Approved Risk Evaluation and Mitigation Strategies Materials (REMS) dataset lists all materials related to REMS process.
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. Together, the goal, communications and/or activities make up the safety strategy.
Each REMS is designed to help one or more of the key participants in a REMS address a specific safety concern.
The most common role(s) of each of the key participants in the Risk Evaluation and Mitigation Strategy (REMS) (e.g., patients, health care providers, pharmacists and health care settings that dispense or administer the drug) are further described below. While these roles may be broadly similar across programs, the specific requirements and key risk messages of each REMS are specific to each medication, the nature of its risks, and the likely setting in which the drug will be or is used.
Patients play an essential role in REMS. The patient role varies and depends on the requirements of the REMS. Patients may receive specific information or counseling about a serious risk associated with the medication, what action they need to take to mitigate a serious risk, and/or what symptoms they need to watch for and/or report to their healthcare provider.
For some medications, patients must sign a form acknowledging that they understand those risks before starting the medication. For other medications, patients need to undergo lab testing. For some REMS, patients must enroll in a registry to ensure monitoring is conducted or to document if a specific adverse event occurs while he or she is taking the medication.
It is important for patients to follow any requirements to ensure that there is no delay or stopping of treatment. For some REMS, patients may not be able to receive the medication until the required documentation is completed.
Patients may also be asked to take surveys about the REMS. The surveys help FDA evaluate the effectiveness of the REMS.
It is important to keep in mind that REMS provide a way for patients to have access to medications with serious risks that would otherwise not be available.
Health care providers with prescribing privileges (e.g., physicians, physician’s assistants, nurse practitioners, or other health care providers) play a key role in ensuring that products with serious risks requiring REMS are prescribed and used safely.
The requirements for health care providers will vary for each REMS. For most REMS, health care providers may receive REMS communications from the manufacturers. Certain REMS may have other requirements for health care providers, such as enrollment in the REMS, completion of training, documentation of counseling of patients, enrollment of patients, monitoring, and/or documentation of compliance with certain safe use conditions.
Pharmacists and other practitioners who dispense medicines play a key role in ensuring that products with serious risks requiring REMS are dispensed and used safely.
The requirements for pharmacists will vary somewhat for each REMS and may vary by setting (e.g., retail pharmacy or inpatient pharmacy). For some REMS, pharmacists and other dispensers will receive REMS communications from the manufacturers.
Certain REMS may also require pharmacies or other healthcare settings to become certified to dispense the REMS medication. Certification generally requires that the pharmacy or the healthcare setting identify an authorized representative to complete the certification process. Generally, the authorized representative enrolls the pharmacy or setting, completes the required training, ensures that policies and procedures put in place to implement the REMS requirements are followed, and ensures staff are trained and comply with the REMS requirements.
Individual pharmacists may be required to complete training, verify safe use conditions (e.g., verifying required laboratory monitoring or that a patient or prescriber is enrolled in the REMS), counsel patients, and/or provide the patient with educational materials or a Medication Guide.