CERSI Collaborators: Yale University: Henry Park, MD, MPH (PI); Joseph Ross, MD, MHS (CERSI PI); Molly Jeffery, PhD (CERSI PI); Cary Gross, MD (Co-I); Laura Baum, MD, MPH (Co-I); Michaela Dinan, PhD (Co-I); Vikram Jairam, MD (Co-I); Nitu Kashyap, MD (Co-I); Michael Leapman, MD (Co-I); Kathryn Ruddy, MD(Co-I); Pamela Soulos, MPH (Co-I); Madhav KC, PhD, MPH (Co-I); Michelle Bernabeo (PM)

FDA Collaborators: Catherine Lerro, PhD, MPH; Hana Lee, PhD; Corinne Woods, RPh, MPH; David Graham, MD, MPH; Donna Rivera, PharmD, MSc; Mark Liberatore, PharmD, RAC; Amy Ho, PharmD, BCPS; Kate Gelperin, MD; Steve Bird, PharmD, PhD

Project Start Date: May 10, 2021

Regulatory Science Challenge

Many efforts are underway to improve overall opioid stewardship; however, the long-terms effects of opioid prescribing practices for cancer-related pain in the United States remain unknown. Patients with advanced or metastatic cancer are at high risk of experiencing acute and chronic pain that can impact quality of life; but patients with localized cancers may have less need for opioid therapy to treat long-lasting cancer-related pain. While efforts indicate a reduction in the overall quantity of opioids dispensed, it remains unclear how these initiatives have impacted the complex needs of patients with cancer. It is important to assess these efforts using a nuanced approach involving stage of disease and type of cancer treatment, to better evaluate patterns of opioid use in patients with cancer.

Project Description and Goals

This study aims to characterize the possible impact of governmental and institutional opioid-reduction efforts on cancer patients for whom these medications may be intended or required, by conducting population-level analysis using SEER-Medicare data and health system analysis using Yale New Haven Hospital data. The goal of this project is to advance knowledge through regulatory science using large complex real-world data sources, generate new insights about the impact of opioid stewardship practices and characterize access to opioid treatment for cancer patients.

Goal 1: Conduct population-level analysis to assess trends in receipt of new opioid use and new persistent opioid use among Medicare beneficiaries from 2012-2017, across four distinct cancer staging and treatment scenarios.

Goal 2: Conduct health system analysis to assess trends in new opioid prescription and new persistent opioid use among patients with cancer in a large health care delivery system from 2016-2020, focusing on three distinct cancer staging and treatment scenarios.