Risk Evaluation Mitigation Strategies became a reality as of July 2012. In a press release from the FDA, “the REMS is part of a federal initiative to address the prescription drug abuse, misuse, and overdose epidemic. The REMS introduces new safety measures designed to reduce risks and improve the safe use of ER/LA opioids, while ensuring access to needed medications for patients in pain.
…The FDA’s goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”
Dr. Fudin has lectured about REMS history, development, and strategies for the last several years at various educational forums locally, regionally, and nationally. While there clearly are attributes to this initiative, some professional groups have raised interesting concerns.