Way of working
Lareb is responsible for the processing and analysis of spontaneous ADR-reports received from healthcare professionals, patients and the Market Authorization Holders. They can report suspicions of adverse drug reactions of medicines and vaccines on a paper form or via the reporting forms on our Dutch website (the reporting forms are written in Dutch only).
Healthcare professionals submitted the majority of the reports. In 2003, the Netherlands became one of the first countries in the world to allow patients to report ADRs. The number of reports submitted by patients has gradually been increasing in the last few years.
After a report is received, it will be assessed by a pharmacist or physician. Every person who submits a report receives personal feedback. In addition to the initial assessment, reports listed as serious (according to the CIOMS criteria) will be assessed by a staff member.
In a weekly signal detection meeting the reports are reviewed on a case-by-case basis. Potential signals undergo further analysis. Statistical techniques are used to support the signal detection process. On a quarterly basis, the signals are forwarded to the Dutch Medicines Evaluation Board where it is decided if further action is necessary.
The reports are subsequently filed into our database and an anonymous copy is sent on a weekly basis to the Eudravigilance database (EMA) and the WHO collaborating center for International Drug Monitoring in Uppsala (Sweden).
Healthcare professionals are informed by means of publications, presentations and an electronic newsletter. Approximately 30 articles are published annually in national and international journals.Lareb also informs the MEB of their findings in a Quarterly report. In this report, the most important observations from the past quarter are presented. This report also includes overviews of reported adverse drug reactions for new medicines, especially those products for which the Netherlands is the Reference Member State. If necessary this information will lead to active measures by the MEB, such as the amendment of the product information or the actual withdrawal of a product from the Dutch market.
The MEB has online access to the anonymous data. The Market Authorization Holders of the products involved will receive a copy of the reports on their products within 15 days of receipt by Lareb. On request, an overview of non serious reports can also be provided.