1. 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

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

3. 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)

4. “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

5. 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%) (34%)

6. 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

7. 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): %; %; %
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   

8. 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   

9. 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   

10. 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%

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. Anti-Diversion Information

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

22. 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

23. 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

24. 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

25. 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.

26. 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.

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

28. 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.