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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 l.jpg

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 l.jpg
Discussion Topics Management in the ED

  • 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 l.jpg
The Primary Role Management in the ED

  • 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 l.jpg
The Primary Role Management in the ED

  • 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 l.jpg
The Primary Role Management in the ED

  • 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 l.jpg
The Professional Prescribing Information – the PI Management in the ED

  • User friendly?

  • Consistent within class:

    • Warnings?

      • Boxed

    • Pharmacology?

  • Help the prescriber/patient?

  • Advisory Committees represent an opportunity to get involved


  • The medwatch system l.jpg
    The MedWatch System Management in the ED

    • 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 l.jpg
    The MedWatch System Management in the ED

    • Serious Adverse Events:

      • Death

      • Life-Threatening

      • Hospitalization

        • Initial

        • Prolonged Admission

      • Disability

      • Congenital Anomaly

      • Requires Intervention to Prevent Permanent Impairment or Damage


    Risk management programs l.jpg
    Risk Management Programs Management in the ED

    • Voluntary

    • Assessment of Risk

    • Surveillance of Risk

    • Management of Risk


    Purdue s modified release opioid analgesic risk management program l.jpg
    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 l.jpg
    Narcotic Analgesics DAWN ED Mentions ProgramPercent of Total Drug Abuse Mentions

    Drug Abuse Warning Network (DAWN), 1995-2002





    Poison control centers 2003 l.jpg
    Poison Control Centers 2003 Program

    *

    *4th quarter incomplete [includes RMPDC, NNEP (Northern New England PC),

    Blue Ridge, Kentucky, Miami, CA, and partial data from the VA poison center]


    Conclusion l.jpg
    Conclusion Program

    • Pharma and the FDA interact

    • Pharma and the Physicians interact

    • Do Physicians interact with the FDA?


    The painless ed l.jpg
    The Painless ED Program

    Physicians

    Pharma

    FDA


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