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.