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.
COVID impacted all REMS programs. Physical distancing was an issue for medications that required extensive postadministration monitoring (ie, esketamine and olanzapine for ER injectable suspension). Access to laboratory services was an issue for clozapine.
Medication-specific themes are listed in Table 3 and relate to terms and descriptions in the REMS or additional regulatory requirements from the Drug Enforcement Agency (DEA). Suggestions for improvement to the REMS are presented in Table 4.
Recommendations for improving REMS
A group consisting of health care professionals, policy experts, and mental health advocates reviewed the information provided by the focus groups and developed the following recommendations.
Overarching recommendations
Each REMS should include a section providing justification for its existence, including a risk analysis of the data regarding the risk the REMS is designed to mitigate. This analysis should be repeated on a regular basis as scientific evidence regarding the risk and its epidemiology evolves. This additional section should also explain how the program requirements of the REMS as implemented (or planned) will achieve the aims of the REMS and weigh the potential benefits of the REMS requirements as implemented (or planned) by the manufacturer vs the potential risks of the REMS requirements as implemented (or planned) by the manufacturer.
Each REMS should have specific quantifiable outcomes. For example, it should specify a reduction in occurrence of the rate of the concerned risk by a specified amount.
