Notification of adverse reactions
Notification of adverse effects
The Belgian Centre for Pharmacovigilance for medicines for Human use (BCPH), that is part of the Federal Agency for Medicines and Health Products (FAMHP), is the central collection point for all adverse effects of medicines in Belgium. In this way, the FAMHP has the possibility to monitor the safety of the medicines available in Belgium.
The BCPH receives both individual reports and compilations of data concerning the adverse effects of medicines. This requires the collaboration of healthcare professionals, marketing authorization holders and research centers conducting clinical studies with medicines.
- The healthcare professionals (doctors, pharmacists and dentists) can report adverse effects of medicines to the BCPH by using the « yellow card ».
Since December 2010 the yellow card is available in an electronic version for the online reporting via www.fichejaune.be
(in French). Click here (PDF, 607.64 Kb)for more information (in French).
The yellow card also remains available in a paper version (PDF, 57.31 Kb). This can be printed and sent by post to the address mentioned to the BCPH. The “paper yellow card” is also available in the “Répertoire Commenté des Médicaments” and three times a year via the Folia Pharmacotherapeutica. In case you wish to receive a paper reporting form, you can request this at any time via the email address: adversedrugreactions@fagg-afmps.be
The paper version can be sent by post to the address mentioned at the back of the yellow card (postage paid by the recipient):
Federal Agency for Medicines and Health Products (FAMHP)
Belgian Centre for Pharmacovigilance for medicines for Human use (BCPH)
Eurostation II
Place Victor Horta 40/40
B-1060 Brussels
- Healthcare professionals (doctors, pharmacists, dentists) can inform the BCPH via the “yellow card” about any suspicion they have concerning adverse effects of medicines they come across in daily practice.
It is nevertheless particularly important to report in the following situations:
- Serious adverse effects: adverse effects that have led to hospitalization or prolongation of the hospitalization, that have been life-threatening, or that have caused death, permanent or significant disability or inability to work, or congenital disorder or malformation.
- Unexpected adverse effects: adverse effects of which the nature, the seriousness and/or the evolution do not correspond with what is mentioned in the Summary of Product Characteristics (SPC).
- Suspected adverse effects: adverse effects that are known but of which the frequency, the seriousness or the result is abnormal.
- Adverse effects occurring in the following particular situations:
o Vulnerable populations (e.g. children, pregnant or breastfeeding women, elderly, patients with hepatic of renal failure).
o Administration of vaccines.
o Switch from one specialty to another during treatment, regardless if it concerns the switch between “original” medicines, from a “generic” to an “original” medicine, from an “original” to a “generic” medicine or between “generic” medicines.
o “Inappropriate” or “off-label” use of a medicine.
It is also important to report adverse effects with the so-called “Black triangle drugs”. These include the medicines that contain a new active substance and the new biological medicines. They are indicated by the symbol ▼ in the “Répertoire Commenté des Medicaments”. The ▼ symbol appears for the first 3 years after the marketing of the medicine.
The BCPH requests the healthcare professionals to report any suspicions they may have of adverse effects – serious and non serious – with these ▼ medicines, even when there is some doubt about the causality.
The list of these ▼ medicines (PDF, 118.13 Kb) (in French) is updated monthly.
Healthcare professionals are encouraged to report all adverse effects they consider as being medically significant, even if they do not meet the above mentioned criteria.
The causality between the suspected medicine and the adverse effect should not necessarily be established to report.
- Patients experiencing an adverse effect after taking a medicine are recommended to contact their doctor, pharmacist or dentist who will fill in the reporting form.