Development And Application Of Adverse Drug Reactions Comprehensive Analysis System

Objective: Adverse drug reaction(ADR) monitoring and analysis is an importantcontent of post-marketing studies, which has great significance in ensuring medicationsafety and discovering new drug adverse reactions. China conducts the detective andanalytical work of adverse drug reactions mainly through spontaneous reporting system.In the process of the application of spontaneous reporting system, there have arisenmany problems such as data accumulation, data classification difficulties, non-standarddata and so on, all of which make the analytical work of adverse reactions/eventreporting hard to carry out. This study plans to developed an open and comprehensiveevaluation system which can standardize ADR reporting data, comprehensive analysisADR/ADE reports, and classifiable analysis system or organ which ADR involved andmonitor and explore ADR signals. Also, the study aims to promote the system forpharmacy personnel at all levels to make ADR/ADE reporting data analysis and ADRsignal detection automatic, the application open and the data sharable.Methods: The system was developed under Windows environment, using Java1.6,JavaScript, css, and hmtl as programming language, Oracle as database and Excel asoutput table. Therefore, We can create local area network or open Internet, allowingusers to take advantage of Internet Explorer for online data import and analysis. Thesystem performs a comprehensive analysis of (ADR/E) cases which are commonlymentioned in relevant literatures internal and broad, and uses five methods ofquantitative ADR signal detection (PRR, ROR, MHRA, Yule Q value and BCPNN) forADR signal detection. The detection method comprehensively guarantees the reliability of the results. The framework of system chooses to use B/S(Browser/Server)structure in order to ensure its openness and diversity of users.Results: In this study, we have completed the development work of Adverse DrugReactions Comprehensive Analysis System——ADRCAS, for the system code we haveapplied for independent Copyright in Copyright Protection Center of China. Using thereport analysis function ofADRCAS, we can complete a quick comprehensive casesanalysis of ADR/E reports, including classification analysis in age, gender, dosageform, route of administration, vesting conditions, drug class, occurring position ofADR of classification analysis etc, and rapidly generate analytic form; We can use fivekinds of common quantitative ADR signal detection method to detect the signalstrength and its confidence interval of a variety of Drug-ADR record combination；ADRCAS system has been promoted in more than a dozen hospitals in cities likeHuangshan, Huaibei, Wuhu, Hefei, Nanjing, Qingdao and other regions, and hascollected nearly30,000lines data from these regionsADRCAS has also provided systemapplication account to corresponding regions.Conclusion: Through actual application, the results have proven the reliable practicalityand excellent openness of theADRCAS system. It makes analysis of adverse drugreactions more simple and feasible, ADR signal monitoring more systematic, methodmore standardized, indicators more quantitative, results more scientific. Promotion ofADRCAS system in hospitals and drug control department can improve the ADRanalytical capabilities of pharmacy staff, strengthen ADR signal detection and improvethe pharmacovigilance level of medical institutions and drug regulatory agencies.