FDA's Proposed New Opioid REMS Revealed

Karen Lee Richards Health Guide
  • In June 2009, I first told you about the FDA's plan to develop “Risk Evaluation and Mitigation Strategies” (or REMS) in an attempt to reduce prescription drug abuse by limiting access to opioid medications.  The ideas they were considering would have made it a great deal more difficult for chronic pain patients to get the medications they need. 

    At that time, the FDA provided an online form where you could express your opinion on the issue. Although the initial comment period ended on June 30, 2009, because the FDA had already received more than 1,250 comments, they realized how much public interest there was and decided to extend the comment period until October 19, 2010. 

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    The FDA has now released a 374-page draft of the proposed REMS guidelines in advance of a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee being held July 22-23.  They are seeking input from all those who would be affected  – physicians, pharmacists, drug manufacturers and patients.  You can download a copy of the proposed REMS here:  FDA Proposed REMS.

    They Heard Us!

    Good news!  Apparently the FDA actually listened to us and took our concerns into consideration when they drafted their guidelines.  The newly proposed REMS are much less restrictive than some of the options initially being considered.  If you have any doubt that the FDA read our comments and paid attention, just take a look at the proposal.  Approximately 226 pages are devoted to reporting on the more than 2,170 comments they received.  It's really interesting to read all the different perspectives people offered. 

    Here are some of the highlights of the proposal:

    • The new REMS would only apply to long-acting and extended-release opioid formulations that contain the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, or oxymorphone.  The immediate-release forumlations of those drugs are not included in the new REMS. 

    • The idea of requiring patients using opioids to enroll in a special registry was dropped due to the public outcry that such a system would be overly burdensome and place a stigma on pain patients.  Instead, physicians would be required to give their patients education sheets and have them sign a Pain Treatment Agreement, which would verify their understanding of safe opioid use. 

    • Physician education prior to being allowed to prescribe opioids is included in the proposal.  It would be up to the drug manufacturers to provide the training and demonstrate prescribing improvement through surveys.

    • Each time one of the drugs subject to the REMS is dispensed, pharmacists would be required to provide the patient with a medication guide explaining the safe use, storage and disposal of long-acting and extended-release opioids.

    Keep in mind, this is just a first draft of the guidelines recommended, which is being presented to the advisory committees for their insights and opinions.  The FDA will not issue a final determination on the REMS until input from the advisory committee process has been considered and all reviews have been finalized.  Even when the REMS is finalized, the FDA points out that it may make further restrictions, including mandatory prescriber education and patient registration, if this more limited REMS fails to curb serious adverse outcomes.

  • The FDA still wants to hear from those who may be affected by the proposed REMS.  If you'd like to comment, just go to “Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs” at regulations.gov, click on “Submit Comment” near the top of the page and share your thoughts and opinions.

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Published On: July 07, 2010