title: Potential problems and recommendations regarding substitution of generic antiepileptic drugs: a systematic review of literature.
abstract: Despite the availability of generic antiepileptic drugs (AEDs), still patients and neurologists hesitate to make a switch due to assorted reasons. The objectives of this review were to evaluate the risks associated with the generic substitution of AEDs. In this context, we also summarized the recommendations of various international societies to treat epileptic patients. We used a number of electronic databases to identify the relevant published studies which demonstrated the potential problems and recommendations regarding generic substitution of AEDs. Of 204 articles found initially, 153 were selected for additional review. Subsequently, 68 articles were finally selected. This review concluded that potential problems linked with the generic substitution of AEDs could be bioequivalence issues, failure of drug therapy, emergence of adverse events and increase in the frequency of seizures. The reasons could be the pharmacokinetics properties of AEDs and unique characteristics of some epilepsy patients. Consequently, the generic substitution of AEDs affects the successful treatment and quality of life of the patients. Various guidelines recommend the well-controlled epileptic patients to avoid switching from brand-to-generic products, generic-to-brand products or generic to some other generic products.
authors.affiliation: Department of Pharmacy, Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Punjab Pakistan.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Atif
authors.affiliation: Department of Pharmacy, Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Punjab Pakistan.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Azeem
authors.affiliation: Department of Pharmacy, Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Punjab Pakistan.
authors.forename: Muhammad Rehan
authors.initials: MR
authors.lastname: Sarwar
keywords: Antiepileptic drugs; Bioavailability; Bioequivalence; Bioinequivalence; Generic substitution; Narrow therapeutic index; Pharmacokinetics