FAQ Frequently Asked Questions
Q. Do I have to report every Adverse Drug Reaction (ADR)?
A. No, only if you want to. Lareb is most interested in new and unexpected adverse drug reactions, ADRs of new drugs, ADRs in children, serious ADRs (also if they are already well-known) and drug-drug interactions.
Q. Does the relationship between the reaction and the drug have to be proven?
A. No, a suspicion is enough for a report. If you have another explanation why the reaction could have taken place, please put this in your report. Please notify us if it the reaction turns out not to be caused by the drug. The report will then be removed from our database.
Q. What will happen with my report?
A. The data from your report are automatically put into our database. The medical doctors and pharmacists who work at Lareb will assess each individual report to see if there is a causal relationship between the suspected drug and the reported reaction. With these reports we try to find new signals, i.e new adverse drug reactions. When a signal is detected we inform the Dutch Medicines Evaluation Board (MEB), who will decide if further action is needed.
Q. When is a report considered serious?
A. Adverse drug reactions that lead to (prolongation of) hospitalization, congenital anomalies, life threatening situations, disability or death are considered to be serious.
Q. Is the Netherlands the only country that have a pharmacovigilance centre?
A. No, pharmacovigilance centers exist in several collaborating countries. The database from the Uppsala Monitoring Centre of the World Health Organization contains reports from over 70 countries. The Eudrovigilance database collects reports from all European countries. The reports from the Lareb database are automatically sent to these databases.
Q. Are personal data (like identity) from reports given to other authorities?
A. No, all personal data that can be used to identify a patient are removed from a report. Guarding the privacy both of the reporter and patient is one of our top-priorities.
Q. On the website a lot of information can be found about drugs, for whom is this information meant?
A. The information on our website is primarily written for medical doctors and pharmacists because there are other website for patients and consumers that give proper information. Of course patients can use the information on our website, but we advice them to discuss health issues with there own general practitioner or pharmacist.
Q. Is Lareb a governmental organization?
A. No, Lareb is an independent foundation that is assigned by the Medicines Evaluation Board (MEB) to collect and assess reports of adverse drug reactions. If necessary Lareb informs the MEB about new signals so further action can be taken.
