USP Medication Safety Forum
Medication Errors:
Experience of the United
States Pharmacopeia (USP)
he United States Pharmacopeia (USP) is a practi-
T tioner-based organization that sets standards for
the identity, strength, quality, purity, packaging,
labeling, and storage of therapeutic products. USP’s stan-
dards-setting body is the Council of Experts. This council
maintains and continuously revises the United States
Pharmacopeia and National Formulary (USP-NF). As a
nonprofit organization working in the public interest,
USP also operates several public health programs seek-
ing to further ensure that practitioners, patients, and con-
sumers have access to high-quality therapeutic products
and that they use these products safely. Patient safety is
one of these programs.
USP’s interest in patient safety began with the under-
standing that names, packaging, and labeling of thera-
peutic products can either reduce or increase the
likelihood of a medication error. Reports from practi-
tioners were critical to this understanding. To facilitate
practitioner reporting, USP operates the following two
complementary error-reporting programs:
■ USP Medication Errors Reporting (MER) Program,
which is operated in cooperation with the Institute for
Safe Medication Practices (ISMP)
■ MEDMARXSM
Both programs yield information that has been highly
useful to USP’s standards-setting activities; practitioners,
patients, and consumers; and regulatory bodies such as the
U.S. Food and Drug Administration (FDA). USP’s Council
of Experts has two expert committees that use informa-
tion from the MER and MEDMARX programs—the
Labeling and Nomenclature Expert Committee and the
Safe Medication Use Expert Committee. Although both
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February 2005
Department Editor
James G. Stevenson, Pharm.D., College of
Pharmacy, University of Michigan, and
University of Michigan Hospitals
This new department will feature medication
error issues based on data collected by the
United States Pharmacopeia (USP).
programs collect essential data on medication errors sub-
mitted by health care practitioners, there are some impor-
tant differences.
The Medication Errors Reporting Program
The MER Program allows health care professionals from
any practice site (for example, hospital, clinic, retail
pharmacy, nursing home) to report both actual and
potential medication errors in a confidential and, if
desired, anonymous manner. Reports can be submitted
via mail, fax, or the Internet,1 and, once submitted, are
compiled into a national database. USP reviews each
report for health hazards and forwards all information to
the ISMP, the FDA, and the product manufacturer. The
MER database is not accessible to individual practition-
ers. However, pertinent findings are disseminated to
practitioners primarily through the USP Quality Review
and Practitioners’ Reporting News releases, as well as
through ISMP newsletters.
By sharing experiences through the MER Program,
reporters contribute to their colleagues’ education about
the types and causes of medication errors. This under-
standing, in turn, leads to recommendations and actions
intended to prevent error recurrence. Reports collected
through the MER Program are reviewed by USP’s Safe
Medication Use Expert Committee, which can recom-
mend changes or additions to USP standards. USP’s
Labeling and Nomenclature Committee can also consid-
er changes to the official title of the drug and its labeling.
Examples of reported “look-alike/sound-alike” errors
that have led to changes in the naming or labeling of a
drug product follow:
Volume 31 Number 2
■ Similarity in packaging of acyclovir 500 mg vials and
acetazolamide 500 mg vials: The manufacturer revised
labeling for acetazolomide with the new label in green
coloring instead of blue and using “TALL MAN” letters
(that is, acetaZOLAMIDE).
■ Ingredients, coloring, and labeling of Baush & Lomb’s
Neomycin/Polymyxin B Sulfates/Bacitracin Zinc
ophthalmic ointment and Neomycin/Polymyxin B
Sufates/Dexamethasone ophthalmic ointment were very
similar: The labeling of the product containing
Dexamethasone was changed to a different color.
USP can also implement error-prevention strategies by
working collaboratively with partners such as the ISMP,
FDA, and the United States Adopted Names Council.
Depending on the nature of the medication error,
MER Program reports may be used for ongoing discus-
sions between the FDA and manufacturers, and if war-
ranted, the reports may lead to regulatory action. The
following is an example of such collaboration:
Confusion between the drug names amrinone and
amiodarone resulted in medication errors including
reports of patient injury and death. The U.S.
Pharmacopeia (USP) Nomenclature Committee and the
United States Adopted Names (USAN) Council approved
changing the nonproprietary name and the current offi-
cial monograph title of amrinone to inamrinone (eye-
nam-ri-none). The name change from amrinone to
inamrinone became effective on July 1, 2000, with the
Second Supplement of the United States Pharmacopeia-
National Formulary (USP-NF).
The reported concerns of practitioners have prompt-
ed USP, the FDA, and various drug manufacturers to
institute numerous changes and improvements to drug
products and have contributed to safer medication pre-
scribing and use. Since 1991, USP has received more
than 9,000 reports to the MER Program, many of which
were submitted by pharmacists. Pharmacists and other
practitioners can use the MER report form as one way to
document error incidents.
Summaries and case studies of medication error
reports from health care professionals are available on
USP’s Patient Safety web page.2,3 A review of these pub-
lished news items from the MER database should help
health care providers identify potential error-prone areas
and analyze causes of error.
February 2005
The MEDMARX Program
Based on the experiences with the MER Program, USP
developed MEDMARX, an Internet-accessible perform-
ance improvement tool initially designed for hospitals and
health systems.4 Hospitals and health systems using MED-
MARX can anonymously collect, track, and analyze med-
ication errors in a standardized format. Subscribing
facilities can access the MEDMARX database, allowing
them to compare their own medication error data with
that of other participating sites across the country. The
database also enables facilities to concurrently and proac-
tively assess error-prone areas, identify opportunities for
systems improvements, and apply risk-prevention strate-
gies by taking steps to “error proof” their organization
based on the experiences and lessons learned by others.
The case study in Sidebar 1 (page 116) provides an
example of the type of information shared through the
national database.
The MEDMARX program uses a definition of medica-
tion error and a medication severity index created by the
National Coordinating Council for Medication Error
Reporting and Prevention (NCC MERP) as the basis for
identifying and categorizing errors.5 NCC MERP is an
independent working body of 25 national organizations
that promotes the reporting, understanding, and preven-
tion of medication errors. The NCC MERP medication
error category index (Figure 1, page 117) consists of nine
categories, ranging in severity from A (the potential for
error existed) to I (the error may have contributed to or
resulted in patient death).6 Categories also differ on
whether the error reached the patient and whether the
error caused temporary or permanent harm. The NCC
MERP developed a corresponding algorithm to assist
practitioners and others in using this index. In addition
to the severity index and algorithm, NCC MERP has
developed the following definition for medication error:
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 health-
care professional, patient, or consumer. Such events
may be related to professional practice; health care prod-
ucts, procedures, and systems, including prescribing;
order communication; product labeling, packaging, and
nomenclature; compounding; dispensing; distribution;
administration; education; monitoring; and use.
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Volume 31 Number 2

Sidebar 1. Miscommunication Leads
to Confusion and Errors
A 50-year-old man who presented to the emergency
department with chest pain was admitted for evaluation
of a possible heart attack. Per protocol, the patient was
started on a routine intravenous anticoagulant. Later,
the medical staff concluded that he had not experienced
a heart attack but rather that his pain was due to an
inflamed gall bladder. Despite the change in diagnosis,
the patient continued to receive the anticoagulant.
Gall bladder surgery was scheduled late in the after-
noon on the second day following admission. The
anesthesiologist and surgeon were both unaware that
the patient was anticoagulated.
Postoperatively, the surgical resident, also unaware that
the patient was on an anticoagulant, wrote to “resume
all pre-op meds.” The patient received one more dose
of the anticoagulant postoperatively. Later that same
evening, the patient became hypotensive, developed
respiratory distress, and was transferred to the inten-
sive care unit. At the time of transfer, the orders were
reviewed, the error discovered, and the anticoagulant
discontinued. However, the patient’s condition had
already deteriorated, involving a distended abdomen
and a return to the operating room for evacuation of a
postoperative hematoma and fluid in the abdomen. The
patient subsequently died within a week.
Standardized definitions, indexes, and nomenclature
can help practitioners more uniformly collect, track, and
compare medication error data. Facilities using MED-
MARX are able to capture detailed information on an
error event, including the following:
■ The NCC MERP error category
■ Type of error
■ Possible cause(s)
■ Contributing factors (for example, workload, staffing
shortages)
■ Location of error
■ Product(s) involved
■ General patient data (for example, age, sex)
■ Type of staff involved.
These facilities can then research their error records,
as well as those from other participating facilities, using
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February 2005
various data fields to capture specific areas of interest (for
example, category, type, cause, location). All reported
information is done so anonymously, and the submitter’s
identity is unknown both to USP and to other hospitals
using the program. MEDMARX enables users to document
where in the medication use process (that is, prescribing,
transcribing, dispensing, administration, or monitoring)
errors have occurred, allowing targeted assessment of spe-
cific process components. MEDMARX allows users to
review the causes and contributing factors associated with
errors facilitywide, thereby identifying specific “problem-
prone” systems or processes that may need changing.
The example in Sidebar 2 (page 118) illustrates how
dissecting an error event into its various components
can uncover process or systems problems.
Health system administrators seeking to examine
error data across a multihospital or integrated health
system can do so through the MEDMARX program’s mul-
tifacility module (MFM). Through the MFM, systemwide
alerts provide timely communication of safety issues
that arise in one facility with other system components.
Although most patient-safety leaders agree that attempts
to create a national error detection rate for benchmark-
ing purposes is of little value, multihospital systems see
value in examining and comparing error data within
their own integrated health system.
To further facilitate data collection and reporting, the
MEDMARX program allows facilities to upload error
reports from internal risk management or other report-
ing programs, thereby eliminating duplication of data
entry. More recently, the program expanded to provide
the capture of adverse drug reactions (ADRs), making it
the first real-time repository available to practitioners
for such events. Unlike medication errors, ADRs are gen-
erally considered nonpreventable.
The MEDMARX system is a valuable database that
has grown from a little more than 6,000 reports submit-
ted in its first year of operation (1999) to its current size
of more than 750,000 reports submitted by more than 800
health care facilities.
What Has Been Learned
Research by USP on both the MER and MEDMARX data-
bases has yielded valuable information that can help
guide health care practitioners in their quality assurance
Volume 31 Number 2
 National Coordinating Council for Medication Error Reporting and
Prevention (NCC MERP) Index for Categorizing Medication Errors

Figure 1. The nine categories in the NCC MERP medication error category index are shown. Source:
http://www.nccmerp.org/medErrorCatIndex.html (last accessed Dec. 16, 2004).

and performance improvement initiatives. Several pub-
lished reports highlighting errors identified in pediatric
patients serve as examples of such research.7–9 Data
analyses have revealed that nearly 6% of pediatric med-
ication errors were harmful, 52% of errors occurred in
the drug administration phase, and 26% occurred
because a procedure or protocol was not followed. For
pediatric patients, the top three types of errors and their
associated medications were as follows:
■ “Improper dose/quantity” (fat emulsion, potassium
chloride, and morphine)
■ “Omission” (albuterol, gentamicin, and cefazolin)
■ “Wrong time” (gentamicin, ampicillin, and van-
comycin)
Recommendations to prevent such errors were also
provided.8 An earlier study found that 31% of MER and
5% of MEDMARX reports involving pediatric patients
were categorized as harmful to patients. In this study,
improper dose/quantity (47%) was the most frequently
reported type of error in the MER database, whereas
omission (27%) and improper dose/quantity (25%) were
the most frequent error types in MEDMARX. The top
products most often involved included intravenous flu-
ids (including premixed and extemporaneously com-
pounded preparations), acetaminophen, and gentamicin.
The finding that most of the reported errors do not
cause harm supports a widely held view that information
should be collected on “near misses”—as well as on errors
that can cause harm. This information can be extremely
useful in advancing patient safety practices. Data collect-
ed through MEDMARX during the past several years has
shown a decline in the percentage of reported harmful
errors (from a high of 3% in 2000 to 1.5% in 2003) and an
increase in the percentage of reported potential errors (8%

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February 2005 Volume 31 Number 2

Sidebar 2. Error Description
A unit clerk who was usually assigned to the critical
care unit (CCU) was required to provide cross coverage
(that is, floated) to a medical unit and was unfamiliar
with the typical medication administration times used
for the medical unit. Laboratory results for a patient
with diabetes who was on the unit revealed a blood
glucose level of 240 mg/dL (normal 70-110 mg/dL). A
registered nurse inspected the patient’s medication
administration record (MAR) and discovered that the
unit clerk inadvertently transcribed an improper sched-
ule for administration of the patient’s insulin and glip-
izide. The incorrect schedules caused a delay in
dispensing the medications and their eventual omission.
Type(s) of error: Omission error
Cause(s) of error: Transcription inaccurate/omitted,
knowledge deficit
Contributing factor(s): Cross coverage
Node in the medication process at which the initial
error occurred: Transcribing
Action taken to avoid the error: Establish standard-
ized drug administration times through the Pharmacy/
Nursing Committee. Modify computer software to
include these times as defaults to enable the Unit
clerk to enter schedules correctly for those medica-
tions requiring special administration times. Provide
facilitywide education and training to all unit clerks.
in 1999 to 16% in 2003) and reported errors that were
intercepted prior to reaching the patient (24% in 1999 to
38% in 2003).10 These findings demonstrate that health
care facilities are adopting the characteristics of high-
reliability organizations by detecting and stopping the
unexpected (that is, error) before it reaches the patient.
Identifying the types, causes, contributing factors, and
products associated with a medication error can help
uncover common problem-prone areas and focus the
facility’s efforts in developing effective risk-reduction
strategies. In 2003, omission error (24%), improper
dose/quantity (23%), and prescribing error (22%) were the
three most frequently reported types of error reported to
MEDMARX.10 The top causes of error reported that same
year included performance deficit (38%), procedure/
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February 2005
protocol not followed (17%), and transcription inaccu-
rate/omitted (13%). A closer analysis of errors caused by
performance deficit revealed that contributing factors,
such as distractions and workload increase, were fre-
quently involved. This combination may reflect the stress
that results from limited resources, downsizing efforts,
and shortages of health care professionals. The most fre-
quently reported products involved with harmful errors
included insulin (8.7%), morphine (5.3%), heparin (3.9%),
potassium chloride (2.9%), and warfarin (2.6%).
Many hospitals and health systems currently have in
place a patient safety or medication safety committee as
part of their overall quality assurance program.
However, traditional “incident report” forms do not often
provide the level of detail necessary for these commit-
tees to perform effective data analyses, thereby limiting
the development of successful system changes.
Constructing a facility-specific database or using a
national database to capture key error event details can
enable a more thorough analysis (including a root cause
analysis) and trending of error incidents.
Joint Commission’s Focus on
Medication Safety
A multidisciplinary, blame-free, proactive approach to
medication errors is part of the intent of the patient safe-
ty standards initially implemented in July 2001 by the
Joint Commission on Accreditation of Healthcare
Organizations. These standards require hospitals and
health systems to establish a defined safety program,
including systems for internal and external reporting of
medical and health care errors. Data collected through
internal and external reports are then used to identify
risk and improve patient safety.
The scope of the initial safety standards has been
expanded and now includes seven National Patient Safety
Goals for hospitals, five of which relate to medication
safety. This indicates that medication management con-
tinues to be recognized as a high-risk process. Given the
complexity of the medication use system within hospitals
and the frequent occurrence of adverse events, Joint
Commission standards have continually evolved, and the
focus on medication safety has increased. Data findings
from USP’s medication error reporting programs can
facilitate hospitals’ compliance with Joint Commission
Volume 31 Number 2
standards and goals by prospectively identifying areas of
the medication-use process that are high-risk (for exam-
ple, programming patient-controlled analgesia [PCA]
pumps) or problem-prone (e.g., look-alike/sound-alike
medications, communication). Such reporting programs
also enhance both internal and external confidential
reporting, improve root cause analysis of sentinel events,
and uncover opportunities for system improvements.
Intent of the USP Medication
Safety Forum
The United States and other countries are focusing to an
increasing degree on systems that enhance quality of
care and promote patient safety. This focus has been
heightened by reports from the Institute of Medicine and
other organizations indicating that errors in a health care
system can be a significant cause of morbidity and mor-
tality.11 A key component of any quality enhancement
system is reporting such errors. USP has been involved
in medication error reporting programs for more than 30
years and expects its MER and MEDMARX reporting
programs to have a positive impact on public health.
Building a national medication error database can con-
tribute to the establishment of better practices, reduced
References
1. USP: USP Medication Errors Reporting (MER) Program
http://www.usp.org/patientSafety/reporting/mer.html (last accessed
Dec. 8, 2004).
2. United States Pharmacopeia: USP’s Practitioners’ Reporting News.
http://www.usp.org/patientSafety/briefsArticlesReports/practitionerRe
portingNews (last accessed Dec. 17, 2004).
3. United States Pharmacopeia: Quality Review. http://www.usp.org/
patientSafety/briefsArticlesReports/qualityReview/qr812004-09-01.html
(last accessed Dec. 17, 2004).
4. Santell J.P., et al.: Medication errors: Experience of the United States
Pharmacopeia (USP) MEDMARX reporting system. J Clin Pharmacol
43:760–767, Jul. 2003.
5. National council focuses on coordinating error reduction efforts.
USP Quality Review No. 57. Rockville, MD: United States
Pharmacopeia; Jan. 1997.
6. National Coordinating Council for Medication Error Reporting and
Prevention (NCC MERP): About Medication Errors: Medication Error
February 2005
medical costs, and improved medication use systems
that ultimately lead to improved patient care.
The successful collection and analysis of error events
is key to understanding the causes of medication errors
and to developing systems-based solutions. USP has
learned that using a standard taxonomy of medication
errors is a critical component for the effective collec-
tion of data to quantify the extent of the problem as well
as to understand and prevent future errors. This depart-
ment’s goal, therefore, will be to pair relevant medica-
tion error data with recommendations and suggestions
to improve the safety of medication use within health
care organizations. This department will use the experi-
ence gained by USP through its reporting programs,
interactions with practitioners, the USP Safe Medication
Use Expert Committee, and leading patient safety
organizations such as the Joint Commisson to help
health care practitioners improve the quality and safety
of patient care. J
John P. Santell, M.S., R.Ph., is Director, Educational
Program Initiatives, Center for the Advancement of Patient
Safety, U.S. Pharmacopeia, Rockville, Maryland.
Category Index. http://www.nccmerp.org/medErrorCatIndex.html (last
accessed Dec. 16, 2004).
7. Summary of Information Submitted to MEDMARX in the Year
2001: A Human Factors Approach to Understanding Medication
Errors. Rockville, MD: United States Pharmacopeia; Dec. 2002.
8. United States Pharmacopeia: Pediatric Population Can Benefit from
USP Recommendations. USP Quality Review No. 77. Rockville, MD:
United States Pharmacopeia, Apr. 2003.
9. Cowley E., Williams R., Cousins D.: Medication errors in children: A
descriptive summary of medication error reports submitted to the
United States Pharmacopiea. Current Therapeutic Research
62:627–639, Sep. 2001.
10. Hicks R.W., et al.: MEDMARXSM 5th Anniversary Data Report: A
Chartbook of 2003 Findings and Trends 1999–2003. Rockville, MD:
USP Center for the Advancement of Patient Safety, 2004.
11. Institute of Medicine: To Err Is Human: Building a Safer Health
System. Washington, D.C.: National Academy Press, 2000.
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