Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009

• Mónica Kyonen ^[3] ; Isabel Folatre ^[1] ; Ximena Lagos ^[1] ; Silvia Vargas ^[2]
  1. [1] Universidad Austral de Chile

     Universidad Austral de Chile

     Valdivia, Chile

     
  2. [2] Clínica Alemana

     Clínica Alemana

     Santiago, Chile

     
  3. [3] Hospital Base Valdivia

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• Localización: Revista Médica de Chile, ISSN-e 0034-9887, Vol. 143, Nº. 7, 2015, págs. 880-886
• Idioma: español
• Títulos paralelos:
  • Comparison of two methods to assess causality of adverse drug reactions
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• Resumen

  • Background: Assessment of causality is an essential part of pharmacological surveillance. Aim: To compare the causality assessment of suspected adverse drug reactions (ADRs) using algorithms proposed by Karch-Lasagna (K & L) and the World Health Organization (WHO). Material and Methods: All spontaneous reports of suspected ADRs in a pediatric ward of a regional hospital were included. Causality was categorized as definitive, probable, possible, conditional or unlikely. The agreement between K & L and WHO algorithms was assessed using binomial test proportions and kappa coefficients. Results: One hundred thirty reports of ADRs in 126 patients aged 2 to 11 years were analyzed. The suspected medications were antineoplastic drugs in 59% of cases and antimicrobials in 23%. The most common affected system was the skin and appendages in 35%. Using K & L algorithm, causality was categorized as definitive in 10% of cases, probable in 28.5%, possible in 35.4%, conditional in 23.1% and unlikely in 3.0%. Using WHO algorithm, the figures were 2.3, 34.6, 59.2, 2.3 and 1.5%, respectively. The degree of agreement between K & L and WHO algorithms was 32.3% (kappa = 0.004). Conclusions: K & L attributed a higher level of ADR causality than WHO algorithm.