The Risk Evaluation and Mitigation Strategy (REMS) program
A comprehensive program to support safe use of Xtampza ER
The goal of REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting opioids.
The following services are provided through REMS to ensure that the benefits of Xtampza ER outweigh the risks of adverse outcomes such as addiction, unintentional overdose, and death:
- Continuing education (CE): REMS-compliant training is available to healthcare professionals who prescribe ER opioids. The accredited CE courses focus on the safe prescribing of ER opioids, patient selection and monitoring, and how to recognize opioid misuse, abuse, addiction, and overdose
- Patient counseling: In addition to the Xtampza ER Medication Guide, you will receive the REMS Patient Counseling Document, which explains how to use, store, and dispose of opioids. You can distribute these materials to your patients to ensure they understand how to safely use opioids
- 24/7 call center: The REMS call center is available to healthcare professionals to answer FAQs and to provide information about program materials and services. Trained call center representatives can also direct questions or concerns to the appropriate outlet
Refer to the REMS Program Letter sent to your office for more detailed information about these services.