Primary Outcome Measures:
- Difference from baseline in the average pain score at each subsequent visit based on a numerical rating scale of pain [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
- The incidence and characterization of AEs [ Time Frame: 3-4 months ] [ Designated as safety issue: Yes ]
- The number of patients at each level of risk for opioid misuse or abuse during each visit as determined by the use of study tools. [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of investigators with greater than or equal to 75% patient compliance with major components of the universal precautions approach to pain management as defined by the protocol. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
- Difference from baseline in the activities of daily living score at each subsequent visit based on a numerical rating scale [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Pain affects more Americans than diabetes, heart disease and cancer combined and although it is one of the earliest known ailments, pain is still without a universal cure. It is estimated that only about 25% of patients with chronic pain receive adequate analgesia.
Long-term treatment of chronic pain with opioids is recognized as an important treatment option for patients with moderate-severe pain related to cancer and other chronic serious illnesses. AVINZA (morphine sulfate extended-release capsules) was approved for marketing by the Food and Drug Administration (FDA) in 2002 as a once daily treatment for the relief of moderate to severe pain requiring continuous opioid therapy for an extended period of time. While opioids, such as AVINZA, are beneficial in the management of chronic pain, they are sometimes associated with illicit activities. Misuse, abuse and diversion of controlled prescription drugs, particularly opioids, are problems that have increased dramatically in the United States (U.S.) since the 1990s.
This study will follow the Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain. Patients will be counseled on the proper storage and destruction of unused AVINZA in accordance with federal and applicable state laws. A universal precautions approach to chronic pain management (KAIR) will be utilized in this study. Although not validated as a risk assessment and management instrument, KAIR is designed to assist clinicians with responsibly managing chronic moderate-severe pain patients prescribed AVINZA. The KAIR tools will be used by the Investigator to determine the level of monitoring required based on the patient's potential risk for opioid misuse or abuse (KAIR level). Investigators and staff participating in this study will be required to participate in a training program on the counseling to be given, procedures to be followed and tools to be used in this study.