
ISMP Action Agenda: July - September,
1998
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From the January 27, 1998 issue
One of the most important methods for preventing adverse
drug events is for organizations to seek and use knowledge
from other organizations that have already experienced problems.
Since ISMP believes that it will make a significant impact
on error prevention efforts, we ask that an interdisciplinary
committee at each practice site review the following agenda
to prompt discussion, and then take the necessary action to
prevent these adverse drug events. Please be sure to share
this agenda with administration. The American Society of Healthcare
Risk Management (ASHRM) will also be enclosing this agenda
with their bimonthly newsletter which is sent to all members.
The following selected items appeared in the ISMP Medication Safety Alert! between July and September, 1998. Each item
is followed by a description of the problem and our recommendations
to promote safe medication practices. The issue number is
also included in parenthesis next to each item.
I. Look-alike/sound-alike drug names, ambiguous or look-alike
labeling and packaging
- Lipid-based amphotericin B products, lipid-based doxorubicin,
and daunorubicin hydrochloride (15, 16, 17, 19; Special
Alert, Aug. 19 )
Problem: with dosing recommendations vastly different,
additional dangerous overdoses have been reported when staff
confuse lipid-based products with their conventional counterparts.
Amphotec, sometimes referred to in texts and drug databases
as amphotericin B colloidal
dispersion, may be confused with conventional amphotericin
B, also thought of as a colloidal dispersion
since it forms a colloidal suspension after
reconstitution
Recommendation: educate staff when introducing lipid-based
products; avoid storing these products next to each other;
use warning labels and add computer warnings; use brand
names only when prescribing lipid-based products; dispense
from pharmacy and restrict nursing access to
pharmacy after hours; assure proper nomenclature is used
in computer systems
- KETALAR (ketamine) and CEREBYX
(fosphenytoin) labeling (17)
Problem: additional reports received about errors
caused by confusing labeling (total volume and concentration
are listed in different locations) and bypassing the pharmacy
dispensing system
Recommendation: whenever possible, avoid using these
drugs until the labeling problem is remedied; store the
drugs in the pharmacy only; if the drug must remain as floor
stock, provide vials with the smallest amount of drug possible;
add auxiliary labels that list total vial contents
- OXYCONTIN (oxycodone HCl controlled-release)
and oxycodone HCl immediate release tablets (17)
Problem: mix-ups occur when staff confuse the
brand name, OxyContin, with oxycodone, or the prescriber
uses the generic name to order the controlled release formulation
without specifying controlled release
Recommendation: do not store immediate release and
controlled release products together; if possible, have
the pharmacy dispense oral oxycodone products for individual
patients; use brand names when prescribing these drugs;
educate staff about the potential for confusion
- INTEGRILIN (eptifibatide) (19)
Problem: with the vial labeled 20 mg/10 mL
bolus vial, staff may believe that an entire vial
is a single bolus dose; with the 2 mg/mL concentration prominently
listed in an enclosed border, but separated from the total
vial contents, staff may misunderstand the strength as the
total vial contents; dosing requires calculation from mcg/kg
to mg/kg
Recommendation: store the product only in the pharmacy
and have them prepare stat loading doses; develop
and post dosing charts to avoid calculations; use the term
loading dose, not bolus dose when
prescribing the drug
II. Dosing errors
- Use of dosage equations (14)
Problem: medication errors occur frequently when
physicians use dosage equations, especially when calculating
pediatric drug orders (Lesar TS. Errors in the use of medication
dosage regimens. Arch Ped Adol Med; 1998;152:340-4)
Recommendation: use pre-established dose ranges or
tables, computer order entry which calculates doses, or
require both the calculated dose and dosage equation on
orders to facilitate independent double checks
- Excessive dosing of nortriptyline (17)
Problem: with dosing recommendations for treatment
of neuropathic pain syndrome significantly different from
conventional antidepressant dosing, two patients receiving
nortriptyline for neuropathic pain received excessive doses
Recommendation: include the drugs indication
with prescriptions; program maximum dose warnings into the
computer for each indication; educate staff about dosing
for neuropathic pain syndrome; teach patients the names,
doses and purposes of all their medications
- Lack of unit dose system in NICU (18)
Problem: an infant died after receiving 7.4 mL (185
mg) of aminophylline instead of 7.4 mg when the drug was
removed from floor stock, prepared, and given without being
independently double checked
Recommendation: examine medication practices in your
NICU units and require pharmacy to dispense medications
(to NICU and all other units) in the most ready-to-use form
possible
III. Ambiguity or errors in drug references or advertisements
- Handbook on Injectable Medications, 8th Ed .( 16)
Problem: another patient died from improper dilution
of albumin when staff relied on an outdated text that implies
safe use of sterile water as a diluent regardless of volume
Recommendation: discard outdated editions of this
text and purchase the 10th edition; educate staff to use
sodium chloride 0.9% or 5% dextrose in water to dilute albumin
regardless of volume; prepare guidelines for albumin dilution
IV. Miscellaneous
- Ineffective patient education (16)
Problem: after a physician demonstrated use of an
inhaler by releasing two puffs into the air, the patient
used his inhaler by releasing puffs into the air (while
sitting in his car to minimize space) and breathing deeply
Recommendation: be clear and complete when providing
instructions for medication use; provide thorough instructions
and always include the obvious; ask patient to repeat instructions
- IV medications administered intrathecally (19)
Problem: one patient died after intrathecal injection
of vincristine, instead of cytarabine; another patient developed
hemiparesis and currently requires mechanical ventilation
after intrathecal injection of rifampin, along with vancomycin
Recommendation: separate the location and delivery
times for intrathecal medications so that IV drugs are never
present with intrathecal medications; have two practitioners
independently verify the accuracy of intrathecal medications
before administration; apply warnings FATAL if given
intrathecally. FOR IV USE ONLY on all vinca alkaloid
products
V. Adverse drug reactions, side effects and product impurities
- VISTIDE (cidofovir injection) (17)
Problem: cases of acute renal failure resulting in
dialysis and/or contributing to death were reported after
as few as one or two doses of the drug
Recommendation: Gilead Sciences has distributed
a letter to reinforce the importance of adhering to specific
treatment guidelines when prescribing and administering
the drug
- Albumin or plasma protein fraction (PPF) use with seriously
ill patients (research cited in British Medical Journal)
(15)
Problem: recent research revealed excess mortality
in patients with hypovolemia, burns or hypoproteinemia who
received albumin instead of or in addition to crystalloid
solutions
Recommendations: FDA urges physicians to exercise discretion
using albumin/PPF; consider development of treatment guidelines
for use of albumin, nonprotein colloid and crystalloid solutions
- Impurities in some 5-hydroxy-L-tryptophan (5-HTP) products
(18)
Problem: FDA has confirmed the presence of impurities,
including peak X, in some 5-HTP products; peak
X has been associated with past epidemics of eosinophilia-myalgia
syndrome (EMS)
Recommendation: although the significance of finding
peak X in these products is unknown, past experience
suggests vigilance is warranted
- Use of high dose epinephrine during cardiopulmonary
resuscitation (CPR) (research cited in Annals of Internal
Medicine) (19)
Problem: a study noted that, while restoration
of circulation is possible, patients revived with high-dose
epinephrine (>6 mg) often left the hospital with severe
neurological impairment
Recommendation: emergency care providers should be
wary of using repeated doses of epinephrine that result
in excessively high doses
VI. For discussion
- Benchmarking medication error rates - when is it dangerous?
(18)
Problem: benchmarking error rates is effective only
if a system of objective measurement, more reliable than
spontaneous error reporting, is used to identify best practices,
and if it is combined with a system to determine the processes
that enable safe medication use
Recommendation: encourage error reporting to identify
and remedy problems, not to provide statistics for comparison
- Florida State Board of Pharmacy the first to require
continuous quality improvement (CQI) (14)
A non-punitive approach to errors is promoted by requiring
a multidisciplinary committee to meet bimonthly to discuss
errors and suggest system improvements while considering,
at a minimum, the effects of staffing levels, work flow
and technological support
- Herbal medicines (17, 19)
Problem: herbal products are not free of risks; no
standards exist for manufacturing, labeling or pre-marketing
approval to demonstrate safety and efficacy; there is limited
human research or practitioner reporting about adverse drug
events
Recommendation: learn about herbal products and keep
reliable references on hand; ask patients about their use
of alternative therapies and monitor them carefully for
unusual/adverse events; report adverse events (see list
of reporting mechanisms in newsletter)
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