What every healthcare practitioner needs to know about REMS.
What are REMS for? Risk evaluation mitigation strategies (REMS) are FDA-approved strategies for managing a known or potential serious risk associated with a drug or biological product. REMS are required by the FDA, if deemed necessary, to ensure that a product's benefits outweigh its risks.
What is included in REMS? Three main components make up REMS: a medication guide (patient package insert), a communication plan for healthcare providers, and elements to assure safe use (EASU). A particular drug's REMS may not include all three of these components as many REMS only require a medication guide. The specific components of particular REMS will vary based on the specific drug risks, the population who will be using the drug, and other safety factors.
Must all drugs now have REMS? No. As of June 3, 2010, 123 drugs have REMS. The most current listing of medications with REMS is at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/ucm111350.htm.
What is a medication guide? This is an FDA-approved patient information pamphlet that must be distributed at time of drug dispensing. It addresses issues specific to the drug and drug class in terms of safety and use of the product. This may be given by the pharmacist when dispensing the medication or by the healthcare provider, such as an oncology nurse, who may be administering the medication.
What is a communication plan? This is a process to give healthcare providers (such as prescribers, pharmacists, infusion nurses) and patients specific safety information deemed necessary by the FDA for the safest, most effective use of a specific drug. This may be given in the form of a "dear healthcare provider" letter, a "dear pharmacist" letter, or special educational materials for prescribers to give to patients.
What is EASU? This is a process by which healthcare providers receive specialized training and education to prescribe, dispense, and/or administer certain products. Healthcare providers must participate and complete this training for those drugs with an EASU in order to use these agents.
* Some drugs with an EASU may only be dispensed by certain pharmacies or administered by facilities that comply with these requirements.
* Some EASUs require the patient to enroll into a patient registry, whereas others require the prescriber and/ or the dispensing pharmacy to enroll into a registry as well.
* Some EASUs require documentation by the facility or pharmacy of how they met the REMS requirements.
* Some EASUs require baseline and periodic reports from prescribers on patients receiving the drug.
Patients or healthcare providers who do not comply with the REMS will not be allowed to receive or prescribe (or administer) these drugs. The drugs with REMS requiring EASUs that most oncology nurses are most familiar include thalidomide (Thalomid[R], Celgene) and lenalidomide (Revlimid[R], Celgene).
Are all REMS the same? No. Each drug has individualized REMS approved by the FDA. Each healthcare provider (whether physician, advanced practice nurse, RN, or pharmacist) is responsible for understanding and following REMS for each agent.
For More Information
* www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPa tientsandProviders/ucm111350.htm
* www.ons.org/CNECentral/Conferences/media/ons/docs/education/confer ences/congress/2010/virtualmeetingorderform.pdf
[By Wendy H. Vogel, MSN, FNP, AOCNP[R], ONS Nurse Practitioner SIG Legislative Issues Liaison]
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|Title Annotation:||risk evaluation mitigation strategies|
|Author:||Vogel, Wendy H.|
|Date:||Oct 1, 2010|
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