People living with pain deserve access to appropriate medications throughout the continuum of their care from acute pain to all components of chronic pain, including persistent, intermittent, and/or breakthrough pain.

Risk Evaluation and Mitigation Strategies (REMS) allow patients continued access to medicines for which there are safety concerns that may be managed through appropriate use. Opioid REMS programs have the potential to lower public health risks of overdose, misuse, abuse, and addiction.

REMS are requirements mandated by the Food and Drug Administration (FDA) for patients and healthcare providers to minimize the risks associated with certain medications. REMS succeeded both the Risk Management Plan (RMP) and the Risk Minimization Action Plan (RiskMAP) following the signing into law of the FDA Amendments Act (FDAAA) of 2007, which enabled better consumer protection by allowing more comprehensive reviews of potential new drugs and devices. Since March 2008, under the FDAAA, the FDA may formally require manufacturers to submit a REMS with drugs or biologics that have a known or potential safety risk. This FDA requirement is being applied to many products including certain opioids. Importantly, risk management is not new to medicine and REMS are not intended solely for opioids.

REMS is about safety, ensuring that medication benefits outweigh the risks, and helping the healthcare provider prevent harm to patients and society.