Prescribers play an important role in reducing the risks of accidental overdose, misuse, and abuse, associated with buprenorphine-containing transmucosal products. To help mitigate these risks, prescribers should:
- Verify the patient meets appropriate diagnostic criteria for opioid dependence.
- Check patient's prescription profile in the Prescription Drug Monitoring Program, as appropriate, and review all medications (e.g., benzodiazepines, other opioids, CNS depressants) and illicit substances to assess for appropriateness of co-prescribing.
- Discuss the risks (including misuse and abuse) and side effects associated with buprenorphine-containing products, including those described in the Medication Guide. (See the brochure, Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers for additional safety information regarding these risks.)
- Explain how to store buprenorphine-containing products safely out of the sight and reach of all others, especially children.
- Strongly consider prescribing naloxone because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose.
- Discuss the importance of having access to naloxone with patient and caregiver, if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.
- Explain what patients should do if they experience side effects.
- Provide induction doses under appropriate supervision.
- Prescribe a limited amount of medication to the patient that will last until the next visit.
- Schedule patient appointments commensurate with patient stability (weekly or more frequent visits recommended for the first month).
- Consider “pill/film count”/dose reconciliation.
- Assess whether the patient is receiving counseling/psychosocial support considered necessary for treatment and if not, encourage them to do so.
- Assess whether the patient is making progress toward treatment goals (including, as appropriate, urine toxicology testing).
- Continually assess appropriateness of maintenance dose.
- Continually assess whether or not benefits of treatment outweigh the risks.
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