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Information For:
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Patient safety alert: Lipid-based products
Confusion and unintentional product interchange between lipid-based and
conventional drug formulation results in serious injury, including death.
DESCRIPTION OF THE PROBLEM:
Confusion between the conventional formulation and the lipid-based formulation
of three drug products has been reported to cause significant errors ranging
from mild injury to fatality. Conventional aqueous products have dosages
that are significantly different from their lipid-based counterparts. The
magnitude of the dose conversion between conventional and lipid-based products
is not consistent. Specifically, some lipid-based products may have a higher
milligram dose than the conventional counterpart (e.g., amphotericin B),
while other lipid-based products may have a lower milligram dose than the
conventional counterpart (e.g., doxorubicin). Several lipid-based formulations
may exist for the same conventional product, doses of which may or may not
be similar.
SCOPE and SEVERITY:
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NCC Medication Error Index
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Number of Cases and Medication Involved
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Category I:
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An error occurred that resulted in patient death
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4
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Amphotericin B (2 cases) Doxorubicin (2 cases)
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Category G:
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An error occurred that resulted in permanent patient harm
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1
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Amphotericin B
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Category F:
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An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm
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1
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Amphotericin B
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Category C:
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An error occurred that reached the patient but did not cause patient harm
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12
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Amphotericin B (4 cases)
Daunorubicin (1 case)
Doxorubicin (7 cases)
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Category B:
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An error occurred but the medication did not reach the patient
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1
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Amphotericin B
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Category A:
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Circumstances or events that have the capacity to cause error
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3
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Amphotericin B (2 cases)
Doxorubicin (1 case)
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* National Reporting programs used as
a source for this data are the USP-ISMP Medication Errors Reporting
program, the FDA MedWatch Program, and the JCAHO Sentinel Event Reporting
Program.
SUGGESTED ACTIONS:
Health care professionals and health care organizations should consider the
following:
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Educate staff about differences between conventional and lipid-based
formulations, including physical appearance, dosages, and administration
schedules.
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Store lipid-based formulations separately from conventional formulations.
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Use cautionary auxiliary labels to distinguish products.
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Prepare and dispense products from pharmacy only - do not stock on floor
or in automated dispensing cabinets.
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Develop a dispensing checklist or criteria that must be met before dispensing
products available in lipid-based and conventional form.
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Routinely specify and refer to lipid-based products by brand
names1.
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Continue to report errors associated with the confusion between drugs with
lipid-based and conventional formulations so that accurate frequency and
severity of these errors can be assessed.
1This suggested action recognizes that many health
care facilities insist generic names be used for drug orders. Using generic
name and specifying "lipid-based" will not, however, specifically differentiate
between products when several "lipid-based" formulations are available for
a single generic item.
Posted: 07/1999
This information provides notification of situations in which
errors may occur. The identification of particular products or brands should
not be interpreted as an adverse reflection of the product or manufacturer.
The suggestions to avoid medication errors are general and should be properly
evaluated before implementation to determine whether they are appropriate
for use in particular work environment.
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