Frequently asked questions
Below are the frequently asked questions. By clicking on the desired question the answer appears automatically. Is your question not listed? Please contact us via the contact form.
Do I have to report every adverse drug reaction?
No, only if you want to. Lareb is most interested in new and unexpected adverse drug reactions, adverse drug reactions of new drugs or vaccines, adverse drug reactions in children, serious adverse drug reactions (also if they are already well-known) and drug interactions.
Does the relationship between the reaction and the drug or vaccine have to be proven?
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 or vaccine. The report will then be removed from our database.
What will happen with a report?
The data from your report are automatically entered into our database. The physicians and pharmacists at Lareb will assess each individual report to see if there is a causal relationship between the suspected drug or vaccine 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, who will decide if further action is needed.
Will the report automatically be sent to the Market Authorisation Holder?
This will be done only if it is a serious message, in an anonymous manner. If there are serious messages first reported by the Market Authorisation Holder, they are passed by them to Lareb
When is a report considered to be serious?
Adverse drug reactions that lead to (prolongation of) hospitalization, congenital anomalies, life threatening situations, disability or death are considered to be serious.
Are the Netherlands the only country that have a pharmacovigilance centre?
No, pharmacovigilance centers exist in several collaborating countries. The database from the Uppsala Monitoring Centre of the World Health Organization contains reports from over 100 countries. The Eudravigilance database collects reports from all European countries. The reports from the Lareb database are automatically sent to these databases.
Why is there a separate report form for patients and healthcare professionals?
A certain amount of medical and/ or pharmaceutical knowledge is expected. The type of questions are the same, so Lareb always receives the same kind of information. However, the difference lies in the terminology and additional medical information of the questions.
How long does it take before Lareb react?
We strive to give a reaction within 21 days. Serious reports are processed within 15 days.
Are personal data (like identity) from reports given to other authorities?
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.
Is Lareb a governmental organisation?
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 will inform the MEB about new signals so further action can be taken.