Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia

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). A...

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Main Authors: Karen Ordóñez, Max M. Feinstein, Sergio Reyes, Cristhian Hernández-Gómez, Christian Pallares, María V. Villegas
Format: Article
Language:English
Published: Elsevier 2019-07-01
Series:Brazilian Journal of Infectious Diseases
Online Access:http://www.sciencedirect.com/science/article/pii/S1413867019301680
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spelling doaj-ba55d4422150440bb54c2e2d4bddb7222020-11-25T03:56:13ZengElsevierBrazilian Journal of Infectious Diseases1413-86702019-07-01234237245Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in ColombiaKaren Ordóñez0Max M. Feinstein1Sergio Reyes2Cristhian Hernández-Gómez3Christian Pallares4María V. Villegas5E.S.E. Hospital Universitario San Jorge, Pereira, ColombiaCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia; Case Western Reserve University, Cleveland, United States; Grupo de Investigación en Resistencia Antimicrobiana y Epidemiología Hospitalaria, Universidad El Bosque, Bogotá, Colombia.Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia; Grupo de Investigación en Resistencia Antimicrobiana y Epidemiología Hospitalaria, Universidad El Bosque, Bogotá, Colombia.Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia; Grupo de Investigación en Resistencia Antimicrobiana y Epidemiología Hospitalaria, Universidad El Bosque, Bogotá, Colombia.Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia; Centro Médico Imbanaco, Cali, Colombia; Grupo de Investigación en Resistencia Antimicrobiana y Epidemiología Hospitalaria, Universidad El Bosque, Bogotá, Colombia.Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia; Centro Médico Imbanaco, Cali, Colombia; Grupo de Investigación en Resistencia Antimicrobiana y Epidemiología Hospitalaria, Universidad El Bosque, Bogotá, Colombia.; Corresponding author at: Research Group on Antimicrobial Resistance and Hospital Epidemiology-RAEH, Universidad El Bosque, Bogotá, Colombia. Mailing address: Cra 9 # 131 A- 02, Lab de Investigacion 2 Piso, Bogotá, Colombia.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 patients treated with BNM. Multivariate analysis showed that the variables most strongly-associated with mortality were cardiovascular disease (OR 18.18, 95% CI 1.25–262.3, p = 0.033) and treatment with generic meropenem (OR 18.45, 95% CI 1.45–232.32, p = 0.024). On the other hand, 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 a risk of death 18 times higher compared to those treated with BNM. Furthermore, economic analysis shows that GM is not more cost effective than BNM. Summary: More studies measuring clinical outcomes are needed to confirm the clinical equivalence of brand-name versus generic antibiotics, not only for meropenem but also for other molecules. Keywords: Generic drugs, Meropenem, Mortality, Costs, Critical care, Gram negative bacteriahttp://www.sciencedirect.com/science/article/pii/S1413867019301680
collection DOAJ
language English
format Article
sources DOAJ
author Karen Ordóñez
Max M. Feinstein
Sergio Reyes
Cristhian Hernández-Gómez
Christian Pallares
María V. Villegas
spellingShingle Karen Ordóñez
Max M. Feinstein
Sergio Reyes
Cristhian Hernández-Gómez
Christian Pallares
María V. Villegas
Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia
Brazilian Journal of Infectious Diseases
author_facet Karen Ordóñez
Max M. Feinstein
Sergio Reyes
Cristhian Hernández-Gómez
Christian Pallares
María V. Villegas
author_sort Karen Ordóñez
title Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia
title_short Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia
title_full Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia
title_fullStr Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia
title_full_unstemmed Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia
title_sort clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in colombia
publisher Elsevier
series Brazilian Journal of Infectious Diseases
issn 1413-8670
publishDate 2019-07-01
description 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 patients treated with BNM. Multivariate analysis showed that the variables most strongly-associated with mortality were cardiovascular disease (OR 18.18, 95% CI 1.25–262.3, p = 0.033) and treatment with generic meropenem (OR 18.45, 95% CI 1.45–232.32, p = 0.024). On the other hand, 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 a risk of death 18 times higher compared to those treated with BNM. Furthermore, economic analysis shows that GM is not more cost effective than BNM. Summary: More studies measuring clinical outcomes are needed to confirm the clinical equivalence of brand-name versus generic antibiotics, not only for meropenem but also for other molecules. Keywords: Generic drugs, Meropenem, Mortality, Costs, Critical care, Gram negative bacteria
url http://www.sciencedirect.com/science/article/pii/S1413867019301680
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