Ecopharmacovigilance and pharmacovigilance: an analysis of environment-related reporting in VigiBase.

There is growing interest in the effects of pharmaceuticals in the environment. However, the focus when assessing the risk of pharmaceuticals in the environment is done in the pre-authorisation phase, and there is no standard approach to identify, report and collect suspected adverse events related to environmental exposure and impact. This study aims to describe the reporting of environment-related terms to VigiBase, the WHO global database of adverse event reports. A search was performed on VigiBase on all data up to July 1st, 2024, since the first report in 1967. The search was for reports with any medicine or vaccine in combination with a set of Preferred Terms identified as being environment-related by the authors. A descriptive analysis of reports with an environment-related Preferred Term was then performed. A total of 713 reports (from a total of 38,141,125) were identified with environment-related Preferred Terms, with a steady increase in reporting since the first report in 2001. Reports were received for a variety of medicinal groups and commonly alongside Preferred Terms potentially describing symptoms of those exposed. There was also a large percentage of reports from non-healthcare professionals. The number of environment-related reports in VigiBase is small but increasing. This overview highlights some important features of environment-related reports that require consideration in any future work. It would be beneficial to develop a framework to guide the reporting and analysis of environment-related adverse effects of medicines, although the eventual relationship to traditional pharmacovigilance is unclear.