1. 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

2. 10/20/2004 2 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. 10/20/2004 3 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. 10/20/2004 4 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. 10/20/2004 5 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. 10/20/2004 6 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. 10/20/2004 7 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. 10/20/2004 8 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. 10/20/2004 9 Risk Management Programs Voluntary Assessment of Risk Surveillance of Risk Management of Risk

10. 10/20/2004 10 Purdues Modified-Release Opioid Analgesic Risk Management Program Promote appropriate patient selection and proper dosing Reduce abuse Minimize diversion Avoid accidental pediatric exposure

11. 10/20/2004 11 Narcotic Analgesics DAWN ED Mentions Percent of Total Drug Abuse Mentions Drug Abuse Warning Network (DAWN), 1995-2002

12. 10/20/2004 12 Drug Diversion Coverage

13. 10/20/2004 13 Drug Diversion Total Mentions 2003

14. 10/20/2004 14 Poison Control Centers Coverage

15. 10/20/2004 15 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. 10/20/2004 16 Conclusion Pharma and the FDA interact Pharma and the Physicians interact Do Physicians interact with the FDA?

17. 10/20/2004 17 The Painless ED Physicians Pharma FDA