Patient safety alert: Esmolol hydrochloride labeling

Confusion and unintentional product interchange between the concentrated and the ready-to-administer formulations of esmolol hydrochloride result in serious injury, including death.

DESCRIPTION OF THE PROBLEM:
Confusion between two significantly different concentrations of the short-acting beta-blocking agent esmolol hydrochloride (Brevibloc^®) has resulted in serious and fatal outcomes. Two concentrations of esmolol hydrochloride are available in 10-mL containers. The more concentrated form, intended to be diluted for intravenous infusion, is packaged in 10-mL ampuls containing 2,500 mg. The less concentrated "ready-to-use" form, intended for direct bolus injection, is packaged in 10-mL vials, containing 100 mg. The more concentrated strength has inadvertently been administered as a loading dose. Despite boxed warnings on the label and packaging of the concentrated ampul, errors continue to occur.

SCOPE and SEVERITY:

NCC Medication Error Index		Number of Cases
Category I:	An error occurred that resulted in patient death	10
Category H:	An error occurred that resulted in a near-death event (e.g., anaphylaxis, cardiac arrest)	15
Category G:	An error occurred that resulted in permanent patient harm	2
Category E:	An error occurred that resulted in the need for treatment or intervention and caused temporary patient harm	3
Category B:	An error occurred but the medication did not reach the patient	1

* 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:

Remove the concentrate (ampul) from patient care areas.
Require the pharmacy to prepare IV infusions of esmolol hydrochloride.
Work with the manufacturer to promote packaging and labeling changes to reduce the risk of error.
Continue to report errors associated with confusion between the concentrated and the ready-to-administer esmolol hydrochloride products so that accurate frequency and severity of these errors can be assessed.

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.