Nutrivigilance: Reporting Adverse Events of Non-registered Products in the Netherlands

Abstract

ObjectivesThe number of reports on products that fall within the grey area of non-registered health-enhancing products, including supplements and herbal extracts, received by the Dutch pharmacovigilance centre Lareb is increasingly yearly. Currently, such spontaneous reports of suspected adverse events are dealt with on a case-by-case basis in various institutions, but there is no structural vigilance approach to handling reports. We have therefore studied whether and how a vigilance framework in the Netherlands can contribute to protecting consumers from adverse reactions to health-enhancing food products. MethodsFor this exploratory study, we have conducted 14 semi-structured interviews were conducted with direct, indirect or external stakeholders to the Dutch vigilance process for non-registered products. This method allowed for a deep understanding of the current process and its difficulties, as well as exploring how a vigilance framework could be organised. ResultsThe results from this study highlight that the organisations currently involved with suspected adverse events of nutritional products form a complex web, in which there is no clear distribution of roles and responsibilities. Organisations lack a legal basis to handling reports, whilst the representatives do feel the need to take reports and signals seriously. At the same time, this study identified various opportunities to improve vigilance, i.a. increasing consumer awareness and improving the reporting system. ConclusionsFollowing conducting this study, first steps towards improving safety of non-registered products were already taken, by officially designating Lareb to submit and study adverse events, and further improvements to the approach of food supplement safety were announced by the Dutch Ministry of Health and Welfare. This study however shows that improved transparency and adequate mutual communication about signals, together with a clearer distribution of tasks and priority setting by involved organisations, both in the Netherlands and in collaboration with other EU Member States and agencies, are essential steps in further increasing consumer protection from unsafe products. Funding SourcesN/A.