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The Risk of Opioid Intoxications or Related Events and the Effect of Alcohol-Related Disorders: A Retrospective Cohort Study in German Patients Treated with High-Potency Opioid Analgesics

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Abstract

Introduction

Intoxications involving prescription opioids are a major public health problem in many countries. When taken with opioids, alcohol can enhance the effects of opioids, particularly in the central nervous system. However, data quantifying the impact of alcohol involvement in opioid-related intoxications are limited.

Methods

Using claims data from the German Pharmacoepidemiological Research Database (GePaRD), we conducted a retrospective cohort study based on users of high-potency opioid (HPO) analgesics during the years 2005–2009. HPO use was classified as extended-release, immediate-release or both. We calculated incidence rates (IRs) for opioid intoxications or related events as well as adjusted IR ratios (aIRR) comparing HPO-treated patients with alcohol-related disorders (ARDs) to those without ARDs overall and within each HPO category.

Results

During the study period, 308,268 HPO users were identified with an overall IR of 340.4 per 100,000 person-years [95 % confidence interval (CI) 325.5–355.7]. The risk was highest when patients received concomitant treatment with extended- and immediate-release HPOs (IR 1093.8; 95 % CI 904.6–1310.9). ARDs increased the risk during HPO use by a factor of 1.7 and the highest aIRR was seen when comparing patients simultaneously exposed to extended- and immediate-release HPOs with ARDs to those without ARD also after excluding patients with potential improper/non-medical HPO use.

Conclusions

Physicians should be aware of these elevated risks in HPO patients with ARDs. Active patient education by healthcare providers regarding the risk of opioid intoxications or related events due to alcohol in conjunction with HPOs is warranted.

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Acknowledgments

The authors thank Inga Schaffer and Stefanie Heidbreder for contributing to the statistical analyses and Heike Gerds for editing the manuscript. The authors are grateful to all statutory health insurances that provided data for this study, namely the AOK Bremen/Bremerhaven, the DAK-Gesundheit, the Techniker Krankenkasse (TK) and the hkk.

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Authors and Affiliations

  1. Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH, Achter Str. 30, 28359, Bremen, Germany

    K. Jobski, B. Kollhorst, T. Schink & Edeltraut Garbe

  2. Core Scientific Area ‘Health Sciences’, University of Bremen, Bremen, Germany

    Edeltraut Garbe

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  1. K. Jobski
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  2. B. Kollhorst
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Correspondence to Edeltraut Garbe.

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Funding source

This study was funded by Mundipharma Research GmbH & Co. KG. The authors had complete autonomy for the process of establishing the protocol, carrying out the analyses and interpreting the results. This also includes the full right to publish the results without limitation. Mundipharma Research GmbH & Co. KG was provided the opportunity to review a preliminary version of this manuscript for factual accuracy but the authors are solely responsible for final content and interpretation.

Conflict of interest

Edeltraut Garbe is running and Kathrin Jobski, Bianca Kollhorst and Tania Schink are working for a department that occasionally performs studies for pharmaceutical industries. These companies include Bayer, Celgene, GlaxoSmithKline, Mundipharma, Novartis, Purdue, Sanofi-Aventis, Sanofi Pasteur MSD and STADA. Edeltraut Garbe served in an advisory or consultancy role for Bayer-Pharma, Nycomed, GlaxoSmithKline, Schwabe, Teva and Novartis. These advisory functions were unrelated to the topic of this study.

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Jobski, K., Kollhorst, B., Schink, T. et al. The Risk of Opioid Intoxications or Related Events and the Effect of Alcohol-Related Disorders: A Retrospective Cohort Study in German Patients Treated with High-Potency Opioid Analgesics. Drug Saf 38, 811–822 (2015). https://doi.org/10.1007/s40264-015-0312-x

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