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Sublocade REMS: Risk Evaluation & Mitigation Strategy

Danny Nieves-Kim, MD profile image
By Danny Nieves-Kim, MD • Updated Oct 15, 2023 • 6 cited sources

The Sublocade Risk Evaluation and Mitigation Strategy (or REMS) is designed to prevent the misuse or abuse of the buprenorphine inside Sublocade.[1] 

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The U.S. Food and Drug Administration (FDA) creates REMS programs for drugs with safety concerns. Long-lasting forms of buprenorphine, like those inside Sublocade, could be dangerous in the wrong hands. 

REMS offers safeguards to ensure the drug is available to help people who need Sublocade as part of Medication for Addiction Treatment (MAT) programs. 

What Is Sublocade REMS?

Sublocade is a safe and effective medication when used appropriately. But per the FDA, it is a risky medication with a high potential for diversion or abuse.[1] The FDA can craft REMS rules for any medication it deems somehow dangerous. 

The FDA says REMS ensures that the benefits of a medication like Sublocade outweigh its risks.[1] 

As a patient, you don’t need to enroll in or otherwise participate in Sublocade REMS. But your doctor, clinic or pharmacy must know about and comply with the rules. 

Since Sublocade is part of REMS, it may be slightly harder to get than other buprenorphine therapies (like Suboxone). If your doctor can’t find a REMS pharmacy, for example, it could be difficult to get your monthly injection. 

But those REMS rules could keep life-saving medications from entering the black market, potentially spurring a government crackdown. If everyone follows the rules, manufacturers could keep safely making the drug you need. 

What Is the Goal of the Sublocade REMS?

Every FDA-created REMS program has a stated goal. Sublocade’s is to mitigate the risk of serious harm or death caused by intravenous administration by drug users.[2]

Sublocade must be administered by a professional into subcutaneous tissues. One dose should last a month. Experts at the FDA worry that Sublocade will enter the black market, and people will use multiple doses at once to get high. 

More than a million people have died in the United States since 1999 due to drug overdoses.[3] While buprenorphine can help people overcome opioid use disorder (OUD) and avoid overdose risks, it can potentially be misused.

Buprenorphine misuse is rare. Data from the 2015–2019 National Surveys on Drug Use and Health showed that an estimated 1.7 million people used buprenorphine legally, compared to 700,000 who misused it.[4] Stats like this prove that MAT therapies are safe. 

But REMS for Sublocade works as another form of safety, ensuring that the drug won’t enter the black market and cause more deaths. 

REMS & Requirements

The steps and guidelines people must follow as part of the Sublocade REMS vary, depending on role.[5]


Doctors, nurse practitioners and other authorized prescribers aren’t required to complete Sublocade REMS enrollment. They can write prescriptions for your injections, and they can administer them too. But they must move through a few extra hoops. 

Your provider must write a prescription for your Sublocade injection and send it to a pharmacy that has REMS certification. That facility organizes the delivery of your prescription based on your appointment date. Your doctor can administer it. 

If providers want to keep the medication on site to serve their patients, they must be REMS certified. Their practice or healthcare setting must be enrolled in REMS too. 

Healthcare Settings

Any hospital, clinic, prescriber office or other location that wants to keep Sublocade onsite must be REMS certified. That step ensures they can keep loaded syringes on the premises without violating the rules. But if their providers are comfortable working with REMS pharmacies to fill prescriptions for their appointments, the settings can skip the certification step. 


Pharmacies that intend to keep Sublocade in stock must be certified in the Sublocade REMS. They must finish this step before they order the drug from an authorized distributor. And they must keep the certification active to fill prescriptions legally. 

How Enrollment Works 

To participate in REMS and provide Sublocade to patients, prescribers, pharmacies and healthcare administrators must complete the following steps:[2]

  1. Identify someone who will handle all of the REMS compliance steps. 
  2. Ensure that the compliance officer enrolls in the program. 
  3. Train all staff and ensure they understand Sublocade can’t be administered by patients. 
  4. Create processes and procedures to ensure that no patients self-administer this drug. 

To maintain compliance with Sublocade REMS, providers must maintain records that prove they don’t hand drugs to patients. And sometimes, they must submit to audits.[2]

What Should You Know as a MAT Patient?

Sublocade REMS is tightly focused on preventing self-administration of this drug. Never ask your provider for at-home doses. 

If you’re heading out of town and can’t make your next appointment, ask your doctor for help. You may need a bigger dose that allows you to skip the next without health issues. They can help you navigate the situation.

If you’re offered Sublocade from a dealer or third party, be suspicious. The needle the person hands you likely contains something else (like fentanyl) and isn’t safe for you to use. It’s simply to never use Sublocade that isn’t prescribed by a doctor and administered in a medical setting.[6]

By Danny Nieves-Kim, MD

... Read More

  1. Risk evaluation and mitigation strategies (REMS). U.S. Food and Drug Administration. Published May 16, 2023. Accessed August 18, 2023.
  2. Approved Risk Evaluation and Mitigation Strategies (REMS): Sublocade. U.S. Food and Drug Administration. Published July 3, 2023. Accessed August 18, 2023. 
  3. Drug overdose deaths. Centers for Disease Control and Prevention. Published August 10, 2023. Accessed August 18, 2023. 
  4. Buprenorphine misuse decreased among U.S. adults with opioid use disorder from 2015-2019. National Institute on Drug Abuse. Published October 15, 2021. Accessed August 18, 2023. 
  5. What is the Sublocade REMS? Sublocade. Accessed August 18, 2023. 
  6. How Sublocade works. Sublocade. Accessed August 18, 2023. 

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