Study of leachable compounds in hospital pharmacy-compounded prefilled syringes, infusion bags and vials.
Détails
Télécharger: 39173742.pdf (1999.24 [Ko])
Etat: Public
Version: Final published version
Licence: CC BY 4.0
Etat: Public
Version: Final published version
Licence: CC BY 4.0
ID Serval
serval:BIB_ECDC35D70135
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Study of leachable compounds in hospital pharmacy-compounded prefilled syringes, infusion bags and vials.
Périodique
Journal of pharmaceutical sciences
ISSN
1520-6017 (Electronic)
ISSN-L
0022-3549
Statut éditorial
Publié
Date de publication
11/2024
Peer-reviewed
Oui
Volume
113
Numéro
11
Pages
3227-3237
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Publication Status: ppublish
Résumé
Hospital pharmacy compoundings are crucial for maintaining patient care. They are time- and cost-effective in hospital pharmacy settings because they prevent waste, preparation errors, dosage errors, microbial contamination and breakage due to handling. Unfortunately, the drawbacks of hospital pharmacy compounding include the selection of inappropriate medical devices (MDs) for long-term storage, which could directly impact patients. In this study, three important hospital pharmaceutical compoundings, vancomycin in prefilled syringes (PFSs) made of polypropylene (PP) material, paediatric parenteral nutrition (PN) in ethylene vinyl acetate (EVA) bags and diluted insulin in cyclic olefin copolymer (COC) vials, were selected for leachate study and risk assessment. These compounds were studied via a semiquantitative screening approach by means of an ultrahigh-performance liquid chromatography coupled to high-resolution mass spectrometry (UHPLC-HRMS) with postcolumn infusion and an in-house built database. 17 leachable compounds for the PFS, 25 for the PN, and 10 for the vial were identified, and their concentrations were estimated for toxicological assessments. In conclusion, all MDs used in hospital pharmacy compoundings were observed suitable thanks to risk assessments. However, suitable MDs recommended for long-term storage would remain with polymers like COC, for higher safety when exposed to frail and vulnerable patients like neonates and infants.
Mots-clé
Syringes, Drug Packaging, Pharmacy Service, Hospital, Drug Compounding/methods, Chromatography, High Pressure Liquid/methods, Humans, Insulin/chemistry, Insulin/administration & dosage, Polyvinyls/chemistry, Polypropylenes/chemistry, Drug Contamination/prevention & control, Drug Storage, Hospital pharmacy compounding, Insulin vial, Leachable compounds, Parenteral nutrition, Prefilled syringes, UHPLC-HRMS
Pubmed
Open Access
Oui
Création de la notice
30/08/2024 14:23
Dernière modification de la notice
20/11/2024 7:29