Unsafe abbreviations
Use of “U” for "unit" can lead to 6U being
confused with 60, 4U with 44 and 25cc/hr
with 25 units/hr (Figure 3). Confusing 1000U
with 10,000 can easily lead to a 10-fold over-
dose. This type of mistake can be prevented
by use of a smart pump drug library.
Verbal order not read back
“Read back” is one of the National Patient
Safety Goals. The order shown in Figure 4
was transcribed so that “10U” was legible as
“10 units,” but the order was not read back
to the prescriber. Read back, it would have
been apparent that for a patient with a blood
sugar of 324, the correct medication would
be insulin, not heparin.
Nomenclature issues
Confusing “HEPARIN” and “HESpan” is
common. Hetastarch, the generic name for
Hespan, can be confused if the product is
referred to as Hespan. The “h,” “e” and “p” are
all in the same sequence. If a bag of heparin
is accidentally placed in the storage location
for hetastarch (Hespan), which is used for
volume replacement for shock, selection of
the wrong bag could lead to a fatal error. A
patient who needs hespan can be in shock
because of hemorrhaging. Administering
heparin to such a patient is fatal. The error
has also happened the other way around, i.e.,
hetastarch administered in place of heparin.
Insulin-heparin mix-ups
Vials of 100-unit heparin flush and 100-
unit insulin are often found together on top
of medication carts and counters, contribut-
ing to mix-ups. Someone could mistakenly
pick up the wrong vial, causing a fatal event.
There is a need to minimize or eliminate the
availability of heparin flushes, to use unit-
dose heparin syringes and to standardize on
a single concentration for newborns where it
is used for vascular catheter patency, e.g., a
1-unit syringe.
Figure 2. Old and New Labeling for IV Heparin
Figure 3. Use of Abbreviation
“U” for “units”
Figure 4. This is your Brain on Call
Discharge Mr. Jones
urinate > daily
Grand rounds in 10 min!
Coffee deficiency
Salvage marriage
Check ptt, adjust UFH gtt
Check GFR before DVT ppx
Notice low plts on exaparin
RN calling about colace
Conference presentation
Call rheum consult
Follow duty hours
Discharge prescriptions
New Admission!
Mrs. Smith fell
Angry patient wants "real doctor"
LOOK GOOD ON ROUNDS
FINISH NOTES
BEEP!
BEEP!
BEEP!
BEEP!
BEEP!
Review medications
Why is Nunez altered?
Figure 4. Telephone order not
read back
Executive Summary Conference Report
12
9th Invited Conference: Improving Heparin Safety
Improper manufacturer labeling
A label can show the concentration of
drug per mL but not indicate the total amount
of drug in the vials. If a 10-mL vial is labeled
"5,000 units/mL," a nurse may read this as a
5,000 unit total, when it actually totals 50,000
units.
Preservatives
Heparin containing benzyl alcohol as a pre-
servative has caused toxicity in newborns.
Dosing errors
Dosing errors can occur if patient weight
is not estimated or not verified or if an incor-
rect nomogram used, e.g., acute cardiac syn-
drome vs. DVT vs. stroke.
Many calculation errors are listed in the
reports sent to ISMP. These include math-
ematical errors in determining the volume
of heparin to use for a bolus or the rate of
infusion and miscalculation of the amount of
heparin to add to total parenteral nutrition
(TPN) solutions.
Dosing errors with infusion pumps can
occur when an infusion pump is used to
deliver a bolus dose and then not adjusted
to a continuous infusion rate, (e.g., admin-
istering a 5,000- to 10,000-unit bolus by
increasing the infusion rate but forgetting
to change the rate back to a 1,000 unit/hr
infusion). Other pump programming errors
include programming concentration or rate
incorrectly. Fortunately, the introduction of
smart pumps has helped to address these
types of errors.
ISMP Medication Safety Self
Assessment®
A free ISMP Medication Safety Self
Assessment® for Antithrombotic Therapy
for Hospitals is available at www.ismp.org
2
.
More than 400 hospitals completed this self-
assessment during the first quarter of 2008.
The self-assessment was put together with
experts from all over the country in hema-
tology, pharmacy practice and nursing. The
text lays out the system enhancements that
need to be in place, system issues that need
to be addressed in order to deliver heparin
safely. Hospitals can enter their data, moni-
tor it over time and compare their perfor-
mance to organizations nationwide.
Conclusion
Heparin errors are both common and a
matter of public concern. There are many
ways to improve the safety of heparin use in
hospitals. The healthcare industry needs to
be proactive, not reactive, in taking action
to address the many issues that contribute
to heparin errors. The necessary informa-
tion is available from many sources. Paying
attention and acting on this information will
play a major role in addressing problems and
improving the safety and quality of heparin
therapy and patient care.
References
1. Pederson CA, Gumpper KF: ASHP National survey on
informatics: Assessment of the adoption and use of
pharmacy informatics in US hospitals. Am J Health Syst
Pharm, 2008; 65:2244-64.
2. ISMP Medication Safety Self Assessment for
Antithrombotic Therapy in Hospitals. Retrieved October
22, 2008 from http://www.ismp.org/selfassessments/
asa2006/Intro.asp.
3. ISMP websites: http://www.ismp.org and http://www.
consumermedsafety.org.
PROCEEDINGS
9th Invited Conference: Improving Heparin Safety
13
Executive Summary Conference Report
Key points
• Adverse drug event surveillance at Brigham and Women’s Hospital (BWH) showed that in
cardiovascular patients, anticoagulants are the drug class most frequently associated with
adverse drug reactions and the second most frequent cause of medication errors.
• Unfractionated heparin (UFH) was associated with the greatest number of anticoagulant
medication errors, with infusion pump and parenteral delivery problems as the most frequent
causes of these errors.
• Of the anticoagulant errors, 1.5% of the events prolonged hospitalization and 6.2% required
medical intervention.
• Continuous quality improvement (CQI) data from smart infusion devices showed that averted
UFH overdoses accounted for 29.0% of intercepted UFH medication errors. Dosing errors
ranged from 30-999 mL/hr (3,000-99,900 units/hr). Averted UFH underdoses accounted for
20.6% of intercepted UFH medication errors. Dosing errors ranged from 0.1-2.7 mL/hr (10-270
units/hr).
• Almost two-thirds of UFH averted errors occurred between noon and 4 p.m., or close to the
time of the principal nursing-shift change at 3 p.m. Averted errors were less common on
Fridays and during weekends.
• For those facilities using smart pump technology, CQI data of infusion-related medication
errors should be reviewed promptly to identify opportunities to improve anticoagulant medi-
cation safety.
Adverse drug events (ADE) consist of
adverse drug reactions (ADR) and medication
errors that result in harm. ADEs can increase
costs, generate adverse publicity, compro-
mise patient trust and demoralize hospital
staff
1-7
. Analysis of ADEs in specific disease-
state populations or medication classes
in the hospital setting has been limited
8-12
.
Anticoagulation in the hospitalized patient
is cited as frequently being associated with
medication errors
3-5
.
As part of the Drug Safety Surveillance
Program at BWH, ADEs in cardiovascular
patients were reviewed, errors with anticoag-
ulant medications analyzed and the impact of
smart pump technology evaluated
12-14
. Smart
pumps with dose-error-reduction software
(DERS) may reduce the number of these med-
ication errors.
Overall medication errors
vs. anticoagulant errors
In the cardiovascular patients reviewed,
ADRs and medication errors occurred with
equal frequency (51.1% and 49.1%, respec-
tively). Anticoagulants were the drug class
most frequently associated with ADRs includ-
ing elevations in laboratory monitoring
tests, thrombocytopenia and hemorrhage.
Anticoagulants were the second most fre-
quent source of medication errors
12
. A review
of all anticoagulant errors showed that antico-
agulants accounted for 1.72 medication errors
per 10,000 patient days
13
. Anticoagulation
therapy accounted for 67% of anticoagulant
medication errors, while 33% were associated
with prophylaxis.
Anticoagulant errors
Among anticoagulant drugs, unfraction-
ated heparin (UFH) was associated with the
greatest number of events followed by war-
farin, low molecular weight heparin (LMWH),
argatroban and lepirudin. The medication
error rate for anticoagulants in general was
1.67 per 1,000 patients treated and for UFH,
1.27 events per 1,000 patients treated. Wrong
rate or frequency were the most commonly
reported errors associated with anticoagulant
administration, and most of these were asso-
ciated with UFH administration.
Infusion pump and parenteral delivery
problems were the most frequent proximate
cause of anticoagulant medication errors
(Figure 1). These errors were only associ-
ated with heparin administration. While no
deaths were attributed to any of the anti-
coagulant errors, 1.5% of the events pro-
longed hospitalization and 6.2% required
medical intervention. Many events required
an increase in laboratory monitoring but
caused no patient harm.
Heparin Medication Safety:
Impact of Smart Infusion Technology
John Fanikos, RPh, MBA, Assistant Director of Pharmacy, Brigham and Woman’s Hospital, Boston, MA
Executive Summary Conference Report
14
9th Invited Conference: Improving Heparin Safety
Averted programming errors
The Alaris® System with Guardrails® soft-
ware from CareFusion Health (formerly known
as the Medley™ Medication Safety System)
was implemented at our hospital. This is a
smart (computerized) infusion device with a
hospital-determined drug library and dose-
error-reduction software (DERS). The software
drug library contains a list of parenteral medi-
cations, their admixture concentrations and
approved dosage ranges. If an infusion were
programmed for an IV infusion rate or dose
that exceeded approved ranges, the soft-
ware would generate an alert that must be
addressed before infusion could begin.
Averted errors were identified by continu-
ous quality improvement (CQI) data show-
ing that a clinician responded to an alert by
reprogramming or cancelling and infusion.
Over a 16-month period, CQI logs in the safety
software documented 7,395 averted errors,
858 (11.6%) of which were triggered by anti-
coagulant therapy
14
. Of 14,012 heparin doses
administered to 3,674 patients, UFH infusion
programming in 246 patients generated 501
alerts that were subsequently reprogrammed
or the infusion cancelled, i.e., averted errors.
“Dose Above Maximum” overdoses accounted
for 29.0% of UFH averted errors, and “Dose
Below Minimum” underdoses, for 20.6%. UFH
averted overdoses ranged from 30-999 mL/hr
(3,000-99,900 units/hr) and averted under-
doses from 0.1-2.7 mL/hr (10-270 units/hr).
The infusion safety software captured
all cases of reprogramming in response to
an alert (Figure 2). CQI data showed a 100-
fold potential overdose in 40 averted errors
(28.5%), 10-fold potential overdose in 40
averted errors (28.5%) and a greater-than-100-
fold potential overdose in 10 (6.5%) averted
errors. A 100-fold potential underdose would
have occurred in 39 (25.2%) and a 10-fold
potential underdose in 26 (16.8%) averted
errors. Programming errors were frequently
duplicated. In 72.8% of averted errors, one
alert was sufficient to have the user reprogram
the device. However, in 27.2% of averted
errors, the user repeated the error in response
to the alert, i.e., reprogrammed the device
with the same incorrect entry.
The highest percentage (18.2%) of avert-
ed errors occurred between 2 p.m. and
4 p.m., and the next-highest (12.7%) between
noon and 2 p.m. (Figure 3). These periods
coincide with the nursing shift change at
3 p.m. Averted errors were equally common
during weekdays Monday through Thursday
and had the lowest occurrence on Fridays and
during weekends.
Discussion
Among cardiovascular patients, ADRs and
medication errors are most commonly asso-
ciated with routinely utilized medications.
Anticoagulant therapy, specifically UFH, was
a common culprit and perhaps the best tar-
get for error-prevention strategies and early
recognition of ADRs and medication errors.
UFH’s broad indications, widespread use,
laboratory monitoring and frequent dosing
changes make ADEs a common occurrence
9-10
.
CQI data showed that heparin medication
errors occurred most commonly during drug
administration. Infusion device programming
errors were identified as the most frequent
cause of heparin errors, which influenced the
decision to purchase smart infusion devices.
Following implementation of these devices,
CQI data generated by the safety software
showed that programming errors involving
incorrect infusion rates or doses are common.
Possible explanations for incorrect program-
ming included transcription errors associ-
ated with misplaced zero(s) and/or decimal
points, and transposition of rate and dose. CQI
data showed that smart infusion technology
helped to avert such errors, thereby reduc-
ing opportunities for anticoagulation over- or
underdosing.
A recent study has shown the difficulties in
achieving and maintaining therapeutic anti-
coagulation with UFH
15
. Smart infusion tech-
nology may help to achieve these goals by
helping to alert staff to incorrect infusion rates
and doses. A recently published, prospective,
randomized, time-series trial assessed infu-
sion safety devices in critically ill patients.
Investigators concluded that the smart pumps
could detect IV medication errors and poten-
tial ADEs
16
.
Averted errors most frequently occurred
between 2 p.m. and 4 p.m., a period associ-
ated with a relatively high rate of admis-
sions and transfers, nursing shift change and
typically the height of medical staff prescrib-
Infusion
pump
p
roblems
M
emo
ry
lapses
Rule
viol
ations
Transc
ription
er
rors
Faul
ty
in
te
ra
ctions
with
other
se
rvi
ces
Faul
ty
drug
ide
nti
ty
chec
king
Lack
p
atie
nt
in
fo
rm
ation
Lack
of
standa
rdiz
ation
Faul
ty
dose
chec
king
Inadequ
at
e moni
to
ring
St
oc
king
&
deli
ve
ry
p
roblems
Pr
epa
ra
tion
er
rors
Lack
of
drug
kn
owledge
25%
20%
15%
10%
5%
0%
23%
19%
13%
12%
8%
8%
3%
3%
2%
2%
2%
2%
2%
Pe
rc
en
t
Cause
Figure 1. Causes of Anticoagulant Errors
15
Executive Summary Conference Report
9th Invited Conference: Improving Heparin Safety
ing. Averted errors occurred with equal fre-
quency during weekdays but with less fre-
quency on Fridays and during weekends.
Past studies have found higher medication
error rates at the time of hospital admission
and during transfer between facilities.
17-18
Recent studies have suggested a higher
patient mortality rate on weekends and cor-
related nurse staffing levels to quality of
care.
19-20
More research is required to deter-
mine possible associations between these
variables and effective drug use, especially
with complex medications such as antico-
agulants.
Conclusion
CQI data from BWH smart pumps provide
a real-life illustration of IV UFH-related poten-
tial ADEs occurring during the routine care
of patients and may provide guidance for
resource allocation to improve practice to pre-
vent or avoid future events. Smart pump CQI
data on infusion medication errors should be
reviewed promptly to identify opportunities
for rapid response to improve anticoagulant
medication safety.
References
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drug events and potential adverse drug events. JAMA
1995;274:29-34.
2. Chyka PA. How many deaths occur annually from
adverse drug reactions in the United States? Am J Med
2000;109:122-30.
3. Johnson JA, Bootman JL. Drug –related morbidity and
mortality: A cost of illness model. Arch Intern Med
1995;155:1949-56.
4. Bates DW, Spell N, Cullen DJ, et al. The cost of
adverse drug events in hospitalized patients. JAMA
1997;277:307-11.
5. Claussen DC, Pestotnik SL, Evans RS, et al. Adverse
events in hospitalized patients. Excessive length of
stay, extra costs and attributable mortality. JAMA
1997;277:301-6.
6. Grant SM. Who’s to blame for tragic error? Am J Nurs
1999; 99 (9).
7. Brink S. 1995 best hospitals. Tragedy at Dana-Farber. US
News & World Report 119(4): 53-4, 56, 1995 Jul 24.
8. Landrigan CP, Rothschild JM, Cronin JW, et al. Effect
of reducing interns’ work on serious medical errors in
intensive care units. N Engl J Med 2004;351:1838-48.
9. Kaushal R, Bates DW, Landrigan C, et al. Medication
errors and adverse drug events in pediatric inpatients.
JAMA 2001; 285:2114-20.
10. Simpson JH, Lynch R, Grant J, et al. Reducing medica-
tion errors in the neonatal intensive care unit. Arch Dis
Child Neonatal Ed 2004;89:480-2.
11. Mehta RH, Alexander JH, Van de Werf F, et al. Relationship
of incorrect dosing of fibrinolytic therapy and clinical
outcomes. JAMA 2005; 293:1746-50.
12. Fanikos J, Cina JL, Baroletti S, et al. Adverse events
in hospitalized cardiac patients. Am J Cardiol 2007;
20:1465-9.
13. Fanikos J, Stapinski C, Kucher N, et al. Medication errors
associated with anticoagulant therapy in the hospital.
Am J Cardiol 2004; 94:532-5.
14. Fanikos J, Fiumara K, Baroletti S, et al. Impact of smart
infusion technology on administration of anticoagu-
lants (unfractionated heparin, argatroban, lepirudin,
and bivalirudin . Amer J of Cardiol 2007;(99);7:1002 - 5.
15. Hylek EM, Regan S, Henault LE, et al. Challenges to the
effective use of unfractionated heparin in the hospital-
ized management of acute thrombosis. Arch Intern Med
2003;163:621-7.
16. Rothschild JM, Keohane CA, Cook EF, et al. A controlled
trial of smart infusion pumps to improve medication
safety in critically ill patients. Crit Care Med 2005;33:522-
40.
17. Cornish PL, Knowles SR, Marchesano R, et al. Unintended
medication discrepancies at the time of hospital admis-
sion. Arch Int Med 2005; 165:424-9.
18. Boockvar K, Fishman E, Kyriacou CK, et al. Adverse
events due to discontinuation in drug use and dose
changes in patients transferred between acute and
long-term care facilities. Arch Int Med 2004; 164:545-50.
19. Bell CM, Redelemeier DA. Mortality among patients
admitted to hospitals on weekends as compared with
weekdays. N Engl J Med 2001;345:663-8.
20. Needleman J, Buerhaus P, Mattke S, et al. Nurse-staffing
levels and the quality of care in hospitals. N Engl J Med
2002;346:1715-22.
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