Risk Evaluation and Mitigation Strategies (REMS) is a program of the US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

for the monitoring of medications with a high potential for serious

adverse effects An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complica ...

. 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 Isotretinoin, also known as 13-''cis''-retinoic acid and sold under the brand name Accutane among others, is a medication primarily used to treat severe acne. It is also used to prevent certain skin cancers (squamous-cell carcinoma), and in th ...

, which causes serious birth defects, Clozaril, which can cause

agranulocytosis Agranulocytosis, also known as agranulosis or granulopenia, is an acute condition involving a severe and dangerous lowered white blood cell count (leukopenia, most commonly of neutrophils) and thus causing a neutropenia in the circulating blood. ...

, and

Thalidomide Thalidomide, sold under the brand names Contergan and Thalomid among others, is a medication used to treat a number of cancers (including multiple myeloma), graft-versus-host disease, and a number of skin conditions including complications o ...

, 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 The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...

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. __TOC__

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.

Communication aspect

In 2020, clinical settings enrolled in the REMS program asked the FDA to make their reviews of REMS compliance public so that they can more easily view the records and adjust to feedback. Between 2014 and 2017, the FDA stated they did not have enough data to determine whether the REMS program was sufficiently preventing opioid abuse. The Health and Human Services Office of the Inspector General recommended that parties in the REMS program provide the FDA more data. The FDA was habitually late in evaluating that data, reportedly leaving those parties with inadequate time to react to the review before their next assessment. In November 2020, the FDA planned to create a “Summary of the REMS Assessment” document that would publicize their assessments of clinical settings and manufacturers in the REMS program. The FDA made a public request for comment on the idea of publishing the Summary of the REMS Assessment. Without the publication of the Summary, parties in the REMS program must request it using the Freedom of Information Act.

References

{{reflist Drug safety Food and Drug Administration 2007 establishments in the United States