How to Check REMS Requirements Before Starting a Medication

Before you start a new medication, especially one for a serious condition, there’s one step many patients and even some providers skip: checking the REMS requirements. REMS stands for Risk Evaluation and Mitigation Strategies. It’s not just bureaucracy-it’s a safety net designed by the U.S. Food and Drug Administration (FDA) to make sure high-risk drugs don’t cause more harm than good. If you ignore this step, your prescription could be denied at the pharmacy, your treatment delayed by weeks, or worse-you could be put at risk without even knowing it.

What Exactly Is a REMS Program?

REMS programs exist for medications that carry serious, potentially life-threatening risks. These aren’t minor side effects like dizziness or nausea. We’re talking about birth defects, severe organ damage, addiction, or sudden death. The FDA doesn’t use REMS to block access to these drugs. In fact, it’s the opposite-they’re used to make sure patients who need these medications can still get them, safely.

Since 2007, the FDA has required REMS for 76 different drugs. Some, like isotretinoin (Accutane), are known for causing birth defects. Others, like thalidomide and bortezomib, carry high risks of nerve damage or blood clots. Even common painkillers like extended-release opioids fall under REMS because of addiction risks. Each REMS is custom-built to match the specific danger of the drug.

Not all REMS are the same. Some just require a printed Medication Guide handed to you at the pharmacy. Others demand much more: prescriber certification, mandatory lab tests, enrollment in a patient registry, or even that the drug be given only in a hospital or clinic. For example, Zyprexa Relprevv can only be injected in certified facilities because it can cause sudden confusion or sedation after injection. You need to be monitored for three hours afterward.

How to Find Out If Your Medication Has a REMS

Don’t wait for your doctor or pharmacist to bring it up. You need to check yourself. Start with the most direct source: the official FDA REMS database. Go to fda.gov/drugs/rems and search by the drug’s brand or generic name. The site shows you exactly what’s required-whether it’s training, registration, or special administration rules.

You can also use the FDA’s REMS Public Dashboard. Launched in March 2023, it’s faster, cleaner, and lets you filter by type of requirement. Look for "Elements to Assure Safe Use" (ETASU). If you see that term next to your drug, you’re dealing with the strictest level of control. You’ll need to take action beyond just picking up a pill.

Another quick check: open the prescribing information (also called the package insert). It’s usually available online via DailyMed or the manufacturer’s website. Look for a section titled "REMS" or "Risk Evaluation and Mitigation Strategy." If it’s there, the requirements are listed in detail.

What to Do If Your Drug Requires Prescriber Certification

If your medication needs prescriber certification, your doctor can’t just write the prescription. They must first complete training and register with the REMS program. For drugs like thalidomide or lenalidomide, this means logging into the manufacturer’s REMS website (often run by the drug company), watching a video, taking a short quiz, and submitting their license number. This process can take 45 to 65 minutes.

That means even if your doctor knows the drug well, they might not be certified yet. Don’t assume they are. Ask them: "Are you certified to prescribe this medication under the REMS program?" If they say no, they’ll need to complete the training before you can get your prescription. Some clinics have staff dedicated to managing this, but many don’t. Be prepared for delays.

For patients, this step is often invisible. But if your doctor says they can’t prescribe it yet, it’s not a refusal-it’s a safety rule. Pushing through without certification could lead to the pharmacy refusing to fill the script, or worse, a preventable adverse event.

Pharmacies Are Your Last Line of Defense

Your pharmacist doesn’t just count pills-they’re trained to catch REMS issues before you leave the counter. Many pharmacies now use automated systems that flag REMS drugs during checkout. But not all do. And even if they do, they can’t override a missing requirement.

If your prescription gets held up, don’t get frustrated. Ask the pharmacist: "Is this medication under a REMS program? What do I need to do?" They can tell you if you need to register in a patient registry, provide proof of negative pregnancy test, or confirm your doctor’s certification. For isotretinoin, for example, pharmacies won’t dispense unless both the prescriber and patient are registered in iPLEDGE. That system requires monthly pregnancy tests for women of childbearing age.

Pharmacists also handle the Medication Guide. By law, you must receive one every time you refill a REMS drug. It’s not optional. Read it. It explains the risks, what symptoms to watch for, and what to do if something goes wrong. If you didn’t get one, ask for it. If they say they don’t have it, they’re not following the rules.

What Patients Often Miss (And Why It Matters)

Most people think REMS is just about the doctor or the pharmacy. But you’re the most important part. If your drug requires enrollment in a registry-like the Mycophenolate REMS for transplant patients-you must sign up yourself. You can’t rely on your doctor to do it. The registry tracks your pregnancy status, lab results, and adherence to safety rules. If you don’t enroll, your prescription won’t be filled.

Another common mistake: thinking one-time certification is enough. Some REMS require annual re-certification for prescribers. Others require monthly lab tests or pregnancy checks. If you miss one, your access stops. A patient on JAZZ Pharmaceuticals’ Vyvanse reported being denied a refill because their REMS enrollment had lapsed-despite taking the medication for two years without issue.

And don’t assume the rules are the same everywhere. REMS requirements can vary slightly by state, pharmacy chain, or insurance plan. What works in one clinic might not fly in another. Always confirm directly with your pharmacy before your next refill.

How Long Will This Take? Real-Time Expectations

On average, checking REMS requirements adds 8 to 12 minutes to the prescribing process. For patients, delays average 6.2 business days-sometimes longer if you’re waiting for lab results or paperwork. A 2022 survey found 42% of patients on REMS drugs experienced treatment delays. That’s not a glitch-it’s the system working as designed, but it’s still frustrating.

Here’s how to cut the wait time:

1. Before your appointment, search the FDA REMS database for your drug.
2. Print or screenshot the REMS requirements and bring them to your doctor.
3. Ask your pharmacist if they’re enrolled in the REMS program for this drug.
4. If certification is needed, ask your doctor to start the process before your visit.

One hospital pharmacy in Atlanta cut isotretinoin processing time from 45 minutes to 15 minutes by creating a standardized checklist. You can do the same. Keep a folder-digital or paper-with your REMS requirements, certification dates, and lab due dates. It saves everyone time.

What’s Changing in 2025?

REMS programs are evolving. In April 2023, the FDA required all new REMS to include smartphone-friendly tools. That means apps, text reminders, and online portals are now standard. You might get a notification if your pregnancy test is due, or if your doctor’s certification is about to expire.

Pharmacy benefit managers (PBMs) are also integrating REMS checks into electronic prescribing systems. That means your doctor’s e-prescription system might block the order if REMS steps aren’t complete-before it even reaches the pharmacy.

By 2026, blockchain technology may be used to securely track REMS compliance across providers, reducing errors and fraud. For now, the focus is on simplifying. The FDA has already modified 37% of existing REMS since 2015 to remove unnecessary steps. The goal is to keep patients safe without turning healthcare into paperwork hell.

Final Checklist: 5 Steps Before Starting Any New Medication

Before you take that first dose, run through this:

• Step 1: Search the FDA REMS database for your drug’s name. Is a REMS listed?
• Step 2: If yes, read the full requirements. Does it need certification, registries, or lab tests?
• Step 3: Ask your doctor: "Are you certified to prescribe this?" If not, ask them to start the process now.
• Step 4: Contact your pharmacy. Ask if they handle REMS for this drug and what you need to bring.
• Step 5: Make sure you receive the Medication Guide. Read it. Keep it. Don’t throw it away.

REMS isn’t a barrier to care-it’s a guardrail. It’s there because people have died from these drugs when safety steps were ignored. Taking 15 minutes to check these requirements isn’t just smart. It’s what keeps you alive.

What to Do If You’re Denied a Prescription

If your prescription is denied because of REMS, don’t panic. First, get the exact reason from your pharmacy. Was it missing certification? A lapsed registry? A failed lab test? Write it down.

Then contact the manufacturer’s REMS support line. Every REMS program has a dedicated phone number and website. For example, iPLEDGE has a 24/7 helpline. They can walk you through what’s missing and how to fix it-often within hours.

If you’re still stuck, ask your doctor to file a REMS exception request. In rare cases-like a life-threatening condition with no alternatives-the FDA allows temporary access while you complete requirements. It’s not common, but it’s possible.

Remember: REMS exists to protect you. It’s not meant to be a roadblock. But it won’t work unless you’re part of the process. Take the time now. It’s the difference between getting better-and getting hurt.