What's in a REMS?

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 these key participants in a REMS are further described elsewhere. 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.

A document that describes the specific requirements for each participant in the REMS, as well as materials to support the REMS, can be found on the REMS@FDA website. Manufacturers often make REMS materials available at a product or REMS specific website.

General descriptions of the major components of REMS are further described below.

Most REMS include a communication component about the specific safety risk or risks that the REMS is intended to mitigate. Some REMS include additional requirements such as clinical activities that the health care providers may need to perform prior to prescribing or dispensing a medication to the patient.

Communicating to Patients

REMS may require the drug manufacturer to develop materials for patients, such as Medication Guides, which are the handouts for patients distributed with many prescription medicines. These handouts contain FDA-approved information in patient-friendly language that can help inform patients about how to use a medication and avoid serious adverse events. Medication Guides are generally provided to the patient at the time the medication is dispensed or administered. All Medication Guides are approved as part of a drug’s labeling, but only a small number of Medication Guides are included as part of REMS.

Communicating to Health Care Providers, Pharmacists and Health Care Settings

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. In some cases, the communications may also target medical professional societies or state licensing boards to make them aware of the REMS, certain safety concerns, and/or to support conveying this information to their members.

Required Activities or Clinical Interventions

REMS may also require participants to conduct activities that support the safe use of the medication. In certain cases, these activities must be undertaken before the medication can be prescribed, dispensed, or received.

These types of requirements or activities are also referred to as “elements to assure safe use (ETASU)” and some examples include:

Health care providers who prescribe the drug have specific training/experience or be specially certified

Prescribers may be required to become certified and/or take training prior to prescribing the REMS drug. As part of the certification, prescribers may need to enroll in the REMS and agree to carry out certain activities for safe drug use. For example, a prescriber may be required to agree to counsel their patients about the particular risk or agree to enroll and/or monitor patients throughout the treatment course.

Pharmacies, practitioners, or health care settings that dispense the drug may be specially certified

Pharmacies, practitioners, or other health care settings that may dispense REMS medications may be required to take the training, train staff, and oversee all processes and procedures needed to implement the REMS requirements. For example, a pharmacy may need to put a process in place that includes verifying that the prescriber of a REMS drug is certified, patients are enrolled, and that laboratory testing or other certain safe use conditions have been carried out prior to dispensing the drug.

Drug be dispensed only in certain health care settings such as hospitals

FDA may require that a REMS drug be dispensed or administered only in a particular setting. For example, a drug may need to be administered or dispensed only in health care settings that have immediate access on-site to supplies and personnel trained to manage a particular adverse event.

Drug be dispensed with evidence of safe-use conditions such as laboratory test results

FDA may require that a REMS drug be dispensed with evidence of safe use conditions. One example of a safe use condition involves ensuring that health care providers and patients have signed a patient-prescriber agreement for a drug that can cause birth defects, so they understand the risk and the need to verify a negative pregnancy test before the drug is dispensed to those patients who could potentially be pregnant.

Each patient using the drug be subject to monitoring

FDA may require that patients using the drug are subject to certain monitoring during and/or after treatment. For example, patients may need to have periodic vision monitoring if the drug is associated with the risk of vision loss.

Each patient using the drug be enrolled in a registry

In certain REMS, patients who take the REMS drug may be required to be enrolled in a patient registry. The patient registry may include all patients enrolled or a subset of all enrolled patients that experience the adverse event of concern. The purpose of a patient registry is to follow patients during and in some cases after treatment with the drug

A brief video with more information about REMS

Current REMS

FDA maintains a website listing medication with approved REMS that are currently active and their associated materials, at (REMS@FDA).