Presentation (CTI)

OBJECTIVES: Healthcare administrative claims data provide new opportunities to assess the benefit-risk profile of products and are increasingly used to generate safety signals and evidence. Examining pharmacovigilance studies utilizing the representative sample of the French national health insurance database (EGB, replaced by ESND in October 2022) can inform on the current use of real-world data sources for post-authorization surveillance. This study aims provide a description of characteristics of pharmacovigilance studies performed using the EGB/ESND database.
METHODS: A targeted search on ScienceDirect and PubMed was conducted in August 2024 to identify published pharmacovigilance studies using the EGB/ESND database from January 2011 to July 2024. Selected studies were screened by two reviewers, and study design, type of exposure, associated risks and outcomes, population type, and publication year were extracted and summarized descriptively.
RESULTS: After screening, 20 unique pharmacovigilance studies were included. Of these, 18 (90%) evaluated product safety, and 2 (10%) focused on signal detection. Fifteen (75%) were retrospective cohorts, 4 (20%) were case-controls, and 1 (5%) was a cross-sectional study. Most studies targeted adults 12 (60%), followed by general 5 (25%), elderly 2 (10%), and adolescent/adult populations 1 (5%). Among safety studies, the most frequently evaluated treatment exposures were analgesics 3 (17%), anti-inflammatories and antirheumatics 3 (17%), and lipid-modifying agents 2 (11%). The most frequently investigated risks and outcomes included circulatory system diseases 3 (17%), death 2 (11%), diseases of the skin and subcutaneous tissue 2 (11%), endocrine and metabolic diseases 2 (11%), and certain infectious and parasitic diseases 2 (11%). The number of publications peaked between 2018 and 2021, with 65% of articles published during this period.
CONCLUSIONS: With over 1.3 million individuals included and a fast-track data access procedure, the ESND proves to be a valuable resource for pharmacovigilance assessments and shows significant potential for conducting robust safety research studies.