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Personalising drug safety—results from the multi-centre prospective observational study on Adverse Drug Reactions in Emergency Departments (ADRED)

European Journal of Clinical Pharmacology volume 76, pages 439–448 (2020)Cite this article

Abstract

Purpose

Adverse drug reactions (ADR) account for 5 to 7% of emergency department (ED) consultations. We aimed to assess medication risk profiles for ADRs leading to ED visits.

Methods

We analysed medication intake and patient demographics in a prospective multi-centre observational study collecting ADR cases in four large EDs in Germany. Odds ratios (OR) were calculated to relate drug classes taken to those suspicious for an ADR after a causality assessment.

Results

A total of 2215 cases of ED visits due to ADRs were collected. The median age of the cohort was 73 years; in median, six co-morbidities and an intake of seven drugs were documented. Antineoplastic/immunomodulating agents had the highest OR for being suspected for an ADR (OR 20.45, 95% CI 14.54–28.77), followed by antithrombotics (OR 2.94, 95% CI 2.49–3.47), antibiotics (OR 2.65, 95% CI 1.78–3.95), systemic glucocorticoids (OR 2.43, 95% CI 1.54–3.82) and drugs affecting the central nervous system (CNS), such as antipsychotics (OR 2.36, 95% CI 1.46–3.81), antidepressants (OR 2.10, 95% CI 1.57–2.83), antiparkinsonian medication (OR 2.11, 95% CI 1.15–3.84), opioids (OR 1.79, 95% CI 1.26–2.54) and non-opioid analgesics (OR 1.32, 95% CI 1.01–1.72).

Conclusions

Patients experiencing ADRs leading to ED visits are commonly old, multi-morbid and multi-medicated. CNS drugs may be more relevant than prior expected. With calculating ORs, we could replicate involvement of antineoplastic agents, antithrombotics, antibiotics, systemic glucocorticoids and non-opioid analgesics as frequently suspected for ADRs in EDs.

Trial registration

DRKS-ID: DRKS00008979.

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Fig. 1

Data availability

The datasets analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

The study trial is registered at the German Clinical Trial Register (DRKS-ID: DRKS00008979).

Funding

The ADRED-study has received financial funding within the framework of the AMTS focus of the German Federal Ministry of Health (BMG), grant number ZMVI5–2514ATA004. M.S. and S.I. are in part supported by the Robert Bosch Foundation, Stuttgart, Germany.

Author information

Affiliations

  1. Institute of Clinical Pharmacology, University Hospital of RWTH Aachen, Aachen, Germany

    Katja S. Just & Julia C. Stingl

  2. Central Emergency Department, Hospital Fürth, Furth, Germany

    Harald Dormann & Bettina Plank-Kiegele

  3. Research Department, Federal Institute for Drugs and Medical Devices, Bonn, Germany

    Miriam Böhme, Marlen Schurig, Katharina L. Schneider, Michael Steffens & Sandra Dunow

  4. Internal Medicine Emergency Department, Ulm University Medical Centre, Ulm, Germany

    Kristin Ettrich & Thomas Seufferlein

  5. Interdisciplinary Emergency Department (INZ), University Hospital of Bonn, Bonn, Germany

    Ingo Gräff

  6. Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Robert-Bosch-Hospital, Stuttgart, Germany

    Svitlana Igel, Simon U. Jaeger & Matthias Schwab

  7. University of Tuebingen, Tuebingen, Germany

    Svitlana Igel & Matthias Schwab

  8. Department of Internal Medicine, Division of General Internal Medicine and Nephrology, Robert-Bosch-Hospital, Stuttgart, Germany

    Severin Schricker

  9. Department of Pharmacy and Biochemistry, University of Tuebingen, Tuebingen, Germany

    Matthias Schwab

  10. Department of Clinical Pharmacology, University Hospital Tuebingen, Tuebingen, Germany

    Simon U. Jaeger & Matthias Schwab

Authors
  1. Katja S. Just
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  2. Harald Dormann
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  3. Miriam Böhme
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  4. Marlen Schurig
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  5. Katharina L. Schneider
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  6. Michael Steffens
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  7. Sandra Dunow
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  8. Bettina Plank-Kiegele
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  9. Kristin Ettrich
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  10. Thomas Seufferlein
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  11. Ingo Gräff
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  12. Svitlana Igel
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  13. Severin Schricker
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  14. Simon U. Jaeger
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  15. Matthias Schwab
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  16. Julia C. Stingl
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Contributions

KJ conducted the analyses and drafted the manuscript. JS designed the ADRED study and supervised all analyses and coordination. MB, MS, SD, MS and KJ conducted the statistical analyses. MS coordinated the study. KS drafted study material. HD, TS, IG and MS supervised the identification of ADR cases at clinical sites. BPK, KE, SI, SS and SJ participated in identification of ADR cases at clinical sites. All authors collaborated in writing and approved the final manuscript.

Corresponding author

Correspondence to Julia C. Stingl.

Ethics declarations

Competing interests

The authors declare that they have no competing interests.

Ethical approval

The study was approved by the responsible ethical committee of the University of Bonn (202/15) and reviewed positively by the respective ethical committees of the study centres of the Universities of Erlangen-Nürnberg (43_16Bc), Tübingen (113/16) and Ulm (493/2016BO1).

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Informed consent was obtained from individual participants included in the study described in the manuscript.

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Just, K.S., Dormann, H., Böhme, M. et al. Personalising drug safety—results from the multi-centre prospective observational study on Adverse Drug Reactions in Emergency Departments (ADRED). Eur J Clin Pharmacol 76, 439–448 (2020). https://doi.org/10.1007/s00228-019-02797-9

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  • DOI: https://doi.org/10.1007/s00228-019-02797-9

Keywords

  • Adverse drug reaction
  • Drug safety
  • Emergency department
  • Drug class
  • Medication
  • Older adults