Review of the ESA APPRISE Oncology Program

Those organizations and pharmacists that provide patient care for oncology patients should be familiar with the erythropoiesis stimulating agents (ESA) APPRISE (Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs) Oncology Program. If you are not familiar with the program, the ESA APPRISE website describes it as:

ESAs include Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa). The FDA determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the decision to initiate ESA treatment for a patient with cancer begins with a discussion between the patient and health care provider (HCP) about the benefits and risks associated with ESA therapy.

Amgen and Janssen Products, LP, have implemented the ESA APPRISE Oncology Program as part of a REMS designed for HCPs treating patients with an ESA for their cancer.

The REMS program, established under the FDA Amendments Act of 2007, took effect on March 25, 2008, and gives the FDA authority to require manufacturers to develop and implement a REMS if the agency determines it is necessary to ensure that the benefits of a drug outweigh the risks.

Here is a general description of how the program works:

Key Program Requirements

HCPs

Hospitals

1. Complete Training

1a. Select a Hospital Designee

1b. Hospital Designee Completes Training

2. Enroll in the ESA APPRISE Oncology Program

2. Enroll in the ESA APPRISE Oncology Program

3. Counsel and Document

• Counsel each patient on the risks of ESAs prior to each new course of ESA therapy.
• Document that the risk:benefit discussion with each patient has occurred by completing the Acknowledgment Form and providing each patient a copy of the signed form.

3. Implement

• Hospital Designee to establish or oversee the establishment of a system, order sets, protocols, or other measures designed to ensure that the hospital is in compliance with the Program.

What happens if I do not train and enroll into the Program?

Failure to comply with the ESA APPRISE Oncology Program requirements will result in suspension of your access to ESAs

•In a private practice-based clinic, store the forms on-site and/or archive them through an electronic medical record system as long as they are retrievable.

•In a hospital, provide the completed Acknowledgment Form to the Hospital Designee responsible for maintaining and storing the forms.

Pharmacy Documentation and Maintenance for ESA APPRISE Program

It is required that a hospital designee be identified to oversee and ensure compliance with the program. In most cases, this would be a pharmacist.

It is required that signed acknowledgment forms be maintained and easily retrievable upon audit. Even if a medication guide is no longer a part of the REMS program, it is important that 1 is sent to the patient upon the initiation of each new course of therapy, as it remains part of the product label.