Today, the U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) 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 health care 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 labeling containing information about the health care provider education available through the new REMS.
“Opioid addiction is an immense public health crisis. Addressing it is one of the FDA’s highest priorities. As part of our comprehensive work in this area, we’re taking new steps to rationalize prescribing and reduce overall exposure to these drugs as a way to cut the rate of new addiction. Many people who become addicted to opioids will have their first exposure in the medical setting. Providers have a critical role to play in making sure these products are appropriately prescribed to patients. Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain. This includes ensuring that prescriptions are written for only appropriate purposes and durations of use. Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements. The action also adds new labeling for all opioids to raise awareness about available educational materials on prescribing these powerful medications,” said FDA Commissioner Scott Gottlieb, M.D. “Appropriate prescribing practices and education are important steps that we’re prioritizing to help address the human and financial toll of this crisis. Our aim is to make sure the medical community can take advantage of the available education on pain management and safe use of opioid analgesic products. At the same time, we’re also taking new steps to advance the development of evidence-based, indication-specific guidelines to help further guide appropriate prescribing of opioids. The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed for different medical conditions for which these drugs may be indicated. The aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines.”
Since 2012, manufacturers of ER/LA opioid analgesics have been subject to a REMS that requires as its primary component, that training be made available to prescribers of those products. To meet this requirement, drug companies with approved ER/LA opioid analgesics have been providing unrestricted grants to accredited continuing education providers for the development of education courses for prescribers based on content outlined by the FDA. As part of the final action being taken today, these REMS requirements now also apply to IR opioid analgesic products intended for outpatient use. The IR drugs account for about 90 percent of all opioid pain medications prescribed for outpatient use. Additionally, the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines have been subject to a REMS since December 2011.
