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Risk Evaluation and Mitigation Strategies
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<p>Risk Evaluation and Mitigation Strategies (REMS) is a program of the US <a href="/facts/Food_and_Drug_Administration/rCEnh9WB">Food and Drug Administration</a> for the monitoring of medications with a high potential for serious <a href="/facts/Adverse_effects/vAhfbr1J">adverse effects</a>. REMS applies only to specific prescription drugs, but can apply to brand-name or generic drugs. The REMS program was formalized in 2007. </p><p>The FDA determines as part of the <a href="/facts/New_drug_application/Hdkw0Mzl">drug approval process</a> 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 manufacturer of the brand-name drug. The FDA may remove the REMS requirement if it is found to not improve patient safety. </p><p>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 <a href="/facts/Isotretinoin/XBKv4fQJ">isotretinoin</a>, which causes serious birth defects; <a href="/facts/Clozapine/N0Lqztg1">clozapine</a>, which can cause <a href="/facts/Agranulocytosis/3AP5MDpD">agranulocytosis</a>; and <a href="/facts/Thalidomide/FWQGuD2A">thalidomide</a>, which is used to treat leprosy and certain cancers but causes serious birth defects. The 2007 Food and Drug Administration Amendments Act created section 505-1 of the <a href="/facts/Food,_Drug,_and_Cosmetic_Act/2WIHtPjC">Food, Drug, and Cosmetic Act</a>, which allowed for the creation of the REMS program for applying individual monitoring restrictions to medications. </p><p>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. </p>