Van Matre Edward T, Rice Peter J, Wempe Michael F, Lyda Clark, McAlwee Tabetha, Larkin Michael, Kiser Tyree H
University of Missouri School of Medicine, Columbia, MO, USA.
University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.
Hosp Pharm. 2023 Apr;58(2):205-211. doi: 10.1177/00185787221130229. Epub 2022 Nov 9.
Vasopressin is frequently utilized for a variety of shock states in critically ill patients. Short stability (≤24 hours) after intravenous admixture with current manufacturer labeling requires just in time preparation and may lead to delays in therapy and increased medication waste. We aimed to evaluate vasopressin stability in 0.9% sodium chloride stored in polyvinyl chloride bags and polypropylene syringes for up to 90 days. Additionally, we evaluated the impact of extended stability on the time to administration and cost savings from reduced medical waste at an academic medical center. Dilutions of vasopressin to concentrations of 0.4 and 1.0 unit/mL were performed under aseptic conditions. The bags and syringes were stored at room temperature (23°C-25°C) or under refrigeration (3°C-5°C). Three samples of each preparation and storage environment were analyzed on days 0, 2, 14, 30, 45, 60, and 90. Physical stability was performed by visual examination. The pH was assessed at each point and upon final degradation evaluation. Sterility of the samples was not assessed. Chemical stability of vasopressin was evaluated using liquid chromatography with tandem mass spectrometry. Samples were considered stable if there was <10% degradation of the initial concentration. Vasopressin diluted to 0.4 and 1.0 unit/mL with 0.9% sodium chloride injection was physically stable throughout the study. No precipitation was observed. At days 2, 14, 30, 45, 60, and 90 all bags and syringes diluted to 0.4 units/mL had <10% degradation. Vasopressin diluted to 1 unit/mL and stored under refrigeration had <10% degradation at all measured days, but when stored under room temperature was found to have >10% degradation at day 30. Implementation of a batching process resulted in reduced waste ($185 300) and improved time to administration (26 vs 4 minutes). Vasopressin diluted to a concentration of 0.4 units/mL with 0.9% sodium chloride injection is stable for 90 days at room temperature and under refrigeration. When diluted to 1.0 unit/mL with 0.9% sodium chloride injection it is stable for 90 days under refrigeration. Use of extended stability and sterility testing to batch prepare infusions may lead to improved time to administration and cost savings from reduced medication waste.
血管加压素常用于危重症患者的多种休克状态。根据目前制造商的标签，静脉混合后稳定性较短（≤24小时），这需要即时配制，可能导致治疗延误和药物浪费增加。我们旨在评估血管加压素在储存在聚氯乙烯袋和聚丙烯注射器中的0.9%氯化钠溶液中的稳定性，最长可达90天。此外，我们还评估了在一所学术医疗中心延长稳定性对给药时间的影响以及减少医疗废物所节省的成本。在无菌条件下将血管加压素稀释至0.4和1.0单位/毫升的浓度。袋子和注射器储存在室温（23°C - 25°C）或冷藏（3°C - 5°C）条件下。在第0、2、14、30、45、60和90天对每种制剂和储存环境的三个样本进行分析。通过目视检查评估物理稳定性。在每个时间点以及最终降解评估时测定pH值。未评估样本的无菌性。使用液相色谱 - 串联质谱法评估血管加压素的化学稳定性。如果初始浓度降解<10%，则认为样本稳定。在整个研究过程中，用0.9%氯化钠注射液稀释至0.4和1.0单位/毫升的血管加压素物理性质稳定。未观察到沉淀。在第2、14、30、45、60和90天，所有稀释至0.4单位/毫升的袋子和注射器降解<10%。稀释至1单位/毫升并冷藏储存的血管加压素在所有测量天数降解<10%，但室温储存时在第30天发现降解>10%。实施批量配制过程减少了浪费（185300美元）并缩短了给药时间（从26分钟缩短至4分钟）。用0.9%氯化钠注射液稀释至0.4单位/毫升浓度的血管加压素在室温和冷藏条件下90天稳定。用0.9%氯化钠注射液稀释至1.0单位/毫升时在冷藏条件下90天稳定。利用延长的稳定性和无菌测试进行批量配制输液可能会缩短给药时间并因减少药物浪费而节省成本。
