Algorithm for the evaluation of therapeutic failure reports--proposal and pilot analysis.
OBJECTIVE
To propose and validate an algorithm to analyze the reports of suspected therapeutic failure (TF) received in pharmacovigilance programs.


METHODS
A Delphi consensus method with a group of 12 international experts was used to identify the different causes that prompt TF and to propose an algorithm to analyze reports of suspected lack of efficacy of medicines. A pilot analysis of 50 reports was the basis to evaluate the interrater and intrarater validity of the algorithm.


RESULTS
A 10-question algorithm was proposed. The evaluation of 50 reports of suspected TF showed that only 8% could be actually attributed to a manufacturing quality problem, whereas the real reason underlying the alleged TF was the inappropriate use of the prescribed drug in 28%. Minimum information to attribute the cause to a TF was lacking in 31% of these reports. The interrater reliability was "moderate" (kappa coefficient = 0.55), and the intrarater reliability ranged from 0.732 to 0.908 ("substantial" to "almost perfect").


CONCLUSIONS
The proposed TF algorithm is a valid, reliable, and reproducible analysis tool that can help to disentangle the frequent and complex reports of suspected TF.
Pharmacy Department, Faculty of Sciences, Universidad Nacional de Colombia, Bogotá, Colombia. cpvacag@unal.edu.co
Claudia Patricia
CP
Vaca González
Roxana Patricia De las salas
RP
Martínez
José Julián
JJ
López Gutiérrez
Ricardo
R
Sánchez Pedraza
Albert
A
Figueras
D000465:Algorithms; D006801:Humans; D060735:Pharmacovigilance; D010865:Pilot Projects; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards*; D017211:Treatment Failure