A Risk Evaluation and Mitigation Strategy (REMS) is a structured drug safety program the U.S. Food and Drug Administration (FDA) can require for certain prescription medications. The purpose of a REMS is to manage known or potential serious risks associated with a drug, ensuring that its benefits continue to outweigh its inherent risks. This regulatory tool allows medically necessary drugs with significant hazards, such as the potential for severe organ damage or birth defects, to remain available under strictly controlled conditions. The program is developed by the drug manufacturer but must be approved and overseen by the FDA.
Defining Risk Evaluation and Mitigation Strategies
The FDA requires a REMS program when routine risk management tools, such as professional labeling and standard warning information, are insufficient for maintaining a favorable benefit-risk profile. This necessity arises when a drug, while highly effective, carries a specific, severe safety concern that requires active intervention beyond simple warnings. For example, a REMS might be mandated for a drug carrying a risk of severe liver toxicity, a life-threatening allergic reaction, or a high potential for causing serious birth defects.
The strategy allows the FDA to approve drugs where the risk is high but manageable through targeted safety measures. Without a REMS, many medications used to treat serious diseases would either not receive FDA approval or would be withdrawn from the market due to unacceptable risks. The complexity of the REMS is tailored to the drug’s specific risk profile, ranging from basic information distribution to highly restrictive dispensing requirements.
Mandatory Components of a REMS Program
A REMS program often includes two primary components aimed at communicating risk and ensuring safe use behaviors: the Medication Guide and the Communication Plan.
The Medication Guide is an FDA-approved handout written in patient-friendly language that must be dispensed with the medication. This guide informs the patient about the medication’s serious risks, what symptoms to watch for, and how to use the drug safely to avoid adverse events. Medication Guides are required when patient adherence to directions is crucial or when the risk might influence a patient’s decision to use the drug.
The Communication Plan is directed toward healthcare professionals, including prescribers, pharmacists, and other relevant staff. This plan outlines how the drug manufacturer will inform these groups about the serious risks and the specific requirements of the REMS program. Manufacturers typically use letters to healthcare providers, educational materials, and outreach through professional societies to disseminate this safety information. These components reinforce the safety information already found in the drug’s professional label.
Ensuring Patient Safety Through Elements To Assure Safe Use (ETASU)
For medications with the most serious risks, the REMS includes Elements To Assure Safe Use (ETASU). These are strictly controlled requirements put in place before the drug can be prescribed or dispensed. ETASU ensure that the benefit-risk ratio remains positive by requiring specific actions from prescribers, dispensers, and patients. These elements are the most extensive and restrictive part of a REMS program and directly limit access to the drug.
A common ETASU requirement is that prescribers must complete specific training or become certified before writing a prescription. Similarly, the pharmacy or dispenser may also need to be certified and agree to carry out safety activities, such as verifying patient enrollment or required lab work. This certification ensures that providers understand the risks and know how to monitor and manage potential adverse events.
Many ETASU programs require documentation of safe use conditions before dispensing. This might involve mandatory laboratory testing, such as a negative pregnancy test for drugs known to cause birth defects, or evidence of specific patient monitoring.
Restricted Settings and Patient Enrollment
Some drugs may only be administered in a restricted healthcare setting, such as a hospital or specialized clinic, to ensure immediate access to necessary equipment for managing a severe reaction. Patients may also be required to enroll in a registry or sign an informed consent form acknowledging the drug’s risks and agreeing to necessary monitoring. These mandatory actions establish a closed-loop system where prescribing, dispensing, and patient use are monitored to prevent specific, severe outcomes.