Pharmacovigilance, signal detection using statistical data mining methods
-
2018-05-29 https://doi.org/10.14419/ijet.v7i2.31.13423 -
Adverse drug reactions, pharmacovigilance, safety signals, statistical methods. -
Abstract
Pharmacovigilance programmes monitor and help safeguarding the use of medicines which is grave to the success of public health programmes. Identifying new possible risks and developing risk minimization action plans to prevent or ease these risks is at the heart of all pharmacovigilance activities throughout the product lifecycle. In this paper we examine the use of data mining algorithms to identify signals from adverse events reported. The capabilities include screening, data mining and frequency tabulation for potential signals, including signal estimation using established statistical signal detection methods. We have standard processes, algorithms and follow current requirements for signal detection and risk management activities.
-
References
[1] Meyboom RH, Hekster YA, Egberts AC, Gribnau FW & Edwards IR, “Causal or casual? The role of causality assessment in pharmacovigilanceâ€, Drug Saf, Vol.17, (1997), pp.374-389.
[2] Harpaz R, Dumouchel W, Shah NH, Madigan D, Ryan P & Friedman C, “Novel Data-Mining Methodologies for Adverse Drug Event Discovery and Analysisâ€, Clin Pharmacol Ther, (2012).
[3] Gould AL, “Accounting for multiplicity in the evaluation of "signals" obtained by data mining from spontaneous report adverse event databasesâ€, Biom J, Vol.49, No.1, (2007), pp.151-165.
[4] Bate A, Lindquist M, Edwards IR, Olsson S, Orre R, Lansner A & De Freitas RM, “A Bayesian neural network method for adverse drug reaction signal generationâ€, Eur J Clin Pharmacol, Vol.54, No.4, (1998), pp.315-321.
[5] Wang X, Chase H, Markatou M, Hripcsak G & Friedman C, “Selecting information in electronic health records for knowledge acquisitionâ€, J Biomed Inform, Vol.43, No.4, (2010), pp.595-601.
[6] Montastruc JL, Sommet A, Bagheri H & Lapeyre-Mestre M, “Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance databaseâ€, Br J Clin Pharmacol, Vol.72,No.6, (2011), pp.905-908.
[7] Lindquist M, Edwards IR, Bate A, Fucik H, Nunes AM & Stahl M, “From association to alert--a revised approach to international signal analysisâ€, Pharmacoepidemiol Drug Saf, Vol.8, (1999), pp.15-25.
[8] Xu R & Wang Q, “Large-scale combining signals from both biomedical literature and FDA adverse event reporting system (FAERS) to improve post-marketing drug safety signal detectionâ€, BMC Bioinformatics, (2014).
[9] Wang X, Hripcsak G, Markatou M & Friedman C, “Active computerized pharmacovigilance using natural language processing, statistics, and electronic health records: a feasibility studyâ€, J Am Med Inform Assoc, Vol.16, (2009), 328–337.
[10] Sriramakrishnan & Latha Parthiban, “Data mining techniques for finding serious Adverse Eventsâ€, Journal of Chemical and Pharmaceutical Sciences, Vol.9, No.4, (2016).
[11] Bate A & Evans SJ, “Quantitative signal detection using spontaneous ADR reportingâ€, Pharmacoepidemiol Drug Saf, Vol.18, No.6, (2009), pp.427-436.
[12] Hauben M, Madigan D, Gerrits CM, Walsh L & Van Puijenbroek EP, “The role of data mining in pharmacovigilanceâ€, Expert Opin Drug Saf, (2005), pp.929-948.
[13] Ahmed I & Poncet A, “PhViD: an R package for PharmacoVigilance signal Detectionâ€, R package version 1.0. (2013).
[14] Evans SJ, Waller PC & Davis S, “Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reportsâ€, Pharmacoepidemiology and drug safety,(2001), pp.483-486.
[15] Van Puijenbroek EP, Bate A, Leufkens HG, Lindquist M, Orre R & Egberts AC, “A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactionsâ€, Pharmacoepidemiology and drug safety, (2002), pp.3-10.
[16] Pearson RK, Hauben M, Goldsmith DI, Gould AL, Madigan D, O’Hara DJ, Reisinger SJ & Hochberg AM, “Influence of the MedDRA® hierarchy on pharmacovigilance data mining resultsâ€, International journal of medical informatics, Vol.78, No.12,(2009), pp.e97-e103.
[17] van der Hooft CS, Sturkenboom MC, van Grootheest K, Kingma, HJ & Stricker BH, “Adverse drug reactionrelated hospitalizations: a nationwide study in the Netherlandsâ€, Drug Saf. (2006), pp.161-168.
[18] Paul SM, Mytelka DS, Dunwiddie CT, Persinger CC, Munos BH, Lindborg SR & Schacht AL, “How to improve R&D productivity: the pharmaceutical industry’s grand challengeâ€, Nat Rev Drug Discov, (2010), pp.203-214.
[19] Hopkins AL, “Network pharmacology: the next paradigm in drug discoveryâ€, Nat Chem Biol, (2008), pp.682-690.
-
Downloads
-
How to Cite
V. Sriramakrishnan, G., Muthu Selvam, M., Mariappan, K., & Suseendran, G. (2018). Pharmacovigilance, signal detection using statistical data mining methods. International Journal of Engineering & Technology, 7(2.31), 122-126. https://doi.org/10.14419/ijet.v7i2.31.13423Received date: 2018-05-29
Accepted date: 2018-05-29
Published date: 2018-05-29