OBJECTIVES: Assess and describe the study scope (i.e., effectiveness, safety, disease epidemiology, drug utilization, or other), and the actual use of electronic health record (EHR) and claims databases in studies recorded on the European Union (EU) post authorization studies (PAS) Register held by the EU Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

METHODS: Cross-sectional descriptive analysis of all studies registered in the ENCePP PAS register with actual funding contract date as of January 2016. We assessed the study scope and the use of EHR/claims databases by year and study scope.

RESULTS: We identified 481 studies on the EU PAS Register. A total of 170 (35.3%) studies included EHR/claims databases; 68 (30.4%), and 38 (36.2%) in 2016 and 2018, respectively. Most studies included risk assessment. The second and third most frequent study scope was drug utilization and effectiveness evaluation, respectively. EHR/claims databases were most frequently used in drug utilization studies.

CONCLUSIONS: Results show a minimal increase in the proportion of studies using EHR/claims databases over time and the use of EHR/claims databases also varies according to study scope. Existing EHR/claims databases are available and expected to be used and accepted more in PAS to observe drug effects in routine practice conditions in larger and more diverse populations, provided that the studies are conducted by experts in the field, using correct methodologies and validation where needed. We strongly encourage study registration in ENCePP to improve transparency in study design and methodology.