Patterns of Spontaneous Adverse Drug Reaction Reporting in Germany From 2012 to 2021

The absolute number of spontaneous adverse drug reaction (ADR) reports increased in the past in several national and international ADR databases. However, in most studies drug exposure was not considered. Our study aimed to evaluate the number of ADR reports from Germany in relation to the number of patients with outpatient drug prescriptions stratified by sex, age groups, seriousness, and reporter types (physician versus consumer). Therefore, 407 882 spontaneous ADR reports from Germany, after exclusion of ADR reports related to vaccines, intentional misuses and accidental exposure, submitted between 01.01.2012 and 31.12.2021 were analyzed. The annual numbers of patients with at least one outpatient drug prescription were provided by the Central Research Institute for Ambulatory Health Care in Germany. Reporting rates per year were calculated by dividing the annual number of spontaneous ADR reports by the annual number of patients with at least one outpatient drug prescription. Between 2012 and 2021 (2.4-fold), and strikingly between 2017 and 2018 (2.2-fold), the annual reporting rate increased. This increase appears to be primarily driven by non-serious ADR reports submitted by consumers (32.5-fold increase), whereas reporting rates for serious ADRs and for reports submitted by physicians remained stable. Furthermore, the rise of non-serious ADR reports from consumers was particularly apparent for females aged 12-17 and 18-64 years. Overall, the observed increase of non-serious ADR reports is most likely related to changes in reporting obligations for pharmaceutical companies. Our study suggests that females might report ADRs more frequently.