[Spontaneous reporting system for the assessment of new, unknown and rare undesirable effects of drugs]

The Swiss Drug Monitoring Center SANZ operates the spontaneous reporting system in Switzerland. Spontaneous reporting schemes represent the systematic approach to the collection of individual case reports on suspected adverse drug reactions (ADR). ADR spontaneous reporting systems are an important component of the postmarketing surveillance of drugs. Spontaneous reporting systems are primarily designed to detect new and unexpected ADR; they generate signals about possible ADR and create hypotheses to be tested in pharmaco-epidemiological studies. Besides collecting, analyzing and evaluating single case reports it is important to extract those cases from the data pool which can be used to produce signals. A computer-assisted early warning system enables SANZ to detect cases with signal function and thus to track down new, rare and unexpected ADR. Carefully selected parameters can help to identify important new hazards. However, the detection of new and unexpected ADR depends to a large extent on the minds of alert physicians and the practicing clinician's awareness of and cooperation with ADR reporting.