Comparación de dos métodos de evaluación de causalidad de sospechas de reacciones adversas a medicamentos (RAM): 2003-2009 / Comparison of two methods to assess causality of adverse drug reactions
Rev. méd. Chile
;
143(7): 880-886, jul. 2015. graf, tab
Article
in Spanish
| LILACS
| ID: lil-757913
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 andMethods:
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.
Full text:
Available
Index:
LILACS (Americas)
Main subject:
Algorithms
/
Drug-Related Side Effects and Adverse Reactions
Type of study:
Etiology study
/
Observational study
/
Prevalence study
/
Risk factors
Limits:
Adolescent
/
Child
/
Child, preschool
/
Humans
/
Infant
Language:
Spanish
Journal:
Rev. méd. Chile
Journal subject:
Medicine
Year:
2015
Type:
Article
Affiliation country:
Chile
Institution/Affiliation country:
Clínica Alemana/CL
Similar
MEDLINE
...
LILACS
LIS