Ensuring Proper Use and Curbing Abuse of Opioids:

1
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 1997Michigan 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 1999Roadblocks 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)

6
Chronic Pain in America 1999Roadblocks 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) 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
•   

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 -- 2001

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 -- 2001

13
Integrated Treatment Approach for Chronic Pain
Individualized Care Plan
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
Integrated Approach to Ensuring Proper Use and
Curbing Abuse with Opioid Therapy
Optimal Public Health
18
Risk Management PlansAn 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
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
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.