HOST: Captain Mary Kremzner
Pharmacist: Dr. Kimberly Chiu
Captain Kremzner: Drug benefits and risks; today, we’ll learn about the many components of Risk Evaluation and Mitigation Strategies (or REMS) and how they can help manage a drug product with known or potential serious risks.
Hi, I’m Captain Mary Kremzner and this is Drug Info Rounds, brought to you by the pharmacists in the FDA’s Division of Drug Information.
REMS are required risk management plans that use risk minimization strategies beyond the professional labeling to ensure that the benefits of certain prescription drugs outweigh their risks. REMS serve as an important tool used to manage serious risks associated with a medication. They also enable patients to have access to medically necessary drug products, which, without REMS, may not receive FDA approval or be allowed to remain on the market. I’m joined today by FDA pharmacist, Dr. Kimberly Chiu, who has more information on the intricacies of REMS.
Dr. Chiu: A REMS may be required by the FDA before or after a drug is approved. The drug sponsors develop REMS programs and the Agency approves all REMS programs before they are implemented. However, the responsibility ultimately falls upon the drug sponsor to successfully implement the program.
Potential components of a REMS may include:
- A Medication Guide - Paper handouts containing FDA approved information that can alert patients to potential serious adverse events or information about how to safely use the drug.
- A Communication Plan - To inform health care providers about safety risks associated with the drug or to support implementation of the REMS. This may include letters to health care providers.
- Elements to Assure Safe Use are intended to address specific serious risks listed in the labeling of the drug. Depending on the risk, a REMS may require one or more of the following:
- Prescriber training or certification
- Special certifications for pharmacies or other dispensers
- Limiting the kinds of health care settings in which the drug may be dispensed
- Documentation or other evidence of safe use conditions prior to dispensing
- Specific patient monitoring
- Enrolling patients in a registry
- An implementation system through which the elements to assure safe use can be monitored, evaluated and improved.
Depending on the risks involved, FDA may approve a Medication Guide as part of labeling without requiring a REMS when it is adequate to address the specific serious risk at issue. In other cases, the Agency may determine that a Medication Guide and other REMS components (such as Elements to Assure Safe Use or a Communication Plan) are necessary to ensure that the benefits of a drug outweigh the risks. In most cases, FDA requires a Medication Guide as part of a REMS when other REMS components are required for the product.
To view if a drug product has a REMS, you may use the Agency’s Drugs@FDA website.
Let’s use Avandia as an example. Search for “Avandia” within the site and access its “Drug Details” page. If a drug has a REMS, there will be a REMS hyperlink on this page just as there is one on Avandia’s.
If a drug does not have a REMS, there will not be a REMS hyperlink on the page. Alternatively, there is also an FDA webpage containing a listing of all FDA approved REMS.
Captain Kremzner: Anything that may help mitigate drug risks is an important tool for pharmacists and their patients. If you have questions about Risk Evaluation and Mitigation Strategies, you can call or email FDA’s Division of Drug Information.