Prescription et dispensation de médicaments en dehors des recommandations du dossier d’autorisation de mise sur le marché. Responsabilités des praticiens. L’exemple des fluoroquinolones

Abstract

Some complaints were filed in 2023 by several patients, victims of serious adverse effects related to treatment with fluoroquinolones. These procedures thus raise questions about the possible consequences of the choice to prescribe and dispense therapeutics outside the recommendations of the indications in the marketing authorization dossier and the health safety agencies. In terms of indemnity liability, prescribing and dispensing antibiotic therapy require to explain potentially serious adverse events such as tendinopathy or neuropsychic impairment, in the respect of law. In this case, the decision to undertake a therapy that is not completely proven or that presents significant health risks will involve to consider all available options, on the basis of clinical documentation validated and recognized by the entire scientific community.