Starting Doses of Buprenorphine to Reduce Non-Fatal Overdoses and Prevent Mortality

CERSI Collaborators: Triangle CERSI: Nabarun Dasgupta, MPH, PhD

FDA Collaborators: Silvia Perez-Vilar, PhD, PharmD; Jana McAninch, MD, MPH, MS; Candice Collins, DrPH, MPH; Amy Seitz, PhD, MPH; Tamra Meyer, PhD, MPH; Yan Li, PhD; Natasha Chihying Pratt, PhD; Brian Gac, PharmD; Olga Rass, PhD; Bartholt Bloomfield-Clagett, MD, MPH

CERSI Subaward Collaborators: University of Kentucky: Daniela C. Moga, MD, PhD, FISPE; Svetla Slavova, PhD, Reuben Adatorwovor, PhD, Michelle Lofwall, MD, DFAPA, DFASAM; Patricia Freeman, RPh, PhD, FAPhA, FNAP; Feitong Lei, PhD

Project Start Date: September 20, 2024

Regulatory Science Framework:

Strengthen post-market surveillance and labeling of FDA-regulated products, Methods to Assess Real-World Data to Support Regulatory Decision-Making

Regulatory Science Challenge:

Buprenorphine is an effective medication for managing opioid use disorder and can be prescribed by any DEA-licensed healthcare practitioner. However, our previous work with FDA suggested that in current clinical practice some patients may not achieve the full benefit of the medication because they are receiving buprenorphine doses that are inadequate. Therefore, we will use advanced epidemiologic methods to examine what doses may be optimal for preventing overdose and reducing mortality.

Project Description and Goals:

We will use healthcare records from Kentucky, linking with prescription dispensing data and death certificates, to create a specially designed database that allows us to employ a study design intended to evaluate questions of cause-and-effect. Specifically, we will compare standard medication doses to see which are associated with the greatest reduction in overdose over a period of time. Because many factors can influence both the dose a patient is prescribed and their risk of overdose, we will use advanced statistical methods to measure and account for differences between individual patients.

Anticipated Outcomes/Impact:

In conjunction with FDA, we will devise and implement analyses about buprenorphine dosing in treatment of opioid use disorder to inform clinical, regulatory, and policy decisions. A scientific paper and presentations will provide evidence for policymakers in considering the appropriateness of rules governing buprenorphine prescribing and dispensing. We also anticipate the findings may lead to changes in professional medical society clinical guidelines.