Adverse reactions by antibiotics in a pediatric and neonatal intensive care unit located in Bogotá, Colombia
Keywords:
pharmacoepidemiology, anti-bacterial agents/adverse effects, hospitalization, intensive care units, pediatric
Abstract
Introduction. Critical care patients have a high probability of presenting adverse drugs reactions because the polytherapy that they receive usually include schemes with two or more antibiotics. Most antibiotics have high toxicity risk, which can be potentialized when being associated with other drugs.Objective. Adverse reactions were detected and described in patients treated with antibiotics in a pediatric and neonatal intensive care.
Materials and methods. A follow up, descriptive and observational study of a cohort was made without control group. A daily follow-up was administered for a three month period for each patient. Causality was evaluated on the basis of the Naranjo scale.
Results. Eighty-five patients were included in the study, 36.5% from the neonatal intensive care unit and 63.5% from the pediatric clinic. Of twenty-seven antimicrobial medications administered, 97 adverse reactions were detected for 15 of these, in 37 patients (20 newborn and 17 older children). They were classified as mild (65%), moderate (35%) and serious (0). According to scale of Naranjo, 68% were possible, 32% probable, and defined, none. Based on laboratory test results, renal toxicity was detected in 38.1%, hematotoxicity in 24.7%,electrolytic abnormalities in 21.6% and hepatotoxicity in 15.5%. The distribution of adverse antibiotic reactions was as follows: gentamycine 20.6%, vancomycin 17.5%, amikacine 16.5%, ceftriaxone 15.5% and piperaciline tazobactam 13.4%.
Conclusions. The proportion of adverse reactions was of 43.7%. 55.6% of antibiotics produced adverse reactions. A program of institutional pharmacovigilance coordinated by a medical pharmacologist or pharmaceutical chemist was recommended by these data.
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References
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17. Evans RS, Pestotnik SL, Classen DC, Horn SD, Bass SB, Burke JP. Preventing adverse drug events in hospitalized patients. Ann Pharmacother 1994;28:523-7.
18. Lundostrom TS, Sobel JD. Antibiotics for gram positive bacterial infection: Vancomycin, quinupristin -dalfopristin, linezolid and daptomycin. Infect Dis Clin North Am 2004;18:651-68.
2. Marin K. Optimizing antibiotic therapy in the intensive care setting. Critical Care 2001;5:189-95.
3. Arbeláez C, Ardila E, Calderón C, Cárdenas M, Chaves M, Escobar J et al. Boletín de Farmacovigilancia. Diciembre 2004. [Consultado 2005, marzo 5]. Disponible en: http://www.invima.gov.co/version1/farmaco-vigilancia/boletindiciembre2004.htm
4. Mandell GL, Bennet JE, Dolin R, Polk RE, Fishman NO. Principles and practice of infectious diseases: Antimicrobial management cost and resistence. Sixth Edition. Philadelphia: Elsevier Churchill Livingstone; 2005. p.611-28.
5. Goodman A. Las bases farmacológicas de la terapéutica. Décima edición. Ciudad de México: Editorial McGraw-Hill Interamericana; 2003. p.1159 -328.
6. Comisión de Farmacovigilancia - Avanzar. Manual de farmacovigilancia. Décima edición. Bogotá; Avanzar; 2002. p.18-24.
7. Cobert B, Briron T. Pharmacovigilance from A to Z: Adverse drug event surveillance. Volumen 38. Massachussets: Blackwell Science; 2003. p.29-34.
8. Rich DS. A process for interpreting data on adverse drug events: Determining optimal target levels. Clin Ther 1998;20(Suppl. C):C59-71.
9. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1998;49:2229-32.
10. Pearson F, Moore N, Fach J. Factors associated with preventable adverse drug reactions. Am J Hos Pharm 1994;51:2268-72.
11. Amariles P. El medicamento: compendio básico para su utilización correcta. Primera edición. Medellín: Impresos LTDA; 2002. p.28-35.
12. World Health Organization. International Drug Monitoring: The Role of National Centers. Technical Report Series No. 498. Geneve: WHO; 1972.
[Consultado: 2005, abril 15]. Disponible en: http://www.who-umc.org/graphics/9277.pdf
13. Naranjo CA, Busto U. Reacciones adversas a medicamentos. En: Métodos en farmacologia clínica. Santiago: OPS; 1992. p.331.
14. Tribiño C, Maldonado C, Segura O, Díaz J. Costos directos y aspectos clínicos de las reacciones adversas a medicamentos en pacientes hospitalizados en el servicio de medicina interna de una institución de tercer nivel de Bogotá. Biomédica 2006;26:31-41.
15. Lazarou J, Pomerans BH, Corey PN. Incidence of adverse drug reactions in hospitalized patient: A metaanalysis of prospective studies. JAMA 1998;279:1200-5.
16. Leape LL, Cullen DJ, Clapp MD, Burdick E, Demonaco HJ, Erickson JI et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA 1999;267:282-3.
17. Evans RS, Pestotnik SL, Classen DC, Horn SD, Bass SB, Burke JP. Preventing adverse drug events in hospitalized patients. Ann Pharmacother 1994;28:523-7.
18. Lundostrom TS, Sobel JD. Antibiotics for gram positive bacterial infection: Vancomycin, quinupristin -dalfopristin, linezolid and daptomycin. Infect Dis Clin North Am 2004;18:651-68.
How to Cite
1.
Vallejos A. Adverse reactions by antibiotics in a pediatric and neonatal intensive care unit located in Bogotá, Colombia. biomedica [Internet]. 2007 Mar. 1 [cited 2024 May 18];27(1):66-75. Available from: https://revistabiomedica.org/index.php/biomedica/article/view/234
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Published
2007-03-01
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Original articles
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