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Y 型接口儿科给药的物理相容性:对美国药典标准提出质疑

Physical Compatibility of Y-site Pediatric Drug Administration: A Call for Question of US Pharmacopeia Standards.

作者信息

Ross Emma L, Petty Kirsten, Salinas Allison, Bremmer Jarrett, Her Cheng, Carpenter John F

机构信息

Department of Pharmacy (ELR, KP, AS), Children's Hospital Colorado, Aurora, CO.

Department of Pharmacy (JB), University of Colorado Skaggs School of Pharmacy and Pharmaceutical Science, Aurora, CO.

出版信息

J Pediatr Pharmacol Ther. 2023;28(1):84-92. doi: 10.5863/1551-6776-28.1.84. Epub 2023 Feb 3.

Abstract

OBJECTIVE

To evaluate the physical intravenous Y-site compatibility of 29 combinations of medications at commonly used pediatric concentrations using both existing and novel techniques.

METHODS

Medication combinations included were selected by a varied group of pediatric inpatient pharmacists, and then assessed by 3 independent reviewers for existing literature. For each combination, 2 different medications were mixed together in a 1:1 ratio and incubated at room temperature for 4 hours to simulate Y-site administration. Each sample was then analyzed using the US Pharmacopeia (USP) <788> recommended analytical technique of light obscuration (LO) in addition to novel flow imaging (FI) microscopy and backgrounded membrane imaging (BMI). Physical compatibility was determined using USP chapter <788> large volume particle count limits for all techniques.

RESULTS

A total of 29 different medication combinations were studied. Five combinations met criteria for compatibility by all 3 techniques. The remaining 24 combinations reached the threshold to be considered incompatible by at least 1 of the 3 techniques. Light obscuration, BMI, and FI identified 14%, 59%, and 76% of combinations as incompatible, respectively. All samples deemed incompatible by LO were also incompatible by at least 1 of the other 2 techniques. Flow imaging and BMI results agreed in 69% of samples tested.

CONCLUSIONS

Most combinations tested were found to be incompatible by at least 1 of the 3 instruments used. Light obscuration appears to have reduced accuracy for identifying particulate resulting in physical medication incompatibility when compared with the novel techniques of FI and BMI.

摘要

目的

运用现有技术和新技术,评估29种常用儿科浓度药物组合在静脉Y型接口处的物理相容性。

方法

药物组合由不同的儿科住院药师团队选定,然后由3名独立评审员评估现有文献。对于每种组合,将2种不同药物按1:1比例混合,在室温下孵育4小时以模拟Y型接口给药。然后,除了采用新型流动成像(FI)显微镜和背景膜成像(BMI)外,每个样品还使用美国药典(USP)<788>推荐的光阻法(LO)分析技术进行分析。所有技术均使用USP第<788>章大容量颗粒计数限值来确定物理相容性。

结果

共研究了29种不同的药物组合。5种组合在所有3种技术下均符合相容性标准。其余24种组合至少在3种技术中的1种下达到了被视为不相容的阈值。光阻法、BMI和FI分别将14%、59%和76%的组合鉴定为不相容。所有被光阻法判定为不相容的样品在其他2种技术中至少有一种下也不相容。流动成像和BMI结果在69%的测试样品中一致。

结论

在所使用的3种仪器中,至少有1种仪器检测到大多数测试组合不相容。与FI和BMI等新技术相比,光阻法在识别导致药物物理不相容的颗粒方面准确性似乎较低。

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