Further Initiatives in Pharmacovigilance 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.

MARKETING AUTHORIZATION HOLDERS

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.

UNIVERSITIES

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.