April - June 2013
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 April-June 2013 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’s 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/Action
Agenda1303.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:
No.
Problem
(11)
An opioid-naïve surgical patient was
started on morphine patient-controlled
analgesia (PCA) with a 3 mg demand
dose, 10 minute lockout, and a basal rate
of 1 mg/hour. During the first night, the
patient was found in respiratory distress
and died. Gaps in patient monitoring,
including a failure to employ pulse
oximetry despite the presence of the
equipment in the patient’s room, were the
predominant factors, as was the failure to
recognize progressive signs of impending
respiratory depression.
(7)
—ISMP high-alert medication
Organization
Assessment
Fatal PCA adverse events linked to inadequate monitoring
Recommendation
Action Required/
Assignment
Date
Completed
Along with a basic physical assessment
and vital signs, other parameters are
vitally important when monitoring patients
receiving PCA. The patient’s level of pain
and sedation must be continually
assessed; early recognition of excessive
sedation and intervention is essential.
Respiratory assessments should include
evaluation of the rate, depth, quality of
respiratory effort, pattern of respirations,
and breath sounds. Technology to
continuously monitor ventilation in
patients known to be at risk for respiratory
depression is recommended.
High-alert medication list useless without bundled risk-reduction strategies
Some hospitals have neither a wellPeriodically update your hospital-specific
reasoned list of high-alert medications nor a list of high-alert medications, and
robust process for managing the drugs on
implement risk-reduction strategies that
their list. The list may not be well known to
address the underlying causes of errors,
clinicians, and hospitals may rely on low
which have been identified through a
leverage risk-reduction strategies to prevent literature search, information from ISMP,
errors. A list of high-alert medications is
analysis of internal reports, and failure
relatively useless unless it is up-to-date,
mode and effects analysis (FMEA). Layer
known by all clinical staff, and accompanied numerous risk-reduction strategies (see
by vigorous risk-reduction strategies which
Table in full article) that impact as many
are more effective than awareness, manual steps of the medication process as
double checks, and staff education.
feasible. Assess the effectiveness of
strategies.
NAN Alert: Mix-ups between ado-trastuzumab emtansine (KADCYLA) and trastuzumab (HERCEPTIN)
July 11, 2013
ISMP MedicationSafetyAlert!

QAA 1
April – June 2013
ISMP
Problem
No.
(8)
The US Food and Drug Administration
(FDA)-approved generic name for
Kadcyla, ado-trastuzumab emtansine,
may not be fully communicated when
prescribed or may be read incompletely,
thus risking confusion with trastuzumab.
Given that the dosing and treatment
schedules for these drugs are quite
different, confusion could lead to dosing
errors and potential harm to the patient.
(12)
As of May 2013, heparin labels must
express the total amount of units in the
container and the units per mL in
parentheses, rather than just the units
per mL. Before the change, the per mL
quantity had been misinterpreted as the
total amount per container, which led to
overdoses and some fatalities. Errors are
still possible during transition in which
vials with the old and new label are both
available, particularly as staff get used to
the new label and then encounter a vial
with the old label.
(7)
QuarterlyActionAgenda
Organization
Assessment
Recommendation
Action Required/
Assignment
Date
Completed
Ensure that you are using the prefix “ado”
with “trastuzumab” when referring to
Kadcyla. Use both the brand and generic
name when communicating orders on
preprinted order sets or in computerized
order entry systems for either of these
drugs. Employ strategies to differentiate
Kadcyla and Herceptin generic names
and increase awareness of this issue.
NAN Alert: Heparin label changes
To minimize the risk of confusion,
hospitals should consider transitioning
fully to the newly labeled heparin, even if
it means discarding some older vials.
Otherwise, separate heparin vials with
the old labeling from those with the new
labeling, and use all vials with the old
labeling first. As space permits,
pharmacy and nursing databases should
express drug amounts the same way as
the vial label (i.e., 10,000 units/10 mL
[1,000 units/mL]).
Assessment shows widespread lack of knowledge regarding safe use of opioids
A Pennsylvania Patient Safety Authority
Based on the results of the opioid
knowledge assessment of prescribers,
knowledge assessment, organizations
pharmacists, and nurses found that 78%
should use a similar tool
did not know a patient’s level of sedation
(www.ismp.org/sc?id=205) to assess the
was the most important predictor of
understanding of prescribers,
respiratory depression while receiving IV
pharmacists, and nurses who care for
opioids; 33% were unaware that 0.4 mg
patients receiving opioids and provide
of HYDROmorphone IV is equianalgesic
staff education based on the findings
to 2 mg of morphine IV. Other lowalong with other safeguards ISMP has
scoring questions dealt with drugs that
published (www.ismp.org/sc?id=210).
potentiate opioid effects, the definition of
an opioid-tolerant patient, and indications
for using long-acting opioids.
July 11, 2013
ISMP MedicationSafetyAlert!

QAA 2
April – June 2013
ISMP
Problem
No.
(8)
(13)
(10)
(11)
More than 1,100 patients may have
received lower doses of
cyclophosphamide and gemcitabine than
prescribed. The amount of overfill in the
containers was not clear, and nurses
failed to infuse the entire volume in each
bag (including overfill), resulting in
administration of lower doses than
intended.
QuarterlyActionAgenda
Organization
Assessment
Confusion regarding overfill with IV chemotherapy
Recommendation
Action Required/
Assignment
Date
Completed
Establish a standard process to identify
the overfill volume on the pharmacy label
for compounded IV
chemotherapy/biotherapy solutions.
Ensure that nurses who administer these
products can locate the final volume on
the label, and can recognize that the full
volume must be infused to administer the
correct dose (unless otherwise stated).
Mix-ups between leucovorin and LEVOleucovorin
Two errors occurred at a hospital
Separate the drugs wherever they are
involving mix-ups between leucovorin
stored. If using automated dispensing
and LEVOleucovorin (FUSILEV) due to
cabinets (ADCs), consider using tall man
name similarity. There is significant
lettering for LEVOleucovorin in ADC
potential for dosing errors when
software listings. Pop-up messages
interchanging leucovorin and
should also be considered, as they may
LEVOleucovorin. The dose of
be useful to educate, alert, and remind
LEVOleucovorin is one-half the dose of
staff of a possible mix-up.
racemic leucovorin injection (leucovorin).
Name confusion with new cancer drugs PAZOPanib (VOTRIENT) and PONATinib (ICLUSIG)
Two new oral chemotherapy agents have Computer systems that list oral
names that may cause confusion:
chemotherapy linked to available dosage
pazopanib and ponatinib. Tablet
strengths will help to minimize the
strengths and dosages are different,
potential for error, as will listing
which may help prevent and detect
appropriate dosing information for
errors.
labeled indications. The use of tall man
lettering with the unique letter characters
differentiated (PONATinib and
PAZOPanib) can also be helpful.
The drug niMODipine is often given via a
nasogastric tube. Unless pharmacy
prepares the liquid and dispenses it in an
oral syringe, nurses have to extract the
product from the gel capsule with a
syringe and needle. On at least 25
occasions, the liquid extracted from a
July 11, 2013
IV administration of oral liquid niMODipine
If pharmacy does not extemporaneously
prepare a liquid formulation of
niMODipine from capsules and dispense
the drug in oral syringes, the hospital
should use a new commercial product for
adults, NYMALIZE (niMODipine) oral
solution (www.ismp.org/sc?id=191). This
ISMP MedicationSafetyAlert!

QAA 3
April – June 2013
ISMP
Problem
No.
QuarterlyActionAgenda
Organization
Assessment
Recommendation
capsule was accidentally injected IV,
resulting in 5 deaths and 5 near-death
events.
product is indicated for improvement of
neurological outcomes in adults with
subarachnoid hemorrhage.
(12)
The value of a manual independent
double check has been questioned by
those who rarely find mistakes. Its use
has been a source of stress for busy
staff. Its overuse with high-alert drugs
has been called to task given its status
as a weak risk-reduction strategy,
particularly if it’s the only safeguard in
place. Its inconsistent use, variability with
how it’s carried out, and the superficial
manner in which many checks are
conducted has rendered it less effective
than anticipated. However, studies have
shown that independent double checks
can detect up to 95% of errors if done
correctly.
Independent double checks are undervalued and misused
Evaluate the procedures for which you
require a double check, monitor
compliance, assess how often the
checks are conducted as designed, and
then make the necessary revisions to
promote effectiveness. Manual double
checks are most effective when
conducted independently in a cognitive
manner, and when used judiciously for
selective high-risk tasks or high-alert
medications. Avoid sole reliance on
double checks as a safety strategy.
Fewer double checks strategically placed
at the most vulnerable points of the
medication use process will be much
more effective.
(7)
Three patients received nalbuphine
instead of naloxone. One event involved
the accidental selection of nalbuphine,
which appeared immediately before
naloxone on an automated dispensing
cabinet (ADC) screen; another involved
an ADC stocking error. The third error
involved selection of the wrong product
from an anesthesia tray.
(9)
British and Spanish authorities have
analyzed 52 overdoses of IV
acetaminophen in children younger than
1 year. Recently in the US,
July 11, 2013
Action Required/
Assignment
Date
Completed
Mix-ups between nalBUPHine and nalOXone
Tall man lettering on ADC screens and
pharmacy labels may help avoid mix-ups,
as well as adding the words “rescue
agent” next to nalOXone entries, if space
permits. Locked lidded drawers for
nalBUPHine and nalOXone could also
prevent inadvertent selection of the
wrong drug.
10-fold overdoses of IV acetaminophen
When prescribing the drug, include the
mg per kg weight-based dose along with
the total calculated dose. For the product
label and medication administration
ISMP MedicationSafetyAlert!

QAA 4
April – June 2013
ISMP
Problem
No.
(10)
(12)
(7)
QuarterlyActionAgenda
Organization
Assessment
Recommendation
Action Required/
Assignment
Date
Completed
acetaminophen IV 250 mg was
record, include both the mg dose and
prescribed for a 25 kg child. A mental slip volume to be infused. Pharmacists
led the clinician to program an infusion
should prepare pediatric doses of 600
pump to deliver 250 mL (2,500 mg)
mg or less in a syringe, and nurses
instead of 250 mg (25 mL). Children and
should administer the drug via a “smart”
low-weight adults are at greatest risk of
syringe pump with dose limits active in
overdoses because they need less than
the drug library. For adult infusions,
a full 100 mL (1 g) bottle, thus requiring a smart pump use is also advised.
calculation to determine the volume to
infuse.
Saline flush administered via ON-Q C-bloc during attempt to collect blood from central venous access device (CVAD)
A laboratory technician who was
Limit access to CVAD lines to those with
attempting to collect blood from what she
professional training. Promote a
thought was a CVAD instead
consistent process for tracing all
administered a saline flush via a yellowcatheters/lines from the access site to an
striped extension tubing connected to an
infusion or capped access port before
ON-Q C-bloc continuous peripheral nerve
drawing blood, connecting tubing, or
block infusion. The ON-Q system catheter administering drugs or solutions. Affix
was anchored to the front of the patient’s
labels on lines if the patient has more
shoulder, and the upper part of the gown
than one port of entry into the body.
obscured the ON-Q system. A blue
connector was visible and thought to be
attached to the CVAD.
Starter doses from the emergency department (ED) may not be dispensed in child-resistant containers
EDs and physician practices often send
Organizations that dispense drug samples
patients home with drug samples or
or starter doses should evaluate their
starter doses in unit dose packages.
practices and modify their procedures as
These packages may not be child
needed to ensure the safety of patients
resistant. If dispensed in plastic bags or
and children in their homes. With the
envelopes, the medications may be easily increased number of 24-hour community
accessed by children, especially if set
pharmacies, these services may not be
down on a counter upon arriving home
necessary.
from the ED.
Mix-ups between risperiDONE and rOPINIRole
Last year, ISMP and FDA received more
When prescribing either drug, the purpose
than 200 reports of mix-ups between
of the drug should be included with the
risperiDONE and rOPINIRole, and these
order, and pharmacists and nurses should
events have continued. In one of the
verify that the therapy matches the
latest cases, a patient experienced
patient’s condition. In pharmacies, the
nausea and an unexpected sedative
products should not be stored near each
July 11, 2013
ISMP MedicationSafetyAlert!

QAA 5
April – June 2013
ISMP
Problem
No.
effect after taking what was thought to be
risperiDONE. Both products were from the
same manufacturer and in the same
shaped bottle with similar label printing.
July 11, 2013
QuarterlyActionAgenda
Organization
Assessment
Recommendation
Action Required/
Assignment
Date
Completed
other, and tall man lettering should be
used for storage, labeling, and computer
listings.
ISMP MedicationSafetyAlert!

QAA 6