Drugs

Advisors Back Expanded Opioid REMS

David McFarland

— 2 min read
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All 30 members of the combined FDA Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted during a 5/3-4 joint meeting to recommend that FDA modify the Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting (ER/LA) opioids, including expanding it to immediate release (IR) products. Committee members said that the current ER/LA REMS fails to assure safe use of the drugs.

In addition to making a strong recommendation that the REMS also cover IR opioids, committee members supported making provider education mandatory. The current REMS has voluntary provider education that is incentivized through continuing education credits.

At the session, advisors reviewed the results of REMS assessments submitted to FDA by drug sponsors. They determined that although the assessment of prescriber knowledge following REMS training is useful, it does not assess the REMS more generally. Committee members suggested that an adequate REMS assessment would include a determination of its impact on both provider behavior and patient safety.

While saying that it may be difficult to measure “appropriateness” of physician prescribing, committee members said it should be assessed since it is a central REMS goal. They also considered ways in which patient safety could be evaluated, including looking at the REMS impact on the rates of overdose and death.

Responding to an agency caution that REMS implementation should not unduly affect patient access to pain medication, committee members said they did not believe that the current requirements are unduly burdensome on patient access.

During the public comment section of the meeting, recommendations for updating REMS included: 

  •          increase transparency for patients;
  •          develop a blueprint for patient information;
  •          increase range of training activities so that practitioners can help close their personal knowledge gaps;
  •          standardize REMS while allowing for more flexibility;
  •          educate healthcare teams and not only doctors;
  •          include in prescriber education information on other treatments that may reduce overall need for opioids;
  •          educate providers on how to manage at-risk patients;
  •          launch a public health campaign to involve the entire country;
  •          focus on education that emphasizes fewer patients, shorter duration of prescribing patterns, and lower dosages; and
  •          have REMS include screening for mental disorders and educate prescribers on handling patients with such illnesses.

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