International Multi-database Pharmacoepidemiology: Potentials and Pitfalls

Abstract

With the rapid progress of computer technology a n d d e v e l o p m e n t o f e l e c t r o n i c h e a l t h r e c o r d s , pharmacoepidemiologic studies using multiple databases across and within nations have become feasible and popular in recent years. Multinational pharmacoepidemiologic studies (MPES) provide opportunities to compare drug utilization and effects across countries, to study rare exposures and outcomes, and to collaborate across nations. Multiple networks in North America, Europe, and Asia/Pacific region have emerged to support MPES and national and cross-national collaborations. We highlight the challenges of MPES and respective solutions with examples, including non-database pharmacoepidemiologic studies for low resource countries, distributed network approaches to address data privacy issues, considerations for biases due to variations in data structure, coding, and practice/behaviors of health care providers and patients. Because there are no standard recommendations in designing and conducting MPES, transparency is the key to adequate conduct and interpretation of the studies. More efforts in developing and standardizing the methods for MPES are required.

Applying a common data model to Asian databases for multinational pharmacoepidemiologic studies: opportunities and challenges

“…A distributed network approach with a CDM protects data confidentiality and facilitates the standardization, efficiency, and quality of analyses across data sources from multiple Asian sites conforming to high scientific standards. 1 , 2 Although several databases are currently available in Asian countries, they have different structures and formats and use different terminology codes. 2 As a result, the SCAN objective to convert data to a CDM is at the foundation of multinational pharmacoepidemiologic studies and reinforces the pharmacoepidemiology and pharmacovigilance system in Asian countries.…”

“…Multinational pharmacoepidemiologic studies provide opportunities to compare medication use and effects across countries. 1 SCAN demonstrated the feasibility and efficiency of studying racial and ethnic differences in medical product use and effects, as the CDM could apply to most routine pharmacoepidemiologic studies by using common software or analytical programs and maintaining data privacy with transparent and scientific standards. 2 , 10 , 18 , 19 Because some information was stored by free text or without consistent definitions in the domestic databases, conversion facilitated the standardization of terminologies before entry into the CDM through review processes to improve the quality of analyses.…”

“…Through SCAN, we gained a better understanding of each site and the countries’ health systems and databases and also enhanced collaboration among countries during study communications. 1 We understood the cultural factors that influenced prescribing or coding behaviors. We were able to discuss the challenges encountered and to come up with better approaches to improve the quality of conversions.…”

“…Multinational pharmacoepidemiologic studies provide opportunities to compare medication use and effects and to enhance collaboration across countries. 1 With advances in technology and informatic methods, studies using multiple databases covering a large number of patients across multiple countries have become more feasible. 2 Because of concerns about data privacy and related ethical issues, a distributed network approach using a common data model (CDM) is preferred.…”

“…However, converting databases from Asian countries can be more challenging than converting databases from North America and Europe, because of greater differences across health care systems, cultures, and languages. 1 We describe the processes and quality of data extraction, transformation, and load (ETL) from participating databases to a CDM, which is the cornerstone of SCAN. We describe the unique opportunities and challenges of applying a CDM to Asian databases.…”