Raymond C. Love, PharmD, BCPP, FASHP Professor and Vice Chair
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Department of Practice, Sciences, and Health Outcomes Research University of Maryland School of Pharmacy Baltimore, Maryland
Disclosures A research project cooperative agreement between the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the US Department of Health and Human Services (HHS) FDA was signed in May 2020. This award was issued to reflect a supplement to support FDA Center for Drug Evaluation and Research and M-CERSI research projects. One of these projects, Evaluation of the Risk Evaluation and Mitigation Strategy (REMS) Programs for Psychiatric Medications, is the subject of this article. Grant number: 3U01FD005946-04S2. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the US Government. Dr. Ehret has served as a consultant to Saladex Biomedical. The other authors report no financial relationships with any companies whose products are mentioned in this article, or with manufacturers of competing products.
Recommendations for olanzapine for ER injectable suspension REMS
Provide clear explicit instructions on what is required to have “ready access to emergency services.”
Ensure the REMS include patient-specific adjustments to allow flexibility for postadministration monitoring (eg, sedation or blood pressure). Specific patient groups may have differential access to certain types of facilities, transportation, or other resources. For example, consider the administration of olanzapine for ER injectable suspension by a mobile treatment team with an adequate protocol (eg, via videoconferencing or phone calls).
Ensure actions with peer-reviewed evidence demonstrating efficacy/effectiveness are included in the REMS. How was the 3-hour cut-point determined? Has it been reevaluated?
Ensure the REMS requirements allow for seamless care during transitions, particularly when clinicians are on vacation.
