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RPA FAQ Guidance Document on Compliance with FDA REMS Requirements for ESAs

Creation/Revision Date: August 12, 2010

 

FDA’s Risk Evaluation and Mitigation Strategy (REMS) for Erythropoeisis Stimulating Agents (ESAs)

GUIDANCE TO NEPHROLOGY PRACTITIONERS

 

Why is the FDA developing REMS programs?
The Food and Drug Administration Act of 2007 (FDAA) gave the FDA the authority and responsibility to require drug manufacturers to develop and implement a Risk Evaluation and Management Strategy (REMS) on certain drugs. This is pursued if the FDA determines that a REMS is necessary to ensure that the benefits of the drug outweigh the risks of the drug. Further, Congress has convened hearings to make sure that the FDA is implementing the provisions of the FDAA. 

Why is this being done in renal care? 

On February 16, 2010, the FDA approved a REMS to ensure the safe use of Erythropoiesis-Stimulating Agents (ESAs). FDA made this decision based on studies demonstrating that use of ESAs can increase the risk of tumor growth and shorten survival in patients with cancer. Studies conducted in patients with cancer and in patients with renal failure also show that use of ESAs can increase the risk of myocardial infarction, congestive heart failure, stroke and thrombotic events. 

What are the goals of the REMS process?

It is the FDA’s intent that REMS will facilitate informed decision-making between patients and healthcare providers when considering treatment with ESAs, and to educate patients on the risk of ESAs. 

What does a nephrology practitioner need to do to comply with the REMS requirements?

As part of the REMS, a Medication Guide has been published by FDA to explain the risks of ESAs. This written document must be provided to all patients receiving ESAs. The Medication Guides are developed collaboratively between the FDA and the manufacturer of the drug. 

How often does the nephrology practitioner need to provide the Medication Guide to kidney patients?

In CKD and ESRD, the FDA REMS program indicates that the Medication Guide be given to every patient on initiation of treatment with ESAs and at least once a month while therapy with ESA continues. 

Can the nephrology practitioner share additional information with the patient along with the Medication Guide?

Yes. Nephrology practitioners are entitled to provide their patients with written information that discusses issues such as: (1) what ESA’s are; (2) why the patient has been prescribed ESAs; (3) what hemoglobin tests measure, why they are important and the current guidelines for appropriate hemoglobin ranges; and (4) further details on the benefits and risks of ESA therapy. Some practices may choose to prepare a letter that addresses these issues to accompany the Medication Guide, and in fact the medication guideline can be appended to a letter similar to the “package inset” provided with all prescribed drugs. 

Are nephrology practitioners the only healthcare providers expected to disseminate the Medication Guide to kidney patients?

No. In a March 12, 2010 letter to the manufacturer of the drug, the FDA includes the physician's office, clinic, hospital inpatient setting, or dialysis center as among the list of healthcare providers for whom FDA” intends to exercise enforcement discretion with respect to the requirements.” 

Are there other REMS requirements with which nephrology practitioners must comply?

For now, in the treatment of CKD and ESRD specifically, there are no other requirements with which to comply. However, this is not the case in other disease states—for example, in the treatment of cancer, health care providers must comply with a program called the APPRISE (Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs) Oncology Program. APPRISE was created for healthcare providers who are prescribing ESAs during the course of treating a patient for cancer. 

If you are treating anemia of CKD in a patient who also has cancer, do you need to complete the APPRISE Oncology Program?

According to manufacturer’s instructions, nephrology practitioners treating patients for anemia of CKD do not need to comply with the APPRISE Oncology Program.

Has RPA provided input to the FDA on the REMS for ESAs?

Yes. In a July 26, 2010 letter to the FDA, RPA expressed support for the underlying principles of the FDA’s REMS program for ESAs, but also voiced concern that the requirement for the medication guide to be distributed on a monthly basis adds an unnecessary burden for the clinical workforce. As such, the RPA recommended that the FDA to consider revising this requirement so that the medication guide may be disseminated quarterly or even annually. RPA’s letter to the FDA can be viewed at: http://www.renalmd.org/legis.aspx?id=2526

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