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:
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
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 !!
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
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
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
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
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]
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
10/20/2004 9 Risk Management Programs Voluntary Assessment of Risk Surveillance of Risk Management of Risk
Your consent to our cookies if you continue to use this website.