In a measure to encourage appropriate and rational prescribing, the U.S. Food and Drug Administration (FDA) has approved new safety measures for immediate-release (IR) opioids.1 The newly finalized Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) will, for the first time, apply to IR opioid analgesics, which are intended for use in outpatient settings. This updated REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to REMS since 2012.
As part of this REMS program, healthcare providers who manage pain patients, including nurses and pharmacists, are required to receive training. The education is required to cover broader information about suitable pain management, including alternative, non-opioid pain treatments.
According to a statement from FDA Commissioner Scott Gottlieb, M.D., “Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain. … [This] action, importantly, subjects immediate release opioids—which are the most commonly prescribed opioid products—to a more stringent set of requirements. … Our aim is to make sure the medical community can take advantage of available education on pain management and [the] safe use of opioid analgesic products.”
In the statement, Dr. Gottlieb also notes the FDA’s efforts in advancing the development of evidence-based, indication-specific guidelines to help further guide appropriate prescribing of opioids, as well as reducing overall dispensing of opioids to further reduce patient exposure to them and prevent patients from becoming addicted.