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Systematic review and meta-analysis of the risk of microbial contamination of parenteral doses prepared under aseptic techniques in clinical and pharmaceutical environments: an update

Systematic review and meta-analysis of the risk of microbial contamination of parenteral doses prepared under aseptic techniques in clinical and pharmaceutical environments: an update
Systematic review and meta-analysis of the risk of microbial contamination of parenteral doses prepared under aseptic techniques in clinical and pharmaceutical environments: an update
Background

Administration of parenteral doses with microbial contamination can lead to infective morbidity or death.
Aim

To test whether aseptic preparation of parenteral doses or additives to sterile doses undertaken in dedicated pharmaceutical rather than clinical environments reduces the risk of microbial dose contamination.

Methods

Data identified from a systematic review were examined using random effects meta-analyses, and t-tests were used to compare dose contamination frequencies.

Findings

In all, 16,552 doses from 34 studies (33 records) were identified. For all the data combined there was a significantly higher frequency of contamination of doses prepared in clinical than in pharmaceutical environments {3.7% [95% confidence interval (CI): 2.2, 6.2; N = 10,272 doses] vs 0.5% (95% CI: 0.1, 1.6; N = 6280 doses); P = 0.007}. Contamination of doses was significantly higher when prepared as individual lots than as part of a batch in pharmaceutical environments [2.1% (95% CI: 0.7, 5.8; N = 168 doses) vs 0.2% (95% CI: 0.1, 0.9; N = 6112 doses); P = 0.002]. There was a significantly higher frequency of dose contamination if additions were made to sterile parenteral doses in clinical environments [risk ratio: 2.121 (95% CI: 1.093, 4.114); P = 0.026]. The overall quality of the studies was judged to be low.

Conclusion

Reported rates of parenteral dose contamination were orders of magnitude higher than accepted reference standards, which may increase infection risk. The limited evidence on contamination rates supports dose preparation in pharmaceutical rather than clinical environments, and does not support batch preparation in clinical environments.
aseptic, batch, contamination, environment, individual lots
0195-6701
1-33
Austin, P.D.
6c773e56-407c-47e5-a957-4b102e6fbb68
Hand, K.S.
d56a252b-540e-4a21-994d-1372c745670d
Elia, M.
964bf436-e623-46d6-bc3f-5dd04c9ef4c1
Austin, P.D.
6c773e56-407c-47e5-a957-4b102e6fbb68
Hand, K.S.
d56a252b-540e-4a21-994d-1372c745670d
Elia, M.
964bf436-e623-46d6-bc3f-5dd04c9ef4c1

Austin, P.D., Hand, K.S. and Elia, M. (2015) Systematic review and meta-analysis of the risk of microbial contamination of parenteral doses prepared under aseptic techniques in clinical and pharmaceutical environments: an update. Journal of Hospital Infection, 1-33. (doi:10.1016/j.jhin.2015.04.007).

Record type: Article

Abstract

Background

Administration of parenteral doses with microbial contamination can lead to infective morbidity or death.
Aim

To test whether aseptic preparation of parenteral doses or additives to sterile doses undertaken in dedicated pharmaceutical rather than clinical environments reduces the risk of microbial dose contamination.

Methods

Data identified from a systematic review were examined using random effects meta-analyses, and t-tests were used to compare dose contamination frequencies.

Findings

In all, 16,552 doses from 34 studies (33 records) were identified. For all the data combined there was a significantly higher frequency of contamination of doses prepared in clinical than in pharmaceutical environments {3.7% [95% confidence interval (CI): 2.2, 6.2; N = 10,272 doses] vs 0.5% (95% CI: 0.1, 1.6; N = 6280 doses); P = 0.007}. Contamination of doses was significantly higher when prepared as individual lots than as part of a batch in pharmaceutical environments [2.1% (95% CI: 0.7, 5.8; N = 168 doses) vs 0.2% (95% CI: 0.1, 0.9; N = 6112 doses); P = 0.002]. There was a significantly higher frequency of dose contamination if additions were made to sterile parenteral doses in clinical environments [risk ratio: 2.121 (95% CI: 1.093, 4.114); P = 0.026]. The overall quality of the studies was judged to be low.

Conclusion

Reported rates of parenteral dose contamination were orders of magnitude higher than accepted reference standards, which may increase infection risk. The limited evidence on contamination rates supports dose preparation in pharmaceutical rather than clinical environments, and does not support batch preparation in clinical environments.

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More information

Accepted/In Press date: 2 April 2015
e-pub ahead of print date: 1 May 2015
Keywords: aseptic, batch, contamination, environment, individual lots
Organisations: NIHR Southampton Biomedical Research Centre, Faculty of Medicine, Faculty of Health Sciences

Identifiers

Local EPrints ID: 376908
URI: http://eprints.soton.ac.uk/id/eprint/376908
ISSN: 0195-6701
PURE UUID: d7902743-a40b-40b8-b66c-32d30e9f2d0a

Catalogue record

Date deposited: 12 May 2015 15:42
Last modified: 19 Jul 2019 20:45

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