Magazine article Drug Topics

Fatal Medication Errors with Heparin

Magazine article Drug Topics

Fatal Medication Errors with Heparin

Article excerpt

The risk for fatal medication errors is highlighted as an important new warning within a revised product label for Heparin Sodium Injection (Baxter Healthcare Corp.) that was approved by the Food & Drug Administration on December 14, 2007. The new WARNINGS section states that fatal hemorrhages have occurred in pediatric patients following medication errors in which vials containing a highly concentrated heparin solution (10,000 units in 1 mL) were confused with 1-mL "catheter lock flush" (10 units in 1 mL) vials because of their visual similarity to one another (i.e., same size, shape, and similar color blue label).

Changes to the label

The new FDA-approved labeling also includes revised container labels for the highly concentrated solutions of Heparin Sodium Injection in 1-mL vials. Now, a tear-off label extends above the main label and must be removed in order to remove the flip-off cap. Additionally, the 1-mL vial labels are differentiated by new colors (1,000 units/mL are purple, 5,000 units/mL are orange, and 10,000 units/mL are brown). These changes pertain only to these strengths of heparin contained within 1-mL vials. The labels for the 1-mL vials of heparin "catheter lock flush" have not changed.

Not all 1-mL vials of Heparin Sodium Injection contain the newly approved vial labels. Healthcare facilities may have a considerable supply of 1-mL vials with the older labels on inventory. Baxter Healthcare is currently distributing Heparin Sodium Injection 1-mL vials with the new labels and other manufacturers of heparin are anticipated to make the changes within the near future.

The highly concentrated solutions of Heparin Sodium Injection within 1-mL vials contain potentially lethal heparin doses for some patients and vigilance is essential to avoid medication errors, espedaily when administering "catheter lock flush" solutions to pediatric patients and especially during the transition time from the older Heparin Sodium Injection vials to the newer vials. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed

Oops!

An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.