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COMPARISON OF TWO METHODS TO ASSESS CAUSALITY OF ADVERSE DRUG REACTIONS

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

dc.contributoren-US
dc.contributores-ES
dc.creatorKyonen, Mónica; particular
dc.creatorFolatre, Isabel; 2Médico Onco-Hematólogo Infantil, Instituto Pediátrico, Universidad Austral de Chile. Valdivia, Chile
dc.creatorLagos, Ximena; Químico Farmacéutico, Docente Escuela de Química y Farmacia, Universidad Austral de Chile.
dc.creatorvargas, silvia; Químico Farmacéutico, Clínica Alemana, Valdivia, Chile
dc.date2015-07-23
dc.date.accessioned2019-11-11T18:27:22Z
dc.date.available2019-11-11T18:27:22Z
dc.identifierhttp://www.revistamedicadechile.cl/ojs/index.php/rmedica/article/view/3570
dc.identifier.urihttps://revistaschilenas.uchile.cl/handle/2250/111080
dc.descriptionBackground: 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.en-US
dc.descriptionBackground: 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.es-ES
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dc.languagespa
dc.publisherRevista Médica de Chilees-ES
dc.relationhttp://www.revistamedicadechile.cl/ojs/index.php/rmedica/article/view/3570/1347
dc.relationhttp://www.revistamedicadechile.cl/ojs/index.php/rmedica/article/downloadSuppFile/3570/13937
dc.relationhttp://www.revistamedicadechile.cl/ojs/index.php/rmedica/article/downloadSuppFile/3570/14577
dc.relationhttp://www.revistamedicadechile.cl/ojs/index.php/rmedica/article/downloadSuppFile/3570/14716
dc.relationhttp://www.revistamedicadechile.cl/ojs/index.php/rmedica/article/downloadSuppFile/3570/17542
dc.relationhttp://www.revistamedicadechile.cl/ojs/index.php/rmedica/article/downloadSuppFile/3570/18929
dc.relationhttp://www.revistamedicadechile.cl/ojs/index.php/rmedica/article/downloadSuppFile/3570/18933
dc.relationhttp://www.revistamedicadechile.cl/ojs/index.php/rmedica/article/downloadSuppFile/3570/20196
dc.sourceRevista Médica de Chile; Vol. 143, núm. 7 (2015): JULIO 2015es-ES
dc.source0034-9887
dc.subjectAlgorithms; Causality; Drug related side effects and adverse reactions; Pediatricsen-US
dc.subjectAlgorithms; Causality; Drug related side effects and adverse reactions; Pediatricses-ES
dc.titleCOMPARISON OF TWO METHODS TO ASSESS CAUSALITY OF ADVERSE DRUG REACTIONSen-US
dc.titleComparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM). 2003-2009.es-ES
dc.typeinfo:eu-repo/semantics/article
dc.typeinfo:eu-repo/semantics/publishedVersion
dc.typees-ES


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