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BACKGROUND

In 2007, the Food and Drug Administration (FDA) mandated special requirements from drug manufacturers known as Risk Evaluation and Mitigation Strategies (REMS) through the FDA Amendments Act of 2007, sometimes called FDAAA1. The purpose of REMS is to ensure that the benefits of a drug outweighs its risks. A REMS acts as a safety strategy to manage a known or potential serious risk associated with a drug while allowing patients to continue on treatment with the drug. REMS may be required as part of a new product approval, or for an approved product with new safety information is gathered. Drug sponsors, which are usually pharmaceutical companies, develop REMS programs and FDA reviews and approves them. FDA also has the authority to require a REMS before or after a drug is approved.

REMS COMPONENTS

A REMS component may be simply dispensing a Medication Guide, Patient Package Insert, or be more extensive, such as a communication plan or implementation system (such as sending out "Dear Doctor" letters). Another and last component of REMS is called Elements to Assure Safe Use (ETASU) which are required medical interventions drugs being dispensed in certain settings such as infusion settings or specialty pharmacies only, or patient registries and prescribers having specific required trainings. Note that some REMS may apply to the entire drug classes (i.e. extended-release or long-acting opioids). This section focuses on REMS drugs with Medication Guides.

At the time of this publication, there are 75 REMS in place for medications. 44 include ETASU as part of their REMS, 13 include only a communication plan, and 18 include only a medication guide requirement.2

MEDICATIONS GUIDES AND REMS REQUIREMENTS

Medication guides are required to be dispensed with the drug and are written in non-technical language in a standardized format. They are provided in addition to the general information sheets. Table 1 below provides a brief list of medications that require Medication Guides in addition to other REMS components.

Table 1Medications with REMS Requirements2,3

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