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The somatosensory cortex in the parietal lobes is crucial for interpreting sensory data such as touch, temperature, and proprioception. The somatosensory cortex, situated in the parietal lobes, plays a vital role in interpreting sensory information like touch, temperature, and proprioception—awareness of body position. This specialized brain region features an organized structure wherein neurons at the top primarily process sensations originating from the lower body. In contrast, those at...
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Association of a Risk Evaluation and Mitigation Strategy Program With Transmucosal Fentanyl Prescribing.

William Fleischman1,2, Doris Auth3, Nilay D Shah4,5

  • 1Department of Patient Safety & Quality, Hackensack Meridian Health, Edison, New Jersey.

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The Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) temporarily reduced TIRF prescribing. The REMS program also decreased TIRF prescriptions for patients without opioid tolerance.

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Area of Science:

  • Pharmacology
  • Public Health
  • Health Policy

Background:

  • Transmucosal immediate-release fentanyl (TIRF) drugs are potent opioids for breakthrough cancer pain in tolerant patients.
  • A US Food and Drug Administration-approved Risk Evaluation and Mitigation Strategy (REMS) was implemented in March 2012 for TIRF drugs.

Purpose of the Study:

  • To evaluate the association of the TIRF-REMS Access Program with TIRF prescribing patterns.

Main Methods:

  • A cohort study utilized interrupted time series analysis of TIRF prescriptions for Medicare Part D beneficiaries from 2010 to 2014.
  • Outcomes included TIRF prescribing rates, and the percentage of prescriptions for patients without cancer or opioid tolerance.

Main Results:

  • TIRF-REMS implementation was associated with a 26.7% decrease in TIRF prescribing, followed by monthly increases.
  • No significant changes were observed in prescriptions for patients without cancer, though a sensitivity analysis showed a decrease.
  • A 22.5% decrease in TIRF prescriptions for patients without known opioid tolerance was observed, followed by monthly decreases.

Conclusions:

  • The TIRF-REMS Access Program temporarily reduced TIRF prescribing rates.
  • The program sustained a decrease in TIRF prescriptions for patients without known opioid tolerance.
  • Implementation may have also temporarily reduced TIRF prescriptions for patients without cancer.