[ANCO Online ListServ] ASH & CMS News

The following information has been received by ANCO.


****ASH NEWS****
The U.S. Food and Drug Administration (FDA) released an alert noting a change to the United States Pharmacopeia (USP) monograph for heparin, effective October 1, 2009. The change will include a new USP reference standard and test method that is used to determine the potency of the drug. The manufacturing and testing requirements under the new monograph will lessen the potential for contamination of heparin and enhance the production of a high quality drug. However, harmonization of the standard will result in approximately a 10% reduction in the potency of the heparin marketed in the United States.
The change in heparin potency may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important. In such situations healthcare providers should consider the change in potency of heparin when making decisions about what dose to administer. The change in heparin potency is expected to be less clinically significant when it is administered subcutaneously due to the low and highly variable bioavailability of heparin when administered by this route. Healthcare providers should also be aware of the decrease in heparin potency as they monitor the anticoagulant effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.

Manufacturers will not begin shipping heparin products manufactured and tested according to the new USP monograph until October 8th or later.

There will be simultaneous availability of heparin manufactured to meet the “old” and “new” USP monograph, with potential differences in potency. This overlap of products on the market is necessary to make certain that there is an adequate supply of heparin available for all patients. Products using the new “USP unit” potency definition are anticipated to be available on or after October 8. FDA is working with the manufacturers of heparin to ensure that an appropriate identifier is placed on heparin made under the new USP monograph. Most manufacturers will place an “N” next to the lot number.

Consider the potential potency variation when administering heparin,particularly in situations where assurance of aggressive anticoagulation is essential to treat or prevent life-threatening thromboses. Clinicians should now consider the potential for up to 10% estimated decrease in heparin activity per “USP unit” when deciding what dose to administer in such cases.

The potency change may require more frequent or intensive aPTT or ACT monitoring.

Clinical judgment is essential in determining dose of heparin. Heparin dosing is always individualized to the patient-specific situation. The FDA-approved labeling for heparin has not changed, including the recommended doses. Individualization of heparin dosing has long been the standard for clinical use of the drug and FDA reiterates the importance of clinical judgment in heparin dosing.

To view the FDA announcement and more information regarding the heparin dosing changes visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm184674.htm.



****CMS NEWS****
The Centers for Medicare and Medicaid Services (CMS) has posted the revised October 2009 ASP and NOC pricing files, which are available for download at http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/01a1_2009aspfiles.asp.


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