Asked by: Demelsa Koerfer
asked in category: General Last Updated: 12th May, 2020

What is a REMS medication?

A Risk Evaluation and Mitigation Strategy ( REMS ) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

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Similarly, you may ask, what does REMS stand for?

Risk Evaluation and Mitigation Strategy

Subsequently, question is, what is REMS pharmacovigilance? Risk evaluation and mitigation strategies ( REMS ) are designed and implemented during the commercialization of a pharmaceutical product to ensure an acceptable risk-to-benefit ratio for products that are known to exhibit specific risks. Elements to assure safe use (ETASU) development, implementation and management.

Similarly, how many drugs have REMS programs?

As of 2018, there are 74 medications subject to REMS monitoring. 62% of these include "elements to assure safe use". These typically require clinicians or health care institutions to become certified prior to prescribing. 12% include only a "communication plan" REMS element which is informational in nature.

How do I get REMS certification?

Prescribers must complete the following requirements to be enrolled: 1. Review the TIRF REMS Access education materials (TIRF REMS Access Education Program), including the Full Prescribing Information (FPI) for each TIRF medicine, and successfully complete the Knowledge Assessment (Knowledge Assessment).

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