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Background/Aim: Previous studies from other countries [1] as well as from Germany [2] have shown that the reporting of adverse drug reactions (ADRs) from consumers differed from that of physicians or health care professionals in general. However, findings from studies conducted in other countries may not be generalizable to Germany due to differences in prescribing practices, genetic backgrounds of the ADRs, awareness of spontaneous reporting systems, and reporting behaviours. Additionally, due to the substantial increase in the number of non-serious consumer reports in recent years following the implementation of the new pharmacovigilance legislation [3], the findings from earlier studies may no longer be applicable. Thus, the aim of our study was to characterize consumer reporting of ADRs. Therefore, consumer reports were compared to reports from physicians and pharmacists.

Methods: Spontaneous ADR reports received between 2018 and 2024 were extracted from the European ADR database, EudraVigilance. ADR reports explicitly submitted by consumers (n= 180,114), physicians (n= 112,927), or pharmacists (n= 60,120) were identified to ensure that reporting patterns were clearly attributed to the respective reporter types. Report characteristics such as the number of reports per year, patient demographics, and the most frequently reported drugs and ADRs were analysed descriptively. Subsequently, reporting odds ratios (RORs) and corresponding 95% confidence intervals (CIs) were calculated to identify the drug classes, and ADRs more frequently reported in consumer reports.

Results: Although the number of consumer reports declined between 2020 (n= 35,797) and 2024 (n= 19,373) following the initial increase observed between 2018 (n= 25,657) and 2020 n= 35,797), the number remained higher than the number of reports from physicians (2024: 13,379) or pharmacists (2024: 5,815). Patients aged 20-45 years were more frequently included in consumer reports than in reports from physicians and pharmacists. ROR analysis revealed that the drug classes "systemic hormonal preparations" (e.g., thyroid preparations) and "genito-urinary system and sex hormones" (e.g., estrogens and progestogens) not only accounted for a large proportion of consumer reports but were also more frequently reported by consumers compared to physicians and pharmacists. Within the drug class "genito-urinary system and sex hormones", sexual desire disorders along with several terms describing psychiatric disorders (e.g., anxiety symptoms, depression, and mood alterations) were more often observed in reports from consumers. In reports related to "systemic hormonal preparations", anxiety symptoms along with disturbances in initiating and maintaining sleep were more frequently reported by consumers.

Discussion/Conclusion: The findings from our study underscore that consumer reporting differs from physician and pharmacist reporting. Consumer reporting may provide complementary information for the detection of subjective neuropsychiatric ADRs. The increased reporting of depression and mood alterations associated with sex hormones supports current recommendations for increased vigilance of patients receiving sex hormones.

Literatur

[1] Inch J, Watson MC, Anakwe-Umeh S. Patient versus healthcare professional spontaneous adverse drug reaction reporting: a systematic review. Drug Saf. 2012;35(10):807-18.
[2] Dubrall D, Schmid M, Alešik E, Paeschke N, Stingl J, Sachs B. Frequent Adverse Drug Reactions, and Medication Groups under Suspicion. Dtsch Arztebl Int. 2018;115(23):393-400.
[3] Dubrall D, Domgörgen S, Christ P, Below M, Schmid M, Sachs B. Patterns of Spontaneous Adverse Drug Reaction Reporting in Germany From 2012 to 2021. Pharmacol Res Perspect. 2026;14(3):e70282.