[Off-label prescriptions of systemic antifungals in 2024 in the Auvergne-Rhône-Alpes region].

OBJECTIVES

Systemic antifungals are frequently prescribed off-label, raising concerns regarding safety, equitable access to health care, and control of health expenditure. The aim of this study was to analyze off-label prescriptions of systemic antifungals in order to update the off-label indications thesaurus and ensure appropriate patient management.

METHODS

Off-label prescriptions of liposomal amphotericin B, voriconazole, isavuconazole, and micafungin reported by healthcare institutions in the Auvergne-Rhône-Alpes (ARA) region as part of prospective monitoring of indications, along with their bibliographic justifications, were analyzed by the Regional Group for the Appropriate Use of Antifungals (GréBA).

RESULTS

One hundred eighty-one (n=181) off-label treatment initiations were reported in the ARA region that represents 20.9% (181/868) of systemic antifungal prescriptions. The majority, 66% (n=119), corresponded to a positioning listed in the thesaurus, including a reference from it. In 18% of cases (n=32), the positioning was justified, but the references used were not derived from the thesaurus. The remaining prescriptions concerned insufficiently documented situations, unjustified cases, or indications already covered by an existing marketing authorization. Finally, 1% (n=2) of prescriptions corresponded to a justified positioning including a reference that enabled an update of the thesaurus.

CONCLUSIONS

The analysis of off-label prescriptions in the ARA region highlights a high rate of bibliographic justification in off-label prescriptions. The off-label indications thesaurus was updated based on the analysis of these prescriptions.