Risk Evaluation and Mitigation Strategies

ONS continues to following a variety of policy issues that effect the oncology nursing field. Risk Evaluation and Mitigation Strategies (REMS) is one of those topics. The FDA has oversight regarding the implementation of REMS, and through this process, it monitors the use of some prescription medications.  For more information, see the resources listed below.

• 1/5/12–The FDA approved a single shared REMS for transmucosal immediate-release fentanyl (TIRF) products in December 2011. This will replace individual REMS, managing opiods used to manage pain in adult cancer patients. The new shared system is call TIRF REMS Access Program.
• Risk Evaluation and Mitigation Strategies (REMS) Overview
• Slides from a presentation by ONS member Wendy H. Vogel, MSN, FNP, AOCNP^®, Oncology Nurse Practitioner, during a REMS meeting at ASCO
• "REMS: Application for the Advanced Practitioner in Oncology," by Wendy H. Vogel, MSN, FNP, AOCNP^®, and Marilyn Haas, PhD, ANP-C in the Journal of the Advanced Practitioner in Oncology, Jan/Feb 2011.
• REMS Testimony by ONS President Carlton Brown,RN, PhD, AOCN^® to the FDA, September, 2010
• FDA removed restricted distribution programs and the safety reporting requirements that were part of the REMS for Romiplostim and Eltrombopag.