REMS (Risk Evaluation and Mitigation Strategy)
A Risk Evaluation and Mitigation Strategy (REMS) is an FDA-required drug safety program for certain medications with serious safety concerns, designed to ensure that the benefits of the drug outweigh its risks through specific requirements such as medication guides, communication plans, and restricted dispensing programs.
Exam Tip
REMS = FDA safety program for high-risk drugs. Know iPLEDGE (isotretinoin) and Clozapine REMS as examples. ETASU = most restrictive component (restricted distribution, certified prescribers/pharmacies). Technicians verify enrollment before dispensing.
What Is REMS?
A Risk Evaluation and Mitigation Strategy (REMS) is a program required by the FDA under the FDA Amendments Act of 2007 (FDAAA) for medications that pose significant safety risks. REMS programs impose additional requirements beyond standard labeling to ensure that a drug's benefits outweigh its risks during post-market use.
REMS Components
| Component | Description | Example |
|---|---|---|
| Medication Guide | Patient-friendly safety information distributed at dispensing | Antidepressant Black Box Warning guides |
| Communication Plan | Letters/materials sent to healthcare providers | Safety alerts for prescribers |
| Elements to Assure Safe Use (ETASU) | Restricted distribution, special certification, monitoring | iPLEDGE (isotretinoin), TIRF REMS (fentanyl) |
| Implementation System | Infrastructure to support ETASU requirements | Registries, databases, certified pharmacies |
Notable REMS Programs
| Drug | REMS Program | Key Requirements |
|---|---|---|
| Isotretinoin (Accutane) | iPLEDGE | Pregnancy testing, registered prescribers/pharmacies, patient agreements |
| Clozapine | Clozapine REMS | Regular blood monitoring (ANC), certified prescribers/pharmacies |
| TIRF opioids (fentanyl) | TIRF REMS Access | Enrolled prescribers, certified pharmacies, patient agreements |
| Mifepristone | Mifepristone REMS | Certified prescribers, specific dispensing requirements |
| Testosterone | Class-wide REMS | Medication guide for patients |
ETASU Requirements May Include
- Prescribers must be specially certified or trained
- Pharmacies must be certified to dispense the drug
- Drug dispensed only in certain healthcare settings
- Patient must undergo specific lab testing before receiving drug
- Patient must be enrolled in a registry
- Patient must sign a patient agreement form
Pharmacy Technician's Role in REMS
- Verify the patient is enrolled in the REMS program before dispensing
- Confirm prescriber is certified for the REMS drug
- Ensure required lab results are current and documented
- Distribute Medication Guides when required
- Flag any REMS compliance issues for the pharmacist
Exam Alert
REMS falls under the Patient Safety and Quality Assurance domain on the PTCE. Know the key REMS components (Medication Guide, Communication Plan, ETASU), examples like iPLEDGE and Clozapine REMS, and the pharmacy technician's role in verifying REMS compliance before dispensing.
Study This Term In
Related Terms
MedWatch (FDA Safety Reporting)
MedWatch is the FDA's safety information and adverse event reporting program that allows healthcare professionals, patients, and consumers to report serious problems suspected to be associated with FDA-regulated drugs, biologics, medical devices, and dietary supplements.
FDA Drug Recall Classifications
FDA drug recall classifications are a three-tier system (Class I, II, and III) that categorizes product recalls based on the severity of the health hazard posed by the defective or potentially harmful product.
Controlled Substance Schedules
Controlled substance schedules are the DEA's five-tier classification system (Schedule I through Schedule V) that categorizes drugs based on their accepted medical use, abuse potential, and likelihood of causing dependence.
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