Detecting Signals of Disproportionate Reporting from Singapore’s Spontaneous Adverse Event Reporting System: An Application of the Sequential Probability Ratio Test

Cheng Leng Chan (), Sowmya Rudrappa, Pei San Ang, Shu Chuen Li and Stephen J. W. Evans
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Cheng Leng Chan: Health Sciences Authority
Sowmya Rudrappa: Health Sciences Authority
Pei San Ang: Health Sciences Authority
Shu Chuen Li: The University of Newcastle
Stephen J. W. Evans: University of London

Drug Safety, 2017, vol. 40, issue 8, No 6, 703-713

Abstract: Abstract Introduction The ability to detect safety concerns from spontaneous adverse drug reaction reports in a timely and efficient manner remains important in public health. Objective This paper explores the behaviour of the Sequential Probability Ratio Test (SPRT) and ability to detect signals of disproportionate reporting (SDRs) in the Singapore context. Methods We used SPRT with a combination of two hypothesised relative risks (hRRs) of 2 and 4.1 to detect signals of both common and rare adverse events in our small database. We compared SPRT with other methods in terms of number of signals detected and whether labelled adverse drug reactions were detected or the reaction terms were considered serious. The other methods used were reporting odds ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN) and Gamma Poisson Shrinker (GPS). Results The SPRT produced 2187 signals in common with all methods, 268 unique signals, and 70 signals in common with at least one other method, and did not produce signals in 178 cases where two other methods detected them, and there were 403 signals unique to one of the other methods. In terms of sensitivity, ROR performed better than other methods, but the SPRT method found more new signals. The performances of the methods were similar for negative predictive value and specificity. Conclusions Using a combination of hRRs for SPRT could be a useful screening tool for regulatory agencies, and more detailed investigation of the medical utility of the system is merited.

Date: 2017
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DOI: 10.1007/s40264-017-0531-4

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