REMS programs for opioid drugs? A worthy approach but many questions remain to be answered.
Developing an effective REMS program – one designed to preserve access for every person who would benefit from a medication while avoiding exposure in situations and individuals with excessive risk factors – is a challenge. The difficulty increases when the risks expand beyond inadvertent misuse to also include intentional abuse.
Recently the FDA signaled its intent to tackle risks involving opioids that have both significant benefits for certain segments of patients and also the potential for misuse and abuse. On March 3, the FDA will sit down with 15 manufacturers of 24 opioid medications to begin the process of outfitting them with REMS.
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