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1802. Off-label Use of Antimicrobial Agents at the University Hospital for Infectious Diseases, Zagreb, Croatia
BACKGROUND: Antimicrobial agents' (AMAs) off-label use can be associated with the prescriber's education. Little is known about the AMAs' off-label use by infectious disease (ID) specialists. We have conducted research at the University Hospital for Infectious Diseases (UHID), Zagreb,...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9752947/ http://dx.doi.org/10.1093/ofid/ofac492.1432 |
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author | Matković, Iva Santini, Marija |
author_facet | Matković, Iva Santini, Marija |
author_sort | Matković, Iva |
collection | PubMed |
description | BACKGROUND: Antimicrobial agents' (AMAs) off-label use can be associated with the prescriber's education. Little is known about the AMAs' off-label use by infectious disease (ID) specialists. We have conducted research at the University Hospital for Infectious Diseases (UHID), Zagreb, Croatia, a 230-bed tertiary center where ID specialists primarily prescribe AMAs. METHODS: A retrospective cross-sectional analysis was conducted on the day with the highest hospitalization number, January 17, 2019. Any use of AMA not complying with the SmPC was considered off-label and evaluated regarding modality (indication, dose, regimen, route of administration, and age) and justification by institutional or/and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guidelines. RESULTS: The study included 155 patients, 63 (40.6%) adults and 92 (59.4%) children. 61 (96.8%) adult patients had at least one AMA. There were 134 AMA prescriptions in adults, 42 (31.3%) off-label. AMAs were most frequently prescribed off-label regarding regimen (21), dose (17), and indication (14). Institutional guidelines justified off-label in 5 cases regarding dose, 4 regarding indication, and 2 regarding regimen. ESCMID guidelines justified off-label prescriptions in 5 cases regarding indication. The rest of the off-label was not supported by the existing guidelines. 60 (65.2%) pediatric patients had at least one AMA. There were 73 prescriptions, 31 (42.5%) off-label. AMAs were most frequently prescribed off-label regarding indication (19), dose (12), and age (2). Institutional guidelines justified 3 off-label cases regarding indication and 1 regarding dose. ESCMID guidelines justified no off-label in children. The lack of guidelines was the leading cause of the off-label AMAs use in children. CONCLUSION: One-third of AMAs are prescribed off-label regarding SmPC by ID specialists. However, institutional and international guidelines can justify part of this use. DISCLOSURES: All Authors: No reported disclosures. |
format | Online Article Text |
id | pubmed-9752947 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-97529472022-12-16 1802. Off-label Use of Antimicrobial Agents at the University Hospital for Infectious Diseases, Zagreb, Croatia Matković, Iva Santini, Marija Open Forum Infect Dis Abstracts BACKGROUND: Antimicrobial agents' (AMAs) off-label use can be associated with the prescriber's education. Little is known about the AMAs' off-label use by infectious disease (ID) specialists. We have conducted research at the University Hospital for Infectious Diseases (UHID), Zagreb, Croatia, a 230-bed tertiary center where ID specialists primarily prescribe AMAs. METHODS: A retrospective cross-sectional analysis was conducted on the day with the highest hospitalization number, January 17, 2019. Any use of AMA not complying with the SmPC was considered off-label and evaluated regarding modality (indication, dose, regimen, route of administration, and age) and justification by institutional or/and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guidelines. RESULTS: The study included 155 patients, 63 (40.6%) adults and 92 (59.4%) children. 61 (96.8%) adult patients had at least one AMA. There were 134 AMA prescriptions in adults, 42 (31.3%) off-label. AMAs were most frequently prescribed off-label regarding regimen (21), dose (17), and indication (14). Institutional guidelines justified off-label in 5 cases regarding dose, 4 regarding indication, and 2 regarding regimen. ESCMID guidelines justified off-label prescriptions in 5 cases regarding indication. The rest of the off-label was not supported by the existing guidelines. 60 (65.2%) pediatric patients had at least one AMA. There were 73 prescriptions, 31 (42.5%) off-label. AMAs were most frequently prescribed off-label regarding indication (19), dose (12), and age (2). Institutional guidelines justified 3 off-label cases regarding indication and 1 regarding dose. ESCMID guidelines justified no off-label in children. The lack of guidelines was the leading cause of the off-label AMAs use in children. CONCLUSION: One-third of AMAs are prescribed off-label regarding SmPC by ID specialists. However, institutional and international guidelines can justify part of this use. DISCLOSURES: All Authors: No reported disclosures. Oxford University Press 2022-12-15 /pmc/articles/PMC9752947/ http://dx.doi.org/10.1093/ofid/ofac492.1432 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Abstracts Matković, Iva Santini, Marija 1802. Off-label Use of Antimicrobial Agents at the University Hospital for Infectious Diseases, Zagreb, Croatia |
title | 1802. Off-label Use of Antimicrobial Agents at the University Hospital for Infectious Diseases, Zagreb, Croatia |
title_full | 1802. Off-label Use of Antimicrobial Agents at the University Hospital for Infectious Diseases, Zagreb, Croatia |
title_fullStr | 1802. Off-label Use of Antimicrobial Agents at the University Hospital for Infectious Diseases, Zagreb, Croatia |
title_full_unstemmed | 1802. Off-label Use of Antimicrobial Agents at the University Hospital for Infectious Diseases, Zagreb, Croatia |
title_short | 1802. Off-label Use of Antimicrobial Agents at the University Hospital for Infectious Diseases, Zagreb, Croatia |
title_sort | 1802. off-label use of antimicrobial agents at the university hospital for infectious diseases, zagreb, croatia |
topic | Abstracts |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9752947/ http://dx.doi.org/10.1093/ofid/ofac492.1432 |
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