A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if the Food and Drug Administration (FDA) determines that a REMS is necessary to ensure the benefits of the drug or biological product outweigh its risks. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system. This resource center contains information for pharmacists, patients, and other healthcare professionals about REMS, and the specific requirements for drugs that require a REMS.
Each drug with a REMS is listed in the database, with answers to 12 basic questions that will allow you to quickly and easily determine the REMS requirements for each particular drug. The REMS database is protected by copyrights owned by the American Society of Health-System Pharmacists®.
See an example of the REMS requirements for Epoetin alfa (Procrit®, Epogen®)
Thank you to James M. Hoffman, Medication Outcomes & Safety Officer, St. Jude Children's Research Hospital, and Tara K. Jellison, Clinical Pharmacy Manager, Parkview Hospital, Fort Wayne, IN, for their significant contributions in keeping this website up-to-date.
For questions, comments or more information on this resource center, please contact the Section of Ambulatory Care Practitioners:
This website is updated on a routine basis, but to ensure you have the most up-to-date REMS information, please check the FDA Website:
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