Adverse drug reactions in Germany: direct costs of internal medicine hospitalizations

Authors

  • Dominik Rottenkolber,

    Corresponding author
    1. Ludwig-Maximilians-Universität München, Institute of Health Economics and Health Care Management and Munich Center of Health Sciences, Munich, Germany
    2. Helmholtz Zentrum München – German Research Center for Environmental Health (GmbH), Neuherberg, Germany
    • Ludwig-Maximilians-Universität München, Institute of Health Economics and Health Care Management, Ludwigstr. 28 RG V, 80539 Munich, Germany.
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  • Sven Schmiedl,

    1. Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Department of Clinical Pharmacology, University Witten/Herdecke, Germany
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  • Marietta Rottenkolber,

    1. Institute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universität München, Munich, Germany
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  • Katrin Farker,

    1. Institute of Pharmacology and Toxicology, Department of Clinical Pharmacology, Regional Pharmacovigilance Center Weimar, University of Jena, Germany
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  • Karen Saljé,

    1. Department of Clinical Pharmacology, Regional Pharmacovigilance Center Greifswald, University of Greifswald, Germany
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  • Silke Mueller,

    1. Institute of Clinical Pharmacology, Regional Pharmacovigilance Center Rostock, University of Rostock, Germany
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  • Marion Hippius,

    1. Institute of Pharmacology and Toxicology, Department of Clinical Pharmacology, Regional Pharmacovigilance Center Jena, University of Jena, Germany
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  • Petra A. Thuermann,

    1. Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Department of Clinical Pharmacology, University Witten/Herdecke, Germany
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  • Joerg Hasford,

    1. Institute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universität München, Munich, Germany
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  • for the Net of Regional Pharmacovigilance Centers


ABSTRACT

Purpose

German hospital reimbursement modalities changed as a result of the introduction of Diagnosis Related Groups (DRG) in 2004. Therefore, no data on the direct costs of adverse drug reactions (ADRs) resulting in admissions to departments of internal medicine are available. The objective was to quantify the ADR-related economic burden (direct costs) of hospitalizations in internal medicine wards in Germany.

Methods

Record-based study analyzing the patient records of about 57 000 hospitalizations between 2006 and 2007 of the Net of Regional Pharmacovigilance Centers (Germany). All ADRs were evaluated by a team of experts in pharmacovigilance for severity, causality, and preventability. The calculation of accurate person-related costs for ADRs relied on the German DRG system (G-DRG 2009). Descriptive and bootstrap statistical methods were applied for data analysis.

Results

The incidence of hospitalization due to at least ‘possible’ serious outpatient ADRs was estimated to be approximately 3.25%. Mean age of the 1834 patients was 71.0 years (SD 14.7). Most frequent ADRs were gastrointestinal hemorrhage (n = 336) and drug-induced hypoglycemia (n = 270). Average inpatient length-of-stay was 9.3 days (SD 7.1). Average treatment costs of a single ADR were estimated to be approximately €2250. The total costs sum to €434 million per year for Germany. Considering the proportion of preventable cases (20.1%), this equals a saving potential of €87 million per year.

Conclusions

Preventing ADRs is advisable in order to realize significant nationwide savings potential. Our cost estimates provide a reliable benchmark as they were calculated based on an intensified ADR surveillance and an accurate person-related cost application. Copyright © 2011 John Wiley & Sons, Ltd.

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