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

Lívia P.  MOREIRA; Marjorie M.  GUEDES; Eunice B.  PERRAUD; Arnaldo A.  PEIXOTO-JUNIOR; Eudiana V.  FRANCELINO; Marta F.  FONTELES

doi:10.30968/rbfhss.2023.141.0868

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

Authors

Lívia P. MOREIRA https://orcid.org/0000-0001-6429-2557
Marjorie M. GUEDES https://orcid.org/0000-0001-9215-5701
Eunice B. PERRAUD https://orcid.org/0000-0001-9215-5701
Arnaldo A. PEIXOTO-JUNIOR https://orcid.org/0000-0001-6225-934X
Eudiana V. FRANCELINO https://orcid.org/0000-0001-8814-0128
Marta F. FONTELES https://orcid.org/0000-0002-2570-9265

DOI:

https://doi.org/10.30968/rbfhss.2023.141.0868

Abstract

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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Published

2023-03-31

How to Cite

MOREIRA LP, GUEDES MM, PERRAUD EB, PEIXOTO-JUNIOR AA, FRANCELINO EV, FONTELES MF. Use of off-label drugs and the prevalence of adverse reaction to drugs in the adult intensive care unit of a Brazilian public hospital. Rev Bras Farm Hosp Serv Saude [Internet]. 2023Mar.31 [cited 2024Dec.22];14(1):868. Available from: https://rbfhss.org.br/sbrafh/article/view/868

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Issue

Vol. 14 No. 1 (2023): Jan-Mar

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ORIGINAL ARTICLES

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