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Expired Epinephrine Maintains Chemical Concentration and Sterility

机译：过期的肾上腺素保持化学浓度和无菌性

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Objectives: Epinephrine shortages affect nearly all American emergency medical services (EMS) systems. Utilization of expired epinephrine could mitigate this situation in daily EMS operations. Concerns about using expired medications include sterility, potency, and potential harmful chemical decay byproducts. There are no cross-platform analyses of sterility and chemical purity of multiple samples of expired parenteral epinephrine. We hypothesized that epinephrine injections will remain sterile and will retain their active ingredient's content for more than 30months past expiration. Methods: Six parenteral epinephrine prefilled syringes, 1mg/10mL, with an expiration date of January 1, 2012 had been stored in the climate controlled setting of a hospital inpatient pharmacy where they remained until they were taken for chemical or microbial analysis 30months after expiration. An unexpired parenteral epinephrine prefilled syringe content was used as a control. Contents of three separate syringes with expired content from the same lot and one control underwent ultra-high pressure liquid chromatography-mass spectrometry (UHPLC-MS) and nuclear magnetic resonance (NMR) to determine epinephrine content and stability. In parallel, contents of another three expired epinephrine syringes were analyzed for sterility by plating on aerobic, anaerobic, and fungal media in a hospital microbiology laboratory. The aerobic plates were checked for growth in 3days, the anaerobic in 5days, and the fungal in 28days. Results: UHPLC-MS and NMR showed that content of epinephrine present in the original sample remained unchanged compared to the control. There was no statistical difference in the UHPLC-MS and NMR signal amplitudes between the control and the expired samples. No chemical degradation byproducts were detected using NMR. There was no growth of any bacteria or fungus. Conclusion: Recurrent epinephrine shortages impact EMS and hospital operations in the United States. Individual administrators may be hesitant to authorize use of expired pharmaceuticals due to perceived potential complications or fear of litigation. This study shows that the original parenteral epinephrine remains sterile and detectably pure more than 2.5years after expiration. Further study of the sterility and chemical integrity of expired medications that had been subjected to the conditions of EMS vehicles may be a future research endeavor based on the aforementioned paradigm.
机译：目的：肾上腺短缺几乎影响所有美国紧急医疗服务（EMS）系统。过期肾上腺素的利用可以减轻日常EMS运营中的这种情况。关于使用过期药物的担忧包括无菌，效力和潜在的有害化学腐烂副产品。没有跨平台的无菌和化学纯度的多重肠外肾上腺素样品分析。我们假设肾上腺素注射将保持无菌，并将其活跃成分的含量保持超过30个月的到期。方法：六种肠胃外肾上腺素预填充注射器，1mg / 10ml，2012年1月1日到期日期，储存在医院住院药房的气候控制环境中，在其中持续到过期后的30个月，才留下了化学或微生物分析。未过期的肠外肾上腺素预填充注射器含量用作对照。具有来自相同批次的三个单独注射器的含量和一个控制接受超高压液相色谱 - 质谱（UHPLC-MS）和核磁共振（NMR）以确定肾上腺素含量和稳定性。并行地，通过在医院微生物学实验室的有氧，厌氧和真菌介质上进行电镀分析另外三个过期的肾上腺素注射器的含量。有氧板在第三天，在第五天的厌氧和28天的真菌中检查了增长。结果：UHPLC-MS和NMR显示，与对照相比，原始样品中存在的肾上腺素含量保持不变。 UHPLC-MS和控制之间的NMR信号幅度没有统计学差异和过期的样本。使用NMR检测未检测到化学降解副产物。任何细菌或真菌都没有生长。结论：复发性肾上腺素短缺影响美国的影响力和医院业务。由于感知的潜在并发症或对诉讼的恐惧，个人管理人员可能会犹豫才能授权使用过期的药物。本研究表明，在呼气后，原始肠胃外肾上腺素仍然是无菌和可检测的纯度超过2.5年。进一步研究已经受到EMS车辆条件的过期药物的无菌和化学完整性可能是基于上述范式的未来研究努力。

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