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 before administration

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]