Methodology for International Drug Monitoring

Because of increasing evidence that the adverse effects of therapeutic drugs often present serious hazards to patients and that available knowledge and experience in this field were not considered to be sufficiently well developed to provide adequate protection against such situations in the future, WHO has been requested to undertake a feasibility study in the field of international co-operation in drug monitoring.

The present paper includes (1) the exploratory activities which preceded and led to the implementation of the WHO Pilot Research Project for International Drug Monitoring, (2) the basic concept and description of methodological research and development undertaken during the pilot phase.

Aufgrund sich häufender Beweise dafür, daß die schädlichen Wirkungen von Arzneimitteln häufig ernsthafte Gefahren für den Patienten darstellen und daß Wissen und Erfahrung auf diesem Gebiet nicht als ausreichend entwickelt anzusehen sind, um in Zukunft einen angemessenen Schutz gegen derartige Situationen zu gewahrleisten, ist die WHO aufgefordert worden, eine Möglichkeitsstudie auf dem Gebiet der internationalen Zusammenarbeit bei der Arzneimitteluberwachung durchzuführen. Die vorliegende Arbeit beinhaltet 1.) die Sondierungstatigkeit, die voranging und die zur Durchführung des Pilot-Forschungsprojektes für internationale Arzneimittelüberwachung führte, und 2.) das Grund-konzept und die Beschreibung der methodologischen Forschung und Entwicklung während des Vor-bereitungsstadiums.

Key-Words

Drug Monitoring - Adverse Reactions - International Pilot Project

Schlüssel-Wörter

Arzneimittelüberwachung - Nebenwirkungen - Internationales Pilot Projekt

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