Belgian community pharmacists' pharmacovigilance perspective and practice

Pharmacovigilance legislation was introduced back in 2012 with new concepts such as the inverted black triangles and risk minimisation activities. Healthcare professionals need to familiarize themselves with these new notions in order to comply with their obligations such as risk mitigation and reporting of adverse drug reactions.

To measure the magnitude and relevance of these new concepts and the impact on everyday dispensing in Belgian community pharmacies.

An inventory database was constructed containing all relevant pharmacovigilance information at product level, and this data was made available within the pharmacy dispensing software. Furthermore, for a typical community pharmacy, the number of concerned products and the number of dispensed products with supplementary pharmacovigilance responsibilities was determined.

The number of available and dispensed medicines with black triangle or additional risk minimisation activities has increased significantly since July 2014. During July 2017, each pharmacy dispensed around 120 packs with risk minimisation obligations and around 70 with a black triangle, clearly illustrating the relevance of having all information at hand.

With relevant safety information available at the point of dispensing, pharmacists can now focus on complying with their pharmacovigilance responsibilities.