Artikel
The most frequently reported adverse drug reactions and suspected drugs – descriptive analysis of spontaneous reports contained in the adverse drug reaction database of the Federal Institute for Drugs and Medical Devices in Germany (1978–2016)
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Autoren
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Diana Dubrall
- Institute for Medical Biometry, Informatics, and Epidemiology (IMBIE), University Hospital of Bonn, Bonn, Germany
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Matthias Schmid
- Institute for Medical Biometry, Informatics, and Epidemiology (IMBIE), University Hospital of Bonn, Bonn, Germany
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Eva Alešik
- German Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
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Norbert Paeschke
- German Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
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Julia Stingl
- German Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
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Bernhardt Sachs
- German Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
| Veröffentlicht: | 23. November 2018 |
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Gliederung
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Background: Spontaneous reporting systems are one appropriate tool to gather further knowledge about drug safety after marketing authorization of a drug. The adverse drug reaction (ADR) database of the German Federal Institute for Drugs and Medical Devices exists since 1978. The aim of the present study was to descriptively analyze all of these spontaneous reports, in order to get an overview about the whole database.
Materials and methods: 345,662 spontaneous reports were contained in the database till data lock point 31/12/2016. These reports were analyzed with regard to demographic parameters, primary sources, number of reports per year, the most frequently reported drug classes and their most frequently reported ADRs.
Results: Since 1978 the number of spontaneous reports has increased steadily. On a high level overview analysis “drugs for the treatment of nervous system disorders” was the drug class most frequently reported as suspected of causing ADRs (23.1%). A more detailed analysis revealed antithrombotic agents, systemic antibiotics, and psycholeptics as the three most frequently reported suspected therapeutic subgroups – causing thrombocytopenia, diarrhea, and drug dependency as the most frequently reported ADRs, respectively. The three most frequently suspected drug classes of reports originating from physicians were diazepines, fluoroquinolones, heparins whereas in reports originating from patients these were interferons, antithrombotic drugs, selective immunosuppressant drugs. Physicians reported more commonly about diagnoses and laboratory results, whereas patients reported more often about subjectively perceived ADRs.
Conclusion: The increasing number of spontaneous ADR reports received by BfArM seems to be linked to the number of reports sent by pharmaceutical companies. This, in turn, could be due to the increasingly strict legal reporting requirements in Germany. The detected disparities between ADR reports of patients and physicians could be a trigger for physicians to inquire patients about potential ADRs.
References
- 1.
- Dubrall D, Schmid M, Alešik E, Paeschke N, Stingl J, Sachs B. Frequent Adverse Drug Reactions, and Medication Groups under Suspicion – A descriptive analysis based on spontaneous reports to the German Federal Institute for Drugs and Medical Devices from 1978–2016. Dtsch Arztebl Int. 2018;115(23):393-400.
