Applying FMEA on the process for reading the labels on ampoules and vials for injectable
drugs
Jennifer Jeon a, Sylvia Hyland b, Catherine M. Burns a, Kathryn Momtahan c
a
Department of Systems Design Engineering, University of Waterloo, Canada
b
Institute for Safe Medication Practices Canada, Canada
c
University of Ottawa Heart Institute, Canada
Abstract
Poor labelling is a contributing factor of medication errors.
As a part of the study that aims to evaluate and improve the
labelling of ampoules and vials for injectable drugs, Failure
Mode and Effects Analysis (FMEA) was applied on the label
reading process. Implementing the FMEA on the low-level
reading process involved various challenges including diffi-
culties in representing a context-sensitive process, defining
the failure modes, causes and effects and developing rating
scales for criticality (i.e. severity, frequency and detectability).
The failure modes were rated via a focus group of pharma-
cists and a nurse. The results will help us redesign existing
labels to prevent medication errors that may result from hu-
man errors in the label reading process.
Keywords
Medication errors, drug labelling, risk assessment
Introduction
Medication errors are the most common type of adverse medi-
cal events [1]. Poor labelling has been identified as a major
contributing factor of medication errors. 33% of the medica-
tion errors reported to the United States Pharmacopoeia (USP)
Medication Errors Reporting (MER) program during a period
of one year (between 1996 and 1997) cited labelling as a con-
tributing factor. Injectable drugs, in particular, were involved
in more than half (50.5%) of the medication reports submitted
by hospital pharmacists to the USP Drug Product Problem
Reporting (DPPR) program between 1995 and 1999 [2].
We are currently conducting a study that aims to evaluate and
improve the labelling of ampoules and vials for injectable
drugs. One of our objectives is to identify potential human
errors that can arise in the label reading process and their
causes to find ways to improve existing labels.
Predicting human errors, however, is not an easy task. Human
errors are the results of complex interactions of various
causes, which can be traced back to neurological functions.
Therefore, it is impossible to predict human errors precisely.
In the field of medication errors, the task is further compli-
cated by the lack of low-level data and subjective nature of the
error reports. Medication error reports collected by error re-
porting programs, such as USP MER and U.S. Food and Drug
Administration (FDA)’s MedWatch, are not categorized by
contributing factors, and therefore cannot be used for making
statistical predictions. Only a few case studies analyzed by the
Institute for Safe Medication Practices (ISMP), FDA, USP
and individual researchers trace back to causes and their inter-
actions. Finally, there is no solid taxonomy available for
predicting human errors.
FMEA
Failure Mode and Effects Analysis (FMEA) is a proactive
technique to identify known and potential failures and their
sources from the system and develop mediations to prevent
the failures. FMEA is used synonymously with Failure Mode
Effects and Criticality Analysis in healthcare (FMECA) [3].
Since the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) required its accredited hospitals to
conduct an annual proactive risk assessment such as FMEA in
2001 [4], FMEA has been widely used by healthcare
organizations.
Many variations of FMEA have been developed in healthcare.
The Department of Veterans Affairs (VA) National Center for
Patient Safety has developed the Health Care Failure Mode
and Effect Analysis (HFMEA™). To overcome difficulties in
directly applying traditional FMEA from engineering,
HFMEA™ uses different definitions and algorithms adopted
from FDA's Hazard Analysis and Critical Control Point
(HACCP) and Root Cause Analysis (RCA). The Institute for
Safe Medication Practices Canada (ISMP Canada) that pro-
vides training to healthcare professionals on FMEA has de-
veloped its own version of FMEA based on process FMEA.
The JCAHO also has its own version of FMEA. These
frameworks, however, were not designed for analyzing a
small sub-process at the human cognition level.
Most applications of FMEA in healthcare have been on organ-
izational processes (e.g. narcotic drug delivery), medical
 3
1 2 4 5
Read
Read common Read brand name Read route of
concentration and/
name (if exists) administration.
or total amount of
the drug ingredient
Figure 1- Proposed label reading process
procedures (e.g. MRI imaging), or complex medical devices
(e.g. IV pump) that involve a large number of sub-processes
and more than one user. The process of reading the label on
an ampoule or a vial involves only one user and a rather sim-
ple sequence of perceptual and cognitive processes. To the
best of the authors’ knowledge, there has not been any study
applying FMEA on such a low-level cognitive process. This
paper describes the modified process FMEA we applied on
the label reading process. The challenges faced for imple-
menting the FMEA and the resulting criticality ratings are
discussed. We conclude with recommendations for applying
FMEA in healthcare and introduction to the next phases of the
study.
Methodology
ISMP Canada’s FMEA framework was used as a basis for this
study. The FMEA team consisted of a pharmacist, a nurse, a
specialist in human factors engineering and a graduate student
in human factors engineering. The FMEA procedure used for
this study was as follows:
1. Define the process of interest
2. Generate a flowchart of the process and their sub-
processes.
3. Brainstorm for potential failure modes and their ef-
fects.
4. Identify causes of failure modes.
5. Rank each failure mode in terms of severity, fre-
quency, and detectability.
6. Calculate Risk Priority Number (RPN) for each failure
mode.
7. Develop interventions to minimize the occurrences of
the failure modes with high RPN values.
Results and Discussion
We faced various challenges in implementing the FMEA on
the label reading process. These challenges are discussed
below in the order of their corresponding FMEA steps.
Representing a context-sensitive process
There is no established procedure that is recommended to
healthcare professionals for reading the labels. Nurses are
6 8
7
Read expiry date Read storage Read formulation 10
Read multi-dose
conditions type (if necessary) Read DIN
information
9
Read non-
medicinal
ingredients (if
necessary)
taught the five rights of medication administration: the right
patient, the right drug, the right dose, the right route and the
right time, and these drive their label reading process. More-
over, the process is fluid depending on the type of medication,
prescription, patient and the user’s profession. For example,
the Drug Identification Number (DIN) is important to the
pharmacist for verification purposes when dispensing, but it is
rarely used by nurses or physicians. There is no guidance in
literature on how to represent a context-sensitive process in
FMEA, and it is impractical to generate different processes for
so many different potential scenarios.
Therefore, a flowchart of an “ideal process” that contains the
processes involved in reading all the important items on the
labels was generated as shown in Figure 1. The process was
developed based on the literature and feedback from nurses
and pharmacists. Although some of the steps in the flowchart
may be relevant to only a certain group of healthcare profes-
sionals, the chart ensures that all potential failure modes in-
volved with the label reading process are included in the
analysis. The flowchart also allowed the organization of what
could be considered random cognitive processes and gave a
structure to the analysis.
Defining failure modes and their effects
There is no generic definition for failure modes in FMEA.
Adverse drug events are often the result of a series of failures
in the chain of causes and effects. Depending on the scope
and the purposes of the analysis, one causal link could be con-
sidered as an effect of the proceeding link(s) or a cause of the
following link(s). Similarly, there is no generic definition for
effects of failure modes. For example, the effect of a pharma-
cist misreading the total amount of drug ingredient contained
in a vial may be defined as dispensing a drug of wrong dose.
On the other than, the effect of the error can be traced down to
the patient and may include patient death.
For this study, the failure mode was defined as any failure in
the human user’s perception/cognition when reading the la-
bels. The effects were defined as potential types of medica-
tion errors that could result from the failure modes. 13 medi-
cation error types used in USP MEDMARX program were
used for the error types. Using the error types as the effects
was expected to facilitate the criticality rating process since
they map nicely to the severity of failure modes. Moreover,
using the established error types would allow comparing the
subjective ratings from FMEA to the statistical results from
the reports that USP publishes every year on their analyses of
the data collected via its MEDMARX program.
Defining rating scales for severity, frequency, and detect- Table 2 - Frequency Rating Scale
ability
Frequency Frequency Description Score
Defining appropriate rating scales for severity, frequency and Rating
detectability is crucial to obtain meaningful RPN values. The Remote May happen some time in 3 to 5 years 1
traditional 10-level scale used for FMEA in engineering is not
suitable for processes in healthcare. For example, most fail- Uncommon May happen some time in 1 to 2 years 2
ures in healthcare could lead to patient death or injury (level Occasional May happen several times in a year 3
10). This is the very reason the VA came up with its modified
severity and frequency rating scales for its HFMEATM [5]. Frequent May happen several times in a month 4
The cognitive nature of the process in this study required fur- Very frequent May happen several times in a day 5
ther modifying the scales used in existing FMEA frameworks
for healthcare.
For detectability, the 4-level scale of ISMP Canada’s FMEA
For severity, the 5-level scale of ISMP Canada’s FMEA (No was adopted without modifications as shown in Table 3.
effect, Slight, Moderate, Major and Severe/Catastrophic) was
considered to be simple yet comprehensive for this study.
However, the framework lacks definitions for each scale. Table 3 - Detectability Rating Scale
Therefore, the definitions were derived from the National Co- Detectability Description Score
ordinating Council for Medication Error Reporting and Pre-
Always 1
vention (NCC MERP)’s index for categorizing medication
errors [6] and the severity rating scale from HFMEATM [5]. Likely 2
Table 1 shows the finalized severity rating scale.
Unlikely 3
Table 1 – Severity rating scale Never 4

Severity Score Patient Outcome

Description
No effect 1 No injury nor increased length of stay
nor increased level of care
Slight 2 Monitoring to confirm no patient
harm and/or intervention to preclude
harm required
Moderate 3 Temporary lessening of bodily func-
tioning (sensory, motor, physiologic,
or intellectual) and intervention re-
quired
Major 4 Permanent lessening of bodily func-
tioning (sensory, motor, physiologic,
or intellectual) or disfigurement, sur-
gical intervention required, increased
length of stay or increased level of
care
Severe/ 5 Death or major permanent loss of
patient function (sensory, motor,
Catastrophic
physiologic, or intellectual)
Rating the failure modes
Due to the lack of low-level data that could be used for statis-
tical prediction and the perceptual/cognitive nature of the
process, the failure modes had to be subjectively rated.
A focus group with 6 pharmacists and 1 registered nurse was
conducted to rate each failure mode in terms of severity, fre-
quency and detectability. The participants were also asked to
determine if there was an effective control measure (i.e. any
mechanism that prevents the failure from happening) for each
failure mode. If there was an effective control measure al-
ready, then there would be no need to develop an intervention
measure for the failure mode. The participants were provided
with partially-completed FMEA table, definitions of the ter-
minologies and the description of the rating scales. A portion
of the FMEA table is shown in Table 4. The participants were
asked to rate each failure mode individually based on a rea-
sonable worst case scenario.
The data from 1 pharmacist was incomplete and was excluded
from the analysis. The median value of the ratings

For frequency, the 5-level scale of ISMP Canada’s FMEA

(Yearly, Monthly, Weekly, Daily and Hourly) was considered
to be too regular for estimating the frequency of human cogni-
tion failures. HFMEATM’s 4-level probability rating scale
(Remote, Uncommon, Occasional and Frequent) reflects the
probability of human errors better, but it spans over a very
low frequency range for human cognition failures. Therefore,
an additional highest frequency level was added to the scale,
and the definitions of the original scale were modified to ar-
rive at the frequency rating scale shown in Table 2.
Table 4 – Portion of the FMEA table (CM: Existence of effective control measure, S: Severity, F: Frequency and D: Detectability)

Potential
Failure Mode Effect(s) of
FM Description Failure Potential Causes of Failure Mode CM S F D
User cannot read the Unavailable information; Illegible typeface size
common name and/or format; Information indicated at an un-
Wrong drug error;
1 expected location; Information covered by fin-
Omission error
ger tips holding the container; Intagliated or
silk-screened information
User does not read Distractive colour and/or trade dress; Informa-
2 the common name. Wrong drug error; tion lacks salience over other information; User
under stress
User misperceives
Excessively salient brand name; Insufficient or
the brand name of a
no distinction from the look-alike/sound-alike
3 wrong drug as the Wrong drug error;
brand name; Common name unavailable; User
common name of the
under stress
correct drug.

50

45

40

35

30

25

20

15

10

0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Failure Mode

Figure 2 - RPN values

across participants for each of severity, frequency and detect-
ability was calculated for each failure mode. Then, the three
median values were multiplied to calculate RPN value for
each failure mode as shown in Figure 2.
The preliminary analysis of the ratings from the focus group
shows that the failure modes 1 to 10 have high severity ratings
and consequently high RPN values compared to the other
failure modes. The ten failure modes are concerned with read-
ing the brand name, common name, total amount of drug in-
gredient per unit volume or per total volume and route of ad-
ministration. The first three items are defined as critical in-
formation in the standard developed by Canadian Standards
Association International (CSA) for the labelling of drug am-
poules, vials and pre-filled syringes [7]. Although not defined
as critical information in the standard, route of administration
is important for injectable drug use. The proportion of wrong
route of administration errors that resulted in harm to patients
was the second highest of all medication error types according
to the analysis of the medication errors reported to USP
MEDMARX during 2003 [8]. Therefore, the RPN values
revealed which pieces of information on the labels are impor-
tant to the user.
In general, the participants found it difficult to rate the failure
modes without a specific scenario. The detectability of failure
modes, in particular, highly depends on at which stage in the
medication use process the failure mode occurs. Moreover, it
was found that the concept of effective control measure is
meaningless since the process is at the human percep- [5] DeRosier J, Stalhandske E, Bagian JP, Nudell T. Using
tion/cognition level. Health Care Failure Mode and Effect Analysis™: The VA
National Center for Patient Safety's Prospective Risk
Analysis System. Jt Comm J Qual Patient Saf. 2002
Conclusion
May;28(5):248-267.

Applying FMEA on the process for reading the labels on vials
and ampoules for injectable drugs required developing cus-
tomized definitions for failure modes, effects and rating
scales. Although there are generic FMEA frameworks devel-
oped for healthcare, they are not suitable to be applied directly
to a low-level process as in this study. Where to draw the
lines for failure modes, their causes and effects in the causal
chain of events depends on the purposes of the analysis and
the nature of the process.
The criticality ratings of the failure modes collected via a fo-
cus group of healthcare professionals yielded RPN values that
allowed extracting contents on the label that are important to
the user. The result also gives directions to the next step of
FMEA in which existing labels will be redesigned as an inter-
vention to prevent the failure modes. Another focus group for
rating the failure modes is planned for the study. The addi-
tional data from the second focus group will allow more in-
depth analysis of the ratings including potential effects of the
participant’s profession on the ratings.
Acknowledgement
This study is funded by Canadian Patient Safety Institute. We
would like to thank Dr. John Senders, members of the ISMP
Canada and the nurses at the University of Ottawa Heart Insti-
tute for their valuable time and advice. Thanks are also ex-
tended to the members of the Advanced Interface Design Lab
at the University of Waterloo for their ideas and support.
[6] National Coordinating Council for Medication Error Re-
porting and Prevention. NCC MERP Index for Categoriz-
ing Medication Errors. 2001 [cited 2006 Nov. 26]; Avail-
able from:
http://www.nccmerp.org/medErrorCatIndex.html
[7] CSA International. Labelling of Drug Ampoules, Vials,
and Prefilled Syringes. Etobicoke, Ontario, Canada: CSA
International; 1999.
[8] Hicks RW, Santell JP, Cousins DD, Williams RL.
MEDMARX 5th Anniversary Data Report: A Chartbook
of 2003 Findings and Trends 1999-2003. Rockville, MD:
USP Center for the Advancement of Patient Safety; 2004.
Address for correspondence
Jennifer Jeon
Department of Systems Design Engineering
University of Waterloo
200 University Ave West
Waterloo ON, Canada
N2L 3G1
Email: hwjeon@uwaterloo.ca

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