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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
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 • The Food and Drug Administration • The Emergency Department Physician • To optimize the management of: • The Patients !!
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 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 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 • User friendly? • Consistent within class: • Warnings? • Boxed • Pharmacology? • Help the prescriber/patient? • Advisory Committees represent an opportunity to get involved
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 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 • Voluntary • Assessment of Risk • Surveillance of Risk • Management of Risk
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 MentionsPercent of Total Drug Abuse Mentions Drug Abuse Warning Network (DAWN), 1995-2002
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 • Pharma and the FDA interact • Pharma and the Physicians interact • Do Physicians interact with the FDA?
The Painless ED Physicians Pharma FDA