Caracterização das reações adversas a medicamentos reportadas ao programa de Fármaco-vigilância de um hospital de alta complexidade e fatores associados com sua evitabilidade
Barra lateral de artigos
Como Citar
Este trabalho está licenciado sob uma licença Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
##plugins.themes.bootstrap3.displayStats.downloads##
Societal impact
Conteúdo do artigo principal
Resumo
Objetivos: caracterizar as reações adversas a medicamentos reportadas ao programa de Fármaco-vigilância de um hospital de alta complexidade entre 2009 e 2012 e identificar os fatores associados com sua evitabilidade.
Metodologia: estudo observacional, transversal, baseado nos reportes de reações adversas notificados ao programa de Fármaco-vigilância. Realizou-se análise uni-variado para as variáveis qualitativas e para as comparações se calculou o Chi-quadrado de independência. O tamanho de mostra estimado com uma potência de 80% foi de 84 casos.
Resultados: reportaram-se 2.973 reações adversas a medicamentos em 2.531 pacientes com frequência similar em ambos sexos e uma idade média de 41.7 anos (DE 24.42). Os antibacterianos sistémicos e os analgésicos são os grupos terapêuticos mais reportados (28.76% e 19.44%, respectivamente). A pele e apêndices foi o sistema corporal mais afetado (47.1%). As reações moderadas e graves representam o 88.7% das reações reportadas e o 9.4% foi evitável. Encontrou-se associação significativa entre a evitabilidade e os medicamentos de alto risco, os antecedentes alérgicos, se a reação foi considerada a causa de rendimento ao hospital e a idade dos pacientes.
Conclusões: os resultados obtidos são comparáveis com outros estudos e permitiram identificar fatores susceptíveis de intervenção para promover o uso seguro de medicamentos; a identificação de fatores associados com a evitabilidade, alguns não reportados até agora, constitui um achado importante na busca de estratégias de minimização de erros previsíveis.
Detalhes do artigo
Referências
World Health Organization. International drug monitoring: the role of the hospital. Geneva, Switzerland: World Health Organization; 1966.
Juntti-Patinen L, Neuvoren PJ. Drug-related deaths in a university central hospital. Eur J Clin Pharmacol. 2002; 58:479–482.
Jimmy J, Padma GM. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res. 2006; 54:226–233.
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998; 279:1200–5.
World Health Organization. Medicines: safety of medicines – adverse drug reactions. Geneva: World Health Organization; 2008.
American Society of Health System Pharmacists. ASHP guidelines on adverse drug reaction monitoring and reporting. Am J Hosp Pharm. 1989;46:336–7.
Alvarez-Requejo A, Carvajal A, Begaud B, Moride Y, Vega T, Martin Arias LH. Under reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system. Eur J Clin Pharmacol. 1998;54:483–8.
Lobo MG, Pinheiro SM, Castro JG, Gomes V, Pranchevicius MC. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacol Toxicol. 2013;14:5
Gallelli L, Ferreri G, Colosimo M, Pirritano D, Guadagnino L, Pelaia G, et al. Adverse drug reactions to antibiotics observed in two pulmonology divisions of Catanzaro, Italy: a six year retrospective study. Pharmacol Res. 2002;46(5):395–400.
WHO Collaborating Centre for Drug Statistics Methodology. Completed ATC Index 2013 [monografía en Internet].Geneva: WHO; 2013 [citada 2013 Ene 5]. Disponible en: http://www. whocc.no/atc_ddd_index/
Institute for Safe Medications Practices. ISMP´s list of high alert medications [monografía en Internet].. Horsham, PA: ISMP; 2013 [citada 2013 Feb 28]. Disponible en: http://www.ismp.org
Asociación para el Avance de la Investigación Clínica en Colombia. Comisión de Farmacovigilancia. Manual de farmacovigilancia. Bogotá: Avanzar;2002.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992; 49:2229–32.
Montastruc JL, Lapeyre-Mestre M, Bagheri H, Fooladi A. Gender dif-ferences in adverse drug reactions: analysis of spontaneous reports to a Regional Pharmacovigilance Centre in France. Fundam Clin Pharmacol. 2002; 16(5):343–6.
Edwards IR. Pharmacological basis of adverse drug reactions. In: Speight TM, Holford NH, editors. Avery’s drug treatment. 4th ed. Auckland, New Zealand: Adis International; 1997. p. 261–99.
Parthasarathi G, Olsson S. Adverse drug reactions. In: Parthasarathi G, Nyfort-Hansen K, Nahata MC, editors. A text book of clinical phar-macy practice-essential concepts and skills. Chennai: Orient Longman Private Limited; 2004. p. 86–102.
Murphy BM, Frigo LC. Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting programin a university teaching hospital. Hosp Pharm. 1993;28(12):1199–204, 1240.
Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, et al. Incidence of adverse drug events and potential adverse drug events—implications for prevention. JAMA. 1995;274(1):29– 34.
Prosser TR, Kamysz PL. Multidisciplinary adverse drug reaction surveil-lance program. Am J Hosp Pharm. 1990;47(6):1334–9.
Kanjanarat P, Winterstein AG, Johns TE, Hatton RC, Gonzalez-Rothi R, Segal R. Nature of preventable adverse drug events in hospitals: aliterature review. Am J Health Syst Pharm. 2003;60:1750–9.
Hakkarainen KM, Hedna K, Petzold M, Hägg . Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions – a meta-analysis. PLoS ONE.2012; 7(3): e33236.
Mitchell AA, Lacouture PG, Sheehan JE, Kauff-man RE, Shapiro S. Adverse drug reactions in chil-dren leading to hospital admission. Pediatrics. 1988;82:24-29.
Einarson TR. Drug-related hospital admissions. Ann Pharmacother. 1993;27:832-840.
Gonzalez-Martin G, Caroca CM, Paris E. Adverse drug reactions (ADRs) in hospitalized pediatric patients—a prospective study. Int J Clin Pharmacol Ther. 1998;36(10):530–3.
Evans RS, Lloyd JF, Stoddard GJ, Neberker JR, Samore MH. Risk factors for adverse drug events: a 10 year analysis. Ann Pharmacother. 2005; 39:1161–8.
Pal SN, Duncombe C, Falzon D, Olsson S. WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems. Drug Saf. 2013; 36(2):75-81.