REMS (Risk Evaluation and Mitigation Strategy)

What Is REMS?

A risk evaluation and mitigation strategy (REMS) is an FDA-required safety program for a particular drug or group of drugs when additional measures are necessary to ensure benefits outweigh risks. A boxed warning or Medication Guide alone does not establish that a current REMS exists.

Possible Program Elements

Programs differ. Not every REMS requires enrollment, pharmacy certification, or laboratory results. Check the current FDA listing and the exact product's program before dispensing.

Examples and a Removed Program

Removal of the clozapine REMS does not remove the neutropenia risk. Prescribers should continue ANC monitoring according to the prescribing information. The pharmacy must follow current labeling and clinical review requirements without treating the removed program as active.

Technician Responsibilities

• Identify whether the actual product has a current REMS.
• Assist with the specific administrative checks required by that program.
• Refer laboratory interpretation, clinical eligibility, and counseling to the pharmacist or prescriber.
• Distribute required patient information and document authorized actions.
• Escalate missing program authorization before completing dispensing.

Exam Alert

Distinguish ordinary labeling requirements from additional REMS controls. Learn ETASU and recognize iPLEDGE as an example, while remembering that REMS programs can change or be removed.

Sources: FDA participant roles; FDA clozapine REMS removal; FDA iPLEDGE.