Retrospective Analysis of Gestational Adverse Drug Reactions from Sichuan Center for Adverse Drug Reaction Monitoring from Nov. 2016 to Nov. 2017 / 中国药房

ABSTRACT

OBJECTIVE： To investigate the characteristics and regularity of gestational （including perinatal period） adverse drug reactions （ADR） in Sichuan province， and to provide evidence for ensuring the safety and effectiveness of drug use in clinic. METHODS： Gestational ADR reported to Sichuan provincial ADR monitoring center from Nov. 2016 to Nov. 2017 were statistically analyzed in respects of report source， personnel distribution， general information of patients， route of administration， drug types and main drugs， involved system/organ， grading and outcome， etc. RESULTS： A total of 1 309 gestational ADR cases   （1 340 case time） were collected， in which 1 305 were from medical institutions， 3 from enterprises and 1 from manufacturer. There were 986 physicians， 188 nurses， 133 pharmacists and 2 commissioners for drug safety. 859 cases （65.62％） were 21-30 years old， accounting for the largest proportion. 867 case time were caused by intravenous administration （64.70％）. ADR-inducing drug types mainly included reproductive system drugs （491 case time， 36.64％）， antimicrobial drugs （479 case time， 35.75％） and blood system drugs （110 case time， 8.21％）. Main of them were Carboprost tromethamine injection （187 case time， 13.96％）， Cefazolin sodium for injection （122 case time， 9.10％） and Oxytocin injection （105 case time， 7.84％）. ADR mainly involved skin and its appendants （517 case time， 33.95％）， gastrointestinal system （387 case time， 25.41％）， whole body （175 case time， 11.49％）.  In 1 309 gestational ADR， 1 251 cases （95.57％） were general ADR； 58 cases （4.43％） were severe ADR， including 14 life-threatening cases， 7 extended hospital stay and 37 others； 592 （45.22％） patients improved， 716 （54.70％） recovered and 1 （0.08％） did not improve. CONCLUSIONS： In clinical practice， it is necessary to strengthen the monitoring of drug use in patients during gestational， especially monitor ADR of uterine contraction drugs and antimicrobial drugs during gestational， use drug cautiously and promote clinical medication safety in gestational patients.