APS E-News | Advocacy Update Report | September 2018
FDA Publishes Final REMS Guidance
The Food and Drug Administration (FDA) has approved its final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. The expanded REMS now, for the first time, applies to immediate-release opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting opioid analgesics, which have been subject to a REMS since 2012.
The REMS program requires, for the first time, that training be made available to healthcare providers who are involved in the management of patients with pain, and not only to prescribers. For example, the training provided through the REMS must be made available to nurses and pharmacists. The new REMS also requires that the education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain. The agency is also approving new product labels containing information about the healthcare provider education available through the new REMS.