A new program by the US Food and Drug Administration (FDA) to inform physicians and patients about the risks of using erythropoiesis-stimulating agents (ESAs) for the treatment of anemia is under way. This risk management program also requires education for physicians prescribing ESAs to treat chemotherapy-related anemia in patients with cancer and documentation that these individuals have learned of the risks associated with ESAs. That education and documentation requirement has the American Society for Clinical Oncology (ASCO) concerned that the program will add to the administrative burdens of its members while not improving care.
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Physicians using genetically engineered forms of erythropoietin to treat anemia in patients with cancer must now document that they have explained the drugs’ risks to patients.
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