Besides the spontaneous reporting system and the activities undertaken by, or under the auspices of, the government, there are various other pharmacovigilance initiatives in the Netherlands.
FURTHER INITIATIVES IN
PHARMACOVIGILANCE IN THE NETHERLANDS
Besides
the spontaneous reporting system and the activities undertaken by, or under the
auspices of, the government, there are various other pharmacovigilance
initiatives in the Netherlands. Of these, the most notable are those undertaken
by the marketing autho-rization holders and universities.
Needless
to say, pharmaceutical companies in the Netherlands must comply with
international legisla-tion relating to pharmacovigilance. Reports that meet the
criteria of the Council for International Orga-nizations of Medical Sciences
(CIOMS) must be send to the Medicines Evaluation Board within 15 days. Those
reports will also be included in Lareb’s database. In addition, Marketing
Authorization Hold-ers are required to submit periodic safety update reports,
including all information known to them concerning the safety of the
preparations for which they hold marketing authorization. The Netherlands does
not have a tradition of reports being made directly to the pharmaceutical
industry by doctors or pharmacists; the vast majority of reports concern-ing
suspected adverse drug reactions pass through Lareb.
Three
Dutch universities have departments of phar-macoepidemiology. The Department of
Pharmacoepi-demiology of the University of Utrecht developed the PHARMO system,
which is operated independently. It is a record-linkage system that uses
information provided by a number of pharmacists in combina-tion with hospital
clinical records. The department of Epidemiology and Biostatistics of
Rotterdam’s Erasmus University is responsible for the Integrated Primary Care
Information (IPCI) system. It relies on digital information recorded by general
practitioners. In cooperation with the Department of Social Phar-macy and
Pharmacoepidemiology of the University of Groningen, Lareb has done a pilot in
order to inves-tigate the viability of an intensive monitoring system which
uses the initial signals notified by pharmacists as well as responses to
surveys conducted among general practitioners (van Puijenbroek, Diemont and van
Grootheest, 2003). It is believed that in the future such a system can result
in a first impres-sion of possible adverse reactions of newly authorized
preparations.
Related Topics
TH 2019 - 2024 pharmacy180.com; Developed by Therithal info.