Analysis of 8 566 New ADR Reports in Shandong Province
- VernacularTitle:山东省8566例新的药品不良反应报告分析
- Author:
Baosheng LIU
1
;
Xiuli ZHOU
2
;
Kaikai GONG
3
Author Information
1. Dept. of Clinical Pharmacy，Weifang Hospital of TCM，Shandong Weifang 261000，China
2. Dept. of Pharmacy，Sunshine Union Hospital，Shandong Weifang 261000，China
3. Cancer Research Laboratory，the Affiliated Hospital of Binzhou Medical University，Shandong Binzhou 256603，China
- Publication Type:Journal Article
- Keywords:
Shandong province;
New;
Adverse drug reactions;
Report analysis;
Safety of drug u se
- From:
China Pharmacy
2021;32(4):475-479
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To investigate the occurrence and characteristics of new adverse drug reactions （ADR）in Shandong province，so as to provide reference for the safety of drug use in the clinic. METHODS ：The data of new ADR reports were collected from Spontaneous Reporting System of Shandong ADR Monitoring Center during Oct. 2019 to Mar. 2020. Those reports were analyzed statistically in respects of report types ，reporting institution ，reporters’occupation，gender and age of patients ，drug type ，organs/ systems involved ，clinical manifestations. RESULTS & CONCLUSIONS ：A total of 8 566 new ADR reports were screened out ， accounting for 10.81％ of the effective ADRs. Among them ，there were 7 961 new and general ADR （92.94％）and 605 new and serious ADRs （7.06％）. For the new ADR ，the reporting institutions were mainly medical institutions （98.42％），and the reporters ’ occupation were mainly doctors （78.44％）. Female （4 860 cases）was slightly more than male （3 698 cases）；most of them were 45 years old and above （70.00％），and intravenous drip （47.67％）was the main route of administration. The top five ADR suspected drugs were TCM preparations （34.50％），anti-microbials（13.75％），circulatory system drugs （11.41％），nervous system drugs （6.39％）and blood system drugs （4.81％），involving 517，91，64，53，50 types，respectively，among which Levofloxacin injection caused the most serious ADR （24 cases）. The new and general ADR mainly involved gastrointestinal system ，skin and its appendant ； their clinical manifestations were nausea ，vomiting，rash，etc. New and serious ADR mainly caused systemic damage ；their clinical manifestations were anaphylactic shock ，chest tightness and shivering ，etc. It is suggested to strengthen the ADR monitoring of TCM preparations，anti-microbials，circulatory system drugs and other drugs ，so as to ensure the safety of clinical drug use.
