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 health care 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.

Below are some questions and answers patients and caregivers might find useful:

1. Why does my medication need a REMS?

   If FDA identifies serious safety concerns either before the medication is approved or after the medication is marketed, it can require a REMS to help ensure the benefits of the medication outweigh its risks.  When deciding to approve a medication, FDA determines that the medication is both effective and safe. A medication is considered safe for purposes of medication approval if the benefits of using the medication are greater than the risks. However, there still may be serious risks associated with the medication. A REMS can help to ensure that the medications are used safely and allow FDA to approve medications that have these risks and would otherwise not be available.

2. As a patient, what is my role in the REMS?

   Patients should follow all the requirements of the REMS. You may be counseled about the serious risks of your medication and your role in taking the medication safely. In some REMS, patients will be asked to follow requirements. This may include identifying and reporting side effects to your doctor, getting lab tests done, reporting on completion of REMS requirements and/or telling other health care providers that you are taking a medication that can have a serious risk.

   It may be helpful for you to ask a caregiver or partner to help you understand the risks and follow the REMS requirements.

3. Will I have to undergo special tests?

   Some REMS medications require special tests or some type of monitoring before, during and/or after treatment. For example, you may need to get lab work done for blood cell counts or liver function tests while taking the REMS medication. You may not be able to get your REMS medication if you do not complete the required tests.

4. Do I have to enroll in a special database?

   Some REMS require you to be enrolled in the REMS or be included in a database or registry that keeps track of the patients receiving the medication and any side effects they may have. Your health care provider will usually enroll you.

   You may also be asked to participate in surveys to measure your understanding of the risk of the drug and the actions you must take to use the drug safely.

5. Can I get my medications from my regular pharmacy?

   Your healthcare provider should give you information about where you can get your REMS medication. Certain REMS medications can only be given to patients in certain healthcare settings (like a hospital or infusion center). Some REMS medications may only be available through certain pharmacies. Other REMS medications can be filled at your regular pharmacy.  Wherever you get your medications, your pharmacist may ask you additional questions or want to discuss the medication with you to ensure that you are aware of the risks and how to use the medication safely.  

6. Can patients provide input or feedback on a REMS?

   Patients are the most important group that FDA thinks about when approving these medications and deciding the requirements of the REMS. REMS are implemented to ensure patient safety and allow patient access to the REMS medication. 

   FDA values patient feedback. If you have feedback or questions about a specific REMS, you can contact FDA at 1-855-543-3784, [email protected] or use the Contact REMS Form.

7. What happens if I switch doctors?

   Depending on the REMS, your new doctor may have to enroll in the REMS for you to continue receiving your medication. This is important to ensure that each doctor is aware of the REMS requirements and all doctors are aware that you are taking a medication with a REMS.  Be sure to let your new doctor know of any REMS medications that you are taking.

8. How do I prevent an interruption or delay in treatment?

   It is important that you get needed labs tests and allow enough time for refills, as it may take longer than other medications that you take.

   If you maintain two permanent residences (for example a "snowbird" or a college student), you should let your healthcare provider know when you will be living in the second residence. The health care provider who prescribed the medication with a REMS will need to make arrangements to conduct lab testing, if required by the REMS, and ensure medication refills are available at the second residence. 

   If you have questions or concerns, contact your health care provider or pharmacist.

9. Where do I go if I have questions?

   It is best to talk to your health care provider if you have a specific question about the benefits and risks of the medication and what requirements you might have under the REMS. If you have questions about a specific REMS, you can contact the FDA or contact a specific REMS.

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.

Details about each REMS, including health care providers’ role, can be found at REMS@FDA, in product labeling or on REMS-specific websites.

Below are some question and answers that health care providers may find useful:

1. Why is a drug required to have a REMS?

   FDA requires REMS when risk mitigation measures beyond FDA-approved labeling are necessary to ensure that the benefits of the medication outweigh the risks. Medications with a REMS would not be approved or would be withdrawn from the market without the REMS in place due to known or potential serious risks associated with the drug product.

2. Who decides if a drug will have a REMS?

   FDA determines if a REMS is necessary. The agency may seek information from outside experts or other participants (e.g., patients and health care providers), or may seek advice through an FDA advisory committee in making this determination. FDA notifies the drug manufacturer of the requirements of the REMS, and the manufacturer submits a proposed REMS for FDA review. Once FDA determines the REMS proposal is acceptable, FDA will approve the REMS. The drug manufacturer is responsible for implementing the requirements of the REMS. 

3. What is the health care provider role in the REMS? What do I have to do?

   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 prescribers will vary for each REMS. For most REMS, prescribers may receive REMS communications from the manufacturers. Certain REMS may require you to enroll in the REMS, complete training, document counseling of patients, enroll patients, perform monitoring, and/or document compliance with certain safe use conditions.

   Details about each REMS, including your role, can be found at REMS@FDA, in product labeling, or on REMS-specific websites.

4. Do I have to enroll the patient in the REMS?

   Some REMS require patient enrollment. Enrollment is used to keep track of the patients receiving the medication, required documentation, laboratory results, and/or adverse events or patient outcomes. Health care providers (or their designee) generally enroll patients. Depending on the program, this may require you to complete and submit a form, either by mail, fax, or online, or by telephoning a contact center. 

5. Can the patient get their medication from their regular pharmacy?

   Certain REMS medications can only be dispensed in specific healthcare settings, such as hospitals or infusion centers.  For example, Lemtrada (a medication used for Multiple Sclerosis) is restricted to hospitals or infusion centers because of the risk of serious and life-threatening infusion reactions. Certain REMS may require the pharmacies to become certified. Sabril (vigabatrin), an anticonvulsant, is currently only available in an inpatient setting or from pharmacies that are able to comply with the REMS’ requirements. Healthcare providers and patients should check with the individual REMS to confirm how to obtain the medication.

6. Is there monitoring involved with medications that are under a REMS?

   Some REMS medications do require monitoring and, at times, there is a need to document that monitoring took place (e.g., lab test results). Since each REMS is different, patients should access the REMS website to determine the specific requirements of a given program. In the case of a drug that requires a specific lab test result or some other type of monitoring took place prior to dispensing, the health care provider’s responsibility may be to order, evaluate, and in some cases, document the information to the REMS.  Health care providers may also have to attest that patients have been counseled and monitored for adverse events associated with the drug. 

7. Am I required to complete specific training?

   Some REMS have required training that includes passing a knowledge assessment before being able to prescribe the drug. Information about training or any other requirements can be found at REMS@FDA, in product labeling, or on REMS-specific websites.

8. Are there restrictions on the amount of medication that I can order to be dispensed?

   Some REMS medications are also controlled substances and are subject to federal and state laws regarding scheduled medications. Additionally, some REMS medications have restrictions on the number of refills allowed or the days supply dispensed. For example, a medication that can cause birth defects may be limited to a one-month supply at a time and cannot be refilled unless certain criteria are met, such as confirmation of a negative pregnancy test.

9. What happens if I get a new patient who is on a REMS medication?

   Depending on the REMS, you may have to enroll in the REMS to prescribe the specific medication for your patient. If it is a drug that you are not familiar with, the prescribing information and the REMS requirements can be found at REMS@FDA.

10. How do I prevent an interruption or delay in treatment for my patient?

    Depending on the REMS, your patient may have to undergo specific monitoring or you may be required to order specific lab tests. It is important that you order the appropriate lab tests and remind your patients to have the lab work completed for them to pick up or receive their medication. Some REMS will require you to document the results of the lab tests (e.g., pregnancy tests or blood cell counts). Additionally, you may need to remind your patient to allow additional time for refills, as it may take the pharmacy longer than normal to refill a REMS medication.

11. What happens if my patient has multiple residences?

    If your patient maintains two permanent residences, such as "a snowbird" or a college student, you and your patient will need to consider alternatives based on the REMS requirements. You may be able to meet the requirements by sharing care with another certified prescriber, using an electronic methodology such as electronic health records to verify required laboratory results long distance, and/or having the patient continue to receive their medicine through a single pharmacy. The best way to determine how to handle this will depend on the REMS requirements and what you and your patient agree is doable to meet the REMS requirement. 

12. If a product has a REMS, can I submit the prescription electronically or send the patient home with a prescription? 

    REMS vary in their requirements for both health care providers and pharmacies.  For some REMS, you can counsel patients and provide a prescription the way you always have.  For other REMS, you will need to send the prescription to a specialty pharmacy to have the prescription dispensed, or complete a separate prescription ordering form.  Specific details can be found at REMS@FDA, in product labeling, or on REMS-specific websites.

13. If I don’t prescribe the REMS medication, how does the REMS affect me?

    Even if you don’t prescribe a REMS medication, you may treat a patient who is taking a medication with a REMS. For example, if you work in an emergency department, you may be treating a patient who experienced a serious adverse event related to a drug he or she is already taking that has REMS requirements. If you work in an inpatient setting, it may be important for you to understand that the hospital may not stock certain REMS medications. The approved prescribing information is a good resource for medication information, as well as information about specific requirements to continue that patient on the REMS medication.  Approved prescribing information can be found at Drugs@FDA or DailyMed. Information about REMS requirements can be found at REMS@FDA, in product labeling, or on REMS-specific websites.

14. How does FDA address the potential administrative burden of REMS on providers and dispensers?

    REMS requirements have raised concerns about the administrative burdens placed on already busy health care providers that might increase the amount of time before patients can start taking needed medications. FDA makes every effort to make REMS requirements the least burdensome they can possibly be, and FDA has the authority to require the manufacturer to modify the REMS to minimize the burden on the health care delivery system. The goal is to maintain patient access while still preserving safe use of a drug.

15. REMS can be time consuming with all the associated paperwork. Is there a way to reduce that?

    FDA acknowledges that the REMS will add some additional burden to health care providers who prescribe a medication with a REMS. To reduce some of the administrative burden associated with completing required paperwork, some sponsors have set up online portals to assist with enrolling multiple patients. In other circumstances, hospitals and practices have trained or provided dedicated time for a staff member to assist with fulfilling the REMS requirements. Some programs that require frequent interactions or activities, such as documenting monthly laboratory results, have allowed health care provider designees to perform some of the administrative functions.

    If you have feedback or suggestions for reducing the administrative burdens of a REMS, you can contact FDA.

16. When I finally figure out what I have to do within a REMS, it changes. Why is that?

    REMS are reviewed and re-assessed on a regular basis to make sure the programs are meeting their goals and not putting unnecessary burdens on participants (e.g., health care providers, pharmacists, and patients).  For example, a REMS modification may be required if a REMS is not sufficiently educating health care providers about key risk messages. Additionally, a REMS may be modified to allow for alternative methods to enroll such as an online option if the original REMS did not include that option. REMS modifications may also occur to align a REMS communication or education materials with changes to FDA-approved prescribing information.

17. Where do I go if I have questions or feedback to offer?

    If you have questions or feedback about a specific REMS you can contact FDA or contact the specific REMS. 

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.

Details about each REMS, including the roles of pharmacies and healthcare settings, can be found at REMS@FDA, in product labeling, or on REMS-specific websites.

Below are questions and answers that pharmacists and other dispensers may find useful:

1. Why is a drug required to have a REMS?

   FDA requires REMS when risk mitigation measures beyond FDA-approved prescribing information are necessary to ensure that the benefits of the medication outweigh the risks. Medications with a REMS would not be approved or would be withdrawn from the market without the REMS in place due to known or potential serious risks associated with the drug product. 

2. Who decides if a drug will have a REMS?

   FDA determines that a REMS is necessary. The agency may seek advice from outside experts, stakeholders (e.g., patients and healthcare providers), and/or through an FDA advisory committee in making this determination. FDA notifies the drug manufacturer of the requirements of the REMS, and the manufacturer submits a proposed REMS for FDA review. Once the FDA determines the REMS proposal is acceptable, it approves the REMS. The drug manufacturer is responsible for implementing the requirements of the REMS. 

3. What does dispensing a REMS medication entail?

   Many REMS do not require pharmacists to do anything outside of their normal dispensing activities. However, for certain REMS, pharmacists and other dispensers may need to complete training, verify safe use conditions (e.g., verifying required laboratory monitoring or that a patient or health care provider is enrolled in the REMS), counsel patients, and/or provide the patient with educational materials or a Medication Guide prior to dispensing a medication with a REMS. Not every program will require these steps, so it is important to check the REMS@FDA website or the manufacturer’s REMS website for a complete list of requirements for the specific medication to be dispensed.

4. Do I, or does my healthcare setting or pharmacy, have to enroll in a certain program? 

   Some REMS require that a pharmacy or healthcare setting be certified to be able to receive or dispense the medication. To fulfill this requirement, the pharmacy or health care setting may identify an authorized representative to enroll on behalf of the pharmacy or setting. However, in some cases, every pharmacist who dispenses the medication may be required to complete training to meet this requirement. Individual pharmacists or pharmacy staff may also be required to enroll to obtain authorization to dispense. Not every program will require these steps, so it is important to check the REMS@FDA website or the manufacturer’s REMS website for a complete list of requirements for the specific medication to be dispensed.

5. Does the patient have to be enrolled in a certain program?

   Some REMS require the patient to be enrolled. In most cases, health care providers enroll patients.  The pharmacist may need to verify that the patient is enrolled before dispensing the medication. Depending on the program, this may require a phone call to the REMS call center, verification through the specific product REMS website, or verification that is built into the pharmacy management system.

6. Does the health care provider have to be enrolled in a certain program?

   Some REMS will require the health care provider to be certified or enrolled. The pharmacist may need to verify that the health care provider is certified or enrolled before dispensing the medication. Depending on the program, this may require a phone call to the REMS call center, verification through the specific product REMS website, or verification that is built into the pharmacy management system.

7. Do I have to dispense a Medication Guide or any other material to the patient?

   All Medication Guides are approved as part of labeling, but only a small number of Medication Guides are included as part of REMS.

   REMS may also provide additional patient-focused materials for distribution or may require patient counseling by pharmacists to ensure that patients are educated about specific risks of the medication. Pharmacists may need to answer patient questions that arise after the patient reads a Medication Guide, other patient focused materials, and/or during patient counseling.

8. Is there monitoring involved with medications that are under a REMS?

   Some REMS medications do require documentation of specific lab test results or some other form of patient monitoring. In the case of a drug that requires specific lab test results or some other type of monitoring prior to dispensing, the pharmacist is responsible for verifying that the lab test or other monitoring tests have been completed before filling or refilling a medication. Depending on the program, verification of the specific requirement may require a phone call to the REMS call center, verification through the specific product REMS website, or verification that is built into the pharmacy management system. If the information cannot be verified, the pharmacist may need to contact a health care provider’s office to ensure the lab test or other monitoring requirement was ordered or conducted.

9. Can I order a medication with a REMS through my usual supplier?

   Check with the individual REMS to confirm the distribution requirements, as some REMS medications can only be obtained from a specific supplier or may not be able to be delivered to all pharmacy settings.

10. I understand pharmacists may have to verify safe use conditions. How is that done?

    Pharmacists play a key role in REMS as the last checkpoint before patients receive their medication. In many REMS with participant requirements, pharmacists are asked to go to a website or a contact a call center to verify that certain safe use conditions are in place prior to dispensing. For example, pharmacists may need to confirm that the prescriber or patient is enrolled or the patient has undergone laboratory monitoring. Certain programs verify safe use conditions directly through the pharmacy management system using an electronic verification system, sometimes referred to as a “switch.”

11. Am I required to complete training?

    Some REMS have required training for pharmacists which may include passing a knowledge assessment test. For most REMS, the authorized pharmacy representative is required to take the initial training that is part of the certification process for pharmacies and to make sure all pharmacists are trained. Information about training or any other requirements can be found at REMS@FDA, in product labeling, or on REMS-specific websites.

12. Are there restrictions on the amount of medication that can be dispensed?

    Some REMS medications have additional restrictions on the number of refills allowed or the days supply dispensed. For example, a medication with a risk of teratogenicity (ability to cause birth defects) may be limited to a one-month supply at a time and may not be refilled unless certain criteria are met, such as verification of a negative pregnancy test.

13. My hospital /health care setting isn’t certified in any REMS, so how does REMS affect me?

    Even if your hospital/health care setting isn’t certified to dispense a REMS drug, a patient who is on a REMS medication may be admitted to your hospital or to your emergency department. For example, if you work in an emergency department, you may be treating a patient who experienced a serious adverse event related to a drug he or she is already taking that has REMS requirements. Patients on a REMS drug may also be admitted to your hospital for an unrelated reason and may need to continue treatment on their REMS drug. If you work in an inpatient setting, it may be important for you to understand that your hospital may not stock certain REMS medications. The approved prescribing information is a good resource for medication information as well as information about specific requirements to continue that patient on a REMS medication.  Approved prescribing information can be found at Drugs@FDA or DailyMed. Information about REMS requirements can be found at REMS@FDA, in product labeling, or on REMS-specific websites.

14. Am I, or is my pharmacy, subject to an audit?

    REMS are subject to assessment plans which help FDA determine if the REMS is meeting its goals. If the REMS has pharmacy requirements, the pharmacy may be subject to an audit by FDA, the manufacturer, or a third party on behalf of the manufacturer, to assess if the pharmacy is meeting requirements.

15. How does FDA address the potential administrative burden of REMS on health care providers and dispensers?

    REMS requirements have raised concerns about the administrative burdens placed on already busy health care providers that might increase the amount of time before patients can start taking needed medicines. FDA makes every effort to make REMS requirements the least burdensome they can possibly be, and FDA has the authority to require the manufacturer to modify the REMS to minimize the burden on the health care delivery system of complying with the REMS. The goal is to maintain patient access while still preserving safe use of a drug.

16. Where do I go if I have questions?

    If you have questions about a specific REMS you can contact FDA or contact the REMS program directly.

17. How can I provide feedback?

    Pharmacist feedback is valued by FDA. If you have feedback or questions about a specific REMS, you can contact FDA. Additionally, you can report drug errors, adverse events, or other safety aspects related to REMS medications to Medwatch. 

More detailed descriptions of individual REMS can be found on the REMS@FDA website.

The following resources can help drug manufacturers and other entities that are involved or interested in the process of planning, developing, submitting for approval, implementing, assessing, and/or modifying REMS.

Since this a continuously evolving area of updated policies, public meetings, and additional guidances, manufacturers and others are encouraged to review this section on a regular basis for the most current information.

FDA Guidances: REMS and Drug Safety

• Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency – Guidance for Industry and Healthcare Professionals
  • This Guidance communicates FDA’s temporary policy for certain REMS requirements involving laboratory testing or imaging studies and continuity of care for patients during the COVID-19 public health emergency  

• Revised Draft Guidance for Industry on Format and Content of a Risk Evaluation and Mitigation Strategy Document

  • This guidance establishes a new REMS document template, designed to make a REMS document easier to write, review and read.

• Guidance for Industry: Use of a Drug Master File (DMF) for Shared System REMS Submissions

  • Use of the DMF is an efficient method for sponsors to coordinate the submission of shared system REMS-related files to FDA.

• Risk Evaluation and Mitigation Strategies: Modifications and Revisions – Guidance for Industry

  • This guidance provides information on how FDA will define and process submissions from application holders for modifications and revisions to approved REMS. Specifically, this guidance provides information on what types of changes will be considered modifications and what types of changes will be considered revisions of the REMS.

• FDA’s Application of Statutory Factors in Determining When a REMS is Necessary

  • This guidance is intended to clarify how FDA applies the factors set forth in section 505-1 of the Federal Food, Drug, and Cosmetic Act in determining whether a REMS is necessary to ensure that the benefits of a drug outweigh its risks.