October – December 2008
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 October-December 2008 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 description of the medication safety problem, 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. The Action Agenda is also available for download in a Word format (www.ismp.org/Newsletters/acutecare/articles/ActionAgenda0901.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 visualized in the ISMP Medication Safety Alert!
section of our website at: http://www.ismp.org. Continuing education credit is available for nurses at: http://www.ismp.org/Newsletters/acutecare/actionagendas.asp.
Key:
No.
Problem
(25)
Color-coded syringes containing
anesthesia drugs are available
from repackaging companies.
The colors are used to specify a
particular drug class. We are
concerned about potentially
deadly mix-ups between various
anesthesia drugs within a class,
particularly if the color-coded
syringes are available outside
the OR.
(22)
(23)
An insulin mix-up occurred when
patient-labeled caps on insulin
pens were accidentally switched.
(21)
For a second quarter, varenicline
(CHANTIX) accounted for more
reported injuries than any other
drug. Ranked second in serious
injuries was heparin, the subject
of a major recall. Other drugs on
the top of the list include
fentaNYL, interferon beta,
January 29, 2009
Recommendation
—ISMP high-alert medication
Organization Assessment
Action Required/
Assignment
Date Completed
Color-coded syringes for anesthesia drugs may result in mix-ups
f your facility chooses to use these
prefilled syringes, limit their use to the OR
environment. Bar-coding systems would
prevent most mix-ups, but if you don’t
have this technology, work with
anesthesia staff to limit the variety of
drugs within a class. For example,
purchase prefilled syringes for one opiate
that is used most often, and require
anesthesia staff to prepare other opiates
and affix labels.
Use “flag” labels on insulin pens instead of labeling the caps
Do not place labels on the caps of insulin
pens. Although it’s difficult to label the
body of the pen, it can be done using a
“flag” or “tadpole labels,” which have a
very narrow strip or clear portion that
sticks to the container on one end, and a
wider unglued surface on the other end
for label information.
ISMP QuarterWatch report shows increase in adverse drug event (ADE) reports
Make consumers aware of the risk of accidents
associated with varenicline. Prescribers should
weigh the risks associated with varenicline
against the benefits, and consider alternative
treatments when appropriate. Review your
processes for recalled products to ensure that
staff notification and removal of all the product
occurs in a reliable fashion.
ISMP MedicationSafetyAlert!

QAA 1
October- December 2008
QuarterlyActionAgenda
Problem
No.
(20)
(21)
(22)
(25)
ISMP
Recommendation
Organization Assessment
Action Required/
Assignment
Date Completed
inFLIXimab, and etanercept.
ADACEL (diphtheria and tetanus toxoids, acellular pertussis vaccine) and DECAVAC (diphtheria and tetanus toxoids)
Prefilled syringes of Adacel and
If your facility stocks both Adacel and
Decavac are fairly easy to
Decavac syringes, affix an auxiliary label
differentiate when in their outer
to the inner packages that hold the
cartons. But once the syringes are
syringes to help differentiate the two
removed from the boxes, the only
products once removed from their outer
label available is a set of peel-off
cartons.
stickers that look almost identical.
The font size on the stickers is also
very small, and the black plunger of
the syringe makes the stickers
difficult to read.
Flumazenil mistaken as flu vaccine
A nurse couldn’t find a unit-dose
Have pharmacy dispense vaccines as
syringe of flu vaccine in the
they are ordered. When drug names
automated dispensing cabinet
appear sequentially on selection screens,
(ADC) because pharmacy had
consider whether warnings to alert users
removed the supply due to a
to possible errors would be helpful. While
recall. She thought flumazenil
it may be appropriate for the removal of
was also “flu” vaccine, so she
flumazenil from an ADC, the override
used the override feature to
feature should not be used for vaccines.
obtain a vial. A pharmacist on
Pharmacy should post a note about
the unit noticed the error after
products removed from stock due to a
the nurse asked if she should
recall.
return the rest of the “flu” vaccine
vial to the ADC.
Use of “IU” on label risks accidental IV administration of topical thrombin products
RECOTHROM, a newer topical
Information about topical thrombin—including
thrombin recombinant product,
dose, route, and safe storage (see the FDA
uses the abbreviation “IU” for
Patient Safety News video on the drug)—
international units on its label.
should be included in the competency
“IU” is an abbreviation that
validation of staff who work where this
should never be used because it product might be used. Make rounds to areas
has sometimes been misread as where this drug might be stored to see
IV. Extensive intravascular
firsthand how the drug is being used and to
clotting and death may result if
assure proper labeling. Have pharmacy
topical thrombin is injected
prepare and label the drug when possible.
intravascularly.
Zymogenetics plans to eliminate use of IU on
Recothrom product labeling.
January 29, 2009
ISMP MedicationSafetyAlert!

QAA 2
October- December 2008
QuarterlyActionAgenda
Problem
No.
(23)
ISMP
Recommendation
Organization Assessment
Action Required/
Assignment
Date Completed
Pint-size concentrated acetaminophen (PEDIAPHEN) may be confused with conventional strength acetaminophen
Pint-sized bottles of Pediaphen
Limited quantities and affordances (e.g.,
concentrate (80 mg/ 0.8 mL)
small dropper bottle, cusps around the
have been relabeled to reduce
bottle opening to prevent pouring the
confusion with conventional
medication into a cup) are important
children’s liquid acetaminophen
safety features because they cue
(160 mg/5 mL). The revised label practitioners that small volume dosing is
reduces the risk of mix-ups
required. If you decide the features of this
between the concentrate and
pint-sized container outweigh the safety
conventional strengths, but
risks, please take precautions (e.g., use
confusion is still possible, as
in pharmacy only) to prevent errors.
concentrated products often
come in smaller containers.
Labeling of antihemophilic factor (recombinant) does not make it clear that these products are factor VIII
(23)
The carton and vial labeling of
recombinant antihemophilic factor
(e.g., KOGENATE FS) does not
indicate that the product is factor
VIII, which is used to treat
hemophilia A. The products are
labeled correctly as antihemophilic
factor (recombinant), but this may
be too general, as factor IX is also
an antihemophilic factor, which is
used to treat hemophilia B.
(24)
The trimethoprim component in
Bactrim causes a potassiumsparing effect, much like the
potassium-sparing drug
amiloride.Trimethoprim blocks
sodium channels (particularly
amiloride-sensitive sodium
channels) in the distal tubule of
the nephron. This blockade
inhibits potassium secretion into
the urine, leading to reabsorption
January 29, 2009
Use auxiliary labeling to list “factor VIII”
on the product labels of antihemophilic
factor (recombinant) to reduce the risk of
an error. To encourage label changes,
we’ve communicated our concern to
Bayer and the FDA Center for Biologics
Evaluation and Research (CBER).
BACTRIM (sulfamethoxazole and trimethoprim) induced hyperkalemia
Prescribers, pharmacists, and nurses
need to be aware of this adverse effect of
Bactrim. Obtain a baseline
BUN/creatinine, adjust the dose if renal
impairment exists, and periodically
monitor potassium levels in patients at
risk for hyperkalemia and those taking
high doses of the medication. These
recommendations should also be
included as reminders in pharmacy
computer systems and electronic
ISMP MedicationSafetyAlert!

QAA 3
October- December 2008
QuarterlyActionAgenda
Problem
No.
in the blood and possible
hyperkalemia.
(22)
New staff, new graduates, and
others may believe they need to
“prove” themselves in order to
gain the trust and respect of their
coworkers. A patient received a
fatal overdose of sodium
bicarbonate because a new
pharmacist was too
embarrassed and insecure to
ask for help when compounding
the product.
(24)
In April, all lots of Digitek (a
branded generic digoxin product
manufactured by the Actavis
Group and dis-tributed by Mylan
Pharmaceuticals under the
Bertek and UDL Labs labels)
were recalled because the
tablets could have twice the
intended drug. Num-erous
deaths have been linked to the
recalled tablets.
(24)
A pharmacist almost dispensed
charcoal in sorbitol (Kerr InstaChar) instead of an aqueous
base. Kerr Insta-Char has a
straw and cherry-flavor ampul
attached to the bottle, which
makes it hard to see the label
clearly. The use of sorbitol, even
when administered as indicated
for only the first dose, is
controversial since it could lead
January 29, 2009
ISMP
Recommendation
Organization Assessment
Action Required/
Assignment
Date Completed
prescribing software.
New staff intimidation contributes to fatal error
The code of conduct in an organization
should promote an atmosphere where
questions are expected and rewarded,
regardless of staffs’ rank, experience, or
education. Other important steps to help
reduce intimidation in the workplace can be
found in the 2004 March 11 and March 25
issues of this newsletter
(http://www.ismp.org/Newsletters/%20acutec
are/archives.asp) and at
http://www.jointcommission.org/SentinelEve
nts/SentinelEventAlert/sea_40.htm.
Digitek Class I recall
Please check your inventory and remove
any Digitek tablets from storage. To
return the recalled product, call 888-2776166.
KERR INSTA-CHAR charcoal product in sorbitol needs auxiliary labeling
If you have these products in stock,
consider affixing an auxiliary label to
identify the presence or absence of
sorbitol. If the products are available in
automated dispensing cabinets, you also
might want to make a cautionary note
visible on the screen (e.g., contains
sorbitol, first dose only). We have
contacted the maker of Kerr Insta-Char to
ask them to enhance recognition of
sorbitol on the label.
ISMP MedicationSafetyAlert!

QAA 4
October- December 2008
QuarterlyActionAgenda
Problem
No.
ISMP
Recommendation
Organization Assessment
Action Required/
Assignment
Date Completed
to diarrhea, cramping, and fluid
and electrolyte loss—a particular
concern in children.
(24)
A hospitalized patient with a
history of alcohol abuse was
witnessed on two occasions
ingesting AVAGARD foam hand
antiseptic from a wall dispenser.
(25)
A nurse did not have her
patient’s next scheduled dose of
levetiracetam, so she notified the
pharmacy by electronically
initiating a reprint of the label.
The label printed in the “central”
pharmacy (not in the IV room),
where a technician misread it as
levofloxacin 750 mg IV. The
error was related to name
similarity of the two products and
overlapping dosages.
(21)
Sanofi-aventis distributed a letter
to pharmacists regarding the risk
of mix-ups between its Carac
cream and Altana’s Kuric cream.
The letter was sent after an error
caused by a verbal order for
Kuric that was misheard as
Carac. The involved patient
developed a rash and infection.
(25)
ConsumerMedSafety.org is the
first and only website exclusively
designed to bring the message of
adverse drug event prevention to
consumers
(www.ConsumerMedSafety.org).
January 29, 2009
Hand sanitizers may be ingested by patients with a history of alcohol abuse
When high-risk patients with a history of
alcohol abuse are hospitalized, consider
temporarily removing the alcohol-based
hand sanitizers from nearby wall
dispensers.
Levetiracetam and levofloxacin mix-up
Ensure that a label for any product that
requires compounding is printed in the IV
preparation area where it is made, not the
central pharmacy. Pharmacists should
also review the patient’s profile before
dispensing any missing doses to a patient
care unit. Ensure that labels generated by
nurses can be clearly identified as a
missing medication request.
Mix-ups between CARAC (fluorouracil) and KURIC (ketoconazole)
Prevent confusion by clarifying oral and
written orders, verifying the brand and
generic names, spelling the product name
when reading back oral orders, matching
the product’s indication to the patient’s
condition, and drawing attention to the
differences in the names of these
products.
ConsumerMedSafety.org: An ISMP website that alerts consumers to drug safety issues
Hospitals can link their websites to
ConsumerMed- Safety.org and
encourage their patients (and staff) to
take advantage of a unique system that
sends personalized safety alerts to
consumers based on the medications
ISMP MedicationSafetyAlert!

QAA 5
October- December 2008
ISMP
Problem
No.
This website provides patients with
a trusted Internet source from
which to learn about error
prevention, report their experiences
with errors and side effects, and
share their opinions about drug
effectiveness
(22)
As of November 5, 2008, ISMP is a
federally certified Patient Safety
Organization (PSO). Reporting
errors or safety information to a
PSO confers both privilege and
confidentiality so that the information
is protected and cannot be used
against an organization or its staff in
the event of a lawsuit.
January 29, 2009
QuarterlyActionAgenda
Recommendation
Organization Assessment
Action Required/
Assignment
Date Completed
they take at home.
ISMP gains PSO status
Practitioners should continue to report
medication errors to ISMP as they have in
the past. Safety/quality committees in
organizations can also work with ISMP to
analyze risk, adverse events, and aggregate
data to help improve safety. Information (not
medical records) provided to ISMP for the
purpose of improving safety is afforded the
full protection of a PSO.
ISMP MedicationSafetyAlert!

QAA 6