How to Check REMS Requirements Before Starting a Medication

Starting a new medication isn’t just about picking up a prescription. If that drug has serious safety risks, you’re likely dealing with a REMS-a Risk Evaluation and Mitigation Strategy mandated by the FDA. These aren’t optional paperwork. They’re legal requirements designed to prevent life-threatening side effects. Skip checking REMS, and you risk delays, denied fills, or worse-serious harm to the patient.

What Exactly Is a REMS?

REMS stands for Risk Evaluation and Mitigation Strategy. It’s a safety program the FDA requires for certain medications that carry serious risks, like birth defects, severe infections, or sudden death. The goal isn’t to block access-it’s to make sure the benefits outweigh the dangers. Without REMS, drugs like isotretinoin (for acne) or thalidomide (for cancer) might never reach patients. But because they can cause devastating harm if misused, the FDA puts strict controls in place.

There are 76 active REMS programs as of 2025. Some are simple-like handing out a Medication Guide. Others are complex, requiring doctors to get certified, patients to enroll in registries, or medications to be given only in special clinics. For example, Zyprexa Relprevv can only be administered in certified facilities where staff monitor patients for three hours after injection to catch dangerous sedation reactions. Isotretinoin (Accutane) requires both prescriber and patient registration in the iPLEDGE system to prevent pregnancy during treatment.

When Do You Need to Check REMS?

You don’t check REMS because it’s a good idea-you check it because you have to. If you’re prescribing, dispensing, or starting any new medication, ask: Is this one of the drugs that needs special controls?

High-risk categories almost always trigger REMS:

• Teratogenic drugs (can cause birth defects)-like isotretinoin, mycophenolate, thalidomide
• Drugs with high abuse potential-like extended-release opioids
• Medications linked to severe immune reactions-like certain biologics for autoimmune diseases
• Drugs with narrow therapeutic windows-like some cancer treatments

Don’t assume a drug is safe just because it’s been on the market for years. The FDA updates REMS regularly. In 2022 alone, 14 REMS programs were modified to reduce burden without lowering safety. A drug that didn’t need REMS five years ago might require it now.

Where to Find REMS Information

There are three trusted places to verify REMS requirements before prescribing or dispensing:

1. The FDA REMS Public Dashboard-This is your go-to source. Launched in 2023, it’s interactive, searchable, and updated weekly. Go to fda.gov/drugs/rems and search by drug name, manufacturer, or REMS type. You’ll see if the drug has ETASU (Elements to Assure Safe Use), like prescriber certification or patient enrollment.
2. The medication’s prescribing information-Every FDA-approved drug’s official prescribing label (found on DailyMed.nih.gov) includes a REMS section. Look for the heading: “REMS Program” or “Risk Evaluation and Mitigation Strategy.” It will list exactly what’s required.
3. The manufacturer’s REMS website-Many drugmakers run their own REMS portals. For example, iPLEDGE (ipleDGEprogram.com) handles isotretinoin. Thalidomide’s program is managed by Celgene. These sites have enrollment forms, training modules, and FAQs.

Pharmacists are often the last line of defense. If you’re unsure, call the pharmacy that dispensed the drug. According to the Opioid Analgesic REMS FAQ, they’re required to confirm REMS compliance before filling the prescription.

What REMS Elements Could Affect You?

Not all REMS are the same. The FDA uses four main components, but only some require action from providers or patients:

• Medication Guides-Paper handouts given to patients at every fill. Required for nearly all REMS drugs. Patients must sign they received it.
• Communication Plans-Educational materials sent to prescribers. Usually just an email or PDF. No action needed unless you’re the provider.
• Elements to Assure Safe Use (ETASU)-The heavy lifters. These are the restrictions that actually delay care. Examples:

Prescriber Certification: Doctors must complete training and register with the REMS program before writing the script. Thalidomide and lenalidomide require this. Training takes about 65 minutes and must be renewed every 12 months.

Patient Enrollment: Patients must register in a database. For iPLEDGE, both men and women must complete monthly pregnancy tests and confirm contraceptive use. Failure to enroll = no fill.

Dispensing Restrictions: Only certified pharmacies or clinics can give out the drug. Zyprexa Relprevv must be injected in a certified facility. Some opioids can only be dispensed by pharmacies enrolled in the Opioid Analgesic REMS.

Monitoring Requirements: Blood tests, EKGs, or regular check-ins. Mycophenolate requires monthly pregnancy tests for women of childbearing age.

How to Verify REMS in 3 Steps

Here’s a simple, repeatable process every provider and pharmacist should follow:

1. Check the label-Look at the prescription or medication bottle. If it says “REMS” or “Medication Guide Required,” proceed to step two.
2. Search the FDA REMS Dashboard-Type in the drug name. If a REMS is active, note whether it has ETASU. If yes, you’ll need to take action.
3. Confirm with the pharmacy or manufacturer-Call the pharmacy. Ask: “Does this drug require prescriber certification or patient enrollment?” If they’re unsure, direct them to the manufacturer’s REMS site. Never assume.

Don’t rely on memory. Even experienced providers get tripped up. A 2022 survey found 42% of patients on REMS drugs experienced delays averaging over six business days because someone missed a step.

Common Mistakes and How to Avoid Them

Here’s what goes wrong-and how to fix it:

• Mistake: Thinking the Medication Guide is enough. Fix: If the REMS has ETASU, the guide alone won’t cut it. You need certification, enrollment, or monitoring.
• Mistake: Using outdated REMS info. Fix: REMS change. The FDA modified 37% of them between 2015 and 2020. Always check the dashboard before prescribing.
• Mistake: Assuming the patient already knows. Fix: Patients often don’t understand REMS. One Reddit user said their pharmacy cut isotretinoin processing time from 45 minutes to 15 by using a standardized checklist. Create your own.
• Mistake: Skipping training. Fix: If prescriber certification is required, complete the training. It’s usually free and accredited. Skipping it means you can’t prescribe.

The American Society of Health-System Pharmacists recommends spending 8-12 minutes per new REMS drug to verify everything. That’s not wasted time-it’s prevention.

What Happens If You Ignore REMS?

Pharmacies will refuse to fill the prescription. No exceptions. The pharmacy’s computer system often blocks REMS drugs automatically if the prescriber isn’t certified or the patient isn’t enrolled.

Legally, you’re at risk. The FDA issued 27 warning letters to drugmakers for REMS non-compliance in 2022. Providers can face disciplinary action if a patient is harmed due to a missed REMS step.

And ethically? You’re putting someone in danger. A patient on mycophenolate who didn’t know about pregnancy risks could lose a child. A patient on opioids without proper education could overdose. REMS exists to stop those outcomes.

What’s Changing in REMS?

REMS isn’t static. The FDA is trying to make it less burdensome without sacrificing safety:

• In 2023, the FDA required all new REMS to include smartphone-friendly tools-like apps that send reminders for pregnancy tests or certification renewals.
• Eight of the top 10 pharmacy benefit managers now integrate REMS checks into e-prescribing systems. If you’re using an EHR, the system may pop up a REMS alert before you hit “send.”
• By 2026, blockchain may be used to securely track prescriber certification across multiple clinics, cutting down on duplicate paperwork.

Expect more REMS in the future. About 85-90% of new cancer drugs approved after 2025 will likely need them. The same goes for gene therapies and complex biologics.

Bottom Line: Don’t Skip the Check

REMS isn’t bureaucracy. It’s a safety net. Every step-whether it’s signing a form, completing training, or calling the pharmacy-is there to prevent a tragedy. The system isn’t perfect. It’s slow. It’s confusing. But it works.

Before you start any new medication, ask: Is this a REMS drug? Then verify. Use the FDA dashboard. Confirm with the pharmacy. Complete the training. Fill out the forms. Don’t guess. Don’t rush. And don’t assume someone else already did it.

One missed step can delay treatment for weeks. Or worse-it can cost a life. That’s why checking REMS isn’t just a procedure. It’s a responsibility.