How to Check REMS Requirements Before Starting a Medication

Before you start a new medication, especially one with serious risks, you need to know if it’s covered by a REMS program. REMS stands for Risk Evaluation and Mitigation Strategy. It’s not just paperwork-it’s a safety net designed by the U.S. Food and Drug Administration (FDA) to make sure the benefits of a drug outweigh its dangers. If you skip checking REMS requirements, you could face delays, denied prescriptions, or worse-serious side effects that could have been prevented.

What Is a REMS Program and Why Does It Matter?

REMS programs were created in 2007 after Congress passed the Food and Drug Administration Amendments Act. They’re required for medications that carry serious risks-like birth defects, life-threatening infections, addiction, or sudden death. The FDA doesn’t use REMS to block access. It uses them to allow access safely. Without REMS, drugs like isotretinoin (for severe acne) or thalidomide (for multiple myeloma) wouldn’t be available at all.

There are 76 active REMS programs as of 2025. Some are simple-like giving patients a printed Medication Guide. Others are complex. For example, Zyprexa Relprevv can only be given in certified clinics because it can cause sudden drowsiness or confusion after injection. Patients must be monitored for at least three hours. That’s not optional. That’s the law.

How to Find Out If Your Medication Has a REMS Program

You can’t rely on your doctor or pharmacist to remember every REMS rule. You need to check yourself. Here’s how:

1. Look at the prescribing information. Every FDA-approved drug has a detailed document called the Prescribing Information (or “package insert”). It’s usually available on the manufacturer’s website or through DailyMed. If the drug has a REMS, it’s listed under Section 17-“Patient Counseling Information.”
2. Use the FDA REMS Public Dashboard. Go to fda.gov/drugs/rems. You can search by drug name, company, or condition. The dashboard shows you exactly what’s required: prescriber certification? Patient registry? Lab tests? Facility restrictions?
3. Check the manufacturer’s REMS website. Many drugs have their own dedicated REMS site. For isotretinoin, it’s ipleDGEprogram.com. For mycophenolate, it’s mycophenolaterems.com. These sites have enrollment forms, training videos, and FAQs.
4. Ask your pharmacy. Pharmacists are on the front lines. If they can’t fill your prescription, it’s often because REMS requirements weren’t met. Call them before you go in. Ask: “Does this drug need a REMS program? What do I need to do?”

Common REMS Requirements You Might Encounter

Not all REMS are the same. Here’s what you might run into:

• Medication Guides: A paper handout you must receive every time you fill the prescription. It explains the risks in plain language. Don’t throw it away. Read it.
• Prescriber Certification: Your doctor must complete training and register in the REMS system. For drugs like thalidomide or lenalidomide, this takes about an hour. If your doctor hasn’t done it, you won’t get the drug.
• Patient Enrollment: You might need to sign up in a registry. For isotretinoin, both you and your doctor must register in iPLEDGE. You’ll need to pass monthly pregnancy tests if you’re a woman of childbearing age.
• Lab Monitoring: Some drugs require blood tests before and during treatment. For example, clozapine requires weekly white blood cell counts for the first six months because it can cause a deadly drop in white blood cells.
• Restricted Distribution: The drug can only be dispensed by certain pharmacies or given in specific clinics. This applies to drugs like Zyprexa Relprevv or Opioid Analgesics under the Opioid REMS program.

What Happens If You Skip REMS Steps?

It’s not just about getting your prescription filled. Skipping REMS requirements puts you at risk.

If you take isotretinoin without registering in iPLEDGE, you could become pregnant and have a baby with severe birth defects. If you get thalidomide without proper training, you might not know how to handle it safely or recognize early signs of nerve damage. And if you take an opioid without completing the required education, you might not understand the risks of addiction or overdose.

Pharmacies are required to refuse dispensing if REMS steps aren’t completed. That means even if your doctor writes the script, the pharmacy won’t fill it. You’ll waste time, miss doses, and risk your health.

How Long Does REMS Verification Take?

It varies. For a simple Medication Guide, it’s a few minutes. For something like iPLEDGE, it can take days. The average time to complete REMS steps is 6-12 business days, according to a 2022 survey by the National Organization for Rare Disorders.

Here’s a realistic timeline:

1. Day 1: Doctor checks REMS status and decides to prescribe.
2. Day 2-3: Doctor completes certification (if needed). This might involve logging into a website, watching a video, and answering quiz questions.
3. Day 3-5: You enroll in the patient registry. You may need to sign forms, provide ID, or schedule a pregnancy test.
4. Day 5-7: Pharmacy receives the prescription and verifies your enrollment.
5. Day 7-10: You pick up the medication.

If you wait until the last minute, you’ll delay your treatment. Start the process as soon as you get the prescription.

Who’s Responsible for REMS Compliance?

Everyone plays a role:

• Doctors: Must be certified, complete training, and document compliance.
• Pharmacists: Must verify enrollment, check lab results, and refuse to dispense if requirements aren’t met.
• Patients: Must enroll, complete required tests, and follow safety rules.
• Manufacturers: Must maintain the REMS system, update training materials, and report compliance data to the FDA.

The FDA doesn’t enforce this alone. It relies on the entire healthcare system to follow through. That’s why it’s so easy for things to slip through the cracks.

Recent Changes to REMS Programs (2023-2025)

REMS isn’t static. The FDA is actively improving them.

In March 2023, the FDA launched a new version of the REMS Public Dashboard with real-time updates and mobile-friendly design. In April 2023, they required all new REMS programs to include smartphone tools-like apps that send reminders for lab tests or pregnancy screenings.

Eight of the top 10 pharmacy benefit managers now integrate REMS checks directly into e-prescribing systems. That means your doctor’s electronic system might flag a REMS requirement before the prescription even leaves the office.

The FDA also started modifying existing REMS to reduce burden. In 2022 alone, 14 REMS programs were simplified-cutting paperwork, reducing lab frequency, or allowing telehealth for training. The goal: keep patients safe without making access impossible.

What to Do If You’re Facing a REMS Delay

If your medication is stuck because of REMS, don’t give up. Here’s what to do:

1. Ask your doctor for help. They might not realize how long REMS takes. Ask them to call the manufacturer’s REMS support line. Most have dedicated staff to help providers.
2. Call the REMS program directly. For example, iPLEDGE has a 24/7 helpline. Mycophenolate REMS has live chat. Don’t wait for email.
3. Ask for a temporary alternative. If your drug has a similar alternative without REMS, ask your doctor. Sometimes, switching for a few weeks avoids a months-long delay.
4. Document everything. Keep copies of all forms, emails, and call logs. If you’re denied care, this helps you appeal.

Bottom Line: Don’t Guess. Check.

REMS isn’t bureaucracy-it’s protection. But it only works if you know it’s there. Always check REMS requirements before starting any new medication, especially if it’s for cancer, mental health, autoimmune disease, or pregnancy-related risks.

Use the FDA dashboard. Talk to your pharmacist. Read the Medication Guide. Don’t assume your doctor already handled it. And never skip steps-even if it’s inconvenient. The risks aren’t theoretical. They’re real. And they’re preventable.