Drug utilization study of two generic antibiotics in a tertiary hospital in Bogotá

José Julián López, Yira Cortázar, Ángela Acosta, Claudia Marcela Vargas-Peláez, Francisco Rossi, .

Keywords: Anti-bacterial agents, drugs, generic, drug utilization, cephalosporins, thienamycins, Colombia

Abstract

Introduction: The Colombian national pharmaceutical policy establishes as a strategy the generation of greater pharmaco-epidemiological research at the national level, especially in the case of antibiotic drugs.
Objective: To provide local pharmaco-epidemiological evidence regarding the effectiveness, conditions of use and safety of generic meropenem and cefepime in a tertiary hospital in Bogotá.
Materials and methods: We conducted a descriptive, longitudinal and retrospective drug utilization study. The data were collected from the medical histories of all the patients who had cefepime or meropenem prescribed.
Results: We included 82 patients treated with cefepime and 91 treated with meropenem in the study. Most of the patients were in services different from the intensive care unit (taking cefepime: 59.8%, and meropenem: 52.7%). Only 21.9% of the patients treated with cefepime and 49% of those treated with meropenem were seen by an infectious disease specialist. The antibiogram was performed for 47% and 60% of the patients treated with cefepime and meropenem, respectively. The most frequent
indication for cefepime were respiratory infections and for meropenem, genitourinary ones. Therapeutic success rates were 61.7% for cefepime and 63.0% for meropenem.
Conclusions: This study contributes evidence regarding the therapeutic performance of two generic antibiotics used in tertiary hospitals. There were no reports of therapeutic failure during the study period. In the cases of non-response, pharmacokinetic alterations, unfavorable clinical conditions, and inappropriate choice of antimicrobial treatment were identified as frequent factors.

Downloads

Download data is not yet available.
  • José Julián López Grupo de Investigación de la Red para el Uso Adecuado de Medicamentos, Departamento de Farmacia, Facultad de Ciencias, Universidad Nacional de Colombia, Bogotá, D.C., Colombia
  • Yira Cortázar Grupo de Investigación de la Red para el Uso Adecuado de Medicamentos, Departamento de Farmacia, Facultad de Ciencias, Universidad Nacional de Colombia, Bogotá, D.C., Colombia
  • Ángela Acosta Instituto Suramericano de Gobierno en Salud, ISAGS, Rio de Janeiro, Brasil
  • Claudia Marcela Vargas-Peláez Fundación IFARMA, Bogotá, D.C., Colombia http://orcid.org/0000-0001-5011-8718
  • Francisco Rossi Fundación IFARMA, Bogotá, D.C., Colombia
    Director Fundación IFARMA

References

Acosta A. Descripción del gasto y consumo de medicamentos biotecnológicos útiles en el tratamiento de artritis reumatoide refractaria: series temporales para Argentina, Colombia y Ecuador (tesis). Buenos Aires: Universidad de Buenos Aires; 2017.

World Health Organization. Global action plan on antimicrobial resistance. 1st edition. Geneva: WHO; 2015. p. 19.

Vesga O, Agudelo M, Salazar B, Rodríguez C, Zuluaga A. Generic vancomycin products fail in vivo despite being pharmaceutical equivalents of the innovator. Antimicrob Agents Chemother. 2010;5:3271-9. https://doi.org/10.1128/AAC.01044-09

Rodríguez CA, Agudelo M, Aguilar YA, Zuluaga AF, Vesga O. Impact on bacterial resistance of therapeutically nonequivalent generics: The case of piperacillintazobactam. PLoS One. 2016;11:e0155806. https://doi.org/10.1371/journal.pone.0155806

Tattevin P, Saleh-Mghir A, Davido B, Ghout I, Massias L, García De La María C, et al. Comparison of six generic vancomycin products for treatment of methicillin-resistant Staphylococcus aureus experimental endocarditis in rabbits. Antimicrob Agents Chemother. 2013;57:1157-62. https://doi.org/10.1128/AAC.01669-12

Tattevin P, Crémieux AC, Rabaud C, Gauzit R. Efficacy and quality of antibacterial generic products approved for human use: A systematic review. Clin Infect Dis. 2014;58:458-69. https://doi.org/10.1093/cid/cit769

Pallares CJ, Martínez E. Factores de riesgo asociados a mortalidad en infecciones relacionadas con la atención en salud en un hospital universitario de tercer nivel en Colombia. Biomédica. 2014;34:148-55. https://doi.org/10.7705/biomedica.v34i0.1646

McKinnon PS, Davis SL. Pharmacokinetic and pharmacodynamic issues in the treatment of bacterial infectious diseases. Eur J Clin Microbiol Infect Dis. 2004;23:271-88. http://dx.doi.org/10.1007/s10096-004-1107-7

Arnau J, Vallano A. Estudio de utilización de medicamentos. Medicamentos y Salud. 2000;2:78-82.

Elseviers M, Andersen M, Benko R, Bennie M, Godman B, Vander Stichele R, et al. Drug utilization research: Methods and applications. 1st edition. Chichester: John Wiley & Sons; 2016. p. 3-14.

Vaca CP, de las Salas RP, López JJ, Sánchez R, Figueras A. Algorithm for the evaluation of therapeutic failure reportsproposal and pilot analysis. Pharmacoepidemiol Drug Saf. 2013;22:199-206. https://doi.org/10.1002/pds.3355

Saturni S, Bellini F, Braido F, Paggiaro P, Sanduzzi A, Scichilone N, et al. Randomized controlled trials and real life studies. Approaches and methodologies: A clinical point of view. Pulm Pharmacol Ther. 2014;27:129-38. https://doi.org/10.1016/j.pupt.2014.01.005

Angkasekwinai N, Werarak P, Chaiyasoot K, Thamlikitkul V. Monitoring of effectiveness and safety of generic formulation of meropenem for treatment of infections at Siriraj Hospital. J Med Assoc Thai. 2011;94(Suppl.1):S217-24.

Badaró R, Molinar F, Seas C, Stamboulian D, Mendonça J, Massud J, et al. A multicenter comparative study of cefepime versus broad-spectrum antibacterial therapy in moderate and severe bacterial infections. Braz J Infect Dis. 2002;6:206-18. https://doi.org/10.1590/S1413-86702002000500001

Lizarazo M, Andrea N, Villamil L, Alicia M, Lopera-Velásquez V, Robledo J, et al. Characterization of the infection prevention and control programs in hospitals located in Medellín - Colombia, 2011. Infectio. 2013;17:136-45. https://doi.org/10.1016/S0123-9392(13)70720-3

Carrillo P, Álvarez CA, Arboleda D, Yomayusa N. Estado actual de los comités de infecciones en cinco ciudades de Colombia. Rev Med Sanitas. 2010;13:34-9.

Rattanaumpawan P, Sutha P, Thamlikitkul V. Effectiveness of drug use evaluation and antibiotic authorization on patients’ clinical outcomes, antibiotic consumption, and antibiotic expenditures. Am J Infect Control. 2010;38:38-43. https://doi.org/10.1016/j.ajic.2009.04.288

Llor C, Bjerrum L. Antimicrobial resistance: Risk associated with antibiotic overuse and initiatives to reduce the problem. Ther Adv Drug Saf. 2014;5:229-41. https://doi.org/10.1177/2042098614554919

Murthy R. Implementation of strategies to control antimicrobial resistance. Chest. 2001;119(Suppl.2):405S-11S. https://doi.org/10.1378/chest.119.2_suppl.405S

Torres NMC, Rodríguez JJ. Notificación de las reacciones adversas a los medicamentos antiepilépticos en Bogotá (Colombia, 2008-2012). Rev Cuba Neurol Neurocir. 2014;4:117-23.

Monterrosa DA, Bolívar HC. Caracterización de las reacciones adversas a medicamentos (RAMs) observadas en una institución asistencial de III nivel de complejidad. Cienc E Innov En Salud. 2015;3:11-16. https://doi.org/10.17081/innosa.3.2.90

Truven Health Analytics. Micromedex. Fecha de consulta: 12 de enero de 2017. Disponible en: www.micromedex. com/support

Figueras A, Pedrós C, Valsecia M, Laporte J-R. Therapeutic ineffectiveness: Heads or tails? Drug Saf. 2002;25:485-7. https://doi.org/10.2165/00002018-200225070-00002

How to Cite
1.
López JJ, Cortázar Y, Acosta Ángela, Vargas-Peláez CM, Rossi F. Drug utilization study of two generic antibiotics in a tertiary hospital in Bogotá. biomedica [Internet]. 2018 Sep. 1 [cited 2024 May 10];38(3):398-406. Available from: https://revistabiomedica.org/index.php/biomedica/article/view/3831

Some similar items:

Published
2018-09-01
Section
Original articles

Altmetric

Article metrics
Abstract views
Galley vies
PDF Views
HTML views
Other views
Crossref Cited-by logo
QR Code