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

  • Susanne Schiek
  • Katja Hildebrandt
  • Olaf Zube
  • Thilo BertscheEmail author
Pharmacoepidemiology and Prescription

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.

Keywords

Patient safety Inpatients Drug therapy Fall-risk-increasing drugs Adverse reactions Drug label 

Notes

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.

Authors’ 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.

Funding

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

Compliance with ethical standards

Conflict of interest

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.

Supplementary material

228_2019_2628_MOESM1_ESM.pdf (228 kb)
ESM 1 (PDF 227 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Susanne Schiek
    • 1
  • Katja Hildebrandt
    • 2
  • Olaf Zube
    • 2
  • Thilo Bertsche
    • 1
    Email author
  1. 1.Institute of Pharmacy, Department of Clinical Pharmacy and Drug Safety CenterLeipzig University and University Hospital of LeipzigLeipzigGermany
  2. 2.Pharmacy DepartmentMilitary HospitalHamburgGermany

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