Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation

Abstract

Objective: Electronic healthcare databases (EHDs) are useful tools for drug development and safety evaluation but their heterogeneity of structure, validity and access across Europe complicates the conduct of multidatabase studies. In this paper, we provide insight into available EHDs to support regulatory decisions on medicines.

Methods: EHDs were identified from publicly available information from the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance resources database, textbooks and web-based searches. Databases were selected using criteria related to accessibility, longitudinal dimension, recording of exposure and outcomes, and generalisability. Extracted information was verified with the database owners.

Results: A total of 34 EHDs were selected after applying key criteria relevant for regulatory purposes. The most represented regions were Northern, Central and Western Europe. The most frequent types of data source were electronic medical records (44.1%) and record linkage systems (29.4%). The median number of patients registered in the 34 data sources was 5 million (range 0.07-15 million) while the median time covered by a database was 18.5 years. Paediatric patients were included in 32 databases (94%). Completeness of information on drug exposure was variable. Published validation studies were found for only 17 databases (50%). Some level of access exists for 25 databases (73.5%), and 23 databases (67.6%) can be linked through a personal identification number to other databases with parent-child linkage possible in 7 (21%) databases. Eight databases (23.5%) were already transformed or were in the process of being transformed into a common data model that could facilitate multidatabase studies.

Conclusion: A Few European databases meet minimal regulatory requirements and are readily available to be used in a regulatory context. Accessibility and validity information of the included information needs to be improved. This study confirmed the fragmentation, heterogeneity and lack of transparency existing in many European EHDs.

Keywords: benefit-risk evaluation; electronic healthcare databases; post-authorisation studies; real-world data; regulatory science.

Figure 1

Coding of the characteristics of electronic healthcare databases available in Europe for the benefit–risk evaluation of medicines. The coding system was binary: 0 if information was absent and 1 if it was present. The degree of completion for a specific variable was not recorded. An exception to the binary classification was done for the accessibility variable: 0, no access; 1, indirect access through database owner or third party; 2, direct access to specific data sources; 3, direct access to full data source.

Figure 2

Flow chart of database selection.

Figure 3

European data sources and duration of data collection. Box plots indicate the median (horizontal black line) data collection time by country while the margins of the box plot represent the IQR, the vertical lines indicate the minimum and maximum values. The number of databases per country are provided above the box plots.