10/20/2004 1 The Pharmaceutical Industry and Their Influence on Pain Management in the ED J. David...
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10/20/2004 1 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
Transcript of 10/20/2004 1 The Pharmaceutical Industry and Their Influence on Pain Management in the ED J. David...
10/20/20041
The Pharmaceutical Industry and Their Influence on Pain Management in the ED
J. David Haddox, DDS, MD
VP, Risk Management & Health PolicyPurdue Pharma L.P.
Stamford, CT
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Discussion Topics
This part of the session will explore the interaction between: The Pharmaceutical Industry The Food and Drug Administration The Emergency Department Physician
To optimize the management of: The Patients !!
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The Primary Role Pharma:
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
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The Primary Role FDA:
Review and approve new drugs for: Safety Efficacy
Encourage Effective Risk Management Analyze Adverse Event information to:
Improve professional prescribing information Restrict uses Remove medications from the market
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The Primary Role
ED Physicians: Understand the use of new drugs
Appropriate patient selection Optimize Benefit/Risk ratio for
patients Contribute knowledge of public health
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The Professional Prescribing Information – the PI
User friendly? Consistent within class:
Warnings? Boxed
Pharmacology?
Help the prescriber/patient? Advisory Committees represent an
opportunity to get involved
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The MedWatch System
Adverse Drug Reactions, or Adverse Events
An adverse event is any unintended event associated with the use of a medical product in a patient. [emphasis added]
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The MedWatch System Serious Adverse Events:
Death Life-Threatening Hospitalization
Initial Prolonged Admission
Disability Congenital Anomaly Requires Intervention to Prevent
Permanent Impairment or Damage
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Risk Management Programs
Voluntary Assessment of Risk Surveillance of Risk Management of Risk
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Purdue’s Modified-Release Opioid Analgesic Risk Management Program
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
0%
2%
4%
6%
8%
10%
12%
1995 1996 1997 1998 1999 2000 2001 2002
Drug Abuse Warning Network (DAWN), 1995-2002
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Drug Diversion Coverage
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Drug Diversion Total Mentions 2003
0
200
400
600
800
1000
1200
1400
1Q03 2Q03 3Q03 4Q03
Buprenorphine Fentanyl Hydrocodone Hydromorphone
Methadone Morphine OxyContin Other Oxycodone
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Poison Control Centers Coverage
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Poison Control Centers 2003
*4th quarter incomplete [includes RMPDC, NNEP (Northern New England PC), Blue Ridge, Kentucky, Miami, CA, and partial data from the VA poison center]
*0
50
100
150
200
250
300
350
1Q03 2Q03 3Q03 4Q03*
Rat
e p
er 1
00,0
00 P
op
ula
tio
n Buprenorphine
Fentanyl
Hydrocodone
Hydromorphone
Methadone
Morphine
Other oxycodone
OxyContin®
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Conclusion 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 FDA
