FAQs: Heparin: Important Changes to Heparin Container Labels

FAQs for Healthcare Practitioner

1. Why are the labels of Heparin Sodium Injection, USP and Heparin Lock Flush Solution, USP being changed?

This change from the existing USP requirements is intended to prevent medication errors. It will align required labeling for heparin products with USP’s general requirements for all small-volume injectable products, which currently display the total drug content. A small-volume injectable product is a single-dose injection that is intended for intravenous use and is packaged in a container labeled as containing 100 milliliters or less.

2. How are the labels for Heparin Sodium Injection, USP and Heparin Lock Flush Solution, USP being changed?

The label change will require manufacturers of Heparin Sodium Injection, USP and Heparin Lock Flush Solution, USP to clearly state the strength of the entire container of the medication followed by how much of the medication is in each milliliter. These modifications will eliminate the need for health care professionals to calculate the total amount of heparin medication in a product containing more than 1 milliliter, thereby reducing the risk of miscalculations that may result in medication errors.

3. What will the labels look like?

Click here to view examples provided by FDA of current and revised heparin container labels.

4. When will the change occur?

This labeling transition has already begun, and prior to the date on which the revised standards become official (May 1, 2013), USP, FDA, and professional organizations are attempting to get the word out since both the current and the revised heparin container labels may appear simultaneously in the marketplace during the transition.

5. What are some strategies to protect patients during the transition?

To minimize the potential for medication errors, hospitals and pharmacies may wish to consider separating the supplies of “current” and “revised” labeled heparin and exhausting the supplies of the “current” heparin before transitioning to products with the “revised” label.

Practitioners should always look at the label on the heparin vial being dispensed and counsel the patient or caregiver on how to administer the correct dose.

It is strongly recommended for general heparin safety that facilities put in place heparin protocols, policies and procedures that highlight this label transition. An independent double-check process that is robust will help practitioners identify the new labeling and apply correct dosing.

6. Does the labeling change affect all types of heparin products?

The labeling change only affects Heparin Sodium Injection USP and Heparin Lock Flush Solution USP products.

7. How will USP communicate to practitioners?

Pharmacopeial Forum, and the publication of the revised standard, practitioners will be notified regarding these changes through letters, webinars and organizational communications.