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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. Discussion Topics. This part of the session will explore the interaction between: The Pharmaceutical Industry

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the pharmaceutical industry and their influence on pain management in the ed

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

discussion topics
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 !!
the primary role
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
the primary role4
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
the primary role5
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
the professional prescribing information the pi
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
the medwatch system
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. [emphasisadded]
the medwatch system8
The MedWatch System
  • Serious Adverse Events:
    • Death
    • Life-Threatening
    • Hospitalization
      • Initial
      • Prolonged Admission
    • Disability
    • Congenital Anomaly
    • Requires Intervention to Prevent Permanent Impairment or Damage
risk management programs
Risk Management Programs
  • Voluntary
  • Assessment of Risk
  • Surveillance of Risk
  • Management of Risk
purdue s modified release opioid analgesic risk management program
Purdue’s Modified-Release Opioid Analgesic Risk Management Program
  • Promote appropriate patient selection and proper dosing
  • Reduce abuse
  • Minimize diversion
  • Avoid accidental pediatric exposure
narcotic analgesics dawn ed mentions percent of total drug abuse mentions
Narcotic Analgesics DAWN ED MentionsPercent of Total Drug Abuse Mentions

Drug Abuse Warning Network (DAWN), 1995-2002

poison control centers 2003
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]

conclusion
Conclusion
  • Pharma and the FDA interact
  • Pharma and the Physicians interact
  • Do Physicians interact with the FDA?
the painless ed
The Painless ED

Physicians

Pharma

FDA

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