Hopkins James N, Waldman Michael, Sahai Raghvendra, Battle Jason
Vanderbilt University Medical Center, Nashville, TN, USA.
ARL-EuTech Scientific Services, Mount Oliver, NJ, USA.
SAGE Open Med. 2024 Feb 26;12:20503121241230449. doi: 10.1177/20503121241230449. eCollection 2024.
Impact of drug wastage is a legitimate and persistent concern. Financial impact of drug waste is borne by the hospital network, patients, and healthcare systems. Measures to reduce drug wastage may have a positive impact throughout healthcare systems.
This study investigated the stability and sterility of single-dose vials when repeatedly accessed with a closed system transfer device. By evaluating the sterility and stability, these results may be used to validate the extension of vial usage and lead to potential drug wastage reduction.
Sterility testing was performed in accordance with US Pharmacopeia 71. A closed system transfer device was incorporated into simulated compounding tasks, utilizing growth media. Simulated compounding tasks were performed in the clinical environment, followed by incubation to stimulate growth. Stability testing was performed in accordance with US Pharmacopeia monographs at multiple timepoints post access. Test samples were comparatively tested via high-performance liquid chromatography to freshly opened vials at each timepoint.
No growth was observed in test samples. Control vials displayed growth, where appropriate. The drugs retained stability, when compared to freshly opened vials at 0, 24, 48, and 72 h, post access.
This study confirms that closed system transfer devices do not contribute to microbial contamination of drug vials, following the repeated access, for up to 7 days and the tested drugs retained equivalent chemical stability for up to 72 h post access. This study may offer a manner by which a facility may assess single-dose vials' sterility and stability, following repeated access by a closed system transfer device.
药物浪费的影响是一个合理且长期存在的问题。医院网络、患者和医疗保健系统都承担着药物浪费的经济影响。减少药物浪费的措施可能会对整个医疗保健系统产生积极影响。
本研究调查了使用封闭系统转移装置反复取用单剂量瓶时的稳定性和无菌性。通过评估无菌性和稳定性，这些结果可用于验证延长药瓶使用期限，并可能减少潜在的药物浪费。
按照美国药典71进行无菌测试。将封闭系统转移装置纳入使用生长培养基的模拟配药任务中。在临床环境中执行模拟配药任务，然后进行培养以刺激生长。在取用后的多个时间点按照美国药典专论进行稳定性测试。通过高效液相色谱法将测试样品与每个时间点新开封的药瓶进行对比测试。
测试样品中未观察到生长。对照药瓶在适当情况下显示有生长。与取用后0、24、48和72小时新开封的药瓶相比，药物保持了稳定性。
本研究证实，使用封闭系统转移装置反复取用单剂量瓶后长达7天，不会导致药瓶受到微生物污染，并且测试药物在取用后长达72小时内保持了同等的化学稳定性。本研究可能为医疗机构提供一种评估封闭系统转移装置反复取用后单剂量瓶无菌性和稳定性的方法。
