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FDA Approves Final Opioid Analgesic Risk Evaluation and Mitigation Strategy

September 27, 2018
Guideline now applies to immediate-release opioid analgesics

A PPM Brief

FDA has approved the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS),1 which includes several measures for communicating the serious risks of opioid use to patients and healthcare professionals. This expanded REMS for the first time applies to immediate-release (IR) opioid analgesics in an outpatient setting, which account for about 90% of all opioid pain medications prescribed.

The REMS program now requires training to be made available to healthcare providers who are involved in the management of patients with pain, not just prescribers; for example, training must now be made available to nurses and pharmacists. The new REMS also requires broader educational information about appropriate pain management, including alternative therapies. The agency has also approved new product labeling containing information about the healthcare education available through REMS.

“Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain,” said FDA Commissioner Scott Gottlieb, MD, in the announcement. “This includes ensuring that prescriptions are written for only appropriate purposes and durations of use.”

Since 2012, manufacturers of extended-release/long-acting (ER/LA) opioid analgesics have been subject to a REMS that requires training be made available to prescribers of those products. Pharmaceutical companies with approved ER/LA opioid analgesics have been providing unrestricted grants toward the development of education courses for prescribers based on content outlined by FDA.

Risk and safety terms, in line with REMS for opioid analgesicsRise evaluation and mitigation strategies (REMS) are now available for immediate release opioid analgesics.


The agency has also approved a new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain, including updated educational content. It is expected that continuing education training under the modified REMS will be made available by March 2019, according to the release.

“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,” Dr. Gottlieb continued. “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.”




Last updated on: September 27, 2018
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FDA Adds Immediate-Release Opioids to REMS Program
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