Review of studies examining microbial contamination of vials used for preparations done with closed-system drug transfer devices.
beyond-use date
closed-system drug transfer device
compounding
conventional system, hazardous drugs
preparations
Journal
European journal of hospital pharmacy : science and practice
ISSN: 2047-9956
Titre abrégé: Eur J Hosp Pharm
Pays: England
ID NLM: 101578294
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
25
02
2019
revised:
05
04
2019
accepted:
08
04
2019
entrez:
20
2
2021
pubmed:
21
2
2021
medline:
2
4
2022
Statut:
ppublish
Résumé
The main objective was to identify all studies that present data regarding microbial contamination of vials used for preparation with closed-system drug transfer devices (CSTDs). Our secondary objective was to compare the reported contamination of vials punctured with a CSTD versus no CSTD and to evaluate the quality of data reporting as defined by the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria. A literature review was conducted on 31 December 2018 on PubMed, EMBASE and Cumulative Index to Nursing and Allied Health Literature. A manual search of the archives of relevant pharmaceutical conferences was made. All studies that presented data about microbial contamination of vials punctured with a CSTD or about beyond-use date extension were included. Two researchers independently graded the articles according to the STROBE criteria. Of the 280 articles identified initially, 12 were retained for analysis. Studies evaluated microbial contamination according to different incubation times and different culture media. Nine studies did not use any comparator group. Five studies found no contamination of vials punctured with CSTDs. For the others, the contamination was between 0.3% and 27%. Three studies compared the contamination of vials punctured with a CSTD and with a conventional system and did not show a significant difference between the groups. Seven studies declared a conflict of interest. The mean number of STROBE criteria fulfilled was 12.2±4.1 out of 34 (7 not applicable) for studies, and the mean number was 5±0 out of 12 for abstracts. Vials punctured in ISO5 conditions with a CSTD presented a low frequency of microbial contamination. No study showed a significant difference between vials punctured with a CSTD and with a conventional method. Centre-specific sterility testing is needed to reflect the variability of handling procedures and equipment.
Identifiants
pubmed: 33608432
pii: ejhpharm-2019-001913
doi: 10.1136/ejhpharm-2019-001913
pmc: PMC7907703
doi:
Substances chimiques
Antineoplastic Agents
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
65-70Informations de copyright
© European Association of Hospital Pharmacists 2021. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Am J Health Syst Pharm. 2014 Mar 15;71(6):476-81
pubmed: 24589539
Am J Vet Res. 2018 Jul;79(7):704-710
pubmed: 29943636
J Hosp Infect. 2015 Dec;91(4):306-18
pubmed: 26164526
J Oncol Pharm Pract. 2013 Dec;19(4):338-47
pubmed: 23975556
Drugs R D. 2013 Mar;13(1):1-8
pubmed: 23526368
J Oncol Pract. 2012 Jul;8(4):e45-9
pubmed: 23180998
Asian Pac J Cancer Prev. ;17(11):4951-4957
pubmed: 28032722
Am J Health Syst Pharm. 2007 Apr 15;64(8):837-41
pubmed: 17420200
Int J Pharm Compd. 2016 Mar-Apr;20(2):148-54
pubmed: 27323425
Eur J Clin Pharmacol. 2019 May;75(5):609-617
pubmed: 30683970
Lett Appl Microbiol. 2008 Dec;47(6):543-8
pubmed: 19120923
Am J Health Syst Pharm. 2009 Nov 15;66(22):2032-6
pubmed: 19890087
Am J Health Syst Pharm. 2005 Nov 15;62(22):2386-92
pubmed: 16278330
PLoS Med. 2007 Oct 16;4(10):e297
pubmed: 17941715