A study of adverse reaction algorithms in a drug surveillance program

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Abstract
To improve agreement among observers, several investigators recently proposed methods (algorithms) to standardize assessments of causality for presumed adverse drug reactions. One such method was evaluated in the context of an intensive pediatric drug surveillance program. Four observers rated 50 randomly selected case reports drawn from the program, 1st using only general guidelines and then, several mo. later, using the strict criteria of the algorithm. Agreement among observers was poor in both study phases. The presence of selected characteristics of adverse events (e.g. major severity) did not improve agreement in either phase of the study. Routine use of such algorithms in drug surveillance programs is not likely to be of benefit.