REMS Summary of Terms

RISK EVALUATION AND MITIGATION STRATEGY (REMS)

A REMS is a program established under the Food and Drug Administration Amendments Act of 2007 (FDAAA). The FDAAA grants the FDA the authority to require a drug manufacturer to develop and implement a REMS if the FDA determines a REMS is necessary to ensure that the benefit of a drug outweighs the risks. The FDA considers risk management to be the continuing process of minimizing risks throughout a product’s life cycle to optimize its benefit-risk balance. For more information, please go to http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

REMS ELEMENTS

A REMS may include one or more of the following: A Medication Guide or patient package insert for patients, a Communication Plan for healthcare providers, and Elements to Assure Safe Use (ETASU), which often involve some form of restricted distribution and/or evidence of safe-use conditions.

Medication Guide

A Medication Guide provides FDA-approved patient labeling. A Medication Guide can be required if the FDA determines one or more of the following apply:

• Patient labeling could help prevent serious adverse events.
• The product has serious risks that could affect a patient’s decision to use or continue to use the drug.
• Patient adherence to directions is crucial to product effectiveness.

A Medication Guide must be used as a review tool in counseling the patient on the risks of the prescribed medicine. Healthcare providers are required to dispense a Medication Guide with each prescription.

Communication Plan

A Communication Plan is targeted at healthcare providers to support implementation of the REMS. The communication plan may include sending letters to healthcare providers; disseminating information about REMS elements to encourage implementation by healthcare providers or to explain certain safety protocols, such as medical monitoring by periodic laboratory tests; or disseminating information to healthcare providers through professional societies about any serious risks of the drug and any protocol to assure safe use.

Elements to Assure Safe Use (ETASU)

ETASU are intended to provide safe access for patients to drugs with known serious risks that would otherwise be unavailable. Required ETASU are put in place to mitigate a specific serious risk listed in the labeling of a drug. ETASU can include one or more of the following requirements:

• Prescribers have particular training or experience, or are specially certified
• Certification of dispensers
• Drug administration restricted to certain healthcare settings
• Documentation of safe-use conditions prior to dispensing
• Monitoring of patients
• Enrollment of patients in a registry