How to Check REMS Requirements Before Starting a Medication

Before you start a new medication, especially one with serious side effects, you need to know if it’s covered by a REMS program. REMS stands for Risk Evaluation and Mitigation Strategy. It’s not just a formality - it’s a safety system put in place by the U.S. Food and Drug Administration (FDA) to make sure the benefits of certain drugs outweigh their risks. If you skip checking REMS requirements, you could face delays, denied prescriptions, or worse - serious harm from a drug you weren’t properly prepared for.

What Is a REMS Program and Why Does It Matter?

REMS programs exist for medications that carry serious, sometimes life-threatening risks. These aren’t your everyday pills. Think of drugs like isotretinoin (for severe acne), thalidomide (for multiple myeloma), or extended-release opioids. These drugs can cause birth defects, addiction, or sudden death if not used under strict conditions. The FDA doesn’t ban them - it allows them, but only if doctors, pharmacists, and patients follow specific safety steps.

There are currently 76 active REMS programs in the U.S. as of 2025. Each one is tailored to the drug’s specific danger. Some just require handing out a patient guide. Others demand prescriber certification, mandatory lab tests, or even that the drug be given only in a hospital. Ignoring REMS isn’t an option. Pharmacies won’t fill the prescription. Insurance won’t cover it. And if something goes wrong, liability falls on everyone involved.

Step 1: Check the Prescribing Information

The first place to look is the official prescribing information - also called the package insert. Every FDA-approved drug comes with this document. It’s not hidden. It’s right there in the packaging or available online through DailyMed, a free FDA-run database.

Open the prescribing info and scroll to the section labeled “REMS” or “Risk Evaluation and Mitigation Strategy.” If it’s there, it will list exactly what’s required. For example:

• Isotretinoin (Accutane): Requires enrollment in the iPLEDGE program for both patient and prescriber.
• Thalidomide: Requires prescriber certification and patient enrollment in a registry.
• Zyprexa Relprevv: Must be administered in a certified facility with 3-hour post-injection observation.

Don’t rely on memory. Even if you’ve prescribed this drug before, REMS requirements change. In 2022 alone, the FDA modified 14 REMS programs to reduce paperwork while keeping safety intact. Always check the latest version.

Step 2: Use the FDA REMS Public Dashboard

The FDA’s REMS Public Dashboard is the most reliable, up-to-date source for all active REMS programs. It’s free, searchable, and updated regularly. As of March 2023, it includes real-time data on every REMS, including recent changes.

Go to fda.gov/drugs/rems and type in the drug name. You’ll see:

• Whether a REMS is active
• What elements are required (like ETASU - Elements to Assure Safe Use)
• Links to the manufacturer’s REMS website
• When the program was last updated

Pro tip: Use the filter tool to show only programs with ETASU. That’s where the real hurdles are - certification, registries, special facilities. If the drug has ETASU, you’re looking at a multi-step process, not just a form to sign.

Step 3: Contact the Pharmacy or Manufacturer

Pharmacists are on the front lines of REMS verification. If you’re unsure after checking the FDA site, call the pharmacy that will dispense the medication. They know what’s needed to fill it - and they’ll tell you if you’re missing something.

Many manufacturers run their own REMS websites. For example:

• iPLEDGE for isotretinoin: ipleDGEprogram.com
• MyCophenolate REMS: mycophenolaterems.com
• Opioid Analgesic REMS: opioidrems.com

These sites have enrollment portals, training modules, and checklists. For prescribers, completing training can take 45 to 90 minutes. For patients, registration can take 15-30 minutes. Plan ahead - you can’t rush this.

Step 4: Know What’s Required - ETASU vs. Communication Plans

Not all REMS are the same. There are two main types:

• Communication Plans: These are the easiest. They just mean the drug comes with a Medication Guide - a printed handout explaining risks. You hand it to the patient. They read it. You document they received it. Done.
• Elements to Assure Safe Use (ETASU): These are the heavy ones. They require action before the drug can be given:

• Prescriber certification (you must register and complete training)
• Patient enrollment (patient signs up in a registry)
• Lab testing (e.g., monthly liver tests for mycophenolate)
• Restricted distribution (only certified pharmacies or hospitals can dispense)
• Special monitoring (e.g., 3-hour observation after injection)

If a drug has ETASU, you’re not just writing a prescription - you’re managing a safety protocol. One hospital pharmacist in Chicago told me they reduced isotretinoin processing time from 45 minutes to 15 minutes by creating a checklist. That’s the kind of system you need.

What Happens If You Skip REMS?

Skipping REMS doesn’t mean you’ll get caught right away. But when problems happen, the fallout is serious.

- A pharmacy won’t fill the script. You’ll have to start over.

- Insurance will deny payment. The patient gets stuck.

- A patient suffers a preventable side effect. You could face legal consequences.

- The FDA can issue a warning letter to the manufacturer - and that can delay other drugs.

In 2022, the FDA issued 27 warning letters for REMS non-compliance - up from 19 in 2021. That’s not just paperwork. That’s a red flag.

Patients aren’t immune either. A 2022 survey found 42% of patients on REMS drugs had treatment delays - averaging over 6 days. That’s not just inconvenient. For someone with cancer or a rare disease, it can be dangerous.

How Much Time Should You Spend on REMS?

You can’t afford to rush this. The American Society of Health-System Pharmacists recommends 8-12 minutes per new REMS drug. That includes:

• Checking the prescribing info (2 min)
• Searching the FDA REMS dashboard (3 min)
• Verifying prescriber status or patient enrollment (3 min)
• Documenting everything (2 min)

Some providers try to cut corners - they assume “it’s probably fine.” But a 2019 AMA survey found physicians spent an average of 12.7 extra minutes per REMS prescription. That’s time you’re already spending - you’re just doing it inefficiently.

Build a system. Use templates. Create a checklist. Train your staff. The goal isn’t to slow things down - it’s to prevent delays later.

What About Patients? How Do They Know What to Do?

Patients are often confused. One Reddit user said, “I got my prescription for Vyvanse and the Medication Guide looked like a legal contract.” That’s not rare. Many guides are written in dense medical language.

The FDA is fixing this. Since April 2023, all new REMS programs must include patient-friendly tools - like smartphone apps or plain-language videos. But for now, you need to help.

- Print out a simple summary of the REMS steps.

- Explain why it matters - not just “it’s the law,” but “this prevents you from having a baby with birth defects” or “this stops you from overdosing.”

- Give them the manufacturer’s website and tell them to call if they get stuck.

Patients who understand REMS are more likely to comply. And compliance saves lives.

What’s Changing in REMS? What Should You Watch For?

REMS isn’t static. It’s evolving.

- More drugs will need REMS: Experts predict a 25% increase over the next five years, especially for gene therapies and biologics.

- Electronic systems are catching up: Eight of the top 10 pharmacy benefit managers now integrate REMS checks into e-prescribing systems. That means fewer missed steps.

- Blockchain may be coming: By 2026, some REMS systems could use blockchain to track prescriber certification and patient enrollment securely across clinics and pharmacies.

- Documentation is getting stricter: Records must be kept for 10 years. If you’re not storing them digitally, you’re at risk.

Stay updated. Subscribe to FDA alerts. Attend REMS training. Don’t assume what you learned last year is still valid.

Final Checklist: Before You Prescribe or Start Any New Medication

Use this every time:

1. Check the prescribing information for “REMS” or “ETASU.”
2. Search the FDA REMS Public Dashboard - confirm it’s active and what’s required.
3. Visit the manufacturer’s REMS website - enroll if needed.
4. Call the pharmacy - ask if they can fill it and what they need from you.
5. Explain the REMS to the patient in plain language.
6. Document everything: certification numbers, patient enrollment IDs, dates.

If you follow this checklist, you won’t just avoid delays - you’ll prevent harm. That’s the whole point of REMS.