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Postoperative Respiratory Events in Surgical Patients Exposed to Opioid Analgesic Shortages Compared to Fully Matched Patients Non-exposed to Shortages

Drug Safety volume 45, pages 359–367 (2022)Cite this article

Abstract

Introduction

Shortages of opioid analgesics critically disrupt clinical practice and are detrimental to patient safety. There is a dearth of studies assessing the safety implications of drug shortages.

Objective

We aimed to assess perioperative opioid analgesic use and related postoperative hypoxemia (oxygen saturation less than 90%) in surgical patients exposed to prescription opioid shortages compared to propensity score-matched patients non-exposed to opioid shortages.

Methods

We conducted a retrospective study including adult patients who underwent elective surgery at The University of California San Francisco in the period August 2018–December 2019. We conducted a Gamma log-link generalized linear model to assess the effect of shortages on perioperative use of opioids and a weighted logistic regression to assess the likelihood of experiencing postoperative hypoxemia.

Results

There were 1119 patients exposed to opioid shortages and 2787 matched non-exposed patients. After full matching, patients exposed to shortages used a greater mean of morphine milligram equivalents/day (146.94; 95% confidence interval 123.96–174.16) than non-exposed patients (117.92; 95% confidence interval 100.48–138.38; p = 0.0001). The estimated effect was a 1.25 (95% confidence interval 1.12–1.40; p = 0.0001) times greater use of opioids in patients exposed to opioid shortages than non-exposed patients. After full matching, a greater proportion of patients exposed to shortages (19.06%) experienced hypoxemia compared with non-exposed patients (16.91%). In addition, a greater proportion of patients exposed to opioid shortages (1.20%) experienced hypoxemia reversed by intravenous naloxone administration compared with non-exposed patients (0.44%).

Conclusions

Given the shortage prevalence, reliance on opioid medications, and related risk of respiratory depression, harm prevention measures remain critical to prevent postoperative complications that may compromise patients’ safety.

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Acknowledgments

The authors thank two anonymous referees and the editor for their insightful suggestions. We are also grateful to all clinicians who work restlessly managing prescription drug shortages to provide optimal patient care.

Author information

Authors and Affiliations

  1. Department of Clinical Pharmacy, School of Pharmacy, University of California San Francisco, San Francisco, CA, USA

    Rosa Rodriguez-Monguio

  2. Medication Outcomes Center, University of California San Francisco, 521 Parnassus Ave, San Francisco, CA, 94143, USA

    Rosa Rodriguez-Monguio & Zhixin Lun

  3. Philip R. Lee Institute for Health Policy Studies at the University of California San Francisco, San Francisco, CA, USA

    Rosa Rodriguez-Monguio, Tasce Bongiovanni & Catherine L. Chen

  4. Division of General Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA

    Tasce Bongiovanni

  5. Department of Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, CA, USA

    Catherine L. Chen

  6. Department of Biomedical and Pharmaceutical Sciences, Chapman University School of Pharmacy, Irvine, CA, USA

    Enrique Seoane-Vazquez

Authors
  1. Rosa Rodriguez-Monguio
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  2. Zhixin Lun
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Corresponding author

Correspondence to Rosa Rodriguez-Monguio.

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Funding

This study was funded in part by the National Center for Advancing Translational Sciences, National Institutes of Health through UCSF-CTSI (#UL1 TR991872).

Conflict of interest

The authors have no conflict of interest. All authors assert that the views expressed in this article are their own and do not necessarily reflect those of any organization with which they may be associated.

Ethics approval

The University of California San Francisco Institutional Review Board approved this study and the waiver of written informed consent (#18-25355).

Consent to participate

Not applicable.

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Not applicable.

Availability of data and material

The raw data generated at our institution and analyzed during the current study are not publicly available because of the Health Insurance Portability and Accountability Act. De-identified data may be available from the corresponding author on reasonable request and execution of a data use agreement. The data sources are described in the article.

Code availability

Not applicable.

Author contributions

RRM conceptualized and designed the study, conducted the study, analyzed and interpreted the data, and wrote the first draft of the manuscript. ZL contributed to the study design, analyzed and interpreted the data, and critically revised the manuscript. BT helped interpreting the data and critically revised the manuscript. CLC interpreted the data, helped draft the manuscript, and critically revised the manuscript. ESV helped contribute the study design and data interpretation, and critically revised the manuscript. All authors contributed to manuscript revision and approved the final manuscript.

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Cite this article

Rodriguez-Monguio, R., Lun, Z., Bongiovanni, T. et al. Postoperative Respiratory Events in Surgical Patients Exposed to Opioid Analgesic Shortages Compared to Fully Matched Patients Non-exposed to Shortages. Drug Saf 45, 359–367 (2022). https://doi.org/10.1007/s40264-022-01171-6

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  • DOI: https://doi.org/10.1007/s40264-022-01171-6