He Wei, Yao Difei, Hu Yangmin, Dai Haibin
Department of Pharmacy, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China,
Ther Clin Risk Manag. 2018 Oct 30;14:2139-2147. doi: 10.2147/TCRM.S178297. eCollection 2018.
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).
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.
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.
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 (<0.05). There was a correlation between the proportions of severe ADEs and the proportion of ADEs reported by clinical pharmacists (=0.873, =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]).
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.
药品不良反应（ADEs）的自发报告长期以来一直是药物警戒的基石。中国的医疗机构一直是ADE病例报告的主要来源，但由于病例报告严重漏报，三级医院的报告比例较低。浙江大学医学院附属第二医院（SAHZU）也存在同样的问题。
为了增加ADE报告数量并促进医院药物警戒，SAHZU的临床药师建立了以药师为主导的ADE管理模式。本文旨在介绍这种管理模式并探讨其优缺点。
2015年至2017年期间，SAHZU逐步形成了以药师为主导的ADE管理模式。这种“以药师为主导”的模式不仅体现在临床药师是SAHZU的ADE主要报告者，还体现在他们是分析和管理ADE及用药差错的主要群体。临床药师报告的ADE来源主要包括药学查房、与ADE相关的药师会诊、集中监测、ADE警示信号分析、新引进药物评估以及药物安全性研究。
2017年SAHZU向中国自发报告系统（SRS）共报告了533例ADE，而2012年的数据为177例，增长了201%。2012年，“新的”和“严重的”报告比例为16.4%。2015年至2017年期间的比例分别为41.4%、60.8%和52.2%，与2012年的比例相比具有统计学意义。2014年至2017年期间临床药师报告的ADE比例分别为51.5%、57.3%、68.8%和90.8%，与2013年的比例相比具有统计学意义（<0.05）。严重ADE比例与临床药师报告的ADE比例之间存在相关性（=0.873，=0.023）。2017年临床药师向中国SRS报告的484例ADE病例主要在临床药师查房中发现（74.17%[359/484]）。
以药师为主导的药物警戒工作模式显著提高了SAHZU的ADE报告数量和质量，并促进了药物警戒。这种模式在中国三级医院及以下医院值得推广，这些医院的医生在ADE报告上花费的时间和精力较少，或者医生成本较高，而临床药师团队具有较强的专业技能。
