What it means
For some drugs, the FDA requires extra steps beyond the label to make sure the benefits outweigh the risks. A REMS can require a medication guide for the client, special training or certification for prescribers and pharmacies, lab tests before each refill, or enrollment of the client in a registry. Examples include isotretinoin (the iPLEDGE program), clozapine and mifepristone.
For the nurse
Know which drugs on the unit have a REMS and follow its steps, such as checking that required lab tests are done and giving the client the medication guide.
At a glance
| Also written | Risk Evaluation and Mitigation Strategy, Risk Evaluation and Mitigation Strategies |
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Related terms
mifepristone
A drug that blocks the hormone progesterone, used with misoprostol to end an early pregnancy, and for some hormone disorders.
isotretinoin
A vitamin A-related drug taken by mouth for severe acne that has not cleared with other treatment.