Rx Note

Introduction Off-label use is the use of pharmaceutical drugs For an unapproved indication or In an unapproved age group, dosage or route of administration In clinical practice, unlicensed or off-label drug use occurs across all medical specialties and is more prevalent in areas where patient populations are less likely to be included in clinical trials (e.g. paediatric, pregnant, or psychiatric) due to ethical reasons. Indeed, off-label drug uses can become standard practices and even predominate as treatments for specific conditions. Nevertheless, pharmaceutical companies may be reluctant to invest in additional regulatory approvals due to the associated costs, especially if the anticipated financial return is insufficient. This is particularly true for low-cost drugs, those with generic or biosimilar alternatives, or medications prescribed to a small patient population. Even without updated product information, off-label prescribing will still occur in hospitals when supported by ...