A perfect storm for errors
Currently nursing is in the midst of a
perfect storm for heparin errors. There is an
unprecedented combination of factors that
greatly increase the probability of poten-
tially life-threatening errors. One of the condi-
tions creating this circumstance is the nursing
PROCEEDINGS
Executive Summary Conference Report
52
9th Invited Conference: Improving Heparin Safety
shortage that affects many practice settings
in the United States, including the medical-
surgical and critical care units where heparin
is frequently used. Nurses are challenged by
higher patient acuity, unrelenting pressures
to decrease cost and improve patient out-
comes and increasingly complex therapies
with high-risk medications.
Human factors further affect the potential
for error. Nurses work in restricted, congested
spaces with high traffic and frequent inter-
ruptions. They must master a growing num-
ber of new, complicated technologies, work
longer hours and manage professional and
personal distractions
1,2
.
,5,6
The combination of
these demands can often exceed the ability
of even highly experienced nurses to function
without error.
Ensuring the safety of highly complex
heparin administration requires a multidisci-
plinary approach. Unfortunately, literature on
the nurse’s perspective in safe heparin admin-
istration is limited; therefore, the following
discussion is based on anecdotal reports and
personal experience.
Challenges in heparin administration
The first challenge nurses face when
administering heparin is look-alike labels.
Until recently, vials containing 10,000 units/
mL and those vials containing 10 units/mL
had labels that closely resembled each other.
Confusion between labels was one of fac-
tors leading to heparin errors in infants that
resulted in mortality and morbidity.
Manufacturers have changed prod-
uct labels to enhance visual differentiation
between the two concentrations by nurs-
ing and pharmacy staff, but poorly labeled
vials may still remain in hospital inventories.
Therefore, hospitals must implement mea-
sures to ensure that vials of highly concen-
trated heparin are kept only in the hospital
pharmacy and not stocked in patient care
areas
7,8
.
A second challenge is the complexity of cal-
culating heparin infusion dose rates. Variable
physician practices and lack of standardized
protocols further increase the potential for
error. A nurse might have two patients on
heparin receiving different concentrations
and/or different dosages based on weight-
based or non-weight-based protocols. Within
weight-based dosing protocols, practitioners
may disagree on which weight to use in dos-
age calculations—current, admission or “dry”
weight—further increasing nursing staff con-
fusion. Nurses are inconsistently taught to
double-check heparin dosages before admin-
istration and, even when correctly taught,
inconsistently perform this practice because
of time constraints. Many nurses are not highly
skilled in dose calculations and find the com-
plex calculations required for heparin dosage
adjustments challenging
9
.
A third challenge is obtaining and doc-
umenting a patient’s weight
10
. Determining
the patient’s weight often is not consistently
ordered or consistently performed. Staff may
rely on patients to self-report their weight,
which may be incorrect. Staff members do
not always know the correct use and calibra-
tion of scales. Errors may occur in recording
weights as pounds or kilograms. If these units
of measures are confused, significant under or
overdosing of heparin may occur and result in
a serious adverse drug event.
A fourth challenge is posed by the imple-
mentation of new smart pump (computerized
infusion) technology with dose-error-reduc-
tion software. Smart pumps assist nurses by
providing dosage limits and warnings when
doses are outside these limits. The nurse
performs a series of entries to program the
pump. If the dose programmed into the pump
exceeds pre-established limits in the pump’s
database, the safety software generates an
alert that must be addressed before infusion
can proceed, thus helping to avert a potential
error. When faced with competing priorities,
a nurse has a perceived “need for speed” and
may bypass the safety features offered by
the pump
11
. Both Rothschild
12
and Keohane
13
found that the use of smart pump technol-
ogy is beneficial in identifying errors but had
no impact on the serious error rate in their
facilities. Both authors concluded that this
technology requires systematic implementa-
tion and continued follow-up to prevent clini-
cians from having to circumvent or bypass the
safety system.
A fifth challenge is the lack of standard-
ized heparin protocol. Most institutions allow
a prescriber to individualize each order when
prescribing heparin. This leads to variation
in dosage (weight-based versus non-weight-
based), titration schedules (every four hours,
six hours and others) and monitoring pro-
tocols (timing and laboratory parameters).
Because of shortages in nursing staffing,
agency and floating nurses are often used.
These nurses encounter variation both within
and among facilities. Lack of standardization
increases the likelihood of making incorrect
assumptions or incorrect entries.
A sixth challenge is the recognition of
heparin-related complications. The two pri-
mary complications of heparin therapy are
over-anticoagulation and heparin-induced
thrombocytopenia (HIT). A nurse is in the
unique position of being the last step in the
medication therapy process and the person
who monitors the patient. Most nurses are
well educated to monitor for over-anticoagu-
lation but many are not educated to monitor
for HIT. Detection of HIT can be challenging
because of unpredictability and the use of
heparin throughout acute care. Nurses car-
ing for patients should be educated about
these complications for all patients receiving
either unfractionated heparin or low molecu-
lar weight heparin
14,15
to prepare them for
both over-anticoagulation and HIT.
53
Executive Summary Conference Report
9th Invited Conference: Improving Heparin Safety
Conclusion
Nurses have a critical role in the safe use
of heparin. The nurse must work as a full
partner of a multidisciplinary team and advo-
cate for a learning culture to prevent errors,
for nurses’ rights in heparin administration
and, most importantly, for patient safety to
be a priority for all practitioners. Other team
members must respect nurses and listen to
their concerns and observations. Without this
partnership, consistently error-free heparin
treatment cannot be realized.
References
1. Mayo AM, Duncan D. Nurse perceptions of medication
errors: what we need to know for patient safety. J Nurs
Care Qual 2004 Jul-Sep;19(3):209-17.
2. Tucker AL, Spear SJ. Operational failures and interrup-
tions in hospital nursing. Health Serv Res 2006 Jun;41(3
Pt 1):643-62.
3. Pape TM. Applying airline safety practices to medica-
tion administration. Medsurg Nurs 2003 Apr;12(2):77-
93; quiz 4.
4. Cook M. Nurses' six rights for safe medication adminis-
tration. 2008 [cited 2008 February 23]; Available from:
http://www.massnurses.org/nurse_practice/sixrights.
htm
5. Hatcher I, Sullivan M, Hutchinson J, et al. An intrave-
nous medication safety system: preventing high-risk
medication errors at the point of care. J Nurs Adm 2004
Oct;34(10):437-9.
6. Schneider PJ. Applying human factors in improving
medication-use safety. Am J Health Syst Pharm 2002 Jun
15;59(12):1155-9.
7. Institute for Safe Medication Practices. Another hepa-
rin error: Learning from mistakes so we don't repeat
them. 2007 [cited 2008 February 23]; Available from:
http://www.ismp.org/Newsletters/acutecare/arti-
cles/20071129.asp?ptr=y
8. Jennings J, Foster J. Medication safety: just a label away.
AORN J 2007 Oct;86(4):618-25.
9. Matthew L. Injectable medication therapy: a patient
safety challenge. Nurs Stand 2007 Apr 11-17;21(31):45-8.
10. Hilmer SN, Rangiah C, Bajorek BV, et al. Failure to weigh
patients in hospital: a medication safety risk. Intern Med
J 2007 Sep;37(9):647-50.
11. Fields M, Peterman J. Intravenous medication safety
system averts high-risk medication errors and provides
actionable data. Nurs Adm Q 2005 Jan-Mar;29(1):78-87.
12. Rothschild JM, Keohane CA, Cook EF, et al. A controlled
trial of smart infusion pumps to improve medica-
tion safety in critically ill patients. Crit Care Med 2005
Mar;33(3):533-40.
13. Keohane CA, Hayes J, Saniuk C, et al.. Intravenous
medication safety and smart infusion systems: lessons
learned and future opportunities. J Infus Nurs 2005 Sep-
Oct;28(5):321-8.
14. Cooney MF. Heparin-induced thrombocytopenia:
advances in diagnosis and treatment. Crit Care Nurse
2006 Dec;26(6):30-6; quiz 7.
15. Valenstein PN, Walsh MK, Meier F. Heparin monitoring
and patient safety: a College of American Pathologists
Q-Probes study of 3431 patients at 140 institutions.
Arch Pathol Lab Med 2004 Apr;128(4):397-402.
Executive Summary Conference Report
54
9th Invited Conference: Improving Heparin Safety
PROCEEDINGS
Key points
• An evidence-based heparin protocol can help to standardize and guide heparin dosage and
adjustments.
• A venous thromboembolism (VTE) prevention protocol, which included order sets, real time
patient identification and intervention increased the percent of patients with adequate VTE
prophylaxis from 50% to 98% over a two-year period resulting in decreased rates of VTE and
pulmonary embolism (PE).
• Active surveillance for adverse drug events (ADE) associated with heparin and other medi-
cations using rescue medication / pharmacist and laboratory triggers identifies far more
events than relying on billing codes and voluntary reporting alone.
• Physician compliance with heparin safety measures can be improved by involving physi-
cians when the anticoagulation management protocol is developed and ensuring the pro-
tocol is efficient and user-friendly.
Using Heparin Safely:
A Hospitalist Perspective
Ian Jenkins, MD, Hospitalist, University of California San Diego, San Diego, CA
Need for protocol use
An evidence-based heparin protocol can
be straightforward (Figure 1). So, why do
physicians, especially interns and residents,
not comply with it? One explanation is that
physicians are overloaded because of distrac-
tions, interruptions and competing demands
(Figure 2). A distracted physician can easily
fail to adjust a heparin infusion, notice that a
patient who is being treated with heparin has
developed new thrombocytopenia or check
renal function before choosing an anticoagu-
lant. The highly complex clinical environment
is a reality that must be addressed to improve
heparin safety.
The aviation industry is recognized for low
error rates and an excellent safety culture that
promotes doing things right and speaking
up if something is wrong. Each pilot is not
expected to develop, or even recall, preflight
safety checks before each take off; a check-
list is already standard procedure. Similarly,
physicians should not have to remember all
of the details involved in decisions about
the optimal monitoring, product, dose, fre-
quency of administration and duration for
each course of anticoagulation. Evidence-
based information should be incorporated
into a protocol that standardizes and guides
heparin dosage and adjustments.
Aviation safety principles are based on
the fact that pilots cannot evaluate informa-
tion on an entire instrument panel to detect
a minor abnormality. Pilots need warning
lights. Physicians also need alerts, such as
alerts for newly developing thrombocytope-
nia or for a history of heparin-induced throm-
bocytopenia (HIT), a condition which may
occur with a normal platelet count or may be
hidden in the past medical history, but not be
listed as an allergy, and may therefore be easy
to overlook.
Improving VTE prophylaxis
At the University of California San Diego
(UCSD), as at most medical centers, a large
majority of inpatients are at risk for deep
vein thrombosis (DVT) and pulmonary embo-
lism (PE) and can benefit from subcutaneous
heparin to reduce their risk. In January 2007,
a baseline assessment showed that only
50% to 55% of patients received appropriate
VTE prophylaxis; the VTE rate was 13.4/1000
patients. The baseline assessment highlight-
ed the need for a hospital-wide VTE prophy-
laxis protocol.
A team of physicians, pharmacists, and
programmers developed a VTE prophylaxis
order set that employed a simple, three-
tiered risk assessment tool. The first page of
the computerized order set requires a physi-
cian to assess a patient as high, moderate, or
low risk for VTE and included a link to a table
of VTE risk factors. The second page prompt-
ed the prescriber to consider both absolute
(e.g., active hemorrhage) and relative (e.g.
cirrhosis) contraindications for prophylactic
heparin therapy, as well as other conditions
such as HIT or the presence of an epidural
catheter.
Based on the patient’s risk level and the
55
Executive Summary Conference Report
9th Invited Conference: Improving Heparin Safety
presence or absence of contraindications, the
protocol provided a suggested regimen on
the third page. Most commonly, this included
a subcutaneous heparin when not contrain-
dicated, as well as intermittent compression
devices for patients who were at high risk or
unable to take pharmacologic prophylaxis.
This screen also displays safety reminders,
such as a warning that enoxaparin should
not be used if there is renal insufficiency, and
that dose reductions in unfractionated hepa-
rin (UFH) should be considered for small or
elderly patients.
Compliance was ensured by mandating
use of the protocol for all inpatient admis-
sions and transfers. Implementation of the
order set was followed by surveillance and
real time alerts for patients who appeared
to be untreated, but eligible for prophylaxis.
These situations prompted notification of the
treating physicians that VTE prophylaxis could
be considered.
Results
During a two-year period, the percent
of patients with adequate VTE prophylax-
is increased from 50% to 98% (Figure 3).
Preventable VTE decreased more than 80%
and the total VTE rate was almost cut in half.
The PE rate decreased from 4 to about 1.2 per
1,000 patients (Figure 4).
Investigators also sought to determine
whether treatment had caused any harm. A
retrospective review of service codes for sec-
ondary thrombocytopenia was conducted to
determine the rate of HIT. A review of about
50,000 charts showed a relative risk of about
1.44, which was not significant.
Evaluating the risk of bleeding, a rela-
tively rare event, led to another concern.
Wein found that the relative risk of bleeding
is about 1.5 for UFH and not significant for
low molecular weight heparin [LMWH]
1
. After
implementing the order set, analysis of a sam-
ple population at UCSD found no bleeding
events when reviewing anticoagulant-related
adverse drug events (ADE). This observation
raised the question of whether voluntary
reporting and physician billing data provide
trustworthy information on these events.
Improving ADE reporting
Intermountain Healthcare in Salt Lake City
suggests that billing codes and voluntary
reporting do not adequately reflect the real
rate of ADEs. Their quality improvement team
sought to determine how many ADEs could
be detected with passive compared to active
surveillance. During a period of time when
a voluntary reporting system identified six
ADEs (none serious), encouraging staff to
report ADEs by making the system easy to
use and protecting them from punishment
identified 60 events. Lastly, a full-time phar-
macist reviewed the use of antidotes, rescue
medications and critical laboratory test results
to identify patients whose charts should be
reviewed to determine whether these events
were the result of an ADE. For example, in the
case of heparin-related complications, use of
protamine or argatroban would suggest an
adverse event. This active surveillance indenti-
fied 481 new ADEs
2
. When a passive search for
ADEs is conducted, the result is often a false
sense of security based on inaccurately low
reported ADE rates—and opportunities to
care for affected patients and prevent future
complications are lost. In the case of the VTE
prophylaxis protocol, an aggressive search for
Figure 1. Physician's Brain on Protocol
Identify heparin
indication
Check allergies,
baseline labs
Order correct,
weight based product
Monitor and adjust
per protocol
Figure 2. Physician's 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?
Executive Summary Conference Report
56
9th Invited Conference: Improving Heparin Safety
HIT complicating heparin therapy indentified
more than 500 patients tested or treated for
HIT, and preliminary analysis suggests that
confirmed HIT was both exceedingly rare and
not associated with use of the protocol, con-
firming its safety with regard to the develop-
ment of HIT.
Heparin best practices
Despite a robust VTE prevention program,
community and hospital acquired VTE still
occurs, and usually results in a prolonged
course of anticoagulation which can be com-
plex and risky to administer. A UCSD evi-
dence-based VTE protocol (Table 1) has been
developed and is in the process of being
implemented that incorporates evidence-
based guidelines and standards from the
Joint Commission on Hospital Accreditation.
Selected components of this protocol include
obtaining proper baseline laboratory tests,
overlapping heparins with warfarin for at least
five days (including two therapeutic INR mea-
surements), patient education, timely labora-
tory and clinic follow-up, use of UFH when
patients have a creatinine clearance less than
30, protocol-based UFH infusions and warfa-
rin loading regimens, and long-term LMWH
treatment for eligible patients with cancer. A
grant-funded study will analyze the results of
protocol implementation.
As with the VTE prevention protocol, the
ultimate goal is a user-friendly but thorough
CPOE order set that makes it easier for physi-
cians to make good decisions and more diffi-
cult to make mistakes. It may take six to eight
months to develop CPOE order sets. While
these are being developed, interim measures
can be used such as paper versions of the pro-
tocol, staff education, and nursing protocols.
Pharmacy collaboration is crucial, as it offers
a chance to review orders before medica-
tion is delivered to the patient, ensuring that
issues such as drug/warfarin interactions are
addressed before patient harm can occur. One
warning light already in place is the reporting
of a calculated eGFR with every creatinine,
which can alert doctors to the presence of
renal failure when age or malnutrition blunts
the elevation of creatinine levels.
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