Hazard Alert! Medication errors with
certain lipid-based drug products
From the August 18,
1998 issue MSA Acute Care Edition Newsletter
Important: We urge the director of pharmacy to distribute this
safety message to all home health care organizations affiliated with your
facility! Serious accidents have taken place in home health care settings
as well as in hospitals.
We wish to call your attention to medication errors resulting from
confusion between certain lipid-based drug products and their
conventional counterparts. Serious medication errors, including deaths,
have occurred. Do not confuse lipid-based products with
conventional forms of the same drug!
Amphotericin B
Medication errors, including deaths, have resulted from confusion between
lipid-based forms of amphotericin (Abelcet., Amphotec., Ambisome.) and conventional amphotericin
B desoxycholate (available generically and as Fungizone.). Conventional amphotericin
B desoxycholate doses should not exceed 1.5
mg/kg/day. Doses of lipid-based products are higher but vary from product
to product.
Doxorubicin and daunorubicin
Accidental administration of the pegylated liposomal form of doxorubicin (Doxil.),
instead of the conventional form, doxorubicin hydrochloride, has resulted
in severe side effects and death. Doxil is
indicated for AIDS-related Kaposi’s sarcoma. Doxorubicin
hydrochloride (Adriamycin., Rubex.)
is used in leukemias and lymphomas, as well as
breast, ovarian, and other forms of cancer. The lipid-based formulation
dosing guidelines differ significantly from the non-lipid formulations
because the plasma clearance of the liposomal form is reduced compared to free doxorubicin. The standard dose of the liposomal product is 20 mg/m2 given at 21-day
intervals, compared to doses of 50 to 75 mg/m2 every 21 days for
conventional drug. A liposomal form of daunorubicin (DaunoXome., daunorubicin citrate liposomal)
is also available and has been confused with conventional daunorubicin hydrochloride (Cerubidine.).
Doses of liposomal daunorubicin are typically 40 mg/m2 repeated every two weeks
while doses of conventional daunorubicin hydrochloride vary greatly and may be administered more frequently.
The following measures should be considered in order to prevent
tragic errors with lipid-based formulations:
All staff involved in the medication use process must be made
aware of the differences between conventional and lipid-based
formulations of these drugs. In addition to in-house newsletters or other
communication mechanisms, education about medication errors, including
errors with these products, should take place at the time of new employee
orientation and during continuing education programs. We recommend that
this letter be posted in prominent locations. Staff education should also
include long term care and home care staff.
- In the pharmacy, conventional and lipid-based products should not
be stored together. Consider the use of cautionary labels or other
mechanism to remind staff about the differences between products.
- In order to preserve a redundant check system, these products are
best restricted to dispensing by a pharmacist after required preparation
and labeling is accomplished. Storage in patient care areas and automated
dispensing equipment is discouraged.
- Encourage staff to refer to the lipid-based products by their
brand names. Get this information into the medical
staff newsletter or use other available methods to communicate this to
medical staff.
- Stop and verify that the correct drug is being used if staff,
patients or family members notice a change in the solution’s
appearance from previous infusions. Lipid-based products may be seen as
“milky” rather than as a clear solution.
Note: A table listing these products can be found on our web site at
www.ismp.org. It will also be included in a national mailing.