors reported to the Medication Error Reporting Program between

2002-2005 was conducted using the qualitative content analysis approach.

Research Questions

• Question 1: What are the patient outcomes in the medication errors reported in

this sample?

• Question 2: What are the communication issues that are identified in the

medication error reports?

• Question 3: What attributes supportive of a culture of safety are present in the

medication error reports?

• Question 4: What attributes not supportive of a culture of safety are present in

the medication error reports?

• Question 5: What types of interpersonal issues are evident in a review of the

medication error reports?

• Question 6: What “actions taken” and/or “recommendations” to address errors

are described in the medication error reports?

19
These questions focus on exploring the cause of medication errors using Reason’s

framework using a person approach and a systems approach to explain human errors, and

the communication issues associated with medication errors using Berlo’s Model of

Communication.

Definitions

Culture of Safety: The definition used in this study for a culture of safety is

adapted from several sources. It is a culture that promotes efforts to deliver safe patient

care through individuals, process and systems targeted toward reducing the risk of harm

in the delivery of care and enhancing safety (IOM, 2000, 2004a, 2004b, 2007; Lindblad

et al., 2004). The cultural attributes include a just culture, supportive leadership, adequate

resources, open communication, teamwork, focus on learning, reporting of errors and

striving for continuous improvements through synergy in an environment of trust (ECRI

Institute, 2005; IOM, 2000, 2004a, 2004b, 2007; Lindblad et al., 2004; Marx, 2001;

Nieva & Sorra, 2003; Paine et al., 2004; Reason, 1997; Singer et al., 2003; Smetzer,

2007).

Culture Not Supportive of Safety: A culture of blame is defined as a culture

focused on ignoring or punishing errors, rather than efforts to promote safety (Larson,

2000; Smetzer, 2007). A culture not supportive of safety includes the following

attributes: leadership not visibly supportive of safety initiatives, lacking necessary

resources, hierarchical and/or ineffective communication, fear of reporting and lack of

open discussion regarding errors (Friesen et al., 2005; IOM, 2004a; Reason, 1997).

20
Medication Errors: The National Coordinating Council for Medication Error

Reporting and Prevention (NCC MERP) definition was used for medication errors. The

medication error may occur at any point in the “medication use process”, which includes

“procurement prescribing, transcribing/documenting, dispensing, administering, or

monitoring” (Hicks, Becker, & Cousins, 2006b, p. 11).

A medication error is any preventable event that may cause or lead to

inappropriate medication use or patient harm while the medication is in the

control of the healthcare professional, patient, or consumer. Such events may be

related to professional practice, healthcare products, procedures, and systems

including prescribing; order communication; product labeling, packaging, and

nomenclature; compounding; dispensing; distribution; administration; education;

monitoring; and use. (National Coordinating Council for Medication Error

Reporting and Prevention [NCC MERP], n.d.)

Communication: The definition for communication related to medication errors is

“a cause of error” which “involves communication that is confusing, intimidating, or

lacking between staff, between hospital staff and patient/family, or between hospital staff

and another facility’s staff” (Hicks et al., 2004, p. 113).

A common definition of the word communicate is “to transmit, information

thought or feeling so that it is satisfactorily received or understood” (“Communicate,”

2007, p. 251). The term communication is defined as “a verbal or written message” “a

process by which information is exchanged between individuals through a common

system of symbols, signs, or behavior” (Communication 2007, p. 251). Communication

21
in this study will also include any process (verbal, non-verbal, electronic, telephonic,

written, handoff) that involves transmitting information related to the medication

utilization process involving healthcare providers and/or patient and family members.

Handoffs: Communication in the handoff process related to medication therapy

was also studied. It has been noted that several terms are used interchangeably for

handoffs, (Friesen, White, & Byers, 2008) the terms include: handovers (Australian

Council for Safety and Quality in Health Care, 2005), shift change (Hicks et al., 2004;

Santell et al., 2005), shift report (Hays, 2003; Lamond, 2000), patient transfer (Hicks et

al., 2004; Santell et al., 2005), sign-out (Frank, Lawler, Jackson, Steinberg, & Lawless,

2005; Petersen, Brennan, O’Neil, Cook, & Lee, 1994; Petersen, Orav, Teich, O’Neil, &

Brennan, 1998) and cross coverage (Hicks et al., 2004; Petersen et al., 1994; Santell et

al., 2005). The definition to be used in this research is “the transfer of information (along

with authority and responsibility) during transitions in care across the continuum; to

include the opportunity to ask question, clarify, and confirm” (Agency for Healthcare

Research and Quality, 2006b, p. 31).

Summary

Because medication errors are a threat to patient safety, efforts must continue to

reduce the incidence of medication errors. An analysis of reported medication errors may

provide information that would help lead to a better understanding of why such errors

occur and possible solutions to address conditions contributing to medication errors. The

purpose of this research was to explore communication and cultural issues associated

22
within a sample of medication errors reported between 2002 and 2005 to the Medication

Errors Reporting Program.

23
II. REVIEW OF THE LITERATURE

The literature review provides an overview of trends observed in the patient safety

movement related to medication errors. The IOM reported 7,000 deaths in 1993 related to

medication errors, based on an earlier study by Phillips and colleagues (IOM, 2000;

Phillips et al., 1998); a subsequent report cited 9,856 deaths in 1998 related to medication

prescription errors (Phillips & Bredder, 2002). The IOM also reported that medication

errors are “costly” (IOM, 2000) and pose a threat to the public (IOM, 2000, 2007).

A leading root cause of medication errors reported to the Joint Commission is

communication (Joint Commission, 2007g). In recognition of the threat posed to patient

safety by faulty communication, the Joint Commission has promulgated patient safety goals

that address communication in delivering safe patient care (Joint Commission, 2007a, 2007f).

Both medication errors and related communication factors pose a threat to patient safety.

A literature search was undertaken in the following databases: MEDLINE,

PUBMED, Cumulative Index of Nursing and Allied Health Literature (CINAHL), Pre-

CINAHL, EMBASE, PsychoINFO, Communication Abstracts, Communication and Mass

Media, Digital Dissertations, and PSNET. The search for topics encompassed

communications, handoffs, patient safety and medication errors. Additionally, references in

retrieved articles were obtained and reviewed when applicable.

24
This literature review addressing medication errors and communication is composed

of two parts, each divided into several sections.

Medication Errors and Patient Safety includes:

• Frequency of Medication Errors

• Harmful Outcomes of Medication Errors

• Costs of Medication Errors

• Causes of Medication Errors

• Types of Errors by Stage

• Medication Errors and Nurse Staffing

• Reporting of Errors

• Barriers to Reporting Errors

• Medication Errors and Communication

• Medication Errors and Handoffs

• Reaction to Medication Errors.

Communication and Patient Safety includes:

• Communication Among Healthcare Team Members

• Communication Interruptions and Distractions

• Communication and Handoffs

• Communication and Technology

• Communication and Verbal Interaction

• Communication and Intimidation and Disruptive Behavior

• Communication Disruption.

25
Medication Errors and Patient Safety

The IOM reported that “medication errors account for 1 out of 131 outpatient

deaths and one out of 854 inpatient deaths” (IOM, 2000, p. 27). A subsequent report

indicated: “on average, a hospital patient is subject to at least one medication error per

day” (IOM, 2007, p. 1). Numerous efforts have been undertaken to detect medication

errors, including observation, chart review and self report (Barker, Flynn, Pepper, Bates,

& Mikeal, 2002; Barker & McConnell, 1962; IOM, 2007; Leape et al., 1995; VHA,

2002). Hospitals are a frequent setting for medication error studies, with less research

focused on nursing homes and ambulatory care settings (IOM, 2007). Nurses are often

the last line of defense in drug administration. In one study, nurses were found

“responsible for 86 percent of interceptions” related to medication errors (Leape et al.,

1995, p. 37).

Frequency of Medication Errors

Although healthcare providers have long recognized the adverse consequences of

medication errors, one problem is quantifying the numbers associated with such errors.

Various methods have been used to assess the frequency of medication errors (IOM,

2007), and the variance in methods and results is illustrated in the following review of

medication error studies.

Barker and McConnell (1962) designed a study incorporating three methods to

identify errors: observation (a pharmacy intern observed nurses administering

medication), a self-report process (questionnaire and anonymous reporting of medication

errors using a specially designed form) and review of hospital records. The researchers

26
observed “one error for every six medications given” (Barker & McConnell, p. 368). The

researchers estimated an occurrence of 51,200 medication errors—even though there

were only 36 medication errors documented by incident report for the year studied.

Taxis and Barber focused on intravenous medication errors using an observation

method and found 249 errors related to 430 doses (2003b), as well as 265 errors observed

in 483 drug preparations and 447 medication administrations (2003a). Allan and Barker’s

analysis of 18 medication error studies conducted between 1975-1987, which had several

objectives including examining the “validity of medication error studies” (1990, p. 556),

found a wide range in the quality of the studies themselves, and the error rates reported

ranged from 0.4 to 24.7% (excluding wrong time errors). Medication errors were termed

as a problem that “continues to haunt health-care professionals” (Allan & Barker, 1990,

p. 568) and the authors called for additional study focused on preventing errors. A study

of 36 healthcare organizations reported an average medication error rate of 19% related

to doses (Barker et al., 2002).

Fortescue et al.’s study (2003) focused on pediatric patients reported that

medication errors occurred in 31% of the patients. A total of 616 errors out of 10,788

medication orders were identified; 120 of these errors were considered “potentially

harmful” (Fortescue et al. p. 725). Of particular relevance to this research project is the

fact that Fortescue et al. identified three interventions that could have potentially

prevented harmful medication errors: using computerized physician order entry (CPOE)

with clinical decision support, unit-based clinical pharmacists and “improved

communication” among healthcare providers. A retrospective study undertaken by

27
Cowley, Willams, and Cousins (2001) examined medication errors in pediatric patients

using both the Medication Error Reporting (MER) Program data and MEDMARX. The

study reported the most common type of error for MER Program data was “improper

dose/quantity” and for MEDMARX was “omission” and “improper dose/quantity.”

(Cowley, Williams, & Cousins, 2001, p. 632). The most frequently identified medication

product involved in errors in this study were intravenous fluids (Cowley et al., 2001). A

later study of MEDMARX data focused on children found the most frequent error

reported was “improper dose/quantity” followed by “omission errors” (Hicks, Becker, &

Cousins, 2006a, p. 295), with the type of medication reported in the harmful errors being

opioid (11.5%), anti-microbial (7.5%) and insulin (4.5%).

In a study of errors made by nurses, Ballas, Scott, and Rogers (2004) found that

the most common type of error was medication errors, accounting for 58% of errors and

59% of “near errors.” Medication errors emerged as the most frequent type of errors in a

study at a 500-bed hospital over a six-month period (Nordgren, Johnson, Kirschbaum, &

Peterson, 2004). A study of 29 rural hospitals focusing on identifying medical errors

found medication errors to be most common type of medical error (Cook, Hoas,

Guttmannova, & Joyner, 2004).

In summary, the frequency of medication errors is difficult to grasp given the

wide range of rates reported in the literature. The reasons for this wide variance include

different methods used to define and identify errors, and differences in settings, among

other factors (IOM, 2007). However measured, the IOM concludes the medication errors

are “at unacceptably high levels” (IOM, 2007, p. 400).

28
Harmful Outcomes of Medication Errors

As studies have reported different rates of the occurrence of medication errors,

there are also differences in the rates of harm reported as associated with medication

errors. Medication errors associated with potential harm occurred in 7% of the errors in a

study of 36 healthcare organizations (Barker et al., 2002). MEDMARX data, which

included a total of 1,002,972 medication errors from 2001 to 2005, indicated 1.5 % of

medication errors were categorized as harmful, including fatalities; within that 1.5% of

the harmful errors, 0.6% were categorized as fatal (Hicks et al., 2006b). Reports indicate

the deaths related to medication error have increased nationwide (Phillips & Bredder,

2002). In 1983 there were in 2,876 deaths, but 7,391 in 1993 (Phillips et al., 1998).

Deaths related to medication prescription errors were 9,856 in 1998 (Phillips & Bredder,

2002).

Costs of Medication Errors

There is substantially less research on the costs associated with medication errors

than the frequency of such errors (IOM, 2007). The total cost for a preventable hospital

adverse drug event was reported to be $5,857 (Bates et al., 1997). A study of a healthcare

network that included four hospitals reported preventable adverse drug events projected

at an annual cost of $257,000 for such events (Senst et al., 2001). It is estimated the cost

of hospital preventable adverse drug events was “$3.5 billion in 2006 dollars” (IOM,

2007, p. 5).

29
Causes of Medication Errors

Many causes of medication errors have been identified. One of the most

significant studies identified 16 systems failures related to medication errors (Leape et al.,

1995), with the most frequent proximal cause “lack of knowledge of the drug” in 22% of

errors followed by “lack of information about the patient” in 14% of errors. The Institute

for Safe Medication Practices (ISMP) has delineated 10 major system elements that cause

medication errors:

1. Lack of information about the patient,

2. Lack of information about the drug,

3. Communication and teamwork failures,

4. Unclear, absent or look-alike drug labels and packages, and confusing or look-

alike or sound-alike drug names,

5. Unsafe drug standardization, storage, and distribution,

6. Nonstandard, flawed, or unsafe medication delivery devices,

7. Environmental factors and staffing patterns that do not support safety,

8. Inadequate staff orientation, ongoing education, supervision, and competency

validation,

9. Inadequate patient education about medications and medication errors, and

10. Lack of a supportive culture of safety, failure to learn from mistakes, and

failed or absent error-reduction strategies, such as redundancies. (Cohen,

2007b, p. 58)

30
The top 12 causes of errors for calendar year 2005 based on the USP MEDMARX

data are: “performance deficit,” “procedures/protocols not followed,” “computer entry,”

“communication,” “transcription inaccurate/omitted,” “knowledge deficit,”

“documentation,” “computerized physician order entry,” “written order,” “workflow

disruptions,” “abbreviations” and “monitoring inadequate/lacking” (Hicks et al., 2006b,

p. 150).

Types of Error by Stage

There are various phases or stages in which medication errors occur. According to

Bates and colleagues the stages are ordering, transcription, dispensing and administering

(1995). Danish researchers Lisby, Nielsen, and Mainz described five stages; ordering,

transcription, dispensing, administering and discharge summaries (2005). The USP

identifies the phases as procurement, prescribing, transcribing, documenting, dispensing,

administering and monitoring (Hicks, Becker & Cousins 2006b).

The most frequent stage identified in two studies was the ordering stage in 49% of

errors studied (Bates et al., 1995) and in 39% of errors (Leape et al., 1995). Ordering was

followed by errors in the administering stage of 38% (Leape et al., 1995) and 26% (Bates

et al., 1995). Seventy-one percent of errors implicated in preventable adverse drug events

in a New Mexico study were related to prescribing (Senst et al., 2001). Another study

found the discharge summary had a 76% medication error frequency (Lisby, Nielsen, &

Mainz , 2005). Data for 2003 released by the United States Pharmacopeia indicates the

most frequent stage is “administering,” followed by “prescribing” and “transcribing”

(Hicks et al., 2004). A study of errors involving pediatric patients identified the most

31
failures in physician ordering (78%), followed by administration (12.8%) (Fortescue et

al., 2003).

Medication Errors and Nurse Staffing

Several studies have been conducted exploring relationships between nurse

staffing and patient outcomes (Blegen, Goode, & Reed, 1998; Blegen & Vaughn, 1998).

Nursing units with more experienced nurses were found to have lower medication error

rates but units with a higher proportion of bachelor’s degree-level prepared nurses had

higher rates (Blegen, Vaughn, & Goode, 2001). A question raised by these findings is

whether there really are more errors with increased nursing education—or is there more

accurate reporting of errors (Blegen et al., 2001). Further studies will need to assess

whether the actual rates of errors increases or the reported rate of errors increases.

Reporting of Errors

Reporting of errors is an important strategy to improve patient safety, as lessons

can be learned from errors (IOM, 2000, 2004b, 2007; Leape, 2002). One reason not all

errors are reported is disagreement on how errors are defined, which can hinder reporting

(Tamuz, Thomas, & Franchois, 2004). There is also disagreement regarding

categorization of errors: “what some consider error, others may simply consider business

as usual” (VanGeest & Cummins, 2003, p. 8).

The benefits of reporting are illustrated in a study focused on errors involving

administering neuromuscular blockers (Mohseni & Wong, 1998). A review of the

contributors to the errors identified system weaknesses, knowledge, and performance

deficits. The reporting process allowed some of the problems related to neuromuscular

32
medications to be identified and, therefore, encouraged developing recommendations to

decrease such errors (Mohseni & Wong, 1998). Reporting errors on a national basis has

contributed to enhanced understanding about causes or medication errors among

healthcare providers (Santell, 2005). The national reporting of errors also affords the

opportunity to develop actions to address problems and improve patient safety related to

medication administration (Santell, 2005).

Barriers to Reporting Errors

Despite the benefits in terms of patient safety, there has been an historical

reluctance to report errors of any type in healthcare (Leape, 2002). There has been a long

standing code of silence related to reporting errors “the prevailing ethic noted in the

ancient texts was not to disclose error to the patient” (Gibson & Singh, 2003, p. 135).

Reporting medical errors is problematic from a number of perspectives (IOM,

2000), Nurses report the code of silence as being a barrier; both physicians and nurses

indicated errors may go unreported because reporting errors does not inevitably result in

change (VanGeest & Cummins, 2003). A number of barriers were explored by Barach

and Small (2000), including legal, cultural (code of silence), regulatory, and financial

issues from the individual, organizational, and societal perspective. Physicians face

numerous barriers in disclosing errors such as fear of reaction from peers and being

perceived as being incompetent (Hevia & Hobgood, 2003), and impact on reputation

(Wu, 1999).

There are many reasons medication errors are not reported (Gladstone, 1995;

IOM, 2007; Mayo & Duncan, 2004; Osborne, Blais, & Hayes, 1999; Wakefield,

33
Wakefield, Uden-Holman, & Blegen, 1996; Wakefield, Wakefield, Uden-Holman,

Borders, & Blegen, 1999b). Identified barriers include administrative response, fear,

disagreement over error, and reporting effort (Wakefield et al., 1996; Wakefield et al.,

1999b).

The underreporting of medication errors is acknowledged in various studies. In a

study comparing survey results of nurses and complete incident reports, only 30% of the

medication errors identified were documented via a written report (Antonow, Smith, &

Silver, 2000). A Florida study of 57 nurses found 73.7% of hospital nurses surveyed

estimated medication administration errors were reported less than 50% of the time

(Osborne et al., 1999). Bulla’s sample of 111 hospital-based nurses found only 7.7% of

certified nurses and 5.6% of non-certified nurses perceive that 100% of medication

administration errors are reported (2003). A California study of 983 nurses reported “less

than half of the nurses” surveyed perceive that all medication errors are reported via “an

incident report”(Mayo & Duncan, 2004, p. 214). Two Iowa surveys of 1384 nurses in

1994 and 1428 nurses in 1996 found about 60% of medication administration errors are

thought to be reported (Wakefield et al., 1999a). A study of 775 nurses found 36% “failed

to report one or more medication error because I thought reporting an error would be

personally or professionally damaging” (Cohen, Robinson, & Mandrack, 2003, p. 38).

Four studies of nurses practicing in the United States (Bulla, 2003; Mayo &

Duncan, 2004; Osborne et al., 1999; Ulanimo, O'Leary-Kelley, & Connolly, 2007) used a

modified Gladstone survey to assess nurses’ perceptions of medication errors and provide

34
insight into barriers to reporting. Several of the studies’ survey statements and results are

compared in this review:

1. Some medications are not reported because nurses are afraid of the reaction

they will receive from the nurse manager or coworkers (Bulla, 2003; Osborne

et al., 1999). Two studies separated this statement into two questions

regarding nurse manager and coworkers (Mayo & Duncan, 2004; Ulanimo et

al., 2007).

2. Have you ever failed to report a medication error because you did not think

the error was serious enough to warrant reporting (Bulla, 2003; Mayo &

Duncan, 2004; Osborne et al., 1999; Ulanimo et al., 2007).

3. Have you ever failed to report a medication error because you were afraid that

you might be subject to disciplinary action or even lose your job (Bulla, 2003;

Mayo & Duncan, 2004; Osborne et al., 1999; Ulanimo et al., 2007)

Each surveys’ results for these questions are delineated in Table 1.

35
Table 1

Comparison of Barriers to Reporting by Nurses


Osborne Bulla Bulla Mayo Ulanimo Range
et al. (2003) (2003) and et al.
(1999) Certified Non- Duncan (2007)
Nurses Certified (2004)
Nurses
Number of 57 39 72 983 25 25-983
Nurses
Response to n % n % n % n % n % %
Statement = Yes
Fear of Reaction 49 86 32 82 61 84 * * * * 82-86
From Nurse
Manager or
Coworkers
Fear of Reaction * * * * * * 737 77 * 64 64-77
From Manager
Fear of Reaction * * * * * * 590 61 * 60 60-61
From Peers
Not Serious 33 58 18 46 36 50 509 53 * 36 36-58
Fear of 14 25 5 13 7 10 190 20 * 16 10-25
Disciplinary
Action
Note. * = not reported.

Thirty-six to 58% of nurses indicated they did not report an error because it was

not serious enough to warrant reporting. Ten to 25% of nurses indicated they did not

report an error because of fear of disciplinary action.

In another study potential barriers to reporting medication errors were studied and

four subscales emerged: disagreement over error, reporting effort, administrative

response, and fear (Wakefield et al., 1999b). Gibson (2001) criticized earlier medication

reporting systems that emphasized actions directed at the nurse. Errors were tracked by

points and if the nurse accumulated a certain amount of points, corrective actions were

36
initiated—up to and including termination. This paradigm promotes a “blame” mentality

and “good nurse” versus “bad nurse” mentality (Gibson, 2001), which detracts from a

systems approach to addressing errors and focuses blame on the individual nurse.

There are serious implications for studying medication errors. If it is perceived

that reporting is not a valued activity and, in fact, is perceived as being risky due to fear

of a punitive response, healthcare providers will continue to be reluctant to report errors

(Cohen, 2000). Any related opportunities to improve patient care will remain

undiscovered (Leape, 2002). Healthcare can learn from the aviation industry to promote

reporting of errors (Leape, 1994). The Aviation Safety Reporting System (ASRS) was

started in 1975 to promote aviation safety by encouraging reporting of incidents,

analyzing such incidents and allowing them to be addressed (Aviation Safety Reporting

System, 2006). The ASRS reports there have been over 600,000 reports received without

a “breach” in identity of the person reporting the incident (2006). This type of incident

reporting system promotes reporting of near misses and problems because the fear

associated with reporting is removed. One example of a healthcare organization that uses

a system based on the Aviation Safety Reporting System (ASRS), Children's Hospitals

and Clinics of Minnesota (2006) encourages reporting of errors through several methods,

including paper, phone or online. The reports are reviewed, de-identified and distributed

to content experts and safety action teams which are “department-based safety groups”

(Children's Hospitals and Clinics of Minnesota, 2006, p. 28). Lessons learned are shared

with others to enhance patient safety (Children's Hospitals and Clinics of Minnesota,

2006).

37
Medication Errors and Communication

A study focused on medication variances used qualitative analysis to enhance

patient safety and “provide information not available from the quantitative data” (Krol,

Stump, Collins, Roumanis, & Radford, 2002, p. 317). The qualitative method allowed the

researchers to identify “domains” that might not have been identified otherwise. One

example of an identified domain was communication, “which repeatedly surfaced…as a

cause of different variances” (Krol et al., 2002, p. 320). The quantitative approach did not

allow communication to be as easily identified as a cause of medication variance while

the qualitative approach allowed the yielding of additional valuable information related to

communication (Krol et al., 2002). Additionally, qualitative analysis of medication

variance reports allowed the researchers to ascertain root causes and help to “move on to

problem solving” (Krol et al., 2002, p. 321).

The USP has identified a number of causes of error, including the top 10 for

medication errors reported in 2004 being performance deficit, procedure not followed,

documentation, computer entry, transcription, communication, knowledge deficit,

abbreviations, written orders and computerized order entry order and abbreviations

(Santell et al., 2005). Many of the causes of error are related to the transmission of

information (communication) such as: transcription errors, computer entry,

documentation, written order, abbreviations, computerized order entry and illegible

handwriting. A qualitative study conducted on transmission of information related to

medications identified a number of issues with admission orders, discharge medication

instructions and inadequate communication among providers (Bayley, Savitz, Rodriguez,

38
Gillanders & Stoner, 2005). It has been noted that patients who have received counseling

on medications are reported to have enhanced compliance with medications as compared

with patients who did not receive such counseling (Smith et al., 1997).

Medication Errors and Handoffs

A specific type of communication issue involves handoffs such as transfers, shift

change and cross coverage (Friesen, White, & Byers, 2008). Handoffs clearly present

many challenges to healthcare providers and potential threats to patient safety (Beach,

Croskerry, & Shapiro, 2003; Friesen, White & Byers, 2008; Gandhi, 2005; Institute for

Safe Medication Practices [ISMP], 2005a; Joint Commission Resources, 2007; Wachter

& Shojania, 2004).

Handoffs have emerged as a contributor to medication errors across the care

continuum (ISMP, 2005a; Santell et al., 2005, USP, 2005a). The dangers of medication

errors related to handoffs have been observed when patients are discharged from

hospitals (Boockvar et al., 2004; Forster, Murff, Peterson, Gandhi, & Bates, 2003; Murff

& Bates, 2001). Rozich and Resar (2001) reported that 60% of medication errors in one

study occurred during transfers and transitions or “interfaces of care” (p. 28).

A type of error linked to handoffs is medication reconciliation errors. Medication

reconciliation is defined as: “a process of identifying the most accurate list of all

medications a patient is taking—including name, dosage, frequency, and route—and

using this list to provide correct medications for patients anywhere within the health care

system” (Midlefort, n.d.). According to one study the majority of medication

reconciliation errors occur during handoffs (United States Pharmacopeia [USP], 2005a).

39
Another report indicates that up to half of all medication errors are related to

communication issues during transition in care (Institute for Healthcare Improvement,

n.d.a).

The Joint Commission has developed patient safety goals to address medication

reconciliation errors and promote patient safety (Joint Commission, 2007a), and patient

safety goal number eight specifically states that healthcare organizations “accurately and

completely reconcile medications across the continuum of care”(Joint Commission,

2007a). Other organizations have also identified strategies to reduce the risk of a handoff

medication error (Institute for Safe Medication Practices, 2005a; Massachusetts Coalition

for the Prevention of Medical Errors, 2005; Pronovost, Weast, Schwarz, et al., 2003;

United States Pharmacopeia, 2005a; WHO Collaborating Centre for Patient Safety

Solutions 2007a).

Reaction to Medication Errors

The reactions of healthcare providers to medication errors have been reported and

commonalties have been noted in the literature. A study of 402 physicians, nurses and

pharmacists found that healthcare providers reported the following as the “highest ranked

responses” to making a medication error: feeling “guilty,” “worried,” “nervous” (Wolf,

Serembus, Smetzer, Cohen, & Cohen, 2000, p. 281). Other responses included feeling

“embarrassed,” “hypervigilant,” “fearful,” “sad” and “shock” (Wolf et al., 2000, p. 283).

The two top ranked concerns of the healthcare providers regarding medication errors

were “fear for [the] patient” and “fear of disciplinary actions” (Wolf et al., 2000, p. 283).

In a qualitative study of two healthcare providers who made fatal medication errors, the

40
terms “it haunted me every day” (p. 48) and “dying of guilt” (p. 49) were used to describe

their experience (Wolf, 2007). Even though in both cases there were multiple contributors

to the errors. Another study of 11 healthcare providers involved in fatal errors described

an array of emotions including guilt and depression (Serembus, Wolf, & Youngblood,

2001). Another account of a fatal error describes the nurses’ reaction in terms of

“psychological trauma” (Golz & Fitchett, 1999). Other studies have described nurses

suffering emotional consequences in response to errors (Arndt, 1994; Meurier, Vincent,

& Parmar, 1997; Spears, 2002). In three studies learning from errors emerged from the

descriptions provided by the nurses (Arndt, 1994; Meurier et al., 1997; Spears, 2002).

Communication and Patient Safety

With communication being a leading root cause of medication errors (Joint

Commission, 2007g) it is imperative that communication process among healthcare

providers be explored and understood. A review of studies focusing on communication

issues is presented to inform the reader of the complexity and nuances of communication

with the healthcare system.

Communication Among Healthcare Team Members

Communication among members of the healthcare team is often in disarray, as

many of the studies and reports in the literature attest. Ineffective communication

processes can impact negatively on patient care and increase the risk of medication

errors. The following review of related literature presents an overview of communication

issues impacting patient safety negatively, followed by an examination of communication

issues and medication errors.

41
The problems of communication and patient safety have been documented for

decades. An article in the American Journal of Nursing in 1939 is remarkable in that this

narrative is still applicable today in some healthcare settings.

Nurses are in a peculiar and often difficult situation in carrying out the orders of

physicians. Friction may arise where it could be avoided if both nurses and

doctors would remember that the only thing which really matters is the welfare of

the patient and not that one group gives and the other carries out orders. Nurses

and doctors are not always so tactful and discreet in their daily relations as they

ought to be (Faddis, 1939, p. 1219).

More recently, a “Patient Safety Culture and Teamwork Survey” was sent to 466

nurses; with a 56% response rate. The 261 nurses’ survey results revealed that 99.6% of

those responding “believed good communication and coordination among team members

were as important as technical proficiency for patient safety”(Kaissi, Johnson, &

Kirschbaum, 2003, p. 214. A detailed case analysis of the wrong patient undergoing an

invasive procedure revealed multiple errors that contributed to the event, and it was noted

“the most striking feature of this case…is the frighteningly poor communication it

exemplifies” (Chassin & Becher, 2002, p. 829). As the authors describe, the “physicians

failed to communicate with nurses, attendings failed to communicate with residents and

fellows, staff from one unit failed to communicate with those from others, no one listened

carefully to the patient” (Chassin & Becher, 2002,p. 829-830).

A survey of 156 German healthcare providers (including surgeons,

anesthesiologists, surgical nurses, anesthesia nurses) included open-ended questions; “the

42
majority of comments stressed the need for better communication and team coordination”

(Helmreich & Schaefer, 1994, p. 240). A study of nurses, using a focus group

methodology, found that a commonly cited characteristic of unhealthy work

environments was poor communication (Heath, Johanson, & Blake, 2004). In a study of

75 reported errors by 18 physicians, communication problems were found to contribute to

63% of the reported incidents (Woolf, Kuzel, Dovey, & Phillips, 2004).

Research on 26 physicians who reported “70 mishaps” identified physician and

nurse communication issues in addition to physician-to-physician communications issues

(Sutcliffe et al., 2004). The use of written orders is standard in hospitals but was found to

be problematic in this study, as delays in treatment resulted if the orders on the patient’s

chart were “missed.” The importance of the type of communication between nurses and

physicians also has implications for patient care. The study found both individual and

systemic barriers to communication, recommended improvement in communication

processes, and suggested adopting a method used by the U.S. Forest Service:

• Situation: Here’s what I think we face;

• Task: Here is what I think we should do;

• Intent: Here’s why;

• Concern: Here’s is what we should keep our eye on;

• Calibrate: Now talk to me. Tell me if you don’t understand, cannot do it, or

see something I do not. (Sutcliffe et al., 2004, p. 193)

The researchers emphasize it is not easy to correct communication problems because they

involve more than just “faulty transfer of information” (Sutcliffe et al., 2004. p.194).

43
Beyea noted that one of the problems in healthcare is that healthcare providers “receive

little education on how to communicate with each other” (2004, p. 1053). Physicians and

nurses communicate differently, nurses tend to be more descriptive and “paint the big

picture” and physicians are more “concise” (Leonard et al., 2004, p. i86). Kaiser

Permanente has embarked on efforts to improve patient safety such as undertaking a key

strategy in improving communication among healthcare providers based on a technique

adapted from the U.S. Navy (Institute for Healthcare Improvement, n.d.b; McFerran,

Nunes, Pucci, & Zuniga, 2005). This technique is dependent on the context and

environment to be successful. To that end, Kaiser has rolled out an interdisciplinary

education program that includes assertion techniques which need to be used with this

model to assure both sender and receiver (for example, doctor and nurse) are actively

engaged in the communication process (McFerran et al., 2005). The Situation,

Background, Assessment, Recommendation (SBAR) model promotes communicating in

a structured manner, and helps share common “critical language” that alerts team

members to situations requiring immediate response (Institute for Healthcare

Improvement n.d.b; Leonard et al., 2004). After adopting strategies to enhance

communication between healthcare providers, various improvements were noted—

including an increase in correct medications when patients transferred from one

healthcare setting to another (Leonard et al., 2004).

A study entitled “Silence Kills” underscores the role of communication related to

avoidable medical errors (Maxfield, Grenny, McMillan, & Patterson, 2005). As noted

earlier, other industries such as aviation have recognized the importance of

44
communication, and have correspondingly placed a great emphasis on team management,

crew resource management, and communication processes (Grogan et al., 2004)—lessons

that could be used in healthcare (Grogan et al., 2004; Rivers, Swain, & Nixon, 2003).

In an effort to educate healthcare providers and organizations about developing

and sustaining efforts among team members the Department of Defense and Agency for

Healthcare Research and Quality disseminated TeamSTEPPS (Agency for Healthcare

Research and Quality, 2006a). TeamSTEPPS are strategies and tools to enhance

performance and patient safety. The multimedia TeamSTEPPS™ program offers

evidence-based teamwork strategies to improve patient care by enhancing

communication among healthcare providers, and seeks to educate healthcare providers

regarding leadership, communication and other teamwork skills to enhance patient safety

(Department of Defense Patient Safety Program, 2007). The program’s scenarios address

many situations encountered in healthcare including strategies to improve communication

among healthcare providers to decrease the risk of medical errors including medication

errors.

Communication Interruptions and Distractions

Interruptions and distractions can disrupt the workflow of healthcare providers

involved in providing medication therapy to patients and contribute to medication errors.

Distractions were ranked as the most common contributing factor (45%) to medication

errors from 1999-2003 by the USP MEDMARX program (Hicks et al., 2004). The

MEDMARX program is an “internet-accessible medication error reporting program

operated by the US Pharmacopeia that complements quality improvement activities at the

45
local and national levels. MEDMARX is available through a subscription service ”

(Hicks et al., 2006b, p. 160).

Interruptions are frequent in the healthcare environment. One study reported an

interruptions rate of 11.15 per hour for healthcare providers (Coiera, Jayasuriya, Hardy,

Bannan, & Thorpe, 2002). Another study reported an interruption rate of 15 per hour

(Spencer, Coiera, & Logan, 2004). Thus, the impact of interruptions on patient care needs

to be considered when examining healthcare intervention—particularly related to

medication therapy, as this is a potentially high risk activity if the work flow is

interrupted. “The combination of multitasking and interruption may be a potent cocktail

and a potential source of error” (Coiera et al., 2002, p. 417).

One study on interruptions during medication administration used protocols based

on aviation practices in the process of medication administration (Pape, 2003). Two

protocols were tested, each including at least 12 interventions (for example, not allowing

interruptions), and using the seven rights of medication administration. One protocol of

the two protocols included wearing a Medsafe vest by the nurse administering

medications to alert others not to interrupt that nurse. Results indicated a decrease in

interruptions using the protocols as compared with the control group (Pape, 2003).

Communication and Handoffs

From a nursing perspective there is a tremendous exposure for handoff risks in

today’s healthcare environment (Friesen, White & Byers, 2008); it has been reported that

“nursing units transfer or discharge 40 - 70% of their patients each day” (Hendrich, Fay,

& Sorrells, 2004, p. 36). Additionally, handoffs occur during shift changes, and the

46
omission of information and shift reports that are not congruent with the patient’s

condition have been observed (Richard, 1988). A qualitative study of novice RNs

involved in a near miss or adverse event found that nine themes emerged, and seven

themes occurred in seven of the eight cases studied. One of the seven themes involved

communication in handoffs between healthcare providers, specifically incomplete or

confusing information (Ebright, Urden, Patterson, & Chalko, 2004).

Pothier, Monteiro, Mooktiar, & Shaw, studied several methods for conducting

nursing handoffs (2005). For instance, using pre-printed sheets populated with patient

information and a verbal report were associated with retention of 96 - 100% of data

compared with a retention of 0 - 26% using a verbal-only handoff (Pothier, Monteiro,

Mooktiar, & Shaw, 2005). A study of handoffs in high risk settings reported on a variety

of communication strategies used in handoffs (Patterson, Roth, Woods, Chow & Gomes,

2004). This information may have implications for handoffs in healthcare related to

medication errors and patient safety.

Communication and Technology

As technology is used in the process of communication related to medication

therapy, a brief literature review regarding technology and medication errors was

conducted. Adopting technology to reduce medication errors has been recommended

(Bates et al., 1998; IOM, 2007) to reduce the occurrence of medication errors related to

transmitting information. Studies support the benefits of technology to improve patient

safety (Evans et al., 1998; IOM, 2007; Upperman et al., 2005). In one study, after

47
implementing computerized physician order entry (CPOE), elimination of transcription

errors was reported (Upperman, et al., 2005).

However, recent studies have also found that the CPOE is associated with other

types of errors (IOM, 2007). One study linked 22 other types of medication error risks

(for example, loss of data, loss of orders, wrong medication selections) to the CPOE’s

design—and actually implicated the CPOE in the “facilitation” of some medication errors

(Koppel et al., 2005). In another study the mortality rate increased after CPOE was

implemented (Han et al., 2005).

Using technology, then, is recommended, but deploying adequate resources is

also necessary to assure safe patient care (IOM, 2007). A consensus statement of experts

regarding successful implementation of CPOE cautions healthcare provides there are

major areas which must be considered and addressed if CPOE is to be successfully

implemented (Ash, Stavri, & Kuperman, 2003). The literature indicates, technology holds

many promises for improving the delivery of care and reducing medication errors, but it

must be implemented carefully with input from healthcare providers if the technology is

to be effectively and safely deployed.

Communication and Verbal Interaction

Many of the oral or verbal communication processes between nurses and doctors

have, historically, contributed to communication failure. As a nurse wrote in 1939 about

doctors and verbal orders, in an article on medication errors, “You insist upon our taking

verbal orders when we are taught not to do so” (Faddis, p. 1219). In recent times the use

of verbal orders has “been a way of life” (Paparella, 2004, p. 157). But verbal orders can

48
be problematic, and many factors increase the risks associated with verbal orders (ISMP,

2005b; Paparella, 2004) including pronunciations, distractions, misinterpretation and

sound-alike drug names (ISMP, 2001, 2005b). The Joint Commission has developed

patient safety goals related to verbal orders to improve the quality of care and urges

practitioners to implement safeguards when using verbal orders such a “read-back” of the

order (Joint Commission, 2007a).

An Israeli study conducted on medical errors in a critical care unit included

medication errors (administration of wrong dose of medication, order to administer via

incorrect route). Verbal communication between physician and nurses occurred in just

2% of all activity studied by the researchers; however, 37% of the medical errors in the

unit were related to physician-nurse communication (Donchin et al., 1995). The literature

demonstrates that there are concerns with verbal orders and communication among

healthcare providers. Messages may not be received and understood by the receiver as the

sender intended. The problems described related to verbal communication, such as a

verbal order, can be a cause of a medication error.

Communication, Intimidation and Disruptive Behavior

Intimidation can potentially contribute to communication breakdown and impact

adversely on patient safety (ISMP, 2004). In a study of 2,095 healthcare providers, 49%

modified their communication regarding medication therapy due to intimidation, and

75% sought clarification of a medication order with another healthcare professional in an

effort to avoid interacting with the intimidating prescriber (ISMP, 2004).

49
In a study of 1,091 Registered Nurses, 402 physicians and 16 administrators to

examine disruptive behavior and its impact on clinicians and clinical outcomes, 60% of

respondents were aware of potential adverse events that could have occurred from

disruptive behavior, and “17% knew of an adverse event that occurred as a result of

disruptive behavior” (Rosenstein & O’Daniel, 2005, p. 61).

The literature indicates disruptive behaviors such as intimidation can contribute to

patient safety risks and this in turn has implications related to medication errors. For

example, if a healthcare provider is reluctant to approach and clarify a medication order

with a prescriber, the patient may suffer because the order was not verified.

Communication Disruption

The complexity of the present healthcare environment poses many dangers to the

accurate transmission of information and patient safety (Anthony & Preuss, 2002).

Contributors to communication disruption include both information decay and funneling

(Anthony & Preuss, 2002). Decay of information occurs when information is superseded

by more current information; for example, the patient’s vital signs are dynamic and may

change significantly during an episode of care (Anthony & Preuss, 2002). Funneling is

“progressive loss of information” (Anthony & Preuss, 2002, p. 211), as reflected by

omission or loss of information when the patient is transferred from one healthcare

provider to another. A patient may be admitted to the hospital and the medication

regimen changed, but information about the medication change is not communicated

(funneled) when the patient was transferred—and a medication errors results. There is a

paradox in the present healthcare delivery system as “the demand for accurate and timely

50
information has increased, the likelihood that this same information is fragmented across

care providers has also increased” (Anthony & Preuss, 2002, p. 209).

Summary

This literature review presented an overview of selected topics related to

medication errors and communication processes. While not exhaustive, its purpose was to

provide the background and context in which this research was conducted. The review

demonstrated that medication errors are a threat to patient safety both in human and

financial terms. There are a number of contributors to medication errors, but

communication is the leading root cause of medication error sentinel events. It is difficult

to gauge the actual number of medication errors that occur as not all errors are reported.

There are many barriers to reporting medication errors, including healthcare providers

who may be reluctant to report errors due a fear of reporting and/or the consequences of

admitting an error. Reactions of healthcare providers to the commission of a medication

error have been reported to include feelings of fear, worry, guilt and embarrassment

among other emotional responses.

The literature indicates communication processes in healthcare are extremely

complex, and effective communication skills are essential to provide safe patient care.

Yet the barriers to effective communication among healthcare providers are daunting.

Information may be corrupted, omitted or misunderstood when being communicated.

Healthcare providers may not possess the skills to communicate effectively, and some

providers actually harm communication processes and threaten patient safety due to

disruptive communication behaviors. However, there are strategies in the literature to

51
improve communication and also reduce the risk of medication errors, including adopting

procedures from other industries such as aviation.

The literature review did not reveal a previous qualitative analysis of medication

errors involving nurses reported to the Medication Errors Reporting (MER) Program

database focused specifically on aspects of communication and culture.

52
III. METHODOLOGY

Methods

Descriptive statistics and qualitative content analysis were used in this study.

Certain attributes of the medication error reports (who initiated the error, who discovered

the error, patient outcomes and location) were evaluated using descriptive statistics. The

study’s qualitative component consisted of a qualitative content analysis method that

included quantitative components in order to help with “interpreting the pattern that is

found in the codes” (Morgan, 1993, p. 115). Weber notes “the best-content analytic

studies use both qualitative and quantitative operations on texts” (1990, p. 10). It is

further noted that quantitative methods do have a role in qualitative research: Numbers

can be used to help capture the complexity of data with a qualitative study, and the use of

counts can be helpful in the analysis process to discover patterns within the information

being studied (Sandelowski, 2001).

A study of medication errors reported to the New York Patient Occurrence

Reporting and Tracking System used qualitative and quantitative methods to study the

errors (Duthie et al., 2005). The quantitative analysis focused on frequencies, types of

errors and the process related to the error and the qualitative analysis was used to identify

themes including: patient safety threats and systems issues. The researchers reported the

narrative data was also the “richest source for system fixes” (Duthie et al., p. 138).

53
Data Collection: Medication Errors Reporting (MER)

Program

This study’s source of data to analyze medication errors was the Medication

Errors Reporting (MER) Program “operated by the United States Pharmacopeia in

cooperation with the Institute for Safe Medication Practices” (USP, n.d.a) The Program

houses reports of errors and “near misses” that have been submitted voluntarily and from

healthcare providers throughout the nation. It also “ allows healthcare professionals to

report potential and actual medication errors directly to USP on a confidential and

anonymous basis (USP, n.d.a). It is a unique program because the reports are directly

from the healthcare providers and others who have knowledge of the incident. Even

though the Medication Errors Reporting Program “database cannot be used for

epidemiological purposes” (Scarrow & Routon, 2005, p. 30), it does provides valuable

information on medication errors and is considered a safe venue for practitioners to report

safety concerns (Scarrow & Routon, 2005).

The MER Program data has been used in published medication error safety

research (Cowley, Williams, & Cousins, 2001; Mohseni & Wong, 1998), and

recommendations from analysis of MER Program data have resulted in changes being

made to prevent additional medication errors (Santell, 2005; Scarrow & Routon, 2005).

The ISMP and USP publish newsletters that highlight the MER Program: the ISMP

Medication Safety Alert!® and the USP Patient Safety CAPSLinkTM, respectively. Both

newsletters provide information on medication errors and health errors reported to the

54
MER Program database that can be used by healthcare providers to prevent additional

errors.

Sampling

The USP was approached to explore the feasibility of accessing data for the

purpose of this study. The USP granted permission to this researcher and committee

chairperson to obtain access to specific data from selected medication error reports

related to communication in the MER Program database. A total of 2,172 medication

error narratives were reported to the MER Program between January 2002 and December

2005. Given that the medication error reports are generated by individuals having

knowledge of the incident and are reported in a narrative format, a sampling method

needed to be identified to capture medication errors involving communication issues and

healthcare providers, specifically nurses. A purposive sampling method was proposed

that would allow retrieval of applicable specific data from medication errors reports

containing a communication component. After discussion with USP staff including both

the Manager of Patient Safety Research and the Quality Control/Quality Assurance

Analyst of the Center for the Advancement of Patient Safety, given the large number of

errors in the data bank it was recommended to limit the scope of the data retrieval query

and to focus on retrieving all reported errors involving a nurse. The term “involving a

nurse” is defined as a nurse or nursing student who discovered, initiated, or was involved

in the error.

Since the medication error reports are housed by the USP, the data could be

accessed only through USP staff after approvals were obtained by USP and George

55
Mason University. All data provided to the researcher was de-identified prior to release

from the USP. Therefore, all the medication error reports from January 2002 to

December 2005 were screened by USP to assure the reports were de-identified and met

sampling criteria before being provided to the researcher. A selection criteria query was

designed in conjunction with nurses from the USP’s Patient Safety Center to identify

medication errors and appropriate prompts meeting the selection criteria for this research

project (any medication error involving a nurse). The query was not limited to hospital

locations and the USP search included acute care and outpatient settings.

Nurses from the USP Center for the Advancement of Patient Safety, including the

Manager of Patient Safety Research and Quality Control/Quality Assurance Analyst of

the Patient Safety Center at the USP screened the medication error reports for those

involving a nurse. Only specific data elements from medication errors reports meeting

the selection criteria query were provided to the researcher. All reports received by the

researcher were de-identified: no patients’ names, healthcare providers’ names, or names

of the sites of error occurrence were provided.

A total of 590 medication error reports met the selection criteria query conducted

by the USP. The committee chair and student researcher received the specific data

elements from USP in a Microsoft® Excel spreadsheet which delineated the following:

1. Case number

2. Category Index: outcome of the medication error using the National

Coordinating Council for Medication Error Reporting and Prevention

categories

56
3. Staff initiating the error

4. Other staff involved (nurse, physician, etc.)

5. Who discovered the error

6. When and how the error was discovered

7. Location of error

8. Action taken and recommendations

9. Date error report was received by USP.

A separate report titled Medication/Product was also received as a Microsoft®

Excel spreadsheet which contained the medication product data including the case

number, product name, generic name, dosage/form, administration route, and strength.

Three other reports containing the detailed narratives of the medication error

descriptions were provided by USP: Error Description (124 pages), Actions

Taken/Recommendations (48 pages), and When and How Discovered (22 pages).

Quantitative Data Analysis

The MER Program data provided by USP was aggregated in the following

categories: location of error, initiation of error by individual or group, and discovery of

error by individual or group. The aggregation of patient outcome categories was based on

the National Coordinating Council for Medication Error Reporting and Prevention

Categories A to I (see Table 2).

57
Table 2

Categories Adapted From National Coordinating Council for Medication Error


Reporting and Prevention (NCC MERP) Index for Categorizing Medication Errors
Category Description Patient Outcome
A Circumstances or events that have the capacity No Error, No Harm
to cause error
B An error occurred but the error did not reach Error, No Harm
the patient
C An error occurred that reached the patient but Error, No Harm
did not cause the patient harm
D An error occurred that reached the patient and Error, No Harm
required monitoring to confirm that it resulted
in no harm to the patient and/or required
intervention to preclude harm
E An error occurred that may have contributed to Error, Harm
or resulted in temporary harm to the patient
and required intervention
F An error occurred that may have contributed to Error, Harm
or resulted in temporary harm to the patient
and required initial or prolonged
hospitalization
G An error occurred that may have contributed to Error, Harm
or resulted in permanent patient harm
H An error occurred that required intervention Error, Harm
necessary to sustain life
I An error occurred that may have contributed to Error, Death
or resulted in the patient’s death
Note. Source from National Coordinating Council for Medication Error Reporting and
Prevention (NCC MERP), 2001.

Answering Research Questions

From a practical standpoint, access to the MER Program data provides an

opportunity to analyze a number of reported errors in a timely and cost-effective manner.

The MER Program data can be analyzed and dissected to answer questions and compare

the meaning from different reports of errors.

58
Table 3 delineates each research question as it relates to the source of information

and reason for selection.

Table 3

Research Questions as Related to Medication Errors Reporting Form


Research Question Medication Errors Reporting Reason for Selection
Form*
(The reporting form includes the
following prompts for submission of
information)
What are the patient This information was retrieved from The researcher is seeking to
outcomes in the a review of the medication error identify the type of patient
medication errors outcome category. outcomes in this cohort of
reported in this reported medication errors.
sample?
What are the Please describe the error. Include Reporters may describe
communication description/sequence of events, type communication issues that
issues that are of staff involved, and work contributed to the medication
identified in the environment (e.g., code situation, error.
medication error change of shift, short staffing, no 24- The researcher is seeking
reports? hr. pharmacy, floor stock). to explore and identify the
type of errors that are
recognized and reported
encompassing communication
issues.
What attributes Please describe the error. Include Reporters of errors may
supportive of a description/sequence of events, type describe environmental
culture of safety are of staff involved, and work factors and organizational
present in the environment (e.g., code situation, issues that could have
medication error change of shift, short staffing, no 24- contributed to the error.
reports? hr. pharmacy, floor stock). If causes are delineated it
And may be helpful to analyze and
How was the error (or potential for code with a focus on
error) discovered/intercepted? attributes of the culture.
And There may be evidence of
Suggest any recommendations to attributes of a culture of
prevent recurrence of this error, or safety such as “learning
describe policies or procedures you culture” and/or “just culture.”
instituted or plan to institute to There may be evidence in
prevent future similar errors. the narratives of actions and
strategies to reduce the risk of
reoccurrence.

59
Table 3 (continued)
Research Question Medication Errors Reporting Reason for Selection
Form*
(The form includes the following
prompts for submission of
information.)
What attributes not Please describe the error. Include Reporters of errors may
supportive of a description/sequence of events, type describe environmental
culture of safety are of staff involved, and work factors and organizational
present in the environment (e.g., code situation, issues that could have
medication error change of shift, short staffing, no 24- contributed to the error.
reports? hr. pharmacy, floor stock). There may be attributes
And not supportive of safety
How was the error (or potential for described in medication error
error) discovered/intercepted? reports.
And
Suggest any recommendations to
prevent recurrence of this error, or
describe policies or procedures you
instituted or plan to institute to
prevent future similar errors.
What types of Please describe the error. Include Reporter of errors may
interpersonal issues description/sequence of events, type describe interpersonal issues
are evident in a of staff involved, and work and or interpersonal
review of the environment (e.g., code situation, communication problems
medication error change of shift, short staffing, no 24- related to the medication
reports? hr. pharmacy, floor stock). error.
What “actions Suggest any recommendation to The researcher is seeking to
taken” and/or prevent recurrence of this error, or identify “lessons learned,”
“recommendations” describe policies and procedures you actions taken and
to address errors are instituted or plan to institute to recommendations described
described in the prevent future similar errors. by reporters of medication
medication error errors.
reports?
Note. *These prompts are from the USP Medication Errors Reporting Program available
on line (USP, n.d.b) or on the reporting form (USP, 2003)

Qualitative Data Analysis

The data provided by USP is based on information submitted by healthcare

providers and others who had firsthand knowledge of the medication error. The method

60
used to analyze the data was qualitative descriptive which “entails the presentation of the

facts of the case in everyday language” (Sandelowski, 2000, p. 336).

Content Analysis

There are varying explanations and descriptions of content analysis as defined by

Berelson in 1952 as “a research technique for the objective, systematic, and quantitative

description of the manifest consequence of communication” (as cited in Krippendorf,

1980, p. 21). Weber notes content analysis is “a research method that uses a set of

procedures to make valid inferences from text” (1990, p. 9). Qualitative content analysis

is also described as “a dynamic form of analysis of verbal and visual data that is oriented

toward summarizing the informational contents of that data” (Sandelowski, 2000, p. 338)

and focused on efforts “to identify prominent themes, and patterns among the

themes”(Polit & Beck, 2004, p. 580). Krippendorf’s definition is “content analysis is a

research technique for making replicable and valid inference from texts (or other

meaningful matter) to the contexts of their use” (2004, p. 18).

In qualitative analysis there is an effort to understand both the manifest and the

“latent content of data” as “qualitative content analysis is the least interpretative of the

qualitative analysis approaches in that there is no mandate to re-present the data in any

other terms but their own” (Sandelowski, 2000, p. 338). The strategy of using codes that

“emerge from the data” (Morgan, 1993, p. 116) is characteristic of qualitative content

analysis. Weber observes, “there is no simple right way to do content analysis”(p. 13),

rather, it is up to each researcher to select methods suitable for the issue being studied

(1990).

61
Content analysis requires that the researcher be interested and aware of the

“reality of the data and the reality of what the researcher wants to know

about”(Krippendorf, 1980, p. 170). This researcher was interested in learning more about

the specific communication factors that may lead to a medication error and

communication processes that may avert or mitigate an error.

The qualitative content analysis was conducted using a process to permit a

context-sensitive approach. The meanings were interpreted based on the situational

perspective as reported in the medication error report. There are various methods and

steps suggested for content analysis; Weber described eight steps and Cavanagh

described nine steps, as delineated in Table 4.

Table 4

Steps for Content Analysis


Cavanagh, Based on the Work of Weber
Weber
and Down-Wamboldt
1.Define the recording units 1. Select the unit of analysis
2.Define the categories 2. Create and define categories
3.Test coding on sample of text 3. Pre-test the category and definition of rules
4.Assess accuracy or reliability 4. Asses the reliability
5.Revise the coding rules 5. Assess the validity
6.Return to step three—test coding 6. Revise the rules, if needed
7.Code all the text 7. Pre-test the category scheme
8.Assess achieved reliability or 8. Code all data
accuracy 9. Reassess the reliability and validity
(Weber, 1990, p. 21-24) (Cavanagh, 1997)

62
Krippendorf (2004), on the other hand, describes six components of content

analysis: See Figure 4.

Figure 4. Components of content analysis. From Content Analysis: An Introduction to


Its Methodology (p. 86), by K. Krippendorff, 2004, Thousand Oaks, CA: Sage
Publications, Inc. Reprinted with permission of Sage Publications.

63
Krippendorf (2004) describes each component as delineated in Table 5.

Table 5

Description of Six Components of Qualitative Analysis (Krippendorf, 2004)


Component Description
1. Unitizing “systematic distinguishing of segment of text” (p. 83)
2. Sampling selecting the data/observations to be analyzed “allows the
analyst to economize research efforts by limiting
observations to a manageable subset that is statistically or
conceptually representative of the set of all possible units”
(p. 84)
3. Recording/Coding “to transform unedited texts, original images, and/or
unstructured sounds into analyzable representations” (p. 84)
4. Reducing this component addresses using statistical “or other methods
for summarizing or simplifying data”(p .83)
5. Inferring in content analysis abductive inference is used to “proceed
across logically distinct domains, from particulars of one
kind to particulars of another kind” and “proceed from texts
to answer the analyst’s questions” (p. 36)
6. Narrating explaining findings and analysis to others

Content analysis was used in this study and the emphasis was on a qualitative

approach. Krippendorf notes “avowedly qualitative scholars” (2004, p. 87) use a

hermeneutic process until a “satisfactory interpretation is reached” (2004, p. 88) as

illustrated in Figure 5.

64
Figure 5. Qualitative content analysis. From Content Analysis: An Introduction
to Its Methodology (p. 89), by K. Krippendorff, 2004, Thousand Oaks, CA: Sage
Publications. Inc. Reprinted with permission of Sage Publications.

Reliability and Validity – Content Analysis

Krippendorf (1980) and Weber (1990) do address that both reliability and

validity are important to content analysis.

Reliability

The types of reliability are:

1. Stability: This refers to the “degree to which a process is unchanging overtime

(Krippendorf, 2004, p. 131); and this type of reliability also is the “weakest

form.” (2004).

2. Reproducibility: This refers to the ability to replicate the process and is also

termed “inter coder reliability,” “intersubjective agreement” and “parallel-

forms reliability” (Krippendorf, 2004, p. 215) and is considered to be stronger

than stability (2004).

65
3. Accuracy: The text classification is congruent with a standard and is the

strongest of the three forms of reliability (Krippendorf, 1980; Weber, 1990).

Application is limited; for example, it is used for coder training purposes in

which “objective standards are readily available” (Krippendorf, 2004, p. 216).

Validity

Validity is simply the “degree to which an instrument measures what it intended

to measure” (Polit & Beck, 2004, p. 735). Krippendorf states “content analysis is valid if

the inferences drawn from the available texts withstand the test of independently

available evidence, of new observations, of competing theories or interpretations, or of

being able to inform successful actions” (2004, p. 313). There are different types of

validity: face, social, and empirical. Face validity addresses the “obvious” and what

“makes sense” (p. 313). Social validity refers to those findings that are accepted for their

contribution to addressing public issues and concerns (Krippendorf, 2004). Empirical

validity is described as “the degree to which available evidence and established theory

support intermediate stages of a research process and its results”(p. 319). Krippendorf

(2004) describes validity in terms of truthfully representing the phenomena under study.

Every effort was made to assure consistency (reliability) within the assignment of

codes to foster an accurate presentation of the data. The codes were carefully defined and

reviewed on an ongoing basis to assure that the codes were accurate and appropriate.

Definitions were established as part of an audit trail to allow “confirmability of the

findings” (Streubert Speziale & Carpenter, 2003, p. 38). Each time a new code was

identified that was open to several interpretations, it was defined so the researcher could

66
refer to the definition while immersed in the coding process. The researcher maintained

an audit trail using NVivo software to allow others to evaluate the process and enhance

the rigor of the analysis. Assigning and defining codes was an evolutionary process.

Content Analysis Method in This Study

The following process was selected based on the steps described by Cavanagh,

Weber and components explained by Krippendorf to allow the researcher to conduct

content analysis in an organized systematic manner.

1. The analysis was conducted on selected medication errors reported to the

MER Program between January 2002 and December 2005 meeting selection

criteria.

2. The process of defining codes was evolutionary and iterative. Each of the

descriptions of the incident, recommendations/action taken and how the error

was discovered were coded as separate components. A number of codes were

identified for each narrative. As common codes were identified, definitions

were constructed to help assure consistency in the coding process. The codes

emerged from the data. The definitions were modified during the coding

process as new data was analyzed and subsequently coded. During the coding

process assigned codes were also analyzed continually for consistency. The

codes evolved over several periods of reading, interrupting and analyzing the

data, defining codes, assigning codes and refining definitions of codes. An

audit trial of codes and definitions was used to document the coding and

analysis process; the coding process was memorialized using Nvivo 2

67
software. The evolution, narrowing and focusing of the coding process is

observable through the many iterations of coding of the narratives. Questions

regarding medications described in the narrative that the researcher

encountered in the data review were identified and discussed with a doctorally

prepared pharmacist who served as a consultant to the committee regarding

questions related to actions of medication to assure correct understanding and

interpretation of the description of an event.

3. After coding was completed, all the medication error reports were reviewed

again to assure consistency in the coding process.

4. The selection of narratives for inclusion into the analysis and the assignment

of codes was at this point reviewed by a member of the committee. Non-

congruence in the selection of narratives for review and coding was noted.

The discrepancies were addressed, then selection criteria was revisited and

refined. Selection criteria and definitions were refined and coding was

repeated and then reviewed by another doctorally prepared nurse.

5. Quasi-statistics defined as “tabulation of the frequency with which certain

themes, relations, or insights are supported by the data” (Polit & Beck, 2004,

p. 580) were be used. The quasi-statistics were used in the aggregation of data

to allow a more systematic approach in analyzing the data and exploring how

frequently some codes emerged.

6. Categories emerged based on the aggregation of similar codes. Creating

categories is considered essential in qualitative analysis (Cavanagh, 1997;

68
Graneheim & Lundman, 2004), as “creating categories is the core feature of

qualitative content analysis” (Graneheim & Lundman, p. 107). There does

seem to be debate on whether or not categories should be mutually exclusive

(Graneheim & Lundman, 2004; Weber, 1990). As Graneheim and Lundman

noted, “it is not always possible to create mutually exclusive categories”

(p.107). The codes were analyzed for frequency of occurrence and categories

emerged as like codes were identified and combined. An attempt was made to

develop categories that were mutually exclusive—but this was not always

possible. A taxonomy was developed to assist with categorization based on

the work of Berlo (1960), Reason (1997) and Weinger and Blike (2003) which

addresses communication failure, success and context.

7. Themes are described in various ways. The definition of theme used for this

research is “an abstract entity that brings meaning and identity to a recurrent

experience and its variant manifestations. As such, a theme captures and

unifies the nature or basis of the experience and into a meaningful whole”

(DeSantis & Ugarriza, 2000, p. 362). Themes were identified after coding was

completed and aggregated into categories. Once the themes were established,

an iterative approach was applied to verify that the themes identified reflected

the data analyzed (Polit & Beck, 2004). Two software programs, NVivo2 and

Excel, were used to assist in the data analysis.

8. The research process and rigor of analysis was evaluated by members of the

dissertation committee and an external consultant.

69
Study Assumptions

The data used in this study was from the MER Program. It was assumed that the

errors reported reflect incidents that did occur and were reported by those having

knowledge of circumstances related to the error. It was also an assumption that data

retrieved from the MER Program was accurate.

Ethical Considerations

Researching medication errors is often perceived as a very sensitive topic. Such

research may be viewed by a human subjects review board as placing the participant at

risk for harm, litigation or disciplinary action. The advantage of the MER Program data

set is that it contains de-identified written reports of medication errors, thereby protecting

the confidentiality of those reporting the errors. Thus the MER Program data presents an

excellent opportunity to analyze medication errors that would otherwise not be available

to a researcher. The availability of such de-identified data affords the researcher the

unique opportunity to study a potential high-risk incident (harmful medication error)

without any risk to the reporters of the incident of being identified. Further, by using data

that already exists, one can examine what has been reported about the phenomena of

medication errors.

Although the research design included analysis of secondary de-identified data

that was provided by USP, the student researcher did submit a Human Subjects Review

Board Application for Human Subjects Research Review to the George Mason

University. It was determined by the Office of Research Subject Protections that this

research project was exempt from review given that it involved the study of existing data

70
that was de-identified (see Appendix A). In addition, the chairperson of the dissertation

committee was required to sign a data sharing and confidentiality agreement with the

USP in order access the MER Program data. The de-identified data provided by USP

were kept in a secure location. Outside consultants/reviewers who read excerpts of the

data were required to sign a confidentiality statement.

Summary

The purpose of this research was to explore communication and cultural issues

associated within a sample of medication errors reported between 2002 and 2005 to the

Medication Errors Reporting (MER) Program. This chapter described the research

methodology. Content analysis and quantitative methods were used to study

communication and cultural issues associated with reported medication errors.

71
IV. FINDINGS

The findings of the data are presented in this chapter. First, descriptions of the

attributes of the medication errors are provided. Second, the quantitative descriptive

findings to answer the first research question are presented. Third, the qualitative findings

related to each of the remaining five research questions are reported.

Descriptions of Attributes of Medication Errors

The data provided by the United States Pharmacopeia (USP) was reviewed and of

590 error reports, 322 met this study’s inclusion criteria. Each USP medication error

report meeting criteria was reviewed and selected attributes (location, initiation of error,

discovered by, outcome of each error) were analyzed by the SPSS® Version 14 program.

The frequency of medications identified by generic name was determined using

Microsoft® Excel. Each USP medication error report reflected the facts and events as

described by a person having knowledge of the reported error.

Location of Error

The location of the medication errors was retrieved from the question “indicate

the location of the error” (USP, 2003) on the Medication Errors Reporting (MER)

Program reporting form. As depicted in Table 6, data were combined by the researcher

into 16 categories for ease of reporting. For example, errors occurring in an emergency

department or intensive care unit were categorized as occurring in a hospital. Errors

72
reported as occurring in a hospital pharmacy were reported as such. Pharmacies not

specified as hospital pharmacies were aggregated to the pharmacy category. The majority

of reported medication errors occurred in the hospital/medical center setting.

Table 6

Location of Error
Type of Facility n Percentage**
Hospital/Medical Center 199 61.8
Hospital Pharmacy 41 12.7
Pharmacy 25 7.8
Correctional Facility 20 6.2
Clinic 12 3.7
Skilled Nursing Facility/
9 2.8
Nursing Home
Physician’s Office/
3 0.9
Doctor's Office
Long Term Care (LTC) 3 0.9
NI* or Unknown 2 0.6
Patient Home 2 0.6
Public Health Office 1 0.3
Rehab 1 0.3
Residential Treatment 1 0.3
Ambulatory Endoscopy
1 0.3
Center
Hospice 1 0.3
Intermediate Facility 1 0.3
Total 322 99.8
Note. *The definition of “NI” was not specified. **Percentages
have been rounded and may not equal 100%.

Initiation of Error by Individual or Group

The source of the data for this category was obtained from the MER Program

question “What type of staff or healthcare practitioner made the initial error?” (USP,

73
2003). The information provided by USP was aggregated into 15 categories by the

researcher for ease of reporting (Table 7). Nurses were identified as making the initial

error in 49.4% of cases analyzed. Various categories of nurses were combined into the

nurse category, including Registered Nurses, Licensed Vocational Nurses/Licensed

Practical Nurses, Advance Practice Nurses, and nurses not otherwise specified. This

category did not include unlicensed personnel. The term “prescriber” was retained from

the USP data, as it was not specified if the prescriber was a Physician, Advance Practice

Nurse, Physician Assistant, or other category. There were five not specified or not

indicated responses. “Hospital staff” was retained from the USP data as a category. Two

errors were reported to be initiated by patients, one by a nursing student and one by a

family member.

74
Table 7

Initiation of Error by Individual or Group


Individual or Group n Percentage**
Nurse 159 49.4
Physician 66 20.5
Pharmacist/Pharmacy
63 19.6
Tech/Pharmacy Staff
Prescriber 10 3.1
NI* or Unknown 5 1.6
Hospital Staff 4 1.2
Physician Assistant 3 0.9
Clerk or Secretary 3 0.9
Patient 2 0.6
Nurse and Physician 2 0.6
Nurse and Clerk 1 0.3
Staff Radiology 1 0.3
Technician Order Entry 1 0.3
Nursing Student 1 0.3
Family Member/Caregiver 1 0.3
Total 322 99.9
Note. *The definition of “NI” was not specified. **Percentages
have been rounded and may not equal 100%.

Discovery of Error by Individual or Group

The information provided by USP related to discovery of error by an individual or

group was aggregated by the researcher into 13 categories for ease for reporting (Table

8). The information was retrieved from the USP data delineated in response to the query

“What type of staff or healthcare practitioner discovered the error or recognized the

potential for error?” found on the MER Program reporting form (USP, 2003).

Two categories of healthcare providers (Nurses and Pharmacists/Pharmacy

Tech/Pharmacy Staff) discovered the majority of errors in this sample. The identity of the

75
individual who discovered an error was not specified in 8% of errors. The patient

discovered the error in 6% of cases, and family members discovered it in 4%of the cases.

Table 8

Error Discovered by Individual or Group

Individual or Group Frequency Percentage**

Pharmacist/Pharmacy Tech/
105 32.6
Pharmacy Staff
Nurse 105 32.6
Physician 40 12.4
NI* or Unknown 26 8.1
Patient 19 5.9
Family Member/Caregiver 13 4.0
Nurse and Pharmacist/
5 1.6
Pharmacy Staff
Hospital Staff 2 0.6
Respiratory Therapist 2 0.6
Nurse and Physician 2 0.6
Physical Therapist 1 0.3
Staff Other 1 0.3
Clerk or Secretary 1 0.3
Total 322 99.9
Note. *The definition of “NI” was not specified. **Percentages have
been rounded and may not equal 100%.

The medications most frequently identified in this analysis are delineated in Table

9. Some medication errors involved several types of medications. The cases meeting the

criteria were analyzed within the spreadsheet and the medication names were ranked by

frequency.

76
Table 9

Most Frequently Identified Medications by Generic Name in


322 Medication Error Reports
Percentage***
Generic Name n
(Total = 322)
Insulin 42 13.0
Morphine Sulfate 15 4.6
Warfarin Sodium 10 3.1
Oxycodone Hydrochloride 9 2.8
Fentanyl*/
Fentanyl Citrate** 9 2.8
Diltiazem Hydrochloride 8 2.5
Heparin Sodium 7 2.2
Enoxaparin Sodium 7 2.2
Levothyroxine Sodium 6 1.9
Paroxetine Hydrochloride 6 1.9
Note. This listing only includes the top 10 identified medications
by generic name. *Fentanyl identified five times. **Fentanyl
Citrate identified four times.***Percentages have been rounded.

The most frequently cited medication in the subject error reports, by generic

name, was insulin.

Three descriptive attributes of medication errors were presented in this section:

location, initiator of error, discoverer of the error. Additionally, the generic medications

involved were ranked by frequency. The last attribute, outcome of error, is presented in

the next section, the quantitative descriptive findings, as part of the answer to the first

research question.

77
Research Question One: What Are the Patient Outcomes in the Medication

Errors Reported in This Sample?

No harm to patients was reported in 234 error reports cases, or 72%. However,

harm to patients not including death was reported in 66 error reports, or 20.5% of cases

reviewed. Errors involving patient deaths were reported in 21 error reports, or 6.5% of

the sample, as delineated in Table 10.

Table 10

Patient Outcomes From Medication Errors


Outcome Frequency Percentage
No Harm 234 72.7
Harm 66 20.5
Death 21 6.5
Not Reported 1 0.3
Total 322 100.0
Note. Percentages have been rounded.

A more specific breakdown of patient outcomes is presented in Table 11, ranked

by frequency, and is based on the NCC MERP Index for Categorizing Medication Errors

(National Coordinating Council for Medication Error Reporting and Prevention [NCC

MERP], 2001).

78
Table 11

Patient Outcomes From Medication Errors in Rank Order

Category Definition in NCC MERP Index n Percentage*

C - Error, No Harm An error occurred that reached


the patient but did not cause the 114 35.40
patient harm.
B - Error, No Harm An error occurred but the error
79 24.53
did not reach the patient.
D - Error, No Harm An error occurred that reached
the patient and required
monitoring to confirm that it
40 12.42
resulted in no harm to the patient
and/or required intervention to
preclude harm.
E - Error, Harm An error occurred that may have
contributed to or resulted in
37 11.49
temporary harm to the patient and
required intervention.
I - Error, Death An error occurred that may have
contributed to or resulted in the 21 6.52
patient’s death.
F - Error, Harm An error occurred that may have
contributed to or resulted in
temporary harm to the patient and 14 4.34
required initial or prolonged
hospitalization.
H - Error, Harm An error occurred that required
intervention necessary to sustain 11 3.41
life.
G - Error, Harm An error occurred that may have
contributed to or resulted in 4 1.24
permanent patient harm.
A - No Error, No Circumstances or events that have
Harm the capacity to cause error. 1 0.31

Not Reported 1 0.31


Total 322 99.95
Note. Categories adapted from National Coordinating Council for Medication Error
Reporting and Prevention (NCC MERP) Index for Categorizing Medication Errors
(2001). *Percentages have been rounded and may not equal 100%.

79
Categorization of these same errors by patient outcome is presented in Table 12.

Table 12

National Coordinating Council for Medication Error Reporting and Prevention (NCC
MERP) Index for Categorizing Medication Errors and Patient Outcomes by Category
Category Description n Percentage*
A - No Error, No Harm Circumstances or events that have the 1 0.31
capacity to cause error.
B - Error, No Harm An error occurred but the error did 79 24.53
not reach the patient.
C - Error, No Harm An error occurred that reached the 114 35.40
patient but did not cause the patient
harm.
D - Error, No Harm An error occurred that reached the 40 12.42
patient and required monitoring to
confirm that it resulted in no harm to
the patient and/or required
intervention to preclude harm.
E - Error, Harm An error occurred that may have 37 11.49
contributed to or resulted in
temporary harm to the patient and
required intervention.
F - Error, Harm An error occurred that may have 14 4.34
contributed to or resulted in
temporary harm to the patient and
required initial or prolonged
hospitalization.
G - Error, Harm An error occurred that may have 4 1.22
contributed to or resulted in
permanent patient harm.
H - Error, Harm An error occurred that required 11 3.41
intervention necessary to sustain life.
I - Error, Death An error occurred that may have 21 6.52
contributed to or resulted in the
patient’s death.
Not Reported 1 0.31
Total 322 99.95
Note. Categories and description from National Coordinating Council for Medication
Error Reporting and Prevention (NCC MERP) Index for Categorizing Medication Errors
(2001). *Percentages have been rounded and may not equal 100%.
80
The frequency of patient outcomes based on the NCC MERP Index for

Categorizing Medication Errors are depicted in Figure 6.

120

100

80
Count

60

40

20

0
A -No Not B - Error, C - Error, D - Error, E - Error, F - Error, G - Error, H - Error, I - Error,
error, No Reported no harm no harm no harm harm harm harm harm Death
harm

Outcome

Figure 6. Patient outcomes from medication errors by category.

Thus, in answer to the first research question, “What are the patient outcomes in

the medication errors reported in this sample,” Category C, “error, no harm,” was the

most frequent outcome in the sample, meaning an error occurred that reached the patient

but did not cause the patient harm. However, harm to patients not including death was

reported in 20.5% of cases and deaths reported in 6.5% of cases reviewed.

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In the next section, a brief review of the qualitative methods used to answer

research questions two, three, four, five and six will be presented along with the findings

related to each question.

Analysis and Coding of Qualitative Data

Initial Selection Criteria

The narratives were imported into Nvivo2 for analysis. The 590 error descriptions

and their corresponding actions and recommendations were reviewed by the researcher

five different times to determine if they met the inclusion criteria for qualitative analysis.

All narratives were reviewed for inclusion. The initial criteria for inclusion were all

narratives within the reported medication errors that met the pre-established criteria for

any of the following: communication, clarity of the report and cultural issues.

Communication Criteria

The first criterion related to communication was that the medication error would

be included if it contained a communication issue, meaning some reference to a

communication issue (written, oral, labeling of medications). The second criterion was

the presence of communication that was confusing, intimidating, or lacking between

staff, between hospital staff and patient/family, or between hospital staff and another

facility’s staff. This criteria is based on the USP definition of communication as “a cause

of error…[which] involves communication that is confusing, intimidating, or lacking

between staff, between hospital staff and patient/family, or between hospital staff and

another facility’s staff” (Hicks et al., 2004, p. 113).

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Clarity of the Report

The reader reviewing the report can obtain a clear description of the medication

error from the description provided in the error reports. Some of the reports were

excluded because the report did not provide a clear or understandable description of the

medication error.

Cultural Issues

The final criterion for inclusion was cultural issues. Medication error reports

would be included that contained evidence of attributes associated with a culture of

safety, or a culture of blame, or attributes not supportive of culture of safety (as discussed

in Chapters One and Two).

Exclusions. This criterion excluded errors involving calculation, and those reports

not providing enough information to be understood clearly by the researcher.

Initial Coding

The researcher interpreted the criteria broadly and determined 508 of the

provided 590 medication error reports met the inclusion criteria. These 508 narratives

were read and codes were assigned by the researcher. The initial coding resulted in

assigning over 1000 codes, including medication names. This proved unwieldy, so the

coding was modified to focus on answering the research questions related to

communication issues, culture supportive of safety, culture not supportive of safety,

interpersonal issues and actions taken/recommendations. A coding check for both

selection of narratives for inclusion in the study and congruence for coding the data was

performed by a member of the dissertation committee. A sample of 50 of the 508

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medication error reports coded was selected randomly for this outside review. The 50

medication error reports were provided to the committee member, an expert in qualitative

analysis methodology, who conducted an independent review of the medication error

reports for both inclusion in the study and coding congruence. This review indicated there

were 21 cases where there was a question or disagreement between the student researcher

and the reviewer, therefore the inter-rater agreement was only 58% for selection of the

narratives for inclusion in the study (Table 13).

Table 13

Coding Check for Selection of Narratives and Congruence for Coding


Data Between First Reviewer and Student Researcher
First Reviewer n Percentage
Do Not Include 16 32.0
Yes Include 29 58.0
Questionable 5 10.0
Total 50 100.0

Subsequently a meeting was held with the student researcher, qualitative

researcher (first reviewer) and committee chairperson at which the criteria were reviewed

and clarified in order to more effectively answer research questions two through six. The

selection criterions were refined and restated, with the finalized criteria listed in the next

section.

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Final Criteria for Selection of Medication Error Report

Errors meeting one or more of the following criteria were included:

1. Narrative within the reported medication error that included a communication

component, meeting the USP definition of communication “a cause of error

…[which] involves communication that is confusing, intimidating, or lacking

between staff, between hospital staff and patient/family, or between hospital

staff and another facility’s staff” (Hicks et al., 2004, p. 113).

2. Narrative that provides description of communication process that averted an

error, or communication process that identified and remedied an error.

3. Narratives that describe attributes of a Culture of Safety and attributes of

Cultures that do not promote safety.

4. Description of verbal and/or non-verbal communication processes.

Exclusions

Issues related to manufacturers’ labeling-related medication errors, although a

contributor to medication errors, did not necessarily meet the inclusion criteria for this

study which focused on communication among healthcare providers and/or patient/

family. Narratives that were unclear or ambiguous were also excluded.

Second Round of Coding

Therefore, all 590 medication error reports were reassessed for inclusion and

Nvivo2 again was used in the analysis. The narratives were read and codes were assigned

by the researcher. All medication error reports meeting the inclusion criteria were

reanalyzed and recoded. In order to check adherence to the final selection criteria and

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agreement with coding, the same sample of 50 medication error reports were submitted to

a second doctorally prepared nurse who has conducted research on medication errors.

The second reviewer was provided with the 50 medication error reports for review

including reports meeting inclusion criteria and those not meeting inclusion criteria.

The information provided to the second reviewer included:

1. Medication Error Reports consisting of Error Description and Actions Taken/

Recommendations (if recorded).

2. Coding of first reviewer prior to revision of inclusion criteria and recoding.

3. Coding by student researcher.

The second reviewer was requested to review the 50 medication error reports and

determine agreement with selection of medication error reports for inclusion and coding.

The second reviewer agreed with exclusions and coding of cases included in 88% of

cases (Table 14).

Table 14

Initial Review Congruence Between Student Researcher and


Second Reviewer With Revised Criteria
Second Reviewer n Percentage
Non congruence 6 12.0
Congruence 44 88.0
Total 50 100.0

After meeting to discuss the selections, exclusions, coding and rationale for the

assignment of codes, consensus was reached in 92% of the cases reviewed with

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disagreement in one case (#28) and questionable in three cases (#34, 39, 42): See Table

15.

Table 15

Review After Meeting With Student Researcher and Reviewer


Congruence Between Student Researcher and Second Reviewer
With Revised Criteria
Second Reviewer n Percentage
Non congruence 1 2.0
Congruence 46 92.0
Question 3 6.0
Total 50 100.0

After completion of the final check, the student researcher re-reviewed the

narratives based on the more stringent selection criteria and 322 were found to meet the

inclusion criteria. Another 85 errors involving labeling and packaging issues were

analyzed separately under “other findings.”

The data to answer the research questions were extracted from three components

of the medication error narratives submitted to the USP Medication Errors Reporting

Program. There are three components identified below.

1. Error Description

“Please describe the error. Include description/sequence of events, type of

staff involved, and work environment (e.g., code situation, change of shift,

short staffing, no 24-hr. pharmacy, floor stock).” Include description/sequence

of events.

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2. Error discovery

“How was the error (or potential for error) discovered/intercepted?”

3. Actions Taken/Recommendations

“Suggest any recommendations to prevent recurrence of this error, or describe

policies or procedures you instituted or plan to institute to prevent future

similar errors.”

Taxonomy

A taxonomy was used to help categorize communication processes observed in

reported medication errors. The taxonomy was derived from Weinger & Blike (2003) and

modified based on the work of Reason (1997) and the communication theory of Berlo

(1960). Weinger and Blike identified the following communication failures: failure of

message transmission, failure of message reception and failure of message

acknowledgement (2003). According to Reason communication problems can be

categorized as “system failures,” “message failures,” or “reception failures” (1997, p.

135). Communication includes the source, message, channel and receiver in the S-M-C-R

model (Berlo, 1960). The source of the message is influenced by social and cultural

systems (Berlo, 1960) The narratives of medication errors in which the defenses were

breached, contributing to an error, were analyzed based on James Reason’s Swiss Cheese

Model (Reason, 1997). The taxonomy was expanded to reflect the context, including the

attributes of a culture of safety. See Table 16 for the taxonomy.

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   Table 16

Taxonomy of Communication Failure, Success and Context

Classification Explanation/Example

Failure
Failure of Message The transmission of the message is compromised or is
(FOM) Transmission ambiguous.

The source encodes the Examples:


message to be sent Written: Illegible information is transmitted by
physician.
Verbal/Oral: Use of a sound-alike medication in an
order.

Failure of Message The reception of the message is compromised in some


(FOM) Reception way; therefore, the receiver of the message
misunderstands or does not receive the message as
The receiver does not intended.
decode the message
correctly as intended Examples:
by the source  Written: the written abbreviation is misinterpreted by
the receiver.
Verbal/Oral: the medication name sounds like another
medication name to the receiver and consequently the
receiver (a nurse) decodes the message incorrectly and
administers the wrong medication.
 
Failure of Message The message is sent but it is not acknowledged or
(FOM) clarified to assure accuracy by the receiver, contributing
Acknowledgment/ to a communication failure.
Clarification
Examples:
The receiver does not Verbal/Oral: The prescriber orders a medication but it
verify the message was is not read back by the nurse and the wrong medication
sent and received is provided to the patient.
correctly Written: A check/clarification of a written medication
order is not conducted and a wrong medication is
dispensed.

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Table 16 (continued)

Classification Explanation/Example

Success
Confirmation of A check of the message is conducted to assure the
Message (COM) accuracy of the communication.
Acknowledgement/
Clarification Example:
An illegible order is clarified by contacting the
prescriber to verify the intent of the order. Therefore
an ambiguous message is clarified to assure the
accuracy of the message.

Context
Culture, Systems, The context in which a message is transmitted, received
Knowledge, Attitudes, and acknowledged.
Skills, Support
Examples: Culture of Safety
Influence Source and Culture: Supports open communication.
Receiver Systems: Standardized systems in place to allow
accurate transmission of physician orders; for example,
computerized physician order entry (CPOE).
Systems: Pharmacy available to check medication
orders and dispense medications.
Knowledge: Source (healthcare provider) has
knowledge to transmit accurate medication order.
Skills: Source and receiver possess skills to
communicate effectively verbally/orally, in writing and
electronically.
Support: Leadership provides resources to transmit
messages in a safe manner.

Examples: Culture Not Supportive of Safety


Culture: Does not support open communication
Systems: Pharmacist not available to answer questions,
or check medication orders.
Knowledge: Source (healthcare provider) lacks
knowledge to transmit accurate medication order.
Attitudes: Receiver (nurse) afraid to ask source
(physician) question because physician screams at
receiver.
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Table 16 (continued)

Classification Explanation/Example

Skills: Source lacks skill to communicate effectively


in verbal/oral, written, or electronic form.
Support: Leadership does not provide resources to
transmit messages in a safe manner.

Efforts to Improve Efforts undertaken to improve communication and other


processes to enhance patient safety.

Example:
Restrict use of abbreviations to decrease occurrence
of errors related to FOM reception.

Note. Taxonomy Based on Berlo (1960), Reason (1997), Weinger and Blike (2003).

Research Question Two: What Are the Communication Issues That Are

Identified in the Medication Error Reports?

The analysis of the data revealed many nuances and complexities of

communication processes occurring within medication errors reports. Many of the reports

encompassed more than one type of communication process. The variety of methods in

which communication processes were compromised or other wise abridged was

formidable. The communication issues that emerged in this analysis included failure of

message transmission, failure of message reception and failure of message

acknowledgement/clarification. The failures were influenced by the source’s and

receiver’s communication skills, attitudes, knowledge, systems and culture. The message

transmission was impacted by the encoding and decoding.

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This analysis focused on communication that was “confusing, intimidating, or

lacking between staff, between hospital staff and patient/family, or between hospital staff

and another facility’s staff” (Hicks et al., 2004, p. 113). In reviewing and analyzing these

errors many “at- risk” behaviors—those behaviors “that may compromise patient

safety”—emerged (NCC MERP, 2007b). In answer to the research question, “What are

the communication issues that are identified in medication error reports?”, narratives

were analyzed to identify communication issues. The communication issues were

categorized as non-verbal, verbal, threats, technology challenges, lack of knowledge,

healthcare provider–patient/ family interactions and “Swiss Cheese” model error

trajectory.

Non-Verbal Communication: Written/Printed Communication

Written and printed communication is an essential component in the delivery of

care. Documentation (handwritten, electronically generated and combinations of the two)

occurs throughout the healthcare system. Providing quality care is dependent on accurate

and timely documentation of essential information. However, problems with written

communication can contribute to committing a medication error. Subcategories of non-

verbal communication issues included: illegibility, confusing abbreviations, confusing

symbols and numbers, transcribing errors, misinterpretation of orders and labeling issues.

Illegibility

Illegibility was described as communication that was confusing or lacking related

to the written or printed word. If the physician/prescriber order is not legible, a failure of

message (FOM) transmission and a FOM of message reception can occur and the

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message may be interpreted incorrectly, as illustrated in the following descriptions of

errors that include wrong dose and/or wrong medication.

• Insulin
“Pharmacist and RN both read 50 units, not 5.” In this case the doctor
intended 5 units not 50 units.

• Lexapro (escitalopram; antidepressant) and Loxitane (loxapine;


antipsychotic) (Skidmore-Roth, 2008)
“The physician wrote an order for Lexapro (Escitalopram) 10 mg tab, which
as written looked like Loxapine (Loxitane) 10 mg. After the error was
discovered, the order was read by five pharmacists on staff and each one said
that it was Loxapine [sic].”

In the following error description a nurse and pharmacist noted and corrected the

original incorrect interpretation of the physician order.

• “The prescriber was running out of space and wrote the strength just below
the word ‘syrup.’ The ‘P’ in syrup was very long and was mistaken for 1 in
front of the 6 mg.”

The nurse and the pharmacist reviewing the order corrected the Medication

Administration Record (MAR) to accurately reflect the order as intended for 6 mg, not 16

mg. However, later in the time line, another nurse changed the MAR back to the incorrect

interpretation of the order, 16mg, and the patient received the wrong dose of medication.

In this case there was a FOM transmission and reception.

• “The next shift nurse was certain that the…order was 16 mg instead of 6 mg.
She manually changed the MAR and issued the medication incorrectly.”

The previous examples provide a brief representation of the many medication errors

related to illegible or confusing written communications in this sample.

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Confusing Abbreviations

The use of abbreviations was a very frequent finding in this analysis of

medication errors. Using abbreviations contributed to confusing communication between

healthcare providers because of FOM transmission and FOM reception. The receiver of

the message interpreted the abbreviations differently than intended by the prescriber

sending the message. In the following case, the nurses misread the order but another

healthcare provider corrected the misinterpretation.

• “Received an order…where a ‘qd’ was misread as ‘q8’ by the nurse but the
pharmacist read the order as daily, therefore the error did not reach the
patient.”

In a case involving the abbreviation “IU” (international unit) the “IU” was

interpreted as the IV route. This resulted in the medication being administered

intravenously (IV) which was not the correct route of administration. The use of

abbreviations to designate medication is a practice that contributes to confusion as

observed in the following report.

• “Abbreviation DPH: One physician at our organization uses this abbreviation


for Diphenhydramine (Benadryl) and another physician at our organization
uses this abbreviation for [another medication].

Abbreviations as written and as interpreted may not be congruent. In the

following instance an abbreviation contributed to an unintended change in medical

therapy for the patient. The physician intended to discontinue insulin, but the pharmacist

interpreted the abbreviations differently than the physician’s intention.

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• Zoloft( sertraline; selective serotonin reuptake inhibitor (SSRI);
antidepressant) and Insulin (Skidmore-Roth, 2008)
“[Physician order] decrease Accuchecks to BID. If no Insulin required x 48 h,
d/c SSRI.” By the context of the order, she obviously meant sliding scale
Regular Insulin. Two days later, the patient had not required any Insulin for
48 hours, so a nurse rewrote the order as follows: “SSRI to be discontinued
(per MD order).… This order was not sent to the pharmacy…but was
communicated to the pharmacist via a pharmacy-nursing communications
note as merely ‘d/c SSRI.’” Zoloft was discontinued instead of insulin.

Healthcare organizations and practitioners may develop their own unique

abbreviations as illustrated in the previous two cases. This can add to confusion in

communication if the abbreviation is not understood consistently by those involved in

patient care. The use of confusing abbreviations in this sample ranged from known

problematic abbreviations that are prohibited by the Joint Commission to more unusual

and unique adaptations of abbreviations.

Confusing Symbols and Numbers

Another type of communication issue found in written communication involved

the use of symbols and numbers. The interpretation of the actual written word, symbol or

number can be influenced by how the written communication is formatted on the medical

record. The act of “numbering” orders can contribute to an unintended misinterpretation

of the order.

• Toradol (ketorolac; nonsteroidal anti-inflammatory) (Skidmore-Roth, 2008)


“order was written as follows: ‘1. 25 mg Toradol IV x 1’…the ‘1.’ intending
to number the order, looked like part of the dose. So instead of 25 mg, it
appeared to say ‘1.25 mg.’”

The use of a written check mark also contributed to dosages of medication being

misinterpreted.

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• Insulin order
“A nurse decided to check off the orders and made the order for 12 units into
42 units.”

In the above case a pharmacist intervened and the error was addressed. In the following

case a symbol was interpreted incorrectly by an unlicensed person as a number.

• Coumadin Order (Coumdain; warfarin sodium; anticoagulant) (Skidmore-


Roth, 2008
“The PA ordered ‘no Coumadin’ via a symbol of a zero with a line through it.
This was interpreted as a ‘4’ by the unit secretary. Fortunately an alert nurse
checked the lab work,…and called the PA to find out that the intent of the
order was for ‘no Coumadin.’”

The reporter in this case also included a comment highlighting the dangers of symbols

related to a confusing order.

• “Yet another example of the perils of using symbols rather than clear language
and instructions in written orders.”

As illustrated in the previous cases, using symbols can have unplanned communication

consequences if interpreted differently than intended.

Transcribing

A host of communication breaches involved FOM transmissions and FOM

receptions, errors that occurred because transcription processes were flawed. Medication

orders were copied incorrectly, contributing to wrong medications, wrong doses and

omission errors.

• Wrong medication: Paxil (paroxetine,, selective serotonin reuptake inhibitors


(SSRIs) and Prozac (fluoxetine, selective serotonin reuptake inhibitors
(SSRIs). (Skidmore-Roth, 2008)
“Nurse copied med wrong Paxil instead of Prozac.”

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• Wrong dose transcribed:
“‘Insulin N 14 units’ was transcribed onto MAR by nurse as ‘94 units.’” In
this case the error did not reach the patient.

“Nurse wrote Humalog 4 units subcu instead of 14 units subcu.” This error did
reach the patient and cause harm.

• Omitted medication: Lovenox (enoxaparin sodium; anticoagulant) (Skidmore-


Roth, 2008)
“RN signed off order for Lovenox…but did not transcribe it to the med
administration record.”

Transmission of information among healthcare providers was compromised in

numerous medication error reports related to transcription processes. The act of

transmitting information via a written communication can contribute to corrupting the

intent of the message because there was a FOM of transmission and FOM reception—as

these cases illustrated.

Misinterpretation

The misinterpretation of a written order is a type FOM reception. In one unusual

case the written message was unintentionally modified when the nurse noted the orders

with her initials—and the nurse’s initials were actually interpreted as part of the order,

changing the dose of the medication. However, the error was intercepted before reaching

the patient.

Label Problems (Internal)

The written communication process was impacted by labeling issues within the

healthcare organization in a number of instances.

In one case, a physician ordered a medication for inhalation but the inhalation

label was missing on the drug and the nurse gave the medication orally instead.

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• “The physician had written an order for ‘Spiriva oral inhalation once daily.’
An RN retrieved one Spiriva HandiHaler capsule from the…machine which
appeared to have been cut from a package of 3 capsules so the ‘inhalation’
labeling was not all present…. She saw ‘oral’ as part of the physician’s order
and thought the capsule was an oral drug.”
Labels that were confusing, applied incorrectly or missing information contributed to

communication breakdown and medication errors.

This analysis illustrates that written communication can be vulnerable to FOM

transmission and FOM reception. Written communication is critical to the delivery and

continuity of patient care and is a process that can be corrupted, resulting in confusing,

missing or lacking communication among healthcare providers.

Verbal Communication: Oral Communication

Verbal communication can be corrupted in a number of ways. In this analysis

many of the verbal interactions involved verbal orders that involved FOM transmission

and FOM reception. The verbal communication subcategories identified were verbal

message, implementation of verbal message incorrectly, accents, confusing abbreviations

(verbal).

Verbal Message

A number of processes contribute to possible errors with verbal orders. When a

verbal order is received but not clarified, miscommunication of the order can ensue. In a

medication order transmission if the information is not received correctly it can have

potential adverse consequences for the patient.

In the following case there was a FOM transmission, FOM reception and FOM

acknowledgement. In this instance the order went through several persons; additionally,

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an abbreviation was used, contributing to a degraded transmission of the message. The

organization had a policy for verification of verbal orders and the nurse indicated she had

complied. However, there was a transmission, reception and acknowledgment

communication failure for this error to occur and reach the patient.

• “A physician was performing a procedure in a cath lab and gave a verbal order
for ‘40 of K’ for a patient in intensive coronary care. The message was
relayed through a cath lab staff member to the nurse caring for the patient.
The nurse reduced the order to writing as ‘40 mg of Vitamin K IV
[intravenous] now’.… The intended order was for 40 mEq of KCl (Potassium
Chloride).”

This verbal order was compromised through a series of communication processes as the

doctor did not communicate directly with the nurse caring for the patient, there was

misinterpretation of the order, and the acknowledgment did not apparently lead to

identifying the misunderstanding.

Implementation of Verbal Message Incorrectly

In this next case the order was apparently heard as the sender intended, but the

verbal order was processed and stamped with the wrong patient name. Consequently the

verbal order was implemented for the wrong patient.

• Glyburide (antidiabetic) (Skidmore-Roth, 2008)


“A RN (registered nurse) took a verbal from a physician. The pharmacy
received a fax copy of the order. Glyburide 10 mg po bid (by mouth twice a
day) with patient T name on it. The order was intended for patient D.”

In this case a patient who did not have diabetes received glyburide and experienced

hypoglycemia and was transferred to intensive care. This was a FOM transmission to the

pharmacy who received the information for the wrong patient.

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Accents

Key to effective communication is being able to understand the spoken word. But

if the words sound different or are pronounced differently, the message received may not

be the intended message to be sent. In an increasingly diverse population there may be

language issues and accents that can affect the accurate transmission of verbal

information.

In the following exemplar an accent is identified as a possible contributor to the

commission of an error. The doctor ordered Zestril via a verbal order but the nurse heard

Vistaril.

• Vistaril (hydroxyzine; anxiolytic)(Nursing 2007) and Zestril (lisinopril;


angiotensin converting enzyme (ACE) inhibitor; antihypertensive) (Skidmore-
Roth, 2008)
“This [Zestril] sounded very close to ‘Vistaryl’ [sic] on the phone due to a
possible accent.”

Accents and pronunciation of medications can play a role in contributing to a

FOM in transmission and reception in verbal orders as the previous case illustrates. This

order was clarified so the patient did not receive the wrong medication, but if there had

been a FOM acknowledgment/clarification the patient could have received the wrong

medication.

Confusing Abbreviations (Verbal)

In the following case there was confusion involving two different drugs when a

verbal order was written using abbreviations rather than the full name of the medication.

• “A telephone order was written by a nurse as ‘MgSO4 2 mg IV q4 prn’


(Magnesium Sulfate 2 mg intravenous every four as needed). However, when
pharmacy received the order, we knew it had to have meant Morphine Sulfate
instead of Magnesium Sulfate because there was an order for Phenergan

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above it and the ‘as needed.’ When we contacted the physician, he asked,
‘Isn’t MgSO4 for Morphine? What is the abbreviation for Morphine?’”

Abbreviations can pose a threat to patient safety when used in verbal

communication, as illustrated above. In the above case the patient could have received

the wrong medication if the pharmacy was not diligent in contacting the physician. A

concern is also noted that there is a knowledge deficit involved as the doctor did not

know the difference between two distinct abbreviations. The abbreviation MgSO4 is on

the Joint Commission “do not use” list of abbreviations along with MSO4: These should

not be used by healthcare providers as these two abbreviations have been confused for

one another (Joint Commission, 2007b). Using abbreviations with a verbal order can lead

to a FOM transmission and reception.

Threats to Communication Process and Transmission of the Message

A number of causes and contributors related to techniques and processes were

observed in both verbal and non verbal communication. The subcategories identified are:

lack of verification, handoff disruptions, similar medication names, missing/incorrect

information, missed opportunity, distractions.

Lack of Verification or Checking

Common to both written and verbal communication that was confusing or missing

was a FOM acknowledgement/clarification, the lack of a process to verify that the

communication was understood by the receiver as intended by the sender. The

importance of checking and verifying emerged in this analysis. The absence of such

checks disrupts accurate communication among practitioners and allows errors to occur.

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In a case involving lack of checking there were several communication problems,

one of which was the illegibility of an order complicated by a lack of verification that the

correct medication was ordered. A physician order was misread due to illegibility and

Avandia (antidiabetic) was mistaken for Coumadin (anticoagulant). A nurse subsequently

requested Coumadin that was not actually ordered for a patient. The error continued

because the pharmacy provided the Coumadin, an un-ordered medication, without first

checking to see if the medication was in fact ordered. The patient received the wrong

medication for several days before the physician discovered the error.

The importance of checking with the correct person and hospital policy is

highlighted in the following case of an incorrect dose of potassium chloride being

dispensed and administered to a patient. The pharmacist checked the order with the nurse

but did not check with the ordering physician. The potassium administration policy of the

healthcare organization was not checked, either. Consequently, the wrong dose of the

medication was dispensed and partially administered before another nurse intervened and

had the infusion stopped. The order read:

• “‘IVF: NS w/40 mEq KCl @ 125 cc/hr.’ However, the ‘w/40’ looked like ‘NS
~140 mEq KCl.’ The pharmacist entered order as 140 mEq KCl in 1 liter NS.”

In the following case a patient in a correctional facility received a double dose of

medication because the nurses did not check medications previously administered and the

patient provided incorrect information.

• “The patient…lied to nurse about receiving medication from transferred site.


Nurse gave meds without verifying and thus gave double dose of LithoBid.”

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A contributor to this next error involving communication was the lack of checking

by read-back and verifying the order with the prescriber by this nurse working in the

labor and delivery area:

• Terbutaline (bronchodilator; unlabled use premature labor) and Methergine


(methylergonovine; oxytoxic) (Skidmore-Roth 2008)
“An experienced LDRP nurse took a verbal order for Terbutaline…, the nurse
accidentally wrote ‘Methergine’…instead of the oral Terbutaline. The order
was not read back to the prescriber”

and consequently the nurse administered the wrong medication to the patient. This error

did result in patient harm. These drugs have “opposite effects in the pregnant patient” (R.

T. Reilly, personal communication, February 12, 2008).

Several errors involved patients receiving medications to which they were allergic

and were related to a FOM transmission, reception and acknowledgment/clarification.

These errors occurred for various reasons including: lack of documentation, lack of

verification of allergy status, not reading information in the chart, lack of knowledge

regarding medication and lack of verification.

An exemplar illustrates a number of defenses that were breached. In the following

case the patient allergy to non-steroidal anti-inflammatory drugs (NSAID) was

documented. However, Toradol (an NSAID) was ordered and administered anyway

because of communication problems and other issues. In this case, the patient’s medical

information was not reviewed by the healthcare provider nor did the healthcare provider

ascertain whether or not the patient had an allergy before ordering the medication. The

patient did not tell the nurse about the allergy until after the medication was injected. It is

unclear why the nurse administered the medication when there was a documented allergy

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to the medication. As seen in this excerpt below, there were many opportunities for this

error to be stopped before the patient had an adverse outcome—but the defenses were

breached.

• “Known allergy to Aspirin and NSAID. History of asthma, history of anxiety,


and PTSD.… Chart/kardex/MAR was not in hand when Toradol ordered;
allergy band was not checked. The patient was informed about the Toradol
about to be given, and after it was injected she told the nurse about the allergy
and prior resp [respiratory] distress.”

The patient subsequently began wheezing and became dyspneic. Communication

problems among healthcare providers continued in this case, and the FOM transmission,

reception and acknowledgement/clarification involved a number of healthcare providers.

Handoff Issues

Handoffs present many opportunities for FOM transmission, reception and

acknowledgment/clarification. A review of the narratives in this sample revealed many

communication failures related to the handoff. In the following case, one defense is

breached after another. It is apparent from review of this case that a handoff is a complex

but fragile communication process that is vulnerable to breaches in defenses. The

following is a summary of the case.

Patient Z, who had lung cancer, was admitted to the Emergency Department with

dehydration and the plan was to administer intravenous fluids and discharge the patient.

Patient X was admitted after a motor vehicle accident to the same Emergency

Department and required intubation. The physician, Doctor C, was caring for both

patients. Dr. C gave verbal orders to Nurse A for a neuromuscular blocker (vecuronium)

and sedation (midazolam) for the intubation of Patient X. But there was a FOM related to

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transmission as Dr. C entered an electronic order for the neuromuscular blocker and

sedation on the wrong patient record and actually entered the order on the medical record

for Patient Z, the patient with dehydration. Patient X was medicated per the verbal orders

then intubated and prepared for transfer. Meanwhile, Nurse A caring for Patient Z went

on break and another Nurse B reviewed the orders that were entered by the ER physician

on the wrong patient (Patient Z) in the electronic record. A FOM reception occurred

because the nurse was reading the information for the wrong patient. Nurse B

administered the sedative and neuromuscular blocker without questioning the physician’s

order. There was also a FOM acknowledgement/clarification. Nurse B then left the

patient unmonitored after administering the medication and the patient stopped breathing.

Communication issues observed in this narrative:

1. Physician incorrectly entered an order for neuromuscular blocker intended for

trauma Patient X. The order was entered in the record of a patient with lung

cancer (Patient Z) who was admitted for intravenous therapy to treat

dehydration. (FOM transmission)

2. Nurse A caring for Patient Z went on break and another Nurse B took over

care of Patient Z. There is not documentation of communication between

Nurse A and Nurse B regarding the patient. (FOM transmission, FOM

reception)

3. Nurse B did not question order for neuromuscular blocker without ventilator

support for Patient Z and apparently did not realize the order was for Patient

X. (FOM Acknowledgment/Clarification)

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4. Nurse B obtained neuromuscular blocker (process not stopped by double

check of any type). (FOM Acknowledgment/Clarification)

5. Nurse B administered neuromuscular blocker to Patient Z who was not

intubated and did not check with anyone about this order prior to

administration. (FOM Acknowledgment/Clarification)

6. Nurse left Patient Z unmonitored and without ventilator support. There is no

evidence that any other healthcare provider received communication to

monitor patient or provide ventilator support.

7. The patient stopped breathing.

A host of factors contributed to this fatal error within a handoff between one nurse

and another. Nurses A and Nurses B apparently did not communicate effectively

regarding patient Z. If the patient had remained under the care of the same nurse the error

on the chart may have been noted and questioned as the nurse knew the context of care

for the patient.

The following case also involves a fumbled handoff as there is a lack of

transmission of critical information during a transition in care. There does not appear to

be effective verbal communication of administration of a bolus of Dilantin (phenytoin;

anticonvulsant). The written communication was not available and complicated by the

presence of two documentation systems that were not consistent through the facility. The

patient suffered a severe adverse outcome.

• “ER did nursing notes on paper at the time. PICU did nursing notes on the
computer. A portion of patient’s chart did not accompany patient to PICU….
Physician did not see a bolus of Dilantin was given in ER and ordered another

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bolus of Dilantin. Pharmacy did not recognize the double bolus order. The
drug was given.”

Another handoff scenario illustrates the problem of lack of report compounded by

not reviewing the medical record. A patient received morphine from a Certified

Registered Nurse Anesthetist (CRNA) and than the patient was transferred to a nurse in

the recovery room. The CRNA apparently did not provide a report to the nurse, resulting

in a FOM transmission. The accepting nurse reportedly did not review the OR record and

also administered morphine. The patient subsequently coded.

Even if information is transmitted between healthcare providers, it can be

interpreted incorrectly. A patient was transferred from a hospital to a skilled nursing

facility but the record “was difficult to read” and the medication was transcribed

incorrectly. The error was not noticed by the physician who signed off on the order, nor

was the order questioned. Consequently, the patient received the wrong medication.

Problems with handoffs are complex and can have grave consequences for

patients when the communication between healthcare providers is so compromised that

the therapeutic interventions are not implemented as planned.

Similar Medication Names: Look-Alike and/or Sound-Alike Medications

A number of examples where look-alike medications were mistaken for other

medications were seen in transcription and the interpretation processes contributing to

confusing communication regarding medication administration.

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• Omacor (omega-3-acid ethyl esters; used to lower high triglyceride levels)
(Nursing 2007 Handbook) and Amicar (aminocaproic acid; hemostatic)
(Skidmore-Roth, 2008)
“Order received for Omacor.... Nursing transcribed it as Amicar.”

• Avandia (rosiglitazone; antidiabetic) and Coumadin (warfarin sodium;


anticoagulant) (Skidmore-Roth, 2008)
“A Physician wrote an order for Avandia 4 mg PO daily, but the Pharmacist
interpreted the order as Coumadin 4 mg PO daily and entered it on the MAR.”

The look-alike and similar medication name was a frequent finding in this

analysis. There are many risks with verbal communication, especially when

communication involves sound-alike medications. A “repeat-back” was used in the

following case to confirm a medication but the medication was still misunderstood,

because complete information was not provided and a FOM acknowledgment/

clarification occurred.

• Diabeta (glyburide; antidiabetic) and Zebeta (Bisoprolol; beta blocker; anti-


hypertensive) (Skidmore-Roth, L. 2008)
“The nurse thought the reporter said Zebeta back to her, but it was Diabeta the
reporter said back to her.”

The person sending the order thought the read-back was Zebeta, not Diabeta. In this

instance, more information would be helpful, including the indication for the medication,

to assure the correct medication was “read back.” In another case involving a verbal order

transmitted by a nurse to a pharmacist, the pharmacist heard the wrong medication. The

pharmacist noted when the environment “was loud and busy” and “a possible error

cause(s) and contributing factor(s): sound-alike drug that was orally communicated to the

pharmacist.”

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Table 17 illustrates some of the medications designated as look-alike/sound-alike

by the reporters of medication errors in this study and were related to a FOM

transmission and reception.

Table 17

Examples of Look-Alike/Sound-Alike Medications


Identified by Reporters of Medication Errors
Ephedrine Epinephrine
Oxycodone Oxybutynin
Paxil Plavix
Diabeta Zebeta
Zyrtec Zantac

Missing or Incorrect Information

A FOM transmission of critical information can contribute to the process for an

accident trajectory in a handoff or at any point in the healthcare continuum. In the

following handoff case information was omitted at several points, contributing to a

medication error and an adverse outcome for the patient. The medication error was

identified by the doctor reviewing the medications when the patient was readmitted to the

hospital.

• “The patient…was discharged from the NICU (neonatal intensive care unit)
with a prescription for nebulized Albuterol.… There was no mg or mL
designated, nor an amount to dispense. The pharmacist in the outpatient
hospital pharmacy dispensed Albuterol syrup in an amber bottle, and the label
did not state a route. The parents received instruction by a nurse in the
hospital on how to use the nebulizer, and it was demonstrated using the
Albuterol syrup they had picked up from the hospital outpatient pharmacy.
They went home and had frequent home nursing visits where the home health
nurse also used the syrup in the nebulizer.”

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Communication issues observed in this narrative:
1. Incomplete prescription order. (FOM transmission)

2. The pharmacist filled the prescription with syrup but did not document a

route. (FOM transmission)

3. The care providers did not understand the route and administered the syrup via

the nebulizer, and the error trajectory continued. (FOM reception, FOM

acknowledgement/ clarification)

4. Error complicated by lack of clarification at the ordering, dispensing and

administering phases by healthcare providers. (FOM acknowledgment/

clarification)

5. Lack of adequate medication reconciliation. (FOM acknowledgment/

clarification)

The communication issues contributed to this medication error and the condition of

patient worsened, requiring hospitalization where the error was identified by a doctor.

The previous case illustrates a problem with missing information involving a

discharged patient that contributed to a cascade of errors. There was evidence of FOM

transmission, FOM reception, FOM acknowledgment/clarification. This analysis revealed

many episodes related to missing information. Information can be missed at any point in

the healthcare continuum.

The problem of missing information and the lack of a systematic process in

gathering patient data is highlighted in the following example related to Methotrexate, a

chemotherapy agent.

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• “None of the admitting orders or assessments had the dose or schedule for
Methotrexate listed.… We have no formal policy for details on what to collect
for medication histories on admission assessment.”

Medication Reconciliation: Lacking or Compromised

The FOM transmission can contribute to wrong information being entered in the

medical record. The error can be complicated by a FOM acknowledgement/clarification.

In the following case a reconciliation to verify the correct medication did not

occur and subsequently the patient received the wrong medication.

• Paxil (paroxetine hydrochloride; antidepressant selective serotonin reuptake


inhibitor (SSRI) and Plavix (clopidogrel bisulfate; platelet aggregation
inhibitor)(Nursing 2007 Handbook; Skidmore-Roth, 2008)
“The RN (registered nurse) wrote down ‘Plaxil’ in the ED intake note under
medication history. The nurse did not write down a strength, dose, frequency
or anything else at this point. The admitting physician then had a discussion
with the patient prior to writing her admission orders and got the dose from
the patient.… When the physician wrote the admission orders she wrote for
Paxil.”

In this case the patient was actually supposed to be on Plavix, not on Paxil, and the

patient suffered an adverse outcome as a result of this series of communication

breakdowns, including incorrect spelling of a medication. The medications were not

reconciled in this exemplar and the omission of effective medication reconciliation

contributed to this error.

The medication reconciliation process is recognized as an important strategy

improving the safety of medication therapy. However, the importance of access to

information is echoed by this reporter attempting to verify medication information during

a medication reconciliation process.

• “The accuracy of the medication histories on admission is a risk point in my


opinion for most reconciliation processes that I have seen.”

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When the reconciliation process is not used or the information is missing or inaccurate,

communication of essential information is compromised.

Missed Opportunity: Pharmacy Not Open or Bypassed

Given the complexity of healthcare, the knowledge base of all team members

working synergistically is critical to execution and delivery of safe patient care. When the

pharmacy is bypassed or not available to review orders another error defense is omitted.

The lack of opportunity for communication and subsequent checks is disrupted and there

is a FOM acknowledgment/clarification by pharmacy.

In the following instance the medication was prescribed incorrectly by a physician

and the nurses administered the medication before pharmacy noted the error, as described

below.

• “ordered by MD q8h instead of q24 hour per normal dosing schedule.…


Pharmacy recognized error when opened in a.m.”

In another case, a pharmacy was closed, necessitating that a nursing supervisor

obtain the medication from another hospital; the medication was obtained but sent

without the strength being documented. The patient received an overdose of the

medication as there was confusion regarding its concentration that could not verified by a

pharmacist.

The danger of not having a pharmacist check an order can be lethal—especially if

there is a knowledge deficit regarding the medication by the prescriber and other

healthcare providers.

This next case illustrates the benefit of having a pharmacist available to intervene

and provide a barrier to patient harm. A “lethal order” was written by a doctor and

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entered by nursing. However, pharmacy caught the “lethal order” and notified the

physician and the order was changed. The comment from the reporter of this incident

underscores the critical importance of having a pharmacist review orders.

• “There is great value in all the steps we go through and clearly demonstrates
the danger in bypassing pharmacies in overrides or at night.”

A potentially fatal outcome was averted because a pharmacist was available and able to

communicate with the healthcare providers involved in this error report. The medication

was not administered to the patient.

Distractions

In this review of communications issues related to medication errors, distractions

were cited as a contributor to medication errors. Two examples illustrate this issue.

• Wrong dose: Cardizem (diltiazem hydrochloride; calcium channel blocker,


antiarrythmic) (Nursing 2007 Handbook; Skidmore-Roth, 2008)
“Transcribed an order with the wrong strength of Cardizem. Possible error
cause(s) and contributing factor(s): distractions during order transcription.”

• Medication Omission: Lovenox (enoxaparin sodium; anticoagulant) (Nursing


2007 Handbook)
“RN signed off order for Lovenox 30 mg Sub Q every 12 hours, but did not
transcribe it to the med administration record…. Possible error cause(s) and
contributing factor(s): distraction; order not transcribed to MAR.”

Both distractions impeded the communication process by contributing to a FOM

transmission. In the latter case, since the message was not transmitted the medication was

not administered.

Technology Challenges

Another communication issue identified in this analysis was the role of

technology in the medication errors. The subcategories of the issues observed in this

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category encompass order entry errors/electronic communication and design issues

related to technology.

Entry Errors/Electronic Communication

Human error can disrupt the flow of accurate communication even when

electronic communication systems are in place. In the first exemplar the error was

intercepted by confirmation of message (COM) acknowledgement/verification before

reaching the patient. However, the error did reach the patient in the second and third

exemplars.

• oxycodone (opiate analgesic) and oxybutynin (anticholinergic) (Skidmore-


Roth, 2008)
“Oxycodone 10 mg BID written on paper. This error occurred during a period
of implementation of CPOE. Written orders were transcribed by nursing into
the CPOE system. Transcribing nurse entered Oxybutynin XL 10 mg bid.
Pharmacy caught the error by comparing original paper with nurse’s CPOE
error.”

In the second exemplar entry errors also occurred when inputting medication

doses incorrectly to an infusion pump. Two nurses were inputting dosage information to a

patient-controlled analgesia pump. The first nurse entered the dosage information

incorrectly and the second nurse was supposed to check the first nurse’s input

information but that second nurse was interrupted. The entry error made by the first nurse

was not identified and the patient suffered an adverse outcome and died.

In a third case, the nurse double entered a number, resulting in the patient

receiving an accelerated infusion. The patient died after the error was discovered.

• “The RN programming the pump double hit the key #4, and delivered 442
mL/hr…. The error was not discovered until the pump alarmed ‘dose given.’”

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These three examples underscore the risks of entering information incorrectly and

the lack of verifying the information inputted or safeguards that identify or prevent such

errors.

Design

In all of the following cases technology design contributed to errors that reached

the patient.

A design factor contributed to miscommunication by adding information to an

order via a default. The cascade of error causes included: lack of route clearly specified

on physician order, legibility issues with the order, the route not checked with the

physician, and a Licensed Vocational Nurse’s (LVN) lack of knowledge regarding the

appropriate route of medication. The computer default assigned IJ for “injectable”

resulting in a FOM transmission. The entry was not manually overwritten to the

subcutaneous route. The reporter states the LVN reviewed the MAR (medication

administration record) and:

• “interpreted the order to be intrajugular. Upon entering the patient’s room,


[the LVN] noticed that the patient did not have intrajugular access and
consulted with the RN (registered nurse). Both reviewed the chart and
interpreted that the order was not intrajugular, rather, interpreted the order to
be IV.”

As a result of this error the patient did incur harm. This case illustrates the challenges in

design issues related to electronic documentation systems and their impact on

communication.

In another case the patient identification display on the electronic order system

was deemed so problematic that the system was turned off until a display could be

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redesigned to more clearly display patient identification. In this case, the doctor had

inputted the physician order (a neuromuscular blocker) on the wrong patient and the

patient receiving the neuromuscular blocker suffered an adverse outcome.

A different type of technology issue caused a miscommunication of an order. A

TPN order was sent via a fax that “had a streak down the side of the order. The order for

Dextrose 15% looked like 5%.” The error was identified and no harm came to the patient.

The action to address the problem involved assuring that the glass on the scanner is

cleaned to prevent the reoccurrence of a set of circumstances that contribute to the

information being interpreted incorrectly.

Technology permeates the healthcare delivery system and can contribute to

unanticipated communication breaches resulting in FOM transmissions as illustrated in

these examples.

Healthcare Provider and Patient/Family/Significant Other Communication

There were numerous examples of confusing or inadequate communication

among healthcare providers. Impaired communication processes were also observed

between healthcare providers and patient/family. The medication dispensing and

administration process is complex and can be compromised if there is miscommunication

between healthcare providers and patient or family members. Several exemplars illustrate

how fragile the communication process can be in healthcare and are presented in two

subcategories: impaired communication process and misidentification of patient.

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Impaired Communication Process

In the following case, a patient’s wife is at the fulcrum of one of the

communication processes gone awry, involving failure of message (FOM) transmission,

receptions and acknowledgement/clarification. Through a series of communication

breakdowns the incorrect medication (oral contrast) was issued and administered. The

wife did not make contact with the healthcare professional familiar with the case.

Subsequently a staff person not aware of the details of the case provided the wrong

medication to the wife of the patient and the errors continued:

• “The patient’s wife was sent to pick up the IV contrast from the radiology
department. She was supposed to ask for a specific individual who was
informed of the details of the arrangement of the IV contrast. Instead, the wife
announced to another staff person that she was there to pick up a bottle of
x ray prep for her husband. She was given the oral contrast. The radiology
staff did not check the schedule to verify the patient’s test. The wife returned
to the nephrologist’s office with the oral contrast.”

The patient had a central venous dialysis catheter. The oral contrast was

administered into the dialysis catheter. The patient did suffer an adverse outcome as a

result of this medication error. In this case a number of defenses were breached and this

scenario displays several at-risk behaviors. The dispensing healthcare provider did not

verify the patient was to receive an IV contrast and gave the wife oral contrast..

Reportedly the bottle did not have any warning or label for oral/enteral use only. The

administering healthcare provider apparently did not observe that the contrast dispensed

was oral contrast not IV contrast, in addition to other breaches of defenses. The patient’s

wife was unwittingly part of the trajectory of error due to miscommunication and systems

issues.

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Another type of a FOM transmission that emerged in this analysis occurred when

a patient provided incorrect information to healthcare providers regarding a medication,

and the:

• “order was written that way by covering physician…by patient’s physician.


Pharmacist called nurse to inquire as to why the patient was on a daily dose
and was told the patient had cancer. Unfortunately, the drug (Methotrexate)
(sic) was being prescribed for arthritis every week.”

The patient received multiple doses of methotrexate and died. There was a FOM

acknowledgement/clarification. The healthcare providers in this case did not adequately

verify the purpose of the medication. Due to the seriousness of this error, the hospital

instituted various corrective actions after this tragic incident.

Another failure of transmission illustrates the importance of family members

needing to understand the importance of communicating essential information

consistently. The incident involved a mother and a child. The “mother got shots at

doctor’s office using two different last names of the child.” Later it was determined the

immunization had already been given to the patient under another last name, and

therefore the child had received a duplicate set of immunizations that were unnecessary.

Misidentification of Patient

One of the “seven rights” of medication administration is the right patient. Lack

of, or confusing, communication can lead to misidentifying the patient and the wrong

patient receiving medication.

More effective communication processes with the family in the following case

could have averted a patient receiving medication that was not ordered.

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• “The nurse asked the mom to hold the infant so the nurse could give the shot.
Mom asked, ‘Why is he getting a shot?’ The nurse replied, ‘For his breathing.’
No ID was asked for. The injection was given to the infant.”

The nurse engaged in an at-risk behavior by not verifying identification of the patient or

thoroughly explaining the reason for the medication until the patient’s mother queried the

nurse.

In another incident, communication between the patient and healthcare provider

was not clear and verification not adequate to assure the correct patient was receiving the

medication. A patient received another patient’s medication by responding to the

healthcare provider calling another patient’s name. In this case the patients’ “first names

were similar.”

In both of the preceding cases there was lack of clarification to assure the correct

patient was receiving the medication. These cases illustrate the at-risk behavior of not

verifying and clarifying information and lack of clear and accurate communication

between healthcare providers and patient/family members resulting in errors that could

have been avoided.

Communication Issues Involving Lack of Knowledge

Lack of Knowledge and Assumptions

At-risk behavior includes lack of knowledge related to prescribing, dispensing or

administering a medication (NCC MERP, 2007b). Lack of knowledge combined with

communication deficits was observed in a number of medication errors.

In one situation the physician did not specify a route when writing the medication

order. Therefore, there was a FOM transmission since critical information was omitted

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from the communication process when ordering the medication. The nurse lacked

knowledge regarding the correct route of the medication. The pharmacy realized the

medication was for an oral route and dispensed the medication in an oral syringe.

However, the nurse assumed that since the medication came from pharmacy in a syringe

it was to be administered via an intravenous route. The nurse was unfamiliar with oral

syringes and assumed a route rather than checking the route prior to administration. The

nurse bypassed the use of the oral syringe in which the medication was dispensed and

transferred it to a parental syringe for administration and injected the medication.

Fortunately, the nurse communicated with another nurse and immediate action was taken

to address the error and serious harm to the patient was averted.

Lack of knowledge played a role in the following miscommunication in which the

ordering physician misunderstood the treatment plan. Subsequently the nurse essentially

bypassed the pharmacy and obtained the sterile water for injection from a source other

than the pharmacy.

• “The resident participated in a discussion during rounds in which the patient’s


hypernatemia was evaluated and a decision made to administer ‘free water’ in
an effort to normalize the sodium level. Though other physicians present
understood that the administration of free water was to be via the patient’s
feeding tube, the resident assumed that the order was to be written for
intravenous infusion. The primary nurse was concerned with this order and
called pharmacy to inquire if the IV was available. The question of clinical
appropriateness was not discussed, and the pharmacy technician who
answered the telephone did not understand the significance of the question.”

In this complex case there was a FOM reception as the ordering physician

understood a therapeutic intervention differently than the other physicians, even though

all were involved in the same discussion. There was a FOM transmission and reception as

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the nurse’s and pharmacist technician’s communication was lacking and the importance

of the question was not recognized by the pharmacy technician nor communicated by the

nurse. Even though there was communication by healthcare providers it was not

effective. The potentially fatal error was caught by another nurse who recognized this

serious error and intervened by confirmation of message (COM) acknowledgment/

clarification.

In the following case two nurses demonstrated a knowledge deficit about a

medication that was complicated by making incorrect assumptions and not confirming

the order.

• Reminyl* (galantamine hydrobromide; anti-Alzheimer agent) and Amaryl


(glimepiride; antidiabetic) (Skidmore-Roth, 2008)
“The pharmacist entered Amaryl 4 mg BID (twice a day) into the computer
for the patient. The nurse transcribed the order on to their M.A.R. (medication
administration record) as Reminyl 4 mg BID.”

Reminyl was ordered for a patient, but the pharmacy dispensed the medication

Amaryl because there was a FOM reception. When the Amaryl medication was received

by nursing, two nurses incorrectly assumed Amaryl and Reminyl were the same

medication. Amaryl was given to the patient who subsequently became hypoglycemic

and required treatment. The nurses did not question why Amaryl was being dispensed by

the pharmacy for a patient without diabetes. Therefore a FOM acknowledgement/

clarification occurred. The lack of knowledge by the nurses and lack of communication

between nursing and pharmacy contributed to the patient receiving the wrong medication.

It was a third nurse who actually sought to clarify the discrepancy between the ordered

medication and the dispensed medication. *Due to the name confusion between Reminyl

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(indicated for Alzheimer’s disease) and Amaryl® (indicated for diabetes), the Reminyl

trade name was changed and is now marketed as Razadyne™ (immediate-release) and

Razadyne™ ER (extended-release) (U.S. Pharmacopeia, 2005b).

In another case involving assumption and lack of clarification of information, a

nurse assumed data on a piece of paper was blood glucose levels. The nurse

misinterpreted the data, resulting in a FOM reception. In actuality, the numbers indicated

the patients’ room numbers—not patient’s glucose readings. Many errors in found in this

data set occurred related to a lack of knowledge coupled with communication failures.

Lack of Access to Information/References/Instructions

Healthcare providers are faced with constant changes and new products emerging

on the market. Access to current information and references is critical to providing safe

care. In several reports healthcare providers sought additional information about

medications to be administered. Of those, there were several reports of nurses consulting

reference books that were confusing, contributing to nurses making medication errors.

In other cases communication regarding information about drugs was impeded

because of problems retrieving accurate information in a timely manner from established

references, or lack of clear instructions. In one case a nurse questioned the pharmacy

about administering a medication. The pharmacist then looked the medication up on a

computer-based reference program but did not review all computer screens. The

pharmacist did not see information regarding the different formulations for the

medication, thereby missing information regarding its administration route.

Subsequently, there was a FOM transmission as the pharmacist communicated incorrect

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information to the nurse. The nurse then administered an intravenous (IV) preparation via

the wrong route.

Communication can be compromised in the event that information cannot be

retrieved, as illustrated in the previous case. The lack of written communication regarding

medication instructions was noted in a tragic case where a patient died.

• “There were no standard instructions provided for feeding tube administration


nor instructions provided regarding the requirement to flush the dose with 30
mL of saline.”
The drug was incorrectly administered by the nurse via the intravenous route.

Swiss Cheese Model Error Trajectory

In answer to research question two, What are the communication issues that are

identified in medication error reports?, numerous communications issues were identified

in this research. But the most frequent finding to emerge related to communication issues

was exemplars of Reason’s Swiss Cheese model (1997, 2000, 2001). Observed error

trajectories included communication issues within medication errors illustrating how

defenses were breached and/or how defenses were maintained.

Defenses Breached

In the majority of narratives the Swiss Cheese model error trajectory was

observed. In a number of errors multiple defenses were penetrated and the error followed

a trajectory that reached a patient, causing harm.

A case with several breaches and patient harm is described in the following error

report. There was a FOM transmission (unclear order) complicated by a FOM reception

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(the order was misunderstood) and a FOM acknowledgment/clarification (order not

clarified).

• Colazal (balsalazide; gastrointestinal antiinflammatory) and Clozaril


(clozapine; antipsychotic) (Skidmore-Roth, 2008)
“We had a look-alike/sound-alike medication error. Physician wrote unclearly
for Colazal (Balsalazide) which was read as Clozaril (Clozapine)…. Pharmacy
and nursing dropped the ball in getting the medication clarified.... Error
discovered when ordering physician came back on Monday and over the
weekend, on-call physician could not clarify order correctly.”

A series of communication issues were involved:

1. This error involved a handoff as the on-call physician was unfamiliar with the

medication order and could not verify the order written by patient’s ordering

physician. (FOM acknowledgment/clarification)

2. The order was written unclearly and looked like another medication. (FOM

transmission).

3. The order was not clarified by nursing. (FOM clarification)

4. The order was not clarified by pharmacy. (FOM clarification)

5. The wrong medication was dispensed.

6. The wrong medication was administered to the patient.

7. The reported outcome for this error was that harm did occur to the patient.

This error could have been prevented from reaching the patient at a number of points

along the continuum. Additionally the reporter of this error noted, “Error could have been

prevented with CPOE (Computerized Physician Order Entry).”

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Defenses Maintained

The Swiss Cheese Model can also be used to illustrate examples of defenses not

being breached, thereby preventing a potentially harmful error from reaching a patient. In

one exemplar there is a tortuous effort to communicate with a physician to verify an

order. A nurse had called in the order; the pharmacist had a question about it. The

pharmacist then attempted to contact the physician and encountered numerous obstacles

via an automated message system. Upon finally reaching the physician’s office and

speaking with the nurse in the office, the pharmacist was advised as to the dosing

schedule and it was discovered the patient’s weight was being calculated based on

pounds not kilograms. The COM acknowledgment/verification allowed this error to be

identified and it was averted from reaching the patient. The reporter of this error

graphically described “holes” encountered in this medication use process.

• “This points to several ‘holes’ in the system: Off site orders with no physician
present to verify;…no indication on this order of what table or dosing formula
was used; endless and frustrating phone mazes that might cause someone to
simply hang up and say forget it; a dosing table that is very easy to confuse.”

In this case the pharmacist’s intervention was the defense that deflected the error

trajectory. The pharmacist provided a defense by questioning the order and clarifying the

order to assure the patient received the correct dose of a medication.

There were many exemplars of the Swiss Cheese model in this analysis, including

cases where defenses were breached and cases where defenses remained intact, as

depicted in Figure 7.

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Figure 7. “Swiss Cheese” Model: The ideal and the reality for defences-in-depth.
From Managing the Risks of Organizational Accidents (p. 9) by J. Reason (1997),
Aldershot, England: Ashgate. Reprinted with permission of Ashgate.

Summary

The data suggest that there are multiple communication failures within medication

errors. Some of the errors are multifaceted. For example, the physician order may be

written illegibly and contribute to a FOM transmission. The order is not clarified (FOM

acknowledgment/clarification) and the medication order is misinterpreted by the

pharmacist and the nurse (FOM reception) and the wrong medication is dispensed and

than administered to a patient.

The verbal communications used in healthcare are highly vulnerable to the

commission of an error, as in the case where a verbal order is given and the medication

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sounds like another medication (FOM transmission) and is misinterpreted (FOM

reception) subsequently the wrong medication is administered. This analysis reveals that

communication failures contributed to and caused errors. Conversely, effective, timely

COM identified transmission and/or reception problems and contributed to averting an

error from reaching a patient in many of the cases reviewed. The context also influenced

the error trajectory; for example, if a process was not in place to allow verification of a

communication, this could and did lead to communication failures. A summary of the

findings for Research Question 2 is in Table 18.

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Table 18

Summary of Findings for Research Question Two – Communication Issues Identified in


Reported Medication Errors
Taxonomy of Communication
Categories Subcategories
Failure, Success and Context
Non-Verbal Illegibility Failure of Message Transmission
Communication and/or Failure of Message Reception
Confusing Abbreviations
(Written/Printed and/or Failure of Message
Communication) Confusing Symbols and Numbers Acknowledgment.
Transcribing
Culture, Systems, Knowledge,
Misinterpretation Attitudes, Skills, Support – Influence
Label Problems (Internal) Source and Receiver.
Verbal Verbal Message Failure of Message Transmission
Communication and/or Failure of Message Reception
(Oral Implementation of Verbal Message and/or Failure of Message
Communication) incorrectly Acknowledgment.
Accents
Culture, Systems, Knowledge,
Confusing Abbreviations (Verbal) Attitudes, Skills, Support – Influence
Source and Receiver.
Threats to Lack of Verification or Checking Failure of Message Transmission
Communication Handoff Issues and/or Failure of Message Reception
Process and and/or Failure of Message
Transmission of Similar Medication Names: Look- Acknowledgment.
Message Alike and/or Sound-Alike Medications Culture, Systems, Knowledge,
Missing or Incorrect Information Attitudes, Skills, Support – Influence
Medication Reconciliation: Lacking or Source and Receiver.
Compromised
Missed Opportunity: Pharmacy Not
Open or Bypassed
Distractions
Technology Entry Errors/Electronic Failure of Message Transmission
Challenges Communication and/or Failure of Message Reception
and/or Failure of Message
Acknowledgment.
Design Culture, Systems, Knowledge,
Attitudes, Skills, Support –Influence
Source and Receiver.

Healthcare Impaired Communication Process Failure of Message Transmission


Provider and and/or Failure of Message Reception
Patient/Family/ and/or Failure of Message
Significant Other/ Acknowledgment.
Communication Culture, Systems, Knowledge,
Attitudes, Skills, Support – Influence
Source and Receiver.

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Table 18 (continued)
Taxonomy of Communication
Categories Subcategories
Failure, Success and Context
Communication Lack of Knowledge and Assumptions Failure of Message Transmission
Issues Involving and/or Failure of Message Reception
Lack of and/or Failure of Message
knowledge Acknowledgment.
Lack of Access to Information Culture, Systems, Knowledge,
/References/Instructions Attitudes, Skills, Support – Influence
Source and Receiver.

Swiss Cheese Defenses Breached Failure of Message Transmission


Model Error and/or Failure of Message Reception
Trajectory and/or Failure of Message
Acknowledgment.

Culture, Systems, Knowledge,


Attitudes, Skills, Support – Influence
Source and Receiver.
Defenses Maintained Confirmation of Message (COM)
Acknowledgement/Clarification

Culture, Systems, Knowledge,


Attitudes, Skills, Support – Influence
Source and Receiver.

Note. Taxonomy based on the work of Berlo (1960), Reason (1997), Weinger and Blike (2003).

Research Question Three: What Attributes Supportive of a Culture of Safety

Are Present in the Medication Error Reports?

The analysis of these reported medication errors offers exemplars of

characteristics associated with a culture of safety. Many of the medication error reports in

this sample described initiatives taken to promote safety. Errors were prevented from

actually reaching the patient due to the vigilance of and actions by a number of healthcare

providers, who were commendable in their tenacity to promote safe delivery of patient

care. Other actions were unique and required innovative strategies to resolve an identified

problem. In a number of errors related to healthcare providers’ lack of knowledge and

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communication failure, the error was actually prevented from reaching the patient due to

another healthcare provider intervening. Attributes of a culture of safety observed in this

sample included: open communication (healthcare providers, patients and families)

teamwork, learning culture, just culture, reporting culture, systems approaches and

support from leadership.

Open Communication – Healthcare Providers

Open communication includes being comfortable asking questions of others and

seeking clarification as needed. Such communication was observed between healthcare

providers in a number of instances.

There were several cases in which the pharmacist openly communicated with the

nurse to address concerns. In one case both the nurse and the pharmacist discussed an

unusual order and identified a problem with it. Subsequently there was a confirmation of

message (COM) acknowledgement/clarification: The nurse called the doctor back to

verify the order. The interactive communication between the nurse and pharmacist

contributed to this order being rectified. The role of open communication is valuable and

critical if errors are to be prevented. The reporter below acknowledges the importance of

being able to ask questions to prevent an error. This comment was in response to an error

made by a “new nurse”:

• “Therefore, we inform our nursing practitioners to never be embarrassed, and


to never hesitate to ask a question about something that is unclear or about
something they simply do not know.”

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Open and Flexible Communication – Being Present

A phenomenon observed in preventing some errors was being present and

working effectively with others to provide safe patient care. The reporter of the following

incident illustrates how by being present—interacting with staff and working as a team—

an error was identified and rectified.

• “The reporter had not seen the nurse give the pre-medications, so on a hunch,
the reporter asked if pre-medication had been given. The nurses [sic] response
was, ‘Oh, I thought that was just supposed to be given before the big bag.’
The reporter had the nurse stop the test dose, give pre-medications, and then
proceed.… Sometimes, it pays to just be available.”

The reporter in this case noted the value of being present, as it helped to be available to

prompt the needed intervention from the nurse.

In several other situations the pharmacists physically went to the nursing unit to

confirm the correct dosage of medications. In such cases open communication and the

initiative to seek clarification beyond telephone communication helped identify the error

and intervene to prevent a potential adverse outcome. The added component of in-person

communication proved to be valuable in the following cases.

This incident occurred in a hospital that did not have a pharmacist on site at all

times:

• “The pharmacist called…and spoke to the nurse who would be preparing the
drip.… Not being able to see the vial herself, the pharmacist asked the nurse
to verify the vial contents several times…. A few minutes later, still not
comfortable with the response, the pharmacist came into the hospital.”

The pharmacist found the nurse had misread the vial, therefore the calculation was

incorrect and the medication infusion was stopped and restarted with the correct dosing.

A similar incident, in which a pharmacist came to double-check an ampule, occurred in

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an Intensive Care Unit. Telephone communication alone was not enough to identify and

adequately address these errors. The communication between the pharmacist and the

nurses allowed these errors to be identified in a way that telephone communication could

not. Identification of the error occurred because the pharmacist was communicating and

interacting in-person with other members of the healthcare team.

The challenge of obtaining relevant information can be problematic given the

fragmentation in the present healthcare environment. The advantage of being present is

observed in an unusual case. In the following narrative there was a questionable order.

Additionally, incorrect information was on the patient record. Two healthcare providers

could not retrieve the patient data needed and had to seek out the information by

physically going to the doctor’s office to obtain the clarification needed to avoid having a

patient receive the wrong medication.

• “Staff pharmacist who fielded the initial order knew something was wrong,
spoke with floor nurse, and put things on hold; really tried hard to get PCP
doc to call back so we could clarify these orders, but no response.”

In this case there was a FOM transmission but it was addressed through a COM. The

pharmacist recognized a problem with the physician order and followed up by

intervening in this situation to protect the patient. The orders in this case revealed that the

wrong medication had been ordered and if the questionable orders had been implemented

the patient would have received the incorrect medication. This convoluted effort to obtain

necessary patient information also demonstrates systemic problems that need to be

addressed so communication can occur more efficiently.

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Open Communication – Patient and/or Family and/or Significant Other Intervention

Patients and family members must be included in the process of open

communication if the culture of safety is to be truly inclusive.

In one case, a patient received the wrong medication but the patient raised a

question and the order was subsequently clarified.

• Omacor (omega-3-acid ethyl esters; used to lower high triglyceride levels)


(Nursing 2007 Handbook) and Amicar (aminocaproic acid; hemostatic )
(Skidmore-Roth, L. 2008)
“The patient called the pharmacy after reading the patient information
pamphlet and stated that he was expecting something for cholesterol
reduction….the patient did not take any Amicar …[and returned the wrong
medication (Amicar)] and received Omacor.”

Family members can also play an important role in contributing to safe care, as

illustrated in an example where a nurse was preparing to administer medication to a

patient. The nurse had misinterpreted the order. The patient’s mother queried the nurse

about the volume of medication in the syringe. At that point the nurse realized she had

made an error in preparing the medication and did not administer the medication. In this

case the nurse assured a COM of the message from the mother by listening and

confirming the dosage. The nurse referring to the mother reported that “her vigilance

saved her baby from receiving the wrong dosage.”

The value of involving the patient in medication therapy is evident in this next

case. The nurse advised the patient of the medication and dose about to be administered;

the patient noted the discrepancy through a COM and spoke up and the message was then

received by the nurse, which helped to avert further error related to the insulin.

• “the nurse said to the patient ‘here is your 44 units of insulin.’ The patient
responded, ‘44 units? I take 4 units.’”

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These error reports illustrate how a patient or family member can help avert an

error from reaching a patient by questioning the healthcare providers about medications

being administered—and by the healthcare provider listening and responding

appropriately.

Teamwork

Effective teamwork and communication are found in a culture of safety. Narrative

reports described a number of instances in which communication among team members

helped avert a medication error from reaching the patient. One team member may not

realize there was an error, but another member of the team would identify an error and

efforts would be undertaken to address the error.

A pharmacist discovered this error when reviewing the admission orders that had

been phoned in by the doctor to a nurse. The pharmacist sought clarification and asked

why a patient was on an antihypertensive drug. The COM acknowledgement/clarification

helped rectify an error related to a verbal order. The patient was supposed to be on

Anafranil, not Vasotec.

• Enalapril (antihypertensive) and Anafranil (clomipramine hydrochloride;


antidepressant) (Nursing 2007 Handbook, Skidmore-Roth, 2008)
“I called the nurse…. The patient had no history or indication for Enalapril but
had a long history of multiple psychiatric diagnoses, and…was taking
Anafranil 25 mg BID prior to admission, which a call to her doctor
confirmed.”

A number of cases involved pharmacists working as team members and catching

errors as illustrated in the previous case. Nurses as team members also caught errors as in

the following cases:

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• Avandia (rosiglitazone; antidiabetic) and Coumadin (warfarin sodium;
anticoagulant) (Skidmore-Roth, 2008)
“A Physician wrote an order for Avandia 4 mg PO daily, but the Pharmacist
interpreted the order as Coumadin 4 mg PO daily and entered it on the MAR.
The Nurse caught the error and notified Pharmacy before any medication was
given to the patient.”

In another case a written order’s intent was compromised due to illegibility and look-

alike names. Both nursing and pharmacy engaged in a COM and questioned an order

which seemed unusual given the patient’s history. The teamwork of both pharmacy and

nursing professionals identified a problem. An intervention was made on behalf of the

patient, thereby averting the patient receiving the wrong medication.

In a culture of safety the value of having members of the team independently

check each other’s interventions provides an additional layer of protection. The process

of double-checking orders is an example of a redundant activity but it provides a valuable

defense to prevent an error from reaching a patient. The following three summaries of

error reports highlight examples of effective teamwork illustrate the benefit to patient

safety of double-checking stopping an error from reaching a patient.

1. Pharmacist and Nurse: The pharmacy intercepted an error by double-

checking the inputted medication by the nurse against the original physician

order, noted the discrepancy and acted upon it. The administration of the

wrong drug was avoided.

2. Nurse and Nurse: An error involving an erroneously transcribed dose of

insulin by a nurse was caught and corrected by another nurse. The

administration of the wrong dose was avoided.

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3. Nurse and Prescriber: A nurse addressed a confusing order for Coumadin by

checking lab values and seeking verification of the order from the prescriber

who wrote the original order. Subsequently the unintended administration of

Coumadin was avoided.

In the preceding cases, if checking with other team members and a COM had not

been conducted, the patients could have received the wrong doses or wrong medication.

These examples illustrate how verification of communication, a COM among team

members, can help avert an error reaching the patient.

Learning Culture

A hallmark of organizations that promote a culture of safety is the emphasis on

learning and education. Learning can be facilitated by allowing others to “know” about

problems so they can learn from such occurrences. The following exemplars indicate a

desire to share and learn from the lessons of others.

In the first case, a nurse shares information she learned from an error in which she

administered a drug via the intravenous route too rapidly and the patient subsequently

complained of “burning.” The nurse researched the drug and found it should be diluted

and given slowly as opposed to be given IV push. She developed a flyer to alert nurses

and discussed the medication error report at a staff meeting and received a positive

response to this strategy from the other healthcare providers.

• “Another experienced nurse began to share her recent med error…. The
director of a department came over after the meeting and said, ‘I really liked
the idea of sharing errors to improve patient care.’”

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This exemplar illustrates a nurse willing to share what was learned from an error and a

culture receptive to learning from others’ errors to promote safe care for patients.

In the second exemplar a healthcare provider comments on benefit of learning

from others’ errors.

• “It would be useful if the pharmacy would provide a summary of these types
of errors in a monthly newsletter so that we can learn from the mistakes of
others and not just our own.”

Both exemplars illustrate the desire to learn from others’ errors. The helpfulness of

sharing errors so others can learn is also apparent in these descriptions.

The most frequent action reported in response to a medication error in this sample

was some form of education. For example, one organization, in response to a complex

error involving inaccurate transcription of a verbal order, used the medication error as a

case study to educate healthcare providers.

• “The case is being used as an educational case study to promote the reading
back of verbal orders....”

Healthcare providers seeking to learn from errors was frequently observed in this

sample. The types of learning and education varied but the intent of learning from an

error emerged repeatedly in this sample.

Just Culture

Another attribute supportive of a culture of safety observed in this sample was the

just culture. In the following case a healthcare provider disclosed an error and safety

concern, which helped reduce the potential reoccurrence of a medication error. The

healthcare professional communicating the concern in this case was acknowledged and

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recognized for taking the initiative to identify and address the problems, rather than being

punished for contributing to an error. A physician alerted the organization that a different

concentration of a medication (not normally used in the organization) had been

inadvertently stocked and he had given the wrong dose to a patient. Rather than

punishing this healthcare provider for giving the wrong dose of medication (Nimbex, a

neuromuscular blocker), an investigation was undertaken to detect how this concentration

surfaced in the hospital when it was not in stock or ordered. The analysis revealed the

hospital had loaned medication to another hospital and the second hospital returned a

product with a different concentration in similar packaging to the lending hospital. The

other “unordered” concentration was removed to avoid a reoccurrence of the error.

Although this was an unusual event, the actions on the part of a healthcare

provider helped detect and address a threat to patient safety. The doctor was recognized

by the organization for his vigilance and contributing to preventing other errors. If the

focus had been on punitively addressing the error and going no further, the problem may

not have been identified and other patients could have been exposed to the same type of

error.

This scenario illustrates characteristics of a just culture where the physician

making the error was not punished for making an error because there were other

contributors. In the Nimbex case “a previously unrecognized source of error” was

addressed and remedied. A just culture encourages reporting errors in an environment

that is not focused solely on meting out punishment in response to errors. In another

medication error involving a myriad of deficiencies and systems problems, several nurses

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were involved in the error. The hospital made the decision to address systems issues

rather than blaming the nurses. However, the just culture does not embrace a totally

blame-free culture because there is also a need for accountability among healthcare

professionals who have a duty to protect the public.

In this sample there were a few reports of healthcare providers incurring

disciplinary procedures. But it is not known if other persons who made errors were not

disciplined, or if discipline was meted but not documented on the error reports.

Reporting Culture

Closely related to both a just culture and a learning culture is the ability to freely

report errors. In the exemplar involving Nimbex interventions to improve patient safety

were undertaken after the error was reported. Sharing lessons learned from errors cannot

occur if errors are not acknowledged and reported.

In one narrative, an error was reported “to the Medication Safety Committee as a

lesson for the importance of patient education and communication.” This report was

generated in response to a patient being seen post discharge in the doctor’s office wearing

(incorrectly) two medication patches instead of one. The patient apparently did not

understand the dosing of the medication.

Problems can not be addressed unless they are identified. In order to learn from

errors, healthcare providers need to feel free to report errors—a characteristic of a culture

of safety.

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Systems Approaches

In a culture of safety there is a focus on systems approaches. When an error

occurs there is an attempt to focus on the system rather than blame one person. Systems

also provide mechanisms to avert errors from reaching patients. The presence of effective

systems contributed to deflecting errors in several instances.

In the following case, there were many contributions to an error, including

knowledge deficit of healthcare providers and the non-availability of the specialty

physician. However, in this system, the medications had to be mixed by pharmacy which

included an opportunity to check the order. If pharmacy had not been included in the

process, this error could have reached the patient. The pharmacy engaged in a

confirmation of message (COM) and deflected the error.

• “If processed as written, this would have resulted in a sentinel event because
the order reflected a 13-fold increase…another example where ‘triad of
safety’ was crucial.”

The culture of safety is characterized by seeking to lower the risk of harm.

Actions taken in many of the error narratives involved organizations addressing systems

issues. A number of actions and recommendations to medication errors involved system

approaches to addressing errors. Some of the descriptions of such actions were extremely

detailed. Narratives included descriptions of identifying process that contributed to the

error and actions undertaken to address the error. Several exemplars are presented

illustrating system changes.

The follow-up action in the next case occurred in response to a “near miss” where

a pharmacist prevented a nurse from mistakenly administering epinephrine by pointing

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out that the medication was incorrect. The healthcare organization took steps to highlight

the difference between the two drugs to improve the transmission and reception of the

written message. In this case more than one person had made the same error thinking

epinephrine was ephedrine.

• “Since this incident, we have sent out a hospital-wide summary of the uses of
Ephedrine and Epinephrine. We have also added tall man letting [sic] on the
[xxx] computer screen for each drug in addition to tall man lettering on each
bin. In addition, we have labeled each Epinephrine bin in the [xxx] machines
with a warning....”

In a case involving a patient receiving medication via the wrong route, a number

of actions were initiated including adding a warning for nursing staff to the computer. It

was also suggested that the product involved be removed from the formulary as there

other products available “from an error prevention standpoint.”

These cases illustrate systems changes that encompass software modifications,

changes in policy, practice and other systems modifications.

Support From Leadership

The role of leadership in promoting a culture of safety is observed in the

following report in which the leadership provides acknowledgement of a nurse who

identified a patient safety concern.

• Zyrtec (cetirizine hydrochloride; antihistamine) and Zantac (ranitidine


hydrochloride; antiulcer) (Nursing 2007 Drug Handbook, 2007)
“A pharmacist dispensed Zyrtec syrup for Zantac syrup…. This nurse did not
recognize the smell of the Zyrtec and questioned the pharmacist on duty. (The
nurse will be recognized and will receive a patient safety award from the chief
executive officer of the institution).”

This case scenario illustrates key components found in a culture of safety

including open communication, willingness of the nurse to question a discrepancy,

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willingness to investigate the problem, followed by senior leadership recognizing and

rewarding the nurse. This case not only presents a good call in catching and rectifying an

error, but the organization rewards behavior that promotes patient safety so that other

healthcare providers can learn from this situation. As noted previously, recognition was

also afforded to the physician who identified the problem with the Nimbex stocked in the

hospital. Support of healthcare providers who demonstrated behaviors congruent with a

culture of safety is demonstrated in the previous exemplars.

Summary

Attributes of culture of safety were identified in these error reports, including

exemplars of deflections of errors. The summary of the findings are listed in Table 19.

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Table 19

Summary of Findings for Research Question Three – Attributes Supportive of a


Culture of Safety
Taxonomy of Communication
Category Subcategories
Failure, Success and Context
Culture of Open Communication – Confirmation of Message
Safety Healthcare Providers Acknowledgement/Clarification
Open and Flexible
Communication– Being Present Culture, Systems, Knowledge,
Attitudes, Skills, Support –
Open Communication – Patient
Influence Source and Receiver
and/or Family and/or Significant
Other Intervention
Teamwork

Learning Culture Efforts to Improve

Just Culture Confirmation of Message


Acknowledgement/Clarification
Reporting Culture
Culture, Systems, Knowledge,
Attitudes, Skills, Support –
Systems Approaches Influence Source and Receiver

Support From Leadership

Note. Taxonomy based on the work of Berlo (1960), Reason (1997), Weinger and Blike
(2003).

Research Question Four: What Attributes Not Supportive of a Culture of Safety

Are Present in Medication Error Reports?

A number of attributes counterproductive to a culture of safety were observed in

this analysis of medication errors. Organizations that support at-risk behavior are

supporting efforts counter to a culture of safety. At risk-behavior are those behaviors

“that may compromise patient safety” (NCC MERP, 2007b) and may arise because of

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“system-based problems with healthcare organizations” (NCC MERP, 2007b). For

example, organizations that support not reporting errors contribute to a culture not

supportive of safety. Many at-risk communication behaviors have been previously

described in this analysis. Additional at-risk behaviors are presented here including: lack

of teamwork, not reporting errors and a culture of secrecy regarding errors and (NCC

MERP, 2007b). The attributes counter to a culture of safety observed in this sample of

medication errors included the following: lack of open/effective communication, lack of

teamwork, process/system problems and not reporting errors.

Lack of Open Communication

A variety of cases included lack of open communication which contributed to a

FOM transmission and/or reception. Disruptive behavior can impede open

communication as seen in the following case.

A medication was ordered every eight hours instead of the usual once-a-day

dosing, but the nurse did not want to question the order because “the physician was

known to scream.” This error did reach the patient because a nurse did not want to

intervene and deal with a doctor known to engage in disruptive behavior. Additionally,

the pharmacy was closed and not available to check the order until the next day. This

unfortunate circumstance provides an illustration of how disruptive behavior such as

screaming at others can prevent communication and impact the medication regimen.

In another case of factors leading to error, a physician bypassed a protocol and

sent a patient to a regular nursing unit instead of a critical care unit. This resulted in a

medication error reaching a patient and causing harm to the patient. An interdisciplinary

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group of healthcare providers, including physicians, conducted a review of the error “to

identify all breaks in system and develop or enforce existing protocol.” However, the

reporter of this incident also noted:

• “The physician remains unconvinced of the need for a protocol or


standardization.”

This reporter is identifying a significant concern: Even though a team has identified

strategies to improve the delivery of care, the physician involved in the incident remained

“unconvinced.” The physician was apparently not open to the strategies the team

identified to address the error.

A number of cases involving poor communication processes between patient and

healthcare provider were observed. For example, the wrong medication was dispensed for

a patient. The patient communicated to the nurse this was a “different medication.” The

patient was told “this is the medicine the doctor prescribed.” The nurse displayed at-risk

behavior by not appropriately acknowledging the patient’s concern and checking on the

discrepancy identified by the patient. Additionally, there was no checking or validation

process in place to verify that the correct medication was being administered. The

reporter of the error did submit this error to the MER Program with the recommendation

to use a review/checking process and respond to the patient.

• “the staff to be responsive when the patient and family tells them that a
medication was never taken before as opposed to waiting…for the doctor to
review the medication list.”

The lack of open and effective communication in these cases contributed to medication

errors and placed patients at risk for harm.

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Lack of Teamwork

In contrast to the teamwork observed in a culture of safety, the lack of synergy

and coordination among healthcare providers was observed in a culture not supportive of

safety. It seemed in many cases healthcare providers were unaware that they needed to

work together. The lack of teamwork is influenced by the silos within which healthcare

providers often practice.

The problem with a “silo” mentality is articulated well in the exemplar below.

This comment by a pharmacist was in response to incorrect information recorded by a

nurse on the medical record.

• “I’ve tried to reinforce how important it is to have accurate detail since many
orders are subsequently written off information they record, but they work in a
silo and also have a certain number of charts to try and get done each day.”

The need for open and effective communication is necessary if all members of the

team are to be informed of changes. The following narrative describes how the

introduction of a new product was not effectively communicated to nursing staff by

another department.

• “For one thing, we did not inform nursing ahead of time about the change”

The lack of communication resulted in confusion regarding the new product.

When healthcare providers do not work together for the benefit of the patient,

errors that place patients at risk can occur. In the following case a nurse administered the

wrong dose of morphine, which is considered a high-alert medication and as such

requires “special precautions” (Cohen, Smetzer, Tuohey, & Kilo, 2007). Attitudes that

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promote resistance to safety precautions place patients at risk and are not consistent with

a culture of safety.

• “We had a patient who was started on a PCA pump post-operatively. The
doctor intended for a 1.5 mg per hour continuous infusion (in addition to bolus
doses), but the nurse interpreted it as 15 mg…. Possible error cause(s) and
contributing factor(s): We don’t use double-checks for PCAs due to nursing
resistance.”

In this scenario it does not appear nursing is using double checks. Although redundancies

and independent double checks are among the safety measures to be used with high-alert

drugs (Cohen, Smetzer, et al., 2007), but double checks were not used in this case.

The problems of lack of teamwork and working in silos are illustrated in the

previous incidents. In these cases communication was slowed, compromised or

prevented, resulting in a FOM transmission and or a FOM reception, thereby contributing

to medication errors.

Process/Systems Problems

Many communication issues are also related to process and system problems. The

previous exemplar involving administering the wrong dose of morphine also is an

illustration of a system issue. The error could have possibly been avoided if the

organization had a system mandating communication such as independent double checks

to assure that the right dose of medication is provided, but such communication was not

required and therefore a double check did not occur. Blaming one individual would not

prevent this error from reoccurring because the error could easily be repeated by another

nurse if there is no double check mechanism in place.

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In the following case several problems are described; the wrong dosage was

written in the medical record and then complicated by an inability to access and verify

information.

• “Pharmacist had no access to history for comparison…if history is wrong,


error just spills downstream, is easily missed, and can even be incorrectly
written into the discharge instructions.”

These cases illustrate systems that are not conducive to patient safety. Both cases

involve communication failures. In one case there is a FOM acknowledgement/

clarification as there is no independent double check. In the second case the FOM

transmission occurred because of an error in written communication and there was not a

system in place to help prevent the error. The system is only as strong as the weakest

link. Therefore initiatives need to be in place to maintain strength in the links within the

system.

Not Reporting Errors

One characteristic of a culture of blame, in contrast to a culture of safety, is fear

of reporting errors. Healthcare providers may be fearful of reporting an error, as observed

in the following narratives involving medication errors. In the following case the nurse

administered a medication to the wrong patient.

• “Unfortunately and sadly, I did not report this error. I was fearful of losing my
job. Our hospital had yet to publicize their new direction of a culture of safety
instead of punitive. I didn’t feel safe or secure to report this error which
occurred years ago.… My previous experience with errors (minor) was
negative.… I honestly thought I would lose my job and license.”

A culture that does not support reporting errors has negative consequences for

both patients and the healthcare providers providing care. This exemplar illustrates the

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fear of repercussions as a factor for not communicating and reporting errors. Another

example of culture that is not supportive of reporting errors is observed in the following

description. Trental was ordered but the patient received Tegretol and suffered an adverse

reaction.

• Trental (Pentoxifylline; hemorrheologic agent) was ordered for a patient but


the patient was incorrectly administered Tegretol (carbamazepine;
anticonvulsant) (Skidmore-Roth, 2008)
“Patient was given last rites by priest with family present.”

The family was not notified of the error and the organization indicated this was not a

reportable error. By not openly acknowledging this error the organization was treating the

error in a secretive manner. However, a healthcare provider did report this error to the

MER Program even though the provider’s organization did not consider this error

reportable.

Honest communication of errors is necessary for optimal patient safety so

necessary monitoring and treatment can be rendered to patients and so other healthcare

providers can learn from the errors of others and seek to prevent reoccurrences.

Summary

Several attributes counter to a culture of safety were observed in this sample.

Reporters clearly described systems and behaviors that increased the risk of medication

errors occurring. The findings are summarized in Table 20.

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Table 20

Summary of Findings for Research Question Four – Attributes Not Supportive of


a Culture of Safety
Category Subcategories Taxonomy of Communication
Failure, Success and Context
Culture Not Lack of Open Failure of Message Transmission
Supportive of Communication and/or Failure of Message
Safety Lack of Teamwork Reception and/or Failure of
Message Acknowledgment.
Process/System Problems
Culture, Systems, Knowledge,
Attitudes, Skills, Support –
Not Reporting Errors Influence Source and Receiver.

Note. Taxonomy based on the work of Berlo (1960), Reason (1997), Weinger and Blike
(2003).

Research Question Five: What Types of Interpersonal Issues Are Evident

in a Review of the Medication Error Reports?

A number of interpersonal issues emerged in these medication error reports which

encompassed emotional reaction to errors by healthcare providers, patients and family

members. The issues were aggregated in the following categories: healthcare provider

interpersonal issues and patient/family/friend interpersonal issues.

Healthcare Provider Interpersonal Issues

The qualitative analysis of medication errors permitted examining interpersonal

issues described in medication error reports. Healthcare providers described a number of

interpersonal issues and reactions related to errors, including interactions deflecting an

error, interactions contributing to an error, response to an error in the form of apology

and emotions of healthcare providers.

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Deflecting Error

A number of the errors were deflected because of effective interpersonal

interactions. In one case a physician ordered tissue plasminogen activator (TPA). The

nurse retrieved the wrong medication but checked the medication with another nurse

prior to administering, and the nurse sought clarification from the physician who also

checked the medication when the error was discovered. By interacting with the physician

a potential error was avoided. If the nurse had been reluctant, or afraid, to interact with

another healthcare provider, the error could have reached the patient.

Contributing to an Error

Errors also occurred because of the absence of human interaction, as in the case of

a nurse not clarifying an order because the “the physician was known to scream.” In other

cases the healthcare provider’s interaction with a patient contributed to a medication

error. In one case a nurse did not listen to the patient when the patient identified a

medication discrepancy, and consequently the patient received the wrong medication.

Interpersonal interactions in the form of open, interactive communication could help

deflect an error. But interactions that avoided or were ineffective could, and did,

contribute to errors.

Apology by Healthcare Providers

This analysis revealed that when errors occurred apologies were reported in some

cases. In a case involving an error identified by the patient (wrong medication) the

healthcare provider who provided the wrong medication reported

• “I then called the patient’s mother to apologize for the miscommunication


error on my part.”

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In a case in which doctor gave an incorrect order, the doctor later called the nurse

and apologized after issuing the order. The pharmacist and nurse had intervened in this

previously described case, and therefore the wrong medication was not actually

administered to the patient. While the apology did not prevent an error it illustrates a type

of interpersonal interaction related to an error and indicates a healthcare provider realized

his or her culpability in contributing to an error.

Emotions of Healthcare Providers

Healthcare providers’ emotions were evident in a number of these reports. There

were reports of healthcare providers not being comfortable with a situation and

intervening to prevent an error. There were also situations when healthcare providers did

not report errors because of fear. In one fatal medication error in this sample, the reaction

of nurses involved in the error was described as “devastated.” The emotional reactions of

healthcare providers to errors that emerged in this analysis spanned a range of feelings

including guilt, not feeling right, being nervous, fear of making another error and

devastated.

Two poignant descriptions recount the angst among a nurse and a nursing student

in response to separate medication errors they made. In the first case the nurse reported

the error and in the second case the nursing student did not report the error to others.

• Nurse: “I started telling other nurses how bad I felt about the discomfort I
caused my patient. The more nurses I talked with, the more I realized many of
our nurses were doing the same thing.”

• Nursing Student: “I was afraid to tell the nurses and thought that I would get
in trouble and not be hired to work on the floor.… I haven’t healed and have
felt horrible and so fearful of making another error.”

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Healthcare providers also report other emotions related to errors occurring. In one

case two nurses realized an error had occurred after leaving the nursing unit. The nurses

reported not feeling right which led them to contact the staff:

• “The nurses phoned after leaving the nursing unit because something did not
‘feel’ right.”

In this case not feeling right helped alert other healthcare providers that there was a

problem with a patient’s intravenous infusion.

The reaction of being nervous is understandable in the following case as a patient

almost receives the incorrect medication post procedure. The reporter described feeling

“nervous” about an error that occurred. A patient had an order for Omacor but the order

was interpreted as Amicar and the wrong medication was dispensed to a patient.

• Omacor (omega-3-acid ethyl esters; reduce high triglyceride levels) (Nursing


2007) and Amicar (aminocaproic acid; hemostatic) (Skidmore-Roth, 2008)
“Luckily the patient refused the doses…. It still makes me nervous to think
that we dispensed a fibrinolytic inhibitor to a patient that had just undergone a
cardiac procedure.” [This patient was not supposed to receive Amicar].
In another case, “being nervous” led to communicating with the doctor to address

a potential problem. Subsequently, through proactive communication, the concern was

addressed and the patient care plan was modified.

Patient/Family/Friend/Significant Other Interpersonal Issues

The interpersonal issues identified in medication errors reports were not limited to

healthcare providers: Interpersonal issues related to patients and family members were

evident in this sample. A total of 20 cases were found to be reported by the patient,

family member or friend (my father, my husband, my boyfriend, my sister-in-law, my

wife, my mother, reporter’s mother, I was given…). Three of the reports did not meet the

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inclusion criteria and thus were not included in the sample for qualitative analysis. In

many of the error reports emotions were described in reaction to a medication error or

perceived medication error. Some of these cases involved communication failures that

occurred because interpersonal communication between the patient/family and healthcare

provider/organization were ineffective, which contributed to a FOM transmission and/or

reception. Other cases provided descriptions of a FOM transmission or reception among

healthcare providers. The subcategories were perceptions and family reaction to patient

deaths.

It was noted that the incidence of reported harm to patients occurred in 82%

(14/17) of the cases (see Table 21). Categories with patient harm are categories E, F, G,

H and I. In 82% (14/17) of these cases the reports were described by family members and

18% (3/17) were described by the patients themselves. Table 21 provides a summary of

the cases included in this analysis.

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Table 21

Summary of Cases Described by Patient/Family Member/Friend


Case Describer of
Category Result Description
Number Error
1 F Harm My husband Family Member
2 I Death Reporter’s mother Family Member
3 B No Harm My father-in-law Family Member
4 D No Harm My boyfriend Friend
5 I Death My sister-in-law Family Member
6 E Harm I have epilepsy Patient
7 D No Harm My father Family Member
8 E Harm My wife Family Member
9 F Harm I lost a needed Patient
10 E Harm I was given Patient
11 G Harm My husband Family Member
12 G Harm My father Family Member
13 I Death My father Family Member
14 H Harm My wife Family Member
15 I Death My mom Family Member
16 G Harm My father Family Member
17 I Death My mother Family Member
Note. Category based on Coordinating Council for Medication Error Reporting and
Prevention (NCC MERP) Index for Categorizing Medication Errors (2001).

Perceptions

One of the issues noted in healthcare provider and patient /family interaction was

the perceived lack of communication after an error. In the following case a patient

received a dose of Lovenox in error and his family expressed their concern regarding the

lack of information and communication. The family desired information that was not

provided.

• “My father is very ill and already on Coumadin. The Lovenox was given an
hour after the Coumadin dose by the nurse.… We were only told at the time
that my father was given the wrong medication and that the doctor would be
there shortly. In hindsight, I feel we should have been told what was given,

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what the adverse reactions could be, and whether it was life threatening or not.
Also, if it wasn’t a concern, it would have been very comforting to know
instead of left worrying about the outcome.”

One of the reactions that emerged in this analysis of medication errors reported by

family members is the family member’s perception of lack of supportive communication

and concern by healthcare providers. A family member describes how his wife incurred a

reaction to a medication that is contradicted for intravenous administration. The

medication was given intravenously and the patient experienced a venous thrombosis and

phlebitis.

• “very little concern was given, and we were told it would clear up in a few
days. Well it has been three months…. Hospital administrator was notified of
incident, and he played it down too.”

The relative of another patient expressed concern that the allergies were not

assessed prior to administering medication and he or she was not notified of the particular

medication being administered to the patient.

• “She [nurse] never told us what it was, and she never asked if he had
allergies…. She didn’t even acknowledge that this might be an issue.”

In the following case the patient required resuscitation after receiving an overdose

of morphine via a Patient Controlled Analgesia (PCA) pump. This was a complex case as

it was the patient’s family member who recognized the patient was in distress and called

for help. The reaction to the medication error and response are described in a number of

terms. The family member describes feeling “blessed” that he was in the room to

summon help and “lucky” that the patient survived without long-term physical adverse

outcomes. The family member had to advocate for his wife by calling for help and was

present when the code was called.

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• “We were very lucky. We were very blessed in that I was in the room to get
help for my wife.… The team with the crash cart arrived, and I was still in the
room. I was obviously very upset. The doctor wanted to know what happened,
and the nurse had no idea. I was the one who told him that they had a problem
with the PCA pump.”

The family member was upset with the overdose. He was also upset by having to wait

two days for an administrative response, and by the attitude of the administrator when a

response was provided.

• “I was extremely upset as you can imagine and the administrator in charge of
nursing has a less than pleasant attitude. This upset me even more.”

The family member had asked repeatedly to speak to someone from the hospital. Attitude

during communication played a significant role in this interaction. When a hospital

administrator finally did respond, he or she was “less than pleasant.” Consequently, it

seems the communication contributed to the husband being more upset with the situation.

In another case the patient experienced convulsions after taking a medication. The

patient reported that healthcare providers did not follow up to address the patient’s needs.

• “I am very depressed by the lack of concern or treatment.”

In the following instance, medication name confusion related to verbal

communication between the patient and healthcare provider is reported (there were other

contributors to this error also):

• Klonopin (clonazepam; anticonvulsant) and clonidine (antihypertensive)


(Skidmore-Roth, 2008)
“Patient asked for Klonopin. Nurse asked him, ‘you mean Clonidine?’”
Subsequently the patient received the wrong medication and suffered an
adverse outcome.

In two cases family members reported perceiving a lack of truthfulness and trust.

In one example, a family member wanted to see the infusion pump after the patient

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experienced an overdose of morphine while on the infusion pump, requiring resuscitation

and admission to the critical care unit. The patient recovered but the family member

reports doubts about obtaining the correct information about the pump (make, model,

serial number):

• “I know now that I probably wasn’t even shown the actual pump, and even if I
were, the hospital got rid of the data that could have implicated a nurse’s
programming error.”

Families and patients also had reported perceived knowledge deficits and

miscommunication among healthcare providers:

• “new nurse who did not know the patient or his history.”

• “the doctor had not yet informed her [nurse] of his planned order change.”

Staffing inadequacy and/or work demand was also perceived to be a contributing

factor in a medication error:

• “Possible error cause(s) and contributing factor(s): too many patients, not
enough medical staff to help out, and a nurse who was mad because she was
so busy.”

Many of the reactions of family members and patients are in response to a

provider’s lack of perceived support, caring and knowledge. These perceptions by

patients and family members provide another perspective to communication issues

related to medication errors.

Family Reactions to Patients’ Deaths

The family members describe relatives’ deaths in each of two instances in

emotional terms. But in addition to the grief related to a family member’s death, these

first-person accounts describe distress with the care provided and the perceived lack of

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appropriate response from healthcare providers. In both examples presented,

communication seems to be lacking. Family members are very concerned, but the issues,

from the family’s perspective, do not seem to be adequately addressed by the healthcare

providers.

This first-person report of a family member describing the care rendered to their

96-year-old father raises questions about the interpersonal communication between the

family and caregivers. The family of a geriatric patient case perceived the patient’s death

was related to the medication prescribed.

• “Even after family kept insisting the problem was the patch, and the doctor
removed it, he failed to monitor my father…. It appeared that the nursing staff
and his cardiologist had all been given the word that he was going to die and
no one did anything to get to the cause of the problem before it was too late.…
Family’s conclusion: He either overdosed, or had an allergic reaction, and his
body could not tolerate the narcotic in the patch.”

The family termed the “fentanyl patch” as “opium.” Both fentanyl and opium are opioids

but they are not the same drug. It is unclear if a healthcare provider explained the actions

of fentanyl to the family members. It is also unclear why the family member refers to the

fentanyl patch as opium.

In another case where a parent died, the relative expressed concern regarding

how his or her mother was treated in the hospital. The family reported this scenario as a

medication error.

• “My mother was severely allergic to penicillin, which was noted in her
chart.… She was given vancomycin, which is of the same family as penicillin
[sic]…. I had told the nurse that my mother had developed a rash from this
vancomycin. I assumed that this medication had been discontinued. [Note:
The patient continued to receive the medication in the hospital.] My sisters
and I are now horrified that we have made a terrible mistake and that this

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medication, if it had been stopped, may have made all the difference in my
mother’s ability to fight her condition more aggressively.”

In this case the family had access to their mother’s medical records, and evidently

read them. It is unclear if any healthcare provider helped answer questions that may have

arisen as a result of their review of her medical records, in which the family discovered

that the patient had continued to receive vancomycin. While it is true both penicillin and

vancomycin are antibiotics, they are different pharmacologic classifications of

antibiotics. Vancomycin’s chemical structure and mechanism of action are different than

that of penicillin (McKenry & Salerno, 2003), and “vancomycin is used as an alternative

to penicillins in penicillin-allergic patients” (R. T. Reilly, personal communication, July

6, 2007). It does not appear a healthcare provider from the hospital addressed the family’s

concerns regarding the medication therapy. Also, it does not appear that the differences in

the two medications were explained to the family. The angst for this family might have

been addressed if there had been a more open dialogue between the family and the

healthcare providers caring for their mother.

This data provides an opportunity to learn about the perceptions of patients and

family regarding communication by healthcare providers related to medication errors. In

particular, the lack of effective communication between healthcare providers and

patients/family members was observed in this sample. Communication influences were

also observed in which there seemed to be a lack of communication skill by healthcare

providers and/or their attitudes were not perceived as supportive by family members in

the exemplars presented. Knowledge gaps among family members were noted due to

information not being provided by healthcare providers, or information not being

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understood by family members. The majority of the errors reported to MER Program in

this study by patients or family members in this sample involved harm to the patient.

Summary

Exemplars presented illustrate the range of interpersonal issues experienced by

those involved in or impacted by medication errors. A summary of the findings is

presented in Table 22.

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Table 22

Summary of Findings for Research Question Five – Interpersonal Issues


Taxonomy of Communication
Categories Subcategories
Failure, Success and Context
Healthcare Deflecting Error Confirmation for Message (COM)
Provider Acknowledgement/ Clarification.
Interpersonal
Issues
Contributing to an Error Failure of Message Transmission
and/or Failure of Message Reception
and/or
Failure of Message
Acknowledgment.
Apology by Healthcare
Providers Culture, Systems, Knowledge,
Attitudes, Skills, Support – Influence
Source and Receiver.
Emotions of Healthcare
Providers

Patient/Family/ Perceptions Failure of Message Transmission


Friend/ and/or Failure of Message Reception
Significant Other and/or Failure of Message
Interpersonal Acknowledgment.
Issues Family Reactions to Patient
Deaths Culture, Systems, Knowledge,
Attitudes, Skills, Support – Influence
Source and Receiver

Note. Taxonomy based on the work of Berlo (1960), Reason (1997), Weinger and Blike
(2003).

Research Question Six: What “Actions Taken” and/or “Recommendations” to

Address Errors Are Described in the Medication Error Reports?

Reason (1997) identified in the Swiss Cheese Model that if defenses are not

breached an error could be averted from causing harm. In many of the errors reported an

analysis occurred after the error in an attempt to identify what contributed to the error.

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Multiple actions and recommendations emerge from the reported medication

errors and encompassed several categories. Of 322 reports analyzed, in 233 (72%) of the

cases actions and/or recommendations were documented by the reporter. In 89 cases

(28%) there were no such comments. The most frequent categories of actions and

recommendations from this analysis included: education, use of checking or verification

processes, technological applications, undertaking a change and improvement process, to

reduce the risk of an error reoccurring. A listing of the categories and subcategories is

provided in Table 23 and will be explained in further detail in the rest of the chapter.

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Table 23

Summary of Findings for Research Question Six – “Actions Taken” and


“Recommendations”
Taxonomy of Communication
Categories Subcategories
Failure, Success and Context
Education In-Services/Staff Efforts to Improve
Education
Educational Campaigns and Culture, Systems, Knowledge,
Sharing Information Attitudes, Skills, Support
Creative Strategies
Case Study
Competency
Just in Time Education
Patient Involvement/Patient
Education
Checking and Careful Checking of COM
Verification Information Acknowledgement/Clarification
Medication Reconciliation Effort to Improve

Confirm Message Culture, Systems, Knowledge,


Attitudes, Skills, Support
Received

Technological Deployment Efforts to Improve


Applications
Culture, Systems, Knowledge,
Correcting
Attitudes, Skills, Support

Change and Improvement Policy/Procedures Efforts to Improve


Processes
Process/System
COM
Warnings/Alerts Acknowledgement/Clarification
Documentation
Culture, Systems, Knowledge,
Abbreviations Attitudes, Skills, Support
Design/Use Restrictions
Diagnosis/Indication
Address Similar/Sound-
Alike/ Look-Alike
Medications
Dialogue and Investigation
Note. Taxonomy based on the work of Berlo (1960), Reason (1997), Weinger and Blike
(2003).

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Education

Education was the most frequently reported action taken and recommendation.

Education took many forms, including in-services and sharing information, competency,

education campaigns, case studies, patient education and sharing of information.

Examples of educational strategies reported in the follow-up action and recommendations

include:

In-Services/Staff Education

Numerous examples of in services and staff education were observed in this


sample

• “educate all staff, re-evaluate every month for approximately six months.”
Educational Campaigns and Sharing Information

The sharing of information occurred using various strategies

• “We will be doing a big educational push over the next few months.”

The importance of forwarding important education information through e-mails and/or

distributing articles was noted in this education subcategory.

• “used emails to convey an educational message to our staff.”

• “As an educational piece, I sent the physician a copy of the ISMP article.”

Creative Strategies

Several creative and innovative educational programs were described in detail.

One educational initiative describes how an organization would highlight when a new

drug substitution was being introduced. This educational strategy was in response to a

substitution that resulted in an adverse outcome for a patient because nurses were

unfamiliar with how to administer the new medication.

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Case Study
The case study approach to education was highlighted in this exemplar:
• “The case is being used as an educational case study to promote the reading
back of verbal orders…and the importance of interdepartmental
communication.”
Competency

The use of competency evaluation was noted in this follow up action

• “develop protocol with algorithm, educate staff, competency evaluation.” This


action was in response to complex error involving unsafe practice.
Just in Time Education

Just in Time education is providing education at critical moment in care, as in this

case when a nurse was about to administer an oral medication via a parental route and

was stopped by the pharmacist.

• “The pharmacist quickly educated the nurse about this event and its
inappropriateness”

Due to the education provided by pharmacist the error did not reach the patient.
Patient Involvement/Patient Education

Several follow-up actions address involving the patient as a partner and listening

to the patient to prevent an error from reaching the patient. The patients actively

identified and deflected a number of errors in this sample, highlighting the importance of

patient involvement and education.

Checking and Verification


The importance of healthcare providers checking and verifying as a follow-up

action was cited in a number of cases.

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Careful Checking of Information

Carefully checking information can provide another safety layer to deflect a

patient medication error before it reaches a patient. One reporter noted:

• “it’s crucial to have an intact system of double checks between prescriber


(plus supervising physician)…. This should be considered planned
redundancy, not unnecessary duplication of effort.”

Checking sound-alike/look-alike drugs also emerged:

• “Pharmacists and other healthcare personnel carefully check sound-alike and


look-alike drugs”

as well as checking laboratory results in response to an error involving Coumadin:

• “Make sure the healthcare practitioner checks the INR before ordering or
administering Coumadin.”
Checking high alert medications, in addition to other actions, was suggested in

response to a fatal error involving a chemotherapeutic agent:

• “We have initiated the following: Mandatory dose and diagnosis, checking
orders…by the pharmacist, and mandatory high alert medication classes and
counseling for all nurses.”
Medication Reconciliation

The importance of medication reconciliation as a checking process was observed.

• “Procedures instituted to reconcile medications on enrollment.”

Confirm Message Received

A number of checks were suggested in this sample in response to verbal

interactions. A specific type of double check is the read-back process. A read-back is

used after the verbal order is written and then the order is read back to the prescriber.

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This recommended action was cited in response to an error involving verbal

communication.

• “Also, we recommend that all verbal orders be read back to the physician by
the nurse to confirm that the order is written correctly.”

A read-back is required by Joint Commission when receiving verbal or telephone

orders (Joint Commission, 2007a). The read-back allows the prescriber to hear what the

receiver has actually written.

A variety of checks including repeat-backs were suggested within these

medication errors. The exemplars presented provide a representation of checking and

verification actions and recommendations described in response to medication errors.

Checks and verification processes can offer another layer of protection and redundancy

that may deflect an error from reaching a patient.

Technological Applications

Deployment

The actions taken and recommendations included deploying technological

applications including computerized physician/provider order entry (CPOE), bar coding

and developing and implementing computerized alerts. Comments indicating support of

CPOE included:

• “Error could have been prevented with CPOE”

• “CPOE could be used as a tool/vehicle to guide prescribers in the right


direction (e.g., limiting the number of permissible abbreviations if allowing
them at all or having preset orders for certain meds, having additional alerts
etc.).”

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Actions to address medication errors included developing electronic alerts and

safety cues for order entry systems to advise and warn healthcare providers of potential

safety problems.

• “In addition, the computer alerts have been added for look alike, sound alike
warnings.”

Another action reported to help prevent medication errors was increasing utilization of

bar coding.

• “We are trying to obtain as many meds as possible with barcode on package.”

This action was in response to a patient receiving the wrong medication which was

attributed “in part, to poor labeling.”

Correcting

While many of the actions taken spoke to adopting and using technological

strategies to improve patient safety, there were references to problems with electronic

systems necessitating actions to address the problems. In one case the use of use of an

electronic system was suspended until a problem could be resolved. The patient in this

case died after receiving the medication intended for another patient.

• “Electronic order entry system turned off until issues with patient
identification could be resolved. Goal is to improve patient identification on
the system display by revising the display to more clearly identify patient.”

Electronic systems do not always function as expected, as in the following case in

which the computer system did not issue a warning.

• “The issue of why the duplication didn’t fire is being brought up with our
software vendor.”

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Using alerts was a recurring finding; however, one reporter voiced a concern with

excessive computer rules:

• “I had suggested creating a rule in the computer. However, my staff is a little


rule overloaded so we did not pursue this time, but may if the error occurs
again.”

These exemplars demonstrate recognition by healthcare providers of both

advantages and challenges in using technology to reduce medication errors.

Change and Improvement Process


The change and improvement process category contained a number of

subcategories, including making modifications to policies/procedures, processes/

systems, warnings/alerts, documentation, abbreviations, design, ordering medication, and

medication names. The use of discussion and investigation was also frequently cited in

response to a medication error.

Policy/Procedures

In a number of reports the initiation or reinforcement of policies was a

recommendation that emerged in this analysis.

• “We have…restated our policies for abbreviations and reviewing orders.”

Instances whereby a policy needs to be developed or revised were also noted as a

follow-up action.

• “There will be a policy drafted against this practice.”

Process/System

A number of process and system changes were undertaken in response to

medication errors. The following suggestion was in response to medication being sent to

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the nursing unit with no volume noted on the vial and the nurse calculated the drug dose

incorrectly.

• “The indication of the volume and/or concentration of the product on the vial
would be extremely helpful in preventing future errors.”

Efforts to enhance accurate communication of the names of medication include

using different types of print, fonts and/or “tall man” lettering to enhance medications’

legibility and name identification of medications.

• “tall-man lettering to distinguish product names.”

Warnings/Alerts

Developing and adopting warning alerts was a frequently cited strategy as a

follow-up action and/or recommendation. Alerts were developed in response to various

types of medication errors.

In one error, the physician order was for methadone but methotrexate was

administered. The healthcare organization undertook several actions to prevent a

reoccurrence. One action taken was labeling chemotherapy agents with the alert notice

“Biohazard and Chemo RN to administer.”

The following actions were initiated in response to wrong route errors:

• “We have printed up ancillary labels to state ‘For inhalation only.’” In this
case the medication had been administered orally.

• “Auxillary [sic] labels indicating ‘not for injection’ and ‘for oral use only’
placed in two locations on the container.”

Healthcare organizations reported developing warnings and alerts for healthcare

providers regarding potential problems that could impact negatively on patient safety.

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The alerts and warnings were disseminated via various methods including newsletters, as

in the following case:

• “This error will also be highlighted in the Med Error Prevention section of our
P&T Newsletter.”

Warnings and alerts provided a method to alert healthcare providers regarding

errors and to seek to decrease the risk of the reoccurrence of an error.

Documentation

As many of the communication breaches involved confusing documentation,

initiating improvements in the documentation processes was a frequent action or

recommendation. The proposed documentation changes included addressing legibility

and standardizing processes to decrease the risk of medication errors by enhancing

communication. In one case, adopting a specific order sheet to prevent confusion and

improve communication is identified as a strategy to address ordering errors and

confusion involving insulin.

• “We are investigating the use of an Insulin order sheet to facilitate ordering.”

Revising and standardizing documentation forms to address communication

deficits is noted in the following cases:

• “The adoption of standardized forms to help reduce errors.”

Further, one response noted:

• “treatment sheet to be standardized.”

This action was undertaken in response to the wrong dose of medication being

administered because the nurse read the order incorrectly.

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These cases are a small representation of the many suggestions to improve written

communication processes among healthcare providers.

Abbreviations

Many of the errors reported in both written and verbal communication involved

using abbreviations which contributed to miscommunication. A common response was to

reaffirm the need to limit or prohibit abbreviations.

• “We already have a ‘prohibited’ list of abbreviations. On this list, we do say


‘do not abbreviate drug names or use acronyms.’”

In a case involving an error with insulin, one healthcare organization stated:

• “We have adopted a policy of accepting no Insulin orders with any


abbreviations.”

Increasing awareness regarding abbreviations was another strategy.

• “We have re-posted the list of error-prone names and abbreviations.”

Issues with abbreviations emerged in both written and oral communication

processes. Given the dangers identified in this sample with certain abbreviations,

restrictions and limiting the use of abbreviation emerged as a frequent recommendation.

Design/Use Restrictions

Restricting access to a product or medication was used as strategy more than once

after a medication error occurred.

A number of factors contributed to an error in which a patient received Sterile

Water for Injection, which is not for direct intravenous infusion. Subsequent to the

administration of sterile water the patient died. Neither the nurse nor pharmacy

questioned the order, nor did the nurse notice the warning label that stated “Pharmacy

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Bulk Package, Not For Direct Infusion” when hanging the sterile water for infusion.

Eight recommended actions to address this error were described by the reporter. One of

the actions was to change the product design assist in precluding this type of error from

occurring.

• “Also a change in the port design of sterile bulk package products for
injection that would make IV administration tubing incompatible with the
bulk compounding fluid bags will be recommended.”

In another case the type of medications which could be accessed was restricted to

avoid inappropriate administration. Another type of design modification involved

changing storage of medications to reduce errors, as seen in the following example.

• “have separated the two medications so they are no longer next to each other.”
In this case one medication was mistaken for another.

These interventions could provide an added safety layer to defend against

breaches in safety and trajectories resulting in harm to a patient. Changes in design and

storage modification were findings in the narratives describing efforts to improve patient

safety in response to a medication error.

Diagnosis/Indication

Another recommendation to enhance patient safety was to include the reason the

medication is being ordered. If the medication order is interpreted in such a way that it is

not congruent with the indication or reason the medication is being ordered, this can

provide a safety cue for healthcare providers. Indicating why a medication is ordered can

help identify a potential error and prevent a patient from receiving the wrong medication.

Examples of comments and actions in response to medication errors included:

• “this is another plug for attaching an indication to the medication order.”

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The following reporter of errors that involved confusing sound-alike/look-alike

medication recommends a legislative approach:

• “If someone would please pass legislation requiring all prescriptions to


include an indication, errors such as these would never happen.”

These comments underscore the importance of healthcare providers understanding why a

specific medication is being ordered for a particular patient.

Address Similar/Sound-Alike and/or Look-Alike Medications


A variety of recommendations and actions were documented by reporters to

address errors related to sound-alike and/or look-alike medications. Actions taken and

recommendations included education, use of alerts, health system responses, use of

generic and brand names, indications and change the name of medications.

• Education: “Education of nursing staff of look-alike, sound-alike meds.”

• Alerts: “We have heightened the awareness to this problem by alerting our
staff of the look-alike sound-alike names” and “computer alerts have been
added for look alike, sound alike warnings.”

• Health System: “The health-system takes into account look-alike, sound-alike


issues when evaluating meds for formulary inclusion.”

• Generic and Brand Name: Checking medication by both the brand and
generic name was suggested and incorporates a redundant mechanism to
improve safety. “Match brand and generic drug name to ensure you have the
right drug.”

• Indication for Medication: Several reporters suggested using diagnosis or


indication when ordering sound-alike/look-alike medication to reduce
confusion.

• Change Name of Medication: Changing the names of medications was


suggested to decrease confusion between sound-alike and or look-alike
medications and medications with similar names: “Consider changing name”

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and “First and foremost, is that products should not be allowed to have the
same name or only differ by two letters.”

Dialogue and Investigation

Many of the actions and recommendations included reviewing and/or discussing

incidents with staff after the error occurred.

• “We’ll talk about the case in our medication safety team meeting and will
likely agree on specific steps then.”

Sharing information and involving the staff in discussions regarding medication errors

was a common response to medication errors.

Investigations were undertaken to find out why errors occurred, including causes

and contributors. Using interdisciplinary teams in conducting investigations was observed

on several instances.

• “We hope to outline all the things that went wrong with the order as well as to
identify all of the missed opportunities to discover the error.”

The strategy in the previous case encompasses including various members of the

health team to explore factors contributing to the error and address the deficiencies that

placed a patient at risk. The investigation processes described in the reports often focused

on finding out what may have caused and contributed to the error. The investigations

were not focused on blaming individuals but rather identifying deficiencies to address the

error.

Summary

Cause and contributors to medication errors were multifaceted, and many of these

reporters recognized the need to initiate improvements to decrease the risk of a

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medication error. The actions taken and recommendations provided by the reporters of

medication errors included a variety of approaches. Some of the actions taken and

recommendations were very direct “quick fixes” while others were complex, involving

process and system modification to address systems issues and prevent reoccurrence of

errors.

Other Findings: Label and Packaging Issues

In addition to the 322 cases analyzed, another 85 cases involved manufacturer

labeling and packaging issues as a main cause of the medication error and did not meet

inclusion criteria for this study because it was determined that manufacturer

labeling/packaging issues did not meet the communication definition for inclusion in this

particular study: “communication that is confusing, intimidating, or lacking between

staff, between hospital staff and patient/family, or between hospital staff and another

facility’s staff” (Hicks et al., 2004, p. 113). However, a review of these 85 errors

indicates findings that present patient safety concerns and are associated with a FOM

transmission or a FOM reception. Berlo has stated that “anything to which people can

attach meanings may be and is used in communication” (1960, p. 2). Healthcare

providers did attach meaning to labels and packaging issues. In this analysis, healthcare

providers often misinterpreted labels or had difficulty reading and/or comprehending the

labels correctly. There were a number of contributors to problems with labeling and

packaging. Since labeling and packaging involves using print, symbols, colors and

design, it is related to a non-verbal communication process.

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Although a detailed analysis of label and packaging issues was outside the realm

of this study, a brief summary of issues observed related to labeling and packaging is

presented here. These findings indicate the need to broaden the communication definition

when seeking to explore communication errors related to medication errors.

Appendix B lists categories and subcategories for this set of 85 errors. Harm to

patients occurred in 19 cases, and death in 1 case (see Table 24).

Table 24

Occurrence of Harm in Errors Involving


Manufacturer Labeling and/or Packaging
Number
Level of Harm
No Harm 65
Harm 19
Death 1
Total 85

The labels’ issues are presented in three parts: descriptions of errors, reactions to

label issues, and actions taken/recommendations in response to label issues.

Descriptions of Errors

Healthcare providers dispensed and/or administered the wrong medications in part

because the packaging and/or labels were similar. The following case illustrates the

complexity of this problem. This reporter provided a detailed description of an error in

which the wrong medication was administered, methylergonovine (Methergine) instead

of terbutaline (Brethine), and the patient incurred harm.

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• “a significant contributing factor for this error is that both products are
manufactured to appear too similar. For example: 1) Both are 1 mL ampules.
2) The packaging of both products is identical; both in terms of the amber
plastic backing as well as the paper wrapper. 3) Both products are labeled in
almost the same format, font, font size and location of print. 4) Both ampules
have very similar colored rings around the ampule necks. All the above
factors may pre-dispose both drugs to be interchanged with the other resulting
in errors.”

The most frequent medications cited by generic name out of a small sample of 85

medication error reports involving labels and packaging issues were:

• Morphine Sulfate

• Methylergonovine Maleate

• Heparin Sodium

• Epinephrine

• Terbutaline Sulfate

Another example of labeling and packaging issues includes:

• “The health system has seen several medication errors due to similar labeling
and packaging of pre-mixed medications by the manufacturer.”

There were also labeling issues related to the print on the labels. In the following

case the lack of readability was linked to the aging workforce by the reporter:

• “As I read all of the information about the aging workforce in nursing, and I
myself have had difficulty reading some of the small print, I think this is
something that pharmaceutical companies need to take into consideration
(print size and the information size not only on their packets for individual
dose administrations, but also on some of their flyers and inserts containing
information on the medication).”

In all of these medication errors the receiver of the message had some problem

decoding the message.

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Reactions to Labeling and Packaging Issues

Healthcare providers expressed numerous reactions to labeling and packaging

issues and identified concerns with packaging.

One reporter described being “mad” and “angry” because an error occurred:

• “I’m also mad because these two meds are so close in name and packaging
and pill size and color.… I read similar mess-ups on ISMP’s site; it makes me
angry. It’s if they are trying to create an accident.”

Another healthcare provider states,


• “I also feel that the manufacturer can impact patient safety by taking some
ownership to prevent look-alike packaging.”
The following reporter was disheartened by the response provided by a company

when a packaging issue was identified. When the packaging issue was brought to the

attention of manufacturer, the response was:

• “‘Reading the label is Nursing 101, the packaging shouldn’t matter.’ I found it
to be quite disheartening that a large company like [XXX] would respond in
that way to a suggestion that could have positive effects on patient safety.”

These responses by healthcare providers indicate a level of dissatisfaction with

manufacturers’ labeling/packaging issues, which contributed to communication failures

that in turn contributed to medication errors. Healthcare providers provided a number of

suggestions to address problems with labeling and packaging.

Actions Taken/Recommendations Related to Labeling and Packaging

Organizations and individuals did undertake actions and suggest

recommendations to address patient safety concerns.

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Change Labeling and/or Packaging

The most frequent recommendation to address a labeling and/or packaging

concern was to suggest the manufacturers change the labeling and/or packaging. For

instance, reporters recommended:

• “the manufacturer change the product labels to utilize tall-man lettering and
bold-face fonting.”

• “use of different packaging materials, labeling, and greater differentiation of


the ampules will help prevent further errors.”

• “have completely different colors for each strength.”

• “change product labeling to make concentration clearer.”

Warnings/Alerts

Some healthcare organizations responding to errors involving labels developed

their own warning labels and or alerts for their healthcare providers in instances where

manufacturers’ labels were confusing, ambiguous or at risk for confirmation bias.

Design: Change Storage Procedures

A number of organizations separated similar products after errors; for instance:

• “Separate products on the shelf.”

was an action taken in response to a patient receiving the wrong formulation of a

medication; both vials for the oral and parental were reported to have similar labeling.

Changing and/or Restricting

Some organizations responded to some errors related to packaging and labeling

by suspending the use of products or removing products from stock.

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In efforts to reduce errors, some facilities recommended seeking different

manufacturers to avoid the problem with labels that look similar.

Technological Applications

Using technology, such as bar coding, was cited as a recommendation. For

instance:

• “Products are bar-coded and institution of this technology could have


prevented error.”

Report Label and Packaging Concerns

Reporting of numerous label and packaging concerns was observed in this

sample. In one case healthcare providers specifically sought assistance regarding a

concern related to manufacturer’s packaging of the medication as illustrated below;

• “We have contacted the manufacturer with this recommendation, but are also
seeking assistance as we voice our concern about this product.”

Education

Some organizations responded to errors involving labeling and packaging by

educating and alerting staff to problems regarding those specific labeling and packaging

issues. Education was provided to advise staff about initiatives undertaken to address

errors.

• “Educate staff about the potential for error.”

One organization that implemented new warning labels provided in-services after

the change in packaging that involved:

• “labeling vials in baggies with auxiliary warning labels.”

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Patient involvement through patient counseling education was also cited as a follow-up

recommendation.

Checking and Verification

The process of checking, verifying and validating was discussed in several

follow-up actions and recommendation reports.

• “Ensure product validation by nursing.”

Summary of Action Taken/Recommendations Related to Labels and Packaging

The most frequent actions and recommendations described were:

• Change label and/or packaging to prevent reoccurrence of error.

• Use a warning or alert to advise healthcare providers of the problems with

labeling or packaging.

• Design/change storage procedures and use/arrange storage areas in a manner

to decrease to the recurrence of an error.

• Educate healthcare providers.

• Changing products and/or seek to restrict access to problematic situations by

restricting access to look-alike labels and packages.

• Careful checking and verification.

• Deploy technology to enhance patient safety.

• Report concerns with packaging and labels.

Healthcare providers expressed concerns—and even anger—related to the labels

and packaging issues. As the role of labels and packaging in medical errors is extremely

complex, these findings present only an overview of the many related issues and indicate

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the need for another study to examine human factors associated with error prevention

strategies to mitigate errors related to labeling and packaging.

Themes

At the conclusion of this examination of codes, subcategories and categories, a

thematic analysis was undertaken. Five themes emerged across categories that identify

risks to patient safety and create a picture of behaviors that healthcare providers could

take to implement and maintain a culture of safety and an understanding of the impact of

errors in human terms:

1. Risking patient safety through behaviors and systems that breach defenses.

2. Standing watch for errors.

3. Stepping in to prevent harm.

4. Experiencing the human impact of medication errors.

5. Seeking to prevent reoccurrence of medication errors.

Risking Patient Safety Through Behaviors and Systems That Breach Defenses

The theme risking patient safety through behaviors and systems that breach

defenses was prominent in this analysis. Many actions that contributed to errors included

at-risk behaviors and at-risk communication.

At-risk behaviors are those behaviors by healthcare providers that place patient at

risk for harm (NCC MERP, 2007b). At-risk behaviors encompassed a range of behaviors

ranging from administering medication when lacking knowledge about the medication to

using confusing abbreviations (NCC MERP, 2007b). At-risk communication was

observed in the interactions between healthcare providers, such as in the case related to

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disruptive behavior: A nurse did not want to intervene with a physician known to

“scream” at people, contributing to a lack of communication resulting in the patient

receiving the wrong dosing of a medication.

At-risk behaviors were not limited to one individual’s actions or inactions. The at-

risk behaviors also included components related to quality and culture, such as not openly

addressing medication errors (NCC MERP, 2007b). Not disclosing errors is an at-risk

behavior that was observed in several exemplars. Not reporting errors places the affected

patient and other patients at risk because problems may continue to go undetected and

may contribute to the other medication errors.

A common at-risk behavior in both verbal and non-verbal at-risk communication

was a lack of checking or verifying the message that was being sent. At-risk

communication was characterized by the exchange of information that was compromised

in some manner and /or was not transmitted effectively or accurately or received

correctly. Some examples of at-risk communication included illegible handwriting and

not verifying or checking questionable physician orders. At-risk communication involved

any or all of the following: Failure of Message (FOM) transmission, FOM reception and

FOM acknowledgment/clarification.

At-risk behaviors contributed to breaches in defenses. These breaches are well

illustrated using Reason’s Swiss Cheese model (1997). Breaches emerged repeatedly in

this analysis of medication errors. At-risk communication processes encompassed both

active and latent breaches of defenses. Active failures included communicating

information inaccurately because of a lack of knowledge or not checking and verifying

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information. Examples of other active failures included not heeding a patient’s or

family’s concerns and not checking a patient’s identification before administering

medication. These type of active failures occurred “at the sharp end” (Reason, 2005, p.

58)—by healthcare providers.

Additionally, latent failures were observed. For example, a number of systems

problems emerged in this analysis that contributed to communication problems and

medication errors, including technology issues such as a computer system defaulting to

an incorrect route thereby communicating incorrect information. Lack of standardization

in systems impacted communication processes negatively and contributed to confusion.

Both active and latent failures were observed in a number of error trajectories.

Standing Watch for Errors

The theme standing watch for errors emerged from many of the error descriptions

in which safety-promoting behaviors and communication were observed, indicating

healthcare professionals’ watchfulness. Using redundancies in the communication

process, such as checking a medication order by another member of healthcare team and

addressing discrepancies, helped prevent errors from reaching patients. Safe

communication included the presence and active utilization of redundant checks. For

example, a medication was transcribed incorrectly, but the error did not reach the patient

because of a COM acknowledgement/clarification process.

Exemplars were presented that illustrated errors being deflected when systems

were in place such as a verifying process. This was observed especially in situations

where the pharmacy was instrumental in identifying a problematic order and intervening

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and communicating to correct the order. If the pharmacy had not been included in the

system, or had been bypassed, errors could have reached the patient. Both patients and

healthcare providers benefited from systems with redundancies that could block an error

from reaching the patient.

Successfully executing clarification and verification procedures to prevent errors

depended on the conscientiousness of healthcare providers. If procedures were in place

but were not used by the healthcare providers errors would, and did, occur. In some cases

healthcare providers took an extra step and used problem-solving approaches to identify

and correct errors, such as walking to a doctor’s office to clarify a questionable order

when information was otherwise not readily available. Other behaviors included taking

the time to be present and available to check on potential problems, speaking up, and

questioning and cueing another healthcare professional.

Safe communication involved being receptive and listening to patient and family

concerns. In several reports, standing watch for errors was displayed by patients or

family members. That is, errors did not reach the patient because the patients themselves

or their family members notified healthcare providers of discrepancies. The healthcare

providers who listened and acted prevented an error from reaching the patient. A sprit of

caring was also evident in cases where the healthcare provider listened to the patient or

family member and responded to a concern that was articulated. These safety-promoting

behaviors and communication processes posed a barrier and contributed to deflecting

errors from reaching a patient. Standing watch also encompassed reporting errors so

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others could learn from those errors. Reporting errors is a strategy to watch for errors so

cause could be addressed and actions taken to seek to prevent a recurrence.

Stepping in to Prevent Harm

In many instances an individual’s active intervention—stepping in to prevent

harm—was the last defense before an error would reach a patient. This is a vital

component of a culture of safety, in that even with the commission of an error, the

healthcare provider may still have the ability to prevent harm. There were many

exemplars of healthcare providers being receptive to transmitting information and being

vigilant in advocating for patient care. In some instances healthcare providers acted in

response to a “hunch,” as in the case of a pharmacist who asked a nurse if she pre-

medicated a patient, and when something “did not feel right” as when a nurse called in

after leaving the unit to check on an infusion. In these cases healthcare providers openly

spoke up about concerns.

In one example involving a potentially fatal physician order, serious patient harm

was averted because other healthcare providers recognized the error, communicated the

concern and rectified the problem. Healthcare providers had to be willing to check on

other colleagues and work together. And healthcare providers were not the only

individuals to “step in”: Informed patients and family members also stepped in to prevent

harm by speaking up to healthcare providers when a discrepancy or concern was noted.

It is expected that healthcare providers should act in the best interest of patients

and be strong advocates for patients’ safety. Safe practice should be the standard, but

sometimes events are stacked against both the healthcare provider and patient. For

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example, when an order is illegible and the physician who wrote the order is unavailable,

that presents a challenge. A system where medications are entered electronically and

legibly could have provided a system solution to this problem. Stepping in to prevent

harm, then, encompassed both individuals taking an active role in acting to deflect the

impact of an error and systems which supported individuals safeguarding patients from

harm.

Experiencing the Human Impact of Medication Errors

Many of the error reports reviewed were written in an objective narrative fashion

describing the facts without any other comments. But a number of both patient/families

and healthcare providers’ narratives contained descriptions of experiencing the human

impact of medication errors which added an important perspective to the narratives.

Many of these errors were very serious in terms of patient outcomes. In this sample of

322 errors 20.5% of the patient outcomes were described as harmful but not fatal; another

6.5% involved patient deaths.

Both healthcare providers and patients were victims of systems that failed, or did

not exist. Latent failures were prevalent in this analysis and were emblematic of a wide

variety of systems issues. Errors occurred, multiplied and kept traveling through the

system without being stopped. Most of the errors in this analysis involved multiple

breaches of defenses. Some reports indicated a type of relief when a medication error was

prevented. Others indicated a type of disbelief that some errors occurred:

• “I have been a pharmacist for 21 years and would never of [sic] dreamed that
this could still occur.”

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There was concern with systems, such as lack of communication among

healthcare providers. For example:

• “Similar errors have and continue to occur, and in my opinion, we have a lot
of work to do in this area.”

There was also guilt and angst expressed when an error did occur and the healthcare

provider felt responsible for the error. Fear of reporting errors was explicitly described in

two cases.

Many of the first-person narratives by patients and their families were very

poignant to read because of the evident distress that persons experienced within the

healthcare system. Several narratives by family members contained emotional overtones

of disappointment and/or being upset with the care provided. The narratives only

presented one view of the situation: It was unclear from reading them if the healthcare

providers in these cases were aware of the family’s perceptions. However, the family’s

perceptions of the communications from healthcare providers and medication errors

provide insight into what family members experience and perceive, and thus help provide

an understanding of experiencing the human impact of medication errors.

Seeking to Prevent Reoccurrence of Medication Errors

A consistent theme that emerged from the data was seeking to prevent

reoccurrence of medication errors. The error reports also illustrated healthcare providers

dealing with situations and working to prevent recurrence of errors. Lack of knowledge

contributed to committing many errors. One prevalent action taken and recommendation

in response to a medication error was an attempt to learn from the error to help prevent a

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recurrence. Comments ranged from “lessons to be learned” to descriptions of in-services

and education initiatives.

Education was the most frequently identified action in response to medication

errors. Some of the most dangerous errors occurred because clinicians lacked essential

knowledge, contributing to potentially fatal errors. In some of these cases “just in time”

education took place, as in a case when a pharmacist intervened and educated the

physician and the order was changed. Some of the education described addressed the

basics of safe medication administration, while other education programs were developed

to educate healthcare providers about new medications.

The value of education and information was not limited to healthcare providers.

The importance of educating and informing patients was evident in a number of reports in

which patients identified errors healthcare providers had made. Patients who read,

prescription labels, information inserts, observed care providers and asked questions did

identify errors. The danger of lack of knowledge by both healthcare providers and

patients as contributors to errors was apparent in this analysis. Most of the errors in this

analysis involved educated healthcare providers, yet knowledge deficits were apparent,

thereby highlighting the importance of continuing education and assuring competency.

Systems issues were prominent in both safe and unsafe communication. In many

reports of errors being deflected from the patient, processes and systems were in place to

defend against an error reaching the patient. The systems approach was observed in many

of the actions taken in response to an error, and specific actions were undertaken to

address systems to reduce the recurrence of error. Approaches to system improvements

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included modifying software, implementing process changes and communicating such

changes within the organization.

It seems counterintuitive that the theme seeking to prevent reoccurrence of

medication errors would emerge for medication errors reports. However, these reports

not only detailed causes and contributors to medication errors, but also efforts undertaken

to improve care. At the crux of many of the preventive actions was a focus on the patient.

Seeking to do right by the patient and seeking to improve healthcare delivery for the

patients of the future was identified in culture of safety exemplars.

A quest to improve care and seeking to prevent the reoccurrence of medication

errors emerged in the many actions and recommendations described which encompassed

various strategies to improve and decrease the risk of a medication error occurring. The

improvement strategies ranged from simple to complex initiatives. Often times the

medication error exposed systems that needed to be enhanced or changed. The actions in

these cases were aimed at improving systems to improve the delivery of care.

The theme indicates that seeking to prevent reoccurrence of medication errors is a

dynamic, ongoing process. Sometimes the apparent cause was not the only cause and/or

contributor to the error. Investigations of errors were conducted so that the defects and

failures within systems could be adequately identified and addressed. The many lessons

from hundreds of errors provide an opportunity for healthcare providers and patients to

benefit from these lessons. But these lessons can only be learned if healthcare providers

share this information with others. Therefore, reporting errors is an important component

in seeking to prevent reoccurrence of an error. Documenting errors and identifying

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actions taken to prevent recurrence allows individuals and healthcare organizations to

learn from the errors encountered by others and—hopefully—prevent those errors’

recurrence.

Summary of Results

The data provided by the USP provided descriptions of medication errors ranging

from circumstances that did not cause patient harm to errors that resulted in patient

deaths. There were 322 cases that met this study’s inclusion criteria. Most of the errors

reported occurred in hospital settings, were initiated by nurses and discovered by

pharmacists and nurses. The percentage of errors associated with patient harm was 20.5%

and the percent of patients who died in this sample was 6.5% for a cumulative rate of

harm and/or death from medication errors of 27%. There were 15 categories and 65

subcategories identified. Five themes emerged in this analysis.

One of the most prevalent findings in the medication error reports analyzed was

multiple exemplars of the Reason’s Swiss Cheese model (1997). The communication

processes seen in this sample included a wide array of at-risk behaviors and practices.

Narratives of medication errors illustrated how at-risk behaviors and at-risk

communication actually contributed to FOM transmissions, FOM receptions and FOM

acknowledgment/clarification. This analysis also reveals that a number of errors did not

reach the patient because of effective COM acknowledgement/clarification. Examples of

safe communication practices included questioning orders and listening to patients when

the patients identified a concern related to the medication.

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Attributes supportive of a culture of safety were apparent in a number of

exemplars, including open communication, teamwork, learning cultures, just culture,

reporting cultures, systems approaches and support from leadership. Conversely,

attributes not supportive of a culture of safety were also observed: lack of open

communication, lack of team work, process and systems issues and not reporting errors.

The context in which errors occurred was detailed in many narratives.

Several cases in this analysis revealed angst and pain caused by medication errors

in individual human terms. Among the most compelling and disturbing narratives were

the first-person reports from patients and family members regarding their perceptions

surrounding reported medication errors. These narratives highlighted communication

gaps between patient/family members and healthcare providers, some of the patient and

family concerns may have been able to be addressed by providers being more

communicative. The descriptions of errors from the perspectives of patients and/or their

family members provided another dimension to the study of medication errors.

Many commonalities in addressing medication errors were observed in this

sample. Among the most frequent actions taken and recommendations for further actions

were education and implementing changes in systems to decrease the recurrence of an

error.

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V. STUDY SUMMARY, DISCUSSION, IMPLICATIONS, AND CONCLUSIONS

Each of the findings for the six research questions is reviewed for the readers in

this chapter. The results are discussed and summarized, and the implications for practice,

research, education and policy are discussed and presented with the conclusions.

Summary

This study sought to answer six questions in order to gain an understanding of the

communication processes in medication errors and explore cultural attributes that emerge

in reported medication errors. The data for this sample was obtained from the Medication

Errors Reporting Program which is “operated by the USP and in cooperation with the

Institute for Safe Medication Practices” (USP, n.d.a)

A purposive sample was used to select narratives that described communication

processes and cultural issues in medication errors. The quantitative analysis addressed the

error’s initiation, who discovered the error, the type of medication involved and patient

outcomes. The quantitative analysis of medication errors was conducted using Excel and

SPSS 14. The qualitative component was conducted using Nvivo 2 in analyzing the

description of the medication error, error discovery, actions taken and recommendations

in response to the error.

A total of 322 medication errors were included in the analysis of communication

and cultural issues; 15 categories and 65 subcategories were identified (see Appendix C).

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Five themes emerged in the analysis. The majority of analyzed errors, 62%, occurred in

the hospital/medical center setting. Nurses initiated 49% of these errors followed by

physicians and pharmacy staff. Errors were discovered by pharmacists and nursing staff

in the majority cases. In addition, another 85 medication errors involving labeling and

packaging issues were not included in the overall analysis but were reported under other

findings and analyzed separately.

Research Question One: What Are the Patient Outcomes in the Medication

Errors Reported in This Sample?

Findings

The patient outcomes in this sample of errors compared with another larger

sample using the same categories of harm indicated a higher rate of patient harm and

deaths (see Table 25; for a detailed explanation of the lettered categories, see Table 2).

The MEDMARX data (Hicks et al., 2006b) which is a sample of 897,369 medication

errors for the calendar years 2002 – 2005, had a rate of harm or death of 1.4% compared

with a rate of harm or death of 27% in this sample of 322 errors as delineated in Table 26.

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Table 25

Comparison of Patient Outcomes From 897,369 MEDMARX Data and 322 Reports
From Medication Error Reporting (MER) Program Data
Current Current Study
MEDMAR
MEDMARX Study MER MER
Categories X
n Program Program
Percentage
n Percentage*
A (No Error, No
Harm) 125,994 14.04 1 0.31
Not Reported 0 0 1 0.31
B (Error, No Harm) 358,594 39.96 79 24.53
C (Error, No Harm) 345,289 38.48 114 35.40
D (Error, No Harm) 54,555 6.08 40 12.42
E (Error, Harm) 10,278 1.15 37 11.49
F (Error, Harm) 2,180 0.24 14 4.34
G (Error, Harm) 134 0.01 4 1.24
H (Error, Harm) 252 0.03 11 3.41
I (Error, Death) 93 0.01 21 6.52
Total Errors 897,369 100.00 322 99.97
Note. Categories from National Coordinating Council for Medication Error Reporting
and Prevention (NCC MERP) Index for Categorizing Medication Errors (2001).
*Percentages have been rounded and may not equal 100%.

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Table 26

Comparison of Errors Resulting in Patient Harm From 897,369 MEDMARX Data and
322 Medication Error Reporting (MER) Program Reports
Current
Study Current
MER Study MER
MEDMARX MEDMARX Program Program
Categories n Percentage n Percentage
E (Error, Harm) 10,278 1.15 37 11.49
F (Error, Harm) 2,180 0.24 14 4.34
G (Error, Harm) 134 0.01 4 1.24
H (Error, Harm) 252 0.03 11 3.41
I (Error, Death) 93 0.01 21 6.52
Total Harmful Errors 12,937 1.44 87 27
Total Errors 897,369 322
Note. Categories from National Coordinating Council for Medication Error Reporting
and Prevention (NCC MERP) Index for Categorizing Medication Errors (2001).

Discussion

There may be many reasons for this difference in rates between the MEDMARX

sample and the MER Program reports used in this study. For one, MEDMARX accepts

reports from healthcare organizations enrolled in the MEDMARX Program. In contrast,

the MER Program is open to anyone who wishes to report an error, and reports can be

faxed, mailed or submitted online to the MER Program. This study’s sample is very small

but contains a number of medication errors which were harmful to patients.

It would seem logical that healthcare providers and consumers would take the

time to report those errors that have more serious consequences. In this sample some of

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the healthcare providers reported errors to the MER Program but did not report the errors

where they practiced.

The MER Program does receive confidential reports and some anonymous

reports; these options allow healthcare providers and the public to report errors and warn

and educate other healthcare providers. The anonymous option may be advantageous for

those who wish to alert others about an error, but may not want to disclose their identity..

Research Question Two: What Are the Communication Issues That Are

Identified in the Medication Error Reports?

Findings

Confusing and lacking communication contributing to Failure of Message (FOM)

transmission, FOM reception and FOM acknowledgment/clarification was evident in this

study’s medication errors reports. A variety of at-risk communication behaviors were

observed among healthcare providers in these errors such as not verifying, not

questioning or clarifying medication orders, and using confusing abbreviations. The

categories to emerge in these results were: non-verbal communication issues, verbal

communication issues, threats to the communication process, technology challenges,

healthcare provider and patient/family communication issues, lack of knowledge and the

Swiss Cheese model error trajectory.

The most frequent finding in this analysis was the Swiss Cheese model error

trajectory. This sample of medication errors provided many examples of defenses being

breached. Although medication errors had many contributors and causes, in error after

error more than one defense was breached. Conversely, the sample also included errors

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that were near misses because at least one defense remained intact, thereby deflecting an

error from reaching a patient and causing harm. The defenses involved an array of

interventions by healthcare providers, including verifying and raising questions. Some of

the actions taken by healthcare providers involved extra efforts to address and

compensate for system issues. It became apparent using Reason’s model (1997, 2000,

2004) that the healthcare providers are at the “sharp end” (Reason, 2001, 2005) of the

error and can either be the last defense or the last breach in the defense (Reason, 2001,

2004).

Discussion

Several communication issues common to both non-verbal and verbal

communication are highlighted in this discussion. Such issues included abbreviations,

FOM acknowledgement/clarification, ineffective handoffs, similarity in medication

names, missing and omitted information, pharmacy not available or by-passed. Two other

communication issues are addressed separately verbal communication and technology

New abbreviations are constantly being developed (Davis, 2007). This is

understandable as new treatments and technologies continue to emerge. Additionally, the

creativity of healthcare providers in seeking to be efficient and parsimonious in

communication can lead to short cuts at the expense of patient safety as illustrated in the

cases presented. The title of a medical abbreviation text describes abbreviations as

“28,000 conveniences at the expense of communication and safety” (Davis, 2007). Some

abbreviations pose such threats to patient safety that Joint Commission developed a “Do

Not Use List” of abbreviations in 2004 (Joint Commission, 2007b). An impetus for this

200
list was the recognition that commonly used abbreviations can be misinterpreted and

cause a medication error. Several of the medication errors in this sample predate the Joint

Commission “Do Not Use List.” The prohibited abbreviations seen in this sample

include: “qd,” “IU,” “U,” “MSO4” and “MgSO4” (Joint Commission, 2007b). The ISMP

has developed a list which included “error-prone abbreviations.” Some of the

abbreviations on the list were noted in this sample, for example “SSRI” (ISMP, 2006).

No list can be all-inclusive as new products are being developed, technology is evolving

and creativity is used by healthcare providers in developing “convenient” short cuts.

Abbreviations can be “a time saver, a space saver, and a way of avoiding the possibility

of misspelling words” (Davis, 2007, p. 1), but abbreviations can also pose threats to

patient safety. The danger of abbreviations had been addressed by the National Summit

on Medical Abbreviations which included representatives from over 70 groups including

ISMP and the American Nurses Association (Joint Commission, 2007c; Kuhn, 2007).

The major disadvantage of abbreviations is that they can contribute to confusion within

the communication between healthcare providers and place patients at risk (Brunetti,

Santell, & Hicks, 2007; Gaunt & Cohen, 2007; IOM, 2007, Kuhn, 2007).

The FOM of acknowledgment/clarification evidenced by a lack of verification or

checking process recurrently emerged in this sample in both verbal and non-verbal

communications. Using independent double checks is recommended for high alert

medications (Cohen, Smetzer, et al., 2007). The importance of “independent double

checks” is a safety strategy that is recommended to decrease errors by offering another

layer of redundancy (ISMP, 2005b). In many instances errors occurred because a double

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check was not used. Communication could have been clarified in many instances if a

read-back communication technique was used which allows an order to be verified to

assure it is understood correctly. The read-back is a Joint Commission National Patient

Safety Goal (NPSG) that accredited organizations are expected to observe (Joint

Commission, 2007a, 2007d). Using redundant communication techniques is

recommended by a number of agencies (AHRQ, 2005; ISMP, 2005b; National

Coordinating Council for Medication Error Reporting and Prevention, 2006) to clarify

medication orders and reduce the risk of error.

An ineffective handoff process encompassing transfer of care of a patient from

one healthcare provider is known to pose risks to patients (Friesen et al., 2008; IOM,

2001; ISMP, 2005b; Joint Commission Resources, 2007; Santell et al., 2005; USP,

2005a). Problematic handoffs were observed in this study of medication errors. The

handoffs contained a communication process that had gone awry either through omission

of information, or lack of adequate communication through verbal and/or non-verbal

means.

Similarity in medication names contributed to confusion in the communication

process. Similar medication names “increase the risk of medication errors” (Institute of

Medicine, 2007, p. 275) in both non-verbal and verbal communication processes. Look-

alike and sound-alike medications can impede effective and accurate communication and

are recognized as a cause of medication error (Cohen, Di Domizio, & Lee, 2007; Hicks et

al., 2006b; Hicks et al., 2004; IOM, 2007; Joint Commission, 2006-2007; Santell et al.,

2005). Sound-alike medication names contributed to a FOM transmission in verbal

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orders. The Joint Commission has developed a list of “potential problematic drug names”

and established a national patient safety goal (NPSG) to address look-alike/sound-alike

drugs. This standard requires organizations to conduct an annual review of such drugs

and initiate strategies to prevent medication errors (Joint Commission, 2007a, 2006-

2007). A number of medications on the Joint Commission Look-Alike/Sound-Alike List

were found in this sample of medication errors, including: Omacor and Amicar; Zyrtec

and Zantac, Ephedrine and Epinephrine (Joint Commission, 2006-2007). Several

medications not on the Joint Commission list were also categorized as look-alike/sound-

alike by reporters of errors.

Missing or omitted information compromised communication processes and

contributed to errors. In this sample errors occurred because of lack of medication

reconciliation, and errors were discovered during reconciliation, highlighting the

importance of reconciliation across the continuum of care. The medication reconciliation

process is recommended to improve patient safety and is required by Joint Commission

(Joint Commission, 2007a). The reconciliation process is a strategy to reduce medication

errors during transitions in care (IOM, 2007; ISMP, 2005a; Pronovost, Weast, Schwarz,

et al., 2003; Rogers et al., 2006; Sullivan, Gleason, Rooney, Groszek, & Barnard, 2005;

WHO Collaborating Centre for Patient Safety Solutions, 2007a).

A number of errors were described when the pharmacy was not available or was

bypassed. Errors occurred in situations when pharmacy was not able to check a

prescription or dispense a medication. The lack of pharmacy access on a 24-hour basis is

reported in the literature to be a contributor to errors (Hicks et al., 2006b; Hicks et al.,

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2004; Santell et al., 2005). If there is a question about a medication but there is not a

pharmacist to communicate with regarding the issue, this presents a possible breach in a

defense that can contribute to an error reaching patient. Distractions were also cited as

contributors to errors in this analysis.

Verbal Communication

The subcategories for verbal communication issues included verbal orders,

accents and abbreviations. Verbal orders are more error prone than written or electronic

orders (ISMP, 2001). Verbal orders were a cause of many errors in this study for a variety

of reasons. Among the problems with verbal orders observed in this sample were process

issues including misunderstanding the order, corrupting the message and transcribing

incorrectly. Language problems with verbal orders emerged, including accents and

communication of sound-alike medication without clarifying the medication’s indication

or purpose. Abbreviations also presented a problem with verbal orders. These findings

are congruent with the literature and demonstrated the many risks associated with verbal

orders and verbal communication (Cohen, 2007b; Hicks et al., 2006b; IOM, 2007; ISMP,

2005b; Paparella, 2004; Pennsylvania Patient Safety Authority, 2006; Santell et al.,

2005).

Technology

Technology is a widely regarded as a strategy to reduce the occurrence of

medication errors. The IOM recommends using technology to help improve patient safety

(IOM, 2001, 2004b, 2007). A number of studies support the efficacy of CPOE (Bates et

al., 1998; Institute of Medicine, 2007; Upperman et al., 2005). Several medication error

204
reports included a recommendation to adopt technological strategies such as CPOE to

decrease errors. Utilization of CPOE has been found to reduce transcription errors

(Upperman et al., 2005).

However, technology proved not to be risk-free in this sample—and actually

contributed to several errors. Entry errors by healthcare providers using technological

devices contributed to errors with adverse outcomes for patients. Technology can not

prevent all types of errors. As seen in this sample, use of technology must be coupled

with effective communication among healthcare providers. Incorrect data entry can lead

to communication breaches as inaccurate information is inputted and acted upon.

Technology is not without risks, as noted in the IOM report To Err is Human: Building a

Safer Health System: “all technology introduces new errors, even when its sole purpose is

to prevent errors” (2000, p. 175). Attention must paid to the human interface with

technology in the healthcare setting to monitor unforeseen problems and address them

accordingly for optimal patient safety (Battles, 2007). Even if systems are redesigned to

address system errors, given the rapid changes, new medications and new technologies,

individuals on the front lines are the “last line of defence” (Reason, 2004, p. ii28).

Research Question Three: What Attributes Supportive of a Culture of Safety

Are Present in the Medication Error Reports?

Findings

A number of attributes of a culture of safety were prominent in the error reports

that described actions taken to prevent an error from reaching a patient. The

subcategories of a culture of safety identified in this analysis included open

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communication, teamwork, learning culture, just culture, reporting culture, systems

approaches and support from leadership.

Discussion

A variety of communication processes congruent with a culture of safety were

observed and can be categorized as open communication. Some of the “safety

promoting” communication processes among healthcare providers included questioning,

seeking clarification, speaking up and seeking additional information. Communication

takes place “not only verbally and in writing but through behavior” (ECRI Institute,

2005, p. 7). A particular type of communication process involving in-person

communication termed being present emerged in this analysis which added another

component of safety by assisting in identifying and preventing errors that in a way that

was not possible via telephone or written communication. The face-to-face interaction

between healthcare providers allowed errors to become apparent that otherwise would not

have been identified in a timely manner. In several cases one healthcare provider did not

realize there was an error until a second healthcare provider pointed out the error. Open

communication was also observed between healthcare providers and patients/family

members. Errors were deflected in cases where patients/family members spoke up and

healthcare providers listened.

Teamwork is an important aspect in the delivery of safe patient care (Agency for

Healthcare Research and Quality, 2006a). Indeed, in a culture of safety, there is an

“obligation to work as a team” (Paine et al., 2004, p. 543). “Training teams” is deemed

as a “pragmatic, effective strategy for enhancing patient safety by reducing medical

206
errors”(Baker, Salas, Barach, Battles, & King, 2007, p. 259). When team members work

together an error by one provider can be caught by another provider, thereby preventing

an undesired outcome (Kalisch & Aebersold, 2006). In this analysis teamwork

contributed to deflecting errors from reaching patients and causing harm. Nurses,

pharmacists and physicians recognized problems and actively intervened.

The most commonly reported action in response to medication errors in this

sample was providing education to healthcare providers. The aspects of a learning culture

include “observing (noticing, attending, heeding, tracking), reflecting (analysing,

interpreting, diagnosing), creating (imagining, designing, planning) and acting

(implementing, doing, testing)” (Reason, 1997, p. 218). The learning culture encourages

gaining knowledge from errors in order to prevent those errors from recurring. In the

exemplars presented of a learning culture, healthcare providers displayed a willingness

to, as one reporter said, “learn from the mistakes of others.” One cannot learn from

others’ errors if the errors are hidden or not reported (IOM, 2004a). In a culture of safety

providers of care must be willing to learn and apply what has been discovered to improve

the delivery of care (IOM, 2004b).

Errors need to be reported in a manner that allows systems to be analyzed and

modified if needed (IOM, 2004b). A just culture is supportive of a reporting culture

(Reason, 1997). The just culture requires an honest, objective appraisal of circumstances

contributing to an error, so the error can be addressed appropriately in the interest of

safety (Marx, 2001). One has to be careful to recognize when someone should be held

accountable (IOM, 2004a). A technique recommended within a just culture is the

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Johnston “substitution test” (Reason, 1997, p. 208). If faced with the same events would

another person have acted in a different manner and have been able to avoid the error

(Reason, 1997). In one exemplar in this analysis a doctor was recognized for seeking to

find the root causes that contributed to the error so as to prevent a recurrence. The

question to be asked in a just culture is: Would another person act differently in the same

situation? If “probably not,” then assigning blame has no real purpose (IOM, 2004a,

Reason, 1997).

A culture that supports confidential reporting is a powerful factor in decreasing

medical errors (Agency for Healthcare Research and Quality, 2004). One of the most

important contributions to patient safety is a culture that supports reporting errors (Zhan

et al., 2005).

In a culture of safety there is an emphasis on improving systems rather than

blaming individuals (Friesen et al., 2005; IOM, 2004b; Paine et al., 2004; Reason, 1997;

Singer et al., 2003; Smetzer, 2007). Many of the actions taken in response to errors were

focused on improving systems such as changes to computer software, policy changes,

revising processes and modifying the environment. These type of systems changes are

considered to enhance the prospects of longer-term change—in contrast to efforts focused

on individuals (Hicks et al., 2004).

Cultures of safety include an organizational commitment to safety (IOM, 2004a,

2004b, 2007; Singer et al., 2003). In two exemplars presented, organizations rewarded

healthcare providers for identifying and preventing recurrent errors. In one exemplar

supportive leadership was exhibited by the chief executive officer who presented a safety

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award to a nurse for speaking up regarding an error. Leadership plays an essential role in

promoting the culture of safety, from being visible in supporting safety initiatives to

providing the resources necessary for such a culture to develop (Institute for Healthcare

Improvement, 2005; IOM, 2004a, 2004b). The leader of an organization has an

opportunity to promote behavior that fosters patient safety through acknowledging and

rewarding desired behaviors. The organization, by providing a reward, is highlighting

behavior it “wants repeated” (IOM, 2004a, p. 291). This type of support and recognition

is instrumental in achieving and maintaining a culture of safety.

Research Question Four: What Attributes Not Supportive of a Culture of Safety

Are Present in the Medication Error Reports?

Findings

The attributes not supportive of a culture of safety identified in this analysis

included; lack of open communication, lack of teamwork, process/systems issues and not

reporting errors.

Discussion

Open communication in a culture of safety is not limited to interactions between

healthcare providers. There were several examples in which healthcare providers did not

listen when the patient/family member identified a discrepancy or had a question. The

culture of safety must include the patient because “the more involved a patient is in their

care, the less likely an error will occur” (Joint Commission, 2007k, p. 35).

Lack of teamwork has been recognized as a deterrent to delivering safe care.

When healthcare providers work apart from each other, this can contribute to the creation

209
of “a silo mentality” (Paine et al., 2004, p. 549). The IOM reports that “silos” in

organizations can “impede safety improvements” (2000, p. 146). Exemplars of lack of

teamwork were presented illustrating that when members of the healthcare team did not

effectively work together they caused or contributed to errors.

System issues that contributed to errors were apparent in this review of

medication errors. A number of the exemplars presented illustrations of high risk

behaviors in organizations. Organizational culture that accepts at-risk behaviors in

providing care contributes to placing patients at risk.

In this analysis several errors were not reported to the organization where the

providers practiced. The healthcare providers described reasons for not reporting errors

in-house included “fear of losing my job” and “thought I would get in trouble.” In one

case the error, which resulted in an adverse outcome for a patient, was deemed not

reportable and neither the patient nor family was advised of the error. Healthcare

providers cannot learn from errors unless errors are reported. By not reporting an error,

an opportunity to identify causes and contributors to an error is missed. A culture that

does not promote sharing lessons learned from errors is not conducive to patient safety

(ECRI Institute, 2005).

Research Question Five: What Types of Interpersonal Issues Are

Evident in a Review of the Medication Error Reports?

Findings

Interpersonal issues were categorized into two types: those among healthcare

providers and those occurring between healthcare providers and patients/families.

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Seventeen medication error reports generated by patients/family members were included

in the qualitative analysis. The majority of these errors involved the patient incurring an

injury. First-person reports by patient and family members describing flawed

communication included one or more of the following perceptions: lack of response, lack

of support and lack of caring from healthcare providers.

Discussion

The interpersonal issues to emerge in this analysis varied. Differences were noted

in interpersonal communication described in situations where errors were deflected from

reaching the patient and also those that did reach the patient. In error deflections

interpersonal interactions encompassed open communication and teamwork. Conversely,

in cases where errors did reach the patient, lack of interpersonal communication was

noted: for example, not seeking clarification of an order. One of the compelling aspects to

emerge in this analysis was the emotional reactions of healthcare providers to errors

including fear, guilt, being nervous and not feeling right.

Emotional overtones were detected in some errors described by patients and

family members, included feelings of “disappointment,” “being upset” and “depressed.”

These narratives offer an opportunity to understand communication processes from the

view of the healthcare consumer. Such insight can help increase the awareness of

healthcare providers regarding the importance of effective, empathic communication with

patient and family members.

211
Research Question Six: What “Actions Taken” and/or “Recommendations” to

Address Errors Are Described in the Medication Error Reports?

Findings

Many of the descriptions of actions undertaken in response to an error delineated

multiple actions taken and/or recommendations. The most frequent recommendation and

action taken was education for healthcare providers. Patient education was also reported,

although not as frequently as educational efforts aimed at healthcare providers. The

process of checking and verifying was frequently cited in this analysis. Implementing

technology, specifically computerized physician/provider order entry (CPOE), was

recommended to decrease errors.

Change and improvement processes emerged as a major category and included a

wide array of strategies. The use of warnings and alerts to caution healthcare providers

regarding potential risks was a frequent recommendation. Changes occurred and policies

were initiated, revised or reinforced in response to errors. Efforts to improve

communication addressed safety techniques to enhance clarity of orders and specifying

the indication or reason the medication was being ordered. This technique would be

especially valuable in orders involving sound-alike/look-alike medications. Improving

written communication via adopting standardized processes and using of more legible

forms of such communication emerged in this analysis. Redesigning to decrease errors

included using restrictions and forcing functions. Changes and modifications in

medication storage to enhance safety were implemented. Discussing and reviewing errors

212
with staff, sharing information related to errors and conducting a root cause analysis were

reported.

Discussion

A number of actions taken and recommendations were observed in this study and

selected examples are included in Table 27 at the end of this section. Additionally

selected references/sources are included for actions taken and recommendations also

cited in Table 27. Several actions and recommendations are discussed in detail in this

section: checking and verifying, and implementation of technology.

Checking and verifying can provide an extra defense layer in identifying potential

errors and preventing them from reaching the patient (Institute for Safe Medication

Practices, 2005b; NCC MERP, 2007b). A type of verification and checking process is

medication reconciliation. Critical to effective medication reconciliation are the

involvement and participation of the multiple disciplines working as team (Poon, 2007;

Rogers et al., 2006; Whittington & Cohen, 2004). The read-back is also an essential

safety strategy (Joint Commission, 2007a; NCC MERP, 2006; WHO Collaborating

Centre for Patient Safety Solutions, 2007c).

The recommendation to implement technology to decrease errors is congruent

with research that identifies safety benefits of such technology (Bates et al., 1998;

Institute of Medicine, 2007; Upperman et al., 2005). Although there is literature

supportive of CPOE there is also literature that describes problems and safety risks with

the implementation of technology (Han et al., 2005; Institute of Medicine, 2007; Koppel

et al., 2005). Another technological application suggested to reduce errors in this sample

213
was adopting and implementing bar-coding, which has been linked to decreased

medication errors after implementation (Coyle & Heinen, 2005). However “negative”

unanticipated “side effects” impacting work processes related to the implementation of

bar-coding have been reported (Patterson, 2002). Yet, the adoption of both bar-code and

electronic medication administration records was linked to a reduction in medication

errors (Paoletti et al., 2007) Technology presents many promises to enhance patient

safety—yet it also presents perils if design, planning and implementation do not consider

workflow changes and address human interfaces with the technology (Grissinger, Cohen,

& Vaida, 2007; Institute of Medicine, 2007). The perils of technology lie in the yet-

unknown errors that can occur with new technology: “technology can be used to

eliminate and minimize currently known types of errors, but in the process new, yet-to-be

discovered types of error could be introduced” (Nadzam & Macklis, 2001, p. 436).

These narratives of medication errors provide insights into efforts undertaken to

reduce the risk of medication errors by healthcare providers and organizations, although

28% of the 322 medication error reports in this analysis did not include mention of

actions taken or recommendations.

214
Table 27

Actions Taken and Recommendations: Categories and Subcategories


Actions Taken*
and/or
Problem (Examples References/Sources**
Categories and Recommendations
Observed in This for Actions Taken and
Subcategories (Examples
Sample) Recommendations
Observed in This
Sample)

Education
In Services/ Healthcare provider Various types of Institute of Medicine,
Staff Education/ knowledge deficit education (2004a; 2007) Institute
Staff Competency, regarding medications interventions were for Safe Medication
Educational (actions, purposes, presented in this Practices (2005b);
Campaigns and routes, dosages, sample of errors. Massachusetts Coalition
Sharing names, protocols, for the Prevention of
Information, process and systems) Medical Errors (1999a);
Creative Strategies, causing a medication National Coordinating
Case Study, error. Council for Medication
Just In Time Error Reporting and
Education Prevention (2005a);
Smetzer & Cohen(2007)

Patient Patient knowledge Patient education Aimette, Tuohy, and


Involvement / deficit regarding counseling cited to Cohen (2007); Institute
Patient Education medication leading to improve safety. of Medicine (2007);
medication error. Institute for Safe
Medication Practices
(2005b); Massachusetts
Coalition for the
Prevention of Medical
Errors (1999a)

Checking and
Verification
Careful Checking Did not verify Verifying/checking Institute of Medicine
of Information physician order medication orders. (2007); Institute for Safe
leading to an error. Medication Practices
Use read-backs to (2005b); Joint
verify verbal orders Commission (2007a);
Clarify ambiguous National Coordinating
medication orders. Council for Medication
Error Reporting and
(see also Similar Prevention (2005a)
Medications)

215
Table 27 (continued)
Actions Taken*
and/or
Problem (Examples
Categories and Recommendations References/Sources**
Observed in This
Subcategories (Examples for Actions Taken and
Sample)
Observed in This Recommendations
Sample)

Medication During patient Design Institute for Healthcare


Reconciliation progression through process/system to Improvement (n.d.a);
continuum of care, conduct effective Institute for Safe
medication medication Medication Practices
information reconciliation. Use (2005a); Institute of
incorrectly medication Medicine (2007); Joint
transmitted causing an reconciliation Commission (2006;
error. process to verify 2007a); Massachusetts
information and Coalition for the
resolve Prevention of Medical
discrepancies. Errors (2005);
Communicate Northwestern Memorial
medication Hospital (2007); Poon
information to (2007); USP
other providers as (2005a);WHO
patient moves Collaborating Centre
through continuum for Patient Safety
of care. Solutions (2007a)

Confirm message Verbal Verifying/checking Institute for Safe


received communication medication orders. Medication Practices
misheard or not (2005b); Institute of
understood causing an Use read-backs to Medicine (2007); Joint
error. verify verbal orders Commission (2007a);
Clarify ambiguous National Coordinating
medication orders. Council for Medication
Error Reporting and
Prevention (2005a)

216
Table 27 (continued)
Actions Taken*
and/or
Problem (Examples References/Sources**
Categories and Recommendations
Observed in This for Actions Taken and
Subcategories (Examples
Sample) Recommendations
Observed in This
Sample)

Technological
Applications
Deploying Physician orders not Use of Institute of Medicine
Technological legible contributing to technological (2000, 2004b, 2007);
Applications to confusion causing a upgrades to Massachusetts
Improve Safety medication error. improve patient Coalition for the
safety. Prevention of Medical
System issues Errors (1999a);
contributing to error Example; Use of National Coordinating
computerized Council for Medication
physician/provider Error Reporting and
order entry/CPOE. Prevention (2005a,
2007a)

Correcting Problem with Address and correct Institute of Medicine


technology not problems as (2007);
functioning as identified. “aggressively fix
intended, and technology” Koppel et
contributes to or al. (2005, p. 1202)
causes a medication
error.

Change and
Improvement
Process
Policy/Procedures Policy and procedure Instituting updating National Coordinating
issue contributes to or and clarifying Council for Medication
causes a medication policy. Error Reporting and
error. Prevention (2006)

Process/System Process or system Develop process or Institute for Safe


failure that systems to enhance Medication Practices
contributes to or safety. (2005b); Institute of
causes a medication Medicine (2000, 2001,
error. 2004a, 2004b, 2007)

217
Table 27 (continued)
Actions Taken*
and/or
Problem (Examples References/Sources**
Categories and Recommendations
Observed in This for Actions Taken and
Subcategories (Examples
Sample) Recommendations
Observed in This
Sample)

Warnings/Alerts Confusion between Development of Cohen, Di Domizio, &


sound-alike/look- reminder/warning to Lee (2007). Institute for
alike medications alert healthcare Safe Medication
causes a medication providers of sound- Practices (2005b) Joint
error. alike/ look- alike Commission (2001);
medications. (also
see Design and
Similar/Sound Alike
Look Medications)

Documentation Unclear physician Use of standardized Institute of Medicine


order form order forms to (2007); Institute for
contributed to improve clarity of Safe Medication
confusion causing a communication. Practices (2005b)
medication error.
Use of CPOE.

Abbreviations Misinterpretation of Restrict/limit use of Brunetti et al. (2007);


abbreviation causing abbreviations to Institute for Safe
a medication error. decrease errors. Medication Practices
(2006); Institute of
Comply with “do Medicine (2007); Joint
not use” list for Commission (2007a,
abbreviations. If 2007b, 2007f); Kuhn
abbreviation used, (2007); National
clarify intent of Coordinating Council
abbreviation to for Medication Error
prevent Reporting and
misinterpretation. Prevention (2005b)

218
Table 27 (continued)
Actions Taken*
References/Sources**
Problem (Examples and/or
Categories and for Actions Taken
Observed in This Recommendations
Subcategories and
Sample) (Examples Observed
Recommendations
in This Sample)

Design One similarly named Store sound-alike/ Cohen, Di Domizio, &


medication mistaken look-alike medication Lee (2007); Institute
for another causing a apart from each other for Safe Medication
medication error. to prevent confusion Practices (2005b);
Use the generic and Joint Commission
brand name on (2001); WHO
medication orders to Collaborating Centre
help avoid error. for Patient Safety
Solutions (2007c)
(also see Similar/
Sound-Alike/Look-
Alike Medications;
Warning/Alerts)

Diagnosis and Confusing, unclear Indicate the purpose Cohen, Di Domizio, &
Indication physician order was of medication being Lee (2007); National
written for a look – utilized when Coordinating Council
alike medication ordering. for Medication Error
without indication or Reporting and
purpose, causing a Prevention (2005b);
medication error. WHO Collaborating
Centre for Patient
Safety Solutions
(2007c)

Similar/ Sound-alike and Education of Cohen, Di Domizio, &


Sound-Alike/ look-alike healthcare providers Lee (2007); Institute
Look-Alike medications mistaken and patients. Indicate for Safe Medication
Medications for one another. purpose of drug to Practices (2005b);
Names of some reduce confusion with Joint Commission
medications another medication. (2001); WHO
contribute to Store sound-alike/ Collaborating Centre
confusion causing a look-alike medications for Patient Safety
medication error. apart from each other Solutions (2007c)
to prevent confusion
Use the generic and
brand medication to
help avoid error. Use
tall man lettering To
help avoid error.

219
Table 27 (continued)
Actions Taken*
and/or
Problem (Examples References/Sources**
Categories and Recommendations
Observed in This for Actions Taken and
Subcategories (Examples
Sample) Recommendations
Observed in This
Sample)

Dialogue and Complex or high risk Discussion of Burkhardt et al. (2007);


Investigation processes contributed errors. Analysis Institute for Safe
to error. Breaches in conducted to Medication Practices
defenses contributed identify (2005b); Institute of
to error. contributors to Medicine (2004a,
and/or causes of 2004b); Joint
error and action Commission (2007h)
taken to prevent
reoccurrence of
medication error.

Note. *This table presents examples of actions taken and/or recommendations by reporters
of medication errors in this sample and are not inclusive of all actions taken and
recommendations. **This is not an inclusive listing of all references for medication errors.
References and sources are provided to the reader for additional information.

Limitations

There were a number of limitations in this study. The study is limited by the

source of the data. The reports made to the MER Program are all voluntary and only

represent those errors that are recognized as an error and that a healthcare provider,

patient, family member or significant other reported. The data was for the time period

2002 to 2005. While hospitals and healthcare organizations generally require that errors

be reported via medication incident report or similar report internally, there is no federal

mandate that requires all medication errors be reported. Not all errors are reported or

captured, and the MER Program represents a small sample of medication errors. Between

2002 and 2005 the MER Program received 2,172 error reports. In contrast, the

220
MEDMARX program, in which participating facilities report errors, received 897,369

error reports for the same time period (Hicks et al., 2006b).

Secondary data was utilized; therefore, the researcher did not have access to the

original submission from the persons completing the medication errors reports. The

information was downloaded from the original reports by the USP, de-identified by USP,

and abstracted data for selected prompts was provided to researcher.

The researcher did not have the opportunity to interview the persons who reported

errors. Questions arose during review of narratives reports of medication errors that could

not be asked by the researcher of those submitting the medication error report. While this

is a limitation of this dataset, it is also an opportunity, as it contains rich information that

is not widely accessible. Persons reporting errors to this database are assured reports are

treated in a confidential manner. Additionally, persons may report anonymously to this

database (Scarrow & Routon, 2005; USP, n.d.a). This dataset was unique in that it

provided an opportunity to qualitatively analyze hundreds of richly detailed medication

error reports.

The source of data is self-reporting and thus provides a perspective based on the

individual(s) reporting the error. The researcher could not verify the accuracy of the

reports and it was an assumption that the reports were accurate from the perception of the

reporter. However, this type of reporting may have presented only one perception of a

complex situation.

The depth of the information reported varied: Some reports were very detailed, in

other instances there were fewer details.

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A limitation in the analysis portion of this research is the lack of a clinical

multidisciplinary team to aid in the content analysis—although members of the

committee and a consultant did review the researcher’s analysis and coding. Using

multidisciplinary teams is suggested in the literature (Krol et al., 2002). The advantage of

a team approach in conducting analysis of medication variance reports is that it

contributes to the “completeness of the analyses”(Krol et al., 2002, p. 320). One

discipline may identify issues another discipline may not identify (Krol et al., 2002).

However, a doctorally prepared pharmacist served as a consultant to the committee

regarding questions that arose related to medications and medication dispensing.

While the medication “error descriptions” selected for this research underwent in-

depth analysis from a qualitative perspective, but there is much more information that

could be analyzed in the MER program data set. The error descriptions data were very

rich and the narratives provided insight into the “stories” of many who are impacted by

medication errors—from patient to provider—albeit a very small sample when one

considers the numbers of medications dispensed and administered every day.

Thematic Analysis and Implications

The themes that threaded through this data illustrate the need for strategies and

actions to improve patient safety related to medications. The five themes that emerged

were informative in indicating implications for practice, education, policy, and research.

The themes and implications are depicted in Figure 8 followed by an explanation of each

implication.

222
Themes
Seeking
Standing Stepping Experiencing
Risking to prevent
watch in to the
Patient safety reoccurrence
for prevent human impact
of
errors harm of errors
medication errors

Implications
Education
Practice &
of Policy Research
Delivery of Care
Healthcare Providers

Themes

1. Risking patient safety through behaviors and systems that


breach defenses.

2. Standing watch for errors.

3. Stepping in to prevent harm.

4. Experiencing the human impact of medication errors.

5. Seeking to prevent recurrence of medication errors.

Figure 8. Themes and implications.

223
Practice and Delivery of Care – Implications

A major theme that emerged in this sample was risking patient safety through

behaviors and systems that breach defenses. The sample revealed that many errors occur

because of multiple breaches in defenses. Communication failures and systems issues are

reflective of the culture in which care is provided, and therefore these causes of error

cannot be addressed in isolation. An organizational focus on a culture of safety can

harness efforts to support effective performance. Breaches in defenses typically occur at a

weak point in the system. An emphasis on an organizational approach to promoting

optimal performance, systems functioning and delivery of safe care, while complex, is in

the best interest of safe patient care. The IOM reports have advocated for the appropriate

organizational response to the problem of errors in healthcare for years (IOM, 2000,

2001, 2004a, 2004b, 2007).

Cultural Influences

The theme standing watch for errors encompassed culture, systems and

individual behaviors. The IOM report Preventing Medication Errors noted that “patient

safety can best be achieved through the adoption of a culture of safety”(Institute of

Medicine, 2007, p. 15). The IOM recommends organizations promote cultures of safety

through various strategies, including but not limited to:

• Specifying short- and long-term safety objectives.

• Continuously reviewing success in meeting these objectives and providing

feedback at all levels.

224
• Conducting an annual confidential survey of nursing and other healthcare

workers to assess the extent to which a culture of safety exists.

• Instituting a deidentified, fair, and just reporting system for errors and near

misses.

• Engaging in ongoing employee training in error detection, analysis, and

reduction.

• Implementing procedures for analyzing errors and providing feedback to

direct-care workers.

• Instituting rewards and incentives for error reduction. (IOM, 2004, p. 15)

A culture of safety requires a commitment to safety encompassing the leadership

and all staff (ECRI Institute, 2005; IOM, 2004a, 2004b, 2007; Pizzi et al., 2001; Singer et

al., 2003). There is a need for adequate resources, the ability to report errors and ongoing

learning to deliver safe care (ECRI Institute, 2005; IOM, 2004a, 2004b; 2005; Pizzi et al.,

2001; Singer et al., 2003). Barriers to a culture of safety include lack of support from

leadership, a fear of reporting, fear of speaking up and system failures. Organizations that

do not acknowledge or respond to problems are engaging in organizational silence which

is counter to attributes found in a culture of safety (Henriksen & Dayton, 2006). A

strategy to assess the culture of safety is using a confidential survey (IOM, 2004), for

example the Hospital Survey on Patient Safety (Sorra & Nieva, 2004). Such a survey can

be used to help establish a baseline regarding willingness to report errors, and other

perceptions regarding the organization. Healthcare organizations using this survey can

now compare their results with other hospitals (Sorra, Nieva, Famolaro, & Dyer, 2007).

225
Patient safety problems can not be addressed unless they are identified, and a survey

offers a strategy to receive confidential and/or anonymous input from the staff.

The organization’s culture needs to support healthcare providers in reporting near

misses and errors in order to inform and educate others. The organization needs to

identify the causes of the event and develop strategies to prevent reoccurrences. Yet

healthcare providers will likely not report errors if there is fear of punitive response

(Cohen, 2000; IOM, 2000, 2004a; Marx, 2001; Smetzer, 2007). The just culture is a

valued a component of a culture of safety (IOM, 2004b; Reason, 1997; Smetzer, 2007)

and is a necessary organizational force to foster and support a reporting culture. The just

culture recognizes the importance of reporting errors, and persons are supported for

reporting so that information obtained can be used to address safety problems (Marx,

2005; Reason, 1997). Yet this culture is not equivalent to blame free and also recognizes

the need for accountability (Marx, 2001; Reason, 1997).

The analysis of medication errors in this sample underscores the threat of

ineffective communication to patient safety. Conversely, effective communication

processes are essential to safe patient care and averting medication errors. The theme

stepping in to prevent harm became apparent in this analysis in many instances in which

more serious harm to a patient was averted because someone stepped in, intercepted the

error trajectory and stopped an error from reaching a patient.

The theme experiencing the human impact of errors applied to all those affected

by errors: patients, families and healthcare providers. In order to promote open

communication and learning from errors there needs to be genuine encouragement of

226
error reporting. Research reveals healthcare providers may feel fear of reporting errors

(Bulla, 2003; Mayo & Duncan, 2004; Osborne, et al., 1999; Ulanimo et al., 2007).

Studies of healthcare providers involving medication errors also indicate a perceived lack

of support by other healthcare providers (Serembus et al., 2001; Wolf & Serembus,

2004). There needs to be less blame and more support—which may encourage more

reporting of medication errors (Wolf & Serembus, 2004).

Cultures of safety recognize the benefits of learning and ongoing education (ECRI

Institute, 2005; IOM, 2004a, 2004b; Singer et al., 2003). Given the complexity of

healthcare, adequate resources need to be allocated to continuously educate and update

providers of care. A flexible culture is necessary to adapt, especially when facing a

potentially hazardous situation (Reason, 1997) and is a component of a culture of safety

(Reason, 1997; Smetzer, 2007). This culture is dependent on skilled staff who can meet

various challenges (Reason, 1997). Organizations must support educating healthcare

providers to maintain competency in clinical, communication and teamwork skills.

Healthcare Organizations’ Role

In healthcare there has been a pattern of “low expectations” related to

communication; healthcare providers “have become so used to poor communication”

(Dayton & Henriksen, 2007, p. 39). Many of the medication errors in this sample

included at-risk communication behaviors by healthcare providers. Organizations need to

address at-risk behaviors and explore why such behaviors are occurring, as there may be

system issues contributing to the behavior (NCC MERP; Smetzer, 2007). Punishing the

individual alone for such behavior does not resolve system deficiencies: There needs to

227
be on emphasis on risk-reducing behaviors (Marx, Comden, & Sexhus, 2005) by

healthcare organizations.

Organizations can improve patient safety by clearly defining expectations related

to effective communication between healthcare providers, Doing so reflects the themes

standing watch for errors and stepping in to prevent harm. In one study, an organization

that adopted behavior-based expectations and error prevention tools reported a decrease

in sentinel events (Yates et al., 2005). Among the behavior-based expectations are those

related to communication including using “repeat-backs/read-backs, clarifying questions,

phonetic and numeric clarifications” (Yates et al., 2005, p. 688). Use of standardized

communication behaviors can enhance communication among healthcare providers and

improve safety overall (Leonard et al., 2004).

Innovations and contributions to improving patient safety need to be recognized

and rewarded (ECRI Institute, 2005; IOM, 2004b). The importance of human factors in

the communication process must be considered by organizations. Work design issues that

impact negatively on communication need to assessed when analyzing medication errors

(Burkhardt et al., 2007) and deploying effective designs can both enhance patient safety

and improve working conditions for healthcare providers (Gosbee & Gosbee, 2005).

Organizations need to set the standard for expected behaviors among healthcare

providers (Yates et al., 2005)—and patient safety must be considered the primary goal.

To that end healthcare providers must be competent and professional in behavior and

communication. The exemplar of the “physician known to scream” indicates such

nonprofessional behavior can have a deleterious effect on inter-professional

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communication. Healthcare organizations need to recognize “poor behavior is really no

different than incompetence, as they both affect the ability of others to get their jobs

done” (Lin, 2004, p. 5). Various organizations have recognized that “safety must be

incorporated into the organization’s strategic plan” (American Hospital Association,

Health Research and Educational Trust, & Institute for Safe Medication Practices, 2002).

The Joint Commission developed accreditation standards that are multi-pronged and

crystallize components of a culture of safety (Joint Commission, 2007e). Such standards

recognize that effective leadership is required to develop a culture of safety: “Leadership

provides the foundation for effective performance” (Joint Commission, 2007e). The Joint

Commission’s 2009 leadership standards specifically address maintaining a culture of

safety, effective communication and performance improvement (Joint Commission,

2007e).

Organizational Deployment of Technology

In exemplars of seeking to prevent reoccurrence of medication errors in this study

there were comments that technology including CPOE and bar-coding was desirable to

prevent errors. Using computerized physician order entry/computerized provider order

entry (CPOE) to reduce errors has been studied extensively (Bates et al., 1998; IOM,

2007; Kaushal et al., 2006; Kuperman et al., 2007) and in one study amelioration of

transcription errors was reported (Upperman et al., 2005). Bar-coding has been linked to

a reduction in medication errors (Roark, 2004). The adoption of technology to reduce

medication errors and improve patient safety is recommended (IOM, 2000, 2004a, 2007).

229
However, other types of errors and concerns may emerge related to using

technology such as CPOE (IOM, 2007; Koppel et al., 2005) and bar-coding (McDonald,

2006; Patterson, Cook & Render, 2004; Roark, 2004). Within the theme risking patient

safety through behaviors and systems that breach defenses exemplars of medication

errors related to technological problems was observed. While CPOE is hailed as a

strategy to reduce medication errors, its implementation is complex and costly (IOM,

2007). It has been reported the majority of United States hospitals do not meet CPOE

standards (Cutler, Feldman, & Horwitz, 2005).

The literature supports using technology to improve patient safety (IOM, 2000,

2004a, 2004b, 2007); however, the literature also cautions healthcare providers there are

challenges to address when implementing technology (IOM, 2007). Appropriately

implemented technology could reduce problems with illegible orders, transcription errors

and other written communication related to medication therapy (IOM, 2004a). Such

technology would be an asset to the communication processes among healthcare

providers. But deploying technology requires an orchestration of many persons with

various talents and skills including leadership, coordination, intensive planning,

investment of adequate financial resources, education and training to be successful (Ash

et al., 2003).

Nurses and the Provision of Care

As the largest group of healthcare professionals in the United States with a

presence throughout the continuum of care, nurses can be active in standing watch for

errors, stepping in to prevent harm and seeking to prevent reoccurrence of medication

230
errors. Healthcare environments that are counterproductive to safe patient care must be

re-engineered (IOM, 2000, 2004a, 2004b). Nurses must be engaged in policy

development and organizational redesign to promote optimal environments of patient

safety. Yet nurses “have not been on the forefront of developing policies and procedures

to reduce errors” (Burke, Mason, Alexander, Barnsteiner, & Rich, 2005, p. 3).

The IOM report Keeping Patients Safe: Transforming the Work Environment of

Nurses (2004a) advocates for changes to improve quality of care delivery. Because the

nursing work environment is also the environment of care, the work environment needs

to allow a culture of safety to develop and thrive (IOM, 2004a). There are essential

components of environments that promote and support safe patient care. Such

environments are termed healthy work environments and encompass skilled

communication, true collaboration, effective decision making, appropriate staffing,

meaningful recognition and authentic leadership (American Association of Critical-Care

Nurses, 2005). There have been multiple efforts initiated to improve nurses’ work

environments to promote quality care. Exemplars of programs focused on improving the

healthcare work environment include the Nurse Friendly Criteria developed by Texas

Nurses Association which specifically addresses non-retaliatory reporting of patient

concerns and “zero tolerance” for abuse of nurses (Texas Nurses Association, 2005). The

Beacon (American Association of Critical-Care Nurses, 2007) and Magnet awards

(American Nurses Credentialing Center, 2007) recognize organizations that promote

work conditions congruent with the components found in a culture of safety and healthy

work environment.

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Nurses can and should impact the healthcare practice through both their critical

mass and their critical place at the synapse of care between the provider and patient

(IOM, 2004a). Additionally, nurses have a role in modeling safe behaviors for nursing

students and other healthcare providers (Kuhn, 2007).

On an individual level the nurse should comply with the code of ethics for nursing

including maintaining competence (American Nurses Association, 2001). A number of

causes of errors were related to knowledge deficits in this sample. Nurses need to

advocate for systems and resources that support maintaining current knowledge to deliver

safe and appropriate care (IOM, 2004a). Nurses are further compelled by the nursing

code of ethics to address errors: “under no circumstances should the nurse participate in,

or condone through silence, either an attempt to hide an error or a punitive response that

serves only to fix blame rather than correct the conditions that lead to the error”

(American Nurses Association, 2001, p. 14). Nurses need to be involved in promoting

cultures that foster open reporting of errors (IOM, 2004b, 2007).

Breaches in defenses must be recognized and addressed. Many breaches are

related to systems failures (IOM,2004a; Reason, 1997). Unless errors are reported, causes

of errors cannot be analyzed and systems’ defects may go undetected—contributing to

future errors (Leape, 2002). Nurses in leadership positions must foster non-threatening

environments that allow nurses to report errors to advance patient safety (IOM, 2004b).

Allowing and encouraging staff nurses to be involved in analyzing reported errors

improves trust and enhances the culture of safety (Conerly, 2007).

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Patient and Family Involvement in Care

One of the defenses observed in this sample of reported medication errors was the

efficacy of patients alerting healthcare providers to medication errors. Families and

patients were also involved in standing watch for errors and stepping in to prevent

errors. It has been reported that an informed patient can “decrease the probability they

will experience a medication error”(IOM, 2007, p. 165). A feature of a culture of safety is

open communication not only among healthcare providers but between healthcare

providers and patients and families (ECRI Institute, 2005). The benefit of such open

communication was evident in number of “near misses” in which a patient or patient’s

family provided the defense and deflected and error.

The Joint Commission and AHRQ have both launched well-known campaigns to

encourage patients to become more involved in their care and ask questions (Agency for

Healthcare Research and Quality, n.d.; Joint Commission, 2007i, 2007j). A number of

publications are specifically designed to address medication safety for patients (Agency

for Healthcare Research and Quality & National Council on Patient Information and

Education, 2003; American Society of Health-System Pharmacists, n.d.; Institute for Safe

Medication Practices, 2007; Massachusetts Coalition for the Prevention of Medical

Errors, 1999b; National Patient Safety Foundation, n.d.).

A study of several major safety campaigns including those by AHRQ, Joint

Commission, and National Patient Safety Foundation (NPSF) concluded there were

opportunities for improvement in addressing patient safety (Entwistle, Mello, & Brennan,

2005). The study provided three recommendations regarding patients’ participation in

233
their care. The first recommendation focused on the need for additional research in the

area of patient involvement in promoting patient safety. Second, patient education

materials need to be assessed toward the patient’s interpretation of the material presented.

Third, healthcare providers must work to address “harm-prevention” and provide support

to patients in encouraging their involvement in promoting safety (Entwistle et al., 2005).

In the IOM report Preventing Medication Errors, the first recommendation is

aimed at enhancing the safety of medication use for patients (2007). The recommendation

further addresses patient rights, access to medication information, meeting patient

educational needs, and access to consultation across the healthcare continuum. Healthcare

providers have an obligation to educate patients. Further, when a patient identifies a

medication discrepancy the healthcare provider needs to listen and assure the concern is

addressed. Patients need to be included in the medication reconciliation process (Joint

Commission Resources, 2007; Poon, 2007; WHO Collaborating Centre for Patient Safety

Solutions, 2007a). Patients can play an important role in preventing errors, but they need

to be encouraged and engaged as partners. A variety of interventions require partnering

with the patient such as obtaining a medication history and educating patients on keeping

a current list of medications (Aimette et al., 2007; Poon, 2007; IOM, 2007; Sullivan et

al., 2005). There is a balance to be achieved in the patient–healthcare provider

partnership and it rests on effective and respectful communication. “Patient-centered

communication is the linchpin of patient-centered care. Care cannot be patient centered if

it does not effectively involve the patient” (Joint Commission, 2007k, p. 31). There are

knowledge gaps regarding how healthcare providers can encourage patients in the role of

234
“vigilant partner” (Hibbard, Peters, Slovic, & Tusler, 2005, p. 602). Hibbard et al.’s study

of 195 persons found not all persons are likely to engage in questioning behaviors of

healthcare providers to prevent an error. Participants were asked how likely they were to

engage in preventative actions for medical errors, and several of the questions addressed

strategies to reduce medication errors. The results indicate patients are more likely to

notify doctors about allergies and reactions to medication and medications being taken

than to confirm if the medication is correct. Hibbard et al. noted that efforts to improve

safety have been centered on changes at the institutional level and focused on providers

(2005). Patients can contribute to improving safety (Hibbard, 2005). The study indicated

that their actions are perceived as being effective in preventing errors, but patients are

less likely to embrace “actions that require them to question health professionals’ actions

or judgments” (Hibbard et al., 2005, p. 612). It is recommended that educational efforts

to involve patients in care address enhancing self-efficacy, and there needs to be

recognition that asking patients to question healthcare providers will require multiple

strategies (Hibbard et al., 2005). Healthcare providers need to be open to questions raised

by patients and create environments of care that allow and promote more active patient

involvement.

The National Patient Safety Foundation (NPSF) has proposed four issues that

need to be addressed to develop a “patient-centered culture of patient safety in

healthcare” (NPSF, 2003, p. 1): education, culture, research and support services. The

education recommendations include raising awareness, building curricula for healthcare

providers and maintaining education programs for patients and providers. The NPSF

235
recommends that research focused on patient and family needs to be increased in such

suggested topics as identifying strategies to improve communication among healthcare

providers and patients/families.

Some of the exemplars provided by patients and family members illustrated

experiencing the human impact of errors, such as patients’ and families’ perceived lack

of caring by healthcare providers. Effective compassionate care in today’s complex

environment requires orchestrating many providers, processes and systems focused on

the patient. However, care starts at the synapse between the provider and the patient. A

worthy goal for individual practitioners is to practice “dignity conserving care” guided by

four values of care:

A - attitude

B - behavior,

C - compassion

D - dialogue (Chochinov, 2007).

These A, B, C, D’s of caring speak to addressing many of the causes of error. For

example, the behavior value specifically addresses the importance of “facilitating

communication” with the patient through being attentive, repeating information, speaking

in understandable terms and asking if there are questions (Chochinov, 2007).

Patients have a right to be informed of matters regarding their health, and

healthcare providers have an obligation to act ethically regarding disclosing medication

errors. Disclosure is required by Joint Commission (Joint Commission, 2008). Disclosure

allows “the open communication about all aspects of care with patients and families”

236
(American Society for Healthcare Risk Management, 2003, p. 9). Research indicates the

majority of patients surveyed want to be informed of errors (Gallagher, Waterman, Ebers,

Fraser, & Levinson, 2003; Mazor et al., 2004). Lamb (2004) reports that in many cases

patients and families sued organizations and/or care providers because of lack of

communication after an adverse event. The patients and families specifically reported

there was a lack of honest and open communications (Lamb, 2004). In one exemplar in

this study a family member reported it would have been helpful to know what to expect

after a medication error. The family was not given specific information and was “left

worrying about the outcome.” Leaving a family member worrying contributes to

experiencing the human impact of errors, and this negative impact could be addressed

somewhat by honestly and compassionately communicating after a medication errors.

Healthcare providers can engage patients and families using various strategies.

Crucial to this engagement is open honest communication so information can be obtained

and shared. There needs to be an emphasis on true patient-centered care, defined as “a

call for improved communication and collaboration with patients” (Sehgal, 2007). The

seven attributes that contribute to patient-centered care at the organizational level are:

• “Leadership”

• “Strategic vision clearly and consistently communicated”

• “Involvement of patient and families”

• “Care for the caregiver via a supportive work environment”

• “Systematic measurement and feedback”

• “Quality of the built environment”

237
• “Supportive technology.” (Shaller, 2007, p. 1-2)

The healthcare system must seek to welcome the patient and his or her family’s

participation in mitigating experiencing the human impact of errors and seeking to

prevent reoccurrence of errors. If progress is to be made in patient safety initiatives, key

to the success of such efforts is adopting a true patient-centered approach to healthcare—

which means involving the patient and families and not keeping important information

from them. These attributes are congruent with a commitment to patient safety.

Improvement Efforts

Reporters in this study provided multiple recommendations in response to

medication errors encompassing several categories of actions in seeking to prevent

recurrence of error. The most frequently cited recommendations and actions to emerge

from this analysis included education, use of checking or verification processes,

undertaking a change process and implementing improvements to reduce the risk of an

error recurring, In this sample of medication errors many reporters identified the need for

improvement in the delivery of care. Cohen, Smetzer, et al. suggest a framework for

improvement related to high alert medications which consists of three principles:

1. “Reduce or eliminate possibility of error.”

2. “Make errors visible.” [so they can be identified and addressed] to “help

prevent patient harm”

3. “Minimize consequences of errors.” (Cohen, Smetzer, et al., 2007, p. 318-

320)

238
These principles were observed in the actions taken and recommendations by reporters of

errors in this study. Reducing or eliminating the possibility of error was seen in cases

where problematic medications were restricted and/or removed from floor stock. Errors

were made visible when another person checked the drug and communicated finding a

discrepancy, and therefore administering the incorrect medication was avoided.

The ongoing monitoring and evaluating of the care delivered is necessary in seeking to

improve the quality of care and in seeking to prevent reoccurrence of error.

According to the IOM a number of organizations have disseminated strategies to

reduce the occurrence of medication errors and improve the delivery of care including:

• Agency for Healthcare Research and Quality (AHRQ)

• American Society of Health-System Pharmacists (ASHP)

• Institute for Healthcare Improvement (IHI)

• Institute of Medicine (IOM)

• Institute for Safe Medication Practices (ISMP)

• Joint Commission on Accreditation of Healthcare Organizations [presently

known as Joint Commission]

• Massachusetts Coalition for the Prevention of Medical Errors

• National Quality Forum

• National Coordinating Council for Medication Error Reporting and

Prevention (NCCMERP)

• Pathways for Medication Safety

• U.S. Pharmacopeia (USP). (Institute of Medicine, 2007, p. 410)

239
These organizations’ recommendations address a variety of strategies to prevent

medication errors. Table 28 lists examples of failures and breaches identified from the

medication error narratives. Strategies to strengthen defenses and improve care identified

in the literature are also provided. Efforts need to be undertaken to strengthen defenses to

block error trajectories and improve care.

240
Table 28

Examples of Medication Errors and Improvement Strategies in the Literature


Examples of Holes Observed
Examples of Strategies*
in Defenses in This Sample References for Strategies
To Improve Delivery of
Related to a Medication Cited**
Care
Error
Lack of Knowledge Education and training in Institute for Safe Medication
medication safety. Practices (ISMP) (2005b);
Example: Nurse lacked Access to pharmacist to Institute of Medicine (2004a,
knowledge regarding answer questions. Access to 2007); Massachusetts
medication causing a resources and references. Coalition for the Prevention
medication error. of Medical Errors (1999a)
National Coordinating
Council for Medication Error
Reporting and Prevention
(2005a)
Lack of Effective Organizations build culture Agency for Healthcare
Communication of safety and seek to Research and Quality
eliminate “at- risk” (2006a); Institute of
Example- Nurse avoids seeking behaviors that can lead to Medicine (2000, 2004a,
clarification of a physician medication errors. 2007); National Coordinating
order from a doctor known to Provide education and Council for Medication Error
scream and patient training on effective Reporting and Prevention,
subsequently receives wrong communication. 2007b
dosing of medication.
Impaired Communication Promote involvement of Institute for Safe Medication
Process Between Healthcare patient and significant Practices (2005b); Institute of
Provider and Patient others (SO)/family. Provide Medicine (2007); Joint
patient education regarding Commission (2007j)
Example: Patient notes medications.
medication discrepancy but Encourage and allow
healthcare provider does not patients/SO/family to raise
listen and/or follow up and questions. Address
medication error ensues. patient/family questions.
Lack of Teamwork Promote teamwork. Provide Agency for Healthcare
resources and education to Research and Quality
Example: Working in silos and learn effective strategies to (2006a); IOM (2000, 2004a,
not communicating with others improve team effectiveness. 2007); National Coordinating
in other departments leading to Seek to eliminate at-risk Council for Medication Error
medication error. behaviors. Reporting and Prevention
(2007b); Smetzer, (2007)

241
Table 28 (continued)
Examples of Holes
Observed in Defenses in Examples of Strategies* References for Strategies
This Sample Related to a Improvement Efforts Cited**
Medication Error
Handoff Disruptions Use medication Friesen et al., (2008); Institute
reconciliation. for Safe Medication Practices.
Lack of effective Standardize reporting of (2005a); Joint Commission
transmission of critical relevant clinical information. International Center for Patient
information between Allow asking of questions Safety (2005); Joint
healthcare providers. and clarification. Use read- Commission (2007a); Joint
backs in communicating Commission Resources (2007);
Example: Patient receives critical information. Use Northwestern Memorial
incorrect dosing of technology to improve Hospital (2007); Poon,
medication after transition in transmission of information (2007);WHO Collaborating
care due to lack of and access to information. Centre for Patient Safety
communication. Avoid use of abbreviations Solutions (2007b)
and terms that can be
misinterpreted. Encourage
patient involvement and
speaking up regarding any
concerns.
Multiple System Failures Commitment to safety Burkhardt et al., (2007); Cohen
(Latent and Active) Promote culture of safety. (2007a); Institute of Medicine
Example: Medication error Analysis of causes and (2000, 2004a, 2004b, 2007);
occurs because of multiple contributors to errors. Take Smetzer (2007).
latent failures and active action taken to prevent
failures. reoccurrence

Note. *This table presents examples of some strategies used to address medication errors. This is
not an inclusive listing of all specific safety strategies and/or references. **References are
provided to the reader for additional information.

Education of Healthcare Providers – Implications

In seeking to prevent reoccurrence of errors there are many implications for

educating healthcare providers. The lack of knowledge displayed among healthcare

providers regarding medication in these exemplars indicates that licensure alone does not

ensure healthcare providers have adequate knowledge regarding medications. This

finding is congruent with other studies that have identified knowledge deficit as a cause

242
of medication errors (Hicks et al., 2006b; Leape et al., 1995). There is a need for ongoing

education for all healthcare professionals simply given the rapidly changing healthcare

environment. Among 10 causes of medication errors identified by the ISMP, both lack of

information about the drug and inadequate ongoing education were listed (Cohen,

2007b). Current, user- friendly, accurate educational resources regarding medications

must be available to healthcare providers at all times (IOM, 2007; ISMP, 2005b; National

Coordinating Council for Medication Error Reporting and Prevention, 2005a),

Communication skills are as important as clinical skills in the delivery of patient

care (American Association of Critical-Care Nurses, 2005). The education process needs

to prepare healthcare providers to work collaboratively and respectfully together to

enhance teamwork. The advantage of a team working together is that different talents,

perspectives, knowledge and skills are available and team work offers a safeguard: If one

member of the team does not recognize an error another member of the team may and can

avert the error from reaching the patient (Baker, Day & Salas, 2006; Kalisch &

Aebersold, 2006). The strong, effective team can be useful in both standing watch for

errors and stepping in to prevent harm. Providing healthcare in this day and age is an

interdisciplinary team effort, yet healthcare professionals are “generally” not prepared in

educational environments that are interdisciplinary (IOM, 2003a; Miller, 2004). Silos in

healthcare practice need to be replaced (IOM, 2000) by synergistic teamwork that fosters

open communication. Efforts to promote cultures that are supportive of open

communication and teamwork are needed for safe patient care (IOM, 2000, 2004a, 2007).

243
Creighton University undertook an effort to provide an interdisciplinary course on

patient safety targeting nursing, medical, pharmacy and other heath-related students. The

majority of students enrolled indicated the course contained fundamental information for

healthcare providers and should be required (Galt et al., 2006). Education of healthcare

professionals needs to promote “building bridges rather than silos” (Miller, 2004, p. 8).

Five core competencies identified by the IOM are that health providers provide patient-

centered care, work in interdisciplinary teams, employ evidence-based practice, apply

quality improvement and utilize informatics (IOM, 2003a). Educational programs for

healthcare providers need to address these five competencies.

Specific communication strategies; “read-backs, Situation-Background-

Assessment-Recommendation (SBAR), critical assertions, and briefings and debriefings”

(Dayton & Henriksen, 2007, p. 41), that have been used in other industries can be helpful

in clarifying communication (2007). The use of structured communication techniques

while recommended to improve “clarity” (Dayton & Henriksen, 2007). The adoption of a

technique such as SBAR requires education and members of the healthcare team need the

opportunity to learn SBAR in an environment that encourages teamwork and values all

members of the team (Leonard et al., 2004; McFerran et al., 2005).

One method for seeking to reduce the recurrence of errors is using a paradigm

that recognizes “every error [as] a treasure” (Lehmann et al., 2007, p. 401) and promotes

learning from errors. Medication errors can be utilized by nurse educators and other

healthcare providers to teach both students and experienced healthcare providers. The

lessons learned can educate both the novice and the expert nurse, although the novice and

244
expert may perceive situation differently based on their knowledge and experience

(Benner, 1982, 1984). The narratives and stories contained within case studies of

medication errors can serve to inform healthcare providers and help prevent error

recurrence. The education process can be instrumental in preparing nurses to contribute

in a meaningful way to promoting a culture of safety and seeking to prevent the

recurrence of medication errors. It is important that educators not only acknowledge to

students that errors do and will occur, but there needs to be an understanding of why the

error occurred to prevent recurrence (IOM, 2007). Educating nurses and all healthcare

providers needs to include recognizing the many factors that influence an error trajectory

(IOM, 2007). A merely punitive response to an error does not encourage reporting errors

and does not promote a through analysis of errors (Larson, 2000). Educators have a major

role in acculturating students into the profession, and the paradigm of seeking to

acknowledge and learn from errors is important if safety in healthcare delivery is to be

improved (IOM, 2007).

The education process needs to address a systems approach to error prevention

and recognize the importance of human factors and design in preventing errors (Milligan,

2007). Healthcare providers need to know when to seek guidance from human factors

experts to improve medication safety (Schneider, 2002). Educational efforts need to also

address the continuing education needs of licensed professionals related to medication

errors. Presently, only one state requires continuing education for nurses that addresses

medication errors (IOM, 2007). The use of a root cause analysis applied to case studies of

medication errors can be a helpful mechanism in not only identifying the causes but

245
increasing the awareness regarding risks (American Hospital Association, Health

Research and Educational Trust, & Institute for Safe Medication Practices, 2002;

Burkhardt et al., 2007). In summary, there are multiple education implications for both

preparing students entering the healthcare professions and licensed professionals

throughout their careers.

Policy – Implications

Seeking to prevent medication errors encompasses reporting errors when they do

occur so other can learn from the errors. The policies of national, state and local

jurisdictions need to support cultures of safety within healthcare organizations. The state

of reporting medication and medical errors is a patchwork quilt of different programs and

organizations. According to the National Quality Forum (NQF) “there is not standardized

reporting across states to provide reliable and consistent information on the number and

type of the most serious preventable adverse events” (National Quality Forum, 2002, p.

1). However, several states now do require public reporting of adverse events identified

by NQF as adverse events (NQF, 2006)

Reporting Errors

The MER Program provides an excellent opportunity for all providers and

consumers to report medication errors; however, the percentage of errors reported is

minuscule when one considers the breath and width of medication errors that occur. The

MER Program utilizes voluntary reporting, performs analysis of errors and is “focused on

learning from the event and preventing future errors through system-based solutions that

can be extrapolated widely to all healthcare settings” (Scarrow & Routon, 2005, p. 30).

246
Learning from an error allows healthcare providers to engage in seeking to prevent

reoccurrence of errors.

But the environment first needs to be supportive of reporting errors (Barach &

Small, 2000; Cohen, 2000; IOM, 2000; Larson, 2000; Lovern, 2001; O’Leary, 2000,

2003). Cohen notes, “reporting will occur only if practitioners feel safe doing so and it

becomes a culturally accepted activity within the healthcare community” (2000, p. 729).

This statement has policy implications. Although the Patient Safety and Quality

Improvement Act was signed by the president in 2005 (Office of Press Secretary, 2005)

the Act at this writing is still pending implementation. This Act supports a culture of

safety by encouraging voluntary reporting of errors (Patient Safety and Quality

Improvement Act of 2005. 2005; White House, 2005). Many organizations handle errors,

analyze the cause and take corrective actions to prevent recurrence, as evidenced in this

sample analysis of medication errors. But the lessons learned at the individual

organizational level need to be reported to a greater audience so that the causes and

lessons learned can aid other healthcare providers in preventing errors (IOM, 2000). The

National Association for Healthcare Quality (NAHQ) states in order for error reporting

systems to be effective these systems depend on “as much data as possible” (2000, p. 1).

Further,

Practitioners and other providers must feel that their livelihood will not be

jeopardized simply because they disclosed information about errors associated

with their services. Likewise, knowledgeable professionals must feel free to

candidly explore the root causes of reported errors without fear that their honest

247
appraisals will jeopardize their professional positions or place them in an

adversarial position with colleagues in litigation or in the media. (p. 1)

Resources need to be allocated for learning from errors (IOM, 2000). Implementation of

public policy is needed that encourages and indeed supports reporting errors without fear

of reprisal (IOM, 2000). The Patient Safety Act provides protections for voluntary

reporting and includes provision for Patient Safety Organizations (PSOs) (Patient Safety

and Quality Improvement Act of 2005). The utilization of PSOs in tracking and analyzing

causes of medication errors could contribute to better understanding and remediation of

systems that contribute to such errors. The Act seeks to provide assistance to PSOs so

that data can be aggregated and comparisons can be made.

Adopting Medication Error Reporting Taxonomy

The adoption of a single taxonomy for reporting medication errors is

recommended by experts in patient safety (IOM, 2007). Reporters of medication errors,

in this sample, used many different explanations in describing medication errors. The

challenge of coding this small sample required a time- and labor-intensive process. For

coding, trending and research purposes, implementing a national taxonomy for

medication errors could prove beneficial to categorize medication errors and allow more

accurate comparisons of medication error patterns across healthcare organizations. The

NCC MERP has developed a taxonomy of medication errors (1998). But at the present

time there is no national requirement to use a specified taxonomy. A nationally accepted

taxonomy would provide a common nomenclature to allow more effective

communication among researchers regarding errors. The lack of a consistently used

248
taxonomy presents a hurdle to developing health policy related to patient safety, as

“incomplete or inconsistent taxonomies do not provide adequate data to direct the making

of healthcare policy” (Byers, Genovich-Richards, & Unruh, 2007, p. 2). The taxonomy

would be a useful tool in studying medication errors and moving the patient safety policy

agenda forward.

Support for Cultures of Safety

There needs to be ongoing incentives to promote cultures of safety. Accrediting

organizations that develop standards play an important role in supporting cultures of

safety. The Joint Commission has established patient safety goals addressing

communication processes including medication reconciliation and handoffs (Joint

Commission, 2007a, 2008). These patient safety goals are supportive of standing watch

for errors and stepping in to prevent harm.

The introduction of the 2009 Joint Commission standards that address disruptive

behavior among members of the healthcare team are an important signal to healthcare

providers that behaviors which impact communication processes negatively are not

acceptable (Joint Commission, 2007e). Such standards play an important role in

supporting the further evolution of cultures of safety and seeking to prevent the

reoccurrence of error.

Research – Implications

The theme seeking to prevent reoccurrence of error emerged repeatedly. There is

a need for research to inform healthcare providers on how to best to prevent the

recurrence of errors. The IOM recommendations to prevent medication errors encompass

249
four categories: technology, utilizing clinical pharmacists, medication use process and

non-technological interventions. Yet some of these recommendations have “limited

evidence“ (IOM, 2007). Although there has been an increase of patient safety literature

research since the release of the IOM’s To Err is Human (Stelfox et al., 2006), there is a

need for continuing research in the field of patient safety.

Healthcare providers already utilize evidenced-based practice guidelines and

share best practices in order to provide optimal care in disease management and treatment

of health-threatening conditions. Patient safety needs to be treated in a similar manner.

Research needs to be conducted and results disseminated regarding strategies to reduce

the occurrence and harm of errors in healthcare. Research could provide additional data

that would be used in standing watch for errors, stepping in to prevent harm and seeking

to prevent recurrence of errors. Evidence-based and best practice need to be used in

improving patient safety (IOM, 2007).

Given the limitations of this study, one of the questions that arose in this analysis

for those errors reported by patients and family members was how the healthcare

providers perceived the reported medication error. It would be illuminating to engage

healthcare providers and healthcare consumers in a dialog about medication errors to

assess differences in perceptions regarding errors and how best to enhance

communication processes between healthcare providers and patients/families. This type

of study would require a multidisciplinary team to conduct interviews of both healthcare

providers and patients/families regarding the same medication errors. Discussing serious

medication errors maybe very emotional for those affected by such errors, and efforts and

250
resources would need to be available to offer support and debriefing if needed in this type

of study.

Other questions that arose during this analysis and that could inform future

implications for research included:

1. Culture and Leadership

• What strategies are most effective in attaining and maintaining a high-

level culture of safety in a various healthcare organization settings

including acute care, extended care, and out-patient care?

• What are the most effective rewards leaders can provide to staff in

developing and maintaining a culture of safety?

2. Technology

• What technological applications are the most user friendly in allowing

access to information regarding medications in order to prescribe, dispense

and administer them safely?

• What techniques and technologies can be used to mitigate communication

decay in transmitting patient medication information?

3. Education

• How can education strategies be most effectively utilized to mitigate

practicing in a “silo” and improve teamwork?

• How can nursing educators best promote interdisciplinary communication

and cooperation in providing care by nurses with other members of the

healthcare team?

251
• Across the continuum of nursing education, what education strategies are

effective in promoting learning from medication errors for different stages

of professional development within the nursing profession (the novice,

advanced beginner, competent, proficient, expert categories as identified

by Benner (1982, 1984)).

4. Reporting Errors

• What are the best strategies to adopt to increase reporting of errors by

healthcare providers and patients/family members?

• What are the most user-friendly methods for healthcare providers and

patients/ families to report errors?

• What are the most effective and compassionate strategies in

communicating and informing patients and families of errors and adverse

outcomes?

5. Design

• How can design processes for equipment and technology be enhanced to

reduce at-risk communication behaviors among healthcare providers?

• What methods can be used to better distinguish medication names to

reduce harm associated with look-alike and sound-alike medications?

• How can printed labels be designed to improve patient safety?

6. Patient and Family

• What can we learn from the reported experiences of patients and families

regarding medication errors?

252
• What are the concerns or barriers related to communication that patients

and families encounter?

• What are the most effective strategies to engage patients and families in

learning about their medications?

Research in the area of medication errors presents a number of challenges. Not all

medication errors are reported, and not all errors are categorized using the same

classification or taxonomy. The majority of error narratives in this study were reported by

healthcare providers. A recommendation for future research is to focus on patients and

families as a source of data to identify the concerns and perspectives from the consumers’

view.

Additional research needs to be conducted on labeling and packaging issues.

Although not the subject of this study, the impact of labeling and packaging was

observed in this study’s “other findings” and it is strongly recommended this topic be

addressed further in another study.

Conclusions

This research chronicles not only causes of medication errors, it also illustrates

defenses against errors. The theme of risking patient safety through behaviors and

systems that breach defenses was a predominant theme in this analysis. The lessons

learned repeatedly in these errors were that there were multiple causes and contributors to

medication errors. Systems need to be in place that “make it easy to do it right and hard

to it wrong” (Kizer, 2003). The use of at-risk behaviors by healthcare providers needs to

be addressed. Some of these behaviors are used because of system-based problems or

253
processes that could be simplified (NCC MERP, 2007b). Reducing at-risk behaviors

requires organizational commitment to provide resources and systems that mitigate the

use of such behaviors (NCC MERP, 2007b). In addition, healthcare providers need to be

aware of the dangers at-risk behaviors pose to patients and seek to eliminate them from

practice. Some at-risk behaviors become normalized—and there is great danger in

allowing the normalization of at-risk behaviors (Smetzer, 2007).

Healthcare providers have a responsibility to safeguard patients and a duty to treat

compassionately. The importance of knowledgeable healthcare providers who work

collaboratively to provide safe care was observed in errors that were averted from

reaching the patient. Conscientious behaviors, intervening and questioning orders or

practices were oftentimes successful defenses in stopping error trajectories. These

behaviors are necessary when standing watch for errors and/or stepping in to prevent

harm.

A component of safe care is respectful communication between healthcare

providers and patient. Safe delivery of patient care requires effective communication

among members of the healthcare team within work environments (IOM, 2000, 2004a,

2007). In this study there were many exemplars of effective communication among team

members deflecting a medication error from reaching a patient. However, the patient

must be included in the team as an additional safeguard in preventing an error (IOM,

2007). This analysis found patients and families also did help avert harm related to errors.

Many of these errors present opportunities for healthcare providers to learn from

the mistakes, lapses and system failures reported. Narrative-style error reports allow

254
healthcare providers to learn from the story and present a fuller albeit more complex

report than statistical data (Krol et al, 2002). Many actions taken and recommendations

were documented that were undertaken by healthcare providers seeking to prevent a

recurrence of an error. This study demonstrated that a qualitative method is a useful

adjunct to quantitative methods in studying errors (Hoff & Sutcliffe, 2006), because it

allowed for a more in-depth examination of the complexities related to medication errors

(Krol et al, 2002).

There is a great opportunity to learn from the stories told in these narratives.

There are messages that need to be heard and heeded. Perhaps most profound in this

analysis is the theme experiencing the human impact of errors—the human suffering in

terms of medication errors. The message in this theme is clearly transmitted: We must

communicate—effectively, accurately, efficiently, respectfully and compassionately—in

order to provide safe and humane care. We must continue to strive to develop and

maintain cultures of safety for the sake of patients and their families. In order to promote

a culture of safety we must remember to build, design and support work environments

that support healthcare providers’ best practices for those patients entrusted to their care.

255
Appendix A. George Mason University Office of Research Subject Protections Letter

256
Appendix B. Summary of Categories, Subcategories, Taxonomy for Other Findings’ 85
Labeling and/or Packaging Cases

Summary of Categories, Subcategories, Taxonomy for Other Findings’ 85


Labeling and/or Packaging Cases
Failure of Message (FOM)
Communication of Message (COM)
Efforts to Improve (EI)
Subcategories Taxonomy: Communication
Categories (Codes Were Combined Into Subcategories Failure, Success and
and Categories) Context
Manufacturer/ FOM Transmission/
Label Font/Print Issues (1)
Vendor Labeling FOM Reception
and/or Packaging Confusing Labels (for Example, Concentrations)
Issues* (2) FOM Acknowledgment
(Non-Verbal)
Similar or Look-Alike Packaging (3)
Culture, Systems,
Knowledge, Attitudes, Skills,
Confirmation Bias (4)
Support
Swiss Cheese Defenses Breached (5) FOM Transmission/
Model Error FOM Reception/
Trajectory FOM Acknowledgment

COM Acknowledgement,
Defense Maintained (6) Clarification

Culture, Systems,
Knowledge, Attitudes, Skills,
Support
Manufacturer/ Human Reactions (7) Culture, Systems,
Vendor/ Knowledge, Attitudes, Skills,
Healthcare System Changes (8) Support
Industry Culture*
Seek Assistance From Manufacturer/ Efforts to Improve (EI)
External Organizations (9)
Change and Change Label and/or Packaging (10) Efforts to Improve (EI)
Improvement
Process Warnings/Alerts (11) COM Acknowledgement,
Clarification
Design: Change Storage Procedure (12)
Culture, Systems,
Changing/Restricting Products (13) Knowledge, Attitudes, Skills,
Support
Technological Applications (14)

Report Labeling and Packing Concerns (15)

Dialogue and Investigation (16)

257
Summary of Categories, Subcategories, Taxonomy for Other Findings’
85 Labeling and/or Packaging Cases (continued)
Subcategories Taxonomy:
Categories (Codes Were Combined Into Subcategories and Communication Failure,
Categories) Success and Context
Education In-Services/Staff Education (17) Efforts to Improve
Culture, Systems,
Educational Campaigns and Sharing Information Knowledge, Attitudes,
(18) Skills, Support
Patient Involvement/Counseling (19)

Checking and Checking of Labels (20) Efforts to Improve


Verification Checking of Information (21)
Culture, Systems,
Knowledge, Attitudes

Note. *Marks additional categories to those categories listed in the analysis of the 322 medication errors.
This table also contains additional subcategories to those listed in the analysis of the 322 medication errors.
Taxonomy based on the work of Berlo (1960), Reason (1997), Weinger and Blike (2003).

258
Appendix C. Summary of Research Questions, Categories, Subcategories, Taxonomy
for 322 Medication Error Reports

Summary of Research Questions, Categories, Subcategories, Taxonomy for


322 Medication Error Reports
Failure of Message (FOM)
Communication of Message (COM)
Efforts to Improve (EI)
Subcategories Taxonomy:
Research
Categories (Codes Were Combined Into Communication Failure,
Question
Subcategories and Categories) Success and Context
2 Non-Verbal Illegibility (1) FOM Transmission FOM
Communication Reception
(Written/Printed Confusing Abbreviations (2) FOM Acknowledgment
Communication)
(1) Confusing Symbols and Numbers (3) Culture, Systems,
Knowledge, Attitudes,
Transcribing (4) Skills, Support
Misinterpretation (5)

Label Problems/Issues(Internal) ( 6)

2 Verbal Verbal Messages (7) FOM Transmission


Communication FOM Reception
(Oral Implementation of Verbal Message – FOM Acknowledgment
Communication) Incorrectly (8)
(2) Culture, Systems,
Accents (9) Knowledge, Attitudes,
Skills, Support
Confusing Abbreviations (Verbal) (10)

2 Threats to Lack of Verification or Checking (11) FOM Transmission


Communication FOM Reception
Processes Handoff Issues (12) FOM Acknowledgment
(3)
Culture, Systems,
Similar Medication Names: Look-Alike
Knowledge, Attitudes,
and /or Sound-Alike (13)
Skills, Support
Missing or Incorrect Information (14)

Medication Reconciliation: Lacking or


Compromised (15)
Missed Opportunity: Pharmacy Not
Open or Bypassed (16)
Distractions (17)

259
Summary of Research Questions, Categories, Subcategories, Taxonomy
for 322 Medication Error Reports (continued)
Subcategories Taxonomy:
Research
Categories (Codes Were Combined Into Communication Failure,
Question
Subcategories and Categories) Success and Context
2 Technology Entry Errors/Electronic FOM Transmission
Challenges (4) Communication (18) FOM Reception
FOM Acknowledgment
Design (19)
Culture, Systems,
Knowledge, Attitudes,
Skills, Support
2 Healthcare Impaired Communication Process FOM Transmission
Provider and (20) FOM Reception
Patient/Family/ FOM Acknowledgement
Significant
Other Misidentification of Patient (21) Culture, Systems,
Communication Knowledge, Attitudes,
(5) Skills, Support

2 Communication Lack of Knowledge and Assumptions FOM Transmission


Issues (22) FOM Reception
Involving Lack FOM Acknowledgement
of Knowledge
(6) References: Lack of Access to Culture, Systems,
Information/References/Instructions Knowledge, Attitudes,
(23) Skills, Support

2 Swiss Cheese Defenses Breached (24) FOM Transmission


Model Error FOM Reception
Trajectory (7) FOM Acknowledgement

Culture, Systems,
Knowledge, Attitudes,
Skills, Support

Defenses Maintained (25) COM Acknowledgement,


Clarification

Culture, Systems,
Knowledge, Attitudes,
Skills, Support

3 Culture of Open Communication – Healthcare COM Acknowledgement,


Safety (8) Providers (26) Clarification
Open and Flexible Communication –
Being Present (27) Efforts to Improve
Open Communication – Patient and/or
Family Intervention/Significant Other Culture, Systems,
(28) Knowledge, Attitudes,
Teamwork (29) Skills, Support

260
Summary of Research Questions, Categories, Subcategories, Taxonomy
for 322 Medication Error Reports (continued)
Subcategories Taxonomy:
Research
Categories (Codes Were Combined Into Communication Failure,
Question
Subcategories and Categories) Success and Context
Learning Culture (30)

Just Culture (31)

Reporting Culture (32)

System Approaches (33)

Support From Leadership (34)

4 Culture Not Lack of Open Communication (35) FOM Transmission


Supportive of FOM Reception
Safety (9) Lack of Teamwork (36) FOM Acknowledgment

Process/Systems Problems (37) Culture, Systems,


Knowledge, Attitudes,
Not Reporting Errors (38) Skills, Support

5 Healthcare Deflecting Error (39) COM Acknowledgement/


Provider Clarification
Interpersonal
Issues (10) Culture, Systems,
Contributing to an Error (40) Knowledge, Attitudes,
Skills, Support –
Influence Source and
Receiver

Apology by Healthcare Providers (41) FOM Transmission and/or


FOM Reception and/or
FOM Acknowledgment

Culture, Systems,
Emotions of Healthcare Providers (42) Knowledge, Attitudes,
Skills, Support –
Influence Source and
Receiver

5 Patient/ Patient/Family Perceptions (43) Culture, Systems,


Family/Friend/ Knowledge, Attitudes,
Significant Other Skills, Support –
Interpersonal Influence Source and
Issues (11) Receiver
Family Reactions to Patient Deaths (44)
FOM Transmission
FOM Reception
FOM Acknowledgment

261
Summary of Research Questions, Categories, Subcategories, Taxonomy
for 322 Medication Error Reports (continued)
Subcategories Taxonomy:
Research
Categories (Codes Were Combined Into Communication Failure,
Question
Subcategories and Categories) Success and Context
6 Education (12) In Services /Staff Education (45) Efforts to Improve

Educational Campaigns and Sharing Culture, Systems,


Information (46) Knowledge, Attitudes,
Creative Strategies (47) Skills, Support

Case Study (48)

Competency (49)

Just in Time Education (50)

Patient Involvement /Patient


Education (51)
6 Checking and Careful Checking of Information (52) COM Acknowledgement,
Verification (13) Clarification

Medication Reconciliation (53) Effort to Improve

Culture, Systems,
Confirm Message Received (54) Knowledge, Attitudes,
Skills, Support

6 Technological Deployment (55) Efforts to Improve


Applications
(14) Culture, Systems,
Correcting (56)
Knowledge, Attitudes,
Skills, Support
6 Change and Policy/Procedure (57) Efforts to Improve
Improvement
Process (15) Process/Systems (58) COM Acknowledgement/
Clarification
Warnings/Alerts (59)
Culture, Systems,
Documentation(60) Knowledge, Attitudes,
Skills, Support
Abbreviations (61)

Design/Use Restrictions (62)

Diagnosis/Indication (63)

Address Similar/Sound-Alike/
Look-Alike Medications (64)
Dialogues and Investigation (65)
Note. Taxonomy based on the work of Berlo (1960), Reason (1997), Weinger and Blike (2003).

262
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263
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CURRICULUM VITAE

Mary Ann Friesen was born in New York. She graduated from Pace University in
Pleasantville, New York with an Associate’s in Applied Science, and from Cameron
University in Lawton, Oklahoma with a Bachelor’s of Arts in Sociology. She earned her
Master’s of Science in Nursing at the University of Texas at El Paso. Mary Ann has
practiced in a wide variety of settings and locations throughout her nursing career. Her
clinical experience includes critical care, cardiac, home health and geriatric nursing.
Professional roles have included nursing education, patient education, utilization
management, performance improvement and consulting. She is a Certified Professional in
Healthcare Quality (CPHQ) and a published author. Mary Ann is a member of the
American Nurses Association, National Association of Healthcare Quality, and the
American Organization of Nurse Executives, and has been inducted into Sigma Theta
Tau and Phi Kappa Phi.

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