• GISELE S LEMOS Department of Social Pharmacy, Federal University of Minas Gerais/UFMG, Belo Horizonte. Brazil.
  • IONARA VR MOTA State University of Southwest Bahia, Jequié, BA, Brazil.
  • MARIO B ROSA Hospital Foundation of the State of Minas Gerais (MG) – FHEMIG, Belo Horizonte, MG, Brazil.
  • EDSON PERINI Department of Social Pharmacy, Federal University of Minas Gerais/UFMG, Belo Horizonte, MG, Brazil.
  • CRISTIANE AM PÁDUA Department of Social Pharmacy, Federal University of Minas Gerais/UFMG, Belo Horizonte, MG, Brazil.


Objective: The objective of the study was to describe the off-label use of antibacterial in prescriptions for hospitalized adult patients as per the Brazilian drug regulatory agency, namely, the National Health Surveillance Agency (ANVISA).

Methods: This is a cross-sectional study with prescriptions for inpatients in a teaching hospital. Data collection and analysis were based on the checklist of the Medicine Prescription, Use and Administration Protocol of the Ministry of Health, where the off-label use is classified as per information of ANVISA’s Electronic Bulletin. Descriptive analyses were performed, and the method of logistic regression was used to evaluate the association between the off-label use of antibacterial and the explanatory variables age, gender, hospitalization clinic, and medical specialty.

Results: About one-third of the antibacterial was prescribed for off-label use, and the frequency of administration was the primary use outside standards established in the products’ licenses (87.3%), and dose (7.4%) and the administration route was next. The third-generation cephalosporin was the most consumed class in this regimen (69.5%). In some cases, the off-label use was not supported by scientific evidence. The off-label use was positively associated with the variables gender (odds ratio [OR] = 2.48; confidence interval [CI] = 1.23–4.92) and the prescribing clinic (OR = 4.94; CI = 2.61–8.96).

Conclusion: Off-label use is a frequent practice in the studied environment, and in the face of a dramatic scenario of increased antibacterial resistance, it is imperative to adopt measures for the standardization of records and the rational use of this class of drugs.

Keywords: Drug prescriptions,, Anti-infective agents,, Drug use,, Patient safety,, Off-label use,, Hospitals.


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