Managing drug safety and developing drug safety systems is an ongoing challenge for all involved in regulating drug use, manufacturing drugs, prescribing drugs, and consuming drugs. Risk evaluation and mitigation strategies (REMS) are the newest tool of the Food and Drug Administration (FDA) to help manage and ensure safe drug use. The FDA may require manufacturers to develop REMS for both existing drugs and drugs in development when it determines special action is needed to ensure benefits of a drug outweigh its risk.
Within oncology there are drugs, including several supportive care medications, which currently have associated REMS. Availability of and access to these appropriate drugs are essential for patients with serious and life-threatening terminal illness. In addition, the proposed class-wide REMS for long-acting and extended release opioids is particularly relevant to cancer care. The use of REMS is expected to grow substantially in the future, especially for oncology therapies. As the new REMS paradigm develops, the practical implications of REMS policies and process must be carefully considered so that REMS are implemented in a feasible manner.
The successful design, implementation, and analysis of the FDA’s recent requirement for REMS for high-risk drugs and biologics presents significant challenges for stakeholders, including patients, providers, manufacturers, payers, health information technology vendors, and government agencies. To provide guidance to these stakeholders regarding these challenges, NCCN assembled a Work Group in March of 2010 comprised of thought leaders from NCCN Member Institutions and outside organizations. These multidisciplinary thought leaders represented providers (physicians, pharmacists, nurses), patients, manufacturers, payers, and government. The Work Group developed recommendations around nine main areas of concern that were presented at the NCCN Oncology Summit: Recommendations for REMS Stakeholders on May 7, 2010 in Washington, DC. Based on the presentations and resulting discussion, NCCN published a white paper entitled "NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper: Recommendations for Stakeholders" in JNCCN in September 2010.