What are REMS Medications?

Published: January 06, 2022
Indrani Kar
By Indrani Kar, PharmD
By Margaret J. Kronz, PharmD
By Atem Fontem, PharmD

The Food and Drug Administration (FDA) carefully reviews every medication before it is available to patients to make sure that the medication is safe and effective for the approved use. However, some medications that are necessary to treat a condition or a disease carry an increased risk of side effects. To reduce the risk of these side effects, the FDA has established a set of medication-specific guidelines called a Risk Evaluation and Mitigation Strategy (REMS).

What is a REMS medication?
A REMS is a specific set of guidelines created to prevent possible serious side effects related to the use of certain high-risk medicines. Each REMS medication has a different safety plan because medications may have different risks associated with their use.

To minimize these risks, REMS programs are established to increase communication between you and your health care providers to explain these risks and identify what needs to be done to use the medications safely. This may include telling you about specific side effects that may occur and what you need to do if they happen to you. Some REMS programs require your pharmacist and doctor to complete additional training before prescribing or dispensing them. Other REMS programs may require you to get periodic lab tests.

What if I am prescribed a REMS medication?
If you are prescribed a REMS medication, you should discuss the REMS program and the requirements with your health care provider before starting treatment. You may be asked to enroll in a program to monitor you while you are receiving the medication. For some medications, you also may be asked to sign an agreement to document that you understand the risk of treatment and the program requirements.

You may need to get your medication from a certain pharmacy. Be sure to allow enough time for medication refills to avoid a delay in your treatment.

A Medication Guide is written information that may accompany a REMS medication when it is dispensed. Patients are responsible for reading and understanding the information. If you have any questions after reading the material, be sure to ask your doctor or pharmacist. It is important to read all of the REMS material provided by your pharmacist and to follow all of the instructions.

Tell your doctor or pharmacist if you have any side effects, particularly those identified in the Medication Guide or other REMS materials. You should also let other providers on your health care team know that you are taking a REMS medication.

Your doctor or pharmacist can answer any questions about the medication or REMS requirements. Be sure to let your doctor or pharmacist know how you are feeling and report any side effects. Visit the FDA website for more information about REMS.

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