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[Comparison of two methods to assess causality of adverse drug reactions].

Mónica Kyonen,Isabel Folatre,Ximena Lagos,S. Vargas

Published 2015 in Revista médica de Chile (Impresa)

ABSTRACT

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.

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