Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Clinical Pharmacy, Drug Production & Compounding Unit, University Medical Center Utrecht, Utrecht University, the Netherlands.
Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht University, the Netherlands; Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands.
Eur J Pharm Sci. 2023 Dec 1;191:106590. doi: 10.1016/j.ejps.2023.106590. Epub 2023 Sep 22.
The availability of ready-to-administer (RTA) syringes for intravenous (IV) drugs facilitates rapid and safe administration in emergency and intensive care situations. Hospital pharmacies can prepare RTA syringes through aseptic batchwise filling. Due to excess production of these RTA syringes for sufficient availability for patient care and their limited (microbiological) shelf-life, waste is unavoidable, which contributes to environmental pollution. RTA prefilled sterilized syringes (PFSSs) have much longer shelf-lives than aseptically prepared RTA syringes and might contribute to reducing drug waste.
This study aimed to evaluate the difference in drug waste between RTA syringes that were prepared through aseptic batchwise filling and RTA PFSSs in the Intensive Care Unit (ICU).
We measured drug waste of RTA syringes over an 8-year time period from August 2015 to May 2023 in the 32-bed ICU of the University Medical Center Utrecht. We distinguished between RTA syringes prepared through aseptic batchwise filling by our hospital pharmacy ("RTA aseptic syringes", shelf-life of 31 days) and RTA PFSSs (shelf-life of 18 months). An intervention group of three drug products that were replaced by PFSSs was compared to a control group of five drug products that were not replaced by PFSSs during the study period. We then defined four different periods within the total study period, based on quarantine time of the RTA aseptic syringes and time of PFSS introduction: 1) no quarantine, 2) 3-day quarantine, 3) 7-day quarantine and 4) PFSS introduction. Our primary endpoint was the number of RTA syringes that was wasted, expressed as the percentage of the total number of syringes dispensed to the ICU in each of these four periods. We used a Kruskall-Wallis test to test if waste percentages differed between time periods in the control and intervention groups, with a post-hoc Dunn's test for pairwise comparisons. Furthermore, we applied two interrupted time series (ITS) analyses to visualize and test the effect of introducing different quarantine times and the PFSSs on waste percentage.
Introduction of PFSSs significantly decreased drug waste of RTA syringes irrespective of drug type in the intervention group, from 31% during the 7-day quarantine period to 5% after introduction of the PFSS (p<0.001). The control group showed no significant decrease in drug waste over the same time periods (from 20% to 16%; p=0.726). We observed a significant difference in the total drug waste of RTA aseptic syringes between time periods, which may be attributed to the implementation of different quality control quarantine procedures. The ITS model of the intervention group showed a direct decrease of 17.7% in waste percentage after the introduction of PFSSs (p=0.083).
Drug waste of RTA syringes for the ICU can be significantly decreased by introducing PFSSs, supporting hospitals to enhance environmental sustainability. Furthermore, the waste percentage of RTA syringes prepared through aseptic batchwise filling is significantly impacted by duration of quarantine time.
静脉（IV）药物的即用型（RTA）注射器的可用性便于在紧急情况和重症监护环境中快速和安全地给药。医院药房可以通过无菌批量填充来制备 RTA 注射器。由于为了满足患者护理的充分可用性而过度生产了这些 RTA 注射器，并且它们的有限（微生物）保质期，浪费是不可避免的，这会造成环境污染。预充式无菌 RTA 注射器（PFSS）的保质期比无菌制备的 RTA 注射器长得多，可能有助于减少药物浪费。
本研究旨在评估重症监护病房（ICU）中通过无菌批量填充制备的 RTA 注射器与 RTA PFSS 之间的药物浪费差异。
我们测量了 2015 年 8 月至 2023 年 5 月期间，在乌得勒支大学医学中心 32 张床位的 ICU 中，RTA 注射器在 8 年内的药物浪费情况。我们通过我们医院的药房区分通过无菌批量填充制备的 RTA 注射器（保质期为 31 天）和 RTA PFSS（保质期为 18 个月）。干预组的三种药物被 PFSS 替代，与研究期间未被 PFSS 替代的五种药物的对照组进行比较。然后，我们根据 RTA 无菌注射器的检疫时间和 PFSS 引入时间，将整个研究期间分为四个不同的时间段：1）无检疫期，2）3 天检疫期，3）7 天检疫期和 4）PFSS 引入期。我们的主要终点是浪费的 RTA 注射器数量，表示为每个时间段内分配给 ICU 的注射器总数的百分比。我们使用 Kruskal-Wallis 检验测试对照组和干预组在不同时间段内的浪费百分比是否存在差异，并用事后检验的 Dunn 检验进行两两比较。此外，我们应用了两个中断时间序列（ITS）分析来可视化和测试引入不同检疫时间和 PFSS 对浪费百分比的影响。
无论药物类型如何，干预组中 PFSS 的引入都显著降低了 RTA 注射器的药物浪费，从 7 天检疫期的 31%降至 PFSS 引入后的 5%（p<0.001）。同一时期，对照组的药物浪费没有显著减少（从 20%降至 16%；p=0.726）。我们观察到 RTA 无菌注射器的总药物浪费在不同时间段之间存在显著差异，这可能归因于实施了不同的质量控制检疫程序。干预组的 ITS 模型显示，PFSS 引入后，浪费百分比直接下降了 17.7%（p=0.083）。
通过引入 PFSS，可以显著减少 ICU 中 RTA 注射器的药物浪费，从而支持医院提高环境可持续性。此外，通过无菌批量填充制备的 RTA 注射器的浪费百分比受检疫时间的持续时间显著影响。
