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.

Access the REMS Database

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®)