Some Physicians Just Say No to Generic AEDs

Nearly two thirds of physicians reported that a patient in their care experienced a breakthrough seizure when they were switched from a brand-name to a generic antiepileptic drug (AED), according to a recent survey.

Michel J. Berg, MD, associate professor of neurology and medical director of the Strong Epilepsy Center at the University of Rochester Medical Center, New York, led the online study of 550 adult patients with epilepsy and 606 physicians who treat epilepsy. "Our study shows that there is a significant problem, and there are consequences to this," he said. Of the physicians who participated in the survey, 90% believed that generic substitution of a patient's regular, effective AED may result in breakthrough seizures; however, only 34% of patients also believed this to be true.

The effectiveness of generic AEDs also was a concern of 75% of physicians and 65% of patients. This shows discordance between physician and patient perceptions about generic substitution and the FDA's position that generic and brand-name medications are therapeutically equivalent, according to Berg, who reported his finding during the 2006 annual meeting of the American Epilepsy Society held December 1 to 5 in San Diego.

Berg also noted that only 62% of patients and 75% of physicians are aware that pharmacists may substitute a generic for a brand-name AED without physician consent, and only 43% of physicians are aware of mandatory generic substitution laws for brand-name prescription medications. Almost 90% of patients and physicians agreed that pharmacists should only be allowed to substitute a generic for a brand-name AED after obtaining physician consent.

This raises questions about whether generic substitution requirements for neurologic medications should be mandatory, said Berg. He hopes that the results of his study will encourage the FDA to reexamine its position on the bioequivalence of brand-name and generic AEDs.
-Myra Partridge