Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China

Wei He, Difei Yao, Yangmin Hu, Haibin Dai Department of Pharmacy, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China Background: Spontaneous reporting of adverse drug events (ADEs) has long been the cornerstone of pharmacovigilance. Medical institutions in C...

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Main Authors: He W, Yao D, Hu Y, Dai H
Format: Article
Language:English
Published: Dove Medical Press 2018-10-01
Series:Therapeutics and Clinical Risk Management
Subjects:
Online Access:https://www.dovepress.com/analysis-of-a-pharmacist-led-adverse-drug-event-management-model-for-p-peer-reviewed-article-TCRM
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spelling doaj-985c4d13ca2c4af699b2731fdc8bc1dc2020-11-25T00:36:42ZengDove Medical PressTherapeutics and Clinical Risk Management1178-203X2018-10-01Volume 142139214741900Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in ChinaHe WYao DHu YDai HWei He, Difei Yao, Yangmin Hu, Haibin Dai Department of Pharmacy, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China Background: Spontaneous reporting of adverse drug events (ADEs) has long been the cornerstone of pharmacovigilance. Medical institutions in China have been a major source of ADE case reports, but the proportion of reports from tertiary hospitals is low due to the serious underreporting of case reports. The same problem existed in the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU).Objective: In order to increase the number of ADE reports and promote hospital pharmacovigilance, SAHZU’s clinical pharmacists established a pharmacist-led ADE management model. The aim of this paper is to introduce this management model and explore the advantages and disadvantages of the model.Methods: Pharmacist-led ADE management model was gradually formed from 2015 to 2017 in the SAHZU. This “pharmacist-led” model is reflected not only in the fact that clinical pharmacists are the main reporters of SAHZU’s ADEs but also in that they are the main groups to analyze and manage ADE and drug errors. The sources of ADEs reported by clinical pharmacists mainly include pharmacy rounds, ADE-related pharmacist consultations, centralized monitoring, ADE warning signal analysis, newly introduced drug evaluations, and drug safety research.Results: A total of 533 ADEs were reported by SAHZU to China’s spontaneous reporting system (SRS) in 2017, while the data in 2012 was 177, with an increase by 201%. In 2012, the proportion of “new” and “serious” reports was 16.4%. The proportions during the period from 2015 to 2017 were 41.4%, 60.8%, and 52.2%, respectively, which were statistically significant compared with the proportion in 2012. The proportion of ADEs reported by clinical pharmacists during the period from 2014 to 2017 were 51.5%, 57.3%, 68.8%, and 90.8%, respectively, which were statistically significant compared with the proportion in 2013 (P<0.05). There was a correlation between the proportions of severe ADEs and the proportion of ADEs reported by clinical pharmacists (r=0.873, P=0.023). Four hundred eighty four ADE cases reported by clinical pharmacists to China’s SRS in 2017 were mainly found in rounds of clinical pharmacists (74.17% [359/484]).Conclusion: The pharmacist-led pharmacovigilance working model significantly increased the quantity and quality of ADE reporting in SAHZU and promoted pharmacovigilance. This model is worth developing in Chinese tertiary hospitals and the following hospitals, where the physicians working there spend little time and energy on ADE reporting or the cost of physicians is high, while the clinical pharmacist team has strong professional skills. Keywords: tertiary hospitals, new adverse drug events, serious adverse drug events, clinical pharmacist, active surveillancehttps://www.dovepress.com/analysis-of-a-pharmacist-led-adverse-drug-event-management-model-for-p-peer-reviewed-article-TCRMPharmacovigilanceadverse drug event monitoringclinical pharmacistactive surveillance
collection DOAJ
language English
format Article
sources DOAJ
author He W
Yao D
Hu Y
Dai H
spellingShingle He W
Yao D
Hu Y
Dai H
Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China
Therapeutics and Clinical Risk Management
Pharmacovigilance
adverse drug event monitoring
clinical pharmacist
active surveillance
author_facet He W
Yao D
Hu Y
Dai H
author_sort He W
title Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China
title_short Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China
title_full Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China
title_fullStr Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China
title_full_unstemmed Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China
title_sort analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in china
publisher Dove Medical Press
series Therapeutics and Clinical Risk Management
issn 1178-203X
publishDate 2018-10-01
description Wei He, Difei Yao, Yangmin Hu, Haibin Dai Department of Pharmacy, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China Background: Spontaneous reporting of adverse drug events (ADEs) has long been the cornerstone of pharmacovigilance. Medical institutions in China have been a major source of ADE case reports, but the proportion of reports from tertiary hospitals is low due to the serious underreporting of case reports. The same problem existed in the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU).Objective: In order to increase the number of ADE reports and promote hospital pharmacovigilance, SAHZU’s clinical pharmacists established a pharmacist-led ADE management model. The aim of this paper is to introduce this management model and explore the advantages and disadvantages of the model.Methods: Pharmacist-led ADE management model was gradually formed from 2015 to 2017 in the SAHZU. This “pharmacist-led” model is reflected not only in the fact that clinical pharmacists are the main reporters of SAHZU’s ADEs but also in that they are the main groups to analyze and manage ADE and drug errors. The sources of ADEs reported by clinical pharmacists mainly include pharmacy rounds, ADE-related pharmacist consultations, centralized monitoring, ADE warning signal analysis, newly introduced drug evaluations, and drug safety research.Results: A total of 533 ADEs were reported by SAHZU to China’s spontaneous reporting system (SRS) in 2017, while the data in 2012 was 177, with an increase by 201%. In 2012, the proportion of “new” and “serious” reports was 16.4%. The proportions during the period from 2015 to 2017 were 41.4%, 60.8%, and 52.2%, respectively, which were statistically significant compared with the proportion in 2012. The proportion of ADEs reported by clinical pharmacists during the period from 2014 to 2017 were 51.5%, 57.3%, 68.8%, and 90.8%, respectively, which were statistically significant compared with the proportion in 2013 (P<0.05). There was a correlation between the proportions of severe ADEs and the proportion of ADEs reported by clinical pharmacists (r=0.873, P=0.023). Four hundred eighty four ADE cases reported by clinical pharmacists to China’s SRS in 2017 were mainly found in rounds of clinical pharmacists (74.17% [359/484]).Conclusion: The pharmacist-led pharmacovigilance working model significantly increased the quantity and quality of ADE reporting in SAHZU and promoted pharmacovigilance. This model is worth developing in Chinese tertiary hospitals and the following hospitals, where the physicians working there spend little time and energy on ADE reporting or the cost of physicians is high, while the clinical pharmacist team has strong professional skills. Keywords: tertiary hospitals, new adverse drug events, serious adverse drug events, clinical pharmacist, active surveillance
topic Pharmacovigilance
adverse drug event monitoring
clinical pharmacist
active surveillance
url https://www.dovepress.com/analysis-of-a-pharmacist-led-adverse-drug-event-management-model-for-p-peer-reviewed-article-TCRM
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