CERSI Collaborators: Triangle CERSI: Stefanie Ferreri, PharmD (co-PI); Tamera Hughes, PharmD, PhD (co-PI); Delesha Carpenter, PhD; Lori Armistead, MA, PharmD; Tamara Baker, PhD; Abby Gamble, MA; Jacquelyn Covington (PM); Jennifer Cavender, MPH (PM); Paul Watkins, MD (CERSI PI/ UNC); Susan Halabi, PhD (CERSI PI/Duke); Robert Mentz, MD(CERSI PI/Duke); Ehsan Samei, PhD (CERSI PI/Duke)

FDA Collaborators: FDA CDER SMEs: Olga Rass, PhD (Lead); Caroline Huang, PhD; Veronica Uzoebo, EdD, MBA, MS, MA; Blair Coleman, PhD, MPH; Lukas Glos, MA; Henry Appiah, PharmD; Sheheryar Muhammad, PharmD; Amy Seitz, PhD, MPH; Candice Collins, DrPH; Mitra Ahadpour. MD, DABAM; Nancy Chang, MD; Sandrine Ly, PharmD; Paula Rausch, PhD, RN; Brian Gac, PharmD; Hillary Dolinsky, MBA, MSW (PM); FDA OMHHE SMEs: Christine Lee, PharmD, PhD; Julie Hsieh, PhD, MPH

Project Start Date: September 8, 2023

Regulatory Science Framework

Charges: Invigorate Public Health Preparedness and Response of FDA, Patients & Consumers
Topic Area: Substance Use & Misuse

Regulatory Science Challenge

The misuse of opioid medications harms many people, impacting both patients and communities. Some populations and geographic areas have less access to support services for opioid misuse, resulting in greater health harms. For example, the number of opioid overdose deaths has been increasing in the United States, especially for those living in rural areas and among racial and ethnic minority communities (e.g., non-Hispanic Black or African American people and non-Hispanic American Indian or Alaska Native people).

New approaches are needed to help reduce harms from opioid misuse by supporting treatment for opioid use disorder and increasing access to medications that reverse opioid overdoses for all people, regardless of where they live or who they are.

Project Description and Goals

The goal of this project is to understand how community pharmacies work collaboratively with patients to reduce the harm that opioid misuse can cause. Investigators are also seeking to understand what challenges community pharmacies face when trying to decrease harm from opioids by supporting safe use of opioid medications and access to medications for opioid use disorder treatment and opioid overdose reversal.

Information gathering efforts are being focused on community pharmacies that serve racial and ethnic minority communities in rural areas. Triangle CERSI scientists are working collaboratively with the FDA to survey and interview pharmacists, pharmacy technicians, patients, and other community members to collect and analyze data needed to better understand community pharmacy challenges in these areas. Ultimately, investigators seek to explore effective ways to reduce the harm from opioid misuse among underserved communities.