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Fall-risk-increasing adverse reactions—is there value in easily accessible drug information? A case-control study

  • Pharmacoepidemiology and Prescription
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European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

The individual fall risk of a patient is often multifactorial. Polymedication contributes to an additional risk of fall-risk-increasing adverse reactions (FRIARs). Previous studies have not sufficiently investigated the complexity facing prescribers when balancing the therapeutic benefits of individual drugs against their potential fall risk.

Methods

An expert panel identified drugs with FRIARs based on the Summary of Product Characteristics (SmPC). These FRIARs and other parameters (such as the total number of drugs, dosage, dose adjustments, and drug changes) were then analyzed for their impact on falls in a case-control study using logistic regression.

Results

During a 1-year period, 112 (1%) of 11,481 hospital patients experienced at least one fall event. Complete data was available for evaluation from 87 of them (case group). We matched these patients to another 87 patients who had no fall events (control group). FRIAR drugs were more frequently prescribed in the case group (4.26 (Q25–Q75, 3.75–4.78) per patient; p = 0.033) than in the control group (3.48 (2.97–3.99)). Drugs with FRIARs (β = 0.137; p = 0.035) and the total number of FRIARs (β = 0.033; p = 0.031) increased the fall risk. The total number of drugs, dosage, dose adjustments, and drug changes showed no influence.

Conclusions

FRIARs were associated with a higher number of falls. To consider FRIARs offers a chance to address the complexity of the individual medication. This data can support future computerized physician order entries with clinical decision support.

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Acknowledgments

We thank all physicians and nurses in the participating departments for their helpful support in this study and Professor Benjamin R. Auer, Ph.D., for statistical guidance and Katharine Worthington, Jena M. Gaines, and Professor Astrid Bertsche, M.D., for language editing.

Funding

This study was financed by the institutions as mentioned above and was performed without third party funding.

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Authors and Affiliations

  1. Institute of Pharmacy, Department of Clinical Pharmacy and Drug Safety Center, Leipzig University and University Hospital of Leipzig, Bruederstraße 32, 04103, Leipzig, Germany

    Susanne Schiek & Thilo Bertsche

  2. Pharmacy Department, Military Hospital, Lesserstraße 180, 22049, Hamburg, Germany

    Katja Hildebrandt & Olaf Zube

Authors
  1. Susanne Schiek
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  2. Katja Hildebrandt
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  3. Olaf Zube
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  4. Thilo Bertsche
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Contributions

Susanne Schiek contributed to the study conception, analyzed and interpreted the data, and wrote the manuscript.

Katja Hildebrandt contributed to the study conception, collected and analyzed the data, and revised the manuscript.

Olaf Zube initiated the study, contributed to the study conception, and revised the manuscript.

Thilo Bertsche contributed to the study conception, interpreted the data, and wrote the manuscript.

Corresponding author

Correspondence to Thilo Bertsche.

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The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study (retrospective case-control study), formal consent is not required.

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Schiek, S., Hildebrandt, K., Zube, O. et al. Fall-risk-increasing adverse reactions—is there value in easily accessible drug information? A case-control study. Eur J Clin Pharmacol 75, 849–857 (2019). https://doi.org/10.1007/s00228-019-02628-x

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  • DOI: https://doi.org/10.1007/s00228-019-02628-x

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