Number of tables:8
Active Surveillance and Clinical Analysis of anaphylaxis Based on China Hospital Pharmacovigilance System
Chengcheng Wang1, Zejing Li2, Yingying Yu1, Maoyan Feng1, Anchang Liu*
1 Department of Pharmacy, Qilu Hospital(Qingdao), Cheeloo College of Medicine, Shandong University, Qingdao, Shandong Province, China
2 Department of Otolaryngology head and Neck Surgery, Qilu Hospital(Qingdao), Cheeloo College of Medicine,Shandong University,Qingdao, Shandong Province, China)
* Correspondence: Anchang Liu* acleu@126.com
Keywords: Active surveillance, Anaphylaxis, China Hospital Pharmacovigilance system (CHPS), Epinephrine, Delphi method
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.
Key Points
China Hospital Pharmacovigilance System can effectively use both structured and unstructured data to construct anaphylaxis active surveillance programs, which compensate for the under-reporting by spontaneous reporting system.
The treatment and management of anaphylaxis are inappropriate and needed to be improved to reduce the risk of death.
Plain language summary
Anaphylaxis is a severe, potentially fatal adverse drug reaction(ADR), and drug induced anaphylaxis remains the leading cause of allergic death in adults. But there were few active surveillance studies and epidemiological data on anaphylaxis in China, and studies showed gaps in the initial treatment of anaphylaxis between China and international guidelines. This study aims to develop anaphylaxis triggers by the Delphi method and construct active surveillance programs based on China Hospital Pharmacovigilance System (CHPS). The programs were then ran on 238,194 discharged patients to evaluate their performances and analyze the characteristics, allergens, and management of anaphylaxis in the Chinese population. Results showed that the positive predictive value (PPV) of the program and the incidence of anaphylaxis were 30.42% and 0.03%, respectively. The number of anaphylaxis cases detected by the active surveillance programs was 5.64 times higher than that by the spontaneous reporting system. 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.