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REMS Resource Center

REMS Resource Center

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 Members Only

ASHP's easy to use database contains basic information about each medication along with its risk management program. Use the alpha list below to select from the generic drug name. 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. See an example of the REMS requirements for Epoetin alfa (Procrit®, Epogen®)

more A to G - drug listed by generic name
more H to P - drug listed by generic name
more Q to Z - drug listed by generic name

REMS Resources

  

FDA Provided Information

Special Thanks

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.

Contact Us

For questions, comments or more information on this resource center, please contact the Section of Ambulatory Care Practitioners:




Disclaimer

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: