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FDA Adds Immediate-Release Opioids to REMS Program

July 14, 2017
The Risk Evaluation and Mitigation Strategies program will now extend to IR opioid formulations (while already including ER and LA opioids), and the training program will be expanded to all health professionals involved in patient pain management.

The Food and Drug Administration (FDA) is expanding the Risk Evaluation and Mitigation Strategies (REMS) program to include immediate release (IR) opioid medications,1 according to FDA Commissioner Scott Gottlieb, MD, who made the announcement at the start of a regularly scheduled meeting in Washington, DC.

“America is simply awash in IR opioid products,” with 90% of all opioid prescriptions for IR analgesics, amounting to 200 million scripts annually, said Dr. Gottlieb, to MedPage Today,2 aimed at intensifying control over opioid prescribing as well as to extend training to allied health professionals, including nurses/nurse practitioners and pharmacists, who are involved in pain management.

Accelerating Efforts to Control Opioid Use

Responding to ongoing problems of abuse, misuse, and addiction regarding all opioids analgesics, the FDA aims to promote the challenges inherent in prescribing IR opioid medications to patients.2

The FDA announcement appears to be the first step in extending the system already in place due to the “FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain,”3 for training physicians on the risks and benefits of prescribing extended release (ER) and long-acting (LA) opioid analgesics. For now, training will remain voluntary.

The plan is to expand the REMS program to include all “IR opioid products available in dosages intended for outpatient use,” which would affect an estimated 50 manufacturers.4

However, the FDA does not intend for this program to impact parenteral opioid formulations which are usually administered in hospital settings, or transmucosal immediate-release fentanyl (TIRF) products, which is administered under the REMS program with Elements to Assure Safe Use (ETASU) program.5

REMS Past and Future

The FDA Amendments Act of 2007 gave the agency the authority to mandate that opioid manufacturers comply with the REMS requirement to provide and pay for training clinicians regarding use of ER/LA opioids.6

In this latest announcement,1,4 a 3-part plan was unveiled based on recommendations from the FDA Advisory Committee:

  • Extend the REMS program to IR opioid analgesics
  • Expand the FDA Blueprint beyond physicians to other health care professionals involved in pain management and educational messages
  • Consider recommendations to make training mandatory for all practitioners involved in pain management  

Manufacturers will have to meet the same Risk Evaluation and Mitigation Strategy (REMS) program-training requirements already in place for ER and LA opioids,1 according to the FDA. At present, training for all pain practitioners will remain voluntary.

Over the next few weeks, letters will be mailed to manufacturers notifying them of the new program compliance requirements intended to curb the number of prescriptions written.

The expectation is that by adding IR opioids to the REMS program, the FDA will be more effective in hastening a reduction in the healthcare burden arising from opioid medication overuse.

Last updated on: July 14, 2017
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