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FDA Mandates Enrollment for Erythropoesis Stimulating Agents

From: The Hospitalist, April 2011

New FDA rules went into effect in February and will affect who can prescribe ESAs, including epoetin (Epogen, Procrit) and darbepoetin (Aranesp)

Dr. Hospitalist

I heard from my hospital’s pharmacist director that soon I will not be able to prescribe Epogen unless I get some additional certification. Is this true? Can you explain what is going on?
Ritesh Magge, MD,
Detroit

Dr. Hospitalist responds: Your pharmacist is referring to the new FDA-mandated requirements, which went into effect in February, that will affect who can prescribe erythropoesis-stimulating agents (ESAs), including epoetin (Epogen, Procrit) and darbepoetin (Aranesp). This is part of a broader FDA strategy to improve patient safety as it relates to medications.

According to the FDA website, “The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.”

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The ESAs are not the only class of drug that will require a REM. More than 150 drugs already have varying requirements. For a complete list of these medications, please visit the FDA website (www.fda.gov) and search “drug safety.” The FDA plans to create additional REMs for additional drugs and biologic agents.

If you are a provider who will prescribe a medication with a REM, you will be obligated to adhere to the FDA REM associated with that medication. The drug manufacturers are working with the FDA to set up REMs for their drugs. For example, if you plan to prescribe an ESA for a patient with cancer, you will first need to enroll in the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) Oncology Program, which was established by ESA drug manufacturers. Once enrolled in the program, you will be assigned a unique ESA APPRISE ID number. ESA prescribers will be required to provide and review the ESA Medication Guide and counsel each patient on the risks and benefits of ESAs before each course of therapy. This counseling must be done no more than every 30 days after the first dose. (At the same time, prescribing ESAs to non-cancer patients basically only entails patient education.)

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Providers also will be required to fill out the ESA APPRISE Oncology Program Patient and Healthcare Professional Acknowledgment form, which documents that the risk-benefit discussion occurred. This form is in triplicate and includes both the patient and the provider signature. One copy is given to the patient, another copy placed in the chart, and the third copy is stored for potential future audit.

For more information about the ESA APPRISE Oncology Program, please visit www.esaapprise.com/ESAAppriseUI/ESAAppriseUI/default.jsp. TH


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