Study On Active Monitoring Of Adverse Drug Reactions Induced By Anti-Tumor Drugs In Hospitalized Patients With Tumor

Objective 1. To get information of the incidence of adverse reactions in a tertiary hospital in Anhui, and to determine the active monitoring of the target drug. 2. To design target drug active monitoring software. 3. To active monitor of adverse drug reactions induced by target drug, and evaluate the situation of active monitoring of adverse reactions combined with the collection of adverse drug reactions reported of the target drug. To provide the reference for the further adverse drug reaction monitoring work.Methods 1. Excel2007 was used to comprehensive analysis of adverse drug reactions reported by the spontaneous reporting system during the period of May 2010 to 2014 January. 2. By summarized target drug adverse reactions, designed of active surveillance system monitoring conditions, core procedures and operation interface. 3. Self-developed active monitoring procedure relying on the hospital information system was used to monitor adverse drug reactions of target drug with hospitalized patients actively from July 2015 to December 2015. The resulting adverse reaction cases and spontaneous reporters in the same period would be analyzed.Results 1. Because the incidence of adverse drug reactions in patients with cancer was the highest; the adverse reactions were harm, and the situation was most serious. 2. The antitumor active monitoring system of adverse drug reaction was designed. 3.1 Active monitoring system showed 340 cases of possible adverse reactions of anti-tumor drugs. 1614 suspected adverse reactions were obtained, including 1113 trigger signals and 501 text signals. Trigger and text searched 229 common warning signals; the number of first screening signals was 1351, of which 933 trigger signals, 418 text signals, 187 common signals; the number of second screening signals was 1240, of which 887 trigger signals, 353 text signals, 176 common signals. 3.2 After assessment that 305 cases of adverse reactions occur, including 146 men(45.45%) and 159 women(54.55%). Average age was 55.97±13.31 years old, major years was from 41 to 70, a total of 236 cases(77.38%). Blood and lymphatic system damage was the most and the digestive system damage was in the second place. There were 170 cases(55.74%) and 119 cases(39.02%). The most original disease was respiratory system tumor, having 115 cases(37.70%). 3.3 Spontaneous reporting system collected 55 reports, including male 25 cases(45.45%), 30 cases of female patients(54.55%). Average age was(59.42 + 9.67). The main years were from 51 to 60, a total of 28 cases(50.91%). Blood and lymphatic system damage was the most and the digestive system damage was in the second place, getting 30 patients(54.55%) and 20 cases(36.36%) respectively; There were most cancer patients with digestive system cancers with a total of 36 cases(65.45%). 3.4 Spontaneous reporting and active monitoring repeated eight cases. Men case was only one. Adverse reactions involved in six cases of digestive system and two cases of blood and lymphatic system.Conclusion 1. Anti-tumor drug was chosen as active monitoring target. 2. The designed antitumor active monitoring system of adverse drug reaction can run well. 3.1 According to antitumor drug adverse reaction amplification trigger projects and text keywords is helpful to detect the signals. 3.2 Active monitoring system is now at the stage of trying to run and needs more application, modify and improve the core program can better applied to antitumor drugs and other security monitoring. 3.3 The standards of cases of early signal selection, sieve and evaluation need to be combined with clinical medicine and always bad response analysis for further elaboration and clear. 3.4 Active monitoring program can improve the quantity and save power and time. It has the obvious superiority. When patients will be adverse reactions or adverse reaction latency in advance exposed may signals in real-time and timely expose the ongoing adverse reaction. The standardization of the course record and the integrity of electronic case have influence on active monitoring. Active monitoring can make up for the shortcomings of passive monitoring and the limits of traditional spontaneous reporting can be added active monitoring. A combination can reduce the harm caused by adverse drug reactions occurred or avoid the potential adverse drug reactions and help to adverse drug reaction monitoring work better.