1. Aschenbrenner, Diane S. MS, RN


* The Food and Drug Administration has added an online table to its risk evaluation and mitigation strategy (REMS) Web page that summarizes information on the REMS for every drug with a high risk of serious adverse effects.


* Nurses should educate patients receiving any of the drugs listed in this table on the potential risks and to self-monitor for adverse effects.



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This column often highlights the safety precautions to take with drugs for which the Food and Drug Administration (FDA) requires a risk evaluation and mitigation strategy (REMS). Now, the FDA has revised the REMS page on its website to include a table of all the REMS drugs in one place ( The table lists these drugs by both trade and generic name. It also includes information on when the REMS was approved and last updated; whether a medication guide is available; a link to the drug's communication plan, if there is one; a link to elements required to ensure safe use; and whether there is an implementation system for the drug. The communication plan provides an online summary of key information related to the drug's risks, as well as links to full prescribing information, medication guides, and downloads of REMS communications such as "Letters to Healthcare Providers," fact sheets, and "Letters to Professional Societies" supplied by the pharmaceutical company. The elements required to ensure safe use include the information needed by all REMS participants (patients, pharmacies, and health care providers).


The REMS program stems from 2007 legislation in which the FDA was given the authority to require safety provisions for a drug as a way of guaranteeing that the benefits of a drug outweigh its serious risks. Organ damage, fetal effects (such as toxicities, developmental consequences, and teratologic effects), and severe allergic reactions are examples of serious risks. Participants should use the REMS program when a drug's basic labeling information is considered insufficient to guarantee its safe use. Managing a drug's risk requires active participation from everyone involved, including patients. Drugs can receive a REMS designation from the FDA when first approved or whenever a serious risk becomes known (this information may come from a research study, published case reports, or reports to the FDA's MedWatch program, for example).


Nurses and NPs should be familiar with the REMS for any drug their patients receive. Understanding the professional responsibilities for safe use is crucial. Medication guides, when available, are dispensed with each filled prescription. Patient education should include both a review of the information in the medication guide and an emphasis on the importance of reading the guide with each filled prescription. Regular reading of the medication guide provides the patient with the most up to date information about potential serious adverse effects as well as guidance on self-monitoring. Early recognition of a serious adverse event through active self-assessment decreases the risk of injury from continued drug use.


For more information about REMS see