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.
For further information, please visit the ESA APPRISE Oncology Program Website.
If you need any further assistance, please contact pharmacy at extension 64696.