The first is a newly revised Risk Evaluation and Mitigation Strategy (REMS) blueprint for prescriber education. The 13-page document, titled "Opioid Analgesic REMS Education Blue Print for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain," focuses on what prescribers should learn about managing acute and chronic pain. It includes information on both opioid and nonopioid analgesics, as well as nonpharmacologic treatments for pain.
The agency also announced that it is considering new packaging regulations for opioid medications, particularly for immediate-release opioids. The FDA specifically mentioned the use of blister packaging for short-term prescriptions. The goal is to prevent overprescribing, which can lead to medication misuse.
"If more immediate-release opioid drugs, in particular, were packaged in three- or six-day blister packs, then more doctors may opt for these shorter durations of use," FDA Commissioner Scott Gottlieb, MD, stated in a press release. "Additionally, provided the FDA concluded that there was sufficient scientific support for these shorter durations of use, this could provide the basis for further regulatory action to drive more appropriate prescribing."
The FDA announcement corresponded with a January 30 public hearing on how to address the worsening opioid crisis. The FDA is accepting public comments on the topic through March 16, 2018.
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