Pharmacy Department, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
School of Pharmacy, University of Birmingham, Birmingham, UK.
Eur J Hosp Pharm. 2023 Mar;30(2):64-69. doi: 10.1136/ejhpharm-2021-002937. Epub 2021 Dec 3.
Outpatient parenteral antimicrobial therapy (OPAT) services using continuous infusions (CIs) of antimicrobial agents in elastomeric devices require evidence of acceptable stability of the agent over the infusion period. A period of refrigerated storage of filled devices, followed by the CI period, is useful for OPAT services but can present a significant challenge to the stability of drugs. The aims of this study were to review fresh-filled stability data on antimicrobials which would be useful for OPAT services and to identify suitable candidates for further assessment.
Searches identified papers relating to stability assessments of antimicrobials for immediate use tested above 31°C using a stability-indicating method.
We identified 18 stability studies published in 12 papers between 2015 and 2020, assessing the stability of 10 agents. Aminopenicillins like ampicillin and amoxicillin appear too unstable for CI, while benzylpenicillin may benefit from buffering to improve its stability. Cephalosporins vary in their stability and CI periods of 24 hours may not be achievable. Of the carbapenems, there are insufficient data for doripenem but meropenem has been extensively studied and is unsuitable for CI longer than 6 hours. Voriconazole may be suitable for CI but needs further investigation.
Some drugs identified in our review are unlikely to be suitable for continuous infusion in OPAT services due to instability. Using a 'fresh-fill' approach, without refrigerated storage, may make some drugs useful while other agents should be considered for further assessment to Yellow Cover Document standards. The impact of buffering for penicillins should be assessed further.
使用弹性装置中抗菌药物连续输注(CI)的门诊患者的肠外抗菌治疗(OPAT)服务需要证明在输注期间药物具有可接受的稳定性。充满设备的冷藏储存期后进行 CI 期,这对 OPAT 服务很有用,但会对药物的稳定性构成重大挑战。本研究的目的是回顾对适合 OPAT 服务的抗菌药物的新鲜填充稳定性数据,并确定进一步评估的合适候选药物。
搜索确定了与立即使用的抗菌药物稳定性评估相关的论文,这些论文使用稳定性指示方法在 31°C 以上进行测试。
我们确定了 2015 年至 2020 年期间发表的 12 篇论文中的 18 项稳定性研究,评估了 10 种药物的稳定性。氨苄西林和阿莫西林等氨基青霉素类药物似乎太不稳定,不适合 CI,而苯唑西林可能需要缓冲以改善其稳定性。头孢菌素的稳定性不同,24 小时的 CI 期可能无法实现。对于碳青霉烯类药物,缺乏多尼培南的数据,但美罗培南已得到广泛研究,不适合超过 6 小时的 CI。伏立康唑可能适合 CI,但需要进一步研究。
由于不稳定性,我们的综述中确定的一些药物不太可能适合 OPAT 服务中的连续输注。使用“新鲜填充”方法,不进行冷藏储存,可能会使一些药物变得有用,而其他药物应根据黄色封面文件标准进行进一步评估。还应进一步评估青霉素缓冲的影响。