Sequence Symmetry Analysis and Disproportionality Analyses: What Percentage of Adverse Drug Reaction do they Signal?

Post-marketing surveillance systems rely on spontaneous reporting databases maintained by health regulators to identify safety issues arising from medicines once they are marketed. Quantitative safety signal detection methods such as Proportional Reporting ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and empirical Bayesian technique are applied to spontaneous reporting data to identify safety signals [1-3]. These methods have been adopted as standard quantitative methods by many pharmaco-surveillance centres to screen for safety signals of medicines [2-5]. Studies have validated these methods and showed that the methods have low to moderate sensitivity to detect adverse drug reaction (ADR) signals, ranging between 28% to 56%, while the specificity of the methods ranged from 82% to 95% [6-8].