Microbial Contamination of Infusion Fluids Arising from Drug Additions and Administration

Ernerot, L; Thoren, Sone; Sandell, E

doi:10.1177/106002807300701204

Cited by 4 publications

(14 citation statements)

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“…Ten studies involved doses that had been sampled during (27) or after (15, 16,18,22,23,29,35,38,42) administration. Eight of these were prepared in a clinical environment (15, 16,18,22,23,27,38,42) (total combined N = 2976), and two in a pharmaceutical environment (29,35) (total combined N = 226).…”

Section: Individual Dosesmentioning

confidence: 99%

“…Eight of these were prepared in a clinical environment (15, 16,18,22,23,27,38,42) (total combined N = 2976), and two in a pharmaceutical environment (29,35) (total combined N = 226). Contamination was greater in those doses prepared in a clinical environment rather than a pharmaceutical environment but there were large overlapping confidence intervals which would preclude significant differences (point estimates 0.050 (95% CI 0.018, 0.131) vs 0.035 (95% CI 0.014, 0.085).…”

Section: Individual Dosesmentioning

confidence: 99%

“…Five of these were batch doses prepared in a clinical environment (17,19,20,22,30) (total combined N = 2096) and one study considered batch doses prepared in a pharmaceutical environment (43) (N = 1002). Those doses prepared in a clinical environment were sampled immediately after preparation or after storage for up to 8 days.…”

Section: Batch Dosesmentioning

confidence: 99%

“…The contamination rates of the other two individual dose studies were not significantly different from that of the batch study. One of these was a small study involving only 50 doses (p = 0.133) (22) and therefore the comparison lacked power, and the other was a larger study with no contamination (p = 0.868) (20). The variability between clinical studies was confirmed by the heterogeneity statistic (I 2 = 96%), in contrast to the single pharmaceutical study which lacks heterogeneity (I 2 = 0%).…”

Section: Batch Dosesmentioning

confidence: 99%

“…The only study that compared these in a clinical environment used a different methodology in each setting (22).…”

Section: Hypothesis 2 (Individual V Batch Preparation Of Doses)mentioning

confidence: 99%

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A Systematic Review and Meta-Analysis of the Risk of Microbial Contamination of Aseptically Prepared Doses in Different Environments

Austin

Elia

2009

J Pharm Pharm Sci

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Purpose. To review microbial contamination rates about preparation of individual and batch doses using aseptic techniques within pharmaceutical (controlled) and clinical (ward and theatre) environments. Methods. Systematic review, involving amalgamation of data using a random effect model and metaanalysis. Results. A total of 19 studies from 17 reports (7277 doses), mostly single arm studies, were identified for analysis. The overall contamination rates for doses prepared in clinical environments were found to be 5.0% (95% CI; 1.8%, 13.1%, n = 8 studies) for individual doses and 2.0% (95% CI; 0.3%, 13.1%; n = 5) for doses prepared as part of a batch. Rates for doses prepared in pharmaceutical environments were found to be 1.9% (95% CI; 0.8%, 4.2%; n = 5) for individual doses and 0.0% (95% CI; 0.0%, 0.8%; n= 1) for doses prepared as part of a batch. The results indicate greater overall contamination rates of doses prepared in clinical than pharmaceutical environments, in those prepared individually than in batch preparation, and in those in which additions rather than no additions were made. Significant differences were only found between pharmaceutical and clinical environments for batch doses, and between batch and individual doses prepared in a pharmaceutical environment. The studies differed substantially in sample size, interventions and comparison conditions, especially in the clinical setting. The quality of the data was judged to be low. Conclusion. Contamination rates in clinical and pharmaceutical environments were commonly found to be unacceptably high. Intuitive recommendations for reducing contamination rates by carrying out the procedures in a pharmaceutical environment using batch doses are supported by an evidence base that needs to be strengthened further. ________________________________________________________________________________

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