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  1. Advancing Regulatory Science

Prescription Stimulants for Attention-Deficit/Hyperactivity Disorder (ADHD): Prescribing Patterns and Associated Consequences in the Veterans Health Administration

CERSI Collaborators: E. Jennifer Edelman, MD, MHS; Christopher T. Rentsch, PhD, FISPE; Charles Warnock, MPH, PhD; David A. Fiellin, MD, Amy Justice, MD, PhD

FDA Collaborators: Silvia Perez-Vilar, PhD, PharmD; Jana Mcaninch, MD, MPH, MS; Rose Radin, PhD; Tamra Meyer, PhD; Celeste Mallama, PhD; Andrew D Mosholder, MD, MPH; Yandong Qiang, MD, PhD, MPH, MHS; Marc Stone, MD; Camille Smith, MS, PharmD

Project Start: March 18, 2024

Regulatory Science Framework

Primary Charge: II. Strengthen post-market surveillance and labeling of FDA-regulated products: A. Methods to Assess Real-World Data to Support Regulatory Decision-Making
Secondary Charge: III. Invigorate public health preparedness and response of FDA, Patients & Consumers: D. Substance Use and Misuse

Regulatory Science Challenge

Stimulant medications for attention-deficit/hyperactivity disorder (ADHD) are effective treatments, but they may also be associated with stimulant use disorder and cardiovascular and neuropsychiatric complications. These risks have not been fully characterized, particularly in adults receiving these medications. Because stimulant medications are increasingly prescribed in adults, there is a need to identify factors that influence stimulant medication prescribing and quantify related health consequences. Using real-world data from the largest integrated healthcare system in the United States, investigators aim to increase FDA’s understanding of stimulant medication prescribing and safety in adults.

Project Description and Goals

Investigators aim to understand current patterns of prescription stimulant prescribing and health outcomes associated with prescription stimulant receipt among adult patients diagnosed with ADHD. Using rich, longitudinal electronic health record data for >13.5 million patients receiving care from the Department of Veterans Affairs (VA), the largest integrated healthcare system in the United States, investigators will specifically: 1) characterize patterns of and identify patient- and facility-level factors associated with receipt of prescription stimulant medication; 2) test and validate the accuracy of structured data to identify patients with ADHD and stimulant use disorder using medical records as the reference standard; and 3) examine the association between receipt of prescription stimulant medication and incident stimulant use disorder and other neuropsychiatric outcomes as well as cardiovascular outcomes.

Anticipated Outcomes/Impact

At the end of this project, investigators aim to enhance the FDA’s and other stakeholders’ understanding of who is most likely to receive prescription stimulants, the settings in which they are most likely to be prescribed, and risks associated with prescription stimulant receipt among Veterans with diagnosed ADHD, ultimately providing evidence to help improve the health and well-being of these vulnerable populations. Findings will be disseminated via presentations at national and international scientific conferences, publication in peer-reviewed scientific literature, and presentations, interim and final reports to the FDA.

 
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