NCCN Resource Tool: Risk Evaluation & Mitigation Strategies (REMS)

View all Drugs with REMS for:

• Active Treatment
• Supportive Care Indications

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What are REMS?

Effective March 25, 2008, the Food and Drug Administration Amendments Act of 2007 (FDAAA) reserved the right for the U.S. Food and Drug Administration (FDA) to order Risk Evaluation & Mitigation Strategies (REMS) for drugs or biologics with significant toxicity levels and/or demonstrable risk factors. These strategies are meant to ensure that the benefits of particular drugs continue to outweigh the risks that they pose for patients. REMS are currently being mandated to assess adverse risks associated with specific oncologic drugs, biologics, and supportive care therapies.

There are three components to a REMS program:

1. a medication guide or a patient package insert
2. a communication plan for healthcare providers
3. elements to assure safe use (ETASU).

A drug's REMS program may not require the provision of all three components, as the specific components a REMS program employs will vary based on the severity of the risks, the population likely to be exposed, and other factors. In fact, the most common REMS only require the provision of a medication guide.

While REMS components are not uniform, some do and will contain new provisions and requirements for physicians and other certified health care providers. For REMS requiring ETASU, clinicians may be required to:

• obtain and dispense drugs through specific distribution channels
• possess specific training, education, experience, or certification(s) in order to prescribe these drugs
• enroll patients in registry programs
• issue mandatory, time-sensitive reports of patient responses to treatment

Your ability to prescribe and dispense certain medications, even some that have been on the market for years, could be contingent upon compliance with these REMS provisions.

For a comprehensive list of FDA-approved REMS, please visit: FDA-Approved REMS.

Companies interested in supporting a link to REMS Information: Contact Sherry Ulrich, MBA, Market Insights & Business Analytics Program Manager.