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Comparison of EMERPHED® (Ephedrine Sulfate) Injection with Current Concentrated Ephedrine Products in Simulated Clinical Settings

Received: 3 May 2021    Accepted: 20 May 2021    Published: 31 May 2021
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Abstract

During surgical procedures, patients can have potentially life-threatening hypotension that requires immediate treatment with ephedrine sulfate, which requires compounding at the patient’s bedside. This study was conducted to validate and compare Nexus Pharmaceutical’s EMERPHED®, a pre-diluted ephedrine sulfate injection, with commercially used concentrated ephedrine sulfate in a simulated clinical setting. Twenty-four compounding simulations were performed in the clinical setting to simultaneously formulate EMERPHED® and concentrated ephedrine with a standardized dose of 10mg. The time to prepare the formulations, syringe volume, and the remaining contents of each vial were measured to determine compounding efficacy. Wastage reduction was theoretically discussed based on the waste disposal, and beyond use date. Inter-day variations were evaluated on different parameters. The time taken to formulate EMERPHED® was significantly faster (104.10±21.78 vs 70.63±12.45 seconds) than concentrated ephedrine (P≤0.05). The mean value for EMERPHED® was higher for the syringe accuracy, although it was not statistically significant (P=0.20) compared to concentrated ephedrine. Whereas for the remaining vial volume accuracy, EMERPHED® performed better (97.70±1.55% Vs 78.85±10.81%) than concentrated ephedrine (P≤0.05). Participants improved in the time to formulate both products between the first and second day. There was no significant difference in the percent mean accuracy of syringe dosing and remaining vial volume between days. There was no detected difference in waste reduction. EMERPHED® showed significantly greater compounding efficacy and ease of use compared to commercially available concentrated ephedrine in the clinical simulations. The results indicate that EMERPHED® could be a potential replacement option to institutions using concentrated ephedrine.

Published in Pharmaceutical Science and Technology (Volume 5, Issue 1)
DOI 10.11648/j.pst.20210501.14
Page(s) 24-36
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Clinical Simulation, Ephedrine, Compounding, Dose Accuracy, Error Reduction, EMERPHED®

References
[1] Sipes SL, Chestnut DH, Vincent RD Jr, DeBruyn CS, Bleuer SA, Chatterjee P. Which vasopressor should be used to treat hypotension during magnesium sulfate infusion and epidural anesthesia? Anesthesiology. 1992 Jul; 77 (1): 101-8. doi: 10.1097/00000542-199207000-00015. PMID: 1609983.
[2] Lonjaret L, Lairez O, Minville V, Geeraerts T. Optimal perioperative management of arterial blood pressure. Integr Blood Press Control. 2014 Sep 12; 7: 49-59. doi: 10.2147/IBPC.S45292. PMID: 25278775; PMCID: PMC4178624.
[3] Ephedrine Sulfate. In: Lexi-Drugs. Hudson, OH: Lexi-Comp, Inc. [Updated October 17, 2020; Accessed November 11, 2020].
[4] Rhodes A, Evans LE, Alhazzani W, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar; 43 (3): 304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18. PMID: 28101605.
[5] Mayo Clinic. Medication Errors: Cut your risk with these tips. https://www.mayoclinic.org/healthy-lifestyle/consumer-health/in-depth/medication-errors/art-20048035#:~:text=The%20most%20common%20causes%20of,and%20medications%20that%20look%20alike Updated: September 03, 2020. Accessed November 11, 2020.
[6] Food and Drug Administration: Center for Drug Evaluation and Research. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213407Orig1s000SumR.pdf Updated: April 13, 2020. Accessed November 11, 2020.
[7] Hertig JB, Degnan DD, Scott CR, Lenz JR, Li X, Anderson CM. A Comparison of Error Rates Between Intravenous Push Methods: A Prospective, Multisite, Observational Study. J Patient Saf. 2018 Mar; 14 (1): 60-65. doi: 10.1097/PTS.0000000000000419. PMID: 28902007.
[8] Burger M, Degnan D. Comparative Safety, Efficiency, and Nursing Preference Among 3 Methods for Intravenous Push Medication Preparation: A Randomized Crossover Simulation Study. J Patient Saf. 2019 Sep; 15 (3): 238-245. doi: 10.1097/PTS.0000000000000269. PMID: 27128107; PMCID: PMC6727910.
[9] Business Wire. Nexus Pharmaceuticals, Inc. Announces Approval of EMERPHED® (ephedrine sulfate) Injection, the First and Only FDA-approved Ready-to-Use Ephedrine Injection (50mg/10mL vial). https://www.businesswire.com/news/home/20200421005925/en/ Updated: April 21, 2020. Accessed October 12, 2020.
[10] Institute for Safe Medication Practices. Targeted medication safety best practices for hospitals. ISMP. February 18, 2020. https://www.ismp.org/guidelines/best-practices-hospitals.
[11] Anesthesia Patient Safety Foundation. Recommendations for improving medication safety. APSF. 2018. https://www.apsf.org/medication-safety-recommendations/.
[12] American Society of Health-System Pharmacists: ASHP guidelines on preventing medication errors in hospitals. ASHP. 2018; 75: 1493-1517. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/preventing-medication-errors-hospitals.ashx.
[13] Ephedrine Sulfate. In: DailyMed. Bethesda, MD: U.S. National Library of Medicine. [Updated February 17, 2017; Accessed November 21, 2020].
[14] Emerphed. In: DailyMed. Bethesda, MD: U.S. National Library of Medicine. [Updated April 20, 2020; Accessed November 21, 2020].
[15] Nexus Pharmaceuticals, Inc., October 19, 2020.
Cite This Article
  • APA Style

    Alexander James Sperry, James Cruikshank, Aaron Winn, Karen Jean MacKinnon, Nashaat Zakaria Gerges, et al. (2021). Comparison of EMERPHED® (Ephedrine Sulfate) Injection with Current Concentrated Ephedrine Products in Simulated Clinical Settings. Pharmaceutical Science and Technology, 5(1), 24-36. https://doi.org/10.11648/j.pst.20210501.14

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    ACS Style

    Alexander James Sperry; James Cruikshank; Aaron Winn; Karen Jean MacKinnon; Nashaat Zakaria Gerges, et al. Comparison of EMERPHED® (Ephedrine Sulfate) Injection with Current Concentrated Ephedrine Products in Simulated Clinical Settings. Pharm. Sci. Technol. 2021, 5(1), 24-36. doi: 10.11648/j.pst.20210501.14

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    AMA Style

    Alexander James Sperry, James Cruikshank, Aaron Winn, Karen Jean MacKinnon, Nashaat Zakaria Gerges, et al. Comparison of EMERPHED® (Ephedrine Sulfate) Injection with Current Concentrated Ephedrine Products in Simulated Clinical Settings. Pharm Sci Technol. 2021;5(1):24-36. doi: 10.11648/j.pst.20210501.14

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  • @article{10.11648/j.pst.20210501.14,
      author = {Alexander James Sperry and James Cruikshank and Aaron Winn and Karen Jean MacKinnon and Nashaat Zakaria Gerges and George Edward MacKinnon III and Abhay Singh Chauhan},
      title = {Comparison of EMERPHED® (Ephedrine Sulfate) Injection with Current Concentrated Ephedrine Products in Simulated Clinical Settings},
      journal = {Pharmaceutical Science and Technology},
      volume = {5},
      number = {1},
      pages = {24-36},
      doi = {10.11648/j.pst.20210501.14},
      url = {https://doi.org/10.11648/j.pst.20210501.14},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.pst.20210501.14},
      abstract = {During surgical procedures, patients can have potentially life-threatening hypotension that requires immediate treatment with ephedrine sulfate, which requires compounding at the patient’s bedside. This study was conducted to validate and compare Nexus Pharmaceutical’s EMERPHED®, a pre-diluted ephedrine sulfate injection, with commercially used concentrated ephedrine sulfate in a simulated clinical setting. Twenty-four compounding simulations were performed in the clinical setting to simultaneously formulate EMERPHED® and concentrated ephedrine with a standardized dose of 10mg. The time to prepare the formulations, syringe volume, and the remaining contents of each vial were measured to determine compounding efficacy. Wastage reduction was theoretically discussed based on the waste disposal, and beyond use date. Inter-day variations were evaluated on different parameters. The time taken to formulate EMERPHED® was significantly faster (104.10±21.78 vs 70.63±12.45 seconds) than concentrated ephedrine (P≤0.05). The mean value for EMERPHED® was higher for the syringe accuracy, although it was not statistically significant (P=0.20) compared to concentrated ephedrine. Whereas for the remaining vial volume accuracy, EMERPHED® performed better (97.70±1.55% Vs 78.85±10.81%) than concentrated ephedrine (P≤0.05). Participants improved in the time to formulate both products between the first and second day. There was no significant difference in the percent mean accuracy of syringe dosing and remaining vial volume between days. There was no detected difference in waste reduction. EMERPHED® showed significantly greater compounding efficacy and ease of use compared to commercially available concentrated ephedrine in the clinical simulations. The results indicate that EMERPHED® could be a potential replacement option to institutions using concentrated ephedrine.},
     year = {2021}
    }
    

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Author Information
  • School of Pharmacy Medical College of Wisconsin, Wauwatosa, the United States

  • Department of Pharmacy, Froedtert Hospital, Milwaukee, Wauwatosa, the United States

  • School of Pharmacy Medical College of Wisconsin, Wauwatosa, the United States

  • School of Pharmacy Medical College of Wisconsin, Wauwatosa, the United States

  • School of Pharmacy Medical College of Wisconsin, Wauwatosa, the United States

  • School of Pharmacy Medical College of Wisconsin, Wauwatosa, the United States

  • School of Pharmacy Medical College of Wisconsin, Wauwatosa, the United States

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