Before you start a new medication, especially one that treats serious conditions, there’s something critical you might not know about: REMS. Risk Evaluation and Mitigation Strategies are not optional. If your doctor prescribes a drug with a REMS program, skipping the required steps could mean your prescription won’t be filled - or worse, put you at serious risk. These programs exist because some medications, while life-saving, carry dangers so severe that the FDA won’t approve them unless specific safety steps are followed. Whether you’re taking isotretinoin for acne, thalidomide for cancer, or an opioid for chronic pain, REMS requirements are part of the process. And if you don’t check them, you could face delays, denials, or even harm.
What Exactly Is a REMS?
REMS stands for Risk Evaluation and Mitigation Strategy. It’s a safety program required by the U.S. Food and Drug Administration (FDA) for certain medications with known, serious risks. Think of it as a safety net. The FDA introduced REMS in 2007 after Congress passed the Food and Drug Administration Amendments Act. Since then, 76 REMS programs have been approved. These aren’t just paperwork - they’re legally enforced protocols designed to make sure the benefits of a drug outweigh its risks.
Not all REMS are the same. Some are simple. Others are complex. A Medication Guide (a printed handout you get at the pharmacy) is the most basic element. But many REMS go further. Some require prescribers to be certified. Others require patients to enroll in a registry, get regular blood tests, or even have the drug administered in a certified clinic. For example, Zyprexa Relprevv - a long-acting antipsychotic - must be given in a certified facility where staff can monitor you for three hours after the injection. Why? Because some patients develop sudden dizziness or confusion that could lead to falls or injury.
How to Find Out If Your Medication Has a REMS
The first place to look is the medication’s prescribing information. That’s the official document your doctor uses, and it always says whether a REMS is required. But most patients don’t see this. So where should you look?
- Ask your pharmacist - they’re legally required to know if a REMS applies to the drug they’re dispensing. Call them before you pick up your prescription.
- Check the FDA’s REMS Public Dashboard - it’s free, updated daily, and searchable by drug name. Go to fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems. Type in your medication. If it shows up, click on it to see exactly what steps you need to take.
- Look at the manufacturer’s website - companies like Janssen (for Zyprexa) or iPLEDGE (for isotretinoin) run their own REMS portals. These often have step-by-step guides for patients and prescribers.
- Read the Medication Guide - if it mentions a REMS program, don’t ignore it. It’ll tell you where to go next.
Some drugs have multiple REMS elements. For instance, isotretinoin (Accutane) requires both prescriber and patient registration through the iPLEDGE program. You can’t get a refill unless both you and your doctor are enrolled. And if you miss a monthly check-in? Your prescription stops.
What You Might Need to Do
REMS requirements vary widely. Here are the most common ones you’ll encounter:
- Prescriber Certification - Your doctor must complete training and register with the REMS program before they can prescribe the drug. For drugs like thalidomide, this means logging into a website, watching a video, passing a quiz, and getting certified. It takes about an hour. If your doctor hasn’t done this, they can’t write the script.
- Patient Enrollment - You may need to create an account, sign a form, and agree to regular monitoring. The iPLEDGE program for isotretinoin requires monthly pregnancy tests for women of childbearing age. If you don’t submit your test results, your pharmacy won’t fill your prescription.
- Lab Monitoring - Some REMS require blood tests before each refill. Mycophenolate, used after organ transplants, requires liver and blood cell counts every few weeks. If you skip a test, your refill is held.
- Restricted Distribution - Some drugs can only be given in certified hospitals or clinics. This is common with high-risk biologics or gene therapies.
It’s not just about paperwork. These steps exist because people have died. Isotretinoin caused thousands of birth defects before iPLEDGE. Opioid overdoses spiked before the Opioid Analgesic REMS required prescriber education. These programs aren’t bureaucracy - they’re lifesavers.
What Happens If You Skip REMS Steps?
Pharmacies are legally required to check REMS compliance before dispensing. If you don’t meet the requirements, your prescription will be rejected - no exceptions. You might think it’s just a delay, but it’s more than that.
One patient in Texas waited 11 days for her mycophenolate refill because she didn’t know about the monthly lab requirement. Her transplant team had to rush her into an emergency clinic. Another in Florida couldn’t get his opioid prescription filled because his doctor hadn’t completed the required education. He ended up in the ER with uncontrolled pain.
Even if you’re not in the U.S., you might still encounter REMS. Many global manufacturers follow FDA guidelines, especially for drugs sold internationally. If your doctor says, “This drug has special requirements,” don’t brush it off.
How Long Does REMS Verification Take?
It varies. For most medications with simple REMS (like a Medication Guide), it’s instant. But for those with prescriber certification or patient enrollment, it can take days - sometimes weeks.
A 2022 survey by the National Organization for Rare Disorders found that 42% of patients on REMS drugs experienced treatment delays. The average delay? 6.2 business days. That’s more than a week without medication. For someone with epilepsy, cancer, or a transplant, that’s dangerous.
That’s why it’s smart to start early. If your doctor says you’ll need a REMS, ask them to begin the process the same day they write the prescription. Don’t wait until you get to the pharmacy. Call the REMS program hotline. Go to the website. Fill out the forms. The sooner you start, the sooner you get your medicine.
Who Can Help You?
You don’t have to figure this out alone.
- Your pharmacist - they’re trained to handle REMS. Ask them: “Does this drug have a REMS? What do I need to do?”
- Your doctor’s office - many have REMS coordinators who help patients enroll.
- The REMS program itself - most have customer service lines. The iPLEDGE program has a 24/7 hotline. The Opioid REMS has a help center.
- Online tools - the FDA’s REMS Public Dashboard lets you search by drug name, view requirements, and find links to enrollment portals.
Pharmacists in Australia and Canada often see U.S. REMS requirements when patients bring in prescriptions from American providers. If you’re traveling or using a U.S.-based pharmacy, REMS still applies.
What’s Changing in 2026?
REMS isn’t static. The FDA is actively improving them. In March 2023, they launched a redesigned Public Dashboard with real-time updates. By April 2023, all new REMS programs had to include smartphone-friendly tools. Now, patients can get reminders, upload lab results, and check their status via apps.
Pharmacy benefit managers (PBMs) - the middlemen between insurers and pharmacies - have started integrating REMS checks into electronic prescribing systems. That means fewer phone calls and faster approvals. By 2026, blockchain-based verification systems are expected to roll out, making it harder to fake certifications and easier to track compliance.
But don’t wait for tech fixes. Right now, the system still relies on you - the patient - to take action. The FDA doesn’t call you. Your doctor doesn’t always remind you. It’s up to you to ask, check, and follow through.
What to Do Next
If you’re about to start a new medication:
- Ask your doctor: “Does this drug have a REMS program?”
- Search the FDA’s REMS Public Dashboard using the exact drug name.
- Check the Medication Guide - if it mentions a REMS, follow the instructions.
- Contact the pharmacy - ask if they can fill the script and what you need to do.
- If certification or enrollment is needed, start immediately. Don’t wait.
It’s not about paperwork. It’s about safety. REMS programs exist because people have died from preventable mistakes. They’re not perfect - they’re slow, confusing, and sometimes frustrating. But they work. Skipping them isn’t a shortcut. It’s a risk you can’t afford to take.
Do all new medications have REMS requirements?
No. Only medications with serious safety risks require REMS. About 15-20% of new drugs approved by the FDA each year need some form of REMS. These are typically drugs that can cause severe birth defects, life-threatening side effects, addiction, or death if misused. Common medications like antibiotics or blood pressure pills rarely have REMS.
Can I get my REMS medication from any pharmacy?
Not always. Some REMS programs require you to use a certified pharmacy - especially for drugs like thalidomide or isotretinoin. Many large chain pharmacies are certified, but smaller ones may not be. Always confirm with your pharmacy before your prescription is sent. If they can’t fill it, they should be able to direct you to one that can.
What if my doctor doesn’t know about the REMS?
It happens. Some prescribers, especially those who don’t regularly use the drug, aren’t aware of REMS requirements. If your pharmacist says the prescription can’t be filled due to REMS, ask your doctor to check the FDA’s REMS Public Dashboard or contact the drug manufacturer’s REMS program directly. Many manufacturers provide free training materials and support lines for prescribers.
Are REMS requirements the same in other countries?
No. REMS is a U.S.-only FDA program. Other countries have their own risk management systems - like the EU’s Risk Management Plans or Canada’s Risk Evaluation and Mitigation Programs. But if you’re prescribed a U.S.-approved drug, even outside the U.S., the REMS requirements still apply if the manufacturer enforces them globally. Always check with your provider or pharmacist.
How often do REMS requirements change?
REMS programs are reviewed regularly. Between 2015 and 2020, 37% of REMS were modified to reduce unnecessary burdens. In 2022 alone, 14 REMS were updated to simplify requirements. Changes are announced on the FDA’s REMS website. Always check for updates before refilling - especially if you’ve had delays before.