Generic Anti-Epileptic Drugs
Generic Anti-Epileptic Drugs: Is There Cause for Concern?
by Barry E. Gidal, Pharm.D., School of Pharmacy & Neurology, University of Wisconsin and Andres M. Kanner, M.D., Rush University Medical Center
Instructions:
Option #1: To watch and listen simultaneously on your computer: Click on the link below (“Click here to begin”) to view slides and hear audio together. You will need Flash Player 6.0 or higher to view the presentation.
Option #2: To print the slides and review: Download and print the handout materials for the program by clicking on the word PowerPoint below.
Lecture
Target Audience
This program is designed for neuroscience and advanced practice nurses, physician assistants, nurse practitioners, behavioral health professionals, pharmacists, general neurologists and others involved in the care of persons with epilepsy who are interested in enhancing their ability to treat and counsel their patients.
Program Goal:
To offer professionals in epilepsy care the most up-to-date tools and knowledge so that they can provide the best treatment and education to patients and their families.
Program Objectives
Upon completion of this program participants should be able to:
- Discuss current perceptions of potential problems with generic substitution of anti-epileptic drug formulations.
- Summarize the FDA approval process for generic drugs.
- Describe clinical evidence regarding potential issues with generic substitution of anti-epileptic drugs.
Speakers will discuss the regulatory guidelines required to approve a generic drug product in the U.S. FDA required study design and interpretation of pharmacokinetic studies will be addressed.
US and worldwide perceptions of generic substitution of AEDs in patients with epilepsy will also be covered. Speakers will review position papers from various professional and patient-advocate organizations. The program will also examine the current clinical evidence both supporting and refuting potential problems with either pharmacokinetic or therapeutic inequivalence with generic AEDs.
Faculty
Barry E. Gidal, Pharm.D., Professor of Pharmacy and Neurology, University of Wisconsin-Madison, School of Pharmacy and Department of Neurology, Madison, WI
Dr. Gidal has completed his residency as well as a research fellowship in Clinical Pharmacokinetics. His research interests are in the pharmacotherapy of epilepsy. He has numerous research, clinical publications and book chapters relating to antiepileptic drug pharmacokinetics/pharmacodynamics and drug interactions in adult patients with epilepsy. Dr. Gidal maintains an active clinical practice at the William S. Middleton VA Hospital Epilepsy Clinic. In particular, his interests are in the use of antiepileptic drugs in the elderly patient with epilepsy.
Andres M. Kanner, M.D., Professor of Neurological Sciences and Psychiatry, Rush Medical Cokkege and Rush University Medical Center, Chicago, IL
Dr. Kanner was trained in psychiatry before he completed his residency in neurology and an epilepsy fellowship. He has performed research on psychiatric aspects of epilepsy and on pharmacologic and surgical treatment of refractory epilepsy. He has published extensively in these areas and co-edited five textbooks related to various aspects of epilepsy.