July - September 2014
ISMP
QuarterlyActionAgenda
One of the most important ways to prevent medication errors is to learn about problems that have occurred in other organizations and to use that information to prevent
similar problems at your practice site. To promote such a process, the following selected items from the July—September 2014 issues of the ISMP Medication Safety Alert! have been
prepared for an interdisciplinary committee to stimulate discussion and action to reduce the risk of medication errors. Each item includes a brief description of the medication safety
problem, a few recommendations to reduce the risk of errors, and the issue number 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 (www.ismp.org/Tools/highalertmedications.pdf). The Action Agenda is also
available for download in a Microsoft Word format (www.ismp.org/Newsletters/acutecare/articles/ActionAgenda1404.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. Many product-related problems can also be viewed in the ISMP Medication
Safety Alert! section of our website at: www.ismp.org. Continuing education credit is available for nurses at: www.ismp.org/Newsletters/acutecare/actionagendas.asp.
Key:
— ISMP high-alert medication
Organization
Assessment
Error with lomustine caused by dispensing more than a single course of therapy
No.
Problem
(14)
A patient with brain cancer was prescribed
a single 150 mg dose of lomustine,
followed by reassessment in 6 weeks to
evaluate the benefit of additional doses. A
mail-order pharmacy dispensed a 3-cycle
supply of the drug (3 doses). Expecting a
single dose, the patient took all of the
capsules totaling 450 mg. The overdose
led to a slow and painful death 6 weeks
later. Similar errors with dispensing this
drug have been published previously with
fatal results.
(16,
20)
Early in 2015, manufacturers will distribute
administration sets with the new enteralonly connector, called ENFit, at the end
that connects to the feed-ing tube. The
new feeding tubes will not be available
until later in 2015. Thus, a temporary
transition adapter will be attached to the
administration set. Once new enteral
feeding tubes are in place, ENFit syringes
will be required to flush or administer
enteral liquid medications via a feeding
tube. An oral or Luer syringe will not
connect to the port.
Recommendation
Action Required/
Assignment
Date
Completed
Order entry systems should not allow more
than a single dose to be entered and
should limit the quantity dispensed.
Pharmacists should provide patient
counseling, supply leaflets, and enhance
labels (e.g., CAUTION: TAKE A SINGLE
DOSE ONLY ONCE EVERY 6 WEEKS).
Nurses should reinforce education prior to
discharge, and insurers should pay only for
a single dose at a time.
URGENT! Health systems need to plan for changes in enteral connectors
October 23, 2014
Convene an interdisciplinary team to
assess the existing systems and
processes that may need to change during
and after transition to the new enteral
connectors. The team should specifically
focus on how the change will be
communicated, how the enteral
medications will be dispensed, how the
connectors and sets will be stored, and
how to transition to the new connectors. To
stay updated, visit this website frequently:
www.stayconnected2014.org/.
ISMP MedicationSafetyAlert!

QAA 1
July - September 2014
ISMP
QuarterlyActionAgenda
Organization
Assessment
Mix-ups between vaccine diluents and neuromuscular blockers
No.
Problem
(19)
In the past, vaccine diluents have been
mixed up with neuromuscular blockers
primarily due to look-alike vials and
ampules, as happened recently in Syria,
leading to the death of 15 children
vaccinated against measles. Similar errors
have happened around the world and in
the US where several patients received
doses of pancuronium instead of influenza
vaccine because the similar vials were
stored in the refrigerator next to each
other.
ISMP has called upon regulators and
manufacturers to improve vaccine
packaging, including the use of dualchamber containers and redesigned vials
that allow larger labels. Until then, when
pos-sible, stock prefilled vaccine syringes
to decrease reconstitution in patient care
units. Limit or eliminate the storage of
neuromuscular blockers on patient care
units and sequester remaining storage.
Educate staff about vaccine and diluent
errors.
(16)
Two children sustained leg lacerations
while receiving EpiPen injections when
they moved while the needle was still
under the skin. The directions for use say
that the EpiPen must be held in place for
10 seconds. The needle does not retract
until the pen is removed. The needle can
cut through the subcutaneous tissue and
cause a laceration if the child moves
during administration.
Leg lacerations following EPIPEN (EPINEPHrine) autoinjector use
Providers using EPINEPHrine
autoinjectors for children should pay close
attention to patient restraint prior to
injection, as the child may move if the
needle remains in the thigh for 10 seconds.
If the needle is dislodged, reinsertion
should never be attempted. If it was in
place for at least 3 seconds, the
EPINEPHrine was likely delivered. Repeat
doses only if clinically necessary.
(13,
16)
Recommendation
Action Required/
Assignment
Date
Completed
Confusion between NAROPIN (ropivacaine) and OFIRMEV (acetaminophen injection)
Glass vials of Naropin, intended for
Consider adding auxiliary labels (“For
epidural use, have been repeatedly
nerve block and epidural use only”) to the
confused with glass vials of Ofirmev,
Naropin containers before dispensing the
intended for IV use. Either product can be
product from the pharmacy. Store the
administered without further dilution.
products in different drawers or, when
Although, the labels are dissimilar, the
possible, limit ADC storage to only one of
drugs may be the only two available in
the drugs. Use barcode scanning for
similar glass vials in some patient care
stocking and removal of the products from
areas. The risk of error is highest if they
ADCs.
are stored near one another, such as in the
same automated dispensing cabinet (ADC)
drawer.
October 23, 2014
ISMP MedicationSafetyAlert!

QAA 2
July - September 2014
ISMP
Organization
Assessment
Baxter DOBUTamine overwrap label change contributes to error
Problem
No.
Recommendation
(13)
With the new labeling on Baxter’s
DOBUTamine IV bags, the concentration
appears on the overwrap but there’s no
longer reverse print used for the 250
mg/250 mL bag to differentiate it from the
500 mg/250 mL bag. A mix-up happened
when 500 mg/250 mL bags were
accidentally used in place of the lower
concentration to restock an automated
dispensing cabinet (ADC).
(13)
To prepare an 850 mg dose of Alimta, a
total of 34 mL were needed using one 500
mg vial and four 100 mg vials after being
reconstituted to obtain a final concentration
of 25 mg/mL. But pharmacy staff were able
to obtain 34 mL of Alimta without using the
last 100 mg vial of drug. When contacted,
Lilly confirmed that the vials contain
overfill. In this instance, one vial was
wasted, but the patient could have
received a larger dose than prescribed.
(16,
17)
QuarterlyActionAgenda
Action Required/
Assignment
Date
Completed
Standardize to a single concentration when
possible and use barcode scanning when
restocking or removing the product from
ADCs. In hospitals where more than one
concentration must remain, consider
storing only one concentration in the ADC,
and dispense the less common strength
from the pharmacy. Add bold auxiliary
labels to draw attention to the
concentration differences.
ALIMTA (PEMEtrexed) vials contain overfill
Overfill is mentioned in the package insert,
but the details aren’t specified. Be sure
staff are aware of vial overages with this
drug, especially when a small difference
could be clinically important.
New ISOVUE (iopamidol) imaging bulk package (IBP) for use with power injectors
Isovue is now packaged in an imaging bulk The Isovue PBP and Isovue IBP products
package (IBP) approved for use with
must be used exactly as described in the
multiple patients in the CT suite in
package insert to ensure sterility.
conjunction with an automated contrast
injection system or syringe-based injection
system. Use of the Isovue Multipack PBP
(pharmacy bulk package), renamed Isovue
PBP, is limited to the preparation of
syringes in an ISO Class 5 environment in
the pharmacy.
Misleading KCENTRA (prothrombin complex concentrate [human]) label leads to dosage errors
October 23, 2014
ISMP MedicationSafetyAlert!

QAA 3
July - September 2014
ISMP
QuarterlyActionAgenda
Organization
Assessment
No.
Problem
Recommendation
(15)
When 4,500 units of Kcentra were ordered,
pharmacy staff noted the “500 U” in the
upper right corner of the carton and vial
label and assumed each vial contained
500 units. Each vial actually contains a
range (400-620 units) of factor IX, which is
listed on the back panel or the carton and
vial label. Nine vials were used to prepare
an infusion labeled “4,500 units in 180 mL,”
but the bag contained 5,026 units given the
actual units in each vial.
Use an auxiliary label or computer
reminder to alert staff to verify the actual
number of units in each vial listed on the
back label panel on the carton and vial. We
asked the company to modify the label so
the range is better communicated. We also
suggested that additional information is
needed where “500 U” appears on the
front label panel—perhaps specifying “500
Units Range” as a midpoint of dosages in
each vial.
(19)
The Docefrez brand of DOCEtaxel is
available as a lyophilized powder that
reconstitutes to a concentration different
than most commercially available
DOCEtaxel products. Instead of a 10
mg/mL or 20 mg/mL concentration,
reconstitution results in 24 mg/mL (80 mg
vial) or 25 mg/mL (20 mg vial)
concentrations. Overdoses have occurred,
as the concentration is not clearly visible
on the label.
Action Required/
Assignment
Date
Completed
Unfamiliar concentration of DOCEFREZ (DOCEtaxel) increases risk of error
(15)
List Docefrez along with the concentration
after reconstitution in order entry systems.
Have a process in place to review new
products (particularly for replacement
products on backorder or during drug
shortages) so that staff are aware of the
differences, and make adjustments to the
IT system (including strengths and
concentrations) as needed for safe use.
“Once-Daily” designation on label of long-acting ASTAGRAF (tacrolimus) leads to error
A renal transplant patient who had been
Properly label containers dispensed to
taking oral tacrolimus 3 mg every 12 hours patients and provide education to them
was converted to a once-daily product,
about how to take the medicine. ISMP
Astagraf, and instructed to take 6 mg.
reported this risk to FDA for consideration
Despite application of a pharmacy label,
of label modifications.
the manufacturer’s label was visible, which
prominently displays “ONCE-DAILY” below
the drug name and 1 mg strength. The
patient took just 1 mg once daily.
October 23, 2014
ISMP MedicationSafetyAlert!

QAA 4
July - September 2014
ISMP
No.
Problem
(17)
Dantrolene, used to treat malignant
hyperthermia (MH), is often available in
kits containing 20 mg vials of the drug and
a liter bag of sterile water to dilute each
vial with 60 mL. Preparation during an
emergency takes time because multiple 20
mg vials are often needed. Accidental IV
administration of the liter bag of sterile
water as also occurred with catastrophic
results.
(17)
QuarterlyActionAgenda
Organization
Assessment
New dantrolene (RYANODEX) product can improve safety
Recommendation
Action Required/
Assignment
Date
Completed
A new formulation of dantrolene,
Ryanodex, is available in a 250 mg per 20
mL vial, which requires further dilution with
5 mL of sterile water for injection. One vial
provides a loading dose as opposed to 12
or more vials of traditional dantrolene,
allowing quicker treatment of MH. The new
formulation also eliminates the need to
stock liter bags of sterile water.
VARIZIG (varicella zoster immune globulin [human]) dilution issues reported
A child was to receive 125 units of Varizig
Consider adding an auxiliary label that
IM. A nurse used the entire 8.5 mL of the
reminds practitioners to reconstitute the
supplied diluent to reconstitute the drug
drug with the correct volume (1.25 mL per
instead of 1.25 mL as stated in the
125 unit vial, which provides 100 units per
package insert. To administer this volume,
mL) and then to discard the remaining
the nurse needed to give the child three IM diluent. A new liquid form of the product is
injections. Subtherapeutic doses are also
under development that will not require
possible if the entire diluent is used and
reconstitution.
staff believes this provides the labeled 100
units per mL concentration (the
concentration when 1.25 mL of diluent is
used).
Dinoprostone (PROSTIN E2) suppository confused with progesterone
(17)
A pregnant patient with asymptomatic
uterine contractions was given a Prostin
E2 vaginal suppository instead of a
progesterone vaginal suppository. Both
suppositories were available in the labor
and delivery area. Prostin E2 suppositories
are used for evacuation of uterine contents
for missed abortion or intrauterine fetal
death (IUFD). The patient developed
contractions and delivered a 1.1 kg baby.
Remove the Prostin E2 suppository from
stock in patient care areas and add a
warning on the screens of pharmacy and
electronic prescribing systems that Prostin
E2 is indicated for IUFD, uterine
evacuation, and termination of pregnancy
only. Barcode scanning verification at the
point-of-care should be used when
available.
Nitroglycerin injection labeling issues during shortages
October 23, 2014
ISMP MedicationSafetyAlert!

QAA 5
July - September 2014
ISMP
QuarterlyActionAgenda
Organization
Assessment
No.
Problem
Recommendation
(17)
Baxter labels nitroglycerin with the mg per
total volume (100 mg/250 mL) listed first,
and the mcg/mL concentration (400
mcg/mL) below in parentheses, while
Hospira labels nitroglycerin with the
mcg/mL (100 mcg/mL) listed first, and the
total mg/volume below it in parentheses. In
a recent report, a nurse set an infusion
pump for 200 mg/250 mL after misreading
200 mcg per mL on a container label.
During shortages, draw attention to the
nitroglycerin label information that matches
the way staff are used to it appearing on
nitroglycerin labels, and reprogram infusion
pump libraries as necessary. Meanwhile,
FDA is examining the differences in the
labels, and ISMP is conducting a survey
regarding nurses’ preferences.
October 23, 2014
ISMP MedicationSafetyAlert!

Action Required/
Assignment
Date
Completed
QAA 6