The Pharmaceutical Industry and
Their Influence on Pain Management
in the ED
J. David Haddox, DDS, MD
VP, Risk Management & Health Policy
Purdue Pharma L.P.
Stamford, CT
10/20/2004
1
Discussion Topics
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This part of the session will explore the
interaction between:
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To optimize the management of:
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10/20/2004
The Pharmaceutical Industry
The Food and Drug Administration
The Emergency Department Physician
The Patients !!
2
The Primary Role
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Pharma:
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10/20/2004
Bring new medicines to the market
Meet unmet therapeutic needs
Educate about disease state management
Educate about specific drug products
Assess and manage risk associated with
specific drug products
3
The Primary Role
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FDA:
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Review and approve new drugs for:
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Encourage Effective Risk Management
Analyze Adverse Event information to:
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Safety
Efficacy
Improve professional prescribing information
Restrict uses
Remove medications from the market
4
The Primary Role
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ED Physicians:
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Understand the use of new drugs
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Appropriate patient selection
Optimize Benefit/Risk ratio for patients
Contribute knowledge of public health
5
The Professional Prescribing
Information – the PI
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User friendly?
Consistent within class:
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Warnings?
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Boxed
Pharmacology?
Help the prescriber/patient?
Advisory Committees represent an
opportunity to get involved
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The MedWatch System
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Adverse Drug Reactions, or
Adverse Events
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An adverse event is any unintended event
associated with the use of a medical
product in a patient. [emphasis added]
7
The MedWatch System
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Serious Adverse Events:
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Death
Life-Threatening
Hospitalization
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Initial
Prolonged Admission
Disability
Congenital Anomaly
Requires Intervention to Prevent
Permanent Impairment or Damage
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Risk Management Programs
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Voluntary
Assessment of Risk
Surveillance of Risk
Management of Risk
9
Purdue’s Modified-Release Opioid
Analgesic Risk Management Program
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Promote appropriate patient selection
and proper dosing
Reduce abuse
Minimize diversion
Avoid accidental pediatric exposure
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Narcotic Analgesics DAWN ED Mentions
Percent of Total Drug Abuse Mentions
12%
10%
8%
6%
4%
2%
0%
1995
1996
1997
1998
1999
Drug Abuse Warning Network (DAWN), 1995-2002
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2000
2001
2002
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Drug Diversion Coverage
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12
Drug Diversion Total Mentions 2003
1400
1200
1000
800
600
400
200
0
1Q03
10/20/2004
2Q03
3Q03
4Q03
Buprenorphine
Fentanyl
Hydrocodone
Hydromorphone
Methadone
Morphine
OxyContin
Other Oxycodone
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Poison Control Centers Coverage
10/20/2004
14
Poison Control Centers 2003
Rate per 100,000 Population
350
300
Buprenorphine
Fentanyl
250
Hydrocodone
200
Hydromorphone
Methadone
150
Morphine
100
Other oxycodone
OxyContin®
50
*
0
1Q03
2Q03
3Q03
4Q03*
*4th quarter incomplete [includes RMPDC, NNEP (Northern New England PC),
Blue Ridge, Kentucky, Miami, CA, and partial data from the VA poison center]
10/20/2004
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Conclusion
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Pharma and the FDA interact
Pharma and the Physicians interact
Do Physicians interact with the FDA?
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The Painless ED
Physicians
Pharma
10/20/2004
FDA
17