Display options
Share it on

Klin Wochenschr. 1991 Oct 31;69(17):775-9. doi: 10.1007/BF01744267.

A need to intensify drug surveillance in Germany.

J F Kapp, R Zentgraf, A Widmer, E Schöpf


  1. Universitäts-Hautklinik, Freiburg.

PMID: 1762382 DOI: 10.1007/BF01744267


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.

Similar articles

Show all 79 similar articles

Cited by


  1. Verh Dtsch Ges Inn Med. 1977 Apr 17-21;83:1487-502 - PubMed
  2. Verh Dtsch Ges Inn Med. 1989;95:687-90 - PubMed
  3. J Clin Epidemiol. 1990;43(5):509-22 - PubMed
  4. JAMA. 1990 Apr 4;263(13):1785-8 - PubMed
  5. Infection. 1987;15 Suppl 5:S236-40 - PubMed
  6. Br Med J (Clin Res Ed). 1987 Jan 17;294(6565):147-50 - PubMed
  7. Am J Pharm Sci Support Public Health. 1978 May-Jun;150(3):81-8 - PubMed
  8. Br Med J (Clin Res Ed). 1983 Feb 5;286(6363):458-60 - PubMed
  9. N Engl J Med. 1977 Mar 3;296(9):481-5 - PubMed
  10. Drug Intell Clin Pharm. 1987 Sep;21(9):741-7 - PubMed
  11. JAMA. 1970 Aug 31;213(9):1455-60 - PubMed
  12. Nouv Rev Fr Hematol. 1987;29(4):265-70 - PubMed
  13. J Hepatol. 1990 Sep;11(2):272-6 - PubMed
  14. Nervenarzt. 1985 Jan;56(1):12-8 - PubMed

MeSH terms

Publication Types

LinkOut - more resources