U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Science & Research
  3. Science and Research Special Topics
  4. Advancing Regulatory Science
  5. Quantifying the relationship between inappropriate prescribing of opioid-tolerant-only medications to patients without prior opioid tolerance and opioid-related harms
  1. Advancing Regulatory Science

Quantifying the relationship between inappropriate prescribing of opioid-tolerant-only medications to patients without prior opioid tolerance and opioid-related harms

CERSI Collaborators: William Becker, MD (Yale), W. Michael Hooten, MD (Mayo Clinic), Molly Jeffery, PhD (Mayo Clinic) (PI), Hongfang Liu, PhD (Mayo Clinic), Joseph Ross, MD, MHS (Yale), Nilay Shah, PhD (Mayo Clinic)

FDA Collaborators: Catherine Dormitzer, PhD, MPH, Faith England, Christina Greene, PhD, Cynthia Kornegay, PhD, Mark Liberatore, PharmD, RAC, Judith Racoosin, MD, MPH

CERSI Subcontractors: Optum Labs- Omid Ameli, MD, Maureen Carlyle, MPH, Christine Chaisson, MPH, William Crown, PhD, Pamela Hansen, Erin Hulbert, MS, Jane Sullivan, Margot Walthall, MHA

Project Start Date: August 2017

Regulatory Science Challenge

A previously completed project investigated if opioids were prescribed correctly according to their labeling with respect to whether the patients who are prescribed these medicines can tolerate these drugs based on their prior exposure to opioid analgesics, which are commonly used for pain relief. The project team discovered that more than half of patients starting these drugs had no prior evidence of opioid tolerance. This is inconsistent with how these drugs are advised to be prescribed based on the labelling. These prescribing behaviors may create safety risks for patients; however, the severity of this risk and prevalence of harms are not well described.

Project Description and Goals

This project used Optum medical billing and mortality data to measure the risk of opioid-related harms associated with inappropriately prescribing any opioid analgesic labeled for opioid-tolerant patients to individuals who do not meet the opioid tolerance requirements. In addition, the project also identified factors associated with these harms. The project goals were to examine the risks of potentially inappropriate prescribing to patients using the medical billing data, and to analyze any mortality seen in this study using the National Death Index. Ultimately, the findings from this study will help us better understand the prescribing patterns of these products. This, in turn will aid in the ongoing efforts to ensure safe use of opioid analgesics.

 

 

Back to Top