Jornal de Toxicologia Clínica
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Abstrato

Pharmaceutical Production Problems Detected by Adverse Drug Reactions Reports: A Documentary Study from the German Democratic Republic, 1982 to 1990

Lise 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.

Results: From 1982 to 1990 a total of 3990 ADR reports covering information about 6706 ADRs were submitted to the GDR health authorities. The largest share, 26% of all ADRs referred to the SOC “ skin and subcutaneous disorders ”, followed by the SOCs “ general disorders and administration site conditions ” (23% of total ADRs) and “ gastrointestinal disorders ” (11% of total ADRs). Two-thirds of all ADRs were related to the therapeutic groups: “ anti- infectives for socs use” (ATC group J) and “ blood and blood forming organs” (ATC group B). Approximately 85% of ADRs from ATC group B was reported for dextran 40, the majority of these ADRs of the general type, followed by skin ADRs and ADRs concerning respiratory disorders. Additionally a high number of circulatory collapse/shock were reported for dextran 40. The increased level of ADR reporting was related to an abnormal distribution of low and high molecules of dextran 40 occurring due to production problems. Fifteen percent of ADRs were reported for radiographic contrast media; the majority for the substance amidotrizoate, and more than one half of these were of the type skin and respiratory disorders.

Conclusion: In the GDR during the 1980s, the spontaneous ADR reporting system managed to detect serious pharmaceutical quality problems in dextran products. The products of lower quality could not be replaced easily due to lack of safer national alternatives as well as lack of foreign currency necessary to import of purer products from Western countries.