Addiction, abuse, misuse, and diversion

• Butrans contains buprenorphine, a Schedule III controlled substance. As an opioid, Butrans exposes users to the risks of addiction, abuse, and misuse. Because extended-release products such as Butrans deliver the opioid over an extended period of time, there is a greater risk for overdose and death, due to the larger amount of buprenorphine present.
• Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Butrans. Addiction can occur at recommended doses and if the drug is misused or abused.
• Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Butrans, and monitor all patients receiving Butrans for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Butrans, but use in such patients necessitates intensive counseling about the risks and proper use of Butrans, along with intensive monitoring for signs of addiction, abuse, or misuse.
• Abuse or misuse of Butrans by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose and death.
• Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Butrans. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

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 ER/LA opioid analgesics, while maintaining patient access to these medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.

• FDA has required a REMS for opioid analgesics
• Purdue Pharma is a member of the REMS Program Companies

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 Medication Guide
• Reviewing the Opioid REMS Patient Counseling Document with the patient and/or caregiver at the time of prescribing