A need to intensify drug surveillance in Germany.
Despite all its limitations, the spontaneous reporting system still forms the basis for drug safety assessments in the Federal Republic of Germany. Although there have been some promising attempts to standardise the methodology of detecting, analysing and evaluating adverse drug events (ADEs) in certain clinico-pharmacological institutes and psychiatric departments, the approaches have not been integrated and are used only locally. The only exception is the Freiburg Documentation Centre for Severe Skin Diseases, which is attempting comprehensive, country-wide documentation of toxic epidermal necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome. We show that surveillance of 40% of all hospital beds would allow the acquisition of reliable data even on rare and serious AEs which could then be extrapolated in a statistically meaningful way. The medical societies in Germany have traditionally taken a leading role in establishing standards for the preclinical and clinical investigation of new drug compounds. We suggest that they also make it their task to define the framework for an intensified adverse events monitoring system, since it is the patient who ultimately benefits from a quantification of drug therapy risks.
Kapp
J F
JF
Universitäts-Hautklinik, Freiburg.
Zentgraf
R
R
Widmer
A
A
Schöpf
E
E
D001509:Bed Occupancy; D064420:Drug-Related Side Effects and Adverse Reactions; D005858:Germany; D006753:Hospital Records; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*