FDA Announces New Risk Mitigation Strategy To Address Opioid Crisis

As part of the ongoing effort to combat opioid addictions, federal regulators have announced more stringent guidelines for transmucosal immediate-release fentanyl (TIRF) drugs, to mitigate the risk of abuse and misuse.

On December 23, the FDA announced new guidelines to strengthen the Risk Evaluation and Mitigation (REMS) program for  fentanyl, amid a worsening opioid addiction crisis.

TIRF medicines are used to manage breakthrough pain in adults with cancer who routinely take opioid pain medicines around-the-clock for pain. TIRF medicines should only be used by patients who are tolerant to opioids. However, according to the FDA, while overall TIRF use has declined, it is still often prescribed to patients who are not opioid tolerant. The REMS program modifications finalized last week are meant to address that problem.

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The new guidelines require doctors to document patient’s opioid tolerance with each TIRF prescription, require outpatient pharmacies dispensing TIRF medicines to document and verify a patient’s opioid tolerance before dispensing, require inpatient pharmacies to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized, and require a new patient registry to monitor for accidental exposure, misuse, abuse, addiction, and overdose.

The guidelines focus on ensuring the benefits of the use of TIRF medicines outweighs the risks.

The FDA evaluated the opioid analgesic REMS and hosted a workshop, inviting discussions about methods to evaluate the impact of opioid REMS on prescriber behavior for treatment and monitoring of patients with pain.

In recent years much attention has focused on doctor prescribing habits and how they contribute to the development of the opioid crisis. Data indicates roughly one-third to half of all patients don’t need opioids to treat their pain and are prescribed the narcotic painkillers inappropriately. Many doctors prescribe more opioids than they realize, often because they are rewarded by drug companies to prescribe more painkillers.

The new REMS guidelines are part of the FDA’s ongoing focus to decrease unnecessary exposure to prescription opioids and prevent new addiction. The new REMS guidelines are the latest in a number of steps the FDA has taken in recent years to confront the worsening opioid crisis.

“Effectively addressing the opioid crisis requires continued focus and collaboration across many different stakeholders,” the press release states. “The FDA’s REMS are an important tool, and it’s critical we ensure they are continuing to fulfill their purpose.”


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