CERSI P.I.s and Collaborators: Catherine E. Cooke, Pharm.D., M.S., UMB School of Pharmacy, Raymond C. Love, Pharm.D., UMB School of Pharmacy, Megan Ehret, Pharm.D., M.S., UMB School of Pharmacy
FDA SME and Collaborator: Gita A. Toyserkani, (PI) Pharm.D. M.B.A., CDER FDA, Esther Zhou, M.D., Ph.D., Barbara Bergquist, Pharm.D., Leah Hart, Pharm.D., Kate Heinrich, M.A., and Cynthia LaCivita, Pharm.D., Co-PIs CDER FDA
FDA SME and Collaborator: Gita A. Toyserkani, (PI) Pharm.D. M.B.A., CDER FDA, Esther Zhou, M.D., Ph.D., Barbara Bergquist, Pharm.D., Leah Hart, Pharm.D., Kate Heinrich, M.A., and Cynthia LaCivita, Pharm.D., Co-PIs CDER FDA
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.
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.
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