Artikel
Rare blood disorders and reports of adverse drug reactions : intermediate results of the Berlin case control surveillance study (FAKOS)
Seltene Bluterkrankungen und Meldungen von unerwünschten Arzneimittelwirkungen : Zwischenergebnisse von der Berliner Fall-Kontroll Surveillance-Studie (FAKOS)
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Autoren
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Elisabeth Bronder
- Institut für Klinische Pharmakologie, Charité Campus Mitte, Humboldt Universität Berlin; Institut für Pharmakoepidemiologie und Technologiebewertung IPTA (Studienzentrale), Invalidenstr. 115, 10115 Berlin, Germany
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F. Andersohn
- Institut für Klinische Pharmakologie, Charité Campus Mitte, Humboldt Universität Berlin; Institut für Pharmakoepidemiologie und Technologiebewertung IPTA (Studienzentrale), Invalidenstr. 115, 10115 Berlin, Germany
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A. Klimpel
- Institut für Klinische Pharmakologie, Charité Campus Mitte, Humboldt Universität Berlin; Institut für Pharmakoepidemiologie und Technologiebewertung IPTA (Studienzentrale), Invalidenstr. 115, 10115 Berlin, Germany
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E. Garbe
- Institut für Klinische Pharmakologie, Charité Campus Mitte, Humboldt Universität Berlin; Institut für Pharmakoepidemiologie und Technologiebewertung IPTA (Studienzentrale), Invalidenstr. 115, 10115 Berlin, Germany
| Veröffentlicht: | 16. Oktober 2003 |
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Gliederung
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Introduction
Aims of the Berlin Case-Control surveillance study (FAKOS) are 1) to detect serious rare hematotoxicity of drugs in the postmarketing period; 2) to quantify the risk of these adverse drug reactions (ADR's) and 3) to investigate possible susceptibility factors for these ADR's. FAKOS is being funded by the Federal Institute for Drugs and Medical Devices (BfArM, Germany).
Material and Methods
Study region is Berlin, Germany, with a source population of about 3.5 million inhabitants. 51 hospitals participate with 224 clinical departments and 13 hematological practices. Since October 2000 FAKOS has included patients with following blood disorders (both idiopathic cases and ADR): Immune hemolytic anemia (IHA), acute idiosyncratic agranulocytosis (AGR), aplastic anemia/pure red cell anemia (AA/PRCA), immune thrombocytopenia (ITP), thrombotic-thrombocytopenic purpura/hemolytic uraemic syndrome (TTP/HUS), and Heparin-induced thrombocytopenia (HIT-II). Cases are matched 1:1 (sex, age) with hospital patients as controls.
A standardized personal interview is conducted about drug use, diseases, lifestyle habits, and occupational exposures. Blood samples are obtained for pharmacogenetic testing. The possibility of drug-induced blood disease is examined for each patient. Suspicion of ADRs are notified to BfArM.
Results
Up to April 2003 the following numbers of cases have been included: ITP (N 80), IHA (N 36), AGR (N 30), AA (N 18), TTP/HUS (N 13) and HIT-II (N 153). The response rate is 90% (N 330) in cases and 88% (N 298) in controls. FAKOS has currently notified 168 ADRs to BfArM. In addition, 27 ADRs have been reported from hospital physicians. As an example, figures are given for agranulocytosis (N 30): 28 (93%) ADRs were reported (26 reports from FAKOS and two from hospital doctors). Two cases were not judged to be drug-induced.
Conclusion
FAKOS takes an active surveillance to identify ADRs. The project is an important model project of pharmacovigilance in Germany beside the spontaneous reporting system.
