Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada

Abstract

To achieve substantial healthcare cost reductions, the provincial government of Quebec, Canada, promotes generic substitutions and restricts access to brand-name drugs by economical and administrative strategies. 5 Once generic analogs become available, market is then shared between brand-name and generics, but little is published about the rate of this market sharing, neither regarding the clinical impact of generics commercialization. Generic and brand-name drugs are assumed to be clinically equivalent and are used interchangeably once approved Background-Once the patent of a brand-name drug expires, generic drugs are commercialized, and substitution from brand-name to generics may occur. Generic drug equivalence is evaluated through comparative bioavailability studies. Few studies have assessed outcomes after generic drug commercialization at a population level. We evaluated the impact of 3 generic angiotensin II receptor blockers commercialization on adverse events: hospitalizations or emergency room consultations. Methods and Results-This is an interrupted time series analysis using the Quebec Integrated Chronic Disease Surveillance System. Rates of adverse events for losartan, valsartan, and candesartan users (N=136 177) aged ≥66 years were calculated monthly, 24 months before and 12 months after generics commercialization. Periods before and after generics commercialization were compared by negative binomial segmented regression models. Sensitivity analyses were also conducted. For all users, there was a monthly mean rate of 100 adverse events for 1000 angiotensin II receptor blocker users before and after generic commercialization.

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