Data collection, evaluation and measures

Pharmacovigilance data collection

The BCPH (Belgian Centre for Pharmacovigilance) receives both individual reports and a compilation of data concerning the adverse effects of medicines, herbal medicinal products included. This requires collaboration between healthcare professionals, authorisation holders and research centres conducting clinical studies.

-         The “yellow" form (in French) or the electronic version (in French) enables healthcare professionals (doctors, pharmacists, dentists) to advise BCPH about any suspicion they have about adverse effects in medicines they come across during their work, particularly for adverse effects for which no information has been found, if it is a serious adverse effect, even if the effect is well known, and if it is an adverse effect concerning children.

Patients showing adverse effects of a medicine are requested to contact their doctor, dentist or pharmacist, who will fill in this form.

The yellow form can also be found in the “Répertoire Commenté des Médicaments” (formulary listing all the medicines for human use available in Belgium) and three times a year in Folia Pharmacotherapeutica.

A hard copy of the form can be sent by post to the address shown on the back of the yellow form (postage paid by the recipient):

Federal Agency for medicines and health Products (FAMHP)
Belgian Centre for Pharmacovigilance (medicines for human use)
Eurostation II
Place Victor Horta 40, box 40
B-1060 Brussels.

The electronic version can be sent to the following e-mail address:

adversedrugreactions@afmps.be   

All medicines are covered but certain medicines receive special attention. That is so for medicines that contain a new active substance. They are shown by the following symbol : ▼ which is shown next to the medicine’s name in the ”Répertoire Commenté des Medicaments”. The ▼ symbol appears for the first 3 years after authorisation. The list (in French) of medicines with the ▼ symbol is updated monthly.

It is important for these medicines to be followed closely as soon as they are marketed. Indeed, at the time a medicine is authorised the knowledge about its adverse effects is still limited. The clinical studies conducted for marketing authorisation are mainly conducted to show the efficacy of the medicine and are limited in detecting adverse effects:

-         the number of patients included in the studies is usually too low to detect rare adverse effects ;

-         the studies do not last long enough to detect adverse effects that appear later on ;

-         the studies usually do not include patients that present a high risk of adverse effects (e.g. elderly people, patients with various medicines, patients with kidney and liver complaints).

The Belgian Centre for Pharmacovigilance requests people to notify any suspicions they may have of adverse effects, even when there is some doubt as to the cause. 

- Authorisation holders who are advised about a serious adverse effect, either by healthcare professionals, or by investigators for clinical trials, or by scientific publications, must advise BCPH within 15 days of receipt of such information. In this context a serious adverse effect is defined as follows:             

-        leads to death,

-        puts a patient’s life in danger

-        requires a patient being hospitalised or hospitalised for a longer period

-        provokes a handicap or a serious or long-lasting disability

-        results in a congenital abnormality or deformation.

Authorisation holders must also regularly write and communicate to BCPH  periodic updated reports about safety (= periodic pharmacovigilance reports)  or "PSUR's (Periodic safety update reports)" -see circular 476 (in French) + Guidelines + Template for the e-submission of PSURs/ARSs  + e-submission guidelines and circular 530 . For the first years after marketing authorisation or registration they are required to communicate at regular intervals an overview and an evaluation of all reactions, whether serious or not, that occur, both inside and outside the European Union. After a longer period they must provide a global overview within the framework of a marketing authorisation or registration renewal file.       

-Since 2004 promoters of clinical trials are also required to submit all SUSARs (Suspected Unexpected Serious Adverse Reactions) that occurred during the clinical trials, whether that be for medicines with marketing authorisation / registration  or not.  The former are the responsibility of BCPH. In order to evaluate how safe medicines used in clinical trials are, the promoter must each year write a safety report about the serious adverse reactions that happened during a clinical trial and submit it to BCPH = ASR's (Annual safety reports) - see circular 476 (in French) + Guidelines + Template for the e-submission of PSURs/ARSs  + e-submission guidelines .

BCPH can, if it considers it necessary, ask for a particular safety report in which the authorisation holder has to answer a specific problem concerning a medicine or a particular reaction.    

Evaluation of the data

The evaluation of the available pharmacovigilance data comes in two parts.

BCPH evaluates the individual reports about adverse effects (spontaneous reports and SUSARs) but also evaluates the summary reports:

- periodic pharmacovigilance reports concerning a medicine

- annual safety reports concerning a clinical trial  

- specific safety reports.

BCPH is helped in these tasks by a team of internal and external experts.

The individual reports are evaluated at regular intervals by a specific working group. The evaluation reports about periodic pharmacovigilance reports and the marketing authorisation renewal files are submitted to a second specific working group.  It is the Commission for Medicines for Human Use that gives the final opinion whether or not the measures suggested by the two working groups can be implemented.

BCPH takes any necessary action based on the conclusions of these evaluations.

Taking action

After evaluating a file BCPH can take necessary action, in particular :

- asking authorisation holders 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 registration of a medicine following the decision of the Ministry of Public Health

- in urgent cases informing healthcare professionals about a   pharmacovigilance problem by means of a press release or circular.

The authorisation holder can be requested to send a Dear Doctor letter to relevant healthcare professionals to inform them about the pharmacovigilance problem.

Furthermore BCPH works closely with  the Belgian Centre for Pharmacotherapeutic information  which publishes each month a communiqué from the Pharmacovigilance Centre for healthcare professionals. This publishes all the updated news that has been sent to BCPH or new data from specialist publications.

Last updated on 23/06/2009