the American Epilepsy Society
Release Date: May 17, 2016
Expiration Date: May 17, 2019
Original Recording Date: May 10, 2016
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.
Instructions for Participation to Earn CME Credit
- Read the needs statement, target audience, learning objectives, and planner/faculty disclosures.
- View/read the educational content online or printed out.
- Complete the evaluation.
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.
Ignacio Valencia, MD, St. Christopher's Hospital for Children, Philadelphia, PA
Dr. Valencia has indicated he has no financial relationships to disclose relevant to this activity.
Resolution of Conflicts of InterestIt is the policy of the American Epilepsy Society to ensure balance, independence, objectivity and scientific rigor. All persons involved in the selection, development and presentation of content are required to disclose any real or apparent conflicts of interest. In accordance with the ACCME Standards for Commercial Support of CME, the AES implemented the mechanisms of prospective peer review of this CME activity, to identify and resolve any conflicts. Additionally, the content of this activity is based on the best available evidence.
Unapproved Use DisclosureThe American Epilepsy Society requires CME authors to disclose to learners when products or procedures being discussed are off-label, unlabeled, experimental, and/or investigational (not FDA approved); and any limitations on the information that is presented, such as data that are preliminary or that represent ongoing research, interim analyses, and/or unsupported opinion. This information is intended solely for continuing medical education and is not intended to promote off-label use of these medications. If you have questions, contact the medical affairs department of the manufacturer for the most recent prescribing information. Information about pharmaceutical agents/devices that is outside of U.S. Food and Drug Administration approved labeling may be contained in this activity.
Contact InformationFor further information on this activity contact the American Epilepsy Society at email@example.com or call 312.883.3800.
Privacy and ConfidentialityThe American Epilepsy Society respects the privacy and confidentiality of users of this CME activity. You may access the privacy statement for this activity here .
Policy on Commercial Support and Conflict of InterestAs an ACCME-accredited provider the American Epilepsy Society must ensure 100% compliance with the ACCME Standards for Commercial Support: Standards to Ensure Independence in CME Activities. The American Epilepsy Society has implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity
Disclosure of Unlabeled/Unapproved UsesThis educational activity may include references to the use of products for indications not approved by the FDA. Faculty have agreed to disclose intent to discuss any off-label, experimental, or investigational use of drugs, devices, or equipment or devices in their presentations. Furthermore, faculty have attested that all the recommendations involving clinical medicine they make in this activity will be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients; and, all scientific research referred to, reported, or used in their presentation in support or justification of a patient care recommendation will conform to the generally accepted standards of experimental design, data collection and analysis. Faculty opinions expressed with regard to unapproved, investigational or experimental uses of products are solely those of the faculty and are not endorsed by the American Epilepsy Society.
DisclaimerThis CME activity is for educational purposes only and does not constitute the opinion or endorsement of, or promotion by, the American Epilepsy Society. Reasonable efforts have been taken to present educational subject matter in a balanced, unbiased fashion, and in compliance with regulatory requirements. However, each activity participant must always use his or her own personal and professional judgment when considering further application of this information, particularly as it may relate to patient diagnostic or treatment decisions including, without limitation, FDA-approved uses and any off-label, investigational and/or experimental uses.
$0.00 - $25.00