The Portuguese Pharmacovigilance System

Maria Teresa Herdeiro, Mónica Ferreira, Inês Ribeiro-Vaz, Jorge Junqueira Polónia, Altamiro Costa-Pereira

Abstract


In Portugal, the National Pharmacovigilance System (NPS) was created in 1992, completing during this year 20 years of existence. Having been established in a centralized manner, it soon became aware that its geographic decentralization would bring advantages in terms of proximity of the System to health professionals as well as the involvement of the universities. The NPS currently has four regional pharmacovigilance centres, which cover the entire mainland, which became centers of scientific vocation, carrying out pharmacoepidemiological studies in the area of drug safety. Also, they are the guarantee of proper collection, processing and evaluation of spontaneous reports of adverse drug reactions (ADRs), as well as the continuing disclosure of the System among health professionals and promotion of spontaneous reporting. Over these 20 years, the NPS has been adapting to the EU requirements in the area of pharmacovigilance, and is currently a mature and well implemented system, with the objectives of the evaluation of the safety profile of marketed drugs and triggering of actions to reduce the risk of these drugs. From the second half of 2012, new adaptation will be run with the implementation of recent European legislation on Pharmacovigilance, published in December 2010. Among other changes, there is the possibility for consumers to report their suspicious of ADR directly to the NPS (exclusive, so far, to health professionals). This work aims to be a reflection about the evolution of the National Pharmacovigilance System and its growing importance in the protection of public health.


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