Hep­arin clar­i­fi­ca­tion

Modern Healthcare - - Opinions Letters -

Your March 15 Daily Dose ar­ti­cle “Bax­ter fac­ing chal­lenges on hep­arin,” was a missed op­por­tu­nity to pro­vide fac­tual in­for­ma­tion to health­care pro­fes­sion­als and ex­ec­u­tives about an im­por­tant change re­lated to new U.S. Phar­ma­copeia, or USP, stan­dards for hep­arin.

In Oc­to­ber 2009, the USP in­tro­duced a mod­i­fi­ca­tion of the ref­er­ence stan­dard for hep­arin unit dose, which af­fected stated po­tency of the prod­uct. Ad­di­tion­ally, they re­quired a new as­say, which has been dif­fi­cult to im­ple­ment. And the new meth­ods have pro­vided dif­fer­ent re­sults in some hep­arin prod­ucts. Though your ar­ti­cle men­tioned only Bax­ter, in ac­tu­al­ity nearly all man­u­fac­tur­ers of hep­arin have faced chal­lenges im­ple­ment­ing the new stan­dards and the new test method, as ev­i­denced by the mul­ti­ple com­pa­nies listed on the U.S. Food and Drug Ad­min­is­tra­tion’s drug short­age list.

Un­for­tu­nately, your ar­ti­cle pro­vided an in­com­plete pic­ture of an is­sue with im­por­tant clin­i­cal con­se­quence. As such, we would strongly en­cour­age your read­ers to view in­for- ma­tion avail­able on USP, FDA and hep­arin man­u­fac­tur­ers’ Web sites.

Fran­cois Lebel Vice pres­i­dent, global med­i­cal and clin­i­cal af­fairs med­i­ca­tion de­liv­ery Bax­ter Health­care Corp.

Deer­field, Ill.

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