High-Alert
Medications: Safeguarding
Against Errors
(Part 2)
Learning Objectives
• Describe examples of specific safety
improvements to prevent errors with highalert medications
• Outline a framework to examine high-alert
drugs in your institution
This presentation describes the steps
for specific safety improvements for the
use of just two separate high-alert
medications. The Medication Errors
textbook has similar suggestions for
approximately 30 more high-alert drugs
and classes of drugs.
Instructors may assign students to
prepare similar strategies for safeguarding
the use of high-alert medications in their
respective institutions.
Step #1
• Identify potential or actual problems that
have occurred with use of the high-alert
drugs in your institution or system-wide
within your organization
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Review adverse drug reaction (ADR) reports
Review literature
Refer to examples in the textbook, chapter 14
Confer with a multidisciplinary group within
your organization
Step #1 (continued)
• Problems or errors may occur because of:
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Dosing errors
Calculation errors
Concentration errors
IV admixture errors
Duplicate or concurrent therapy
Step #1 (continued)
• Problems or errors may occur because of:
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Improper manufacturer labeling
Look-alike drug names and packages
ADRs
Injection of drug with preservatives
Contamination
Incompatibilities
Step #2
• Make the key improvements described in
the first part of the high-alert medications
section of this program, including the use of:
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Fail-safes
Constraints
Externalize error-prone processes
Improve access to information
Standardize
Step #2 (continued)
• Make the key improvements including the
use of:
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Simplification
Differentiation
Reminders
Redundancies
Patient monitoring
Failure mode and effects analysis
Unfractionated Intravenous
Heparin
• Known dosing errors include:
– Temporary increase in the pump rate to deliver
a bolus dose has caused errors because staff
have forgotten to reset the pump after delivery
of the bolus
– Abbreviating heparin units as “U” has led to
10-fold overdoses
– Pump setting errors involving either
concentration or rate of infusion have resulted
in dosing errors
Unfractionated Intravenous
Heparin
• Known calculation errors include:
– Math errors in determining the volume of
heparin to administer for a bolus dose, or the
rate of infusion of a maintenance heparin
solution
– Practitioners, particularly pharmacy staff, have
miscalculated the volume of heparin to be
added to TPN or other electrolyte solutions
Unfractionated Intravenous
Heparin
• Known concentration errors include:
– Various concentrations of IV heparin bags
and heparin vials have been mixed up, in
part because of look-alike vials and bags
– Mix-ups have occurred between heparin
1,000 units/500 mL bags used for
maintenance of adult arterial lines and
25,000 units/500 mL bags for IV use
Unfractionated Intravenous
Heparin
• Known IV admixture errors include:
– In settings where a standard concentration
of commercially available heparin is not in
use, nurses and pharmacists have made
errors when mixing heparin solutions
Unfractionated Intravenous
Heparin
• Known duplicate or concurrent therapy
errors include:
– Patients already receiving low-molecular
weight heparin who are inadvertently also
placed on continuous IV heparin
Unfractionated Intravenous
Heparin
• Known errors involving improper
manufacturer labeling include:
– Labeling of small-volume injectable
products may display the concentrations
(e.g., 10,000 units/mL) but not the total
volume (10 mL), which can lead
practitioners to believe the container holds
10,000 units, not 100,000 units
Unfractionated Intravenous
Heparin
• Known errors involving look-alike drug
names and packages include:
– Look-alike vials of heparin (flush solutions)
and insulin (both dosed in “units”) are often
found together on top of medication carts or
counters, resulting in occasional mix-ups
– Prefilled syringes or cartridges may resemble
other drugs
Unfractionated Intravenous
Heparin
• Known errors involving adverse drug
reactions include:
– Poor monitoring of potential thrombocytopenia
• Known errors involving injection of drug
with preservatives include:
– In newborns, administration of IV heparin that
is not preservative-free has caused benzyl
alcohol toxicity
Unfractionated Intravenous
Heparin
• Known errors with incompatibilities
include:
– Reteplase and heparin, which are
incompatible, have been used in combined
administration through the same IV line,
causing a precipitating mass that stopped an
infusion
Suggested Key Improvements for
the Use of IV Unfractionated Heparin
• Fail-safes
– Use only free-flow protected pumps to
administer heparin infusions
• Constraints
– Do not store heparin vials (flush solution) on
top of medication carts and counters
– Do not store heparin solutions for arterial lines
near other injectable solutions
Suggested Key Improvements for
the Use of IV Unfractionated Heparin
• Externalize error-prone processes
– Use commercially premixed solutions
• Improve access to information
– Have the pharmacy place a label on both
sides of the bag, taking care not to obscure
the manufacturer’s label
– Affix dosing charts (printed on labels) to
heparin infusion bags
– Use the patient’s actual weight in kilograms
(kg) as the basis for determining heparin
doses
Suggested Key Improvements for
the Use of IV Unfractionated Heparin
• Simplify
– Use weight-based heparin infusion charts or
nomograms to determine bolus doses and
infusion rates
– Do not deliver a bolus by temporarily
modifying the rate of a maintenance infusion;
administer the bolus directly from a syringe
connected to an IV access port
Suggested Key Improvements for
the Use of IV Unfractionated Heparin
• Differentiate
– Use unit-dose syringes for heparin flushes to
differentiate them from other injectable
products that are packaged in vials (e.g.,
insulin, normal saline) and to avoid potential
contamination of vials
– Separate the storage of heparin syringes from
look-alike syringes of other medications
Suggested Key Improvements for
the Use of IV Unfractionated Heparin
• Differentiate (continued)
– Separate heparin and insulin, which are both
measured in units and may have a similar
100 unit/mL concentration, adding to
potential for confusion
– Use TALL-man letters on auxiliary labels and
order entry screens to differentiate HeSpan
and hEParin
Suggested Key Improvements for
the Use of IV Unfractionated Heparin
• Reminders
– Affix to infusion bags a reminder to perform an
independent double check before starting the
infusion
– Build alerts into order entry systems to remind
pharmacists to dispense preservative-free
heparin to neonates
Suggested Key Improvements for
the Use of IV Unfractionated Heparin
• Redundancies
– Require an independent double check of the
drug, concentration, dose calculation, rate of
infusion, pump settings, line attachment, and
patient identity before the start of a heparin
infusion and with each change of the bag or
rate of infusion
– Have infusion pump settings independently
checked by two persons
Suggested Key Improvements for
the Use of IV Unfractionated Heparin
• Redundancies (continued)
– Have line placement on dual-channel pumps
independently checked by two persons
– Require an independent check of all
admixtures involving heparin in the pharmacy
(including the addition of heparin to TPN or
other electrolyte solutions)
Suggested Key Improvements for
the Use of IV Unfractionated Heparin
• Patient monitoring
– Develop and follow a standard format for
communicating to the pharmacy dose
adjustments based on laboratory values
– Develop and follow a standard process for
obtaining aPTT values at required intervals
and communicating the results to prescribers
Suggested Key Improvements for
the Use of IV Unfractionated Heparin
• Patient monitoring (continued)
– Establish and follow a protocol for detecting
heparin-induced thrombocytopenia, treating
patients who develop signs of this ADR, and
communicating this information
Suggested Key Improvements for
the Use of IV Unfractionated Heparin
• Failure mode and effects analysis
– Have an interdisciplinary team perform FMEA
for all forms of heparin therapy (including
flushes), and remedy risks that could harm
patients
– Evaluate the packaging and labels on all
heparin products to identify potential for
confusion and remedy problems by
repackaging or switching manufacturers to
improve distinction and clarity of labeling and
packaging
Opioids
• Known dosing errors include:
– Misprogramming of infusion pumps leading to
serious opioid overdoses
– Fentanyl patches have not been removed prior
to application of a new patch, leading to
overdoses; the clear backing of some patches
makes them difficult to see once applied to the
skin
Opioids
• More known dosing errors include:
– Fentanyl has sometimes been improperly
prescribed for episodes of acute pain, such as
postoperative pain or pain from dental surgery
– Poor patient education has led to multiple
patches being applied to the site of pain,
leading to serious overdoses and fatalities
Opioids
• More known dosing errors include:
– Physicians have prescribed fentanyl patches
in doses that were too high for opioid-naïve
patients, leading to overdoses and fatalities
– Opium tincture has been dispensed and
administered instead of paregoric
(camphorated tincture of opium), leading to
overdoses and fatalities
Opioids
• Redundancies bypassed
– Narcotic accidents are among the most
frequent of all serious incidents reported.
One reason for errors with these drugs is that
injectable narcotics are usually kept in
nursing areas as floor stock items. Doses are
identified, prepared, and administered by the
same nurse; no redundant safety checks are
performed.
Opioids
• Look-alike drug names
– Mix-ups between hydromorphone and
morphine are common; most often they are
related to the look-alike product names and
some practitioners’ misconception that
hydromorphone is the generic name for
morphine. Hydromorphone is approximately
five times more potent than morphine.
Opioids
• Look-alike drug names (continued)
– Opioids are often stored side by side in
secured cabinets or drawers. This has
contributed to selection of the wrong
medication, as have the look-alike syringes,
vials, and minibags of various opioids.
Opioids
• Miscommunication of drugs
– The abbreviations MSO4 (for morphine sulfate)
and MgSO4 (for magnesium sulfate) have
been confused, leading to administration of
morphine when magnesium was intended
– DTO (as an abbreviation for deodorized
tincture of opium) has been used to mean
diluted opium tincture (1:25) or paregoric,
leading to confusion about the actual dose and
to serious dosing errors
Opioids
• Concentration errors
– Concentrated forms of oral liquid morphine
(20 mg/mL) have often been confused with
the standard solution (2 mg/mL), leading to
serious errors and fatalities
– Pharmacists and nurses have selected the
5 mg/mL morphine concentration instead of
the 1 mg/mL concentration for patientcontrolled analgesia (PCA) use
Opioids
• Concentration errors (continued)
– Overdoses of oral liquid morphine have
resulted when physicians prescribe the drug
by volume rather than by metric weight and
nurses use the more concentrated form to
prepare the dose
– Extended-release and immediate-release
morphine products have been confused
Opioids
• Errors caused by “PCA by proxy”
– Delivery of opioid doses via PCA devices by
nurses or family members has led to serious
and fatal dosing errors
– Improper patient selection for PCA has led to
unsafe use in unresponsive adults, young
children, and neonates, who cannot activate
the pump themselves
Opioids
• Errors caused by accidental epidural
administration
– PCA and epidural lines are sometimes
confused, leading to errors in route of
administration
Opioids
• Errors with PCA infusion pump design
flaws
– Several manufacturers’ PCA pumps have
unsafe default settings; for example, one pump
defaults to a 0.1 mg/mL setting, which has
been misread as 1 mg/mL during programming
for a morphine infusion
Opioids
• Adverse drug reactions
– Allergic reactions to opioids are common
– Gastrointestinal complaints are common
– Meperidine use, especially in the elderly,
has led to toxic levels of its metabolite,
normeperidine, which, in turn, may induce
irritability and nervousness, agitation,
tremors, and even seizures
Opioids
• Inadequate pain control
– Some patients have not received adequate
pain control because they do not know how to
use the PCA device
• Patient monitoring problems
– Insufficient monitoring of patients receiving
opioids has resulted in respiratory arrest
Opioids
• Errors caused by unintended use
– Fentanyl patches prescribed for adults have
been applied by young children because of
unsecured storage or disposal (used patches
still contain significant amounts of the active
drug)
Suggested Key Improvements
for the Use of Opioids
• Constraints
– Limit oral liquid narcotics in floor stock to
conventional concentrations; avoid stocking
concentrated morphine solutions in patient
care areas
– Dispense concentrated oral morphine
solutions only when ordered for a specific
patient (not as unit stock)
Suggested Key Improvements
for the Use of Opioids
• Constraints (continued)
– Separate morphine and hydromorphone in all
drug storage areas
– Avoid the use of meperidine for pain control,
especially in the elderly
– Consider deleting paregoric and opium
tincture from all formularies
Suggested Key Improvements
for the Use of Opioids
• Constraints (continued)
– Return unused supplies of concentrated liquid
morphine to the pharmacy immediately after
patient discharge
– Instruct patients who use fentanyl patches to
store and dispose of the patches in a secure
manner to avoid unintended access by
children, pets, or drug-seeking adults
Suggested Key Improvements
for the Use of Opioids
• Improve access to information
– Educate staff about the possibility of mix-ups
between hydromorphone and concentrated
morphine
– Post equianalgesic charts for opioid-to-opioid
conversions on all patient care areas for
reference by prescribers and nurses
Suggested Key Improvements
for the Use of Opioids
• Improve access to information (continued)
– Include the brand name “Dilaudid” along with
the generic name hydromorphone when
prescribing, transcribing, and dispensing (on
labels) this drug
– Educate patients and caregivers about the
proper use of PCA
Suggested Key Improvements
for the Use of Opioids
• Improve access to information (continued)
– Before applying a fentanyl patch to a newly
admitted patient, ask about patches that may
have been applied at home; if the patient is
unable to respond, thoroughly inspect the skin
before applying the patch
– Establish dose ranges for opioids by weight,
and build alerts into the order entry system for
exceeding maximum doses
Suggested Key Improvements
for the Use of Opioids
• Standardize
– Establish one standard concentration for each
opioid in use
– Use only generic names, except for
hydromorphone, which can be more easily
distinguished by using the brand name,
Dilaudid, followed by the generic name
– Reduce the variety of available opioids
through the use of protocols and standard
order sets
Suggested Key Improvements
for the Use of Opioids
• Standardize (continued)
– Establish protocols and preprinted orders for
PCA
– In establishing patient selection criteria for
PCA, consider this safety feature: a sedated
patient will not press the PCA button
– Standardize to a single drug, morphine, as the
opioid of choice for PCA
Suggested Key Improvements
for the Use of Opioids
• Differentiate
– Stock morphine and hydromorphone in
different strengths or forms (e.g., 1 mL
prefilled syringes of hydromorphone 1 mg/mL;
2 mL prefilled syringes of morphine 2 mg/mL
– Use TALL-man lettering, HYDROmorphone,
on pharmacy labels, auxiliary labels,
medication administration records, and drug
listings in the computer
Suggested Key Improvements
for the Use of Opioids
• Differentiate (continued)
– Affix an auxiliary label to concentrated
solutions to avoid confusion with standard
concentrations
– Apply auxiliary labels to prefilled syringes of
opioids that look similar to help people
differentiate them
Suggested Key Improvements
for the Use of Opioids
• Reminders
– Label the distal ends of all access lines to
distinguish IV from epidural lines
– Apply auxiliary labels to concentrated forms
of morphine or other opioids, noting that the
drugs are highly concentrated
Suggested Key Improvements
for the Use of Opioids
• Reminders (continued)
– If concentrated morphine is available on
patient units, affix an auxiliary label to the
bottle and segregate the concentrated solution
from the other strengths
– Build alerts into the computer system to warn
staff about the differences between paregoric
and opium tincture
Suggested Key Improvements
for the Use of Opioids
• Redundancies
– Implement protocols for the use of PCA and
other opioids that ensure independent double
checks of the appropriateness of the drug,
dose, pump setting, and line placement
– Question all patients about allergies and
sensitivities to opioids before administration
Suggested Key Improvements
for the Use of Opioids
• Patient monitoring
– Ensure that oxygen and naloxone are
available in areas where narcotics are
administered
– Establish guidelines for appropriate monitoring
of patients receiving opioids
– Do not rely on just pulse oximetry readings to
detect opioid toxicity
Suggested Key Improvements
for the Use of Opioids
• Failure mode and effects analysis
– Conduct FMEA for PCA to uncover risks and
take action to reduce the chance of harmful
errors
Reference
Cohen MR, Smetzer JL, Tuohy NR, Kilo CM.
High-alert medications: safeguarding against
errors. In: Cohen MR, ed. Medication Errors.
2nd ed. Washington, DC: American Pharmacists
Association; 2007.