Collecting, evaluation and taking measures on pharmacovigilance data relating to medicinal products for human use
The FAMHP receives both individual reports and compilations of data concerning the adverse effects of medicines. This requires the collaboration of healthcare professionals and patients, marketing authorisation holders and research centres conducting clinical trials with medicines.
Healthcare professionals (doctors, pharmacists, dentists, nurses and midwives) can inform the FAMHP via the website about any suspicion they have concerning adverse effects of medicinal products for human use they come across in daily practice. Further information on reporting adverse effects by healthcare professionals is available on the website.
Patients experiencing an adverse effect after taking a medicine are recommended to contact their doctor or pharmacist. In some cases, it may be necessary to consider adjusting the treatment. Patients can report suspected adverse effects of medicines directly to the FAMHP via the website. Further information on reporting adverse effects by patients is available on the website.
The marketing authorisation holders (MAH) who are informed about a serious adverse effect must record this in the pharmacovigilance databases of the European Medicines Agency (EudraVigilance of the European Medicines Agency, EMA). Adverse effects may be reported by healthcare professionals, patients, clinical trial investigators or through scientific publications. Marketing authorisation holders must also draw up Periodic Safety Update Reports (PSURs) on a regular basis and submit them to the FAMHP.
Since 2004, promoters of clinical trials are also required to submit all Suspected Unexpected Serious Adverse Reactions (SUSARs) that occurred during a clinical trial, both for medicines with and without marketing authorisation. The former are the responsibility of the FAMHP’s Vigilance Division. In order to evaluate the safety of the medicines used in clinical trials, the promoter must each year write a safety report (Development Safety Update Report, DSUR) about the serious adverse events that happened during a clinical trial, and submit it to the FAMHP.
Furthermore, the FAMHP can, if it considers this necessary, ask for a specific safety report in which the marketing authorisation holder is obliged to evaluate a specific safety problem concerning a medicine.
Evaluation of the data
The evaluation of the available pharmacovigilance data consists of two parts.
The Vigilance Division evaluates the individual reports of adverse effects (spontaneous reports and SUSARs) but also evaluates the summary reports submitted by marketing authorisation holders (PSURs). For these tasks, it is assisted by a team of internal and external experts.
The individual reports are evaluated at regular intervals by a first specific working group. The evaluation reports about periodic safety reports (PSURs) and the marketing authorisation renewal dossiers are submitted to a second specific working group.
In case of medicines for which the responsibility for the evaluation is at national level, it is the Commission for Medicinal Products for Human Use that gives the final advice about whether or not the measures suggested by the two working groups can be implemented. In other cases, the evaluation is carried out at European level by the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA.
On the basis of the conclusions drawn from these evaluations at national and European level, the FAMHP takes the necessary measures.
Taking measures
If required, after the evaluation of a dossier, the FAMHP can take the necessary measures, by:
- asking the marketing authorisation holder to modify the information in the 'undesirable effects', 'special warnings and precautions for use', 'contraindications' sections of the SPC (Summary of Product Characteristics) and the leaflet for the patient;
- limiting the indications of a medicine and, in some rare cases, suspending or withdrawing the marketing authorisation of a medicine following the decision of the Ministry of Public Health;
- in urgent cases, informing healthcare professionals about a specific pharmacovigilance problem by means of a press release and/or a circular.
The authorisation holder can also be requested to send a Direct Healthcare Professionals Communication (DHPC) to the concerned healthcare professionals to inform them about the pharmacovigilance problem.
The FAMHP has also launched a web portal PharmaInfo, which is specifically designed for members of the public and patients to provide reliable, understandable and up-to-date information on medicines and health products available on the Belgian market.
In addition, the FAMHP actively collaborates with the Belgian Centre for Pharmacotherapeutic Information which issues a monthly publication entitled ‘Communication from the Pharmacovigilance Centre' for healthcare professionals. It describes discussions about adverse effects reported to the FAMHP or new data from the specialist literature.