Risk Evaluation and Mitigation Strategies is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for seriousadverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. The REMS program was formalized in 2007. The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacture of the brand name drug. The FDA may remove the REMS requirement if it is found to not improve patient safety. The REMS program developed out of previous systems dating back to the 1980s for monitoring the use of a small number of high-risk drugs such as the Accutane, which causes serious birth defects, Clozaril, which can cause agranulocytosis, and Thalidomide, which is used to treat leprosy but causes serious birth defects. The 2007 Food and Drug Administration Amendments Act created section 505-1 of the Food, Drug, and Cosmetic Act which allowed for the creation of the REMS program for applying individual monitoring restrictions to medications. Some of the provisions required by the REMS program are training and certification of physicians allowed to prescribe the drug, requiring that the drug be administered in a hospital setting, requiring pharmacies to verify the status of patients receiving REMS drugs, requiring lab testing of patients to ensure that health status is satisfactory, or requiring that patients be entered into a registry.
Usage
As of 2018, there are 74 medications subject to REMS monitoring. 62% of these include "elements to assure safe use". These typically require clinicians or health care institutions to become certified prior to prescribing. 12% include only a "communication plan" REMS element which is informational in nature. These communication plans are typically composed of letters, websites, and fact sheets describing the specific safety risks identified in the REMS. 26% include only the "medication guide" REMS element.
