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A systematic review and meta-analysis of the risk of microbial contamination of aseptically prepared doses in different environments

A systematic review and meta-analysis of the risk of microbial contamination of aseptically prepared doses in different environments
A systematic review and meta-analysis of the risk of microbial contamination of aseptically prepared doses in different environments
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.
0022-3549
233-242
Austin, Peter
6c773e56-407c-47e5-a957-4b102e6fbb68
Elia, Marions
964bf436-e623-46d6-bc3f-5dd04c9ef4c1
Austin, Peter
6c773e56-407c-47e5-a957-4b102e6fbb68
Elia, Marions
964bf436-e623-46d6-bc3f-5dd04c9ef4c1

Austin, Peter and Elia, Marions (2009) A systematic review and meta-analysis of the risk of microbial contamination of aseptically prepared doses in different environments. Journal of Pharmaceutical Sciences, 12 (2), 233-242.

Record type: Article

Abstract

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.

Full text not available from this repository.

More information

Published date: 27 August 2009
Additional Information: ejournals.library.ualberta.ca/index.php/JPPS/article/view/6402/5466
Organisations: Dev Origins of Health & Disease

Identifiers

Local EPrints ID: 153623
URI: https://eprints.soton.ac.uk/id/eprint/153623
ISSN: 0022-3549
PURE UUID: 0f1f30ef-c12d-4030-a589-f45ea59cd8e2

Catalogue record

Date deposited: 21 May 2010 09:06
Last modified: 18 Jul 2017 12:48

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