Barriers to generic antiseizure medication use: Results of a global survey by the International League Against Epilepsy Generic Substitution Task Force

Abstract

The objective of this study was to identify and quantify barriers to generic substitution of antiseizure medications (ASM). A questionnaire on generic ASM substitution was developed by the International League Against Epilepsy (ILAE) Task Force on Generic Substitution. Questions addressed understanding of bioequivalence, standards for generic products, experiences with substitution, and demographic data. The survey was web‐based and distributed to ILAE chapters, their membership, and professional colleagues of task force members. Comparisons in responses were between ILAE regions and country income classification. A total of 800 individuals responded, with 44.2% being from the Asia‐Oceania ILAE Region and 38.6% from European Region. The majority of respondents had little or no education in generic substitution or bioequivalence. Many respondents indicated lack of understanding aspects of generic substitution. Common barriers to generic substitution included limited access, poor or inconsistent quality, too expensive, or lack of regulatory control. Increase in seizures was the most common reported adverse outcome of substitution. Of medications on the World Health Organization Essential Medication list, problems with generic products were most frequent with carbamazepine, lamotrigine, and valproic acid. Several barriers with generic substitution of ASM revolved around mistrust of regulatory control and quality of generic ASM. Lack of education on generic substitution is also a concern. Generic ASM products may be the only option in some parts of the world and efforts should address these issues. Efforts to address these barriers should improve access to medications in all parts of the world.

Breakthrough Seizures in Patients Switched from Brand to Generic Antiseizure Medications

“…These results were in line with Niyongere et al (8) they wanted to identify and measure obstacles to the generic replacement of anti-seizure drugs. It was most generally believed that generic replacement would be difficult for valproic acid.…”

Suitability of paediatric legislation beyond the USA and Europe: a qualitative study on access to paediatric medicines

“…54 This could include extending regulatory provisions to generic formulations that remain largely unavailable. 55 However, a negative attitude to generics found in our study and other healthcare contexts [56][57][58] may threaten the success of such policies. Strengthening public confidence in generic manufacturing standards should be considered alongside regulatory changes.…”

Affordability of newer antiseizure medications in Asian resource‐limited countries

“…In a survey to identify barriers to generic ASM use by the ILAE Generic Substitution Task Force, it was found that poor and inconsistent ASM quality is one of the concerns about generic ASMs 26 . This raised the concern of patients' safety and efficacy of generic products on seizure control, as the regulatory control to ensure the quality and standards of these bioequivalents are not as extensive in middle‐ and low‐income countries (38% and 35% respondents, respectively) compared with 79% of respondents in HICs 26 …”

“…26 This raised the concern of patients' safety and efficacy of generic products on seizure control, as the regulatory control to ensure the quality and standards of these bioequivalents are not as extensive in middle-and low-income countries (38% and 35% respondents, respectively) compared with 79% of respondents in HICs. 26…”