Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009
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...
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Sociedad Médica de Santiago
2015
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oai:scielo:S0034-988720150007000092015-09-03Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009Kyonen,MónicaFolatre,IsabelLagos,XimenaVargas,Silvia Algorithms Causality Drug related side effects and adverse reactions Pediatrics 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.info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.143 n.7 20152015-07-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872015000700009es10.4067/S0034-98872015000700009 |
| institution |
Scielo Chile |
| collection |
Scielo Chile |
| language |
Spanish / Castilian |
| topic |
Algorithms Causality Drug related side effects and adverse reactions Pediatrics |
| spellingShingle |
Algorithms Causality Drug related side effects and adverse reactions Pediatrics Kyonen,Mónica Folatre,Isabel Lagos,Ximena Vargas,Silvia Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009 |
| description |
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. |
| author |
Kyonen,Mónica Folatre,Isabel Lagos,Ximena Vargas,Silvia |
| author_facet |
Kyonen,Mónica Folatre,Isabel Lagos,Ximena Vargas,Silvia |
| author_sort |
Kyonen,Mónica |
| title |
Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009 |
| title_short |
Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009 |
| title_full |
Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009 |
| title_fullStr |
Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009 |
| title_full_unstemmed |
Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009 |
| title_sort |
comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (ram): 2003-2009 |
| publisher |
Sociedad Médica de Santiago |
| publishDate |
2015 |
| url |
http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872015000700009 |
| work_keys_str_mv |
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