Use of off-label drugs and the prevalence of adverse reaction to drugs in the adult intensive care unit of a Brazilian public hospital

Objective: To Identify the occurrence of adverse reactions to medications (ADR) in patients using off-label prescriptions admitted in an adult intensive care unit (ICU). Methods: Cross-sectional and prospective study evaluated the use of off-label medications and the appearance of ADR in an adult c...

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Main Authors: Lívia P. MOREIRA, Marjorie M. GUEDES, Eunice B. PERRAUD, Arnaldo A. PEIXOTO-JUNIOR, Eudiana V. FRANCELINO, Marta F. FONTELES
Format: Article
Language:English
Published: Sociedade Brasileira de Farmácia Hospitalar e Serviços de Saúde 2023-03-01
Series:Revista Brasileira de Farmácia Hospitalar e Serviços de Saúde
Online Access:https://rbfhss.org.br/sbrafh/article/view/868
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author Lívia P. MOREIRA
Marjorie M. GUEDES
Eunice B. PERRAUD
Arnaldo A. PEIXOTO-JUNIOR
Eudiana V. FRANCELINO
Marta F. FONTELES
author_facet Lívia P. MOREIRA
Marjorie M. GUEDES
Eunice B. PERRAUD
Arnaldo A. PEIXOTO-JUNIOR
Eudiana V. FRANCELINO
Marta F. FONTELES
author_sort Lívia P. MOREIRA
collection DOAJ
description Objective: To Identify the occurrence of adverse reactions to medications (ADR) in patients using off-label prescriptions admitted in an adult intensive care unit (ICU). Methods: Cross-sectional and prospective study evaluated the use of off-label medications and the appearance of ADR in an adult clinical ICU of a Brazilian hospital from March to Aug/2018. The prescriptions were classified as label, off-label, and unlicensed, and the NARANJO algorithm assessed ADR occurrence. The suspected cases of ADR were separated into label and off-label. Results: The prevalence of off-label use was 73.0%, with 73.9% prescribed after admission to the ICU. Regarding the category of off-label use, 23.6% were due to the volume of the diluent. The predominant drug classification was systemic antimicrobials, accounting for 16.8%. The PHD represented 68.7% of the off-label medicines. Sixty suspected ADR were identified in 26 patients registered with suspected ADRs, from that 85.0% resulted from the use of off-label medications. The most prevalent reactions were classified as probable (81.7%), and diarrhoea was the most frequent symptom. There was a significant association between the use of off-label drugs, PHD prescriptions, and the occurrence of ADR (p <0.05).Conclusion: The findings showed that the event of ADR was higher among off-label drugs and PHD prescriptions.
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spelling doaj.art-318eb20e069f4643b19a0c81d6bae3642023-03-31T23:20:28ZengSociedade Brasileira de Farmácia Hospitalar e Serviços de SaúdeRevista Brasileira de Farmácia Hospitalar e Serviços de Saúde2179-59242316-77502023-03-0114110.30968/rbfhss.2023.141.0868Use of off-label drugs and the prevalence of adverse reaction to drugs in the adult intensive care unit of a Brazilian public hospitalLívia P. MOREIRAMarjorie M. GUEDESEunice B. PERRAUDArnaldo A. PEIXOTO-JUNIOREudiana V. FRANCELINOMarta F. FONTELES Objective: To Identify the occurrence of adverse reactions to medications (ADR) in patients using off-label prescriptions admitted in an adult intensive care unit (ICU). Methods: Cross-sectional and prospective study evaluated the use of off-label medications and the appearance of ADR in an adult clinical ICU of a Brazilian hospital from March to Aug/2018. The prescriptions were classified as label, off-label, and unlicensed, and the NARANJO algorithm assessed ADR occurrence. The suspected cases of ADR were separated into label and off-label. Results: The prevalence of off-label use was 73.0%, with 73.9% prescribed after admission to the ICU. Regarding the category of off-label use, 23.6% were due to the volume of the diluent. The predominant drug classification was systemic antimicrobials, accounting for 16.8%. The PHD represented 68.7% of the off-label medicines. Sixty suspected ADR were identified in 26 patients registered with suspected ADRs, from that 85.0% resulted from the use of off-label medications. The most prevalent reactions were classified as probable (81.7%), and diarrhoea was the most frequent symptom. There was a significant association between the use of off-label drugs, PHD prescriptions, and the occurrence of ADR (p <0.05).Conclusion: The findings showed that the event of ADR was higher among off-label drugs and PHD prescriptions. https://rbfhss.org.br/sbrafh/article/view/868
spellingShingle Lívia P. MOREIRA
Marjorie M. GUEDES
Eunice B. PERRAUD
Arnaldo A. PEIXOTO-JUNIOR
Eudiana V. FRANCELINO
Marta F. FONTELES
Use of off-label drugs and the prevalence of adverse reaction to drugs in the adult intensive care unit of a Brazilian public hospital
Revista Brasileira de Farmácia Hospitalar e Serviços de Saúde
title Use of off-label drugs and the prevalence of adverse reaction to drugs in the adult intensive care unit of a Brazilian public hospital
title_full Use of off-label drugs and the prevalence of adverse reaction to drugs in the adult intensive care unit of a Brazilian public hospital
title_fullStr Use of off-label drugs and the prevalence of adverse reaction to drugs in the adult intensive care unit of a Brazilian public hospital
title_full_unstemmed Use of off-label drugs and the prevalence of adverse reaction to drugs in the adult intensive care unit of a Brazilian public hospital
title_short Use of off-label drugs and the prevalence of adverse reaction to drugs in the adult intensive care unit of a Brazilian public hospital
title_sort use of off label drugs and the prevalence of adverse reaction to drugs in the adult intensive care unit of a brazilian public hospital
url https://rbfhss.org.br/sbrafh/article/view/868
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