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Updated: Jun 26, 2026
11:17
Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
Published on: August 30, 2018
[Off-label antibiotic use: malpractice or good clinical practice?].
L Lazzarin1, P Fabris, A Tramarin
1Unita Operativa di Malattie Infettive e Tropicali, ULSS 6, Ospedale S. Bortolo, Vicenza, Italy.
Le Infezioni in Medicina
|January 22, 2009
Summary
Off-label antibiotic use is common and vital for infectious diseases specialists in Italy, despite legal restrictions. Guidelines should reflect this reality for effective clinical practice.
Area of Science:
- Infectious Diseases
- Pharmacology
- Medical Law
Context:
- Italian law since 1998 restricts off-label drug use, permitting it only for irreplaceable single cases under physician responsibility.
- This study examines the impact of these regulations on infectious diseases specialists in Italy.
- Antibiotic indications in a hospital pharmacy were compared against established clinical guidelines and textbooks.
Purpose:
- To assess the consequences of Italian off-label drug regulations for infectious diseases specialists.
- To determine the extent of off-label antibiotic use in daily clinical practice.
- To evaluate the alignment between current antibiotic indications and recommended treatments for bacterial infections.
Summary:
- A review of intravenous and oral antibiotic indications revealed that standard treatments for several bacterial infections are considered off-label in Italy.
- A panel of nine infectious diseases specialists concluded that some off-label antibiotic use is essential for effective patient care.
- The study highlights a discrepancy between legal restrictions and clinical necessity in antibiotic prescribing.
Impact:
- The findings suggest that current regulations may hinder optimal infectious diseases management.
- There is a need for updated guidelines that acknowledge and incorporate essential off-label antibiotic use.
- This research underscores the importance of balancing legal frameworks with evidence-based clinical practice in infectious diseases.
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