RM Alert: REMS

What is a REMS?

The Food and Drug Administration Amendments Act of 2007 gave the FDA authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers.

This strategy would ensure the benefits of certain drugs or biological products with serious safety concerns would help outweigh the risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. There are 62 medications on the current REMS list. REMS are not designed to mitigate all adverse events of medication but rather focus on preventing, monitoring, and/or managing specific risks. They also work to inform, educate, and/or reinforce the actions of patients and providers to reduce the frequency and/or severity of events. A complete listing of approved REMS can be found at https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm.

Recent REMS information has been popping up due to system changes associated with more frequently dispensed medications such as isotretinoin and clozapine. The FDA has temporarily suspended the updated clozapine REMS due to system issues. For more information on the suspension, visit https://www.fda.gov/drugs/drug-safety-and-availability/fda-temporarily-suspending-certain-clozapine-rems-program-requirements-ensure-continuity-care.

In addition, pharmacists should be aware that the FDA will modify the iPLEDGE REMS effective December 13, 2021. The modification to the system will start December 10 at 11:59 EST, and the system will be unavailable December 11-12. Patients needing their prescription for isotretinoin on either of those days should be instructed to fill the medication on December 10 or wait until December 13. For more information, visit the iPLEDGE Risk Evaluation and Mitigation Strategy webpage at https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation-strategy-rems.

Changes to REMS affect providers, pharmacists, and patients’ access to medications. Stay abreast of changes with these drugs so you can better assist providers and their patients.

For additional information, please contact us at riskmgmt@phmic.comcreate new email.