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 are designed to reinforce medication use behaviors and actions that support the safe use of that medication. While all medications have labeling that informs health care stakeholders about medication risks, only a few medications require a REMS.
REMS are not designed to mitigate all the adverse events of a medication, these are communicated to health care providers in the medication’s prescribing information. Rather, REMS focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.
REMS in Action: An Example
Here is one example of a product that has a serious risk and a REMS. The set of REMS requirements were designed to make sure all patients receive special monitoring during the period when a side effect is most likely to occur so it can be detected and treated:
Zyprexa Relprevv is a long-acting injectable anti-psychotic medication used to treat schizophrenia in adults. Zyprexa Relprevv can cause serious reactions following injection called post-injection delirium sedation syndrome. Symptoms, including feeling sleepier than usual (sedation), coma, and feeling confused or disoriented (delirium) occurred in clinical studies within 3 hours after treatment with Zyprexa Relprevv. The risk of post-injection delirium sedation syndrome is present with every injection, although it is a small risk - less than 1 percent.
To reduce the risk of post-injection delirium sedation syndrome, FDA required the manufacturer of Zyprexa Relprevv to develop a REMS. The purpose of the REMS is to ensure that the drug is administered only in certified health care facilities that can observe patients for at least three hours and provide the medical care necessary in case of an adverse event.