REMS

REMS stands for risk evaluation and mitigation strategy.

The Food and Drug Administration (FDA) governs the REMS program. The purpose is to provide drug safety information to the public to improve transparency and communication. The manufacturer is required to disseminate information to be sure that patients are aware of both the benefits and risks of drugs.

This program was initiated in accordance with Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Below are two websites that list the REMS strategies and give further information on REMS:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm REMS stands for risk evaluation and mitigation strategy.

The Food and Drug Administration (FDA) governs the REMS program. The purpose is to provide drug safety information to the public to improve transparency and communication. The manufacturer is required to disseminate information to be sure that patients are aware of both the benefits and risks of drugs.

This program was initiated in accordance with Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Below are two websites that list the REMS strategies and give further information on REMS:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm

The ESA APPRISE Oncology Program is part of a Risk Evaluation and Mitigation Strategy (REMS) the Food and Drug Administration (FDA) has started. It has determined that REMS are necessary for ESAs to be sure that the benefits of these drugs outweigh the risks of shortened overall survival and/or increased risk of tumor progression or recurrence as shown in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. The ESA APPRISE Oncology Program addresses those who are to receive an ESA for the Treatment of Anemia in patients with cancer and patients on Chemotherapy.

ESA is an erythropoiesis stimulating agent. These drugs are Procrit (epoetin alfa), Epogen (epoetin alfa), or Aranesp (darbepoetin alfa).

The Procrit/ Epogen/ ESA APPRISE QUESTIONNAIRE must be completed by a physician, nurse, or pharmacist prior to dispensing the drug. The completion of the questionnaire insures that the patient has been educated about these medications and has been informed of the advantages and disadvantages of these drugs. The ESA APPRISE Oncology Program is part of a Risk Evaluation and Mitigation Strategy (REMS) the Food and Drug Administration (FDA) has started. It has determined that REMS are necessary for ESAs to be sure that the benefits of these drugs outweigh the risks of shortened overall survival and/or increased risk of tumor progression or recurrence as shown in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. The ESA APPRISE Oncology Program addresses those who are to receive an ESA for the Treatment of Anemia in patients with cancer and patients on Chemotherapy.

ESA is an erythropoiesis stimulating agent. These drugs are Procrit (epoetin alfa), Epogen (epoetin alfa), or Aranesp (darbepoetin alfa).

The Procrit/ Epogen/ ESA APPRISE QUESTIONNAIRE must be completed by a physician, nurse, or pharmacist prior to dispensing the drug. The completion of the questionnaire insures that the patient has been educated about these medications and has been informed of the advantages and disadvantages of these drugs.