Algorithm for the evaluation of therapeutic failure reports-proposal and pilot analysis

Claudia Patricia Vaca González, Roxana Patricia De las salas Martínez, José Julián López Gutiérrez, Ricardo Sánchez Pedraza, Albert Figueras

    Research output: Contribution to journalArticleResearchpeer-review

    10 Citations (Scopus)


    Purpose: 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. © 2012 John Wiley & Sons, Ltd.
    Original languageEnglish
    Pages (from-to)199-206
    JournalPharmacoepidemiology and Drug Safety
    Publication statusPublished - 1 Feb 2013


    • Algorithm
    • Causality
    • Pharmacoepidemiology
    • Pharmacovigilance
    • Rational drug use


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