The National Pharmacovigilance System (NPS) was created in Portugal in 1992 to monitor adverse drug reactions. Over time, it decentralized into four regional centers to be closer to health professionals and universities. The NPS collects, processes, and evaluates spontaneous reports of adverse drug reactions to monitor drug safety. It has adapted to EU pharmacovigilance requirements and is a mature system that aims to reduce drug risks. Recent EU legislation from 2010 gave consumers the ability to directly report adverse reactions and increased transparency, public involvement, and efficiency in pharmacovigilance.

1. Ibrahim Mahamoud
Alomari
AAPS-Toronto
Sept. 2014

2. NPS National Pharmacovigilance System
In Portugal, the National Pharmacovigilance System
(NPS) was created in 1992, completing during this year
22 years of existence

3. 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.

4. The NPS currently has four regional
pharmacovigilance centres , which cover the entire
Portugal, which became centers of scientific vocation,
carrying out pharmacoepidemiological studies in
the area of drug safety.
To insure proper collection, processing and evaluation
of spontaneous reports of adverse drug reactions
(ADRs)

5. 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.

6. From the second half of 2012, implementation of recent
European legislation on Pharmacovigilance, published in
December 2010.
http://www.pharmacovigilance2012.nl/about/
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.

7. European legislation on Pharmacovigilance,
published in December 2010.
It aims to better protect and promote public health by:
I. Increasing public involvement in pharmacovigilance.
II. Increasing transparency.
III. Improving communication of decisions and reasons of
decisions.
IV. Providing a legal basis for more proactive
pharmacovigilance.
V. Simplifying reporting rules for e.g. spontaneous adverse
drug reactions.
VI. Improving pharmacovigilance efficiency.

8. Reference
ActaMed Port. 2012 Jul-Aug;25(4):241-9. Epub 2012
Aug 31.
[The Portuguese Pharmacovigilance System].
[Article in Portuguese]
Herdeiro MT1, Ferreira M, Ribeiro-Vaz I, Junqueira
Polónia J, Costa-Pereira A.

9. Thank you