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Risk Evaluation and Mitigation Strategy (REMS)

Butrans is subject to the Opioid Analgesics REMS

The goal of the REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, abuse, and misuse of opioid analgesics, while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.

Butrans should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Documentation and maintenance of careful prescribing and treatment records are essential, and should include:

  • Physician and patient agreement
  • Proper assessment of the patient
  • Proper prescribing practices
  • Periodic reevaluation of therapy
  • Proper dispensing and correct storage and handling
  • Careful record keeping of prescribing information, including quantity, frequency, and renewal requests, is strongly advised
  • Providing patient and/or caregiver with the
  • Reviewing the Opioid REMS with the patient and/or caregiver at the time of prescribing
For more information, including REMS-compliant educational CME/CE programs on safe prescribing of REMS for opioid analgesics, visit .