Toxic Signal Detection in Pharmacogigilance of Anticancer Drugs in Cancer Treatment

Abstract

newline newlinePharmacovigilance (PV) is a continuous and ongoing process which allows assessing the safety newlineof medicinal product through its life cycle. Pharmacovigilance collects, records, codes Adverse newlineDrug Events (ADEs) / Adverse drug reactions (ADRs) analyses and assesses the reports, newlinepromotes the safe use of drugs, creates appropriate structures, and means of communication newlineneeded to perform its tasks. Spontaneous individual case safety reports gatherings are the main newlineasset for early discovery of unknown ADR to drugs once they are introduced to the general newlinepublic. The objective of the study was to identify possible significant signal associated with newlinepaclitaxel, docetaxel, cisplatin, carboplatin, cyclophoshphamide and vincristine by searching newlinedatabase of Canada Adverse Drug Reaction Monitoring Program (CADRMP) newlinePatient and Methods newlineA total of 10429 reports of patients between January 1970 to March 2010 were downloaded newlinefrom Canada Adverse reaction Monitoring Program website. These reports contained newlineinformation of adverse events associated with all other drugs inclusive of paclitaxel, docetaxel, newlinecisplatin, carboplatin, cyclophoshphamide and vincristine. Adverse drug reaction (ADR) signal newlinedetection were determined by proportional reporting ratio (PRR), reporting odds ratio (ROR), newlinePRR calculated by chi-square statistics, 95% confidence interval of PRR, observed to expected newline(O/E) ratio and De Mouchel method calculated PRR. Information component (IC) was given newlineby Bayesian confidence propagation neural network. (As per regulatory criteria, PRR and#8805; 2, ROR newlineand#8805; 1, Chi-square statistics calculated PRR and#8805; 4 and lower bound limit of 95% CI of PRR and#8805; 1 to newlineconsider particular adverse drug reaction as a signal. Further by BCPNN method, if IC and#8722; 2SD newlineand#8804; 0 then that drug-ADR pair considered as no signal; if 0 lt IC and#8722; 2SD and#8804;1.5, then that drug-ADR newlinepair considered as weak signal; if 1.5 lt ICand#8722;2SD and#8804; 3.0, then that drug-ADR pair considered as newlinemiddle signal; if IC and#8722; 2SD gt 3.0, then that drug-ADR pair considered as strong signal).