ISMP Quarterly Action
Agenda - july and september 2007
From the October 4, 2007 issue
One of the most important ways to prevent medication errors is to learn about problems that have occurred in other organizations and use that information to prevent similar problems at your practice site. To promote
such a process, the following selected agenda items have been prepared for your senior leaders and an interdisciplinary committee to stimulate discussion and action to reduce the risk of medication errors. These
agenda topics appeared in the ISMP Medication Safety Alert!® between July and September 2007. Each item includes a brief description of the medication safety problem, recommendations to reduce the risk of errors, and
the issue number in parentheses to locate additional information as desired. Look for our high-alert medication icon under the issue number if the agenda item involves one or more medications on the ISMP List of High-
Alert Medications. Many product-related problems can be viewed in the ISMP Medication Safety Alert!® section of our website. The Action Agenda is also available for download in a Word format (www.ismp.org/Newsletters/acutecare/articles/ActionAgenda0704.doc) that allows expansion of the columns in the table designated for organizational documentation of an assessment, actions required, and assignments for each agenda item. Continuing
education credit is available for nurses at: www.ismp.org/Newsletters/acutecare/actionagendas.asp.
Key: — ISMP high-alert medication
Fatal 1,000-fold overdose of zinc in TPN due to confusion between mcg and mg (18)
Problem:A fatal 1,000-fold overdose of zinc sulfate
contained in a TPN solution was administered to
a preterm neonate. A calculation was made to
convert zinc, prescribed in mcg/100 mL, to
mcg/kg, which was required for the automated
compounder software. The calculation was
correct, but it was entered incorrectly into the
pharmacy computer as mg, not mcg. Several
system failures contributed to the error,
including nonstandard ways of prescribing
electrolyte additives in TPN and inadequate
Recommendation: Standardize the way zinc sulfate (and other
electrolytes) is prescribed. Ensure that the
prescribed dosing method matches the dosing
method required for order entry into pharmacy
software. Add low-volume trace elements to TPN
admixtures manually. Build and heed dose
warnings in automated compounders and
pharmacy software. Develop comprehensive education
modules and validate the competency of
individuals involved in TPN. See the full article with
additional recommendations at: www.ismp.org/Newsletters/acutecare/articles/20070906.asp.
Inappropriate prescribing of FENTORA (fentanyl buccal tablets) (19)
Problem: Fentora has been linked to serious adverse
outcomes, including death, when prescribed for
the management of acute pain in patients who are
not opiate tolerant. Prescribers are also cautioned
that mcg-to-mcg conversions between fentanyl
patches and other forms of fentanyl products,
including ACTIQ (fentanyl transmucosal lozenges)
or buccal fentanyl tablets, are not safe.
Recommendation: Make FDA's Healthcare Professional Sheet
(www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora) available to practitioners who
prescribe, dispense, or administer fentanyl
products. Validate each patient’s opiate tolerance
before use and require personnel who dispense or
administer these products to verify that the
patient meets prescribing criteria.
World Health Organization (WHO): Dilute vincristine in a minibag (15)
Problem: Humapen Memoir is a pen device that was recently launched for use with HUMALOG (insulin lispro injection [rDNA origin]). This product may be confused with Humira Pen used to treat immune-related disorders. The brand names look and sound very similar
Recommendation: Dilute vincristine and other vinca alkaloids in a
minibag rather than a syringe so it looks dissimilar
to drugs that are given intrathecally. For more on
preventing fatal vincristine errors, view the free FDA
Patient Safety Video at: www.accessdata.fda.gov/psn/transcript.cfm?show=68#7.
Lack of standard dosing methods contributes to IV errors (17)
Problem:A large variety of IV drug dosing methods exist in
hospitals. For example, the same drug might be
administered within the same facility using the
dosing methods of mcg/kg, mcg/kg/min, or
mcg/kg/hour concentrations. Lack of standardization
makes recognition of dosing errors difficult,
even when using smart pumps.
Recommendation: Define and standardize adult (and if applicable,
pediatric) dosing methods to be used for each
drug administered IV in your organization.
Employ smart pumps and program them using
the endorsed dosing method. The dose on the
prescriber's order, the MAR, and the drug label
should match the dosing method required to
program the infusion pump.
IV fluorouracil infused in 4 hours instead of 4 days (19)
Problem:A patient undergoing treatment for advanced
carcinoma received a fatal dose of fluorouracil,
given over 4 hours instead of 4 days. Two
nurses miscalculated the infusion rate, forgetting
to divide the daily dose by 24 hours. The
pharmacy label listed the mL/24 hour rate of
infusion first, then the mL/hour rate. The nurses
saw the mL/24 hour infusion rate and thought
their erroneous calculations were correct. Failed
double-check systems and pump design flaws
also contributed to the error.
Recommendation: Display information needed to program infusion
pumps in a standard way. The mL/hour rate, not
the mL/24 hour rate, should be prominent.
Minimize the need for calculations at the
bedside. Use checklists to structure task
workflow. Use chemotherapy certification
processes to validate that staff possess and
maintain an appropriate level of skills, knowledge,
and abilities before working independently.
See the full article for details at: www.ismp.org/Newsletters/acutecare/archives/Sep07.asp#20.
Confusion with SYMLIN (pramlintide acetate) dosing (17)
Problem:Symlin may be prescribed for insulin-dependent
diabetic patients to enhance glucose control. It
is prescribed in mcg, not units. Patients may
confuse the "mcg" dose of Symlin with the"unit" dose markings on the insulin syringes
used to administer the dose, leading to potentially
serious dosing errors.
Recommendation: Teach patients how to draw up the correct dose
of Symlin using an insulin syringe, and validate
understanding by observing a return demonstration.
Also validate that the patient knows how to
measure doses in general in case the dose is
changed. Instruct the patient not to mix Symlin
and insulin in the same syringe.
New ROCEPHIN (ceftriaxone) warning (14)
Problem:FDA and Roche published an advisory about a
potential problem when Rocephin is used
concomitantly with calcium or calciumcontaining
products within 48 hours, especially
Recommendation: A second advisory (www.fda.gov/medwatch/safety/2007/Rocephin_HCP_august2007.pdf)
stresses that Rocephin and calcium-containing
solutions, including parenteral nutrition, should
not be mixed or co-administered within 48 hours
to any patient, even via different infusion lines at
different sites. Computer alerts or smart pumps
can help warn clinicians about such conditions.
Insulin CONCENTRATE U-500 (15)
Problem:With use of U-500 insulin products in hospitals on
the rise, reports of mix-ups between U-100 and
U-500 insulin are also increasing. The way insulin
products are listed on computerized order-entry
screens is often a causative factor in erroneously
selecting U-500 insulin when entering orders.
Access to concentrated insulin on patient care
units also increases the likelihood of an inadvertent
Recommendation: Evaluate how insulin is listed on order entry
screens; if the concentration appears at the far
right of the drug information, the risk of
selecting the wrong product increases. Drug
information vendors have agreed to incorporate
the word "CONCENTRATED" to U-500 insulin
entries. Consider adding a hard stop on U-500
insulin orders to require prescriber and pharmacist
verification before proceeding. Segregate the
storage of these two strengths of insulin.
Failure to cap IV tubing and disinfect IV ports place patients at risk (15)
Problem: Leaving the distal end of IV tubing uncapped
between intermittent infusions and failing to
disinfect IV ports on needle-free valves before
access increases the likelihood that patients will
acquire a healthcare-associated infection.
Meticulous attention to aseptic technique
including proper disinfection of IV access devices
is not the observed norm in many organizations.
Recommendation: Organizational policies and procedures should
detail the expectations related to maintenance
of aseptic technique including disinfection of
vascular access lines and ports. Teach these
expectations to individuals who administer
medications and conduct rounds on patient
care units to document baseline compliance
and measure improvement.
Preventing mix-ups between various formulations of amphotericin B (18)
Problem:Several reports of fatal mix-ups between conventional
and lipid-based formulations of amphotericin
B were recently published in the United
Kingdom. Alerts issued by ISMP since 1997 have
called attention to mix-ups between the lipidbased
and conventional formulations of drugs.
Recommendation: Communicate orders for drugs with liposomal
and conventional forms using both the proprietary
and complete generic name (e.g., AMBISOME
[amphotericin B liposomal]). Restrict
the preparation and dispensing of amphotericin B
products to the pharmacy. Separate the storage
of different formulations. Additional recommendations
can be found at: www.ismp.org/Newsletters/acutecare/articles/20070906_1.asp.
BYETTA (exenatide) barcode scanning inconsistencies (16)
Problem:Two formulations of Byetta are distributed in pen
injectors, one delivering 5 mcg/injection and one
delivering 10 mcg/injection. The wrong strength
may be dispensed because both pens have
similar NDC numbers. Only the final digits of the
NDC numbers are different, and the barcodes for
both products may not include these final digits.
Recommendation: Manual double-checks of Byetta products are
warranted to ensure the correct strength is
dispensed, especially in community settings
where erroneous dispensing could lead to
repeated dosing errors.
Another problem with Byetta (exenatide) (16)
Problem:A nurse reported administering the full contents
(1.2 mL) of a Byetta prefilled pen to a patient
instead of the intended dose of 5 mcg (0.02 mL),
a 60-fold overdose. The nurse saw the prescribed
dose of 5 mcg on the pen's label but no directions
on the pen itself. She missed the concentration
and total volume listed on the pen in fine
print. She'd never used Byetta and was unsure
how to activate it, so she withdrew the entire
contents from the pen into a separate syringe
and administered the full amount to the patient.
Recommendation: Review educational processes that are used
when new products are introduced in your
organization. Do not assume that all pen
injector devices operate similarly; evaluate the
steps necessary to ensure that a dose is delivered
successfully and accurately each time a
new product is considered. Ensure that nurses
receive adequate, hands-on education with pen
injector devices before introducing new
products into patient care areas.
Potential problem with EXACTACAIN spray (benzocaine 14%, butamben 2%, tetracaine 2%) (14)
Problem: Some Exactacain applicator straws have been"popping off into patients' throats." Recent
product changes to the spray release button
necessitated re-sizing applicator straws. Straws
for use with the original Exactacain spray release
button are not compatible with newly designed
spray release button and will pop off during use.
Recommendation: Use only the straws packaged with each
Exactacain container, not leftover straws from
the older container. Discard leftover straws when
starting a new container. For more information,
view a free FDA Patient Safety Video on this
topic at: www.accessdata.fda.gov/psn/transcript.cfm?show=68#6.
Updated: ISMP's List of High-Alert Medications (16)
Problem: High-alert medications are drugs that bear a
heightened risk of causing significant patient
harm when used in error. Special safeguards
may reduce the risk of error.
Recommendation: Based on a 2007 practitioner survey and review
by ISMP and other medication safety experts,
ISMP's List of High-Alert Medications has been
updated (www.ismp.org/Tools/highalertmedications.pdf). Organizations are strongly encouraged
to evaluate the error potential for each high-alert
drug, and take proactive measures to reduce risk.
Talc given IV (17)
Problem: A patient died after a talc suspension was administered
IV instead of being instilled through a
chest tube during a pleurodesis (causes the
membranes around the lung to stick together to
prevent fluid buildup in the space between the
membranes). The nurse misinterpreted the word"in" amid the order for "talc in saline" as "IV."
The product was dispensed in a parenteral syringe
with "IV additive product" listed on the label.
Recommendation: Drugs used for pleurodesis should be delivered to
the unit immediately prior to the procedure; they
should be prepared in a catheter-tipped syringe
(not a parenteral syringe) which is labeled “for
chest tube instillation only." Use a pre-procedure "time out" to confirm patient identity, clarify the
plan of care, and ensure that appropriate equipment
and medications have been brought to
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