the American Epilepsy Society
Recording Date: May 10, 2016
Release Date: May 17, 2016
Expiration Date: May 17, 2019
Review Date: March 27, 2020
Release Date: March 31, 2020
Expiration Date: September 30, 2021
OverviewThe American Epilepsy Society (AES) recognized that well-designed, prospective studies of generic antiepileptic drug (AED) substitution were needed and collaborated with the Epilepsy Foundation and the Food and Drug Administration to initiate several studies. These studies have been completed. Three studies demonstrated bioequivalence of generic products in patients with epilepsy taking concomitant AEDs.
Additionally, an analysis of Abbreviated New Drug Application (ANDA) data suggests that generic products of branded modified-release products (e.g., extended release, delayed release) are bioequivalent and safely interchangeable. Results from these studies have shown no difference in bioequivalence when switching from a brand to generic product or between multiple generic products. These studies confirm that the United States Food and Drug Administration (FDA) standards for bioequivalence are appropriate for patients with epilepsy.
If unaware of these study outcomes, physicians cannot apply the information in their practice and appropriately select a generic AED for a brand or another generic AED and therefore physicians are unable to appropriately counsel these patients.
Target AudienceEpileptologists, neurologists, professionals in epilepsy care, and other interested healthcare professionals
Learning ObjectivesFollowing participation in the activity, the learner should be able to:
- Summarize the results of the three studies that demonstrated bioequilvalence of generic products in patients with epilepsy taking concomitant antiepileptic drugs (AED).
- Select a bioequivalent FDA-approved generic product for substitution for a brand or another generic AED.
- Discuss clinical strategies for counseling patients regarding generic AED substitution.
AccreditationThe American Epilepsy Society is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Credit DesignationThe American Epilepsy Society designates this enduring material activity for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
International Credits: The American Medical Association has determined that non-US. licensed physicians who participate in this CME activity are eligible for AMA PRA Category 1 Credits™.
Physician Assistants: AAPA accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credits™ from organizations accredited by ACCME or a recognized state medical society. Physician assistants may receive a maximum of 0.5 hours of Category 1 credit for completing this program.
Faculty, Planning Committee, Reviewers’ Disclosures of Financial RelationshipsIn accordance with the ACCME Standards for Commercial Support, the AES requires that any person who is in a position to control content of a CME activity must disclose all relevant financial relationships that they have with a commercial interest. The following individuals contributed to this activity’s content.
Dennis Dlugos, MD, Childrens Hospital of Philadelphia, Philadelphia, PA
Dr. Dlugos has indicated he has no financial relationships to disclose relevant to this activity.
Tricia Ting, MD, University of Maryland Medical System, Baltimore, MD
Dr. Ting has indicated she has no financial relationships to disclose relevant to this activity.
AES Staff involved in this activity have indicated they have no financial relationships to disclose relevant to this activity.
Jay Salpekar, MD, Kennedy Krieger Institute, Baltimore, MD
Dr. Salpekar has disclosed the following relevant relationships:
- Lundbeck: Investigator initiated study-research funding to institution only; contracted research