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FDA determines if a REMS is necessary. The agency may seek information from outside experts or other participants (e.g., patients and health care providers), or may seek advice through an FDA advisory committee in making this determination.

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.

REMS may require the drug manufacturer to communicate directly to health care providers, pharmacists, nurses and other participants involved in the delivery of health care or medications. They may provide information about a specific serious risk associated with that medication and steps to take to reduce the risk.

Risk Evaluation and Mitigation Strategies (REMS)

Types of REMS Requirements. REMS include a risk mitigation goal, and are comprised of information communicated to and/or required activities to be undertaken by one or more participants (e.g., health care providers, pharmacists, patients) who prescribe, dispense or take the medication.

Risk Evaluation and Mitigation Strategies (REMS)

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.

Which pain medicines are included in this REMS? The branded and generic drug products subject to this REMS include all the following: Oral dosage forms containing: codeine and codeine analogs, , , , meperidine, , , , , , .