Abstracts

Rationale: Controversy persists whether generic antiepileptic drugs (AEDs) are interchangeable with brand name as well similar drugs that are currently used in Brazil with respect to efficacy and adverse events. As there is a paucity of data in this field specially in underdeveloped nations, the “Associação Brasileira de Epilepsia”, which is the Brazilian Branch of the “International Bureau for Epilepsy”, performed a multicentric survey among people with epilepsy (PWE) about their knowledge of different AED formulations (reference, generic, similar drugs) as well the clinical effects of their switch during treatment. Methods: A questionnaire was applied for PWE after Ethical Committee approval. The survey regarding different AED formulations consisted of 18 multiple choice questions, 4 related to socio demographical data and 14 about their knowledge of this subject, as well the evidence of clinical status change during AED formulation switch. Results: Five hundred and nineteen PWE from six Healthy Centers responded to the survey, most of all attending Brazilian Unified Public Healthy System. Most PWE were socially classified in middle and low income classes; 1/3 was functionally illiterate, 1/3 completed elementary school, and 1/3 high school. The majority of the interviewed PWE (70%) were taking more than one AED, 16% monotherapy with CBZ, and 6% with VPA; 76% of the responders obtained all AEDs from public resources and 24% bought AED only in private pharmacies. Most PWE (60%) did not know the types of formulations (reference, generic, similar AEDs); only 44% knew that the first drug to be produced is the reference and 10% considered that generics were “the official governmental drugs”. After being instructed by the interviewers about the difference between the AED formulations, 24% of the PWE did not know that generics are cheaper than reference drugs. Almost half the PWE considered the quality of generics worse when compared to reference drugs, and only 1/5 of them knew the packing details of generic drugs (in Brazil the name of active substance with a letter G in a yellow band). Only half of the PWE admitted to receive the same AED formulation prescribed by his doctor, mostly because of changing the available formulation in the public drugstore, and 1/5 did not know this answer. During the last year, 1/3 said that they received different AED formulations (mainly CBZ and OXC) and from these 12% referred breakthrough seizures after a switch (CBZ, VPA, and LTG) and 11% reported increased side effects in this situation (CBZ and LTG). Conclusions: The knowledge of different AED formulations was small in this sample of PWE from the “Associação Brasileira de Epilepsia”. It was common to receive different AED formulations, and this caused breakthrough seizures and/or increased side effects. This fact should alert healthy specialists that narrow therapeutic window medications such as some AEDs should be considered as a special group regarding Public Politics of Generics and Similar drugs.