Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China
Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China
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中国上市后药品安全监测和药物流行病学电子医疗数据库评价
DOI：
10.1007/s40264-017-0589-z
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发表时间：
2018-01-01
期刊：
影响因子：
4.2
通讯作者：
Zhan, Siyan
中科院分区：
文献类型：
--
作者：
Yang, Yu;Zhou, Xiaofeng;Zhan, Siyan
简介 在欧洲和北美，电子医疗数据库 (EHD) 越来越多地用于上市后药物安全监测和药物流行病学。然而，很少有研究探讨这些数据源在中国的潜力。方法选择中国三种主要类型的EHD（即基于区域社区的数据库、国家索赔数据库和电子病历[EMR]数据库）进行评估。基于美国迷你哨兵（MS）通用数据模型（CDM）以及中国支持药品安全监测的数据特征，得出了四十个核心变量。对这些核心变量和八个一般性问题进行了电子邮件调查，并对其他变量进行了后续询问。对三个 EHD 中的 40 个核心变量以及每个 EHD 中的所有变量以及美国 MS CDM 和观察性医疗结果合作伙伴 (OMOP) CDM 中的变量进行可用性比较，并根据特定标准进行标记。 结果 所有 EHD 的保管人均确认愿意在获得适当批准后与学术机构共享其数据库。 2015年，区域社区数据库包含119万人，核心变量占85%。每年在全国范围内进行重新抽样，国家理赔数据库2014年包含540万人，核心变量占55%；电子病历数据库2015年包含60家医院的300万住院患者，核心变量占80%。与MS CDM或OMOP CDM相比，三种EHD中可用或能够从原始来源转化/衍生的变量比例分别为24-83%或45-73%。结论这些EHD为中国上市后药品安全监测和药物流行病学提供了潜在价值。未来的研究有必要评估这些 EHD 或中国其他数据源的质量和完整性。
Introduction Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China.Methods Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards.Results All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively.Conclusions These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.