Prescribing generic antiepileptic drugs: Issues and concerns for nurse practitioners

Abstract

Purpose: To educate prescribing clinicians about bioequivalent standards for therapeutic equivalence of brand and generic antiepileptic drugs (AEDs) as more generic drugs come to market, and to increase awareness of practice and safety issues surrounding the use of these drugs for people with seizures.

Data sources: Information was gathered from a search of the scientific literature as well as the author's clinical experience.

Conclusions: Controversy exists regarding the therapeutic equivalence of brand and generic AEDs, even when bioequivalent standards are satisfied. Generic AEDs have been associated with breakthrough seizures and adverse events that may outweigh cost savings encouraged by third-party payors. Further research is needed comparing brand to generic drugs in a rigorous manner in order to make a consensus statement regarding the safety and equivalency of generic AEDs for all patient populations.

Implications for practice: Generic AEDs may be safely prescribed in certain situations if clinicians are aware of ethical, legal, and practice issues surrounding their use. Sufficient time should be spent educating patients, caregivers, and pharmacists about implications of a switch made without the knowledge of the patient and/or prescriber.