Research on active monitoring of serious adverse drug reactions using laboratory critical values
10.3760/cma.j.cn114015-20240326-00196
- VernacularTitle:利用实验室危急值对严重药物不良反应的主动监测研究
- Author:
Ke'nan LI
1
;
Huihui SHI
;
Xueying WANG
;
Lixia YUWEN
;
Lihua WANG
;
Ya'nan FENG
;
Wenjuan CHEN
Author Information
1. 河北省邢台市药品不良反应和药物滥用监测中心，邢台 054002
- Publication Type:Journal Article
- Keywords:
Laboratory critical values;
Drug-related side effects and adverse reactions;
Pharmacovigilance;
Active monitoring
- From:
Adverse Drug Reactions Journal
2024;26(12):732-736
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the role of using laboratory critical values for active monitoring of serious adverse drug reactions (SADRs) in pharmacovigilance.Methods:Xingtai Central Hospital was used as a sentinel hospital. The reports containing critical value in blood routine, blood biochemistry, blood gas analysis, and coagulation function from July 2022 to December 2022 were collected by the laboratory information system in the hospital. The electronic medical records of patients involved in the reports were reviewed, and the correlation between therapeutic drugs and the critical values was evaluated. The critical values related to adverse drug reactions (ADRs) and SADRs, and the suspicious drugs were analyzed by descriptive statistics. The occurrence of ADRs and SADRs in outpatients/emergency patients and hospitalized patients were compared.Results:A total of 1 597 reports containing critical values were included in the analysis. In these reports, 174 (10.90%) were judged to be related to ADRs, of which 68 (39.1%) were related to SADRs. The proportion of reports containing critical values in the Inpatient Department was significantly higher than that in the Outpatient/Emergency Department [0.39% (1 114/288 541) vs. 0.16% (483/307 176), P<0.001]; the proportion of reports related to ADR in all laboratory reports of the Outpatient/Emergency Department was significantly higher than that of the Inpatient Department [14.29% (69/483) vs. 9.43% (105/1 114), P=0.004]; the proportion of reports involving SADRs in those involving ADRs [31.88% (22/69) vs. 43.81% (46/105)] and that in all reports [4.55% (22/483) vs. 4.13% (46/1 114)] both were similar between Outpatient/Emergency Department and Inpatient Department, and the differences were not statistically significant (all P>0.05). Six-eight reports of SADR involved 80 critical values, and the top 3 were leukopenia (mainly involving anticancer drugs), coagulation dysfunction (mainly involving anticoagulants) and electrolyte disorder (mainly involving antihypertensive drugs), some of which were induced by medication errors or improper drug use. Conclusions:Reporting laboratory critical values can effectively do some help in implement of active monitoring of SADRs in blood cells, blood biochemistry and coagulation function caused by drugs, which is conducive to the timely detection of SADRs in outpatient/emergency and hospitalized patients, as well as serious adverse events caused by medication errors and inappropriate treatments.
