New strategies required to prevent
esmolol related accidental deaths
From the September 25,1996 Issue
PROBLEM: In 1995, after a series of accidental deaths resulting
from the misuse of BreviblocÒ (esmolol) ampuls by hospital
personnel, the drug's manufacturer, Ohmeda Pharmaceuticals,
notified pharmacists of packaging changes designed to minimize
confusion. Fatalities were reported when the concentrated
form of the drug, packaged in 2.5 g ampuls and meant for dilution,
had been given as a direct IV push injection instead of the
100 mg, 10 mL vial which is supposed to be used for the loading
dose. New packaging includes a "black box" warning
on the ampul and storage carton as well as a bright red flag
on the ampul bulb. Both warn that the product must be diluted
Unfortunately, two new esmolol related accidents indicate
that other strategies are required to prevent further deaths.
Last month, an OR nurse used one of the newly packaged ampuls
instead of the vial to prepare a loading dose. The patient
arrested, was resuscitated, but suffered permanent CNS impairment.
In a second case, an intern working in an ICU decided to use
esmolol for a patient with tachycardia (SVT). He prescribed
a loading dose of 500 mcg/kg but did not calculate the dose.
The dose was then miscalculated by other ICU personnel. An
ampul was used to prepare a syringe, and the contents were
injected directly. The patient later died. Again, this involved
the new packaging with warnings and an auxiliary label affixed.
Therefore, the new packaging is not an adequate deterrent,
and it appears that errors will continue despite the company's
attempts to clarify the labeling.
SAFE PRACTICE RECOMMENDATION: In order to reduce error potential,
wherever possible, esmolol ampuls should not be available
in patient care areas. Ampuls should remain in the pharmacy
for use only in preparing infusions. The only way the problem
will be overcome entirely is to remove the ampul dosage form
from the market and replace it with a premixed drug. While
the company is considering such a move, it is unknown how
long it will be before such a product is marketed. Stability
problems prevent pharmacists from preparing doses themselves
for distribution to patient care areas far in advance of their
need. [D, N (ICU, ER, OR), P]