Will Overlap of Old and New Heparin Be a Problem?

Washington, DCHeparin contamination will hopefully become a thing of the past thanks to a new protocol that will impact all heparin products, including heparin injection and that found in heparin syringes. The issue however will be whether or not the health care community is sufficiently informed of the change, given a change in the potency to the standard unit.

The United States Pharmacopeia (USP), a nonprofit standards-setting organization, has adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug's unit dose that is now aligned with the international standard observed by the World Health Organization.

The good news is that as of October 1st, the four manufacturers that are responsible for most of the heparin produced for the US market are making the anti-clotting product with new standards that include, among other things, a test for the contaminant found in tainted Chinese heparin that resulted in numerous deaths and brought the industry to its knees.

However, it was revealed that the change to the unit structure in heparin manufactured to the new protocols after October 1st will result in a unit that will be, potentially about 10 percent less potent than the previous standard.

What's more, the labeling approved by the US Food and Drug Administration (FDA) for heparin in the US has not changed. Thus, it puts the onus on health care providers and dispensing facilities top ensure that the change is articulated to all concerned, in order to make adjustments to pharmacy procedures and dosing practices.

John Jenkins, MD, is director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research:

"Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug," he said in a statement to the Medical Letter on the CDC and FDA.

Heparin manufacturers were asked to delay shipping of the new batches of heparin until October 8, to give the health care community a chance to become familiarized with the new USP standard.

There was no mention of disposing of old heparin when new vials come in. The FDA did ask all manufacturers to identify their new products in a way that would assist pharmacies and health care professionals differentiate between the old and the new.

Advocates and the legal community will be watching for the aftermath of any mix-ups.