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  1. Advancing Regulatory Science

Evaluation of the REMS Programs for Psychiatric Medications

CERSI Collaborators: University of Maryland: Catherine E. Cooke (PI), PharmD, MS, Raymond C. Love, PharmD and Megan Ehret, PharmD, MS

FDA Collaborators: Gita A. Toyserkani (PI), PharmD, MBA, Esther Zhou (Co-PI), MD, PhD, Barbara Bergquist, PharmD, Leah Hart, PharmD, Kate Heinrich, MA, and Cynthia LaCivita, PharmD

Project Start Date: July 1, 2020

Regulatory Science Challenge

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS programs may require that extra safety measures are performed by healthcare professionals and patients to ensure the drug is used safely. These requirements may have unintended consequences on patient access or cause burden on various stakeholders (e.g., hospitals, doctors’ offices, clinics and pharmacies). Because of these issues, it is important to carefully look at the REMS programs to make sure they help patients and minimize unintended problems.

Project Description and Goals

This project will focus on the REMS programs for three psychiatric medications used by community psychiatrists. These medications are clozapine, esketamine (Spravato) and olanzapine for extended-release injectable suspension (Zyprexa® Relprevv™). It will provide input from healthcare providers on what is working well with these REMS programs and potential areas that may cause burden to health workers or cause hospitals, doctors’ offices, and clinics to use additional resources. When the project is completed, a report will provide ideas to the FDA about how to improve REMS programs for these three psychiatric medications.

A Steering Committee will oversee the project and a Working Group will look at the various requirements of each REMS program. The Working Group will develop questions to ask health workers about the REMS programs. The health workers will meet to discuss how these programs can be improved. Finally, the Steering Committee will approve a report for the FDA that summarizes what everyone had to say about the REMS programs and suggestions on how they could be improved.

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