"Active pharmacovigilance" project - December 2010
At the beginning of 2008 the Belgian Centre for Pharmacovigilance for medicines for Human use (BCPH) of the Federal Agency for Medicines and Health Products (FAMHP) launched the “Active Pharmacovigilance” project. This project is at present one of the four centres of excellence identified by FAMHP: the centre of excellence "Proactive Vigilance".
The goal of the project
The goal of the “Active Pharmacovigilance” project is to improve the knowledge of the safety profile of medicines thanks to:
- An increase in the number of reports of adverse effects of medicines, directly transmitted to the BCPH by the healthcare professionals.
- An improvement of the quality of these reports.
The first stage of the project was to obtain the collaboration of a group of about 200 healthcare professionals (general practicioners, specialists, pharmacists and hospital pharmacists - including clinical pharmacists).
At the end of April 2008 the number of participants in the project had already largely exceeded the target. At present, 335 healthcare professionals are involved in the project.
Repartition by category of healthcare professionals and linguistic role:
|Number of participants||DU||FR||Total|
|Percentage of participants||DU||FR||Total|
As the ultimate goal is to expand the project to all healthcare professionals after the pilot phase, the BCPH decided not to limit inscriptions. The address firstname.lastname@example.org therefore remains available for all new inscriptions of interested doctors and pharmacists.
Reporting in the context of the project
The project participants are invited to report systematically to the BCPH:
- Serious adverse effects: adverse effects that have lead to hospitalisation or prolongation of the hospitalisation, 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:
-Vulnerable populations (e.g. children, pregnant or breastfeeding women, elderly, patients with hepatic of renal failure).
-Administration of vaccines.
-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.
-“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.
To announce the project, increase the number and improve the quality of reports, several actions were undertaken and are still planned:
- A communication announcing the project was published in the Folia Pharmacotherapeutica of January 2008.
- A leaflet (French version) about the project was distributed with the Folia Pharmacotherapeutica of April 2008.
- A call for participation was published on the website of the FAMHP, CBIP, several professional associations and the Medical Pharmaceutical committees.
- A letter was sent at the end of February 2008 to doctors and pharmacists who had reported one or more adverse effects in the past years.
- A more detailed and individualized feedback is sent to the reporter in response to each report (it includes a summary of the evaluation by the BCPH working group and the used documentation).
- An electronic newsletter "VIG-NEWS" is sent to the project participants and is, since May 2010, available on the FAMHP’s website. The VIG-NEWS includes recent pharmacovigilance news from different sources (ao FAMHP, BCPH, FDA, EMA, literature);
- Articles about pharmacovigilance are regularly published in specialized journals.
- Awareness sessions for pharmacovigilance have been and will continue to be organized for universities, hospitals and various medical and pharmaceutical associations.
- A new, more user-friendly "paper yellow card", has been distributed via the Folia Pharmacotherapeutica since March 2009 and via the “Répertoire Commenté des Médicaments” of the Belgian Centre for Pharmacotherapeutic Information.
- The online reporting tool has been made available for the project participants in September 2010 in the context of a testing phase. Since December 2010 the "online" reporting tool is available to all healthcare professionals in Belgium.
- French training sessions concerning active pharmacovigilance are being organized on Thursday 28/04, 09/06 and 16/06/2011.
Results: yellow cards received by the BCPH
Number of reports
The number of reports received by the BCPH through the "yellow cards" has almost doubled since the start of the project in 2008. This positive evolution continued in 2009:
- In 2006: 360 yellow cards
- In 2007: 320 yellow cards
- In 2008: 616 yellow cards
- In 2009: 716 yellow cards
Quality of the reports
The actions in the context of the "Active Pharmacovigilance" project seem to have a positive effect on the quality of the reports.
Overall, the reports are more complete than in the past and thanks to the new paper yellow card some important elements (such as dechallenge-rechallenge, the description of the adverse effect, the comorbidity and the comedication) are better documented.
Greater involvement of the part of hospitals has also been observed.
The reports are better documented and allow a more qualitative evaluation.
The "Active Pharmacovigilance" project has been succesful amongst the healthcare professionals: 335 doctors and pharmacists are involved, the number of reports of adverse effects received by the BCPH has increased and the quality of the reports has improved. The project seems to meet a real need.
The BCPH hopes that thanks to this project, pharmacovigilance will be better integrated into day-to-day clinical practice.
The healthcare professionals alert to the occurrence of adverse effects in his patients will allow, by early recognition of a drug etiology, to limit the adverse effects of medicines.
If the healthcare professionals have the reflex to report adverse effects to the BCPH, they contribute to public health through their contribution to:
- More complete pharmacovigilance databases;
- Faster signal detection;
- A better evaluation of the benefit-risk balance;
- Improved knowledge of the safety profile of medicines.
For this reason, the FAMHP encourages healthcare professionals to participate in its "Active Pharmacovigilance" project.
For questions about the "Active Pharmacovigilance” project, please contact the project team via email@example.com.