US Food and Drug Administration REMS Program

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We received a question recently from a reader, asking for details on REMS – Risk Evaluation and Mitigation Strategy programs – that are often mentioned in Drug Cards.  Here is a brief summary of the REMS system.  Additional information can be found on the FDA web site, and links to those resources are provided below.

The US Food and Drug Administration (FDA) was given the authority to require REMS programs as part of the Food and Drug Administration Amendments Act (FDAAA) of 2007.  A program can be required for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.  REMS are designed to ensure medication use behaviors (related to prescribing, dispensing, administering and monitoring) that support the safe use of that medication.  While all medications are associated with some risk, REMS are not designed to mitigate all the adverse events of a medication.  They are required when certain specific risks exist that might otherwise limit the approvability and use of medications.  At this time, there are 76 REMS approved by the FDA, and a link below can be used to access a full list of REMS.

REMS can be required when medications are first approved by the FDA when risks associated with the use of a medication is known from initial clinical trials, or may be added after marketing when risks are recognized through routine clinical experience.  While the FDA places the REMS requirement and enforces its use, the responsibility for creating and implementing the REMS is placed on the product manufacturer.

REMS programs place requirements and restrictions on many individuals involved in the medication use process, including prescribers, dispensers, those who administer medications and even medication distributors.  There are a number of different requirements that may be placed in a REMS – each is different and tailored to the specific issues presenting safety concerns with an individual medication.  Some REMS require patient education (through Medication Guide requirements, as described below), training and certification for prescribers, specific patient testing to ensure adequate monitoring for adverse effects, or track patient use through registry systems.

Medication Guides are paper handouts that FDA requires to be provided to patients when certain medications are dispensed.  The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. The Medication Guide program is separate from the REMS program.  While many REMS programs include a Medication Guide requirement, there are hundreds of products that require Medication Guides but are not in the REMS program.  A list of products that currently have a Medication Guide requirement can be found using the link below, to the FDA web site.

Additional information about REMS can be found on the FDA web site using links below.

References

Use this link to the FDA web site for more information about REMS.

Use this link for the list of products currently requiring REMS.

Use this link for the list of products that currently require Medication Guides.


Many products that require REMS are can be found in the Top 300 Pharmacy Drug Cards or the Top 100 Nonprescription Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Flash Card section.  If your institution does not provide access, ask your medical librarian about subscribing.

For a chance to win GREAT prizes and learn more about medications in the Top 300, check out the Drug Card Scavenger Hunt page on AccessPharmacy. Follow us to receive email alerts when new Drug of the Week and Drug Card Scavenger Hunt updates are posted.

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Jill Kolesar & Lee Vermeulen

Professors, University of Kentucky

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