Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza (ACCESS 2008)

• Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6) [ Time Frame: Baseline (Week 0) to Visit 3 (Week 6) ] [ Designated as safety issue: No ]
  Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 3
  
  
• Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10) [ Time Frame: Baseline (Week 0) to Visit 4 (Week 10) ] [ Designated as safety issue: No ]
  Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 4
  
  
• Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study) [ Time Frame: Baseline (Week 0) to Visit 5 (Week 14 / End of Study) ] [ Designated as safety issue: No ]
  Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 5 / End of Study
  
  
• Number of Subjects With Treatment Emergent Adverse Events [ Time Frame: Up to 4 months ] [ Designated as safety issue: Yes ]
  Adverse events that occur or worsen after the first dose of Avinza
  
  
• Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) [ Time Frame: Visit 3 (Week 6) ] [ Designated as safety issue: No ]
  Risk level was determined by the investigator using the subject's SOAPP-R (Screener and Opioid Assessment for Patients with Pain® - Revised Questionnaire) score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.
  
  
• Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) [ Time Frame: Visit 4 (Week 10) ] [ Designated as safety issue: No ]
  Risk level was determined by the investigator using the subject's SOAPP-R score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.
  
  

• Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study. [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]
  After each subject completed participation in the study, investigators reported satisfaction with the utility of the risk minimization program in handling each subject's particular case. The risk minimization program is a set of tools used to assist clinicians in responsibly managing pain patients prescribed Avinza. The tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT (Pain Patient Follow-up Tool), Investigator Assessment and Plan and prescription card data. These tools were used at each visit to assess subject risk and to aid in the management of subject's pain.
  
  
• Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion. [ Time Frame: 3 months post study ] [ Designated as safety issue: No ]
  The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.
  
  
• Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion. [ Time Frame: 6 months post study ] [ Designated as safety issue: No ]
  The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.
  
  

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.