New USP heparin standards now in force

Phil Taylor

02-Oct-2009

Big heparin bottle The US Pharmacopeia's revised quality standards for the blood thinner heparin, designed to prevent a recurrence of the adverse reactions and deaths caused by adulterated supplies of the active pharmaceutical ingredient (API) in 2008, came into force yesterday.

The change in the heparin monograph was introduced on October 1 and includes a new test method to determine the potency of the drug and to detect impurities that may be present.

The USP started revising the standards for heparin in 2008 after intentionally adulterated with over-sulphated chondroitin sulfate (OSCS) entered the supply chain and led to around 250 deaths. OSCS is a less costly substance that can mimic the blood-thinning properties of heparin.

A first round of changes came into effect in June 2008 in an effort to avert the public health crisis caused by the contamination, but at the time it was recognised that more sweeping changes would be needed to ensure the continuing quality of heparin supplies.

The new test and standards were first announced in February of this year, and have now come into force following a period of public comment.

Dr. Roger Williams, chief executive of the USP, said in a statement: "The growth of economically motivated adulteration of medicines worldwide is a tragic by-product of global supply chains, and the safety nets that protect us all must be constantly re-assessed and improved."

The change, will also harmonise the USP unit dose with the WHO International Standard unit dose, will result in approximately a 10% reduction in the potency of the heparin marketed in the United States.

The US Food and Drug Administration (FDA) said the change 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.

It also warned physicians to be aware that there will be simultaneous availability of heparin manufactured to meet the old and new USP monograph, with potential differences in potency. The intention is that material manufactured using the new standards will carry an 'N' next to the lot number.

Related articles:

EMEA adds APIs to rapid alert system

EFCG unveils supply chain security template

Germany debates adding APIs to counterfeit legislation

Two more Chinese companies linked to tainted heparin

Globalisation and supply chain security: the view from Interphex

USP sets new standards for heparin, glycerin

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