Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China

Yu Yang, Xiaofeng Zhou, Shuangqing Gao, Hongbo Lin, Yanming Xie, Yuji Feng, Kui Huang and Siyan Zhan ()
Additional contact information
Yu Yang: Peking University Health Science Center
Xiaofeng Zhou: Pfizer Inc.
Shuangqing Gao: Beijing Brainpower Pharmacy Consulting Co. Ltd
Hongbo Lin: Center for Disease Control of Yinzhou
Yanming Xie: China Academy of Chinese Medical Sciences
Yuji Feng: Chinese Medical Doctor Association
Kui Huang: Pfizer Inc.
Siyan Zhan: Peking University Health Science Center

Drug Safety, 2018, vol. 41, issue 1, No 10, 125-137

Abstract: Abstract 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.

Date: 2018
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DOI: 10.1007/s40264-017-0589-z

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