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Adverse drug events related to COX inhibitors in patients presenting at an emergency department

Cross-sectional study of prevalence and risk factors

Unerwünschte Arzneimittelereignisse im Zusammenhang mit COX-Inhibitoren bei Patienten in einer Notaufnahmeeinheit

Querschnittstudie zu Prävalenz und Risikofaktoren

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Abstract

Background

The use of cyclooxygenase (COX) inhibitors is increasingly common. Most of them are available for self-medication, either as analgesic or for cardio- and cerebrovascular prevention.

Objectives

We aimed to analyze adverse drug events (ADE) related to COX inhibitors and the concomitant use of proton pump inhibitors (PPI) according to guidelines in patients presenting at an emergency department (ED).

Methods

In a prospective study, 2262 patients presenting consecutively at the ED of a tertiary care university teaching hospital were evaluated by intensive chart review in order to detect and classify all ADE. In this cross-sectional analysis all patients taking COX inhibitors at home were evaluated further.

Results

Of all evaluated patients, 753 (33.3 %) took COX inhibitors at home, 258 (34.3 %) with concomitant PPI. A total of 168 (22.3 %) patients suffered from at least one ADE related to COX inhibitors. The most common ADE observed were anemia (55.9 %) and gastrointestinal ADE (31.6 %, e. g., bleeding, gastritis, and ulcer). In 10.1 % of patients, a medication error (e. g., intake without proper clinical indication) contributed to the ADE and in 40.8 % of the ADE involved further contributing drugs. Only 38.8–42.1 % of patients with a high gastrointestinal risk were prescribed a PPI concomitantly.

Conclusion

ADE related to COX inhibitors were found in every fifth patient taking COX inhibitors. One-tenth of all ADE involving COX inhibitors were related to medication errors. The guideline-based concomitant use of PPI was only in part implemented.

Zusammenfassung

Hintergrund

Cyclooxygenase (COX)-Hemmer werden immer häufiger angewendet. Viele sind zur Selbstmedikation erhältlich, entweder als Analgetikum oder zur kardio- und zerebrovaskulären Prävention.

Ziel der Arbeit

Ziel dieser Untersuchung war es, durch COX-Hemmer verursachte unerwünschte Arzneimittelereignisse (UAE) und die leitliniengerechte Begleitmedikation durch Protonenpumpenhemmer (PPI) zu analysieren.

Methode

In die prospektive Beobachtungsstudie wurden 2262 Patienten eingeschlossen, die sich konsekutiv in der zentralen Notaufnahme (ZNA) eines Schwerpunktversorgers vorstellten. Alle UAE wurden durch Intensivdokumentation erfasst und klassifiziert.

Ergebnis

Von allen evaluierten Patienten nahmen 753 (33,3 %) COX-Hemmer zuhause ein, 258 (34,3 %) zusammen mit einem PPI. Unter mindestens einer durch COX-Hemmer verursachten UAE litten 168 (22,3 %). Die am häufigsten beobachteten UAE waren Anämie (55,9 %) und gastrointestinale UAE (31,6 %, z. B. Blutungen, Gastritis und Ulkus). Bei 10,1 % der Patienten war ein Medikationsfehler (z. B. die Einnahme ohne bekannte Indikation) am UAE beteiligt, an 40,8 % aller UAE eine Interaktion. Nur 38,8–42,1 % aller Patienten mit hohem Risiko für gastrointestinale UAE erhielten begleitend ein PPI.

Diskussion

Bei jedem fünften Patienten, der NSAR einnahm, wurde eine durch COX-Hemmer verursachte UAE gefunden. An jeder zehnten UAE durch COX-Hemmer war ein Medikationsfehler beteiligt. Die leitliniengerechte begleitende Anwendung von PPI wurde nur zum Teil umgesetzt.

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Acknowledgements

We would like to thank board chairman Peter Krappmann and the business management committee of Fürth Hospital, led by Martin Vitzithum, for supporting the care research project and collaboration in designing the technical infrastructure for study conduct.

Medizinische Medien Informations GmbH (MMI, Neu-Isenburg, Germany) made its drug and drug interaction databases Pharmindex Plus® and OntoDrug® AMTS available to the study free of charge.

Sponsor

This research project was supported by The German Federal Ministry of Health within the “German Coalition for Patient Safety” by a BMG grant II A 5 – 2509 ATS 003 to HD, RM and TB.

Author information

Authors and Affiliations

  1. Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Fahrstraße 17, 91054, Erlangen, Germany

    B. Pfistermeister, F. Müller, H. Glaeser, B. Plank-Kiegele & R. Maas

  2. Department of Emergency Medicine, Klinikum Fürth, Jakob-Henle-Str. 1, 90766, Fürth, Germany

    H. Dormann & A. Sonst

  3. Chair of Medical Informatics, Friedrich-Alexander-Universität Erlangen-Nürnberg, Am Wetterkreuz 13, 91058, Erlangen-Tennenlohe, Germany

    A. Patapovas

  4. Institute for Medical Informatics, Bern University of Applied Science BFH, Höheweg 80, 2502, Biel, Switzerland

    T. Bürkle

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  1. B. Pfistermeister
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Corresponding author

Correspondence to H. Dormann.

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Conflict of interest

F. Müller holds shares in Novartis and has been an employee of Boehringer Ingelheim Pharma GmbH & Co. KG since 2014. B. Pfistermeister, H. Dormann, A. Patapovas, A. Sonst, H. Glaeser, B. Plank-Kiegele, T. Bürkle, and R. Maas state that there are no conflicts of interest.

The accompanying manuscript does not include studies on humans or animals.

Additional information

B. Pfistermeister and H. Dormann contributed equally

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Pfistermeister, B., Dormann, H., Patapovas, A. et al. Adverse drug events related to COX inhibitors in patients presenting at an emergency department. Notfall Rettungsmed 19, 671–678 (2016). https://doi.org/10.1007/s10049-016-0184-3

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