One of the critical lessons the heparin crisis taught us as a community of scientists, regulators and manufacturers is that we need to pool our efforts and expertise to properly secure our global supply of medicines.
Rockville, Md (PRWEB) August 02, 2012
As part of its role in ongoing efforts to better safeguard the global supply of medicines, the U.S. Pharmacopeial Convention (USP) will co-host the “Fifth Workshop on the Characterization of Heparin Products” at its U.S. headquarters in Rockville, Md., August 14-15, 2012. Since 2008, USP’s workshop on heparin products has provided a forum for manufacturers, regulators and other stakeholders dedicated to disseminating information on methods and practices for testing heparin quality and analyzing its components.
In 2008, the U.S. heparin supply came under close scrutiny from the Centers for Disease Control (CDC) and the U.S. Food and Drug Administration (FDA) when adverse health events in 2007 and 2008—including more than 200 deaths—evidently associated with the use of adulterated or counterfeit heparin prompted an investigation of this commonly-used blood thinner. The investigation led to the discovery of an adulterant, oversulfated chondroitin sulfate (OSCS), in heparin sourced from China. OSCS is a less costly substance than heparin, and was used for economic adulteration because it can mimic some chemical properties of heparin when using older, less-sensitive tests. In response to the immediate public health crisis, USP worked with FDA and manufacturers to develop more sophisticated test methods related to its heparin standards, which were further strengthened in a second stage of revisions. A third stage, including new proposed methods for molecular weight determinations and nucleotidic impurity detection, will be discussed at the workshop.
According to USP’s chief executive officer, Roger L. Williams, M.D., “The public has come to expect that medicines are safe and of good quality. One of the critical lessons the heparin crisis taught us as a community of scientists, regulators and manufacturers is that we need to pool our efforts and expertise to properly secure our global supply of medicines. Events like the heparin workshop are critical for ensuring that we are employing the best scientific methods and technologies available to help protect public health.”
Co-organized by the National Institute for Biological Standards and Controls (NIBSC) and the European Directorate for the Quality of Medicines and Healthcare (Council of Europe)—which publishes the European Pharmacopeia—the workshop will bring together participants from around the world. The keynote speaker is Roger Bate, Ph.D., resident scholar at the American Enterprise Institute, who will address potential problems associated with poor quality drugs and how to limit them. In addition, a workshop session focused on regulatory and dossier requirements for heparin will include perspectives from the FDA as well as regulatory bodies from Brazil, Argentina, Japan and others.
A scientific, nonprofit organization, USP develops public standards that test for the identity, strength, quality and purity of medicines and their ingredients. Written or documentary standards (called monographs) are published in USP’s compendia, United States Pharmacopeia and National Formulary(USP-NF). USP also develops reference material standards that are components of the monograph standards used by manufacturers, regulatory authorities and other stakeholders to test products for quality.
A meeting agenda and registration information are available at: http://uspgo.to/heparin-workshop. Click here to view videos about the heparin workshop featuring USP Expert Panel members on unfractionated heparin and low molecular weight heparin products.
Media interested in attending this event may register for free by contacting Theresa Laranang-Mutlu at trl(at)usp(dot)org.
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USP – Advancing Public Health Since 1820
The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP’s standards are relied upon and used worldwide. For more information about USP visit http://www.usp.org.