Journal of Clinical Toxicology
Open Access
ISSN: 2161-0495
+44 1478 350008
ISSN: 2161-0495
+44 1478 350008
Lise Aagaard
Faculty of Health,
JB Winsløws Vej 19, 5000 Odense C
Germany
Research Article
Pharmaceutical Production Problems Detected by Adverse Drug Reactions Reports: A Documentary Study from the German Democratic Republic,
1982 to 1990
Author(s): Lise Aagaard, Ulrich Meyer, Marion Schaefer and Ebba Holme HansenLise Aagaard, Ulrich Meyer, Marion Schaefer and Ebba Holme Hansen
Objectives: To characterise spontaneous adverse drug reactions (ADRs) reported in the former German Democratic Republic (GDR) and to identify ADRs related to quality problems with pharmaceuticals.
Material and methods: In 1964 a spontaneous ADR reporting system was established in the GDR with the purpose to collect information about possible toxic and damaging ADRs from medicine use. The spontaneous reporting system was also seen as an important tool for securing the quality of the pharmaceutical production. Data on ADRs occurring in the GDR were located in the national German archive, Bundesarchive in Berlin. Only ADR reports submitted from 1982 to 1990 were identified. The reports were analysed with respect to type of ADR (System Organ Class [SOC]) and substance.
Result.. View More»
DOI:
10.4172/2161-0495.1000120