# Presentation: 857982

## An Industry Perspective 

- 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

**Individualized**
**Care Plan**

## 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

## Integrated Approach to Ensuring Proper Use and Curbing Abuse with Opioid Therapy

**Optimal**
**Public Health**

## 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

**Tamper-Resistant Prescription Pad**

## 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

##  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

**The**
**Researched Abuse, Diversion and**
** ****Addiction-Related Surveillance (RADARS) **
**System****TM**

## 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.