Erythropoiesis Stimulating Agents (ESA) Risk Evaluation and Mitigation Strategy (REMS)
Effective February 16, 2011 Erythropoiesis Stimulating Agents (ESA) must be prescribed and used in accordance to the FDA-mandated risk management program, known as the Risk Evaluation and Mitigation Strategy (REMS).
Goals of the REMS for ESAs are:
To assist patients and clinicians in making informed decisions on the use of ESAs; and
To mitigate the risk of increased mortality and poorer tumor outcome in patients with cancer.
- All patients receiving ESAs (Epogen, Procrit, Aranesp) must be provided a Medication Guide
For patients with Cancer, in addition to providing medication guide:
- Hospital Certification: Hospital providing ESA must receive ESA APPRISE Oncology Certification.
- Healthcare provider (HCP) Enrollment: Clinicians prescribing ESAs in patients with cancer must enroll in the ESA APPRISE Oncology Program.
- Acknowledgment Form: certified HCP and patient documentation of Risk vs. Benefit discussion must be maintained.
If you need any further assistance, please contact pharmacy at extension 64696.