Addiction, abuse, misuse, and diversion

OxyContin can be abused and is subject to misuse, addiction, and criminal diversion.

• Addiction, Abuse, and Misuse
  OxyContin contains oxycodone, a Schedule II controlled substance. OxyContin exposes users to the risks of opioid addiction, abuse, and misuse. Because extended-release products such as OxyContin deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxycodone present
• Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OxyContin. 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 OxyContin, and monitor all patients receiving OxyContin 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 OxyContin, but use in such patients necessitates intensive counseling about the risks and proper use of OxyContin along with intensive monitoring for signs of addiction, abuse, and misuse
• Abuse or misuse of OxyContin by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of oxycodone and can result in 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 OxyContin. 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)

OxyContin is subject to the REMS for opioid analgesics

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.

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

OxyContin 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 Guide 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 opioidanalgesicrems.com