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Chapter: Pharmacovigilance: Pharmacovigilance in the Netherlands

In the Netherlands, consideration regarding the surveillance of adverse drug reactions developed at a relatively early stage.


Pharmacovigilance in the Netherlands

HISTORY AND ORGANIZATION

HISTORY

In the Netherlands, consideration regarding the surveillance of adverse drug reactions developed at a relatively early stage. In the early 1950s, at a time when international literature had included only inci-dental reports of ‘side effects’, Leo Meyler laid the basis for paying more systematic attention to adverse drug reactions. In 1951, he published his book in Dutch: Schadelijke nevenwerkingen van geneesmidde-len (literally: Harmful Effects of Prescription Drugs). The second edition, fully revised with a number of supplements, appeared in 1954.

In his preface to the first edition, Meyler wrote the following (here in translation):

The prescribing of drugs will always entail a greater or lesser degree of risk, and in each case the physician must ask himself whether the nature of the condition about which he is being consulted justifies taking such a risk.

Meyler’s work was prompted by his own experiences with tuberculostatic preparations. He also warned against the inappropriate use of drugs.

Meyler based much of his work on reports in various medical journals, at a time when the Internet or other conveniences of modern times were non-existent. The first English edition of Meyler’s seminal work was published in 1952 as The Side Effects of Drugs: An Encyclopaedia of Reactions and Interactions. Its fourteenth edition, edited by Graham Dukes, appeared in 2000. Dukes has been the editor since the eighth edition, published in 1978, of what now has become the standard reference work in its field. Dukes’ own scientific background was largely gained in the Netherlands.

ORGANIZATION OF PHARMACOVIGILANCE IN THE NETHERLANDS

Following the thalidomide affair of the late 1950s and early 1960s, the Netherlands decided to adopt a more systematic approach to the safety of prescription medicines. The Dutch Medicines Evaluation Board was founded in 1963. Based on the American model of the Food and Drug Administration, this board would assess new pharmaceutical preparations for both effectiveness and safety prior to marketing autho-rization. Also in 1963, the Royal Dutch Medical Association (KNMG) joined the government in setting up a reporting system for adverse drug reactions. In 1965, the task of processing reports was taken over by the National Drug Monitoring Centre, which was part of the Public Health Supervisory Service and came to acquire an extremely good reputation (Meyboom, 1996). With a relatively small staff, Lareb produced a significant number of publications calling attention to the potential adverse effects of prescription drugs (de Koning, 1994). Each year, the National Drug Monitor-ing Centre received approximately 1000 reports from interested doctors.

In 1986, a number of pharmacists called for greater attention to be devoted to the potential adverse effects of prescription medicines. These pharmacists were convinced that greater awareness of the possibility of adverse effects would improve the quality of phar-macotherapy as a whole. Their initiative led to the creation of the Netherlands Pharmacovigilance Centre Lareb in 1991. A new aspect was that pharmacists too felt their responsibility in the identification of adverse effects and would consider it their task to call attention to such effects (van Grootheest et al., 2002, 2003b).

In 1995, European legislation having been made more stringent, the Dutch government decided to restructure the system of pharmacovigilance in the Netherlands. Lareb was designated the national centre for all reports of suspected adverse drug reactions concerning registered drugs. Currently, the Health Inspectorate is responsible for monitoring the quality of pharmacovigilance.

The Medicines Evaluation Board plays a central coordinating role. It receives reports from Lareb, as well as those made directly by the pharmaceu-tical industry, and it advises the Medicines Evalua-tion Board. The Medicines Evaluation Board makes the final decision regarding marketing authoriza-tion for the Netherlands. Where deemed necessary it is empowered to require amendments to a drug’s ‘Summary of Product Characteristics’ and in serious cases may revoke a drug’s marketing authorization altogether. The Medicines Evaluation Board includes a pharmacovigilance department primarily concerned with adverse drug reactions and with maintaining international contacts in this field. Many decisions are taken at European level by the European Medicines Agency (EMEA).

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