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Reduction in Medication Errors: The Fentora Case Study.

Gopal Reddy Palvatla1, Irwin G Martin1

  • 11 School of Health Sciences, Eastern Michigan University, Ypsilanti, MI, USA.

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Summary
This summary is machine-generated.

The Risk Evaluation and Mitigation Strategy (REMS) for Fentora (fentanyl citrate) significantly reduced prescribing errors. This cooperative FDA and industry effort improved the safe use of this breakthrough pain medication.

Keywords:
FDAFentorafentanylprescribing errorrisk evaluation and mitigation strategy

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Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Regulatory Science

Background:

  • Fentora (fentanyl citrate) is an opioid analgesic for breakthrough cancer pain.
  • Medication errors, predominantly prescribing errors, were reported after Fentora's 2006 launch.
  • A Risk Evaluation and Mitigation Strategy (REMS) was implemented in 2011.

Purpose of the Study:

  • To evaluate the impact of the REMS program on the safe use of Fentora.
  • To assess the reduction in prescribing errors following REMS implementation.

Main Methods:

  • Analysis of reported medication errors before and after REMS implementation.
  • Comparison of prescribing error rates pre- and post-REMS.

Main Results:

  • A rapid and significant decrease in reported prescribing errors was observed after the REMS initiation.
  • The REMS program appears to have positively impacted the safe use of Fentora.

Conclusions:

  • The REMS program demonstrated a substantial positive effect on reducing prescribing errors for Fentora.
  • This case highlights the potential of FDA and industry collaboration through REMS to enhance pharmaceutical product safety.