Analysis of 182 Case of Serious Adverse Drug Reactions/events Reports in a Hospital

doi:10.19803/j.1672-8629.2020.11.12

Abstract

Abstract: Objective To analyze the characteristics of serious adverse drug reactions/events (ADR/AE) reported in one hospital so as to provide reference for rational drug use in clinical practice. Methods One hundred and eighty-two reports of serious ADR/AE in one hospital were retrospectively analyzed, while drug categories, routes of administration, prognosis, systems or organs involved and clinical manifestations were studied. Results Among the 182 cases, 90 were males and 92 were females, and the group aged 15 to 44 accounted for 35.71%. According to categories, antimicrobial drugs ranked first (28.04%), followed by Chinese patent medicines and central nervous system drugs. Hepatobiliary disorders, general disorders, skin and appendages disorders were the most common involved systems organ classes(SOCs). The main clinical manifestations were abnormal hepatic function, increased hepatic enzymes, and anaphylactic shock. Conclusion Antimicrobial drugs and Chinese patent medicines remain the focus of monitoring of serious ADR/AE. Patients over 45 years old who have taken more than one drug for a long time should be monitored for liver and kidney function to ensure medication safety．

Key words: adverse drug reactions(ADR), adverse drug events(AE), serious, Safe medication

CLC Number:

R994.11

WU Wenli, JING Jing, LU Zhaogang, ZANG Guixiang, WANG Jian, WANG Xiaoxu, WANG Jiyun. Analysis of 182 Case of Serious Adverse Drug Reactions/events Reports in a Hospital[J]. Chinese Journal of Pharmacovigilance, 2020, 17(11): 803-807.

References

[1] Wang J, Yu LL, Li W.Analysis of 358 cases of serious adverse drug reactions/events in Nanjing[J]. Drug Evaluation Research(药物评价研究),2018,41(12):2221-2226.
[2] Wang YC, Peng L, Luo FY, et al.Analysis of 139 cases of new and serious adverse drug reactions/events[J]. Ningxia Med J(宁夏医学杂志),2016,38(11):1078-1080.
[3] Chen XQ, Jin YY, Tang G, et al.New Edited Materia Medica[M]. 17th Edition. Beijing: People's Medical Publishing House(人民卫生出版社), 2018: 1-938.
[4] National Center for ADR Monitoring, Center for Drug Reevaluation. WHO Adverse Reaction Terminology[M]. Beijing: China Medical Science and Technology Publishing House(中国医药科技出版社),2003:3-172.
[5] Liu H,Zhou JC,Fan GR, et al.Pareto diagram analysis of 128 cases of serious adverse drug reactions from 2013 to 2016 in Shanghai First Hospital Affiliated to Shanghai Jiaotong University[J].Pharm Care Res(药学服务与研究), 2018, 18(5):385-388.
[6] Bao HL, Li JF, Wu ZA.Analysis on Influencing Factors of Quality of Adverse Drug Reaction Reports in China[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2018,15(4):226-229.
[7] Niu LL, Li B, Li XL.Considerations about Present Situation of Hospital ADR Mornitoring[J].Chinese Journal of Pharmacovigilance(中国药物警戒), 2014,11(7):416-419.
[8] Zhao X, Lin P, Guo J, et al.Pareto Chart Analysis of Irrational Drug Use in Outpatient and Emergency of Our Hospital[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2018,15(7):429-433.
[9] Li LW, Ma LF, Li SQ.Retrospective Clinical Evaluation of Anti-tuberculosis Drug Induced Liver Injury[J].Chin J Pharmacoepidemiol(药物流行病学杂志), 2016,25(12):773-776.
[10] Qiu YQ, Lu XY, Yu YS, et al.Guidance on skin allergy test of cephalosporins antibiotics in Zhejiang Province[J]. Chin J Mod Appl Pharm(中国现代应用药学),2018,35(12):1906-1908.
[11] Zhu CM, Wu M.Analysis of New and Serious Adverse Drug Reactions Reports in Our Hospital from 2007 to 2016[J]. Chin J Pharmacoepidemiol(药物流行病学杂志),2017,26(4):551-555.
[12] Lv XQ, Ma MK, Zhu Y, et al.Analysis of Leaflets' Safety Information and Adverse Reaction Monitoring Data of Chinese Patent Drugs[J]. Chin J Mod Appl Pharm(中国现代应用药学), 2019,36(4):493-497.
[13] The basic principles for clinical use of Traditional Chinese Medicine Injections[S]. 2008.
[14] Fu H, Qiu ZJ,Rong YH.Pareto Diagram Analysis on 1786 Cases of Adverse Drug Reactions/Adverse Drug Events Induced by Intravenous Medication[J]. Evaluation and analysis of drug-use in hospitals of China(中国医院用药评价与分析),2016,16(6):832-835.
[15] Ge FL, Xue CM, Sun Y, et al.Advances in Drug Epidemiology of Drug-induced Liver Injury in our Country[J]. Chinese Hepatology(肝脏),2018, 23(11):1032-1033.
[16] Chen FQ, Chen Z, Zhang JR, et al.Advances in Clinical Epidemiology of Drug-induced Liver Injury[J]. Chin J Pharmacoepidemiol(药物流行病学杂志), 2016,25(12):810-812.
[17] Lin LF, Xu LJ, Chen SZ,et al.Analysis on 74 Cases of Anaphylactic Shock Induced by Nonionic Coronary Contrast Media[J]. Chin J of Clinical Rational Drug Use(临床合理用药), 2015,8(10): 32-33.
[18] Idee JM, Pines E, Prigent P, et al.Allergy-like reactions to iodinated contrast agents. A critical analysis[J]. Fundam Clin Pharmacol, 2005, 19(3): 263-280.