Adverse drug reaction in an internal medicine unit at the University Hospital
Abstract
Introduction: implementing intensive pharmacovigilance (FV) strategies within the clinical context may contribute to know more about the extent of drug induced pathologies.
Objective: to estimate the frequency and characteristics of adverse drug reactions through intensive pharmacovigilance in patients hospitalized in an internal medicine unit at the "Dr. Manuel Quintela" University Hospital.
Method: we designed a prospective observational study. We carried out pharmacological anamnesis of all patients hospitalized between March 31 and April 4, 2008, in an internal medicine service with 40 beds. All patients suspicious of adverse drug reaction were included and imputability was determined using the Karch and Lasagna algorithm. We analysed age, sex, drugs involved, disease caused, severity and polypharmacy.
Results: 21 drug adverse reactions were identified in 19 patients out of the 48 patients hospitalized during the study. Frequency of adverse drug reaction in hospitalized patients was 43.7% (IC 95% 21-66). Average age was 73 years old, most of them evidenced polypharmacy and comorbility. The most frequently involved drugs were cardiovascular, anti-infectious drugs for systemic use and glucocorticoids. The digestive and cardiovascular system and organs were the most severely affected. Three drug adverse reactions were classified as severe.
Conclusions: Adverse drug reactions are a highly usual problem in this hospital unit. It may be possible that the characteristics of patients seen in this unit (old age, frequent polypharmacyy and comorbility) contribute to this finding. We stand out the importance of intensive hospital pharmacovigilance as a strategy to identify adverse drug reactions and other problems involving drugs.
References
(2) Güemes Artiles M, Sanz Álvarez E, García Sánchez-Colomer M. Reacciones adversas y problemas relacionados con medicamentos en un servicio de urgencia. Rev Esp Salud Pública 1999; 73(4): 511-8.
(3) Pirmohamed M, Breckenridge AM, Kitteringham NR, Park BK. Adverse drug reactions. BMJ 1998; 316(7140): 1295-8.
(4) Laporte J, Tognoni G. Estudios de utilización de medicamentos y de farmacovigilancia. In: Laporte J, Tognoni G. Principios de epidemiología del medicamento. 2a ed. Barcelona: Masson-Salvat, 1993:1-23.
(5) de Abajo FJ. El medicamento como solución y como problema para la salud pública. Una breve incursión a los objetivos de la farmacoepidemiología. Rev Esp Salud Pública 2001; 75(4): 281-4.
(6) Armijo J, González Ruiz M. Estudios de seguridad de los medicamentos: métodos para detectar las reacciones adversas y valoración de la relación causa-efecto. En: García AG, Gandía L, eds. El ensayo clínico en España. Madrid: Farmaindustria, 2001: 163-91.
(7) Organización Mundial de la Salud. La farmacovigilancia: garantía de seguridad en el uso de los medicamentos. (Perspectivas políticas de la OMS sobre medicamentos, 9). Ginebra: OMS, 2004.
(8) Olmos I, Giachetto G, Olmos V, Szerman D, Daners M. Hospitalizations for Adverse Drug Reactions Health Maintenance Organization in Montevideo (Uruguay). (Abstract). Drug Safety 2007; 30: 950.
(9) Giachetto G, Danza A, Lucas L, Cristiani F, Cuñetti L, Vázquez X, et al. Hospitalizaciones por reacciones adversas a medicamentos y abandono del tratamiento farmacológico en el hospital universitario. Rev Med Urug 2008; 24(2): 102-8.
(10) World Health Organization. Requirements for adverse reaction reporting. Geneva: World Health Organization, 1975.
(11) Laporte JR, Carné X. Metodología epidemiológica básica en farmacovigilancia. In: Laporte JR, Tognoni G: Principios de epidemiología del medicamento, 2a ed. Barcelona: Masson-Salvat, 1993: 111-30.
(12) Laporte J, Capellà D. Mecanismo de producción y diagnóstico clínico de los efectos indeseables producidos por medicamentos. In: Laporte JR, Tognoni G: Principios de epidemiología del medicamento, 2a ed. Barcelona: Masson-Salvat, 1993: 95-109.
(13) Rawlins MD, Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM, ed. Textbook of adverse drug reactions. Oxford: Oxford University Press, 1977: 10.
(14) Edwards RI, Aronson JK. Adverse drug reactions: definitions, diagnosis and management. The Lancet 2000; 356: 1255-9.
(15) Laporte J. Farmacovigilancia en el hospital. In: Laporte JR, Tognoni G. Principios de epidemiología del medicamento. 2a ed. Barcelona: Masson-Salvat, 1993: 219-29.
(16) Camargo AL, Cardoso Ferreira MB, Heineck I. Adverse drug reactions: a cohort study in internal medicine units at a university hospital. Eur J Clin Pharmacol 2006; 62(2): 143-9.
(17) Tribiño G, Maldonado C, Segura O, Díaz J. Direct costs and clinical aspects of adverse drug reactions in patients admitted to a level 3 hospital internal medicine ward. Biomedica 2006; 26(1): 31-41.
(18) Fattinger K, Roos M, Vergères P, Holenstein C, Kind B, Masche U, et al. Epidemiology of drug exposure and adverse drug reactions in two Swiss departments of internal medicine. Br J Clin Pharmacol 2000; 49(2): 158-67.
(19) Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol 1998; 45(3): 301-8.
(20) Robles NR, Fernández Carbonero E, Romero B, Sánchez Casado E, Cubero JJ. Long-term antiproteinuric effect of dual renin-angiotensin system blockade. Cardiovasc Ther 2009; 27(2): 101-7.
(21) Krairittichai U, Chaisuvannarat V. Effects of dual blockade of renin-angiotensin system in type 2 diabetes mellitus patients with diabetic nephropathy. J Med Assoc Thai 2009; 92(5): 611-7.
(22) Pintado-García V. Infectious spondylitis. Enferm Infecc Microbiol Clin 2008; 26(8): 510-7.
(23) Gabillot-Carré M, Roujeau JC. Acute bacterial skin infections and cellulitis. Curr Opin Infect Dis 2007; 20(2): 118-23.
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