FDA News

REMS programs help FDA, other stakeholders enhance drug safety

By Theresa Toigo, MBA, RPh, and Cynthia LaCivita, PharmD

When prescribing or dispensing a drug, clinicians may be required to take specific safety steps prior to the patient receiving the medication.

These measures may be part of an FDA–required safety program called Risk Evaluation and Mitigation Strategies (REMS).

Theresa Toigo
Cynthia LaCivita

REMS programs are FDA–required drug safety measures designed to reduce a known or potential risk identified in a product’s prescribing information. Pharmaceutical companies must develop and implement REMS to ensure the benefits of a prescription drug outweigh its risks.

REMS programs can address a drug’s potential risks through a range of tools. One example might involve a known drug side effect — life-threatening infections.

FDA could require a REMS that helps ensure patients are aware of the initial signs of this infection and can seek treatment before the infection becomes severe. In a case in which a drug could cause a severe allergic reaction immediately after administration, a REMS might require that health care professionals agree to observe the patient for a period of time after the initial dose.

Some REMS might require ongoing monitoring. For example, if a drug can cause liver injury or failure, regular studies that evaluate liver function may be required.

Each REMS is unique and targets a specific risk or risks associated with a particular drug or drug class. Depending on the risk involved, a REMS program can be simple or complex. Options include providing an information sheet to a patient or health care professional; enrolling a patient in a registry prior to taking the drug; monitoring a patient’s lab values during treatment; or requiring patients to take preventive measures, such as requiring that women ensure they use effective birth control if they are taking a drug that has fetal toxicity.

REMS requirements have prompted concerns about clinical and administrative burdens placed on already busy health care professionals that also might increase the amount of time before patients can start taking needed medicines.

FDA makes every effort to make REMS requirements as least burdensome as possible. Our goal is to maintain patient access while still preserving safe use of a drug.

FDA may remove a REMS if it determines it is no longer necessary to assure a drug can be safely used without extra measures to help ensure the drug’s benefits outweigh its risks. An example is a REMS designed to inform health care professionals about established risks associated with prescribing a drug.

If, after review, FDA determines that the health care community knows and understands these risks, FDA may determine the REMS is no longer necessary and remove it.

FDA also may remove certain components of a REMS deemed no longer necessary. For instance, FDA removed part of or all of the REMS for dofetilide (Tikosyn, Pfizer) and alosetron hydrochloride (Lotronex, Sebela).

It is important for health care professionals, patients and all others affected by REMS to be aware that REMS provide safe access for patients to certain drugs with serious risks that otherwise may not be approved.

REMS programs provide an additional element of safety to help ensure a drug remains available to patients in need.

FDA’s website provides a list of every drug for which FDA requires a REMS, along with all of the details for that drug’s REMS requirements. For more information, go to www.accessdata.fda.gov/scripts/cder/rems.

For more information:

Theresa Toigo, MBA, RPh, is associate director for drug safety operations in FDA’s Center for Drug Evaluation and Research. She can be reached at theresa.toigo@fda.hhs.gov. Cynthia LaCivita, PharmD, is director of FDA’s division of risk management. She can be reached at cynthia.lacivita@fda.hhs.gov.

Disclosure: Toigo and LaCivita report no relevant financial disclosures.

 

By Theresa Toigo, MBA, RPh, and Cynthia LaCivita, PharmD

When prescribing or dispensing a drug, clinicians may be required to take specific safety steps prior to the patient receiving the medication.

These measures may be part of an FDA–required safety program called Risk Evaluation and Mitigation Strategies (REMS).

Theresa Toigo
Cynthia LaCivita

REMS programs are FDA–required drug safety measures designed to reduce a known or potential risk identified in a product’s prescribing information. Pharmaceutical companies must develop and implement REMS to ensure the benefits of a prescription drug outweigh its risks.

REMS programs can address a drug’s potential risks through a range of tools. One example might involve a known drug side effect — life-threatening infections.

FDA could require a REMS that helps ensure patients are aware of the initial signs of this infection and can seek treatment before the infection becomes severe. In a case in which a drug could cause a severe allergic reaction immediately after administration, a REMS might require that health care professionals agree to observe the patient for a period of time after the initial dose.

Some REMS might require ongoing monitoring. For example, if a drug can cause liver injury or failure, regular studies that evaluate liver function may be required.

Each REMS is unique and targets a specific risk or risks associated with a particular drug or drug class. Depending on the risk involved, a REMS program can be simple or complex. Options include providing an information sheet to a patient or health care professional; enrolling a patient in a registry prior to taking the drug; monitoring a patient’s lab values during treatment; or requiring patients to take preventive measures, such as requiring that women ensure they use effective birth control if they are taking a drug that has fetal toxicity.

REMS requirements have prompted concerns about clinical and administrative burdens placed on already busy health care professionals that also might increase the amount of time before patients can start taking needed medicines.

FDA makes every effort to make REMS requirements as least burdensome as possible. Our goal is to maintain patient access while still preserving safe use of a drug.

FDA may remove a REMS if it determines it is no longer necessary to assure a drug can be safely used without extra measures to help ensure the drug’s benefits outweigh its risks. An example is a REMS designed to inform health care professionals about established risks associated with prescribing a drug.

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If, after review, FDA determines that the health care community knows and understands these risks, FDA may determine the REMS is no longer necessary and remove it.

FDA also may remove certain components of a REMS deemed no longer necessary. For instance, FDA removed part of or all of the REMS for dofetilide (Tikosyn, Pfizer) and alosetron hydrochloride (Lotronex, Sebela).

It is important for health care professionals, patients and all others affected by REMS to be aware that REMS provide safe access for patients to certain drugs with serious risks that otherwise may not be approved.

REMS programs provide an additional element of safety to help ensure a drug remains available to patients in need.

FDA’s website provides a list of every drug for which FDA requires a REMS, along with all of the details for that drug’s REMS requirements. For more information, go to www.accessdata.fda.gov/scripts/cder/rems.

For more information:

Theresa Toigo, MBA, RPh, is associate director for drug safety operations in FDA’s Center for Drug Evaluation and Research. She can be reached at theresa.toigo@fda.hhs.gov. Cynthia LaCivita, PharmD, is director of FDA’s division of risk management. She can be reached at cynthia.lacivita@fda.hhs.gov.

Disclosure: Toigo and LaCivita report no relevant financial disclosures.