TITLE:
Adverse Drug Reactions Reported in the German Democratic Republic: A Retrospective Analysis of Reports to the WHO-ADR Database
AUTHORS:
Lise Aagaard, Marion Schaefer, Ulrich Meyer, Ebba Holme Hansen
KEYWORDS:
Pharmacovigilance, Spontaneous Reporting Systems, VigiBase, German Democratic Republic
JOURNAL NAME:
Open Journal of Safety Science and Technology,
Vol.1 No.2,
September
28,
2011
ABSTRACT: The German Democratic Republic (GDR) joined the WHO collaboration on drug safety in 1983 in order to strengthen their national pharmacovigilance system. We aim to characterize adverse drug reaction (ADR) reports which were forwarded to the WHO-ADR database by the GDR health authorities, as these data is unknown to the public. ADR reports were analysed with respect to time, type of reporter, age and sex of the patient, category of ADR (System Organ Class [SOC]), seriousness and suspected medicines. The unit of analysis was one ADR. A total of 180 individual ADR reports covering 329 ADRs were forwarded from 1985 to 1990. The largest share of ADRs was reported for psychotropic medicines (23% of total ADRs) followed by anti-infectives for systemic use (19% of ADRs), and medicines for the cardiovascular system (16% of ADRs). The largest share of reported ADRs was from the SOC “hepatobiliary disorders” (16% of total ADRs), followed by the SOCs “skin and subcutaneous disorders” (14% of total ADRs) and “blood and lymphatic disorders” (11% of total ADRs). Approximately 10% of ADRs were serious and included fatal cases. In conclusion, only a limited number of ADR cases occurring in the former GDR, the majority being non-serious, were located in the WHO database. However from government files we know that a large number of serious and fatal ADRs were reported, but information about these were never communicated to the public.