The Pharmaceutical Industry and Their Influence on Pain Management in the ED

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. 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. 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. 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. 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. 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. 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]

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. Risk Management Programs • Voluntary • Assessment of Risk • Surveillance of Risk • Management of Risk

10. Purdue’s Modified-Release Opioid Analgesic Risk Management Program • Promote appropriate patient selection and proper dosing • Reduce abuse • Minimize diversion • Avoid accidental pediatric exposure

11. Narcotic Analgesics DAWN ED MentionsPercent of Total Drug Abuse Mentions Drug Abuse Warning Network (DAWN), 1995-2002

12. Drug Diversion Coverage

13. Drug Diversion Total Mentions 2003

14. Poison Control Centers Coverage

15. 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]

16. Conclusion • Pharma and the FDA interact • Pharma and the Physicians interact • Do Physicians interact with the FDA?

17. The Painless ED Physicians Pharma FDA