As policy advocates for the Hemophilia Association of the Capital Area (HACA) and the Virginia Hemophilia Foundation (VHF), we are writing to express our concerns with the proposed labeling amendments before the Board of Pharmacy. Our members are individuals with inherited bleeding disorders and their family members. To achieve high quality of life, many individuals with inherited bleeding disorders receive clotting factor replacement therapy to treat bleeding episodes or prevent bleeding.  The two main types of clotting factor concentrates are plasma-derived factor concentrates or recombinant factor concentrates.  Other common treatment products include Hemlibra, DDAVP or Stimate, and Amicar.

Because medication is critically important in the treatment of inherited bleeding disorders, timely access to products is essential. And transparent labeling is vital. Persons should be able to determine who filled their prescriptions; therefore, attempts to alter pharmacy identifiers should be minimized. If we pick up products at a pharmacy that is serving as a depot for the products, we should be able to read the label information and contact the person who was responsible for filling the prescription. There should be minimal delays in obtaining this information, should we be obtaining a product that is to be used immediately to treat an emergent situation.

We recommend that you make no changes to current labeling requirements at this time.

Kelly Waters, MSW, LCSW

Executive Director

Virginia Hemophilia Foundation

Brenda Bordelon

Executive Director

Hemophilia Association of the Capital Area