Evaluation of the REMS Programs for Psychiatric Medications-View Recording

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Video Summary

In honor of World Schizophrenia Day, researchers from the University of Maryland, including Catherine Cook, Dr. Megan Errett, and Dr. Ray Love, presented their collaborative project with the FDA. The project examined the perspectives of healthcare providers using medications associated with REMS (Risk Evaluation and Mitigation Strategies) to manage specific psychiatric drugs like esketamine, olanzapine, and clozapine. The researchers sought to offer recommendations for improving REMS to balance patient access, safe medication use, and healthcare professional workload.<br /><br />The team conducted focus groups exploring how REMS impacts prescriber workload, patient safety, and access. Findings revealed that while REMS increase awareness of specific medication risks, they also result in considerable administrative burdens on providers, potentially limiting patient access and giving certain REMS drugs a stigma.<br /><br />Recommendations aimed at the FDA included advocating for transparent criteria justifying REMS needs, enhancing REMS integration with health records and pharmacy systems, and promoting standardization across different REMS. They emphasized the importance of involving more diverse healthcare stakeholders in REMS development processes to anticipate unanticipated consequences.<br /><br />The research underscored the necessity of balancing REMS goals of heightened patient safety and improved drug risk awareness with the realities of increased workloads for healthcare providers. This requires ongoing dialogue among policymakers, healthcare professionals, and stakeholders to refine and optimize REMS frameworks.

Keywords

World Schizophrenia Day

University of Maryland

REMS

esketamine

olanzapine

clozapine

patient safety

healthcare providers

FDA recommendations

medication access