Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China
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.
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.
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.
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.
We would like to thank Dr. Jingping Mo, Dr. Yun Gu, and Dr. Andrew Bate at Pfizer Inc. for their review and comments.
Compliance with Ethical Standards
Conflict of interest
Xiaofeng Zhou and Kui Huang are employees of Pfizer Inc., New York, NY, USA. Yuji Feng is a former employee of Pfizer Investment Co. Ltd., Beijing, China. Yu Yang, Shuangqing Gao, Hongbo Lin, Yanming Xie, and Siyan Zhan have no conflicts of interest that are directly relevant to the content of this study.
This research was funded/supported by National Natural Science Foundation of China (No. 81473067); Major Project of Science and Technology Planning of Beijing (No. D151100002215002); China Postdoctoral Science Foundation (2015M570905) and Pfizer Investment Co. Ltd., Beijing.
Ethics committee approval was waived because this study was conducted to describe the availability, characteristics, and structures of databases and did not involve any individuals’ data.
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