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.
- 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 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.
- Explain how to safely store the medication out of the reach of children.
- Schedule patient appointments commensurate with patient stability (weekly or more frequent visits recommended for the first month).
- Consider "pill/film count"/dose reconciliation.
- whether patient is receiving counseling/psychosocial support considered necessary for treatment and if not, encourage them to do so.
- whether patient is making progress toward treatment goals (including, as appropriate, urine toxicology testing).
- the appropriateness of the maintenance dose.
- whether or not benefits of treatment outweigh the risks.
To prescribe products covered under the SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets 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.