Clinical and Economic Impact of Generic Versus Brand Name Meropenem Use in an Intensive Care Unit in Colombia

Abstract

Background: Recent studies suggest that sustained use of generic antibiotics may be associated with clinical failure and emergence of antibacterial resistance. The present study was designed to determine the clinical outcome between the use of generic meropenem (GM) and brand-name meropenem (BNM). Additionally, this study evaluated the economic impact of GM and BNM to determine if the former represents a cost effective alternative to the latter. Methods: Patients treated between January 2011 and May 2014 received GM while patients treated between June 2014 and March 2017 received BNM. Mortality was compared between groups. Total infection cost was defined by the cost of antimicrobial consumption, length of stay, and laboratory and imaging exams until infection resolution. Findings: A total of 168 patients were included; survival rate for the 68 patients treated with GM was 38% compared to 59% in the 100 patients treated with BNM. Multivariate analysis demonstrated that patients treated with GM had a risk of death 18 times higher (OR: 18.45 95%CI 1.47-232, p=0.024) than patients treated with BNM. Total infection cost did not show a significant difference between groups (BNM $10,771 vs GM $11,343 p=0.91). Interpretation: The present study suggests that patients treated with GM have worse clinical outcomes compared to those treated with BNM. Economic analysis shows that GM is not more cost effective than BNM. Summary: More studies measuring clinical outcomes are needed to confirm the clinical superiority of brand-name vs. generic antibiotics, not only for meropenem but also for other molecules. Funding: This study was funded by the International Center for Medical Training and Research (CIDEIM in Spanish). This study did not receive any funding from drug manufacturers or any other sources. Conflicts of interest: The authors declare no conflicts of interest. Ethics Approval Statement: The study was conducted under the appropriate local and international ethics guidelines. The study was approved by the institutional review board of the International Center for Training and Medical Research (CIDEIM, per its abbreviation in Spanish) and the participating institution. CIDEIM deemed that informed consent was not necessary for the study given that its design entailed minimal risk for subjects.