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Active Surveillance and Clinical Analysis of anaphylaxis Based on China Hospital Pharmacovigilance System
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  • Chengcheng Wang,
  • Zejing Li,
  • Yingying Yu,
  • Maoyan Feng,
  • Anchang Liu
Chengcheng Wang
Qilu Hospital of Shandong University Qingdao

Corresponding Author:[email protected]

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Zejing Li
Qilu Hospital of Shandong University Qingdao
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Yingying Yu
Qilu Hospital of Shandong University Qingdao
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Maoyan Feng
Qilu Hospital of Shandong University Qingdao
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Anchang Liu
Qilu Hospital of Shandong University Qingdao
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Abstract

Objective This study aimed to construct active surveillance programs for anaphylaxis based on China Hospital Pharmacovigilance System(CHPS) and analyze the characteristics, allergens, and management for anaphylaxis in a tertiary hospital in China. Methods The anaphylaxis cases reported to the National Adverse Drug Reaction Monitoring System in our hospital from 2014 to 2021 were retrospectively analyzed. Characteristic medical orders, progress notes, and diagnoses in these cases were recorded to obtain initial anaphylaxis trigger entries. According to the initial entries, the questionnaire was designed, and the Delphi method was used to develop consensus entries for anaphylaxis triggers. The CHPS was used to program these trigger entries and construct active surveillance programs. The programs were then ran on the 238,194 discharged patients to evaluate their performance and analyze the relevant clinical data. Results A total of 10 anaphylaxis triggers and 3 active surveillance programs were finally identified. 309 cases were obtained by the active surveillance program, and 94 cases were identified as anaphylaxis after the manual screening. After removing duplicates,76 patients with 79 times of anaphylaxis were finally obtained. The positive rate of triggers and the positive predictive value (PPV) of the programs were 0.13% and 30.42%, respectively. The incidence of anaphylaxis in our study was 0.03%, and the number of anaphylaxis cases detected by the active surveillance programs was 5.64 times higher than that by the spontaneous reporting system. Anaphylaxis was more common in female patients. Antibacterial drugs, antineoplastic drugs, and contrast media were the most common allergens in clinical practice, and the proportion of anaphylaxis to antineoplastic drugs was highest (0.6%) when compared with patients admitted during the same period. Significant underuse of epinephrine and overuse of second-line therapy (glucocorticoids and antihistamines) existed in the management of anaphylaxis, and the usage and dosage of epinephrine were irrational. Conclusion CHPS can effectively use both structured and unstructured data to construct anaphylaxis active surveillance programs, and this could compensate for the under-reporting by spontaneous reporting system, which was the primary adverse reaction monitoring method in China. The treatment and management of anaphylaxis are inappropriate and needed to be improved to reduce the risk of death.