About Us
As a REMS provider, Presonyx manages the safe use of specific medications by facilitating patient enrollment and educating patients, prescribers, and pharmacies about associated risks to ensure the proper prescribing and dispensing of pharmaceuticals. We monitor compliance with REMS requirements, collect and report data for audits, and maintain clear communication among all parties. To best support you and your partners, we offer dedicated assistance, including 24/7 pharmacist availability, to ensure effective medication management and patient safety.
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What is REMS?
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. 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.
What Makes Up a REMS?
A REMS includes a risk mitigation goal, and is comprised of information communicated to and/or required activities to be undertaken by one or more participants who prescribe, dispense or take the medication. Together, the goal, communications and/or activities make up the safety strategy.
What Drives a REMS Safety Strategy?
Each REMS is designed to help one or more of the key participants in a REMS address a specific safety concern. These roles may be similar across programs, but the specific requirements and risk messages of each REMS is tailored to each medication, the nature of its risks, and the likely setting in which the drug will be, or is being, used.
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Benefits section contains member benefits information.