Ethical Issues Regarding Off - Label Administration of Antibiotics
Ethical Issues Regarding Off - Label Administration of Antibiotics

Summary/Abstract: Off-label administration of a drug (uses not included in the approved product labeling regarding indications, patient populations, doses or routes of administrations) is generally accepted, but is not regulated in the legislation in Romania, nor in the European Union.Starting from the classic example of the use of acetylasliclic acid in cardiology, many cases of off- label administration are already well known and practiced, reaching 40% cases in adults and even up to 90% cases in children. At the same time, antibiotic therapy is another example for off-label use, especially in the critically ill patients, where the increased incidence of infections with multidrug-resistant agents is one of the most common causes of antibiotic administration outside the authorized indications, when there are no therapeutic alternatives. However, the use of off - label antibiotics could be a cause of ethical concern, especially in vulnerable patients (children, elderly, pregnant women). Most of the time, many factors that could affect the efficacy, but especially the safety of off-label treatment have not been studied in the special categories of patients (pharmacokinetic / pharmacodynamic particularities, drug interactions, comorbidities).For this reason, in order to ensure a safe and ethical antibiotic treatment, without inducing an increase in the risk of antibacterial resistance, the clinical decision must be based on relevant scientific evidence, after a proper evaluation of the risk-benefit ratio and in accordance with the specific guidelines.

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