A colleague in the Gulf Coast area of the United States would like to know what others plan to do, if anything, regarding the new version of the 'Uniform Donor History Questionnaire'. As way of background, on April 23, 2004, FDA issued "Draft Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components." This guidance announced FDA's acceptance of the full-length questionnaire and accompanying materials. According to the AABB website the new Donor History Questionnaire was developed to encompass both FDA requirements and AABB standards. The Gulf Coast colleague would like to know the plans of others for medications and medical conditions.

• Medications: The drug list of deferrable medications includes only those specifically indicated by the FDA. However, many donor centers defer for other drugs, including some that may be teratogenic, such as methotrexate, or may cause abortions, such as Arthrotec. Will these be added to the medication list?
• Medical conditions: The questionnaire asks specifically only about cancer, bleeding conditions, blood diseases, and heart and lung conditions. Is anyone planning to ask about other conditions, such as autoimmune diseases?

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator