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What You Need to Know About the Sublocade REMS Program

Why can’t consumers walk into a pharmacy with a prescription for Sublocade and walk out with the medication? The Sublocade REMS program is responsible. 

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The Sublocade REMS program is a set of rules and requirements from the U.S. Food and Drug Administration, designed to reduce the risks associated with this medication. 

Sublocade includes buprenorphine, a partial opioid agonist people might try to inject to get high. However, Sublocade uses a gel to deliver buprenorphine. That gel becomes a solid when it hits water in the body.[1] People who inject Sublocade into their veins could die.

Sublocade REMS keeps the substance under tight control so it’s harder to abuse and more likely to be available for people who need it. 

What Is the Sublocade REMS (Risk Evaluation & Mitigation Strategy)?

The U.S. Food and Drug Administration (FDA) requires medications with serious safety concerns to participate in REMS.[2] This drug safety program involves identifying risks and developing strategies to mitigate them whenever possible. 

More than 65 drugs participate in REMS, including Sublocade.[3] 

Sublocade is included in REMS due to the risks of serious harm or death that could result from intravenous administration.[4] People who put this drug into their veins—rather than injecting it into the abdomen as designed—could die when the gel solidifies. 

Breaking Down Sublocade REMS Requirements

Risks associated with Sublocade involve self-injection into veins and arteries. The Sublocade REMS program is designed to reduce those dangers. 

These components are part of the Sublocade REMS program:[5]

  • Timing: Sublocade is administered monthly only. 
  • Placement: The medication is injected into the abdominal region. 
  • Professional: Only a healthcare provider can administer the drug. 
  • Availability: Only facilities that participate in REMS can order and dispense the medication to providers. 

Consumers can’t buy Sublocade and inject it at home. Instead, they can only get the drug via a healthcare professional who injects the substance for them. 

Everything You Need to Know About the REMS Program for Sublocade

When you start using Sublocade for opioid use disorder (OUD), you’ll be working with a network of professionals who are either directly or indirectly participating in REMS. Their work ensures that the medication is never dispensed directly to patients.[6] 

Here’s what you need to know about every part of that network: 

Providers and Sublocade

Doctors and other healthcare providers aren’t required to sign up for the Sublocade REMS program. However, they must be connected with a pharmacy that is part of REMS.[5]

A doctor can write a prescription for Sublocade and send it to a dispensing pharmacy. That pharmacy can coordinate the delivery of Sublocade in time for the patient’s appointment.[5] The provider can then administer the injection per the medication’s package instructions. 

Healthcare Settings & Sublocade 

Getting medications from pharmacies may not be ideal for providers who treat many patients with Sublocade. If these doctors want to keep a supply of the medication on hand, the facility must be part of the Sublocade REMS program before the first dose is ordered from the manufacturer.[5]

Pharmacies & Sublocade 

Any pharmacy that wants to stock Sublocade and dispense it must be certified with the Sublocade REMS program before ordering doses from the manufacturer.[5] With that done, they can dispense the medication to healthcare professionals only, never to consumers. 

4 Steps to Enroll in the Program 

Anyone who wants to order Sublocade from the manufacturer must enroll in the Sublocade REMS program. The following steps are involved:[7]

  1. Designate an authorized representative. This person will finish the certification process, communicate directly with REMS authorities, and ensure that the facility follows all of the required rules. 
  2. Review the materials. The representative will read all provided Sublocade documents and ensure that they understand the rules. 
  3. Complete the forms. The representative will fill out and sign the required forms and submit them. 
  4. Implement the protocol. The representative will train staff, set up processes to keep the medication safe and create protocols for reporting and REMS communication. 

Where to Learn More 

Sublocade can be a life-saving medication for people struggling with OUD when used as part of a medication-assisted treatment (MAT) program. Anyone who wants to learn more about how it’s protected and dispensed can do so on the official Sublocade REMS site
Use this site to learn more about specific requirements for providers, facilities, and pharmacies. Download forms to help you learn more about the rules and regulations. And get started on enrollment to dispense the medication.

Updated March 18, 2024
Resources
  1. Thakare E, Malpure P, Maru A, et al. Atrigel implants and controlled release drug delivery system: A review. American Journal of Pharmtech Research. 2019;9(2).
  2. Risk evaluation and mitigation strategies. U.S. Food and Drug Administration. Published May 16, 2023. Accessed February 27, 2024.
  3. Approved risk evaluation and mitigation strategies (REMS). U.S. Food and Drug Administration. Accessed February 27, 2024.
  4. Sublocade prescribing information. U.S. Food and Drug Administration. Published March 2021. Accessed February 27, 2024.
  5. What is the Sublocade REMS (risk evaluation and mitigation strategy)? Sublocade. Accessed February 27, 2024.
  6. FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder. U.S. Food and Drug Administration. Published November 30, 2017. Accessed February 27, 2024.
  7. Pharmacies. Sublocade. Accessed February 27, 2024.
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