gms | German Medical Science

15th Annual Meeting of the German Drug Utilisation Research Group (GAA)

Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

20.11. - 21.11.2008, Bonn

Article

Send article

Pharmacovigilance and Patient Safety – Results of the German Net of Regional Pharmacovigilance Centers

Pharmakovigilanz und Patientensicherheit – Ergebnisse des Netzwerks Regionaler Pharmakovigilanzzentren

Meeting Abstract

Search Medline for

  • corresponding author S. Schmiedl - Institute of Clinical Pharmacology, University of Witten/Herdecke, HELIOS Klinikum Wuppertal, Germany
  • J. Hasford - Institute of Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany
  • M. Rottenkolber - Institute of Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany
  • J. Szymanski - Institute of Clinical Pharmacology, University of Witten/Herdecke, HELIOS Klinikum Wuppertal, Germany
  • B. Drewelow - Institute of Clinical Pharmacology, University of Rostock, Germany
  • S. Mueller - Institute of Clinical Pharmacology, University of Rostock, Germany
  • G. Haase - Institute of Clinical Pharmacology, University of Rostock, Germany
  • W. Siegmund - Institute of Clinical Pharmacology, University of Greifswald, Germany
  • K. May - Institute of Clinical Pharmacology, University of Greifswald, Germany
  • M. Hippius - Institute of Clinical Pharmacology, University of Jena, Germany
  • K. Farker - Institute of Clinical Pharmacology, University of Jena, Germany
  • D. Gruca - Institute of Clinical Pharmacology, University of Jena, Germany
  • I.R. Guenther - Institute of Clinical Pharmacology, University of Jena, Germany
  • P.A. Thuermann - Institute of Clinical Pharmacology, University of Witten/Herdecke, HELIOS Klinikum Wuppertal, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 15. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Bonn, 20.-21.11.2008. Düsseldorf: German Medical Science GMS Publishing House; 2008. Doc08gaa12

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/gaa2008/08gaa12.shtml

Published: November 6, 2008

© 2008 Schmiedl et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

Text

Background and aim: Since 1996, a net of regional Pharmacovigilance Centers has been developed in Germany. Among the major objectives is the identification of serious ADRs in outpatient care leading to hospital admission.

Material and method: In four hospitals all non-elective hospital admissions are screened for the presence of ADRs as cause of admission. The causality is assessed using Bégaud’s algorithm and the incidence of ADR-related hospital admission is estimated using the prescription data of the hospital service areas. We have analysed all ‘possible’, ‘likely’ and ‘very likely’ (I2 - I4) rated ADRs between 2000 and 2007.

Results: There were 6168 serious ADRs with at least a severity level of 4 according to Hartwig in 5686 patients. The mean age of patients was 70.06 (SD=15.72) years and 3440 (60.50 %) were female. The most common ADRs were gastrointestinal ulcers and bleedings (22.76 %), hypoglycemia (14.96 %) and bradycardia (6.71 %). The proportion of fatal ADRs was 1.32 % and the most frequently type of ADR was Type A (88.31 %). The five drugs most commonly imputed were ASA (1208), phenprocoumon (715), digitoxin (529), diclofenac (406) and human insulin fast-acting (378). Ten drugs accounted for 39.30 % of all ADR-related hospital admissions. The incidences of ADR related hospital admissions for certain drug groups and drugs based on ATC code will be presented, too.

Conclusion: It is highly relevant to learn that the majority of serious ADRs leading to hospital admission are well known and that the imputed drugs are marketed since very many years. It is widely accepted that many of these ADRs are preventable. The results of this study emphasize the value of this type of pharmacovigilance for the promotion of the safe use of drugs and patient safety. Routine pharmacovigilance monitoring of hospital admissions allows identifying the risks that agencies for patient safety need to know to act properly and in time.

Supported by BfArM: Fo 2.1-68502-201