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.
Highlights
During the 1960s, in the wake of the thalidomide catastrophe in the late 1950s [1], pharmacovigilance systems were established in many western European countries, Canada and Australia [2]
adverse drug reaction (ADR) reports were provided by the Uppsala Monitoring Centre (UMC) as CIOMS reports, and data from these reports were manually entered into Microsoft Excel
The ADR reports were of high quality and very detailed with information about causality assessment and reaction outcome
Summary
During the 1960s, in the wake of the thalidomide catastrophe in the late 1950s [1], pharmacovigilance systems were established in many western European countries, Canada and Australia [2]. The World Health Organization (WHO) established an international reporting system in 1968 and over the years an ever-increasing number of countries have joined this collaboration [3]. The German Democratic Republic (GDR) was wellknown for its large production of pharmaceuticals, often copies of medications developed by pharmaceutical companies in capitalistic countries, produced in large state-owned companies which supplied the other Comecon members [4]. New medicines were introduced years later in the GDR than in western European countries, and due to safety reasons thalidomide was never marketed in the GDR. Limited information about data reported to this system was communicated to the prescribers and patients, as such type of information was considered as being a state secret and only available to OJSST
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