The Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD)
A REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure that the benefits of a drug outweigh its risks.
The purpose of the BTOD REMS program is to inform healthcare professionals and patients about the safe use conditions and serious risks, including accidental overdose, misuse, and abuse, associated with buprenorphine-containing transmucosal products indicated for the treatment of opioid dependence.
Verify that patients meet diagnostic criteria for opioid dependence
Counsel patients and/or their caregivers on safe use of the product, including appropriate storage and disposal, and risks associated with treatment, at each visit
Monitor and document safe use conditions for each patient by using the Appropriate Use Checklist (or by other means specific to office practice)
Assess appropriateness of treatment and adequate progress towards treatment goals for each patient
To prescribe products covered under the BTOD REMS, a prescriber must be certified to treat opioid dependence under the Drug Addiction Treatment Act of 2000 (DATA 2000). For certification information, click here.
Click here for a complete list of products covered under the BTOD REMS program