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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.

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Presentation on theme: "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."— Presentation transcript:

1 10/20/ 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

2 10/20/ 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 !!

3 10/20/ 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

4 10/20/ 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

5 10/20/ 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

6 10/20/ 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

7 10/20/ 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]

8 10/20/ The MedWatch System Serious Adverse Events: Death Life-Threatening Hospitalization Initial Prolonged Admission Disability Congenital Anomaly Requires Intervention to Prevent Permanent Impairment or Damage

9 10/20/ Risk Management Programs Voluntary Assessment of Risk Surveillance of Risk Management of Risk

10 10/20/ Purdues Modified-Release Opioid Analgesic Risk Management Program Promote appropriate patient selection and proper dosing Reduce abuse Minimize diversion Avoid accidental pediatric exposure

11 10/20/ Narcotic Analgesics DAWN ED Mentions Percent of Total Drug Abuse Mentions Drug Abuse Warning Network (DAWN),

12 10/20/ Drug Diversion Coverage

13 10/20/ Drug Diversion Total Mentions 2003

14 10/20/ Poison Control Centers Coverage

15 10/20/ Poison Control Centers 2003 *4 th quarter incomplete [includes RMPDC, NNEP (Northern New England PC), Blue Ridge, Kentucky, Miami, CA, and partial data from the VA poison center] *

16 10/20/ Conclusion Pharma and the FDA interact Pharma and the Physicians interact Do Physicians interact with the FDA?

17 10/20/ The Painless ED Physicians Pharma FDA


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