Active surveillance and clinical analysis of anaphylaxis based on the China Hospital Pharmacovigilance System
Objective: This study aimed to develop active surveillance programs (ASPs) for anaphylaxis using the China Hospital Pharmacovigilance System (CHPS) and analyze the characteristics, allergens, and management strategies for anaphylaxis within a tertiary hospital setting in China.Methods: We retrospect...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-07-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1180685/full |
| _version_ | 1797783508691714048 |
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| author | Chengcheng Wang Zejing Li Yingying Yu Maoyan Feng Anchang Liu |
| author_facet | Chengcheng Wang Zejing Li Yingying Yu Maoyan Feng Anchang Liu |
| author_sort | Chengcheng Wang |
| collection | DOAJ |
| description | Objective: This study aimed to develop active surveillance programs (ASPs) for anaphylaxis using the China Hospital Pharmacovigilance System (CHPS) and analyze the characteristics, allergens, and management strategies for anaphylaxis within a tertiary hospital setting in China.Methods: We retrospectively analyzed the anaphylaxis cases reported to the National Adverse Drug Reaction Monitoring System in our hospital from 2014 to 2021. Characteristic medical orders, progress notes, and diagnoses in these cases were recorded to identify initial anaphylaxis trigger entries. Based on these initial entries, the questionnaire was developed, and the Delphi method was used to establish consensus entries for anaphylaxis triggers. The CHPS was used to program these trigger entries and construct ASPs, which were then tested on the 238,194 discharged patients to evaluate their performance and analyze the related clinical data.Results: Ten anaphylaxis triggers and three ASPs were ultimately identified. The ASPs captured 309 cases, out of which 94 cases were confirmed as anaphylaxis following manual screening. After removing duplicates, we noted 76 patients who experienced anaphylaxis 79 times. The positive rate of triggers and the positive predictive value 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 ASPs was 5.64 times higher than those detected by the spontaneous reporting system. Anaphylaxis was more common among female patients. Antibacterial drugs, antineoplastic drugs, and contrast media were the most prevalent allergens in clinical practice. Anaphylaxis to antineoplastic drugs had the highest incidence (0.6%) when compared with patients admitted during the same period. Our study revealed a significant underuse of epinephrine and overuse of second-line therapy (glucocorticoids and antihistamines) in the management of anaphylaxis. Furthermore, we found the use and dosage of epinephrine to be inappropriate.Conclusion: The CHPS can effectively utilize both structured and unstructured data to construct anaphylaxis ASPs, and this could counteract the under-reporting by the spontaneous reporting system, the primary adverse reaction monitoring method in China. The treatment and management of anaphylaxis are currently inadequate and require improvement to reduce mortality risk. |
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| format | Article |
| id | doaj.art-489207b11ccd491dbced7cd64357054d |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-13T00:26:56Z |
| publishDate | 2023-07-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-489207b11ccd491dbced7cd64357054d2023-07-11T04:34:44ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-07-011410.3389/fphar.2023.11806851180685Active surveillance and clinical analysis of anaphylaxis based on the China Hospital Pharmacovigilance SystemChengcheng Wang0Zejing Li1Yingying Yu2Maoyan Feng3Anchang Liu4Department of Pharmacy, Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University, Qingdao, ChinaDepartment of Otolaryngology Head and Neck Surgery, Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University, Qingdao, ChinaDepartment of Pharmacy, Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University, Qingdao, ChinaDepartment of Pharmacy, Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University, Qingdao, ChinaDepartment of Pharmacy, Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University, Qingdao, ChinaObjective: This study aimed to develop active surveillance programs (ASPs) for anaphylaxis using the China Hospital Pharmacovigilance System (CHPS) and analyze the characteristics, allergens, and management strategies for anaphylaxis within a tertiary hospital setting in China.Methods: We retrospectively analyzed the anaphylaxis cases reported to the National Adverse Drug Reaction Monitoring System in our hospital from 2014 to 2021. Characteristic medical orders, progress notes, and diagnoses in these cases were recorded to identify initial anaphylaxis trigger entries. Based on these initial entries, the questionnaire was developed, and the Delphi method was used to establish consensus entries for anaphylaxis triggers. The CHPS was used to program these trigger entries and construct ASPs, which were then tested on the 238,194 discharged patients to evaluate their performance and analyze the related clinical data.Results: Ten anaphylaxis triggers and three ASPs were ultimately identified. The ASPs captured 309 cases, out of which 94 cases were confirmed as anaphylaxis following manual screening. After removing duplicates, we noted 76 patients who experienced anaphylaxis 79 times. The positive rate of triggers and the positive predictive value 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 ASPs was 5.64 times higher than those detected by the spontaneous reporting system. Anaphylaxis was more common among female patients. Antibacterial drugs, antineoplastic drugs, and contrast media were the most prevalent allergens in clinical practice. Anaphylaxis to antineoplastic drugs had the highest incidence (0.6%) when compared with patients admitted during the same period. Our study revealed a significant underuse of epinephrine and overuse of second-line therapy (glucocorticoids and antihistamines) in the management of anaphylaxis. Furthermore, we found the use and dosage of epinephrine to be inappropriate.Conclusion: The CHPS can effectively utilize both structured and unstructured data to construct anaphylaxis ASPs, and this could counteract the under-reporting by the spontaneous reporting system, the primary adverse reaction monitoring method in China. The treatment and management of anaphylaxis are currently inadequate and require improvement to reduce mortality risk.https://www.frontiersin.org/articles/10.3389/fphar.2023.1180685/fullactive surveillanceanaphylaxisChina Hospital Pharmacovigilance SystemepinephrineDelphi method |
| spellingShingle | Chengcheng Wang Zejing Li Yingying Yu Maoyan Feng Anchang Liu Active surveillance and clinical analysis of anaphylaxis based on the China Hospital Pharmacovigilance System Frontiers in Pharmacology active surveillance anaphylaxis China Hospital Pharmacovigilance System epinephrine Delphi method |
| title | Active surveillance and clinical analysis of anaphylaxis based on the China Hospital Pharmacovigilance System |
| title_full | Active surveillance and clinical analysis of anaphylaxis based on the China Hospital Pharmacovigilance System |
| title_fullStr | Active surveillance and clinical analysis of anaphylaxis based on the China Hospital Pharmacovigilance System |
| title_full_unstemmed | Active surveillance and clinical analysis of anaphylaxis based on the China Hospital Pharmacovigilance System |
| title_short | Active surveillance and clinical analysis of anaphylaxis based on the China Hospital Pharmacovigilance System |
| title_sort | active surveillance and clinical analysis of anaphylaxis based on the china hospital pharmacovigilance system |
| topic | active surveillance anaphylaxis China Hospital Pharmacovigilance System epinephrine Delphi method |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1180685/full |
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