January 3, 2013
Heparin Label Change Expected to Reduce Medication Errors

Washington, D.C.—Container and carton labels for heparin products will change in the next 6 months under a new FDA requirement.

Manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP will need to clearly state the strength of the entire container of the medication, followed by how much of the medication is in 1 milliliter (mL).

FDA notes that the modifications will eliminate the need for health care professionals to calculate the total amount of heparin medication in a product containing more than 1 mL, thereby reducing the risk of miscalculations that sometimes result in medication errors.

Health care professionals should be aware of the transition period before and after the May 1, 2013, implementation date and should consider separating the supplies of “current” and “revised” labeled heparin, using up “current” supplies first, according to the FDA.

The high rate of medication errors was one of the issues leading to the new requirements.

The United States Pharmacopeia’s (USP) Safe Medication Use Expert Committee noted in 2003 that containers labeled with the strength per mL were often misunderstood as the total drug content, potentially resulting in dosing errors with serious consequences to patients.

No medication errors have been reported with container labels that have already been changed to state the strength per total volume, according to an FDA safety communication.

The labeling requirement in the current heparin monographs states that the label must reflect only strength per mL, although it allows for single-dose vials to be labeled additionally to indicate the total drug content. To address this conflict, USP has proposed revising the labeling section of the heparin monographs to ensure that the heparin container labels comply with the USP General Chapter <1> Injections section.

That section reads, in part, “The strength per total volume should be the primary and prominent expression on the principal display panel of the label, followed in close proximity by strength per mL enclosed by parentheses. For containers holding a volume of less than 1 mL, the strength per fraction of a mL should be the only expression of strength. Strength per single mL should be expressed as mg/mL, not mg/1 mL.”

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