Senior Medical Director, Health Policy Ensuring Proper Use and Curbing Abuse of Opioids: An Industry Perspective J. David Haddox, DDS, MD Senior Medical Director, Health Policy Purdue Pharma L.P. FDA ALSDAC January 31, 2002

Outline Disease Burden of Chronic Pain Treatment of Chronic Pain Prescription Drug Abuse and Diversion Risk Management Plans

Disease Burden from Chronic Pain No overall national statistics Surveys (representative demographics) State of Pain Survey (EPIC/MRA 1997) Chronic Pain in America (RSW 1999) Patients’ Attitudes Towards Opioids (HI 2002)

“State of Pain” – 1997 Michigan Pain Study – a statewide survey 1.2 out of 9.8 million population have chronic pain 77% experienced pain for over a year 35% missed 20+ days of work in past year 13% denied medications, devices or referral to pain specialists 10% have thought about committing suicide

Chronic Pain in America – 1999 Roadblocks to Relief Focused on moderate to severe, chronic pain, not due to cancer 9% of all US adults suffer this type of pain Verbal Pain Estimate Ranges (0-10 Scale): 5-6 (43%) 7 (23%) 8-10 (34%)

Chronic Pain in America – 1999 Roadblocks to Relief 51% seeing primary care physician 2/3 have lived with pain for 5+ years 78% reported daily pain 10% admit to turning to alcohol for pain relief

Attitudes and Beliefs 2002 N = 1439 Patients with chronic pain, taking an opioid at least 4 months Most commonly reported: arthritis, low back pain, migraine, cancer Analgesics: C-II 638; CIII-V 1125; NSAIDs 1398; APAP 820 VPE Ranges (1-10): 1-3 11%; 4-7 67%; 8-10 22% Pain Controlled? Well 18%, Sometimes 62%, Not 20% Well Controlled: 39% 3+ MDs and 38% took 6 months + to get control Not Controlled: 65% 3+ MDs and 92% have been trying 9+ months   

Attitudes and Beliefs 2002 “Patients do not have trouble obtaining needed pain medicines.” 54% Disagree “I have not experienced any problems getting treatment for my pain.” 35% Disagree   

Attitudes and Beliefs 2002 Imagine that a patient was taking a pain medication for 6 months and suddenly stopped taking it. As a result of not taking the medication they experienced nausea, sweats, had difficulty sleeping, and felt tense and jittery. Based on this information, can you state conclusively that the patient is..? Addicted to the medication Physically dependent on the medication Both addicted and physically dependent on the medication Neither addicted nor physically dependent on the medication Not sure   

Attitudes and Beliefs 2002 Imagine that a patient was taking a pain medication for 6 months and suddenly stopped taking it. As a result of not taking the medication they experienced nausea, sweats, had difficulty sleeping, and felt tense and jittery. Based on this information, can you state conclusively that the patient is..? Addicted to the medication Physically dependent on the medication Both addicted and physically dependent on the medication Neither addicted nor physically dependent on the medication Not sure    16% 37% 35% 2% 10%

Addiction Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. AAPM, ASAM, APS -- 2001

Physical Dependence Physical dependence is a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and / or administration of an antagonist. AAPM, ASAM, APS -- 2001

Integrated Treatment Approach for Chronic Pain Physical Therapy Therapy for Comorbidities Pharmacotherapy Rehabilitation Services Individualized Care Plan Cognitive Therapies Surgery Behavioral Therapies Nerve Blocks, etc

Prescription Medication Appropriate Use: Patients with pain / legitimate need Inappropriate Use: Abusers / Diverters No reliable, nationally representative statistics on Rx medication abuse -- NIDA Press Conference

Prescription Drug Diversion “Doctor Shoppers” Organized or “sole proprietor” Abuse, traffic or both Prescription Fraud Altered, forged, counterfeit Theft Patients, pharmacies Prescribers Dated, Duped, Dishonest, Disabled

Prescription Drug Abuse and Diversion Public Health Ramifications: Experimentation in naïve persons Mixing multiple drugs and alcohol Substance abuse Impacting access for patients with pain

Education / Prevention Integrated Approach to Ensuring Proper Use and Curbing Abuse with Opioid Therapy Statutes / Regulation Improved Practice Surveillance / Interventions Optimal Public Health Risk Management Plans Law Enforcement NCE’s & New Formulations Access to Addiction Treatment Education / Prevention

Risk Management Plans: An Evolving Practice Scheduling Labeling Education of Health Care Professionals Education of Patients and Caregivers Surveillance Activities Stepped Interventions Outcomes Assessment Re-assessment, Re-emphasis, Revision

Balancing the Need to Treat Chronic Pain While Limiting Abuse Government Encouraging education about pain care and addiction Class labeling Law enforcement Industry Encouraging education about pain care and addiction Risk communication

Anti-Diversion Information

Tamper-Resistant Prescription Pad “VOID” appears on photocopied or scanned blanks

Balancing the Need to Treat Chronic Pain While Limiting Abuse Government Assist with data collection and interpretation on pain, abuse, addiction, diversion Promulgating model State statutes Industry Develop and administer product specific risk management plans Develop progressively abuse resistant formulations Discovery research

Researched Abuse, Diversion and The Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System™ Objective: Develop more robust and reliable indicators of diversion or abuse than current publicly accessible databases Rate estimations on abuse and diversion of specific pharmaceuticals Earlier signal detection

Balancing the Need to Treat Chronic Pain While Limiting Abuse Health Practitioners Learn about pain care and addiction Support model State statutes Prescribe carefully Academia Educate about pain care and addiction Research best educational practices Research best care practices

Summary - I There is a significant burden of unnecessary suffering from chronic pain in the US. Opioids have a significant role in therapy. Opioids have a recognized abuse potential. Product specific risk management plans can reduce abuse.

Summary - II Improvements can and should be made in the assessment and treatment of both pain and substance abuse. Better data are needed on the prevalence and characteristics of pain, and abuse, addiction, & diversion of Rx medications. The most cogent approach to protecting patient access to opioids is a multilateral, integrated strategy, based on data.

Conclusion - I To ensure access to effective and appropriate care for patients with pain, Curb abuse, Diagnose and treat addiction, and Prevent diversion,

Conclusion - II Regulators, Health care professionals, Law enforcement officials, Industry, Educators, Legislators, The Public, Must engage in active dialog, respecting differing viewpoints and varying experiences to optimize public health.